State Operations Manual, Chapter 2 the Certification Process

State Operations Manual

Chapter 2 - The Certification Process

Table of Contents

(Rev. 224; Issued: 06-28-24)

Transmittals for Chapter 2

Identification of Providers and Suppliers and Related Pre-Survey Activities

2000 - Certification Surveys - Citations and Responsibility

2002 - Meaning of Providers and Suppliers

2003 - SA Identification of Potential Providers and Suppliers

2003A - Assisting Applicant Providers and Suppliers

2003B - Initial Certification “Kits”

2003C - Deemed Status Providers/Suppliers, Excluding CLIA

2004 - Provider-Based Determinations

2005 - Medicare Health Care Provider/Supplier Enrollment

2005A - Approval or Denial

2005A1 - Enrollment Denial Based on MAC Review

2005A2 - Approval or Denial of Certification Based on Survey

Findings

2005A3 - Reconsideration of Denial

2005A4 - Deemed Providers/Suppliers, Excluding CLIA

2005B - Deemed Providers/Suppliers Except CLIA - Additional Information

2005C - Clinical Laboratory Improvement Amendments of 1988 (CLIA)

Laboratories

2005D - Supplementary Applications

2005D1 - Forms CMS-855A or the CMS-855B for Changes in

Provider/Supplier Information

2005D2 - Form CMS-855R

2005E - Changes of Ownership

2005E1 - CHOW Occurs

2005E2 - Change in Intermediary as Result of CHOW

2005E3 - CHOWs Involving Multi-Regional Chain Organizations

2005E4 - Change of Owners, but Not CHOW

2005F - Voluntary Terminations

2008 - Prioritizing SA Survey Workload - Initial Surveys and Recertifications

2008A - Surveys of New Providers and Suppliers

2008B - Initial Surveys of HHAs

2008D - Effective Date of Medicare Provider Agreement or Approval for

Suppliers

2008E - Administrative Considerations

2008F - SA Scheduling of Resurveys

2010 - Ascertaining Compliance With Civil Rights Requirements

2012 - SA Identifying Eligible Providers and Suppliers

2016 - Readmission to Medicare or Medicaid Program After Involuntary

Termination - Reasonable Assurance

2016A - Readmission Criteria

2016B - Reasonable Assurance Concept

2016C - Request for Readmission

2016D - Reasonable Assurance Surveys

2016E - Effective Date of Provider Agreement After Reasonable Assurance

2016F - Readmission of ICF/IID After Termination

2016G - Under LSC at Time of Readmission

2017 - Readmission Following Voluntary Termination of Program Participation

2018 - Reinstatement Following Termination of Swing-Bed - Approval

Hospitals

2020 - Hospitals - Definition and Citations

2021 – Non-deemed Hospitals

2021A – Recertification of Non-deemed Hospitals

2022 - Deemed Status: Hospitals Accredited by an Accrediting Organization with

a CMS-approved Medicare Hospital or Medicare Psychiatric Hospital

Accreditation Program

2022A - Notice that a Participating Hospital Has Been Accredited and

Recommended for Deemed Status

2022B - Recertification

2022C - Notification of Withdrawal or Loss of Deemed Status Acccreditation

2024 - Hospital Merger/Multiple Campus Criteria

2026 - Certification of Parts of Institutions as Hospitals

2026A - Hospitals (Other Than Psychiatric Hospitals)

2026B - Excluded Non-Service Units May be Appropriate

2030 - Temporary Waivers Applicable to Rural Hospitals

2034 - Time Limit on Temporary Waiver

2036 - Definition, Authority and Requirements for Hospital Providers of Extended

Care Services (“Swing-Beds”)

2037 - Requirements Assessed Prior to Survey for Swing-Bed Approval

2037A - Request from a Medicare Participating Hospital to Add Swing-Bed

Approval

2037B - Screening

2037C - Provider Agreement

2037D - Calculation of Bed Count

2037E - Rural Area

2037F - Certificate Of Need (CON) Approval

2038 - Survey Procedures for Swing-Bed Approval

2039 - Post-Survey Procedures for Swing-Bed Hospitals

2040 - RO Approval Procedures for Swing-Bed Approval

2042 - Psychiatric Hospitals

2044 - Psychiatric Hospitals and Deemed Status

2048 - Distinct Part Psychiatric Hospital

2048A - General

2048B - Physical Identification

2048C - Documentation of Findings

2050 - Medical-Surgical Unit of Psychiatric Hospitals

2052 - Nonparticipating Emergency Hospitals

2052A - Emergency Hospital Services

2052B - Preparation of Initial Certification

2052C - Recertification and Follow-Up

2053 - Medicaid-Only Hospitals

2053A - Initial Certification of Medicaid-Only Hospitals

2053B - Certification Surveys of Medicaid-Only Hospitals

2053C - Change in Certification

2053D - Termination

2053E - Complaint Investigation

2054 - Religious Nonmedical Health Care Institutions (RNHCIs)

2054.1 - Certification of Religious Nonmedical Healthcare Institutions (RNHCIs)

2054.1A - Other Medicare Conditions of Coverage

2054.1B - Valid Election Requirements

Organ Transplant Programs

2060 -Organ Transplant Programs

2060B – Definitions

2060C – Regulatory Background

2061 – Request for Medicare Approval of an Organ Transplant Program

2062 – Survey and Approval Procedures for Organ Transplant Programs

2062B – Types of Surveys and Related Guidance

2062C – Determining Level of Deficiency for Clinical Experience (Volume) and

Outcome Requirements Standards:

2062D – Post-Survey Activities

2062E – Transmission of Program Approval Information

2062F – Mitigating Factors

2063 – Relationship Between the Transplant CoPs and Hospital CoPs

Hospices

2080 - Hospice - Citations and Description

2080A - Citations

2080B - Description

2080C - Hospice Core Services

2080C.1 - Waiver of Certain Staffing Requirements

2080C.2 - Contracting for Highly Specialized Services

2080C.3 - Hospice Nursing Shortage Provision

2080D - Hospice Required Services

2080D.1 - Hospice Interdisciplinary Group (IDG)

2081 - Revoking Election of Hospice Care

2082 - Discharge from Hospice Care

2083 - Hospice Regulations and Non-Medicare Patients

2084 - Hospice Inpatient Services

2084A - Hospice Provides Inpatient Care Directly

2084B - Hospice Provides Inpatient Services Under Arrangements

2085 - Operation of Hospice Across State Lines

2086 - Hospice Change of Address

2086A - Effective Date

2086B - Administrative Review

2086C - Move After certification Survey

2087 - Simultaneous Surveys

2088 - Multiple Locations

2089 - Survey Requirements When the Hospice Provides Care to Residents of a SNF/NF

or ICF/IID

Intermediate Care Facilities

2130 - ICFs/IID – Citations and Description

2130A - Citations

2130B - Definitions

2134 - Distinct Part ICF/IID

2138 - Approval Procedures for ICFs/IID

2138A - Initial Certification of ICF/IID

2138B - Multiple Certification of Dispersed Locations

2138C - Minimum Size of ICF/IID

2138D - Interpretive Guidelines for ICFs/IID

2138E - Survey Report (Form CMS-3070G-I)

2138F - Application of LSC to ICFs/IID of 16 Beds or Less

2138G - Schedule for Recertification

2139 - Assessment of ICFs/IID Based on CoPs for Active Treatment

2139A - Comprehensive Functional Assessment

2139B - Individual Program Plan (IPP)

2139C - Program Implementation

2139D - Program Documentation

2139E - Program Monitoring and Review

2140 - Waiver and/or Variance of ICF/IID Requirements

2140A - ICF/IID Room Size and Occupancy

2140B - Waiver of LSC

2141 - Recertifications - ICFs/IID

2141A - Full 12 Months

2141B - Conditional 12 Month Agreement Subject to Automatic Cancellation

Clause

2141C - Period of Certification Which Expires 60 Days After PoC

2141D - Extending the Term of ICF/MR TLA

2142 - Evacuation Drills for ICFs/IID Certified Under the Life Safety Code NFPA

101, 2000 Edition

2143 - The Use of Video Cameras in Common Areas in ICF/IID

Spell of Illness Certifications

2160 - Purpose of Certifying §§1861(e)(1) and 1819(a)(1) of the Act Status of

Hospitals and SNFs

2160A - Benefit Period Provision

2160B - Defining Medicare Eligible Individual’s “Home” for Purposes of Durable

Medical Equipment (DME) and Home Health Benefits

2160C - Defining “Institution” for Ambulance Benefit

2162 - Defining Hospital for Spell of Illness, DME, and Home Health Benefit

Purposes

2164 - When to Make Spell of Illness Certification

2166 - Criteria for Certifying §1819(a)(1) of the Act Status of LTC Facilities Other

Than SNFs

2166A - Nursing Services

2166B - 24-Hour Nursing Services

2166C - Nurse-Bed Ratio

2166D - Other Services

2168 - Additional Development Required for Spell of Illness Certifications

Home Health Agencies (HHAs)

2180 - HHA – Citations and Description

2180A - Citations

2180B - Types of Agencies

2180C - General Requirements

2180D - Services Provided

2180E – Application of Home Health Agency Conditions of Participation to

Patients Receiving Chore Services Exclusively

2182 - Organization of HHA

2182.1 - Characteristics Differentiating Branches From Subunits of HHAs

2182.2 - Guidelines for Determining Parent, Branch, or Subunit

2182.3 - Processing A Change From Branch to Subunit

2182.4 - CMS Approval Necessary for Non-Parent Locations

2182.4A - Notification by HHA to Add Non-Parent Location

2182.4B - SA Review of Requirement for Branch Determination

2182.4C - Onsite Monitoring of Approved Branches by the SA

2182.4D – Drop Sites

2182.5 - Branch Identification Numbers

2183 - Separate Entities (Separate Lines of Business)

2183.1 - Operation of the HHA

2183.2 - Consumer Awareness

2183.3 - Staff Awareness

2184 - Operation of HHAs Cross State Lines

2185 - HHA Change of Address

2185.1 - Move after Certification Survey and Before Final Medicare Approval

2186 - Health Facility-Based HHAs

2188 - Survey of State-Operated HHAs

2194 - Surveying Health Maintenance Organization (HMO)-Operated Home

Health Agencies (HHAs) Providing Home Health Services Through Medicare

Survey and Certification Process

2195 - Guidelines for Determining Standard Survey Frequency

2197 – Surveyor Worksheets

2202 - Outcome and Assessment Information Set (Oasis) Requirements

2202.1 - OASIS Related Definitions

2202.2 - History of OASIS

2202.2A - Current Version of OASIS

2202.2B - OASIS as Part of the HHA’s Comprehensive Assessment

2202.2C - Incorporation of OASIS Data Items Into the

Comprehensive Assessment (See §484.55(e))

2202.3 - Applicability

2202.3A - Medicare and Medicaid Patients

2202.3B - OASIS and the Medicare Home Health Benefit

2202.3C - Non-Medicare/Non-Medicaid Patients

2202.3D - Skilled Versus Nonskilled Care

2202.3E - Agencies Serving Medicaid Waiver and State Plan

Patients

2202.3F - Patients Turning 18

2202.3G - Patients Receiving Maternity Services

2202.4 - Comprehensive Assessment and OASIS Reporting (Refer to §484.20 and

§484.55)

2202.4A - Comprehensive Assessment and OASIS Collection

2202.4B - OASIS Encoding and Locking

2202.4C - OASIS Reporting (Refer to §484.20)

2202.5 - Outcome-Based Quality Improvement (OBQI)

2202.5A - Using Outcome Based Quality Monitoring (OBQM) and

Risk Adjusted OBQI Reports in the Survey Process

2202.5B - Case-Mix Stratified Sample

2202.5C - Privacy Act Requirements

2202.5D - Accessing the OBQM, OBQI, and Process Based Quality

Improvement (PBQI) Reports

2202.5E - Role of the OASIS Coordinators in OBQI

2202.6 - OASIS Instructions

2202.6A - OASIS User’s Manual

2202.6B - Other Manuals

2202.6C - Other Teaching Tools

2202.7 - OASIS and the Medicare Home Health Prospective Payment System

(PPS)

2202.8 - Surveying for the OASIS Requirements

2202.8A - Condition of Participation: Comprehensive Assessment

of Patients (See §484.55)

2202.8B - Record Keeping

2202.8C - Condition of Participation: Reporting OASIS

Information

2202.8D - Condition of Participation: Release of Patient

Identifiable OASIS Information

2202.9 - Patient Notification of OASIS Collection and Reporting

2202.9A - Informing Patients of OASIS Collection and Reporting

2202.9B - Right to See, Review, and Request Changes

2202.10 - OASIS and HHAs Seeking Initial Certification

2202.10A - Determining Compliance With the OASIS

Transmission Requirements

2202.10B - HHAs Seeking Initial Certification Through Deemed

Status

2202.10C - Exceptions to Demonstrating Compliance With OASIS

Submission Requirements Prior to Approval

2202.10D - Compliance Dates and PPS

2202.10E - Instructions for Handling Medicare Patients in HHAs

Seeking Initial Certification

2202.10F - Instructions to New HHAs Concerning all Other

Patients

2202.11 - Correction Policy

2202.11A - Determining When to Inactivate an Assessment

2202.11B - Deleting Assessments

2202.11C - Types of Corrections an HHA Can Make in HAVEN

2202.11D - Documentation of Corrected Assessments

2202.11E - Clinical Implications of Corrected Assessment Records

2202.11F - Regarding Corrections in Lieu of Required Assessments

2202.11G - Timeliness of Corrections

2202.11H - Multiple Corrections in a Record

2202.12 - OASIS State System

2202.12A - System Description

2202.12B - Administration Requirements

2202.12C - Validation and Editing Process

2202.12D - Reports

2202.12E - Replication to the CMS Repository

2202.12F - System Security

2202.12G - Security of Transmission

2202.12H - Provider Relations

2202.13 - Protection of the Confidentiality of OASIS Data

2202.13A - OASIS System of Records

2202.13B - Protection of Confidentiality Under the Privacy Act of

1974

2202.14 - SA and RO Roles and Responsibilities

2202.14A - State

2202.14B - Regional Office

2202.15 - OASIS Education and Training

2202.15A - State

2202.15B - RO

2202.15C - HHAs

2202.16 - Fax Transmission of OASIS or Other Patient Identifiable Information

2202.17 - Change of Ownership (CHOW), Merger, and Termination Procedures

Affecting HHAs and OASIS Requirements

2202.18 - Wound Ostomy Continence Nurses Society (WOCN) and the National

Pressure Ulcer Advisory Panel (NPUAP) OASIS Guidance

2202.19 - OASIS Collection on Private Pay (Non-Medicare/Non-Medicaid)

Patients

Ambulatory Surgical Centers (ASCs)

2210 - ASCs - Citations and Description

Rural Health Clinics (RHCs)

2240 - RHCs - Citations and Description

2242 - Conditions to Be Assessed Prior to Scheduling RHC Survey

2242A - General

2242A1 - Location of Clinic

2242A2 - Medical Direction

2242A3 - Physician Assistant, Nurse Practitioner, and/or Certified

Nurse Midwife Staff

2242B - Clinic Is Determined Ineligible

2242D - Identifying Clinic as Provider-Based

2242E - Compliance With Civil Rights Statutes

2242F - Laboratory Services Provided in RHCs

2244 - Preparing for RHC Survey

2246 - Clinic’s Request to Provide Visiting Nurse Services

2248 - Clinic’s Request for Waiver of Staffing Requirements

2248A - Applying Waiver to Applicants

2248B - Applying Waiver to Participating RHCs

2248C - Documentation Demonstrating Efforts to Meet Staffing Requirements

2248D - Monitoring Waivers

2248E - Notification

2249 - RO Notification of RHC Initial Certification Approval

Community Mental Health Centers

2250 - Community Mental Health Centers (CMHC) - Citations and Descriptions

2250A - Citations and Definitions

2250B - Special Requirements

2250C - Partial Hospitalization and/or Intensive Outpatient Services Provided by

CMHCs or by Others Under Arrangements with the CMHC

2251 - Certification Process

2251A - Request to Participate

2251B - Processing CMHC Initial Certification Requests, SA Role

2251C - Processing CMHC Initial Certification Requests, CMS Location

Role

2251D - Center Alleges it is Provider-Based

2251E - Voluntary Termination

2251F - Involuntary Termination

Critical Access Hospitals (CAHS)

2254 - CAHS (Critical Access Hospitals)

2254A - Statutory Citation

2254B - Regulatory Citation

2254C - Submission of a State Plan

2254D - Requirements for Critical Access Hospitals

2255 - SA Procedures for CAH Approval

2255A - CAH Applications

2255B - Pre-Survey Activity

2255C - Arranging a CAH Survey

2255D - Onsite Survey Activity

2255E - Preparing a Statement of Deficiencies

2256 - RO Procedures for CAH Approval

2256A - Verification Criteria

2256B - Notification

2256C - Effective Dates

2256D - RO Processing Complaints Against a CAH

2256E - RO Processing Denials or Terminations of a CAH

2256F - Relocation of CAHs with a Grandfathered Necessary Provider

Designation

2256G – Co-Location of Critical Access Hospitals

2256H – Off-Campus CAH Facilities

2257 - CAH Anti-Dumping Requirements

2258 - Advance Directive Requirements for CAHS

2259 - Procedures for Processing CAH Swing-Bed Applications

2259A - Definition, Authority and Requirements for CAH Providers of Extended

Care Services (“Swing-Beds”)

2259B - Request from a Medicare Participating CAH to add Swing-bed Approval

2259C - Pre-Survey Activity

2259D - Certificate Of Need (CON) Approval

2260 - Survey Procedures for Swing-Bed Approval

2261 - Post-Survey Procedures for Swing-Bed CAHS

2262 - RO Approval Procedures for Swing-Bed Approval

End Stage Renal Disease (ESRD) Facilities

2270 - Medicare and ESRD

2270A – ESRD Conditions for Coverage

2270B – ESRD Survey and Certification Communication, Information,

Tools

2270C – Definitions

2271 – General Requirements for In-center and Home Dialysis Program

2271A – Dialysis in Nursing Homes

2271B – Dialysis in Hospitals

2272 - ESRD Facility Classifications

2273 – Dialysis Modalities and Dialysis-related Services

2274 - ESRD Survey and Certification Forms

2274A – Form CMS-855A: “Medicare Enrollment Application:

Institutional Providers”

2274B - 2274B - Form CMS-3427: “End Stage Renal Disease Application

and Survey and Certification Report”

2274C - Form CMS 670: “Survey Team Composition and Workload

Report”

2274D - Form CMS-2567: “Statement of Deficiencies and Plan of

Correction”

2274E - Form CMS 2567B: “Post Certification Revisit Report”

2274F - Form CMS 1539: “Medicare/Medicaid Certification and

Transmittal”

2276 - SA Control of Form CMS-3427

2278 - ESRD Survey Procedures

2278A - Facility Withdraws Application Prior to Survey

2278 B - Certificate of Need (CON)

2278 C - Initial RO Approval

2278 D - Expansion or Addition of Services – SA/RO Procedures

2279 - ESRD CMS Certification Numbers

2280 - ESRD Survey Activities

2281 - Waivers

2281A - Isolation Room Waiver

2281B - Medical Director Waiver

2281C - Life Safety Code Waiver

2282 - RO Use of Provider Tie-In Notice, Form CMS-2007, for Suppliers of

ESRD Program Services (Exhibit 156)

2283 - Termination Procedures

2284 - Specialized Areas of ESRD Oversight

2284A - Centralized Dialyzer Reprocessing

2284B - ESRD Services across State Lines

2286 - ESRD Network Participation and Data Submission

2286A - ESRD Network Participation

2286B - Furnishing Data and Information for ESRD Program

Administration (42 CFR ........................................................... 494.180(h))

2286C – Using ESRD Data

2286C.1 - Dialysis Facility Reports and Outcomes Lists

2286C.2 - Dialysis Facility Compare

2287 - ESRD Patient Care Technician (PCT)

2287A - PCT Certification

2287B - Independent ESRD Facility

2287C – Certification and Additional Requirements

2287D – State and National Certification Programs for PCTs

2288 – Infection Control Considerations

Providers of Outpatient Physical Therapy and/or Outpatient Speech Pathology

Services Specified in §485.701 - §485.729

2290 – Providers of Outpatient Physical Therapy and Speech-Language Pathology

Services - Citations

2292 - Types of Organizations, Who May Provide Outpatient Physical Therapy

and Speech-Language Pathology Services, Specified in §485.701 - §485.729

2292A - Rehabilitation Agency

2292B – Rehabilitation Agency Clinic and Public Health Agency

2292C - Public Health Agency

2294 – Change of Address

2296 – Medicare Approved Sites of Service Provision

2298 – Extension Locations for Rehabilitation Agencies

2298A – Criteria for Extension Location Approval

2298B – Extension Location Approval Process

2298C – Survey of Rehabilitation Agency Extension Locations by SAs

2298D – Accreditation Organization (AO) Surveys of Rehabilitation Agencies

2300 – Outpatient Physical Therapy and/or Speech-Lanaguage Pathology Services

at Other Locations such as a Patients’s Private Residence, Assisted Living or

Independent Living Facility

2302 – CMS - 381 Model Letter Requesting Identification of Extension Locations

2304-- Operation of an Organization on the Premises of a Supplier/Provider

2306 – When a Rehabilitation Agency’s Extension Location Becomes Its Primary

Site

2308 – Relocations of Providers of Outpatient Physical Therapy and Outpatient

Speech-Language Pathology Services Concurrent with CHOWs

Comprehensive Outpatient Rehabilitation Facilities (CORFs)

2360 - CORF - Citations and Description

2362 - Scope and Site of Services

2364 - CORF’S Relationship With Other Providers or Suppliers

2364A - Shared Space With Another Provider or Supplier

2364B - Sharing of Equipment

2364C - Employee Sharing

2366 - Conversion of OPT/OSP to CORF

Suppliers of Portable X-Ray Services

2420 - Suppliers of Portable X-Ray Services - Citations

2422 - Location of Portable X-Ray Service

2424 - Suppliers Using Improperly Labeled or Post-1974 Equipment

2424A - Labeling Requirements

2424B - Request for and Review of Labeling Information

Screening Mammography

2460 - Mammography

Life Safety Code (LSC)

2470 - LSC - Citations and Applicability

2470A - Background

2470B - Citations for Application to Provider Facilities

2470C - Citations for Application to ASCs

2470D - Special Application in ICFs/IID

2470E - Substitution of State Fire Code for the Life Safety Code (LSC)

2472 – Life Safety Code (LSC) Surveys

2472A - Authority to Grant Waivers for LSC Surveys

2472B - Subagreements With State Fire Authorities

2472C - Coordinating LSC Survey

2472D - ASC Surveys

2472E - Involvement of SA Surveyors in LSC Surveys

2474 - Fire Safety Survey Report Forms (Form CMS-2786 Series)

2476 - Fire Safety Survey Report - Short Form, Form CMS-2786S

2476A - Background

2476B - When to Use Short Form

2476C - When NOT to Use Short Form

2476D - Results of LSC Screening Process - SA Review of Completed Form

CMS-2786S

2476F - Waivers

2478 - Application of Fire Safety Evaluation System (FSES)

2478A - General

2478B - Application of System

2478C - Survey Completion

2478D - Certification of Compliance with FSES

2480 - LSC Waivers

2480A - General

2480B - Meeting Intent of LSC

2480C - Elements Considered in Determination of Unreasonable Hardship

2482 -Technical Bulletins

2490 - Compliance With §504 of the Rehabilitation Act of 1973, as Amended

Utilization Review

2496 - Utilization Review (UR)

2496A - Definition

2496B - Hospitals

2496C - SMAs

2496D - Background and Scope of Work

2496D1 - Extent of PRO Review

2496D2 - Availability/Disclosure of QIO Information

2496E - Action When a QIO Ceases Utilization Review

2496F - Including UR in Next Scheduled Resurvey

The Survey Process

2700 - Conducting Initial Surveys and Scheduled Resurveys

2700A - Unannounced Surveys

2700B - SA Schedule for Conducting Health and Safety Resurveys

2700C - Coordinating LSC Surveys

2702 - SA Conducting Unscheduled Surveys

2702A - Survey Due to Unanticipated Events

2702B - Change of Size or Location of Provider Institution

2704 - SA Presurvey Preparation

2705 - SA Survey Team Workload

2706 - SA Survey Team Composition

2708 - Facility Refuses to Allow Survey

2710 - Reviewing Forms at Beginning of Survey

2712 - Use of Survey Protocol in the Survey Process

2713 - During Survey

2713A - Accompanying Surveyors

2713B - Physical Contact With Patients/Residents

2714 - Interviewing Key Personnel

2714.1 - Application of Medicare/Medicaid Requirements to Private Pay Patients

2715 - Interviewing Residents Using the LTC Survey Process

2716 - Special Survey of Pharmaceutical Service Requirements in SNFs, NFs, and

ICFs/IID

2718 - Assistance in Surveying Psychiatric Hospitals

2718A - Use of CMS Surveyors

2718B - CO Responsibility

2718C - Survey Responsibility

2718D - RO Responsibility

2720 - Completing the Survey Report

2720A - Traditional SRF

2720B - Specific Items to Consider When Completing SRF

2720C - Completing ICF/IID Survey Report

2720D - Completing HHA and SNF/NF Survey Reports

2722 - Preparation for Exit Conference (Excluding SNFs and NFs)

2723 - Citing Deficiencies in SNFs and NFs

2724 - Exit Conference

2724A - Introductory Remarks

2724B - Ground Rules

2724C - Presentation of Findings

2724D - Closure

2726 - Summary of SA Certification Actions Performed After Survey

2727 - Limitations on Technical Assistance Afforded by Surveyors

2728 - Statement of Deficiencies and Plan of Correction, Form CMS-2567

2728A - Statement of Deficiencies

2728B - PoC

2728C - Review of PoCs by SA

2728D - Modifications of PoCs

2728E - Rejection of Unacceptable PoCs

2728F - Major Deficiencies Requiring Long-Term Correction in Hospitals, SNFs,

NFs, SNF/NFs, and ICFs/IID

2732 - Follow-Up on PoCS

2732A - Post-Survey Revisit

2732B - Form CMS-2567B (See Exhibit 8)

2732C - Notifying Governing Bodies of Continuing Deficiencies

2734 - SA Evaluation of Compliance

2734A - Conditions for Certifying Compliance

2734B - Certifying Noncompliance

2736 - The Outcome-Oriented Survey Process

2760 - Forwarding SA Certification

2762 - Medicare/Medicaid Certification and Transmittal, Form CMS-1539

2762A - Purpose of Form CMS-1539

2762B - Definitions of Terms Used on Form CMS-1539

2762C - Distributing Form CMS-1539

2762D - Amended Certifications

2764 - SA Completion Instructions for Certification and Transmittal, Form CMS-

1539, Items 1 - 32

2764A - In Compliance With Program Requirements

2764B - Not in Compliance With Program Requirements

(Termination Development)

2764C - Not in Compliance With Program Requirements (Denial of

Payments for New Admissions for SNF, NF, and ICF/IID)

2764D - Resurvey Does Not Find Significant Progress

2765 - MAC Tie-In Activities

2766 - Spell of Illness Supplement, Form CMS-1539A (Exhibit 10)

2766A - Form(s) to Use

2766B - Items on Form CMS-1539A

2772 - Packet of Documentation Attached to Certification and Transmittal by SA

2774 - Routing of Medicaid-only Certifications

2776 - RO Requests for Additional Information

2777 - RO Review of SA Certifications

2777A - Medicaid-Only Certifications

2777B - State-Operated Medicaid NFs

2777C - Medicare Certifications

2777D - Change in Certification

2777D1 - Medicaid NF and Medicaid Distinct Part NF Providers

Seeking to Participate as Medicare SNF Provider

2777D2 - Medicare- and Medicaid-participating Hospitals Seeking

to Become Medicaid-Only Hospitals

2777D3 - Medicaid-Only Hospitals Seeking to Participate in

Medicare and Medicaid

2778 - Objectives of RO Certification Review

2779 - RO Assignment of CMS Certification Numbers

2779A - Numbering System for CMS Certification Numbers (CCN)

2779A1 – CCN for Medicare Providers

2779A2 – CCN for Suppliers

2779B – CMS Certification Numbers for Medicaid Providers

2779C - Special Numbering System for Units of Hospitals That Are Excluded

From the Inpatient Prospective Payment System (IPPS) and Hospitals and CAHs

with SNF Swing-Bed Approval

2779C1- Special Numbering System for IPPS-Excluded Hospitals

with IPPS-Excluded Units

2779D - Assigning LTC CMS Certification Numbers

2779E - Assigning Emergency Hospital CMS Certification Numbers (Non-

Participating Hospitals)

2779F - Merger of Facilities or CHOW

2779G - Notification of Change in CMS Certification Numbers

2779H - Retirement of CMS Certification Numbers

2779I - Control of CMS Certification Numbers

2779J - ESRD CMS Certification Numbers

2779K - HHA Branch CMS Certification Numbers

2779L – Outpatient Physical Therapy (OPT) Extension CMS Certification

Numbers

2780 - Effective Date of Provider Agreement, Form CMS-1561, and Supplier

Approval

2780A - Compliance with All Federal Requirements

2780B - All Health and Safety Requirements Are Not Met on the Day of the

Survey

2781 - RO Countersigning Provider Agreement

2782 - RO Notice of Acceptance

2783 - Provider Tie-In Notice (Form CMS-2007)

2783A – Purpose

2783B – CMS Responsibility for Form CMS-2007 Completion

2783C - CMS Completion of Form CMS-2007

2783D – Distribution

2784 - Effective Date of Certification of Coverage for Suppliers of Services

2800 - Strikes at Participating Facilities

Organ Procurement Organizations

2810 - Organ Procurement Organizations (OPOs) – Citations - Statutory Authority

2810.1 - Definitions

2811 - OPO Requirements for Certification

2812 - OPO Designation Requirements

2812.2 - Waivers

2812.3 - Opening the Donation Service Area (DSA) for Competition from other

OPOs (42 CFR 486.316)

2812.4 - Application

2812.5 - Application Review

2812.6 - Selection Process

2812.7 - OPO Transition

2812.8 - No OPO applications for the open DSA

2813 - Re-Certification Cycle (42 CFR 486.309)

2814 - Change in Control/Ownership or Service Area (42 CFR 486.310)

2815 - De-certification and Competition:

2817 - De-certification and Competition:

2818 - Involuntary Termination and Non-renewal of an Agreement:

2819 - Appeals (§486.314)

2820 - Outcome Measures/Data Reporting (§486.318, 486.328): NOT

REVIEWED ON SITE

2821 - Information Management (§486.330):

Federally Qualified Health Centers

2825 - Federally Qualified Health Centers (FQHCs) - Citations and Description

2825A - Citations

2825B - Description

2826 - RO Approval Process for FQHCs

2826A - General

2826B - Information to Be Provided to Potential Applicants

2826C - Request to Participate

2826D - Processing Requests

2826E - RO Assigning Applicants an FQHC CMS Certification Number (CCNr

2826F - Effective Date

2826H - Complaint Investigations

Psychiatric Residential Treatment Facilities (PRTF)

2830 – Psychiatric Residential Treatment Facilities (PRTF) – Citations and

Definitions

2830A - Citations

2830B – Definitions

2831 – Determination-Making Authority

2831A - Survey Agency and State Medicaid Agency Interaction

2831B - Authorization of Certification Expenditures

2831C - Look-behind Authority on State Determinations

2831D- Appeals

2831D.1- State Appeal Rights

2831D.2- Facility Appeal Rights

2831E - Accreditation

2832 – Survey Agency, State Medicaid Agency, and PRTF Responsibilities &

Obligations

2832A - Attestations

2832B - Plan of Correction (POC)

2832C - Assigning CMS Certification Numbers (CCN)

2832D - ASPEN Data Input

2832E - Multi-State Issues & Interagency Relationships

2832E.1-State –to-State Differences

2832E.2-Action for Non-Compliance and Termination

2832E.3-State Agency-Who Can Survey

2833 – Survey Process

2833A - Survey Types

2833A.1- Recertification Surveys

2833A.2- Complaint Surveys

2833B - Survey Frequency

2833C - Survey Procedures

2833C.1- Pre-Survey Procedures

2833C.2- On-Site Survey Procedures

2833C.2a- Entrance Conference

2833C.3- Survey Team Composition

2833C.4- Information Gathering

2833C.4a- Task 1- Representative Sample of Residents-Selection Methodology

2833C.4b- Task 2- Record Review of Individuals in The Sample

2833C.4c- Task 3- Review of Other Records

2833C.4d- Task 4- Direct Resident Observations

2833C.4e- Task 5- Interviews

2833C.4f- Task 6- Visit to Each Area of The Facility Serving Residents

2833C.4g- Task 7- Compliance Determination and Preparation For Exit

Conference

2834 - Other Applicable SOM Sections

Identification of Providers and Suppliers and

Related Presurvey Activities

2000 - Certification Surveys - Citations and Responsibility

(Rev. 1, 05-21-04)

Section 1864 of the Social Security Act (the Act) establishes the framework within which

SAs, under agreements between the State and the Secretary, carry out the Medicare

certification process. Sections 1902(a)(9) and (33) of the Act stipulate that the same

agency is authorized to set and enforce standards for Medicaid. (The SA may partially

redelegate the functions to local agencies.)

42 CFR 488 requires the SA to perform surveys to support its certifications. 42 CFR Part

431, Subpart M, sets forth the functions the SA performs for the SMA. SAs perform

initial surveys and periodic resurveys of all providers and certain kinds of suppliers.

These surveys are conducted to ascertain whether a provider/supplier meets applicable

requirements for participation in the Medicare and/or Medicaid programs, and to evaluate

performance and effectiveness in rendering a safe and acceptable quality of care.

Although the regional office (RO) is ultimately responsible for deciding whether a

provider/supplier may participate in the Medicare program, certification is an SA function.

After the SA completes an inspection for the Medicare program, it submits evidence and a

certification recommendation for a final RO determination. When the SA certifies for

Medicaid purposes, it is reporting its own adjudicative determination.

2002 - Meaning of Providers and Suppliers

(Rev .40, Issued: 03-20-09, Effective: 03-20-09, Implementation: 03-20-09)

The Medicare law differentiates between providers and suppliers. The general distinction

between providers and suppliers is that providers are parties who care for patients

awaiting, receiving, or recuperating from treatment by intervening practitioners. The term

suppliers” includes those who furnish goods and services used in care and treatment.

Medicaid terminology, by contrast, uses “provider” generically to include all health care

vendors. (See 42 CFR 431.107(a) and 433.37.) Medicare providers and suppliers are

defined at 42 CFR 498.2.

In Medicare, as specified in §1861(u) of the Act, providers include hospitals, critical

access hospitals (CAHs), skilled nursing facilities (SNFs), home health agencies (HHAs),

hospices and comprehensive outpatient rehabilitation facilities (CORFs). Under

§1835(a)(2) of the Act, clinics, rehabilitation agencies, or public health agencies are

included as providers if such clinic or agency meets the requirements of §1861(p)(4)(A).

Community Mental Health Centers (CMHC) are providers of services for partial

hospitalization services only. Providers must meet CoPs or Requirements for SNFs to

participate in Medicare. (See definitions at 42 CFR 498.2.)

Portable x-ray services, end stage renal disease (ESRD) facilities, ambulatory surgical

centers (ASCs), and organ procurement organizations (OPOs) are suppliers that must meet

conditions for coverage to participate in Medicare; rural health clinics (RHCs) are

suppliers that must meet conditions for certification to participate in Medicare.

Federally Qualified Health Centers (FQHCs) are also recognized as suppliers of services

and provide ambulatory care services similar to those provided by RHCs. FQHCs may be

located in urban, as well as rural, areas. FQHCs are required to meet the same health and

safety standards as RHCs, with the exception of the certification procedures. FQHCs self-

attest to their compliance with Medicare conditions for coverage and are only surveyed by

CMS in connection with complaint investigations.

The above types of suppliers are distinguished from other suppliers, e.g., pharmacies,

prosthesis suppliers, etc., for which there are no conditions for coverage or certification,

and which qualify for Medicare through the enrollment process. Laboratories that

examine human specimens for the diagnosis, prevention, or treatment of any disease or

impairment of, or the assessment of the health of, human beings are yet another category

of suppliers and must meet Clinical Laboratory Improvements of 1988 Act (CLIA)

requirements.

As previously stated, Medicaid does not distinguish between providers and suppliers.

Section 1902(a)(27) of the Act provides for agreements with every person or institution

providing services under the State plan. 42 CFR 431.107(a) refers to all providers of

services (including individual practitioners and groups of practitioners).

2003 - SA Identification of Potential Providers and Suppliers

(Rev. 1, 05-21-04)

Often, first indications of interest in program participation by potential participants will be

contacts with State licensing agencies. These contacts make the SA aware that a provider

or supplier wishes to participate. The SA identifies, surveys, and makes certification

recommendations to CMS or the SMA about providers and suppliers that are potential

program participants.

2003A - Assisting Applicant Providers and Suppliers

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Pre-certification assistance to prospective providers and suppliers is a proper certification-

related activity. It may take the form of providing them with a copy of the applicable

regulations. The objective is to provide the party with information about the requirements

of the certification component of the process for enrolling and participating in Medicare,

including compliance with the requirements for SNFs and NFs, Conditions of

Participation, Conditions for Coverage, or Conditions for Certification, as applicable. The

effective date of Medicare participation in accordance with 42 CFR 489.13 may not be

earlier than the date on which the applicant meets all the federal requirements.

2003B - Initial Certification “Kits”

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

When an entity seeks to participate in Medicare, it must first complete and submit an

enrollment application. Information on enrollment as well as applicable forms and

instructions may be found at http://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/MedicareProviderSupEnroll/index.html. Entities subject to survey and

certification file either a CMS Form 855A -- Medicare Enrollment Application for

Institutional Providers, or a CMS Form 855B--Medicare Enrollment Application for

Clinics, Group Practices, and Certain Other Suppliers, or, in some cases, both.

Prospective providers and suppliers should be aware that the initial review of the Form

CMS-855A or Form CMS-855B by the Medicare Administrative Contractor (MAC) and

its recommendation for approval must occur before the on-site initial certification survey

is conducted and action is taken by the RO.

CMS has established Internet-based Provider Enrollment, Chain and Ownership System

(PECOS) as an alternative to the paper enrollment process. Internet-based PECOS allows

provider and supplier organizations to enroll, make a change in their Medicare enrollment,

view their Medicare enrollment information on file with Medicare, or check on the status

of a Medicare enrollment application via the Internet.

When the MAC completes its review of the application, it either: 1) sends the SA and the

RO its recommendation to approve the applicant; or 2) denies the application. The SA

must not perform a survey of an initial applicant until it has received notice from the

MAC that the information provided on the enrollment application has been verified

and that the MAC is recommending approval of the application. A SA may, however,

start planning for an unannounced survey upon initial contact from an applicant.

(NOTE: SA surveys of initial applicants must be consistent with the priorities for Federal

survey work, established by CMS each fiscal year. Depending upon available resources,

initial surveys are typically a lower priority and SAs generally should not perform such

work unless all higher priority Federal work will be completed. SAs may consult with the

CMS Regional Office (RO) to determine whether a specific initial applicant would

address an access to care issue and thus warrants an exception.)

The prospective provider/supplier must contact the SA for Medicare and/or Medicaid

certification materials for their provider/supplier type. The SA mails the initial

certification materials under cover of the appropriate form letter. (See Exhibits 1A-1F and

Exhibit 63.) If the applicant has not contacted the SA before the SA receives the MAC’s

recommendation for approval, then the SA contacts the applicant using the phone number

listed on the application.

Upon receipt of the completed certification materials from the prospective applicant, the

SA reviews the materials to see that they are properly completed and secures any

necessary changes or additional information. It makes sure any required SNF transfer

agreements are received. If a distinct part of an organization is being considered for

program participation, the SA reviews the diagram (or floor plan) submitted to make sure

the size and location of the distinct part are clearly shown. The SA works in conjunction

with the RO and the MAC to gather the appropriate documentation from the entity that

supports its position of being a distinct part before forwarding the package to the RO, in

order to make a recommendation to the RO. Both copies of the signed provider agreement

or supplier approval are sent to the RO, along with the Title VI Assurance of Compliance

with Civil Rights (Form HHS-690). In title XIX-only cases, the SA sends the Form HHS-

690 or comparable form to the SMA.

If the entity indicates that it is requesting a provider-based determination under the

Medicare program, the SA must notify the RO immediately. Distinct Part and Provider-

Based are not synonymous terms. Determinations concerning provider-based status are

made by RO Financial Management personnel.

The SA refers questions about enrollment, MACs, payment rules, financial solvency, or

title VI clearance to the RO or the State Medicaid agency, as appropriate. For questions

concerning the downloading, completion, and submission of the Form CMS-855A or

CMS-855B, the provider/supplier should be directed to the CMS Web site or the

appropriate MAC.

Initial Certifications Involving New Owners who Reject Assignment of the Existing

Medicare Agreement

In the case of a prospective applicant that is planning to acquire an existing Medicare-

participating provider or supplier, the RO should provide pre-certification assistance to the

prospective applicant which includes making the prospective applicant aware of the

consequences of accepting or rejecting assignment of the existing provider’s/supplier’s

Medicare agreement. The RO should be consulted if the prospective applicant is

considering rejecting assignment of the agreement so that the RO can provide detailed

information on the consequences of such action before the prospective applicant makes a

final decision and submits an application.

In the case of an applicant that has acquired an existing Medicare-participating provider or

supplier and has rejected assignment of that entity’s Medicare agreement, that applicant is

considered a new applicant seeking initial certification and the SA must prioritize

scheduling an initial survey for that applicant accordingly. This includes adhering to

workload priorities identified by CMS for surveys of initial applicants to enroll in

Medicare. Unless specifically directed by the RO to do so, SAs must not conduct initial

surveys unless they are able to complete their higher priority workload. For initial

applicants that have an accreditation option, initial certification surveys are the lowest SA

priority. When an SA conducts an initial certification survey of an applicant that acquired

a provider/supplier but rejected assignment, the RO must review the facts of the case

carefully to determine whether the SA deviated from CMS workload priorities as well as

the SA’s typical practice for initial applicants. Such deviation may raise reasonable doubt

that the survey was unannounced.

Section 2700A of the SOM requires all surveys of providers and suppliers (other than

clinical laboratories) to be unannounced. This requirement applies to AO as well as SA

surveys. An unannounced survey provides an opportunity to assess how the provider or

supplier typically operates. On the other hand, if a provider or supplier knows the exact or

approximate date of a survey, it may temporarily adjust its typical practices to enhance its

compliance at the time of the survey. In doing so, it presents an unrepresentative picture to

surveyors of the quality of care typically provided to its patients or residents. It is

therefore in the best interest of patients and residents that surveys be unannounced.

Given the lead time normally required to schedule and prepare for a full survey, if an

initial survey takes place shortly after the acquisition date, such timing suggests discussion

with the new owner prior to the acquisition date to arrange the timing of the survey to

occur shortly thereafter, compromising the requirement that the survey be unannounced.

While the new owner, like any other initial applicant to the Medicare program, will be

expecting to be surveyed at some point, there must be some degree of uncertainty about

just when that survey will occur, in order to permit an assessment of compliance when the

facility is operating in a typical manner.

The RO may refuse to accept a SA survey certifying compliance or an AO

recommendation for deemed status if the survey timing creates reasonable doubt that the

survey was unannounced. Each case must be assessed based on the facts specific to it;

however, any survey that takes place within fourteen days after the effective date of an

acquisition that involves rejection of assignment of the provider agreement may warrant

closer review by the RO of the circumstances of the case and the timing of the survey.

However, it is also possible that the facts of a specific case may indicate that an initial

certification survey taking place at a later date was announced.

See Section 3210 for more information about policies and procedures related to

acquisitions of Medicare-participating providers or suppliers.

2003C – Deemed Status Providers/Suppliers, Excluding CLIA

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

There is an alternative to SA surveys for demonstrating compliance with the applicable

CoPs/CfCs/Conditions for Certification. Accreditation based on a survey by a CMS-

approved Medicare accreditation program of a national accrediting organization may be

used by CMS to “deem” a provider or supplier as complying with the applicable

regulatory standards. For certain types of providers/suppliers, for example hospitals or

psychiatric hospitals, Medicaid will also accept accreditation under a CMS-approved

Medicare accreditation program as evidence of compliance for Medicaid purposes.

Section 1865(a) of the Act provides that CMS may recognize and approve national

accrediting organization (AO) Medicare accreditation programs which demonstrate that

their health and safety standards and survey and oversight processes meet or exceed those

used by CMS to determine a health care provider’s or supplier’s compliance with

applicable Medicare CoPs, CfCs, Conditions for Certification or requirements.

The regulations which govern Medicare survey, certification, and enforcement procedures

are generally found in 42 CFR Part 488. Section 488.1 defines an accredited provider or

supplier as “a provider or supplier that has voluntarily applied for and has been accredited

by a national accreditation program meeting the requirements of and approved by CMS in

accordance with §488.5 or §488.6.” Accreditation under a CMS-approved Medicare

accreditation program is voluntary and is not required for Medicare participation.

Consistent with Section 1865 of the Act, 42 CFR §§488.5 and 488.6 permit deemed status

certification for ambulatory surgical centers; comprehensive outpatient rehabilitation

facilities; critical access hospitals; home health agencies; hospices; hospitals; clinics,

rehabilitation agencies or public health agencies providing outpatient physical therapy,

occupational therapy or speech pathology services; psychiatric hospitals; religious

nonmedical health care institutions; rural health clinics; screening mammography services;

skilled nursing facilities; and transplant centers, except for kidney transplant centers.

However, at this time only certain AOs have requested CMS approval of Medicare

accreditation programs, and those programs are only for some of these provider/supplier

types. A current list of CMS-approved Medicare accreditation programs may be found at

https://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/SurveyCertificationGenInfo/Accreditation.html.

The enrollment and certification requirements also apply to providers/suppliers seeking

deemed status through their accreditation by a CMS-approved Medicare accreditation

program. AOs with approved Medicare accreditation programs are also required by CMS

not to survey initial applicants until they provide evidence that the MAC has reviewed

their application and recommended approval.

The prospective provider/supplier seeking deemed status through accreditation must still

contact the SA for Medicare and/or Medicaid certification materials for their

provider/supplier type. The SA mails the initial certification materials under cover of the

appropriate form letter. (See Exhibits 1A-1F and Exhibit 63.) If the applicant has not

contacted the SA before the SA receives the MAC’s recommendation, then the SA

contacts the applicant using the phone number listed on the application.

In the case of a “deemed” provider or supplier, the SA does not conduct a survey to

initially certify or recertify compliance with the applicable Medicare CoPs, CfCs, or

requirements. Rather, such providers or suppliers are under the jurisdiction of the AO, not

the SA, for oversight of their ongoing compliance, unless the SA conducts a validation

survey (either a representative sample or substantial allegation validation survey) at the

direction of CMS and CMS determines as a result of such validation survey that the

provider or supplier fails to comply with one or more CoPs, CfCs, Conditions for

Certification or requirements.

Note that some AOs offer multiple accreditation programs for a given type of provider or

supplier, but for each provider/supplier type an AO may offer no more than one CMS-

approved Medicare accreditation program. In addition, some AOs may offer only one

program for a provider/supplier type, but they offer this program to their customers with

and without the option of the AO recommending Medicare deemed status to CMS. Thus,

it is possible for a healthcare entity to be “accredited” without being “deemed” for

Medicare participation. For certification purposes, CMS considers only accreditation

under a CMS-approved Medicare accreditation program where the AO has recommended

deemed status. SAs must enter information on the Deemed tab within the certification kit

in ASPEN only for those initial applicants that are seeking deemed status on the basis of

accreditation under a CMS-approved Medicare accreditation program. CMS has

established a process for AOs to provide notice to the applicable CMS Regional Office

(RO) when it has accredited a provider or supplier under its CMS-approved Medicare

accreditation program and is recommending the provider or supplier for deemed status.

The RO forwards these notices to the applicable SA for inclusion in the certification kit

that the SA subsequently forwards to the RO. In initial certification cases where there is

no AO notice of accreditation under a CMS-approved Medicare accreditation program for

the applicant, SAs must not use other sources of information about the applicant being

“accredited” to conclude that the applicant is “deemed” and must not enter deemed status

for the applicant in ASPEN.

An AO may not conduct an initial certification survey of a prospective provider or

supplier for Medicare certification purposes until the MAC has completed its initial

review of the enrollment application and has made a recommendation for approval to

CMS. CMS requires AOs subject to its oversight to employ a survey process that is

comparable to the process required for an SA, which may not conduct an initial survey

until it receives notice from the MAC recommending approval of the applicant (see

Section 2003B). Accordingly, an AO must also wait until the MAC has made its

recommendation before it conducts an initial survey.

The MAC gives the applicant written notice when its review has been completed.

Therefore, AOs must inform providers or suppliers seeking to participate in Medicare via

the AO’s CMS-approved Medicare accreditation program that an initial, unannounced

survey will not take place until after the applicant has received notice from the MAC that

it has completed its review of the enrollment application and that the MAC is

recommending approval. If the MAC denies approval of the application, the AO must not

proceed with a survey.

Notices that the MAC provides to the SA and RO are internal communications among

CMS and its contractors. AOs are not entitled to receive copies of the MAC notice from

the MAC, SA, or RO, but are expected to obtain copies of the MAC notice that was

provided to the applicant.

In the case of an applicant that is planning to acquire an existing Medicare-participating

provider or supplier and that is considering rejecting assignment of the prior Medicare

agreement, the AO must refer the applicant to the RO, so that the RO can provide detailed

information on the consequences of acceptance or rejection of assignment. In the case of

an applicant that has acquired an existing Medicare-participating provider or supplier and

has rejected assignment, the applicant is considered an initial applicant. Generally, it is

not acceptable for the AO to schedule an initial survey to minimize the period of time

between the termination of the prior Medicare agreement and the effective date of the new

agreement. Surveys conducted either on the date an acquisition is effective or within

days thereafter do not qualify as unannounced surveys and also are inconsistent with CMS

regulations and policy that require such applicants to be treated in the same way as any

other initial applicant. See Section 3210 for more information about policies and

procedures related to acquisitions of Medicare-participating providers or suppliers.

The AO is required to notify CMS whenever it newly accredits and recommends Medicare

deemed status for a provider or supplier seeking Medicare participation. This notice must

be sent to both CO and the applicable RO via a designated email box (See Section 1022).

However, the prospective provider or supplier must also provide the SA with

documentation of the AO’s accreditation decision and recommendation for deemed status.

This documentation is included in and becomes part of the certification packet the SA

submits to the RO. Therefore, AOs must instruct the prospective provider or supplier to

furnish a copy of this documentation to the SA for inclusion in the applicant’s certification

packet.

2004 - Provider-Based Determinations

(Rev. 193, Issued: 09-20-19, Effective: 09-20-19, Implementation: 09-20-19)

“Distinct Part” and “Provider-Based” are not synonymous terms. When a location,

department, remote location or satellite is established as being provider-based, it is an

integral part of the provider, covered by the provider’s Medicare agreement, and therefore

subject to the same Medicare conditions of participation as any other part of that provider.

Unless covered by a specific exception listed in the rule, the provider-based regulations at

§413.65 apply to any provider of services under the Medicare program, as well as to

physicians’ practices or clinics or other suppliers that are not themselves providers, but

which the provider asserts are an integral part of that provider.

Providers are not required to seek a determination from CMS that all of their provider-

based components satisfy the provider-based rules at 42 CFR 413.65, but they may

voluntarily seek such determinations. The RO Division of Financial Management makes

provider-based determinations in response to a specific request. If a provider requests the

SA for a provider-based determination under the Medicare program for one or more of its

component services, the SA must notify the RO immediately so that the request can be

routed appropriately to the RO Division of Financial Management. In the case of a

request concerning an off-campus department, remote location or satellite, the provider’s

survey and certification file about the locations included under its provider agreement

must not be revised to add the new location until and unless the provider is issued a

positive determination about its request.

For Critical Access Hospitals (CAHs) adding a provider-based location – also see SOM

Chapter 2, Section 2256H – Off-Campus CAH Facilities – Process Requirements.

2005 - Medicare Health Care Provider/Supplier Enrollment

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

The Centers for Medicare & Medicaid Services (CMS) is authorized to collect enrollment

information in order to ensure that correct payments are made to providers and suppliers

under the Medicare program established by Title XVIII of the Act for payment under Part

A of Title XVIII [42 U.S.C. §1395f(a)(1) and 1395g(a)] and §1833(e) [42 U.S.C.

§13951(e)] for payment under Part B. In addition, CMS is required to ensure that no

payments are made to providers or suppliers who are excluded from participation in the

Medicare program under §1128 of Title XVIII [42 U.S.C. §1320a-7], or who are

prohibited from providing services to the federal government under §2455 of the Federal

Acquisition Streamlining Act of 1994 (P.L. 103-355) [31 U.S.C. §6101 note].

The primary use of this information is to verify the eligibility of providers/suppliers to

participate in the Medicare program, which will more effectively prevent fraud and abuse.

The protocol that CMS uses to ensure that providers/suppliers meet these requirements is

referred to as the enrollment process. The enrollment process is also to be used for

providers/suppliers that plan to seek certification for participation in Medicare based on

deemed status through a CMS-approved Medicare accreditation program. An applicant

must complete the enrollment application process in order for CMS to obtain certain

required information before a certification survey is conducted or, in the case of an FQHC,

the RO countersigns the self-attestation.

Providers/suppliers should be informed of the enrollment and certification process so that

they do not have unrealistic expectations about the effective date of their provider or

supplier agreement with Medicare, e.g., an applicant should not expect its effective date to

be the date it submitted its enrollment application. Should the applicant have any

questions concerning the enrollment process form, it should be referred to the following

Web site: http://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/MedicareProviderSupEnroll/index.html.

The Medicare enrollment process is not applicable to the Medicaid program. State

Medicaid Agencies use their own enrollment process.

2005A - Approval or Denial

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

2005A1 - Enrollment Denial Based on MAC Review

When the MAC determines, after reviewing the Form CMS 855 application, that

an applicant has failed to meet the enrollment process requirements, the MAC will

issue a written denial to the applicant. The RO is not involved in the issuance of

the denial or in the processing of any request by the applicant for reconsideration

or appeal. Reconsideration requests or appeals are handled by the Center for

Program Integrity Provider Enrollment Operations Group in the CO.

Additionally, when an applicant is denied enrollment by the MAC, no survey is

conducted.

2005A2 - Approval or Denial of Certification Based on Survey Findings

The SA (or RO, when applicable – all references below to SA surveys also apply to

surveys conducted by the RO), surveys applicants that are subject to an on-site

certification survey after it receives the recommendation of approval from the MAC,

unless the applicant has the option of participation via deemed status (See Sections 2003C

and 2005A4). Additionally, the applicant must be operational and providing care to

patients/residents in order for a certification survey to be conducted. (See Section 2008A.)

All surveys are unannounced.

Applicant in Compliance - The SA surveys the applicant and certifies or recommends

Medicare approval if it determines that the applicant is in compliance with all conditions

of participation/coverage/certification or requirements, as applicable. (See Section 2008D

for more information on the circumstances under which the SA certifies the applicant is or

is not in compliance.) The SA forwards the survey results and certification kit to the RO

which determines whether and when all Federal requirements have been met by the

applicant. If all Federal requirements have been met, the RO proceeds with the provider’s

or supplier’s Medicare participation approval. (In the case of HHAs, there is a

requirement for the MAC to conduct a second verification of the enrollment information

after the SA or accrediting organization survey is completed. However, a second MAC

review that takes place after the on-site certification survey will only delay the effective

date of the HHA’s Medicare agreement if that review identifies noncompliance with any

Federal requirements. If the HHA is found upon a post-survey second MAC review to

continue to meet all requirements, there would be no change in the initial certification

effective date previously provided by the MAC to the RO. However, if the MAC finds the

HHA does not meet all Federal requirements during the second review, there would be a

delay in the effective date of any provider agreement that might eventually be issued to the

HHA applicant until all requirements are determined to be met.)

The RO will issue a provider or supplier agreement with an effective date, and assign a

CMS Certification Number (CCN). (See Section 2008.) The RO will notify the MAC of

the applicant’s approval for participation in the Medicare program by sending the Provider

Tie-In Notice (Form CMS-2007), and/or a copy of the approval letter that will include the

CCN. The RO will send the SA a copy of the applicant’s approval letter.

Applicant Not in Compliance – The SA surveys the applicant and certifies that the

applicant is not in compliance with the conditions of participation/coverage/certification

or requirements, as applicable. (See Section 2008D for more information on the

circumstances under which the SA certifies the applicant is or is not in compliance.) The

SA forwards the survey results to the RO, which will send the provider/supplier a denial

letter. The RO will forward a copy of the denial letter to the MAC and to the SA. Claims

will not be paid if the applicant is not approved through both the enrollment and the

survey and certification processes.

The applicant is issued a denial letter for noncompliance with the conditions of

participation/coverage/certification. The applicant may correct the deficiencies and

reapply for certification. The applicant who reapplies for certification must undergo a new

survey which is a full, standard survey, except:

• If on the first survey an applicant subject to the Life Safety Code (LSC)

requirements was in substantial compliance with the LSC, the SA has the

discretion to not resurvey for LSC compliance (although it must receive an

acceptable Plan of Correction for any lower-level LSC deficiencies before it may

recommend certification); and

• In the case of an applicant seeking to participate as a hospital, the SA has the

discretion to conduct a new survey of only those conditions for which the applicant

was found non-compliant during the prior survey. If the SA chooses to conduct

such a focused subsequent survey, the hospital applicant must submit an

acceptable plan of correction for all noncompliance identified in the prior survey,

including for conditions where there were only lower-level deficiencies cited,

before the SA may conduct the subsequent survey.

NOTE: It is not possible for an initial applicant to seek CAH status; the applicant

must first be certified as a hospital, and then subsequently the hospital may apply

to convert to CAH status. This is technically a conversion, not an initial

application. If the SA certifies that the CAH applicant is not in compliance, then

the RO sends a letter denying the hospital’s request to convert to CAH status.

Unless the denial was based on the applicant not satisfying the CAH location

requirements, the applicant may seek to be surveyed again for CAH conversion.

As with initial hospital applicants, the SA has the discretion to conduct a new

survey of only those conditions for which the CAH applicant was found non-

compliant during the prior survey. If the SA chooses to conduct such a focused

subsequent survey, the CAH applicant must submit an acceptable plan of

correction for all noncompliance identified in the prior survey, including for

conditions where there were only lower-level deficiencies cited, before the SA

may conduct the subsequent survey.

In all cases the RO retains the authority to require a new full survey if it has concerns

about a certification recommendation based on a focused survey after a prior survey

identified substantial noncompliance. In cases where the RO anticipates that it will

require a new full survey, it should notify the SA of this as soon as possible, to facilitate

planning for the full survey by the SA.

If the SA continues to find the applicant is not in compliance with the conditions of

participation/coverage/certification or requirements, as applicable, on the subsequent

survey, the above process may be repeated. However:

• The applicant may submit no more than two reapplications for certification in

connection with one enrollment application; and

• No more than six months may elapse between the date of the RO’s first denial of

certification and receipt by the RO of a second reapplication for certification (for a

total of three certification applications).

If the applicant fails to demonstrate compliance by the end of this six month period, the

RO not only issues a final denial of certification, but also sends a written recommendation

to the MAC that the enrollment application be closed out as denied. If the applicant

continues to seek enrollment and certification, the RO must receive a new MAC

recommendation for approval before it may process a new certification application.

2005A3 - Reconsideration of Denial

Procedure for Reconsideration - An applicant has the right to request a reconsideration of

an initial certification denial decision. See Chapter 3, Sections 3050 – 3054 for

reconsideration procedures and timeframes. Note that the RO may not simultaneously

process a certification reapplication and a request for reconsideration. However, in

accordance with Section 3054A, the applicant may withdraw its reconsideration request

and reapply for certification if it has corrected the deficiencies identified on the survey.

2005A4 – Deemed Providers/Suppliers, Excluding CLIA

Initial Survey by an AO with a CMS-Approved Medicare Accreditation Program

The AO’s CMS-approved Medicare accreditation program must provide reasonable

assurance that providers or suppliers accredited by the AO meet all Medicare Conditions

of Participation (CoPs) or Conditions for Coverage/Certification (CfCs), as applicable.

CMS evaluates and reviews AOs seeking recognition of their accreditation programs for

Medicare participation on a number of factors specified in 42 CFR §488.8, including the

AO’s accreditation standards, survey and oversight processes, and their comparability to

CMS' standards and processes. Furthermore, 42 CFR §489.13 governs how CMS

determines the effective date of a provider’s or supplier’s Medicare agreement or

approval, including provisions related to certification survey findings.

Accordingly, before the AO makes a recommendation to CMS that an applicant seeking

initial certification and enrollment in Medicare be “deemed” to meet Medicare’s health

and safety standards, the AO must conduct a survey and determine that the applicant

meets all requirements for accreditation, including compliance with all applicable

Medicare CoPs or CfCs.

Applicant in Compliance

If the applicant is found to comply with all accreditation requirements, the AO may award

deemed status accreditation, effective no earlier than the accreditation survey end date,

and recommend the applicant to the RO for Medicare certification via deemed status. The

AO must inform the applicant and the RO of the results of the initial accreditation survey

and of its recommendation of the applicant for certification via deemed status, including

the effective date of the applicant’s accreditation.

If the applicant is found to be in substantial compliance, but has lower-level deficiencies,

then the AO must receive an acceptable plan of correction (POC) for such deficiencies.

(See Section 2008D.) Once the AO receives an acceptable POC from the applicant, the

AO may award deemed status accreditation and recommend the applicant for Medicare

certification via deemed status. The AO may not make the effective date of the

applicant’s deemed status accreditation prior to the date of receipt of a POC that the AO

finds acceptable. The AO must inform the applicant and the RO of the results of the

initial accreditation survey, the receipt of an acceptable POC, and its recommendation of

the applicant for deemed status, including the effective date of accreditation. The AO

must also send its survey report to the RO.

When the AO notifies CMS of an applicant’s accreditation and the AO’s recommendation

of deemed status for that applicant, the RO reviews the AO’s accreditation survey report

and other documentation. If the RO accepts the AO’s recommendation of deemed status,

it forwards the AO’s notice of accreditation and recommendation of deemed status to the

SA. The SA must prepare an initial certification packet for the provider or supplier. The

certification packet is sent by the SA to the RO, with the Medicare Health Insurance

Agreement (Form CMS-1561, 1561A or 370, depending on provider/supplier type)

submitted to the SA by the applicant, along with any other documentation required for

initial certification of that provider/supplier type. (See Exhibit 63 for documentation

requirements.) In the remarks section of the Form CMS-1539, the SA indicates that it is

transmitting an initial certification kit for an accredited, deemed provider/supplier. Once

the RO receives the certification packet, it proceeds as described in Section 2005A2. The

RO must send to the AO in a timely manner a copy of its approval letter to the applicant.

Among other things, the copy of the approval letter advises the AO of the CCN assigned

to the new provider’s/supplier’s Medicare agreement, facilitating the AO’s ability to

report accurate data to CMS on its deemed status providers/suppliers.

If the RO’s review of the accreditation survey suggests a problem, including, but not

limited to:

• the AO’s survey report describes findings which represent substantial noncompliance

with a Medicare condition, but the AO awarded accreditation anyway; or

• the AO’s survey report indicated the applicant was required to submit an acceptable

POC for lower-level deficiencies, but the AO issued its accreditation effective on a

date prior to its receipt of the POC; or

• the AO conducted an extension survey but the applicant is a new owner that rejected

assignment of the prior owner’s Medicare agreement and must therefore undergo a full

accreditation survey;

the RO may, consistent with §488.6(c)(2), reject the AO’s recommendation of deemed

status. In such cases the RO contacts the AO to discuss its concerns and ways the AO

may remedy them, if possible. If the problems are not remedied, the RO may issue a

denial of certification to the applicant and provides a copy to the AO in a timely manner.

Applicant Not in Compliance

If the AO finds the applicant’s failure to meet its CMS-approved Medicare accreditation

program requirements represents substantial noncompliance with accreditation standards,

including applicable Medicare CoPs or CfCs, the AO may not recommend the applicant

for Medicare certification via deemed status. Rather, the AO must inform the applicant

and the RO of the results of the initial survey and that it is not recommending the applicant

for deemed status. The RO issues a denial of certification based on the AO’s information,

and provides a copy to the AO in a timely manner.

The applicant may, at the AO’s discretion, continue to work with the AO to correct the

deficiencies and again seek initial certification through deemed status. If the applicant is

surveyed again by the AO the survey must be a new survey which is a full, standard

survey, except:

• If on the first survey an applicant subject to the Life Safety Code (LSC)

requirements was in substantial compliance with the LSC, the AO has the

discretion to not resurvey for LSC compliance (although it must receive an

acceptable Plan of Correction for any lower-level deficiencies before it may

recommend deemed status); and

• In the case of an applicant seeking to participate as a hospital, the AO has the

discretion to conduct a new survey of only those conditions for which the applicant

was found non-compliant during the prior survey. If the AO chooses to conduct

such a focused subsequent survey, the hospital applicant must submit an

acceptable plan of correction for all noncompliance identified in the prior survey,

including for conditions where there were only lower-level deficiencies cited,

before the AO may conduct the subsequent survey.

NOTE: It is not possible for an initial applicant to seek CAH status; the applicant

must first be certified as a hospital, and then subsequently the hospital may apply

to convert to CAH status. This is technically a conversion, not an initial

application. If the AO advises CMS that it is not recommending the applicant for

CAH deemed status or if the RO determines that the applicant does not satisfy the

CAH location requirements, then the RO sends a letter denying the hospital’s

request to convert to CAH status. Unless the denial was based on the applicant not

satisfying the CAH location requirements, the applicant may, at the AO’s

discretion, continue to work with the AO to correct the deficiencies and again seek

CAH certification through deemed status. As with initial hospital applicants, the

AO has the discretion to conduct a new survey of only those conditions for which

the CAH applicant was found non-compliant during the prior survey. If the AO

chooses to conduct such a focused subsequent survey, the CAH applicant must

submit an acceptable plan of correction for all noncompliance identified in the

prior survey for all noncompliance identified in the prior survey, including for

conditions where there were only lower-level deficiencies cited, before the AO

may conduct the subsequent survey.

In all cases the RO retains the authority to require a new full survey if it has concerns

about a deemed status recommendation based on a focused survey after a prior survey

identified substantial noncompliance. In cases where the RO anticipates that it will

require a new full survey, it should notify the AO of this as soon as possible, to facilitate

planning for the full survey by the AO.

If the AO continues to find substantial noncompliance on the subsequent survey, the

above process may be repeated. However:

• The applicant may submit no more than two reapplications for certification in

connection with one enrollment application; and

• No more than six months may elapse between the date of the RO’s first denial of

certification and receipt by the RO of a second reapplication for certification (for a

total of three certification applications).

If the applicant fails to demonstrate compliance by the end of this six month period, the

RO not only issues a final denial of certification, but also sends a written recommendation

to the MAC that the enrollment application be closed out as denied. If the applicant

continues to seek enrollment and certification, the RO must receive a new MAC

recommendation for approval before it may process a new certification application.

2005B - Deemed Providers/Suppliers Except CLIA – Additional

Information

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

AO renewal of deemed provider/supplier accreditation:

AOs conduct re-accreditation surveys of Medicare-deemed providers and suppliers on a

triennial basis. Upon awarding re-accreditation, the AO also makes a recommendation for

the provider’s or supplier’s continued Medicare deemed status. The provider’s or

supplier’s deemed status continues without interruption.

When the AO notifies CMS of its renewal of accreditation and recommendation of

continued deemed status, the RO forwards the notice to the SA and the SA must prepare a

recertification kit for the provider or supplier. The recertification packet is sent by the SA

to the RO, with the Form CMS-1539 and any other documentation required for that

provider/supplier type. (See Exhibit 63 for documentation requirements.) In the remarks

section of the Form CMS-1539, the SA indicates it is transmitting an accredited, deemed

provider/supplier update.

Termination/Withdrawal; Removal of Deemed Status

The AO must notify CMS whenever a provider’s or supplier’s accredited status is not

renewed, as well as the reason for the loss of accreditation. If the AO notifies CMS that

the AO has terminated a provider’s or supplier’s accreditation, or that the provider or

supplier has voluntarily withdrawn from the AO’s CMS-approved Medicare accreditation

program, the RO must remove the provider’s or supplier’s deemed status, unless there is

evidence of accreditation under another CMS-approved Medicare accreditation program.

For example, if the provider or supplier was accredited simultaneously under two CMS-

approved programs, and one AO notifies CMS of a termination or withdrawal, the

provider/supplier would continue to have deemed status based on the other accreditation.

However, if the notice of termination by the first AO indicates that the reason for

termination was the provider’s/supplier’s failure to meet accreditation standards, the RO

must consider this a substantial allegation of noncompliance with Medicare standards and

must authorize the SA to conduct a complaint investigation.

If one AO provides notice of termination or withdrawal and concurrently another AO

recommends deemed status, a recertification packet including the new AO

recommendation must be submitted by the SA to the RO. (See also Section 3258.)

If the RO removes the provider’s or supplier’s deemed status, it places the

provider/supplier under the jurisdiction of the SA and must advise the SA of the change in

the provider’s/supplier’s status. The SA surveys the facility in order to provide assurance

that the facility is in compliance with the applicable Medicare conditions. The timing of

the SA survey depends on the reason for the provider’s/supplier’s loss of accreditation:

• If the AO terminates accreditation due to failure of the provider/supplier to meet

accreditation standards, then the SA must conduct a standard survey within 45

calendar days of notification by the RO that deemed status has been removed. If

the AO’s reason for termination appears to be related to an immediate jeopardy,

then the RO instructs the SA to conduct the standard survey as soon as possible.

• If the AO terminates accreditation due to voluntary withdrawal or failure to pay

fees by the provider/supplier, the SA prioritizes the provider’s/supplier’s survey on

the basis of the current CMS policy concerning survey frequencies and SA

workload priorities, using the date of the most recent accreditation survey to

calculate the survey interval, unless:

• The facility is a home health agency (HHA). Then the SA must conduct the

survey no later than 3 years after the last accreditation survey; or

• The RO exercises its discretion to request the SA to conduct the survey by a

specified date.

CMS may also temporarily remove deemed status (and therefore AO jurisdiction) when a

SA or Federal survey team identifies condition-level non-compliance in a deemed

provider or supplier during either a representative sample or substantial allegation

validation survey. The RO advises the provider or supplier that its deemed status is

removed and that it is being placed under SA jurisdiction. However, no change is made to

the provider’s or supplier’s deemed status in the Automated Survey Process Environment

(ASPEN). Instead, the placement of the provider or supplier under SA jurisdiction is

noted under the Deeming tab within the certification kit in ACO.

The provider/supplier remains under SA jurisdiction until it either demonstrates

substantial compliance or CMS terminates its Medicare participation. If the

provider/supplier demonstrates substantial compliance to the SA, CMS restores its deemed

status. Note that there is no prohibition against an AO also conducting its own survey of a

provider/supplier that is temporarily under SA jurisdiction.

Other AO adverse actions

The AO is required to inform CMS of significant adverse actions it takes against the

accreditation status of a provider/supplier participating through deemed status. However,

as long as the accreditation under the AO’s CMS-approved Medicare accreditation

program is not terminated, the provider/supplier's participation in Medicare is not affected.

See Section 3258 for information on actions to take when an AO terminates the

accreditation of a deemed provider or supplier.

The AO is also required to inform CMS by close of business the next day when it

identifies an immediate jeopardy situation on a survey. In such cases, the RO generally

triages this as an immediate jeopardy complaint and directs the SA to conduct a

substantial allegation validation survey, based on the information provided by the AO.

2005C - Clinical Laboratory Improvement Amendments of 1988 (CLIA)

Laboratories

(Rev. 1, 05-21-04)

The procedures for initial certification basically apply to CLIA laboratories with a few

exceptions. The enrollment procedures for CLIA laboratories are outlined as follows.

CLIA laboratories will be surveyed (if applicable) and registered for CLIA participation

whether or not the laboratory enrolls in Medicare. The enrollment Form CMS-855A or

CMS-855B process applies to all CLIA laboratories that participate in Medicare. This

includes laboratories that have a certificate of waiver, certificate for physician performed

microscopy procedures, certificate of accreditation, certificate of compliance, certificate of

registration, or are state exempt. However laboratories that bill through the fiscal

intermediary (are part of a Part A institutional provider, such as a hospital or SNF) will not

need to complete the Form CMS-855A or CMS-855B.

The Form CMS- 855A or CMS-855B will be downloaded from the CMS Web site -

http://www.cms.hhs.gov/forms/ and completed by the CLIA laboratory. The SA will mail

out Form CMS-116, and any other form needed for CLIA registration to the laboratory. A

CLIA laboratory is only required to complete a Form CMS-855A or CMS-855B if it

decides to enroll in Medicare. At the time a laboratory initially applies for CLIA

registration, inquire as to whether the laboratory intends to bill Medicare.

If the laboratory intends to bill Medicare, send the laboratory Form CMS-116 and Form

CMS-855A or CMS-855B. Questions on the Form CMS-855A or CMS-855B, form

should be addressed to the intermediary/carrier. The SA will send the laboratory the Form

CMS-116. The laboratory will complete and return the Form CMS-116 to the SA and the

Form CMS-855A or CMS-855B to the FI or Carrier. The SA will enter the Form CMS-

116 into the CLIA data system, and the system will assign a CLIA number to the

laboratory. For CLIA laboratories, the intermediary/carrier will be responsible for all

aspects of the Form CMS-855A or CMS-855B and Medicare enrollment processing. After

the intermediary/carrier has reviewed and verified the Form CMS-855A or CMS-855B, it

will send a completed copy of the Form CMS-855A or CMS-855B to the RO and State

survey agency along with its recommendation for approval or denial. (See §2005.A) for

instructions regarding approvals, denials and appeals.) Processing of the Form CMS-

855A or CMS-855B will not affect the scheduling of CLIA surveys since CLIA

registration must occur regardless of Medicare enrollment. If a laboratory is denied for

Medicare, follow the instructions for denials and take all appropriate CLIA-related

actions.

If the laboratory does not plan to bill Medicare, it should complete Forms CMS-116 and

return it to the State survey agency.

2005D - Supplementary Applications

(Rev. 1, 05-21-04)

An additional application used for supplementary purposes to support the Form CMS-

855A or the CMS-855B is The Medicare Individual Reassignment of Benefits Health Care

Provider/Supplier Application (Form CMS-855R). The Medicare Change of Information

Health Care Provider/Supplier Application (Form CMS-855C) is no longer used. The

CMS-855A or the CMS-855 B is used to report changes to enrollment (see also §2003).

The fiscal intermediary/carrier will send a copy of the Form CMS-855A or CMS-855B

with the updated/changed information to the appropriate State Agency and RO.

2005D1 - Forms CMS-855A or the CMS-855B for Changes in

Provider/Supplier Information

(Rev. 1, 05-21-04)

Application changes are changes to any items on the Form CMS-855A or CMS-855B.

These changes require the submission of the appropriate updated sections of the Form

CMS-855A or CMS-855B with a signed certification statement. The changes will be

reviewed by the fiscal intermediary/carrier. The review will result in a recommendation

for approval, denial, or return for additional information. The fiscal intermediary/carrier

will send a copy of the Form CMS-855A or CMS-855B with the updated/changed

information to the State agency or RO that distributed the initial application.

When a provider experiences a change of ownership the current owner will check the box

marked “potential termination of current ownership” on the Form CMS-855A or CMS-

855B.

Voluntary use of the Form CMS-855A or CMS-855B is encouraged for

providers/suppliers that were previously certified without completing the Form CMS-

855A or CMS-855B. However, these providers/suppliers may submit these changes in

writing on letterhead with an authorized signature.

2005D2 - Form CMS-855R

(Rev. 1, 05-21-04)

In general, Medicare only makes payments to the individual or entity that directly

provides services. However, an individual may reassign benefits to an eligible entity as

defined in 42 CFR 424.80. This application must be completed when an individual

practitioner is reassigning his/her benefits to an eligible entity. An eligible entity is a

business organization that is eligible to receive reassigned benefits (e.g., employer,

facility, health care delivery system or agent). Not every provider/supplier will need to

complete the Form CMS-855R. Organizations that are likely to receive reassigned benefits

are: hospitals, hospices, SNF, ESRD, RHC, CORF, FQHC, and CMHC.

The Form CMS-855R is available to applicants for downloading via the CMS Web site at

http://www.cms.hhs.gov/forms/. The State survey agency should inform the applicant that

any questions concerning the Form CMS-855R should be directed to the intermediary or

carrier. If the State agency receives the Form CMS-855R, it will forward the Form CMS-

855R to the intermediary. After reviewing the application and making a recommendation,

the intermediary will forward the package to the carrier for the carrier’s review of the

reassignment of benefits.

2005E - Changes of Ownership

(Rev. 1, 05-21-04)

See §3210 for a full discussion of change of ownership (CHOW). The following

procedures apply to all provider/supplier types that are subject to survey and/or

certification.

2005E1 - CHOW Occurs

(Rev. 1, 05-21-04)

For a CHOW, the current owners will submit a Form CMS-855A or CMS-855B citing the

termination of current ownership. The current owner will check the box marked “potential

termination of current ownership” on the Form CMS-855A or CMS-855B and complete

Section 1 (Provider/Supplier Information), Section 8 (Potential Termination of Current

Ownership), and Section 10 (Attestation Statement). The new owners will complete and

submit a new Form CMS-855A or CMS-855B.

The current and new owners will submit the Form CMS-855A or Form CMS-855B along

with any supporting documents to the FI or carrier. The RO has the delegated authority for

making the determination if a CHOW actually exists. [However, the RO may delegate

this responsibility to the State agency.] For complex or questionable situations, the

FI/carrier will forward all documents to the RO for review. Upon review of all documents,

the RO will make the decision as to whether or not a CHOW has occurred. The

intermediary/carrier will verify the Forms CMS-855A or CMS-855B and may take one of

three actions on a CHOW:

● Recommendation for approval;

● Recommend for denial; or

● Request for additional information.

Verification of Information From Intermediary/Carrier - After a complete review and

verification of the application, if no additional information is needed, and there is no need

to issue a denial, the intermediary/carrier notifies the RO/SA of its verification of

information provided about the CHOW within 30 calendar days (absent extenuating

circumstances) of the receipt of the completed enrollment applications. The notification

will be written and accompanied by a copy of the completed Forms CMS-855A or

CMS-855B, if any changes were made to the forms.

RO Determines CHOW Has Occurred - If the RO determines that a CHOW has

occurred, the RO waits until it receives the intermediary/carrier’s verification of

information about the CHOW before completing the process. When the process is

completed, the RO will notify the provider/supplier, State agency and intermediary/carrier

that a CHOW has occurred.

RO Determines CHOW Has Not Occurred - The RO makes the final decision whether

a CHOW has actually occurred. If the RO determines that a CHOW has not occurred, the

RO notifies the provider/supplier, the State survey agency, and the intermediary/carrier

that a CHOW has not taken place. The notification should explain the reason(s) why a

CHOW has not occurred.

Recommendation for Denial from Intermediary/Carrier - After a complete review and

verification of the application, the intermediary/carrier may recommend a denial of the

Form CMS-855A or Form CMS-855B based on one or more of the reasons for denial

stated in §2005.A.3. The intermediary/carrier will send the recommendation of denial to

the RO/SA.

For a CHOW, the provider agreement may be automatically assigned to the new owner.

However, the new owner could choose to come into Medicare as a new applicant and

should be advised of this option. In such a case if the new owner accepts the assignment it

also assumes the former owners liabilities. (The new owner could also receive an

outstanding underpayment under this scenario). The new owner must enroll the same as

any other new applicant (see §3210), undergo the survey and certification process, and be

issued a new provider agreement/number. The RO/SA processes a voluntary termination

of the provider agreement of the former owner.

2005E2 - Change in Intermediary as Result of CHOW

(Rev. 1, 05-21-04)

Providers who are changing their intermediary as a result of a CHOW, acquisition,

merger, or consolidation should submit the information to the new intermediary of

preference. This information, which is required to be submitted by Form CMS-855A,

should be promptly processed by the new intermediary. However, the provider should

also request a change of intermediary from the RO. If an FI receives a Form CMS-855A

for a CHOW that requires a change of intermediary, it should contact the provider and

advise it to contact the current RO for a change of intermediary. The new intermediary

shall contact the outgoing intermediary and provide it with the submitted information. If

the provider mistakenly submits the CHOW information to the old intermediary, the old

intermediary shall contact the new preferred intermediary and forward the submitted

information to it. The new intermediary shall note on any recommendation for approval if

a required change of intermediary request has not yet been approved by the RO.

NOTE: CHOW determinations are the responsibility of the RO unless otherwise

delegated.

2005E3 - CHOWs Involving Multi-Regional Chain Organizations

(Rev. 1, 05-21-04)

When a CHOW involves a multi-regional chain organization, a lead or coordinating RO is

designated. This will typically be the RO serving the State in which the headquarters of

the chain doing the acquiring is located. The coordinating RO will notify all other affected

ROs and intermediaries involved in the CHOW determination and processing of

enrollment activities. The lead RO may decide which intermediary(ies) will process the

new CHOW applications. A separate Form CMS-855A is still required for each

separately surveyed provider/supplier. However, they all may be processed simultaneously

by the receiving intermediary when the incoming chain requests one intermediary for all

the units. Each intermediary shall follow the instructions of the lead RO for CHOWs

involving multi-regional chains.

For a CHOW which involves multiple incoming or multiple outgoing intermediaries

handled by the same RO, the RO shall also direct where and how the new application

should be reviewed, and serve as the coordinator for the CHOW in a manner similar to

being the lead RO for a multi-regional CHOW.

2005E4 - Change of Owners, but Not CHOW

(Rev. 1, 05-21-04)

A partnership provider sometimes experiences an addition or deletion of personnel, but a

CHOW does not occur. For example, a provider may add or delete owners without

experiencing a CHOW. In these situations, the provider should complete section 10

(Ownership Information) on the Form CMS-855A or CMS-855B. It should also complete

identifying information in section 1 (Applicant Information) and section 19 (Certification

Statement). The rest of the form does not need to be completed. Advise the

provider/supplier to submit the Form CMS-855A or CMS-855B directly to the

intermediary/carrier. The intermediary/carrier will send a copy of the Form CMS-855A or

CMS-855B to the SA/RO when it has completed its verification.

In certain situations, based on the review of a submitted Form CMS-855A or CMS-855B,

the intermediary/carrier may suspect that a CHOW has occurred that the RO may not be

aware of. In these cases, the intermediary/carrier may notify the State survey agency and

RO and request a determination. The intermediary/carrier will send a letter to the State

survey agency and RO, along with a copy of the Form CMS-855 or CMS-855B and any

supporting documentation. The RO will determine whether a CHOW has actually

occurred and report its findings to the intermediary and the State survey agency.

2005F - Voluntary Terminations

(Rev. 201, Issued: 06-19-20, Effective: 06-19-20, Implementation: 07-27-20)

A provider agreement may be voluntarily terminated in accordance with the regulations at

42 CFR §489.52. The provider must send written notice of its intention, a letter on

letterhead with an authorized signature, to its RO or SA within the timeframes addressed

in §489.52. Suppliers must provide notice in accordance with the regulatory requirements

specific for the supplier type.

Additionally, a provider/supplier must properly complete and submit the applicable Form

CMS-855A or CMS-855B to the MAC. If the provider/supplier sends the Form CMS-

855A or CMS-855B for voluntary termination directly to the MAC, then the MAC will

notify the RO and SA via email within three days from the receipt of the completed form.

NOTE: In a change of ownership situation, the rejection of automatic assignment of the

existing provider/supplier agreement (by the new owner) is a voluntary termination of the

agreement/approval, including its associated CCNs, in accordance with 42 CFR 489.52.

Further, if the new owner rejects automatic assignment of the acquired facility’s existing

provider/supplier agreement, and that facility previously was deemed to meet the

applicable conditions based on its accreditation under a CMS-approved Medicare

accreditation program, the accrediting organization (AO) may not “extend” the facility’s

prior deemed status to the new owner. Instead, the AO must conduct a full initial

accreditation survey of the facility under its new ownership after the acquisition date. The

effective date of the new owner’s Medicare provider agreement or supplier approval is

established in accordance with the provisions of 42 CFR 489.13. For complete

information on CHOWs, see SOM 3210.

NOTE: A cessation of business is a voluntary termination under 42 CFR 489.52(b)(3).

2008 - Prioritizing SA Survey Workload - Initial Surveys and

Recertifications

(Rev. 1, 05-21-04)

2008A - Surveys of New Providers and Suppliers

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

New providers/suppliers, including providers/suppliers whose previous Medicare

agreement was terminated and are now seeking initial certification, must be in full

operation and providing services to patients when surveyed. This means that at the time

of survey, the institution must have opened its doors to admissions, be furnishing all

services necessary to meet the applicable provider or supplier definition, and demonstrate

the operational capability of all facets of its operations. To be considered “fully

operational,” initial applicants must be serving a sufficient number of patients so that

compliance with all requirements can be determined.

A survey evaluates the manner and degree to which the provider or supplier satisfies the

various requirements or standards within each condition. Surveyors must directly observe

the provision of care and services to patients, and the effects of that care, in addition to

interviewing staff and patients and reviewing medical records to assess whether the care

provided meets the needs of individual patients and is in compliance with all

requirements. Surveyors also review selected provider/supplier policy and procedure

documents if needed to support or clarify observations suggesting deficiencies.

When the provider/supplier notifies the SA of full operation, the SA documents the file

with the date of notification. The SA conducts the survey in a timeframe consistent with

CMS policy regarding budget and workload priorities.

2008B - Initial Surveys of HHAs

(Rev. 1, 05-21-04)

In addition to an onsite survey to determine compliance with the health and safety

conditions of participation (CoP), an HHA applicant must now meet capitalization

requirements, and complete the enrollment information contained on the Form CMS-855A

or CMS-855B, which includes the HHA’s ownership information. Also, the Centers for

Medicare & Medicaid Services (CMS) is now requiring each HHA applicant to have

provided skilled home health services to a minimum of 10 patients before a survey is

conducted. At least 7 of the 10 required patients should be receiving care from the HHA

at the time of the initial Medicare survey.

2008D - Effective Date of Medicare Provider Agreement or Approval for

Suppliers

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

In accordance with 42 CFR 489.13, the effective date of participation in the Medicare

program, i.e. the effective date indicated on the provider or supplier agreement issued by

the RO, may not be earlier than the date on which the provider or supplier meets all

federal requirements. Federal requirements include, but are not limited to:

• Meeting all Medicare enrollment requirements addressed in 42 CFR 424;

• Meeting all Medicare provider agreement requirements addressed in 42 CFR 489.10

and 42 CFR 489.12, and;

• Compliance with Medicare health and safety standards, i.e., the Conditions of

Participation, Conditions for Coverage, Conditions for Certification, or long term care

Requirements, as applicable.

• For an agreement with a federally qualified health center (FQHC), no survey is

required to determine compliance. The effective date is the date on which CMS

accepts a signed agreement in which the FQHC attests that it meets all Federal

requirements. For FQHCs, the RO uses as the effective date of the supplier

approval the date that the MAC indicates it determined that the FQHC’s

enrollment application was complete and approvable.

• A Medicare supplier approval of a laboratory is effective only while the laboratory

has in effect a valid CLIA certificate issued under 42 CFR Part 493, and only for

the specialty and subspecialty tests it is authorized to perform.

• Other types of providers and suppliers demonstrate compliance with applicable

conditions or requirements via a standard survey by the SA (or Federal

surveyors/contractors), or by an AO with a CMS-approved Medicare accreditation

program.

• If on that survey the provider or supplier meets all health and safety standards

(including elements, where applicable), then the effective date of the Medicare

agreement is the last day of the survey, unless there are other Federal

requirements, such as providing evidence of compliance with Civil Rights

requirements, that the provider or supplier has not yet met. The date when all

other Federal requirements have been met is the effective date of the Medicare

agreement.

• If on that survey the provider or supplier does not meet all health and safety

standards (including elements, if applicable), then, assuming all other Federal

requirements have been met, the effective date of the Medicare agreement

would be:

• For SNFs, the date the SNF has been found to be in substantial

compliance with the requirements for participation, and, if applicable,

has submitted an approvable waiver request. (See 42 CFR 488.301.)

• For non-long term care providers/suppliers, the date when the

provider/supplier has:

• Met all applicable conditions; or

Has been found to be in substantial compliance, but has standard-level (or element-level,

where applicable) deficiencies and the RO (in the case of surveys conducted by

contractors), SA or AO has received an acceptable plan of correction (POC) and/or CMS

receives an approvable waiver request. If a provider or supplier submits both a POC and

an approvable waiver request, the later of the dates of the two submissions would be the

effective date.

2008E - Administrative Considerations

(Rev. 1, 05-21-04)

The SA will schedule more frequent surveys and follow-up visits for providers and

suppliers with a history of poor performance. Keep in mind geographical considerations

and the scheduling of licensure visits and coordinate visits whenever possible. Changes of

Ownership (CHOWs) may necessitate adjustment of the survey interval. (See §2702.)

2008F - SA Scheduling of Resurveys

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

Sections 1819(g)(2)(A)(iii) and 1919(g)(2)(A)(iii) of the Act require that each SNF and

NF respectively be subject to a standard survey no later than 15 months after the previous

standard survey and that the state-wide average interval between such surveys not exceed

12 months. Section 1891(c)(2)(A) requires that each HHA be subject to a standard survey

within a 36-month interval. Since the law also prohibits the announcing of such surveys,

utilize flexible survey schedules to ensure that these surveys are as “unpredictable” as

possible. (Sections 1819(g)(2)(A)(i), 1919(g)(2)(A)(i), and 1891(c)(1) of the Act establish

civil money penalties (CMPs) for any individual who notifies a SNF, NF, or HHA of a

survey.) A facility should not be surveyed during the same month each year. The SA may

conduct surveys of these providers as frequently as it deems necessary, but no more than

15 months after the last standard survey of any SNF or NF, or 36 months for any HHA.

In developing the SA survey schedule for HHAs, SNFs, and NFs (at a minimum), the SA

utilizes information from SA files, the Online Survey Certification and Reporting System

(OSCAR), and other sources at its disposal to identify those providers with poor

performance records who should be resurveyed more frequently. Conversely, the SA

utilizes the same information to identify those providers that have established a history of

good performance, who could be resurveyed less frequently. (See §2702.)

For example, the SA may find that some facilities should be resurveyed within 4 months

of the prior standard survey, while others may not require a resurvey for up to 15 months

from the prior standard survey. The statewide average for SNFs and NFs may not exceed

12 months in a given Federal fiscal year. Schedule surveys to provide a “cushion” against

any unforeseeable events, such as staff turnover. Section 1891(c)(2)(B)(ii) of the Act also

requires conducting a standard survey (or abbreviated standard survey) of any HHA

against which a significant number of complaints have been reported. Sections

1819(g)(2)(A)(iii), 1919(g)(2)(A)(iii), and 1891(c)(2)(B)(i) of the Act also state that such

surveys of SNFs, NFs, and HHAs may be conducted within 2 months of any change in

ownership, administration, management, and (for SNFs and NFs) director of nursing

(DON) to determine whether the change has caused any decline in the quality of care

furnished.

Based on documented evidence of current accreditation, the SA recertifies accredited

entities on a schedule consistent with their accreditation interval. For example, for

hospitals, that interval may be only every three years.

The timing of the Life Safety Code (LSC) survey is at the discretion of the SA. It may

occur before, after, or simultaneously with the health portion of the survey. (See §7410

for more guidance on LSC for SNFs and NFs.)

2010 - Ascertaining Compliance With Civil Rights Requirements

(Rev. 53; Issued: 10-16-09; Effective/Implementation Date: 10-16-09)

Before an agreement is executed with a provider to participate in the Medicare program or

with a provider undergoing a change in ownership (CHOW), there must be a

determination of compliance with civil rights requirements. OCR conducts necessary

investigations and makes determinations related to compliance with the requirements. If

the RO cannot secure an OCR clearance within 20 calendar days, it issues a restricted

provider agreement with a contingency clause, which states that if OCR approval is not

obtained, payment will be recouped as of the date the provider agreement is effective.

The SA provides potential providers with the required OCR Civil Rights Certification

Information Request Packet (Packet) for clearance. The SA collects the completed Packet

(including the signed questionnaire, signed HHS-690 form, and policies and procedures)

from potential providers and forwards them to the RO.

SAs should take the following steps:

• Include the Packet with the initial enrollment package that is sent to a potential

provider or to a provider undergoing a CHOW;

• Ask the potential provider or provider undergoing a CHOW to return the

completed signed questionnaire, HHS-690 Form, and civil rights policies and

procedures to the SA with the rest of the Medicare application package;

• Ensure that completed OCR documents are included in the Medicare package

before forwarding to the CMS RO; and

• Inform the potential provider or provider undergoing a CHOW that the Medicare

application will not be forwarded to CMS until the civil rights documents and

forms have been completed and returned to the SA.

NOTE: OCR has Civil Rights Corporate Agreements (Agreements) with certain health

care corporations. Providers that belong to those corporations need to submit

ONLY the signed certification sheets, as specified in the corporations’

Agreements.

Processing OCR Documents - Upon receipt of the OCR documents, the CMS RO

forwards them to the OCR for processing and clearance. The role of the SA and CMS is

limited to obtaining the documents and forwarding them to OCR.

Copies of the current version of the Packet can be downloaded from

http://www.hhs.gov/ocr/civilrights/resources/providers/medicare_providers/index.html.

SAs must include this link with their initial certification and CHOW packages.

Regarding Medicaid-only providers, the States themselves are recipients of the Federal

funds and may be considered to have a direct obligation to assure OCR of their

compliance by assuring that funds go to providers who are in compliance. As with

Medicare, potential providers or providers undergoing a CHOW must be determined to be

in compliance with civil rights laws by OCR as a condition for approving the provider’s

participation in the Medicaid program.

2012 - SA Identifying Eligible Providers and Suppliers

(Rev. 1, 05-21-04)

Initial certifications of providers or suppliers involve steps, including enrollment, to

survey applying providers/suppliers and confirm their eligibility. These steps are not

repeated on cyclical recertification if the basic eligibility factors have not changed. Since

the requirements in the statute and regulations differ for specific provider/supplier

categories, the initial identification and screening procedures are unique to each type of

provider or supplier.

For Medicare purposes, the SA initial certification of compliance occurs before the RO

makes its official determination that the provider/supplier meets all necessary

requirements. The SA may contact the RO for advice if some aspect of Medicare

eligibility is in dispute. Ordinarily, the SA develops as much information on the issue as is

appropriate, completes the certification, and forwards the documentation to the RO for its

decision. The SA should use the following criteria:

• If the provider/supplier meets the CoPs, Conditions for Coverage, or in substantial

compliance with the Requirements for SNFs, and is in full compliance with all

other requirements, i.e., no deficiencies, send the Certification and Transmittal

(Form CMS-1539) and all other documents to the RO within 10 calendar days of

the survey; or

• When the provider/supplier meets the CoPs or Conditions for Coverage, but it fails

to meet other requirements, i.e., it has deficiencies below the Condition level,

transmit all documentation to the RO within 45 calendar days of the survey. A

provider/supplier found to be deficient with one or more standards, or other

requirements below the Condition level may participate if it has submitted an

approved PoC for achieving compliance within a reasonable period of time. A

PoC must be submitted within 10 calendar days of the facility’s receipt of the

official Form CMS-2567. The entity may be granted additional time if the plan is

complex. (See Chapter 7 for SNFs and NFs.)

Provider institutions are often complex health care delivery institutions centered around

primary short-term hospitals. Although a totally new hospital may be rare, provider

complexes frequently re-combine and reform or merge. This may or may not create new

certification entities. In general, if the statute or regulations provide for separate

certification of related or satellite components, they must be separately certified, e.g., a

distinct part SNF in a hospital.

In some instances a satellite’s certification depends upon the primary provider being

approved to participate, e.g., a hospital-based hospice or an ESRD transplant center. The

SA should recognize and act upon organizational combinations, and complete Form CMS-

1539 to reflect a change. A provider is the party having ultimate responsibility and

liability for the operational decisions of the institution. Consequently, the SA should

know what components are under the control of the provider’s governing body (as

opposed to being loosely affiliated), and when the governing body’s control of a

component has changed.

2016 - Readmission to Medicare or Medicaid Program After Involuntary

Termination - Reasonable Assurance

(Rev. 1, 05-21-04)

(See also Chapter 7 for SNFs and NFs.)

2016A - Readmission Criteria

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

After involuntary termination of a provider’s agreement, an institution cannot participate

in the Medicare or Medicaid program again unless:

The provider submits with its request for readmission sufficient justification to

indicate that the reasons for termination no longer exist; and

All of the applicable statutory and regulatory requirements are met; or

There is reasonable assurance for Medicare entities or Medicaid ICFs/IID

(terminated under §1910(b) of the Act by CMS) that the deficiencies that caused

the termination will not recur.

2016B - Reasonable Assurance Concept

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

A Medicare provider terminated under 42 CFR 489.53 and reinstated under 42 CFR

489.57 or a Medicaid ICF/IID provider terminated pursuant to §1910(b)(1) of the Act is

required to operate for a certain period of time without recurrence of the deficiencies

which were the basis for the termination. The reasonable assurance concept also applies

to terminated Medicare suppliers such as ASCs (42 CFR 416.35(e)), FQHCs (42 CFR

405.2440), RHCs (42 CFR 405.2404(e)), and ESRD facilities (42 CFR 405.2180(c)).

The length of this “reasonable assurance” period is determined by the RO after an

evaluation of the provider or supplier’s previous compliance history. Reasonable

assurance periods are usually 30-120 days, but depending on the circumstances, can be for

a shorter or longer period of time. Participation can only resume following that period if

the provider or supplier has maintained compliance with program requirements.

The RO determines the reasonable assurance period for:

● Medicare suppliers;

● Medicare providers, including a SNF in a dually-participating facility,

terminated pursuant to §1866(b)(2) of the Act; and

● ICFs/IID terminated by CMS pursuant to §1910(b)(1) of the Act.

In considering the decision to readmit a previously-terminated provider/supplier to the

Medicare or Medicaid program, the RO takes into account not only certification, but also

the intermediary’s statement concerning the institution’s financial responsibility and the

OCR’s report on compliance with civil rights requirements.

NOTE: There is no statutory or regulatory requirement that States must establish a

reasonable assurance period for Medicaid-only facilities or a NF in a dually-participating

facility that has been terminated by the SMA under §§1902(i) and 1919(h)(1) of the Act.

The reasonable assurance decision is an administrative action (not an initial determination)

and is not subject to the appeals process at 42 CFR Part 498.3(d)(5).

NOTE: These provisions do not apply where a termination action was the result of a

sanction imposed by the OIG. The RO forwards reinstatement requests involving these

provisions to the OIG for appropriate action.)

To determine the reasonable assurance period, the RO will evaluate the following:

1. Provider’s or Supplier’s Compliance History

When the provider/supplier previously participated in either Medicare or Medicaid

(ICF/IID), was compliance maintained historically?

Were PoCs implemented on time?

Does the provider/supplier have a history of making good faith efforts to correct

deficiencies and to maintain compliance?

Does it have a record of being cited repeatedly for essentially the same problems?

Were previous adverse actions initiated, but not put into effect?

2. Previous Adverse Action

Has the applicant/institution previously been terminated and readmitted to the Medicare

program? If yes:

How long was compliance maintained after being readmitted?

Have all deficiencies been corrected?

Are corrective actions permanent; i.e., is compliance likely to continue?

3. Other Factors Impacting Continued Compliance

Is the facility located in an area that is underserved by health professionals, meaning that

staffing deficiencies may continue?

Does the applicant’s pay scale or the facility’s location deter the hiring and retention of

staff?

Does it have inherent problems that are likely to cause recurrence of significant

deficiencies?

Has there been a change in staff or services furnished that might affect continued

compliance?

The following are examples using these criteria to determine reasonable assurance periods.

(See Chapter 7 for examples for SNFs/NFs.)

EXAMPLE A:

Green Acres Community Hospital was terminated on November 1, 1996. The provider

was cited as not meeting several CoPs. On December 1, 1996, the hospital board alleged

to have corrected all deficiencies the SA found. While reviewing the provider’s

compliance history, the RO notes that one or more CoPs were cited in previous surveys,

but the provider usually managed to achieve compliance just before termination.

Reasonable Assurance - The RO establishes 90 days from December 1, 1996, as

reasonable based on the provider’s history of not maintaining compliance.

EXAMPLE B:

Fox Chase General Hospital was terminated on December 21, 1996, for its failure to

maintain required staffing in nursing, dietary, and medical records. On January 2, 1997,

the provider alleged that he hired the necessary staff and requested readmission. Upon

review, the RO finds that the provider is located in a remote, under-served rural area and

has been unable to maintain staff since participation began in 1989.

Reasonable Assurance - The RO establishes 90 days from January 2, 1997, as reasonable

on the grounds that the location of the provider has militated against staff retention, and

that 3 months of continued compliance would evidence the provider’s ability to retain

qualified health professionals.

EXAMPLE C:

The XYZ Home Health Agency was terminated on September 15, 1997. On the four prior

surveys the agency had been cited for failure to meet several of the CoPs, but had, until

the most recent survey, achieved compliance before termination action was completed. On

October 1, 1997, the agency alleged compliance.

Reasonable Assurance - The RO establishes a 120-day reasonable assurance period

based on the provider’s repeated failure to meet the CoPs necessary to ensure the health

and safety of patients.

EXAMPLE D:

The Visiting Nurses, Inc., was readmitted following a 60-day reasonable assurance period.

On the next survey, The Visiting Nurses, Inc., is found not to meet one or more CoPs and

is again terminated. The provider corrects the deficiencies and requests readmission.

Reasonable Assurance - The RO establishes a 120-day waiting period based on prior

termination and failure to maintain compliance following a 2-month reasonable assurance

period.

EXAMPLE E

Pleasant Plains ICF/IID was terminated by CMS on January 10, 1996. The provider was

terminated for deficiencies that posed a threat to client health or safety. The provider

corrected its deficiencies and requested readmission on February 1, 1996. The SA

surveyed the facility on February 10, 1996, and determined that the deficiencies that were

the reason for the termination had been corrected and certified compliance. The

documentation was forwarded to the RO on February 21, 1996. While reviewing all

available documentation, the RO finds that the provider has a history of serious

deficiencies. Moreover, the deficiencies that led to termination have been cited

repeatedly.

Reasonable Assurance - The RO establishes a 180-day waiting period based on the

provider’s history of serious deficiencies and disregard for the health and safety of

patients.

2016C - Request for Readmission

(Rev. 1, 05-21-04)

A terminated provider or supplier may reapply for certification at any time. Upon receipt

of a request from an involuntarily terminated entity that desires readmission to the

program, the SA immediately contacts the entity and informs it of the requirements for

readmission. If the reasonable assurance time-period was not established at the time of

termination, the SA contacts the RO and requests that it establish the reasonable assurance

period so that it may be included in the letter to the facility informing it of the

requirements for readmission to the program. (The RO may choose to delay

establishment of the reasonable assurance period pending the results of the first

survey.) Use Exhibit 41 to inform the provider or supplier of the reasonable assurance

provisions and to transmit the required documents necessary for future participation. (See

the applicable initial certification section in Exhibit 63 for the required documents.)

If the institution then indicates that it meets the requirements for participation and returns

the initial application packet, forward the application packet to the RO via a Form CMS-

1539. The RO will contact the previous servicing intermediary. The intermediary, in

turn, advises the RO whether there are any outstanding financial problems, such as

overpayments, that need to be resolved before the institution is readmitted. In addition,

the RO takes immediate action to obtain title VI clearance.

2016D - Reasonable Assurance Surveys

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Upon receipt of the initial application packet from the SA, the RO will provide the SA

with instructions concerning how to conduct the necessary reasonable assurance surveys.

Two surveys are required for Medicare certification to verify that the reason for

termination no longer exists, and that the provider/supplier has maintained continued

compliance. At least one of these surveys must be a full/standard survey to ensure that all

CoPs/CfCs are met or the SNF is in substantial compliance. The RO has the discretion to

determine whether both surveys will be full/standard surveys, or whether one may be a

partial survey to document compliance with requirements for which there were previous

deficiencies. If the RO decides that one survey will be a partial survey, the RO also

decides whether the partial survey will be the first or the second survey. (CMS, at its

discretion, conducts the survey for a ICF/IID it originally surveyed and terminated

pursuant to §1910(b)(1) of the Act.)

The reasonable assurance period of time begins on the date of completion of the first

survey documenting compliance with requirements for which there were prior

deficiencies.

The SA conducts the first of the reasonable assurance surveys as instructed by the RO and

submits the results of the survey (this may be submitted on Form CMS-2567) to the RO

within 10 working days of the survey. Based on the results of this first survey, the RO

determines if the reasons for termination no longer exist, or for SNFs, the deficiencies that

caused their termination are at the level of substantial compliance. The RO notifies the

SA and the provider/supplier of its determination. If the RO determines that the reasons

for termination no longer exist, or for SNFs that the deficiencies that caused the

termination are at the level of substantial compliance, the reasonable assurance period

begins effective with the last day of this first survey. If not, the provider must reapply.

Once the RO determines that the reasonable assurance period has begun, the SA will

schedule a second survey to coincide with the end of the reasonable assurance period.

The SA informs the RO of the scheduled survey date. The SA conducts the survey,

completes the Survey Report (as applicable), and prepares a statement to accompany Form

CMS-1539 that includes:

• The finding that the deficiencies which led to termination of the provider

agreement have (or have not) been corrected;

• The evidence showing that compliance has been maintained, and the reasons for

concluding that the deficiencies will not recur; and

• A description of any other deficiencies and, if appropriate, an explanation as to

why the facility is nevertheless in compliance with all CoPs or the SNF is in

substantial compliance (see §§7203.B and 7300.C).

If the RO determines after the second survey that the reasons for termination continues to

exist and/or determines that the provider/supplier does not meet the CoPs or the SNF is

not in substantial compliance, the provider/supplier must again begin the reasonable

assurance process to gain reentry into the program(s). (See §§7203.B and 7300.C for the

exception for SNFs and NFs.)

If an involuntarily terminated provider/supplier attempts to re-enter the Medicare program

via deemed status accreditation under a CMS-approved Medicare accreditation program, it

must still satisfy the reasonable assurance requirements at 42 CFR 489.57. The RO has

the discretion to deny Medicare reentry based solely on deemed status accreditation

surveys and may instead require two surveys be performed by the SA if it is not

reasonably assured the provider/supplier meets the Medicare conditions. The RO also has

the discretion to accept an accreditation survey for either the first or second of the

reasonable assurance surveys. Generally an AO would not conduct both reasonable

assurance surveys, but if it is willing to do so and the RO is reasonably assured that the

provider/supplier meets the Medicare conditions, the RO may permit the AO to conduct

both reasonable assurance surveys.

In cases involving readmission of an involuntarily terminated provider seeking deemed

status, the RO will determine the IF (when it is reasonably assured that the reason for the

termination will not occur), the WHEN (the reinstatement effective date) and the HOW

(e.g., a survey by the SA) of the provider’s/supplier’s reentry into the Medicare program.

The RO will make an analysis of the facts in the case and issue a decision because

receiving deemed status is a separate issue from reinstatement (Reasonable Assurance)

following involuntary termination by CMS under 42 CFR 489.57.

The regulation at 42 CFR 489.57 does not apply to a provider’s voluntary termination of

its agreement under the provisions of the regulation at 42 CFR 489.52. In a scenario

similar to the situation described above except that the provider’s termination from

Medicare was voluntary, CMS (the RO) would still be responsible for the if, when and

how of the provider agreement under 42 CFR 489.12. However, the provider’s

accreditation by a recognized accrediting body and subsequent deemed status would mean

that compliance with the CoP would not be one of the unmet requirements under title

XVIII of the Act that could be invoked under 42 CFR 489.12(a)(3). This is pointed out

because some providers voluntarily withdraw from Medicare in the face of a proposed

involuntary termination. A RO could decide to process an involuntary termination in such

a case. In the absence of having processed an involuntary termination, the RO could apply

42 CFR 488.6(c)(2) in concert with 42 CFR 489.12(a)(3) in a case where a provider facing

involuntary termination voluntarily withdrew from Medicare and subsequently attempted

to re-enter the program through accreditation under a CMS-approved Medicare

accreditation program.

The regulation at 42 CFR 489.57 also does not apply to a provider’s initial application for

Medicare participation. Again, as with a voluntary termination, the CMS (RO) is

responsible for the if, when and how of the provider agreement and a decision to deny the

provider an agreement must be in accordance with 42 CFR 489.12. Also, if an accrediting

organization has determined that the provider is accredited, the provider is deemed to meet

the Medicare conditions and we would have satisfactory assurance of compliance with the

conditions under 42 CFR 489.12(a)(3). However, as with a voluntary termination, we

might look at 42 CFR 488.6(c)(2) in tandem with 42 CFR 489.12(a)(3) in an individual

case. This means that we should notify accrediting bodies if and when we deny a provider

entry into Medicare based on a State survey agency survey. This includes providers that

are surveyed by the State but do not respond to a Statement of Deficiencies.

2016E - Effective Date of Provider Agreement After Reasonable

Assurance

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

If the provider or supplier has maintained compliance throughout the reasonable assurance

period, it may reenter the program and be issued a new provider agreement or supplier

approval. The effective date of the new Medicare agreement and Medicaid FFP is

calculated based on the date of completion of the second reasonable assurance survey.

See Section 2008D for details on the calculation of the effective date.

2016F - Readmission of ICF/IID After Termination

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

Before the SMA readmits an ICF/IID to the Medicaid program after termination by CMS

pursuant to §1910(b)(1) of the Act, the RO must determine that the facility has provided

the SA reasonable assurance that the deficiencies that were the cause for termination will

not recur. The RO will determine the reasonable assurance period, and the RO, or the SA,

at the RO’s request, will monitor the facility to determine that it remains in compliance for

the period of time designated by the RO as the reasonable assurance period. The SA or

the RO will monitor the facility by conducting the necessary survey and revisits.

The reasonable assurance period must be satisfied before the SMA issues an agreement to

that facility and before that facility can qualify for FFP. Failure to provide reasonable

assurance is a basis for CMS to continue to disallow FFP for services furnished by that

facility. (See 42 CFR Part 442.30 and 431.610(f)(1).)

2016G - Under LSC at Time of Readmission

(Rev. 1, 05-21-04)

1. Termination Based on LSC or Health Conditions

Upon readmission, an institution that was terminated for noncompliance with the LSC

must be surveyed under the edition of the Code in effect under current regulations.

2017 - Readmission Following Voluntary Termination of Program

Participation

(Rev. 1, 05-21-04)

If termination action has been initiated but the entity is allowed to terminate Medicare

participation voluntarily before the action is made effective, the reasonable assurance

provision will be applied. If there is not a SA certification of noncompliance at the time a

provider/supplier notifies the RO of voluntary termination, the reasonable assurance

provision does not apply.

2018 - Reinstatement Following Termination of Swing-Bed - Approval

(Rev. 1, 05-21-04)

If swing-bed approval has been terminated for any reason, there is a statutory 2-year

minimum waiting period for reinstatement. Do not apply the “reasonable assurance”

concept in these situations. (See §1883(c) of the Act.)

Hospitals

2020 - Hospitals - Definition and Citations

(Rev. 1, 05-21-04)

A hospital is defined in §1861(e)(1) of the Act. A hospital is an institution primarily

engaged in providing, by or under the supervision of physicians, inpatient diagnostic and

therapeutic services or rehabilitation services. The remainder of §1861(e) defines a

hospital eligible for Medicare participation. Section 1861(f) defines Medicare eligible

psychiatric hospitals. 42 CFR 482 sets forth the CoPs for hospitals, including psychiatric

hospitals. The interpretive guidelines for hospitals appear in Appendix A and

Appendix AA.

2021 – Non-deemed Hospitals

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

2021A – Recertification of Non- deemed Hospitals

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Hospitals that are certified for Medicare participation based on a SA survey should be

recertified on a schedule consistent with the survey guidelines for non-deemed hospitals

issued by CMS each fiscal year. A recertification packet for each hospital is to be sent to

the RO by the SA. Exhibit 63 has a complete list of documents to be completed and

included in the recertification packet. The Certification & Transmittal Form, CMS-1539

(C&T), which is part of the recertification packet, should indicate in the “remarks” section

that the C&T is transmitting a non-deemed hospital recertification. If the hospital has

undergone a change of ownership with acceptance of assignment of the Medicare provider

agreement by the new owner since the last recertification survey, also indicate if a Change

of Ownership (CHOW) package was forwarded to the hospital by the SA.

In addition, the SA also updates Exhibit 286, the Hospital/CAH Medicare Database

Worksheet, with any new information regarding the hospital. It is not permissible to

forward the Hospital/CAH Medicare Database Worksheet to the hospital for completion.

The SAs are not expected to conduct an onsite visit of the hospital solely to obtain

information for the worksheet. However, the SAs may be able to use State licensure data

to update the worksheet. The updated Hospital/CAH Medicare Database Worksheet

should be forwarded with the recertification packet to the RO. The ASPEN system must

also be updated to reflect any changes to the information on the Hospital/CAH Medicare

Database Worksheet. This policy applies to ALL non-deemed hospitals.

2022 - Deemed Status: Hospitals Accredited by an Accrediting

Organization with a CMS-approved Medicare Hospital or Medicare

Psychiatric Hospital Accreditation Program

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

2022A - Notice that a Participating Hospital Has Been Accredited and

Recommended for Deemed Status

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

A hospital accredited and recommended for deemed status by a national accreditation

organization with a CMS-approved Medicare hospital accreditation program may be

deemed to meet all CoPs for hospitals (except the SNF Requirements for swing-bed

designation and any higher-than-national standards approved by the Secretary for a State

under §1863 of the Act). Additionally, a psychiatric hospital accredited and

recommended for deemed status by a national accreditation organization with a CMS-

approved Medicare psychiatric hospital accreditation program may be deemed to meet all

CoPs for psychiatric hospitals.

When notified that a participating hospital or psychiatric hospital has been accredited and

recommended for deemed status, the RO verifies the accreditation and recommendation

for deemed status and notifies the SA. The SA executes Form CMS-1539 to report the

accreditation and recommendation for deemed status.

2022B - Recertification

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Hospitals or psychiatric hospitals that receive their Medicare certification via deemed

status based on accreditation by a CMS-approved Accreditation Organization (AO) should

be recertified by the State Survey Agency (SA) on a schedule consistent with the

accreditation interval of the AO. Upon receipt of a notice from the AO indicating that it

has renewed a hospital’s accreditation and is recommending continued deemed status, a

recertification kit should be created in the Automated Survey Processing Environment

(ASPEN) or recertification packet for each deemed hospital or psychiatric hospital is to be

sent to the RO by the SA. Exhibit 63 has a complete list of documents to be completed

and included in the recertification packet. The Certification & Transmittal Form, CMS-

1539 (C&T), which is part of the recertification packet, should indicate in the “remarks”

section that the C&T is transmitting an accredited hospital recertification.

In addition, the SA also updates the Hospital/CAH Medicare Database Worksheet, Exhibit

286, with any new information regarding the hospital. It is not permissible to forward the

Hospital/CAH Medicare Database Worksheet to the hospital for completion. The SAs are

not expected to conduct an onsite visit of a deemed hospital solely to obtain information

for the worksheet. However, the SAs may be able to use State licensure data to update the

worksheet. The updated Hospital/CAH Medicare Database Worksheet must be entered

into ASPEN and be included in the recertification kit forwarded to the RO; the

recertification kit will not upload to the national data base unless a Hospital/CAH

Medicare Database Worksheet has been completed.

2022C - Notification of Withdrawal or Loss of Accreditation

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

See Section 2005B.

2024 - Hospital Merger/Multiple Campus Criteria

(Rev. 1, 05-21-04)

When two or more hospitals merge, the SA ascertains whether to continue to certify the

hospitals separately or to certify them as a single hospital (i.e., hospital with a main

campus and an additional location). Also, when a hospital establishes an additional

hospital facility, geographically separate but in the same metropolitan area, the SA

determines whether the additional hospital facility will be certified as a separate hospital

or whether it can be considered a single hospital. A hospital may establish an additional

hospital facility so organizationally or geographically separate as to make it impossible to

operate as a multi-campus hospital.

Each location of a single hospital must meet the applicable CoPs. A certification of non-

compliance at the CoP level at any of the hospital locations affects the certification of the

hospital as a whole. Consequently, when noncompliance at the CoP level is found, the

hospital will either be denied participation or terminated from participation in the

Medicare/Medicaid program. When a hospital is to be terminated, the SA follows the

termination procedures contained in §3010 and 3012.

In addition, all locations of a single hospital must comply with applicable State licensure

laws. When it is determined that any of the hospital locations does not comply with State

licensure laws, the hospital as a whole will either be denied participation or terminated

from participation in the Medicare/Medicaid program.

Where two or more previously separate hospitals merge, all locations of the surviving

hospital must meet the criteria found in §2004. In addition, all non-hospital providers of

service under Medicare that state they are part of a single hospital must meet the criteria

for provider based designation in §2004 in order to be treated as a single hospital for

payment purposes.

2026 - Certification of Parts of Institutions as Hospitals

(Rev. 1, 05-21-04)

2026A - Hospitals (Other Than Psychiatric Hospitals)

(Rev. 1, 05-21-04)

The SA evaluates each general hospital as a whole for compliance with the CoPs and

certify it as a single provider institution including all components:

● Under the legal control of the hospital governing body and part of the same

corporation or governmental administrative entity; and

● Subject to the direction of the hospital administrator and medical staff

organization.

The SA evaluates and certifies the whole hospital even when the components are

separately housed.

It is not permissible to certify only part of a general hospital. However, the following are

not considered parts of the hospital and are not to be included in the evaluation of the

hospital’s compliance:

● Components appropriately certified as other kinds of providers or suppliers. i.e., a

distinct part SNF and/or distinct part NF, HHA, RHC or hospice; and

● Excluded residential, custodial, and non-service units not meeting the definitions

in §1861(e)(1) or (j)(1) of the Act.

2026B - Excluded Non-Service Units May be Appropriate

(Rev. 1, 05-21-04)

The hospital ordinarily requests exclusion of a unit by a letter to the RO through the fiscal

intermediary. The RO may then ask the SA to certify information it needs to make the

exclusion. Otherwise, the SA excludes from any regular certification those portions of a

hospital that are separately identifiable units that do not meet the §1861(e)(1) or (j)(1)

definitions.

2030 - Temporary Waivers Applicable to Rural Hospitals

(Rev. 1, 05-21-04)

If a hospital is found to be out of compliance with the 24-hour registered nurse (RN)

requirement, a temporary waiver may be granted by the RO. This waiver, however, may

be approved only to the extent that it would not jeopardize or adversely affect the health

and safety of patients. The waiver may be issued for any one-year period or less under

certain circumstances, and may be withdrawn earlier if this action is necessary to protect

the health and safety of patients. The hospital must meet all CoPs except for the waived

requirement.

In determining whether a hospital qualifies for a waiver, the SA verifies that these

additional criteria are met:

● The hospital is located in a rural region. The Census Bureau in the most recent

census defines Rural as all areas not delineated as an “urbanized” areas. (Use the

material in Appendix G, Standard II A, and Tabs A-C of Appendix G, to ascertain

whether the area is rural or urbanized);

● The hospital has 50 or fewer beds. Exclude from the bed-count newborn and

intensive care beds;

● The character and seriousness of the deficiencies do not adversely affect the health

and safety of patients;

● The hospital has made and continues to make a good-faith effort to comply with

personnel requirements consistent with the waiver. Record information

concerning the hospital’s effort to employ additional RNs. Document the

recruitment efforts of the hospital and whether the wage level offered is consistent

with other hospitals in the area. Hospitals that pay below the wage level for the

area might not be able to attract new personnel; therefore, the RO might determine

that they are not making a good-faith effort to attract new nurses;

● The hospital’s failure to comply with the 24-hour nursing requirement is

attributable to a temporary shortage of qualified nursing personnel in the area in

which the hospital is located. Obtain and include any information substantiating

the prediction that the shortage is temporary, e.g., names of personnel scheduled to

complete qualifying training or scheduled to be engaged and anticipated dates of

arrival on duty;

● An RN is present on the premises to furnish or supervise nursing services during at

least the daytime shift 7 days a week;

● On all tours of duty not covered by an RN, a licensed practical (vocational) nurse

(LPN) is in charge.

The SA includes in the certification package documentation of the above requirements for

waiver and the most recent 2-week duty roster for RNs and LPNs.

2034 - Time Limit on Temporary Waiver

(Rev. 1, 05-21-04)

A temporary waiver of the hospital 24-hour RN coverage requirement may not exceed a

12-month period and may not be renewed. A shorter period may be recommended. The

RO notifies the hospital of:

● The duration of the waiver;

● A list of deficiencies; and

● A statement indicating that the waiver may be removed prior to its stated

expiration date if the hospital fails to maintain its effort to correct its nursing

deficiencies.

Regardless of the approved duration of the waiver, it may be withdrawn at any time

patient health and safety are adversely affected. Therefore, the SA should plan frequent

revisits, make telephone contacts, and request nurse staffing duty rosters to monitor the

hospital’s progress and to determine that patient health and safety are not jeopardized.

The frequency of SA monitoring efforts depends on the hospital’s efforts to make

corrections, the number and types of patients served, functional arrangement and design of

the patient care facility, and the number and qualifications of the RNs and auxiliary

nursing personnel.

If the SA finds that continuation of the waiver is not appropriate, it documents the case for

termination of the provider agreement. Conversely, if it finds that the hospital has

corrected its nursing deficiency, it certifies the hospital without reference to the prior

waiver.

2036 - Definition, Authority and Requirements for Hospital Providers of

Extended Care Services (“Swing-Beds”)

(Rev. 1, 05-21-04)

“Swing-bed” is a reimbursement term that means the care and reimbursement for the care

of a patient in a small rural hospital or CAH “swings” from acute care to post hospital

skilled nursing care (SNF). A swing-bed hospital means a hospital or CAH participating

in Medicare that has an approval from CMS to provide post hospital SNF care and meets

the requirements specified in §482.66 for a hospital or §485.645 for a CAH.

Certification to provide swing-beds is an approval separate from the certification to

operate as a hospital or CAH. When a survey of swing-beds is completed, any

deficiencies and Plans of Correction (PoC) must be documented on a separate Form

CMS-2567. If the swing-beds are voluntary terminated or terminated by CMS, that action

does not affect the continuing operation of the provider as a hospital or CAH. It

terminates the approval to operate and receive reimbursement for the swing-beds.

The swing-beds in a hospital or CAH do not have to be separated from the acute patients

although the facility may choose to do so. The patients do not have to move to a different

location in the facility when changing from acute care status to swing-bed status unless the

facility requires it.

There is no length of stay restriction for a swing-bed patient whether they are in a hospital

or a CAH. There is no required discharge to a nursing home and no transfer agreement.

Patients may be discharged to a nursing home as part of discharge planning, but it is not

required.

A medical order in the chart by the physician is required to change status from acute care

to swing-bed because the patient is being discharge from acute care status and admitted to

swing-bed status. This is necessary for reimbursement purposes because the billing and

reimbursement change or “swing.” Accordingly, the facility is given a subprovider

number for billing swing-bed services.

For Medicare patients, a 3-day qualifying stay in any hospital or CAH is required to prior

to admission to a swing-bed and the admission must be for treatment of the same

condition. This 3-day qualifying stay only applies to a Medicare patient.

Section 1883 of the Act authorizes payment under Medicare for post-hospital SNF

services provided by any hospital that meets the following requirements at

42 CFR 482.66. These requirements include the following.

● The hospital has a Medicare provider agreement;

● The facility has fewer than 100 hospital beds, excluding beds for newborns and

beds in intensive care type inpatient units;

● The hospital is located in a rural area. This includes all areas not delineated as

“urbanized” areas by the Census Bureau, based on the most recent census;

● The hospital does not have in effect a 24-hour nursing waiver granted under

42 CFR 488.54(c);

● The hospital has not had a swing-bed approval terminated within the two years

previous to application;

● The hospital meets the Swing-bed CoPs (see 42 CFR 482.66) on Resident Rights;

Admission, Transfer, and Discharge Rights; Resident Behavior and Facility

Practices; Patient Activities; Social Services; Discharge Planning; Specialized

Rehabilitative Services; and Dental Services.

NOTE: The 30-day patient transfer notice requirement at 42 CFR Part 483.12(a)(5) does

not apply to swing-bed hospitals.

2037 - Requirements Assessed Prior to Survey for Swing-Bed Approval

(Rev. 1, 05-21-04)

2037A - Request from a Medicare Participating Hospital to Add Swing-

Bed Approval

(Rev. 1, 05-21-04)

The request can be initiated on the provider’s letterhead stationery and sent to the SA.

Acknowledgement and request for further information can be sent from the SA to the

provider in a letter, see Exhibit 81, “Letter Transmitting Materials to a Hospital

Requesting Swing-bed Approval.”

2037B - Screening

(Rev. 1, 05-21-04)

Prior to scheduling a survey, the SA reviews the provider file as well as any other

information maintained on the hospital to ascertain whether the six basic requirements are

met. If these requirements are met and the hospital has begun to provide swing-bed

services, the SA schedules a survey. No hospital may receive initial swing-bed approval

without an onsite survey of the actual provision of such services. The SA may send a

letter to the provider notifying them of the required documents for a future survey, see

Exhibit 82, “Notification to a Hospital Regarding an Initial Survey for Swing-bed

Approval.” This notice acknowledges that a survey is required and the expectation for

certain information that will be needed, but it does not disclose the date of the survey.

2037C - Provider Agreement

(Rev. 1, 05-21-04)

Prior to survey the SA verifies that the hospital has a valid Medicare provider agreement.

2037D - Calculation of Bed Count

(Rev. 1, 05-21-04)

Exclude from the bed count newborn and intensive care beds.

A hospital licensed for more than 100 beds may be eligible for swing-bed approval if it

utilizes and staffs for fewer than 100 beds. The SA forwards to the RO documentation

that the hospital is operating within the bed category. Include in the packet floor plans,

bed assignments by room number, staffing schedules, and census information for the

previous 12 months. The SA obtains written assurance from appropriate hospital officials

that the hospital will not operate with a greater number of inpatient hospital beds than

permitted by the category for which approval is requested.

2037E - Rural Area

(Rev. 1, 05-21-04)

The SA includes as eligible those facilities that are not located in an “urbanized area”

based on the most recent census of the Census Bureau. Before concluding that a hospital

is ineligible on the basis of location, the SA telephones the Census Bureau RO for

verification.

2037F - Certificate Of Need (CON) Approval

(Rev. 1, 05-21-04)

States that have a CON requirement for the initiation or expansion of long-term care

services may require a CON for a limited number of beds for LTC use. There is no

federal requirement for a CON but CMS will not intervene if there is a state requirement.

2038 - Survey Procedures for Swing-Bed Approval

(Rev. 1, 05-21-04)

The SA surveys any hospital that meets the six items listed in §2036 and that has begun to

provide post-hospital SNF and NF care services. The SA may choose to use the optional

Swing-Bed Survey Report that can be found with the Appendix T to record survey

findings.

The survey for swing-bed approval may be conducted at the same time as a survey of the

hospital CoP at 42 CFR Part 482, although the findings must be documented on a separate

Form CMS-2567.

2039 - Post-Survey Procedures for Swing-Bed Hospitals

(Rev. 1, 05-21-04)

To receive swing-bed approval, a hospital must be found in compliance with the

provisions of 42 CFR Part 482.66 and the specific skilled nursing requirements in

42 CFR 483 that apply to swing-bed hospitals, see Appendix T. If a plan of correction is

required following the survey, send a copy of Exhibit 162, “Request for a Plan of

Correction Following an Initial Survey for Swing-bed Approval in a Hospital” to the

provider.

Effective dates for all swing-bed approvals are based on the provisions at 42 CFR 489.13

that state the agreements will be effective on the date the onsite survey is completed if all

Federal requirements are met on the date of the survey. If the provider fails to meet any of

the requirements, the approval will be effective on the earlier of the following dates:

● The date on which the hospital meets all requirements, or

● The date the hospital submits a correction plan acceptable to CMS.

2040 - RO Approval Procedures for Swing-Bed Approval

(Rev. 1, 05-21-04)

The RO prepares a formal determination and notifies the hospital of its approval or denial.

For approvals, see Exhibit 83,”Approval Notification for Swing-beds in a Hospital” or

denials, see Exhibit 83B, “Denial for Swing-bed Approval in a Hospital.”

If the provider is found to be in non-compliance after they have started to provide swing-

bed services, a termination of the approval can be accomplished through a termination

letter, see Exhibit 163, “Termination Letter for Hospital Swing-Bed Services.” Failure to

satisfy requirements for swing-bed approval does not affect Medicare approval as a

provider of hospital services, but it does withdraw the approval to provide SNF level

services at the hospital.

2042 - Psychiatric Hospitals

(Rev. 1, 05-21-04)

The statutory requirements for psychiatric hospitals are found in §1861(f) of the Social

Security Act (the Act.) The regulatory requirements are found at 42 CFR 482.60 –

42 CFR 482.62. The term psychiatric hospital means an institution which:

• Is primarily engaged in providing, by or under the supervision of a Doctor of

Medicine or Osteopathy, psychiatric services for the diagnosis and treatment of

mentally ill persons;

• Satisfies the requirements of §§1861(e)(3) through (e)(9) of the Act (general

hospital requirements);

• Maintains clinical and other records on all patients as the Secretary finds necessary

to determine the degree and intensity of the treatment provided to individuals

entitled to hospital insurance benefits under Part A; and

• Meets such staffing requirements as the Secretary finds necessary for the

institution to carry out an active program of treatment for individuals receiving

services in the institution.

In the case of an institution that satisfies the first two criteria and contains a distinct part

that also satisfies the last two criteria, the distinct part is considered to be a “psychiatric

hospital.”

There are some psychiatric hospitals that are designated as “forensic hospitals.” These

hospitals focus on serving individuals who are in the custody of penal authorities. As a

general rule, institutions that house only prisoners are excluded from Medicare payment.

However, in accordance with 42 CFR 411.4(b) payment may be made for services

furnished to individuals who are in the custody of penal authorities if (1) State or local law

requires such individuals to repay the cost of the medical services they receive while in

custody and (2) the State or local government entity enforces the requirement by billing all

individuals who are prisoners whether or not they are insured by Medicare on any other

insurance program. The pursuit of repayment from the prisoners for Medical services

must be done with the same vigor as would be done for the collection of any other debts

owed the state. The determination of payment eligibility in these cases is made by the FI

and CMS financial personnel.

Regardless of whether a state meets the payment requirements for prisoners housed in

these hospitals, the hospital must apply the CoP, including the restraint and seclusion

rules, to all patients including the prisoners. If a hospital wants to apply different health

and safety rules to prisoners, it may want to consider establishing a distinct part.

Medicaid rules for institutionalized individuals are found at 42 CFR 435.1008 – 435.1009.

If there is an issue concerning a Medicaid prisoner, contact the RO account representative

for the particular state for resolution.

2044 - Psychiatric Hospitals and Deemed Status

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Psychiatric hospitals have a Medicare accreditation option available to them. Prior to this

being the case, however, CMS permitted a psychiatric hospital to have deemed status with

respect to all hospital conditions (identified as “A” tags in ASPEN) except the special

psychiatric CoPs at 42 CFR 482.60-62 (identified as “B” tags in ASPEN). Under this

arrangement, the AO was responsible for assessing the psychiatric hospital’s compliance

with all other hospital CoPs, i.e., those provisions with A tags, and either the SA or CMS’

contract surveyors assessed compliance with the special psychiatric CoPs, i.e., the B tags.

Currently almost all deemed status psychiatric hospitals are accredited under the approved

Medicare psychiatric hospital accreditation program, and their AO is responsible for

assessing compliance under both the A and B tags.

Any psychiatric hospital seeking initial participation in Medicare through deemed status

must be accredited under a CMS-approved Medicare psychiatric hospital accreditation

program. This also is the case for any non-accredited participating psychiatric hospital

seeking to switch to deemed status. CMS no longer permits a psychiatric hospital to seek

participation through deemed status for the A tags only. However, there are a small

number of participating psychiatric hospitals that were deemed to meet the requirements

for the A tags only prior to CMS approving a psychiatric hospital Medicare accreditation

program. CMS considers these hospitals to have grandfathered deemed status for the A

tags only, and SAs or CMS contract surveyors remain responsible for B tag surveys in

these facilities.

If a psychiatric hospital currently has deemed status for the A tags through accreditation

by an AO which has a CMS-approved Medicare hospital accreditation program but does

not have a CMS-approved Medicare psychiatric hospital accreditation program, and the

psychiatric hospital wishes to be deemed for the special psychiatric hospital CoPs, it must

seek accreditation from an AO with a CMS-approved Medicare psychiatric hospital

accreditation program. In this instance, the psychiatric hospital may not choose to

continue its current Medicare hospital accreditation with one AO in addition to obtaining

its new Medicare psychiatric hospital accreditation with another AO; it must withdraw

from its current Medicare hospital accreditation program and seek or maintain

accreditation under a CMS-approved Medicare psychiatric hospital accreditation program

only. It is not permissible for the psychiatric hospital to both be accredited by one AO

under its hospital program and by another AO for the special psychiatric CoPs only.

When the SA is responsible for surveying the special psychiatric CoPs of an otherwise

deemed psychiatric hospital, the SA completes the Medicare/Medicaid Psychiatric

Hospital Survey Data, Form CMS-724, and all other relevant survey documents (Form

CMS-2567, etc.) for the survey.

2048 - Distinct Part Psychiatric Hospital

(Rev. 1, 05-21-04)

2048A - General

(Rev. 1, 05-21-04)

A psychiatric hospital may elect to participate in its entirety, or it may designate a distinct

part and apply for Medicare participation of that portion only (see §1886(d)).

The distinct part provisions of the law are designed to permit the participation of those

identifiable sections of psychiatric hospitals that are adequately staffed, supervised, and

equipped to provide active treatment on a continuing basis. The participating distinct part

must meet the hospital CoPs and the two special CoPs and have appropriate treatment

services available. Patients in the distinct part must be provided treatment that may

reasonably be expected to improve their condition.

The provisions for certification of distinct parts of psychiatric hospitals apply only where

the entire institution is primarily for the treatment of mental illness. Thus, a psychiatric

wing or building of a general hospital or of a large medical center or complex may not be

certified as a “distinct part psychiatric hospital.” Such facilities are included in the

certification of the institution of which they are an integral part.

2048B - Physical Identification

(Rev. 1, 05-21-04)

To qualify for participation as a distinct part psychiatric hospital, the distinct part must be

physically distinguishable from the larger institution or institutional complex; that is, a

group of beds specifically for patients who need active treatment. The section(s) or unit(s)

to be included in the distinct part certification must be clearly defined. An institution or

institutional complex can only be certified with one distinct part. Multiple certifications

within the institution or institutional complex are strictly prohibited. The distinct part can

be a wing, separate building, a floor, a hallway, or one side of a corridor. The beds in the

certified distinct part area must be physically separate from (that is, not commingled with)

the beds of the institution or institutional complex in which it is located. However, the

distinct part need not be confined to a single location within the institution or institutional

complex’s physical plant. It may, for example, consist of several floors or wards in a

single building or floors or wards that are located throughout several different buildings

within the institutional complex. Where an institution or institutional complex owns and

operates a distinct part, that distinct part is a single distinct part even if it is operated at

various locations throughout the institution or institutional complex. The aggregate of the

locations represents a single distinct part subprovider, not multiple subproviders, and must

be assigned a single provider number.

Specialized services such as physical therapy and occupational therapy services may be

included in the distinct part certification. If any specialized services are included in the

distinct part, the SA surveys the service and identifies them on Form CMS-1539.

2048C - Documentation of Findings

(Rev. 1, 05-21-04)

In the documentation on the survey report, the SA includes its observations about the

distinct part and an assessment of the overall ability of the hospital to provide the services

required. As appropriate, the SA must provide information about the entire hospital’s

staffing pattern, such as the number, kind, and location of patient care personnel, including

physicians, nursing personnel in all categories, social workers, and occupational and other

therapists.

The nonparticipating portion of an institution is required to meet the CoPs only insofar as

it affects the health and safety of patients in the distinct part or provides facilities or

services used by such patients. In certifying the distinct part, the SA considers the impact

of nonparticipating sections of the institution to ascertain whether there are any hazardous

conditions which might endanger patients in the distinct part; for example, the lack of

adequate fire or sanitation safeguards, particularly where the distinct part is attached to the

rest of the institution.

It is rare that a distinct part of a hospital is completely self-contained. Therefore, the SA

evaluates services, facilities, and activities of the overall institution that are provided or

made available to patients throughout the institution.

Inpatients of the distinct part may receive specialized services such as physical therapy or

occupational therapy in a portion of the hospital not included in the distinct part. Services

and facilities that may be shared vary with the type and size of the institution and the size

of the distinct part. However, in most instances, the distinct part shares with the rest of the

institution such central support services as dietary, housekeeping, maintenance,

administration and supervision, and some medical and therapeutic services.

The primary consideration in evaluation of shared services is whether the sharing can be

done without sacrifice to the quality of care given the patients in the distinct part and

without endangering their health and safety.

Where personnel assignments are shared, the SA should show the extent of sharing. The

SA verifies copies of staffing patterns and assignments furnished by the institution

through personal observation, interviews with various personnel, examination of job

descriptions and personnel records, and inspection of patient clinical records. The SA

reviews medical records for an indication of the extent to which patients of the distinct

part receive the services of skilled personnel.

In general, the distinct part, either by itself or in conjunction with the overall institution of

which it is a part, must be able to demonstrate the capacity to provide the services,

facilities, and supervision required by the CoPs to patients of the distinct part.

2050 - Medical-Surgical Unit of Psychiatric Hospitals

(Rev. 1, 05-21-04)

A medical-surgical unit of a psychiatric hospital may qualify for participation as a general

hospital independent of the institution as a whole, regardless of whether the remainder of

the institution is participating. The unit is regarded as a separate institution for this

purpose since the law does not provide for the participation of a “distinct part general

hospital.” It must be a separate, functioning entity that is a distinct and identifiable unit

within the institutional complex and be in compliance with all the CoPs for hospitals.

Although a medical-surgical unit may find it necessary to share some services with the

nonparticipating part of the institution, the location of shared services in relation to the

medical-surgical unit must clearly show that the latter meets the CoPs.

2052 - Nonparticipating Emergency Hospitals

(Rev. 1, 05-21-04)

2052A - Emergency Hospital Services

(Rev. 1, 05-21-04)

Any nonparticipating hospital meeting the definition of an emergency hospital for

Medicare purposes may claim payment for emergency inpatient and outpatient diagnostic

services furnished to Medicare patients. There are six statutory requirements that a

hospital must meet to qualify as an emergency hospital (§1861(e)(1), (2), (3), (4), (5), and

(7)). The hospital must:

• Be primarily engaged in providing, by or under the supervision of physicians, to

inpatients, diagnostic and therapeutic services or rehabilitation services;

• Maintain clinical records on all patients;

• Have bylaws in effect with respect to its staff of physicians;

• Have a requirement that every patient must be under the care of a physician;

• Provide 24-hour nursing service rendered or supervised by a registered

professional nurse and have a licensed, practical, or registered professional nurse

on duty at all times; and,

• Be licensed or meet standards for licensing pursuant to State and local law.

2052B - Preparation of Initial Certification

(Rev. 1, 05-21-04)

• For the initial certification, the SA obtains a completed Hospital Request to

Establish Eligibility, Form CMS-1514. The SA annotates at the top; “Emergency

Hospital Services Only.” When possible, the SA evaluates the capability of an

institution to meet the statutory requirements from information contained in State

licensure files and other available State records or through previous contacts with

the hospital.

• The SA prepares a Form CMS-1539, completing items 3, 4, 6, 7, 9, 12, 13, and 16

- 18.

2052C - Recertification and Follow-Up

(Rev. 1, 05-21-04)

The SA maintains an emergency hospital listing on a continuous basis and annually

recheck it to ensure that the certifications are still correct. If a hospital no longer meets the

definition of an “emergency hospital,” the SA prepares a new Form CMS-1539.

2053 - Medicaid-Only Hospitals

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Many hospitals choose to participate in both the Medicare and Medicaid programs.

However, a hospital may choose to only participate in Medicaid. Medicaid regulations at

42 CFR 440.10 and 42 CFR 440.140(a) require a hospital or psychiatric hospital (also

referred to in Medicaid as an “institution for mental disease,” which is defined at 42 CFR

435.1010) participating in Medicaid to meet the requirements for participation in

Medicare in order to receive Medicaid payment. These regulations do not require a

hospital or psychiatric hospital to enroll in the Medicare program in order to demonstrate

compliance with Medicare participation requirements. The provider agreement rules at 42

CFR 489.10 establish the basic Medicare participation requirements for providers,

including requirements for hospital participation. These requirements include, but are not

limited to, complying with the following: applicable hospital Conditions of Participation

(CoPs) at 42 CFR Part 482; specified Office of Civil Rights requirements; and the

advanced directive requirements at 42 CFR 489.100 and 42 CFR 489.102.

2053A- Initial Certification of Medicaid-Only Hospitals

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Hospitals seeking initial certification to participate in the Medicaid program only must

contact the State Agency (SA), in accordance with §§1902(a)(9)(A) and 1902(a)(33) of

the Act, to initiate the certification process. Requirements for this process are established

in the Medicaid State Plan’s required written agreement (or formal written intra-agency

arrangement) between the State Medicaid Agency (SMA) and the SA (See 42 CFR

431.610(f).

The SMA must approve the hospital’s request for enrollment into the Medicaid program

prior to the initiation of the certification process by the SA.

2053B - Certification Surveys of Medicaid-Only Hospitals

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

Following verification by the SMA that the enrollment application process has been

initiated by the hospital, the SA must determine if the hospital seeking Medicaid-only

certification demonstrates compliance with requirements for Medicare participation,

including all applicable CoPs, through the completion of an on-site survey. Hospitals

have the option of establishing compliance with applicable CoPs through accreditation

under 42 CFR 488.6(b) by a nationally recognized Accreditation Organization (AO) with

a CMS-approved Medicare hospital or psychiatric hospital program. Hospitals choosing

this option must provide the SA with a letter issued by the AO confirming its accreditation

under a CMS-approved Medicare accreditation program and recommending deemed status

as a Medicaid-only hospital. (As with Medicare-participating hospitals, it is possible that

a hospital might be accredited, but not have deemed status. The AO letter must indicate

the hospital is recommended for deemed status.) However, regardless of whether the

survey is conducted by the SA or a CMS-approved AO, the SA must issue a determination

to the SMA as to whether the hospital has met all Medicare participation requirements for

Medicaid-only hospital participation.

Upon receipt of the SA’s determination, the SMA issues an effective date for the

hospital’s participation in the State Medicaid program. The SA then compiles and

forwards a Medicaid-only certification packet to the RO. This packet consists of the

hospital’s request for an applicable Medicaid-only hospital or psychiatric hospital CMS

Certification Number (CCN), the SA’s certification of compliance with Medicare CoPs,

and the SMA-issued State Medicaid program effective date. After review of all

documentation, the RO issues the appropriate Medicaid-only hospital CCN.

2053C - Change in Certification

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

If the hospital decides to seek participation in Medicare as well as Medicaid, see Section

2777D3.

2053D - Termination

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

The SMA must terminate the hospital’s Medicaid agreement when the SA determines that

the hospital does not meet the applicable requirements. See Section 3005C-3.

2053E - Complaint Investigation

(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)

All allegations of non-compliance with Federal or State requirements in Medicaid-only

hospitals must be referred to the SA.

Under 42 CFR 431.610, the SA in collaboration with the SMA must determine the

policies and procedures for the intake, triage and investigation of all allegations of non-

compliance in both deemed and non-deemed Medicaid-only hospitals. The SA is solely

responsible for reporting complaint investigation findings to the SMA, including a

determination whether a Medicaid-only hospital meets Medicare CoPs and other federal

requirements in accordance with §1902(a)(33)(B) of the Act.

2054 - Religious Nonmedical Health Care Institutions (RNHCIs)

(Rev. 1, 05-21-04)

Section 4454 of the Balanced Budget Act of 1997 (BBA’97, Public Law No. 105-33,

enacted August 5, 1997) deletes statutory references to Christian Science Sanatoria and

amended the following sections of the Act: §§1821, 1861(e), (y) and (ss), 1869, and 1878

(Medicare provisions); 1902(a) and 1908(e)(1) (Medicaid provisions); and

1122 (h) and 1162 (conforming provisions). Additionally, §4454 provides for coverage of

inpatient services furnished in qualified RNHCIs under Medicare and as a State Plan

option under Medicaid. The new amendments make it possible for RNHCIs meeting the

defining criteria in §4454 of BBA’97 or §1861(ss)(1), to participate in the Medicare

and/or Medicaid program. The RNHCI provider is responsible for meeting both

Conditions of Coverage and Conditions of Participation to qualify as a Medicare provider

and that portion of the Conditions of Coverage that define an RNHCI and the Conditions

of Participation to qualify as a Medicaid provider.

2054.1 - Certification of Religious Nonmedical Healthcare Institutions

(RNHCIs)

(Rev. 1, 05-21-04)

The Boston Regional Office has the primary responsibility for the approval and

certification process to ensure and verify that the RNHCI conforms to specific Conditions

of Coverage and all of the Conditions of Participation. An RNHCI is a provider that

meets the definition as described in §1861(ss)(1) of the Act and meets the following

qualifying Medicare Conditions of Coverage provisions as specified in 42 CFR 403.720.

To qualify as a Medicare or Medicaid RNHCI an institution must meet all ten of the

following requirements:

• Is described in subsection (c)(3) of §501 of the Internal Revenue Code of 1986 and

is exempt from taxes under subsection 501(a);

• Is lawfully operated under all applicable Federal, State, and local laws and

regulations;

• Furnishes only nonmedical nursing items and services to beneficiaries who choose

to rely solely upon a religious method of healing, and for whom the acceptance of

medical services would be inconsistent with their religious beliefs. (NOTE:

Religious components of the healing are not covered);

• Furnishes nonmedical items and services exclusively through nonmedical nursing

personnel who are experienced in caring for the physical needs of nonmedical

patients. For example, caring for the physical needs such as assistance with

activities of daily living; assistance in moving, positioning, and ambulation;

nutritional needs; and comfort and support measures;

• Furnishes nonmedical items and services to inpatients on a 24-hour basis;

• Does not furnish, on the basis of religious beliefs, through its personnel or

otherwise, medical items and services (including any medical screening,

examination, diagnosis, prognosis, treatment, or the administration of drugs) for its

patients;

• Is not owned by, under common ownership with, or has an ownership interest of 5

percent or more in, a provider of medical treatment or services and is not affiliated

with a provider of medical treatment or services or with an individual who has an

ownership interest of 5 percent or more in a provider of medical treatment or

services (permissible affiliations are described in §403.738(c));

• Has in effect a utilization review plan that meets the requirements of

§403.720(a)(8);

• Provides information CMS may require to implement §1821 of the Act, including

information relating to quality of care and coverage determinations; and

• Meets other requirements CMS finds necessary in the interest of the health and

safety of the patients who receive services in the institution.

2054.1A - Other Medicare Conditions of Coverage

(Rev. 1, 05-21-04)

The remaining Conditions of Coverage are specific to Medicare; however, a State may

elect to employ any or all of these requirements within their optional Medicaid State plan

amendment.

2054.1B - Valid Election Requirements

(Rev. 1, 05-21-04)

The regulations at 42 CFR 403.724 present the elements necessary for a Medicare

beneficiary to complete an election to receive care in an RNHCI. The RO determines

whether or not the RNHCI has adequately ensured that the Medicare beneficiary’s valid

election statement has been included with the RNHCI’s administrative records and/or

patient care records.

NOTE: The facility is to provide the fiscal intermediary the original of the election

statement, which will be used for each Medicare beneficiary in the RNHCI and retain a

copy in its files.

The provisions for valid elections include the following general requirements:

• The election statement must be made by the Medicare beneficiary or by his or

her legal representative. It must include written statements that:

o The beneficiary is conscientiously opposed to acceptance of nonexcepted

medical treatment;

o The beneficiary acknowledges that acceptance of nonexcepted medical

treatment is inconsistent with his or her sincere religious beliefs;

o The beneficiary acknowledges that receipt of nonexcepted medical care

constitutes a revocation of the election and may limit further receipt of

services in an RNHCI;

o The beneficiary acknowledges that the election may be revoked by

submitting a written statement to CMS; and

o The beneficiary acknowledges that the revocation will not prevent or delay

access to medical services available under Medicare Part A in other types

of facilities.

A valid election must also:

• Be signed and dated by the beneficiary or by his or her legal representative, not

prior to reaching Medicare eligibility and beneficiary status;

• Be notarized;

• Include an original copy submitted on file to CMS (CMS is represented for this

purpose by the intermediary); and

• Include any other information obtained regarding prior elections or revocations.

A beneficiary’s election is revoked by one of the following:

• The beneficiary receives nonexcepted medical treatment for which Medicare

payment is made; or

• The beneficiary voluntarily revokes the election and notifies CMS in writing.

NOTE: “Excepted” and “nonexcepted” medical care are defined are defined in 42 CFR

403.702. The receipt of excepted medical care or treatment as defined in 403.702 does not

revoke the election made by a beneficiary.

The beneficiary’s ability to elect is limited once the election has been made and revoked

twice (see §403.724(c)).

Organ Transplant Programs

2060 - Organ Transplant Programs

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

2060A – Citations

The Conditions of Participation (CoPs) for Transplant Centers were established under

several statutory authorities. Section 1102 of the Social Security Act (the Act)

authorizes the Secretary to publish rules and regulations “necessary for the efficient

administration of the functions” with which the Secretary is charged under the Act.

Section 1871(a) of the Act authorizes the Secretary to “prescribe such regulations as

may be necessary to carry out the administration of the insurance programs under this

title.” Section 1881(b)(1) of the Act contains specific authority for prescribing the

health and safety requirements for facilities, including renal transplant centers, that

furnish end stage renal disease (ESRD) care to beneficiaries. Section 1861(e)(9) of the

Act authorizes developing standards necessary for the health and safety of individuals

furnished services in hospitals. Organ transplant programs are required to be in

compliance with the federal requirements set forth in the Medicare CoPs in order to be

eligible to receive Medicare payment. In addition to meeting the CoPs for Transplant

Centers in 42 CFR Part 482, Subpart E, transplant programs must also meet the

Hospital CoPs specified in §§482.1 through 482.57.

2060B – DEFINITIONS

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

2060B-1 Organ Procurement and Transplantation Network (OPTN)

The OPTN is a public-private partnership that links all professionals involved in the

donation and transplantation system. The OPTN operates the national network for

organ procurement and allocation and works to promote organ donation. The OPTN

was established by the National Organ Transplant Act of 1984 and is operated by

United Network for Organ Sharing (UNOS) under a contract from the Health

Resources and Services Administration (HRSA) in accordance with section 372 of the

Public Health Service (PHS) Act. Through its policies, the OPTN works to increase

the number of transplants, provide equity in access to transplants, improve outcomes

for waitlisted patients, living donors and transplant recipients, and promote living

donor and transplant recipient safety.

2060B-2 Scientific Registry of Transplant Recipients (SRTR)

The SRTR, founded in 1987, is a national database of transplant statistics that

provides analytic support for the ongoing evaluation of the scientific and clinical

status of solid organ transplantation in the United States. It was established pursuant

to section 373 of the PHS Act.

2060C - Regulatory Background

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

The Conditions of Participation for transplant programs were published in the Federal

publication on June 28, 2007.

2061 – Request for Medicare Approval of an Organ

Transplant Program

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom:

06-14-19)

Effective January 1, 2019, transplant programs seeking to participate in the Medicare

program must submit a request for Medicare approval to the applicable State Survey

Agency and not the CMS RO. The SA will provide a packet of information to the

applicant including a list of documents that must be submitted to the SA.

The hospital in which the transplant center is located must submit a revised CMS-

855A to its Medicare Administrative Contractor (MAC) to indicate the addition of a

service.

2061A Programs Serving both Adult and Pediatric Populations

A transplant program can apply for and be approved for both an adult (age 18 and over)

and a pediatric (under age 18) transplant program for the same organ type. They can apply

to be approved separately, but are not required to do so.

If a transplant program is seeking separate approval of its adult and pediatric programs,

the programs will be surveyed separately. If a program seeks a single approval for both

age groups, the program must apply for the primary age group that it serves. That is, a

program that provides more than 50 percent of its transplants in a 12-month period to

pediatric patients must apply as a pediatric program. A program that provides more than

50 percent of its transplants in a 12-month period to adults must apply as an adult program.

2061B Organ Procurement and Transplantation Network Membership

Membership in the OPTN by the transplant hospital in which the transplant program is

located is a requirement for Medicare approval.

2062 - Survey and Approval Procedures for Organ

Transplant Programs

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom:

06-

14-19)

2062A - The Transplant Program Quarterly Report (TPQR)

The TPQR is a pre-survey report generated by CMS. It conveys information from

transplant program data received from the SRTR and the OPTN. The TPQR includes:

• Types of transplant programs;

• Program data including data submission, clinical experience (the number

of transplants performed) and program outcomes for patient and graft

survival.

During pre-survey, the survey team reviews the TPQR to determine the number of

surveyors that will be indicated based upon the number of programs that will be

reviewed. The team also identifies any non-compliance with the requirements of

§482.80 and §482.82. Any non- compliance identified during the pre-survey will be

communicated to the applicable program at the entrance conference of the survey.

There is no additional survey activity required regarding the TPQR.

During the process of the transplant program survey, the surveyors review compliance

with both the transplant program and general hospital regulations. If a deficiency with

the hospital requirements is identified in the hospital in which the transplant program is

located and that hospital is a deemed provider, the surveyor, (or their management)

must contact the applicable CMS Regional Office for approval to investigate and cite

the deficiency on a hospital survey report.

2062B Types of Surveys and Related

Guidance

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

2062B.1 Initial Survey for Medicare Approval

Once the MAC notifies the SA/RO of its approval of the revised CMS-855A, a survey

may be scheduled. Initial surveys are unannounced. If the applicant transplant

program is found to be in compliance with the CoPs, it is assigned a CCN. The

program will not be issued a separate provider agreement. Once transplant program

approval is completed, the RO will forward a form CMS-2007 (Provider Tie-In Notice)

to the MAC. In order for CMS to make a compliance determination with §482.80, the

applicant must have submitted sufficient data to the SRTR for CMS to review.

2062B.2 Re-

approval Surveys

Once a transplant program has been approved to participate, it will be periodically re-

surveyed for compliance with the CoPs. Re-approval surveys are unannounced surveys

and are performed at a frequency consistent with the CMS Mission and Priority

Document (MPD).

A transplant program may voluntarily declare an “Inactive Status” with the CMS

and may remain inactive and retain its Medicare approval for a period not

exceeding 12 months under §488.61(e). The program must provide immediate

written notification to its SA of the anticipated inactivity period. Notification to the

SA and to the potential recipients must occur prior to the beginning of the planned

inactivity period. During its inactivity period, the program must continue to

comply with all of the Medicare CoPs and routine surveys or complaint

investigations should not be delayed based on an “Inactive Status.” During survey

activity either during the inactive status or following an inactive status, the

surveyor should determine that:

• The patients on the waitlist during the period of inactivity were notified of

the inactive status; and

• The notifications were accomplished in a manner consistent with §482.102(c)(3).

2062B.3 Outcomes Non-Compliance

2062B.4 Clinical

Experience

To be considered for an initial approval, a transplant program must generally perform

10 transplants over a 12 month period. If the program performs at least eight

transplants over a 12 month period, it may be approved with an acceptable plan of

correction.

Currently approved transplant programs must perform at least 10 transplants a year over

the prior three years. Programs not meeting this standard should be cited for non-

compliance at the Standard level. The program may be reapproved with an acceptable

plan of correction if all other CoPs are in compliance.

2062B.4 Complaint Surveys

See SOM, Chapter 5, for a description of the general complaint investigation process.

For complaint investigations of a transplant program, the scope of survey activities is

generally limited to the specific transplant CoPs associated with the allegation(s). If

allegations are substantiated, the scope may be expanded to review any associated

CoPs.

Complaints related to disease transmission via an organ from a deceased donor should

be communicated to the RO for their determination of the need for an OPO complaint

investigation.

There must be a formal arrangement between the hospital in which the transplant

program is located and any other hospital which provides living donor services for the

transplant program. It is the transplant program’s responsibility to ensure that the

CoPs applicable to living donors are met by the associated hospital providing the

living donor services. The medical record of the living donor must confirm that all the

requirements of the CoPs were met.

2062C - Determining Level of Deficiency for Clinical Experience

(Volume) and Outcome Requirements Standards:

(Rev. 190, Issued:06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

Compliance with the clinical experience (volume) standards at 42 CFR §§482.80(b)

and 482.82(b) and the outcome requirements standards at 42 CFR §§482.80(c) and

482.82(c) is determined by reviewing the program’s performance compared to the

objective standards outlined in the regulation. The goal of this section is to achieve

consistency in determining the level of a deficiency citation, (i.e., condition level, or

standard level) under these CoPs. The information outlined below will be provided to

surveyors in the TPQR.

Determining the Level of the Deficiency for Non-Compliance with Clinical

Experience Requirements:

A program’s inactivation does not create an exception to the clinical experience

requirement for the entire 3 year period.

Initial Approval of Transplant Programs under §482.80(b):

If the transplant program has not performed at least eight transplants in the past 12

months, a deficiency will be cited at the condition-level deficiency and it will not be

approved for Medicare participation. If the program has performed at least eight but

less than 10 transplants in that time period, a deficiency should be cited at the standard-

level. The program may still be approved with a standard-level citation for Clinical

Experience if an acceptable plan of correction is received and the program is in

compliance with all remaining CoPs. Kidney programs that have not performed at

least three transplants in a 12 month period may not be surveyed for initial approval.

Re-approval of Transplant Programs under §482.82(b):

If the transplant program has performed an average of less than 10 transplants per

year over the re-approval period (three years), a deficiency should be cited at the

standard-level. The program may be re-approved with a standard-level citation for

Clinical Experience if an acceptable plan of correction is received and the program is

determined to be in compliance with all remaining CoPs.

The determination of condition-level non-compliance is made based upon the extent of

non- compliance findings with the standards within a Condition. A finding of non-

compliance for the Clinical Experience standard alone with no other non-compliance

within the Condition would generally not result in condition-level non-compliance at

§482.80 or §482.82.

Determining the Level of the Deficiency for Non-Compliance with the

Outcome Requirements at 42 CFR §482.80(c) and §482.82(c)

Compliance with outcome measures is assessed using data from the most recent

Center-Specific Report from the SRTR. Surveyors must utilize the SRTR information

reported in the TPQR that is provided by the CMS CO. The SRTR outcome measures

reported in the TPQR are risk- adjusted, 1-year post transplant graft and patient

survival measures. The SRTR reports are released every six months and CMS

compares the results for the programs’ outcomes to the outcome requirements at 42

CFR §482.80(c) and §482.82(c) for transplants performed over a 2.5 year window

(between one year prior and 3.5 years prior to the date the report is published) and

enters the compliance determination onto the TPQR. The TPQR identifies the number

of center- specific SRTR reports in that timeframe that failed to meet the outcome

requirements. Surveyors do not conduct the statistical analysis to determine

compliance nor may the program provide any information to the surveyor on-site to

change the compliance determination.

The following transplant program types are subject to the outcome requirements:

• Adult Kidney-Only (AKO)

• Adult Heart-Only (AHO)

• Adult Lung-Only (ALO)

• Adult Liver-Only (ALI)

• Pediatric Kidney-Only (PKO) (includes only 1-year graft survival)

• Pediatric Heart-Only (PHO)

• Pediatric Lung-Only (PLO)

• Pediatric Liver-Only (PLI)

The following transplant program types are not subject to the outcome requirements:

• Adult Pancreas- (APA)

• Pediatric Pancreas- (PPA)

• Adult Intestine/Multivisceral- (AIM)

• Pediatric Intestine/Multivisceral- (PIM)

Standard – If the most recent SRTR report shows that the program did not meet

outcome requirements, but none of the four outcome reports prior to the most recent

one show that the program was out of compliance, a deficiency should be cited at

the standard-level.

Condition – If the most recent SRTR report shows that the program has not met

outcome requirements in two consecutive reports and there is either unchanged or a

decline in outcome data, a deficiency should be cited at the condition-level.

Every six months, CMS CO receives a list of transplant programs that exceed the

outcomes thresholds for patient and graft survival. When a program is identified to be

out of compliance with the measures, CMS CO will notify the provider of its non-

compliance. More current SRTR data will be reviewed by CMS to determine if the

program is improving.

At the time of the next bi-annual SRTR report, if a program continues to exceed the

acceptable patient and graft survival rate, with all thresholds crossed over, more recent

SRTR data will again be requested and reviewed. If the more recent data indicates that

the program’s outcomes are not improving, CMS will consider the program to be non-

compliant at a condition level and an on-site survey may be scheduled to

review/identify associated process requirement concerns.

Deficiencies for non-compliance with the outcome requirements, as well as any

additional deficiencies identified at the time of the on-site survey, will be cited upon

completion of the survey. If an on-site survey is not conducted, the program will be

notified of its non-compliance with the outcome requirements by letter that includes the

form CMS-2567.

If a transplant program is cited at a condition-level for §482.82, include the following

language in the letter accompanying the CMS-2567:

“The prospective termination date based on noncompliance determination with 42 CFR

§482.82 will be set at 210 days. This deficiency must be corrected by [Date] in order

for Medicare approval to continue for the program. The program has two options for a

plan of correction for

§482.82:

The program may state that it expects to be back into compliance with §482.82

within 210 days; or

The program will apply for mitigating factors review under §488.61(f).”

2062D - Post-Survey Activities

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

Following the survey, the surveyor will complete the following forms:

Organ Transplant Hospital Worksheet;

CM 670;

and

CMS-2567

Once the CMS-2567 is finalized, it will be forwarded to the hospital administrator with

a request for a Plan of Correction (PoC) if substantial compliance with all the

requirements was not found. The SA will review and accept or not accept the PoC. In

the case of a finding of Immediate Jeopardy, see Section 3010B of the SOM for a

description of the special procedures to be followed.

Plan of Correction Transplant Centers

The PoC should include plans for completion of corrective actions at a maximum of 90

days.

The PoC for all deficiency citations, with the exception of §482.80 or §482.82, must

indicate projected correction within 90 days from the receipt of the notification of non-

compliance. The plan of correction for §482.80 or §482.82 must indicate whether the

provider intends to submit mitigating factors to CMS. Prior to the 90

day follow-up

by the SA should occur. If the provider has not been determined to have achieved

compliance with the CoPs (other than

§482.80 or §482.82), the program approval must be terminated.

2062E - Transmission of Program Approval

Information

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

The RO will assign one CMS Certification Number (CCN), within the 9800 series, to

all transplant programs operating within a single hospital. The Medicare approval date

for the individual program will be determined as follows:

• When there are no deficiencies cited, the approval date is the last date of the

survey.

• When there are standard-level deficiencies cited, the approval date is the date

on which an acceptable Plan of Correction was received by the SA.

• When there are condition-level deficiencies cited, the approval date is the date

on which the transplant program is determined to be back in compliance either

through a revisit or, as determined by the CMS based on the approval of

mitigating factors.

2062F-Mitigating Factors

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

2062F.1 Medicare Approval Based on Mitigating

Factors

Under §488.61(f), a transplant program may request that CMS consider mitigating

factors in the initial approval and re-approval of a transplant program that does not

meet the CoPs at §482.80 or §482.82. Mitigating factors will not, however, be

considered in situations of immediate jeopardy.

§488.61(f)(1) describes the general areas that will be reviewed in determining whether a

program can be initially approved or re-approved based on mitigating factors. These areas

include (but are not limited to):

The extent to which outcome measures are not met or exceeded;

The availability of Medicare-approved transplant centers in the area;

Extenuating circumstances (such as natural disasters) that may have a

temporary effect on the program;

Program improvements that substantially address root causes of graft failures

or patient deaths, that have been implemented and institutionalized on a

sustainable basis, and that are supported by outcomes more recent than the

latest available SRTR report, for which there is a sufficient post-transplant

patient and graft survival period and a sufficient number of transplants such

that CMS finds that the program demonstrates present-day compliance with

the requirements at §482.80(c)(2)(ii)(C) or

§482.82(c)(2)(ii)(C);

Whether the program has made extensive use of innovative transplantation

practices relative to other transplant programs, such as a high rate of

transplantation of individuals who are highly sensitized or children who have

undergone the Fontan procedure, where CMS finds that the innovative

practices are supported by evidence- based, published research or nationally

recognized standards or Institutional Review Board (IRB) approvals, and the

SRTR risk-adjustment methodology does not take the relevant key factors

into consideration; and

If the program’s performance, based on the OPTN method of calculating

patient and graft survival, is within the OPTN’s thresholds for acceptable

performance and does not flag OPTN performance review under the

applicable OPTN policy.

2062F.2 Mitigating Factors Application and Review

Process

Intent to Apply for Review of Mitigating Factors

The program must state on the CMS-2567, which is submitted to the SA that

it will apply for mitigating factors as its plan of correction (POC) for non-

compliance with data submission, clinical experience, or outcomes

noncompliance.

Upon receipt of a POC that includes an intent to apply for mitigating factors

by the provider, the SA will provide a copy of the POC to the CMS CO

mailbox at QSOG_TransplantTeam.cms.hhs.gov and the SA will refer the

provider to 488.61(f) for the list of the information that should be submitted

for the mitigating factors application.

Applying for Mitigating Factors

All information necessary for consideration of mitigating factors must be

received within 120 calendar days of receipt of the formal written notification of

noncompliance at§482.80 or §482.82. Failure to submit a complete and timely

application within 120 calendar days may be the basis for denial of mitigating

factors. See 488.61(f) for the materials required for a mitigating factors

application.

A request for consideration of mitigating factors must include sufficient

information to permit an adequate review of the transplant program, factors that

have contributed to outcomes, program improvements or innovations that have

been implemented or planned, and in the case of natural disasters, the recovery

actions planned.

The provider must submit the specific information requested by CMS for

review. Information and documents submitted for mitigating factors review

must have all Personally Identifiable Information (PII) removed prior to its

submission.

The CMS Process for Reviewing Requests for Approval Based on

Mitigating Factors

The CMS CO reviews all requests for mitigating factors review. It will include

analysis by CMS staff with programmatic and clinical expertise for each

transplant program and will be conducted on a case-by-case basis in accordance

with §488.61.

CMS Determination

According to §§488.61(g)(1)(i)-(iii), CMS has three options after

considering applications for mitigating factors. CMS may:

Approve or re-approve a program’s request for approval

based on the consideration of mitigating factors;

Deny the program’s request for approval or re-approval

based on the consideration of mitigating factors; or

Offer the program an opportunity to enter into a time-limited

Systems Improvement Agreement (SIA) with CMS, under

certain conditions.

2062 F.3 Processing Medicare Approval based on

Mitigating Factors

If a request for approval based on a mitigating factors application is approved, the

condition- level non-compliance under §482.80 or §482.82 is rescinded and the

prospective termination date is rescinded. Generally:

The CO will send an approval letter for mitigating factors to the program with

a copy to the SA and RO.

The RO will send an approval letter (if it is an initial application) or a letter

that removes the prospective termination date (if it is already a Medicare-

approved transplant program).

The SA/RO will enter an offsite revisit survey into ASPEN and the RO will

document the program’s approval based on the presence of mitigating factors.

The approval based on mitigating factors does not carry forward to future re-

certification periods, and CMS may remove approval based on mitigating

factors at any time if improvements are not sustained, subject to prior notice to

the program and an opportunity to reply.

2062 F.4 Processing Denial of a Mitigating Factors

Request

CMS will deny approval based on mitigating factors if it finds that a basis for approval

consistent with §488.61(f) has not been adequately established by the transplant

program.

If a mitigating factors request is denied, CMS CO will send a letter to the program

communicating its denial of the mitigating factors request and copy of that letter will

be sent to the SA and RO.

2062 F.5 Systems Improvement Agreements

(SIA)

When a transplant program has condition-level non-compliance with the CoP

requirements at

§482.80 or §482.82 triggering a pending termination date, CMS may extend the

termination date and offer the hospital the opportunity to enter into a time-limited

Systems Improvement Agreement (SIA) with CMS. A SIA is a binding agreement that

may be offered by CMS pursuant to §488.61(h). The SIA is entered into voluntarily by

the hospital. Under an SIA, CMS extends the prospective Medicare termination date

and offers the program additional time to achieve compliance with the CoPs, contingent

upon the hospital's agreement to participate in a structured regimen of quality

improvement activities, to demonstrate improved outcomes, and to waive their right to

appeal the noncompliance determination leading to the termination.

To be considered for a SIA, the program must demonstrate that it has developed,

implemented, and evaluated interventions that are designed to address root causes that

are institutionally supported by the hospital’s governing body on a sustainable basis and

has requested more time for further improvements or demonstrate compliance with the

outcome requirements. SIAs include a mechanism for monitoring the program to

ensure that the terms of the SIA are being met and program efforts to undertake targeted

and systemic improvements to ensure ongoing and sustainable compliance with the

regulatory requirements are occurring.

The SIA is signed by program individuals who have the authority to commit the

hospital to the terms of the Agreement. The Agreement is between CMS and the

transplant hospital.

In exchange for the additional time to initiate or continue activities to achieve

compliance with the CoPs, the hospital must agree to a regimen of specified activities,

including (but not limited to) all of the following:

(i)

Peer Review: An external independent peer review team that conducts an onsite

assessment of the program. The peer review must include—

(A)

Review of policies, staffing, operations, relationship to hospital services, and

factors that contribute to program outcomes;

(B)

Both verbal and written feedback provided directly to the

hospital;

(C); and

(D) Onsite review by a multidisciplinary team that includes a transplant surgeon

with expertise in the relevant organ type(s), a transplant administrator, an

individual with expertise in transplant QAPI systems, a social worker or

psychologist or psychiatrist, and a specialty physician with expertise in

conditions particularly relevant to the applicable organ types(s) such as a

cardiologist, nephrologist, or hepatologist. Except for the transplant surgeon,

CMS may permit substitution of one type of expertise for another individual

who has expertise particularly needed for the type of challenges experienced by

the program, such as substitution of an infection control specialist in lieu of, or

in addition to, a social worker.

(iii)

Action Plan: An action plan that addresses systemic quality improvements and

is updated after the onsite peer review;

(iv)

Onsite Consultant: An onsite consultant whose qualifications are approved by

CMS, and who provides services for eight (8) days per month on average for the

duration of the agreement, except that CMS may permit a portion of the time to be

spent offsite and may agree to fewer consultant days each month after the first three (3)

months of the SIA. The function of the onsite consultant is established under the

discretion of the program.

(v)

Policy & Procedures Review: A comparative effectiveness analysis that

compares policies, procedures, and protocols of the transplant program with those of

other programs in areas of endeavor that are relevant to the center's current quality

improvement needs;

(vi)

Outcomes Data Proficiency: Development of increased proficiency, or

demonstration of current proficiency, with patient-level data from the SRTR and the use

of registry data to analyze outcomes and inform quality improvement efforts;

(vii)

Staffing Review: A staffing analysis that examines the level, type, training, and skill

of staff in order to inform transplant center efforts to ensure the engagement and

appropriate training and credentialing of staff;

(viii)

QAPI: Activities to strengthen performance of the QAPI program to ensure full

compliance with the requirements of §482.96 and §482.21;

(ix)

Monthly Dialogue: Monthly (unless otherwise specified) reporting with

designated monitor regarding the status of programmatic improvements,

results of the deliverables in the SIA, and the number of transplants, deaths,

and graft failures that occur within one (1) year post- transplant; and

(x)

Other: Additional or alternative requirements specified by CMS, tailored to the

transplant program type and circumstances.

The content elements under (v), (vi), (vii), or (viii) above may be waived if CMS finds

that the program has already adequately conducted the activity, the program is already

proficient in the function, or the activity is clearly in applicable to the deficiencies that

led to the SIA.

When CMS has offered a SIA to a transplant program, and the program agrees to enter

into it, the following occurs:

CMS develops the initial draft of the proposed SIA, based on (i)-(x) above, and

forwards the draft to the program for review and comment;

CMS reviews the program’s comments and provides feedback regarding any

changes to the SIA;

CMS and the program will negotiate the final SIA document.

CMS completes the final SIA and forwards it to the program for signature.

The SIA becomes effective on the date CMS signs the agreement.

2063 - Relationship Between the Transplant CoPs and Hospital CoPs.

(Rev. 190, Issued: 06-14-19, Effective: 06-14-19, Implementatiom: 06-14-19)

The transplant program must be in compliance with all hospital CoPs as well as all

transplant program CoPs. Certain hospital requirements are inherently included in the

transplant program survey process. When hospital requirements are thought to be out

of compliance and in need of investigation the transplant program survey team must

contact their supervisor to consult with the CMS RO for further instructions on citing

the hospital deficiencies and must notify the hospital administration of any such

citation.

The transplant program and hospital survey findings are documented on separate

CMS-2567 forms even though the surveys are conducted together.

Hospices

2080 - Hospice - Citations and Description

(Rev. 1, 05-21-04)

2080A - Citations

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

Section 1861(u) of the Act establishes hospices as a provider of services. Section

1861(dd) of the Social Security Act (the Act) defines hospice care and the hospice

program. 42 CFR 418 sets forth the Conditions of Participation (CoPs) that hospices must

meet and applies to a hospice as an entity as well as to the services provided to each

individual under hospice care. 42 CFR Part 418.110 is a condition applicable only to

hospices that provide short-term inpatient care and respite care directly, rather than under

arrangements with other participating providers. Section 1866(a)(1)(Q) of the Act

requires hospices, among other providers, to file an agreement with the Secretary to

comply with the requirements found in Section 1866(f) of the Act regarding advance

directives.

The Centers for Medicare & Medicaid Services (CMS) has a Web site for survey and

certification information including hospice policy memos, the State Operations Manual,

§§2080-2089 relating to hospices, and Appendix M, “Hospice Survey Procedures and

Interpretive Guidelines.” This information is available at

http://www.cms.hhs.gov/SurveyCertificationGenInfo/

Definition

A hospice is a public agency or private organization or a subdivision of either of these that

is primarily engaged in providing care and services to terminally ill individuals, meets the

CoPs for hospices, and has a valid Medicare provider agreement. The law governing the

provision of Medicare hospice services is found at Section 1861(dd) of the Act. The law

further clarifies that “terminally ill individuals” are individuals having a “medical

prognosis that the individual’s life expectancy is 6 months or less.” This definition is

further clarified at 42 CFR 418.3 to provide for a life expectancy of 6 months or less “if

the illness runs its normal course.” Although the law does not explicitly define its

expectations for “primarily engaged,” CMS has interpreted it to mean exactly what it says,

that a hospice provider must be primarily engaged in providing hospice care and services

(Section 1861(dd)(2)(A)(i)). “Primarily” does not mean “exclusively.” This requirement

does not preclude the hospice from providing services to terminally ill individuals who

have not elected the hospice benefit or providing services to individuals who are not

terminally ill, as long as the primary activity of the hospice is the provision of hospice

services to terminally ill individuals and the hospice meets all requirements for

participation in Medicare.

Hospice Benefit Periods

An individual may elect to receive Medicare hospice benefits for two periods of 90 days

and an unlimited amount of periods for 60 days each. (See 42 CFR 418.21.)

Eligibility Requirements

In order to be eligible to elect hospice care under Medicare, an individual must be entitled

to Part A of Medicare and be certified as being terminally ill. (See 42 CFR 418.20.) An

individual is considered to be terminally ill if the individual has a medical prognosis that

his or her life expectancy is 6 months or less if the illness runs its normal course.

Referrals may come from any source, but patients must be assessed by the hospice

medical director for appropriateness of admission in consultation with the patient’s

attending physician (if the individual has one). The hospice medical director must

consider the diagnosis of the terminal condition of the patient, other health conditions,

whether related or unrelated to the terminal illness, and current clinically relevant

information supporting all diagnoses. The medical director may consult with the attending

physician directly or through information obtained indirectly. Information could be

obtained through the hospice nurse or others who would bring the attending physician’s

knowledge of the patient to the medical director when the admission decision is being

made.

The hospice must obtain written certification of terminal illness within 2 calendar days for

each of the benefit periods listed in 42 CFR 418.21, even if a single election continues in

effect for an unlimited number of periods. If the hospice cannot obtain the written

certification within 2 calendar days, after a period begins, it must obtain oral certification

within 2 calendar days and written certification before a claim for payment is submitted.

For the initial 90-day period, certification of terminal illness must be obtained from the

medical director of the hospice or the physician member of the hospice interdisciplinary

group (IDG) and the individual’s attending physician (if the individual has one).

Recertification for subsequent periods only requires the certification of the hospice

medical director or the physician member of the IDG. Certification statements must be on

file and dated by the physician before the hospice submits a claim for payment. (See 42

CFR 418.22.)

2080B - Description

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

Hospice care means a comprehensive set of services described in Section1861(dd)(1) of

the Act, identified and coordinated by the individual’s attending physician, medical

director and by an interdisciplinary group to provide for the physical, psychosocial,

spiritual and emotional needs of a terminally ill patient and family members, as delineated

in a specific patient plan of care.

Hospice uses an interdisciplinary approach to caring for terminally ill individuals that

stresses palliative care as opposed to curative care. Palliative care means patient and

family-centered care that optimizes quality of life by anticipating, preventing, and treating

suffering. Palliative care throughout the continuum of illness involves addressing

physical, intellectual, emotional, social, and spiritual needs and facilitating patient

autonomy, access to information, and choice. The emphasis of hospice care is on effective

symptom management, with the goal of making the patient as physically and emotionally

comfortable as possible, and enabling the patient to remain at home as long as possible

with minimal disruption to normal activities. Counseling and respite services are available

to the family of the hospice patient. Hospice considers both the patient and the family as

the unit of care.

Although some hospices are located as part of a hospital, skilled nursing facility (SNF),

and home health agency (HHA), hospices must meet specific CoPs and be separately

certified and approved for Medicare participation as a hospice provider of services. (See

Exhibit 129 for “Hospice Survey and Deficiencies Report,” Form CMS-643, and Exhibit

72 for “Hospice Request for Certification in the Medicare Program,” Form CMS-417.)

2080C - Hospice Core Services

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

With the exception of physician services, substantially all core services must be provided

directly by hospice employees on a routine basis. These services must be provided in a

manner consistent with acceptable standards of practice. The following are hospice core

services:

• Physician services;

• Nursing services, (routinely available and/or on call on a 24-hour basis, 7 days a

week) provided by or under the supervision of a registered nurse (RN) functioning

within a plan of care developed by the hospice (IDG) in consultation with the

patient’s attending physician, if the patient has one;

• Medical social services by a qualified social worker under the direction of a

physician; and

• Counseling (including, but not limited to, bereavement, dietary, and spiritual

counseling) with respect to care of the terminally ill individual and adjustment to

death. The hospice must make bereavement services available to the family and

other individuals identified in the bereavement plan of care up to 1 year following

the death of the patient.

The hospice may contract for physician services as specified in 42 CFR 418.64(a).

A hospice may use contracted staff, if necessary, to supplement hospice employees in

order to meet the needs of patients under extraordinary or other non-routine

circumstances.

2080C.1 - Waiver of Certain Staffing Requirements

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

Hospices are prohibited from contracting with other hospices and non-hospice agencies on

a routine basis for the provision of the core services of nursing, medical social services

and counseling to hospice patients. A hospice may, however, enter into arrangements

with another hospice program or other entity for the provision of these core services in

extraordinary, exigent, or other non-routine circumstances. An extraordinary

circumstance generally would be a short-term temporary event that was unanticipated.

Examples of such circumstances might include unanticipated periods of high patient loads,

caused by an unexpectedly large number of patients requiring continuous care

simultaneously, temporary staffing shortages due to illness, receiving patients evacuated

from a disaster such as a hurricane or a wildfire, or temporary travel of a patient outside

the hospice’s service area. The hospice that contracts for services must maintain

professional management responsibility for all services provided under arrangement or

contract at all times and in all settings. Regulations at 42 CFR 418.100(e) discuss the

professional management responsibilities of the hospice for services provided under

arrangement.

Hospices must maintain evidence of the extraordinary circumstances that required them to

contract for the core services and comply with the following:

• The hospice must assure that contracted staff is providing care that is consistent

with the hospice philosophy and the patient's plan of care and is actively

participating in the coordination of all aspects of the patient’s hospice care, and

• Hospices may not routinely contract for a specific level of care (e.g., continuous

care) or during specific hours of care (e.g., evenings and week-ends).

2080C.2 - Contracting for Highly Specialized Services

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

A hospice may contract for the services of a registered nurse if the services are highly

specialized, provided non-routinely, and so infrequently that the provision of such services

directly would be impracticable and prohibitively expensive. Highly specialized services

are determined by the nature of the service and the nursing skill level required to be

proficient in the service. For example, a hospice may need to contract with a pediatric

nurse if it cares for pediatric patients infrequently, and employing a pediatric nurse would

be impracticable and expensive. Continuous care is not a highly specialized service,

because while time intensive, it does not require highly specialized nursing skills.

2080C.3 – Hospice Nursing Shortage Provision

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

CMS has instituted a temporary measure for hospices that are unable to hire a sufficient

number of nurses directly due to the nursing shortage. During the time period from

October 1, 2010 – September 30, 2012, in order to qualify for an “extraordinary

circumstance” exemption, a hospice must notify the state agency (SA) responsible for

licensing and certification that it intends to elect an exception under the “extraordinary

circumstance” authority. This may be accomplished by providing written notification to

the SA when it believes that the nursing shortage has become an “extraordinary

circumstance” in its ability to hire nurses directly, and it must estimate the number of

nurses it believes it will currently need to employ under contract. Notification may be

made prior to September 30, 2012, and should address the following:

• An estimate of the number of potential patients that the hospice has not been able

to admit during the past --3 months due to the nursing shortage and provide the

current and desired patient/nurse ratio for the agency;

• Evidence that the hospice has made a good faith effort to hire and retain nurses,

including:

- Copies of recent advertisements (e.g., in local newspapers, Web sites, etc.,)

that demonstrate recruitment efforts;

- Copies of reports of telephone contacts with potential hires, professional

schools and organizations, recruiting services, etc., and

- Job descriptions for nurse employees;

• Evidence that salary and benefits are competitive for the area;

• Evidence of any other recruiting activities (e.g., recruiting efforts at health fairs,

educational institutions, health care facilities, and contacts with nurses at other

providers in the area);

• Ongoing self-analyses of the hospice’s trends in hiring and retaining qualified

staff; and

• Evidence that the hospice has a training program in place to ensure that contracted

staff are trained in the hospice philosophy, and able to provide palliative care prior

to patient contact;

Contracted nurses may only be used to supplement the hospice nurses employed directly

and should not be used solely to provide the continuous nursing level of care or on call

service. The hospice is expected to continue its recruitment efforts during the period that

it is contracting for nurses.

No approval action is required on the SA’s part when it receives written notification from

a hospice for an exemption, as long as the hospice provides the appropriate information.

The SA will maintain copies of each exception notification and validate the hospice’s

stated need for an exemption during complaint and re-certification surveys. Of particular

importance will be the extent to which the hospice nurses have been trained in the hospice

philosophy and are able to effectively provide care to the patients consistent with the

patient specific plan of care established by the IDG.

NOTE: CMS has instituted a temporary measure to allow individual hospices to

contract for nurses until September 30, 2012, if the hospice can

demonstrate that the nursing shortage is creating an extraordinary

circumstance that prevents it from hiring an adequate number of nurses.

2080D - Hospice Required Services

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

Requirement for 24-Hour Services

The hospice is required by the CoPs at 42 CFR 418.100 to make nursing services,

physician services, drugs, and biologicals routinely available on a 24-hour basis, 7 days a

week. It also has to make all other covered services available on a 24-hour basis, 7 days a

week, when reasonable and necessary to meet the needs of the patient and family.

In addition to the hospice core services (physician services, nursing services, medical

social services, and counseling), the following services must be provided by the hospice,

either directly or under arrangements, to meet the needs of the patient and family:

• Physical and occupational therapy and speech-language pathology services;

• Hospice aide services A hospice aide employed by a hospice, either directly or

under contract, must meet the qualifications required by Section1891(a)(3) of the

Act and implemented at 42 CFR 418.76;

• Homemaker services;

• Volunteers;

• Medical supplies (including drugs and biologicals on a 24-hour basis) and the use

of medical appliances related to the terminal diagnosis and related conditions;

• Short-term inpatient care (including respite care and interventions necessary for

pain control and acute and chronic symptom management) in a Medicare/Medicaid

participating facility; and

• Continuous home care provided during a period of crisis. Nursing care may be

covered on a continuous basis for as much as 24 hours a day during periods of

crisis, as necessary to maintain the patient at home. 42 CFR 418.204(a) defines a

crisis as the period in which an individual requires continuous care for as much as

24 hours to achieve palliation or management of acute medical symptoms. The

care provided must require at least 8 hours of care in a 24 hour period, and the care

must be provided predominantly by a licensed nurse (RN, LVN, LPN).

Homemaker or hospice aide services or both may also be covered if needed.

Section 1861(dd)(5) of the Act allows CMS to permit certain waivers of the requirements

that the hospice make physical therapy, occupational therapy, speech language pathology

services, and dietary counseling available (as needed) on a 24-hour basis. CMS is also

allowed to waive the requirement that hospices provide dietary counseling directly. These

waivers are available only to an agency or organization that is located in an area which is

not an urbanized area (as defined by the Bureau of Census) and that can demonstrate to

CMS that it has been unable, despite diligent efforts, to recruit appropriate personnel.

These waivers are codified at 42 CFR 418.74.

2080D.1 - Hospice Interdisciplinary Group (IDG)

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

Hospices participating in the Medicare program must use an interdisciplinary approach to

assessing and meeting the physical, medical, psychosocial, emotional, and spiritual needs

of the hospice patients and families facing terminal illness and bereavement. The hospice

IDG members include, but are not limited to, the hospice physician (doctor of medicine or

osteopathy) who must be an employee of or under contract with the hospice, registered

nurse, social worker, and pastoral or other counselor. The IDG is required to conduct a

comprehensive assessment of the patient and update the assessment at required time

points. In addition, the group, in consultation with the patient's attending physician, if the

patient has one, must prepare a written plan of care for each patient that reflects patient

and family goals and interventions based on the needs identified in the initial,

comprehensive, and updated assessments. The plan of care must include all services

necessary for the palliation and management of the terminal illness and related conditions.

The attending physician may either be a doctor of medicine or osteopathy or a nurse

practitioner. This person is identified by the individual, at the time he or she elects to

receive hospice care, as having the most significant role in the determination and delivery

of the individual’s medical care. In the event that a beneficiary’s attending physician is a

nurse practitioner, the hospice medical director and/or physician designee must certify or

re-certify the terminal illness. Nurse practitioners cannot certify a terminal diagnosis or

the prognosis of 6 months or less, if the illness or disease runs its normal course, or re-

certify a terminal diagnosis or prognosis.

The hospice IDG is responsible for developing and maintaining a system of

communication, coordination, and integration of services that ensures that the plan of care

is reviewed and updated no less frequently than every 15 calendar days. It is not

permissible for either the attending physician or the hospice medical director to provide

the sole guidance for the plan of care. The law and regulations require that it be the

combined work of the IDG.

2081 - Revoking Election of Hospice Care

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

The hospice patient or representative may revoke the patient’s election of hospice care at

any time during the election period according to 42 CFR 418.28. Revocation is a

voluntary action taken by the patient or representative. The election of the hospice benefit

is the beneficiary’s choice rather than the hospice’s choice, and the hospice cannot revoke

the beneficiary’s election. It is important for the hospice to educate the patient and family

before the start of care that hospice entails certain limits in the way care will be provided,

including restrictions on obtaining care outside the care arranged for or provided by the

hospice, and the patient’s liability for care received without the hospice’s involvement.

The hospice should neither request nor pressure the patient/family or representative in any

way to revoke his/her election.

2082 - Discharge from Hospice Care

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

Once a hospice chooses to admit a Medicare beneficiary, it may not automatically or

routinely discharge the beneficiary at its discretion, even if the care promises to be costly,

inconvenient, or the State allows for discharge under State law. The situations under

which a hospice may discharge a patient are addressed in the regulation at 42 CFR 418.26

and include the following situations:

• The patient moves out of the hospice’s service area or transfers to another hospice;

• The hospice determines that the patient is no longer terminally ill; and

• The hospice determines under a policy set by the hospice for the purpose of

addressing discharge for cause, that the patient’s (or other persons in the patient’s

home) behavior is disruptive, abusive, or uncooperative to the extent that delivery

of care to the patient or the ability of the hospice to operate effectively is seriously

impaired.

The hospice must do the following before it seeks to discharge a patient for cause:

• Advise the patient that a discharge for cause is being considered;

• Make a serious effort to resolve the problem(s) presented by the patient’s (or other

persons in the patient’s home) behavior or situation;

• Ascertain that the patient’s proposed discharge is not due to the patient’s use of

necessary hospice services; and

• Document in the clinical record, the problem(s) and efforts made to resolve the

problem(s).

Prior to discharging a patient for any reason stated above, the hospice IDG must obtain a

written physician’s discharge order from the hospice medical director. If a patient has an

attending physician involved in his or her care, this physician should be consulted before

discharge and his/her review and decision included in the discharge note.

The hospice notifies its Medicare administrative contractor (MAC) and SA of the

circumstances surrounding the impending discharge. The hospice should also consider

referrals to other appropriate and/or relevant state/community agencies (i.e., Adult

Protective Services) or health care facilities before discharge.

2083 - Hospice Regulations and Non-Medicare Patients

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

The hospice CoPs apply to all patients of the hospice (Medicare and non-Medicare), with

the exception of the following regulations, which apply only to Medicare beneficiaries:

• 42 CFR 418.100(d) - the continuation of care requirement, and

• 42 CFR 418.108(d) - the 80-20 inpatient care limitation.

In addition, the following CoPs regarding the certification and recertification of terminal

illness are necessary to determine eligibility for Medicare and Medicaid patients and may

or may not be a requirement by other payment sources:

• 42 CFR 418.102(c);

• 42 CFR 418.104 (a)(5); and

• 42 CFR 418.112 (e)(3)(iii).

2084 - Hospice Inpatient Services

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

Hospices must make inpatient care available for pain control, symptom management, and

respite purposes. This inpatient care may be provided directly by the hospice or indirectly

under arrangements made by the hospice. If services are provided under arrangements,

the hospice must ensure that the services are in full compliance with all applicable

standards relating to inpatient care found at 42 CFR 418.110 and 42 CFR 418.108.

2084A - Hospice Provides Inpatient Care Directly

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

When the hospice provides inpatient care directly, it may do so either in space that it owns

or leases or in space shared with a Medicare certified hospital, SNF, or Medicaid certified

nursing facility (NF).

• If the hospice provides care in its own inpatient facility, the care may be provided

in space that the hospice either owns or leases from another facility or building.

The inpatient unit may consist of several beds, a group of beds, or a wing and must

meet all applicable Federal and State requirements and be surveyed for compliance

with 42 CFR 418.110 prior to providing inpatient care to patients. This survey

includes a Life Safety Code survey (which has currently adopted the 2000 edition

of the Life Safety Code of the National Fire Protection Association) that must be

done both at the time of initial certification of the inpatient facility and at the time

of recertification surveys.

• If the hospice provides care directly with hospice staff in space shared with a

Medicare-certified Hospital, SNF, or a Medicaid certified NF (for respite care

only), the SA reviews the agreement and patient files for compliance with 42 CFR

418.110(b) and 42 CFR 418.110(e) since the location already meets the remaining

requirements of 42 CFR 418.110 as a Medicare/Medicaid participating facility.

2084B - Hospice Provides Inpatient Services Under Arrangements

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

When the hospice provides inpatient services under arrangements with a Medicare

participating hospital or SNF, a Medicaid participating NF (for respite care only), or an

inpatient unit of another Medicare-certified hospice, a separate survey of each site is not

required. In these cases, the SA reviews the agreement and patient files to assure that the

standards in 42 CFR 418.110(b) regarding 24-hour nursing service and 42 CFR

418.110(e) regarding comfort and privacy of patient and family members are satisfied.

However, if in reviewing contracts and other documentation (e.g., clinical records, plans

of care), questions arise concerning the contract arrangements, the SA conducts an onsite

visit to the institution providing the inpatient services to review the care provided under

arrangements, not to inspect the facility. This includes hospitals that are accredited by

The Joint Commission or the American Osteopathic Association that are providing

inpatient services under arrangements.

Applicability of Inpatient Care CoP 42 CFR 418.110

Location Where Inpatient Care is Provided

Applicability of Condition

Hospice freestanding inpatient facility

Survey for compliance with 42 CFR

418.110.

Medicare certified hospital or SNF and/or

Medicaid certified NF (for respite care

only.)

Survey for compliance with 42 CFR

418.110(b) and 42 CFR 418.110(e). The

institution already meets the remaining

requirements of 42 CFR 418.110 as a

Medicare/Medicaid certified hospital or

SNF/NF.

A hospice freestanding inpatient facility is defined in this context as a facility that is not a

part of another Medicare/Medicaid certified facility (e.g., hospital or SNF/NF).

2085 - Operation of Hospice Across State Lines

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

When a hospice provides services across State lines each respective State Agency (SA)

must be aware of and approve the action. Each SA must verify that applicable state

licensure, personnel licensure, and other State requirements are met in its respective State.

The provision of services across State lines is appropriate in most circumstances. Areas in

which community services, such as hospitals, public transportation, and personnel services

are shared on both sides of State boundaries are most likely to generate an extension of

hospice services.

When a hospice provides services across State lines, it must be certified by the State in

which its CMS certification number (CCN) is based, and its personnel must be qualified in

all States in which they provide services. The appropriate SA completes the certification

activities. The involved States must have a written reciprocal agreement permitting the

hospice to provide services in this manner. The reciprocal agreement must indicate that

both States are aware of their respective responsibilities for assessing the hospice’s

compliance with the CoP within their State. The agreement should assure that home visits

are conducted to a sample of all patients, in all States served by the hospice.

The CMS Regional Office (RO) will review the required reciprocal agreement between

the States to assure that the SA where the practice location resides is assuming

responsibility for any necessary surveys of the location. If the SAs are unable to come to

a reciprocal agreement on assuring the necessary surveys of the location, the location

should not be approved as a part of the hospice. The provision of interstate service

without a written reciprocal agreement could severely undermine the State’s ability to

fulfill its statutory responsibilities under Section 1864 of the Act to enforce Medicare’s

health and safety requirements. It is at the discretion of the States to decide whether

entering into reciprocal agreements is in the best interest of their residents, provider

markets, and quality assurance and oversight systems.

Exhibit 289 ”Model Reciprocal Agreement Survey and Certification” contains a model

reciprocal agreement document for States to use to assist them in fulfilling their statutory

responsibility to enforce Medicare’s health and safety requirements when a hospice

provides services across State lines.

In States that have a reciprocal agreement in place, providers are not required to be

separately approved in each State; consequently, they would not have to obtain a separate

Medicare provider agreement/certification number in each State. Providers residing in a

State that does not have a reciprocal agreement with a contiguous State are precluded from

providing services across State lines.

In the event that the hospice operates in two CMS ROs, the RO responsible for the State in

which the hospice provider agreement/certification number is based should take the lead

in assuring that the required survey and certification activities are met.

2086 - Hospice Change of Address

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

It is inherent in the provider certification process that a provider notifies CMS of its intent

to change the location or site from which it provides services. Absent such notification,

CMS has no way of carrying out its statutorily mandated obligation of determining

whether the provider is complying with applicable participation requirements at the new

site or location. It is a longstanding CMS policy that there is no basis for a provider to bill

Medicare for services provided from a site or location that has not been determined to

meet applicable requirements of participation. This guidance is contained in Chapter 3,

section 3224 of Publication 100-07.

When an existing hospice intends to move from its surveyed, certified location to a new

site or location, it notifies CMS either directly or through the SA, and, if deemed, it

notifies its approved national accreditation organization (AO), in writing of the proposed

change of location. The provider also notifies its MAC and submits all required

documentation including an amended Form CMS-855A before CMS approval can be

granted. The provider obtains CMS’ approval of the new address before it provides

Medicare services from the new address.

Upon receipt of a provider’s notice and request for approval of the move to the new site or

location, the RO will carefully evaluate the information, together with any supporting

documentation from the provider and any other relevant information known to the RO in

making its decision. If a decision can be made on the written application and supporting

documentation, CMS will grant or deny an approval without requiring a survey. If,

however, the RO concludes that circumstances warrant a survey to establish whether the

new address complies with all applicable requirements, CMS will advise the provider and

will make no further findings until a survey has been completed and submitted to CMS for

its review. In either event, CMS will notify the provider of its decision in writing, as

appropriate.

CMS generally will not approve a change of location of a primary hospice with one or

more previously approved multiple locations if the new location increases the distance

between the primary hospice location and its previously approved multiple location(s) to a

point that prevents the hospice from exerting the supervision and control necessary at each

multiple location to assure that all hospice care and services continue to be responsive to

the needs of the patient/family at all times and in all settings. In that event, the application

for approval of the new location would usually be denied without a survey, and the

provider would apply for a new certification number for the new location. Request for

approval of a proposed change of location of an approved multiple location is handled as a

request for approval of a new multiple location, in accordance with the regulations and

guidelines at 42 CFR 418.100(f).

NOTE: CMS will not approve a change of location for a hospice’s own inpatient

facility without a survey to assure that the facility meets all requirements specified at 42

CFR 418.110.

2086A - Effective Date

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

A hospice may not bill for services provided from the new site or location and should not

bill Medicare until the new site or location has been approved by CMS. The effective date

of coverage for services provided from the new location is the date CMS grants approval

to the hospice’s request to change locations. The fact that a national AO has approved a

new site or location will not affect CMS’ decision. CMS’ determination will be based on

its independent application of its regulations to the facts in the case. Services provided

before the effective date of approval should not be billed to Medicare.

2086B – Administrative Review

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

CMS’s decision on a request for approval of a change of address does not qualify as an

initial determination subject to administrative review under 42 CFR 498.3. Such a

determination does not affect the existing provider agreement, which continues in effect at

the surveyed, certified location until voluntarily terminated by the provider pursuant to 42

CFR 489.52 or involuntarily terminated by CMS pursuant to 42 CFR 489.53. In the event

approval of the new change of address is denied, the provider has the option of formally

applying for initial certification of the new site or location as a separate Medicare provider

of hospice services. In that event, an initial certification survey by CMS or the SA (or

accreditation based on survey by a national AO with deeming authority) would be

required.

2086C – Move after Certification Survey

(Rev. 73, Issued: 12-02-11 Effective: 12-02-11, Implementation: 12-02-11)

Requests for initial certification cannot be processed to completion if a prospective

provider moves to a new location after it is surveyed and/or deemed to meet the CoPs by a

national AO with deeming authority. If a prospective provider moves after its location

has been surveyed and/or accredited but prior to a certification determination by CMS, the

prospective provider’s application for certification becomes incomplete. Absent a survey

of the new location to which the prospective provider has moved, CMS is unable to

determine whether applicable program requirements are met at the new location, and

therefore is prevented from completing its review of the pending application. In these

circumstances, CMS advises the prospective provider that its application is incomplete.

Such an incomplete application is held in abeyance pending receipt of a report of survey

of the current location from the SA or a national AO with deeming authority meeting the

requirements of and approved by CMS. The decision to hold an incomplete application in

abeyance does not qualify as an initial determination as defined in 42 CFR 498.3.

2087 - Simultaneous Surveys

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

If a hospice is established by an entity which participates in the Medicare program as another

type of provider (hospital, SNF, HHA), the SA should attempt to coordinate simultaneous

certification surveys of these entities, i.e., for compliance with hospice CoPs and for

compliance with the other appropriate CoPs/requirements.

NOTE: Section 1861(dd)(4)(A) of the Act states that if a hospice is approved as being part of

another type of provider, with a separate certification number, it shall be considered to meet

those CoPs that are common to both the hospice and the other type of provider.

2088 – Multiple Locations

(Rev. 69, Issued: 12-15-10, Effective: 10-01-10, Implementation: 10-01-10)

When an existing hospice intends to add a multiple location, it must notify CMS, the SA,

and, if deemed, it should notify its’ approved national AO, in writing, of the proposed

location if it expects this location to participate in Medicare or Medicaid. The hospice

must also submit a Form CMS-855A Change of Information Request (including all

supporting documentation) to its MAC before CMS approval can be granted. The

provider must obtain CMS approval of the new location before it is permitted to bill

Medicare for services provided from the new location.

Upon receipt of a hospice’s notice and request for approval of a multiple location, the

CMS RO will carefully evaluate the information, together with any supporting

documentation from the hospice and any other relevant information known to the RO in

making its decision. If a decision can be made based on the written application and

supporting documentation, CMS will grant or deny an approval without requiring a

survey. If, however, the RO concludes that circumstances warrant a survey to establish

whether the new location complies with all applicable requirements, CMS will advise the

provider and will make no further findings until a Medicare certification survey has been

completed and submitted to CMS for its review. In either event, CMS will notify the

provider of its decision in writing, as appropriate.

In evaluating a hospice’s request for approval of a multiple location, the SA and RO

should consider the following in determining whether the new location meets all

applicable Medicare requirements:

• Ability of the governing body to manage the location;

• Any changes made to the lines of authority, and professional and administrative

control;

• Ability of the Medical Director to assume responsibility for the medical

component of the hospice’s patient care at all locations;

• Ability of the hospice to monitor and exercise control over services provided by

personnel under arrangements or contracts at the multiple location;

• Changes in the IDG(s) providing hospice services;

• Changes in staffing or the client population, or both;

• Changes in the way clinical records are maintained, protected and safeguarded

against loss, destruction or unauthorized use; and

• Ability of the hospice to provide all hospice services at the multiple location.

A hospice may not bill Medicare for services provided from a multiple location until the

new site or location has been approved by CMS. The fact that a national AO with

deeming authority has approved a new site or location will not affect CMS’ decision.

CMS’ determination will be based on its independent application of its regulations to the

facts in the case. Services provided before the effective date of approval should not be

billed to Medicare.

If the hospice does operate at multiple locations, a deficiency found at any location will

result in a compliance issue for the entire hospice.

For further information on hospice multiple locations, see 42 CFR 418.100(f) and

418.116.

2089 – Survey Requirements When the Hospice Provides Care to

Residents of a SNF/NF or ICF/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

When a SNF or NF is the hospice patient’s residence for purposes of the hospice benefit,

the SNF or NF must comply with the requirements for participation in Medicare or

Medicaid. The Medicare/Medicaid regulations for long term care facilities regarding the

completion and submission of the Resident Assessment Instrument/Minimum Data Set

(RAI/MDS) data do not change when the resident elects the Medicare Hospice Benefit.

This means the SNF or NF must assess the hospice resident using the RAI, and have a

care plan and provide the services required under the plan of care. This can be achieved

through cooperation between the hospice and facility staff with the consent of the resident.

In these situations, the hospice IDG should participate with the facility in completing the

RAI.

Similarly, the SNF/NF must complete the RAI for any hospice patient who receives short

term inpatient care in a Medicare/Medicaid participating SNF/NF if the hospice patient

resides in the facility for more than 14 days. For further information on the hospice

requirements when it provides care in these settings, see 42 CFR 418.112.

Intermediate Care Facilities

2130 - ICFs/IID – Citations and Description

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

2130A - Citations

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

An ICF/IID is defined in §1905(d) of the Act. The ICF/IID CoPs appear in

42 CFR Part 483 Subpart I. Regulatory requirements for ICF/IID services which appear in

42 CFR 435, Subpart K (Federal Financial Participation) and Part 440 Subpart A

(Definitions), augment the CoPs listed in 42 CFR Part 483.

2130B - Definitions

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

An ICF/IID is an institution that meets Federal CoPs and has as its primary purpose the

provision of health or rehabilitation services to individuals with intellectual disabilities or

related conditions receiving care and services under the Medicaid program.

The ICF/IID CoPs recognize the developmental, social, and behavioral needs of

individuals with intellectual disabilities who live in residential settings by requiring that

each individual both require and receive active treatment for the ICF/IID care to be

eligible for Medicaid funding.

Active treatment means the aggressive, consistent implementation of a program of

specialized and generic training, treatment, health, and related services directed toward the

acquisition of the behaviors necessary for the individual to function with as much self-

determination and independence as possible. It includes the prevention or deceleration of

regression or loss of current optimal functional status.

An injury should be reported as an “injury of unknown source” when:

1. The source of the injury was not witnessed by any person and the source of the

injury could not be explained by the client; and

2. The injury raises suspicions of possible abuse or neglect because of the extent of

the injury or the location of the injury (e.g., the injury is located in an area not

generally vulnerable to trauma) or the number of injuries observed at one

particular point in time or the incidence of injuries over time.

The definition of “immediately” means there should be no delay between staff awareness

of the allegation and reporting to the administrator or other officials in accordance with

State law unless the situation is unstable at the time the allegation comes to the attention

of the staff. In this case, reporting should occur as soon as the safety of all clients is

assured and all necessary emergency measures have been taken.

Section 42 CFR § 483.420(d)(2) of the ICFs/IID regulations addresses the obligation of

the facility staff to report allegations of mistreatment, neglect or abuse, and injuries of

unknown source immediately to the administrator of the facility or to other officials in

accordance with State law through established procedures.

An injury should be reported as an “injury of unknown source” when:

1. The source of the injury was not witnessed by any person and the source of the

injury could not be explained by the client; and

2. The injury raises suspicions of possible abuse or neglect because of the extent of

the injury or the location of the injury (e.g., the injury is located in an area not

generally vulnerable to trauma) or the number of injuries observed at one

particular point in time or the incidence of injuries over time.

It is important to note that members of the ICF/IID population are a mobile population and

lead active lives. Therefore, they experience normal day-to-day bumps and minor

abrasions as they go about their lives. These minor occurrences which are not of serious

consequence to the individual and do not present as a suspicious or repetitive injury (as

discussed above) should be recorded by the facility staff once they are aware of them and

follow-up should be conducted as indicated. For injuries that do not rise to the level of

reportable “injuries of unknown source”, the facility should follow its policies and

procedures for incident recording, investigation, and tracking.

42 CFR § 483.420(d)(2) further requires that allegations of mistreatment, neglect or abuse

and injuries of unknown source must be, “reported immediately to the administrator or to

other officials in accordance with State law, through established procedures”. For the

purpose of this regulation “immediately” means there should be no delay between staff

awareness of the allegation and reporting to the administrator or other officials in

accordance with State law unless the situation is unstable at the time the allegation comes

to the attention of the staff. In this case, reporting should occur as soon as the safety of all

clients is assured and all necessary emergency measures have been taken.

This reporting must be done on a 24/7 basis. Conformity with this definition will

necessitate that the facility administration have procedures in place to receive reports,

even on off-duty hours (e.g., electronic mail, answering machine, voice mail, and fax). It

is critical that the administrator, as designated by the Governing Body under 42 CFR §

483.410(a)(2)-(3), be notified of such occurrences as quickly as possible to ensure the

safety of all residents. There must also be evidence that the information was received, in a

timely manner, by that facility administrator. When the administrator is not on duty, the

facility policies and procedures should detail who (either by name or title) will be acting in

the administrator’s absence. The person(s) acting for the administrator must have the

authority to immediately take whatever corrective action is necessary to ensure client

health and safety. For example if an employee is to be removed from client contact

pending an investigation, the acting administrator must have the authority to take this

action without approval from another official.

CMS expects that such reporting is always made to the administrator of the facility (unless

the administrator is suspected to be involved in the mistreatment, neglect or injury) and

that the administrator then ensures that the appropriate State officials are notified. In any

instance where a staff member is concerned that the administrator of the facility may have

been involved in an incident of mistreatment, neglect, abuse or injury, the staff member

should follow the facility policy for reporting to the appropriate person above the level of

the administrator. The facility should have a written policy that directs the staff in these

situations.

2134 - Distinct Part ICF/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

Neither the law nor Federal regulations define or require ICF/IID services in terms of

distinct parts. However, as a State Medicaid program requirement, States may provide for

distinct part ICF/IID approvals. Where the SMA elects to define the ICF/IID program in

terms of distinct parts, these additional Federal provisions must be met:

• The distinct part must be a clearly identified unit, such as an entire ward, wing,

floor, building, or a number of designated rooms;

• The distinct part consists of all beds and related facilities in the unit; and

• The institution does not need require transfer of patients or individuals to or from

the distinct part, where, in the opinion of the attending physician, transfer might be

harmful to the physical or mental health of the patient or individual. Otherwise, the

unit houses all ICF/IID residents in the institution.

2138 - Approval Procedures for ICFs/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

2138A - Initial Certification of ICF/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

Initial certification of ICFs/IID may be granted by the SA only as a result of a complete

survey which has found the agency to comply with all of the CoPs specified in

42 CFR 483, Subpart I. A facility must be operational prior to scheduling an initial

survey.

Even though a facility may be part of a larger corporation, the fact that it is separately

certified means that it is an independent institution and must be capable of providing all of

the services necessary to meet the client’s needs. Therefore, the survey of each separately

certified ICF/IID must ensure that any evidence used in the determination of compliance

for the requirements stands on its own.

A facility may request that the SA review relevant aspects of its existing immediate track

record as part of the initial survey process if the following is true. A facility must have

been fully operational as a licensed group home or a distinct part that was never certified

because of physical plant limitations yet it provided treatment comparable to that required

by a certified ICF/IID. For example, if the entity claims that it has provided active

treatment to the same clients who will be certified, with the same staff, and consistent with

the components of active treatment described in the Federal regulations, then an initial

survey may be scheduled immediately. To the extent that a survey determines that the

agency’s current and immediate past practices comply with the ICF/IID requirements, the

SA surveyor may utilize this information in making a compliance determination, as part of

the survey, but not as a substitution for the survey.

There is no specific number of days that an ICF/IID must be operational prior to its initial

survey, but in most cases approximately 30-35 days (except as described above) would be

a general safety measure. This timeframe, however, is only a recommendation since

42 CFR Part 483.440(c)(4) only requires that the client’s initial individual program plan

(IPP) must be developed within 30 days after admission. 42 CFR Part 483.440(d)(1)

requires that as soon as the IPP is developed, each client receives a continuous active

treatment program. Therefore, should the facility wish to have its initial survey prior to

being operational for 30-35 days, it should identify the date by which it will be able to

demonstrate its compliance with 42 CFR Part 483.440(a) for each of its clients.

Additionally, for an initial survey, a facility may not demonstrate its “compliance” with

active treatment based primarily on its policies and procedures. Policies and procedures

are designed to describe how a facility intends to provide active treatment. This is

inconsistent with §1905(d)(2) of the Act, which requires that each individual with

intellectual disabilities for whom a request for payment is made is receiving active

treatment.

For purposes of the initial survey of an agency in which clients have just moved to the

agency, the following key components of the active treatment process that are most

relevant to the survey methodology for the CoP, Active Treatment Services (data tag W

195; Appendix J) are:

• The comprehensive functional assessment (42 CFR Part 483.440(c)(3));

• The IPP (42 CFR Part 483.440(c)(4));

• Program implementation (42 CFR Part 483.440(d)); and

• Program documentation (42 CFR Part 483.440(e)).

It would not be necessary to measure the component of active treatment dealing with

program monitoring and change (42 CFR Part 483.440(f)) unless it is determined through

the survey that the initial program clearly does not meet the client’s needs and there is no

evidence of appropriate oversight and attention.

2138B - Multiple Certification of Dispersed Locations

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

When surveying ICFs/IID with more than one unit at dispersed locations, either for an

initial certification or recertification, the SA surveys each unit. Even if a group of small

ICFs/IID is centrally administered, the SA prepares a certification package for each unit.

2138C - Minimum Size of ICF/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

An ICF/IID is defined as a facility that furnishes food, shelter, treatment, or services to 4

or more individuals unrelated to the proprietor. ICFs/IID vary in size from very large

multi-unit, multi-level facilities with sophisticated programs to very small, home-like

settings with required services provided through an arrangement with community

organizations. “Satellite” facilities off the main grounds of an institution are certified as

separate ICFs/IID. Each must meet the 4-individual minimum.

Not withstanding common ownership or unified administration, a “cluster” of separate

facilities in the community cannot be considered as one establishment meeting the

definition of “institution.” Separate cluster facilities in the community must be viewed as

separate establishments. Each must meet the 4-individual minimum to qualify as an

“institution.”

An individual living unit that is part of an overall ICF/IID may be separately certified

under its own provider number if the living unit meets the criteria for a freestanding

ICF/IID. Each separately certified facility, at any point in time, must be able to

independently meet all standards and CoPs. This includes, among other things,

maintaining independent staffing and management. Any services which are not provided

directly by the separately certified facility would have to be provided through a written

agreement with outside sources as required by 42 CFR Part 483.410(d).

It is unlikely that, for example, a facility with several units housed within one building

sharing common corridors and utilizing a common kitchen/dining area could meet the

requirements for maintaining independent staffing and management to meet the criteria for

a freestanding ICF/IID.

There is no minimum number of individuals who must be in residence at the time of the

initial survey. The facility must have enough individuals in residence to demonstrate that

it is able to, and does in fact, provide services to the total number of individuals it

proposes to serve. For example, a facility established to serve 4 individuals would need to

show capacity to serve 4 people, even though not all 4 people would be required to have

actually moved in at the time of the initial survey. (42 CFR Part 435.1009(b)(2) requires

that a facility serve a minimum of 4 persons in order to meet the definition of an

institution.)

2138D - Interpretive Guidelines for ICFs/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

Guidelines for surveying ICFs/IID are located in Appendix J. They provide an

interpretation of the ICF/IID regulations that are applicable to all sizes of facilities that

provide services. They focus on individual and staff performance rather than on

compliance with process and paper requirements and reflect current philosophies and

practices in training individuals with intellectual disabilities and related conditions.

2138E - Survey Report (Form CMS-3070G-I)

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

To survey ICFs/IID, the SA must use the Interpretive Guidelines and Survey Procedures

(see Appendix J) in conjunction with Forms CMS-3070G-I. The forms and optional work

sheet permit the SA to summarize pertinent facility, individual, and survey data, record

observations about active treatment provided for individuals by staff, and summarize

deficiency-related data on the standards and CoPs.

In an effort to monitor the number of allegations of abuse and neglect investigated and the

number of deaths related to restraints and unusual incidents, CMS revised Form CMS-

3070G, the ICF/IID survey report form, to now include an item “M” - Allegations of

Abuse and Neglect, to capture this information. All surveys, including initials,

recertifications, complaints, and follow-ups, occurring after January 2, 2002, must be

entered into the Online Survey and Certification System (OSCAR).

2138F - Application of LSC to ICFs/IID of 16 Beds or Less

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

When conducting a LSC survey, the SA applies the appropriate occupancy chapter (see

Appendix I) of the LSC of the National Fire Protection Association (NFPA), 2000 edition.

2138G - Schedule for Recertification

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

The SA completes a recertification survey an average of every 12 months and at least once

every 15 months (see §2141).

2139 - Assessment of ICFs/IID Based on CoPs for Active Treatment

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

To be certified as a Medicaid provider of ICF/IID services, a facility is required by

§1905(d) of the Act to provide active treatment services for each individual for whom

payment is claimed. Federal regulations in 42 CFR Part 435.1009 and 483, Subpart I

outline the requirements for active treatment in ICFs/IID. While a facility must comply

with the CoPs to be certified, the SA must place particular emphasis on an assessment of

whether active treatment is in fact received by individuals for whom payment is claimed.

Appendix J contains a basic methodology for surveying these requirements.

The definition of “active treatment” in intermediate care facilities for individuals with

intellectual disabilities in 42 CFR Part 435.1009 refers to treatment that meets the

requirements specified in the CoPs for active treatment in 42 CFR Part 483.440(a). The

components of the active treatment process most relevant to this survey methodology are:

2139A - Comprehensive Functional Assessment

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

Within 30 days of admission, the individual’s interdisciplinary team must produce

accurate comprehensive functional assessment data that identifies all her/his present

problems and disabilities. Also, when possible, their causes; specific developmental

strengths and needs; behavioral management needs; and the need for services without

regard to the availability of those services.

1. Money Management Program

• Citing Deficiencies: Surveyors currently cite a deficiency during the

ICF/IID survey process if every client in the facility does not have a formal

money management program in place.

• Regulatory Provisions: The regulations at 42 CFR 483.420(a)(4) state that

clients in the ICF/IID must be allowed to manage their financial affairs and

be taught to do so to the extent of their capabilities.

• Determination of Compliance: The determination as to the

appropriateness of a formal money management program for an ICF/IID

client is based upon the results of a comprehensive functional assessment

and a consensus by the interdisciplinary team.

The need for a formal money management program must be addressed in every

client’s IPP by the IDT on an annual basis.

The determination of the appropriateness of a formal money management program

is made by the IDT and must be based upon a CFA. The IDT discussions resulting

in that determination must be established through documentation in the client’s

IPP.

Surveyors will question and cite any IDT team decision that a formal money

management program is not appropriate when the client clearly exhibits and the

CFA supports the skills needed to implement such a program.

2. Self-Administration of Medications

It has been the expectation of ICF/IID surveyors pursuant to previous Centers for

Medicare & Medicaid Services interpretations of §483.460(k)(4), that every client

residing in an ICF/IID must participate at some level in a formal, self-

administration program for medications.

• Regulatory Requirement for Self Administration Programs: There is

no regulation that requires every client to have a formal, self-administration

program for medications. The appropriateness of such a program for a

client is determined by the interdisciplinary team in consideration of the

comprehensive functional assessment data.

• Regulatory Requirement for Those Clients Not in Self-Administration

Programs: The concept of continuous active treatment at §483.440(d)(1)

requires that the facility utilize the time during medication administration

by staff as a teaching opportunity for clients who have formal training

programs for the development of skills that are transferrable to the drug

administration process.

Self administration of medication refers to the intentional, independent application

or ingestion of over the counter or prescribed medications by an individual without

assistance, instruction or direction. The regulation at §483.460(k)(4) requires the

interdisciplinary team to develop and implement training objectives for

individuals, “determined” to be appropriate for self administration of medications

unless the client’s physician specifies otherwise.

The interdisciplinary team must determine, based on comprehensive assessment,

whether an individual possesses, or has the potential to develop, the requisite skill

set needed to safely self administer medications and individually tailor training

objectives to advance the individual toward the goal of self administration.

§483.460(k)(4) does not require that all individuals in an ICF/IID be engaged in

self administration training programs. The interdisciplinary team decision that a

self administration program is appropriate, as is the case for all formal training

objectives, must be based upon accurate, current, valid assessment of the

individual’s skills and potential. The determination as to the appropriateness of a

self administration program must never be made singularly on the individual’s

diagnosis or current functional abilities.

For individuals assessed to be inappropriate for a self administration program, but

determined by the interdisciplinary team to possess the capacity to functionally,

cognitively, emotionally or developmentally benefit from participation in the drug

administration process, it is expected that the facility will provide opportunities for

the client to participate in the medication administration process under direct

supervision. This participation can include but is not limited to identifying the

medication taken, reaching/grasping a cup of water during the process and placing

oral medications in the mouth, etc.

During drug passes observe whether clients are offered the opportunity to

participate consistent with their functional skill level and verify that the programs

are being carried out consistently and in accordance with the written objective.

For individuals not in need of formal self-administration programs who are not

provided opportunities to participate in administration process, cite a deficiency at

§483.440(c)(6)(vi).

If, as a result of observations and interviews, there are any concerns as to why a client is

not on a formal program, the surveyor should review the associated assessments and

interdisciplinary discussions. During this review look for evidence that the

interdisciplinary team documented a justification as to why the client was not appropriate

for a formal self-administration program and that the justification provided was based on

an evaluation of the assessment results. Deficiencies for a failure by the facility to

properly assess, to develop written self administration objectives or to carry out the self-

administration programs consistently should be cited at §483.460(k)(4).

2139B - Individual Program Plan (IPP)

(Rev. 1, 05-21-04)

The individual’s interdisciplinary team must prepare an IPP which identifies the discrete,

measurable, criterion-based objectives the individual is to achieve; the timetables for

expected mastery; and the specific individualized program of specialized and generic

strategies and techniques to be employed. The IPP must be directed toward the acquisition

of the behaviors necessary for the individual to function with as much self-determination

and independence as possible and the prevention or deceleration of regression, or loss of

current optimal functional status.

2139C - Program Implementation

(Rev. 1, 05-21-04)

Each individual must receive continuous active treatment consisting of needed

interventions and services in sufficient number and frequency to achieve the IPP

objectives. Each individual’s IPP must be implemented by all staff working with the

individual, except where only licensed personnel may implement certain areas of the

program.

2139D - Program Documentation

(Rev. 1, 05-21-04)

Accurate, systematic, behaviorally-stated data about an individual’s performance toward

meeting the criteria in the IPP objectives must be documented and serve as the basis for

changes and revisions, whenever necessary.

2139E - Program Monitoring and Review

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

At least annually, the comprehensive functional assessment of each individual is reviewed

by the interdisciplinary team for relevancy and updated as needed. The IPP is revised, as

appropriate. The IPP must also be reviewed by a qualified intellectual disabilities

professional and revised as necessary.

Approximately one-third of the ICF/IID CoPs (42 CFR Part 483, Subpart I) deals with the

sufficiency and adequacy of staff to deliver each service. The regulations provide

guidance about what constitutes active treatment and enable the SA to assess these

standards from the standpoint of whether active treatment is being provided in a consistent

and aggressive manner. SA entries on both Form CMS-3070G-I and Form CMS-2567

should reflect this approach.

Of greatest importance in determining if active treatment is being provided is whether the

facility provides competently trained staff of all types and at all levels who, in fact, do

implement individually identified objectives established for each individual. A correct

certification addresses these objectives in terms of whether the services are being

delivered to each individual whose IPP indicates that they are needed and whether

adequate staff and facilities are engaged in furnishing them. A certification which affirms

no more than that the services, staff, and facilities are available is incorrect and

unacceptable. A provider agreement may be held invalid under 42 CFR Part 483.440(a)

of the CoPs if the regulation is not correctly applied.

If a facility has the necessary resources available but does not actually provide active

treatment to individuals in accordance with identified needs or does not conduct the

comprehensive functional assessment evaluations to identify individuals’ needs, the SA

denial, nonrenewal, cancellation, or termination of the agreement is supportable. The SA

carefully explains the deficiency in the SA notice of determination.

2140 - Waiver and/or Variance of ICF/IID Requirements

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

2140A - ICF/IID Room Size and Occupancy

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

No waivers are available to an ICF/IID to change the square footage requirements for

bedrooms. 42 CFR Part 483.470(b) allows as little as 80 square feet for individual

bedrooms and 60 square feet for multiple individual bedrooms.

However, the SA may grant a variance to the requirement in 42 CFR Part 483.470(b)(iii)

of no more than four individuals per room if a physician who meets the qualifications for a

qualified intellectual disabilities professional in 42 CFR Part 483.430(a) and is also a

member of the individual’s interdisciplinary team has justified, in writing, in each IPP, the

following:

• How the individual is so medically impaired as to require direct and continuous

monitoring during sleeping hours;

• Whether the individual is on a medical care plan, as described in

42 CFR Part 483.460(a)(2);

• The extent of life support services needed to meet the individual’s medical needs;

and

• The specific reason why housing the individual in a room of four or fewer

individuals would not meet the individual’s medical needs.

The variance must not adversely affect the health or safety of the individual. The variance

must assure that the minimum square footage requirements specified in

42 CFR Part 483.470(b) have been met. The variance expires unless renewed each time

the ICF/IID is certified. It is not meant to justify the long-term continued use of open

wards or nominally partitioned wards for housing individuals.

The only acceptable reason for individuals being housed in bedrooms serving more than 4

individuals is that the individual is in very fragile health and needs extensive life support

services, such as posturing for clearing the airway, monitoring for uncontrolled seizures,

etc. Each individual placed in the grouping must have such a high level of medical

monitoring need as to require supervision which is possible only through the use of

bedrooms housing more than four individuals.

2140B - Waiver of LSC

(Rev. 1, 05-21-04)

See §2472.

2141 - Recertification - ICFs/IID

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

• The regulation at §442.15 provides that provider agreements for ICF/IID’s would

remain in effect as long as the facility remains in compliance with the Conditions Of

Participation (COP’s). Regulations at §442.109 through §442.111.

• Beginning on May 16, 2012, ICF/IID’s are no longer subject to time-limited

agreements. However, they are to be surveyed for re-certification an average of

every 12 months and at least once every 15 months.

• If during a survey the survey agency finds a facility does not meet the standards for

participation the facility may remain certified if the survey agency makes two

determinations – The facility may maintain its certification if the survey agency

finds Immediate Jeopardy doesn’t exist, and if the facility provides an acceptable

plan of correction.

• An ICF/IID may be decertified under procedures outlined in Section 3012 of the

State Operations Manual. More specifically, a facility may be decertified if an

immediate jeopardy finding remains unabated after 23 days or if it fails to regain

compliance with conditions of participation after 90 days.

ICF/IID’s will be subject to survey an average of every 12 months and at least every 15

months, the same period that is applied to Nursing Homes.

If a survey agency finds a facility deficient in meeting the standards for ICFs/IID, as

specified under subpart I of part 483 of chapter 42, the agency may continue

certification of the facility for Medicaid purposes as long as the agency finds the

facility’s deficiencies do not constitute immediate jeopardy or seriously limit the

facility’s capacity to provide adequate care. In addition, the agency must find the

facility’s plan of correction is acceptable.

The survey agency may conduct a revisit to assure the conditions for continued

certification are maintained. A facility’s certification may be terminated according to

procedures set out in Section 3012 of the State Operations Manual.

2142 – Evacuation Drills for ICFs/IID Certified Under the Life Safety

Code NFPA 101, 2000 Edition

(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

• Self-evacuation during an emergency. Clients residing in ICFs/IID certified under

Chapter 32/33 of the Life Safety Code NFPA 101, 2000 Edition (LSC) are

expected to be capable of self-evacuation during an emergency.

• Full evacuation drills- All drills under this Chapter must be full evacuation drills

unless the facility is designated as evacuation capability, “impractical.”

• Exceptions to full evacuation drills- With a designation of evacuation capability

“impractical” the facility must meet the requirements of Chapter 18/19 of the LSC

as regards to evacuation drills.

ICF/IID facilities that are certified under Section 32.7.3 or Section 33.7.3 of the LSC must

conduct emergency drills no less than six (6) times per year on a bi-monthly basis. These

drills must all be full evacuation drills and all clients residing in the facility must

participate in each drill. At least two of these drills must take place during sleeping hours.

This requirement is consistent with the requirements of 42CFR 483.470(i)(2)(i) which

require actual evacuation of clients during at least one emergency drill each year on each

shift.

ICF/IID facilities certified under Section 32.7.3 or Section 33.7.3 of the LSC with a

capability classification of “impractical” must meet the emergency drill requirements

found at Section 18.7 or Section 19.7 of the LSC. These sections require that the facility

conduct fire drills which simulate emergency fire conditions on a quarterly basis. Since

these drills are conducted to train staff rather the clients, the Code does not require full

evacuation. However, the facility must also meet the ICF/IID regulations at 42CFR

483.470(i)(2)(i) which do require the actual evacuation of clients during at least one

emergency drill each year on each shift. These drills are conducted primarily to prepare

and train staff and it is critical that the staff from each shift participate in these drills. The

facility may not elect to conduct night shift drills during another shift.

The LSC requires that the facility make the determination of “impractical” utilizing the

criteria of the Code found in Sections 32/33.2.1.2.2 concerning the characteristics of the

client population. The LSC surveyor verifies that the determination was correctly made at

the time of the annual survey.

The requirements of full evacuation during a drill is not intended to address the

requirements for frequency of evacuation drills. The regulation at §483.470 (i) requires

that evacuation/fire drills be conducted at all ICF/IID facilities on a quarterly basis on

each shift. This requirement supersedes the number of evacuation drills required by the

LSC under Chapters 32/33 it does not impact the requirements for full evacuation during

such drills.

2143 - The Use of Video Cameras in Common Areas in ICF/IID

(Rev.91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)

• Use of video cameras in ICFs/IID: To ensure that client’s rights are protected,

the use of video cameras in the ICF/IID must be reviewed, approved and

monitored by the Specially Constituted Committee (SCC) of the facility as

constituted per 42 CFR 483.440(f)(3)(i-iii).

• Informed Consent: If approved by the SCC, written informed consent must be

obtained from every affected client or designated guardian prior to the

implementation of video cameras. Video cameras may be used in common areas

within the ICF/IID facility.

• Prohibitions: Video cameras may never be used for any reason in areas where

there are the highest expectations of privacy such as bathrooms, areas for

private visitation or areas for private phone calls. Video cameras may not be

used as a substitute for or supplement to adequate staffing or supervision

protocols. The cost of the video cameras must be incurred by the facility and

not the clients.

The Condition of Participation §483.420 requires that the facility must ensure the rights of

all clients. Specifically, the facility must:

• ensure that clients are not subjected to physical, verbal, sexual or psychological

abuse or punishment -§483.420(a)(5);

• provide each client with the opportunity for personal privacy and ensure privacy during

treatment and care of personal needs -§483.420(a)(7); and

• ensure clients the opportunity to communicate, associate, and meet privately with

individuals of their choice -§483.420(a)(9).

The above referenced regulations do not unilaterally prohibit the use of video cameras within

the ICF/IID. There may be instances where the use of video cameras may be helpful in

ensuring that the clients are free from physical, verbal, sexual or psychological abuse,

mistreatment or punishment. However, great care must be exercised to prevent any unintended

violation of an individual’s rights and privacy when such equipment is used in the facility.

Consistent with the regulations which require that the ICF/IID provider protect the privacy and

rights of the clients in the facility, video cameras may only be used in the common areas or

shared spaces of the ICF/IID where clients have lower expectations of privacy and where, in

the normal course of their day, they may encounter visitors, staff, other clients, or medical

personnel. Conversely, video cameras may never be used in areas where the clients have the

highest expectations of privacy, such as client bathrooms, or areas where residents meet

privately with visitors or make personal phone calls.

To ensure that any use of video cameras complies with regulatory requirements that client

rights are fully protected, any use of video cameras in the ICF/IID must be approved by the

Specially Constituted Committee (SCC) of the facility as constituted per §483.440(f)(3).

Affected clients and their families or guardians must be informed of the SCC’s approval to

use video cameras in a specified area. Written informed consent must be obtained from

every client or designated guardian living in the physical unit prior to the implementation of

video cameras. If an ICF/IID consists of several physically separate living units, and the

clients (and guardians if applicable) of a single unit have consented to the implementation

of video cameras, it is not required that the clients residing in the other units (and their

guardians as applicable) provide informed consent, since they would be considered guests

when visiting this unit. However, the facility administration should still inform all clients

living on the grounds (and their guardians if applicable) that camera use is in place on this

specific unit.

To ensure the confidential use of the camera recordings, the facility must have policies

and procedures in place that:

a) limit who has access to video viewing or use of the videos;

b) ensure that all staff with video viewing access are properly trained in the facility

policies and the protection of client rights; and

c) ensure that adherence to the facility policies is monitored and that risks or

breeches of the facility policies are promptly addressed.

The ICF/IID may not utilize video cameras in lieu of adequate staffing or supervision

protocols. The use of video cameras must not replace or otherwise substitute for trained

and available direct care staff at a sufficient level to provide active treatment and ensure

client safety.

The ICF/IID must incur the entire cost of any video camera usage in the facility. Clients or

their families may not be charged.

Spell of Illness Certifications

2160 - Purpose of Certifying §§1861(e)(1) and 1819(a)(1) of the Act

Status of Hospitals and SNFs

(Rev. 1, 05-21-04)

2160A - Benefit Period Provision

(Rev. 1, 05-21-04)

A Medicare beneficiary is limited to a specific maximum number of days of covered

inpatient hospital care and covered post-hospital extended care in a SNF within a period of

time known as a spell of illness or benefit period. Once these benefit days have been used,

additional benefit days are not available until the spell of illness ends and a new benefit

period begins.

Section 1861(a) of the Act defines the term “spell of illness” and states that to end a spell

of illness, a beneficiary must not have been an inpatient of any hospital as defined in

§1861(e)(1) of the Act or a resident of a facility described in §1819(a)(1) (formerly

§1861(j)(1)) of the Act for 60 consecutive days.

NOTE: Section 1819(a)(1) of the Act’s basic definition of a SNF for spell of illness

purposes was formerly contained in §1861(j)(1) of the Act. Thus, a reference to

§1861(j)(1) of the Act in older material should be read as a reference to §1819(a) of the

Act.

Therefore, to enable beneficiaries, providers, and intermediaries to ascertain eligibility for

additional benefits, classify institutions to which a beneficiary may have been removed on

the basis of whether the institutions meet the §§1861(e)(1) or 1819(a) definitions.

2160B - Defining Medicare Eligible Individual’s “Home” for Purposes of

Durable Medical Equipment (DME) and Home Health Benefits

(Rev. 1, 05-21-04)

Sections 1861(s)(6) and 1861(n) of the Act provide that purchase or rental of DME such

as iron lungs, oxygen tents, hospital beds, or wheelchairs may be covered under Part B of

the Medicare program if used in the patient’s home. Similarly, home health benefits can

be paid for certain services that are furnished in a patient’s home. An institution that

meets the requirements of §1861(e)(1) or §1819(a)(1) of the Act cannot be considered a

patient’s home for purposes of this benefit. If a facility is certified as a hospital, a

Medicare SNF, or any other facility that meets the requirements of §1861(e)(1) or

§1819(a)(1) of the Act, it is not considered the patient’s home. Therefore, the institution’s

§1861(e)(1) or §1819(a)(1) status is used for these purposes also.

2160C - Defining “Institution” for Ambulance Benefit

(Rev. 1, 05-21-04)

Another use of §1861(e)(1) or §1819(a)(1) of the Act’s definitions is to help determine

whether ambulance benefits can be paid. The benefit requires that transportation be to or

from an institution (i.e., other than the patient’s “home”).

2162 - Defining Hospital for Spell of Illness, DME, and Home Health

Benefit Purposes

(Rev. 1, 05-21-04)

The term “hospital” as used in §1861(e) of the Act and State licensure laws has a

generally accepted meaning that is seldom questioned. A problem arises, however, with

respect to distinct parts of hospitals that render types of care other than hospital care (e.g.,

LTC). For example, a hospital may have separate wings or buildings for services ranging

from residential to skilled nursing services. The SA evaluates these non-hospital parts in

terms of whether they meet the definition of “hospital” in §1861(e)(1) of the Act. The SA

also states whether these parts meet the definition of “skilled nursing facility” in

§1819(a)(1) of the Act.

Although a psychiatric hospital is precluded from participating in the Medicare program

as a SNF, the spell of illness test is applied to such institution, and any non-hospital

portions must be certified for spell of illness purposes.

2164 - When to Make Spell of Illness Certification

(Rev. 1, 05-21-04)

It is not necessary that the SA makes §1861(e)(1) or §1819(a)(1) determinations for

Medicare-certified hospitals or Medicare-certified SNFs. Section 1861(e)(1) of the Act

contains a basic definition that all hospitals meet. Similarly, §1819(a)(1) of the Act

contains the statutory definition of a SNF, which is the basis for Medicare certification

requirements of SNFs in 42 CFR 483, Subpart B.

In many States, licensing laws for all nursing homes have incorporated the requirements

of §1819(a) or §1919(a) of the Act or the criteria contained in §2166. When this is the

case, any nursing home licensed in such States cannot be considered a resident’s home for

purposes of spell of illness, DME, ambulance, and HHA benefits. In other States it may

be necessary for the SA to make §1861(e)(1) or §1819(a)(1) certifications, as appropriate,

in the following instances:

• Nonparticipating parts of newly certified Medicare distinct part SNFs;

• Nonparticipating parts of Medicare SNFs that change from complete to distinct

part certifications or that change the size or location of the participating distinct

part;

• Terminated, denied, or withdrawn Medicare SNFs;

• New institutions offering any level of nursing care or rehabilitation which do not

intend to participate in Medicare;

• Changes in the §1819(a)(1) status of facilities that come to the SA’s attention

through licensure, surveys, or other means; and

• Parts of hospitals providing patient care but not rendering hospital services.

Routine periodic recertifications of spell of illness requirements are not required.

2166 - Criteria for Certifying §1819(a)(1) of the Act Status of LTC

Facilities Other Than SNFs

(Rev. 1, 05-21-04)

As indicated above, SNFs meet §1819(a)(1) requirements, as do LTC facilities in States

where licensure laws require it. In other situations, a facility or a part of a facility meets

the standard set forth in §1819(a)(1) of the Act for purposes of determining spell of illness

status if it meets each of the following: (See Exhibit 10, Form CMS-1539A, “Certification

and Transmittal for Spell of Illness Determination.”)

2166A - Nursing Services

(Rev. 1, 05-21-04)

Nursing services are provided under the direction or supervision of one or more RNs or

licensed practical or vocational nurses without regard to whether the facility has the nurse

staffing requirement “waived.” The SA considers this condition met even if the nurse is

also the administrator of the facility or is employed on a part-time basis.

2166B - 24-Hour Nursing Services

(Rev. 1, 05-21-04)

Nursing personnel are on duty 24 hours a day. The term “nursing personnel” includes

RNs, licensed practical or vocational nurses without regard to whether they are “waived,”

practical nurses, student nurses, nurse aides, and orderlies.

2166C - Nurse-Bed Ratio

(Rev. 1, 05-21-04)

The number of full-time equivalent nursing personnel to the number of beds is not less

than an average ratio of 1 to 15 per shift.

NOTE: Generally, there will be a close equivalency between the number of beds and the

average number of patients in an institution. When circumstances indicate a significant

discrepancy in these factors, the ratio of nurses to the average patient census should be

used in certifying §1819(a)(1) status.

A facility that has three 8-hour shifts must have a minimum of the equivalent of three full-

time nursing personnel during a 24-hour period for each 15 beds. It is not necessary that

the 1 to 15 ratio be maintained for each shift, but the average of all shifts must be at least 1

to 15. In determining the ratio, the SA counts nurses who are also administrators as

nursing personnel.

2166D - Other Services

(Rev. 1, 05-21-04)

Bed and board are provided to inpatients in connection with the furnishing of nursing care,

plus one or more medically-related health services such as physicians’ services, physical,

occupational or speech therapy, diagnostic and laboratory services, and administration of

medication. (Social, diversional, or recreational services provided by the institution are

not considered medically-related health services.)

2168 - Additional Development Required for Spell of Illness

Certifications

(Rev. 1, 05-21-04)

Ordinarily, the SA has sufficient information available in certification, licensure, welfare,

or other records to certify the spell of illness status of an institution under the rules and

criteria set forth in the previous sections.

If the facility assigns staff specifically to separate patient care units, the SA records

separate data for each such unit on the appropriate survey report (i.e., page 12 of Form

CMS-1537 for hospitals or Form CMS-671 for LTC facilities), identifying the location of

the units or the room numbers of each unit.

A. Additional Development

Where existing records are inadequate, the SA uses any reliable method (e.g., letters and

phone calls) to obtain additional evidence to determine spell of illness status. If any

doubts exist, the SA visits to verify.

B. Institution Consists of Single Building

If an institution consists of a single building, the SA completes separate spell of illness

determinations for the nonparticipating part(s) of the institution.

C. Institution Consists of More than One Building

If an institution consists of more than one building, the SA completes separate spell of

illness determination for the nonparticipating parts of the institution in each building.

Home Health Agencies (HHAs)

2180 - HHA – Citations and Description

(Rev. 1, 05-21-04)

2180A - Citations

(Rev. 125,

Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The statutory authority for applying CoPs to HHAs is found in §§1861(o) and 1891 of the

Act. The regulations are found in 42 CFR Part 484 (§484.) Appendix B contains

Investigative Procedures and Interpretive Guidance for surveyors.

The CMS has a web site for information pertaining to HHA survey and certification,

including links to HHA policy memos, HHA-related information in the State Operations

Manual, §§ 2180 - 2202.19, and Appendix B, Part I-Investigative Procedures and Part II

Interpretive Guidelines available at:

http://www.cms.gov/Medicare/Provider-EnrollmentandCertification

/SurveyCertificationGenInfo/index.html?redirect=/SurveyCertificationGenInfo/

Additional information can also be found at the Home Health Agency (HHA) Center at:

http://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-

Center.html?redirect=/center/hha.asp.

2180B - Types of Agencies

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

An HHA may be a public, nonprofit or proprietary agency or a subdivision of such an

agency or organization.

1. Public agency is an agency operated by a State or local government. Examples

include State-operated HHAs and county hospitals. For regulatory purposes,

“public” means “governmental.”

2. Nonprofit agency is a private (i.e., nongovernmental) agency exempt from Federal

income taxation under §501 of the Internal Revenue Code of 1954. These HHAs

are often supported, in part, by private contributions or other philanthropic sources,

such as foundations. Examples would include non-profit visiting nurse

associations or non-profit hospitals.

3. Proprietary agency is a private, profit-making agency or profit-making hospital.

2180C - General Requirements

(Rev. 1, 05-21-04)

Section 1861(o) of the Act defines an HHA as an agency or organization which:

• Is primarily engaged in providing skilled nursing services and other therapeutic

services;

• Has policies established by a group of professionals (associated with the agency or

organization), including one or more physicians and one or more registered

professional nurses, to govern the services which it provides;

• Provides for supervision of above-mentioned services by a physician or registered

professional nurse;

• Maintains clinical records on all patients;

• Is licensed pursuant to State or local law, or has approval as meeting the standards

established for licensing by the State or locality;

• Has in effect an overall plan and budget for institutional planning;

• Meets the CoPs in the interest of the health and safety of individuals who are

furnished services by the HHA; and

• Meets additional requirements as the Secretary finds necessary for the effective

and efficient operation of the program.

For purposes of Part A home health services under Title XVIII, the term “home health

agency” does not include any agency or organization which is primarily for the care and

treatment of mental diseases.

The CoPs for a Medicare-approved HHA found in 42 CFR Part 484 are also based on

§1891 of the Act. These CoPs are listed in Appendix B, Interpretive Guidelines for

HHAs. Section 1891 of the Act requires, among other things, that the HHA:

• Protect and promote the rights of each individual under its care;

• Disclose ownership and management information required under the Act;

• Not use as a home health aide (on a full-time, temporary, per diem, or other basis)

any individual to provide items and services described in §1861(m) of the Act,

unless the individual has completed a training and competency evaluation program

(CEP) or a CEP that meets minimum standards established by the Secretary, and is

competent to provide such items and services;

• Operate and provide services in compliance with all applicable Federal, State, and

local laws and regulations (including the requirements of §1124 of the Act);

• Operate and provide services in compliance with accepted professional standards

and principles which apply to professionals providing items and services for the

HHA;

• Include an individual’s plan of care (PoC) required under §1861(m) of the Act as

part of the clinical record described in §1861(o)(3) of the Act; and

• Comply with the requirements of §1866(f) of the Act relating to maintaining

written policies and procedures respecting advance directives.

2180D - Services Provided

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

All HHAs must provide skilled nursing services and at least one of the following other

therapeutic services: physical therapy, speech language pathology, or occupational

therapy, medical social services, or home health aide services in a place of residence used

as a patient’s home. The HHA must provide at least one of these services (i.e., skilled

nursing, physical therapy, speech language pathology, occupational therapy, medical

social services, or home health aide services) directly and in its entirety by employees of

the HHA. The other therapeutic services and any additional services may be provided

either directly or under arrangement.

An HHA is considered to provide a service “directly” when the person providing the

service for the HHA is an HHA employee. For the purpose of meeting §484.14(a), an

individual who works for the HHA on an hourly or per visit basis may be considered an

agency employee if the HHA is required to issue a Form W-2 on his/her behalf.

An HHA is considered to provide a service “under arrangements” when the HHA provides

the service through contractual or affiliation arrangements with other agencies or

organizations, or with an individual(s) who is not an HHA employee. The HHA is

responsible for ensuring that the applicable CoPs are met, as though the HHA was

furnishing the services directly.

When hourly or per visit contracts are used, or when services are provided under

arrangement, there must be a written agreement or contract between such personnel, or

this agency or organization, and the HHA which specifies:

• Patients are accepted for care only by the primary HHA;

• The services to be furnished under the contract or agreement;

• The necessity to conform to all applicable agency policies, including personnel

qualifications;

• The responsibility for participating in development of plans of care;

• The manner in which services will be controlled, coordinated, and evaluated by the

primary HHA;

• The procedures for submitting clinical and progress notes, scheduling of visits,

periodic patient evaluation; and

• The procedures for payment for services furnished under the agreement or

contract.

2180E – Application of Home Health Agency Conditions of Participation

to Patients Receiving Chore Services Exclusively

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

In addition to the home health services listed in §1861(m) of the Act, and Medicaid State

Plan services identified in §1905(a) of the Act, some HHAs choose to offer additional

services which are clearly non-medical in nature. Such services are typically comprised of

housekeeping, chore, or companion services. The HHA makes these services available to

individuals who choose to pay for them privately, and/or individuals who are provided

these services from other programs, such as a State Medicaid Home and Community-

Based Services (HCBS) Waiver Program under §1915(c) of the Social Security Act. The

HHA may offer these services to current patients of the HHA (to supplement the skilled

services available), to previous patients who have been discharged from skilled care, and

to other individuals in the community who request them.

Many individuals who receive these non-medical services are frail, elderly or disabled and

request these services because they are unable to perform them independently and need

this kind of assistance to remain in the home environment.

In addition to promoting the health and safety of individuals, §1891(b) of the Social

Security Act also directs the Secretary to ensure that requirements “promote the effective

and efficient use of public moneys.” This statutory direction is especially pertinent in the

question of whether expenses ought always to be incurred for a comprehensive assessment

and care plan when the only service requested from an HHA by an individual is a chore or

other clearly non-medical service. When this is the case, we will not consider the

individual to be a patient of the HHA in the traditional sense of the term, and requirements

that must apply to patients will not be required in such limited situations (e.g., the

requirement for a comprehensive assessment under §484.55 will not apply).

The Medicare HHA CoPs do not apply to those individuals who receive only chore

services or other clearly non-medical services from the HHA. Non-medical services

include chore services, companion services, household maintenance and repair services,

lawn and tree services, and clearing walkways. To the extent that there is ambiguity as to

whether a service is non-medical or medical, we will incline towards the medical

interpretation and consider the CoPs to apply.

CMS considers as a medical service any hands-on service, personal care service, cueing,

or activity that is in any way involved in monitoring the patient’s health condition. As

soon as the HHA provides any Medicare service to an individual, or any standard service

permitted by Federal law under the Medicaid State Plan (such as personal care), we will

consider the individual to be receiving medical care. The CoPs will apply for all services

rendered to such an individual. For example, the CoPs would apply in the case of an

individual who received both chore services and personal care (regardless of funding

source), but would not apply in the case of an individual receiving only chore services

from the HHA.

HHAs are required as a part of the patient rights CoP to advise the patient of the extent to

which payment for HHA services may be expected from Medicare or other sources and

the extent to which payment may be required from the patient. The HHA should explain

to a beneficiary who is ending a Medicare episode and continuing to receive chore

services that Medicare does not pay for those services.

HHAs may develop their own comprehensive assessment for each required time point

under the regulations at §484.55 for those patients receiving personal care services only

regardless of payer source. The assessment may be performed any time up to and

including the 60

day from the most recently completed assessment.

The HHA must continue to meet all State licensure and State practice regulations

governing the provision of service to this population. Where state law is more restrictive

than Medicare, (e.g., State law or State Medicaid HCBS requires the HHA to comply with

CoPs when providing only chore services) the provider needs to apply the State law

standard as well.

Note that this instruction does not supersede any current policy related to Medicare

coverage and eligibility rules or instructions from the Medicare Administrative

Contractors (MACs). The HHAs that provide non-medical services must also ensure that

fiscal accounts are structured and maintained in conformance with CMS regulations and

generally accepted accounting standards.

2182 - Organization of HHA

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

It is permissible for an HHA to be located at a single site or have a parent site with

services available at other approved locations, unless prohibited by State law or

regulation. If there is more than one site, there must be a designated parent site with any

other designated sites (branches and/or subunits) being part of that agency as described in

more detail below. The parent, branch or subunit must be operational during normal

business hours as defined by the parent or subunit.

Subdivisions

A subdivision is a component of a multi-function health agency, such as a hospital-based

HHA or the nursing division of a health department, which independently meets the CoPs

for HHAs. A subdivision would need to meet all requirements for the initial survey

including completing the CMS Form-855A and having this form verified by the assigned

MAC. A subdivision may have subunits and/or branch offices and, if so, is regarded as a

parent agency.

Parent HHA

The parent HHA is that part of the HHA that develops and maintains administrative

control of all approved locations. The parent is listed on the Medicare Enrollment

Application (Form CMS -855A.) The parent HHA is responsible for all services provided

at the parent and those provided at any of its approved branch locations. The parent HHA

must also submit any relevant updates for all approved locations on the Form CMS-855A.

Branch Offices

A branch office is a location or site from which an HHA provides services within a

portion of the total geographic area served by the parent agency. The branch office is part

of the HHA and is located sufficiently close to the parent agency so that it shares

administration, supervision, and services with the parent agency on a daily basis. The

branch office is not required to independently meet the CoPs as an HHA. When the

surveyor is conducting a survey of an HHA with branch offices, ascertain from HHA

records whether the branch offices are provided adequate supervision by the parent agency

and whether they are, in fact, sufficiently close to the parent agency to be considered

branch offices rather than subunits. If this judgment cannot be made without direct

observation, the surveyor should visit the branch office to make this determination. When

reviewing records and conducting visits to patients’ homes, the surveyor selects some

records and/or schedules some home visits to patients who are served by each branch

office. The surveyor may also conduct a standard survey of the HHA at a branch office.

When conducting a survey at a branch, the surveyor may request that all necessary

documentation for review be transported to the branch. This may include, but not be

limited to, a sample of clinical records from the parent and any other branches, governing

body minutes, personnel records, etc.

Subunits

A subunit is associated with the parent HHA but is a semi-autonomous organization that:

(1) Serves patients in a geographic area different from that of the parent agency; and

(2) Must independently meet the conditions of participation for HHAs because it is too far

from the parent agency to share administration, supervision, and services on a daily basis.

The standards on governing body, administrator, and under the circumstances noted here,

the group of professional personnel, will be found met by subunits if they are met by the

parent agency. The parent agency’s group of professional personnel may serve as the

subunit’s group of professional personnel if that group is effectively pursuing its

responsibilities for the HHA and its subunits. The parent agency’s and subunit’s records,

i.e., policy statements and minutes of group meetings, must establish that attention is

being paid to the subunit’s operation in delivering services. The subunit may establish its

own group, or the parent HHA may have a subcommittee of its group deal specifically

with the subunit’s policies and procedures.

The subunit must submit an initial enrollment application Form CMS-855A and undergo

an onsite initial survey from the State Agency (SA) or a National Accreditation

Organization (AO) with deeming authority, before it is approved to participate in

Medicare. The SA completes the Form CMS-2567, or the AO completes the equivalent,

and all other applicable documents for the parent organization and each subunit. The SA

or AO does not conduct the initial survey of a subunit prior to the initial survey of the

parent agency. The CMS certification numbers (CCNs) are assigned numerically by the

Regional Office (RO).

NOTE: Some states do not allow HHAs to operate subunits. If an HHA resides in a state

with this prohibition, the HHA must comply with the more stringent State requirement.

2182.1 - Characteristics Differentiating Branches From Subunits of

HHAs

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The comparisons on the following pages identify and clarify policies that assist in making

a distinction between a branch and a subunit. The surveyor discusses any discrepancies

with the administrator or his/her designee and alerts the SA supervisor who then notifies

the CMS RO.

Administrative Functions (Relationship with Parent Agency)

Branch - Not autonomous. Is part of the HHA and shares administration,

supervision and services with the parent agency on a daily basis. The

administration at the parent agency is aware of the staffing, patient census and any

issues/matters affecting the operation of any given branch. The branch location

provides the same services as the parent within a portion of the total geographic

area served by the parent agency.

Subunit - Semi-autonomous and located at such a distance from the parent agency

that it is incapable of sharing administration, supervision, and services on a daily

basis. Serves patients in a geographic area different from that of the parent. A

subunit may have a branch.

Compliance with CoPs

Branch - Does not have to independently meet the CoPs as an HHA.

Subunit - Independently meets all CoPs as an HHA.

Organizational Structure (See §484.14.)

Branch - The lines of authority and professional and administrative control are

clearly delineated in both organizational structure and in practice and can be traced

to the parent agency.

Subunit - The lines of authority and professional and administrative control are

clearly delineated in both organizational structure and in practice.

Supervision (See §484.2.)

Branch - Supervision is shared between the parent agency and the branch.

However, if the branch is so large (i.e., has a large staff and serves many patients)

or is so distant that it is impossible for a supervisor of a specific discipline to

accomplish adequate supervision, the branch must convert to a subunit.

Subunit – It is too far from the parent agency to share supervision on a daily basis.

The subunit functions independently of the parent, and consequently, supervision

is provided by staff designated by the subunit.

Administrator (See §484.4.)

Branch - The administrator of the HHA maintains an ongoing management of the

branch staff and liaison with the group of professional personnel. In order to

accomplish this activity, sufficient time must be allocated for sharing information

with all the parties mentioned. The branch is located sufficiently close to the

parent to share administration. The administrator is apprised of and resolves issues

affecting patients in branch(es) as well as the service area(s) covered by the parent.

Subunit - It is too far from the parent agency to share administration on a daily

basis. Is semi-autonomous and maintains its own administrative staff (e.g.,

supervising physician or registered nurse). It functions as an independent entity.

Supervising Physician or RN (See §484.14(d).)

Branch - The location of the branch, in relation to the parent, is such that the parent

is able to assure adequate supervision during all operating hours. (See §2182.4B)

Subunit - Supervisory M.D. or RN is available during all operating hours.

Personnel Policies (See §484.14(e).)

Branch - The parent office maintains current personnel records on all staff. A

statement of personnel policies is maintained in each branch for staff usage.

Subunit - Personnel policies and records must be maintained at the subunit.

Coordination of Patient Services (See §484.14(g).)

Branch - Information concerning care provided to patients is communicated to

staff in branches and parent agency, particularly when staff of one organizational

unit (e.g., branch) does not base its practice at that site. (Example: A physical

therapist (PT) provides services to patients managed by the parent agency as well

as patients managed by the branch. Most of the PT’s time is spent with patients

from the branch, although occasionally a patient followed by the parent agency is

included in his/her workload. The PT is expected to coordinate care with staff in

each organizational unit [i.e., branch or parent] as required by the patient’s needs

and as practice dictates.)

Subunit - Since the subunit is a semi-autonomous entity, coordination is simplified

because staff is generally available on a regular basis or can easily be reached to

discuss and implement the coordination of patient care.

Services Under Arrangements (See §484.14(h).)

Branch - Contracted arrangements with various entities are the responsibility of the

parent agency, even when the contracted services are used exclusively by the

branch.

Subunit - Maintains contracts with various entities to provide services. The

subunit is responsible for the administration and supervision of those services.

Parent agency monitors subunit services provided under arrangements.

Group of Professional Personnel (See §484.16.)

Branch - The annual review of the agency’s policies is conducted by a group of

professional personnel. Their focus is directed on service delivery throughout the

entire agency including the parent agency and branch(es).

Subunit – The subunit may establish its own group of professional personnel or it

may form a subcommittee of the parent HHA’s group which deals specifically

with the subunit’s policies and procedures at that subunit. The parent agency and

subunit’s policy statements and minutes of group meetings must include specific

references to issues addressed in the delivery of home health services.

Clinical Records (See §484.48.)

Branch - Should retain the clinical records for its patients, since the branch site is

where the professionals providing the services are located. Duplicate records need

not be maintained at the parent agency, but must be made available to the surveyor

upon request.

Subunit - Maintains clinical records on all its patients.

2182.2 - Guidelines for Determining Parent, Branch, or Subunit

(Rev. 1, 05-21-04)

The following guidelines should be used when making a determination as to whether a

proposed HHA unit is a parent, branch, or subunit as defined at 42 CFR Part 484.2:

A. Supervision

Supervision of the branch staff is critical to the provision of quality care for patients. The

regulations require the branch to be within the parent’s geographical service area and close

enough to the parent to share supervision, administration, and services on a daily basis.

Supervision means authoritative procedural guidance by a qualified person for the

accomplishment of a function or activity. Supervision at the branch must be adequate to

support the care needs of the patients.

Supervision of services requires that a qualified person be physically present to directly

supervise the provision of services by any individual who does not meet the qualifications

specified at 42 CFR Part 484.4. For individuals that do meet the qualifications specified at

42 CFR Part 484.4, the supervisor does not have to be physically present during the

provision of all services. The use of telephones, pagers, facsimile machines, or other

electronic devices does not eliminate the requirement for the physical presence of the

supervisor. The parent may appoint an effective full time branch supervisor or manager as

long as this individual is and remains under the supervision of the parent.

B. Distance

Mileage and travel times from the parent to the branch are significant factors to consider

because they are implicitly referenced in the regulations. However, each alone would not

be the single issue in determining appropriateness. The regulations require that a branch

be “sufficiently close” to share administration, supervision, and services in a manner that

makes it unnecessary for the branch to meet the CoPs on its own. To accomplish this, the

parent agency must be physically located so that sharing of administration, supervision,

and services with the branch can occur on a daily basis. If the parent is not capable of

sharing such functions with the branch on a daily basis, then the non-parent office or

location must independently meet the CoPs.

C. Geographic Area

“Geographic area” generally means the location, i.e., address of the clients served by the

parent and non-parent. If the non-parent office is located within a portion of the total

geographic area served by the parent, but serves patients outside the geographic area, then

the non-parent should not be a branch and would be classified as a subunit. (If the State

does not recognize subunits, the HHA would seek a new provider number and establish a

parent location.) This is consistent with the subunit definition that applies to a non-parent

office that serves patients in a geographic location different from the parent.

D. Sharing Administration, Supervision, and Services

In addition, consider that the sharing of HHA administration, supervision, and services

may occur at any time and could flow in either direction, i.e., parent to branch or branch to

parent.

If an entity within the HHA’s organizational structure reports directly to the home or

corporate office or some other office other than the alleged parent HHA, it is more likely a

subunit rather than a branch. As a subunit it would need to independently meet the CoPs.

If the parent HHA and the non-parent use totally different staffs, it is less likely they are

sharing functions on a daily basis, and it is therefore less likely that a parent/branch

relationship exists.

The fact that the non-parent office is located in a different metropolitan statistical area

(MSA) from that of the parent is a consideration in making determinations about

geographic areas. Commuting patterns are one consideration in the establishment of

MSAs. If the parent and non-parent are in different MSAs, it may reflect that the non-

parent is not within sufficient proximity to the parent to share functions on a daily basis.

This is especially true if the parent and non-parent are in non-contiguous MSAs.

If the parent and non-parent are incapable of sharing emergency functions, including

services, on a daily basis, the non-parent is probably not a branch.

State licensure laws that define parent, branch, and/or subunit are a consideration in

making non-parent determinations, but it is the definitions in the Federal regulations

(42 CFR Part 484.2) that must be satisfied in making parent, branch, or subunit

determinations. If an HHA operates across State lines, follow the instructions in §2184 of

the State Operations Manual. The SA in the State in which the parent is located should

take the lead in coordinating with the adjacent State to resolve parent and non-parent

issues.

The fact that the Joint Commission on the Accreditation of Healthcare Organizations or

the Community Health Accreditation Program has awarded branch status to a location will

not affect CMS’ parent/non-parent decision. CMS’ determination will be based on its

independent application of its regulations to the facts in the case.

2182.3 - Processing A Change From Branch to Subunit

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

When a determination is made that a previously approved branch should become a

subunit, either through a request from an existing provider or through a determination by

CMS, an initial survey and certification is required, as with any new provider. In such a

situation, follow the existing survey and certification rules for conducting an initial survey

and issuing a provider agreement and CCN to the subunit. Similarly, if a location is

discovered that has never been identified to the SA or CMS that is subsequently

determined to be a subunit, an onsite survey in accordance with the usual survey and

certification rules will apply. The subunit, as a new provider, must also meet all

requirements for initial certification, including completing the CMS-855A and having this

form verified by the assigned MAC. Note that a subunit may have branches. (See

Medicare Program Integrity Manual, Chapter 15, Medicare Enrollment, Section 15.19.)

2182.4 - CMS Approval Necessary for Non-Parent Locations

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

As part of the provider certification process, an existing Medicare-approved HHA must

provide notification to CMS through the SA of its proposal to add a non-parent location,

i.e., branch or subunit. (See §3224.) In the absence of notification by the HHA to add a

branch office, CMS cannot determine whether the requirements critical to health and

safety are met at the non-parent location. A provider may not bill Medicare for services

provided by either a branch or subunit where the branch or subunit is not a part of an

approved HHA or where the branch or subunit has not been determined to meet the

applicable CoPs.

The Form CMS-855A applications are used to gather information on providers for the

purpose establishing eligibility to furnish services to Medicare beneficiaries. 42 CFR

424.540(a)(2) requires a provider or supplier to update its enrollment information, and

recertify its accuracy when any changes are made. Additionally, §424.515 requires

revalidation of the enrollment information by providers and suppliers every 5 years and

(every 3 years for suppliers of durable medical equipment, prosthetics, orthotics and

suppliers) or when determined by CMS policy. See also Chapter 10 and 15 of the Program

Integrity Manual which can be found at: http://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/downloads/pim83c10.pdf and

http://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/downloads/pim83c15.pdf

Before a subunit can be approved, it must seek initial certification and apply to CMS to

receive a separate provider agreement and CCN. These steps are outlined in Part I of

Appendix B of the SOM under the section on Initial surveys.

2182.4A - Notification by HHA to Add a Branch

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

When an HHA requests approval to add a branch location, it should contact the SA and

provide the following information:

Address and phone number of the branch;

Organizational chart delineating lines of authority, professional and administrative control

for the HHA, including the branch;

Defined geographic service area (counties, cities, zip codes), and any intention to cross

State lines (which would require a reciprocal agreement between the affected States as

well as RO approval);

Services shared with the HHA parent;

Services provided directly and under arrangement;

Contracts for any services provided under arrangement;

Identification of any high-tech services provided (e.g., infusion therapies such as artificial

nutrition and hydration, or chemotherapy, mechanical ventilation, tracheostomy care,

etc.);

Names of all branch staff and their job descriptions;

Proof of branch staff qualifications (resume, licensure, aide training, etc.);

Explanation of how supervision by the HHA parent will occur;

Identification of the person who will resolve patient care issues at the branch;

Explanation of how staff will coordinate care and services;

Policies for addressing clinical and other emergency situations;

Plans for addressing staff absenteeism; and

State issued certificate of need, if applicable.

2182.4B - SA Review of Request for Branch Determination

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The decision to approve a branch should be based on the HHA’s ability to adequately

supervise the branch and monitor all services to assure that the quality and scope of items

and services provided to all patients promotes the highest practicable functional capacity

for each patient so as to meet their medical, nursing, and rehabilitative needs.

The SA reviews the ability of the branch location to meet the definition of a branch as

provided in §484.2. The regulations require the branch to be within the HHA parent’s

geographical service area and sufficiently close enough to the HHA parent to share

administration, supervision, and services on a daily basis.

The SA should review the HHA’s request to open a branch and consider the HHA’s ability

to comply with the following:

Administration, Supervision and Services:

• The HHA’s governing body is responsible for the overall operations of the parent

and branch.

• The lines of authority and professional and administrative control are clearly

delineated in the HHA’s organizational structure and in practice and are traced to

the HHA parent.

• Supervision means authoritative procedural guidance by a qualified person for the

accomplishment of a function or activity. Supervision at the branch must be

adequate to support the care needs of the patients. The HHA’s supervising nurse

or physician, as required by § 484.14(d), is available at all times by phone or other

means of communication during operating hours for individuals who meet the

qualifications specified at §484.4. Supervision of services requires that a qualified

person be physically present to directly supervise the provision of services by any

individual who does not meet the qualifications specified at §484.4. The HHA

may formally appoint a supervisor or manager who is under the direct supervision

of the HHA parent to assist with supervision at the branch. (The HHA parent may

use technological means for supervision in conjunction with periodic onsite visits.

However, the use of telephones, pagers, facsimile machines, or other technological

or electronic devices does not eliminate the requirement for the physical presence

of the supervisor when required.)

• The group of professional personnel required by §484.16 reviews the agency’s

policies and service delivery throughout the entire agency, both parent and any

branch(es).

• The HHA parent is aware of the staffing, patient census and any issues/matters

affecting the operation of the branch.

• The HHA administrator maintains an ongoing liaison with the branch to ensure

that staff is competent and able to provide appropriate, adequate, effective and

efficient patient care and to ensure that any clinical and/or other emergencies are

immediately addressed and resolved.

• The HHA maintains a system of communication and integration of services

throughout the agency, whether provided directly or under arrangement, that

ensures the identification of patient needs, an ongoing liaison between all

disciplines providing care, and physician availability when necessary for relevant

medical issues.

• The HHA parent has a system in place to review patient records and care at the

branch to ensure that the branch is implementing all policies and procedures and

complying with the CoPs for all patients.

• The HHA parent monitors branch activities (clinical and administrative) and the

management of services, as well as personnel and administrative issues.

Depending on the organization, the administrator, quality improvement personnel,

supervisory personnel, etc. should conduct periodic on-site visits to the branch to

ensure the delivery of quality care.

• The HHA parent provides ongoing in-service training to ensure that all staff are

competent to provide care and services;

• The HHA parent is responsible for any contracted arrangements with any

individuals or organizations, even when the contracted services are used

exclusively by the branch;

• Services offered by the HHA parent are also offered by the branch.

Distance

• While mileage and travel times from the parent to the branch are significant factors

to consider because they are implicitly referenced in the regulations, each factor

alone should not be the single issue in determining approval or denial of the

branch. The HHA may use current technology to meet the requirement for shared

supervision, administration and services with the branch where onsite supervision

is not required. A detailed description, including examples, of the application of

this technology must be included in the HHA’s request to add a branch.

• If the parent and non-parent location are incapable of sharing functions, including

services on a daily or emergency basis, the non-parent location is probably not a

branch.

Geographic area

“Geographic area” generally means the location, i.e., address of the clients served by the

parent and non-parent location(s).

• The branch and its service area are located within the HHA parent’s geographic

service area. If the branch is extending the current geographic service area, the

new geographic area must be contiguous. If the non-parent location is located

within a portion of the total geographic area served by the parent, but serves

patients which are located outside of and non-contiguous to that geographic area,

then the non-parent would be classified as a subunit (not a branch) and be required

to submit an enrollment application and to seek a separate CCN. (If the State does

not recognize subunits, the HHA would not be classified as a subunit and would

seek a new CCN and become a separate HHA provider.)

• The fact that the non-parent office is located in a different core based statistical

area (CBSA) from that of the parent is a consideration in making determinations

about geographic areas. Commuting patterns are one consideration in the

establishment of CBSAs. If the parent and non-parent locations are in different

CBSAs, it may reflect that the non-parent is not within sufficient proximity to the

parent to share functions on a daily basis. This is especially true if the parent and

non-parent locations are in non-contiguous CBSAs.

• If the state has a Certificate of Need requirement or other restrictions on

geographic area or expansion of areas, the state rules apply.

• If the HHA intends to operate across State lines, follow the instructions in §2184

of the State Operations Manual. The SA in the State in which the parent is located

should take the lead in coordinating with the adjacent State to resolve parent and

non-parent issues.

In addition, the SA should review the HHA’s past compliance history, including prior

complaints, survey results, number of CoPs and standards out of compliance, and length

of participation in Medicare.

While the HHA may notify the SA (or AO as applicable) of its proposal to establish a

branch, and the SA or AO may make a recommendation to the CMS RO in a particular

case, it is the CMS RO (not the SA or AO) that has the authority for approving the request

for a Medicare approved branch.

The CMS RO will review each HHA’s request for a branch office on a case-by-case basis,

and consider all the CMS guidance. The CMS RO will communicate its final decision in

writing to the parent HHA with a copy to the SA or AO and the HHA’s Medicare

Administrative Contractor (MAC). The approval letter should include notification of the

branch approval and the assigned Federal branch ID number and effective date, if

approved. The effective date of coverage for services provided from the branch is the date

RO determines that the branch meets all CMS requirements. The RO should enter the

branch ID number into the Automated Survey Processing Environment (ASPEN) prior to

sending the approval letter to the HHA, so that the branch can begin providing services

and collect and submit OASIS data. Any decision to deny the request for a branch office

should include the full range of the reasons supporting the denial and include discussion of

the above criteria. Use the Model Denial Letter, Exhibit 284, as appropriate and copy the

SA.

2182.4C - Onsite Monitoring of Approved Branches by the SA

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

During a survey of an HHA with approved branch offices, the surveyor will ascertain from

HHA records whether the branch office is provided adequate supervision by the parent

agency and whether they are, in fact, sufficiently close to the parent agency to be

considered a branch office rather than subunit.

When reviewing records and conducting visits to patients’ homes, the surveyor will select

records and/or if possible, schedule home visits to patients who are served by each branch

office. The surveyor may conduct a standard survey of the HHA at a branch office instead

of the parent location. When conducting a survey at a branch location, the surveyor may

request that all necessary documentation for review, such as a sample of clinical records

from the parent and any other branches, governing body minutes, personnel records, etc.,

be transported to the branch.

When reviewing branches during the survey process, the operations of an approved branch

must demonstrate that:

A copy of the HHA’s policies and procedures is maintained in each branch. Branch office

personnel should be knowledgeable of the policies and consistently apply them;

• Methods of communication between HHA parent and branch assure that all

patients receive the necessary care and services identified through the

comprehensive assessment and plan of care;

• The branch retains the active clinical records for its patients. Duplicate clinical

records need not be maintained at the HHA parent, but must be available to the

surveyor upon request;

• Patients are receiving appropriate care and services at the branch, and

• The HHA is in compliance with OASIS submission requirements.

To assist in the decision making process of determining adequate branch supervision by

the parent and whether the branch is sufficiently close to the parent, the surveyors may

review and utilize the HHA’s branch-specific outcome based reports during the survey

and determine if the CoPs continue to be met with the inclusion of the additional location.

2182.4D - Drop Sites

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

Where permitted by state and local law, an HHA may utilize a drop site for field staff

convenience. These drop sites are not considered branches and should not meet the

Medicare definition of a branch or operate as such. HHAs that allow these locations to

cross the line from drop site to branch are out of compliance with the Medicare

requirements. The HHA should not assign staff to these locations, accept referrals at these

locations, advertise them as a part of the HHA, or operate them in any other way as

branches of the HHA. HHAs that are unsure if the location meets the definition of a

branch may seek advice from the SA. If the location does meet the definition of a branch,

it must request CMS approval before providing services from this location. The HHA’s

policies on drop sites should reflect current Federal and State requirements, including

compliance with the Health Insurance Portability and Accountability Act of 1996 privacy

requirements. While these sites would not be subject to routine surveys, they may be

subject to state or RO inspection at any time. Any violation would be addressed by the

SA and referred to the CMS RO for any necessary program integrity investigation and

follow up.

2182.5 - Branch Identification Numbers

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

CMS assigns an identification number to every Medicare approved HHA branch (of either

a parent or subunit). The identification system uniquely identifies every branch of every

HHA certified to participate in the Medicare home health program. It also links the parent

or subunit to the branch. Having a system to identify branches gives CMS the capability

of associating quality outcome results with individual HHA branches. Also, submission

of branch identification numbers on Outcome and Assessment Information Set (OASIS)

assessments provides the capability of developing outcome reports that will help HHAs

differentiate and monitor the quality of care delivered by their agencies down to the

branch level.

ROs are responsible for assigning branch identification numbers according to the RO’s

existing policies and HHAs and their respective branches are informed of their assigned

branch identification number(s). A sample letter is available at Exhibit 290. HHAs will

need to enter this branch identification number on OASIS item M0016 (Branch ID).

Detailed instructions for completion of M0016 by parent HHAs, subunits, branches, and

HHAs and subunits without branches are included in M0016 Branch ID in Chapter 3 of

the OASIS Guidance Manual.

Each branch is numbered with the same Federally assigned CCN as the parent or subunit

with two modifications. There is a “Q” between the state code and four-digit provider

designation plus three more digits for a 10-character branch identifier. Branch

identification numbers are to be used only once. In the event that an HHA branch closes,

its unique branch identification number is terminated and not re-used to identify another

branch of that HHA or subunit.

EXAMPLE:

ABC Home Health Agency in Alabama has three branches.

ABC Home Health Agency in Alabama = CCN number 017001.

ABC’s branches would be assigned the branch identification numbers 01Q7001001,

01Q7001002, and 01Q7001003.

Collection Of Branch Information During Survey

The Form CMS-1572, the Home Health Agency Survey and Deficiencies Report, captures

survey and deficiency information and requests branch information at field G17 that

includes the HHA’s total number of branches and name and address of each branch

location. This information should be entered into ASPEN after every survey as part of the

survey kit. As surveys are conducted, SAs should verify that the information they have on

branch locations is current and accurate.

Branch Identification Numbers and MACs

The RO notifies the MACs of the branch identification information when it is assigned.

This communication may occur electronically or through a written letter to the provider.

2183 - Separate Entities (Separate Lines of Business)

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The surveyor must be able to identify the corporate, when applicable, and organizational

boundaries of the entity seeking certification or recertification. The Medicare CoPs apply

to the HHA as an entire entity and in accordance with §1861(o)(6) of the Act, are

applicable to all individuals served by the HHA and not just to Medicare beneficiaries.

While the purpose of the CoPs is to help ensure proper care for Medicare beneficiaries, the

CoPs do this by defining the standards for an HHA in which Medicare beneficiaries may

be treated, instead of establishing requirements applicable only to Medicare beneficiaries

served by the HHA. If however, the HHA is able to demonstrate that it operates a

“separate entity” or separate line of business to which the CoPs do not apply, it must

provide the surveyor with the information to differentiate the separate line of business

from the HHA.

Neither the Act nor the Medicare regulations define a “separate entity” with respect to

HHAs that Medicare approves as an HHA in accordance with the Act and the CoPs.

When an HHA alleges that it is operating a separate line of business to which the CoPs do

not apply, ask the HHA to produce information to enable the surveyor to differentiate

between it and the HHA.

Use the following guidelines, on a case-by-case basis, to assist in determining if a separate

entity exists. The following criteria should be considered in making a decision regarding a

separate entity:

• Operation of the HHA;

• Consumer awareness; and

• Staff awareness.

2183.1 - Operation of the HHA

(Rev. 1, 05-21-04)

Ask the HHA administrator to describe the organizational, functional, and clinical

boundaries of the Medicare-certified program in relation to any other programs the larger

organization offers. Other programs should be separate and distinct from the HHA.

Ensure that the HHA has:

• Separate policies and procedures for admission to the HHA, including separate

consent forms;

• Separate clinical records for all patients receiving HHA services;

• Current licensure, in accordance with State requirements. In States which license

HHAs, review if the State has licensed separately the approved HHA and the

separate entity, or has licensed the separate entity as another type of provider or

supplier;

• Current listing of staff employed by or contracted to the HHA;

• Personnel records;

• Time sheets or other records to demonstrate distinct assignment of personnel to the

HHA; and

• Separate budgets.

2183.2 - Consumer Awareness

(Rev. 1, 05-21-04)

The organization should differentiate the services of the HHA from other services offered

by the larger organization. Ask the HHA for a copy of any brochure the HHA uses to

describe itself to the community. Any applicable brochures should identify the HHA

services as separate and distinct from other programs, departments, or entities operated by

the HHA. The HHA should be differentiated from other programs, departments or entities

of the organization in listings, advertisements, etc. Written material should clearly

identify the HHA as separate and distinct from other programs, departments or entities of

the organization.

2183.3 - Staff Awareness

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The HHA staff should be knowledgeable about the HHA’s policies and procedures, the

regulatory requirements related to their role in the delivery of care in an HHA, and be able

to identify the difference in services they provide for the HHA and other programs,

departments, or entities of the organization.

Personnel who divide time between the separate entity and the HHA must be appropriately

trained to deliver HHA services. The HHA maintains separate time sheets for each

individual’s assigned time to the HHA.

If the SA determines, based on the information provided by the HHA or for other reasons,

that the HHA does not have a separate entity, or if the HHA or parent organization is

unable or unwilling to provide the information, inform the HHA that:

• It is in violation of the provisions of §§1861(o) and 1891 of the Act which require

compliance with the CoPs, particularly those conditions that relate to clinical

records and disclosure of the ownership of the HHA;

• It is in violation of its agreement with the Secretary under §1866 of the Act and the

regulations related to this agreement (§489.53(a)) because it has failed to provide

information about ownership and information concerning clinical records;

• It is in violation of §1128(b)(12)(A) of the Act because it has denied access to

records to determine compliance with the CoPs, including those that relate to the

OASIS requirements; and

• It may be in violation of various requirements related to its Medicare cost reports,

which mandate information about all of the HHA’s clients in order to properly pay

Medicare costs, and that the HHA’s MAC must be notified about the allegation of

separate entities. (See §413.5(b)(3), §413.9, §413.13(f)(2)(ii), §413.17,

§413.50(b), §413.53(a), and §413.80(d).)

The SA must report these separate entity situations to the CMS RO, along with any

recommendations the State has concerning the operation of two distinct entities. The State

must also indicate whether the HHA refused access to records or information that make it

impossible for the surveyor to make a determination concerning whether the applicant or

approved HHA complies with the HHA CoPs.

The surveyor will inform the approved HHA that the SA must report the alleged separate

entity to the CMS RO that in turn must report this information to the MAC and, if

necessary, to the State Medicaid Director.

2184 - Operation of HHAs Cross State Lines

(Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

When an HHA provides services across State lines, whether through its own personnel, or

a branch, or subunit, each respective SA must be aware of and approve the action. Each

SA must verify that applicable State licensure, personnel licensure, and other requirements

are met in its respective State. Any branch or subunit of the HHA must meet applicable

State and local laws in the State that it is serving.

The provision of services across State lines is appropriate in most circumstances. Areas in

which community services, such as hospitals, public transportation, and personnel services

are shared on both sides of State boundaries are most likely to generate an extension of

HHA services.

When an HHA provides services across State lines, it must be certified by the State in

which its CCN is based, and its personnel must be qualified in all States in which they

provide services. The appropriate SA completes the certification activities. The involved

States must have a written reciprocal agreement permitting the HHA to provide services in

this manner. The reciprocal agreement must indicate that both States are aware of their

respective responsibilities for assessing the HHA’s compliance with the CoPs within their

State. The agreement should assure that home visits are conducted to a sample of all

patients, in all States served by the HHA.

The CMS RO will review the required reciprocal agreement between the States to assure

that the SA in which the branch resides is assuming responsibility for any necessary

surveys of the branch. If the SAs involved are unable to come to an acceptable

arrangement on assuring the necessary surveys of the branch, even though there may be an

existing reciprocal agreement between the States, or if the reciprocal agreement cannot

assure the necessary surveys, the branch should not be approved. The provision of

interstate service without a written reciprocal agreement could severely undermine a

State’s ability to fulfill its statutory responsibilities under §1864 of the Act to enforce

Medicare’s health and safety requirements. It is at the discretion of the States to decide

whether entering into reciprocal agreements is in the best interest of their residents,

provider markets, and quality assurance and oversight systems.

Exhibit 289 contains a model reciprocal agreement document that States may use to assist

them in fulfilling their statutory responsibilities under §1864 of the Act to enforce

Medicare’s health and safety requirements when an HHA provides services across State

lines. In those States that have a reciprocal agreement, providers are not required to be

separately approved in each State; consequently they would not have to obtain a separate

Medicare provider agreement/number in each State. Providers residing in a State that

does not have a written reciprocal survey agreement with a contiguous State are precluded

from providing services across State lines.

If a State does not have a written reciprocal agreement with other States, the HHA must

establish a separate parent agency or subunit in the State in which it wishes to provide

services.

In the event that an HHA operates in two CMS ROs, the RO responsible for the State in

which the HHA provider agreement and CCN is based should take the lead in assuring

that the required survey and certification activities are met.

A CMS approved branch office may be physically located in a neighboring State if the

SAs responsible for certification in each State approve the operation.

Subunits of an HHA may be physically located in more than one State. A separate

certification is made by the SA where each subunit is located.

While the HHA may notify the SA of its proposal to provide services on an interstate

basis, and the SA may make a recommendation to the CMS RO in a particular case, it is

the CMS RO that has the Medicare approval authority of the parent HHA and assumes

final responsibility for approval of the operation across State lines.

2185 – HHA Change of Address

(Rev. 146, Issued: 09-04-15, Effective: 09-04-15, Implementation: 09-04-15)

It is inherent in the provider certification process that a provider notifies CMS of its intent

to change the location or site from which it provides services. Absent such notification,

CMS has no way of carrying out its statutorily mandated obligation of determining

whether the provider is complying with applicable participation requirements at the new

site or location. It is longstanding CMS policy that there is no basis for a provider to bill

Medicare for services provided from a site or location that has not been determined to

meet applicable requirements of participation. This guidance is contained in §3224.

When an existing HHA intends to move from its surveyed and certified location to a new

site or location that is within the current approved geographic area, it notifies its MAC

within 90 days of the move, and submits all required documentation including an amended

Form CMS -855A. The RHHI reviews the form and makes a recommendation to the RO.

The RO then makes the final decision to approve the change of location. The

provider notifies CMS either directly or through the SA, and, if it is a provider deemed to

meet the requirements, it notifies its AO, in writing of the change of location.

Upon receipt of the MAC’s approval notice, the RO will carefully evaluate the

information, together with any supporting documentation from the provider and any other

relevant information known to the RO in making its decision. If a decision can be made

on the written application and supporting documentation, CMS may grant or deny an

approval without requiring an onsite survey. See §2702B regarding when a resurvey is

necessary based on change of a provider’s size or location.

CMS generally will not approve a change of location of an HHA with one or more

previously approved branches if the new location increases the distance between the

parent HHA and its previously approved branch(es) to a point that prevents the HHA from

exerting the supervision and control necessary to assure the provision of quality care for

the patients served by the branch. If the location change is not approved, the provider may

consider applying for a new provider number at the new location. CMS will consider the

information contained in section 2182.4B in its assessment of the parent’s ability to

supervise the branch before approving or denying the request.

2185.1 – Move after Certification Survey and Before Final Medicare

Approval

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

Requests for initial certification cannot be processed to completion if a prospective

provider moves to a new location after it has been surveyed but before the entity receives a

determination from the RO to participate in Medicare. If a prospective provider moves

from its reported location after that location has been surveyed and/or accredited but prior

to signing a provider agreement with CMS, the prospective provider’s application for

initial certification becomes incomplete. Absent a survey of the new location to which the

prospective provider has moved, CMS is unable to determine whether applicable program

requirements are met at the new location, and therefore is prevented from completing its

review of the pending application. In these circumstances, CMS advises the prospective

provider that its application is incomplete and is denied.

2186 - Health Facility-Based HHAs

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

An HHA based to a hospital, SNF, hospice, or rehabilitation facility is expected to be an

integral but subordinate part of the institution. Administrative and fiscal controls may be

exercised over the HHA. However, the HHA’s policies, personnel files, and clinical

records must be separate and identifiable. Time records must be maintained for all

personnel who provide home health services and must be identifiable as home health

regardless of whether they are part-time or full-time. The HHA’s use of personnel who

are also concurrently employed by a hospital, SNF, hospice, or rehabilitation facility is

acceptable provided the HHA’s operating hours are definite and not arbitrarily subject to

the operation of the other institution, and provided the other institution’s operation does

not interfere with the HHA’s maintaining compliance with the CoPs.

An HHA’s services must be supervised by an employee of the HHA. If members of the

institution’s governing body serve the HHA as the group of professional personnel,

minutes must reflect meetings of this group. Clinical records may be maintained in the

record room or department. However, the clinical records must contain information

pertinent only to the delivery of home health services, and should be readily available for

either claims review or review by the SA.

In surveying the health facility-based HHA, the SA or AO considers the institution’s

ability to share its administrative structure and personnel in fulfilling the needs and

requirements of the HHA on a continuing basis. The CoPs for HHAs must be applied and

met independently.

2188 - Survey of State-Operated HHAs

(Rev. 1, 05-21-04)

The same general procedures applicable to surveying other types of HHAs apply to HHAs

operated by a State. However, individuals associated with the HHA in an administrative,

supervisory, or service capacity must not be involved in the certification and consultation

functions of the SA.

2194 - Surveying Health Maintenance Organization (HMO)-Operated

Home Health Agencies (HHAs) Providing Home Health Services

Through Medicare Survey and Certification Process

(Rev. 1, 05-21-04)

The HMOs (Medicare+Choice) which contract with Medicare to furnish HHA services

may provide such services either directly by the HMO or through Medicare-approved

HHAs that have a provider agreement/number with Medicare. (See 42 CFR Part

417.416(a) and 42 CFR Part 422.20(b)(3).)

If an HMO provides home health services directly as an integral part of the HMO, the

HHA is still required to meet the HHA CoPs, including the OASIS requirements, have a

Medicare provider number, enter into a provider agreement with the Secretary, and meet

other survey and certification requirements, including Office of Civil Rights and

enrollment requirements, that an HHA approved under 42 CFR Part 484.1 would have to

comply with.

When the SA receives a request to survey an HMO-operated HHA for compliance with

the HHA CoPs, it schedules an unannounced standard survey. The SA conducts the

survey, and documents its findings on Form CMS-1572. The SA completes Form CMS-

2567, obtains a PoC when necessary, and sends this information along with a completed

Form CMS-1539 to the CMS RO.

The SA resurveys approved HMO-operated HHAs according to the survey frequency

allowed by the Secretary and determined by the SA to assure quality care and to ascertain

whether they continue to meet the HHA CoPs. In essence, these HHAs are surveyed and

certified the same as any other Medicare-approved HHAs.

2195 – Guidelines for Determining Standard Survey Frequency

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

Section 1891(c)(2)(A) of the Act states that standard surveys will occur not later than 36

months after the previous standard survey, and that the Secretary shall establish a

frequency for surveys within this 36-month interval commensurate with the need to assure

the delivery of quality home health services.

CMS will identify HHAs to be surveyed each fiscal year according to specific criteria and

budget allowances. This list will contain the names of HHAs that have not been surveyed

for 24 months or longer, and that are due for survey during the coming fiscal year. CMS

will send this list to the State Survey Agencies each year. The annual budget criteria also

specify the priority for complaint surveys, validation surveys and any other targeted

surveys for the upcoming fiscal year.

NOTE: The survey process guidance is now found in Part I of Appendix B.

2197 – Surveyor Worksheets

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The following surveyor worksheets are used during each home health survey to assist the

surveyor’s determination of the agency’s compliance with the home health conditions of

participation.

HHA Survey Investigation Worksheet 1 – Patient Sample:

Complete one patient sample investigation worksheet for each patient record and home

visit selected. Use the worksheet to collect and record patient information and findings

related to record review and home visit information to determine the appropriateness of

care or services being furnished. Note interviews with clinicians, record

review findings and

observations. In addition to completing the worksheet, it may be

appropriate to request the HHA to copy the most current plan of care for each patient in

the survey sample that identifies baseline medical information for attachment to the

patient’s worksheet. Additional documentation, including assessments, medication

profiles, visit notes, aide plans or orders may be copied to support findings. Complete

each section with comments related to potential tags identified or indicate “Not

Applicable/NA.”

HHA Survey Investigation Worksheet 2 – Agency Summary:

Use the survey investigation worksheet 2 to record a summary of any deficient practices

identified during the survey. Also record the type of survey(s) performed, the number of

agency admissions in the previous 12 months as well as the number of records reviewed

and home visits completed.

HHA Survey Investigation Calendar Worksheet:

Use the Calendar Worksheet to determine compliance with §484.18(a) and (b) and

§484.55 regarding compliance with orders for service and the findings of the

comprehensive assessment. Services ordered can be compared to services provided to

determine compliance with visits.

2202 - Outcome and Assessment Information Set (Oasis) Requirements

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The home health regulations at §484.55 require that each patient receive from the HHA a

patient-specific, comprehensive assessment. As part of the comprehensive assessment of

adult skilled patients, HHAs are required to use a standard core assessment data set, the

OASIS. See note below for information regarding collection of OASIS data on the non-

Medicare/non-Medicaid patients of an HHA.

The regulations also require that OASIS data be electronically transmitted to the SA or

CMS OASIS contractor. These requirements are detailed at §484.20. This regulation is

referred to as the “reporting regulation.”

The CMS uses the data to achieve broad-based improvements in the quality of care

furnished, through measurement of that care, as well as to maintain a home health

prospective payment system.

In addition to requiring the reporting of OASIS data, the OASIS regulations at §484.11

require HHAs to maintain privacy of their OASIS data and not release patient identifiable

OASIS information to the public. Regulations concerning State survey, certification, and

enforcement responsibilities are found at §488.68.

Effective July 19, 1999, all HHAs participating in the Medicare/Medicaid program have

been required to comply with the comprehensive assessment and OASIS reporting

regulations.

NOTE: HHAs must comply with the comprehensive assessment regulation at §484.55 for

all its patients. However, until further notice, HHAs are not required to incorporate

OASIS items into their patient-specific comprehensive assessment for the HHA’s (1) non-

Medicare/non-Medicaid patients, (2) patients under the age of 18, (3) patients receiving

maternity services, or (4) patients receiving personal care services only (regardless of

payer source). (See additional information in section 2180E.)

• The collection of OASIS data on the non-Medicare/non-Medicaid patients of an

HHA was temporarily suspended on December 8, 2003, as a provision of the

Medicare Prescription Drug, Improvement and Modernization Act of 2003. HHAs

must continue to comply with the aspects of the regulation at §484.55 regarding

the comprehensive assessment of patients. HHAs must provide each agency

patient, regardless of payment source, with a patient-specific comprehensive

assessment that accurately reflects the patient’s current health status and includes

information that may be used to demonstrate the patient’s progress toward the

achievement of desired outcomes. The comprehensive assessment must also

identify the patient’s continuing need for home care, medical, nursing,

rehabilitative, social, and discharge planning needs.

• HHAs may continue to collect OASIS data on their non-Medicare/non-Medicaid

patients for their own use.

• Surveyors must continue to examine the completeness of the comprehensive

assessment for all patients during a survey. However, surveyors must not

investigate whether the HHA included the specific OASIS items in its patient-

specific comprehensive assessments of non-Medicare/non-Medicaid patients, nor

cite deficiencies based solely on this finding.

• HHAs must continue to collect, encode, and transmit OASIS data for their non-

maternity Medicare and Medicaid patients that are age 18 and over and receiving

skilled services.

2202.1 - OASIS Related Definitions

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

OASIS – Outcome and Assessment Information Set - Scientifically tested data items

developed for the purpose of measuring outcomes (and patient risk factors that affect

outcomes) for HHA patients. These data items alone do not constitute a comprehensive

assessment; they must be collected as part of the assessment process at various time points

during a patient’s admission to an HHA.

CMSnet (formerly known as Medicare Data Communications Network-MDCN) - A

private communications network CMS purchased to ensure the security of OASIS and

Minimum Data Set (MDS) data transmissions to the state. This system replaces the

previous process of direct dial-up by public telephone lines to the SA and reflects the

latest technology available for securing the privacy of data during transmission. In

addition to increased security, another benefit of the CMSnet is that it is provided at no

cost to the HHAs. HHAs may also apply for a CMSnet user identification and password

for each of their branches for direct transmissions from their branches. Use of the CMSnet

allows for all data submitted to the CMS OASIS State System to be encrypted during the

transmission process precluding any unauthorized sources from intercepting identifiable

data. Similarly, data reports, which are sent by the OASIS State System to the HHA

across the CMSnet, are also automatically encrypted and decoded. This network

encryption occurs automatically when the HHA uses the CMSnet and requires no special

action on the part of the HHA other than using browser software that supports industry

standard encryption.

Comprehensive Assessment - An assessment of a patient’s condition that accurately and

completely reflects the patient’s current health status at the time of the evaluation. This

assessment must identify the patient’s continuing need for home care and must meet the

patient’s medical, nursing, rehabilitative, social, and discharge planning needs. An HHA

must include the collection of specific OASIS data items at specific time points during a

patient’s admission as part of its comprehensive assessment process for all adult Medicare

and Medicaid patients receiving skilled care unrelated to pregnancy or delivery. The

specific OASIS items associated with each assessment time point are summarized in each

version of the OASIS data set. The required OASIS data set and its time point related

versions include (1) Start of Care (SOC)/Resumption of Care (ROC), (2) Follow-up, (3)

Transfer, and (4) Discharge. HHAs must use the most current version of the OASIS. The

most current version of OASIS is available on the OASIS Web site.

Encode - To enter OASIS data into a computer using the Home Assessment and

Validation Entry (HAVEN) software (provided by CMS) or other HAVEN-like software

(developed by private vendors). HAVEN-like software must meet CMS’ data and edit

specification requirements.

Encryption - A system to translate plain text into scrambled code. Encryption offers a

higher level of security when electronically transmitting information. The sender “locks”

the data before transmitting. The receiver “unlocks” the data upon receipt.

HAVEN – Home Assessment and Validation Entry - A software program provided by

CMS, free of charge, for use by HHAs to encode their OASIS data and save as electronic

files for electronic transmission to the SA. The HAVEN software automatically applies

date range and consistency checks according to CMS’ published data specifications,

which serve as an electronic safety net to preclude the transmission of erroneous or

inconsistent information.

Header Record - Contains basic information that identifies the HHA submitting OASIS

data, as well as, contact persons and telephone numbers to be used in the event the file is

in error.

Initial Assessment - The HHA’s first visit to the patient after referral. In the absence of a

specified start of care date, the initial visit is the first visit made to the patient within 48

hours of the referral. If the physician specifies a particular start of care date, then the

initial visit is the date specified by the physician and includes performance of the skilled

care ordered. In accordance with the regulations, the initial visit must be made by a

registered nurse except for therapy-only cases, in which the initial assessment visit can be

made by a qualified therapist.

Incorporate/Integrate - Incorporating/integrating the OASIS data items into an agency’s

assessment process means replacing similar questions on the agency’s existing assessment

tool with the corresponding OASIS data items. Agencies must merge the OASIS data

items into their existing assessment process rather than simply appending them without

considering which OASIS items could replace similar items on the agency’s assessment

tool. Simply appending the OASIS items adds time to the assessment process and renders

it burdensome and duplicative. Since the OASIS items are not intended to constitute a

complete comprehensive assessment, agencies should gather other pertinent assessment

information not included in the OASIS data items in order to create a comprehensive

assessment. Except as required to meet other Federal, State, or accreditation standards,

agencies are at liberty to determine what other information they require as part of the

comprehensive assessment.

Late Assessment - An assessment transmitted after the specific time frames defined in the

regulations. 42 CFR 484.20(a) requires the HHA to transmit the assessment within 30

days of completing the assessment.

Masking - A term used to describe software that conceals individually identifiable data

elements. When required, HHAs will mask these data elements prior to transmission and

keep the masked identifiers and the original data in their records. Private Pay assessments

are no longer accepted by the State System. If M0150 items 1, 2, 3 and 4 are all equal to

‘0’ unchecked, the state system rejects the record. Any private pay assessment entered

into HAVEN will be marked as ‘Complete’ and is excluded from the export process in

HAVEN.

Outcome - Changes in a patient’s health status between two or more time points.

Outcome-Based Quality Improvement (OBQI) - Performance improvement based on

outcome measurement and reporting.

Outcome-Based Quality Monitoring (OBQM) Reports - The OBQM reports include

the agency patient-related characteristics report and potentially avoidable events outcome

reports.

Overdue OASIS - OASIS assessments not received by the OASIS System within the

specific time frames defined by the regulations. (See also Late Assessment.)

Process Based Quality Improvement (PBQI) - Evaluating or investigating the use of

specific best care processes (such as conducting falls risk assessments or providing drug

education) by reviewing the care provided to determine any needed changes in care

delivery.

Quality Improvement and Evaluation System (QIES) - An online system that supports

the CMS mission and initiatives to improve the quality of care for Medicare beneficiaries

(Providers: Skilled Nursing Home, Home Health Agencies, as well as State Survey

Agencies). (Includes CASPER, MDS, OASIS, RAVEN, HAVEN, and ASPEN).

Reason For Assessment (RFA) - Reason for conducting the assessment, e.g., Start of

Care (SOC), Resumption of Care (ROC), and Follow-Up found in M0100.

Resumption of Care (ROC) – The day that care resumes after an inpatient stay. The

HHA must complete an OASIS assessment and obtain the necessary physician change

orders reflecting the change in the treatment approach in the patient’s plan of care. The

ROC is to be done within 48 hours of the patient’s return home. If the physician’s order

requests that the HHA resume care at a point later than 48 hours or if the patient refuses a

visit within this 48-hour period, a note to this effect should be documented in the patient’s

chart for future reference.

Significant Change in Condition (SCIC) - A SCIC is defined as a significant change in

the patient’s condition during a 60-day episode that was not envisioned in the original plan

of care. While this no longer creates a new case-mix for payment, the HHA must

complete an OASIS assessment and obtain the necessary physician change orders

reflecting the significant change in the treatment approach in the patient’s plan of care.

The SCIC relates to the OASIS data set “other” Follow-Up (RFA5).

Start of Care (SOC) – The day care begins after the referral is received. SOC currently

relates to the “first billable visit.” The “first billable visit” approach was selected largely

because of the Medicare payment requirements and the fact that the first billable visit

defines SOC and start of the episode for Medicare purposes.

Time Points - Specific times during an episode of care when collection of OASIS data

items is required as part of a comprehensive assessment. They are start of care,

resumption of care, recertification, follow-up, and transfer to an inpatient facility, death at

home, and discharge from agency.

Trailer Record - Indicates the end of the submission file. The trailer record includes a

count of the total records in the file, including the header and trailer records.

2202.2 - History of OASIS

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The OASIS is a group of data items developed, tested, and refined over the past decade for

the purpose of enabling the systematic measurement of HHA patient care outcomes.

Initially, the OASIS was a 79-item data set first published in 1994 by the Center for

Health Services and Policy Research at the University of Colorado. Over the years, it has

been modified as a result of input from a variety of home care experts, including

representatives of all home health care disciplines. Future modifications to the OASIS are

expected as we learn more about outcome measurement as well as determine what

information would best serve the continued maintenance of a case-mix adjusted home

health PPS.

Relative to OASIS, the definition of outcomes is very specific: outcomes measure changes

in a patient’s health status between two or more time points. The data are collected at

specific time points following a patient’s admission to an HHA to determine whether

appropriate progress toward desired outcomes is being achieved. These data items must

be incorporated into the agency’s overall patient assessment process as OASIS was not

developed to be a complete comprehensive assessment instrument. HHAs will find it

necessary to integrate the OASIS items into their own process in order to comprehensively

assess the health status and care needs of their own patient population. Effective, January

1, 2010, the OASIS data set was significantly modified to include process measures. Some

points to remember about the uses of OASIS data items into an HHA’s assessment process

can be found in Appendix C of the OASIS-C Guidance Manual.

2202.2A - Current Version of OASIS

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The current version of OASIS and the Guidance manual is found on the CMS Web site at:

http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/HomeHealthQualityInits/HHQIOASISUserManual.html.

2202.2B - OASIS as Part of the HHA’s Comprehensive Assessment

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

OASIS data items are not meant to be the only items included in an agency’s assessment

process for Medicare and Medicaid patients. They are standardized assessment items that

must be incorporated into an agency’s own existing assessment policies process. An

example of a comprehensive assessment showing an integration of the OASIS data items

with other agency assessment items can be found in Appendix C: Sample Clinical Records

Incorporating OASIS Data Set, in the OASIS User’s Manual. For a therapy-only case, the

comprehensive assessment should include OASIS data items as well as other assessment

data items the agency currently collects for therapy-only cases.

2202.2C - Incorporation of OASIS Data Items Into the Comprehensive Assessment (Refer

to §484.55(e))

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

In accordance with the regulations, agencies MUST incorporate the language of OASIS

data items exactly as they are written into their own assessment process. Agencies are

expected to replace similar items/questions on their current assessment as opposed to

simply adding the OASIS items at the end of their existing assessment tool. For agencies

electronically collecting assessment data using software that does not accommodate

bolding or underlining for emphasis of words in the same manner as the current OASIS

data set, capitalizing these words is acceptable. It is also recommended that HHAs

include the data set numbers (M numbers) when incorporating the OASIS. In this way,

the clinician will know that the M labeled items are items that MUST be assessed,

completed, and reported. This will minimize delays in encoding due to incomplete OASIS

data items. Agencies may wish to incorporate the assessment categories (e.g., Activities

of Daily Living (ADLs)/Instrumental Activities of Daily Living (IADLs), Medications,

etc.) into their own assessment process in a different order than presented on the OASIS

form. While HHAs are encouraged to integrate the OASIS data items into their own

assessment instrument in the sequence presented on the OASIS form for efficiency in data

entry, they are not precluded from doing so in a sequence other than that presented on the

OASIS form. However, this is not recommended because of the skip patterns built into

the OASIS form.

2202.3 - Applicability

(Rev. 1, 05-21-04)

2202.3A - Medicare and Medicaid Patients

(Rev. 1, 05-21-04)

In general, the comprehensive assessment and reporting regulations apply to any HHA

required to meet the Medicare CoPs for any reason and are applied to all patients of that

HHA unless otherwise specified. This includes Medicare, Medicaid, Medicare and

Medicaid Managed Care, and private pay patients served by the agency. It also includes

Medicaid waiver and State plan patients to the extent they do not fall into one of the

exception categories listed below, and are required by the State to meet Medicare CoPs.

HHAs providing services under Medicaid’s home health benefit must meet the CoPs for

Medicare, as specified at 42 CFR 440.70(d). As such, HHAs servicing only Medicaid

patients (Medicaid-only HHAs) must meet Medicare CoPs, including the comprehensive

assessment and OASIS reporting requirements.

Health maintenance organizations serving Medicare/Medicaid patients can either provide

home health services themselves or can contract out for those services. If they provide

home health services themselves, they must meet the Medicare home health CoPs. If they

contract out for home health services, they must contract with a Medicare-approved HHA

in order to serve Medicare/Medicaid patients. (See 42 CFR 417.416 and §2194.)

The HHA’s requirement to conduct comprehensive assessments that include OASIS data

items applies to each patient of the agency receiving home health services with certain

exceptions:

● Patients under the age of 18;

● Patients receiving maternity services;

● Patients receiving housekeeping or chore services only; and

● Patients receiving personal care services only.

● Patients for whom Medicare or Medicaid insurance is not billed.

The comprehensive assessment and reporting regulations to patients receiving personal

care only services, regardless of payor source is not applicable.

2202.3B - OASIS and the Medicare Home Health Benefit

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The comprehensive assessment and OASIS data collection requirements apply to

Medicare beneficiaries as described below:

• Medicare beneficiaries, using the Medicare home health benefit provided under

either Part A, Part B, or Part C;

• Medicare beneficiaries who require therapy services provided outside the home for

special equipment needs, and who are using the Medicare home health benefit.

If a Medicare beneficiary is under a home health plan of care, all therapy services, that is

physical therapy, occupational therapy, speech language pathology (PT, OT, SLP),

delivered under the home health benefit whether they are furnished directly by the HHA

or under arrangement on behalf of the HHA are bundled into the PPS payment rate as part

of the consolidated billing requirements.

The consolidated billing governs Medicare home health PPS effective October 1, 2000

and requires that payment for home health services (including medical supplies described

in §1861(m)(5) of the Act, but excluding DME to the extent provided for in §1861(m)(5))

furnished to an individual who (at the time the item or service was furnished) is under a

plan of care of a HHA, be made to the agency (without regard to whether or not the item

or service was furnished by the agency, by others under arrangement with them made by

the agency, or under any other contracting or consulting arrangement, or otherwise). The

services included in the consolidated billing governing home health PPS are:

• Part-time or intermittent skilled nursing services;

• Part-time or intermittent home health aide services;

• Physical therapy;

• Speech-language pathology services;

• Occupational therapy;

• Medical social services;

• Routine and non-routine medical supplies;

• Covered osteoporosis drug as defined in §1861(kk) of the Act, but excluding other

drugs and biologicals; and

• Home health services defined in §1861(m) provided under arrangement at

hospitals, SNFs or rehabilitation centers when they involve equipment too

cumbersome to bring to the home or are furnished while the patient is at the

facility to receive such services.

If a Medicare beneficiary under a home health plan of care is receiving therapy services

from another provider (either an inpatient or outpatient provider) under arrangement made

by the HHA as part of the home health benefit simply because the required equipment

cannot be made available at the patient’s home, the Medicare CoPs apply, including the

comprehensive assessment and collection and reporting of OASIS data by the HHA.

1. Medicare Advantage Plans.

Medicare Advantage Plans are health plan options that are part of the Medicare program.

Medicare beneficiaries who elect to have Medicare services provided by a Medicare

Advantage Plan are entitled to all the Medicare-covered services that are available to

beneficiaries residing in the plan’s geographic area.

Medicare Advantage Plans, like a Medicare Health Maintenance Organization (HMO) or

Preferred Provider Organization (PPO), which contract with Medicare to furnish HHA

services may provide such services either directly by the Plan or through Medicare-

approved HHAs that have a provider agreement and CCN with Medicare. (See

§417.416(a)). If the Medicare Advantage Plan provides home health services directly as

an integral part of the Plan, the HHA is still required to meet the HHA CoPs, including the

OASIS requirements, have a Medicare CCN, enter into a provider agreement with the

Secretary, and meet other survey and certification requirements, including Office of Civil

Rights and enrollment requirements, with which an HHA certified under §484.1 would

have to comply.

When the SA receives a request to survey an HMO-operated HHA for compliance with

the HHA CoPs, it schedules an unannounced standard survey. The SA conducts the

survey, completes the Form CMS-2567, obtains a PoC when necessary, and sends this

information along with a completed Form CMS-1539 to the CMS RO.

The SA resurveys approved HMO-operated HHAs according to the survey frequency

allowed by the Secretary and determined by the SA to assure quality care and to ascertain

whether they continue to meet the HHA CoPs. In essence, these HHAs are surveyed and

certified the same as any other Medicare-approved HHAs.

2. Medicaid Home Health Programs/Medicaid Waiver Programs

The comprehensive assessment regulations apply to HHAs that are required to meet the

Medicare home health CoPs. An HHA that currently must meet the Medicare CoPs under

Federal and/or State law must meet the Medicare CoPs related to OASIS and

comprehensive assessment and reporting. If an HHA provides skilled services to

individuals under Medicaid, then OASIS applies. If the patient is not receiving skilled

nursing, physical therapy, occupational therapy, or speech language pathology services,

then OASIS does not apply. The requirement to collect OASIS on patients receiving only

personal care services has been delayed until further notice.

3. Medicare Hospice Benefit

The comprehensive assessment and OASIS data collection requirements do not apply to

any individual receiving hospice services from a Medicare-approved hospice. A hospice

patient may receive covered home health services for a condition unrelated to the

treatment of the terminal condition for which hospice care was elected. This type of

patient would be subject to the regulations governing the HHA services, including OASIS

collection and reporting.

4. Outpatient Therapy Benefit

If a Medicare beneficiary not under a home health plan of care is receiving therapy

services under the Medicare Part B outpatient benefit from another Medicare provider, the

OASIS collection and reporting requirements do not apply.

5. SNF or Inpatient Hospital Benefit

The comprehensive assessment and OASIS data collection requirements do not apply to

Medicare beneficiaries who are inpatients at a SNF or a hospital because these services are

not considered home health services and the OASIS comprehensive assessment does not

need to be conducted. The MDS is required in certified skilled nursing facilities.

The following table summarizes the type of Medicare/Medicaid service and the

application of the Federal OASIS requirements:

Type of

Medicare/Medicaid

Service

Further Description

Application of OASIS

Home Health Benefit

Part A

Yes

Home Health Benefit

Part B

Yes

Home Health Benefit

Terminal Care

Yes

Home Health Benefit

Therapy services provided

either directly or under

arrangement while under a

home health PoC during

an open episode.

Yes

Medicare Home Health

under a Medicare

Advantage plan

The selected HHA must

be Medicare approved

Yes

Medicaid Home Health

Benefit

Skilled services provided

including expanded home

health services, that are

skilled, provided under a

Home and Community–

based Waiver

Yes

Medicaid Home Health

Benefit

Waiver service or home

health aide services only

provided without skilled

services

Medicare Hospice Benefit

Inpatient or at home

Outpatient Therapy Benefit

(patient not under a home

health plan of care)

Provided in a clinic,

rehabilitation agency, a

public health agency or

other provider of services

Skilled Nursing Facility,

Hospital

Inpatient services

The guidance above applies to all HHAs that participate in Medicare and to HHAs that

are required to meet the Medicare CoPs, including Medicaid HHAs.

2202.3C - Non-Medicare/Non-Medicaid Patients

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The collection, encoding, and transmission requirement for non-Medicare and non-

Medicaid patients receiving skilled care is temporarily suspended. While HHAs are not

required to collect OASIS for non-Medicare/non-Medicaid patients, HHAs may continue

to collect OASIS data for their own use but they may not submit the data for these patients

to the state. The state system will reject any assessment with a M0150 value of ‘0’

(unchecked) for items 1, 2, 3 and 4. Also, HAVEN will not include these assessments in

the submission file, but will mark them as complete.

2202.3D - Skilled Versus Nonskilled Care

(Rev. 1, 05-21-04)

Until the comprehensive assessment and reporting requirement resumes for all patients,

regardless of type of care provided, the following definitions apply for determining

skilled versus non-skilled care for comprehensive assessment purposes only:

● Skilled Services for Medicare Patients - The provision of skilled service is a pre-

condition for Medicare payment for home health care. Therefore, all patients

receiving Medicare (traditional) home health services are, by definition, receiving

skilled care.

● Skilled Services for Non-Medicare Patients - For comprehensive assessment

purposes, skilled services are services which can only be provided by a registered

nurse (RN) (or a licensed practical nurse under the supervision of an RN), a

physical therapist (PT), occupational therapist (OT), or a speech language

pathologist (SLP), licensed by the State. Most States define the kind of care that is

allowed by these practitioners under State practice acts.

The former requirement to conduct an initial evaluation of a patient is expanded in the

comprehensive assessment regulations. The regulations now require that, in addition to an

initial evaluation, the agency must also conduct a comprehensive assessment of a patient

with updates at certain time points. These updates include different combinations of

OASIS data items. An agency that currently must meet the Medicare CoPs under Federal

and/or State law will need to meet the comprehensive assessment and OASIS encoding

and reporting CoPs and apply them to each patient of the agency for whom home health

services are rendered, with the exceptions listed in A. above.

2202.3E - Agencies Serving Medicaid Waiver and State Plan Patients

(Rev. 1, 05-21-04)

If home care is provided by an entity required to meet the Medicare CoPs for any reason,

then the entity must apply all the requirements of the CoPs, including the comprehensive

assessment and OASIS data reporting requirements, to all patients of the agency,

including patients treated under a Medicaid waiver or State plan, as applicable. The same

exceptions apply as listed in A. above, i.e., patients under the age of 18; patients receiving

maternity services; patients receiving housekeeping or chore services only; and until

sometime in the future, patients receiving personal care services only.

If home care is provided by an entity that is not required to meet the Medicare CoPs, then

the provider must comply with only those requirements imposed under State or local law.

In this case if the provider treats patients under a Medicaid waiver or State plan, then none

of the Medicare CoPs for HHAs, including the comprehensive assessment and OASIS

data reporting requirements, apply. See §2183 for information on separate entities.

2202.3F - Patients Turning 18

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

A patient who is under age 18 and turns 18 while under the care of an HHA is to receive a

comprehensive assessment (including OASIS, if Medicare or Medicaid is billed) at the

next appropriate time point. Any assessments due under the regulations at the time the

patient turns 18 would be conducted, including the collection and reporting of OASIS

data, if Medicare or Medicaid is billed.

EXAMPLE

If on 1/5/2013 a patient under the care of the agency turns 18 and is transferred to an

inpatient facility on or after 1/5/2013, a transfer assessment with the corresponding OASIS

data items must be collected. If the patient was discharged on his/her 18th birthday, a

discharge assessment with the corresponding OASIS data items must be collected.

From the day the patient turns 18, any assessment required per the regulations at the next

particular time point is required. Agencies are not expected to collect and report start of

care OASIS data on patients admitted to the agency prior to turning 18.

2202.3G - Patients Receiving Maternity Services

(Rev. 1, 05-21-04)

The HHA should not collect data on patients receiving maternity services, i.e., prenatal,

antepartum, and postpartum. The patient is not exempt from OASIS data collection if

under the care of a physician for a condition unrelated to pregnancy or delivery.

2202.4 - Comprehensive Assessment and OASIS Reporting (Refer to

§484.20 and §484.55)

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

All HHAs participating in the Medicare/Medicaid program are required to comply with

the comprehensive assessment and OASIS reporting regulations as summarized in the

following chart.

PATIENT CLASSIFICATION

COLLECT

ENCODE

TRANSMIT

SKILLED

Medicare (traditional fee-for service)

Medicare (HMO/Managed Care)

Medicaid (traditional fee-for-service)

Medicaid (HMO/Managed Care)

Yes

SKILLED

Non-Medicare/Non-Medicaid:

PATIENT CLASSIFICATION

COLLECT

ENCODE

TRANSMIT

Workers’ Compensation

Title Programs

Other Government

Private insurance

Private pay patients under a HMO/

PPO/Managed Care plan

Self-pay; other; unknown

Temporarily

Suspended

PERSONAL CARE ONLY

Medicaid (traditional fee-for service)

Non-Medicaid:

Workers’ Compensation

Title Programs

Other Government

Private insurance

Private HMO/Managed Care

Self-pay; other; unknown

Patients under age 18;

Patients receiving pre and postpartum

maternity services; Patients receiving only

chore and housekeeping services

2202.4A - Comprehensive Assessment and OASIS Collection

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The comprehensive assessment regulations require a comprehensive assessment (that

includes certain OASIS data items) be conducted at specific time points during a patient’s

admission. Those specific times are:

1. SOC

After admission to the HHA, the SOC comprehensive assessment should be completed

in a timely manner consistent with the patient’s immediate needs but no later than 5

calendar days after the SOC.

2. ROC

The comprehensive assessment is completed within 48 hours of the patient’s return to

the place of residence or of the HHA’s knowledge of the patient’s return after an

inpatient admission of 24 hours or more for any reason other than diagnostic tests.

This applies when the patient was not discharged from the HHA during the inpatient

admission. If the physician’s order requests that the HHA resume care at a point later

than 48 hours or if the patient refuses a visit within this 48-hour period, a note to this

effect should be documented in the patient’s chart for future reference.

3. Follow-Up - The comprehensive assessment that is performed at the end of the

current 60-day period. This assessment must be performed within the last 5 days of

the current 60-day episode. For example:

Start of Care

Certification Period

Follow-Up Assessment Due

1/15/20xx

1/15/20xx - 3/14/20xx

3/10/20xx - 3/14/20xx

1/15/20xx

3/15/20xx - 5/13/20xx

5/09/20xx - 5/13/20xx

1/15/20xx

5/14/20xx - 7/12/20xx

7/08/20xx - 7/12/20xx

4. Transfer to an Inpatient Facility

An assessment update is performed when a patient is transferred to an inpatient facility

for 24 hours or more for any reason except diagnostic testing, regardless of whether

the patient is discharged from the HHA at that time. The update must be completed

within 48 hours of the patient’s transfer to the inpatient facility or within 48 hours after

the HHA becomes aware of the transfer and includes a limited number of OASIS

items.

5. Discharge

The comprehensive assessment is performed when a patient is discharged from home

care. These updates must be completed within 48 hours of the discharge/death or

within 48 hours after the HHA becomes aware of the discharge/death.

2202.4B - OASIS Encoding and Locking

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

HHAs should use HAVEN or HAVEN-like software to encode or enter OASIS data into

their computers. HAVEN will accommodate data entry of OASIS items from all required

time points. Regardless of the time point, OASIS data items should be encoded, and

checked for errors using HAVEN or HAVEN-like software, and made

export/transmission-ready.

1. Availability of HAVEN

The HAVEN software is available for downloading free of charge from the CMS OASIS

and QIES Technical Support (QTSO) Web site. See

https://www.qtso.com/havendownload.html

The HAVEN help line can be reached at: 1-877-201-4721.

Specific information describing how to operate the HAVEN software can be found at

https://www.qtso.com/download/haven/hhahelp32.pdf.

2. Errors and Warnings in Encoding

See Error Messages and Description Guide --

https://www.qtso.com/download/Guides/hha/errors/Errors_sec2.pdf

HHAs may experience two types of messages at completion of data entry.

a. Error Message.

If the HHA uses HAVEN for data entry, an error message may occur if a

mandatory field is left blank. The HHA will receive an error that the field must be

filled in before the assessment can be marked as complete. HHAs should correct

their errors before an assessment may exported to the OASIS Data Management

System. Along with the error message is the name of the window tab where the

error was detected.

b. Warning Message

If the HHA uses HAVEN for data entry, a warning message may occur if timing

criteria for date fields do not match OASIS data specifications. These messages

are informational only and do not preclude an HHA’s assessment from being

exported. Along with the warning message is an explanation of that message and

direction on where the discrepancy was detected.

2202.4C - OASIS Reporting (Refer to §484.20)

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

1. HHA Submissions

HHAs must submit their OASIS data within 30 days of the M0090 date, date

assessment completed. Data received outside of this time frame is considered

overdue. Specific information describing how HHAs are to transmit OASIS data to

the SA is in the OASIS System Users Guide.

2. Errors and Warnings in OASIS Reporting

When submitting OASIS records, a fatal error message may occur if the HHA’s data

record layout does not follow OASIS data specifications. This message should not

occur if the HHA is using the HAVEN software to encode the OASIS items.

3. SA Access

In States where the non-long term care agency is in a location separate from the

OASIS State System (where the MDS Data System resides and is not under the direct

jurisdiction of the home health survey agency), CMS provides access to the OASIS

State System by installing a computer work station at the home health survey agency

address to link to the OASIS State System.

The CMS will provide additional support to the SA to access and operate the off-site

server by providing appropriate software, and technical assistance from CMS and the

CMS OASIS contractors.

2202.5 - Outcome-Based Quality Improvement (OBQI)

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

OBQI is a systematic approach that HHAs can implement and follow in order to

continuously improve the quality of care they provide. OBQI manuals are available on the

CMS Home Health Quality website. Under OBQI, quality is measured against the

ultimate yardstick - patient outcomes. OBQI is fundamentally a two-stage process that

requires the collection of OASIS data for all patients in the agency, except those excluded

by exemption.

The first stage of OBQI is outcome analysis based on the OASIS data. The analysis is

based on an agency-level report showing the agency’s present performance regarding

patient outcomes relative to a national measure of HHA patients. Outcome reports are

generated at the SA and retrieved by the HHA through the same communication process

the HHA uses to transmit OASIS data. Subsequent outcome reports contain comparisons

of an agency’s present patient outcomes performance relative to the preceding time period

for the agency and relative to a national measure of HHA patients. From these reports,

HHAs can target areas for improvement as part of their overall quality assurance process.

The second stage of OBQI is outcome enhancement, whereby the agency, using the data

from its outcome analysis, identifies opportunities to improve care and develops plans.

HHAs are provided with reports on a series of outcomes for their patients in the current

year that compares its performance to the prior year and to the national reference (i.e.,

benchmarking) values.

2202.5A - Using Outcome Based Quality Monitoring (OBQM) and Risk

Adjusted OBQI Reports in the Survey Process

(Rev. 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14)

The OBQM reports consist of the patient-related characteristics and potentially avoidable

event outcome reports, which are derived from the OASIS data that HHAs submit to the

State. The agency patient-related characteristics and potentially avoidable event reports

can be used by HHAs for quality monitoring and improvement purposes. The risk-

adjusted OBQI reports provide measures of patient care based on all of the OASIS data

items. These reports allow an HHA to proceed to outcome enhancement. It is the

outcome enhancement activities that allow an HHA to focus its quality (or performance)

improvement activities on select target outcomes, to investigate the care processes that

contributed to these outcomes, and to make agency-specific changes in clinical actions

that will lead to improved patient outcomes. Using these reports is a first step toward full

implementation of the OBQI program. As a part of the pre-survey preparation, surveyors

should access and review the OBQM and OBQI reports before surveying an HHA. These

reports contain valuable information that may assist surveyors in identifying areas to

review during the survey and possibly identify individuals or types of patients to include

in the sample selection when on site following guidance provided in the Home Health

Survey Protocol Enhancements, effective May 1, 2003 published February 13, 2003 as

S&C Memorandum 03-13. The OBQM Manual, (titled “Quality Monitoring Using Case-

Mix and Adverse Event Outcome Report” available on the OASIS Web site), provides

examples of possible surveyor actions related to adverse event outcomes. The OBQI

Manual (titled Outcome-Based Quality Improvement Implementation Manual provides

guidance to HHAs for establishing a quality improvement program using the risk-adjusted

OBQI reports. This manual is also available on the OASIS Web site.

1. Agency Patient-Related Characteristics Report

The agency patient-related characteristics report presents a picture, or snapshot, of an

HHA’s patients at the beginning of a care episode for the time period selected for the

report. The beginning of a care episode is marked by either a SOC assessment or a

ROC assessment. The body of the case-mix report describes the characteristics of an

HHA’s Medicare and Medicaid patients receiving skilled services compared to the rest

of the Medicare and Medicaid patients receiving skilled home health services across

the country during the same time period. Surveyors should review the case-mix

outcome report as described in the OBQM Manual and the Appendix titled

“Guidelines for Reviewing Agency Patient-Related Characteristics and Potentially

Avoidable Event Reports.” Any significant results should be identified after

reviewing the report, and highlights noted. This will allow surveyors to begin to

identify potential clinical groups of patients that can be included in the case-mix

stratified sample for record review and home visits, as part of the onsite survey.

2. Potentially Avoidable Event Reports

The Potentially Avoidable Event Report displays incidence rates for untoward events

(or outcomes) comparing one HHA’s patients to patients in the CMS OASIS National

repository for the same time period.

Potentially avoidable events serve as markers for potential problems in care because

of their negative nature and relatively low frequency. The Patient Listing can be used

to investigate the care processes that contributed to these outcomes and to make

agency-specific changes in clinical actions that will lead to improved patient

outcomes. As a part of the pre-survey preparation, surveyors should access and

review the OBQM and OBQI reports before surveying an HHA. These reports

contain valuable information that may assist surveyors in identifying areas to review

during the survey.

Surveyors do not look at the potentially avoidable event report in a vacuum. They

review this report in light of the actual circumstances surrounding the delivery of care

to the specific patients.

As a part of the CoPs (§484.16, Group of Professional Personnel and §484.52,

Evaluation of the Agency’s Program), HHAs are required to conduct an annual

evaluation of their total program, including patient services. HHAs are also required

to conduct quarterly clinical record reviews to evaluate the care provided under the

HHA’s policies. The CoPs require an agency to have policies and procedures to

promote patient care that are appropriate, adequate, effective and efficient. HHAs

have access to the OBQM reports and the OBQI reports and may incorporate a review

and investigation of these reports into their evaluation and patient care review

programs and include them as part of their quarterly record review.

3. Risk Adjusted OBQI Reports

The risk adjusted OBQI reports are the third and final of the OASIS-based reports.

These agency-level reports allow individual HHAs to assess their own performance

with respect to patient outcomes and compare their performance to a national reference

or benchmark. In addition, HHAs can use the OBQI data to target and develop plans

of action to improve or maintain HHA performance and patient outcomes. The risk

adjusted OBQI reports became available to all HHAs in February 2002.

CMS anticipates that HHAs will choose to use the OBQI reports for quality improvement

and for consumer education. In CMS-sponsored demonstrations where the OBQI process

has been tested, many HHAs have demonstrated significant improvements in targeted

patient outcomes. These data rich reports now represent a decade of benchmarking that is

risk adjusted for each HHA. This means that every HHA can be compared to the national

reference values, regardless of the types of patients it serves, when compared to another

HHA. Therefore, an HHA that strives to provide quality care services to its patients will

be able to determine its performance and to identify areas for improvement or

reinforcement with the quality reports available to them.

Process Measures were added to the OASIS in 2010. For further information, refer to the

PBQI Manual which is located at: http://www.cms.gov/Medicare/Quality-Initiatives-

Patient-Assessment-Instruments/HomeHealthQualityInits/PBQIProcessMeasures.html

The OASIS C Process Measure Reports are now available in the CASPER Reporting

System. The reports are located in the OASIS C - Quality Improvement report category.

Resources are located on the following CMS websites:

• PBQI – http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/HomeHealthQualityInits/PBQIProcessMeasures.html

• OBQI - http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/HomeHealthQualityInits/HHQIOASISOBQI.html