Medications/Drugs (Outpatient/Part B)

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UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

UnitedHealthcare

Medicare Advantage

Coverage Summary

Medications/Drugs (Outpatient/Part B)

Policy Number: MCS057.32

Last Committee Approval Date: July 10, 2024

Effective Date: August 1, 2024

 Instructions for Use

Table of Contents Page

Coverage Guidelines ............................................................. 1

• Outpatient Medications/Drugs ........................................ 1

• Unlabeled Use of a Part B Drug ..................................... 2

• Medications/Drugs Covered Under Part B ..................... 3

• Medications/Drugs Not Covered ..................................... 8

• Review at Launch ........................................................... 9

• Step Therapy Program ................................................. 10

• Maximum Dosage and Frequency ................................ 10

• Other Specific Medications ........................................... 10

Definitions ............................................................................ 11

Supporting Information ........................................................ 11

Policy History/Revision Information .................................... 30

Instructions for Use ............................................................. 31

Coverage Guidelines

Outpatient/Part B medications/drugs are covered when Medicare coverage criteria are met.

DME Face-to-Face Requirement: Section 6407 of the Affordable Care Act (ACA) established a face-to-face encounter

requirement for certain items of DME (including implantable infusion pumps; implantable programmable infusion pump;

external ambulatory infusion pump and nebulizers). For DME Face-to-Face Requirement information, refer to the

Coverage Summary titled

Durable Medical Equipment (DME), Prosthetics, Orthotics (Non-Foot Orthotics), Nutritional

Therapy, and Medical Supplies Grid.

Note: The guidelines in this Coverage Summary are for specific procedures/medications only. For procedures/

medications not addressed in this Coverage Summary, refer to the Medicare Coverage Database

to search for applicable

coverage policies (National Coverage Determinations, Local Coverage Determinations and Local Coverage Articles).

(Accessed July 1, 2024)

Outpatient Medications/Drugs

Part B Medications/Drugs

Outpatient (Part B) medications/drugs, in accordance with Medicare coverage criteria, are covered when furnished

“incident” to a physician service for drugs that are “not Usually Self-Administered By the Patient.” Refer to the definition of

Not Usually Self-Administered By the Patient

Coverage is Usually limited to drugs or biologicals Administered by infusion or injection. However, if the injection is

generally Self-Administered (e.g., Imitrex), it is not covered under Part B. Despite the general limitation on coverage for

outpatient drugs under Part B, some Self-Administered medications/drugs are also covered. For examples, refer to the

Medications/Drugs Covered Under Part B and Medications/Drugs Not Covered

sections.

For Medicare’s detailed coverage criteria for medications/drugs under Part B, refer to the

Medicare Benefit Policy Manual,

Chapter 15, §50 – Drugs and Biologicals. (Accessed July 1, 2024)

Related Medicare Advantage Policy Guidelines

• Halaven

(Eribulin Mesylate)

• Immune Globulin

• Testosterone Pellets (Testopel

)

• Xgeva

, Prolia

(Denosumab)

Medications/Drugs (Outpatient/Part B)

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Part D Medications/Drugs

A Part D covered drug is available only by prescription, approved by the Food and Drug Administration (FDA), used and

sold in the United States, and used for a medically accepted indication.

A drug for which coverage is available under Part A or Part B, as it is being “prescribed and dispensed or Administered”

with respect to the individual, is excluded from the definition of a Part D drug and, therefore, cannot be included in Part D

basic coverage. CMS interprets this to mean that if payment could be available under Part A or Part B to the individual for

such drug, then it will not be covered under Part D.

Section 1860D-2(e)(4) of the Act defines “medically-accepted indication,” in part by reference to section 1927(k)(6) of the

Act, to any use of a covered Part D drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use

of which is supported by one or more citations included or approved for inclusion in any of the compendia described in

section 1927(g)(1)(B)(i) of the Act. The recognized compendia are:

American Hospital Formulary Service Drug Information, and

DRUGDEX

Information System.

Refer to the Medicare Prescription Drug Benefit Manual Chapter 6, §10.6 – Medically Accepted Indication

Note: Some members may have coverage for Part D drugs under UnitedHealthcare. Refer to the Member’s Pharmacy

Booklet or contact the Prescription Solutions Customer Service Department to determine coverage eligibility for Part D

prescription drug plan benefit.

For Medicare’s detailed coverage information for medications/drugs under Part D, refer to the

Medicare Prescription Drug

Benefit Manual, Chapter 6, §10 – Definition of Part D Drugs. (Accessed July 1, 2024)

Part B vs. Part D Medications/Drugs

For Part B vs. Part D medications/drugs guidelines, refer to the specific medications listed under the Medications/Drugs

Covered Under Part B section.

Unlabeled Use of a Part B Drug

Unlabeled use of a drug may be covered only if a UnitedHealthcare Medical Director or his/her designee determines the

use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or

accepted standards of medical practice.

Refer to the Medicare Benefit Policy Manual, Chapter 15, §50.4.2 – Unlabeled Use of Drug

For the list of the major drug compendia for off-label use of drugs and biologicals in an anti-cancer chemotherapeutic

regimen, refer to the Medicare Benefit Policy Manual, Chapter 15, §50.4.5.B – Recent Revision to Compendia List

In the case of drugs used in anti-cancer chemotherapeutic regimen, refer to the

Medicare Benefit Policy Manual,

Chapter 15, §50.4.5 – Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen.

Notes:

The above information is for determining coverage for the unlabeled use of medication covered under Part B only, not

Part D. Refer to the Member’s Pharmacy Booklet or contact the Prescription Solutions Customer Service Department

for further information on Part D coverage, if any.

Definition of Compendium: CMS revised the definition of “compendium” to include this public transparency

requirement. In this revised definition, a compendium:

o Includes a summary of the pharmacologic characteristics of each drug or biological and may include information

on dosage, as well as recommended or endorsed uses in specific diseases; and

o Is indexed by drug or biological; and

o Has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.

Refer to the Medicare Benefit Policy Manual, Chapter 15, §50 – Drugs and Biologicals §50.4.5.1.A

(Accessed July 1, 2024)

Medications/Drugs (Outpatient/Part B)

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Medications/Drugs Covered Under Part B

Examples of medications/drugs that are covered under Part B include, but not limited to, the following medications/drugs.

Durable Medical Equipment (DME) Supply Drugs

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. This includes

drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the

durable medical equipment or to assure the proper functioning of the equipment. Refer to the

Medicare Benefit Policy

Manual, Chapter 15, §110.3 – Coverage of Supplies and Accessories.

Part B vs. Part D Guideline

Nebulizer Inhalation Drugs (e.g., Albuterol Sulfate, Ipratropium Bromide)

Certain inhalation drugs are generally covered under Part B when used with a nebulizer in the home. These drugs would

not be covered under Part D for use with a nebulizer. However, if these drugs were delivered with a metered dose inhaler

or other non-nebulized administration, they would be Part D drugs.

In the case of a member in a hospital, or a SNF bed, (1) who does not have Part A coverage, (2) whose Part A coverage

for the stay has run out or (3) whose stay is non-covered-infusible DME supply drugs are not covered under Part B

because the law limits coverage under Part B’s DME benefit to those items that are furnished for use in a patient’s home,

and specifies that a hospital or SNF cannot be considered the member’s “home” for this purpose. In this case, coverage

for the drugs would be available under Part D.

In addition to a hospital, a SNF or a distinct part SNF, the following facilities cannot be considered a home for purposes of

receiving the Medicare DME benefit:

A nursing home that is dually certified as both a Medicare SNF and a Medicaid nursing facility (NF); and

A Medicaid-only NF that primarily furnishes skilled care; and

A non-participating nursing home (i.e., neither Medicare or Medicaid) that provides primarily skilled care; and

An institution which has a distinct part SNF and which also primarily furnishes skilled care.

Refer to the

Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D

Coverage Issues.

For the list of nebulizer drugs covered under Part B, refer to the DME MAC LCD for Nebulizers (L33370)

. Compliance with

these policies is required where applicable. (Accessed July 1, 2024)

Infusion Pump Medications (e.g., Some Chemotherapeutic Agents)

In general, the supplier would bill Part B if the drug was Administered using an infusion pump and bill the Part D plan for

infusion using other methods (e.g., IV push). While professional services and supplies related to the administration of the

infused drug are not payable under Part D, some coverage may be available under Part A or B home health benefits,

under Medicaid, or from secondary commercial health benefits.

As a rule, drugs infused using an implantable pump would be covered under Part B. Drugs infused in the home using an

external pump are covered under Part B if they are included under the local coverage policy of the applicable Medicare

DME MAC.

In the case of a member in a hospital, or a SNF bed, (1) who does not have Part A coverage, (2) whose Part A coverage

for the stay has run out or (3) whose stay is non-covered infusible DME supply drugs are not covered under Part B

because the law limits coverage under Part B’s DME benefit to those items that are furnished for use in a patient’s home,

and specifies that a hospital or SNF cannot be considered the member’s “home” for this purpose. In this case, coverage

for the drugs would be available under Part D.

In addition to a hospital, a SNF or a distinct part SNF, the following facilities cannot be considered a home for purposes of

receiving the Medicare DME benefit:

A nursing home that is dually certified as both a Medicare SNF and a Medicaid nursing facility (NF); and

A Medicaid-only NF that primarily furnishes skilled care; and

A non-participating nursing home (i.e., neither Medicare or Medicaid) that provides primarily skilled care; and

An institution which has a distinct part SNF and which also primarily furnishes skilled care.

Medications/Drugs (Outpatient/Part B)

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Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D

Coverage Issues. (Accessed July 1, 2024)

Immunosuppressive Drugs

Immunosuppressive drug therapy following a Medicare covered organ transplant is covered.

Covered drugs include those immunosuppressive drugs that have been specifically labeled as such and approved for

marketing by the FDA. (This is an exception to the standing drug policy which permits coverage of FDA Approved Drugs

for non-labeled uses, where such uses are found to be reasonable and necessary in an individual case.)

Immunosuppressive drugs are substances that suppress or interfere with normal immune responses. They are used in

controlling autoimmune diseases and in enhancing the chances for survival of foreign-tissue grafts and transplants.

Examples of FDA-approved immunosuppressive drugs include, but are not limited to:

Sandimmune (cyclosporine), Sandoz Pharmaceutical.

Imuran (azathioprine), Burroughs Welcomes.

Agma (antithymocyte globulin), Upjohn.

Orthoclone OKT3 (Muromonab-CD3), Ortho Pharmaceutical.

Prograf (tacrolimus), Fujisawa USA, Inc.

Celicept (mycophenolate mofetil), Roche Laboratories.

Daclizumab (Zenapax).

Cyclophosphamide (Cytoxan).

Prednisone and Prednisolone.

Notes:

Prescription drugs, such as prednisone, used in conjunction with immunosuppressive drugs as part of a therapeutic

regimen are covered as reflected in FDA approved labeling for immunosuppressive drugs. Therapeutic regimen is a

combination of drugs which has been clinically recognized for the treatment of a specific type of disorder or to treat

toxicities or side effects of drugs which are used at different times following an approved transplant.

Immunosuppressive drugs for organ transplants are covered under Part B coverage except when furnished during an

inpatient stay or upon discharge from the hospital, then the drugs are covered as Part A.

CMS expects contractors to keep informed of FDA additions to the list of the immunosuppressive drugs.

Members may have additional coverage for immunosuppressive drugs under the Part D Prescription Drug Plan which

are not covered in this benefit interpretation policy. Refer to the Member’s Pharmacy Booklet or contact the

Prescription Solutions Customer Services Department to determine coverage eligibility for prescription drug plan

benefit.

Refer to the Medicare Benefit Policy Manual, Chapter 15, §50.5.1 – Immunosuppressive Drugs

. (Accessed July 1, 2024)

Part B vs. Part D Guideline

Part B would be billed if the individual had a Medicare-covered transplant; otherwise, the Part D plan would be billed.

Pharmacists would bill Part B or the individual’s Part D plan based on information received from the individual or the Part

D plan. Part B would be billed if the individual had a Medicare-covered transplant; otherwise, the Part D plan would be

billed. Part D plan eligibility systems could contain a marker for members who had a Medicare covered transplant. This

information could come from a question included on the Part D sponsor’s enrollment or coordination of benefit (COB)

survey form.

In determining whether to pay for an immunosuppressive drug under Part D, it would not be appropriate for a Part D

sponsor to institute a general policy of requiring a Part B claim rejection, as a substitute for maintaining information on

transplant status and paying claims based on that information. Such a policy would be disruptive to beneficiaries and

pharmacies and would unnecessarily increase Part B contractor costs. Instead, a prior authorization requirement would be

appropriate.

Refer to the

Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D

Coverage Issues. (Accessed July 1, 2024)

Medications/Drugs (Outpatient/Part B)

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Hemophilia Blood Clotting Factors

Part B vs. Part D Guideline

Hemophilia blood clotting factors would not be a Part D benefit because of the Part B coverage. Refer to the Medicare

Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D Coverage Issues.

(Accessed July 1, 2024)

Oral Anti-Cancer Drugs and Oral Anti-Emetics

Oral anti-cancer drugs and oral anti-nausea (anti-emetic) drugs are covered when criteria are met.

For detailed coverage requirements, refer to the

Medicare Benefit Policy Manual, Chapter 15, §50.5.3 Oral Anti-Cancer

Drugs.

For claims payment and coding information, refer to the

Medicare Claims Processing Manual, Chapter 17, §80.1 Oral

Cancer Drugs.

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist and compliance with these policies is

required where applicable. These LCDs/LCAs are available at

https://www.cms.gov/medicare-coverage-database/new-

search/search.aspx.

Note: Members may have additional coverage for oral anti-cancer under the Part D. Prescription Drug Plan, which are not

covered in this coverage summary. Refer to the member’s pharmacy booklet or contact the Prescription Solutions

customer service department to determine coverage eligibility for prescription drug plan benefit. (Accessed July 1, 2024)

Part B vs. Part D Guideline

Certain oral chemotherapy agents used in cancer treatment for which there is an infusible version of the drug.

Pharmacists would need to determine the reason for treatment. If related to cancer treatment, Part B would be billed;

otherwise, the Part D plan should be billed.

To the extent that a Part B-covered oral anti-cancer drug has no other medically accepted indication besides cancer

treatment, Part D sponsors should not include these drugs on their formularies because of Part B coverage. For the

drugs that have other medically accepted indications, prior authorization programs or other mechanisms to obtain

diagnostic information could be used to ensure appropriate payment.

Oral anti-emetics used in cancer treatment as a full replacement for intravenous treatment.

Pharmacists would need to determine the reason for treatment. If both related to cancer treatment and a full

replacement for intravenous administration within 48 hours of cancer treatment, Part B would be billed; otherwise, the

Part D plan should be billed.

Note: In order to receive Part B payment, CMS currently requires that the prescribing physician indicate on the

prescription that the oral anti-emetic is being used “as a full therapeutic replacement for an intravenous anti-emetic

drug as part of a cancer chemotherapeutic regimen.”

If based on a prior authorization program or other mechanism to obtain diagnostic information, a Part D sponsor

determined that a) a Part B-covered oral anti-emetic was being billed, and b) the drug was being furnished in the

context of cancer treatment for use within 48 hours of cancer treatment, the Part D sponsor should deny payment.

Such drugs dispensed for use after the 48-hour period, or any oral anti-emetic prescribed for conditions other than the

effects of cancer treatment, would be Part D drugs.

Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D

Coverage Issues. (Accessed July 1, 2024)

Immunizations

Immunizations (e.g., pneumococcal vaccine, Hepatitis B vaccine, and influenza vaccine) are covered when criteria are

met. Refer to the Medicare Benefit Policy Manual, Chapter 15, §50.4.4.2 – Immunizations

for coverage criteria.

(Accessed July 1, 2024)

Part B vs. Part D Guideline

For Hepatitis B vaccine, physicians would need to determine the level of risk of the individual. If the individual is at high or

intermediate risk, Part B would be billed. For all other individuals, prior authorization programs could be used to ensure

appropriate level of risk.

Medications/Drugs (Outpatient/Part B)

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Pneumococcal and influenza vaccines would not be covered under Part D because of Part B coverage. Refer to the

Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D Coverage Issues

(Accessed July 1, 2024)

Antigens/Antihistamines

Antigens/antihistamines are covered when criteria are met. These are prepared by a physician (Usually an allergist) for a

specific patient. The physician or physician’s nurse generally administers them in the physician’s office. In some cases,

the physician prepares antigens and furnishes them to a patient who has been taught to self-administer them at home.

Refer to the Medicare Benefit Policy Manual, Chapter 15, §20.2 – Physician Expense for Allergy Treatment and

§50.2 –

Determining Self-Administration of Drug or Biological.

Also refer to the:

o Medicare Benefit Policy Manual, Chapter 15, §50.4.4.1 – Antigens.

o Medicare Claims Processing Manual, Chapter 12, §200 – Allergy Testing and Immunotherapy.

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist and compliance with these policies is

required where applicable. These LCDs/LCAs are available at

https://www.cms.gov/medicare-coverage-

database/search.aspx.

(Accessed July 1, 2024)

Part B vs. Part D Guideline

Antigens would not be a Part D benefit because of the Part B coverage. Refer to the Medicare Prescription Drug Benefit

Manual, Chapter 6, Appendix C – Medicare Part B versus Part D Coverage Issues. (Accessed July 1, 2024)

Parenteral Nutrition

Parenteral nutrition, including Intradialytic Parenteral Nutrition (IDPN), is covered under the prosthetic benefit when criteria

are met. Refer to the Coverage Summary titled

Durable Medical Equipment (DME), Prosthetics, Orthotics (Non-Foot

Orthotics), Nutritional Therapy, and Medical Supplies Grid for coverage criteria.

Part B vs. Part D Guideline

If the therapy was being provided because of a non-functioning digestive tract, Part B would be billed; if not, this would be

a Part D drug. Refer to the

Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus

Part D Coverage Issues. (Accessed July 1, 2024)

Intravenous Immune Globulin (IVIG)

Intravenous Immune Globulin (IVIG) in the Home

Intravenous immune globulin (IVIG) for the treatment of primary immune deficiency diseases is covered in the home

under Part B if all of the following criteria are met:

It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease.

The patient has a diagnosis of primary immune deficiency disease.

Note: For specific ICD-10-CM codes that are covered, refer to the

Medicare Benefit Policy Manual, Chapter 15, §50.6

– Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home. Also

refer to the applicable LCDs/LCAs.

The IVIG is Administered in the home.

The treating physician has determined that administration of the IVIG in the patient’s home is medically appropriate.

Refer to the

Medicare Benefit Policy Manual, Chapter 15, §50.6– Coverage of Intravenous Immune Globulin for Treatment

of Primary Immune Deficiency Diseases in the Home.

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist for IVIG and compliance with these policies

is required where applicable. For specific LCDs/LCAs, refer to the table for Intravenous Immune Globulin (IVIG)

(Accessed July 1, 2024)

Part B vs. Part D Guideline

Part B coverage for IVIG in the home is for individuals whose diagnosis is primary immune deficiency disease. Part D

would provide coverage for IVIG in the home for all other medically accepted indications. Prior authorization requirements

could be used to ensure appropriate payment in accordance with the Part D sponsor’s medical necessity criteria. It would

not be appropriate to routinely require a rejection of a claim under Part B before processing a Part D claim. Such a policy

would be disruptive to beneficiaries and pharmacies and would unnecessarily increase Part B contractor cost.

Medications/Drugs (Outpatient/Part B)

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The supplier would bill Part B if the diagnosis is primary immune deficiency disease. IVIG provided in the home for other

diagnoses would be a Part D benefit. As discussed above, it would not be appropriate, as a general rule, for Part D

sponsors to require a rejection of a claim under Part B before processing a Part D claim. Prior authorization programs

could be used to ensure medical necessity in accordance with the Part D sponsor’s policy.

Refer to the

Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C – Medicare Part B versus Part D

Coverage Issues. (Accessed July 1, 2024)

Treatment of Autoimmune Mucocutaneous Blistering Diseases

IVIg is covered for the treatment of biopsy-proven:

Pemphigus Vulgaris.

Pemphigus Foliaceus.

Bullous Pemphigoid.

Mucous Membrane Pemphigoid (a.k.a., Cicatricial Pemphigoid).

Epidermolysis Bullosa Acquisita.

For more specific coverage guidelines, refer to the

National Coverage Determination (NCD) for Intravenous Immune

Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases (250.3).

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist for IVIG and compliance with these policies

is required. For specific LCDs/LCAs, refer to the table for Intravenous Immune Globulin (IVIG)

. (Accessed July 1, 2024)

Other Indications

Medicare does not have an NCD for other indications other than the ones listed above. Local Coverage Determinations

(LCDs)/Local Coverage Article (LCAs) exist for all states/territories and compliance with these policies is required where

applicable. For specific LCDs/LCAs, refer to the table for Intravenous Immune Globulin (IVIG)

Injectable Drugs for the Treatment of Osteoporosis

Injectable drugs for the treatment of osteoporosis when provided by the home health agency and the following criteria are

met:

The member is unable to learn the skills needed to self-administer the drug, or is otherwise physically or mentally

incapable of administering the drug, and that her family or caregiver are unable or unwilling to administer the drug, as

documented by the home health agency, and

The member sustained a bone fracture that a physician certifies was related to (post-menopausal) osteoporosis; and

The member is Homebound.

Refer to the:

Medicare Benefit Policy Manual Chapter 7, §50.4.3 8– Covered Osteoporosis Drugs.

Coverage Summary titled Home Health Services, Home Health Visits, Respite Care, and Hospice Care.

(Accessed July 1, 2024)

Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS)

(HCPCS Code Q2026)

Effective for claims with dates of service on and after March 23, 2010, dermal injections for LDS are only reasonable and

necessary using dermal fillers approved by the Food and Drug Administration (FDA) for this purpose, and then only in

HIV-infected beneficiaries when LDS caused by antiretroviral HIV treatment is a significant contributor to their depression.

Refer to the NCD for Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS) (250.5)

(Accessed July 1, 2024)

Drugs for Chelation Therapy for the Treatment of Heavy Metal Toxicity and Non-

Overload Conditions

Medicare does not have a National Coverage Determination (NCD) for chelation therapy for lead poisoning. Local

Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) do not exist at this time.

For coverage guidelines, refer to the UnitedHealthcare Commercial Medical Policy titled

Chelation Therapy for Non-

Overload Conditions.

Medications/Drugs (Outpatient/Part B)

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Note: After searching the Medicare Coverage Database, if no LCD/LCA is found, then use the policy referenced above for

coverage guidelines. (Accessed July 1, 2024)

Drugs Treated as Hospital Outpatient Supplies

In certain circumstances, Medicare pays for drugs that may be considered Usually self-Administered By the Patient when

such drugs function as supplies. This is the case when the drugs provided are an integral component of a procedure or

are directly related to it, i.e., when they facilitate the performance of or recovery from a particular procedure. Except for

the applicable copayment, hospitals may not bill beneficiaries for these types of drugs because their costs, as supplies,

are packaged into the payment for the procedure with which they are used. Listed below are examples of when drugs are

treated as supplies and hospitals should bill Medicare for the drug as a supply and should not separately bill the member.

Sedatives Administered to a patient while he or she is in the preoperative area being prepared for a procedure.

Mydriatic drops instilled into the eye to dilate the pupils, anti-inflammatory drops, antibiotic drops/ointments, and

ocular hypotensives that are Administered to a patient immediately before, during, or immediately following an

ophthalmic procedure; this does not refer to the patient’s eye drops that the patient uses pre-and postoperatively.

Barium or low osmolar contrast media provided integral to a diagnostic imaging procedure.

Topical solution used with photodynamic therapy furnished at the hospital to treat non-hyperkeratotic actinic keratosis

lesions of the face or scalp.

Antibiotic ointments such as bacitracin, placed on a wound or surgical incision at the completion of a procedure.

The following are examples of when a drug is not directly related or integral to a procedure and does not facilitate the

performance of or recovery from a procedure. Therefore, the drug is not considered a packaged supply. In many of these

cases the drug itself is the treatment instead of being integral or directly related to the procedure or facilitating the

performance of or recovery from a particular procedure.

Drugs given to a patient for his or her continued use at home after leaving the hospital.

Oral pain medication given to an outpatient who develops a headache while receiving chemotherapy administration

treatment.

Daily routine insulin or hypertension medication given preoperatively to a patient.

A fentanyl patch or oral pain medication such as hydrocodone, given to an outpatient presenting with pain.

A laxative suppository for constipation while the patient waits to receive an unrelated X-ray.

These two lists of examples may serve to guide hospitals in deciding which drugs are supplies packaged as a part of a

procedure, and thus may be billed under Part B. Hospitals should follow CMS’ guidance for billing drugs that are

packaged and paid as supplies, reporting coded and uncoded drugs with their charges under the revenue code

associated with the cost center under which the hospital accumulates the costs for the drugs. Refer to the

Medicare

Benefit Policy Manual, Chapter 15, §50.2 – Determining Self-Administration of Drug or Biological, M-Drugs Treated as

Hospital Outpatient Supplies. (Accessed July 1, 2024)

Hereditary Angioedema (HAE) Treatment (HCPCS Codes J0596, J0597, J0598, and

J1290)

Medicare does not have a National Coverage Determination (NCD) for Hereditary Angioedema (HAE) treatment. Local

Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) do not exist.

For coverage guidelines, refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy titled

Hereditary

Angioedema (HAE), Treatment and Prophylaxis.

Note: After searching the Medicare Coverage Database

, if no LCD/LCA is found, then use the policy referenced above for

coverage guidelines. (Accessed July 1, 2024)

Medications/Drugs Not Covered

Examples of medications/drugs that are not covered are:

Vitamin B12 Injections

Vitamin B12 injections to strengthen tendons, ligaments, etc., of the foot are not covered under Medicare because:

There is no evidence that vitamin B12 injections are effective for the purpose of strengthening weakened tendons and

ligaments, and

This is non-surgical treatment under the subluxation exclusion.

Medications/Drugs (Outpatient/Part B)

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Accordingly, Vitamin B12 injections are not considered reasonable and necessary. Refer to the NCD for Vitamin B12

Injections to Strengthen Tendons, Ligaments, etc., of the Foot (150.6). (Accessed July 1, 2024)

Investigational or Experimental Drugs

Investigational or experimental drugs are not covered. Refer to the Medical Benefit Policy Manual, Chapter 15, §50.4.3 –

Examples of Not Reasonable and Necessary. (Accessed July 1, 2024)

Placebos

Placebos are not covered.

Outpatient Prescription Drugs

Outpatient prescription drugs are not covered except those medications/drugs covered under the Member’s Part D

Prescription Drug Plan benefit.

Refer to the Member’s Pharmacy Program booklet or contact the Prescription Solutions Customer Services Department to

determine coverage eligibility for Part D Prescription Drug benefit.

Medications for the Treatment of Sexual Dysfunction

Medications for the treatment of sexual dysfunction including erectile dysfunction, impotence, anorgasmy, or

hypoorgasmy are not covered.

Erectile dysfunction (ED) drugs will meet the definition of a Part D drug when prescribed for medically accepted

indications approved by the FDA other than sexual or erectile dysfunction (such as pulmonary hypertension). However,

ED drugs will not meet the definition of a Part D drug when used off-label, even when the off label use is listed in one of

the compendia found in section 1927(g)(1)(B)(i) of the Act: American Hospital Formulary Service Drug Information, United

States Pharmacopeia-Drug Information (or its successor publications), and DRUGDEX

Information System.

Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.1 – Excluded Categories

(Accessed July 1, 2024)

Medications for Elective Enhancement

Medications for elective enhancement, such as those used for weight loss, hair growth, sexual performance, athletic

performance, cosmetic purposes, anti-aging, and mental performance are not covered. Refer to the Coverage Summary

titled Cosmetic and Reconstructive Procedures

Drugs Included in the CMS Self-Administered Drug Exclusion List

Drugs included in the CMS Self-Administered Drug Exclusion List are not covered.

Notes:

• Self-Administered Drug (SAD) Exclusion List Report: Local Contractors have Self-Administered drugs exclusion

lists. Compliance with these lists is required where applicable. Refer to the Medicare Coverage Database

(Accessed July 1, 2024)

PCSK9 Inhibitors: PCSK9 Inhibitors, i.e., Praluent

™

(alirocumab) and Repatha

™

(evolocumab) are considered self-

Administered drugs and are not covered under the Part B medical benefit. Refer to the Member’s Pharmacy Program

booklet or contact the Prescription Solutions Customer Service Department to determine coverage eligibility for these

drugs under the Part D Prescription Drug benefit.

Off-Label/Unlabeled Drug Use

Off-Label/unlabeled drug use is not covered unless criteria are met. Refer to the Unlabeled Use of a Part B Drug section

for coverage criteria and guidelines.

Review at Launch (RAL)

A pre-service organization determination is highly recommended for certain Part B medications (as defined above):

That are new to the market; and

That have not yet undergone review by UnitedHealthcare; and

For which a utilization management strategy has not been established.

Medications/Drugs (Outpatient/Part B)

Page 10 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

These medications, referred to herein as RAL medications, are identified in the Other Examples of Specific

Drugs/Medications table. Upon receipt of a pre-service organization determination, RAL medications will be reviewed

against National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs). In the absence of an NCD,

LCD or clear Medicare guidance, medical necessity reviews will be conducted using the following:

A UnitedHealthcare Pharmacy and Therapeutics approved medical drug policy; or

All of the following:

o Food and Drug Administration (FDA) approved labeling, including but not limited to indication, patient age

requirements, dosing recommendations, contraindications, and clinical trial inclusion criteria (ex. genetic testing,

comorbid conditions); and

o Compendia (if available); and

o Current standard of care, as per evidenced based literature (if available).

Providers are strongly encouraged to seek a pre-service organization determination for any RAL medication that has been

identified in the Other Examples of Specific Drugs/Medications

table. This will help to avoid gaps in coverage in the event

that a prior authorization program becomes effective at a later date. If a provider believes an item or service may not be

covered, or could only be covered under specific conditions, the appropriate process is to request a pre-service

organization determination.

Step Therapy Program

Certain classes of medical benefit injectables covered under Medicare Part B will include preferred and non-preferred

therapies. Non-preferred therapies will generally require history of use of a preferred therapy among other criteria. This

step therapy requirement will apply to some, but not all, Medicare Advantage Plans.

A medical injectable is subject to step therapy when it is listed in the Other Examples of Specific Drugs/Medications

table

and a notation to refer to the UnitedHealthcare Medicare Advantage Drug Policy titled: Medicare Part B Step Therapy

Programs is provided in the Step Therapy column.

Maximum Dosage and Frequency

Provides information about the maximum dosage per administration and dosing frequency for certain medications

Administered by a medical professional. Most medications have a maximum dosage and frequency based upon body

surface area or patient weight or a set maximal dosage and frequency independent of patient body size.

A medication is subject to maximum dosage and frequency when it is listed in the

Other Examples of Specific

Drugs/Medications table and a notation to refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy titled

Maximum Dosage and Frequency is provided in the Maximum Dosage and Frequency column.

Note: Any LCD/LCA maximum dosage and frequency criteria would be applicable, if available.

Other Specific Medications (Not Listed Above)

For Oncology Medications

Check for available NCDs, LCDs or LCAs at https://www.cms.gov/medicare-coverage-database/new-

search/search.aspx. If there are no applicable NCDs, LCDs or LCAs found, refer to Supporting Information table

within this Coverage Summary.

Also refer to the Medicare Benefit Policy Manual, Chapter 15, §50.4 Reasonableness and Necessity.

o For any off label drug or biological with a NCCN Category 2B indication refer to the UnitedHealthcare Commercial

Medical Benefit Drug Policy titled Oncology Medication Clinical Coverage

For Non-Oncologic Medications

Check for available NCDs, LCDs or LCAs at https://www.cms.gov/medicare-coverage-database/new-

search/search.aspx. If there are no applicable NCDs, LCDs or LCAs found, refer to Supporting Information table

within this Coverage Summary.

For all other drugs or biologicals (non-oncologic) not listed in this Coverage Summary, for which there are no

applicable NCDs, LCDs or LCAs, refer to the relevant UnitedHealthcare Commercial Medical Benefit Drug Policy. If

there is no UnitedHealthcare Commercial Drug Policy, then use the compendia and evidence-based medical literature

for coverage guidance.

o For available UnitedHealthcare Commercial Medical Benefit Drug Policies, refer to

https://www.uhcprovider.com/en/policies-protocols/commercial-policies/commercial-medical-drug-policies.html

(Accessed July 1, 2024)

Medications/Drugs (Outpatient/Part B)

Page 11 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Definitions

FDA Approved Drug: A drug that has received final marketing approval by the Food and Drug Administration (FDA) and

as a part of its labeling contains its recommended uses and dosages as well as adverse reactions and recommended

precautions in using it. Medicare Benefit Policy Manual, Chapter 15, §50.4.1 – Approved Use of Drug

Homebound: An individual shall be considered “confined to the home” (Homebound) if the following two criteria are met:

The patient must either:

o Because of illness or injury, need the aid of supportive devices such as crutches, canes, wheelchairs, and

walkers; the use of special transportation; or the assistance of another person in order to leave their place of

residence, or

o Have a condition such that leaving his or her home is medically contraindicated.

If the patient meets one of the conditions above, then the patient must also meet two additional requirements defined

below.

o There must exist a normal inability to leave home, and

o Leaving home must require a considerable and taxing effort.

If the patient does in fact leave the home, the patient may nevertheless be considered Homebound if the absences from

the home are infrequent or for periods of relatively short duration or are attributable to the need to receive health care

treatment.

Any other absence of an individual from the home shall not so disqualify an individual if the absence is of infrequent or of

relatively short duration. For purposes of the preceding sentence, any absence for the purpose of attending a religious

service shall be deemed to be an absence of infrequent or short duration.

Medicare Benefit Policy Manual, Chapter 15,

§60.4.1 – Definition of Homebound Patient Under the Medicare Home Health (HH) Benefit.

Not Usually Self-Administered By the Patient (as defined by Medicare):

Administered: The term “Administered” refers only to the physical process by which the drug enters the patient's

body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper

technique or side-effects of the drug). Injectable drugs (including intravenous drugs) are typically eligible for inclusion

under the “incident to” benefit. With limited exclusions, other routes of administration including, but not limited to, oral

drugs, suppositories, topical medications are all considered to be Usually Self-Administered By the patient.

Usually: For the purposes of applying this exclusion, the term "Usually" means more than 50 percent of the time for

all Medicare beneficiaries who use the drug. Therefore, if a drug is Self-Administered by more than 50 percent of

Medicare beneficiaries, the drug is excluded from coverage and you may not make any Medicare payment for it.

By the Patient: The term "By the Patient" means Medicare beneficiaries as a collective whole. Include only the

patients themselves and not other individuals (which do not include spouses, friends, or other caregivers).

Medicare

Benefit Policy Manual, Chapter 15, §50.2 – Determining Self-Administration of Drug or Biological.

Unlabeled Use of Drug: A use that is not included as an indication of the drug’s label as approved by FDA.

Medicare

Benefit Policy Manual, Chapter 15, §50.4.2 – Unlabeled Use of Drug. (Accessed July 1, 2024)

Supporting Information

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Aduhelm

™

(aducanumab-avwa)

NCD for Monoclonal

Antibodies Directed

Against Amyloid for the

Treatment of

Alzheimer's Disease

(AD) 200.3

For payment rules for

NCDs requiring CED,

Not Applicable

(N/A)

Medications/Drugs (Outpatient/Part B)

Page 12 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Aduhelm

™

(aducanumab-avwa)

refer to the Medicare

Managed Care Manual,

Chapter 4, §10.7.3 –

Payment for Clinical

Studies Approved Under

Coverage with Evidence

Development (CED)

Not Applicable

(N/A)

Adzynma

(ADAMTS13,

recombinant-krhn)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Adzynma

(ADAMTS13,

Recombinant-Krhn)

No No No

Amvuttra

™

(vutrisiran)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

RNA-Targeted

Therapies

(Amvuttra

and

Onpattro

)

No No

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Antiemetics (oral) for

Oncology -

Neurokinin 1

Receptor Antagonist

(NK1 RA),

5-hydroxytrypta-mine

Receptor Antagonist

(5HT3 RA), NK1

RA/5HT3 RA

combination

Akynzeo

(netupitant and

palono-setron)

capsule

Emend

(aprepitant)

capsule

• Kytril

(granisetron)

tablets

• Varubi

(rolapitant) tablet

• Zuplenz, Zofran

ODT

, and

Zofran

(ondanset-ron)

tablets

Medicare Benefit Policy

Manual, Chapter 15,

§50.5.4 – Oral Anti-

Nausea (Anti Emetic)

Drugs

DME MAC L33827

N/A

Medications/Drugs (Outpatient/Part B)

Page 13 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Antiemetics

(injectable) for

Oncology -

Neurokinin 1

Receptor Antagonist

(NK1 RA),

5-hydroxytrypta-mine

Receptor Antagonist

(5HT3 RA), NK1

RA/5HT3 RA

combination

Akynzeo

(netupitant and

palonosetron)

injection

Aloxi

(palonosetron

hydrochlor-ide)

injection

Cinvanti

(aprepitant)

injectable

emulsion

Emend

(fosaprepitan)

injection

• Kytril

(granisetron)

injection

Sustol

(granisetron)

injection

• Zuplenz, Zofran

ODT

, and

Zofran

(ondansetron)

injection

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Antiemetics for

Oncology

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Adakveo

(crizanlizumab-tmca)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Adakveo

(Crizanlizumab-

Tmca)

No No No

Beqvez

(fidanacogene

elaparvovec-dzkt)

None UnitedHealthcare

Commercial

Medical Drug

Policy titled

Gene

Therapies for

Hemophilia B

Yes

Refer to

Review at

Launch

(RAL)

No No

Medications/Drugs (Outpatient/Part B)

Page 14 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Bevacizumab

Alymsys

(bevacizumab-

maly)

Avastin

(bevacizu-mab)

Mvasi

(bevacizumab-

Awwb)

Vegzelma

(bevacizumab-

adcd)

Zirabev

(bevacizumab-

bvzr) – Oncology

Use Only

NGS

L33394 (A52370)

UnitedHealthcare

Commercial

Medical Drug

Policy titled

Oncology

Medication Clinical

Coverage

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Botulinum toxin

Botox

(onabotulinum-

toxinA)

Daxxify

(daxibotulinum-

toxinA-lanm)

Dysport

(abobotulinum-

toxinA)

Myobloc

(rimabotulinum-

toxinB)

Xeomin

(incobotulinum-

toxinA)

CGS

L33949 (A56472)

First Coast

L33274

(A57715)

NGS

L33646

(A52848)

Noridian

L35170

(A57185)

L35172 (A57186)

Novitas

L38809

(A58423)

Palmetto

L33458

(A56646)

WPS*

L34635

(A57474)

Note: Local Coverage

Determinations

(LCDs)/Local Coverage

Articles (LCAs) exist and

compliance with these

policies is required

where applicable

All states/territories

have LCDs/LCAs

Briumvi

™

(ublituximab-xiiy)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Briumvi

(Ublituximab-Xiiy)

No No No

Medications/Drugs (Outpatient/Part B)

Page 15 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

CAR-T Cellular

Therapy

Abecma

(idecaptagene

cicleucel)

Breyanzi

(lisocabtagene

maraluecel)

Carvykti

™

(ciltacabtagene

autoleucel)

Kymriah

(tisagenlecleucel)

Tecartus

(brexucabtagene

autoleucel)

Yescarta

(axicabtagene

ciloleucel)

None

Optum Clinical

Guidelines titled

Chimeric Antigen

Receptor T-cell

Therapy

Cellular Therapy

Amtagvi

™

(lifeucel)

None

Optum Clinical

Guidelines titled

Tumor-Infiltrating

Lymphocyte (TIL)

Cell Therapy

Colony stimulating

factors

Short acting

Granix

(tbo-

filgrastim)

Neupogen

(filgrastim)

Nivestym

(filgrastim-aafi)

Releuko

(filgrastim-ayow)

Zarxio

(filgrastim-sndz)

Long acting

Fulphila

(pegfilgrastim-

jmdb)

Fylnetra

(pegfilgrastim-

pbbk)

Neulasta

(pegfilgrastim)

Nyvepria

™

(pegfilgrastim-

apgf)

Rolvedon

™

(eflapegrastim-

xnst)

Palmetto

L37176

(A56748)

(A54682)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

White Blood Cell

Colony Stimulating

Factors

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Medications/Drugs (Outpatient/Part B)

Page 16 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Stimufend

(pegfilgrastim-

fpgk)

Udenyca

(pegfilgrastim-

cbqv)

Ziextenzo

(pegfilgrastim-

bmez)

Palmetto

L37176

(A56748)

(A54682)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

White Blood Cell

Colony Stimulating

Factors

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Cosentyx

(secukinumab)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Cosentyx

(Secukinumab)

No No No

Crysvita

(burosumab-twza)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Crysvita

(Burosumab-Twza)

Denosumab

• Xgeva

• Prolia

NGS

L33394 (A52399)

(A52855)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Denosumab

(Prolia

& Xgeva

)

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Elevidys

(delandistrogene

moxeparvovec-rokl)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Elevidys

™

(Delandistrogene

Moxparvovec-Rokl)

No No No

Enjaymo

™

(sutimlimab-jome)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Enjaymo

(Sutimlimab-Jome)

No No No

Medications/Drugs (Outpatient/Part B)

Page 17 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Evenity

(Romosozumab-

Aqqg)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Evenity

(Romosozumab-

Aqqg)

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Entyvio

(vedolizumab)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Entyvio

(Vedolizumab)

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Erythropoietin for

Cancer Related

Conditions

NCD for Erythropoiesis

Stimulating Agents

(ESAs) in Cancer and

Related Neoplastic

Conditions (110.21)

Note: Local Coverage

Determinations

(LCDs)/Local Coverage

Articles (LCAs) exist and

compliance with these

policies is required where

applicable. These

LCDs/LCAs are available

https://www.cms.gov/me

dicare-coverage-

database/new-

search/search.aspx.

N/A No No

Erythropoietin for

Non-cancer Related

Conditions

CGS

L34356 (A56462)

Palmetto

L39237

(A58982)

WPS*

L34633

(A56795)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Erythropoiesis-

Stimulating Agents

Medications/Drugs (Outpatient/Part B)

Page 18 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Evkeeza

(Evinacumab-Dgnb)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Evkeeza

(Evinacumab-

Dgnb)

Gemcitabine

Infugem

™

(gemcitabine)

None

UnitedHealthcare

Commercial

Medical Drug

Policy titled

Oncology

Medication Clinical

Coverage

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Gene Therapy (ex

vivo)

Casgevy

™

(exagamglogene

autotemcel)

Lenmeldy

™

(atidarsagene

autotemcel)

Lyfgenia

™

(lovotibeglogene

autotemcel)

Skysona

(elivaldogene

autotemcel)

Zynteglo

(betibeglogene

autotemcel)

None

Optum Clinical

Guidelines titled

Gene Therapy

No No No

Givlaari

(givosiran)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Givlaari

(Givosiran)

Gonadotropin

Releasing Hormone

Analogs

Leuprolide

Acetate

NGS

L33394 (A52453)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Gonadotropin

Releasing

Hormone Analogs

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Medications/Drugs (Outpatient/Part B)

Page 19 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Hemgenix

(etranacogene

dezaparvovec-drlb)

None

UnitedHealthcare

Commercial

Medical Drug

Policy titled

Gene

Therapies for

Hemophilia B

Infliximab

Avsola

™

(infliximab-axxq)

Inflectra

(infliximab-dyyb)

Infliximab

Remicade

(infliximab)

Renflexis

(infliximab-abda)

Zymfentra

™

(infliximab-dyyb)

NGS

L33394

(A52423)

Palmetto

L35677

(A56432)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Infliximab (Avsola

Inflectra

Remicade

, &

Renflexis

)

No Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Intravenous Immune

Globulin (IVIG)

Refer to the Intravenous

Immune Globulin (IVIG)

table

N/A

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Intravenous iron

therapy for dialysis

patients

NCD for Intravenous

Iron Therapy (110.10)

N/A

Intravenous iron

therapy for non-

dialysis patients

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Intravenous Iron

Replacement

Therapy

(Feraheme

Injectafer

, &

Monoferric

)

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Medications/Drugs (Outpatient/Part B)

Page 20 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Intravitreal vascular

endothelial growth

factor (VEGF)

inhibitors

Cimerli

™

(ranibizumab-

eqrn)

Compounded

Avastin

(bevacizu-mab)

Lucentis

(ranibizumab)

Eylea

(aflibercept)

Eylea

(aflibercept)

Beovu

(brolucizumab-

dbll)

• Byooviz

™

(ranibizumab-

nuna),

• Susvimo

™

(ranibizumab

injection)

• Vabysmo

™

(faricimab-svoa)

NGS

L33394

(A52370, A52451)

Noridian

A53008, A53009

Palmetto

A53387

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Ophthalmologic

Policy: Vascular

Endothelial Growth

Factor (VEGF)

Inhibitors

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Izervay

™

(avacincaptad pegol

intravitreal solution)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Ophthalmologic

Complement

Inhibitors

Kisunla

™

(donanemab-azbt)

NCD for Monoclonal

Antibodies Directed

Against Amyloid for the

Treatment of

Alzheimer's Disease

(AD) 200.3

For payment rules for

NCDs requiring CED,

refer to the

Medicare

Managed Care Manual,

Chapter 4, §10.7.3 –

Payment for Clinical

Studies Approved Under

Coverage with Evidence

Development (CED)

N/A

Yes

Refer to

Review at

Launch

(RAL)

Medications/Drugs (Outpatient/Part B)

Page 21 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Krystexxa

(Pegloticase)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Krystexxa

(Pegloticase)

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical Benefit

Drug Policy titled

Maximum

Dosage and

Frequency

Lantidra

™

(donislecel)

None

Optum Clinical

Guidelines titled

Solid Organ

Transplantation

No No No

Leqembi

™

(lecanemab)

NCD for Monoclonal

Antibodies Directed

Against Amyloid for the

Treatment of

Alzheimer's Disease

(AD) (200.3)

For payment rules for

NCDs requiring CED,

refer to the

Medicare

Managed Care Manual,

Chapter 4, §10.7.3 –

Payment for Clinical

Studies Approved Under

Coverage with Evidence

Development (CED)

N/A

Leqvio

(inclisiran) None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Leqvio

(Inclisiran)

No Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Medications/Drugs (Outpatient/Part B)

Page 22 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Leucovorin/

Levoleucovorin

Fusilev

(levoleuco-vorin)

Khapzory

™

(levoleuco-vorin)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Oncology

Medication Clinical

Coverage

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Luxturna

™

(voretigene

neparvovec-rzyl)

Palmetto

L37863 (A56419)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Luxturna

(Voretigene

Neparvovec-Rzyl)

No No No

Ocrevus

(ocrelizumab)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Ocrevus

(Ocrelizumab)

No No No

Omvoh

™

(mirikizumab-mrkz)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Omvoh

™

(Mirikizumab-mrkz)

Onpattro

(patisiran) None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

RNA-Targeted

Therapies

(Amvuttra

and

Onpattro

)

No No

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Orencia

(abatacept)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Orencia

(Abatacept)

Injection for

Intravenous

Infusion

No No

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Medications/Drugs (Outpatient/Part B)

Page 23 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Oxlumo

™

(lumasiran)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Oxlumo

(Lumasiran) and

Rivfloza

™

(Nedosiran)

Primacor

(milrinone)

– use in home

setting

Note: There are

safety and efficacy

issue regarding the

use of Milrinone in

the home setting.

Read the LCDs/

LCAs before

authorizing.

DME MAC LCD for

External Infusion

Pumps

L33794

All states/territories

have LCDs/LCAs

No No No

Qalsody

™

(tofersen)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Qalsody

(Tofersen)

No No Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Radicava

(edaravone)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Radicava

(Edaravone)

Rituximab

Riabni

™

(rituximab-aarx)

Rituxan

(rituximab)

Ruxience

(rituximab-pvvr)

Truxima

(rituximab-abbs)

for non-chemo-

therapeutic

indications

CGS

L38920

(A58582)

L38268

(A57160)

NGS

L39297

(A59101)

Palmetto

L35026

(A56380)

WPS*

A55639

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Rituximab

(Riabni

™

, Rituxan

Ruxience

, &

Truxima

)

No Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Medications/Drugs (Outpatient/Part B)

Page 24 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Rituximab

Riabni

™

(rituximab-aarx)

Rituxan

(rituximab)

Rituxan Hycela

(rituximab and

hyaluronic-dase)

Ruxience

(rituxi

mab-pvvr)

Truxima

(rituximab-abbs)

for chemo-

therapeutic

indications

NGS

L39297 (A59101)

Palmetto

L35026

(A56380)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Oncology

Medication Clinical

Coverage

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Rivfloza

™

(nedosiran) None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Oxlumo

(Lumasiran) and

Rivfloza

™

(Nedosiran)

No No No

Reblozyl

(luspatercept-aamt)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Reblozyl

(Luspatercept-

Aamt)

Roctavian

™

(valoctocogene

roxaparvovec-rvox)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Roctavian

™

(Valoctocogene

Roxaparvovec-

Rvox)

Ryplazim

(plasminogen,

human-tvmh)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Ryplazim

(Plasminogen,

Human-Tvmh)

No No No

Medications/Drugs (Outpatient/Part B)

Page 25 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Rystiggo

(rozanolixizumab-

noli)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Neonatal Fc

Receptor Blockers

(Vyvgart

, Vyvgart

Hytrulo, &

Rystiggo

)

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Saphnelo

™

(anifrolumab-fnia)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Saphnelo

(Anifrolumab-Fnia)

No Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Skyrizi

(Risankizumab-rzaa)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Skyrizi

(Risankizumab-

Rzaa)

No No No

Sodium hyaluronate

injections for

osteoarthritis of

knee

NGS

L33394 (A52420)

Palmetto

L39260

(A59030)

WPS*

L39529

NGS

L33394

(A52420)

Palmetto

L39260

(A59030)

WPS*

L39529

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Sodium

Hyaluronate

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Soliris

(eculizumab)

NGS

L33394 (A54548)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Complement

Inhibitors (Soliris

& Ultomiris

)

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Medications/Drugs (Outpatient/Part B)

Page 26 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Soliris

(eculizumab)

NGS

L33394 (A54548)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Complement

Inhibitors (Soliris

& Ultomiris

)

Dosage and

Frequency

Spevigo

(spesolimab-sbzo)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Spevigo

(Spesolimab-Sbzo)

No No

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Spinraza

(nusinersen)

Noridian

A58578,

A58579

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Spinraza

(Nusinersen)

Subcutaneous

Immune Globulin

(SCIG)

CGS

L33794 (A52507)

Noridian

L33794

(A52507)

WPS*

L34771

(A57554)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Immune Globulin

(IVIG and SCIG)

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Syfovre

™

(pegcetacoplan

injection)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Ophthalmologic

Complement

Inhibitors

No No

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Medications/Drugs (Outpatient/Part B)

Page 27 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Tepezza

(teprotumumab-trbw)

First Coast

L34007 (A57778)

Novitas

L35093

(A56786)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Tepezza

(Teprotumumab-

Trbw)

Teplizumab

• Tzield

™

(teplizumab-

mzwv)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Tzield

(Teplizumab-

Mzwv)

Testopel

(testosterone pellet)

(CPT code 11980

and HCPCS code

J3490)

Refer to the FDA

Warning

Letter/Notice for

Testopel

(testosterone pellet).

Noridian

L36569 (A57616)

L36538 (A57615)

Palmetto

L39086

(A58828)

UnitedHealthcare

Commercial Medical

Benefit Drug Policy

titled

Testosterone

Replacement or

Supplementation

Therapy

Tezspire

™

(tezepelumab-ekko)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Tezspire

(Tezepelumab-

Ekko)

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Trastuzumab

Herceptin

Hylecta

™

(trastuzumab and

hyaluronidase-

oysk)

Herceptin

(trastuzumab)

Herzuma

(trastuzumab-

pkrb)

Kanjinti

(trastuzumab-

anns)

Ogivri

(trastuzumab-

dkst)

First Coast

L34026

(A56660)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Oncology

Medication Clinical

Coverage

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Medications/Drugs (Outpatient/Part B)

Page 28 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Ontruzant

(trastuzumab-

dttb)

Trazimera

(trastuzumab-

qyyp)

First Coast

L34026 (A56660)

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Oncology

Medication Clinical

Coverage

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Ultomiris

(ravulizumab)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Complement

Inhibitors (Soliris

& Ultomiris

)

No No Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Uplizna

(inebilizumab-cdon)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Uplizna

(Inebilizumab-

Cdon)

Vyjuvek

™

(beremagene

geperpavec-svdt)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Vyjuvek

(Beramagene

Geperpavec-Svdt)

Vyepti

(Eptinezumab- Jjmr)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Vyepti

(Eptinezumab-

Jjmr)

Yes

Refer to the

United-

Healthcare

Medicare

Advantage

Drug Policy

titled

Medicare

Part B Step

Therapy

Programs

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Medications/Drugs (Outpatient/Part B)

Page 29 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Other Examples of Specific Drugs/Medications

Accessed July 1, 2024

*Also refer to the MACs with corresponding States/Territories.

Drug/

Medication

NCD, Medicare

Manual, LCDs/LCAs*

Default Policy for

States Without

LCDs/LCAs

Review at

Launch

(RAL)

Step

Therapy

Maximum

Dosage and

Frequency*

Vyvgart

™

(efgartigimod)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Neonatal Fc

Receptor Blockers

(Vyvgart

Vyvgart

Hytrulo, &

Rystiggo

)

Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Vyvgart

Hytrulo

(efgartigimod alfa

and hyaluronidase-

qvfc)

None UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Neonatal Fc

Receptor Blockers

(Vyvgart

, Vyvgart

Hytrulo, &

Rystiggo

)

No Yes

Refer to the

United-

Healthcare

Commercial

Medical

Benefit Drug

Policy titled

Maximum

Dosage and

Frequency

Zolgensma

(onasemnogene

abeparvovec-xioi)

None

UnitedHealthcare

Commercial

Medical Benefit

Drug Policy titled

Zolgensma

(Onasemnogene

Abeparvovec-Xioi)

Back to Guidelines

Medicare Administrative Contractors (MACs) with Corresponding States/Territories

MACs

States/Territories

CGS

KY, OH

First Coast

FL, PR, VI

NGS

CT, IL, MA, ME, MN, NH, NY, RI, VT, WI

Noridian

AK, AS, AZ, CA, GU, HI, ID, MT, ND, NV, Northern

Mariana Islands, OR, SD, UT, WA, WY

Novitas AR, AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX

Palmetto AL, GA, NC, SC, TN, VA, WV

WPS* IA, IN, KS, MI, MO, NE

Note

: Wisconsin Physicians Service Insurance Corporation Contract Number 05901 - applies only to WPS Legacy

Mutual of Omaha MAC A Providers

DME MACs

States/Territories

CGS (17013)

IL, IN, KY, MI, MN, OH, WI

CGS (18003)

AL, AR, CO, FL, GA, LA, MS, NC, NM, OK, PR, SC, TN,

TX, VA, VI, WV

Noridian (16013) CT, DC, DE, MA, MD, ME, NH, NJ, NY, PA, RI, VT

Medications/Drugs (Outpatient/Part B)

Page 30 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Medicare Administrative Contractors (MACs) with Corresponding States/Territories

DME MACs

States/Territories

Noridian (19003)

AK, AS, AZ, CA, GU, HI, IA, ID, KS, MO, MP, MT, ND,

NE, NV, OR, SD, UT, WA, WY

Back to Guidelines

Intravenous Immune Globulin (IVIG)

Accessed July 1, 2024

LCD/LCA ID LCD/LCA Title Contractor Type Contractor Name

Applicable

States/Territories

L35891

(A56779)

Intravenous Immune

Globulin

Part A and B MAC

CGS Administrators,

LLC

KY, OH

L34007

(A57778)

Immune Globulin

Part A and B MAC

First Coast Service

Options, Inc.

Fl, PR, VI

L39314

(A59105)

Off-Label Use of

Intravenous Immune

Globulin (IVIG)

Part A and B MAC

National Government

Services, Inc.

CT, IL, MA, ME MN, NH, NY,

RI, VT, WI

L34074

(A57194)

Immune Globulin

Intravenous (IVIg)

Part A and B MAC

Noridian Healthcare

Solutions, LLC

AK, AZ, ID, MT, ND, OR, SD,

UT, WA, WY

L34314

(A57187)

Immune Globulin

Intravenous (IVIg)

Part A and B MAC

Noridian Healthcare

Solutions, LLC

CA, AS, GU, HI, MP, NV

L35093

(A56786)

Immune Globulin

Part A and B MAC

Novitas Solutions, Inc.

CO, NM, OK, TX, AR, LA, MS,

DE, DC, MD, NJ, PA

L34580

(A56718)

Intravenous

Immunoglobulin (IVIG)

Part A and B MAC

Palmetto GBA

AL, GA, NC, SC, TN, VA, WV

L34771

(A57554)

Immune Globulins

Part A and B MAC

*Wisconsin Physicians

Service Insurance

Corporation

IA, IN, KS, MI, MO, NE

L33610

(A52509)

Intravenous Immune

Globulin

DME MAC

Noridian Healthcare

Solutions, LLC (16013)

CT, DC, DE, MA, MD, ME,

NH, NJ, NY, PA, RI, VT

CGS Administrators,

LLC (18003)

AL, AR, CO, FL, GA, LA, MS,

NC, NM, OK, PR, SC, TN, TX,

VA, VI, WV

Noridian Healthcare

Solutions, LLC (19003)

AK, AS, AZ, CA, GU, HI, IA,

ID, KS, MO, MT, ND, NE, MP,

NV, OR, SD, UT, WA, WY

CGS Administrators

(17013)

IL, IN, KY, MI, MN, OH, WI

Back to Guidelines

Policy History/Revision Information

Date

Summary of Changes

08/01/2024

Coverage Guidelines

Other Specific Medications

For Oncology Medications

Added reference link to the Medicare Benefit Policy Manual, Chapter 15, §50.4:

Reasonableness and Necessity

For Non-Oncologic Medications

Replaced instruction to “refer to the relevant UnitedHealthcare Commercial Medical Benefit

Drug Policy for all other drugs or biologicals not listed in this Medicare Advantage Coverage

Summary, for which there are no applicable National Coverage Determinations (NCDs), Local

Coverage Determinations (LCDs), or Local Coverage Articles (LCAs)” with “refer to the relevant

Medications/Drugs (Outpatient/Part B)

Page 31 of 31

UnitedHealthcare Medicare Advantage Coverage Summary

Effective 08/01/2024

Date

Summary of Changes

UnitedHealthcare Commercial Medical Benefit Drug Policy for all other drugs or biologicals

(non-oncologic) not listed in this Medicare Advantage Coverage Summary, for which there are

no applicable NCDs, LCDs, or LCAs”

Other Examples of Specific Drugs/Medications

Added coverage guidelines for Kisunla

™

(donanemab-azbt) to indicate a pre-service review

[Review at Launch (RAL)] is required

Revised coverage guidelines for Beqvez (fidanacogene elaparvovec-dzkt); added instruction to

refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy titled Gene Therapies for

Hemophilia B

Supporting Information

Updated list of applicable LCDs/LCAs to reflect the most current information

Administrative

Archived previous policy version MCS057.31

Instructions for Use

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and

unauthorized copying, use, and distribution are prohibited. This information is intended to serve only as a general

reference resource and is not intended to address every aspect of a clinical situation. Physicians and patients should not

rely on this information in making health care decisions. Physicians and patients must exercise their independent clinical

discretion and judgment in determining care. Each benefit plan contains its own specific provisions for coverage,

limitations, and exclusions as stated in the Member’s Evidence of Coverage (EOC)/Summary of Benefits (SB). If there is a

discrepancy between this policy and the member’s EOC/SB, the member’s EOC/SB provision will govern. The information

contained in this document is believed to be current as of the date noted.

The benefit information in this Coverage Summary is based on existing national coverage policy; however, Local

Coverage Determinations (LCDs) may exist and compliance with these policies are required where applicable.

UnitedHealthcare follows Medicare coverage guidelines found in statutes, regulations, NCDs, and LCDs to determine

coverage. The clinical coverage criteria governing the items or services in this coverage summary have not been fully

established in applicable Medicare guidelines because there is an absence of any applicable Medicare statutes,

regulations, NCDs, or LCDs setting forth coverage criteria and/or the applicable NCDs or LCDs include flexibility that

explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD. As a

result, UnitedHealthcare applies internal coverage criteria in the UnitedHealthcare commercial policies referenced in this

coverage summary. The coverage criteria in these commercial policies was developed through an evaluation of the

current relevant clinical evidence in acceptable clinical literature and/or widely used treatment guidelines.

UnitedHealthcare evaluated the evidence to determine whether it was of sufficient quality to support a finding that the

items or services discussed in the policy might, under certain circumstances, be reasonable and necessary for the

diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CPT

is a registered trademark of the American Medical Association.