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Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Rules and Regulations
Therefore, we are soliciting public
comment on each of these issues for the
following information collection
requirements discussed below.
Section 447.299 Reporting
Requirements
Paragraph (c) of this Section requires
the States to submit to CMS information
for each DSH for the most recently-
completed fiscal year beginning with
the first full State fiscal year (SFY) after
the enactment of Section 1001(d) of the
MMA, which for all States will begin
with their respective SFY 2005 and each
subsequent SFY. This paragraph
presents the information to be
submitted.
The burden associated with this
requirement is the time and effort for
the States to prepare and submit the
required information. We estimate that
it will take each State approximately 30
minutes to prepare and submit the
information for each of its DSHs. On
average, each State has approximately
75 DSHs. Therefore, we estimate it will
take 38 hours per State to comply for a
total of 1,976 annual hours. The burden
for this requirement is currently
approved under OMB # 0938–0746 with
an expiration date of August 31, 2011.
Section 455.204 Condition for Federal
Financial Participation
In summary, this Section states what
information must be included in the
audit report and submitted to CMS.
The PRA exempts the information
collection activities referenced in this
Section. In particular, 5 CFR 1320.4
excludes collection activities during the
conduct of administrative actions,
investigations, or audits involving an
agency against specific individuals or
entities.
As required by Section 3504(h) of the
Paperwork Reduction Act of 1995, we
have submitted a copy of this final
regulation to OMB for its review of these
information collection requirements
described above.
If you comment on these information
collection and recordkeeping
requirements, please mail copies
directly to the following:
Centers for Medicare & Medicaid
Services, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attn.:
Melissa Musotto, CMS–2198–F, Room
C5–14–03, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Room 10235, New Executive
Office Building, Washington, DC 20503,
Attn.: Katherine T. Astrich, CMS Desk
Officer, CMS–2198–F,
(202) 395–6974.
VI. Regulatory Impact Analysis
We have examined the impact of this
rule as required by Executive Order
12866 (September 1993, Regulatory
Planning and Review), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), Section 1102(b)
of the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), and Executive Order 13132 on
Federalism, and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Order 12866, as amended,
directs agencies to asses all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts and equity).
A regulatory impact analysis (RIA) must
be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). This rule
does not reach the economic threshold
and thus is not considered a major rule.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations and government
agencies. Most hospitals and most other
providers and suppliers are small
entities, either by nonprofit status or by
having revenues of $7 million to $34.5
million in any 1 year. Individuals and
States are not included in the definition
of a small entity. We are not preparing
an analysis for the RFA because the
Secretary has determined and we certify
that this rule would not have a
significant economic impact on a
substantial number of small entities.
This rule will directly affect States.
In addition, Section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of Section 604 of the
RFA. For purposes of Section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a metropolitan statistical area and has
fewer than 100 beds. Therefore, the
Secretary has determined and we certify
that this final rule will not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act (UMRA) of 1995
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2008 that
threshold level is approximately $130
million. Since this rule would not
mandate spending on State, local, or
tribal governments in the aggregate, or
by the private sector of $130 million or
more in any 1 year, the requirements of
the UMRA are not applicable.
Based upon the parameters of this
rule and comments received, we do not
believe the costs incurred by States will
be significant. The final rule allows the
DSH audits to be part of a hospital’s
annual financial audit (for example, the
auditors would follow the DSH limit
protocol provided in the regulation),
which means a portion of the audit costs
could actually be borne by the hospitals
and not the States. Based upon
comments received, it appears that most
States want to incorporate the DSH
audit into the annual hospital financial
audits. If that is the case, the costs to the
hospital should be minimal as well
since the annual hospital financial audit
is already a requirement.
It is further unknown if any States
will contract with an independent
accounting firm to conduct the audit.
While there would be a contracting cost
to the State, it is unknown what that
cost would be and we believe it unlikely
that States will avail themselves of this
option. The final rule does allow for the
use of the Single State Auditor to
perform the DSH audit and if that is
done, CMS would match the State audit
costs at the 50 percent administrative
matching rate.
Regardless of the mechanism for
conducting the DSH audit, the auditor
will be using existing documentation
(for example, hospital cost reports,
hospital accounting records, and MMIS)
and apply the methodology provided by
this rule, which should result in
nominal costs.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs of State and local
governments, preempts State law, or
otherwise has Federalism implications.
Since this rule would not impose any
costs on State or local governments,
preempt State law, or otherwise have
Federalism implications, the
requirements of E.O. 13132 are not
applicable.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
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