Revisit User Fee Program for Medicare Survey and Certification Activities, 3405-3409 [E8-895]
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Federal Register / Vol. 73, No. 13 / Friday, January 18, 2008 / Rules and Regulations
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[FR Doc. E8–803 Filed 1–17–08; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 488
[CMS–2278–IFC3]
RIN 0938–AP22
Revisit User Fee Program for Medicare
Survey and Certification Activities
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
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AGENCY:
SUMMARY: This interim final rule with
comment period implements the
continuation of the revisit user fee
program for Medicare Survey and
Certification activities, in accordance
with the statutory authority in the
Continuing Appropriations Resolution
entitled, ‘‘Making further continuing
appropriations for the fiscal year 2008,
and for all other purposes,’’ Public Law
110–137 (‘‘Continuing Resolution’’)
passed by the Congress and signed by
the President on December 14, 2007. On
September 19, 2007, we published a
final rule that established a system of
revisit user fees applicable to health
care facilities that have been cited for
deficiencies during initial certification,
recertification or substantiated
complaint surveys and require a revisit
to confirm that previously-identified
deficiencies have been corrected.
DATES: Effective date: These regulations
are effective January 18, 2008, and
applicable beginning December 14,
2007.
Comment date: To be assured
consideration, comments must be
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received at one of the addresses
provided below, no later than 5 p.m. on
March 18, 2008.
ADDRESSES: In commenting, please refer
to file code CMS–2278–IFC3. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–2278–
IFC3, P.O. Box 8010, Baltimore, MD
21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments (one
original and two copies) to the following
address only: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–2278-IFC3, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
PO 00000
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Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850. (Because access to the
interior of the HHH Building is not
readily available to persons without
Federal Government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Kelley Tinsley, (410) 786–6664.
SUPPLEMENTARY INFORMATION:
Submitting Comments: As the public
was provided an opportunity to
comment on the substance of the rule
during the comment period prior to the
publication of the September 19, 2007
final rule, and as the substance of the
rule is not changed by this interim final
rule with comment period, we are
accepting comments only to the extent
that they pertain to the applicability of
the new authority for the rule. You can
assist us by referencing the file code
CMS–2278–IFC3.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://www.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
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Regulations’’ on that Web site to view
public comments.
Comments received timely will be
available for public inspection as they
are received, generally beginning
approximately three weeks after
publication of a document, at the
headquarters of the Centers for Medicare
& Medicaid Services, 7500 Security
Boulevard, Baltimore, Maryland 21244,
Monday through Friday of each week
from 8:30 a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
SUPPLEMENTARY INFORMATION:
I. Background
In the June 29, 2007 Federal Register
(72 FR 35673), we published the
proposed rule entitled, ‘‘Establishment
of Revisit User Fee Program for
Medicare Survey and Certification
Activities’’ and provided for a 60-day
comment period. In the September 19,
2007 Federal Register (72 FR 53628) we
published the Revisit User Fee Program
final rule. That final rule set forth final
requirements and a final fee schedule
for providers and suppliers who require
a revisit survey as a result of
deficiencies cited during an initial
certification, recertification, or
substantiated complaint survey.
The Centers for Medicare & Medicaid
Services (CMS) has in place an
outcome-oriented survey process that is
designed to ensure that existing
Medicare-certified providers and
suppliers or providers and suppliers
seeking initial Medicare certification,
meet statutory and regulatory
requirements, conditions of
participation, or conditions for
coverage. These health and safety
requirements apply to the environments
of care and the delivery of services to
residents or patients served by these
facilities and agencies. The Secretary of
the Department of Health and Human
Services (HHS) has designated CMS to
enforce the conditions of participation/
coverage and other requirements of the
Medicare program. The revisit user fee
will be assessed for revisits conducted
in order to determine whether
deficiencies cited as a result of failing to
satisfy federal quality of care
requirements have been corrected.
Pursuant to the requirements of the
Continuing Appropriations Resolution
budget bill for fiscal year (FY) 2007, the
Secretary directed CMS to implement
the revisit user fees for FY 2007 for
certain providers and suppliers for
which a revisit was required to confirm
that previously-identified failures to
meet federal quality of care
requirements had been remedied. The
fees recover the costs associated with
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the Medicare Survey and Certification
program’s revisit surveys. The primary
purpose for implementing the revisit
user fees is to ensure the continuance of
CMS Survey and Certification quality
assurance activities that improve patient
care and safety. The fees became
effective upon publication September
19, 2007, when the final rule was
published.
as a new fee schedule notice is proposed
and published in final form.’’ (72 FR
53628). The current Continuing
Resolution continues the authority of
the FY 2007 Continuing Resolution from
December 14, 2007 through December
21, 2007. Accordingly, the revisit fees
will continue to be assessed for the
entire time period authorized by the
current Continuing Resolution.
II. Provisions of the Interim Final Rule
The current Continuing Resolution,
Public Law 110–137, amends Public
Law 110–16 Division B by striking the
date specified in section 106(3) and
inserting ‘December 21, 2007’. The
current Continuing Resolution
authorizes HHS to continue to impose
revisit user fees until December 21,
2007, as follows:
III. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
always able to acknowledge or respond
to all of them individually. We will
consider all comments we receive by the
date and time specified in the DATES
section of this preamble, and, when we
proceed with a subsequent document,
we will respond to the comments in the
preamble to that document.
* * * Sec. 101. Such amounts as may be
necessary, at a rate for operations as provided
in the applicable appropriations Acts for
fiscal year 2007 and under the authority and
conditions provided in such Acts, for
continuing projects or activities (including
the costs of direct loans and loan guarantees)
that are not otherwise specifically provided
for in this joint resolution, that were
conducted in fiscal year 2007, and for which
appropriations, funds, or other authority
were made available in the following
appropriations Acts:
*
*
*
*
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(3) The Continuing Appropriations
Resolution, 2007 (division B of Pub. L. 109–
289, as amended by Pub. L. 110–5). (H.J. Res.
20, § 101 (2007)).
Sec. 106. Unless otherwise provided for in
this joint resolution or in the applicable
appropriations Act for fiscal year 2008,
appropriations and funds made available and
authority granted pursuant to this joint
resolution shall be available until whichever
of the following first occurs: * * *
(3) December 21, 2007.
As directed by the Secretary, in the
September 19, 2007 Federal Register (72
FR 53628), we established the revisit
user fee program for revisit surveys. We
put forth in regulation the relevant
definitions, criteria for determining the
fees, the fee schedule, procedures for
the collection of fees, the
reconsideration process, enforcement
and regulatory language addressing
enrollment and billing privileges, and
provider agreements. In the September
19, 2007 final rule, cost projections were
based on FY 2006 actual data and were
expected to amount to $37.3 million for
FY 2007. These calculations were
included in section IV of the final rule
(72 FR 53642).
We stated in the final rule that, ‘‘if
authority for the revisit user fee is
continued, we will use the current fee
schedule in [the final rule] for the
assessment of such fees until such time
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IV. Waiver of Proposed Rulemaking
and Delay in Effective Date
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule in accordance with 5
U.S.C. 553(b) of the Administrative
Procedure Act (APA). The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substance of the proposed
rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued. We find that the notice-andcomment procedure is unnecessary in
this circumstance because providers and
suppliers have already been provided
notice and an opportunity to comment
on the substance of this rule. This
interim final rule with comment merely
updates the Congressional authority
under which the rule operates.
Therefore, we find good cause to
waive the notice of proposed
rulemaking and to issue this final rule
on an interim basis. We are providing a
60-day public comment period.
We ordinarily provide a 30-day delay
in the effective date of the provisions of
a rule in accordance with the
Administrative Procedure Act (APA), 5
U.S.C. 553(d). However, the delay in the
effective date may be waived as, in
pertinent part, ‘‘provided by the agency
for good cause found and published
with the rule.’’ 5 U.S.C. 553(d)(3). The
Secretary finds that good cause exists to
waive the 30-day effective date delay.
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The good cause exception to the 30day effective date delay provision of
section 553(d) of the APA is read to be
broader than the good cause exception
to the notice and comment provision of
section 553(b) of the APA.
The legislative history of the APA
indicates that the purpose for deferring
the effectiveness of a rule under section
553(d) was to ‘‘afford persons affected a
reasonable time to prepare for the
effective date of a rule or rules or to take
other action which the issuance may
prompt.’’ S. Rep. No. 752, 79th Cong.,
1st Sess. 15 (1946); H.R. Rep. No. 1980,
79th Cong. 2d Sess. 25 (1946). In this
case, affected parties do not need time
to adjust their behavior before this rule
takes effect. This rule merely updates
the authority under which the revisit fee
is assessed and does not provide any
additional requirements for the affected
parties. Moreover, with or without a
revisit fee, a provider or supplier must
be found to have corrected significant
deficiencies in order to avoid
termination. Additionally, the
application of a fee for the revisit does
not place appreciable administrative
burdens on the affected providers or
suppliers. We do not expect appreciable
cost to State survey agencies because we
are undertaking the billing and
collection of the revisit user fee.
We identified in the September 19,
2007 final rule the immediacy of this
revisit user fee program and the specific
statutory requirement contained limited
in the Continuing Resolution that
required us to implement the revisit
user fee program in FY 2007.
Accordingly, providers and suppliers
have been on notice for some time that
these fees will be imposed, and do not
need additional time to be prepared to
comply with the requirements of this
regulation. We believe that given the
short timeframe that we have to collect
fees before the statutory authority of the
current Continuing Resolution expires,
there is good cause to waive the 30-day
effective date.
V. Collection of Information
Requirements
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This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
VI. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 (September 1993, Regulatory
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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.
Executive Order 12866 (as amended
by Executive Order 13258, which
merely reassigns responsibility of
duties) directs agencies to assess 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 one year).
This rule is not a major rule. The
aggregate costs will total approximately
$37.3 million in any one year.
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 small
governmental jurisdictions. Individuals
and States are not included in the
definition of a small entity. Small
businesses are small entities, either by
nonprofit status or by having revenues
of $6.5 million to $31.9 million or less
in any one year for purposes of the RFA.
The September 19, 2007 final rule
provided an analysis on the impact of
small entities (72 FR 53642–3). The
analysis published in the final rule
remains valid. Since this interim final
rule with comment merely updates the
Congressional authority under which
the rule operates, we have determined
that this rule will not have a significant
impact on small entities based on the
overall effect on revenues.
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 (superseded by Core
Based Statistical Areas) and has fewer
than 100 beds. This rule affects those
small rural hospitals that have been
cited for a deficiency based on
noncompliance with required
conditions of participation and for
which a revisit is needed to ensure that
the deficiency has been corrected. We
identified in the September 19, 2007
final rule that for the effective period of
that rule that less than 3 percent of all
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3407
hospitals may be assessed a revisit user
fee and that less than 1 percent of those
hospitals would be rural hospitals (72
FR 53643). The analysis published in
the final rule remains valid. Since this
interim final rule with comment merely
updates the Congressional authority
under which the rule operates, we
maintain that this rule will not have a
significant impact on small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any one year of $100 million in 1995
dollars, updated annually for inflation.
That threshold level is currently
approximately $120 million. This
interim final rule with comment will
have no mandated effect on State, local,
or tribal governments and the impact on
the private sector is estimated to be less
than $120 million and will only effect
those Medicare providers or suppliers
for which a revisit user fee is assessed
based on the need to conduct a revisit
survey to ensure deficient practices that
were cited have been corrected.
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 on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This interim final rule with comment
will not substantially affect State or
local governments. This rule establishes
user fees for providers and suppliers for
which CMS has identified deficient
practices and requires a revisit to assure
that corrections have been made.
Therefore, we have determined that this
interim final rule with comment will
not have a significant effect on the
rights, roles, and responsibilities of
State or local governments.
B. Impact on Providers/Suppliers
There is no change on the impact on
providers and suppliers with the
publication of this interim final rule
with comment. The impact remains as
discussed in the final rule (72 FR
53643).
Final Fee Schedule for Onsite and
Offsite Revisit Surveys
The FY 2007 fee schedule published
on September 19, 2007 (72 FR 53647) in
the final rule will be retained. As noted
in the final rule, the published fee
schedule will be used by CMS for the
assessment of fees until a new fee
schedule is proposed and published in
final form. The calculations used to
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determine the fee as identified in the
final rule will be the same (72 FR
53645–6). We will continue to assess a
flat fee based on provider or supplier
type and type of revisit survey
conducted. Table A below identifies the
final fee schedule.
TABLE A.—FINAL FEE SCHEDULE
Fee
assessed
per offsite
revisit
survey
Facility
SNF & NF .................
Hospitals ...................
HHA ..........................
Hospice .....................
ASC ..........................
RHC ..........................
ESRD ........................
Fee
assessed
per onsite
revisit
survey
$168
168
168
168
168
168
168
$2,072
2,554
1,613
1,736
1,669
851
1,490
Costs for All Revisit User Fees Assessed
We anticipated that the combined
costs for all providers and suppliers for
all revisit surveys in FY 2007 would
total approximately $37.3 million on an
annual basis, with onsite revisit surveys
amounting to approximately $34.6
million and offsite revisit surveys
totaling approximately $2.7 million. (72
FR 53645). However, actual fees
assessed in FY 2007 were much less
than this amount, since CMS did not
charge for revisits that occurred prior to
publication of the final regulation. Since
we continue to operate under this same
estimate for FY 07, we provide below
monthly estimates of the impact for the
period of the current Continuing
Resolution in Tables B and C. For the
period of the current Continuing
Resolution, we will use the FY 2007 fee
schedule established in the final rule for
the assessment of fees until a new fee
schedule notice is proposed and
published as final.
In Table B below, we provide the
projected costs for the period of this
current Continuing Resolution based on
the fee schedule of the final rule. We
expect the combined costs for all
providers and suppliers for all onsite
revisit surveys for the period of this
current Continuing Resolution to total
approximately $665,000. We first
multiplied the total number of onsite
revisit surveys in one year by the
expected revisit user fees assessed per
revisits as finalized in Table A above,
estimated by provider or supplier, to
obtain the annual cost of revisit surveys.
We then divided this number by 52 to
obtain the weekly cost per provider or
supplier of onsite revisit surveys to
obtain the total costs for onsite revisit
surveys for the period of the current
Continuing Resolution (roughly 1 week).
We then totaled all providers and
suppliers to achieve the total costs for
all onsite revisit surveys for the period
of this current Continuing Resolution.
TABLE B.—ONSITE REVISIT SURVEYS—ESTIMATED WEEKLY COSTS
Number of onsite
revisit surveys
(FY 2006)
Facility
Fee assessed per
onsite revisit
surveys
(hrs x $112)
Number of onsite
revisit surveys est.
for 1 week *
Monthly costs for
onsite revisit
surveys **
SNF & NF ................................................................................
Hospitals ..................................................................................
HHA .........................................................................................
Hospice ....................................................................................
ASC ..........................................................................................
RHC .........................................................................................
ESRD .......................................................................................
14,288
575
1,068
256
95
149
698
$2,072
2,554
1,613
1,736
1,669
851
1,490
275
11
21
5
2
3
13
$569,321
28,241
33,128
8,546
3,049
2,438
20,000
Total ..................................................................................
17,129
..............................
330
664,723
* Estimated total numbers of onsite revisit surveys per week were rounded up after dividing yearly survey totals from FY 2006 actual data by 52.
** Weekly costs may differ from the multiple of weekly revisits and fee per revisit due to rounding.
We expect the combined costs for all
providers and suppliers for all offsite
revisit surveys to total $52,905 for the
period of the current Continuing
Resolution. In Table C below, we first
estimated by provider or supplier the
number of offsite revisit surveys
expected for an entire fiscal year, and
multiplied this number by the expected
revisit user fee of $168 per offsite revisit
survey to obtain the annual cost of
surveys. We then divided this number
by 52 to obtain the weekly cost of offsite
revisit surveys to obtain the total costs
for offsite revisit surveys for the period
of the current Continuing Resolution
(roughly 1 week).
TABLE C.—OFFSITE REVISIT SURVEYS—ESTIMATED WEEKLY COSTS
Number of offsite
revisit surveys
(FY 2006)
Facility
Fee assessed
per offsite
revisit survey
($112 x 1.5 hrs)
Number of offsite
revisit surveys est.
for 1 week *
Weekly costs for
offsite revisit
surveys **
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SNF & NF ................................................................................
Hospitals ..................................................................................
HHA .........................................................................................
Hospice ....................................................................................
ASC ..........................................................................................
RHC .........................................................................................
ESRD .......................................................................................
15,138
278
517
51
93
67
231
$168
168
168
168
168
168
168
291
5
10
1
2
1
4
$48,907
898
1,670
168
300
216
746
Total ..................................................................................
16,375
..............................
314
52,905
* Estimated total numbers of offsite revisit surveys per week were rounded up after dividing yearly survey totals from FY 2006 actual data by 52.
** Weekly costs may differ from the multiple of weekly revisits and fee per revisit due to rounding.
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As shown in Table D below, we
provide the aggregate costs expected as
projected for the entire FY 2007, as well
as the costs we would expect to offset
for the period of the current Continuing
Resolution.
TABLE D.—TOTAL COSTS COMBINED FOR ALL REVISITS SURVEYS PER FISCAL YEAR & PERIOD OF CR
FY 2007
Period of CR *
Onsite Revisit Surveys ................................................................................................................................
Offsite Revisit Surveys ................................................................................................................................
$34,565,760
2,751,000
$664,723
52,905
Total Costs All Revisits ........................................................................................................................
37,316,760
717,628
* CR period’s costs are based on CR period revisit surveys rounded up to the nearest whole number as shown in Table B & C.
E. Alternatives Considered
We considered a number of
alternatives to the revisit user fee
program. Such alternatives were
discussed in the final rule published on
September 19, 2007 (72 FR 53647). We
affirm the continuing validity of that
analysis. The current Continuing
Resolution provides CMS with the
authority to continue projects or
activities as was otherwise provided for
in FY 2007, and as such CMS is
required to publish an interim final rule
with comment. This interim final rule
with comment merely updates the
Congressional authority under which
the rule operates.
In accordance with Executive Order
12866, this rule was not reviewed by the
Office of Management and Budget.
List of Subjects in 42 CFR Part 488
Administrative practice and
procedure, Health facilities, Medicare,
Reporting and recording requirements.
I For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV, part 488 as set forth below:
PART 488—SURVEY, CERTIFICATION,
AND ENFORCEMENT PROCEDURES
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
1. The authority citation for part 488
is revised to read as follows:
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
Authority: Secs. 1102 and 1871 of the
Social Security Act, unless otherwise noted
(42 U.S.C. 1302 and 1395(hh)); Continuing
Resolution Pub. L. 110–137 H.J. Res. 69.
48 CFR Part 25
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: January 4, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: January 15, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8–895 Filed 1–17–08; 8:45 am]
CFR Correction
I
Foreign Acquisition
In Title 48 of the Code of Federal
Regulations, Chapter 1 (Parts 1 to 51),
revised as of October 1, 2007, on page
508, in section 25.1101, in paragraph
(b)(2)(iii), remove ‘‘$58,550’’ and add
‘‘$64,786’’ in its place.
[FR Doc. 08–55501 Filed 1–17–08; 8:45 am]
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[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Rules and Regulations]
[Pages 3405-3409]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-895]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 488
[CMS-2278-IFC3]
RIN 0938-AP22
Revisit User Fee Program for Medicare Survey and Certification
Activities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This interim final rule with comment period implements the
continuation of the revisit user fee program for Medicare Survey and
Certification activities, in accordance with the statutory authority in
the Continuing Appropriations Resolution entitled, ``Making further
continuing appropriations for the fiscal year 2008, and for all other
purposes,'' Public Law 110-137 (``Continuing Resolution'') passed by
the Congress and signed by the President on December 14, 2007. On
September 19, 2007, we published a final rule that established a system
of revisit user fees applicable to health care facilities that have
been cited for deficiencies during initial certification,
recertification or substantiated complaint surveys and require a
revisit to confirm that previously-identified deficiencies have been
corrected.
DATES: Effective date: These regulations are effective January 18,
2008, and applicable beginning December 14, 2007.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on March 18, 2008.
ADDRESSES: In commenting, please refer to file code CMS-2278-IFC3.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-2278-IFC3, P.O. Box 8010, Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address only: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-2278-IFC3, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of
the HHH Building is not readily available to persons without Federal
Government identification, commenters are encouraged to leave their
comments in the CMS drop slots located in the main lobby of the
building. A stamp-in clock is available for persons wishing to retain a
proof of filing by stamping in and retaining an extra copy of the
comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Kelley Tinsley, (410) 786-6664.
SUPPLEMENTARY INFORMATION: Submitting Comments: As the public was
provided an opportunity to comment on the substance of the rule during
the comment period prior to the publication of the September 19, 2007
final rule, and as the substance of the rule is not changed by this
interim final rule with comment period, we are accepting comments only
to the extent that they pertain to the applicability of the new
authority for the rule. You can assist us by referencing the file code
CMS-2278-IFC3.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: https://
www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS
[[Page 3406]]
Regulations'' on that Web site to view public comments.
Comments received timely will be available for public inspection as
they are received, generally beginning approximately three weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.
SUPPLEMENTARY INFORMATION:
I. Background
In the June 29, 2007 Federal Register (72 FR 35673), we published
the proposed rule entitled, ``Establishment of Revisit User Fee Program
for Medicare Survey and Certification Activities'' and provided for a
60-day comment period. In the September 19, 2007 Federal Register (72
FR 53628) we published the Revisit User Fee Program final rule. That
final rule set forth final requirements and a final fee schedule for
providers and suppliers who require a revisit survey as a result of
deficiencies cited during an initial certification, recertification, or
substantiated complaint survey.
The Centers for Medicare & Medicaid Services (CMS) has in place an
outcome-oriented survey process that is designed to ensure that
existing Medicare-certified providers and suppliers or providers and
suppliers seeking initial Medicare certification, meet statutory and
regulatory requirements, conditions of participation, or conditions for
coverage. These health and safety requirements apply to the
environments of care and the delivery of services to residents or
patients served by these facilities and agencies. The Secretary of the
Department of Health and Human Services (HHS) has designated CMS to
enforce the conditions of participation/coverage and other requirements
of the Medicare program. The revisit user fee will be assessed for
revisits conducted in order to determine whether deficiencies cited as
a result of failing to satisfy federal quality of care requirements
have been corrected.
Pursuant to the requirements of the Continuing Appropriations
Resolution budget bill for fiscal year (FY) 2007, the Secretary
directed CMS to implement the revisit user fees for FY 2007 for certain
providers and suppliers for which a revisit was required to confirm
that previously-identified failures to meet federal quality of care
requirements had been remedied. The fees recover the costs associated
with the Medicare Survey and Certification program's revisit surveys.
The primary purpose for implementing the revisit user fees is to ensure
the continuance of CMS Survey and Certification quality assurance
activities that improve patient care and safety. The fees became
effective upon publication September 19, 2007, when the final rule was
published.
II. Provisions of the Interim Final Rule
The current Continuing Resolution, Public Law 110-137, amends
Public Law 110-16 Division B by striking the date specified in section
106(3) and inserting `December 21, 2007'. The current Continuing
Resolution authorizes HHS to continue to impose revisit user fees until
December 21, 2007, as follows:
* * * Sec. 101. Such amounts as may be necessary, at a rate for
operations as provided in the applicable appropriations Acts for
fiscal year 2007 and under the authority and conditions provided in
such Acts, for continuing projects or activities (including the
costs of direct loans and loan guarantees) that are not otherwise
specifically provided for in this joint resolution, that were
conducted in fiscal year 2007, and for which appropriations, funds,
or other authority were made available in the following
appropriations Acts:
* * * * *
(3) The Continuing Appropriations Resolution, 2007 (division B
of Pub. L. 109-289, as amended by Pub. L. 110-5). (H.J. Res. 20,
Sec. 101 (2007)).
Sec. 106. Unless otherwise provided for in this joint resolution
or in the applicable appropriations Act for fiscal year 2008,
appropriations and funds made available and authority granted
pursuant to this joint resolution shall be available until whichever
of the following first occurs: * * *
(3) December 21, 2007.
As directed by the Secretary, in the September 19, 2007 Federal
Register (72 FR 53628), we established the revisit user fee program for
revisit surveys. We put forth in regulation the relevant definitions,
criteria for determining the fees, the fee schedule, procedures for the
collection of fees, the reconsideration process, enforcement and
regulatory language addressing enrollment and billing privileges, and
provider agreements. In the September 19, 2007 final rule, cost
projections were based on FY 2006 actual data and were expected to
amount to $37.3 million for FY 2007. These calculations were included
in section IV of the final rule (72 FR 53642).
We stated in the final rule that, ``if authority for the revisit
user fee is continued, we will use the current fee schedule in [the
final rule] for the assessment of such fees until such time as a new
fee schedule notice is proposed and published in final form.'' (72 FR
53628). The current Continuing Resolution continues the authority of
the FY 2007 Continuing Resolution from December 14, 2007 through
December 21, 2007. Accordingly, the revisit fees will continue to be
assessed for the entire time period authorized by the current
Continuing Resolution.
III. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not always able to acknowledge or
respond to all of them individually. We will consider all comments we
receive by the date and time specified in the DATES section of this
preamble, and, when we proceed with a subsequent document, we will
respond to the comments in the preamble to that document.
IV. Waiver of Proposed Rulemaking and Delay in Effective Date
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule in
accordance with 5 U.S.C. 553(b) of the Administrative Procedure Act
(APA). The notice of proposed rulemaking includes a reference to the
legal authority under which the rule is proposed, and the terms and
substance of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued. We find
that the notice-and-comment procedure is unnecessary in this
circumstance because providers and suppliers have already been provided
notice and an opportunity to comment on the substance of this rule.
This interim final rule with comment merely updates the Congressional
authority under which the rule operates.
Therefore, we find good cause to waive the notice of proposed
rulemaking and to issue this final rule on an interim basis. We are
providing a 60-day public comment period.
We ordinarily provide a 30-day delay in the effective date of the
provisions of a rule in accordance with the Administrative Procedure
Act (APA), 5 U.S.C. 553(d). However, the delay in the effective date
may be waived as, in pertinent part, ``provided by the agency for good
cause found and published with the rule.'' 5 U.S.C. 553(d)(3). The
Secretary finds that good cause exists to waive the 30-day effective
date delay.
[[Page 3407]]
The good cause exception to the 30-day effective date delay
provision of section 553(d) of the APA is read to be broader than the
good cause exception to the notice and comment provision of section
553(b) of the APA.
The legislative history of the APA indicates that the purpose for
deferring the effectiveness of a rule under section 553(d) was to
``afford persons affected a reasonable time to prepare for the
effective date of a rule or rules or to take other action which the
issuance may prompt.'' S. Rep. No. 752, 79th Cong., 1st Sess. 15
(1946); H.R. Rep. No. 1980, 79th Cong. 2d Sess. 25 (1946). In this
case, affected parties do not need time to adjust their behavior before
this rule takes effect. This rule merely updates the authority under
which the revisit fee is assessed and does not provide any additional
requirements for the affected parties. Moreover, with or without a
revisit fee, a provider or supplier must be found to have corrected
significant deficiencies in order to avoid termination. Additionally,
the application of a fee for the revisit does not place appreciable
administrative burdens on the affected providers or suppliers. We do
not expect appreciable cost to State survey agencies because we are
undertaking the billing and collection of the revisit user fee.
We identified in the September 19, 2007 final rule the immediacy of
this revisit user fee program and the specific statutory requirement
contained limited in the Continuing Resolution that required us to
implement the revisit user fee program in FY 2007. Accordingly,
providers and suppliers have been on notice for some time that these
fees will be imposed, and do not need additional time to be prepared to
comply with the requirements of this regulation. We believe that given
the short timeframe that we have to collect fees before the statutory
authority of the current Continuing Resolution expires, there is good
cause to waive the 30-day effective date.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
VI. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts 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.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
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 one
year). This rule is not a major rule. The aggregate costs will total
approximately $37.3 million in any one year.
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 small governmental
jurisdictions. Individuals and States are not included in the
definition of a small entity. Small businesses are small entities,
either by nonprofit status or by having revenues of $6.5 million to
$31.9 million or less in any one year for purposes of the RFA. The
September 19, 2007 final rule provided an analysis on the impact of
small entities (72 FR 53642-3). The analysis published in the final
rule remains valid. Since this interim final rule with comment merely
updates the Congressional authority under which the rule operates, we
have determined that this rule will not have a significant impact on
small entities based on the overall effect on revenues.
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 (superseded by Core Based Statistical Areas) and has
fewer than 100 beds. This rule affects those small rural hospitals that
have been cited for a deficiency based on noncompliance with required
conditions of participation and for which a revisit is needed to ensure
that the deficiency has been corrected. We identified in the September
19, 2007 final rule that for the effective period of that rule that
less than 3 percent of all hospitals may be assessed a revisit user fee
and that less than 1 percent of those hospitals would be rural
hospitals (72 FR 53643). The analysis published in the final rule
remains valid. Since this interim final rule with comment merely
updates the Congressional authority under which the rule operates, we
maintain that this rule will not have a significant impact on small
rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any one year of
$100 million in 1995 dollars, updated annually for inflation. That
threshold level is currently approximately $120 million. This interim
final rule with comment will have no mandated effect on State, local,
or tribal governments and the impact on the private sector is estimated
to be less than $120 million and will only effect those Medicare
providers or suppliers for which a revisit user fee is assessed based
on the need to conduct a revisit survey to ensure deficient practices
that were cited have been corrected.
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 on State
and local governments, preempts State law, or otherwise has Federalism
implications. This interim final rule with comment will not
substantially affect State or local governments. This rule establishes
user fees for providers and suppliers for which CMS has identified
deficient practices and requires a revisit to assure that corrections
have been made. Therefore, we have determined that this interim final
rule with comment will not have a significant effect on the rights,
roles, and responsibilities of State or local governments.
B. Impact on Providers/Suppliers
There is no change on the impact on providers and suppliers with
the publication of this interim final rule with comment. The impact
remains as discussed in the final rule (72 FR 53643).
Final Fee Schedule for Onsite and Offsite Revisit Surveys
The FY 2007 fee schedule published on September 19, 2007 (72 FR
53647) in the final rule will be retained. As noted in the final rule,
the published fee schedule will be used by CMS for the assessment of
fees until a new fee schedule is proposed and published in final form.
The calculations used to
[[Page 3408]]
determine the fee as identified in the final rule will be the same (72
FR 53645-6). We will continue to assess a flat fee based on provider or
supplier type and type of revisit survey conducted. Table A below
identifies the final fee schedule.
Table A.--Final Fee Schedule
------------------------------------------------------------------------
Fee Fee
assessed assessed
per per
Facility offsite onsite
revisit revisit
survey survey
------------------------------------------------------------------------
SNF & NF.......................................... $168 $2,072
Hospitals......................................... 168 2,554
HHA............................................... 168 1,613
Hospice........................................... 168 1,736
ASC............................................... 168 1,669
RHC............................................... 168 851
ESRD.............................................. 168 1,490
------------------------------------------------------------------------
Costs for All Revisit User Fees Assessed
We anticipated that the combined costs for all providers and
suppliers for all revisit surveys in FY 2007 would total approximately
$37.3 million on an annual basis, with onsite revisit surveys amounting
to approximately $34.6 million and offsite revisit surveys totaling
approximately $2.7 million. (72 FR 53645). However, actual fees
assessed in FY 2007 were much less than this amount, since CMS did not
charge for revisits that occurred prior to publication of the final
regulation. Since we continue to operate under this same estimate for
FY 07, we provide below monthly estimates of the impact for the period
of the current Continuing Resolution in Tables B and C. For the period
of the current Continuing Resolution, we will use the FY 2007 fee
schedule established in the final rule for the assessment of fees until
a new fee schedule notice is proposed and published as final.
In Table B below, we provide the projected costs for the period of
this current Continuing Resolution based on the fee schedule of the
final rule. We expect the combined costs for all providers and
suppliers for all onsite revisit surveys for the period of this current
Continuing Resolution to total approximately $665,000. We first
multiplied the total number of onsite revisit surveys in one year by
the expected revisit user fees assessed per revisits as finalized in
Table A above, estimated by provider or supplier, to obtain the annual
cost of revisit surveys. We then divided this number by 52 to obtain
the weekly cost per provider or supplier of onsite revisit surveys to
obtain the total costs for onsite revisit surveys for the period of the
current Continuing Resolution (roughly 1 week). We then totaled all
providers and suppliers to achieve the total costs for all onsite
revisit surveys for the period of this current Continuing Resolution.
Table B.--Onsite Revisit Surveys--Estimated Weekly Costs
----------------------------------------------------------------------------------------------------------------
Fee assessed per
Number of onsite onsite revisit Number of onsite Monthly costs for
Facility revisit surveys surveys (hrs x revisit surveys onsite revisit
(FY 2006) $112) est. for 1 week * surveys **
----------------------------------------------------------------------------------------------------------------
SNF & NF............................ 14,288 $2,072 275 $569,321
Hospitals........................... 575 2,554 11 28,241
HHA................................. 1,068 1,613 21 33,128
Hospice............................. 256 1,736 5 8,546
ASC................................. 95 1,669 2 3,049
RHC................................. 149 851 3 2,438
ESRD................................ 698 1,490 13 20,000
---------------------------------------------------------------------------
Total........................... 17,129 ................. 330 664,723
----------------------------------------------------------------------------------------------------------------
* Estimated total numbers of onsite revisit surveys per week were rounded up after dividing yearly survey totals
from FY 2006 actual data by 52.
** Weekly costs may differ from the multiple of weekly revisits and fee per revisit due to rounding.
We expect the combined costs for all providers and suppliers for
all offsite revisit surveys to total $52,905 for the period of the
current Continuing Resolution. In Table C below, we first estimated by
provider or supplier the number of offsite revisit surveys expected for
an entire fiscal year, and multiplied this number by the expected
revisit user fee of $168 per offsite revisit survey to obtain the
annual cost of surveys. We then divided this number by 52 to obtain the
weekly cost of offsite revisit surveys to obtain the total costs for
offsite revisit surveys for the period of the current Continuing
Resolution (roughly 1 week).
Table C.--Offsite Revisit Surveys--Estimated Weekly Costs
----------------------------------------------------------------------------------------------------------------
Fee assessed per
Number of offsite offsite revisit Number of offsite Weekly costs for
Facility revisit surveys survey ($112 x revisit surveys offsite revisit
(FY 2006) 1.5 hrs) est. for 1 week * surveys **
----------------------------------------------------------------------------------------------------------------
SNF & NF............................ 15,138 $168 291 $48,907
Hospitals........................... 278 168 5 898
HHA................................. 517 168 10 1,670
Hospice............................. 51 168 1 168
ASC................................. 93 168 2 300
RHC................................. 67 168 1 216
ESRD................................ 231 168 4 746
---------------------------------------------------------------------------
Total........................... 16,375 ................. 314 52,905
----------------------------------------------------------------------------------------------------------------
* Estimated total numbers of offsite revisit surveys per week were rounded up after dividing yearly survey
totals from FY 2006 actual data by 52.
** Weekly costs may differ from the multiple of weekly revisits and fee per revisit due to rounding.
[[Page 3409]]
As shown in Table D below, we provide the aggregate costs expected
as projected for the entire FY 2007, as well as the costs we would
expect to offset for the period of the current Continuing Resolution.
Table D.--Total Costs Combined for All Revisits Surveys per Fiscal Year
& Period of CR
------------------------------------------------------------------------
FY 2007 Period of CR *
------------------------------------------------------------------------
Onsite Revisit Surveys............ $34,565,760 $664,723
Offsite Revisit Surveys........... 2,751,000 52,905
-------------------------------------
Total Costs All Revisits...... 37,316,760 717,628
------------------------------------------------------------------------
* CR period's costs are based on CR period revisit surveys rounded up to
the nearest whole number as shown in Table B & C.
E. Alternatives Considered
We considered a number of alternatives to the revisit user fee
program. Such alternatives were discussed in the final rule published
on September 19, 2007 (72 FR 53647). We affirm the continuing validity
of that analysis. The current Continuing Resolution provides CMS with
the authority to continue projects or activities as was otherwise
provided for in FY 2007, and as such CMS is required to publish an
interim final rule with comment. This interim final rule with comment
merely updates the Congressional authority under which the rule
operates.
In accordance with Executive Order 12866, this rule was not
reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 488
Administrative practice and procedure, Health facilities, Medicare,
Reporting and recording requirements.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV, part 488 as set forth
below:
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
0
1. The authority citation for part 488 is revised to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act,
unless otherwise noted (42 U.S.C. 1302 and 1395(hh)); Continuing
Resolution Pub. L. 110-137 H.J. Res. 69.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: January 4, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: January 15, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-895 Filed 1-17-08; 8:45 am]
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