[Federal Register: October 31, 2007 (Volume 72, Number 210)]
[Rules and Regulations]
[Page 61540-61545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc07-17]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 488
[CMS-2278-IFC]
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.
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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 (``Continuing Resolution'')
budget legislation passed by the Congress and signed by the President
on September 29, 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
[[Page 61541]]
corrections to previously-identified deficiencies have been corrected.
DATES: Effective date: These regulations are effective October 1, 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 December 31, 2007.
ADDRESSES: In commenting, please refer to file code CMS-2278-IFC.
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 http://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-IFC, 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-IFC, 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: Kathryn Linstromberg, (410) 786-8279.
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-IFC.
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: http://www.cms.hhs.gov/eRulemaking.
Click on the link ``Electronic Comments on
CMS Regulations'' on that Web site to view public comments.
Comments received timely will be also 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 determine whether
existing Medicare-certified providers and suppliers or providers and
suppliers seeking initial Medicare certification are actually meeting
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, which was passed by
the Congress and signed by the President, we were directed by the
Secretary 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
functions 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 (Pub. L. 110-92, H. J. Res. 52
Sec. Sec. 101 & 106(2007)) authorizes HHS to continue the revisit user
fees until November 16, 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
[[Page 61542]]
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 Public Law 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) November 16, 2007.
As directed by the Secretary, in the September 19, 2007 Federal
Register (72 FR 53628), we established revisit user fees for revisit
surveys and put forth in regulation the definitions, criteria for
determining the fee, the fee schedule, collection of fees,
reconsideration process for revisit user fees, 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 on an annual basis 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 October 1, 2007 through November
16, 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 able to acknowledge or
respond to 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. section 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
substances 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.
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 proposed rule the immediacy of this revisit
user fee program and the limited nature of FY 2007, Continuing
Resolution Appropriation (Pub. L. 110-5). Specifically, the Continuing
Resolution required us to implement the revisit 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,
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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, and the Secretary certifies, 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 make
sure 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 given the effective period of this rule, we have
determined, and the Secretary certifies, 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 affect 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 utilized by CMS for the assessment
of such fees until such time as a new fee schedule notice is proposed
and published in final form. The calculations utilized to 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
Facility per offsite per 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
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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 annual amount, since CMS did not
charge for revisits that occurred prior to publication of the final
regulation. Since we continue to operate under these same annual
estimates, we provide here estimates of the impact for the period of
the current continuing resolution as listed below in monthly estimates
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 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 continuing resolution to
total approximately $4.3 million. 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 12 to obtain the monthly cost of onsite
revisit surveys and multiplied by the effective period of the
continuing resolution (roughly 1.5 months) to obtain the total costs
for onsite revisit surveys for the period of the continuing resolution.
We then totaled all providers and suppliers to achieve the total costs
for all onsite revisit surveys for the period of this continuing
resolution.
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Table B.--Onsite Revisit Surveys--Estimated Monthly Costs
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Total costs
Monthly number Fee assessed Monthly costs for onsite
of onsite per onsite for onsite revisit
Facility revisit revisit revisit surveys for
surveys surveys (hrs x surveys* period of CR
$112) **
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SNF & NF........................................ 1,191 $2,072 $2,467,061 $3,700,592
Hospitals....................................... 48 2,554 122,379 183,569
HHA............................................. 89 1,613 143,557 215,336
Hospice......................................... 21 1,736 37,035 55,552
ASC............................................. 8 1,669 13,213 19,819
RHC............................................. 12 851 10,567 15,850
ESRD............................................ 58 1,490 86,668 130,003
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Total....................................... 1,427 .............. 2,880,480 4,320,721
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* Monthly costs may differ from the multiple of monthly revisits and fee per revisit due to rounding.
** Monthly costs were multiplied by the effective period of the CR (roughly 1.5 months) Total numbers of onsite
revisit surveys were rounded up based on FY 2006 actual data presented in the final rule.
We expect the combined costs for all providers and suppliers for
all offsite revisit surveys to total $343,875 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 12 to obtain the
monthly cost of offsite revisit surveys and multiplied this number by
the effective period of the continuing resolution (roughly 1.5 months)
to obtain the total costs for offsite revisit surveys for the period of
the continuing resolution.
Table C.--Offsite Revisit Surveys--Estimated Monthly Costs
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Total costs
Monthly number Fee assessed Monthly costs for offsite
of offsite per offsite for offsite revisit
Facility revisit revisit survey revisit surveys for
surveys ($112 x 1.5 surveys* period of CR
hrs) **
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SNF & NF........................................ 1,262 $168 $211,932 $317,898
Hospitals....................................... 23 168 3,892 5,838
HHA............................................. 43 168 7,238 10,857
Hospice......................................... 4 168 714 1,071
ASC............................................. 8 168 1,302 1,953
RHC............................................. 6 168 938 1,407
ESRD............................................ 19 168 3,234 4,851
Total....................................... 1,365 .............. 229,250 343,875
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* Monthly costs may differ from the multiple of monthly revisits and fee per revisit due to rounding.
** Monthly costs were multiplied by the effective period of the CR (roughly 1.5 months).
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 $4,320,512
Offsite Revisit Surveys................. 2,751,000 343,980
-------------------------------
Total Costs All Revisits............ 37,316,760 4,664,492
------------------------------------------------------------------------
* CR period's costs are based on CR period revisit surveys rounded up to
the nearest whole number as shown in Table B & C.
C. Alternatives Considered
CMS considered a number of alternatives to the Revisit User Fee.
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 has been
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.
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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)); Pub. L. 110-
92, H. J. Res. 52 Sec. Sec. 101 & 106 (2007).
(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: October 11, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: October 25, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07-5400 Filed 10-26-07; 12:02 pm]
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