[Federal Register: June 29, 2007 (Volume 72, Number 125)]
[Proposed Rules]
[Page 35673-35683]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn07-23]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 424, 488, and 489
[CMS-2268-P]
RIN 0938-AO96
Establishment of Revisit User Fee Program for Medicare Survey and
Certification Activities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would allow CMS to charge revisit user fees
to health care facilities cited for deficiencies during initial
certification, recertification, or substantiated complaint surveys.
Consistent with the President's long-term goal to promote quality of
health care and to cut the deficit in half by fiscal year (FY) 2009,
the FY 2007 Department of Health and Human Services' (HHS) budget
request included both new mandatory savings proposals and a requirement
that user fees be applied to health care providers that have failed to
comply with Federal quality of care requirements. The ``Revisit User
Fees'' would affect only those providers or suppliers for which CMS has
identified deficient practices and requires a revisit to assure that
corrections have been made. The fees are estimated at $37.3 million
annually and would recover the costs associated with the Medicare
Survey and Certification program's revisit surveys. The fees would take
effect on the date of publication of the final rule, and would be
available to CMS until expended.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on August 27, 2007.
ADDRESSES: In commenting, please refer to file code CMS-2268-P. 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-2268-P, P.O. Box 8016, 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-2268-P, 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: Carla McGregor, (410) 786-0663,
(Policy). Kathryn Linstromberg, (410) 786-8279 (Policy). Edward F.
Mortimore, (410) 786-3509 (Data). David Escobedo, (410) 786-5401
(Budget).
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-2268-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
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 also be available for public
inspection as they are received, generally beginning approximately 3
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
A. Survey & Certification Compliance Process
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
[[Page 35674]]
the Department of Health and Human Services (``HHS'') has designated
CMS to enforce the conditions of participation/coverage and other
requirements with these programs.
Medicare is a Federal insurance program that provides a wide range
of benefits for specific periods of time to Medicare beneficiaries
through providers and suppliers participating in the program. The
Social Security Act (``Act'') designates those providers and suppliers
that are subject to Federal health care quality standards. The Federal
Government makes payment for services through designated fiscal
intermediaries, carriers, and Medicare administrative contractors to
the providers and suppliers.
Providers, in Medicare terminology, include patient care
institutions such as hospitals, critical access hospitals, hospices,
nursing homes, and home health agencies.
Suppliers, in Medicare terminology, include entities for
diagnosis and therapy rather than sustained patient care, such as
laboratories, clinics, and qualified health centers.
Medicaid is a State program that provides medical services to
clients of the State public assistance program and, at the State's
option, other needy individuals. When services are furnished through
institutions that must be certified for Medicare, the institutional
standards must be met for Medicaid as well. State survey agencies,
under agreements between the State and the Secretary, carry out the
Medicare certification process. Section 1864(a) of the Act directs the
Secretary to use the State health agencies or ``other appropriate
agencies,'' also known in this context as State survey agencies, to
determine whether health care institutions meet Federal standards.
B. Authority To Assess Revisit User Fees
The President's HHS budget for FY 2007 included $35 million in new
user fees to finance the costs associated with CMS' Medicare survey and
certification program's activities. The President's HHS budget for FY
2007 included projections based on FY 2005 numbers. CMS has updated
that information based on FY 2006 actual data and thus all other
references to the amount projected reference $37.3 million instead of
$35 million. We have included these calculations in section IV
Regulatory Impact Analysis below. The Continuing Appropriations
Resolution (``Continuing Resolution'') budget bill passed by the
Congress and signed by the President directed HHS to implement the fees
for FY 2007, as follows:
The Secretary of Health and Human Services shall charge fees
necessary to cover the costs incurred under ``Department of Health
and Human Services, Centers for Medicare and Medicaid Services,
Program Management'' for conducting revisit surveys on health care
facilities cited for deficiencies during initial certification,
recertification, or substantiated complaints surveys. Not
withstanding section 3302 of title 31, United States Code, receipts
from such fees shall be credited to such account as offsetting
collections, to remain available until expended for conducting such
surveys.
(Pub. L. 110-5, H.J. Res. 20, Sec. 20615(b)(2007)).
Revisit surveys are conducted pursuant to the citing of deficiencies
that were found during initial certification, recertification, or
substantiated complaint surveys and are conducted for the purpose of
verifying the fact that the deficiencies previously cited have been
corrected.
A crucial component to survey activities are the agreements
established under section 1864 of the Act between the Secretary and the
State survey agencies to determine that an institution meets the
statutory definition for the provider type and that it satisfies all
conditions of participation or regulatory requirements, as well as, any
additional requirements as determined by the Secretary. Section 1864(e)
of the Act, in relevant part regarding the imposition of fees involving
survey activities, states:
Notwithstanding any other provision of law, the Secretary may
not impose, or require a State to impose, any fee on any facility or
entity subject to a determination under subsection (a), or any renal
dialysis facility subject to the requirements of section 1881(b)(1),
for any such determination or any survey relating to determining the
compliance of such facility or entity with any requirement of this
title (other than any fee relating to section 353 of the Public
Health Service Act).
The Congress enacted section 20615(b) of the Continuing Resolution
with the knowledge of section 1864(e) of the Act and took specific
action to carve out fees for revisits as a result of cited deficiencies
while being careful not to specify fees for initial surveys conducted
for those newly entering the Medicare/Medicaid Program or for
conducting statutorily based recertification surveys. The Secretary
believes it was the Congress' intent to harmonize the Continuing
Resolution with section 1864(e) of the Act by limiting the fees to
those quality assurance functions, that is, revisits, necessary to
confirm the correction of previously-identified deficiencies. This
belief is consistent with the rule of statutory interpretation that
provides that, ``[w]here there are two acts upon the same subject,
effect should be given to both, if possible. See Posadas v. National
City Bank of New York, 296 U.S. 497, 503 (1936).
Although the Secretary believes that the Continuing Resolution
language should be read to coexist with the language of the Act, to the
extent that section 20615(b) of the Continuing Resolution and section
1864(e) of the Act are perceived to be irreconcilable, the Secretary
must give effect to the more recent Continuing Resolution for the
period of availability of the appropriations. It is well established
that it is in Congress' power to abrogate or modify a treaty or earlier
legislation that it created. See Fund for Animals, Inc. v. Kempthorne,
472 F.3d 872, 876 (D.C. Cir. 2006) (citing Fund for Animals v. Norton,
374 F.Supp.2d 91, 103 (D.D.C. 2005)) (``Congress clearly has the power
to abrogate or modify a treaty or earlier legislation, and when it does
so, that is the final word''). In resolving similar conflicts, the
Federal courts have applied the principle of lex posterior derogate
legi priori also known as ``lex posterior'' or the ``last-in-time''
rule; that is to say, where two statutory provisions appear to
conflict, the later in time prevails. See Fund for Animals, 472 F.3d at
878 (``[T]he Supreme Court has long recognized that a later enacted
statute trumps an earlier-enacted treaty to the extent the two
conflict.''). The rule is premised on the idea that the interpretation
and application of statutes should reflect the most recent expression
of the Congress' intent. Therefore, application of the last-in-time
rule would result in section 20615(b) of the Continuing Resolution
superseding section 1864(e) of the Act to the extent that the two
provisions conflict.
The Secretary believes the intended section 20615(b) of the
Continuing Resolution to apply only during this current fiscal year (FY
2007) and that a decision on making a permanent change to the statute
will be deferred until a later time. See B-303268 Op. GAO-Legal (2005),
http://www.gao.gov/decisions/appro/303268.htm (concluding that a
nonpermanent provision in an appropriations resolution, which conflicts
with a prior enacted appropriations act, is effective under the ``last-
in-time'' rule, but will expire at the end of the fiscal year). Since
the Congress did not expressly state otherwise, and the authority under
section 1864(e) of the Act is permanent, the authority under section
20615(b) of the Continuing Resolution extends only through FY 2007.
[[Page 35675]]
Accordingly, section 20615(b) of the Continuing Resolution would
only constitute a variation to the general prohibition of fees under
section 1864(e) of the Act through September 30, 2007. These
considerations lend further credence to the Secretary's belief that it
was the Congress' intent to harmonize the two provisions.
Based on the Congress' knowledge of section 1864(e) of the Act, the
unambiguous nature of section 20615(b) of the Continuing Resolution,
and the principles of lex posterior, the Secretary has the authority to
propose and implement this revisit user fee rule.
II. Provisions of the Proposed Regulations
Part 424--Subpart P--Requirements for Establishing and Maintaining
Medicare Billing Privileges
Section 424.535 Revocation of Enrollment and Billing Privileges in the
Medicare Program
[If you wish to comment on issues in this section, please include
the caption ``424.535(a)(1)--REVOCATION OF ENROLLMENT AND BILLING
PRIVILEGES IN THE MEDICARE PROGRAM--USER FEE ADDITION'' at the
beginning of your comments.]
We propose to amend Sec. 424.535(a)(1) by adding a new sentence to
the criteria for which a provider or supplier may be determined not in
compliance and for which we may revoke enrollment and billing
privileges in the Medicare program. We propose to add that the provider
or supplier may also be determined not to be in compliance if it has
failed to pay any user fees as assessed under part 488 of this chapter.
The beginning of the paragraph will continue to read the same and the
ending of the paragraph will continue to read that all providers and
suppliers are granted an opportunity to correct the deficient
compliance requirement before a final determination to revoke billing
privileges. The addition of this sentence does not provide an
opportunity for additional comments on any other component of part 424
or Sec. 424.535.
Part 488--Survey, Certification, and Enforcement: Subpart A--General
Provisions.
Section 488.30 Revisit User Fee for Revisit Surveys
We propose a new Sec. 488.30 which sets forth proposed regulations
that would identify the circumstances under which providers or
suppliers would be assessed a user fee for revisit surveys connected
with deficiencies identified during surveys for initial certification,
recertification, or substantiated complaints. This proposed paragraph
identifies the assessment of fees, criteria for which the proposed fee
schedule will be based, and collection of fees.
Section 488.30(a)--DEFINITIONS
[If you choose to comment on issues in this next section, please
include the caption ``Section 488.30(a) ``DEFINITIONS'' at the
beginning of your comments]
We propose in Sec. 488.30(a) to define terms associated with this
paragraph. Those terms include: ``certification,'' ``complaint
surveys,'' ``substantiated complaint survey,'' ``provider of
services,'' ``provider,'' ``supplier,'' and ``revisit survey.''
``Certification (Initial or Recertification)''
We propose that ``certification'' (both initial and
recertification) would include those activities as defined in Sec.
488.1. ``Certification'' as currently defined in Sec. 488.1 is a
``recommendation made by the State survey agency on the compliance of
providers and suppliers with the conditions of participation,
requirements (SNFs and NFs), and conditions for coverage.'' Conditions
of participation apply to providers of Medicare services, other than
skilled nursing facilities, while conditions for coverage apply to
suppliers of Medicare services.
We propose that a user fee under this proposed rule will be
assessed for revisit surveys conducted to evaluate the extent to which
deficiencies identified during initial certification or recertification
surveys have been corrected.
``Complaint Surveys''
We propose that complaint surveys are those surveys conducted on
the basis of a ``substantial allegation of noncompliance,'' as defined
in Sec. 488.1. The term ``substantial allegation of noncompliance''
means:
A complaint from any of a variety of sources (including
complaints submitted in person, by telephone, through written
correspondence, or in newspaper or magazine articles) that if
substantiated, would affect the health and safety of patients and
raises doubts as to a provider's or supplier's noncompliance with
any Medicare condition. (42 CFR 488.1)
CMS through its authority under the certification and survey
process provisions of sections 1819(g), 1864, and 1891(c) of the Act
has identified in the State Operations Manual (SOM) the procedures by
which complaints/incidents will be handled by CMS and the State survey
agencies. CMS identifies a complaint as ``an allegation of
noncompliance with Federal and/or State requirements.'' An allegation
is further identified as ``an assertion of improper care or treatment
that could result in the citation of a Federal deficiency.'' See U.S.
Centers for Medicare & Medicaid Services. State Operations Manual,
``Complaint Procedures.'' Online. 2006. CMS. Available: http://www.cms.hhs.gov/manuals/downloads/som107c05.pdf
(``SOM-Complaint'').
``Substantiated Complaints Surveys''
The Continuing Resolution includes the term ``substantiated
complaints surveys.'' We propose that ``substantiated complaint
survey'' means a complaint survey that results in the proof or finding
of noncompliance at the time of the survey, a finding that
noncompliance was proven to exist, but was corrected prior to the
survey, and includes any deficiency that is cited during a complaint
survey, whether or not the deficiency was the original subject of the
substantial allegation of noncompliance. The Secretary believes its
term ``substantial allegation of noncompliance'' identified in Sec.
488.1 is the direct correlation for this term in the HHS budget. Thus,
this proposed regulation would consider ``substantiated complaints
surveys'' to be surveys conducted based on CMS or the State survey
agency receiving a ``substantial allegation of noncompliance'' where
the non-compliance has been confirmed through a complaint survey.
We propose that a user fee under this proposed rule will be
assessed for revisit surveys conducted to evaluate the extent to which
deficiencies identified during a substantiated complaint survey have
been corrected.
``Provider of Services, Provider, or Supplier''
The terms ``provider of services,'' ``provider,'' or ``supplier''
are already defined in Sec. 488.1. We propose that all ``provider of
services,'' ``providers,'' or ``suppliers,'' as defined in Sec. 488.1,
will be subject to user fees, unless otherwise exempted through the
final rule. We propose that a ``provider of services'' or ``provider''
subject to user fees, as it applies in this proposed rule, includes a
hospital, critical access hospital, skilled nursing facility, dually-
participating nursing facility (``SNF/NF''), home health agency
(``HHA''), and hospice. Transplant centers will also be subject to user
fees and have been newly defined in Sec. 482.70 of this chapter. See
Medicare Program; Hospital Conditions of Participation: Requirements
for
[[Page 35676]]
Approval and Re-approval of Transplant Centers to Perform Organ
Transplants, published March 30, 2007 (72 FR 15198) (codified at 42 CFR
part 482). We propose that, for FY 2007, ``providers of services'' or
``providers'' that will not be assessed a revisit user fee as defined
in this proposed rule to be comprehensive outpatient rehabilitation
facilities and providers of outpatient physical therapy or speech
pathology services. We have excluded these providers because the time
and cost involved in conducting revisits to these providers are minimal
or the nature in which oversight is conducted is not the same as for
those providers included. Medicaid-only ``providers of services'' or
``providers'' will not be assessed a user fee.
We also propose a ``supplier'' subject to user fees, as it applies
in this proposed rule includes an end-stage renal disease center, a
rural health clinic (``RHC''), and an ambulatory surgical center
(``ASC''). ASCs must have an agreement with CMS to participate in
Medicare and must meet conditions for coverage as defined in part 416
of this chapter.
``Suppliers'' that would not be subject to user fees under this
proposed rule are independent laboratories, portable x-ray centers,
physical therapists in independent practice, Federally Qualified Health
Centers (FQHCs), and chiropractors. We have excluded these suppliers
because the time and cost involved in conducting revisits to these
suppliers are minimal or the nature in which oversight is conducted is
not the same as for those suppliers included. Medicaid-only
``suppliers'' will not be assessed a user fee.
This proposed rule would not interfere with user fees associated
with clinical laboratories as established by the Congress, which passed
the Clinical Laboratory Improvement Amendments (CLIA) in 1988 and
established that outpatient clinical laboratory services are paid based
on a fee schedule in accordance with section 1833(h) of the Act.
``Revisit Survey''
We propose to define the term ``revisit survey'' to mean a survey
performed with respect to a provider or supplier cited for deficiencies
during an initial certification, recertification, or substantiated
complaint survey and which is designed to evaluate the extent to which
previously cited deficiencies have been corrected. We further propose
that for purpose of this rule, revisit surveys include both offsite and
onsite. The fees associated with offsite (``desk'') surveys will be
less than the fees assessed for onsite surveys. Most revisit surveys
include both onsite and offsite time, but a number of revisit surveys
may be accomplished through desk review only. Oftentimes an onsite
revisit survey will require offsite preparation; in these cases only
one user fee will be assessed for an onsite revisit survey.
Section 488.26 provides direction as to how compliance with the
conditions of participation, conditions for coverage, or other
regulatory requirements is determined. Specifically, section 488.26
provides that the compliance determination is made by the State survey
agency and includes a survey process that assesses compliance with
Federal health, safety, and quality standards. While the conditions of
participation, conditions for coverage, and requirements for
determining compliance are unique to each provider and supplier, the
Secretary has created common terms for purposes of survey and
certification.
Revisit policies have been established based on provider/supplier
type.
Skilled Nursing Facilities/Dually-participating Nursing Facilities.
The current policy for skilled nursing facilities and dually-
participating nursing facilities permits two onsite revisits, performed
at the discretion of CMS or the State. This revisit policy indicates
circumstances for which onsite revisits must occur for certifying
compliance and circumstances when onsite revisits are discretionary.
Second revisits may be required if the deficiencies are not fully
corrected, if there continue to be negative outcomes from the
originally-cited noncompliance, or if new and serious deficiencies are
present during the revisit. Further, if the State determines that a
third revisit is necessary, due to continuing noncompliance, it must be
approved at the discretion of the CMS Regional Office. CMS does not
permit a third revisit except in unusual circumstances. See U.S.
Centers for Medicare & Medicaid Services. State Operations Manual, ``
Survey and Enforcement Process for Skilled Nursing Facilities and
Nursing Facilities.'' Online. 2004. CMS. Available: http://www.cms.hhs.gov/manuals/downloads/som107c07.pdf
(``SOM-SNF/NF
Enforcement Process'').
Hospitals/Home Health Agencies/Hospices/Ambulatory Surgical
Centers/Rural Health Clinics/End-Stage Renal Disease Centers. CMS
generally permits only two revisits for hospitals, home health
agencies, hospices, ambulatory surgical centers, rural health clinics,
and end-stage renal disease centers. Of these two revisits permitted by
CMS, one revisit within 45 calendar days of the initial certification,
recertification, or substantiated complaint survey, and one revisit
subject to CMS approval, between the 46th and 90th calendar days. A
revisit is conducted if a State survey agency and/or CMS receives from
the provider or supplier a credible allegation that it is in
compliance, following a determination that the provider or supplier had
failed to substantially meet Federal requirements. If a provider or
supplier fails to make a credible allegation of compliance, a revisit
is not necessary, since the provider agreement is then subject to
termination.
Revisits Related to Immediate Jeopardy. Revisits are also
conducted, if possible, before a termination results in response to an
immediate jeopardy situation. An immediate jeopardy situation is one in
which the provider or supplier's noncompliance with one or more
requirements of participation has caused, or is likely to cause, severe
temporary or permanent injury, disability or death to an individual. A
provider or supplier in this situation will be terminated from the
Medicare/Medicaid program within 23 calendar days from the day the
deficiency was cited if no corrective action steps are taken and
completed. A revisit is conducted if there is a credible allegation
from the provider or supplier that it has corrected the threat or the
deficiency cited as immediate jeopardy. If CMS and the State survey
agency disagree as to whether an immediate jeopardy exists, it may be
necessary for CMS and the State survey agency to conduct a revisit
together. See U.S. Centers for Medicare & Medicaid Services. State
Operations Manual, ``Additional Program Activities.'' Online. 2007.
CMS. Available: http://www.cms.hhs.gov/manuals/downloads/som107c03.pdf.
We welcome public comment regarding all definitions proposed in Sec.
488.30(a).
Section 488.30(b)--Criteria for Determining the Fee
[If you choose to comment on issues in this next section, please
include the caption ``Section 488.30(b) CRITERIA FOR DETERMINING THE
FEE'' at the beginning of your comments]
We propose in Sec. 488.30(b) to provide the criteria for
determining the user fee. We propose that for initial implementation of
revisit user fees in FY 2007, we will use the criteria in proposed
Sec. 488.30(b)(1)(i) and (ii): That a provider or supplier will be
assessed a revisit user fee based on the average cost per revisit
survey per provider or supplier type and the type of the revisit--
onsite review or offsite review.
[[Page 35677]]
We welcome public comment regarding the criteria we propose to use
in FY 2007 to establish the revisit user fee: That of average cost per
revisit survey and the provider or supplier type and the type of the
revisit survey.
We also propose that exceptions to the assessment of a user fee
will be identified based on the type of visit conducted. For example,
we propose that neither a provider nor a supplier will be assessed a
fee if the visit is considered a ``State monitoring visit'' unless the
visit also meets the definition of a revisit. A ``State monitoring
visit'' refers to visits by the State survey agency to oversee a
provider/supplier's compliance status during bankruptcy, after a change
of ownership, during or shortly after the removal of immediate jeopardy
when the purpose of the visit is to ensure the welfare of the
residents/clients/patients by providing an oversight presence, and in
other circumstances as authorized by the CMS regional office where the
provider/supplier is located. See SOM-Complaint, Sec. 5077; see also
SOM-SNF/NF Enforcement Process, Sec. 7504.
Likewise, we also propose that neither a provider nor a supplier
will be assessed a fee if the visit is associated with Medicare
provider or supplier compliance with Life Safety Code (LSC)
requirements. The LSC is a set of fire protection requirements, that
covers construction, protection, and operational features designed to
provide a reasonable degree of safety from fire, smoke, and panic. The
LSC, which is revised periodically, is a publication of the National
Fire Protection Association. The basic requirement for facilities
participating in the Medicare and Medicaid programs is compliance with
the 2000 edition of the LSC. The State survey agency determines whether
the LSC survey is to occur before, after, or simultaneously with the
health survey. Most States require an initial LSC survey before
admitting patients prior to becoming operational. See U.S. Centers for
Medicare & Medicaid Services. ``Life Safety Code Requirements.''
Online. 2007. CMS. Available: http://www.cms.hhs.gov/CertificationandComplianc/11_LSC.asp#TopOfPage.
In addition, we also
propose that neither a provider nor a supplier will be assessed a fee
if the visit is associated with a Federal Monitoring Survey, such as a
Federal look-behind survey.
We also propose in Sec. 488.30(b)(1)(iii) through (b)(1)(iv) that
CMS may adjust revisit user fees to account for the provider or
supplier's size, typically determined by capacity (such as the number
of beds), the number of follow-up revisits resulting from uncorrected
deficiencies, and/or the seriousness and number of deficiencies (such
as the scope and severity of cited deficiencies and the number of
deficiencies cited at each scope and severity level), as these criteria
pertain to particular provider types. These factors impact cost in that
the variance in provider/supplier size, the number of follow-up
revisits, and the type and number of deficiencies cited may have an
impact on the survey hours needed for a revisit. We also propose in
Sec. 488.30(b)(2) that CMS may adjust the fees to account for any
regional differences in cost.
We welcome public comment regarding the criteria for determining
the revisit user fee.
Section 488.30(c)--Fee Schedule
[If you choose to comment on issues in this next section, please
include the caption ``Section 488.30(c) ``FEE SCHEDULE'' at the
beginning of your comments]
We propose in Sec. 488.30(c) that CMS will publish in the Federal
Register the proposed and final notices of a uniform fee schedule
before it adopts this schedule. The proposed and final notices would
set forth the amounts of the assessed fees based on the criteria as
identified in paragraph (b) of this subpart. In future notices, any
changes to the amounts of the assessed fees would include for example,
adjustments based on increases to cost of living, labor and overhead
costs. This proposed rule also constitutes publication of the proposed
fee schedule for this fiscal year.
For FY 2007, we based user fee calculations on the type of revisit
(onsite vs. offsite); the type of provider or supplier; the average
number of hours that a revisit requires; and the average per hour cost
of a revisit. We have proposed the user fee costs below under section
IV, Regulatory Impact Analysis.
Section 488.30(d)--Collection of Fees
[If you choose to comment on issues in this next section, please
include the caption ``Section 488.30(d) COLLECTION OF FEES'' at the
beginning of your comments]
We propose in Sec. 488.30(d)(1) that fees for revisit surveys
under this paragraph may be deducted from amounts otherwise payable to
the provider or supplier. We also propose that fees will be deposited
as an offset collection to be used exclusively for survey and
certification activities conducted by State survey agencies pursuant to
section 1864 of the Act or by CMS, and will be available for CMS until
expended. We also propose that CMS may devise other collection methods
as it deems appropriate. In determining these methods, CMS will
consider efficiency, effectiveness, and convenience for the providers,
suppliers, and CMS. Methods may include: Credit card; electronic fund
transfer; check; money order; and offset of collections from claims
submitted.
We welcome public comment on the forms of payment CMS proposes it
will accept from providers and suppliers for the assessed revisit user
fee.
We propose in Sec. 488.30(d)(2) that fees for revisit surveys
under this section are not allowable items on a cost report, as
identified in part 413, subpart B of this chapter, under title XVIII of
the Act. Part 413 identifies CMS' formulating methods for making fair
and equitable reimbursement for services rendered to beneficiaries of
the program. Payment is to be made on the basis of current costs of the
individual provider, rather than costs of a past period or a fixed
negotiated rate. This cost report also designs this reimbursement
formulation so that at no time is the individual provider's costs borne
by other patients. CMS believes that the assessed revisit user fee is
not an allowable item for a cost report, as it should not be figured
into the services provided to beneficiaries, nor should it be a cost
shared amongst non-Medicare patients. CMS employs several checks and
balances to deter this from occurring. CMS believes that this proposed
language in 488.30(d)(2) would prevent the inclusion of the revisit
user fee costs in any future cost reports. This section will only apply
to a small group of providers who receive cost-based reimbursement. A
significant amount of providers and suppliers are reimbursed through
the prospective payment system (PPS).
We welcome public comment regarding the prohibition of the assessed
revisit user fee being an item on a provider or supplier cost report.
Section 488.30(e)--Reconsideration Process for Revisit User Fees.
[If you choose to comment on issues in this next section, please
include the caption ``Section 488.30(e) RECONSIDERATION PROCESS FOR
REVISIT USER FEES'' at the beginning of your comments]
We propose in Sec. 488.30(e) that a reconsideration process shall
be available to providers or suppliers that have been assessed a
revisit user fee if a provider or supplier believes an error of fact,
such as a clerical error, has been made. We also propose that a request
for reconsideration must be received by CMS within seven calendar days
from
[[Page 35678]]
the date identified on the revisit user fee assessment notice.
Once CMS has determined that a revisit user fee should be put into
effect, CMS shall notify the provider or supplier of its intention to
charge a revisit user fee and the reasons for charging the fee, and
shall give the provider or supplier an opportunity to request a
reconsideration due to an error of fact. If a provider or supplier
believes that a revisit user fee should be reconsidered, due to an
error of fact, it should submit to CMS a written statement, and any
supporting evidence, to that effect within seven calendar days, either
through its authorized officials or through its legal representative.
If, upon reconsideration, it was found that a revisit fee was
assessed due to error of fact, and the provider or supplier has made a
payment of the assessed revisit user fee, then CMS shall credit the
initial revisit payment against any future assessments of revisit fees.
CMS believes this situation will be rare. CMS believes given the
proposed time frame for which providers/suppliers have to submit this
reconsideration request (seven calendar days) and based on the proposed
regulatory obligation of payment (within 30 calendar days, as discussed
below), there would be a limited possibility that payment would be sent
without CMS providing a response to the reconsideration. In the case
that this does occur and CMS credits the initial revisit payment
against any future revisit fees, CMS will provide a refund following
its reconciliation period.
We welcome public comment on the proposed section on the
reconsideration of revisit user fees, including discussion regarding
crediting against future assessments and the provision of refunds.
Section 488.30(f)--Enforcement
[If you choose to comment on issues in this next section, please
include the caption ``Section 488.30(f) ``ENFORCEMENT'' at the
beginning of your comments]
We propose in Sec. 488.30(f) that if the full revisit user fee
payment is not received within 30 calendar days or a request for
reconsideration is not received within seven calendar days from the
date the provider or supplier receives written notice of assessment,
CMS may terminate the facility's provider agreement and enrollment in
the Medicare program or the supplier's enrollment and participation in
the Medicare program, and the provider or supplier may not seek
Medicare payment, nor be considered a Medicare participating provider
or supplier. CMS will adhere to the termination process as identified
in Sec. 489, subpart E, of this chapter.
We welcome public comment on the proposed 30 calendar provision for
receipt of full payment, and the seven calendar provision for the
receipt of request for reconsideration.
Part 489--Provider Agreements and Supplier Approval
Subpart B--Essentials of Provider Agreements
Section 489.20 Basic Commitments
Section 489.20(u)
[If you choose to comment on issues in this next section, please
include the caption ``Section 489.20(u)--BASIC COMMITMENTS'' at the
beginning of your comments]
We propose to add to Sec. 489.20 an additional paragraph that
would require a provider to agree to pay revisit user fees when and if
assessed.
Subpart E--Termination of Agreement and Reinstatement After Termination
Section 489.53 Termination by CMS
Section 489.53(a)(16)
[If you choose to comment on issues in this next section, please
include the caption ``Section 489.53(a)(16)--TERMINATION BY CMS'' at
the beginning of your comments]
We propose to add a new paragraph (16) to Sec. 489.53(a) that
would create an additional basis for termination if a provider has
failed to pay a revisit user fee when and if assessed.
III. 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.
IV. Regulatory Impact Analysis
[If you choose to comment on issues in this next section, please
include the caption ``REGULATORY IMPACT ANALYSIS'' at the beginning of
your comments]
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 1 year).
This proposed rule would not be considered a major rule. The aggregate
costs would 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. CMS
currently has limited information to separate and identify specific
providers and suppliers that may be subject to a revisit user fee by
the requirements described for purposes of the RFA. The percentage by
type of providers and suppliers that may be assessed a revisit user fee
is identified in Table A below, which discusses the overall percentage
of providers and suppliers impacted. CMS also has limited information
on the total revenues collected by provider or supplier type. CMS does
collect information regarding Medicare and Medicaid claims submitted,
however this would not provide the requisite requirements for the RFA
regarding total revenues. Based on available information in 2006 CMS
Statistics, at the time of publication, CMS does collect National level
information which includes personal health care expenditures and
payments. Personal health care includes hospital care, professional
services, nursing and home health care, all of which cover those
services provided by the provider and suppliers who may be assessed a
revisit user fee. Personal health care expenditures amounted to
$1,560.2 billion dollars in calendar year 2004 for which we have the
latest information. See U.S. Department of Health and Human Services,
Centers for Medicare & Medicaid Services. ``2006 CMS
[[Page 35679]]
Statistics.'' Online. 2006. CMS, Office of Research, Development, and
Information. Available: http://www.cms.hhs.gov/CapMarketUpdates/downloads/2006CMSStat.pdf.
(Published July 2006). Table 36, pg. 31
[``2006 CMS Statistics'']. The providers and suppliers that may be
assessed a revisit user fee would fall into the category of revenues
collected under personal health care funds. CMS notes it must compare
different year data sources, calendar year 2004 for personal health
care funds, and FY 2006 actual data to project costs for FY 2007, we
roughly estimate that the $37.3 million that would be assessed for
revisit user fees would only amount to 2.3% of the $1,560.2 million
personal health care revenues collected and only 1.9% of all national
health care expenditures of which personal health care expenditures are
included. See ``2006 CMS Statistics,'' Table 36, Pg. 31. We have
determined, and the Secretary certifies, that this proposed rule would
not have a significant impact on small entities based on the overall
effect on revenues. This is a proposed rule and we are soliciting
public comments regarding any available information that may affect the
percentage of revenues estimated with the implementation of this rule.
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 603 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 proposed 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. Based on FY
2006 actual data from CMS's Online Survey, Certification and Reporting
(OSCAR) database of the 7,139 hospitals identified 2,776 or 3.8% were
classified as rural hospitals. Of all hospitals identified 285 revisits
or 3.9% were conducted in rural hospitals to ensure that deficiencies
identified were corrected. Based on the effective time period of this
proposed rule, less than 3% of all hospitals may in fact be assessed a
revisit user fee in this current fiscal year (FY 2007), we estimate
that less than 1% of rural hospitals will be impacted by this proposed
rule. Currently CMS has limited data at this time to identify how many
of those revisits that will be conducted may be onsite versus offsite
which will determine the amount of the revisit user fee that may be
assessed. We have determined, and the Secretary certifies, that this
proposed rule would not have a significant impact on small rural
hospitals. This is a proposed rule and we are soliciting public
comments regarding any available information that may affect rural
hospitals as identified.
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 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This rule would 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
would 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 rule would not substantially affect State or local
governments. This proposed 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 proposed rule will not have a significant affect
on the rights, roles, and responsibilities of State or local
governments.
B. Impact on Providers/Suppliers
The source of the data used to estimate the number and cost of
revisit surveys is CMS's Online Survey, Certification and Reporting
(OSCAR) database. OSCAR is the repository of information about CMS and
State survey agency survey actions. Data collected include the dates of
surveys, survey findings, and the length of time that surveyors spent
conducting the survey. State survey agencies record survey time on the
CMS-670 form. Data from the CMS-670 form are entered into OSCAR by the
State survey agency. CMS analyzed average survey time length using
actual data from FY 2006.
Based on information entered into OSCAR, we propose user fees in
accordance with the type of revisit survey (onsite vs. offsite); the
type of provider or supplier; the average number of hours that a
revisit survey requires; and the average per hour cost of a revisit
survey.
Overall Effect on Providers and Suppliers
We estimate that there are 47,804 providers and suppliers. We based
this estimate on FY 2006 actual data. Of those providers and suppliers,
as identified in Table A below, based on FY 2006 actual data 34.8%
required a revisit survey, this included both onsite and offsite
revisits. Of this 34.8%, skilled nursing facilities (``SNFs'')/nursing
facilities (``NFs'') made up 87.9% whereas ambulatory surgical centers
made up a low of 2.8% of providers/suppliers that required a revisit
survey. We did not include transplant centers in FY 2006 and 2007
calculations due to lack of available cost and revisit data at this
time. Transplant centers will be newly surveyed providers starting in
FY 2008.
Table A.--Percentage of Providers/Suppliers That Had a Revisit Survey FY 2006
----------------------------------------------------------------------------------------------------------------
Number of Percent of
providers/ provider/
Total Total revisit suppliers that suppliers that
providers/ survey for FY required required
suppliers \1\ 2006 (onsite & revisit survey revisit survey
offsite) (onsite & (onsite &
offsite) offsite)
----------------------------------------------------------------------------------------------------------------
SNF/NF \2\...................................... 15,172 29,426 13,350 87.9
Hospitals \3\................................... 7,139 853 594 8.3
HHAs............................................ 8,901 1,585 1,320 14.8
Hospices........................................ 3,077 307 246 7.9
[[Page 35680]]
ASC............................................. 4,735 188 133 2.8
RHC............................................. 3,828 216 204 5.3
ESRD............................................ 4,952 929 781 15.7
---------------------------------------------------------------
Total....................................... 47,804 33,504 16,662 34.8
----------------------------------------------------------------------------------------------------------------
\1\ Providing Data Quickly (PDQ) system, Provider Summary Table, includes providers considered active at any
time in the fiscal year.
\2\ Total number does not include Medicaid-only Nursing Facilities.
\3\ Total includes accredited and non-accredited hospitals, as well as psychiatric hospitals, and critical
access hospitals.
Frequency and Duration of Revisit Surveys
There are numerous differences across providers and suppliers in
the frequency and duration of revisit surveys. Skilled nursing
facilities/nursing facilities accounted for 83 percent of total onsite
revisit surveys conducted in FY 2006 following the identification of
deficiencies from standard surveys. Home health agencies accounted for
6 percent of onsite revisit surveys in FY 2006, while ESRDs and
hospitals accounted for 8 percent, 4 percent each. Hospice facilities,
ambulatory surgical centers, and rural health clinics combined
comprised the remaining 3 percent of revisits. The average length of a
standard onsite revisit survey varied from 7.6 hours for rural health
clinics to 22.8 hours for hospitals. In comparison, offsite revisit
surveys conducted averaged one and a half hours (1.5) across all
providers and suppliers.
Proposed Fee Schedule for Onsite Revisit Surveys
We propose to base the fee schedule on the average length of time
required for revisit surveys by provider or supplier type in FY 2006.
Averages were calculated separately by type of provider or supplier,
and the hours for revisit surveys were separated by either standard
health surveys, complaint surveys, or offsite surveys. A cost of $100
per hour was incurred in FY 2005, which was the basis of the costs
estimates in the Continuing Resolution. We project that the actual cost
in FY 2007 based on inflation factors and processing expenses is $112
per hour and we would use this projected cost in setting the fee
schedule. In order to obtain this inflation factor, CMS utilized FY
2005 annual expenditures derived from CMS-435 form that captures a
State's cumulative expenditures and divided this by information
obtained from CMS-670 form that identifies State's workload hours or
survey hours, as discussed above. The product of this calculation
resulted in dollars per hour or cost incurred for conducting surveys.
CMS then took this number and multiplied this by a composite rate of
inflation that was obtained from percentage change calculations
identified in annual and semi-annual indexes prepared by the U.S.
Department of Labor's Consumer Price Index for Wage Earners and
Clerical Workers (CPI-W). See U.S. Department of Labor, Bureau of Labor
Statistics. Summary of Annual and Semi-Annual Indexes. Online. 2007.
Bureau of Labor Statistics. Available: http://www.bls.gov/ro3/fax_9125.htm
[22 Feb 2007]. In our proposed fee schedule, the $112 average
cost per hour is then multiplied by the average hours for the revisit
surveys to achieve the average fee cost per onsite revisit survey as
identified in Table B below. For Fiscal Year 2007, we will not adjust
fees based on the length of individual revisit surveys, but will assess
a flat fee per revisit survey, based on provider or supplier type. We
expect these costs to increase annually to incorporate economic
changes, cost of living increases, labor and overhead costs expenses.
All revisit user fees will be assessed in the last quarter of FY
2007. Revisit user fees will be assessed if a revisit survey is
determined necessary.
Table B.--Revisit User Fee Assessed Based on Average Length of Onsite
Revisit Surveys *
------------------------------------------------------------------------
Average length Fee assessed
of onsite per revisit
Facility revisit survey survey (hrs x
(hrs) $112)
------------------------------------------------------------------------
SNF/NF.................................. 18.5 $2,072
Hospitals............................... 22.8 2,554
HHA..................................... 14.4 1,613
Hospice................................. 15.5 1,736
ASC..................................... 14.9 1,669
RHC..................................... 7.6 851
ESRD.................................... 13.3 1,490
------------------------------------------------------------------------
* This includes onsite revisit surveys according to both Standard Health
Surveys and Complaint Surveys.
Proposed Fee Schedule for Offsite Revisit Surveys
For offsite revisit surveys, we expect a revisit user fee of $168
assessed despite provider or supplier type. Based again on recorded
survey time on the CMS-670 form, it was assessed that offsite revisit
surveys on average take one and a half hours (1.5) across all providers
and suppliers. We calculated the base hourly fee of $112 multiplied by
an average of one and a half hours
[[Page 35681]]
to arrive at the $168 fee assessed per offsite revisit survey.
All revisit user fees will be assessed in the last quarter of FY
2007. Revisit user fees will be assessed if a revisit survey is
determined necessary.
Costs for all Revisit User Fees Assessed
We expect the combined costs for all providers and suppliers for
all revisit surveys for FY 2007 to be a little under $37.3 million.
Onsite revisit surveys will total a little under $34.6 million and
offsite revisit surveys will total approximately $2.7 million. The rule
would take effect the date of publication of the final rule. We provide
below an explanation for quarterly costs listed in Tables C and D.
In Table C below, we provide the projected quarterly costs for the
final quarter of FY 2007. We expect the combined costs for all
providers and suppliers for all onsite revisit surveys for one quarter
to total approximately $8.6 million. We first utilized the total number
of onsite revisit surveys for FY 2006, took the expected revisit user
fees assessed per revisits as calculated in Table B above estimated by
provider or supplier and multiplied this number by the number of onsite
revisit surveys expected for one quarter. We then totaled all providers
and suppliers to achieve the total quarterly costs for all onsite
revisit surveys.
Table C.--Estimated Quarterly Costs for Onsite Revisit Surveys
----------------------------------------------------------------------------------------------------------------
Fee assessed
Number of per onsite Number of Total costs
onsite revisit revisit onsite revisit for onsite
Facility surveys (FY surveys (hrs x surveys est. revisit
2006) $112) (see for quarter* surveys for
Table B) quarter
----------------------------------------------------------------------------------------------------------------
SNF & NF........................................ 14,288 $2,072 3,572 $7,401,184
Hospitals....................................... 575 2,554 144 367,776
HHA............................................. 1,068 1,613 267 430,671
Hospice......................................... 256 1,736 64 111,104
ASC............................................. 95 1,669 24 40,056
RHC............................................. 149 851 37 31,487
ESRD............................................ 698 1,490 175 260,750
---------------------------------------------------------------
Total....................................... 17,129 .............. 4,283 8,643,028
----------------------------------------------------------------------------------------------------------------
* Total number of onsite revisit surveys divided by 4 and rounded up based on FY 2006 actual data.
We expect the combined costs for all providers and suppliers for
all offsite revisit surveys to total $687,960. In Table D below, we
first estimated by provider or supplier the number of offsite revisit
surveys expected for one quarter and multiplied this number by the
expected revisit user fee of $168 per offsite revisit survey as
discussed above. We then totaled all providers and suppliers to achieve
the total costs for all offsite revisit surveys for one quarter.
Table D.--Estimated Quarterly Costs for Offsite Revisit Surveys
----------------------------------------------------------------------------------------------------------------
Number of Fee assessed Number of Total costs
offsite per offsite offsite for offsite
Facility revisit revisit revisit revisit
surveys (FY surveys ($112 surveys est. surveys for
2006) x 1.5 hrs.) for quarter * quarter
----------------------------------------------------------------------------------------------------------------
SNF & NF........................................ 15,138 $168 3,785 $635,880
Hospitals....................................... 278 168 70 11,760
HHA............................................. 517 168 129 21,672
Hospice......................................... 51 168 13 2,184
ASC............................................. 93 168 23 3,864
RHC............................................. 67 168 17 2,856
ESRD............................................ 231 168 8 9,744
---------------------------------------------------------------
Total....................................... 16,375 .............. 4,095 687,960
----------------------------------------------------------------------------------------------------------------
* Total number of offsite revisit surveys divided by 4 and rounded up based on FY 2006 actual data.
As shown in Table E below, we provide the total costs expected for
FY 2007, as well as the costs we expect to offset in the final quarter
of this fiscal year by assessing Revisit User Fees for revisit surveys
conducted.
Table E.--Total Costs Combined for All Revisits Surveys per Fiscal Year
& Quarter
------------------------------------------------------------------------
Last quarter
FY 2007 FY 2007 *
------------------------------------------------------------------------
Onsite Revisit Surveys.................. $34,565,760 $8,643,028
Offsite Revisit Surveys................. 2,751,000 687,960
-------------------------------
Total Costs All Revisits............ 37,316,760 9,330,988
------------------------------------------------------------------------
* Last quarter FY 2007 costs are based on quarterly revisit surveys
rounded up to the nearest whole number as shown in Table C & D,
multiplying Table E last quarter numbers in column 2 by 4 would create
a slightly larger cost than identified in FY 2007 column 1 above.
[[Page 35682]]
As discussed above, we have excluded Medicaid-only facilities,
comprehensive outpatient rehabilitation facilities, providers of
outpatient physical therapy or speech pathology services, independent
laboratories, portable x-ray centers, physical therapists in
independent practice, federally qualified health centers, and
chiropractors in all proposed rate-setting calculations.
We also expect that the revisit user fee would have some effect in
motivating providers and suppliers to improve quality, or if quality
problems do occur, to ensure that quality lapses are corrected more
quickly than in the past. Both of these positive effects would result
in fewer revisit surveys being necessary. However, CMS does acknowledge
that the revisit user fee may have a counter effect of prompting
providers or suppliers to engage in the informal dispute resolution
process to dispute State survey agency decisions more frequently in
order to avoid the assessment of a fee.
We welcome public comment including data on any additional time and
costs burden that may affect the public by the assessment of a revisit
user fee.
C. Alternatives Considered
The revisit user fee in the Continuing Resolution addresses
important resource issues in the Medicare survey and certification
programming budget. To implement this revisit user fee process, CMS is
required to promulgate a proposed regulation and proposed fee schedule.
CMS has attempted through a variety of methods to address ways of
providers and suppliers to improve quality and thus decrease the need
to conduct revisit surveys for deficiencies cited prior to the
inclusion of a revisit user fee included in the FY 2007 Continuing
Resolution. CMS continues to conduct outreach and educational efforts,
quality analysis studies, and review of current regulatory requirements
to focus in on health and safety measures. In its outreach efforts, CMS
staff continue to present at trade association meetings representing
home health agencies, hospices, Skilled nursing facilities/nursing
facilities, and other large accreditation organizations. CMS staff
speak to new developments within survey and certification policy,
updating of regulations, and expectations that CMS has for those
providing services to its Medicare beneficiaries. CMS in its continued
outreach and educational efforts surrounding health and safety
requirements regularly posts and shares any modification of policies or
program on its CMS survey and certification Web site and through its
survey and certification online course delivery systems. See U.S.
Centers for Medicare & Medicaid Services. ``Certification &
Compliance.'' Online. 2007. CMS. Available: http://www.cms.hhs.gov/SurveyCertificationEnforcement/01_Overview.asp.
CMS also devoted a
substantial part of the work of the Quality Improvement Organizations
(QIOs) to educate providers and suppliers on best practices and
expectations for meeting Federal health and safety requirements.
Despite these efforts, there continue to be many providers and
suppliers that fail to meet Medicare conditions of participation,
conditions for coverage or requirements and require revisit surveys to
ensure compliance with Federal quality of care requirements. In
addition, costs for these revisits continue to increase. CMS believes
that the assessment of revisit user fees, as directed in the Continuing
Resolution, is a piece of the larger efforts to address health care
providers and suppliers that have failed to comply with Federal quality
of care requirements.
We welcome public comment that would provide some additional
insight on other methods that would help to decrease the need for
conducting revisits. We welcome input that would address those
providers or suppliers who continue to fail to meet Federal quality of
care requirements and how we can work collaboratively to ensure quality
of care for Medicare beneficiaries. We also seek data or other
supported sources that may identify and help to solve the concerns
regarding quality and other policy avenues.
In accordance with Executive Order 12866, this proposed rule has
been reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare, Reporting and recordkeeping requirements.
42 CFR Part 488
Administrative practice and procedure, Health facilities, Medicare,
Reporting and Recording requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR Chapter IV, parts 424,
488, and 489 as set forth below:
PART 424--CONDITIONS FOR MEDICARE PAYMENT
1. The authority citation for part 424 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act,
unless otherwise noted (42 U.S.C. 1302 and 1395hh).
Subpart P--Requirements for Establishing and Maintaining Medicare
Billing Privileges
2. Section 424.535 is amended by revising paragraph (a)(1)
introductory text to read as follows:
Sec. 424.535 Revocation of enrollment and billing privileges in the
Medicare program.
(a) * * *
(1) Noncompliance. The provider or supplier is determined not to be
in compliance with the enrollment requirements described in this
section, or in the enrollment application applicable for its provider
or supplier type, and has not submitted a plan of corrective action as
outlined in part 488 of this chapter. The provider or supplier may also
be determined not to be in compliance if it has failed to pay any user
fees as assessed under part 488 of this chapter. All providers and
suppliers are granted an opportunity to correct the deficient
compliance requirement before a final determination to revoke billing
privileges.
* * * * *
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
1. The authority citation for part 488 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act,
unless otherwise noted (42 U.S.C. 1302 and 1395hh).
Subpart A--General Provisions
2. Part 488, subpart A is amended by adding a new Sec. 488.30 to
read as follows:
Sec. 488.30 Revisit user fee for revisit surveys.
(a) Definitions. As used in this section, the following definitions
apply:
Certification (both initial and recertification) means those
activities as defined in Sec. 488.1.
Complaint surveys means those surveys conducted on the basis of a
substantial allegation of noncompliance, as defined in Sec. 488.1.
Provider of services, provider, or supplier as defined in Sec.
488.1, and ambulatory surgical centers and transplant centers subject
to Sec. 416.2 and Sec. 482.70 of this chapter, respectively,
[[Page 35683]]
will be subject to user fees unless otherwise exempted.
Revisit survey means a survey performed with respect to a provider
or supplier cited for deficiencies during an initial certification,
recertification, or substantiated complaint survey and that is designed
to evaluate the extent to which previously-cited deficiencies have been
corrected and the provider or supplier is in substantial compliance
with applicable conditions of participation, requirements, or
conditions for coverage. Revisit surveys include both offsite and
onsite review.
Substantiated complaint survey means a complaint survey that
results in the proof or finding of noncompliance at the time of the
survey, a finding that noncompliance was proven to exist, but was
corrected prior to the survey, and includes any deficiency that is
cited during a complaint survey, whether or not the cited deficiency
was the original subject of the complaint.
(b) Criteria for determining the fee. (1) The provider or supplier
will be assessed a revisit user fee based upon one or more of the
following:
(i) The average cost per provider or supplier type.
(ii) The type of revisit survey conducted (onsite or offsite).
(iii) The size of the provider or supplier.
(iv) The number of follow-up revisits resulting from uncorrected
deficiencies.
(v) The seriousness and number of deficiencies.
(2) CMS may adjust the fees to account for any regional differences
in cost.
(c) Fee schedule. CMS will publish in the Federal Register the
proposed and final notices of a uniform fee schedule before it adopts
this schedule. The notices will set forth the amounts of the assessed
fees based on the criteria as identified in paragraph (b) of this
subpart.
(d) Collection of fees. (1) Fees for revisit surveys under this
section may be deducted from amounts otherwise payable to the provider
or supplier. As they are collected, fees will be deposited as an offset
collection to be used exclusively for survey and certification
activities conducted by State survey agencies pursuant to section 1864
of the Act or by CMS, and will be available for CMS until expended. CMS
may devise other collection methods as it deems appropriate. In
determining these methods, CMS will consider efficiency, effectiveness,
and convenience for the providers, suppliers, and CMS. Methods may
include: Credit card; electronic fund transfer; check; money order; and
offset collections from claims submitted.
(2) Fees for revisit surveys under this section are not allowable
items on a cost report, as identified in part 413, subpart B of this
chapter, under title XVIII of the Act.
(e) Reconsideration process for revisit user fees. CMS will review
revisit user fees if a provider or supplier believes an error of fact
has been made, such as clerical errors. A request for reconsideration
must be received by CMS within seven calendar days from the date
identified on the revisit user fee assessment notice.
(f) Enforcement. If the full revisit user fee payment is not
received within 30 calendar days from the date the provider or supplier
receives notice of assessment, CMS may terminate the facility's
provider agreement and enrollment in the Medicare program or the
supplier's enrollment and participation in the Medicare program.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
3. The authority citation for part 489 continues to read as
follows:
Authority: Secs. 1102, 1819, 1861, 1864(m), 1866, 1869, and 1871
of the Social Security Act, 42 U.S.C. 1302, 1395i-3, 1395x,
1395aa(m), 1395cc, 1395ff, and 1395hh).
Subpart B--Essentials of Provider Agreements
4. Section 489.20 is amended by adding a new paragraph (u) to read
as follows:
Sec. 489.20 Basic commitments.
* * * * *
(u) To comply with Sec. 488.30 of this chapter, to pay revisit
user fees when and if assessed.
5. Section 489.53 is amended by adding a new paragraph (a)(16) to
read as follows:
Sec. 489.53 Termination by CMS.
(a) * * *
(16) It has failed to pay a revisit user fee when and if assessed.
* * * * *
(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: April 9, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: June 6, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07-3196 Filed 6-26-07; 4:00 pm]
BILLING CODE 4120-01-P