[Federal Register Volume 70, Number 149 (Thursday, August 4, 2005)]
[Proposed Rules]
[Pages 44879-44882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 402

[CMS-6019-P]
RIN 0938-AN48


Medicare Program; Revised Civil Money Penalties, Assessments, 
Exclusions, and Related Appeals Procedures

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule sets forth the general requirements and 
procedures that would allow certain entities who are identified for 
exclusion from the Medicare program to request that CMS act on their 
behalf to recommend to the Inspector General that their exclusion from 
Medicare be waived because of a hardship that would result on Medicare 
beneficiaries. This proposed rule would implement section 949 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA).

DATES: To be assured consideration, comments must be received at the 
appropriate address, as provided below, no later than 5 p.m. on October 
3, 2005.

ADDRESSES: In commenting, please refer to file code CMS-6019-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By 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-6019-
P, P.O. Box 8010, Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. 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) 786-9994 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 stamp 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 could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joel Cohen, (410) 786-3349.

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-6019-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. CMS posts all electronic 
comments received before the close of the comment period on its public 
website as soon as possible after they have been received. Hardcopy 
comments received timely will 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.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The Web site address is: http://www.gpoaccess.gov/fr/index.html.

[[Page 44880]]

I. Background

[If you choose to comment on issues in this section, please include 
the caption ``BACKGROUND'' at the beginning of your comments.]

    Section 1128A of the Social Security Act (the Act) authorizes the 
Secretary of Health and Human Services to impose civil money penalties 
(CMPs), assessments, and/or exclusion from the Medicare program for 
certain health care facilities, practitioners, suppliers or other 
entities under prescribed circumstances. Exclusion, as defined in 42 
CFR 402.3, provides the ultimate enforcement tool for agencies 
attempting to establish compliance with legal and program standards, 
and is used in addition to potential civil, criminal, and/or 
administrative proceedings.
    The Congress has significantly increased both the number and types 
of circumstances under which the Secretary may impose an exclusion of a 
provider or an entity from the Medicare and State health care programs. 
The Secretary has delegated the authority for these provisions to 
either the Office of the Inspector General (OIG) or the Centers for 
Medicare & Medicaid Services (CMS). The exclusion authorities delegated 
to the OIG address fraud, misrepresentation, or falsification, while 
those delegated to us address noncompliance with programmatic or 
regulatory requirements. However, the OIG has the authority to impose 
an exclusion and to prosecute cases involving exclusions that were 
delegated to us, if CMS and the OIG jointly determine it to be in the 
interest of economy, efficiency, or effective coordination of 
activities. The determination may be made either on a case-by-case 
basis, or for all cases brought under a particular listed authority.
    On December 14, 1998, we published a final rule (63 FR 68687) 
delineating the procedures for pursuing CMPs and assessments. That 
final rule added a new part 402 to title 42, chapter IV of the Code of 
Federal Regulations (CFR) to incorporate our CMP and assessment 
authorities. We did not address exclusions in that final rule, but we 
did reserve subpart C to incorporate this information in the future.
    In the December 14, 1998 final rule, we indicated that our 
procedures for imposing the CMPs and assessment authorities delegated 
to us were based on the procedures that the OIG delineated in 42 CFR 
part 1003. We also made the OIG's hearing and appeal procedures set 
forth in 42 CFR part 1005 effective for the CMP, assessment, and 
exclusion authorities delegated to CMS.
    On July 23, 2004, we published a proposed rule in the Federal 
Register (69 FR 43956), delineating the procedures for pursuing 
exclusions. It is our intent to respond to the public comments we 
received from the July 3, 2004 proposed rule and this rule in a single 
final rule.
    Section 949 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended section 
1128(c)(3)(B) of the Act to indicate that, ``Subject to subparagraph 
(g), in the case of an exclusion under subsection (a), the minimum 
period of exclusion shall not be less than 5 years, except that, upon 
the request of the administrator of a Federal health care program (as 
defined in section 1128B(f)) who determines that the exclusion would 
impose a hardship on individuals entitled to benefits under Part A of 
title XVIII or enrolled under Part B of such title, or both, the 
Secretary may, after consulting with the Inspector General of the 
Department of Health and Human Services, waive the exclusion under 
subsection (a)(1), (a)(3), or (a)(4) with respect to that program in 
the case of an individual or entity that is the sole community 
physician or sole source of essential specialized services in the 
community.'' The Conference Agreement accompanying the MMA clarifies 
the intent of the statutory requirement that a hardship determination 
be made before a waiver is approved.

II. Provisions of the Proposed Rule

    [If you choose to comment on issues in this section, please 
include the caption ``PROVISIONS OF THE PROPOSED RULE'' at the 
beginning of your comments.]

    This proposed rule would amend part 402, by adding to subpart C, a 
new section that establishes the general requirements and procedures 
concerning our authority to request a waiver of exclusion, for an 
excluded person, from Medicare exclusions that are imposed by the OIG.
    Specifically, we are proposing to add the following provision to 
subpart C:
     Section 402.308, Waivers of Exclusions.
    This section provides the basis and purpose for the excluded person 
to make a request to us. This subpart also sets forth the requirements 
that must be met by the excluded person in order for us to make a 
request to the OIG of a waiver to the exclusion. The statute specifies 
the basis upon which a request of waiver for an exclusion must be 
based, but provides few details regarding the administrative decision-
making process.
    We will consider any supportive information submitted by the 
respondent. We will not limit nor suggest what type of information may 
be presented. However, while the burden to present convincing 
information is left to the discretion of the respondent, we will 
initiate our own validation of the facts presented. During this 
analysis, we may require the person to furnish additional, specific 
information, and authorization to obtain information from private 
health insurers, peer review organizations (including, but not limited 
to, Quality Improvement Organizations), and others as necessary to 
determine the validity of the facts provided.
    It is our interpretation that unless a hardship (defined for 
purposes of Sec.  402.308 as something that negatively affects Medicare 
beneficiaries and results from the imposition of an exclusion, because 
the excluded person is the sole community physician or sole source of 
essential specialized services in the Medicare community) is met, no 
requests for a waiver of Medicare exclusion will be considered or 
forwarded to the OIG by CMS. Our decision is not subject to 
administrative or judicial review. Furthermore, a request made by CMS 
to the OIG does not automatically grant a waiver. The final decision is 
that of the OIG as defined in Sec.  1001.1801 of the OIG's regulations.

III. Collection of Information Requirements

    The collection of information requirements at 5 CFR part 1320 are 
applicable to requirements affecting 10 or more entities. While this 
proposed rule contains information collection requirements, because we 
believe that these requirements will affect less than 10 entities, we 
believe that these collection requirements are exempt from OMB for 
review and approval, as specified at 5 CFR 1320.3(c)(4). Consequently, 
this proposed rule need not be reviewed by the Office of Management and 
Budget under the authority of the Paperwork Reduction Act of 1995.

IV. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, 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, if we proceed with a subsequent 
document, we will

[[Page 44881]]

respond to the major comments in the preamble to that document.

V. Regulatory Impact Statement

    We have examined the impacts of this proposed 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), Executive Order 13132 (August 4, 1999, Federalism), and the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532).
    Executive Order 12866 directs agencies taking ``significant 
regulatory action'' to reflect consideration of 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 is not a 
significant regulatory action as defined by section 3(f) of Executive 
Order 12866. We believe that there are no significant costs associated 
with this proposed rule that would impose any mandates on State, local 
or tribal governments, or the private sector that would result in an 
expenditure of $100 million in any given year. Since most program 
participants comply with the statutory and regulatory requirements 
making unnecessary the imposition of an exclusion from Medicare, 
Medicaid and, where applicable, other Federal health care programs, we 
do not anticipate more than a de minimis economic impact as a result of 
this proposed rule. Further, any impact that may occur would only 
affect those limited few individuals or entities that engage in 
prohibited behavior. We do not anticipate any savings or costs as a 
result of this proposed rule.
    The RFA (15 U.S.C. 603(a)), as modified by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121), 
requires agencies to determine whether the proposed rule would have a 
significant economic impact on a substantial number of small entities 
and, if so, to identify in the notice of proposed rulemaking any 
regulatory options that could mitigate the impact of the proposed 
regulation on small businesses. For purposes of the RFA, small entities 
include small businesses, nonprofit organizations, and small government 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
$26 million or less annually. Individuals and States are not included 
in the definition of a small entity. We believe that any impact as a 
result of the proposed rule would be minimal, since, as mentioned 
above, the only individuals or entities affected would be those limited 
few who have engaged in prohibited conduct and were excluded from the 
Medicare program by the OIG. Since the vast majority of program 
participants comply with statutory and regulatory requirements and are 
not excluded from the Medicare program, any aggregate economic impact 
would not be significant.
    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 and has fewer than 100 beds. We do not believe a 
regulatory impact analysis is required here because, for the reasons 
stated above concerning our obligations under the RFA and SBREFA, this 
proposed rule would not have a significant impact on the operations of 
a substantial number of 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 that may result in expenditure in any 1 year by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $110 million. We believe that there are no significant costs 
associated with this technical rule that would impose any mandates on 
State, local, or tribal governments, or the private sector that would 
result in an expenditure of $110 million in any given year.
    As was previously mentioned, since the majority of program 
participants comply with statutory and regulatory requirements and are 
not excluded from the Medicare program, any aggregate economic impact 
would not be significant.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it publishes 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. We have determined that this proposed rule would not 
significantly affect the rights, roles, or responsibilities of the 
States. This rule would not impose substantial direct requirement costs 
on State or local governments, preempt State law, or otherwise 
implicate Federalism.
    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget reviewed this regulation.

List of Subjects in 42 CFR Part 402

    Administrative practice and procedure, Health facilities, Health 
professions, Medicaid, Medicare, Penalties.

    For the reasons stated in the preamble, the Centers for Medicare & 
Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 402--CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS

Subpart C--Exclusions

    1. The authority citation for part 402 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

    2. Part 402, subpart C is amended by adding Sec.  402.308 to read 
as follows:


Sec.  402.308  Waivers of exclusions.

    (a) Basis. Section 1128(c)(3)(B) of the Act specifies that in the 
case of an exclusion from participation in the Medicare program based 
upon section 1128(a)(1), (a)(3), or (a)(4) of the Act, the individual 
may request that CMS present, on his or her behalf, a request to the 
OIG for a waiver of the exclusion.
    (b) Definition. For purposes of this part:
    (1) Excluded person has the same meaning as a ``person'' as defined 
in Sec.  402.3 who meets for the purposes of this subpart, the 
definition of the term ``exclusion'' in Sec.  402.3.
    (2) Hardship for purposes of this section means something that 
negatively affects Medicare beneficiaries and results from the 
imposition of an exclusion, because the excluded person is the sole 
community physician or sole source of essential specialized services in 
the Medicare community.
    (c) General rule. If CMS determines that a hardship as defined in 
paragraph (b)(2) of this section results from exclusion of an affected 
person from the Medicare program, CMS may consider and may make a 
recommendation to the Inspector General for waiver of the Medicare 
exclusion.
    (d) Submission and content of a waiver of exclusion request. An 
excluded person must submit a request for waiver of exclusion in 
writing to CMS that includes the following:

[[Page 44882]]

    (1) A copy of the exclusion notice from the OIG.
    (2) A statement requesting that CMS present a waiver of exclusion 
request to the OIG on his or her behalf.
    (3) A statement that he or she is the sole community physician or 
sole source of essential specialized services in the community.
    (4) Documentation to support the statement in paragraph (d)(3) of 
this section.
    (e) Processing of waiver of exclusion requests. CMS processes a 
request for a waiver of exclusion as follows:
    (1) Notifies the submitter that the waiver of exclusion request has 
been received.
    (2) Reviews and validates all submitted documents.
    (3) During its analysis, CMS may require additional, specific 
information, and authorization to obtain information from private 
health insurers, peer review organizations (including, but not limited 
to, Quality Improvement Organizations), and others as necessary to 
determine validity.
    (4) Makes a determination regarding whether or not to submit the 
waiver of exclusion request to the OIG based on review and validation 
of the submitted documents.
    (5) If CMS elects to submit the waiver of exclusion request to the 
OIG, CMS copies the excluded person on the request.
    (6) If CMS denies the request, then CMS notifies the excluded 
person of the decision and specifies the reason(s) for the decision.
    (f) Administrative or judicial review. A determination rendered 
under paragraph (e)(3) of this section is not subject to administrative 
or judicial review.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: April 8, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 15, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-15291 Filed 8-3-05; 8:45 am]
BILLING CODE 4120-01-P