[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Proposed Rules]
[Pages 81556-81558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32705]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
Solicitation of New Safe Harbors and Special Fraud Alerts
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Notice of intent to develop regulations.
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SUMMARY: In accordance with section 205 of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), this annual notice
solicits proposals and recommendations for developing new and modifying
existing safe harbor provisions under the Federal anti-kickback statute
(section 1128B(b) of the Social Security Act), as well as developing
new OIG Special Fraud Alerts.
DATES: To assure consideration, public comments must be delivered to
the address provided below by no later than 5 p.m. on February 28,
2011.
ADDRESSES: In commenting, please refer to file code OIG-118-N. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
[[Page 81557]]
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
recommendations and proposals through the Federal eRulemaking Portal at
http://www.regulations.gov.
2. By regular, express, or overnight mail. You may send written
comments to the following address: Office of Inspector General,
Congressional and Regulatory Affairs, Department of Health and Human
Services, Attention: OIG-118-N, Room 5541, Cohen Building, 330
Independence Avenue, SW., Washington, DC 20201. 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 before the close of the comment period
to Office of Inspector General, Department of Health and Human
Services, Cohen Building, Room 5541, 330 Independence Avenue, SW.,
Washington, DC 20201. Because access to the interior of the Cohen
Building is not readily available to persons without Federal Government
identification, commenters are encouraged to schedule their delivery
with one of our staff members at (202) 619-1343.
For information on viewing public comments, please see the
Supplementary Information section.
FOR FURTHER INFORMATION CONTACT: Patrice Drew, Regulatory Officer,
Office of Inspector General, (202) 619-1368.
SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments
from the public on recommendations for developing new or revised safe
harbors and Special Fraud Alerts. Please assist us by referencing the
file code OIG-118-N.
Inspection of Public Comments: All comments received before the end
of the comment period are available for viewing by the public. All
comments will be posted on http://www.regulations.gov as soon as
possible after they have been received. Comments received timely will
also be available for public inspection as they are received at Office
of Inspector General, Department of Health and Human Services, Cohen
Building, 330 Independence Avenue, SW., Washington, DC 20201, Monday
through Friday from 9:30 a.m. to 5 p.m. To schedule an appointment to
view public comments, phone (202) 619-1368.
I. Background
A. OIG Safe Harbor Provisions
Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C.
1320a-7b(b)) provides criminal penalties for individuals or entities
that knowingly and willfully offer, pay, solicit, or receive
remuneration in order to induce or reward business reimbursable under
the Federal health care programs. The offense is classified as a felony
and is punishable by fines of up to $25,000 and imprisonment for up to
5 years. OIG may also impose civil money penalties, in accordance with
section 1128A(a)(7) of the Act (42 U.S.C. 1320a-7a(a)(7)), or exclusion
from the Federal health care programs, in accordance with section
1128(b)(7) of the Act (42 U.S.C. 1320a-7(b)(7)).
Since the statute on its face is so broad, concern has been
expressed for many years that some relatively innocuous commercial
arrangements may be subject to criminal prosecution or administrative
sanction. In response to the above concern, section 14 of the Medicare
and Medicaid Patient and Program Protection Act of 1987, Public Law
100-93 Sec. 14, the Act, Sec. 1128B(b), 42 U.S.C. 1320a-7b(b),
specifically required the development and promulgation of regulations,
the so-called ``safe harbor'' provisions, specifying various payment
and business practices which, although potentially capable of inducing
referrals of business reimbursable under the Federal health care
programs, would not be treated as criminal offenses under the anti-
kickback statute and would not serve as a basis for administrative
sanctions. OIG safe harbor provisions have been developed ``to limit
the reach of the statute somewhat by permitting certain non-abusive
arrangements, while encouraging beneficial and innocuous arrangements''
(56 FR 35952, July 29, 1991). Health care providers and others may
voluntarily seek to comply with these provisions so that they have the
assurance that their business practices will not be subject to
liability under the anti-kickback statute or related administrative
authorities. The OIG safe harbor regulations are found at 42 CFR 1001.
B. OIG Special Fraud Alerts
OIG has also periodically issued Special Fraud Alerts to give
continuing guidance to health care providers with respect to practices
OIG finds potentially fraudulent or abusive. The Special Fraud Alerts
encourage industry compliance by giving providers guidance that can be
applied to their own practices. OIG Special Fraud Alerts are intended
for extensive distribution directly to the health care provider
community, as well as to those charged with administering the Federal
health care programs.
In developing these Special Fraud Alerts, OIG has relied on a
number of sources and has consulted directly with experts in the
subject field, including those within OIG, other agencies of the
Department, other Federal and State agencies, and those in the health
care industry.
C. Section 205 of the Health Insurance Portability and Accountability
Act of 1996
Section 205 of the Health Insurance Portability and Accountability
Act of 1996 (HIPAA), Public Law 104-191 Sec. 205, the Act, Sec.
1128D, 42 U.S.C. 1320a-7d, requires the Department to develop and
publish an annual notice in the Federal Register formally soliciting
proposals for modifying existing safe harbors to the anti-kickback
statute and for developing new safe harbors and Special Fraud Alerts.
In developing safe harbors for a criminal statute, OIG is required
to engage in a thorough review of the range of factual circumstances
that may fall within the proposed safe harbor subject area so as to
uncover potential opportunities for fraud and abuse. Only then can OIG
determine, in consultation with the Department of Justice, whether it
can effectively develop regulatory limitations and controls that will
permit beneficial and innocuous arrangements within a subject area
while, at the same time, protecting the Federal health care programs
and their beneficiaries from abusive practices.
II. Solicitation of Additional New Recommendations and Proposals
In accordance with the requirements of section 205 of HIPAA, OIG
last published a Federal Register solicitation notice for developing
new safe harbors and Special Fraud Alerts on December 29, 2009 (74 FR
68762). As required under section 205, a status report of the public
comments received in response to that notice is set forth in an
appendix to the OIG's Semiannual Report to Congress covering the period
April 1, 2010, through September 30, 2010.\1\ OIG is not seeking
additional public comment on the proposals listed in Appendix D at this
time. Rather, this notice seeks additional recommendations regarding
the development of proposed or modified
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safe harbor regulations and new Special Fraud Alerts beyond those
summarized in an appendix to the OIG Semiannual Report referenced
above.
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\1\ The OIG Semiannual Report to Congress can be accessed
through the OIG Web site at http://oig.hhs.gov/publications/semiannual.asp.
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A. Criteria for Modifying and Establishing Safe Harbor Provisions
In accordance with section 205 of HIPAA, we will consider a number
of factors in reviewing proposals for new or modified safe harbor
provisions, such as the extent to which the proposals would affect an
increase or decrease in:
Access to health care services,
The quality of services,
Patient freedom of choice among health care providers,
Competition among health care providers,
The cost to Federal health care programs,
The potential overutilization of the health care services,
and
The ability of health care facilities to provide services
in medically underserved areas or to medically underserved populations.
In addition, we will also take into consideration other factors,
including, for example, the existence (or nonexistence) of any
potential financial benefit to health care professionals or providers
that may take into account their decisions whether to (1) order a
health care item or service or (2) arrange for a referral of health
care items or services to a particular practitioner or provider.
B. Criteria for Developing Special Fraud Alerts
In determining whether to issue additional Special Fraud Alerts, we
will also consider whether, and to what extent, the practices that
would be identified in a new Special Fraud Alert may result in any of
the consequences set forth above, as well as the volume and frequency
of the conduct that would be identified in the Special Fraud Alert.
A detailed explanation of justifications for, or empirical data
supporting, a suggestion for a safe harbor or Special Fraud Alert would
be helpful and should, if possible, be included in any response to this
solicitation.
Dated: December 22, 2010.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2010-32705 Filed 12-27-10; 8:45 am]
BILLING CODE 4152-01-P