Service Regulations Committee Meeting, 71869-71870 [E7-24588]
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Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Proposed Rules
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, the Medicare and
Medicaid Patient and Program
Protection Act of 1987, section 14 of
Public Law 100–93, specifically
required the development and
promulgation of regulations, the socalled ‘‘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.
Existing OIG safe harbors describing
those practices that are sheltered from
liability are codified in 42 CFR part
1001.
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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.
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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 Public Law 104–191
Section 205 of Public Law 104–191
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 Public Law 104–191,
OIG last published a Federal Register
solicitation notice for developing new
safe harbors and Special Fraud Alerts on
December 11, 2006 (71 FR 71501). As
required under section 205, a status
report of the public comments received
in response to that notice is set forth in
Appendix D to the OIG’s Semiannual
Report covering the period April 1,
2007, through September 30, 2007.1 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
safe harbor regulations and new Special
Fraud Alerts beyond those summarized
in Appendix D to the OIG Semiannual
Report referenced above.
71869
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.
Daniel R. Levinson,
Inspector General.
[FR Doc. E7–24579 Filed 12–18–07; 8:45 am]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
A. Criteria for Modifying and
Establishing Safe Harbor Provisions
50 CFR Part 20
In accordance with section 205 of
HIPAA, we will consider a number of
factors in reviewing proposals for new
Service Regulations Committee
Meeting
1 The
OIG Semiannual Report can be accessed
through the OIG web site at https://oig.hhs.gov/
publications/semiannual.html.
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Fish and Wildlife Service,
Interior.
ACTION: Notice of meeting.
AGENCY:
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Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Proposed Rules
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SUMMARY: The Fish and Wildlife Service
(hereinafter Service) will conduct an
open meeting on January 30, 2008, to
identify and discuss preliminary issues
concerning the 2008–09 migratory bird
hunting regulations.
DATES: The meeting will be held January
30, 2008.
ADDRESSES: The Service Regulations
Committee will meet at the Embassy
Suites Hotel, Denver—International
Airport, 7001 Yampa Street, Denver,
Colorado, (303) 574–3000.
FOR FURTHER INFORMATION CONTACT:
Robert Blohm, Chief, Division of
Migratory Bird Management, U.S. Fish
and Wildlife Service, Department of the
Interior, ms–4107–ARLSQ, 1849 C
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Street, NW., Washington, DC 20240,
(703) 358–1714.
SUPPLEMENTARY INFORMATION: Under the
authority of the Migratory Bird Treaty
Act (16 U.S.C. 703–712), the U.S. Fish
and Wildlife Service regulates the
hunting of migratory game birds. We
update the migratory game bird hunting
regulations, located at 50 CFR part 20,
annually. Through these regulations, we
establish the frameworks, or outside
limits, for season lengths, bag limits,
and areas for migratory game bird
hunting. To help us in this process, we
have administratively divided the
nation into four Flyways (Atlantic,
Mississippi, Central, and Pacific), each
of which has a Flyway Council.
Representatives from the Service, the
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Service’s Migratory Bird Regulations
Committee, and Flyway Council
Consultants will meet on January 30,
2008, at 8:30 a.m. to identify
preliminary issues concerning the 2008–
09 migratory bird hunting regulations
for discussion and review by the Flyway
Councils at their March meetings.
In accordance with Departmental
policy regarding meetings of the Service
Regulations Committee attended by any
person outside the Department, these
meetings are open to public observation.
Paul R. Schmidt,
Assistant Director, Migratory Birds, U.S. Fish
and Wildlife Service.
[FR Doc. E7–24588 Filed 12–18–07; 8:45 am]
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Agencies
[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)]
[Proposed Rules]
[Pages 71869-71870]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24588]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 20
Service Regulations Committee Meeting
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of meeting.
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[[Page 71870]]
SUMMARY: The Fish and Wildlife Service (hereinafter Service) will
conduct an open meeting on January 30, 2008, to identify and discuss
preliminary issues concerning the 2008-09 migratory bird hunting
regulations.
DATES: The meeting will be held January 30, 2008.
ADDRESSES: The Service Regulations Committee will meet at the Embassy
Suites Hotel, Denver--International Airport, 7001 Yampa Street, Denver,
Colorado, (303) 574-3000.
FOR FURTHER INFORMATION CONTACT: Robert Blohm, Chief, Division of
Migratory Bird Management, U.S. Fish and Wildlife Service, Department
of the Interior, ms-4107-ARLSQ, 1849 C Street, NW., Washington, DC
20240, (703) 358-1714.
SUPPLEMENTARY INFORMATION: Under the authority of the Migratory Bird
Treaty Act (16 U.S.C. 703-712), the U.S. Fish and Wildlife Service
regulates the hunting of migratory game birds. We update the migratory
game bird hunting regulations, located at 50 CFR part 20, annually.
Through these regulations, we establish the frameworks, or outside
limits, for season lengths, bag limits, and areas for migratory game
bird hunting. To help us in this process, we have administratively
divided the nation into four Flyways (Atlantic, Mississippi, Central,
and Pacific), each of which has a Flyway Council. Representatives from
the Service, the Service's Migratory Bird Regulations Committee, and
Flyway Council Consultants will meet on January 30, 2008, at 8:30 a.m.
to identify preliminary issues concerning the 2008-09 migratory bird
hunting regulations for discussion and review by the Flyway Councils at
their March meetings.
In accordance with Departmental policy regarding meetings of the
Service Regulations Committee attended by any person outside the
Department, these meetings are open to public observation.
Paul R. Schmidt,
Assistant Director, Migratory Birds, U.S. Fish and Wildlife Service.
[FR Doc. E7-24588 Filed 12-18-07; 8:45 am]
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