[Federal Register Volume 61, Number 252 (Tuesday, December 31, 1996)]
[Proposed Rules]
[Pages 69060-69062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-33277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
Solicitation of New Safe Harbors and Modifications to Existing
Safe Harbors
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, this notice solicits
proposals and recommendations for developing new and modifying existing
safe harbor provisions under the Medicare and State health care
programs' anti-kickback statute, 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 March 3, 1997.
ADDRESSES: Please mail or deliver your written comments to the
following
[[Page 69061]]
address: Office of Inspector General, Department of Health and Human
Services, Attention: OIG-11-N, Room 5246, Cohen Building, 330
Independence Avenue, S.W. Washington, DC 20201.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commencing, please refer
to file code OIG-11-N. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 5541 of
the Office of Inspector General at 330 Independence Avenue, S.W.,
Washington, D.C., on Monday through Friday of each week from 8:00 a.m.
to 4:30 p.m.
FOR FURTHER INFORMATION CONTACT: Joel Schaer, (202) 619-0089, OIG
Regulations Officer.
SUPPLEMENTARY INFORMATION:
I. Background
A. The OIG Safe Harbor Provisions
Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b))
provides criminal penalties for individuals or entities that knowingly
and willfully offer, pay, solicit or relieve remuneration in order to
induce business reimbursed under the Medicare or State 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.
The types of remuneration covered specifically include kickbacks,
bribes, and rebates, whether made directly or indirectly, overtly or
covertly, or in cash or in kind. In addition, prohibited conduct
includes not only remuneration intended to induce referrals of
patients, but remuneration intended to induce the purchasing, leasing,
ordering, or arranging for any good, facility, service, or item paid
for by Medicare or State health care programs.
Since the statute on its face is so broad, concern has been
expressed for many years that some relatively innocuous commercial
arrangements are technically covered by the statute and are, therefore,
subject to criminal prosecution. As a 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 so-called ``safe harbor''
provisions, designed to specify various payment and business practices
which, although potentially capable of inducing referrals of business
under the Medicare and State health care programs, would not be treated
as criminal offenses under the anti-kickback statute (section 1128B(b)
of the Social Security Act; 42 U.S.C. 1320a-7b(b)) and would not serve
as a basis for a program exclusion under section 1128(b)(7) of the
Social Security Act; 42 U.S.C. 1320a-7(b)(7). The 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 are not subject to any enforcement action under the
anti-kickback statute or program exclusion authority.
To date, the OIG has developed and codified in 42 CFR 1001.952 a
total of 13 final safe harbors that describe practices that are
sheltered from liability, and is continuing to finalize 8 additional
safe harbor provisions (see the OIG notice of proposed rulemaking at 58
FR 49008, September 21, 1993).
B. OIG Special Fraud Alerts
In addition, the OIG has also periodically issued Special Fraud
Alerts to give continuing guidance to health care providers with
respect to practices the OIG regards as unlawful. These Special Fraud
Alerts provide the OIG with a means of notifying the health care
industry that we have become aware of certain abusive practices which
we plan to pursue and prosecute, or bring civil and administrative
action, as appropriate. The Special Fraud Alerts also serve as a tool
to encourage industry compliance by giving providers an opportunity to
examine their own practices. The OIG Special Fraud Alerts are intended
for extensive distribution directly to the health care provider
community, as well as those charged with administering the Medicare and
Medicaid programs.
In developing these Special Fraud Alerts, the OIG has relied on a
number of sources and has consulted directly with experts in the
subject field, including those within the OIG, other agencies of the
Department, other Federal and State agencies, and from those in the
health care industry. To date, eight individual Special Fraud Alerts
have been issued by the OIG and subsequently reprinted in the Federal
Register on December 19, 1994 (59 FR 65372), August 10, 1995 (60 FR
40847) and June 17, 1996 (61 FR 30623)
II. Section 205 of Public Law 104-191
The Health Insurance Portability and Accountability Act of 1996,
Public Law 104-191, effective August 21, 1996, now requires the
Department to provide additional formal guidance regarding the
application of the anti-kickback statute and the safe harbor
provisions, as well as other OIG health care fraud and abuse sanctions.
Among the provisions set forth in section 205 of Public Law 104-191 is
the requirement that the Department develop and publish an annual
notice in the Federal Register formally soliciting proposals for (1)
modifying existing safe harbors, (2) developing new safe harbors and
OIG Special Fraud Alerts, and (3) issuing requests for advisory
opinions. After considering such proposals and recommendations, the
Department, in consultation with the Department of Justice, will
consider the issuance of new and modified safe harbor regulations, as
appropriate. In addition, the OIG will consider the issuance of
additional Special Fraud Alerts. Finally, in accordance with the
statute, the OIG will formally begin accepting requests for advisory
opinions on February 21, 1997. Regulations establishing the procedures
and a process for accepting and issuing advisory opinions are being
prepared for separate publication in the Federal Register and will be
issued in the near future.
Criteria for Modifying and Establishing Safe Harbor Provisions
In accordance with the statute, we will consider a number of
factors in considering 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 health care 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 the existence (or
nonexistence) of any potential financial benefit to a health care
professional or provider that may vary based on their decisions of
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.
[[Page 69062]]
Criteria for Developing Special Fraud Alerts
In determining whether to issue additional Special Fraud Alerts, we
will also consider whether, and to what extent, those practices that
would be identified in new Fraud Alerts may result in any of the
consequences set forth above, and the volume and frequency of the
conduct that would be identified in these Special Fraud Alerts.
III. Solicitation of Public Comments
In order to address the requirements of section 205 of Public Law
104-191, we are requesting public comments from affected provider,
practitioner, supplier and beneficiary representatives regarding the
development of proposed or modified safe harbor regulations and new
Special Fraud Alerts. A detailed explanation of justification or
empirical data supporting the suggestion would prove helpful in our
considering and drafting new or modified safe harbor regulations and
Special Fraud Alerts.
Dated: December 20, 1996.
June Gibbs Brown,
Inspector General, Department of Health and Human Services.
Approved: December 20, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 96-33277 Filed 12-30-96; 8:45 am]
BILLING CODE 4150-04-M