[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Proposed Rules]
[Pages 68223-68224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32806]
[[Page 68223]]
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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 (HIPAA) of 1996, this annual notice
solicits proposals and recommendations for developing new and modifying
existing safe harbor provisions under the Federal 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 February 8, 1999.
ADDRESSES: Please mail or deliver your written comments to the
following address: Office of Inspector General, Department of Health
and Human Services, Attention: OIG-31-N, Room 5246, Cohen Building, 330
Independence Avenue, S.W., Washington, D.C. 20201.
We do not accept comments by facsimile (FAX) transmission. In
commenting, please refer to file code OIG-31-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 (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 business reimbursed under the Federal
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 Federal 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 Federal and State health care programs, would not be treated
as criminal offenses under the anti-kickback statute (section 1128B(b)
of the 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 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. The OIG is also currently drafting a
comprehensive safe harbor rule that intends to finalize certain
proposals for new and clarified safe harbors that were published in the
Federal Register in 1993 and 1994 (58 FR 49008, September 21, 1993 and
59 FR 37202, July 21, 1994). The OIG is also developing an interim
final rule for the shared-risk exception to the anti-kickback statute
(section 216 of HIPAA). This rule, which will set forth two new safe
harbors, is being developed through the negotiated rulemaking process
in accordance with the requirements of HIPAA and the Federal Advisory
Committee Act.
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 serve to notify the health care industry that the OIG has become
aware of certain abusive practices that the OIG plans to pursue and
prosecute, or to 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 those in the health
care industry. To date, nine 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), June
17, 1996 (61 FR 30623) and April 24, 1998 (63 FR 20415).
C. Section 205 of Public Law 104-191
In accordance with the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191), the Department is now
required 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.
In addition to accepting and responding to requests for advisory
opinions from outside parties regarding the interpretation and
applicability of certain statutes relating to the Federal and State
health care programs, 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 accordance with this requirement,
the OIG has published notices in the Federal Register on December 31,
1996 (61 FR 69060) and on December 10, 1997 (62 FR 65049) soliciting
such proposals.
[[Page 68224]]
In developing safe harbors for a criminal statute, the OIG is
compelled to engage in a complete and thorough review of the range of
factual circumstances that may fall within the proposed safe harbor
subject area so as to uncover all potential opportunities for fraud and
abuse. Only then can the 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, the OIG is continuing to study safe harbor and Special Fraud
Alert proposals submitted in response to the annual solicitations
concerning subject areas other than those to be addressed in the safe
harbor rulemakings under development. In response to the 2 previously-
issued Federal Register solicitation notices, the OIG received 32
timely-filed responses to the 1996 notice and 17 responses to the 1997
notice. A status report of these public comments for new and modified
safe harbors is contained in Appendix G of the OIG's Semiannual Report
for the period April 1, 1998 through September 30, 1998.1
The OIG is currently taking these recommendations under advisement and
is not seeking additional public comment on those proposals at this
time. Rather, this notice seeks additional recommendations from
affected provider, practitioner, supplier and beneficiary
representatives regarding the development of proposed or modified safe
harbor regulations and new Special Fraud Alerts beyond those summarized
in Appendix G of the OIG Semiannual Report.
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\1\ The OIG Semiannual Report can be accessed through the OIG
web site at http://www.dhhs.gov/progorg/oig/semann/index.htm.
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Criteria for Modifying and Establishing Safe Harbor Provisions
In accordance with the statute, 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 effect an
increase or decrease in--
Access to health care services;
The quality of 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 health care
professionals or providers that may vary based on 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.
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 Special 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.
A detailed explanation of justifications or empirical data
supporting the suggestion, and sent to the address indicated above,
would prove helpful in our considering and drafting new or modified
safe harbor regulations and Special Fraud Alerts.
Dated: December 4, 1998.
June Gibbs Brown,
Inspector General.
[FR Doc. 98-32806 Filed 12-6-98; 8:45 am]
BILLING CODE 4150-04-P
