Federal Register: December 10, 2004 (Volume 69, Number 237)
DOCID: FR Doc 04-27117
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Inspector General Office, Health and Human Services Department
CFR Citation: 42 CFR Part 1001
NOTICE: PROPOSED RULES
ACTION: Medicare and State health programs; fraud and abuse:
DOCUMENT ACTION: Notice of intent to develop regulations.
SUBJECT CATEGORY:
Solicitation of New Safe Harbors and 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, 2005.
DOCUMENT 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' antikickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
SUMMARY:
Safe harbor provisions and special fraud alerts; intent to develop regulations,
SUPPLEMENTAL INFORMATION
I. Background
A. The OIG Safe Harbor Provisions
Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C. 1320a7b(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. The OIG may also impose civil money penalties, in accordance with section 1128A(a)(7) of the Act (42 U.S.C. 1320a7a(a)(7)), or exclusion from the Federal health care programs, in accordance with section 1128(b)(7) of the Act (42 U.S.C. 1320a7(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
10093, 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 antikickback statute and would not serve as a basis for
administrative sanctions. The OIG safe harbor provisions have been
developed ``to limit the reach of the statute somewhat by permitting
certain nonabusive arrangements, while encouraging beneficial and innocuous arrangements''
[[Page 71767]]
(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 any
enforcement action under the antikickback statute or related administrative authorities.
To date, OIG has developed and codified in 42 CFR 1001.952 a total of 22 final safe harbors that describe practices that are sheltered from liability.
B. OIG Special Fraud Alerts
The 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. The 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. To date, OIG has issued 12 individual Special Fraud Alerts.
C. Section 205 of Public Law 104191
Section 205 of Public Law 104191 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
104191, OIG last published a Federal Register solicitation notice for
developing new safe harbors and Special Fraud Alerts on December 12,
2003 (68 FR 69366). As required under section 205, a status report of
the public comments received in response to that notice is set forth in
Appendix G to the OIG's Semiannual Report covering the period April 1,
2004 through September, 30, 2004.\1\ The OIG is not seeking additional
public comment on the proposals listed in Appendix G 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 G to the OIG Semiannual Report referenced above.
\1\ The OIG Semiannual Report can be accessed through the OIG
Web site at http://oig.hhs.gov/publications/semiannual.html.
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
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. 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: November 24, 2004.
Daniel R. Levinson,
Acting Inspector General.
[FR Doc. 0427117 Filed 12904; 8:45 am]
BILLING CODE 415004P
FOR FURTHER INFORMATION CONTACT
Joel Schaer, (202) 619-0089, OIG Regulations Officer.