[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Proposed Rules]
[Pages 95551-95553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31170]



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.


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 ensure consideration, public comments must be delivered to 
the address provided below by no later than 5 p.m. on February 27, 

ADDRESSES: In commenting, please refer to file code OIG-125-N. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (fax) transmission.
    You may submit comments in one of three ways (no duplicates, 
    1. Electronically. You may submit electronic comments on specific 
recommendations and proposals through the Federal eRulemaking Portal at 
    2. By regular, express, or overnight mail. You may send written 
comments to the following address: Patrice Drew, Office of Inspector 
General, Regulatory Affairs, Department of Health and Human Services, 
Attention: OIG-125-N, Room 5541C, 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 Patrice Drew, Office of Inspector General, Department of Health and 
Human Services, Cohen Building, Room 5541C, 330

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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-
    For information on viewing public comments, please see the 

FOR FURTHER INFORMATION CONTACT: Patrice Drew, Regulatory Affairs 
Liaison, Office of Inspector General, (202) 619-1368.

    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-125-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 after the closing 
of the comment period. 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 10 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 to induce or reward business reimbursable under 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 Federal health care programs, in accordance with section 
1128(b)(7) of the Act (42 U.S.C. 1320a-7(b)(7)).
    Because 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 section 14, specifically required the development and 
promulgation of regulations, the so-called ``safe harbor'' provisions, 
specifying various payment and business practices that, although 
potentially capable of inducing referrals of business reimbursable 
under 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. OIG safe harbor 
regulations are found at 42 CFR part 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 published 
in the Federal Register and on our Web site and are intended for 
extensive distribution directly to the health care provider community, 
as well as to those charged with administering the Federal health care 
    In developing 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 section 205, the Act, section 
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 thoroughly 
reviews 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 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 23, 2015 (80 FR 
79803). As required under section 205, a status report of the proposals 
OIG received for new and modified safe harbors in response to that 
solicitation notice is set forth in Appendix F of OIG's Fall 2016 
Semiannual Report to Congress.\1\ OIG is not seeking additional public 
comment on the proposals listed in Appendix F at this time. Rather, 
this notice seeks additional recommendations regarding the development 
of new or modified safe harbor regulations and new Special Fraud Alerts 
beyond those summarized in Appendix F.

    \1\ The OIG Semiannual Report to Congress can be accessed 
through the OIG Web site at http://oig.hhs.gov/publications/semiannual.asp.

    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 

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 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 health care services, and

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     the ability of health care facilities to provide services 
in medically underserved areas or to medically underserved populations.
    In addition, we will also consider 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 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.

    Dated: December 21, 2016.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2016-31170 Filed 12-27-16; 8:45 am]