[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Proposed Rules]
[Pages 61229-61230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27117]
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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: Notification 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 (HIPAA), this annual
notification solicits proposals and recommendations for developing new,
and modifying existing, safe harbor provisions under the Federal anti-
kickback statute (Sec. 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 26,
2018.
ADDRESSES: In commenting, please refer to file code OIG-127-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,
please):
1. Electronically. You may submit electronic comments on specific
recommendations and proposals through the Federal eRulemaking Portal at
http://www.regulations.gov.
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-127-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 your written
comments by hand or courier 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 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) 619-1368.
For information on viewing public comments, please see the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Patrice Drew, Regulatory Affairs
Liaison, Office of Inspector General, (202) 619-1368.
SUPPLEMENTARY INFORMATION:
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-127-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 in a timely manner will also
be available for public inspection as they are received at the 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
[[Page 61230]]
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 Sec. 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 periodically issues Special Fraud Alerts to give continuing
guidance to health care providers with respect to practices OIG
considers to be suspect or of particular concern. 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 website and are intended
for extensive distribution.
In developing Special Fraud Alerts, OIG relies on a number of
sources and consults directly with experts in the subject field,
including those within OIG, other agencies of the U.S. Department of
Health and Human Services (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 Sec. 205 (the Act), Sec.
1128D, 42 U.S.C. 1320a-7d, requires the Department to develop and
publish an annual notification 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 U.S. 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 notification for
developing new safe harbors and Special Fraud Alerts on December 28,
2016 (81 FR 95551). As required under section 205 of the Act, a status
report of the proposals OIG received for new and modified safe harbors
in response to that solicitation notification is set forth in Appendix
F of OIG's Fall 2017 Semiannual Report to Congress.\1\ OIG is not
seeking additional public comment on the proposals listed in Appendix F
at this time. Rather, this notification seeks additional
recommendations regarding the development of new or modified safe
harbor regulations and new Special Fraud Alerts beyond those summarized
in Appendix F.
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\1\ The OIG Semiannual Report to Congress can be accessed
through the OIG website at http://oig.hhs.gov/publications/semiannual.asp.
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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.
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
the ability of health care facilities to provide services
in medically underserved areas or to medically underserved populations.
In addition, we will 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 12, 2017.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2017-27117 Filed 12-26-17; 8:45 am]
BILLING CODE 4152-01-P