[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Proposed Rules]
[Pages 72289-72291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27202]


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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, 
or modifying existing, safe harbor provisions under section 1128B(b) of 
the Social Security Act (the Act), (the anti-kickback statute), 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 March 2, 2020.

ADDRESSES: In commenting, please refer to file code OIG-128-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: Office of Inspector General, 
Regulatory Affairs, Department of Health and Human Services, Attention: 
OIG-128-N, Room 5527, 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.

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    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 
the following address: Office of Inspector General, Department of 
Health and Human Services, Cohen Building, Room 5527, 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) 619-0335. For 
information on the inspection of public comments, please see the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Samantha Flanzer, Office of Inspector 
General, (202) 619-0335.

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-128-N.
    Inspection of Public Comments: All comments received before the end 
of the comment period will be posted on http://www.regulations.gov for 
public viewing.

I. Background

A. OIG Safe Harbor Provisions

    Section 1128B(b) of the Act, (42 U.S.C. 1320a-7b(b), the anti-
kickback statute), provides for criminal penalties for whoever 
knowingly and willfully offers, pays, solicits, or receives 
remuneration to induce or reward the referral of business reimbursable 
under any of the Federal health care programs, as defined in section 
1128B(f) of the Act (42 U.S.C. 1320a-7b(f)). The offense is classified 
as a felony and is punishable by fines of up to $100,000 and 
imprisonment for up to 10 years. Violations of the anti-kickback 
statute also may result in the imposition of civil monetary penalties 
(CMP) under section 1128A(a)(7) of the Act (42 U.S.C. 1320a-7a(a)(7)), 
program exclusion under section 1128(b)(7) of the Act (42 U.S.C. 1320a-
7(b)(7)), and liability under the False Claims Act (31 U.S.C. 3729-33).
    Because of the broad reach of the statute, concern was expressed 
that some relatively innocuous business arrangements were covered by 
the statute and, therefore, potentially subject to criminal 
prosecution. In response, Congress enacted section 14 of the Medicare 
and Medicaid Patient and Program Protection Act of 1987, Public Law 
100-93 (section 1128B(b)(3)(E) of the Act; 42 U.S.C. 1320a-
7b(b)(3)(E)), which specifically requires the development and 
promulgation of regulations, the so-called safe harbor provisions, that 
would specify various payment and business practices that would not be 
subject to sanctions under the anti-kickback statute, even though they 
potentially may be capable of inducing referrals of business for which 
payment may be made under a Federal health care program. Since July 29, 
1991, there have been a series of final regulations published in the 
Federal Register establishing safe harbors protecting various payment 
and business practices.\1\ These 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.'' \2\ Health care providers and others may 
voluntarily seek to comply with the conditions of an applicable safe 
harbor so that they have the assurance that their payment or business 
practice will not be subject to sanctions under the anti-kickback 
statute. The safe harbor regulations promulgated by OIG are found at 42 
CFR part 1001.
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    \1\ See e.g., Medicare and State Health Care Programs: Fraud and 
Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute 
and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 
81 FR 88368 (Dec. 7, 2016).
    \2\ Medicare and State Health Care Programs: Fraud and Abuse; 
OIG Anti-Kickback Provisions, 56 FR 35952, 35958 (July 29, 1991).
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B. OIG Special Fraud Alerts

    OIG periodically issues Special Fraud Alerts to give continuing 
guidance to health care providers and other entities regarding 
practices OIG considers to be suspect or of particular concern.\3\ 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 OIG's website and 
are intended for extensive distribution.
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    \3\ See e.g., Special Fraud Alert: Physician-Owned
    Entities, 79 FR 19271 (Mar. 29, 2013).
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    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, and section 1128D of the Act 
(42 U.S.C. 1320a-7d), requires the Department to develop and publish an 
annual notification in the Federal Register formally soliciting 
proposals for developing or modifying existing safe harbors to the 
anti-kickback statute and Special Fraud Alerts.
    In developing safe harbors for the anti-kickback statute, OIG, in 
consultation with the U.S. Department of Justice, thoroughly reviews 
the range of factual circumstances that may fall within the proposed 
safe harbor subject area. In doing so, OIG seeks to identify and 
develop regulatory limitations and controls in order to permit 
beneficial and innocuous arrangements while, at the same time, 
protecting Federal health care programs and their beneficiaries from 
the harms caused by fraud and abuse.

II. Solicitation of Additional New Recommendations and Proposals

    OIG seeks recommendations regarding the development of new or 
modified safe harbor regulations and new Special Fraud Alerts. A 
detailed explanation of justifications for, or empirical data 
supporting, a suggestion for a new or modified safe harbor or Special 
Fraud Alert would be helpful and should, if possible, be included in 
any response to this solicitation.
    While OIG welcomes all relevant comments, this solicitation is 
separate and distinct from both OIG's ``Request for Information 
Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP,'' 
published on August 27, 2018 (RFI),\4\ and its notice of proposed 
rulemaking (NPRM) entitled ``Revisions To Safe Harbors Under the Anti-
Kickback Statute, and Civil Monetary Penalty Rules Regarding 
Beneficiary Inducements,'' published on October 17, 2019.\5\ Commenters 
need not duplicate comments previously submitted in response to OIG's 
RFI or NPRM.
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    \4\ Medicare and State Health Care Programs: Fraud and Abuse; 
Request for Information Regarding the Anti-Kickback Statute and 
Beneficiary Inducements CMP, 83 FR 43607 (Aug. 27, 2018).
    \5\ Medicare and State Healthcare Programs: Fraud and Abuse; 
Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil 
Monetary Penalty Rules Regarding Beneficiary Inducements, 84 FR 
55694 (Oct. 17, 2019).
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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:

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     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 influence 
their decision 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 10, 2019.
Joanne M. Chiedi,
Acting Inspector General.
[FR Doc. 2019-27202 Filed 12-30-19; 8:45 am]
BILLING CODE 4152-01-P