```

[Federal Register Volume 89, Number 229 (Wednesday, November 27, 2024)]
[Proposed Rules]
[Pages 93545-93546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27710]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

Solicitation of Proposals for New and Modified Safe Harbors and 
Special Fraud Alerts

AGENCY: Office of Inspector General (OIG), Department of Health and 
Human Services (HHS or the Department).

ACTION: Notification of intent to develop regulations.

-----------------------------------------------------------------------

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 Federal anti-kickback statute, 
as well as developing new OIG Special Fraud Alerts.

DATES: To ensure consideration, public comments must be received no 
later than 5 p.m. on January 27, 2025.

ADDRESSES: You may submit comments electronically at https://www.regulations.gov. Follow the ``Submit a comment'' instructions and 
refer to file code OIG-1124-N.
    For information on viewing public comments, please see the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Benjamin Wallfisch, (202) 339-7980.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov.

I. Background

A. OIG Safe Harbor Provisions

    Section 1128B(b) of the Act (42 U.S.C. 1320a-7b(b)), the Federal 
anti-kickback statute, provides for criminal penalties for whoever 
knowingly and willfully offers, pays, solicits, or receives 
remuneration to induce or reward, among other things, referrals for or 
purchases of items or services 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 a fine of up to $100,000 and imprisonment for up to 10 
years. Violations of the Federal anti-kickback statute also may result 
in the imposition of civil monetary penalties 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, stakeholders expressed 
concern 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 (note to section 1128B of the Act; 42 U.S.C. 1320a-7b), which 
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 Federal 
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 has been a 
series of final regulations published in the Federal Register 
establishing safe harbors to protect 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 Federal anti-kickback statute. 
The safe harbor regulations promulgated by OIG are found at 42 CFR part 
1001.
---------------------------------------------------------------------------

    \1\ See, e.g., Medicare and State Health Care Programs: Fraud 
and Abuse; Revisions to Safe Harbors Under the Anti-Kickback 
Statute, and Civil Monetary Penalty Rules Regarding Beneficiary 
Inducements, 85 FR 77684 (Dec. 2, 2020).
    \2\ Medicare and State Health Care Programs: Fraud and Abuse; 
OIG Anti-Kickback Provisions, 56 FR 35952, 35958 (July 29, 1991).
---------------------------------------------------------------------------

B. OIG Special Fraud Alerts

    OIG periodically issues Special Fraud Alerts to give continuing 
guidance to health care industry stakeholders about practices that OIG 
considers to be suspect or of particular concern.\3\ Special Fraud 
Alerts encourage industry compliance by giving stakeholders guidance 
that can be applied to their own practices. OIG Special Fraud Alerts 
are published in the Federal Register, on OIG's website, or both, and 
are intended for extensive distribution.
---------------------------------------------------------------------------

    \3\ See, e.g., Special Fraud Alert: OIG Alerts Practitioners To 
Exercise Caution When Entering Into Arrangements With Purported 
Telemedicine Companies (July 20, 2022), https://oig.hhs.gov/documents/root/1045/sfa-telefraud.pdf.
---------------------------------------------------------------------------

    In developing Special Fraud Alerts, OIG relies on several sources 
and consults directly with experts in the subject field, including 
those within OIG, other agencies of HHS, 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 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 additional or modifying existing 
safe harbors to the Federal anti-kickback statute and for issuing 
Special Fraud Alerts.
    In developing or modifying safe harbors under the Federal anti-
kickback statute, and in consultation with the Department of Justice, 
OIG thoroughly reviews the range of factual circumstances that may 
receive protection by the proposed or modified safe harbor. In doing 
so, OIG seeks to identify and develop safe harbors that protect 
beneficial and innocuous arrangements and safeguard Federal health care 
programs and their beneficiaries from the harms caused by fraud and 
abuse.

II. Solicitation of New and Modified Safe Harbor Recommendations and 
Special Fraud Alert Proposals

    OIG seeks recommendations regarding the development of additional 
or modified safe harbor regulations and the issuance of new Special 
Fraud Alerts. A detailed explanation of justifications for, or 
empirical data supporting, a suggestion for a new or modified safe 
harbor or for the issuance of a new Special Fraud Alert would be 
helpful

[[Page 93546]]

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 various 
factors in reviewing proposals for additional or modified safe harbor 
provisions, such as the extent to which the proposals may result in 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 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.

Christi A. Grimm,
Inspector General.
[FR Doc. 2024-27710 Filed 11-26-24; 8:45 am]
BILLING CODE 4152-01-P
```