[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Proposed Rules]
[Pages 72953-72954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25901]
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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.
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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 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, 2023.
ADDRESSES: In commenting, please refer to file code OIG-1122-N. Because
of staff and resource limitations, we cannot accept comments by fax
transmission. You may submit comments in one of two ways (no
duplicates, please):
1. Electronically. You may submit comments electronically at
https://www.regulations.gov. Follow the ``Submit a comment''
instructions and refer to file code OIG-1122-N.
2. By regular, express, or overnight mail. You may send written
comments to the following address: OIG, Regulatory Affairs, HHS,
Attention: OIG-1122-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.
For information on viewing public comments, please see the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Susan Edwards, (202) 619-0335.
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.
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\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).
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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.
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\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.
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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
[[Page 72954]]
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 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.
Dated: November 22, 2022.
Christi A. Grimm,
Inspector General.
[FR Doc. 2022-25901 Filed 11-25-22; 8:45 am]
BILLING CODE 4152-01-P