Solicitation of New Safe Harbors and Special Fraud Alerts

CourtInspector General Office
Citation86 FR 71611
Publication Date17 December 2021
Record Number2021-27314
Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)
[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
                [Proposed Rules]
                [Pages 71611-71612]
                From the Federal Register Online via the Government Publishing Office []
                [FR Doc No: 2021-27314]
                Office of Inspector General
                42 CFR Part 1001
                Solicitation of New 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 February 15, 2022.
                ADDRESSES: In commenting, please refer to file code OIG-1121-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
       Follow the ``Submit a comment''
                instructions and refer to file code OIG-1121-N.
                 2. By regular, express, or overnight mail. You may send written
                comments to the following address: OIG, Regulatory Affairs, HHS,
                Attention: OIG-1121-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: Samantha Flanzer, Office of Inspector
                General, (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: Follow the search instructions
                on that website to view public comments.
                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, the referral for
                or purchase 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 fines 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
                [[Page 71612]]
                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 Federal anti-kickback statute.
                The safe harbor regulations promulgated by OIG are found at 42 CFR part
                 \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).
                B. OIG Special Fraud Alerts
                 OIG periodically issues Special Fraud Alerts to give continuing
                guidance to health care industry stakeholders regarding practices 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: Speaker Programs (Nov. 16,
                2020), available at
                 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 Special Fraud
                 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
                II. Solicitation of Additional New Recommendations and Proposals
                 OIG seeks recommendations regarding the development of additional
                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 the Request
                for Information entitled ``OIG Modernization Initiative To Improve Its
                Publicly Available Resources,'' published in the Federal Register on
                September 24, 2021 (RFI).\4\ Commenters need not duplicate comments
                submitted in response to OIG's RFI.
                 \4\ OIG, OIG Modernization Initiative To Improve Its Publicly
                Available Resources--Request for Information, 86 FR 53072 (Sept. 24,
                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 additional 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 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 2, 2021.
                Christi A. Grimm,
                Principal Deputy Performing Duties of the Inspector General.
                [FR Doc. 2021-27314 Filed 12-16-21; 8:45 am]
                BILLING CODE 4152-01-P

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