Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Proposed Rules 93545 

1See, 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). 

2Medicare and State Health Care Programs: Fraud 

and Abuse; OIG Anti-Kickback Provisions, 56 FR 

35952, 35958 (July 29, 1991). 

3See, 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. 

6 Program Description’’, and any other 

materials submitted as part of the 

program revision application or as 

amendment thereto. 

[FR Doc. 2024–27638 Filed 11–25–24; 8:45 am] 

BILLING CODE 6560–50–P 

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 socalled 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 antikickback statute. The safe harbor 

regulations promulgated by OIG 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 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. 

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 antikickback 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
93546 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Proposed Rules 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1