Proposed Rule2026-01817
Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
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Published
January 29, 2026
Issuing agencies
Health and Human Services DepartmentInspector General Office, Health and Human Services Department
Abstract
This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the "Beneficiary Inducements CMP") for emerging direct-to-consumer ("DTC") sales programs established by pharmaceutical manufacturers, including those that will be available through TrumpRx.
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<title>Federal Register, Volume 91 Issue 19 (Thursday, January 29, 2026)</title>
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[Federal Register Volume 91, Number 19 (Thursday, January 29, 2026)]
[Proposed Rules]
[Pages 3857-3860]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01817]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
42 CFR Parts 1001 and 1003
RIN 0936-AA15
Medicare and State Health Care Programs: Fraud and Abuse; Request
for Information Regarding the Federal Anti-Kickback Statute and
Beneficiary Inducements CMP
AGENCY: Office of Inspector General (OIG), Department of Health and
Human Services (HHS).
ACTION: Request for information.
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SUMMARY: This request for information seeks input from the public on
whether any additions or modifications are needed to the safe harbor
regulations under the Federal anti-kickback statute or the exceptions
to the civil monetary penalty provision prohibiting inducements to
beneficiaries (the ``Beneficiary Inducements CMP'') for emerging
direct-to-consumer (``DTC'') sales programs established by
pharmaceutical manufacturers, including those that will be available
through TrumpRx.
DATES: To ensure consideration, comments must be received no later than
5 p.m. on March 30, 2026.
ADDRESSES: Please submit comments electronically at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a comment'' instructions and
refer to file code OIG-2601-N. For information on viewing public
comments, please see the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Chris Hinkle, (202) 465-6245 or
<a href="/cdn-cgi/l/email-protection#35565d475c46415c5b541b5d5c5b5e5950755a5c521b5d5d461b525a43"><span class="__cf_email__" data-cfemail="dfbcb7adb6acabb6b1bef1b7b6b1b4b3ba9fb0b6b8f1b7b7acf1b8b0a9">[email protected]</span></a>.
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 as
soon as possible after they have been received on the following
website: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions on
that website to view public comments.
I. Introduction
Consistent with the Executive Order 14297 ``Delivering Most-
Favored-Nation Prescription Drug Pricing to American Patients,'' the
Department of Health and Human Services (``HHS'') is establishing
TrumpRx, a platform through which American patients can buy their drugs
directly from pharmaceutical manufacturers at a ``Most-Favored-Nation''
price, bypassing middlemen.\1\ TrumpRx and DTC sales prices that will
be offered to Americans by pharmaceutical manufacturers through TrumpRx
put America first by furthering efforts to get American patients and
taxpayers a fair deal for prescription drugs. Removing unnecessary
Government obstacles to ensure appropriate access to affordable
prescription drugs offered by manufacturers through DTC programs is a
key priority for HHS.
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\1\ The White House, Executive Order 14297, ``Delivering Most-
Favored-Nation Prescription Drug Pricing to American Patients'' (May
12, 2025), available at <a href="https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/">https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/</a>.
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To help accelerate the availability of affordable prescription
drugs offered through TrumpRx and other DTC programs established by
manufacturers outside of TrumpRx, HHS has launched this Request for
Information (``RFI''). The HHS Office of Inspector General (OIG) is
issuing this RFI to identify ways in which it might: (i) modify or add
new safe harbors to the Federal anti-kickback statute at 42 CFR
1001.952 and exceptions to the Beneficiary Inducements CMP's definition
of ``remuneration'' at 42 CFR 1003.110; or (ii) publish or amend other
guidance to foster arrangements that promote the affordability of and
patient access to prescription drugs offered through DTC programs,
while also protecting against harms caused by fraud and abuse. To
inform our efforts, we welcome public comment on new or modified safe
harbors to the Federal anti-kickback statute and new or modified
exceptions to the Beneficiary Inducements CMP definition of
``remuneration,'' as well as public comment on other guidance we could
amend or publish, as each of these relate to the goals of the Executive
Order ``Delivering Most-Favored-Nation Prescription Drug Pricing to
American Patients.'' In particular, we welcome comments in response to
the questions presented in this RFI.
II. Background
A. Federal Anti-Kickback Statute
Section 1128B(b) of the Social Security Act (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 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 Federal anti-
kickback statute also may result in the imposition of civil monetary
penalties (``CMPs'') 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).
The types of remuneration covered by the statute include, without
limitation, kickbacks, bribes, and rebates, whether made directly or
indirectly, overtly or covertly, in cash or in kind. In addition,
prohibited conduct includes not only the payment of remuneration
intended to induce or reward referrals of patients but also the payment
of remuneration intended to induce or reward the purchasing, leasing,
or ordering of, or arranging for or recommending the purchasing,
leasing, or ordering of, any good, facility, service, or item
reimbursable by any Federal health care program.
Because of the broad reach of the statute and concerns that some
relatively innocuous business arrangements were covered by the statute
and therefore potentially subject to criminal prosecution, 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); S. Rep. 100-109 (1987), as reprinted in 1987
U.S.C.C.A.N. 682, 683. This provision 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 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.
Section 205 of the Health Insurance Portability and Accountability
Act of 1996, Public Law 104-191, established section 1128D of the Act
(42 U.S.C. 1320a-7d), which includes criteria for modifying and
establishing safe harbors. Specifically, section 1128D(a)(2) of the Act
provides that, in modifying and establishing safe harbors, the
Secretary may consider whether a specified payment practice may result
in:
<bullet> an increase or decrease in access to health care services;
[[Page 3858]]
<bullet> an increase or decrease in the quality of health care
services;
<bullet> an increase or decrease in patient freedom of choice among
health care providers;
<bullet> an increase or decrease in competition among health care
providers;
<bullet> an increase or decrease in the ability of health care
facilities to provide services in medically underserved areas or to
medically underserved populations;
<bullet> an increase or decrease in costs to Federal health care
programs;
<bullet> an increase or decrease in the potential overutilization
of health care services;
<bullet> the existence or nonexistence of any potential financial
benefit to a health care professional or provider, which benefit may
vary depending on whether the health care professional or provider
decides to order a health care item or service or arranges for a
referral of health care items or services to a particular practitioner
or provider; or
<bullet> any other factors the Secretary deems appropriate in the
interest of preventing fraud and abuse in Federal health care programs.
In giving HHS the authority to protect certain arrangements and
payment practices under the Federal anti-kickback statute, Congress
intended the safe harbor regulations to be updated periodically to
reflect changing business practices and technologies in the health care
industry.\2\ Since July 29, 1991, there have been a series of final
regulations published in the Federal Register establishing safe harbors
in various areas.\3\ These safe harbor provisions have been developed
to limit the reach of the statute somewhat by permitting certain non-
abusive arrangements while encouraging beneficial or innocuous
arrangements.\4\
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\2\ H.R. Rep. No. 100-85, Pt. 2, at 27 (1987).
\3\ Medicare and State Health Care Programs: Fraud and Abuse;
OIG Anti-Kickback Provisions, 56 FR 35952 (July 29, 1991); Medicare
and State Health Care Programs: Fraud and Abuse; Safe Harbors for
Protecting Health Plans, 61 FR 2122 (Jan. 25, 1996); Federal Health
Care Programs: Fraud and Abuse; Statutory Exception to the Anti-
Kickback Statute for Shared Risk Arrangements, 64 FR 63504 (Nov. 19,
1999); Medicare and State Health Care Programs: Fraud and Abuse;
Clarification of the Initial OIG Safe Harbor Provisions and
Establishment of Additional Safe Harbor Provisions Under the Anti-
Kickback Statute, 64 FR 63518 (Nov. 19, 1999); 64 FR 63504 (Nov. 19,
1999); Medicare and State Health Care Programs: Fraud and Abuse;
Ambulance Replenishing Safe Harbor Under the Anti-Kickback Statute,
66 FR 62979 (Dec. 4, 2001); Medicare and State Health Care Programs:
Fraud and Abuse; Safe Harbors for Certain Electronic Prescribing and
Electronic Health Records Arrangements Under the Anti-Kickback
Statute, 71 FR 45109 (Aug. 8, 2006); Medicare and State Health Care
Programs: Fraud and Abuse; Safe Harbor for Federally Qualified
Health Centers Arrangements Under the Anti-Kickback Statute, 72 FR
56632 (Oct. 4, 2007); Medicare and State Health Care Programs: Fraud
and Abuse; Electronic Health Records Safe Harbor Under the Anti-
Kickback Statute, 78 FR 79202 (Dec. 27, 2013); 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); and
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).
\4\ Medicare and State Health Care Programs: Fraud and Abuse;
OIG Anti-Kickback Provisions, 56 FR at 35958 (July 21, 1991).
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Health care providers and others may voluntarily seek to comply
with final safe harbors so that they have the assurance that their
business practices would not be subject to any Federal anti-kickback
statute enforcement action. Compliance with an applicable safe harbor
insulates an individual or entity from liability under the Federal
anti-kickback statute and the Beneficiary Inducements CMP only;
individuals and entities remain responsible for complying with all
other laws, regulations, and guidance that apply to their businesses.
B. Overview of OIG CMP Authorities
In 1981, Congress enacted the CMP law, section 1128A of the Act, 42
U.S.C. 1320a-7a, as one of several administrative remedies to combat
fraud and abuse in Medicare and Medicaid. The law authorized the
Secretary to impose penalties and assessments on persons who defrauded
Medicare or Medicaid or engaged in certain other wrongful conduct. The
CMP law also authorized the Secretary to exclude persons from Federal
health care programs (as defined in section 1128B(f) of the Act, 42
U.S.C. 1320a-7b(f)) and to direct the appropriate State agency to
exclude the person from participating in any State health care programs
(as defined in section 1128(h) of the Act, 42 U.S.C. 1320a-7(h)).
Congress later expanded the CMP law and the scope of exclusion to apply
to all Federal health care programs, but the CMP applicable to
beneficiary inducements remains limited to Medicare and State health
care program beneficiaries. Since 1981, Congress has created various
other CMP authorities covering numerous types of fraud and abuse.
Section 1128A(a)(5) of the Act, 42 U.S.C. 1320a-7a(a)(5), the
Beneficiary Inducements CMP, provides for the imposition of CMPs
against any person who offers or transfers remuneration to a Medicare
or State health care program (including Medicaid) beneficiary that the
benefactor knows or should know is likely to influence the
beneficiary's selection of a particular provider, practitioner, or
supplier of any item or service for which payment may be made, in whole
or in part, by Medicare or a State health care program (including
Medicaid). Section 1128A(i)(6) of the Act, 42 U.S.C. 1320a-7a(i)(6),
defines ``remuneration'' for purposes of the Beneficiary Inducements
CMP as including transfers of items or services for free or for other
than fair market value. Section 1128A(i)(6) of the Act also includes a
number of exceptions to the definition of ``remuneration.''
Pursuant to section 1128A(i)(6)(B) of the Act, any practice
permissible under the Federal anti-kickback statute, whether through
statutory exception or safe harbor regulations issued by the Secretary,
is also excepted from the definition of ``remuneration'' for purposes
of the Beneficiary Inducements CMP. However, no parallel exception
exists in the Federal anti-kickback statute. Thus, the exceptions in
section 1128A(i)(6) of the Act apply only to the definition of
``remuneration'' applicable to section 1128A.
Through a ``Special Advisory Bulletin: Application of the Federal
Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by
Manufacturers to Patients with Federal Health Care Program Coverage,''
published on OIG's website, OIG provided information on the application
of the Federal anti-kickback statute to DTC sales of prescription drugs
by manufacturers to patients with coverage under a Federal health care
program. This guidance addresses only the arrangement between the
manufacturer and consumer for the sale of the manufacturer's
prescription drug(s) and does not address the application of the
statute to any other arrangements or remuneration relating to the
provision of drugs offered and provided through a DTC program that a
manufacturer (or others) may have with other individuals or entities
(e.g., pharmacy or telemedicine arrangements). To inform our
understanding of other arrangements or remuneration related to DTC
programs and any perceived need for additional safe harbor or exception
rulemakings, we are seeking additional information through this RFI.
Any new rulemaking would balance additional flexibility for industry
stakeholders to promote the affordability of medically necessary
prescription drugs with protections against fraud and abuse.
III. Request for Information
We welcome public input on any or all of the topics identified
below.
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1. Please tell us about potential arrangements that the industry is
interested in pursuing in connection with prescription drug DTC
programs that may implicate the Federal anti-kickback statute or
Beneficiary Inducements CMP. For example, we are interested in better
understanding the structure and terms of the arrangements (e.g.,
categories or types of parties; financial relationships involving
potential referral sources and seekers created by the arrangements; and
types of items and services provided by the arrangements). We also are
interested in understanding how the arrangements promote access to and
affordability of prescription drugs and prevent potential harms, such
as increased costs, inappropriate steering, unfair competition,
inappropriate utilization, poor quality of care, and distorted decision
making.
2. Please identify what, if any, additional or modified safe
harbors to the Federal anti-kickback statute or exceptions to the
definition of ``remuneration'' under the Beneficiary Inducements CMP
may be necessary to protect such arrangements and any key provisions
that should be included in any additional or modified safe harbor or
exception. Existing safe harbors and exceptions of particular relevance
to DTC programs may include, for example, the safe harbor for personal
services and management contracts (42 CFR 1001.952(d)). Specifically,
please describe what conditions would be appropriate to include in a
safe harbor or exception to protect against fraud and abuse in the
context of such arrangements, including what, if any, disclosures
should be required by such safe harbors or exceptions. Additionally,
please identify which criteria for modifying and establishing safe
harbors under section 1128D(a)(2) of the Act would be impacted and how.
3. Please explain, with specificity, why any existing safe harbors
to the Federal anti-kickback statute or exceptions to the definition of
``remuneration'' under the Beneficiary Inducements CMP do not
adequately protect the arrangements necessary to effectuate beneficial
DTC programs.
4. Please discuss any potential broader impacts or implications--
and in particular, as they relate to the criteria set forth in section
1128D(a)(2) of the Act (e.g., an increase or decrease in access to
health care services, an increase or decrease in costs to Federal
health care programs)--that may result from the proliferation of DTC
programs, additional or modified safe harbors to the Federal anti-
kickback statute, or exceptions to the definition of ``remuneration''
under the Beneficiary Inducements CMP.
5. As noted above, OIG published a Bulletin on its website,
``Special Advisory Bulletin: Application of the Federal Anti-Kickback
Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers
to Patients with Federal Health Care Program Coverage.'' Please explain
whether this Special Advisory Bulletin adequately addresses the
concerns of industry stakeholders in connection with DTC sales to
people covered by Federal health care programs or if additional
guidance, safe harbors, exceptions, or some combination of the three
are necessary to promote beneficial DTC arrangements.
6. Are there opportunities where OIG could clarify its position
through guidance as opposed to regulation? For example, would an
amended or additional Special Advisory Bulletin, an FAQ response, or
other guidance offer sufficient protection in some instances? If so,
please elaborate.
7. The Special Advisory Bulletin includes several guardrails
intended to mitigate risk under the Federal anti-kickback statute.
Please identify any operational difficulties in implementing those
guardrails and potential solutions to ensure appropriate guardrails are
in place to protect Federal health care program enrollees. In addition,
please explain whether additional guardrails may be necessary to
sufficiently address fraud and abuse risks under the Federal anti-
kickback statute.
Respondents are encouraged to provide complete but concise and
organized responses, including any relevant data and specific examples.
Respondents are not required to address every issue or respond to every
question discussed in this RFI to have their responses considered. All
responses will be considered, and we request that responses contain
information OIG can use to identify the commenter.
Please note: This is a request for information only. This RFI is
issued solely for information and planning purposes; it does not
constitute a Request for Proposal (``RFP''), application, proposal
abstract, or quotation. This RFI does not commit the U.S. Government to
contract for any supplies or services or make a grant award. Further,
OIG is not seeking proposals through this RFI and will not accept
unsolicited proposals. Respondents are advised that the U.S. Government
will not pay for any information or administrative costs incurred in
response to this RFI; all costs associated with responding to this RFI
will be solely at the interested party's expense. Not responding to
this RFI does not preclude participation in any future procurement, if
conducted. It is the responsibility of the potential responders to
monitor this RFI announcement for additional information pertaining to
this request. Please note that OIG will not respond to questions about
the policy issues raised in this RFI. Contractor support personnel may
be used to review RFI responses.
Responses to this RFI are not offers and cannot be accepted by the
U.S. Government to form a binding contract or issue a grant.
Information obtained as a result of this RFI may be used by the U.S.
Government for program planning on a nonattribution basis. Respondents
should not include any information that might be considered proprietary
or confidential. This RFI should not be construed as a commitment or
authorization to incur costs for which reimbursement would be required
or sought. All submissions become U.S. Government property and will not
be returned. OIG may publicly post the comments received or a summary
thereof.
IV. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping, or third-party disclosure
requirements. However, section III of this document does contain a
general solicitation of comments in the form of a request for
information. In accordance with the implementing regulations of the
Paperwork Reduction Act (PRA), specifically 5 CFR 1320.3(h)(4), this
general solicitation is exempt from the PRA. Facts or opinions
submitted in response to general solicitations of comments from the
public, published in the Federal Register or other publications,
regardless of the form or format thereof (provided that no person is
required to supply specific information pertaining to the commenter,
other than that necessary for self-identification, as a condition of
the agency's full consideration) are not generally considered
information subject to the PRA. Consequently, there is no need for
review by the Office of Management and Budget under the authority of
the PRA (44 U.S.C. 3501 et seq.).
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and
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time specified in the DATES section of this preamble, and, if we
proceed with a subsequent document, we may respond to the comments in
the preamble to that document.
Thomas Bell,
Inspector General, Office of Inspector General.
Robert F. Kennedy, Jr.
Secretary, Department of Health and Human Services.
[FR Doc. 2026-01817 Filed 1-27-26; 4:15 pm]
BILLING CODE P
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