Safe‐harbor provisions for prescription drug price concessions, point‐of‐sale discounts, and PBM service fees under the Anti‐Kickback Statute (42 C.F.R. § 1001.952(h), (cc), & (dd))

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Push back on price gouging for pharmaceuticals

AKA “Rescind Exploitative Pharmacy Pricing Reform”


Which agency/agencies promulgated the regulation? *
Department of Health & Human Services, Office of Inspector General (HHS OIG)
Which title, parts, and/or sections of the Code of Federal Regulations (C.F.R.) should be rescinded? *
42 C.F.R. § 1001.952(h), (cc), and (dd)
What is your name?
—OPTIONAL--
Is your proposed rescission a notice of proposed rulemaking, final rule, direct final rule, interim final rule, or interpretive rule? *
Notice of Proposed Rulemaking
What is the name of the regulation being rescinded, if applicable? *
Safe‐harbor provisions for prescription drug price concessions, point‐of‐sale discounts, and PBM service fees under the Anti‐Kickback Statute (42 C.F.R. § 1001.952(h), (cc), & (dd))
Please provide a short summary of the justifications for the rescission. *
The existing carve‐outs allow manufacturers to negotiate undisclosed rebates and fees with plan sponsors/PBMs, inflate list prices, and apply point‐of‐sale discounts or service‐fee arrangements without passing true savings to patients or payors. Rescinding §§ 1001.952(h), (cc), and (dd) would close these interlocking loopholes, restore pricing transparency, and require each arrangement to satisfy the Anti‐Kickback Statute’s general prohibition.
Please insert the address of the agency. [NPRM, DFR, and IFR only]
Department of Health & Human Services Office of Inspector General 330 Independence Avenue, SW Washington, DC 20201
Please insert the contact information for the agency. *
(301) 492-4305 (410) 786-1524 (410) 786-8437
What is the background for the regulation being rescinded? *
HHS OIG first issued a suite of safe harbors in 1991 (56 Fed. Reg. 35954) and expanded them in 1999 to protect bona fide discount and rebate arrangements. In November 2020, OIG removed rebate protection under subsection (h) and simultaneously added new carve-outs for point-of-sale discounts (cc) and PBM service fees (dd) via a Final Rule. Over time, these provisions have been used collectively to shield high list prices, secret rebates, at-the-counter discounts, and administrative fees—fostering a dual‐price system that burdens patients and government payors.
Explain the reasons for the rescission. *
Eliminating §§ 1001.952(h), (cc), and (dd) would strip away automatic safe‐harbor cover for all forms of manufacturer concessions—rebates, point-of-sale reductions, and PBM fees—forcing individualized Anti-Kickback analysis. This will deter price‐inflation schemes, ensure that savings are passed to end-users, and empower enforcement to address each arrangement on its merits.
Describe the text of the relevant C.F.R. provisions as it will exist after the rescission. *
Subsections (h), (cc), and (dd) of 42 C.F.R. § 1001.952 would be deleted in their entirety. No safe-harbor or safe-harbor–like exception for prescription pharmaceutical rebates, point-of-sale discounts, or PBM service fees would remain—every discount, rebate, or fee arrangement would be subject to the general prohibition in 42 U.S.C. § 1320a-7b(b).
Please insert the name of the current agency head. *
Robert F. Kennedy Jr.
Please insert the title of the agency head. *
Secretary of Health and Human Services

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