Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
Published Date: 1/29/2026
Proposed Rule
Summary
The government wants your thoughts on updating rules that stop sneaky deals and freebies in Medicare and state health programs, especially for new drug sales like those on TrumpRx. This could change how drug companies sell directly to patients, making meds fairer and cheaper for Americans. Speak up by March 30, 2026, to help shape these important changes that could save money and protect patients.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
TrumpRx: Direct-to-Consumer Drug Platform
HHS is establishing TrumpRx, a platform to let American patients buy prescription drugs directly from manufacturers at a “Most‑Favored‑Nation” price, bypassing middlemen. HHS says removing government obstacles to ensure access to affordable prescription drugs through TrumpRx is a key priority and is seeking public input through this request for information.
Potential Changes to Anti‑Kickback Safe Harbors
The OIG is asking whether to modify or add safe harbors to the Federal anti‑kickback statute (42 CFR 1001.952) and exceptions to the Beneficiary Inducements CMP (42 CFR 1003.110) to support direct‑to‑consumer manufacturer drug sales while protecting against fraud and abuse. The agency requests public comment by March 30, 2026.
Safe Harbor for Personal Services/Management Contracts
The RFI notes that existing safe harbors relevant to direct‑to‑consumer programs may include the personal services and management contracts safe harbor (42 CFR 1001.952(d)) and asks for input on conditions that should be included in any new or modified safe harbor.
Guidance vs Regulation for DTC Sales
OIG is asking whether clarifying guidance (for example, an amended Special Advisory Bulletin, FAQs, or other guidance) might be sufficient instead of new regulations to address direct‑to‑consumer sales to people covered by Federal health care programs. The RFI seeks examples and feedback and sets a comment deadline of March 30, 2026.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-14709, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
This correction fixes some typos and technical mistakes in the 2027 health insurance rules under the Affordable Care Act. It mainly affects people and organizations involved in health coverage plans by clarifying when the rules take effect and restoring some important regulation details. These fixes take effect on July 20, 2026, ensuring smoother and clearer health plan operations next year.
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-12069, Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions
This new rule makes sure the groups that check Medicare providers play fair and follow clear rules to avoid conflicts of interest. It updates how psychiatric hospitals are reviewed and tightens rules for providers who lost their Medicare status but want back in. These changes affect Medicare providers and accrediting groups, start June 16, 2027, and aim to keep care safe and trustworthy.
2026-11530, Employment and Training Services for Noncustodial Parents in the Child Support Program; Rescission
The government plans to cancel a recent rule that let child support agencies offer job training to noncustodial parents using federal funds. This change affects agencies and parents involved in the child support program and could shift how support services are funded and delivered. Comments on this proposal are open until August 10, 2026, so folks have time to weigh in before it’s final.
2026-11140, Federal Independent Dispute Resolution Operations
Starting soon, health plans and insurers must share clearer info when they pay or deny surprise medical bills. They’ll use special codes to explain these decisions, especially when dealing with folks they don’t have contracts with. This helps patients and providers understand bills better and speeds up fixing disputes, with no extra costs for most people.
Previous / Next Documents
Previous: 2026-01807, Notice of Availability and Request for Comment: Revision to the Voluntary Standard for Infant and Cradle Swings
The Consumer Product Safety Commission wants your thoughts on updates to the safety rules for infant and cradle swings. These changes could make swings safer for babies and affect manufacturers and parents. You’ve got until February 12, 2026, to share your opinion—no cost changes announced yet, just safer swings ahead!
Next: 2026-01833, Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage
This new rule updates the rules for Organ Procurement Organizations (OPOs) that help collect and share organs for transplants. It adds clearer guidelines, new quality checks, and updates how OPOs compete and appeal decisions to boost organ donations and save more lives. OPOs and transplant patients will feel the impact, with comments open until March 31, 2026, and no new costs announced yet.