HHS Crowdsources Ideas to Shield Healthcare from Kickbacks
Published Date: 12/9/2025
Proposed Rule
Summary
The Department of Health and Human Services wants your ideas to update rules that protect certain healthcare actions from being seen as illegal kickbacks. These changes could affect doctors, hospitals, and businesses involved in healthcare payments. You’ve got until February 9, 2026, to send in your suggestions—so jump in and help shape the future of fair healthcare deals!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
Anti-Kickback Criminal Penalties Reminder
If you knowingly and willfully offer, pay, solicit, or receive remuneration to induce referrals for items or services reimbursable under Federal health care programs, the offense is a felony punishable by up to $100,000 in fines and up to 10 years in prison. Violations also may lead to civil monetary penalties under section 1128A(a)(7), program exclusion under section 1128(b)(7), and False Claims Act liability.
Safe Harbors Protect Certain Practices
OIG's safe harbor regulations (found at 42 CFR part 1001) describe payment and business practices that, if they meet the safe harbor conditions, will not be subject to sanctions under the Federal anti-kickback statute. Health care providers and others may voluntarily comply with those conditions to have assurance their practices will not be subject to sanction.
Special Fraud Alerts Provide Industry Guidance
OIG issues Special Fraud Alerts to warn health care industry stakeholders about practices it considers suspect or of particular concern. Those Alerts are published in the Federal Register and on OIG's website and are intended to encourage compliance by giving stakeholders guidance they can apply to their own practices.
Evaluation Criteria for Safe Harbor Changes
When considering new or modified safe harbors, OIG will evaluate how a proposal may increase or decrease access to health care services, quality of care, patient freedom of choice, competition among providers, cost to Federal health care programs, potential overutilization, and the ability to provide services in medically underserved areas or to underserved populations. OIG also will consider potential financial benefits to health care professionals that might influence ordering or referral decisions.
Open Call for Safe Harbor Ideas
You can submit proposals to HHS OIG for new or modified safe harbors and for new Special Fraud Alerts. Comments must be received by 5 p.m. on February 9, 2026, using file code OIG-1125-N at https://www.regulations.gov or by mail to OIG, Regulatory Affairs, Room 5628, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201.
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