Anti-Kickback Statute: D.C. Circuit Broadens AKS and Reshapes OIG Advisory Opinion Process

Key Takeaways

• Healthcare companies with federally reimbursable products face an increasingly broad Anti-Kickback Statute (“AKS”). Multiple federal circuits now agree: offering anything of value that could influence a patient’s treatment decision can potentially violate the AKS, even if the program addresses legitimate barriers to care.
• The D.C. Circuit struck down regulations from the U.S. Department of Health and Human Services (“HHS”) that allowed the Office of the Inspector General (“OIG”) to pause the 60-day statutory clock for issuing advisory opinions. This ruling could meaningfully change how the OIG advisory opinion process works in practice.
• The D.C. Circuit required OIG to meaningfully evaluate evidence supporting the Beneficiary Inducement Statute’s access-to-care exception. To support appropriateness of the exception, healthcare companies should consider frontloading their advisory opinion submissions with strong factual records that OIG must quickly evaluate.

Companies across the healthcare industry offer programs that help patients better afford or access treatments. These programs serve real patient needs, but they also implicate the Anti-Kickback Statute (“AKS”) and the Beneficiary Inducement Statute (“BIS”), two broadly written healthcare fraud and abuse statutes.

A recent decision from the U.S. Court of Appeals for the D.C. Circuit underscored how expansively courts are construing the AKS. On September 4, 2026, the court issued a mixed ruling on a challenge to OIG’s refusal to grant an advisory opinion blessing a manufacturer’s proposal to cover fertility costs for patients taking its gene therapy. The D.C. Circuit’s opinion reinforced the AKS’ broad reach, required OIG to more carefully explain its refusal to apply BIS statutory exceptions, and invalidated OIG’s longtime regulatory framework for managing the timeline for preparing advisory opinions. Together, those holdings could affect how companies evaluate patient-support arrangements and how they use the OIG advisory opinion process going forward.

This alert covers the proposed arrangement, the court’s AKS and BIS analysis, and the decision’s potential impact on the OIG advisory opinion process.

Proposed Arrangement at Issue in the D.C. Circuit Case

The D.C. Circuit opinion involved a manufacturer’s proposed patient assistance arrangement for a gene therapy for two hereditary blood disorders. The treatment required intensive chemotherapy, which can significantly affect fertility. Because patients would ideally undergo treatment when young, fertility concerns could deter patients from choosing this potentially lifesaving therapy. To address that obstacle, the manufacturer created a program offering patients up to $70,000 for fertility services.

The manufacturer offered the program to privately insured patients but sought an OIG advisory opinion on whether the program could also cover federally insured patients. OIG, which enforces the AKS and the BIS, issues advisory opinions that are binding on both the agency and the requesting party. Advisory opinions have long served as a practical tool for companies to secure advance clarity about a proposed arrangement’s legal compliance. After a prolonged exchange with the manufacturer that stretched well beyond the statutory 60-day deadline to issue an advisory opinion, OIG issued an unfavorable opinion. OIG concluded that the proposed arrangement would violate the AKS because the proposed financial support would be “remuneration” offered to “induce” patients to choose the manufacturer’s therapy over alternatives. OIG also concluded that the proposed arrangement would violate the BIS because the support would likely influence patients’ choice of providers.

Anti-Kickback Statute: D.C. Circuit Confirms Its Broad Reach

The manufacturer sued in the district court, challenging OIG’s negative determination as arbitrary and capricious under the Administrative Procedure Act (“APA”). The district court granted OIG summary judgment on those claims. The manufacturer then appealed to the D.C. Circuit.

First, the D.C. Circuit affirmed that the proposed arrangement would violate the AKS. The manufacturer argued that “remuneration” and “induce” should be read narrowly, limited to corrupt, quid pro quo transactions. The appeals court disagreed. Consistent with other federal circuit courts, the D.C. Circuit held that “remuneration” and “induce” carry their ordinary, broad meanings rather than the narrower criminal connotations that the manufacturer had urged. Under the D.C. Circuit’s reading, “remuneration” encompasses any valuable compensation, not just corrupt payments. Similarly, “induce” means any effort to influence or prevail upon a person, even short of criminal solicitation. Applying this broad reading of the AKS, the court stated that the proposed program would violate the AKS because its “entire point . . . is to encourage patients to choose [the therapy], as opposed to other treatments, by promising to pay for fertility services that may be necessary to address the treatment’s side effects.” Manufacturers and other parties must therefore consider that even patient assistance programs addressing legitimate patient needs can fall within the AKS’s scope.

Beneficiary Inducement Statute: D.C. Circuit Requires OIG to Meaningfully Evaluate Access-to-Care Exception

Second, the D.C. Circuit reversed OIG’s determination that the proposed arrangement would violate the BIS, finding the agency’s conclusion arbitrary and capricious. The BIS contains a statutory exception for arrangements that promote patients’ ability to access care while posing a low risk of harm. The manufacturer submitted detailed evidence that the proposed arrangement qualified for this “access-to-care” exception, including clinical studies, CMS guidance, and information about the safeguards built into the program. OIG responded with a single sentence that it “lack[ed] data,” without explaining what additional data it needed or why the manufacturer’s evidence fell short.

The D.C. Circuit held this was insufficient. The APA requires that when a party presents meaningful evidence supporting a statutory exception, the agency must address that evidence and explain its reasoning. A conclusory statement that the agency lacks data, without more, does not meet that standard. The court also noted that on remand, OIG might also reconsider its discretionary refusal to grant prospective administrative immunity from AKS enforcement.

OIG Advisory Opinions: D.C. Circuit Enforces the 60-Day Deadline

Finally, the D.C. Circuit’s decision significantly constrains the timeline for developing OIG advisory opinions and for regulated parties to work collaboratively with the agency. By statute, Congress directed OIG to issue advisory opinions within 60 days of receiving a request. For years, OIG regulations have let the agency pause that clock while it gathers additional information or consults outside experts. The D.C. Circuit struck down those tolling regulations as contrary to law. It held that the 60-day deadline runs from when the request is received, and that this is a statutory deadline that cannot be extended by regulation.

The advisory opinion process has long operated on the understanding that OIG and the requesting party would work together over time to develop a complete record. That interactive process may look very different going forward. If OIG must act within 60 days, regardless of whether it has all the information it needs, the agency may have less flexibility to refine requests through supplemental submissions, follow-up questions, or expert consultation before issuing an opinion. Requesting parties, in turn, may need to front-load their submissions with more complete factual records, legal analysis, and supporting evidence at the outset.

The D.C. Circuit’s ruling may also make the advisory opinion process harder for companies to plan around, particularly for novel or fact-intensive arrangements. If OIG has less flexibility to develop the record after a request is submitted, companies may face greater uncertainty about how much information they should submit at the outset and how the agency will handle complex requests within the 60-day deadline.

What the D.C. Circuit’s Decision Means for Healthcare and Life Sciences Companies

At a high level, the decision warrants attention from any company that offers arrangements that give value to patients in connection with federally reimbursable treatments. Courts continue to read the AKS’ key terms expansively — a trend that raises the compliance stakes for patient assistance programs, copay support, side-effect management, and similar arrangements.

• Good intentions do not insulate an arrangement from AKS scrutiny. The proposed arrangement here was designed to address a real barrier to a lifesaving therapy, but the D.C. Circuit still found the proposed arrangement fell within the AKS’s scope. Companies should look at their own patient-centered arrangements and consider whether they could be characterized as influencing treatment decisions.
• Still, when a company builds a strong record supporting a statutory exception, courts should hold OIG accountable for engaging with that record. The D.C. Circuit made clear that the BIS’s access-to-care exception is not just a theoretical defense. The D.C. Circuit took seriously the manufacturer’s clinical studies, CMS guidance, and program safeguards. This opinion reinforces that a robust record supporting the exception’s application carries real weight, and that OIG cannot dismiss it without explanation.
• The D.C. Circuit’s imposition of a strict 60-day deadline changes the practical dynamics of the OIG’s advisory opinion process. That process has been a go-to compliance planning tool for decades. Companies should think about whether advisory opinion requests should be structured differently, and whether they should front-load the evidence that they provide.

For guidance on these issues, please contact a member of AGG’s Healthcare team.