The decision carries practical consequences for life sciences companies that rely on patient support programs and the advisory opinion process.

Key Takeaways

• HHS’s regulatory tolling of the 60-day advisory opinion deadline has been struck down as contrary to law. The agency must now issue opinions within 60 days of receiving a request, with no tolling for additional information-gathering.
• HHS must meaningfully engage with evidence submitted by advisory opinion requestors. Conclusory assertions that the agency “lacks data” are insufficient when a requesting party has provided detailed evidence supporting a statutory exception.
• The D.C. Circuit joins the Second and Fourth Circuits in adopting a broad construction of “remuneration” and “induce” under the AKS, holding that neither term is limited to corrupt transactions. Patient support programs offering financial value to influence treatment decisions can violate the statute even when designed to address meaningful and legitimate clinical concerns.
• The decision reflects the continuing impact of the Supreme Court’s 2024 Loper Bright decision, as the D.C. Circuit refused to credit HHS’s claim that its timing regulations were a reasonable construction of the governing statute. Companies and their counsel should expect courts to apply closer scrutiny to agency claims of administrative discretion, even in the healthcare regulatory space.
• Industry stakeholders must reevaluate strategies for participating in the HHS advisory opinion process in light of favorable new deadlines, expansive constructions of enforcement statutes, and diminishing agency discretion.

On September 4, 2026, the United States Court of Appeals for the D.C. Circuit issued a significant decision in Vertex Pharmaceuticals Inc. v. United States Department of Health and Human Services, No. 25-5133, 2026 U.S. App. LEXIS 27329 (D.C. Cir. Sept. 4, 2026), addressing the scope of the federal Anti-Kickback Statute (“AKS”), the Beneficiary Inducement Statute (“BIS”), and the procedural framework governing HHS advisory opinions. 

The D.C. Circuit (1) affirmed that Vertex’s Fertility Support Program would violate the AKS; (2) reversed HHS’s BIS determination as arbitrary and capricious; and (3) struck down HHS regulations tolling the statutory 60-day advisory opinion deadline.

As we discussed in our May 1, 2025 article, Vertex developed Casgevy, a gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia, two hereditary blood disorders affecting thousands of Americans. The treatment requires intensive chemotherapy that can impair fertility, which could potentially deter many patients from taking advantage of the life-changing therapy. To address this potential barrier, Vertex created a Fertility Support Program offering up to $70,000 for fertility services to Casgevy patients.

Vertex initially limited the Program to privately insured patients and sought an advisory opinion from HHS on extending it to federally insured patients. After a prolonged dialogue with the agency, and only after Vertex brought suit to compel a response, HHS issued an unfavorable opinion concluding the Program would violate both the AKS and the BIS. Altogether, the advisory opinion process took over a year to conclude. 

The central question was whether the AKS’s prohibition on offering “any remuneration ... to induce” the purchase of federally reimbursable healthcare products reaches only corrupt, quid-pro-quo transactions or extends more broadly. 

Writing for the panel, Judge Rao concluded that both terms carry their ordinary, broad meanings. “Induce” means to influence, and “remuneration” captures any valuable compensation, not just corrupt payments. The court reasoned that a narrow reading would render the AKS’s extensive safe harbors—-statutory exceptions to the rule against providing payment to induce behavior--“wholly superfluous.” That’s because expressly exempted conduct like hospitals paying their doctors or pharmacies waiving co-pays would never constitute criminal solicitation. The court expressly joined the Second Circuit in Pfizer, Inc. v. U.S. Dep’t of Health & Hum. Servs., 42 F.4th 67 (2d Cir. 2022), and the Fourth Circuit in Pharmaceutical Coalition for Patient Access v. United States, 126 F.4th 947 (4th Cir. 2025), in adopting this broad construction.

Three circuits are now aligned on the broad construction of “remuneration” and “induce.” The Sixth Circuit, in United States ex rel. Martin v. Hathaway, 63 F.4th 1043 (6th Cir. 2023), has adopted a narrower view, creating a meaningful circuit split.

For life sciences companies, the practical consequence is that patient support programs offering financial value, even where they address legitimate clinical concerns, can trigger AKS penalties if intended to influence treatment decisions reimbursable by federal healthcare programs. The statute also contains a requirement of “knowing and willful” scienter to trigger a violation, limiting the extent of the holding, but this provides little comfort at the advisory opinion stage, where HHS does not formally consider intent.

In contrast to its ruling on the AKS issue, the court reversed HHS’s BIS determination as arbitrary and capricious. At issue was the “Promotes Access to Care Exception,” which protects remuneration that promotes access to care and poses a low risk of harm to patients and federal healthcare programs. Vertex had submitted significant evidence that the Program satisfied this exception, including studies on infertility as a barrier to treatment, evidence of patients’ inability to afford fertility services, and CMS guidance recognizing fertility access as a “significant access barrier” to gene therapies. HHS’s only response was that it “lack[ed] data” without identifying what data was missing or why Vertex’s submissions were insufficient.

The court held this conclusory reasoning insufficient, signaling that HHS must meaningfully engage with evidence submitted by opinion-seekers.
  Perhaps the most consequential holding for the advisory opinion process is the court’s invalidation of HHS’s tolling provisions. 

Life science companies have long wrestled with the lack of concrete deadlines during the advisory opinion process. Delays in the advisory opinion process often impact important business decisions and have a rippling effect throughout an organization. The statute requires HHS to issue an advisory opinion “by not later than 60 days after the request is received.” HHS’s regulations, however, delayed the start of the clock until “formal acceptance” and permitted tolling when the agency requested additional information.

The court struck down both provisions as contrary to the statute’s plain text, holding that HHS has no “unwritten and unilateral power to indefinitely evade” the congressional deadline. The court cited Loper Bright Enterprises v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244 (2024), for the proposition that “the reasonableness of a policy” cannot “expand an agency’s statutory authority.”

The timing holding is a textbook post-Loper Bright application. The court refused to credit HHS’s “reasonable construction” of the advisory opinion statute, including the argument that the absence of a statutory consequence for missing the deadline implicitly authorized tolling. The message is clear: even in the healthcare regulatory space, courts will enforce statutory text against agency claims of administrative necessity.
 
There are practical implications from each element of the ruling.

Perhaps most immediately, the HHS advisory opinion process has been dramatically transformed. Without the benefit of its regulatory tolling procedures, HHS must act on the record as submitted and is less able to avail itself of supplemental information and outside-expert guidance.  This could produce more unfavorable opinions driven by incomplete records, particularly for novel programs.

Moreover, HHS maintains an informal practice of notifying opinion-seekers of an unfavorable result before formally issuing advisory opinions, allowing a requestor to withdraw or modify requests. A hard 60-day deadline compresses the window for dialogue with the agency and may result in requestors receiving unfavorable opinions that they may otherwise have avoided.

These increased procedural risks are exacerbated by the willingness of courts to attribute a broad construction to the AKS, even as agency discretion is cabined in a post-Loper Bright world. It is a critical moment for industry participants to strategically reevaluate their engagement with the advisory opinion system.