Healthcare / False Claims Act · Anti-Kickback Statute · Manufacturer Practice Support · Scienter

Introduction

Manufacturers of physician-administered drugs have long supported the practices that administer them, with reimbursement hotlines, coding guides, nurse training, and advice on operating an infusion suite. Relators have argued that some of that support is really free business consulting, and that free consulting given in conjunction with prescriptions is illegal remuneration under the Anti-Kickback Statute (AKS). Manufacturers have responded that support tied to their own products is part of what providers purchase along with the infusion drugs. Courts have analyzed those claims using a “substantial independent value” test drawn from guidance of the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services: support that has value to the practice apart from the manufacturer’s product can be remuneration, while support whose value depends on the product generally is not.

In United States ex rel. Hart v. McKesson Corp., 602 F. Supp. 3d 575, 589–90 (S.D.N.Y. 2022), aff’d in relevant part, 96 F.4th 145 (2d Cir. 2024), allegations about a free “Margin Analyzer” survived dismissal under the “substantial independent value” test. On September 30, 2026, after nearly ten years of litigation, the U.S. District Court for the District of Massachusetts granted summary judgment for Janssen Biotech in a qui tam case the government declined to join, over Janssen’s programs supporting practices that infuse Remicade and Simponi ARIA in their own offices. The court made two rulings. First, the relator had not produced evidence that the services had value independent of Janssen’s drugs. Second, and in the alternative, she had not produced evidence that Janssen acted knowingly and willfully in violation of the AKS, and therefore of the False Claims Act (FCA).

Executive Summary

Janssen makes Remicade and Simponi ARIA, two infused biologics usually prescribed by rheumatologists and gastroenterologists. Through a team of Area Business Specialists (ABSs), it offered physician practices programming on setting up and operating in-office infusion suites, covering billing and coding, staffing, scheduling, specialty pharmacies, and suite efficiency. Julie Long, an ABS in central Pennsylvania from 2003 to early 2016, filed a qui tam action in 2016 alleging that the programming was free business consulting that amounted to AKS kickbacks and tainted the resulting claims under the FCA. The United States and the states declined to intervene. After discovery limited to her territory and to national or regional policies that applied to her work, Janssen moved for summary judgment on the whole case, and Long cross-moved on scienter.

The court granted Janssen’s motion and denied Long’s. It applied the substantial independent value framework, rejected Janssen’s First Amendment argument, and held that the evidence did not show remuneration. It then held that Long had not shown a knowing and willful violation. Because there was no triable AKS violation, the court did not reach Janssen’s FCA-specific arguments or its constitutional challenges to the qui tam provisions.

Background

The programs, and what the relator conceded

Janssen ran two field teams working with infusion centers. Immunology Specialists detailed the drugs’ clinical benefits at the sites where they were prescribed. ABSs worked at the “Site of Care,” where patients were infused. Janssen’s position was that in-office suites widen patient access and reduce “attrition” by patients who get a prescription but never complete their infusions. 2026 WL 2949353, at *2, *4. A multidisciplinary Promotional Review Committee, including in-house lawyers, approved all written programming. Janssen did not assert an advice-of-counsel defense and did not waive privilege over the lawyers’ communications, so the record showed that the committee approved the materials but not what the lawyers advised. Id. at *5 & n.3. Compliance policies told ABSs they were “not business advisors” and could not offer “consulting services that relate to the management of customers’ business practices.” Id. at *9.

Two features of the record shaped the case. First, Long expressly conceded, in a discovery dispute and again at summary judgment, that the approved slide decks and written materials were not unlawful remuneration. Her theory was that ABSs and outside consultants delivered unlawful “live” services that went beyond those materials. Id. at *2, *15–16. Second, she offered no affidavit of her own, no testimony from any other ABS, and no testimony from any physician or practice manager. The court found “no direct evidence at all of the content of any oral communication between any ABS and any physician practice.” Id. at *16.

The IOM

The court described the Infusion Optimization Modeler (IOM) as the “closest” Long came to establishing an AKS violation. Id. at *3. An ABS took a practice’s data on its Remicade patients, infusion chairs, and staff hours, ran it through a relatively simple program, and produced a printout showing which resource constrained the practice and how many more infusions per week it could deliver if that constraint were removed. Id. at *8–9, *23. In Long’s words, the practice then “had to take the bull by the horns” and make any changes itself. Id. at *23.

The procedural path

Long filed on October 28, 2016. Over the next eight years the court dismissed the state-law claims, trimmed the federal claims on limitations grounds, and denied a public-disclosure-bar motion. Id. at *10. Rather than order nationwide discovery, the court limited the first phase to Long’s territory and to national or regional policies that applied to her work, and allowed Janssen to test the case by summary judgment at the end of that phase. Id.

Legal Analysis

• The court applied the substantial independent value framework. The court reasoned that a literal reading of “remuneration” “would make virtually all pharmaceutical detailing or marketing a crime.” Id. at *11. It followed OIG Advisory Opinion No. 00-10 (Dec. 15, 2000) and the 2003 Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23,731, 23,735 (May 5, 2003), noting that “every court to have considered the issue” had done so. Id. at *12. It added that, after Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), OIG’s views get no deference. 2026 WL 2949353, at *12 n.9.
  • The relator’s challenge to the framework. Long argued that the framework should not apply at all. The court called the argument “perhaps not frivolous” but undeveloped, and declined “to blaze a new trail” given that the AKS is a felony statute whose terms are interpreted the same way in civil and criminal cases. Id. at *13.
  • The guideposts. Medical, clinical, and technical support, and billing and reimbursement advice for the product, are permissible. Business or management advice about the overall practice, or doing tasks that are part of a physician’s overhead, are not. Id. at *13–14. In between, “the landscape is unclear,” and the court said those cases turn on “the actual evidence,” not “conclusory labels.” Id. at *14.
• The First Amendment did not narrow “remuneration.” Janssen argued that treating truthful promotional speech as illegal remuneration would raise constitutional concerns, so the term should be read narrowly. Long responded that the First Amendment does not shield illegal inducements that happen to involve communication. The court rejected Janssen’s argument, reasoning that the AKS regulates conduct, and that “where valuable speech is offered as the quid in a quid pro quo arrangement, prohibiting such arrangements would clearly survive First Amendment scrutiny.” Id. at *14–15.
• The question was not whether the programs were valuable, but whether their value was independent of Janssen’s drugs. The court accepted that the programming had substantial value and that its ultimate purpose was to sell more Remicade and Simponi ARIA. Id. at *20. Under the framework, support lacks “independent” value if its value “would not exist if the products did not exist.” Id. Long’s arguments failed on that point.
  • Other drugs. Long argued the suites could be used for other infused drugs. The court found her evidence consisted, “in substance, of a single sentence by a single witness,” a Janssen Rule 30(b)(6) designee’s acknowledgment that the programs would interest physicians who wanted to infuse other products. Id. at *21.
  • Scale and price. Long pointed to the magnitude of the programs and to the roughly $3,000 per session Janssen paid the outside firm Xcenda to deliver them. The court held that size and cost show value and importance to Janssen, but not independence. Id. at *21–22 & n.23.
  • Tailoring. Customized advice is “relevant, but it is not controlling,” since a device representative assisting a surgeon gives tailored advice that still is not independent of the product. Id. at *22.
  • The IOM. The court assumed the IOM fell outside Long’s concession and treated it as an extension of the approved “Managing Biologics in the Physician Office” deck to a specific practice. Because it was used only with practices already infusing Janssen’s drugs, and the record held no evidence on other infusible products or their infusion times, the court held that “if Remicade and Simponi ARIA did not exist, the IOM would have no value.” Id. at *23–24 & n.25. It distinguished Hart, where the tool compared the profitability of competing drugs, employees reviewed “key areas of improvement” with practices quarterly, and another McKesson division sold the same tools. Id. at *24.
• Scienter was decided in the alternative. Having found no remuneration, the court could have ended its analysis. “Rather than stop at that point,” it also took up willfulness, which gives the ruling a second, independent basis. Id. at *24. Under United States v. Bay State Ambulance & Hospital Rental Service, Inc., 874 F.2d 20, 33 (1st Cir. 1989), and 42 U.S.C. § 1320a-7b(h), the relator must show knowledge that the conduct is unlawful and intent to violate the law, but not intent to violate the AKS specifically. 2026 WL 2949353, at *25.
  • A corporate scienter framework. Adapting United States v. Bank of New England, N.A., 821 F.2d 844, 855–56 (1st Cir. 1987), the court applied the collective knowledge doctrine to “knowingly,” so that the corporation’s knowledge includes everything its employees knew collectively. For “willfully,” it required evidence that an employee acting within the scope of employment intended to violate the law, or that the corporation was “flagrantly indifferent” to its legal obligations. 2026 WL 2949353, at *25–26. It noted that the D.C. Circuit has rejected collective knowledge for FCA scienter in United States v. Science Applications International Corp., 626 F.3d 1257, 1274 (D.C. Cir. 2010), that the First Circuit has not addressed the question, and that it was applying the doctrine to the AKS. 2026 WL 2949353, at *25 n.27.
  • Concealment. Long pointed to compliance edits, such as changing “Operational Efficiency” to “Access Support for our IV Therapies,” and a direction to talk about patient growth rather than vial growth. The court held that it would be unreasonable to read a compliance officer’s suggested changes as concealment, and that “all four instances involved cautions or reminders that ABSs should steer clear of business discussions.” Id. at *27–28.
  • Internal warnings. Compliance staff had flagged “potential risk[s]” and “compliance sensitivities,” including the risk that the programs could be seen as offsetting a practice’s start-up costs. The court held this showed “compliance officers who did their jobs,” and that treating it as willfulness would effectively punish Janssen “for having a compliance department at all.” Id. at *28–29.
  • Institutional history and policies. Prior settlements and a Corporate Integrity Agreement with OIG showed awareness of the AKS, which was not disputed. Id. at *29. Long’s syllogism—that the policies barred consulting, the programs were consulting, and so the violation was willful—failed because compliance personnel approved the programming and no witness believed it was unlawful consulting. Id. at *3, *29–30. Long herself testified that she did not believe at the time that she was providing a kickback. Id. at *31. A training slide saying there is “a lot of gray” in healthcare compliance was, in context, “perfectly accurate,” not an invitation to break the law. Id.
• Disclosure to the government carried limited weight. Janssen argued that it openly disclosed the programs to federal authorities and so could not have intended to conceal them. The court called that evidence relevant but “of limited value,” because the government may not appreciate a disclosure or have resources to follow up. Id. at *26 n.28.

Holding

Janssen’s motion for summary judgment was granted, and Long’s cross-motion on scienter was denied. The court held that, drawing all reasonable inferences in her favor, Long had not produced evidence that Janssen provided services with substantial independent value to induce purchases of Remicade or Simponi ARIA. Id. at *24. Independently, she produced “no evidence that any individual employee of Janssen had the necessary intent to violate the law,” and the evidence fell “well short” of showing corporate flagrant indifference. Id. at *31. The court rejected Janssen’s First Amendment argument. It did not reach Janssen’s FCA-specific arguments or its Appointments Clause and Take Care Clause challenges to the qui tam provisions. Id. at *11 n.8, *31. The court entered judgment on October 6, 2026. Judgment, Long, No. 1:16-cv-12182-FDS (D. Mass. Oct. 6, 2026), ECF No. 674.

What to Watch

• An appeal to the First Circuit. Because the court rested on two independent grounds, Long would need to overturn both. Judgment was entered on October 6, 2026, so a notice of appeal is due by November 5, 2026. See Fed. R. App. P. 4(a)(1)(A). As of October 18, 2026, none had been filed.
• Collective knowledge and AKS scienter. The court adapted the First Circuit’s corporate scienter standard from Bank of New England, a Currency Transaction Reporting Act case, to the AKS, and applied the collective knowledge doctrine to the AKS’s “knowingly” element. It did so even though the D.C. Circuit has held that collective knowledge is “an inappropriate basis for proof of scienter” under the FCA, reasoning that the AKS’s statutory language differs from the FCA’s. 2026 WL 2949353, at *25 n.27 (quoting Science Applications International Corp., 626 F.3d at 1274). The First Circuit has not addressed whether collective knowledge can establish FCA scienter, id., and the opinion cites no First Circuit decision applying the doctrine to the AKS, so an appeal would give the First Circuit the chance to decide whether the court’s approach is right.
• The middle of the independent-value spectrum. The court described the line between product support and practice management advice as “ill-defined” and “far from precise.” Id. at *3, *13. The court contrasted Hart and United States ex rel. Witkin v. Medtronic, Inc., No. 1:11-cv-10790-IT, 2024 WL 1892405, at *17 (D. Mass. Mar. 31, 2024), with United States ex rel. Forney v. Medtronic, Inc., No. 5:15-cv-06264-EGS, 2017 WL 2653568, at *1, *4 (E.D. Pa. June 19, 2017). 2026 WL 2949353, at *13. Because the independence test turned on whether the programs would have had value without Janssen’s drugs, evidence that the same tools served other infusible drugs was the missing piece here. The court noted that a 2013 IOM printout had lines for “other infusions” that neither party addressed. Id. at *8 n.6. That is the gap future relators are likely to try to fill.
• The constitutional challenge left unresolved. Janssen’s Article II challenge to the qui tam provisions was raised but not decided. It would remain available to Janssen if the judgment were reversed.

What This Means for Resolving FCA Disputes

A practice-support case turns on two evidentiary questions. Was the help part of the product or a freestanding benefit? And, on the knowledge and willfulness element, did anyone at the company understand that the help crossed the line into unlawful remuneration? Long shows how a manufacturer with documented compliance review can make the second question hard for a relator to answer. Compliance staff approved the programs, flagged risks, and saw their edits adopted, and the court read that record as diligence, not knowledge. A relator who cannot produce a witness saying the conduct was understood to be unlawful, or a document showing that warnings were ignored, faces a steep climb on scienter even where the remuneration question is close.

That changes how these cases are valued. Exposure in an AKS-predicated FCA case multiplies through trebling and per-claim penalties. But a scienter element that turns on specific evidence of intent discounts all of it, and the defendant’s own compliance record largely sets the amount of the discount. Relator’s counsel will want first-hand witnesses and documents showing that warnings went unheeded. Defense counsel will want to show how compliance review actually worked, which may mean deciding early whether privileged legal review becomes part of the story. Where the record is thin on both sides, an early discovery phase like the one the court used here gives the parties a shared view of the evidence before the full cost of nationwide discovery, and that tends to be when these cases are most resolvable.

John Libby is an arbitrator, mediator, and settlement counsel with LibbyADR LLC. This post contains his own summaries of the decisions discussed, prepared for general informational purposes only. The summaries are not intended to be a complete statement of any court’s reasoning, nor should they be taken to indicate how he would rule as an arbitrator in any particular case. In addition, the summaries are not legal advice, nor should they be construed as legal advice. Readers should not act on these posts, but should review the decisions themselves and consult with legal counsel.

Healthcare / Anti-Kickback Statute · Beneficiary Inducement Statute · HHS-OIG Advisory Opinions

Introduction

Patient-support programs test the outer edge of the Anti-Kickback Statute, with those offering such seemingly beneficial services to patients arguing that, as a criminal bribery statute, the terms “remuneration” and “induce” must be read narrowly to mean corrupt payments and quid-pro-quo dealing, not ordinary financial help that happens to make a treatment easier to choose. The Second Circuit rejected that reading in Pfizer, Inc. v. U.S. Department of Health & Human Services, 42 F.4th 67 (2d Cir. 2022), cert. denied, 143 S. Ct. 626 (2023), and the Fourth Circuit rejected it in Pharmaceutical Coalition for Patient Access v. United States, 126 F.4th 947 (4th Cir. 2025). On September 4, 2026, the D.C. Circuit made it three, in a case about an advisory opinion issued by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concerning a gene therapy for sickle cell disease and a program offering patients up to $70,000 toward fertility services that chemotherapy may cost them. In addition to joining its sister circuits in giving “remuneration” and “induce” their ordinary meanings, the court made two other rulings under the Administrative Procedure Act. First, it held that OIG acted arbitrarily and capriciously by brushing past a statutory exception with the observation that it “lack[ed] data.” Second, it held that OIG had no authority to issue regulations allowing it to determine when the 60-day statutory deadline for issuing advisory opinions began and could be tolled.

Executive Summary

Vertex makes Casgevy, a gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia. The treatment requires intensive chemotherapy that can impair fertility, so Vertex created a Fertility Support Program offering patients up to $70,000 toward fertility services. It opened the program to privately insured patients and, in June 2023, asked OIG for an advisory opinion on whether extending it to federally insured patients would violate the Anti-Kickback Statute or the Beneficiary Inducement Statute. OIG didn’t issue its opinion for more than a year, and only did so three days after Vertex sued to compel it, concluding that the program would violate both statutes. The district court sided with OIG on every issue. The D.C. Circuit affirmed in part, reversed in part, and remanded. On the AKS, it held that “induce” and “remuneration” carry their ordinary meanings — to influence or prevail upon a person, and valuable compensation in any form — rather than a narrower sense drawn from criminal solicitation and facilitation, joining the Second Circuit in Pfizer and the Fourth Circuit in Pharmaceutical Coalition for Patient Access. On that reading, the program is remuneration to induce the purchase of Casgevy. But the court set aside OIG’s conclusion that the program would also violate the Beneficiary Inducement Statute, holding that the agency failed to engage with the evidence that the statutory Promotes Access to Care Exception applied. And it held that OIG’s regulations — which start the 60-day advisory-opinion clock at “formal acceptance” rather than receipt, and toll it while the agency seeks more information — are contrary to law.

Background

The two statutes

The AKS criminalizes knowingly and willfully offering or paying “any remuneration (including any kickback, bribe, or rebate) … to any person to induce such person … to purchase” an item or service reimbursable under a federal healthcare program. 42 U.S.C. § 1320a-7b(b)(2)(B). Violations are felonies, and the statute carries an extensive set of safe harbors, with authority in the Secretary to create more. The BIS is the civil counterpart, reaching remuneration offered to a beneficiary that the offeror “knows or should know is likely to influence” the beneficiary’s choice of provider, practitioner or supplier. Id. § 1320a-7a(a)(5). Among the BIS’s own exceptions is one for remuneration that “promotes access to care and poses a low risk of harm to patients and Federal health care programs.” Id. § 1320a-7a(i)(6)(F). Parties may ask OIG for an advisory opinion on whether proposed conduct would violate either statute; the opinion binds both the agency and the requester.

The program and the request

Because older patients often cannot tolerate the chemotherapy regimen, Casgevy is best taken young — by patients with their childbearing years ahead of them, who may then need fertility treatments costing tens of thousands of dollars. That is the concern the Fertility Support Program was designed to address, and Vertex withheld it from federally insured patients until OIG ruled.

Vertex requested the advisory opinion on June 13, 2023. OIG formally accepted it on June 26, requested more information, and tolled the deadline until Vertex responded on October 10. OIG said at a November teleconference that it could not issue a favorable opinion, then did not publish. Vertex asked repeatedly over the following months. On July 15, 2024, Vertex sued to compel issuance. Three days later — more than a year after the request and nine months after the supplemental information — OIG issued the opinion, concluding the program would provide prohibited remuneration under both statutes and that the Promotes Access to Care Exception did not apply because the agency “lack[ed] data.” The district court granted summary judgment for OIG on every issue and held the challenge to the timing regulations nonjusticiable once the opinion had issued.

Legal Analysis

• “Induce” means to influence, not to solicit a crime. Statutes sometimes use “induce” in a specialized criminal-law sense carrying common-law solicitation and facilitation. The court held the AKS does not, and the distinguishing feature is what is being induced. In United States v. Hansen, 143 S. Ct. 1932 (2023), the induced act — illegal immigration — was itself a crime. Under the AKS, the act induced is a beneficiary’s selection of medical services, which is lawful. With no unlawful act at the end of the chain, the presumption that Congress imported the common-law sense weakens considerably.
• The safe harbors are what settle it. The AKS’s safe harbors cover prosaic transactions — a hospital paying its physicians, a health center waiving coinsurance for a patient who qualifies for subsidized services, a pharmacy waiving a co-pay for a patient in good-faith financial need. If “induce” meant criminal solicitation, none of those would ever have needed excepting, and the safe harbors would be largely surplus. The court quoted the Fourth Circuit’s formulation that the narrow reading would “create vast superfluity in the statute.” Pharm. Coal. for Patient Access, 126 F.4th at 958.
• “Remuneration” is not confined to corrupt payments. Vertex argued that the parenthetical — “(including any kickback, bribe, or rebate)” — colors the term under noscitur a sociis (the canon that a word is known by the company it keeps). The court answered on the list’s own contents: a kickback and a bribe carry corrupt connotations, but a rebate is simply a discount or refund. A list that is not uniformly corrupt cannot narrow the general term to corruption. The court also noted the repeated “any” and the illustrative “including,” both signals of breadth.
• Lenity and vagueness got no traction. Neither the rule of lenity nor constitutional avoidance has a role, the court held, where text, context and structure resolve the question. On vagueness, the possibility of close cases does not make a statute vague, and the AKS’s knowing-and-willful scienter requirement alleviates the concern — a point on which the court noted the First, Ninth and Eleventh Circuits have come out the same way.
• The BIS ruling is an administrative-law ruling. The court held that OIG never explained why the Fertility Support Program does not qualify under the statutory exception promoting access to care. Vertex had submitted studies that infertility risk leads sickle cell patients to forgo potentially lifesaving treatment, evidence that many patients cannot afford fertility services, CMS guidance describing lack of access to fertility preservation as a significant access barrier for gene therapy candidates, and program controls limiting eligibility to patients already prescribed the therapy. OIG’s entire response was that it lacked data to determine that the program improves access. It did not say what data, why it could not obtain it, or why Vertex’s showing fell short. The district court’s view that the agency’s “path may reasonably be discerned” did not survive.
• A statutory deadline is a deadline. Congress specified, as part of the required contents of the advisory-opinion regulations, that the Secretary “shall be required to issue” an advisory opinion “not later than 60 days after the request is received.” 42 U.S.C. § 1320a-7d(b)(5)(B)(i). OIG’s regulations started the clock at formal acceptance — up to ten business days after receipt — and tolled it while the agency sought additional information or outside expert advice. Neither provision is authorized by the statute. Drawing on its en banc decision in Allegheny Defense Project v. FERC, 964 F.3d 1 (D.C. Cir. 2020), the court held that OIG has no “unwritten and unilateral power to indefinitely evade” the deadline, that an agency’s practical need for more time does not license tolling, and that a general grant of procedural authority cannot displace specific statutory text. That the statute attaches no consequence to missing the deadline does not imply permission to regulate around it.
• Mootness did not shield the regulations. Issuing the opinion mooted the claim that it was being unlawfully withheld, but not the challenge to the underlying policy. Vertex, which has sought advisory opinions before and credibly represents that it will again, is a repeat player likely to be subject to the same practice — enough for standing, and the purely legal question was ripe.

Holding

Affirmed in part, reversed in part, and remanded. The court held that OIG correctly concluded that the Fertility Support Program would provide remuneration to induce the purchase of Casgevy within the meaning of the AKS. OIG’s determination that the program would violate the BIS was arbitrary and capricious and is set aside. The advisory-opinion timing provisions are contrary to law: the rules starting the 60-day clock at formal acceptance rather than receipt, 42 C.F.R. §§ 1008.41(b), 1008.43(c)(1), and the tolling provisions, which the court set aside, id. §§ 1008.39(a) (second sentence), 1008.41(e), 1008.43(c).

What to Watch

• What the court expressly left open. There are three. The court did not decide how much influence is required to constitute inducement — it did not need to, given the size and design of this program. It did not decide whether “induce” in the AKS is identical in meaning to “influence” in the BIS. And it did not reach OIG’s alternative theory that the program provides prohibited remuneration to physicians and treatment centers through the opportunity to earn treatment-related fees.
• The remand at OIG. The agency must reconsider the Promotes Access to Care Exception and explain its conclusion. The court also noted that OIG may take a different view on remand of whether to grant prospective immunity under the AKS, a question Vertex did not press on appeal. A reasoned denial remains available; a conclusory one does not.
• Whether the AKS question goes further. Three circuits now read “remuneration” and “induce” broadly and none has held otherwise, which makes this an unlikely vehicle for Supreme Court review and a diminishing argument at the district-court level. Watch for a rehearing or certiorari petition on the ordinary timeline; none had been reported as of this writing.
• Advisory opinions as a usable tool. If the 60-day clock runs from receipt and cannot be tolled, the advisory opinion process becomes something a company can plan around rather than an open-ended wait — Vertex’s own took more than a year. OIG’s response to the compressed deadline it now faces will be interesting to watch.
• Program design in the meantime. Patient-support programs tied to a specific product or service remain exposed under the AKS regardless of the benevolence of their purpose. The defensible space has moved to the exceptions and safe harbors, and to the scienter element — which OIG, following its usual practice, did not formally analyze in the advisory opinion at all.

What This Means for Resolving Disputes Involving the AKS

For parties trying to resolve a dispute involving the meaning and scope of the AKS — disputes that most often arise in False Claims Act litigation — the useful observation is that the range of outcomes on the AKS question has narrowed considerably, and narrowing is what makes matters resolvable. A defendant arguing that “remuneration” reaches only corrupt transactions is now arguing against three circuits and none in the other direction. That argument has gone from a plausible dispositive defense to a discount.

The contested space has shifted to ground that is inherently more negotiable. Whether an activity alleged to violate the AKS is in fact legitimate is a highly factual question, not a clean question of statutory construction. Whether conduct was knowing and willful is a fact question too. Disputes that turn on evidentiary judgments of that kind are the ones where a neutral can be useful, because both sides can see the range and neither can be confident of the ends of it. Disputes that turn on a pure question of law, by contrast, tend to be litigated to a decision — which is what the last several years of AKS scope litigation produced, and what this decision brings closer to a close.

John Libby is an arbitrator, mediator, and settlement counsel with LibbyADR LLC. This post contains his own summaries of the decisions discussed, prepared for general informational purposes only. The summaries are not intended to be a complete statement of any court’s reasoning, nor should they be taken to indicate how he would rule as an arbitrator in any particular case. In addition, the summaries are not legal advice, nor should they be construed as legal advice. Readers should not act on these posts, but should review the decisions themselves and consult with legal counsel.