Key Takeaways

• On September 30, 2026, the District of Massachusetts granted summary judgment to Janssen Biotech and denied the relator’s cross-motion, finding insufficient evidence of either unlawful remuneration or knowing and willful conduct under the AKS.
• Courts continue to apply the HHS-OIG “substantial independent value” framework: product-support services that would have no value absent the manufacturer’s product are generally not remuneration, even if they are valuable and offered to drive sales.
• The opinion reinforces that tailoring a service to a specific practice does not make it unlawful, services with features that transfer across products, address practice-wide operations, or are sold commercially elsewhere carry heightened risk.
• The court affirmed that compliance review, edits, and risk memoranda are not evidence of willfulness, and violating an internal policy does not by itself establish a knowing and willful AKS violation.
• Field-level conduct remains a critical exposure point. Train and monitor field reimbursement, site-of-care, and account teams to stay within approved content, and keep data-driven practice tools tethered to your products to reduce risk under the AKS.

On September 30, 2026, Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts granted summary judgment to Janssen Biotech, Inc. in United States ex rel. Long v. Janssen Biotech, Inc., No. 16-12182-FDS, a qui tam action (in which the government declined to intervene) alleging that Janssen Biotech, Inc. (Janssen or defendant) violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by providing free “business consulting” services to physician practices to induce prescriptions of its infusible biologic products, Remicade and Simponi ARIA. The court also denied the relator’s cross-motion for summary judgment on scienter.

The decision is one of the most detailed judicial treatments of when manufacturer-provided product support services cross the line into unlawful “remuneration.” The court endorsed the “substantial independent value” framework drawn from longstanding HHS-OIG guidance, rejected Janssen’s First Amendment defense, and held that a relator cannot establish “knowing and willful” conduct merely by pointing to a company’s compliance policies and alleging that employees did what those policies prohibited. For manufacturers and distributors that offer reimbursement support, site-of-care programs, field reimbursement teams, or practice-facing tools, the opinion provides both meaningful comfort and important cautionary signals.

Summary of Relevant Facts

The Parties and the Products. Janssen manufactures Remicade (infliximab) and Simponi ARIA (golimumab), IV-infused biologics typically prescribed by gastroenterologists and rheumatologists, with infusions lasting roughly two hours and thirty minutes, respectively. Relator Julie Long worked as a Janssen Area Business Specialist (ABS) from 2003 to early 2016, covering 11 practices in central Pennsylvania.

The site-of-care program. Janssen’s Immunology Specialists supported prescribers, while ABSs focused on the “site of care,” where infusions occurred, presenting company-approved programming on establishing and operating in-office infusion (IOI) suites. Importantly, all programming was approved by a multidisciplinary Promotional Review Committee (PRC) that included in-house lawyers.

The ABS programming included:

• Clinical and nurse education: nurse training on clinical considerations, infusion reactions, and pediatric Crohn’s disease;
• Operational and reimbursement programs: programs on patient counseling, insurance, scheduling, obtaining product, reimbursement and billing, Medicare rules and appeals, prior authorization, procurement, inventory, SOPs, ICD-10, EHR, and payer relationship management;
• Practice-management-adjacent decks: “Checkpoints for Infusion Center Optimization,” “Considerations for Proactive Practice Management” (a 40-page deck on staffing, reimbursement, SOPs, financial management, quality assurance, benchmarks, and inventory), “Setting Up In-Office Infusions,” and decks on implementing and managing GI infusion suites and adapting ambulatory surgery center space;
• MBPO: “Managing Biologics in the Physician Office,” a 75-page deck combining substantial safety information with infusion scheduling tips, data-insertion slides (vials purchased, new patients, and infusions), and infusion workflow, reimbursement, inventory, and infusion tracking forms;
• Hot Buttons: a “Hot Buttons” iPad app that let customers flag operational pain points, after which the ABS presented a matching PRC-approved “Practice Pearl” deck.
• “Infusion Optimization Modeler” (IOM): a program used by ABSs that took a practice’s reported inputs (i.e., existing Remicade patients, chairs, staff hours, budgeted and actual infusion time) and estimated how many more infusions the practice could deliver if a capacity restraint were removed.

Janssen also paid a third-party vendor, Xcenda (an AmerisourceBergen subsidiary), approximately $3,000 per session to deliver the same presentations.

Compliance controls. Janssen’s written policies prohibited giving anything of value to induce prescriptions, required ABSs to use only company-approved materials (ABSs could not even highlight or reorder pages), expressly instructed that ABSs were “not business advisors” and prohibited “consulting services that relate to the management of customers’ business practices,” services that were part of physician overhead, and any calculation, discussion, or promotion of profitability.

The claims and procedural posture. The relator filed suit in 2016; the United States and the states declined to intervene in 2019. Critically, the relator conceded that the approved written materials, and their presentation to practices, were not unlawful remuneration, arguing instead that ABSs’ “live” consultative services went beyond those materials and amounted to free business consulting. She offered little evidence of what those live services were or how they violated the AKS.

The Court’s Findings

   1. “Remuneration” Requires Substantial Independent Value

The AKS, codified at 42 U.S.C. § 1320a-7b, in relevant part, prohibits knowingly and willfully offering or paying any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person to purchase any item for which payment may be made in whole or in part under a Federal healthcare program. The AKS does not specifically define what constitutes “remuneration.” The court acknowledged that “remuneration” carries its ordinary meaning of payment or compensation, but reasoned that a literal reading would make virtually all pharmaceutical detailing and technical support a crime. Instead, the court applied the established HHS-OIG “substantial independent value” framework articulated in Advisory Opinion 00-10 and the 2003 Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731, 23735. Under this framework, the court asked whether the service has value in its own right, independent from the manufacturer’s product.

Although OIG’s views receive no deference after Loper Bright Enterprises v. Raimondo, the court adopted the framework on its own reasoning, finding the relator’s invitation to abandon it undeveloped and declining “to blaze a new trail” in construing a felony statute.

The court outlined boundaries. Manufacturers may provide medical, clinical, and technical support on the use of the product (including operating-room device support) and product-specific e billing and reimbursement advice, even though such advice is, in a sense, business advice. By contrast, manufacturer representatives may not provide business or management advice about the practice as a whole; or perform tasks the practice would otherwise perform in the ordinary course (such as scheduling patient appointments). Between those guideposts, the court acknowledged, “the landscape is unclear,” and the issues must be resolved on the actual evidence.

   2. The First Amendment Does Not Shield Valuable Speech Offered as a Quid Pro Quo

The court rejected Janssen’s argument that “remuneration” should be read narrowly to avoid burdening truthful promotional speech. The AKS regulates conduct, not speech, and prohibiting valuable speech offered as the quid in a quid pro quo readily survives First Amendment scrutiny.

   3. The Relator Failed to Show That the Services Had Independent Value.

Given the relator’s concession, the dispositive questions were what ABSs actually said or did in live meetings and whether that materially varied from approved content. The court found a “large evidentiary hole”: no direct evidence of any ABS communication, no affidavit from the relator, and no testimony from any other ABS, physician, or office staff. It also rejected expert characterizations lacking factual foundation and criticized the relator’s “avalanche of exhibits.”

The court then rejected each of the relator’s theories of independent value:

• The IOM—the closest case. The court called the IOM the closest question but held it was not remuneration. It was used only with practices already infusing the products; its capacity outputs depended on these drugs’ infusion lengths and the staff and equipment needed to administer them. In other words, “[i]f Remicade and Simponi ARIA did not exist, the IOM would have no value.” Calling it “business advice” was insufficient—the same could be said of plainly lawful billing advice.  ABSs supplied information only; practices had to “take the bull by the horns” and implement changes themselves.
• Tailoring is relevant, not controlling. By way of example, operating-room device support is highly tailored yet not independent of the product; conversely, genuinely independent business advice is problematic whether or not tailored.
• Magnitude and the $3,000 vendor fee. The scale of the program showed its importance and Janssen’s intent, but nothing about independence from the products. Likewise, the Xcenda fee showed that the presentations had value, not independent value—manufacturers routinely pay consultants to present safety information.
• No evidence of use for other drugs. The relator offered essentially a single sentence from a Rule 30(b)(6) witness that the programs would be “of interest” to providers wanting to infuse other products, and no evidence of other commonly used infusibles or of the suites’ adaptability to them.

The court distinguished Hart v. McKesson 602 F. Supp. 3d 575 (S.D.N.Y. 2022), where a “Margin Analyzer” service compared reimbursement across interchangeable drugs to maximize profit, where employees identified key improvement areas and met quarterly with customers, and where the same tools were sold by another division for a percentage of revenue. It also contrasted Witkin v. Medtronic (D. Mass. Mar. 31, 2024) (allegations of effectively running clinics) with Forney v. Medtronic (E.D. Pa. June 19, 2017) (product-specific surgical support not remuneration). None of those broader office services were present in Janssen’s programs.

   4. No Evidence of a “Knowing and Willful” Violation

Although unnecessary to the result, the court’s scienter analysis is insightful. Applying First Circuit precedent, the court adopted a modified United States v. Bank of New England, N.A., 821 F.2d 844, 856 (1^st Cir. 1987), approach: knowledge may be established through the collective knowledge of employees (without proof of actual knowledge of the AKS), but “willfulness” requires evidence either 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. The court noted that the D.C. Circuit has rejected collective knowledge as a basis for FCA scienter and that the First Circuit has not addressed the question in this specific context.

The relator failed to supply evidence that supported any of her theories. Compliance officers’ cautions; compliance edits to training slides to make them more product-specific (such as changing “Operational Efficiency” to “Access Support for our IV Therapies,” “IOI Sustainability” to “IOI Support for Our Products,” and replacing “Increase Market Share” with “Improve Site of Care access to enhance product growth”); and a manager’s instruction to reps to discuss patient growth rather than vial growth reflected ordinary compliance review that steered staff away from broader business discussions, not concealment. In addition, “internal warnings” that “flagged” the potential risks and “compliance sensitivities” of the ABS programs showed that compliance personnel “did their jobs.” The court recognized that treating such discussions as proof of willfulness would effectively punish a company for having a functioning compliance department.

The relator also attempted to use prior settlements and a Corporate Integrity Agreement as proof of the requisite scienter. However, the court found that prior settlements and a Corporate Integrity Agreement showed, at most, awareness of the AKS, which was undisputed. Lastly, the relator’s theory of conduct inconsistent with policies failed because there was no evidence that anyone believed the programs were inconsistent with compliance guidelines or unlawful. The relator herself testified that she did not believe at the time that she was violating policy or providing kickbacks.

Having found no triable AKS violation, the court did not reach the FCA elements or Janssen’s constitutional challenges to the qui tam provisions under the Appointments, Vesting, and Take Care Clauses.

Why This Opinion Matters

A judicial endorsement of the “substantial independent value” test, with a clearer map. The opinion gives manufacturers and distributors a well-reasoned articulation of what is permissible (clinical, technical, and product-specific billing and reimbursement support) and what is not (whole-practice business advice and assuming practice overhead). The decisive question remains whether a service would have value if the company’s product did not exist. Programs that are product-specific, informational, and tied to administration of the product stand on firmer ground than tools usable across products or that optimize practice profitability generally.

The gray zone remains, and litigation risk persists. The court expressly acknowledged that the line between product support and business consulting is “far from precise.” The relator lost largely because of evidentiary gaps, most notably her own concession that the written materials were lawful and the absence of testimony about what field personnel actually said. A better-developed record, particularly testimony from field staff or customers describing off-script, practice-wide advice, could produce a different outcome. Companies should also expect the relator’s bar to probe the theory the court flagged: whether services would benefit a practice’s use of competing or unrelated products.

Field conduct, not just approved materials, is where exposure lives. The case turned on whether live interactions materially deviated from company-approved content. Robust material-review processes are necessary but not sufficient; companies should be able to demonstrate that field personnel stay within approved scope, and that data-driven tools (such as capacity or workflow calculators) remain tethered to the company’s products.

Compliance programs as a defense asset. The court refused to treat compliance officers’ cautions, risk memoranda, and edits as evidence of guilty knowledge, and refused to convert a compliance policy into a strict-liability standard. That reasoning rewards companies that document candid compliance review and follow their compliance functions’ recommendations. At the same time, the court signaled that evidence of widespread disregard of compliance policies remains potent proof of willfulness.

Collective knowledge remains a live issue. The court applied the collective knowledge doctrine to AKS scienter while noting the D.C. Circuit’s contrary approach under the FCA and the First Circuit’s silence. Companies operating in the First Circuit should assume that knowledge may be aggregated across employees, even though willfulness still requires individual intent or flagrant corporate indifference.

Recommended Actions For Manufacturers and Suppliers

• Maintain an effective, well-documented compliance program. Route all content—decks, tools, and vendor materials—through legal and compliance review; keep the record of edits and warnings, and document how each warning was resolved. Reassess business-adjacent programs periodically and document fair market value for any customer-affiliated vendor.
• Anchor every program to the product. Build tools around product-specific inputs; avoid comparisons across drugs, generic tools that work equally for other therapies, and any tie to purchase volume.
• Monitor field conduct. Require use of approved materials, provide information rather than implementation, and do not assume practice overhead. Consider call notes or attestations, designed with counsel.

If you have any questions about the decision or its implications for your organization’s field support programs, please contact any of the attorneys listed below.