OIG Issues Favorable Opinion On Manufacturer-Sponsored Patient Testing Program

On June 10, 2026, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued Advisory Opinion No. 26-14 (the “Opinion”)—a favorable opinion addressing a drug manufacturer's program to provide free antibody testing to determine whether it would be appropriate to prescribe the manufacturer’s product. The Opinion is a welcome addition to the growing body of favorable OIG opinions on manufacturer-sponsored diagnostic testing programs,¹ and it offers practical lessons for pharmaceutical and biotech companies contemplating similar arrangements.

A. The Arrangement

Under the proposed arrangement (the “Arrangement”), the requesting manufacturer would sponsor antibody testing for eligible patients to determine whether it may be appropriate to prescribe a drug manufactured by the manufacturer. The drug is the only U.S. Food & Drug Administration (“FDA”)-approved therapy for the relevant condition, which causes severe and progressive muscle weakness, although some patients may receive off-label therapies or no treatment at all, depending on severity, comorbidities, and clinical priorities. The manufacturer does not promote the drug for patients who are not diagnosed with the condition.

Under the Arrangement, the manufacturer contracts with a third-party laboratory (the “Vendor”) to provide the testing at no cost to eligible patients. The Arrangement is open to all patients in all 50 states and the District of Columbia—regardless of income or insurance status—who present with clinical symptoms consistent with the condition or who are diagnosed with cancer and for whom clinical practice guidelines recommend paraneoplastic screening. Although the test is typically covered by Federal health care programs and private insurance, no patient or payor (including Federal health care programs) is billed for the test under the Arrangement.

B. Why OIG Gave the Arrangement a Green Light

OIG concluded that, although the Arrangement would generate prohibited remuneration under the Federal anti-kickback statute (“AKS”) if the requisite intent were present, OIG would refrain from imposing sanctions on the manufacturer. OIG further concluded that the Arrangement does not generate prohibited remuneration under the Beneficiary Inducements civil monetary penalty (“CMP”). This is a favorable outcome—but the Opinion's real value lies in OIG’s reasoning.

1. Low Conversion Rate Means Low Risk of Overutilization

Perhaps the most significant factor in OIG’s analysis was the extremely low probability that any given test would lead to a prescription for the manufacturer's product. In fact, it is estimated that only approximately 1.6 percent of antibody tests performed in the United States demonstrate elevated antibody levels that may be indicative of the condition. Because such a small percentage of tests demonstrate elevated levels, the test is “significantly more likely to show that the product is not indicated for a particular patient” (emphasis added). According to OIG, this means that the Arrangement is unlikely to increase costs to Federal health care programs or beneficiaries through overutilization or inappropriate utilization.

2. Arrangement Addresses an Under-Diagnosed Condition

According to the manufacturer, the condition is frequently under- or mis-diagnosed due to overlapping symptoms with other conditions, and health care providers (“HCPs”) are often unaware of the test and the condition. Accordingly, OIG recognized that the test may “remove a barrier to awareness—and potentially diagnosis and treatment—of the condition.” This framing was critical to the OIG’s finding that the Arrangement satisfied the “promotes access to care” exception to the Beneficiary Inducements CMP, and that the free test could likely improve a beneficiary's ability to obtain items and services payable by Medicare or Medicaid.

3. Robust Marketing Safeguards

According to the Opinion, structural safeguards separating the testing program from the manufacturer’s commercial operations were essential to the favorable outcome. Such safeguards include:

1. The manufacturer’s sales representatives distribute approved, non-branded materials about the Arrangement that do not reference the product;
2. Sales representatives do not distribute materials in a manner that takes into account an HCP’s history prescribing manufacturer’s products;
3. Sales representatives are prohibited from proactively discussing or promoting the Arrangement and from discussing the Arrangement in connection with the product;
4. The manufacturer does not directly pay any remuneration to any HCPs who order the test to recommend, prescribe, or administer any of the manufacturer’s products;
5. The manufacturer does not condition an HCP’s ability to order the test on their purchase of any of manufacturer’s products.

4. Stringent Data Firewalls

The data restrictions built into the Arrangement were another pillar of OIG’s analysis. Under the Arrangement, the Vendor provides the manufacturer with only limited, aggregated, de-identified operational data—specifically, the number of tests performed under the Arrangement. The Vendor does not furnish any information that would enable the manufacturer to identify individual patients or ordering HCPs. The manufacturer restricts access to Vendor-provided data to limited personnel responsible for verifying the amount invoiced by the Vendor, and sales representatives do not have access to data from the Arrangement. Finally, the manufacturer does not use data provided by the Vendor for sales and marketing activities.

OIG emphasized that these various limitations on the exchange of data relating to the Arrangement serve to “foreclose the potential for [the manufacturer] to use the Arrangement to target specific health care providers or patients for further testing or to encourage prescribing or purchasing the [p]roduct.”

C. Critical Role of the Third-Party Vendor

One of the most instructive aspects of the Opinion is the role played by the Vendor. The use of an independent vendor is not merely a logistical convenience—it is a structural feature that does significant legal work in mitigating fraud and abuse risk, particularly in the following ways:

1. Information Firewall

As discussed above, the Vendor operates the laboratory where the tests are performed and provides test results directly to the ordering HCP—it does not provide individual test results to the manufacturer or to patients. By contrast, if the manufacturer had run the testing program in-house, it would have had direct access to the identity of every patient tested, every ordering HCP and every test result—data that could readily be leveraged for marketing purposes. The Vendor’s intermediary position creates a structural barrier that the OIG clearly values.

2. Contractual Safeguards

The written services agreement between the manufacturer and the Vendor prohibits the Vendor from: (i) billing any patient or payor—including Federal health care beneficiaries or programs—for tests provided to eligible patients; (ii) using the Arrangement to market other Vendor services; or (iii) offering any inducement to HCPs to prescribe the product. The Vendor is also contractually prohibited from promoting the manufacturer’s products, as well as the Vendor's other products or services, to HCPs and patients using the Arrangement. These contractual restrictions bind an independent entity and are therefore more structurally credible than purely internal manufacturer policies would be.

3. Arm’s-Length Compensation

The manufacturer compensates the Vendor through itemized fixed set-up fees, fixed monthly operations fees, and per-unit fees for collection and testing services, and the fees reflect fair market value negotiated at arm’s length. This compensation structure ensures that the Vendor relationship itself is not a conduit for improper remuneration.

4. Independent Clinical Pathway

HCPs order the test through the Vendor’s website. As part of the ordering process, HCPs must attest, among other things, that their medical decisions will not be influenced by participation in the Arrangement and that no purchase or prescription of any product or service is a condition of participation. Test results flow from the Vendor directly to the ordering physician—never through the manufacturer. This creates a clinical decision-making pathway that is independent of the manufacturer's commercial infrastructure.

D. Takeaways

The Opinion reinforces a now well-established principle in OIG’s advisory opinion jurisprudence: manufacturer-sponsored diagnostic testing programs can be structured to satisfy both the AKS and the Beneficiary Inducements CMP, provided the program is designed with genuine diagnostic intent and rigorous structural separation from the manufacturer’s commercial operations. Of course, the devil is in the details, and compliance diligence analyzing AKS and CMP exposure is only part of the picture. Manufacturers contemplating these arrangements must also navigate vendor contracting complexities, internal organizational dynamics, and state-law considerations—all while preserving the legitimate business objectives that make these programs worth pursuing in the first place.

From a contracting perspective, the vendor services agreement is where the compliance analysis becomes operational. The structural restrictions that OIG found persuasive in this Opinion—prohibitions on billing patients or payors, restrictions on marketing the Vendor’s own services, data firewalls—were all contractual commitments binding an independent third party, which is precisely what gave them credibility. Manufacturers should ensure that their vendor agreements address, at a minimum: (i) fair market value compensation that is fixed or unit-based and not tied to test volume or outcomes; (ii) explicit prohibitions on the vendor billing any patient, insurer, or Federal health care program for tests provided under the program; (iii) data segregation provisions limiting the manufacturer’s access to aggregated, de-identified operational data, with no access to individual patient identities, test results, or ordering HCP information; (iv) prohibitions on the vendor cross-selling its own products or services to ordering HCPs or patients through the program; (v) HCP attestation requirements confirming that medical decisions will not be influenced by participation; (vi) audit rights permitting the manufacturer to verify vendor compliance; and (vii) representations regarding the vendor’s own regulatory compliance, including applicable Clinical Laboratory Improvement Amendments (“CLIA”) and state licensure requirements. Manufacturers should also bear in mind that the Opinion addresses only Federal law. Many states have their own anti-kickback statutes, fee-splitting prohibitions, and consumer protection frameworks that may impose additional or different requirements on these arrangements, and vendor agreements should be drafted with those obligations in view.

Finally, manufacturers should resist the temptation to view compliance infrastructure as an obstacle to the business objectives of these programs. The legitimate purpose of a manufacturer-sponsored testing program is to facilitate appropriate diagnosis—and, where clinically indicated, treatment—of patients who might otherwise go undiagnosed. That purpose is not inconsistent with the manufacturer’s commercial interest in identifying the patient population for its product; indeed, OIG has implicitly acknowledged as much by issuing favorable opinions on these arrangements. The key is ensuring that the program’s structure channels that commercial interest through compliant pathways. This means, among other things, that internal compliance teams should be involved from the outset in program design—not brought in after the fact to bless a structure conceived by the commercial organization. It also means that manufacturers should establish clear internal policies governing the separation of testing program operations from sales and marketing functions, including restrictions on sales representative access to program data and prohibitions on sales representatives proactively discussing the program in promotional contexts. Periodic compliance audits of the program—including review of vendor performance, data access logs, and sales representative conduct—should be built into the program from inception. With thoughtful structuring and ongoing compliance oversight, these programs can achieve their dual objectives: improving patient access to diagnosis and treatment while managing the regulatory risks inherent in any arrangement where a manufacturer provides free items or services to patients and HCPs.

Footnote

1 SeeAO 22-06; AO 24-12; AO 25-07.