OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing

On June 10, 2026, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26-14 (AO 26-14), another favorable advisory opinion (its fourth in as many years) involving sponsored tests.

While OIG concluded that the proposal in question could violate the federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b)—prohibiting the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by the federal health care programs—the agency declined to impose administrative penalties on AKS grounds, finding a low risk of harm. OIG further concluded the arrangement in question (“the Arrangement”) satisfied the exception for promoting access to care under the Beneficiary Inducements Civil Monetary Penalties (CMP) law, 42 U.S.C. 1320a-7a. The factors that appear to be significant to the favorable outcome include, among others:

• The need for increased physician knowledge regarding the underlying condition and the ability of laboratory testing to distinguish it from diseases that present with similar signs and symptoms;
• The low incidence of test results leading to the administration of the Requestor’s therapy;
• The fact that the laboratory will not provide the Requestor with patient information that allows targeted marketing for Requestor’s therapy;
• A prohibition against the laboratory acting as marketer for the Requestor to providers;
• A prohibition against the laboratory using the sponsored testing as an opportunity to provide additional testing; and
• The use of non-branded promotional collateral promoting the testing program but not the Requestor’s therapy.

We discuss the advisory opinion and its implications in detail below.

Background

As we wrote in 2025, sponsored tests are medical diagnostic tests or laboratory services where the cost is directly or indirectly paid for, in whole or in part, by a third party rather than by the patient, their insurance, or the health care provider performing the test.

Typically, companies agree to pay for sponsored tests because they are necessary for a patient to access or use the company’s therapy but pose high out-of-pocket costs on the patient. Sponsored tests are frequently used to help diagnose rare genetic disorders, match a patient to a specific drug or therapy available from the pharmaceutical manufacturer or medical device company, including true companion diagnostics, or to monitor therapeutic efficacy or to identify dangerous side effects of a prescribed therapy.

The Requestor’s Proposal

In AO 26-14, the Requestor—a manufacturer of an FDA-approved product (the “Product”) proposed to contract with a third-party laboratory (the “Vendor”) to provide a test (the “Test”) to detect an antibody present in patients with an ultra-rare condition causing severe and progressive muscle weakness (the “Condition”). The Condition is frequently under- or misdiagnosed due to overlapping symptoms with other neuromuscular disorders and can also present as a paraneoplastic syndrome in patients with cancer. The proposal provides no-cost antibody testing to eligible patients (the “Arrangement”). Notably:

The Arrangement

• The Arrangement was open to patients—regardless of income or insurance status—who: (i) present with clinical symptoms consistent with the Condition; or (ii) are diagnosed with cancer and for whom clinical practice guidelines recommend paraneoplastic screening (the “Eligible Patients”).
• Requestor certified that no patient or payor (including federal health care programs) is billed for the Test under the Arrangement. Outside of the Arrangement, federal health care program beneficiaries who receive the Test are responsible for any applicable cost sharing.
• Requestor certified that health care providers are often unaware of the Test and the Condition. The Arrangement is intended to: (i) increase awareness, access, and utilization of antibody testing as a diagnostic resource for patients with neuromuscular symptoms suggestive of the Condition; and (ii) support the awareness and diagnosis of the Condition in oncology contexts where paraneoplastic syndromes are suspected, potentially facilitating earlier cancer evaluation.

The Vendor

• Requestor certified that it and the Vendor are parties to a written services agreement that 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 health care providers to prescribe the Product.
• Requestor further certified that it compensates the Vendor through itemized fixed set‑up fees, fixed monthly operations fees, and per‑unit fees for collection and testing services and that the fees reflect fair market value and were negotiated at arm’s length.
• The Vendor operates the laboratory where the Tests are performed and provides Test results directly to the ordering health care provider. It does not provide individual Test results to Requestor or Eligible Patients.
• The Vendor is contractually prohibited from promoting Requestor’s Product to health care providers and patients using the Arrangement, and the Vendor does not promote the Arrangement.

Health Care Provider

• Health care providers must attest that: (i) they are authorized to order the Test under applicable law; (ii) the patient for whom the Test is ordered is an Eligible Patient; (iii) no claim will be submitted to any third party—including federal health care programs—for the Test; (iv) the health care provider’s medical decisions will not be influenced by participation in the Arrangement; and (v) the health care provider understands that no purchase or prescription of any product or service is a condition of participation.
• Requestor certified that its sales representatives are prohibited from discussing the Arrangement in connection with the Product. However, sales representatives do distribute non-branded materials about the Arrangement, and the Arrangement is discussed in a unbranded disease-state awareness website directed at health care providers.
• Requestor certified that it does not directly pay any remuneration to any health care providers who order the Test under the Arrangement to recommend, prescribe, or administer any products manufactured by Requestor, including the Product.
• Requestor does not condition a health care provider’s ability to order the Test pursuant to the Arrangement on the purchase of any products manufactured by Requestor.
• Requestor certified that it does not market or promote the Arrangement to patients.

OIG’s Analysis

The Anti-Kickback Statute. The OIG concluded that the Arrangement implicates the federal AKS because it results in remuneration to Eligible Patients and their health care providers that may induce those patients to purchase, or their treating providers to prescribe, the Product. With respect to patients, the free Test provided through the Arrangement has value: if the Test was covered by insurance, Eligible Patients would have to pay associated cost sharing (interestingly, OIG did not discuss whether the Test is covered by the Clinical Laboratory Fee Schedule (CLFS), which would result in no cost sharing for fee for service Medicare patients and presumably further mitigate AKS risk). If the Test was not covered by insurance, Eligible Patients would have to pay the entire cost of the Test. With respect to health care providers, the Arrangement confers value by enabling them to offer a service, at no cost to them or their eligible patients, that may create an opportunity for health care providers to bill for other services. No AKS safe harbor applies to the Arrangement.

Nevertheless, the OIG concluded that the risk of fraud and abuse presented by the Arrangement is sufficiently low to warrant a favorable advisory opinion. The OIG highlighted several important risk-mitigating factors, finding:

• The Arrangement is unlikely to result in overutilization or inappropriate utilization. The Test determines whether it is possible for the Product to be prescribed and Requestor estimates 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. As a result, the Test is significantly more likely to show that the Product is not indicated for a particular patient.
• The risk of skewed clinical decision-making or steering is mitigated by the fact that Requestor’s sales representatives do not discuss the Product in connection with the Arrangement, and health care providers do not receive any remuneration from Requestor in connection with the Arrangement other than the potential opportunity to bill for other services.
• Various safeguards prevent use of the Arrangement as a marketing or sales tool to steer health care providers to order any items or services from Requestor or the Vendor, including the Product. Specifically, Requestor certified that its sales representatives do not distribute materials in a manner that takes into account a health care provider’s history prescribing Requestor’s products, including the Product.
• Various limitations on the exchange of data relating to the Arrangement foreclose the potential for Requestor to use the Arrangement to target specific health care providers or patients for further testing or to encourage prescribing or purchasing the Product:
  • The Vendor provides Requestor only with the aggregate number of tests performed (no information identifying individual patients or ordering providers).
  • Requestor restricts even that data to limited personnel responsible for verifying the Vendor’s invoice.
  • Sales representatives have no access to any data from the Arrangement.
  • The Requester certifies that it does not use the data from the Vendor for sales and marketing activities.

The Beneficiary Inducements CMP

Similarly, the OIG concluded that the Arrangement implicates the Beneficiary Inducements CMP because Requestor provides remuneration to beneficiaries in the form of a free Test, and the Arrangement could influence a beneficiary to seek follow-up care from the health care provider who ordered the Test. Yet the OIG found that the Arrangement satisfies the Promotes Access to Care Exception, based on certain factors:

• It was likely that the remuneration offered (the free Test) would improve a beneficiary’s ability to obtain items and services payable by Medicare or Medicaid by removing a barrier to awareness, and potentially diagnosis and treatment of, the Condition;
• The risk that the Arrangement interferes with or skews clinical decision-making was sufficiently low because:
  • Other than providing health care providers with a potential opportunity to earn a fee due to the follow up care, Requestor does not incentivize health care providers who order the Test under the Arrangement to recommend, prescribe, or administer any products manufactured by Requestor, including the Product; and
  • Requestor does not condition a health care provider’s ability to order the Test pursuant to the Arrangement on their purchase of any products manufactured by Requestor, including the Product.
• The Arrangement was unlikely to increase costs to federal health care programs or beneficiaries through overutilization or inappropriate utilization because the Test determines whether it is appropriate for the Product to be prescribed.
• The Arrangement does not raise patient safety or quality-of-care concerns because the Test determines whether there are elevated antibody levels that may be indicative of the Condition, thereby providing information that enhances patient safety.

Takeaways

AO 26-14 marks the fourth time OIG has weighed in on the topic of sponsored testing, again issuing a favorable opinion notwithstanding a recognized potential violation of the AKS.

The OIG issued similar favorable opinions in 2022 and 2024 respectively—AO 22-06 and AO 24-12— that approved sponsored test arrangements in which pharmaceutical manufacturers offered free genetic testing and genetic counseling services to patients suspected of having rare conditions for which the manufacturers produced approved medications. Under the facts in these opinions, the genetic test results alone did not directly determine whether the manufacturer's drug would be prescribed.

AO 25-07, from 2025, took the facts one step further, with the OIG approving a sponsored test program proposed by a pharmaceutical manufacturer where the manufacturer would offer a specific companion laboratory test for free to eligible patients where the test is a medically necessary prerequisite for a provider to safely and effectively prescribe a prescription drug made by the pharmaceutical manufacturer.

As in the prior opinion, the Test at issue in this opinion has a close nexus to the sponsoring manufacturer’s drug. But a notable feature of this arrangement is that the vast majority of tests will be negative. The OIG specifically cited the approximately 1.6 percent positive rate, meaning roughly 98.4 percent of tests will show that the drug is not indicated for a given patient. This low positive rate was one of the OIG’s stated reasons for finding a low risk of overutilization or inappropriate utilization, and it is a meaningful factor contributing to the favorable outcome. Moreover, the Requestor represented that it would implement a particularly strong system of compliance risk guardrails which OIG has identified as important features of permissible sponsored testing programs in prior opinions. Although all OIG advisory opinions are specific to the requesting party, they provide invaluable guidance for the industry and continue to signal OIG’s more permissive approach toward well-constructed arrangements that promote patient access to therapies.

If you have questions about the issues discussed in this blog post, please contact one of the authors.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.