OIG Signals Further Support for Manufacturer-Sponsored Testing Programs with Fourth Favorable Advisory Opinion

On June 10, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26-14, a favorable advisory opinion regarding an existing manufacturer-sponsored antibody testing program to determine whether patients may have a condition where treatment with the requestor’s prescription drug may be appropriate.¹ OIG concluded that though the sponsored testing program does implicate the federal Anti-Kickback Statute (AKS) and the Beneficiary Inducement Statute (BIS) and does not fit within an available exception or safe harbor under either law, the risk of fraud and abuse is sufficiently low due to certain characteristics of the arrangement and the presence of key safeguards, as discussed in more detail below.

Advisory Opinion 26-14 is the fourth favorable advisory opinion to address manufacturer-sponsored testing programs within a five-year span (see prior Sidley Updates here, here, and here) — underscoring the agency’s continued desire to ensure patient access to treatments for rare disease.

The Arrangement

The requestor manufactures the only Food and Drug Administration (FDA)–approved treatment for an ultra-rare condition characterized by severe and progressive muscle weakness. Diagnosis of the condition can be confirmed by testing for elevated levels of antibodies in the blood. However, according to the requestor, the condition is often underdiagnosed or misdiagnosed because it is characterized by symptoms that overlap with other neuromuscular disorders. Thus, to increase provider awareness of the condition and the availability of antibody testing as a diagnostic resource, the requestor has entered into a written agreement with a third-party laboratory to provide antibody testing at no cost to patients who present clinical symptoms consistent with the condition or who have cancer and for whom clinical practice guidelines recommend antibody screening.²

Under the arrangement, healthcare providers may order an antibody test using an online form. Assuming the patient is eligible, the specimen is collected by a patient’s healthcare provider or laboratory personnel. Following pickup and processing, the laboratory provides the results directly to the ordering provider. Of the ordered tests, the requestor certified that the vast majority are negative, estimating that only 1.6% of tests performed in the United States may indicate the presence of the condition.³

The requestor certified that healthcare providers are not required to purchase any of requestor’s products to participate in the arrangement. Further, healthcare providers are not paid any remuneration to recommend or prescribe any of the requestor’s products.⁴

Pursuant to its written agreement with requestor, the laboratory is contractually prohibited from billing any patient or third-party payors for the testing, using the arrangement to market other laboratory’s services, or offering any inducement to healthcare providers to prescribe the requestor’s products. Furthermore, the requestor compensates the laboratory for the testing services on fixed fee or per-unit fee basis depending on the nature of the fees. The requestor certified that these fees are consistent with fair market value and were negotiated at arm’s length.⁵

While the requestor receives limited, aggregated, deidentified operational data (e.g., number of tests ordered) from the laboratory, it certified that none of the provided information can be used to identify individual patients or ordering healthcare providers. Further, requestor certified that its sales representatives do not have access to the provided data, nor is such data used for sales or marketing activities.⁶ Requestor’s sales representatives are also prohibited from discussing or promoting the arrangement, particularly in connection with the product.⁷

The Agency’s Analysis

OIG concluded that the arrangement implicates both the AKS and the BIS based on its view that the arrangement provides remuneration to patients (by eliminating cost-sharing that the patient would normally incur to receive the test) and their healthcare providers (by allowing them to offer a free service that could create future billing opportunities, e.g., follow-up appointments to review results) that could induce purchases of requestor’s product. However, despite the OIG’s perception of inherent value of the antibody test and lack of an available exception or safe harbor, OIG ultimately concluded that the risk of fraud and abuse was sufficiently low for the following reasons:

1. Unlikely to Result in Overutilization or Inappropriate Utilization
   
   OIG concluded that the arrangement is unlikely to result in overutilization or inappropriate utilization because with only 1.6% of tests coming back positive for the condition, it is much more likely that the tests will show that requestor’s product is not indicated for a particular patient. OIG also noted that the arrangement is likely to improve patients’ ability to access needed items or services while posing a low risk of harm to such patients and the Medicare and Medicaid programs.
   
   
2. Unlikely to Skew Clinical Decision-Making
   
   OIG found that the risk of the arrangement’s skewing clinical decision-making or inappropriately steering patients to certain healthcare providers was mitigated based on the various safeguards requestor implemented, including (i) preventing its sales representatives from discussing requestor’s product in connection with the arrangement or selectively providing information about the arrangement to certain providers based on their history prescribing requestor’s products and (ii) limitations on the exchange of data related to the arrangement that prevent requestor from leveraging the arrangement for marketing purposes, including the laboratory’s contractual agreement to provide only aggregated, deidentified operational data (e.g., number of tests ordered) that does not allow for the identification of specific patients or healthcare providers. 

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Like all advisory opinions, Advisory Opinion 26-14 applies only to the specific requestor. However, OIG’s analysis in this opinion is largely consistent with its reasoning in the three prior favorable opinions involving manufacturer-sponsored testing programs, further signaling OIG’s support for such programs so long as there are appropriate guardrails in place to mitigate potential fraud and abuse risks.

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¹Dep’t of Health & Hum. Servs. Advisory Opinion No. 26-14, at 1 (June 15, 2026).
²Id. at 3.
³Id. at 2.
⁴Id. at 3.
⁵Id. at 3.
⁶Id.
⁷Id. at 4.