OIG Greenlights Cost-Sharing Waiver for Commercially Insured Patients

On January 16, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-01, offering clarity as to whether a manufacturer may waive patient cost-sharing amounts for certain insured individuals receiving its clinical diagnostic test without triggering liability under the Federal health care fraud and abuse laws.

Background: Cost Sharing and Fraud & Abuse Risks

Under federal law, arrangements that provide “remuneration” to patients can implicate the Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty (“CMP”) statute. In particular, waiving cost-sharing amounts may constitute prohibited renumeration if it is likely to influence the choice of a medical service or provider reimbursable by a Federal health care program.

Historically, the OIG has taken a cautious stance on arrangements reducing financial barriers for patients, especially where those arrangements involve services reimbursed by Federal health care programs. However, the OIG has also recognized that certain patient assistance mechanisms present low risk of fraud and abuse.

The Requestor’s Proposal

In Advisory Opinion 26-01, the Requestor, a manufacturer of a clinical laboratory test for colorectal cancer screening (the “Test”), proposed to waive any applicable cost sharing for certain commercially insured patients who receive its test. Notably:

• Requestor is the only laboratory that performs the Test, which is the first and only FDA-approved, non-invasive, stool-based RNA colorectal cancer screening test available to patients who are age 45 years or older and at average risk for developing colorectal cancer.
• While the Test has been FDA-approved since 2024, at this time it is not included among the categories of U.S. Preventive Services Task Force (“USPSTF”) colorectal screening test recommendations, which have not been updated since 2021. Under the Affordable Care Act (“ACA”), most commercial health plans are required to cover, without cost-sharing, preventive services that receive an “A” or “B” rating from USPSTF. If a screening test is included in USPSTF recommendations with an A or B rating, commercial plans generally cannot impose copays or deductibles. If a test is not included in the USPSTF’s recommendations with an A or B rating, plans may impose cost sharing, even if the test is FDA-approved.
  • The Requestor did certify that it will seek inclusion of Requestor’s stool-based RNA colorectal cancer screening test in the USPSTF colorectal cancer screening recommendations in the next update, which may not be for several years.
• The waiver would apply to commercially insured patients who receive the Test and who do not otherwise qualify for Requestor’s financial assistance policy, regardless of which provider orders the Test, and will not be tied to any other health care item or service.
• The proposed arrangement would continue until the USPSTF updates its colorectal cancer screening recommendations to include the Test, no matter what grade the Test is ultimately assigned by USPSTF.
• Requestor would not offer or pay any remuneration to any ordering prescriber in connection with the proposed arrangement.

OIG’s Analysis

After evaluating the Requestor’s facts and representations, the OIG concluded that the proposed cost-sharing waiver does not constitute prohibit renumeration under the AKS or the Beneficiary Inducement CMP statute. In reaching this conclusion, the OIG highlighted several important risk-mitigating factors, including:

• Because the waiver applies only to commercially insured patients, it does not extend renumeration to Federal health care beneficiaries. This distinction is significant because the primary enforcement focus of the AKS and the Beneficiary Inducements CMP is on renumeration connected with federally funded health care services. The OIG noted that it may come to a different conclusion if Federal health care program coverage of the Test expands and includes circumstances where beneficiaries would be responsible for cost sharing, because in that case, the risk of inadvertently waiving cost sharing for Federal health care program beneficiaries increases.
• Requestor will not be billing Federal health care programs for the Test—even secondarily—and if a commercial insurance automatically bills a Federal health care program as a secondary payor, the claim would likely be denied as the Test is not currently covered by most Federal health care programs (the exception being some state fee-for-service Medicaid programs which prohibit Requestor from collecting any cost sharing amounts and certain Medicaid managed care plans whose enrollees would all qualify under Requestor’s financial assistance policy for cost-sharing waivers).
• The arrangement does not compensate providers, nor does it tie the waiver to orders rendered by specific clinicians. As a result, the proposed arrangement is less likely to influence referral patterns or clinical decision-making. Additionally, since the remuneration would be offered only to commercially insured patients, and any additional services also would be billed to commercial insurers, the opportunity for a prescriber to earn a fee though the proposed arrangement does not implicate the AKS.
• Cost-sharing waivers are available to all qualifying patients regardless of which health care professional ordered the test.
• This arrangement is different from arrangements that “carve out” Federal health care programs, about which the OIG has frequently expressed concerns. The OIG noted these concerns are not present in this proposed arrangement because: (1) this arrangement is not disguising renumeration for Federal health care programs through payments allegedly related to non-Federal health care programs; and (2) the Requestor would not offer or pay any remuneration to any ordering prescriber in connection with the proposed arrangement.

Taken together, these safeguards ultimately led the OIG to conclude that the arrangement presents a low risk of fraud and abuse under applicable statutes.

Takeaways

Advisory Opinion 26-01 offers several takeaways for life sciences companies and compliance professionals evaluating patient assistance or cost-sharing arrangements:

• Cost-sharing waivers are not inherently prohibited. Provided they are carefully targeted and implemented without connection to Federal program beneficiaries or inducement of provider referrals, waivers of patient financial obligations for commercially insured patients can be structured to avoid AKS and CMP liability.
• Ensuring that waivers are broadly available and not contingent on referrals from specific clinicians or networks may help mitigate risk.
• Even where a test is FDA-approved, the absence of a USPSTF A or B rating prohibiting patient cost-sharing for commercially insured patients under the ACA can increase regulatory risk.
• The OIG has historically expressed skepticism towards arrangements that simply “carve out” Federal health care program beneficiaries; however, in this Advisory Opinion, the OIG was persuaded by the structure and controls of the arrangement, concluding that a truly commercial-only cost sharing waiver, implemented uniformly and without provider inducements, presented minimal fraud and abuse risk.
• The absence of prescriber benefit or influence was central to the OIG’s analysis. Arrangements that indirectly relieve provider administrative or financial burdens may be analyzed very differently.

As manufacturers consider ways to address patient out-of-pocket expenses, particularly for innovative diagnostics or treatments with coverage caps, Advisory Opinion 26-01 adds to a growing body of OIG guidance illustrating circumstances in which patient financial support can be structured in a compliant manner.