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HHS-OIG Issues Favorable Opinion on Drug Manufacturer’s Travel Assistance Program for Single-Use Tumor Treatment

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HHS-OIG Issues Favorable Opinion on Drug Manufacturer’s Travel Assistance Program for Single-Use Tumor Treatment

Highlights

The HHS-OIG recently released Advisory Opinion No. 24-13, a favorable opinion involving assistance with patient expenses by a manufacturer of a single-use treatment

The proposed arrangement is consistent with previous agency guidance on patient assistance that promotes access to care 

The HHS-OIG determined the risk of fraud and abuse is sufficiently low under the Anti-Kickback Statute and that there was no prohibited renumeration under civil monetary penalty laws against beneficiary inducements 

The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 24-13, a favorable opinion assessing the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws against beneficiary inducements (CMP) as applied to assistance for certain travel, lodging, meals, and associated expenses for qualifying patients receiving a cell therapy product targeting tumors. To qualify patients must: 1) be residents of the United States or a U.S. territory, 2) have income at or below 600 percent of the federal poverty level, 3) meet program distance requirements, and 4) have an on-label prescription. The advisory opinion was requested by the manufacturer of the cell therapy product.

In the advisory opinion, the HHS-OIG concluded that the proposed arrangement implicates the AKS in two ways: first, patients purchasing the product, and second, treatment centers and treating physicians for the opportunity to earn fees. The HHS-OIG also determined that the arrangement would not fall directly within any exception or safe harbor. However, the HHS-OIG concluded that the risk of fraud and abuse was sufficiently low and that it would not impose sanctions in connection with the proposed arrangement.

The HHS-OIG separately determined the proposed arrangement did not generate prohibited renumeration under the CMP since it fell within the “promotes access to care” exception.

Treatment and Assistance

The manufacturer offers patients who have failed at least one alternative treatment a one-time tumor-derived autologous T-cell immunotherapy product, using the patient’s own tumor sample. All treatments must occur at the limited number of qualified treatment centers that have the expertise to treat the patient’s underlying disease and to administer the product. The patient must be a patient of the treatment center for approximately one month, including time for procurement, chemotherapy, infusion, and post-treatment monitoring. The treatment centers will be listed on the manufacturer's website, and when requested, the manufacturer will provide information on the treatment center geographically closest to the patient.

The proposed travel assistance provided by the manufacturer would include: 1) airfare or ground transportation to the nearest treatment center or the treatment center with which the patient has an established relationship, if the cost is not materially different, 2) lodging, and 3) other support, including $50 per person, per day, to cover meals and other travel expenses, with documented receipts. The assistance would be provided to both the patient and a caregiver, as the patients are extremely ill and may experience serious adverse events thus requiring a caregiver’s presence.

The proposed arrangement would not be provided if alternative assistance is available from another source, such as the treatment center, insurance, or third-party charities. The manufacturer will not advertise the assistance beyond providing a general overview to treatment centers, potential referring physicians, and patients. The assistance is not intended as a marketing tool, and the manufacturer will not require treating physicians or treatment centers to prescribe or use the product exclusively.

Details on the Agency’s Determination

The HHS-OIG concluded that the proposed arrangement implicated the AKS and would not fall directly within any exception or safe harbor. However, the agency concluded the risk of fraud and abuse is sufficiently low and it would not impose sanctions in connection with the proposed arrangement. The HHS-OIG also determined that the proposed arrangement falls within the “promotes access to care” exception of the CMP, meaning it does not generate prohibited remuneration.

In making this determination, the agency considered the removal of both financial and geographical barriers, along with the low risk of harm to Medicare and Medicaid beneficiaries and the Medicare and Medicaid programs.

The HHS-OIG cited the following factors as limiting the possibility for fraud and abuse under the AKS:

  • The proposed arrangement removes barrier to accessing medically necessary care for patients and caregivers if they live a significant distance from a treatment center
  • The product is a one-time, potentially curative treatment eliminating the concern that a manufacturer will provide a first dose to induce patients to continue purchasing the treatment
  • The proposed arrangement includes other safeguards that limit risk of harm which include:
    • The manufacturer does not authorize the proposed arrangement if other assistance is available
    • The manufacturer does not use the assistance as a marketing tool, since it is limited to those who do not have other assistance
    • The manufacturer does not advertise the assistance beyond a general overview to treatment centers, potential referring providers, and patients
    • The manufacturer does not require exclusive prescribing of the product

Takeaways

Similar to Advisory Opinion No. 24-03, this opinion serves as a reminder that drug manufacturers may be able to fund patient and caregiver assistance programs while complying with federal healthcare laws, provided that key safeguards are met and the assistance promotes access to care. Notably, manufacturers of rare single-use drugs may pose a lower risk of triggering AKS and/or CMP violations if the assistance is provided to eliminate barriers to treatment. 

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This Barnes & Thornburg LLP publication should not be construed as legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general informational purposes only, and you are urged to consult your own lawyer on any specific legal questions you may have concerning your situation.

 

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