OIG Issues Favorable Advisory Opinion for Pharmaceutical Manufacturer’s Travel Assistance for Cell Therapy Patients
The Office of Inspector General for the Department of Health and Human Services (“OIG”) issued the final advisory opinion of 2024, Advisory Opinion No. 24-13. In this advisory opinion, Requestor is a pharmaceutical manufacturer that developed a one-time, potentially curative immunotherapy manufactured from a patient’s tumor sample (the “Product”). Requestor certified that the average treatment journey for a patient, including tissue procurement, and post-treatment monitoring, takes approximately one month. In the Proposed Arrangement, patients whose income is at or below 600 percent of the Federal Poverty Level and who have an on-label prescription for the Product would be offered – along with one caregiver – airfare or ground transportation, lodging, and other support during their treatment center stay (e.g., $50 per person, per day to cover meals and authorized travel expenses). Requestor certified that, prior to offering the Proposed Arrangement to a patient, it determines whether assistance for travel, lodging, meals, or associated expenses is available from any other source. If any other source provides full support, Requestor does not offer the Proposed Arrangement. The OIG indicated that, although the Proposed Arrangement would generate prohibited remuneration under the Federal anti-kickback statute if the requisite intent were present, it would not impose administrative sanctions; and the Proposed Arrangement does not generate prohibited remuneration under the Beneficiary Inducements CMP.
OIG Issues Favorable Advisory Opinion for Pharmaceutical Company’s Financial Assistance for Patients Without Adequate Coverage for Specific Pharmaceutical
The Office of Inspector General for the Department of Health and Human Services (“OIG”) then issued the first advisory opinion of 2025, Advisory Opinion No. 25-01. Requestor is a pharmaceutical company that manufactures a disease treating Product intended for patients with mild cognitive impairment or mild disease-related dementia and confirmed presence of amyloid pathology. In the Proposed Arrangement, the Product is provided to patients 18 years of age who apply for assistance; are prescribed the drug for an on-label indication; are uninsured, insured but with no insurance coverage for the Product, or have Medicare coverage for the Product but attest that they are unable to afford their out-of-pocket costs associated with the Product; and have a household income equal to or below 500 percent of the Federal Poverty Level. Eligibility determinations are made without regard to the patient’s insurer or insurance plan, physician, or infusion provider. If a patient qualifies for free Product, the Product is shipped to the site where the patient will receive the Product and clearly designates each vial for use only by the applicable patient. The OIG indicated that, although the Proposed Arrangement would generate prohibited remuneration under the Federal anti-kickback statute if the requisite intent were present, it would not impose administrative sanctions; and the Proposed Arrangement does not generate prohibited remuneration under the Beneficiary Inducements CMP.
New HHS Report on Corporate Ownership Trends in Healthcare
Last week, the Department of Health and Human Services (“HHS”) issued a report following its March 2024 Request For Information (“RFI”) seeking public comment on the impact of corporate ownership trends in healthcare. The goal of the RFI report is to assist agencies in potential actions they may take to improve healthcare competition. This report comes as a part of the Federal Trade Commission (“FTC”), Department of Justice (“DOJ”), and HHS’s tri-agency collaboration to promote competition in healthcare markets.
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