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The Department of Health and Human Services Office of Inspector General (OIG) recently issued two advisory opinions related to proposed arrangements offering financial assistance to individuals who receive gene therapy treatments. These arrangements were specifically targeted to patients who may suffer from infertility as a result of the treatments’ required chemotherapy-based fully myeloablative conditioning (Conditioning).

While proposed arrangements for travel support (as discussed below and in a June 14, 2024 advisory opinion) appear to receive approval from OIG, other proposed financialsupports for infertility services have received unfavorable opinions primarily because of a lack of data available to OIG regarding whether the proposed assistance would improve the ability of patients to access the gene treatment therapies.

These unfavorable decisions effectively chill arrangements to provide additional financial support to individuals who are enrolled in federal and state health care programs and require gene therapy treatments, though OIG has indicated that it may issue favorable decisions in the future if it receives additional data.  Continue Reading OIG Issues Opinions On Arrangements Involving Gene Therapy Treatments

On June 17, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion, approving a plan to provide assistance with travel, lodging, meals, and other associated expenses for qualifying patients receiving a gene therapy product.

OIG determined that it would exercise its enforcement discretion by declining to impose administrative sanctions on gene therapy product manufacturer under the Federal Anti-kickback Statute (AKS), despite finding that the arrangement would generate prohibited remuneration if the requisite intent were present. Additionally, OIG found that the arrangement satisfies the “Promote Access to Care” Exception to the Beneficiary Inducements Civil Monetary Penalties law.Continue Reading OIG Approves Travel and Lodging Assistance for Patients Receiving Gene Therapy