Rare Disease Day
As we discussed in our blog post last week, 2024 saw the Department of Health and Human Services Office of Inspector General (HHS OIG) provide more concrete regulatory guidance for programs sponsored by pharmaceutical manufacturers that provide financial assistance and free genetic testing and counseling services to patients suffering from rare diseases. While the favorable treatment from HHS OIG is a positive development for stakeholders and patients, the Advisory Opinions should not be interpreted as permission slips for stakeholders to push the limits of facilitating testing, assistance, or treatment of federal healthcare program beneficiaries. Recent False Claims Act (FCA) enforcement developments demonstrate that stakeholders should carefully consider the structure and risk associated with providing assistance to patients, regardless of disease state.