Department of Health and Human Services’ (HHS) Proposal to Amend Safe Harbor Regulation


The National Health Council (NHC) appreciates the opportunity to comment on the Department of Health and Human Services’ (HHS) proposal to amend the safe harbor regulation concerning rebates and other discounts.

Founded in 1920, the National Health Council (NHC) is the only organization that brings together all segments of the health community to provide a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 125 national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient advocacy organizations, which control its governance and policy-making process. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities and businesses representing biopharmaceutical, device, diagnostic, generic, and payer organizations.

The increasing cost of prescription drugs, role of rebates, and amount patients pay out-of-pocket for medicines create significant challenges for the patient community. The NHC prioritizes policies that address the rising costs of health care, including but not limited to, the costs of prescription medicines and affordability for patients. We support meaningful policies that promote competition to drive availability of lower-cost, high-quality products and services. We strongly oppose policies that achieve savings at the expense of patient safety, access, affordability, or quality of care.

As the NHC remains committed to ensuring adequate access to affordable, high-value medications for patients, we are supportive of the Administration’s efforts aiming to reduce patient out-of-pocket costs. We agree with HHS’ premise that the rebating process is complex, opaque, poorly understood, and is likely one of many factors contributing to rising list prices and patient out-of-pocket expenses. Thus, the NHC supports the Administration’s proposal to eliminate the safe harbor protecting rebates between manufacturers and Part D plans and introduce a new safe harbor to protect discounts given to beneficiaries at the point of sale if patient safeguards, such as those outlined in this letter, are implemented alongside it to mitigate unintended consequences and ensure beneficiaries are the ultimate recipients of realized cost savings.

Read More