Given the importance of medications to the health and well-being of people living with and at risk of HIV, people with hepatitis B & C, and their growing reliance on Medicare for prescription drugs, we are keenly interested in the implementation of the Medicare Drug Price Negotiation Program that CMS is setting up as required by the Inflation Reduction Act (IRA).
On behalf of the HIV+Hepatitis Policy Institute, an organization dedicated to promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions, we thank you for this opportunity to comment on a National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS) on the use of provider-administered pre-exposure prophylaxis (PrEP). The first provider-administered medication for HIV pre-exposure prophylaxis (Apretude or cabotegravir as PrEP) was approved by the Food and Drug Administration in January 2022. In August 2022, we wrote to you on behalf of 64 organizations to request that CMS quickly and efficiently evaluate provider-administered PrEP for a National Coverage Determination, which is the only pathway to coverage under Medicare Part B. We commend CMS on moving forward with the NCD process and urge CMS to approve the NCD for provider-administered PrEP.
We offer our strong support of adding HIV/AIDS as one of the chronic conditions to be included in the Medicare Part D Medication Therapy Management (MTM) program. The MTM program is designed to assure, with respect to targeted beneficiaries, that covered Part D drugs are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions.
We believe that the EHB regulations governing prescription drugs have generally been working well for patients; however, we propose some areas for improvement and are very concerned that there has been a lack of enforcement of the EHB regulations, an erosion of essential health benefits over the years, and some insurers and pharmacy benefit managers (PBMs) are devising ways to skirt the intent of the EHB law and regulations.
We, the undersigned 71 organizations, on behalf of millions of patients and American consumers who live with complex conditions such as HIV, autoimmune diseases, cancer, diabetes, lupus, hemophilia, mental illness, hepatitis, neurological diseases, and other chronic illnesses, write to comment on the Notice of Benefits and Payment Parameters for 2024 Proposed Rule. The patients we represent appreciate all you are doing to make healthcare more accessible and affordable for beneficiaries. While there are several components of the Proposed Rule that many of us will comment on elsewhere, this letter focuses on those issues that impact access and affordability of prescription drugs.