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Comments on Medicare national coverage determination for long-acting injectable PrEP

Feb 10, 2023

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.

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Comments in support of adding HIV to Medicare medication therapy management

Feb 6, 2023

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.

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64 organizations request expedited Medicare National Coverage Determination for long-acting injectable PrEP

Aug 5, 2022

We are pleased that the Centers for Medicare and Medicaid Services (CMS) has accepted a request for a National Coverage Determination (NCD) for cabotegravir, a new long-acting injectable form of pre-exposure prophylaxis (PrEP) to prevent HIV.  A National Coverage Determination is the only pathway to coverage under Medicare Part B for a provider-administered drug.  We have, however, been disappointed to learn that CMS has given no timeline for action on this National Coverage Determination, which will make this new long-acting PrEP medication out of reach for potential PrEP users.  Combined with a USPSTF recommendation, an NCD will also make the drug available to Medicare Part B beneficiaries without cost-sharing, thus eliminating one of the biggest barriers to PrEP uptake.

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