Comments

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Comments on Medicare NCD for PrEP using antiretroviral therapy

Aug 11, 2023

With deep and widening racial, ethnic, and gender disparities in uptake, access to PrEP through Medicare is of paramount importance to making sure that Medicare beneficiaries are able to benefit from the widening array of PrEP options without cost-sharing.  Medicare beneficiaries (including those dually eligible for Medicaid) comprise 10 percent of the population using PrEP, including both individuals over 65 as well as disabled individuals under 65.  We thank CMS for making clear that all FDA-approved forms of PrEP would be available without cost-sharing.  This means that Medicare beneficiaries will have unfettered access to future novel forms of PrEP immediately after FDA approval. 

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Comments on the Medicare Drug Price Negotiation Program Initial Memorandum

Apr 14, 2023

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).

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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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50 patient groups comment in response to the request for information on essential health benefits [CMS-9898-NC]

Jan 31, 2023

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. 

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