Medicare Drug Price Negotiation Program Draft Guidance Comments

July 2, 2024

VIA ELECTRONIC SUBMISSION

Meena Seshamani, M.D., Ph.D.
CMS Deputy Administrator and Director, Center for Medicare
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-8016

RE: Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year (IPAY) 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Dear Dr. Seshamani,

HealthHIV appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid’s (CMS) IPAY 2027 proposed guidance, which once finalized, will take effect on January 1, 2027. 

We recognize that this guidance has significant implications for the future of HIV treatment and prevention, particularly regarding price setting under the Inflation Reduction Act (IRA).

For background, HealthHIV advances effective prevention, care, support, and health equity for people living with, or at risk for, HIV and hepatitis C—particularly with LGBTQ and other underserved communities—by providing education, capacity building, health services research, and advocacy to organizations, communities and professionals.

HealthHIV is a national non-profit working with healthcare organizations, communities, and providers to advance effective HIV, HCV, STI and LGBTQ health care, harm reduction and health equity through education and training, technical assistance and capacity building, advocacy, communications, and health services research and evaluation.

HealthHIV leads the HealthHCV initiative, the National Center for Health Care Capacity Building, and the National Coalition for LGBTQ Health, as well as PleasePrepMe.org, AgingWithHIV.org, ReduceHarmDC.org, and the HIV Prevention Certified Provider (HIVPCP) Certification Program.

The National Coalition for LGBTQ Health, administered by HealthHIV, is committed to improving the health and well-being of lesbian, gay, bisexual, and transgender + individuals through federal and local advocacy, education, and research. The Coalition strives to address the entire LGBTQ+ community, including individuals of every sexual orientation, gender, gender identity, race, ethnicity, and age regardless of disability, income, education, and geography. The Coalition is an initiative of HealthHIV, a national nonprofit focused on health equity.

In short, both of our primary missions are to champion the rights and well-being of LGBTQ+ individuals, while further emphasizing the distinctive and syndemic needs of those living with HIV. 

Fundamentally, each work to ensure access to innovative treatments and support the HIV community comprehensively. We believe that the CMS guidance must carefully balance cost management with the need to foster continued innovation in HIV treatment and prevention.

Background on HIV Treatment and Prevention Needs

An estimated 1.2 million people in the United States are living with HIV—with at least 10-13 percent unaware of their status. HIV, while once a fatal diagnosis, can now be a manageable, chronic condition thanks to antiretroviral (ARV) treatments. Over 40 percent of people with HIV in the U.S. are now aged 55 or older. In addition to treatment, ARVs are also used as Pre-Exposure Prophylaxis (PrEP) and Post Exposure Prophylaxis (PEP) to prevent HIV acquisition—benefiting approximately 1.2 million people who could benefit from PrEP.

The Importance of Access and Innovation

The health of individuals affected by HIV depends on both access to current treatments and the continuous innovation of new therapies. While CMS has identified ARVs as one of six protected classes in Medicare prescription drug plans, it is crucial that policies do not inadvertently hinder the development of future treatments and prevention tools.

Recommendations for CMS Guidance:

1. Ensuring the Sustainability of ADAPs (Section 40.4)
   
   1. The implementation of MFP for HIV treatments could potentially threaten the sustainability of ADAPs, which are vital for providing FDA-approved medications to low-income individuals with HIV. ADAPs rely on multiple funding streams, including federal grants, state appropriations, program income, and the 340B Drug Pricing Program. The interaction between MFP and the 340B program is unclear, raising concerns about reduced revenue and the subsequent impact on patient care.
      
2. Emphasizing Preventive Benefits (Sections 50, 60)
   
   1. CMS should prioritize factors that demonstrate product value, including preventive benefits, over those focused on cost recovery. Preventive measures such as ARVs not only save lives but also reduce healthcare costs significantly. 
   2. Preventing a single case of HIV is estimated to save the health system approximately $939,946 over the course of an individual’s lifetime. This significant saving arises from reduced healthcare costs, including fewer high-acuity medical needs associated with managing HIV, which will significantly raise those incurred expenses.
      
3. Selection of Therapeutic Alternatives for HIV Treatments (Sections 50, 60)
   
   1. CMS should limit therapeutic alternatives to ARVs, considering the unique nature of HIV treatments. Comparing ARVs to non-ARV antivirals is inappropriate due to differing outcomes and values. Additionally, CMS should account for dosing requirements and last-line ARVs without alternatives when determining comparative value.
      
4. Privacy in Patient-Focused Listening Sessions (Section 60.4)
   
   1. CMS should allow participants to privately provide feedback or offer alternative opportunities for anonymous comments. Given the stigma associated with HIV, a public forum may discourage participation from those who could provide valuable insights.
      
5. Inscribing a Continuous Patient Engagement Process (Section 60.4)
   
   1. CMS should adopt a systematic and continuous patient engagement process, incorporating frameworks from PCORI, the National Health Council, the National Institute for Health and Care Excellence (NICE), the Agency for Healthcare Research and Quality (AHRQ), and the Center for Consumer Engagement in Health Innovation. This approach will ensure meaningful and ongoing patient input, enhancing the relevance and impact of CMS policies.

Summary

HealthHIV appreciates CMS’s consideration of our recommendations. We are committed to working collaboratively to ensure policies that support access to and innovation in HIV treatment and prevention.

---