Advocacy Update – March 2022

Omnibus Bill Includes 151-Day Extension of Telehealth Waivers

Earlier this week, President Biden signed a bill to fund the government through September (the fiscal year 2022) and send humanitarian aid to Ukraine.  The bill also included several health priorities, including a 151-day blanket extension of pandemic telehealth waivers after the Public Health Emergency (PHE) ends. Most notably, the short-term extension temporarily eliminates Medicare originating site and geographic restrictions, maintain the expansion of practitioners eligible to provide services through telehealth, remove in-person requirements and allow for audio-only telehealth appointments.  Ultimately, this means, thanks to the advocacy efforts of UMDF members, patients can continue to receive care via telehealth in their homes which is of critical importance to mitochondria patients.

The administration has committed to giving a 60-days notice before allowing the PHE declaration, which must be renewed every 90 days, to expire. Given this commitment, the PHE declaration is expected to extend through at least July – meaning, at the very least, the telehealth flexibilities would remain in place through the end of the calendar year.  This provides an opportunity to continue to advocate for a longer-term approach that ensures continued access to telehealth.

Mitochondrial Disease Priorities Included in the FY 2022 Appropriations Bill

UMDF has long advocated with help from the Congressional Mitochondrial Disease Caucus (co-chaired by Reps. McGovern (D-MA) and Fitzpatrick (R-PA) for the inclusion of mitochondrial disease as an area of medical research eligible for the Department of Defense (DoD) Peer-Reviewed Medical Research Program.  We are pleased to report that mitochondrial disease is included in the FY 2022 appropriations bill.  To date, due to this inclusion, there has been at least $31 million in funding for mitochondrial disease through DOD’s Peer-Reviewed Medical Research Program.  We will continue to advocate for this important provision in the Fiscal Year 2023 appropriations package.  We will also focus our appropriations efforts on language that directs the National Institutes of Health (NIH) to prioritize mitochondrial disease research.  Please be on the lookout for a forthcoming action alert on how UMDF members can support these efforts with their members of Congress.

User Fee Reauthorization Process Kicks Off in Congress

Congress is working on user fee proposals for major medical products. Every five years, the Food and Drug Administration (FDA) and FDA-regulated industries negotiate user fee agreements for all major human medical products that provide goals and commitments from FDA to provide a timely review of medical products in exchange for fees those industries pay to the FDA attached to new product applications. These fees fund approximately 80 percent of the FDA’s personnel costs. The FDA is currently negotiating with the industry on reauthorizing the user fee agreements that cover prescription drugs, medical devices, generic drugs, and biosimilars. Congress is expected to approve before the current agreement expires on September 30, 2022.

Historically, the user fee legislation serves as a vehicle for provisions that address drug development and other FDA activities. Currently, Congress is considering a few riders that would address the drug development process that could affect the mitochondrial disease community, including innovative and decentralized clinical trial design, clinical trial diversity, and patient-focused drug development. Other provisions currently being considered would establish a Rare Disease Center of Excellence at FDA and inclusion of FDA rare disease staff in the drug review process. Finally, an authorization for the Advanced Research Projects Agency for Health (ARPA-H) may also be included, which would, among other things, pursue innovative research projects in the health space for HHS broadly. The recently released Fiscal Year (FY) 2022 appropriations legislation included $1 billion to get the initiative off the ground. Although far less than the $6.5 billion originally requested by the President, the funding represents a commitment to the goals of the potential agency and an additional tool in the toolbox for the mito community and others to continue the search for treatments and cures for the disease.

Biden Delivers First SOTU

During his first State of the Union (SOTU) address, President Biden pointed to the progress that has been made in combating the coronavirus pandemic and the ability of Americans to return “back to more normal routines.” He also emphasized several health priorities, including expanding access to mental services. Ahead of the address, President Biden announced a strategy to address mental health challenges in the U.S. Notably, this plan previews several initiatives that will be included in the President’s fiscal year (FY) 2023 budget request. The plan also focuses on behavioral health care for children and substance use disorder (SUD) treatment. The president is calling Congress to execute legislation to enact several mental health proposals. This push coincides with Congressional activity by several committees to advance mental health legislation.  The SOTU also focused on funding the Cancer Moonshot and the aforementioned ARPA-H to cut the cancer death rate by 50% over 25 years; lowering prescription drug prices, specifically by allowing Medicare to negotiate drug prices, pushing to make permanent Advance Premium Tax Credits included in the American Rescue Plant Act, and addressing nursing home quality and safety by outlining a minimum nurse staffing ratio and increasing Medicare oversight. In the coming weeks, additional details and opportunities for stakeholder feedback are expected to be announced.