Health Policy Report (4/11)

April 11, 2022

Capitol Hill Update

Congress closed out a productive six-week work period last week with final votes confirming Ketanji Brown Jackson to be a Supreme Court Justice, as well as a pair of bills that would implement further economic sanctions and restrictions on Russia. Lawmakers have now adjourned for a two-week state work period and will return from the holiday break during the week of April 25. When Congress returns, leadership will be pushing for a deal to pass the $10 billion Bipartisan COVID Supplemental Appropriations Act (text; summary), as well as legislation that would provide roughly $55 billion for restaurants and other “hard hit” small business industries. However, policy disagreements over immigration at the U.S.-Mexico border and funding for global health initiatives will need to be ironed out before a path forward emerges. 

Biden Administration Creates Long COVID Plan

The Department of Health and Human Services (HHS) launched (fact sheet) an effort to research, detect, and treat the long-term effects of COVID-19 (long COVID). Stakeholder groups including the American Hospital Association (AHA) and the Children’s Hospital Association have been pushing for guidance from HHS regarding long COVID treatment, as well as urging the Biden administration to extend the public health emergency (PHE) until more is known about the condition. HHS’s plan will begin with efforts to enroll those with long COVID symptoms into existing studies. Other elements of the initiative include issuing guidance pertaining to those with long COVID-related disabilities and to develop coverage determinations through the Centers for Medicare and Medicaid Services (CMS). 

CMS Issues Final Medicare National Coverage Determination for Alzheimer’s Drug 

On Thursday, the Centers for Medicare and Medicaid Services (CMS)announced (TRP analysis) a final national coverage determination (NCD) for aducanumab — brand name Aduhelm — as well as all future Food and Drug Administration (FDA) approved monoclonal antibody treatments directed against amyloid for the treatment of Alzheimer’s disease (press release; fact sheet). Specifically, the agency is approving coverage of the drug — and all future drugs meeting the criteria above — for patients who have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia, both with confirmed presence of amyloid beta pathology consistent with Alzheimer’s disease, as long as the treatment is furnished in accordance with specified coverage criteria.

Specifically, CMS’ coverage determination stipulates that a Medicare beneficiary must be enrolled in a randomized, controlled clinical trial conducted by either the National Institutes of Health (NIH) or the FDA in order for the drug to be covered under the program as it was approved under the accelerated approval process. Contrary to the proposed coverage determination, CMS is updating provisions surrounding future FDA-approved monoclonal antibody treatments directed against amyloid for the treatment of Alzheimer’s disease to allow such drugs approved via a traditional approval process to be covered under Medicare without the requirement of enrollment in a randomized, controlled trial. In place of this requirement, such drugs will be subject to traditional coverage with evidence development measures — namely data collection through routine clinical practice or patient registries — and Medicare will only cover on-label uses for FDA-approved indications.  

Senate HELP Holds User Fee Reauthorization Hearing

On Tuesday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held ahearing (TRP summary) to discuss the Food and Drug Administration’s (FDA) user fee agreements. Senators spoke with a range of industry stakeholders to address concerns and recommend policies in the Medical Device User Fee Agreement (MDUFA), Prescription Drug User Fee Agreement (PDUFA), Biosimilar User Fee Agreement (BsUFA), and Generic Drug User Fee Agreement (GDUFA). Democrats and Republicans discussed biosimilar and generic entry into the pharmaceutical market as a mechanism to promote competition, and they criticized various patent tools that delay the entry of such products.

Members on both sides of the aisle also engaged in conversations surrounding the involvement of rare disease patients in the user fee reauthorization process and ways to encourage rare disease drug discovery. A few Democrats inquired about the influence of cybersecurity on the health care system and in the medical device market, while Republicans examined methods to expand the FDA’s Accelerated Approval Pathway to include a more diverse range of drugs in its pipeline. Lawmakers also raised additional matters with the witnesses, including discussions of MDUFA IV’s shortcomings antimicrobial resistance.

Energy and Commerce Committee Discusses Mental Health, Substance Use Disorder

Last week, the House Energy and Commerce Subcommittee on Health held a hearing (TRP summary) to consider 19 pieces of legislation related to mental health and substance use disorders (SUD) broadly. President Biden has included addressing mental health and addiction as two of the four pillars of the Unity Agenda he outlined in his 2022 State of the Union address (TRP summary), and mental and behavioral health have been at the forefront of congressional committee priorities as of late with ten hearings dedicated to the subject in 2022 alone. Subcommittee Chair Anna Eshoo (D-CA) dubbed the measures discussed during this hearing a “first step in moving a comprehensive legislative package” surrounding mental and behavioral health, though the Chair did not provide a timeline for markup or next steps.

Largely bipartisan efforts, the legislation under consideration in last week’s hearing falls under the umbrellas of: (1) children’s mental health; (2) health care workforce; and (3) SUD and behavioral health prevention, coverage, treatment, and recovery services, among other items. Specifically, these pieces of legislation encompass reauthorizations for over 32 mental health programs administered by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Health Resources and Services Administration (HRSA) set to expire after September 30, 2022, lending itself to the importance of passing a legislative package on the subject.

Education and Labor Committee Questions HHS Secretary Becerra on FY 2023 Budget Request

On Wednesday, the House Education and Labor Committee held ahearing (TRP summary) with Department of Health and Human Services (HHS) Secretary Xavier Becerra regarding President Biden’s fiscal year (FY) 2023 budget request (TRP summary of major health provisions) to Congress. Notably, Secretary Becerra responded to many members on the committee by requesting enhanced funding for health care through a version of Democrats’ Build Back Better Agenda (BBBA). Additionally, he agreed with several Democrats regarding the expansion of policies originating in the American Rescue Plan Act (ARPA), such as child care and the Affordable Care Act (ACA).

Throughout the hearing, several members of the Committee discussed mechanisms to lower health costs, with Democrats focusing on HHS negotiation authority over pharmaceuticals and Republicans discussing enhanced transparency around pharmacy benefit managers (PBM). Democrats also emphasized mental health and substance use disorder (SUD) concerns, as well as funding for child care and children’s education initiatives such as Head Start and the Child Care and Development Block Grant Act (CCDBG). Republicans engaged in discussions around maternal health, noting their disappointment with the budget request’s exclusion of the Hyde amendment, while Democrats inquired about mechanisms to improve maternal health outcomes.

Secretary Becerra fielded questions regarding health plan coverage from members on both sides of the aisle. Democrats were supportive of leveraging ACA and Medicaid reforms to increase access to coverage, while Republicans promoted the use of association health plans and expressed concerns surrounding increased costs of health care program expansion efforts. However, lawmakers found common ground in advocating for telehealth program flexibilities.

House Budget Committee Discusses FY 2023 HHS Budget With Secretary Becerra

After testifying in front of the Education and Labor Committee, the House Budget Committee held a hearing to discuss President Biden’s fiscal year 2023 Department of Health and Human Services (HHS) budget request (TRP summary) with Secretary Becerra. The Secretary fielded a number of questions that pertained to the president’s budget, as well as other health policy-related topics including: (1) COVID-19 efforts; (2) drug research and development (R&D); (3) behavioral health; (4) Medicare and Medicaid; (5) health care equity; (6) child care and maternal health; and (7) other issues, including inflation and nursing home oversight.

Overall, Democrats expressed their support for the administration’s budget proposal, and they focused their questions on investments in behavioral health services, current COVID-19 response efforts, equity for underserved populations, child care, and reproductive health. Members on the opposite side of the aisle were not as supportive of the budget proposal, as several GOP Senators were interested in potential Medicare insolvency, the administration’s early pandemic efforts, and the utilization of previously appropriated COVID-19 funds. Meanwhile, partisan tensions were on display over immigration, family planning, the Hyde Amendment, and LGBTQ+ rights.