Health Policy Report (4/26)

The Senate will convene for legislative business later this afternoon to close out the April legislative session. On the floor, Senators are expected to begin consideration of a bipartisan water infrastructure package (S. 914) out of the Environment and Public Works Committee. The Drinking Water and Wastewater Infrastructure Act would provide $35 billion for water resources development projects that are geared toward: (1) addressing climate change; (2) upgrading aging and outdated water infrastructure; (3) investing in new technology; and (4) providing assistance to marginalized communities. The Senate will also take up a series of presidential nominations this week, which could end up including the nominations of Andrea Palm to be Deputy Secretary of Health and Human Services (HHS) and Chiquita Brooks-LaSure to be Centers for Medicare and Medicaid Services (CMS) Administrator. Meanwhile, House lawmakers have completed votes for the month, but will hold Committee “Work Days” over the next two weeks.

House Democrats Reintroduce H.R. 3

Last Thursday, House Democrats reintroduced their signature drug pricing bill, the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3). The bill, which was first introduced in 2019, creates a program to reduce U.S. drug prices through Medicare “negotiation,” with a price cap based on reimbursement rates in Australia, Canada, France, Germany, Japan, and the UK. The measure also restricts price increases in both Medicare Part B and Part D, and would redesign the Part D benefit to cap beneficiaries’ out-of-pocket costs. The legislation would produce hundreds of billions of dollars in government savings after elimnating Medicare coverage expansions for dental, vision, and hearing that were included in the version passed by the House during the 116th Congress. The House Committee on Energy & Commerce is expected to hold a legislative hearing on the legislation on May 4.

The reintroduction of H.R. 3 comes amidst rumors that the White House is considering leaving health care pay-fors — notably drug pricing reforms — out of its infrastructure plan. Notably, major new spending associated with H.R. 3 was left out of the newly introduced version. This underscores the “plug-and-play” nature of the proposed savings to the federal government of the legislation, with Democrats having proffered the negotiation provisions as a pay-for in legislation last year that would have expanded a variety of Affordable Care Act (ACA) benefits. With little new spending in the bill, lawmakers can propose the reintroduced legislation as a way to pay for other priorities.

Notably left out of the reintroduced bill are two titles from the original that would have expanded Medicare benefits. These titles — which would have made changes to the Medicare program for low-income beneficiaries and created new dental, vision, and hearing benefits— would have cost a total of $462.3 billion over ten years, according to the Congressional Budget Office (CBO). The bill also excludes several “miscellaneous” provisions contained in the original legislation, including those intended to incentivize the uptake of biosimilars. However, some of the excluded provisions, including a waiver of Medicare coinsurance for colorectal cancer screening, have separately become law.

In all, based on the 2019 CBO score of the original H.R. 3, the saving provisions would reduce the deficit by $492 billion. Opioid epidemic spending and Part D restructuring would cost $24.2 billion. CBO can be expected to put out a new score in the coming weeks for the updated and reintroduced bill, including the adjusted funding levels for the opioid epidemic spending.

COVID-19 TRIPS Waiver Debate Continues

Discussion surrounding a proposal from South Africa and India to waive intellectual property protection obligation to facilitate COVID-19 vaccine and therapeutic access around the world remains in deadlock, despite over six months of debate. Originally negotiated during from 1986-94, the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced intellectual property rules into the multilateral trading system for the first time. As a practical matter, TRIPS narrows the gaps in how intellectual property rights are protected and enforced around the world under common international rules and establishes minimum standards of protection and enforcement that each government must give to intellectual property held by nationals of fellow WTO members. In October 2020, South Africa and India submitted a proposal to waive TRIPS protections for COVID-19 vaccines, therapeutics, and other items needed for treatment in order to facilitate the manufacturing of treatments locally and boost global vaccination. The proposal posits that poorer countries will lack access to treatments and vaccines until 2024 unless IP protections are waived, and the proposal has been backed by more than 100 countries — mostly developing countries who would benefit from the waiver.

Members of the WTO met virtually last week to further discuss the proposal, but it continues to be blocked by developed countries like the U.S., European Union, Switzerland, and Japan. These countries question whether the waiver would be effective and if IP protections are actually a barrier to the imbalance in therapeutic and vaccine distribution. Sen. Chris Coons (D-DE) noted last week that the USA’s IP regime plays an “essential role” in incentivizing innovation and that adopting the waiver would harm critical private-sector innovation and investment. The Trump administration was strongly opposed to the proposal, and the Biden administration has not reversed course despite prioritizing equitable global vaccine access. Ten Democratic senators have asked Biden to support the waiver request and Rep. Jan Schakowsky (D-IL) is organizing a letter from members of the House that has roughly 100 signatures already. The WTO’s general council will meet again in early May to discuss the issue.

FDA, CDC Lift Pause on Johnson & Johnson COVID-19 Vaccine

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announced last Friday that they would lift their pause on the Johnson & Johnson vaccine, but with new warnings on the possibility of blood clots. The CDC’s Advisory Committee on Immunization Practices (ACIP) agreed last Friday that use of the vaccine should resume, but were divided between options for warnings to be included with the vaccine — (1) resuming use of the J&J vaccine for all authorized sex and age groups with an included warning statement in the FDA-issued emergency use authorization (EUA) fact sheets; or (2) reaffirm use of the vaccine can resume but with an additional statement letter warning women younger than 50 they should be aware of the risk of blood clots and have the option to choose another COVID-19 vaccine. The majority of members voted against the second option, although those in support said this could leave women in the dark about the potential risks. The FDA will work with the CDC to put out additional education materials like infographics and patient fact sheets and will host clinician outreach and communication activities.

Biden Nominates Assistant Secretary for Mental Health and Substance Use

On Friday, President Biden named Dr. Miriam E. Delphin-Rittmon as his choice for Assistant Secretary Mental Health and Substance Use at the Department of Health and Human Services. She was appointed as Commissioner of the Connecticut State Department Mental Health and Addiction Services in 2015, and previously held the positions of Deputy Commissioner, Senior Policy Advisor and Director of the department’s Office of Multicultural Health Equity. In May 2014, Dr. Delphin-Rittmon completed a two-year White House appointment working as a Senior Advisor to the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA). She has 20 years of experience in the behavioral health field and has committed herself to promoting recovery oriented, integrated, and culturally responsive services and systems that foster dignity, respect, and meaningful community inclusion. Additionally, Dr. Delphin Rittmon has received several awards for her policy work on the design, evaluation, and administration of mental health, substance use and prevention services.