Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


WH Reaches Bipartisan Deal on Infrastructure

President Joe Biden announced last week that a bipartisan agreement had been reached on a pared-back infrastructure proposal. The bipartisan outline would total $973 billion over five years, or $1.2 trillion over eight years. In addition to investments in roads, highways, electric vehicles, and transit systems, the bill includes $65 billion for broadband and $47 billion to address climate change. While the full list of pay-fors has not been released, some spending will be offset by repurposing $125 billion in unspent coronavirus funding. The deal was struck by a bipartisan group led by Sens. Rob Portman (R-Ohio) and Kyrsten Sinema (D-Ariz.).

The President acknowledged that Democrats would likely have to move ahead with the other policy priorities contained in the American Jobs Plan and the American Families Plan on their own through the reconciliation process. According to the President and to congressional Democratic leadership, the two plans – a bipartisan infrastructure bill and a larger reconciliation package – will move in tandem. The broader reconciliation bill would likely include the President’s priorities for the environment, child care, family tax breaks, and increase in taxes on the wealthy and corporations. The Senate is expected to consider the bipartisan package in July, with the larger reconciliation bill receiving a final vote this fall.

A preliminary outline of Senate Budget Committee Chairman Bernie Sanders’ (I-Vt.) budget resolution began circulating on Capitol Hill last week. The budget resolution is necessary to provide the reconciliation instructions to allow Congress to pass legislation through the Senate with a simple majority. The document calls for nearly $6 trillion in spending. It includes an expansion of dental, vision, and hearing care within the Medicare program ($300 billion) and would lower the Medicare eligibility age from 65 to 60 ($200 billion). These costs would be offset by allowing Medicare to negotiate drug prices. Senate Democrats are expected to vote on a budget in July in order to use the budget reconciliation process to pass major items on the President’s agenda this fall.

Senate Confirms ASPR, Assistant Secretary for Mental Health and Substance Use

The Senate confirmed the nominations of Dawn O’Connell to serve as Assistant Secretary for Preparedness and Response (ASPR) and Miriam Delphin-Rittmon as Assistant Secretary for Mental Health and Substance Use by voice vote last week. O’Connell has been a senior counselor for the COVID-19 response since the start of the Biden administration, having previously served as the director of the U.S. Office of the Coalition for Epidemic Preparedness Innovations. Delphin-Rittmon most recently worked as Associate Professor Adjunct of Psychiatry at Yale School of Medicine and Commissioner of the Connecticut Department of Mental Health and Addiction Services.

Recently Passed Health Legislation

The House of Representatives passed H.R. 482, the Newborn Screening Saves Lives Reauthorization Act by an en bloc vote of 325-103 last week. The bill would reauthorize newborn screening programs for five years and revise several programs and activities relating to newborn screening for certain conditions and genetic, endocrine, and metabolic diseases. The House also passed H.R. 3841, the Tribal Health Data Improvement Act. The bill would expand tribal access to public health care data and surveillance and would require the Centers for Disease Control and Prevention (CDC) to address the collection and availability of health data for American Indians and Alaska Natives. In addition, the bill provides grants to tribal epidemiology and public health centers to address under-sampling and misclassification of tribal populations and to improve quality and accuracy of health data. The Senate passed S. 1662, the Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act by voice vote last week. The bill would increase funding for the Reagan-Udall Foundation for the Food and Drug Administration (FDA) and for the Foundation for the National Institutes of Health (NIH).

Latest Cures 2.0 Discussion Draft Unveiled

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have released the latest version of their Cures 2.0 Act discussion draft, which aims to build upon 2015’s landmark 21st Century Cures Act. The bill includes more than 500 provisions to increase biomedical innovation and improve the delivery of breakthrough therapies. The bill would establish the Advanced Research Projects Agency for Health (ARPA-H), a medical research agency housed within the National Institutes of Health (NIH) responsible for accelerating new medical breakthroughs. ARPA-H was first proposed by President Joe Biden in his budget. Cures 2.0 also contains provisions to improve Medicare coverage of innovative technologies, increase diversity in clinical trials, expand the collection and use of real-world evidence by the Food and Drug Administration (FDA), provide training and educational programs for caregivers, increase patient access to health information, and increase access to telehealth services. The initial Cures 2.0 proposal - released prior to the coronavirus pandemic – was largely focused on the delivery of care. The discussion draft still contains these provisions, along with added requirements for the U.S. Department of Health and Human Services (HHS) to conduct a nationwide study on the impact of long COVID and to develop a testing and vaccine distribution strategy in preparation for future pandemics. DeGette and Upton plan to hold roundtables on the Cures 2.0 draft this summer, with the goal of releasing a final bill when Congress returns from August recess and passing the legislation before the end of the year.

The release of the Cures 2.0 discussion draft coincided with the publication of an article in Science by White House Office of Science and Technology Policy Director Eric Lander, NIH Director Francis Collins, and other leaders describing their vision for ARPA-H. The scientists write that ARPA-H should be modeled after the Defense Advanced Research Projects Agency (DARPA) while focusing on solving practical problems that foster breakthroughs to serve patients equitably. The article proposes the following initial mission statement for ARPA-H: “To make pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions that have the potential to transform important areas of medicine and health for the benefit of all patients and that cannot readily be accomplished through traditional research or commercial activity.”

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