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 Releases Complete FY22 Budget

President Joe Biden released his first full budget request on Friday. The fiscal year (FY) 2022 budget would increase federal spending to $6 trillion in the coming year, with annual deficits of approximately $1.3 trillion over the next decade. The proposal predicts that the economy will grow at an annual rate of just under 3% for the next decade. The budget request includes a 16.5% increase in nondefense spending and an increase of 1.6% for defense spending. The overall budget can be found here and the U.S. Department of Health and Human Services’ (HHS) Budget in Brief can be found here.

For HHS, the budget includes a total of $133.7 billion -- a 23.4% increase over FY 2021. Funding increases were included for the Office of Civil Rights, which would receive $430 million, the Office of the Inspector General, which would receive $430 million, and the Centers for Medicare and Medicaid Services (CMS), whose discretionary funding would total $4.3 billion. The Food and Drug Administration (FDA) would receive $6.5 billion, a $477 million increase, including $3.6 billion in discretionary funding and $2.9 billion in user fees. The budget proposes to increase the maximum fees for certificates required to export products and to decrease tax credits for rare disease drug research from 50% to 25%. It would also allow the FDA to collect user fees from e-cigarette companies. The National Institutes of Health (NIH) would receive a total of $52 billion, a $9 billion increase. This budget increase includes $6.5 billion for the creation of the President’s proposed Advanced Research Projects Agency for Health (ARPA-H). The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry would see a total spending level of $8.7 billion, a $1.6 billion increase. The Biomedical Advanced Research and Development Authority’s (BARDA) budget would increase $227 million for a total of $823 million, and $905 million is requested for the Stockpile, an increase of $200 million.

As previously reported, the White House budget does not include proposals to reduce prescription drug prices, strengthen the Affordable Care Act (ACA) and Medicare or Medicaid coverage, or create a public health insurance option. According to Deputy Director of the Office of Management and Budget (OMB) Shalanda Young, the White House believes “that it is more productive to work collaboratively with Congress to develop and build consensus around specific policies” to achieve the President’s goals in these areas.

The President’s budget will serve as a blueprint for Congressional Democrats working to write FY22 spending bills. After receiving the White House proposal on Friday, House Budget Chairman John Yarmuth (D-Ky.) said that House Democrats will immediately commence work on a budget resolution. Senate Appropriations Chairman Patrick Leahy (D-Vt.) has called for jumpstarting bipartisan, bicameral talks in early June on top-line spending figures.

HELP, E&C Begin Work on Public Health Insurance Option

Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Patty Murray (D-Wash.) and House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) are seeking input as they begin work to draft a public option health care plan. “Our goal in establishing a federally administered public option is to work towards achieving universal coverage, while making health care simpler and more affordable for patients and families,” the lawmakers state. They ask for input on who should be eligible to join a government-run plan, how to structure its benefits, and how to maintain a network of doctors. The letter requests that responses be submitted by July 31. The lawmakers plan to have a bill drafted by the end of this year. To date, Washington is the only state to provide a public option. Nevada and Colorado are considering legislation to create a public option in their states.

NIH Director Collins Provides Details on ARPA-H

Director of the National Institutes of Health (NIH) Francis Collins offered more details on the President’s proposed Advanced Research Projects Agency for Health (ARPA-H) during congressional hearings last week. Collins stated that the emerging technologies agency, which will be housed within NIH, will not detract from the NIH’s existing research portfolio, though some existing programs, such as the National Center for Advancing Translational Sciences’ (NCAT) Cures Acceleration Network (CAN), may be folded into the new agency. The White House’s budget proposal included $6.5 billion for the NIH to establish ARPA-H. Collins stressed that ARPA-H could build on lessons learned during the COVID-19 pandemic and “how it’s possible when there’s an urgent sense of the need for clinical advances to happen at unprecedented speed.”

Senate Confirms CMS, OSTP Leaders

The Senate voted last week on the confirmation of Chiquita Brooks-LaSure to serve as Administrator of the Centers for Medicare and Medicaid Services (CMS). Brooks-LaSure was confirmed in a 55-44 vote after consideration of her nomination was delayed due to Republican opposition to the Biden administration’s revocation of a Texas Medicaid waiver extension that required the nominee to clear additional procedural hurdles. Five Republicans ultimately joined Democrats in supporting the confirmation of Brooks-LaSure: Sens. Roy Blunt (Mo.), Richard Burr (N.C.), Susan Collins (Maine), Jerry Moran (Kan.), and Lisa Murkowski (Alaska). Brooks-LaSure is a former Obama administration health official who helped implement the Affordable Care Act (ACA) while serving as deputy director for policy at the Center for Consumer Information and Insurance Oversight (CCIIO). She also chaired President Joe Biden’s health transition team. Earlier in her career, she was a staffer for the House Ways and Means Committee where she helped to draft the ACA while working with HHS Secretary Xavier Becerra, who served on the panel during his time in Congress. She will be the first Black woman to lead CMS.

The Senate also confirmed Eric Lander to lead the White House Office of Science and Technology Policy (OSTP) by voice vote last week. President Joe Biden elevated the OSTP to Cabinet level, making Lander the final member of the President’s Cabinet to be confirmed. Lander previously co-chaired the Council of Advisors on Science and Technology during the Obama administration. He faced criticism during his confirmation process for allegations that he downplayed the contributions of female scientists and has since pledged to focus on the issue of diversity in science in his new position.

Support Grows For Investigating COVID-19 Origins

The Senate passed the COVID-19 Origin Act (S.1867) last week by unanimous consent. The bill would require the Biden administration to declassify intelligence related to any potential links between the Wuhan Institute of Virology and the origins of the COVID-19 pandemic. The President announced last week that he has asked U.S. intelligence agencies to “redouble their efforts” to collect and analyze information that could lead to a definitive conclusion on the origins of the coronavirus pandemic.

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