POLICY BRIEFINGS

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.


THIS WEEK'S BRIEFING - JULY 24, 2023

Senate, House Make Progress on PAHPA Reauthorization


Lawmakers in both the Senate and the House of Representatives are working to advance legislation to reauthorize key pandemic preparedness programs before they expire at the end of the fiscal year. The Senate Health, Education, Labor, and Pensions (HELP) Committee and the House Energy and Commerce Committee each approved their respective Pandemic and All- Hazards Preparedness Act (PAHPA) reauthorization bills last week. While the Senate-version (S. 2333) garnered bipartisan support, Democrats on Energy and Commerce voted against the bills (H.R. 4420, H.R. 4421) during markup on Wednesday. They criticized the legislation for the absence of provisions to address the nation’s ongoing drug shortages. It is the first time that PAHPA reauthorization has not moved on a bipartisan basis through the House committee of jurisdiction. The Senate bill is broader in scope than the House proposal. It would require pharmaceutical manufacturers to notify the Food and Drug Administration about potential drug shortages stemming from increased demand for a product. It also includes a provision backed by HELP Chairman Bernie Sanders (I-Vt.) to study funding models for biomedical research that delink R&D costs from the price of a drug, as well as a proposal from Ranking Member Bill Cassidy (R-La.) to extend the priority review voucher program for five years.


E&C Advances Bipartisan SUPPORT Act Reauthorization


The House Energy and Commerce Committee unanimously advanced legislation (H.R. 4531) to reauthorize the SUPPORT for Patients and Communities Act, “landmark” legislation originally passed in 2018 to respond to the opioid crisis, before the program authorizations expire at the end of September. The legislation would also remove the institutions for mental disease (IMD) exclusion, which prohibits states from using Medicaid money to pay for substance use disorder treatment in large mental health institutions. It also includes proposals to bar states from unenrolling individuals from Medicaid while they are incarcerated awaiting trials, and to permanently require Medicaid coverage of every form of medication-assisted treatment. Xylazine would be scheduled as a Schedule III substance under the reauthorization bill, which would subject the drug to oversight by the Drug Enforcement Administration.


FY 2024 Appropriations Update


The Senate Appropriations Committee advanced its fiscal year (FY) 2024 State-Foreign Operations appropriations bill last week with bipartisan support. The legislation would increase funding for global health security to $900 million. This contrasts with the House version of the bill, which includes cuts to global health funding. The Senate bill also funds the Biden administration’s global health workforce initiative and appropriates $300 million for the vaccine alliance Gavi. The Global Fund to Fight AIDS and the President’s Malaria Initiative would receive a $1.65 billion contribution.

The House of Representatives is set to consider its FY 2024 Agriculture-Rural Development-Food and Drug Administration and Military Construction-Veterans Affairs appropriations bills on the floor this week. This would leave the remaining 10 annual spending bills for consideration in September. House leaders plan to pass each bill individually rather than combine them into an omnibus package. Appropriators in the Senate aim to complete their spending bill markups in July, but are not expected to consider any of the measures on the floor before the August recess.


HELP to Consider Sweeping Community Health Center, Workforce Package This Week


Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) released an $86 billion health care workforce and primary care package last week. The panel is scheduled to mark up the legislation on Wednesday. The bill would reauthorize and significantly increase funding for community health centers, providing $20 billion in annual spending for the Community Health Center Fund over the next five years. In addition to reauthorizing the National Health Service Corps (NHSC), the Teaching Health Center Graduate Medical Education (THCGME) program, and the Children’s Hospital Graduate Medical Education (CHGME) program, the bill includes site neutrality policies to bar hospitals from charging facility fees for services provided by off-site physicians, and prohibit such hospitals and physicians from billing separately for a service. A section-by-section summary of the bill can be found here.

Ranking Member Bill Cassidy (R-La.) has characterized the proposal as irresponsible legislating, criticizing the total amount of spending authorized by the package. Cassidy’s own reauthorization proposal mirrors the narrower measures advanced by the House Energy and Commerce Committee as a part of the PATIENT Act (H.R. 3561). The House measure reauthorizes the NHSC, THCGME program, and Community Health Center Fund, providing only a slight increase for community health centers from $4 billion to $4.2 billion annually for the next two years.


House VA Panel Advances Health Legislation


The House Veterans’ Affairs Subcommittee on Health forwarded a slate of health-related bills last week. The Expanding Veterans’ Options for Long Term Care Act (H.R. 1815) would create a three-year pilot program to offer assisted living to veterans who are not eligible for nursing home care. The VA Zero Suicide Demonstration Project Act (H.R. 1639) would establish the Zero Suicide Initiative pilot program to improve veteran safety and suicide care. The Veteran Care Improvement Act (H.R. 3520) aims to increase access to and transparency around community care outside the VA. The VA Emergency Transportation Act (H.R. 1774) would mandate that veterans be reimbursed for emergency transportation delivered by non-VA providers. The bills will now advance to the full committee for consideration. They could potentially be included in a bipartisan veterans’ health care package being drafted in the Senate.


E&C Republicans Probe FDA Foreign Drug Manufacturing


Republicans on the House Energy and Commerce Committee are asking Administrator of Food and Drugs Robert Califf for information about his agency’s foreign drug inspections in India and China. The lawmakers express concern that the nation is “overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.” The letter was signed by Republican members of the Health and Oversight and Investigations subcommittees. They request details from Califf about the FDA’s foreign inspection activities by August 1.


Lawmakers Continue Push for PEPFAR Reauthorization


Abipartisan group of 75 members of Congress have sent a letter to the State Department expressing support for the reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) and highlighting the urgency of continuing to address mother-to-child HIV transmission. The lawmakers specifically discuss the potential of reviving the Saving Mothers, Giving Life program – an Obama administration-era pilot program that successfully reduced maternal mortality and prevented vertical HIV transmission. The letter, led by Reps. Mike Lawler (R-N.Y.) and Abigail Spanberger (D-Va.), follows a similar bipartisan letter sent by members on the Senate last month.


Upcoming Congressional Hearings and Markups


Senate Judiciary Subcommittee on Privacy, Technology, and the Law hearing “Oversight of A.I.: Principles for Regulation;” 3:00 p.m.; July 25

Senate Homeland Security and Governmental Affairs Committee business meeting to consider 21 bills, including AI and cybersecurity related legislation; 9:00 a.m.; July 26

Senate Health, Education, Labor, and Pensions Committee markup of S.__, The Primary Care and Health Workforce Expansion Act; 10:30 a.m.; July 26

Senate Homeland Security and Governmental Affairs Committee hearing “Governing AI Through Acquisition and Procurement;” 11:00 a.m.; July 26

Senate Judiciary Subcommittee on Intellectual Property hearing “Oversight of the United States Patent and Trademark Office;” 2:30 p.m.; July 26

Senate Veterans’ Affairs Committee hearing “Implementing the PACT Act: One Year Later;” 3:00 p.m.; July 26

House Judiciary Committee hearing “The Dangers and Due Process Violations of ‘Gender-Affirming Care’ for Children;” 10:00 a.m.; July 27

House Judiciary Subcommittee on Crime and Federal Government Surveillance hearing “Oversight of the Drug Enforcement Administration;” 10:00 a.m.; July 27

House Oversight and Accountability hearing “Oversight and Reauthorization of the Office of National Drug Control Policy;” 10:00 a.m.; July 27

Joint Economic Committee hearing to examine the economic impact of diabetes; 2:00 p.m.; July 27

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Because I Said So: Examining the Science and Impact of COVID-19 Vaccine Mandates;” 2:00 p.m.; July 27

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “Hemp in the Modern World: The Yearlong Wait for FDA Action;” 2:00 p.m.; July 27

House Natural Resources Subcommittee on Indian and Insular Affairs hearing on H.R. ___, Restoring Accountability in the Indian Health Service Act of 2023; 2:15 p.m.; July 27



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