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.


House Appropriators Advance Labor-HHS, State- Foreign Ops Funding Bills

The House Appropriations Committee released its Labor-Health and Human Services-Education appropriations bill for fiscal year (FY) 2024 and advanced the package out of subcommittee last week. The bill would cut topline spending levels by 29%, with the U.S. Department of Health and Human Services (HHS) receiving a total of $103.3 billion - $14 billion less than current levels. Funding for the Centers for Disease Control and Prevention would be cut by $1.6 billion, funding for the National Institutions of Health would be cut by $3.8 billion, and funding for the Advanced Research Projects Agency for Health would be cut by $1 billion. Appropriations for the Agency for Healthcare Research and Quality would be eliminated altogether, with appropriators arguing the agency is duplicative of other HHS programs. Title X family planning grants would also be eliminated. The bill includes several contentious policy riders, including a requirement that HHS report to Congress how many abortions are provided under exceptions to the Hyde Amendment. The Senate Appropriations Committee is reportedly planning to mark up its own Labor-HHS-Education appropriations bill on July 27.

The House Appropriations Committee also approved its FY 2024 State and Foreign Operations appropriations bill last week. The bill includes a total of $1.5 billion for USAID, an approximately $500 million cut, and would extend authorization for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for one year. It includes a provision to prevent the administration from entering any international agreement via the World Health Assembly without two-thirds Senate approval. It also includes several abortion- related riders, including the Helms amendment restriction on the use of global health funds to pay for abortions and the Mexico City Policy barring support for organizations that perform or promote abortions. The Senate Appropriations Committee is scheduled to markup its FY 2024 State and Foreign Operations appropriations bill on July 20.

Education Workforce Panel Considers Health Transparency Measures

The House Education and Workforce Committee advanced four bipartisan health care transparency measures out of committee last week. The bills approved by the panel include:

  • H.R. 4509, the Transparency in Billing Act, which would require accurate billing practices by hospitals to ensure that group health plans pay for appropriately billed services.
  • H.R. 4507, the Transparency in Coverage Act, to codify the “Transparency in Coverage” final rule, which provides consumers with price transparency for medical services and prescription drugs.
  • H.R. 4527, the Health DATA Act, to ensure health plan fiduciaries are not contractually restricted from receiving cost or quality of care information about their plan.
  • H.R. 4508, the Hidden Fee Disclosure Act, which would strengthen requirements that pharmacy benefit managers and Third-Party Administrators disclose compensation to plan fiduciaries.

Finance Committee to Markup PBM Package

The Senate Finance Committee has scheduled a July 26 markup of legislative proposals to increase transparency and accountability in the pharmacy benefit manager (PBM) industry. While it remains unclear what legislation the package will contain, it is expected to build on the roadmap released by Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) in April outlining the types of bipartisan solutions they wished to pursue. The Chairman’s Mark will be released 48 hours in advance of the markup.

Senate Democrats Release Report on Generic Insulin Access

Senate Democrats released a report last week shedding light on the accessibility of generic insulin products. The report, which was prepared by the offices of Sens. Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), and Raphael Warnock (D-Ga.), found that while nearly half of the 300 pharmacies surveyed did not have Eli Lilly’s generic insulin Lispro in stock, 80% of those pharmacies had the more expensive brand product Humalog available. The average price of Lispro for uninsured individuals totaled $97.51, more than triple the advertised list price. The three major manufacturers of insulin – Eli Lilly, Novo Nordisk Inc., and Sanofi – publicly committed to limiting patient costs for generic insulin to $25 per vial earlier this year. Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sander (I-Vt.) met with Senate Majority Leader Chuck Schumer (D-N.Y.) to discuss the issue last week. Schumer has stated his intention to advance bipartisan legislation to lower the cost of insulin and prescription drugs during the chamber’s current work period.

Cassidy Releases Proposal to Reauthorize Key Health Programs

Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) has introduced legislation to reauthorize community health centers and several other public health programs. Cassidy’s proposal, which mirrors the bipartisan bill advanced by the House Energy and Commerce Committee, would offer small increases in funding for community health centers, the National Health Service Corps (NHSC), and the Teaching Health Center Graduate Medical Education (THCGME) Program. It stands in contrast to HELP Chairman Bernie Sander’s (I-Vt.) plan, which included significant funding increases. Authorization for the programs is set to expire at the end of the fiscal year on September 30. Cassidy’s Community Health Center Reauthorization Act would extend and increase funding for community health centers at $4.2 billion a year for the next two years. The Community Health Center Fund currently receives $4 billion in federal funding annually. The NHSC would be funded at $350 million for two years, an increase of $40 million per year. Funding for the THCGME program would increase from $175 million to $275 million over six years.

Senate Judiciary Advances Rogue Pharmacy Legislation

The Senate Judiciary Committee advanced bipartisan legislation last week to require social media companies and digital communication service providers to report to the Drug Enforcement Administration when their platforms are used by rogue pharmacies or drug dealers to illegally sell or distribute drugs. S. 1080, the Cooper Davis Act, was advanced in a 16-5 vote. The bill is named in honor of a 16-year-old teenager who died after taking a counterfeit prescription drug laced with fentanyl in August 2021. It was later discovered that a drug dealer solicited the teenager via Snapchat.

E&C GOP Investigation NIH Reappointments

Republican leadership of the House Energy and Commerce Committee are investigating the process surrounding the appointment of 14 National Institutes of Health (NIH) officials, including former National Institutes of Allergy and Infectious Diseases Director Anthony Fauci. The lawmakers assert that the individuals were not correctly reappointed to their positions in late 2021, calling into question the legality of the more than $25 billion in research grants they approved. While NIH center and institute leaders are permitted to serve multiple five-year terms, the 21st Century Cures Act requires the U.S. Department of Health and Human Services Secretary to personally handle such appointments. Chair Cathy McMorris Rodgers (R-Wash.) asserts that in the case of the 14 NIH leaders, reappointments were made by the NIH director and later ratified by Secretary Xavier Becerra. According to committee staff, the panel plans to continue pressing the issue with administration officials and are considering the need for legislation to clarify the appointment process.

Nomination for NIH Director Remains Stalled Before HELP Committee

Dr. Monica Bertagnolli, the White House’s nominee to lead the National Institutes of Health (NIH), has declined Sen. Elizabeth Warren’s (D-Mass.) request to make a public ethics pledge committing to not seek employment in an industry related to her government post for at least four years after leaving public service. Bertagnolli’s nomination also faces a hurdle from Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-Vt.), who has said he will oppose all administration health nominees who do not commit to working to lower drug prices. Bertagnolli reportedly has concerns about the scope of each commitment, and left a meeting with Warren last week without reaching an agreement. The NIH has been without a confirmed director for a year and a half, but administration officials have stated that they remain committed to Bertagnolli’s confirmation.

GAO Updates PHE Preparedness Recommendations

The Government Accountability Office (GAO) has released a new report containing additional recommendations for federal agencies to better prepare for future public health emergencies (PHE). As of April 2023, the GAO has made 386 recommendations to 26 federal agencies and 19 suggestions to Congress to strengthen response and preparedness. About 45% of those have been fully or partially addressed. GAO’s latest recommendations focus on access to diagnostic testing and medical countermeasures, access to real-time information about emerging threats, and the risk of improper payments and fraud.

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health hearing “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology;” 10:30 a.m.; July 18

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “Why Expanding Medicaid to DACA Recipients Will Exacerbate the Border Crisis;” 2:00 p.m.; July 18

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses;” 10:00 a.m.; July 19

Joint Economic Committee hearing to examine the economic impact of diabetes; 2:00 p.m.; July 19

Senate Homeland Security and Governmental Affairs Committee hearing to examine America’s supply chain security, focusing on understanding and mitigating threats; 10:00 a.m.; July 20

Senate Finance Subcommittee on Health hearing “The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System;” 10:00 a.m.; July 20

Senate Health, Education, Labor, and Pensions Committee markup of S. ___, Pandemic and All-Hazards Preparedness and Response Act; 10:30 a.m.; July 20

Senate Appropriations Committee markup of FY 2024 State and Foreign Operations, Energy and Water Development, Housing, and Urban Development; 10:30 a.m.; July 20

July 17, 2023: | Page 1 Page 2



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