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 Ag-FDA Spending

The House Appropriations Subcommittee on Agriculture, Rural Development, and the Food and Drug Administration (FDA) advanced its fiscal year 2024 spending bill by voice vote last week. The bill would provide $6.6 billion in funding for the FDA, less than the $7.2 billion requested in the President’s budget. It includes provisions to block the FDA from allowing mail-order access to mifepristone and from banning menthol or setting a maximum nicotine level in cigarettes. The measure was criticized by panel Democrats who indicated plans to offer numerous amendments during the full committee markup, which is scheduled for May 24.

E&C Health Subcommittee Advances 17 Health Bills

The House Energy and Commerce Subcommittee on Health advanced 17 bills last week, including legislation to overhaul the nation’s organ donation system, mandate additional reporting in the 340B program, reform pharmacy benefit manager (PBM) practices, and permit value-based purchasing agreements in state Medicaid programs. The panel advanced the following bills to the full committee:

  • H.R. 3281, the Transparent PRICE Act which was amended to include the following bills:
    • H.R. 3237, to require each outpatient department of a provider to include a unique identification number on claims for services, and to require hospitals with an outpatient department of a provider to submit to the Centers for Medicare & Medicaid Services an attestation with respect to each outpatient department
    • H.R. 3262, to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information
    • H.R. 3248, the Diagnostic Lab Testing Transparency Act
    • H.R. 3282, the Promoting Transparency and Healthy Competition in Medicare Act
    • H.R. 2679, the PBM Accountability Act
    • H.R. 2559, the Strengthening Community Care Act of 2023
    • H.R. 2550, the Special Diabetes Program Reauthorization Act of 2023
    • H.R. 2547, the Special Diabetes Program for Indians Reauthorization Act of 2023
    • H.R. 2665, the Supporting Safety Net Hospitals Act
    • H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023
  • H.R. 1418, the Animal Drug User Fee Amendments of 2023
  • H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act
  • H.R. 2666, the Medicaid VBPs for Patients (MVP) Act
  • H.R. 3285, the Fairness for Patient Medications Act
  • H.R. 3284, the Providers and Payers COMPETE Act
  • H.R. 3290, to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug
  • discount program

Sanders Drafting $200 Billion Health Package

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) plans to propose a nearly $200 billion health care package that includes $130 billion in funding for community health centers and $60 billion to strengthen the health care workforce. While the HELP Committee has been working on a bipartisan basis on several health care related issues, Ranking Member Bill Cassidy (R-La.) indicated that the total amount of funding included in the Chairman’s plan may be too steep to garner Republican support. Funding for community health centers will expire on September 30th if the program is not reauthorized before the end of the fiscal year. In the House of Representatives, leadership has reached an agreement to increase money for community health centers by approximately 5% over two years – a small fraction of the amount that has been proposed by Sanders.

Lawmakers Press MA Insurers on Claims Denials

Republicans on the House Energy and Commerce Committee have sent a letter to the CEO of The Cigna Group requesting an explanation of how the insurance company uses an automated system to deny medical claims without reading them. The request is in response to an investigative report by ProPublica focusing on Cigna’s procedure-to- diagnosis (PXDX) review process. The lawmakers highlight that 80% of Medicare Advantage (MA) coverage denials were overturned, suggesting that Cigna’s PXDX review process is leading to patients paying out-of-pocket for medical care that should be covered under their insurance policy contract. Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.) ask Cigna to provide documents related to the PXDX process.

The Senate Homeland Security and Governmental Affairs Committee (HSGAC) is conducting its own investigation into the frequency of MA claims denials and the role that artificial intelligence (AI) plays in coverage determinations. The panel sent letters to the three largest MA insurers – Humana, United Healthcare, and CVS – asking for data on their number of prior authorization requests and denials since 2019. The lawmakers also ask for information about the use of software algorithms to deny prior authorization requests. HSGAC’s Permanent Subcommittee on Investigations also convened a hearing last week to consider the subject of health care denials and delays in the MA program.

NIH Nominee to Face Questions on Drug Pricing, EcoHealth Grants

President Joe Biden announced the nomination of National Cancer Institute Director Monica Bertagnolli to lead the National Institutes of Health (NIH). Bertagnolli’s nomination is subject to Senate confirmation. While there is not yet a timeline for consideration of her nomination, Senate HELP Committee Chairman Bernie Sanders (I-Vt.) wrote President Biden last month to say that he “will strongly oppose any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country.” Republicans, including Ranking Member Bill Cassidy (R-La.), are expected to discuss with Bertagnolli the origins of the coronavirus pandemic and NIH grants to EcoHealth Alliance.

Scott Files Paperwork to Run for President

Sen. Tim Scott (R-S.C.) has filed paperwork with the Federal Election Commission to enter the 2024 presidential race. He is expected to formally launch his campaign on Monday. The GOP field currently includes former President Donald Trump, former U.S. ambassador to the United Nations Nikki Haley, entrepreneur Vivek Ramaswamy, former Arkansas Governor Asa Hutchinson, and conservative radio host Larry Elder. Scott has served in the Senate since 2013 and is currently a member of the Finance Committee, Health, Education, Labor, and Pensions Committee, and Special Committee on Aging. Florida Governor Ron DeSantis is expected to announce his plan to run for president mid-week.

GAO Releases New Report on Noncompete Agreements

The Government Accountability Office (GAO) has released a new report detailing its investigation into non-compete agreements, including those in the health care and social assistance employment sector. The GAO found that 57% of health care and social assistance employers surveyed require new hires to sign agreements restricting them from taking jobs with rival companies. The report was requested by Sens. Ron Wyden (D-Ore.), Elizabeth Warren (D-Mass.), Tim Kaine (D-Va.), Christopher Murphy (D-Conn.), Marco Rubio (R-Fla.), and Todd Young (R-Ind.).

ARPA-H Announces Inaugural Program

The Advanced Research Projects Agency for Health (ARPA-H) announced the launch of its first program last week. The Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) aims to develop breakthroughs that would allow the human body to repair its owns joints. Osteoarthritis is a leading cause of disability in the U.S. It impacts more than 32 million Americans and costs an estimated $136 billion per year. Research teams interested in in NITRO can find more information about a Proposers’ Day here.

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Committee hearing “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part I: Self-Interest or Health Care?” 10:00 a.m.; May 23

House Veterans’ Affairs Committee hearing “COVID-19 Supplemental Funding: Did It Protect and Improve Veteran Care?” 10:00 a.m.; May 23

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “VA Information Technology Contracting: Challenges in Consolidation of Competition and Conflict of Interest;” 8:00 a.m.; May 24

House Oversight and Accountability Subcommittee on Economic Growth, Energy Policy, and Regulatory Affairs hearing “Consumer Choice on the Backburner: Examining the Biden Administration’s Regulatory Assault on Americans’ Gas Stoves;” 10:00 a.m.; May 24

House Appropriations Committee markup of fiscal year 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill; 10:00 a.m.; May 24

House Ways and Means Subcommittee on Trade hearing “Modernizing Customs Policies to Protect American Workers and Secure Supply Chains;” 9:00 a.m.; May 25

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation field hearing “Advances in AI: Views from Silicon Valley;” 10:00 a.m.; June 1

May 22, 2023: | Page 1 Page 2



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