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 Passes GOP Debt Ceiling Bill Along Party Lines

The House of Representatives passed the GOP leadership’s legislative proposal to raise the debt ceiling last week in a 217-215 vote. Four Republicans - Matt Gaetz (Fla.), Andy Biggs (Ariz.), Ken Buck (Colo.), and Tim Burchett (Tenn.) – joined Democrats in opposition to the measure. The Limit, Save, Grow Act of 2023 (H.R. 2811) would lift the nation’s $34.1 trillion debt limit by $1.5 trillion or until March 31, 2024, whichever comes first, in exchange for $130 billion in proposed budget cuts. The bill would achieve these cuts by freezing discretionary spending at fiscal year (FY) 2022 levels - $1.47 trillion. Any future spending increases would be capped at 1% annually for the next decade, reaching $1.61 trillion in total discretionary spending in FY 2033. The bill would permit new budget authority only for certain activities, including health care fraud and abuse prevention. The legislation also includes provisions to claw back unspent and unobligated COVID-19 funding and to institute work requirements for social safety net programs. Medicaid recipients would be required to work, look for work, or participate in community engagement for 80 hours a month, exempting those with dependent children and those who are “physically or mentally unfit,” enrolled in an educational program, under 19 years old, or over 56 years old. The Congressional Budget Office estimates that the bill would reduce the federal deficit by $4.8 trillion over the next decade. The Medicaid work requirement proposal would reduce federal spending by $109 billion, with the budget office forecasting that 1.5 million adults would lose federal funding for their Medicaid coverage. Approximately 900,000 of those individuals would retain their health insurance coverage through Medicaid state funding, while 600,000 would become uninsured. H.R. 2811 has been rejected by congressional Democrats and the White House in favor of a clean increase to the debt limit, with Majority Leader Chuck Schumer (D-N.Y.) characterizing the bill as dead on arrival in the Senate and the White House confirming that the President would veto the legislation should it reach his desk. Without an increase or suspension of the debt ceiling, the nation could default on its payment obligations as early as June.

HELP to Markup Four Drug Pricing Bills This Week

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) have announced a bipartisan deal to consider a slate of drug pricing related proposals. The four bills will be marked up by the panel on Tuesday. The committee will consider:

  • The RARE Act (S. 1214), to codify that the scope of orphan drug exclusivity aligns with the approved use or indication of an orphan drug, rather than the disease or condition for which the drug received orphan drug designation.
  • The Ensuring Timely Access to Generics Act of 2023 (S. 1067), which would permit the FDA to deny a citizen petition submitted with the primary purpose of delaying the approval of a follow-on generic or biosimilar application, or if the petition does not raise valid scientific or regulatory issues.
  • The Expanding Access to Low-Cost Generics Act of 2023 (S. 1114), to allow generic companies that are not “first filers” to enter the market if the first filer who otherwise received 180-day exclusivity has failed to come to market by 33 months since the date of submission of the application when there is another applicant who is otherwise ready to market their product.
  • The Pharmacy Benefit Manager Reform Act (S. 1339), which would increase oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage.
Senate Majority Leader Chuck Schumer (D-N.Y.) aims to bring a drug pricing package to the floor this year. The Senate Commerce, Judiciary, and Finance committees are also working to pass their own drug pricing proposals, and Sanders has stated that he expects to see several of the related bills merged when they reach the Senate floor.

House Appropriations Markups to Commence May 17th

The House Appropriations Committee will begin conducting markups of FY 2024 spending bills later this month. According to a letter from Chairwoman Kay Granger (R-Texas) to panel members, the first subcommittee markups will be scheduled for May 17th and 18th, with the first full committee markups tentatively planned for May 23rd, 24th, and 25th. The remaining subcommittee markups will be held June 7th and 8th, with the full committee completing consideration of the measures June 13th, 14th, and 15th.

Senate Republicans Block VA Cannabis Research Proposal

The Senate blocked consideration of legislation last week that would have directed the Department of Veterans Affairs (VA) to conduct research on the effects of cannabis on patients in the VA health care system suffering from trauma, stress, chronic pain, and opioid use disorder. The VA Medicinal Cannabis Research Act (S. 326), introduced by Sens. Jon Tester (D-Mont.) and Dan Sullivan (R-Alaska), was unanimously passed out of committee earlier this year but failed in a 57-42 procedural motion that required 60 votes to advance on the Senate floor. Eight Republicans joined Democrats in support of the bill: Veterans’ Affairs Committee members Jerry Moran (Kansas), Bill Cassidy (La.), Mike Rounds (S.D.), and Dan Sullivan (Alaska), along with Susan Collins (Maine), Lisa Murkowski (Alaska), Josh Hawley (Mo.), and Eric Schmitt (Mo.).

Warren, Jayapal Make Drug Pricing Recommendations for USPTO

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) have sent a letter to the U.S. Patent and Trademark Office (USPTO) reiterating their request that the agency take action against alleged efforts by pharmaceutical manufacturers to prevent generic competition from coming to market. “We have yet to see the USPTO take substantial steps to exercise its existing administrative authorities to help lower drug prices, encourage competition, and increase innovation,” the letter states. The lawmakers sent similar letters to the agency in June 2021 and December 2022. Warren and Jayapal specifically urge the USPTO to consider the following recommendations:

  • Revise the practice of granting obvious patents;
  • When challenged, patents tied together by terminal disclaimers should all stand or fall together;
  • Raise filing fees and limit the number and time period for continuation applications to discourage “obviousness-type double patents;”
  • Require applicants to disclose at the time of filing whether the drug compound covered by the patent application is in clinical trials;
  • Reverse policies that have led to an increase in discretionary denials of petitions filed through the inter partes review process; and
  • Establish an office dedicated to building public transparency, serving the public interest, and strengthening interagency communication.

Coronavirus Select Subcommittee Requests Intel from Chinese Scientists

Republicans on the House Select Subcommittee on the Coronavirus Pandemic have asked the Chinese embassy to permit five Chinese scientists to be interviewed about how the coronavirus pandemic started. The request comes in response to the Chinese embassy’s opposition to a recent subcommittee hearing regarding the origins of COVID-19. “Continued stonewalling by China will not only harm the globe’s ability to predict, prepare, protect, and prevent the next pandemic but will also...fail to promote ‘international solidarity,’” the letter states. The committee asks to hear from Dr. George Gao, former director of the Chinese Center for Disease Control and Prevention; Dr. Shi Zhengli, director of the Center for Emerging Infectious Diseases, the Wuhan Institute of Virology; Dr. Ben Hu, a researcher with the Wuhan Institute of Virology; and Dr. Chen Wei, Major General of the People’s Liberation Army.

E&C Republicans Launch Probe into NIH Communications Spending

House Energy and Commerce Committee Republicans have launched an investigation into spending by the National Institutes of Health (NIH) on public information and communication services. The NIH has spent nearly $1 billion over the last five years on public relations contracts. The committee sent letters to the 10 communications and consulting firms awarded a contract in 2018 that is due to expire in December to request more information about their work for NIH. “Government contracts for public relations, consulting, and media services can devolve into a kind of de facto public relations service for the personal aggrandizement of senior leadership. They can be used to promote an agency’s brand and image instead of being used to communicate accurate information to the public,” the letter states. The panel aims to determine how the agency uses contract public relations firms and whether they are an appropriate use of taxpayer dollars.

Physicians Consider Impact of Potential Mifepristone Restrictions on Off-Label Prescribing

Physicians across the country are working to determine the impact of recent legal rulings related to the accessibility of mifepristone on their prescribing practices. Earlier this month, the Supreme Court acted to prevent lower court rulings suspending access to mifepristone from taking effect. Mifepristone is approved by the Food and Drug Administration (FDA) for abortion, though it is frequently prescribed off-label for miscarriage management. The U.S. 5th Circuit Court of Appeals will hear arguments on May 17 from anti-abortion groups in support of overturning the FDA’s approval of mifepristone and counterarguments from the Biden administration and the pill’s manufacturer seeking to maintain access to the pill nationwide. The 5th Circuit’s prior ruling would have kept the drug on the market but restricted access to telemedicine prescriptions, mail delivery, pharmacy dispensing, and generic versions of the drug and only permitted prescriptions within seven weeks of gestation. Meanwhile, a separate federal court ruling from Washington state could shield some states and the District of Columbia from any attempts to restrict mifepristone availability. While some legal experts assert that any future restrictions on the medication abortion pill could be circumvented by prescribing the drug off-label, many prescribers are concerned about the possibility of prosecution, harassment, and retaliation from state licensing boards and civil litigation. “We don’t feel at all comfortable,” American Medical Association President Jack Resneck stated in an interview. “Off-label prescribing is common, but it is really unclear in this case what physicians would be able to do.”

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions Committee markup of S. 1067, Ensuring Timely Access to Generics Act of 2023, S. 1114, Expanding Access to Low-Cost Generics Act of 2023, S. 1214, RARE Act, and S. 1339, Pharmacy Benefit Manager Reform Act; 10:00 a.m.; May 2

Senate Finance Committee hearing “Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks;” 10:00 a.m.; May 3

Senate Veterans’ Affairs Committee hearing “Examining the Effectiveness of the Office of Integrated Veteran Care;” 3:00 p.m.; May 3

Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies hearing “Fiscal Year 2024 budget for the National Institutes of Health;” 10:00 a.m.; May 4

Senate Health, Education, Labor, and Pensions Committee hearing “Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act;” 1:00 p.m.; May 4

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Pharmacy;” 3:00 p.m.; May 9

Senate Health, Education, Labor, and Pensions Committee hearing “The Need to Make Insulin Affordable for All Americans;” 1:00 p.m.; May 10

May 1, 2023: | Page 1 Page 2



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