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 Republicans Call for Debt Limit Negotiations

Republicans continue to call on the White House and Democrats in Congress to engage in negotiations to increase the federal debt limit. The U.S. reached its $31.4 trillion debt limit on January 19, prompting the Treasury Department to begin taking “extraordinary measures” to delay a default on the national debt and urging Congress to act quickly. Treasury is projected to exhaust its borrowing authority around June of this year, and House Republicans are pushing for an agreement on spending cuts in exchange for increasing the statutory ceiling for the federal debt. House Speaker Kevin McCarthy (R-Calif.) has indicated that changes to entitlement programs as well as to annual discretionary spending are both under consideration. Biden administration officials, however, remain opposed to any bargaining around the debt limit, arguing that the nation’s borrowing authority should be addressed without conditions and is not something that should be politicized. While congressional Democratic leadership appear aligned with this position, Sen. Joe Manchin (D-W.Va.) stated last week that he is willing to seek a deal with Republicans on the debt limit. Manchin specifically expressed support for Sen. Mitt Romney’s (R-Utah) plan to create commissions charged with making recommendations to extend the solvency of the Medicare and Social Security trust funds. Romney’s proposal would guarantee a vote on the commissions’ recommendations before Congress. Senate Minority Leader Mitch McConnell (R-Ky.) has offered assurances that the nation will not breach the debt limit and expressed his confidence that talks with President Joe Biden on a spending compromise will resolve any standoffs.

Banks, Gallego Announce Senate Intentions

Rep. Jim Banks (R-Ind.) announced that he will run for Sen. Mike Braun’s (R-Ind.) seat in the Senate in 2024. Braun decided last year to retire from Congress and run for Indiana governor in 2024. Rep. Ruben Gallego (D-Ariz.) also announced his plans to challenge Sen. Kyrsten Sinema (I-Ariz.) for her seat in the Senate in 2024 last week. Gallego currently serves on the House Committee on Armed Services, the Committee on Natural Resources, and the Committee on Veterans’ Affairs. Sinema has yet to decide whether she will seek re-election after leaving the Democratic Party and becoming an independent late last year.

GAO Report Raises Concerns with Gain of Function Research Oversight

Anew report from the Government Accountability Office (GAO) examining the U.S. Department of Health and Human Services’ (HHS) oversight of gain-of-function research was released last week. The report expresses concerns about the effectiveness of and lack of transparency around grantee monitoring, and describes shortcomings related to the review of research proposals involving potential pandemic pathogens. While HHS is required to conduct extra reviews of the risks and benefits of research grant proposals that are “reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens,” there is no standard for what this actually means. The GAO recommends that HHS set a standard to ensure consistency in identifying high-risk research for departmental review and identify and share non-sensitive information with researchers, Congress, and the public about the review process. In response to the report, Republicans in the House of Representatives reiterated their intent to further investigate HHS funding of research involving pathogens with pandemic potential. House Oversight and Accountability Chair James Comer (R-Ky.) and House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) both plan to conduct investigations into gain-of- function research and its potential role in the cause of the COVID-19 pandemic.

Pallone Highlights Lack of Clinical Trial Transparency Enforcement

House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) has sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) regarding the agencies’ enforcement of regulations governing clinical trial transparency. Trials that are subject to FDA oversight and NIH funding are required to register their studies within 21 days of their first subject enrollment and post their results within a year of the trial’s completion. While the FDA released guidance on penalties for non-compliance with these standards in 2020, only four non-compliance notices have been posted – and none required the subjects to pay a civil money penalty. Pallone cites a study indicating that 31% of registered trials failed to report any results, while another 30% of trial sponsors failed to do so on time. He requests a response from the agencies by February 17 regarding clinical trial sponsor compliance with applicable requirements and appropriate agency enforcement.

Study Shows Barriers to Psychiatric Care for Military Families

Up to 35% of military families do not have access to adequate psychiatric care despite being insured by a government program that covers these services, according to a new study published in JAMA Network Open. The study found that 35% of Tricare beneficiaries lived in communities where the ratio of residents to psychiatrists – military or civilian – is more than 20,0000 to one, and another 6% lived more than 30 minutes driving distance from a psychologist. Individuals living in places with both low incomes and high-income inequality were more than two times more likely to face a shortage of psychiatrists, while retirees were nearly twice as likely to experience shortages and four times as likely to have no access to psychiatric care at all.

Recently Introduced Health Legislation

H.R.366 — To amend title 38, United States Code, to treat certain individuals who served in Vietnam as a member of the armed forces of the Republic of Korea as a veteran of the Armed Forces of the United States for purposes of the provision of health care by the Department of Veterans Affairs. Sponsor: Takano, Mark [Rep.-D-CA-39]; Committees: House - Veterans’ Affairs

H.R.363 — To amend title 18, United States Code, with respect to the sale, purchase, shipment, receipt, or possession of a firearm or ammunition by a user of medical marijuana, and for other purposes. Sponsor: Mooney, Alexander X. [Rep.-R- WV-2]; Committees: House - Judiciary

H.R.382 — To terminate the public health emergency declared with respect to COVID-19; Sponsor: Guthrie, Brett [Rep.- R-KY-2]; Committees: House - Energy and Commerce

H.R.383 — To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R- TN-1]; Committees: House - Energy and Commerce

H.R.384 — To prohibit the use or declaration of a public health emergency with respect to abortion, and for other purposes; Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House - Energy and Commerce

January 23, 2023: | Page 1



 -  2023

 +  2022

 +  2021

 +  2020

 +  2019

 +  2018