POLICY BRIEFINGS

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Coronavirus Panel Requests Details on Political Interference in Vaccine Approvals

Republicans on the House Select Subcommittee on the Coronavirus Pandemic are requesting information from the Biden administration related to the Food and Drug Administration’s COVID-19 vaccine approval process. The lawmakers assert that the agency “may have bypassed, wrongly compressed, and possibly compromised the longstanding process for awarding a full biologics approval to a vaccine.” The letter asserts that this effort “may not have been to save lives, but concernedly to provide cover for implementing and enforcing vaccine mandates across the country.”

Reps. Kim, Kelly to Lead Maternity Care Caucus

Reps. Young Kim (R-Calif.) and Robin Kelly (D-Ill.) will serve as co-chairs of the bipartisan Maternity Care Caucus for the 118th Congress. Kim and Kelly replace outgoing co-chairs Reps. Lucille Roybal-Allard (D-Calif.) and Jaime Herrera Beutler (R-Wash.). The new co-chairs have highlighted their goal of exploring the biggest challenges to America’s maternity care system and the most promising solutions to expand safe and effective care for mothers and babies. These include increasing access to and expanding training for the material health care workforce, improving maternal mental health, addressing disparities in maternal mortality rates, expanding access to telehealth, and increasing clinical trial participation among pregnant and breastfeeding women.

Rep. McClain Joins Mental Health Task Force Leadership

Rep. Lisa McClain (R-Mich.) will serve as the fourth co-chair of the Bipartisan Mental Health and Substance Use Disorder Task Force for the 118th Congress. The 130-member caucus aims to combat the mental health and substance use disorder epidemics in American communities. McClain joins current co-chairs David Trone (D-Md.), Brian Fitzpatrick (R-Pa.), and Ann Kuster (D-N.H.).

Democratic Health Leaders Praise Proposed Rollback of Conscience Regulations

On March 7, House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.), House Education and the Workforce Committee Ranking Member Bobby Scott (D-Va.), and House Ways and Means Committee Ranking Member Richard Neal (D-Mass.) sent a letter to the U.S. Department of the Health and Human Services (HHS) in support of the Office for Civil Rights’ notice of proposed rulemaking, “Safeguarding the Rights of Conscience as Protected by Federal Statues.” The proposed rule seeks to partially rescind a 2019 rule promulgated during the Trump administration that allowed medical professionals the ability to deny care based on religious or conscience objections. The 2019 rule was blocked by federal courts in response to several lawsuits. The letter expresses the members’ support for HHS’ partial recission of the rule “because it aims to restore the balance between enforcing conscience laws and ensuring that individuals have unimpeded access to comprehensive health care services. Having access to health care services is critical, especially for certain communities such as racial and ethnic minorities, women, and LGBTQ+ individuals who have historically faced barriers to access in our health care system, and often continue to face discrimination in access to care today.”

Democrats Criticize Walgreens’ Plan for Mifepristone Dispensing

Agroup of 12 Democratic Senators have sent a letter to Walgreens CEO Rosalind Brewer criticizing the company’s stated plans for its Mifepristone dispensing policies. While Walgreens is seeking pharmacy certification to dispense the medical pregnancy termination drug through the Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy program, it has also informed 20 Republican state attorneys general that it will avoid dispensing the product in certain states – mostly those where abortion is banned or heavily restricted – that have threatened legal action. “We urge Walgreens demonstrate its commitment to putting patients first by prioritizing obtaining FDA specialty certification to dispense Mifepristone and publicly clarifying that any hypothetical dispensing decisions remain undecided and premature at best, while the company seeks pharmacy certification,” the letter states.

McConnell Hospitalized with Concussion Following Fall

Senate Minority Leader Mitch McConnell (R-Ky.) was hospitalized last week after a fall at a Washington, D.C. area hotel. The Minority Leader suffered a concussion and is being treated at a D.C.-area hospital. McConnell is expected to remain in the hospital for a few days of observation and treatment.

Representative Jennifer McClellan sworn into the House of Representatives

On March 7, Rep. Jennifer McClellan (D-Va.) was sworn into the U.S. House of Representatives to represent Virginia’s fourth district. Rep. McClellan was elected in a special election on February 21st to succeed the late-Rep. Donald McEachin (D-Va.)—who passed away of complications of colorectal cancer three weeks after being re-elected to the seat in November. McClellan makes history as the first Black woman to represent the state of Virginia in Congress. With Representative McClellan, the number of women serving in Congress reached a record high at 150. In addition, the House is now operating at full membership, a first since 2019, with 435 seats occupied in the 118th Congress. This slightly shifts the balance of power in the chamber—narrowing Republican’s majority to 222 to 213.

HHS OIG Issues Reminder on Expiration of PHE

The U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a notice last week reminding the health care community that OIG flexibilities issued during the time period covered by the COVID-19 public health emergency (PHE) declaration will expire on May 11. These flexibilities - covered by two policy statements and a series of frequently asked questions – were designed to minimize burdens for the health care industry as it faced the challenges of the COVID-19 pandemic. More information on what each flexibility did can be found here.

ASPR Releases Cybersecurity Guide for Health Care Sector

The Administration for Strategic Preparedness and Response (ASPR) released the Cybersecurity Framework Implementation Guide last week to support the health care sector in preventing cybersecurity incidents. The document, which was jointly developed by ASRP and the Health Sector Coordinating Council Cybersecurity Working Group, outlines steps organizations can immediately take to manage cyber risks to their information technology systems. It aims to assist health care organizations in implementing the National Institute for Standards and Technology’s Cybersecurity Framework, including by guiding risk management principles and best practices; providing common language to address and manage cybersecurity risk; outlining a structure for organizations to understand and apply cybersecurity risk management; and identifying effective standards, guidelines, and practices to manage cybersecurity risk cost-effectiveness based on business needs.

HHS Update on Pandemic Accord

The U.S. Department of Health and Human Services (HHS) has provided an update on work among the Intergovernmental Negotiating Body of the World Health Organization on a pandemic accord. According to HHS, the U.S. sought to “promote an accord that would build capacity, reduce the threat posed by zoonotic disease, enable rapid and more equitable responses, and establish sustainable financing, governance, and accountability to break the cycle of pandemic panic and neglect” at the fourth meeting of the Intergovernmental Negotiating Body last week. Its next meeting will take place in a month. The group aims to conclude its work on a pandemic accord in May 2024.

Upcoming Congressional Hearings and Markups

Senate Veterans’ Affairs Committee hearing “Examining the Future Path of VA’s Electronic Health Record Modernization Program;” 3:30 p.m.; March 15

Senate Energy and Natural Resources Committee meeting to receive a closed briefing on the assessment of the origins of COVID-19; 9:30 a.m.; March 16

Senate Homeland Security and Government Affairs Committee hearing “In Need of a Checkup: Examining the Cybersecurity Risks to the Healthcare Sector;” 10:00 a.m.; March 16

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

House Energy and Commerce Subcommittee on Health hearing “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care;” 1:00 p.m.; March 28

Recently Introduced Health Legislation

H.R.1376 — To require the Director of National Intelligence to declassify information relating to the origin of COVID-19, and for other purposes; Sponsor: Turner, Michael R. [Rep.-R-OH-10]; Committees: House – Intelligence; Energy and Commerce

H.R.1375 — To allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House - Energy and Commerce

H.R.1374 — To amend the Higher Education Act of 1965 to prohibit the imposition of COVID-19 vaccine mandates by institutions of higher education, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House - Education and the Workforce

H.R.1373 — To prohibit any head of a Federal agency from providing assistance to the Wuhan Institute of Virology and other laboratories in certain other foreign nations; Sponsor: Stewart, Chris [Rep.-R-UT-2]; Committees: House - Foreign Affairs

H.R.1361 — To authorize the Director of the Bureau of Justice Assistance to make grants to States, units of local government, and gun dealers to conduct gun buyback programs, and for other purposes. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House - Judiciary

H.R.1360 — To establish a cybersecurity literacy campaign, and for other purposes; Sponsor: Obernolte, Jay [Rep.-R- CA-23]; Committees: House - Energy and Commerce

H.R.1359 — To expand the take-home prescribing of methadone through pharmacies; Sponsor: Norcross, Donald [Rep.- D-NJ-1]; Committees: House - Energy and Commerce; Judiciary

H.R.1352 — To require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House - Energy and Commerce; Ways and Means

H.R.1350 — To amend the Internal Revenue Code of 1986 to restore the amount of the orphan drug tax credit, and for other purposes; Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House - Ways and Means; Energy and Commerce

H.R.1346 — To require the Director of National Intelligence to declassify information relating to the origin of COVID-19, and for other purposes; Sponsor: Gallagher, Mike [Rep.-R-WI-8]; Committees: House - Intelligence (Permanent Select); Energy and Commerce

H.R.1345 — To amend the National Telecommunications and Information Administration Organization Act to establish the Office of Policy Development and Cybersecurity, and for other purposes; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House - Energy and Commerce

H.R.1342 — To amend title XIX of the Social Security Act to improve coverage of dental and oral health services for adults under Medicaid, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; House - Energy and Commerce

H.Res.196 — Memorializing those impacted by and lost to the COVID-19 pandemic; Sponsor: Stanton, Greg [Rep.-D- AZ-4]; Committees: House - Energy and Commerce

S.Res.94 — A resolution memorializing those lost to the COVID-19 pandemic; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate - Health, Education, Labor, and Pensions

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