The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 12 - April 18. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On April 12, Ways & Means Ranking Member Kevin Brady (R-TX) announced that he will not seek reelection.
On April 13, the House voted 384-38 in favor of H.R. 1868, To prevent across-the-board direct spending cuts, and for other purposes, which will provide relief from the Medicare sequester cuts through 2021. President Biden signed the legislation into law on the same day.
On April 13, Reps. Suzan DelBene (D-WA), Jan Schakowsky (D-IL), and Mark Pocan (D-WI) led a group of Democrats urging Health & Human Services (HHS) Secretary Xavier Becerra to revoke restrictions imposed during the Trump Administration on fetal tissue use in biomedical research.
On April 13, Energy & Commerce Chairman Frank Pallone (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Anna Eshoo (D-CA), and Ranking Member Brett Guthrie (R-KY) urged Secretary Becerra to ensure that HHS conducts proper oversight and enforces full compliance with the Hospital Price Transparency Final Rule, which went into effect on January 1, 2021. The Senators voiced their concern regarding reports of some hospitals acting slowly to comply with the rule requirements or not taking any action to comply.
On April 14, Reps. Cheri Bustos (D-IL), Tom Cole (R-OK), Jim McGovern (D-MA), and Markwayne Mullin (R-OK) reintroducedH.R. 4004 Social Determinants Accelerator Act, which would set aside funding for states and local governments to solve economic and social issues that contribute to poorer health outcomes.
On April 14, the House voted 412-8 to pass S. 164 Advancing Education on Biosimilars Act of 2021 and Ensuring Innovation Act.
On April 15, the House passed H.R. 941 TRANSPLANT Act of 2021.
On April 14, the Energy & Commerce Health Subcommittee helda hearing entitled An Epidemic within a Pandemic: Understanding Substance Use and Misuse in America. Subcommittee Ranking Member Brett Guthrie (R-KY) highlighted that COVID-19 has exacerbated the opioid epidemic and noted that the rise of synthetic drugs has contributed to opioid overdose rates. Chairman Pallone advocated for the bipartisan, public health approach to addressing the opioid epidemic and improving access to substance use treatment. The hearing considered the following bills:
H.R. 654, the Drug-Free Communities Pandemic Relief Act;
H.R. 955, the Medicaid Reentry Act of 2021;
H.R. 1384, the Mainstreaming Addiction Treatment Act of 2021;
H.R. 1910, the Federal Initiative to Guarantee Health by Targeting Fentanyl Act;
H.R. 2051, the Methamphetamine Response Act;
H.R. 2067, the Medication Access and Training Expansion Act;
H.R. 2355, the Opioid Prescription Verification Act;
H.R. 2364, the Synthetic Opioid Danger Awareness Act;
H.R. 2366, the Support, Treatment, and Overdose Prevention of Fentanyl Act of 2021;
H.R. 2379, the State Opioid Response Grant Reauthorization Act; and
H.R. 2405, the Streamlining Research on Controlled Substances Act.
On April 15, the Appropriations Labor, HHS, Education and Related Agencies Subcommittee held a hearing entitled FY2022 Budget Request for HHS. Chair Rosa DeLauro (D-CT) advocated for increased investment in public health infrastructure and for greater commitment to address health disparities.
Senate
On April 14, the Homeland Security and Governmental Affairs Committee held a markup to vote on the nominations of Deanne Bennett Criswell for Federal Emergency Management Agency Administrator and Jason Scott Miller for Office of Management and Budget (OMB) Deputy Director for Management.
On April 15, Sens. Chris Murphy (D-CT), Jeff Merkley (D-OR), and Dianne Feinstein (D-CA) reintroduced the Choose Medicare Actthat would allow those not already eligible for Medicaid or Medicare the opportunity to enroll in Medicare and give every employer the ability to purchase Medicare for their employees.
On April 15, the Finance Committee held a hearing entitled Nomination Hearing of Chiquita Brooks-LaSure for Centers for Medicare & Medicaid Services (CMS) Administrator and Andrea Palm for HHS Deputy Secretary. Committee members raised a variety of topics for the nominees to discuss, including expanding telehealth, supporting states’ 1115 and 1132 waivers, addressing health disparities and targeting vulnerable populations, supporting mental and behavioral health, supporting home and community-based care, lowering drug prices, and increasing health coverage.
NON-CORONAVIRUS REGULATORY UPDATE
On April 12, Acting Food & Drug Administration (FDA) Commissioner Janet Woodcock announced the permanent appointment of Patrizia Cavazzoni for FDA Center for Drug Evaluation and Research Director.
On April 12, CMS extended the deadline for interested applicants to apply to Primary Care First (PCF) Cohort 2. The deadline for PCF practice applications has been extended to May 21, 2021 and the deadline for payer applications has been extended to June 18, 2021
On April 12, HHS approved a waiver, made possible by the American Rescue Plan, for Illinois to extend postpartum Medicaid coverage for one year after a woman gives birth, an increase over the current 60 day coverage period. HHS Secretary Xavier Becerra also announced a Notice of Funding Opportunity that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies program that will allow awardees to test models to address unmet needs for their target population.
On April 14, FDA issued a notice of withdrawal of proposed exemptions entitled Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements, due to the notice being published without adequate scientific support.
On April 14, FDA issued guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On April 12, President Biden nominated former New Jersey Attorney General Anne Milgram for the position of Drug Enforcement Administration Administrator.
On April 13, the White House and HHS announced a number of initiatives and funding to address the maternal health crisis in the U.S., including strengthening Medicaid; increasing investment in reducing maternal mortality and morbidity; approving Illinois' Medicaid section 1115 waiver to extend postpartum coverage; awarding $12 million in additional funds for maternal obstetrics care in rural communities; and issuing a presidential proclamation calling on all Americans to recognize the importance of addressing the crisis of Black maternal mortality and morbidity. This is the first-ever presidential proclamation marking Black Maternal Health Week as part of an effort to highlight racial gaps in pregnancy and childbirth-related deaths. A summary of the initiatives is available here.
On April 13, the White House appointed Sandra Elizabeth Ford as the White House Domestic Policy Council Special Assistant for Public Health and Science.
CORONAVIRUS UPDATE
House
On April 15, the Coronavirus Crisis Subcommittee held a hearing entitled Reaching the Light at the End of the Tunnel: A Science-Driven Approach to Swiftly and Safely Ending the Pandemic. The witnesses provided updates of U.S. progress toward vaccinating all Americans. Witnesses include Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky, National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci, and HHS Chief Science Officer Dr. David Kessler.
Senate
On April 16, 10 Democrat Senators urged President Biden to support a temporary waiver of intellectual property rules as proposed by India and South Africa to the World Trade Organization to increase address vaccine shortages in developing countries.
Regulatory
On April 12, CDC Director Dr. Rochelle Walensky urged Michigan Governor Gretchen Whitmer (D) to impose additional COVID-19 restrictions, rather than ask for more vaccines, and that Michigan cannot vaccinate its way out of the surge the state is experiencing.
On April 13, the FDA and CDC recommended an immediate halt of the use of Johnson & Johnson's (J&J) COVID-19 vaccine due to six reports of a rare and severe type of blood clot. The CDC Advisory Committee on Immunization Practices declined to change the current recommendation to pause administration of J&J's COVID-19 vaccine, citing the need for more complete evidence to justify voting on the measure. The panel agreed to reconvene on April 23 to review additional data. J&J delayed the rollout of its vaccine in Europe and paused vaccinations in its COVID-19 vaccine clinical trials. The White House announcedthat the pause of J&J’s vaccine administration will not have a significant impact on the Administration’s vaccination plan.
On April 13, HHS held a virtual COVID-19 Health Equity Task Force meeting focusing on: Equity in COVID-19 Vaccinations: Understanding and Addressing Gaps, Achieving Health Equity for Asian American and Native Hawaiian and Pacific Islander Communities, and Equitable Vaccine Access for People with Disabilities. HHS will hold a virtual COVID-19 Health Equity Task Force meeting on April 30 to consider interim recommendations specific to mental and behavioral health across the life course.
On April 13, the HHS Office for Civil Rights, the Administration for Community Living, and the Office of the Assistant Secretary for Planning and Evaluation published several new resources to help states and vaccination providers to improve access to vaccines for people with disabilities and older adults. These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies to ensure accessibility.
On April 14, the National Institute of Allergy and Infectious Diseases (NIAID) launched the Centers of Excellence for Influenza Research and Response to establish a network of research sites to study the natural history, transmission and pathogenesis of influenza and provide an international research infrastructure to address influenza outbreaks.
FDA is expected to receive an application from AstraZeneca for emergency authorization (EUA) of its COVID-19 vaccine candidate, AZD1222, in the coming weeks.
White House
On April 16, the White House announced $1.7 billion to improve the detection, monitoring, and mitigation of these COVID-19 variants, and help states and other jurisdictions more effectively fight these mutations.
Other
On April 11, former FDA Commissioner Scott Gottlieb wrote an op-ed in the Wall Street Journal advocating for the use of “vaccine passports” and that they would empower consumers by giving them more control over their own health information.
On April 12, COVAX announced that it will deliver 14.1 million doses of the Pfizer vaccine to nearly 50 participating countries. The organization is seeking $2 billion to secure access to additional doses.
On April 12, Regeneron released results from its Phase III trial of REGEN-COV, an antibody cocktail of casirivimab with imdevimab, reduced the risk of developing symptomatic disease by 81% among household contacts of COVID-19 infected individuals. Regeneron indicated that it will seek emergency authorization for the treatment's use among unvaccinated people who have been exposed to the virus. Regeneron also released Phase III trial results demonstrating that REGEN-COV shortened symptom duration and markedly reduced viral levels.
On April 12, Lilly announced changes to the purchase agreements with the U.S. government, modifying the purchase agreement of bamlanivimab alone in favor of the supply of bamlanivimab and etesevimab together as a treatment for COVID-19. This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021. On April 16, Lilly requested for cancellation of the EUA for bamlanivimab due to concerns that variants could be resistant to bamlanivimab when used alone.
On April 12, a study published in the Lancet Infectious Diseasesfound that the COVID-19 variant B.1.1.7 from the U.K. is more easily transmissible but does not lead to more severe disease among hospitalized patients.
On April 12, Gilead stopped its Phase III clinical trial of the COVID-19 treatment, Veklury, for high-risk non-hospitalized COVID-19 patients.
On April 12, Novavax announced it pushed back the timeline for hitting its production target of 150 million COVID-19 vaccine doses per month until the third quarter, due to supply shortages including bags used to grow cells
On April 13, the Rockefeller Foundation launched a $20 million Equity-First Vaccination Initiative to improve the vaccination rate among communities of color who have been disproportionately impacted by COVID-19.
On April 13, Moderna released results supporting that its COVID-19 vaccine is more than 90% effective against COVID-19 and more than 95% effective against severe disease after six months. These results are similar to Pfizer’s COVID-19 vaccine after 6 months.
On April 13, Pfizer CEO Albert Bourla announced that Pfizer increased COVID-19 vaccine production and can deliver 10% more doses to the U.S. by the end of May than previously agreed (total of 220 million) and supply the full supply of 300 million for the end of July, two weeks early. On April 15, Bourla suggested that people will likely need a third booster Pfizer COVID-19 vaccine within 12 months of being fully vaccinated.
On April 14, Montana Governor Greg Gianforte (R) issued an executive order banning the development or use of vaccine passports in Montana. Florida, Idaho, Texas, and Utah have issued similar orders.
On April 14, U.S. Trade Representative Katherine Tai stressed the need for collective action with pharmaceutical companies to address vaccine shortages in developing countries.
On April 14, Pfizer began COVID-19 vaccine clinical trials for children ages 2 to 5.
On April 15, Merck announced positive results from the Phase II/III trial of molnupiravir for the treatment of COVID-19 patients out of hospitals who have at least one risk factor for poor outcomes, such as advanced age, obesity or diabetes. Merck will also discontinue the development of MK-7110 for the treatment of hospitalized patients with COVID-19.
On April 16, the World Health Organization is seeking to expand the capacity of low- and middle-income countries to produce COVID-19 vaccines and scale up manufacturing to increase global access to COVID-19 vaccines.
As of April 16, more than 131 million people have received the first dose of COVID-19 vaccines (more than 84 million have received both doses) and more 264 million doses have been distributed, according to the CDC COVID Data Tracker.
As of April 16, the U.S. had 31,668,343 confirmed COVID-19 cases resulting in 567,210 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
FY 2022 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, and the Long-Term Care Hospital Prospective Payment System (CMS-1752); Proposed Rule; Received 2/16/21
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
Comprehensive Care for Joint Replacement Model Three-Year Extension and Modifications to Episode Definition and Pricing (CMS-5529); Final Rule; Received 3/19/21
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Final Rule, Received 3/24/21
COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414); Interim Final Rule; 3/29/21
REPORTS
HHS Office of Inspector General (OIG)
On April 12, OIG released a report entitled Blue Cross Blue Shield of South Carolina Overstated Its Supplemental Executive Retirement Plan III Medicare Allowable Segment Pension Assets as of January 1, 2017. The report found that Blue Cross Blue Shield (BCBS) of South Carolina did not correctly update its Supplemental Executive Retirement Plan III (SERP III) Medicare Allowable segment pension assets from January 1, 2015, to January 1, 2017, in accordance with Federal requirements, and overstated its assets by $4,948. OIG recommended that BCBS South Carolina decrease its SERP III Medicare Allowable segment pension assets and improve policies and procedures to ensure that going forward, it calculates Medicare Allowable segment pension assets in accordance with Federal requirements. A summary of the report is available here.
On April 13, OIG released a report entitled Georgia Generally Ensured That Nursing Facilities Reported Allegations of Potential Abuse or Neglect of Medicaid Beneficiaries and Prioritized Allegations Timely. The report found that Georgia generally ensured that nursing facilities reported potential abuse or neglect of Medicaid beneficiaries transferred from nursing facilities to hospital emergency departments. Georgia generally complied with Federal and State requirements for assigning a priority level, investigating, and recording allegations of potential abuse or neglect. OIG recommended that the Georgia Department of Community Health remind nursing facilities of Federal and State requirements for reporting incidents of potential abuse or neglect, strengthen its procedures for monitoring nursing facilities and follow up with those that may not be following required policies and procedures, ensure that it documents actions it takes when nursing facilities fail to report incidents and fail to report incidents on time, and ensure that it assigns a priority level to all incidents or complaints by the mandatory deadline. Georgia concurred with our recommendations and described actions that it has taken to address them. A summary of the report is available here.
On April 15, OIG Leadership released a message on the COVID-19 Vaccination Program and Provider Compliance. The message reminds vaccine providers and the public that the COVID-19 vaccine is being provided by the Federal Government and must be administered at no cost to recipients. Providers participating in the CDC's COVID-19 Vaccination Program are obligated to comply with the terms of that program.
Government Accountability Office (GAO)
On April 13, GAO released a report entitled Graduate Medical Education: Programs and Residents Increased during Transition to Single Accreditor; Distribution Largely Unchanged. The report found that the number of graduate medical education (GME) programs for physicians and the number of residents in those programs increased during the transition to a single accreditor for GME programs. Between 2014-2015 and 2019-2020 the number of GME programs increased by 14%, from 10,608 to 12,117. Overall, the number of residents training in GME programs increased by 13%. The composition of GME programs and residents, and the geographic distribution of programs and residents did not change between 2014-2015 and 2019-2020. A summary of the report is available here.
On April 14, GAO released a report entitled COVID-19: Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation. The report found that federal government has taken several actions to increase the availability of COVID-19 vaccine doses and indicated it expects to have enough doses available for all adults in the United States by the end of May. Manufacturing and distribution must increase significantly to make enough doses available for all adults. GAO identified that state and local health officials face challenges navigating COVID-19 vaccinations, such as not knowing how many doses they would get or when. A summary of the report is available here.
On April 14, GAO released a report entitled Global Health Security: U.S. Agency for International Development (USAID) and CDC Funding, Activities, and Assessments of Countries' Capacities to Address Infectious Disease Threats before COVID-19 Onset. The report found that USAID and CDC had obligated more than $1.2 billion and disbursed about $1 billion for global health security activities. GAO found that USAID and CDC supported activities to help build countries' capacities in technical areas related to addressing infectious disease threats. A summary of the report is available here.
HEARINGS
House
None of note
Senate
HELP Committee
Protecting U.S. Biomedical Research: Efforts to Prevent Undue Foreign Influence
April 22, 10:00AM
Witnesses include: Michael Lauer, MD, Deputy Director for Extramural Research, NIH; Lisa Aguirre, Acting Director, Office of National Security, HHS; Gary Cantrell, Deputy Inspector General for Investigations, HHS OIG; Candice Wright, Acting Director, Science, Technology Assessment, and Analytics; GAO.
OTHER HEALTH POLICY NEWS
On April 9, former Oregon Gov. John Kitzhaber (D) wrote a blog post on how to achieve universal health coverage, suggesting the Administration use state 1115 and 1332 waivers.
On April 12, Covered California announced it will keep the state’s COVID-19 Special Enrollment Period open for the rest of the year to let residents take advantage of cost savings offered in the American Rescue Plan.
On April 13, the Kaiser Family Foundation released a report entitled Data Note: 2021 Medical Loss Ratio Rebates. Insurers estimated they will be issuing a total of about $2.1 billion across all markets, the second-largest amount since rebates were first issued in 2012 under the Affordable Care Act (ACA). Insurers in the individual market estimate they will issue $1.5 billion in rebates, small group market insurers will issue $308 million in rebates, and large group market insurers will issue $310 million in rebates. The 2020 rebates are roughly $400 million lower than last year’s record high of $2.5 billion, but more than 50% higher than the amount in 2019.
On April 13, PhRMA launched an ad campaign focused on pharmaceutical companies' role in developing COVID-19 treatments and vaccines and proposing drug pricing reforms that are smaller than the drug pricing proposals being considered by Democrat lawmakers.
On April 12, the U.S. claimed as part of Sanford Health Plan v. United States and Community Health Choice v. United Statesthat health insurers that increased premiums to make up for losses they incurred when the federal government stopped reimbursing them for lowering out of pocket costs are not entitled to unpaid cost-sharing reductions
On April 13, Oklahoma House passed House Bill 1019 to cap 30-day supplies of insulin at $30 and sent the bill to Governor Kevin Stitt (R).
On April 13, the U.S. Court of Appeals for the 5th Circuit upheld a decision by the Federal Trade Commission claiming that a 2010 pay-to-delay deal between Endo International and Impax Laboratories violated anti-competitive laws.
On April 16, CMS revoked Texas’s 10-year waiver for state’s Medicaid program due to the waiver being granted without the required public comment period during the final days of the Trump Administration.