Lewis-Burke Health Highlights
A Weekly Dose of Federal Highlights Impacting Academic Medicine and Health Professions 

September 24, 2021

Table of Contents

Washington Continues Debate on Biden Priorities 

House Energy and Commerce Committee Holds Hearing on the Impact of COVID-19 on Children 

House Veterans’ Affairs Committee Holds Hearing on Veteran Suicide Prevention  

CMS Updates Enrollment Rules for Marketplace

Senate Finance Committee Requests Stakeholder Input on Access to Mental Health  

Supreme Court Schedules Oral Arguments for Mississippi Abortion Case; House Passes the Women's Health Protection Act 

FDA Authorizes Pfizer Booster Shot for High-Risk Populations; CDC Panel Issues Different Recommendations  

Non-NIH Grants

Washington Continues Debate on Biden Priorities 
Members of the House of Representatives and the Senate continued work on the $3.5 trillion budget reconciliation bill.  Committees in the House marked up their sections of the bill and Speaker Pelosi (D-CA) and Senate Majority Leader Chuck Schumer (D-NY) agreed this week to a “framework” for those committee bills to be combined into one package by the House Budget Committee before heading to the House floor for a vote.  It is currently anticipated that the House and Senate will take up this package later in the fall.  

Congress must also reach an agreement to fund the government and raise the debt limit to allow the government to borrow funds and finance its operations.  On Monday, the Senate will consider a bill to continue government funding at fiscal year (FY) 2022 levels through December 3.  The bill, which has already been passed by the House, would also lift the current debt limit to December 2022 and provide aid to parts of the country affected by disasters.  Government funding expires on September 30, and the Treasury Department has indicated that measures to borrow additional money will likely end in October.   

The Speaker also reached an agreement between members of her party to take up the Senate-passed bipartisan infrastructure package by September 27.  That bill totals $1.1 trillion, with approximately $550 billion in new spending for items such as transportation and utility projects, expanding broadband access, and pollution clean-up.  Passage of the bill is also urgent given that programs authorized under the current surface transportation law expire on September 30.  


House Energy and Commerce Committee Holds Hearing on the Impact of COVID-19 on Children 
The House Committee on Energy and Commerce (E&C) Subcommittee on Oversight and Investigations held a hearing titled “Putting Kids First, Addressing COVID-19’s Impact on Children.”  Subcommittee Chairwoman Diana DeGette (D-CO) noted that many experts argue that students have the best outcomes while in classrooms, but only if steps are taken to make schools a safe place for students, teachers, and faculty.  Chairwoman DeGette highlighted that nearly 500 children have died due to COVID-19 in the United States, and another 5,000 children continue to suffer from a rare but serious inflammatory condition.  Chairwoman DeGette stated that the Committee is anxiously waiting for the Food and Drug Administration (FDA) to authorize a safe and effective COVID-19 vaccine for children under 12, expressing optimism over Pfizer’s trial results for five to 11 year old children released earlier this week.  Subcommittee Ranking Member Morgan Griffith (R-VA) noted that COVID-19 cases in children have increased, currently making up nearly 28 percent of reported COVID-19 cases.  Ranking Member Griffith highlighted the need to look at the impacts of COVID-19 on children holistically, taking into account children’s elevated levels of anxiety, obesity, and eating disorders, as well as the lag in educational and social development resulting from the pandemic and school closures.  

Witnesses at the hearing included Dr. Lee Savio Beers, President of the American Academy of Pediatrics (AAP); Dr. Margaret G. Rush, President of Monroe Carell Jr. Children’s Hospital at Vanderbilt; Dr. Arthur Evans, Jr., CEO of the American Psychological Association (APA); Kelly Danielpour, founder of VaxTeen; and Dr. Tracy Beth Hoeg, an epidemiologist and public health expert.  The witnesses offered conflicting perspectives on whether masking children in schools prevents the transmission of COVID-19.  Dr. Hoeg stated that experts do not have solid data showing that masking children in schools has had any impact on preventing the spread of the disease.  Dr. Beers countered that the AAP has reviewed hundreds of studies to develop its interim guidance, which includes masking for children in schools, and found that the science is robust.  Dr. Beers stated that she and the AAP are observing that schools who have implemented strong mitigation policies have lower rates of COVID-19 than schools who have not implemented universal masking.  Representative Kim Schrier (D-WA) raised whether the “test to stay” model would be an effective strategy to keep children in school.  The “test to stay” model is a new policy being implemented in some Los Angeles schools in which if one person tests positive, the whole classroom can be tested daily while continuing to follow other mitigation measures instead of quarantining the whole class at home for two weeks.  Dr. Beers and Dr. Hoeg both support the model and that it can be an effective strategy for keeping children in school.  Dr. Evans called on lawmakers and others to avoid promoting the false choice between protecting children’s education and mental health.  Dr. Evans highlighted that policymakers should be doing everything possible to reopen schools safely, as well as providing virtual options if they become necessary.  

The topic of COVID-19 in children also remains a priority at the National Institutes of Health (NIH).  At its fall advisory council meeting, leadership from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) focused on progress made through the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) Return to School Diagnostic Testing Approaches program.  Through July 2021, the program has funded around $56 million in awards across 16 sites focused on strategies for school-based testing, combining tests with other proven safety measures to reduce the spread of COVID-19.  From the studies conducted thus far, NICHD has found that testing in schools is feasible and can be implemented with strong community and school support as well as continual engagement and outreach to families and communities.  
 

House Veterans’ Affairs Committee Holds Hearing on Veteran Suicide Prevention
The House Committee on Veterans’ Affairs held a hearing titled “Veteran Suicide Prevention: Innovative Research and Expanded Public Health Efforts.”  The hearing included two panels of witnesses which were made up of public health researchers and members of veteran advocacy organizations.  Both Committee Chairman Mark Takano (D-CA) and Ranking Member Mike Bost (R-IL) were encouraged by the release of a Department of Veterans Affairs (VA) report that showed a 7.2 percent decrease in veteran suicide in 2019, the most recent year available.  While the progress is a good sign, the Committee and witnesses agreed that more needs to be done, especially considering the mental and behavioral health challenges associated with COVID-19, and the recent with withdrawal from Afghanistan.  Ranking Member Bost added that according to the VA, compared to the same time period in 2020 from August to September, the Veterans Crisis Line experienced a 6 percent increase in calls, a 32 percent increase in chats, and a 71 percent increase in texts, which appear to be a direct result of the withdrawal from Afghanistan.   

Chairman Takano also stated that more needs to be done to address the mental and behavioral health challenges that veterans face and argued the importance of using a holistic model for suicide prevention.  Chairman Takano noted that his staff is working on a legislative package of mental health and suicide prevention bills that will include provisions to improve how VA trains community mental health service providers, increase the number of peer specialists in VA medical centers, expand the VA’s Lethal Means Safety Training, add more resources to the Veterans’ Crisis Line, and increase the number of veteran centers across the country to ensure that suicide prevention outreach and care is able to reach traditionally underserved veteran communities.  

CMS Updates Enrollment Rules for Marketplace
Last week, the Centers for Medicare and Medicaid Services (CMS) issued a final rule providing consumers until January 15, 2022 to enroll in health insurance coverage for the benefit year.  States with their own exchange have the flexibility of setting their own enrollment deadline, but must do so on or after December 15.  

The final rule from CMS also provides for a monthly special enrollment period for individuals with a projected household income of 150 percent of the poverty line, as they would qualify for zero or very low out-of-pocket coverage, and would not have to purchase coverage with their own funds prior to receiving the advanced premium tax credit.  
  

Senate Finance Committee Requests Stakeholder Input on Access to Mental Health
The Senate Finance Committee released a request for information from stakeholders seeking evidence-based policy proposals to address barriers to accessing mental healthcare.  According to a statement released by Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID), their goal is to ultimately “develop a bipartisan legislative package before the end of the year addressing many of the behavioral health care challenges currently faced by millions of Americans.”  Key areas of focus for the Committee are:  

• Strengthening the workforce;  
• Integration and coordination of care;  
• Ensuring physical and mental health parity;  
• Telehealth; and  
• Access to behavioral healthcare for children and young people.  

Responses are due to the Committee by November 1st. 


Supreme Court Schedules Oral Arguments for Mississippi Abortion Case; House Passes the Women's Health Protection Act
The Supreme Court scheduled oral arguments for the Mississippi case of Dobbs v. Jackson Women’s Health Organization for December 1.  The case is a challenge to a state law that bans abortion after 15 weeks, and is the first case to be heard by the Supreme Court of a state ban on pre-viability since the landmark Roe v. Wade decision, which held that the Constitution protects a woman’s right to an abortion prior to the viability of the fetus.  The case was appealed from the 5th Circuit Court of Appeals which held the law violated the standard set in Roe.  

The court’s decision to hear the case comes weeks after the Governor of Texas signed into law a prohibition on abortions in the state after 6 weeks.  The Court temporarily declined to hear a case challenging the constitutionality of the law.  In response to the Texas law, Secretary of Health and Human Services Xavier Becerra announced that the Department would seek to protect women in Texas through administrative action.  The Department will build on the approximately $19 million recently provided to Title X providers, by having the Office for Population Affairs (OPA) award additional funding to Every Body Texas, a Title X grantee.  The Secretary also announced that the Office for Civil Rights (OCR) will enforce the Church amendments (42 U.S.C. 300a-7) to protect individuals from employment discrimination because they performed or assisted with a lawful abortion, or from employment discrimination because they refused to perform or assist in an abortion because of their religious beliefs. 

The House of Representatives passed the Women’s Health Protection Act on Friday.  The bill establishes a federal right for health care providers to provide an abortion, and for patients to receive abortion care, free from state restrictions.  The bill would also allow health care providers to provide abortion services without medically unnecessary restrictions that single out these services when compared to other medical procedures with similar risk. 


FDA Authorizes Pfizer Booster Shot for High-Risk Populations; CDC Panel Issues Different Recommendations 
On September 22, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer’s COVID-19 booster shot for individuals 65 years and older and other high-risk populations, including healthcare workers.  The CDC Advisory Committee on Immunization Practices (ACIP) also voted this week on boosters for various populations.  While ACIP voted for authorizing boosters for individuals over 65 years old, the panel voted against boosters for individuals in “high-risk” jobs.  CDC Director Rochelle Walensky overruled the panel’s recommendation earlier today and instead announced her support for booster shots for those also working in high-risk environments.  The Biden Administration announced its plan to expand booster shots this week for individuals over age 65 and at high risk, following the recommendations made by the CDC and FDA, including full coverage of shots by the Centers for Medicare and Medicaid Services (CMS).  CMS Administrator Chiquita Brooks-LaSure said that “CMS will pay Medicare vaccine providers who administer approved COVID-19 boosters, enabling people to access these vaccines at no cost.”  

 

Non-NIH Grants OPPORTUNITY NUMBER OPPORTUNITY TITLE AGENCY NAME CLOSE DATE         NAP-AX-18-003 Leading Edge Acceleration Projects (LEAP) in Health Information Technology Office of the National Coordinator 9/30/2021 HRSA-22-006 Service Area Competition Health Resources and Services Administration 10/4/2021 RFA-FD-21-001 Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Food and Drug Administration 10/5/2021 HRSA-22-106 Service Area Competition-Additional Areas: Colebrook, NH and San Juan, PR Health Resources and Services Administration 10/25/2021 PA-16-422 Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB)(R18) Agency for Health Care Research and Quality 10/30/2021 PA-16-423 Large Research Projects for Combating  Antibiotic-Resistant Bacteria (CARB) (R01) Agency for Health Care Research and Quality 10/30/2021 PA-16-453 AHRQ Conference Grant Programs (R13) Agency for Health Care Research and Quality 11/1/2021 HRSA-22-007 Service Area Competition Health Resources and Services Administration 11/1/2021 RFA-CK-22-003 Emerging Infections Sentinel Networks (EISN) Research Centers for Disease Control and Prevention - ERA 11/1/2021 CDC-RFA-CE22-2202 E-Learning Collaborative for Sexual Violence and Intimate Partner Violence Prevention Centers for Disease Control - NCIPC 11/17/2021 PA-20-074 Disseminating and Implementing Patient-Centered Outcomes Research (PCOR) Evidence into Practice through Interoperable Clinical Decision Support Agency for Health Care Research and Quality 1/25/2022 PAR-20-083 Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional Food and Drug Administration 4/4/2022 PAR-20-105 Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Food and Drug Administration 4/6/2022 PA-18-794 AHRQ Small Research Grant Program (R03) Agency for Health Care Research and Quality 7/6/2022 PA-18-795 AHRQ Health Services Research Projects (R01) Agency for Health Care Research and Quality 7/6/2022 PA-17-232 AHRQ Mentored Clinical Scientist Research Career Development Award (K08) Agency for Health Care Research and Quality 7/12/2022 PA-17-481 Agency for Healthcare Research and Quality (AHRQ)-sponsored National Research Service Award (NRSA)Individual  Postdoctoral Fellowship (F32) Agency for Health Care Research and Quality 8/8/2022 PA-20-028 Medication Safety:  Advancing the Development of Improvement Strategies and Tools (R18) Agency for Health Care Research and Quality 9/25/2022 PA-18-793 AHRQ Health Services Research Demonstration and Dissemination Grants (R18) Agency for Health Care Research and Quality 9/29/2022 PAR-19-306 FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Food and Drug Administration 10/11/2022 PA-20-067 AHRQ Mentored Research Scientist  Career Development Award (K01) Agency for Health Care Research and Quality 11/13/2022 PA-20-068 Improving Quality of Care and Patient Outcomes During Care Transitions (R01) Agency for Health Care Research and Quality 12/6/2022 PA-21-266 Patient Safety Learning Laboratories: Advancing Patient Safety through Design, Systems Engineering, and Health Services Research (R18 Clinical Trial Optional) Agency for Health Care Research and Quality 1/26/2023 PA-18-765 AHRQ Health Services Research Dissertation Program (R36) Agency for Health Care Research and Quality 5/1/2023 PAR-21-178 Drug Development Tools Research Grants (U01) Clinical Trial Optional Food and Drug Administration 5/3/2023 PA-21-202 AHRQ/PCORI Learning Health System Small Grant Pilot Program Agency for Health Care Research and Quality 6/19/2023 PAR-18-604 Vet-LIRN Network Capacity-Building Projects Food and Drug Administration 9/2/2023 PAR-18-799 K01 Mentored Research Scientist Development Award Centers for Disease Control and Prevention - ERA 11/17/2023 PAR-18-798 NIOSH Exploratory/Developmental Grant Program (R21) Centers for Disease Control and Prevention - ERA 11/17/2023 PAR-18-797 NIOSH Small Research Grant Program Centers for Disease Control and Prevention - ERA 11/17/2023 PAR-18-812 Occupational Safety and Health Research (R01) Centers for Disease Control and Prevention - ERA 11/17/2023 PAR-21-179 Minor Use Minor Species Development of Drugs (R01) Food and Drug Administration 2/3/2024 PA-21-267 Making Health Care Safer in Ambulatory Care Settings and Long-term Care Facilities (R18) Agency for Health Care Research and Quality 5/26/2024 PA-21-164 Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional) Agency for Health Care Research and Quality 7/17/2024 PA-21-264 Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18) Agency for Health Care Research and Quality 5/26/2025 PA-21-265 Large Research Projects for Prevention of Healthcare-Associated Infections (R01) Agency for Health Care Research and Quality 5/26/2025 RFA-FD-22-001 Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required Food and Drug Administration