HEALTH HIGHLIGHTS

June 24, 2022 | Lewis-Burke Associates LLC

IN THIS ISSUE:

• Washington Prognosis: Supreme Court Strikes Down Roe v Wade; House Passes Mental Health and ARPA-H Authorization Legislation
• House Appropriations Subcommittee Approves Health Spending Bill  
• Congress Passes Landmark Gun Violence Prevention Legislation 
• House Passes Bipartisan Mental Health Legislation 

NON-NIH GRANTS
 

Washington Prognosis: Supreme Court Strikes Down Roe v Wade; House Passes Mental Health and ARPA-H Authorization Legislation

The Supreme Court of the United States issued an opinion in the Dobbs, State Health Office of the Mississippi Department of Health et al, v. Jackson Women’s Health Organization et al. case, holding in a six to three vote that the Constitution does not confer a right to abortion, overruling the cases of Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey that conferred and affirmed abortion as a constitutional right.  The immediate effect of the decision is to uphold the Mississippi law at the center of the case which bans abortion after the 15th week of pregnancy.  However, 13 states currently have laws that will trigger an abortion ban if Roe v. Wade is overturned.  Additional states are likely to impose further restrictions on abortion access.  

In Congress, the House of Representatives passed a mental health package and legislation providing authorizing language for the Advanced Research Projects Agency for Health (ARPA-H).  While ARPA-H was established in the fiscal year (FY) 2022 appropriations process, this bill adds further direction on the agency structure and program directions.  Additionally, the House and Senate passed landmark gun violence prevention legislation, sending the final bill to President Biden’s desk for signature. 
 

House Appropriations Subcommittee Approves Health Spending Bill  

The House Labor, Health and Human Services, Education, and Related Agencies (L-HHS-ED) Appropriations Subcommittee, responsible for allocating funding for agencies across the Department of Health and Human Services (HHS), released and approved its draft fiscal year (FY) 2023 appropriations bill.  Additional information on programmatic level funding is expected to be released prior to the full Appropriations Committee mark-up on June 30.  In the bill, HHS would receive a total of $124.2 billion, a $15.6 million increase over the FY 2022 enacted level and $298 million below the President’s budget request for FY 2023.  Of that amount: 

• The Health Resources and Services Administration (HRSA) would receive $9.6 billion, an increase of $683 million over the FY 2022 enacted level.  This would include a $132 million increase to behavioral health workforce programs, a $44 million increase to nursing workforce development programs, and $25 million for provider resilience programs.  
• The Substance Abuse and Mental Health Services Administration (SAMHSA) would receive $9.2 billion, an increase of $2.6 billion above FY 2022 levels.  This would include major increases to the Mental Health Block Grant and Substance Use Prevention and Treatment Block Grant to states, the Project AWARE program for youth mental health, and the Primary and Behavioral Health Care Integration program.  
• The Centers for Disease Control and Prevention (CDC) would receive $10.5 billion, a 2 billion increase over FY 2022 levels but $231 million below the President’s budget request.  Approximately $880 million of this increase would be put towards various public health infrastructure, surveillance, workforce, and preparedness programs.  The bill would also provide funding increases for gun violence prevention research, the Racial and Ethnic Approaches to Community Health (REACH) program, social determinants of health programs, and climate change programs. 
• The Agency for Healthcare Research and Quality (AHRQ) would receive $385 million, a $35 million increase above the FY 2022 enacted level. 
• The Biomedical Advanced Research and Development Authority (BARDA) would receive $845 million, an increase of $100 million over the FY 2022 enacted level. 
• The Food and Drug Administration (FDA), funded through the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill which was approved by the full House Appropriations Committee this week, would receive $3.6 billion, an increase of $341.6 million over FY 2022 levels.  
• The National Institutes of Health (NIH) would receive $47.5 billion, an increase of $2.5 billion above the FY 2022 enacted level. 
  • The bill would provide $2.75 billion for the newly established Advanced Research Projects Agency for Health (ARPA-H), a $1.75 billion increase over the FY 2022 level.  This funding would be available through the end of FY 2025 and is not included in the total amount that would be provided for NIH. 
  • The draft bill would retain the investigator salary cap at Executive Level II and includes legislative language prohibiting the Administration or HHS from making any changes to facilities and administrative (F&A) cost policies. 

Lewis-Burke will continue to monitor and report out agency funding information as the House and Senate make progress on their respective appropriations bills.  
 

Congress Passes Landmark Gun Violence Prevention Legislation 

The House and Senate passed a bipartisan gun violence prevention bill by a vote of 234-193 and 65-33 respectively, a major step in finalizing Congress’s first piece of legislation on the topic in decades.  The package contains provisions aimed at closing various firearm purchasing loopholes, funding for expansion of mental health services, and school safety support.  Specifically, the bill would: 

• Provide $120 million for the Substance Abuse and Mental Health Services Administration (SAMHSA) Mental Health Awareness Training program and $240 million for the Project AWARE program, with funding available through fiscal year (FY) 2025; 
• Provide $60 million, available through FY 2025, for the Health Resources and Services Administration (HRSA) Primary Care Training and Enhancement programs focused on pediatric care and vulnerable populations, and $80 million for HRSA Pediatric Mental Health Care Access projects; 
• Provide $500 million each, available through FY 2026, for the Department of Education (ED) School Based Mental Health Services Grants and Mental Health Services Professional Demonstration Grants programs; 
• Expand the Medicaid Certified Community Behavioral Health Clinic demonstration program to all states; 
• Direct the Centers for Medicare and Medicaid Services (CMS) to issue additional guidance on school-based mental health programs, telemental health services for children, and other topics; 
• Provide $750 million in funding to states for creation and administration of “red flag” laws and crisis intervention programs;  
• Close the “boyfriend loophole” allowing unmarried individuals convicted of domestic violence to purchase firearms; 
• Establish federal penalties for straw purchasing and trafficking of firearms; 
• Provide $250 million, available through FY 2026, for community violence intervention and prevention initiatives at the Department of Justice (DOJ) Office of Justice Programs;  
• Provide $100 million through FY 2026 to the DOJ Community Oriented Policing Services (COPS) Office; and 
• Delay implementation of the anti-kickback statute safe harbor protection for prescription drug rebates rule by one year, to provide cost savings used to offset the spending in the bill. 

Now that the bill has passed the House and Senate, it will be sent to President Biden for his signature.  
 

House Passes Bipartisan Mental Health Legislation 

On June 23, the House of Representatives passed H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act, by a vote of 402-20.  Introduced by House Energy and Commerce Committee Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA), the bill would authorize new and existing programs within the Department of Health and Human Services (HHS) that strengthen the overall behavioral healthcare workforce and that directly address mental health and substance use disorder treatment and recovery.  The bill would also provide funding to states to partner with community programs, primary care providers, or health centers to provide evidence-based, integrated behavioral health services.  More information about the bill can be found here. 

The bill would create a Behavioral Health Crisis Coordinating Office, which would coordinate efforts regarding behavioral health crisis care across agencies within HHS, including the Substance Abuse and Mental Health Administration (SAMHSA), Health Resources and Services Administration (HRSA), the Centers for Medicare and Medicaid Services (CMS), and external stakeholders.  The bill also seeks to establish a Mental Health Crisis Response Partnership Pilot program, which directs the Secretary of HHS to award competitive grants to states, localities, territories, and tribes to establish or enhance mobile crisis response teams that divert the response for mental health and substance use crises away from law enforcement.  Other reauthorized programs include the Minority Fellowship Program at $25 million for fiscal year (FY) 2023 through FY 2027; mental and behavioral health training grants, which fund the Behavioral Health Workforce and Education Training (BHWET) Program, through FY 2027; and mental and behavioral health training demonstration grants administered by HRSA at $31.7 million through FY 2027.  

Additionally, the legislation would strengthen parity for mental health and substance use services by requiring self-funded and non-governmental health plans to comply with parity requirements and by funding state implementation efforts.  The legislation would also extend Medicaid and the Children’s Health Insurance Program (CHIP) coverage for health screenings of juvenile inmates and includes a provision requiring the HHS Secretary to issue guidance to states on how to expand pediatric behavioral health services for children covered by Medicaid and CHIP.  The bill calls for research on the effects of smartphone and social media use on adolescents and would also direct the National Institute of Health (NIH) to conduct and support research concerning the health and developmental effects of media on infants, children, and adolescents, which may include the positive and negative effects of exposure to and use of media, including social media, websites, mobile devices, computers, video games, among others. 

While the legislation passed the House with broad bipartisan support, it is unclear whether the legislation will pass the Senate.  Currently, the Senate Health, Education, Labor and Pensions (HELP) Committee and the Senate Finance Committee are drafting and releasing their own mental health reauthorization packages.  It is likely that both the Senate HELP and Finance committees will release their own legislation before producing a final package in the fall or winter.  Mental health and substance use disorder research, treatment, and care continue to be a priority for both Congress and the Biden Administration.   

NON-NIH GRANTS Opportunities are sorted with those posted most recently at the top of the table. OPPORTUNITY NUMBER OPPORTUNITY TITLE AGENCY NAME CLOSE DATE HRSA-23-020 Service Area Competition Health Resources and Services Administration 8/15/2022 NAP-AX-22-001 Leading Edge Acceleration Projects (LEAP) in Health Information Technology Office of the National Coordinator 9/30/2027 HRSA-23-072 Strengthen the Evidence for Maternal and Child Health Programs Health Resources and Services Administration 9/8/2022 HRSA-22-160 Leveraging Health Service Equity Approaches for Sustainable HIV Epidemic Control Health Resources and Services Administration 8/5/2022 HRSA-22-167 Rural Emergency Hospital Technical Assistance Center Health Resources and Services Administration 7/27/2022 RFA-FD-22-027 Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Prescribing of Benzodiazepines Food and Drug Administration 8/3/2022 RFA-FD-22-028 Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Obstetrics Pain Food and Drug Administration 8/3/2022 CMS-1W1-22-001 Minority Research Grant Program (MRGP) Centers for Medicare & Medicaid Services 7/28/2022 CDC-RFA-PS22-2210 Mass Mailing of HIV Self-Tests to Persons Disproportionately Affected by HIV in the U.S. Centers for Disease Control - NCHHSTP 7/11/2022 CDC-RFA-PS23-2302 Accelerating the Prevention and Control of HIV, Viral Hepatitis, STDs, and TB in the U.S. Affiliated Pacific Islands Centers for Disease Control - NCHHSTP 7/31/2022 HRSA-22-166 Rural Northern Border Region Healthcare Support Program Health Resources and Services Administration 7/1/2022 HRSA-23-019 Service Area Competition Health Resources and Services Administration 7/18/2022 CDC-RFA-DD23-2301 Enhancing Public Health Surveillance of Autism Spectrum Disorder through the Autism and Developmental Disabilities Monitoring (ADDM) Network Centers for Disease Control - NCBDDD 9/9/2022 HRSA-23-018 Service Area Competition Health Resources and Services Administration 7/5/2022 HRSA-22-163 Rural Behavioral Health Workforce Centers - Northern Border Region Health Resources and Services Administration 7/13/2022 PA-22-168 AHRQ Administrative Supplements for Grants in Health Services Research Agency for Health Care Research and Quality 4/11/2027 RFA-FD-22-020 OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Optional Food and Drug Administration 6/30/2022 PAR-22-108 Innovative ways to provide education on antimicrobial stewardship practices in animals. Food and Drug Administration 6/30/2022 PAR-22-063 CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) Clinical Trials Food and Drug Administration 2/10/2024 PA-22-049 AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Research Scientist Career Development Award (K01) Agency for Health Care Research and Quality 3/12/2025 PA-22-051 AHRQ Mentored Career Enhancement Awards for Established Investigators in Patient-Centered Outcome Research (K18) Agency for Health Care Research and Quality 7/12/2025 PA-22-050 AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Clinical Scientist Career Development Award (K08) Agency for Health Care Research and Quality 3/12/2025 RFA-OH-22-001 NIOSH Education and Research Centers Centers for Disease Control and Prevention - ERA 2/24/2025 RFA-OH-22-003 Occupational Safety and Health Training Project Grants Centers for Disease Control and Prevention - ERA 10/24/2025 PA-22-047 Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01) Agency for Health Care Research and Quality 10/30/2026 PA-22-048 Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R18) Agency for Health Care Research and Quality 10/30/2026 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-21-265 Large Research Projects for Prevention of Healthcare-Associated Infections (R01) Agency for Health Care Research and Quality 5/26/2025 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-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-21-202 AHRQ/PCORI Learning Health System Small Grant Pilot Program Agency for Health Care Research and Quality 6/19/2023 PAR-21-179 Minor Use Minor Species Development of Drugs (R01) Food and Drug Administration 2/2/2024 PAR-21-178 Drug Development Tools Research Grants (U01) Clinical Trial Optional Food and Drug Administration 5/3/2023 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 2/13/2024 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-20-068 Improving Quality of Care and Patient Outcomes During Care Transitions (R01) Agency for Health Care Research and Quality 12/6/2022 PA-20-067 AHRQ Mentored Research Scientist Career Development Award (K01) Agency for Health Care Research and Quality 11/13/2022 PA-20-028 Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18) Agency for Health Care Research and Quality 9/25/2022 PAR-19-306 FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Food and Drug Administration 10/11/2022 PAR-18-812 Occupational Safety and Health Research (R01) 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-18-799 K01 Mentored Research Scientist Development Award 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 PA-18-795 AHRQ Health Services Research Projects (R01) Agency for Health Care Research and Quality 7/6/2022 PA-18-793 AHRQ Health Services Research Demonstration and Dissemination Grants (R18) Agency for Health Care Research and Quality 9/29/2022 PA-18-794 AHRQ Small Research Grant Program (R03) Agency for Health Care Research and Quality 7/6/2022 PA-18-765 AHRQ Health Services Research Dissertation Program (R36) Agency for Health Care Research and Quality 5/1/2023 PAR-18-604 Vet-LIRN Network Capacity-Building Projects Food and Drug Administration 9/2/2023 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-17-232 AHRQ Mentored Clinical Scientist Research Career Development Award (K08) Agency for Health Care Research and Quality 7/12/2022 PA-16-453 AHRQ Conference Grant Programs (R13) Agency for Health Care Research and Quality 11/2/2022