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

April 16, 2021

Table of Contents

Non-NIH Grants

House Labor-HHS-ED Appropriations Subcommittee Holds Hearing on FY 2022 HHS Budget Request
The House Labor, Health and Human Services, and Education (Labor-HHS-ED) Appropriations Subcommittee held a hearing on the fiscal year (FY) 2022 budget request for the Department of Health and Human Services (HHS).  Secretary of HHS Xavier Becerra was the sole witness.  Chairwoman Rosa DeLauro (D-CT) commended the President’s FY 2022 budget request for the Department but emphasized the need to do more to improve failures in the nation’s public health infrastructure.  She also highlighted the importance of addressing maternal and infant mortality, mental health, and supports for women in the workforce.  Ranking Member Tom Cole (R-OK) stated that the budget request needs to spend more on defense priorities and less on domestic programs, however agreed with the approach to increase investments in public health and biomedical research.  He noted the critical role of the National Institutes of Health (NIH) throughout the pandemic, but expressed disappointment with no mention of the Biomedical Advanced Research and Development Authority (BARDA) in the budget request.

Some Members on the Subcommittee also touched on the Biden Administration’s proposal to invest $6.5 billion to create a new office known as the Advanced Research Projects Agency – Health (ARPA-H) within NIH.  According to the President’s initial FY 2022 budget request, ARPA-H’s mission would be to “drive transformational innovation in health research and speed application and implementation of health breakthroughs” with an initial focus on cancer, diabetes, and Alzheimer’s Disease.  Chairwoman DeLauro said that it is critical to strike a balance between the new ARPA-H approach and investments already made in basic research and fundamental discovery at NIH.  She also stated that the Subcommittee plans to hold a hearing with NIH after the full budget request is released and will reserve questions about ARPA-H until then.  Additionally, Congressman Andy Harris (R-MD) discussed concerns with the ARPA-H approach and how to avoid duplicating efforts with work already occurring at NIH, particularly at the National Center for Advancing Translational Sciences (NCATS).

Other topics raised at the hearing included how health equity will be prioritized through increased investments in programs that eliminate health disparities across HHS, growing support for addressing social determinants of health, and plans to reverse several policies imposed by the previous administration, such as a ban on fetal tissue research. Secretary Becerra stated that the NIH plans to make an announcement on this policy in the near future.

House Select Subcommittee on the Coronavirus Crisis Holds Hearing on Safely Ending the Pandemic
The House Select Subcommittee on the Coronavirus Crisis held a hearing titled “Reaching the Light at the End of the Tunnel: A Science-Driven Approach to Swiftly and Safely Ending the Pandemic.”  Witnesses included Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH); Dr. David Kessler, Chief Science Officer of the COVID-19 Response in the Department of Health and Human Services (HHS); and Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC).

The hearing focused on the Biden Administration’s progress in vaccine distribution and access nationwide, the importance of adhering to public health measures to slow the spread of the virus, and the spread of COVID-19 variants.  While the Subcommittee praised the pace of vaccinations throughout the country, Dr. Fauci cautioned that cases have begun to stay at a high level for those who have not received a vaccine.  Dr. Walensky’s testimony addressed vaccine safety and the joint recommendation by the CDC and Food and Drug Administration (FDA) to pause the administration of the Johnson & Johnson (J&J) vaccine while the agencies review data and assess the significance around adverse events reported in six people.  Dr. David Kessler also addressed the J&J vaccine pause, stated the supply and administration of vaccines will continue to increase over the next several weeks, and the Biden Administration is planning for potential booster doses of vaccines if they are needed. Other topics included the how the Administration is dealing with COVID-19 spread in migrant facilities and how the vaccine distribution will impact re-opening measures.

CMS Administrator, Deputy HHS Secretary Nominees Testify before Senate Committee
Chiquita Brooks-LaSure, nominee for Centers for Medicare and Medicaid Services (CMS) Administrator, and Andrea Palm, nominee for Deputy Secretary of Health and Human Services, testified before the Senate Finance Committee as part of their confirmation process.  Ms. Brooks-LaSure touted her experience working on the House Ways and Means Committee and the Department of Health and Human Services (HHS) on creation and implementation of universal healthcare coverage in the Patient Protection and Affordable Care Act (ACA).  Ms. Palm spoke on her background as a social worker and her previous role leading the Wisconsin Department of Health Services.  Both Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) questioned Ms. Brooks-LaSure about CMS’s role in issuing 1115 Medicaid demonstration waivers and 1332 state innovation waivers to states under the ACA.  Ms. Brooks-LaSure stated her belief that CMS’s responsibility should be issuing fair and consistent guidance and working closely with states to navigate the process.  Senator Bob Menendez (D-NJ) asked Ms. Brooks-LaSure about her plans to implement increased graduate medical education (GME) slots provided by Congress; Ms. Brooks-LaSure stated that she understood that the congressional intent was for these slots to go towards underserved areas and CMS would be responsive to community comments.  When asked about setting reimbursement rates for telehealth services by Senator Maria Cantwell (D-WA), Ms. Brooks-LaSure stated that ensuring program integrity would be an important component of the decision, potentially referencing arguments that setting reimbursement rates too high could lead to Medicare fraud or delivery of low-quality services. The Senate Finance Committee will next vote to advance the nominations of Ms. Brooks-LaSure and Ms. Palm to the full Senate floor, through the vote has not yet been scheduled.

COVID-19 Health Equity Task Force Holds Second Meeting, Discusses Vaccine Equity
The COVID-19 Health Equity Task Force (HETF), located in the Office of Minority Health (OMH) within the Department of Health and Human Services (HHS), held its second meeting and discussed vaccine equity for different populations throughout the country.  The HETF was established through Executive Order (EO) and is part of the government-wide effort to “identify and eliminate health and social disparities that result in disproportionately higher rates of exposure, illness, hospitalization and death related to COVID-19.”

Dr. Marcella Nunez-Smith, Chair of the COVID-19 HETF gave opening remarks on the importance of recognizing and understanding the structural barriers that exist in underrepresented communities in terms of access to healthcare resources, the rise in anti-Asian xenophobia and Administration efforts to combat racism, and that while vaccine distribution and access is rising nationwide, minorities and underrepresented groups are getting vaccinated at lower rates.  The HETF also heard updates from Dr. Rachel Levine, Assistant Secretary for Health at HHS, and HHS Secretary Xavier Becerra.  Secretary Becerra stressed that during his tenure at HHS, equity will be part of every action taken at the department. 

HETF Subcommittees which include the Communications and Collaboration Subcommittee; the Data, Analytics, and Research Subcommittee; the Healthcare Access and Quality Subcommittee; and the Structural Drivers and Xenophobia Subcommittee each gave presentations and provided interim recommendations to the task force.  Meeting materials and presentations can be found here.  The third HETF meeting is scheduled for April 30.

CMS Issues Proposed Medicare Payment Rules for Inpatient Rehabilitation, Hospice Care, Skilled Nursing Facilities, and Inpatient Psychiatric Facilities for FY 2022
The Centers for Medicare and Medicaid Services (CMS) issued four proposed Medicare payment rules for fiscal year (FY) 2022.  The first involves payment to inpatient rehabilitation facilities (IRF).  Under the proposed rule, CMS is proposing to increase the prospective payment rates, while keeping outlier payments at 3.0 percent of total payments, resulting in a 0.3 percentage point decrease in outlier payments.  Overall, IRF payments for FY 2022 would increase by 1.8 percent, or $160 million, compared to payments in FY 2021.

The second proposed rule involves payments to hospice facilities.  Under the proposed rule, hospice facilities would see a 2.3 percent, or $530 million, increase in their payments for FY 2022.  According to CMS, the proposed 2.3 percent update is based on their estimated 2.5 percent inpatient hospital market basket, reduced by the multifactor productivity adjustment of 0.2 percentage point.  In addition, hospices that fail to meet quality reporting requirements would receive a 2 percent reduction to the annual market basket update for FY 2022.  The Biden Administration made a point to focus on quality reporting in the rule by seeking ways to improve data collection to improve health outcomes and analyze disparities across programs and policies that apply to the Hospice Quality Reporting Program (HQRP).  These improvements are part of CMS’ effort to comply with the President’s Executive Order (EO) 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.

The third proposed rule pertains to Medicare payments to skilled nursing facilities (SNF).  Under the proposed rule, skilled nursing facilities, according to CMS estimates, would receive an increase of $444 million in Medicare Part A payments for FY 2022.  In the proposal, CMS is seeking to close the health equity gap in SNFs through the adoption of “standardized patient assessment data elements” which includes several social determinants of health that were finalized in the FY 2020 SNF Prospective Payment System final rule.  This is also a part of President Biden’s Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.  In addition, the Consolidated Appropriations Act of 2021 (Section 111), included a provision allowing the Secretary of the Department of Health and Human Services (HHS) to expand the SNF Value Based Purchasing program and apply up to ten payment measures beginning in FY 2024, such as measures of functional status, patient safety, care coordination, and patient experience.

The fourth proposed rule involves Medicare payments to Inpatient Psychiatric Facilities (IPF).  In total, CMS is proposing to increase payments to IPF’s by 2.3 percent, or $90 million, in FY 2022 compared to payments in FY 2021.  In addition, as part of President Biden’s Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, CMS is seeking comment on how to breakout into different groups quality measure results by dual eligibility and other social risk factors.  CMS is also seeking input on ways to improve demographic data collection, and the potential creation of a facility equity score to combine results across multiple measures and social risk factors.

HHS Issues Proposed Revisions to the Title X Family Planning Program
The Department of Health and Human Services (HHS) issued a proposed rule to revise the Trump Administration’s rule issued on March 4, 2019, which established standards for compliance by family planning service providers.  Under the 2019 rule, the Trump Administration eliminated Title X’s long-standing requirement that pregnant women be offered nondirective counseling, including information about parenting, adoption and abortion.  The rule also required all pregnant women at Title X sites be referred for prenatal care. 

The Biden Administration’s rule reverses the 2019 rule by returning Title X to its status prior to Trump entering office, and calls for ensuring “equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients.” 
 

Non-NIH Grants OPPORTUNITY NUMBER OPPORTUNITY TITLE AGENCY NAME CLOSE DATE         HHS-2021-ACL-NIDILRR-REGE-0030 Rehabilitation Engineering Research Centers (RERC) Program:  RERC on Blindness and Low Vision Administration for Community Living 4/19/2021 RFA-FD-21-024 Training Alliance to Enhance Produce Safety and FDA Food Safety Modernization Act Compliance (U2F) Clinical Trial Not Allowed Food and Drug Administration 4/19/2021 TI-21-008 Screening, Brief Intervention, and Referral to Treatment Substance Abuse and Mental Health Services Adminis 4/19/2021 HRSA-21-019 Dental Faculty Loan Repayment Program Health Resources and Services Administration 4/19/2021 TI-21-003 Provider’s Clinical Support System - Universities Substance Abuse and Mental Health Services Adminis 4/20/2021 HRSA-21-030 Telehealth Centers of Excellence Health Resources and Services Administration 4/20/2021 MP-CPI-21-006 Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 Office of the Assistant Secretary for Health 4/20/2021 HRSA-21-040 Bridging the Word Gap Research Network (BWG) Health Resources and Services Administration 4/22/2021 RFA-FD-21-019 Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01) Food and Drug Administration 4/22/2021 RFA-FD-21-029 Alliance to Support Integrated Food Safety System (IFSS) Activities (U2F) Clinical Trials Not Allowed Food and Drug Administration 4/23/2021 HHS-2021-ACL-AOA-OMRC-0044 National Ombudsman Resource Center Administration for Community Living 4/26/2021 HHS-2021-ACL-NIDILRR-REGE-0029 Rehabilitation Engineering Research Centers (RERC) Program:  RERC on Wireless Technologies Administration for Community Living 4/26/2021 RFA-FD-21-020 Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required Food and Drug Administration 4/26/2021 HHS-2021-ACL-NIDILRR-RTCP-0028 Rehabilitation Research and Training Center (RRTC) on Interventions to Promote Community Living Among People with Disabilities. Administration for Community Living 4/26/2021 TI-21-006 Medication Assisted Treatment - Prescription Drug and Opioid Addiction Substance Abuse and Mental Health Services Adminis 4/27/2021 HRSA-21-036 Sickle Cell Disease Newborn Screening Follow-up Program Health Resources and Services Administration 4/29/2021 HHS-2021-ACL-AOA-CSSG-0020 ACL National Chronic Disease Self-Management Education Resource Center Administration for Community Living 4/29/2021 HHS-2021-ACL-AOA-FPSG-0019 ACL National Falls Prevention Resource Center Administration for Community Living 4/29/2021 SP-21-001 Strategic Prevention Framework for Prescription Drugs Substance Abuse and Mental Health Services Adminis 4/30/2021 HRSA-21-032 Sickle Cell Disease Treatment Demonstration Program Health Resources and Services Administration 5/3/2021 HRSA-21-079 Long-term Follow-up for Severe Combined Immunodeficiency and Other Newborn Screening Conditions Health Resources and Services Administration 5/3/2021 HRSA-21-086 Behavioral Health Workforce Development Technical Assistance and Evaluation (BHWD TAE) Program Health Resources and Services Administration 5/3/2021 HRSA-21-064 Capacity Building for Sustainable HIV Services Health Resources and Services Administration 5/7/2021 HHS-2021-ACL-NIDILRR-DPCP-0061 Disability and Rehabilitation Research Projects (DRRP) Program: Reducing Social Isolation and Loneliness among People With Disabilities Administration for Community Living 5/7/2021 HRSA-21-096 Quality Improvement Solutions for Sustained Epidemic Control Project (QISSEC) Health Resources and Services Administration 5/7/2021 HHS-2021-ACL-NIDILRR-DPCP-0060 Disability and Rehabilitation Research Projects (DRRP) Program: National Research Center for Parents with Disabilities Administration for Community Living 5/7/2021 HRSA-21-067 Ryan White HIV/AIDS Program Part B States/Territories Supplemental Grant Program Health Resources and Services Administration 5/10/2021 HRSA-21-085 State Newborn Screening Interoperability Implementation Program Health Resources and Services Administration 5/10/2021 HHS-2021-ACL-NIDILRR-SIMS-0049 Spinal Cord Injury Model Systems Administration for Community Living 5/10/2021 HHS-2021-ACL-AOA-ADPI-0083 Alzheimer's Disease Programs Initiative - Grants to States and Communities Administration for Community Living 5/10/2021 HRSA-21-066 Global Reach I Health Resources and Services Administration 5/10/2021 CMS-2G2-21-001 Community Health Access and Rural Transformation (CHART) Centers for Medicare & Medicaid Services 5/11/2021 CMS-2F2-21-001 Emergency Triage, Treat, and Transport (ET3) Model Centers for Medicare & Medicaid Services 5/11/2021 HHS-2021-ACL-NIDILRR-DPHF-0059 Disability and Rehabilitation Research Projects (DRRP) Program: Disability and Pregnancy Administration for Community Living 5/11/2021 HHS-2021-ACL-NIDILRR-DPKT-0062 Disability and Rehabilitation Research Projects (DRRP) Program: Model Systems Knowledge Translation Center (MSKTC) Administration for Community Living 5/11/2021 RFA-FD-21-022 Expanding the opioids system modeling efforts to more comprehensively address fentanyl, stimulants use, polysubstance use and associated outcomes.(U01) Clinical Trials Not Allowed Food and Drug Administration 5/17/2021 HHS-2021-ACL-AOA-PCPN-0039 National Resource Center for Women and Retirement Administration for Community Living 5/17/2021 TI-21-009 First Responders-Comprehensive Addiction and Recovery Act Grants Substance Abuse and Mental Health Services Adminis 5/17/2021 RFA-FD-21-033 Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases (R01) Clinical Trials Not Allowed Food and Drug Administration 5/18/2021 HHS-2021-ACL-NIDILRR-SIMS-0000 Spinal Cord Injury (SCI) Model Systems National Data and Statistical Center Administration for Community Living 5/18/2021 RFA-FD-21-25 SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) Public-Private Partnership (PPP) under PASI (Pediatric Anesthesia Safety Initiative) (U01) Clinical Trials Not Allowed Food and Drug Administration 5/24/2021 RFA-FD-21-026 Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) Clinical Trials Not Allowed Food and Drug Administration 5/24/2021 RFA-FD-21-017 Renewal : UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (U01) Clinical Trials Optional Food and Drug Administration 5/25/2021 RFA-FD-22-002 Data Standards for Tobacco Research and Scientific Review Program (U24) Clinical Trial Not Allowed Food and Drug Administration 6/2/2021 CMS-1W1-21-002 Minority Research Grant Program Centers for Medicare & Medicaid Services 6/11/2021 PA-17-007 Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18) Agency for Health Care Research and Quality 6/15/2021 HRSA-21-050 Maternal, Infant, and Early Childhood Home Visiting Program – Formula Health Resources and Services Administration 6/15/2021 PA-18-794 AHRQ Small Research Grant Program (R03) Agency for Health Care Research and Quality 7/5/2021 PA-18-795 AHRQ Health Services Research Projects (R01) Agency for Health Care Research and Quality 7/5/2021 PA-17-008 Large Research Projects for Prevention of Healthcare-Associated Infections (R01) Agency for Health Care Research and Quality 7/6/2021 PA-17-246 Health Information Technology (IT) to Improve Health Care Quality and Outcomes (R21) Agency for Health Care Research and Quality 7/16/2021 PA-18-750 Making Health care Safer in Ambulatory Care Settings and Long Term Care Facilities (R18) Agency for Health Care Research and Quality 9/7/2021 HHS-2021-ACL-AOA-DASG-0002 Disaster Assistance for State Units on Aging (SUAs) and Tribal Organizations in Major Disasters Declared by the President Administration for Community Living 9/7/2021 NAP-AX-18-003 Leading Edge Acceleration Projects (LEAP) in Health Information Technology Office of the National Coordinator 9/30/2021 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 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 RFA-FD-18-001 Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U18) Food and Drug Administration 12/1/2021 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 PAR-20-124 NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) Clinical Trials Not Allowed Food and Drug Administration 5/2/2022 PA-21-202 AHRQ/PCORI Learning Health System Small Grant Pilot Program Agency for Health Care Research and Quality 6/16/2022 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-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 PAR-18-604 Vet-LIRN Network Capacity-Building Projects Food and Drug Administration 9/2/2023 PAR-21-179 Minor Use Minor Species Development of Drugs (R01) Food and Drug Administration 2/3/2024 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