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HEALTH HIGHLIGHTS

July 21, 2023 | Lewis-Burke Associates LLC

IN THIS ISSUE:

Washington Prognosis: Congress Enters its Final Week Before the August Recess with Unfinished Business
House and Senate Committees Markup Pandemic Preparedness Reauthorizing Legislation
Energy and Commerce Committee Holds Hearing on Medicare Coverage of Innovative Drugs and Devices
Centers for Medicare and Medicaid Services Release Proposed Rules for Physician and Outpatient Services
PCAST Seeking Input on Federal Nutrition Research

WHAT WE'RE READING:

RAND Researchers Publish Paper Alleging Hospitals Received More COVID Relief Funds than Necessary
SAMHSA Announces Over $48 Million in Awards to Combat Substance and Opioid Use Disorder

Washington Prognosis: Congress Enters its Final Week Before the August Recess with Unfinished Business

Congress will enter its last week of the July work period with much uncertainty before leaving Washington for the long August recess. The full Senate Appropriations Committee is scheduled to consider the fiscal year (FY) 2024 Labor, Health and Human Services, Education, and Related Agencies (Labor-H) appropriations bill on July 27, while the House Labor-H Appropriations Subcommittee passed its version of the bill last week with deep proposed cuts to biomedical research, public health, and health workforce programs. The House bill, like others approved by the House so far, included policy riders regarding abortion and reproductive health, which will complicate negotiations in September. It is expected that Congress will need to pass a continuing resolution before the September 30 deadline to prevent a government shutdown.

This week, the House Energy and Commerce Committee and Senate Health, Education, Labor, and Pensions (HELP) Committee advanced their versions of bills to reauthorize the Pandemic and All-Hazards Pandemic Act (PAHPA). The bills would reauthorize federal pandemic preparedness programs and the Biomedical Advanced Research and Development Authority (BARDA). In addition, both Committees are also working on legislation to reauthorize key public health programs, including the Community Health Center Fund (CHCF), the National Health Service Corps (NHSC), the Teaching Health Center Graduate Medication (THCGME) program, and substance use disorder prevention programs. In addition to PAHPA, these programs must be reauthorized by September 30.

House and Senate Committees Markup Pandemic Preparedness Reauthorizing Legislation
The House Energy and Commerce (E&C) and Senate Health, Education, Labor, and Pensions (HELP) Committees held markups this week to consider legislation that would be a part of the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). The House full Committee markup came after the E&C Health Subcommittee held a markup of the same legislation, passing it on a partisan line vote. Similar to the dynamic at the Subcommittee markup, Republicans rebuked Democratic calls to include additional provisions aimed at addressing drug shortages, while Democrats criticized the low authorized funding levels and additional oversight of federal public health agencies in the legislation. The legislation passed the full Committee on a party-line vote. In total, E&C considered a total of 15 bills in the markup, ranging in focus from rare disease research, maternal health research, and reauthorization of the National Firefighter Registry for Cancer.

The Senate HELP Committee’s version of PAHPA reauthorization legislation received much more bipartisan support, with most Republican and Democratic members of the Committee lauding the bill, notably its inclusion of a provision addressing drug shortages. Senator Rand Paul (R-KY) did propose multiple contentious amendments aimed at limiting or banning federal support of “gain of function” research, which were supported by some other Republicans on the Committee but not included in the final version of the bill. The Committee approved the legislation by a 17-3 vote.

Energy and Commerce Committee Holds Hearing on Medicare Coverage of Innovative Drugs and Devices
The House Energy and Commerce Committee (E&C) held a hearing entitled “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology.” The hearing primarily focused on coverage determinations made by the Centers for Medicare and Medicaid Services (CMS). Members of both parties raised concerns at the hearing about medical products that have been approved by the Food and Drug Administration (FDA) that are ultimately denied coverage under Medicare. The most common example that members cited was CMS’s decision to restrict accessibility of new Alzheimer’s Disease therapies after they were approved through the FDA’s Accelerated Approval Program. By statute, medical products are only available under Medicare Parts A and B if the Secretary of Health and Human Services (HHS) determines they meet the “Reasonable and Necessary Standard.” Under the Social Security Act, the Secretary may prohibit an item from being covered if it is not “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” CMS has the authority to exercise its discretion over the Reasonable and Necessary Standard regardless of a decision by the FDA.

Centers for Medicare and Medicaid Services Release Proposed Rules for Physician and Outpatient Services
Centers for Medicare and Medicaid Services (CMS) issued proposed rules for the calendar year (CY) 2024 Physician Fee Schedule (PFS) and CY 2024 Outpatient Prospective Payment System (OPPS). In keeping with budget neutrality requirements, CMS set the CY 2024 conversion factor to $32.75, a decrease of $1.14 compared to the CY 2023 PFS conversion factor of $33.89. The fiscal year (FY) 2023 omnibus delayed a 4 percent cut to physicians, mandated under Congressional Pay-As-You-Go rules, until 2025. The law provided for a 2.5 percent update for 2023 and 1.25 percent update for 2024. In this proposed rule, CMS assumed the expiration of additional congressional action. CMS is also proposing to implement a separate add-on payment for Healthcare Common Procedure Coding System (HCPCS) code G2211, which was originally finalized in the CY 2021 PFS final rule but delayed by Congress as part of FY 2021 appropriations until 2024. The proposed rule also includes provisions to expand access and coverage for focused on telehealth, behavioral health, and social determinants of health services.

Regarding OPPS and Ambulatory Surgical Centers (ASC), CMS is proposing to update OPPS rates for hospitals by 2.8 percent. Acknowledging the continued impact of COVID-19, CMS is also proposing to continue using the hospital market basket to update payments for CY 2024 and 2025 and update the ASC rates for CY 2024 by 2.8 percent. The proposed rule also contains provisions that request input on prescription drug shortages, create an Intensive Outpatient Program (IOP) under Medicare, update payment rates under the Partial Hospitalization Program (PHP), provide additional payments to cancer hospitals, and aim to increase hospital price transparency.

Comments on both the PFS and OPPS proposed rules are due by September 11, 2023. Lewis-Burke’s full analysis of the PFS proposed rule is available here and the OPPS proposed rule analysis is available here.

PCAST Seeking Input on Federal Nutrition Research
The President’s Council of Advisors on Science and Technology (PCAST) is soliciting input to inform a coordinated strategy on federal nutrition science and research. This notice follows the White House National Strategy on Hunger, Nutrition, and Health, published in September 2022, which included a recommendation for PCAST to “identify scientific opportunities, gaps, and priorities to continue to advance nutrition science, emphasizing equitable access to the benefits of research,” in collaboration with the White House Office of Science and Technology Policy (OSTP), the Interagency Committee on Human Nutrition Research, and external stakeholders.

The notice lists the following specific questions that will assist the White House in developing a unified framework to advance nutrition science:

“How can the United States obtain the greatest return from federal investment in nutrition research?
1. What are the crucial evidence gaps in nutrition research and what steps could PCAST recommend that would substantially fill those gaps?
2. What tools, methods, or other resources (in addition to funding) are needed to conduct that research?
3. Are there other barriers to research (other than inadequate funding)?
4. Are there models from other fields of science that could be employed to fill nutrition research evidence gaps?
How could/should research-based interventions for primary and secondary prevention of diet-related chronic diseases be introduced into federal programs?
What can be done to assure equitable access to the benefits of the federal nutrition research investment?”

Input must be shared with pcast@ostp.eop.gov; the White House has not indicated a deadline to provide feedback. Additional details can be found in the full notice.

What We're Reading

RAND Researchers Publish Paper Alleging Hospitals Received More COVID Relief Funds than Necessary: According to an article published in the Journal of the American Medical Association, the size of COVID-19 relief funds provided to hospitals may have been larger than needed. The research, conducted by individuals at the RAND Corporation, used financial data from hospitals between 2017 and 2021. The study is limited by its abbreviated time scale, not encompassing the full timeline of the public health emergency. It also does not account for the impact of patients who delayed care during the pandemic.
SAMHSA Announces Over $48 Million in Awards to Combat Substance and Opioid Use Disorder: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it was issuing $47.8 million in awards available through five grant programs to combat substance and opioid use disorder, including funds to enhance access to appropriate medications.

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-24-069	Service Area Competition	Health Resources and Services Administration	9/18/2023
EP-U3R-23-003	Medical Reserve Corps Small Grant Program	Assistant Secretary for Preparedness and Response	9/18/2023
RFA-FD-23-035	Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Laparoscopic Abdominal Surgeries (U01) Clinical Trials Not Allowed	Food and Drug Administration	8/15/2023
RFA-FD-23-034	Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Acute Low Back Pain (U01) Clinical Trials Not Allowed	Food and Drug Administration	8/15/2023
HRSA-24-087	Service Area Competition-Additional Area	Health Resources and Services Administration	8/21/2023
HRSA-24-068	Service Area Competition	Health Resources and Services Administration	8/21/2023
MP-CPI-23-001	Health Equity Leadership Development Initiative	Office of the Assistant Secretary for Health	8/1/2023
ID-IDP-23-001	Evaluation of linkage to care programs in support of hepatitis C elimination	Office of the Assistant Secretary for Health	8/2/2023
MP-CPI-23-003	National Lupus Outreach and Clinical Trial Education Program	Office of the Assistant Secretary for Health	8/1/2023
HHS-2023-ACF-ACYF-EV-0061	Family Violence Prevention and Services Culturally Specific Sexual Assault Capacity Building Center for the African American Community	Administration for Children & Families - ACYF/FYSB	7/27/2023
HHS-2023-ACF-ACYF-EV-0059	Sexual Assault Capacity Building Centers	Administration for Children & Families - ACYF/FYSB	7/27/2023
HHS-2023-ACF-ACYF-EV-0060	Family Violence Prevention and Services Culturally Specific Domestic Violence and Sexual Assault Discretionary Grants	Administration for Children & Families - ACYF/FYSB	8/11/2023
HHS-2023-ACL-AOA-ADPI-0035	Alzheimer's Disease Programs Initiative (ADPI) - States and Community Grants (SUMMER 2023)	Administration for Community Living	8/7/2023
HHS-2023-ACF-ORR-ZU-0153	Home Study and Post-Release Services for Unaccompanied Children	Administration for Children and Families - ORR	8/8/2023
HHS-2023-ACF-OCS-ET-1121	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region V	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1117	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region II	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1118	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region III	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1119	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region IV-A	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1122	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region VI	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1125	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region IX	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1124	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region VIII	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1123	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region VII	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1126	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region X	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1120	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region IV-B	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-1116	Community Services Block Grant (CSBG) Regional Performance and Innovation Consortium (RPIC) Capacity Building and Quality Improvement (CBQI) - Region I	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-OCS-ET-0003	Community Services Block Grant (CSBG) Legal Training and Technical Assistance (T/TA)	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-ACYF-AK-0063	Personal Responsibility Education Program (PREP) Competitive Grants: New Hampshire	Administration for Children & Families - ACYF/FYSB	8/2/2023
MP-CPI-23-002	Center for Indigenous Innovation and Health Equity	Office of the Assistant Secretary for Health	8/1/2023
HHS-2023-ACF-ACYF-CA-0020	Field-Initiated Approach to Addressing Racial Bias and Inequity in Child Welfare	Administration for Children and Families - ACYF/CB	7/31/2023
HHS-2023-ACF-OCS-ET-0049	Community Services Block Grant (CSBG) Performance Management Alignment Training and Technical Assistance (PMATTA)	Administration for Children and Families - OCS	7/31/2023
HHS-2023-ACF-ACYF-EV-0043	Alaska Native Tribal Resource Center on Domestic Violence	Administration for Children & Families - ACYF/FYSB	7/31/2023
HHS-2023-ACF-ORR-ZU-0189	Residential Treatment Center Services for Unaccompanied Children	Administration for Children and Families - ORR	7/31/2023
CDC-RFA-EH-23-0005	Supporting Communities to Reduce Lead Poisoning	Centers for Disease Control - NCEH	7/31/2023
HHS-2023-ACF-ACYF-CY-0070	FY 2023 Runaway and Homeless Youth-Prevention Demonstration Program (RHY-PDP)	Administration for Children & Families - ACYF/FYSB	7/31/2023
HHS-2023-ACF-ACYF-CT-0012	The National Child Welfare Workforce Institute	Administration for Children and Families - ACYF/CB	7/31/2023
HHS-2023-ACF-ACYF-CA-0078	Trauma-Interventions for Children and Youth in Foster Care with Complex Mental, Behavioral, and Physical Health Needs	Administration for Children and Families - ACYF/CB	7/31/2023
HRSA-24-067	Service Area Competition	Health Resources and Services Administration	7/24/2023
HHS-2023-ACF-ORR-ZU-0246	Residential (Therapeutic Group Home) Services for Unaccompanied Children	Administration for Children and Families - ORR	7/24/2023
HHS-2023-ACL-CIP-ATTF-0098	Assistive Technology Alternative Financing Program	Administration for Community Living	7/24/2023
PAR-23-202	Vet-LIRN Capacity-Building Project and Equipment Grants (U18)	Food and Drug Administration	9/4/2028
PA-23-196	AHRQ Health Services Research Dissertation Program (R36)	Agency for Health Care Research and Quality	5/6/2028
PA-23-115	AHRQ Small Research Projects to Advance the Science of Primary Care (R03)	Agency for Health Care Research and Quality	3/19/2027
PAR-23-072	FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)	Food and Drug Administration	10/10/2025
RFA-OH-23-003	Occupational Safety and Health Education and Research Centers (T42)	Centers for Disease Control and Prevention - ERA	11/23/2027
PA-22-255	AHRQ Mentored Research Scientist Career Development Award (K01)	Agency for Health Care Research and Quality	11/9/2025
PA-22-238	AHRQ Conference Grant Programs (R13)	Agency for Health Care Research and Quality	10/31/2026
PA-22-232	AHRQ Mentored Clinical Scientist Research Career Development Award (K08)	Agency for Health Care Research and Quality	2/13/2027
RFA-OH-22-006	Commercial Fishing Occupational Safety Training Project Grants (T03)	Centers for Disease Control and Prevention - ERA	1/31/2028
RFA-OH-22-005	Commercial Fishing Occupational Safety Research Cooperative Agreement (U01)	Centers for Disease Control and Prevention - ERA	1/31/2028
RFA-FD-23-001	Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required	Food and Drug Administration	9/22/2024
NAP-AX-22-001	Leading Edge Acceleration Projects (LEAP) in Health Information Technology	Office of the National Coordinator	9/30/2027
PA-22-175	Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research	Agency for Health Care Research and Quality	2/28/2025
HHS-2022-ACF-ORR-ZU-0157	Standing Announcement for Residential (Shelter and/or Transitional Foster Care) Services for Unaccompanied Children-PRELICENSED	Administration for Children and Families - ORR	7/24/2023
RFA-OH-22-001	NIOSH Education and Research Centers	Centers for Disease Control and Prevention - ERA	2/24/2025
RFA-CE-22-003	Rigorously Evaluating Programs and Policies to Prevent Child Sexual Abuse (CSA)	Centers for Disease Control and Prevention - ERA	12/1/2023
RFA-OH-22-003	Occupational Safety and Health Training Project Grants	Centers for Disease Control and Prevention - ERA	10/24/2025
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-22-047	Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01)	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-21-264	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
PAR-21-179	Minor Use Minor Species Development of Drugs (R01)	Food and Drug Administration	2/2/2024
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
PAR-21-148	NIOSH Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)	Centers for Disease Control and Prevention - ERA	12/15/2025
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-18-797	NIOSH Small Research Grant Program	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
PA-18-793	AHRQ Health Services Research Demonstration and Dissemination Grants (R18)	Agency for Health Care Research and Quality	10/1/2023
PA-18-794	AHRQ Small Research Grant Program (R03)	Agency for Health Care Research and Quality	7/8/2024
PA-18-795	AHRQ Health Services Research Projects (R01)	Agency for Health Care Research and Quality	7/8/2024