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

July 23, 2021

Table of Contents

Congressional Update: House Set to Vote on Package of Appropriations Bills, Senate Infrastructure Deal Closer with Medicare Provisions Included as Potential Pay-Fors

Agency Officials Provide Update on COVID-19 Response and Challenges Ahead

Senate Health, Education, Labor and Pensions Committee Holds Hearing on Addressing Disparities in Life Expectancy

New Congressional Social Determinants of Health Caucus Launches

CDC to Establish U.S. Public Health Pathogen Genomics Centers of Excellence in Fiscal Year 2022

CMS Releases Proposed CY 2022 Medicare Hospital Outpatient and Ambulatory Surgical Center Rule

Non-NIH Grants

Congressional Update: House Set to Vote on Package of Appropriations Bills, Senate Infrastructure Deal Closer with Medicare Provisions Included as Potential Pay-Fors
As the annual August recess approaches, the House of Representatives and the Senate are pursuing their own legislative agendas relevant to health.  The House is set to take up a seven-bill appropriations package next week as one of their last major actions before departing for the August recess.  The fiscal year (FY) 2022 appropriations package or “minibus” includes the Labor, Health and Human Services, and Education funding bill along with other spending measures popular among House Democrats.  In the Senate, work on FY 2022 appropriations has not yet begun.  Instead, lawmakers continue to focus on a bipartisan $579 billion infrastructure package.  The Senate hopes to officially begin debate on the package as early as next week, though final text and a cost estimate from the Congressional Budget Office (CBO) are still not available.  Some of the “pay-fors” under consideration for the infrastructure package include allowing Medicare to negotiate the price of some single source drugs in Part D, and a repeal of a Trump-era Medicare prescription drug rule.  The Medicare rule, aimed at lowering out-of-pocket costs, would eliminate rebates drug manufacturers give to pharmacy benefit managers in Medicare Part D, and shift the rebates to the point of sale.  Delaying the rule would reduce expenditures by the Medicare program and, according to estimates by the CBO, may free up nearly $177 billion in Medicare spending over a decade.  Additional pay-fors that are still on the table for an infrastructure package include a continuation of Medicare sequestration and using unspent COVID-19 relief funding.  Lewis-Burke will continue to monitor both progress on FY 2022 appropriations and the pending infrastructure package for inclusion of any relevant health provisions. 

Agency Officials Provide Update on COVID-19 Response and Challenges Ahead
The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing titled “The Path Forward: A Federal Perspective on the COVID-19 Response.”  Witnesses included Dr. Rochelle Walensky, Director of the Centers for Diseases Control and Prevention (CDC); Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Janet Woodcock, Acting Commissioner of the Food and Drug Administration (FDA); and Dawn O’Connell, Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS).  Topics included the rise of the SARS-CoV-2 delta variant and effectiveness of vaccines, the possibility of approving a third booster dose, gain of function research, and efforts to replenish the Strategic National Stockpile.
 
In their opening statements, both HELP Committee Chairwoman Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) stressed the importance of receiving a vaccine in light of the spread of the delta variant and the need to ensure a robust public health infrastructure to address future outbreaks.  Ranking Member Burr emphasized the Committee will work on a public health infrastructure and health security bill starting this fall. 
 
In the member questions portion of the hearing, Dr. Walensky was asked about the spread of the delta variant.  She noted that the delta variant now makes up 83 percent of current cases and highlighted the need to get vaccinated to protect against severe symptoms, hospitalization, and death.  Dr. Fauci assured the Committee that the slate of vaccines available in the U.S. remain durable and effective against the delta variant and although there have been a few breakthrough infections, nearly 99 percent of deaths are among the unvaccinated.  Members of the Committee also raised the possibility of a potential third booster vaccine dose given research out of Israel indicating that the vaccines are less effective against the delta variant.  Witnesses highlighted the strong immune response of the two-dose regimen of both the Pfizer and Moderna vaccines and Dr. Woodcock stated that while the FDA is continuing to research the effectiveness of the vaccines, the agency cannot comment on the current state of approval for a third booster dose.  Pfizer has specified that the company will seek an emergency use authorization (EUA) for a booster dose in August.  Witnesses stated that if a third booster is needed, it will likely be most important for the immunocompromised.
 
Senator Rand Paul (R-KY) and Dr. Fauci had a testy exchange over Senator Paul’s assertations that the National Institute of Health (NIH) supported gain of function research on coronaviruses that would increase their transmissibility or lethality for humans.  Senator Paul asserted that Dr. Fauci previously lied to Congress when he stated that the NIH has not supported gain of function research.  Dr. Fauci stood by his previous statements and reiterated that the NIH has not engaged in or supported gain of function research for coronaviruses.
 
Senator Bill Cassidy (R-LA) highlighted the importance of replenishing the Strategic National Stockpile and the critical need to secure supply chains for future outbreaks.  Assistant Secretary O’Connell noted that while she was recently confirmed as ASPR, her office is currently working to replenish the Stockpile and is taking measures to ensure supply chains are secure in case of a future public health emergency.  Chairwoman Murray and Ranking Member Burr closed the hearing by restating the importance of vaccination and that well-funded public health infrastructure is critical to mitigate future pandemics.  Next week, the Committee will hold a hearing on building on lessons learned from the pandemic. 

Senate Health, Education, Labor and Pensions Committee Holds Hearing on Addressing Disparities in Life Expectancy
The Senate Committee on Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security held a hearing titled “Addressing Disparities in Life Expectancy.”  Witnesses included Kathleen Mullan Harris, Ph.D., James E. Haar Distinguished Professor of Sociology at the University of North Carolina and Chair of the Committee on Rising Midlife Mortality Rates and Socioeconomic Disparities at the National Academies of Sciences, Engineering, and Medicine; William E. Cooke, MD, Owner and Medical Director of Foundations Family Medicine; and Robert F. MacKenzie, Chief of the Kennebunk Police Department in Kennebunk, Maine.  Topics discussed at the hearing included substance use and overdoses, mental health, access to health care, economic inequality, and community engagement.

In his opening remarks, Subcommittee Chairman Bernie Sanders (I-VT) outlined the relationship between higher levels of education and income and increased life expectancy.  Senator Sanders explained that people with lower income, less education, and who live in rural areas, are the most impacted by declining life expectancy, even before the COVID-19 pandemic, as they experience significantly greater levels of stress than those who are wealthier, have stable housing, and easier access to medical care.  He further acknowledged the surge in drug overdoses, alcoholism, and suicides, especially when combined with isolation and reduced social support during the pandemic, accounting for decreases in life expectancy, particularly among lower-income populations.  Subcommittee Ranking Member Susan Collins (R-ME) stated in her opening remarks that the COVID-19 pandemic has brought on more cases of extreme stress, anxiety, and substance use disorders, particularly among young adults, which are exacerbated by increased difficulty of access to treatment and counseling also induced by the pandemic.

Dr. Harris led a study at the University of North Carolina to examine what specific causes of death were increasing among which populations between 1990 and 2017.  She found that the largest contributors to the decrease in life expectancy were drug- and alcohol-induced deaths, with suicide and cardiovascular diseases also being significant components.   Dr. Harris argued that to address unequal declining life expectancy, solutions need to be multifaceted, taking into account economic drivers, drug regulatory policy, obesity prevention programs, and healthcare coverage, especially for racial and ethnic minorities.  Dr. Cooke expressed the role of equitable access to clean air and water, nutritious food, safe housing, adequate transportation, primary health care, earning a livable wage, and a sense of belonging in the community to improving overall health and well-being.  Mr. MacKenzie described three initiatives in his region that have been successful in addressing substance use disorders.  The first concentrated on reducing the stigma of substance use, including training community leaders to administer naloxone; the second convened stakeholders from local government, law enforcement, recover centers, faith groups, and mental health providers to identify gaps and create a strategic plan to reduce them; and the third was a fundraising effort to train people from the community to become recovery coaches. 

The need to rely on community partners and implement interventions at the local level, the impacts of the COVID-19 pandemic, and racial/ethnic disparities in life expectancy were common themes in the testimony of all three witnesses.  Dr. Cooke spoke about the importance of restoring a sense of purpose and meaning for those struggling from severe depression, stress, and substance use disorders, and the effectiveness of telemedicine to build and maintain connections with people in the community who are able to provide help.  He asserted that in order for health programming to be effective, it should focus on social services, health care, and community support.  Following a question from Senator Collins, Mr. MacKenzie pointed out that COVID-19 has not only forced millions of individuals into isolation, which has exacerbated rates of drug overdoses, but that the pandemic has also made support resources more difficult to access.  In response to a question from Senator Sanders, Dr. Harris argued that livable wages, adequate housing, and expanded access to health coverage would positively impact life expectancy and address racial and ethnic disparities.

New Congressional Social Determinants of Health Caucus Launches
Reps. Cheri Bustos (D-IL), Tom Cole (R-OK), G.K. Butterfield (D-NC), and Markwayne Mullin (R-OK) recently launched a new bipartisan Congressional Social Determinants of Health Caucus.  The Caucus brings together Members from different jurisdictions to examine opportunities and federal investments for social determinants of health, including food, transportation, housing, and other drivers.  The Caucus also published a request for information (RFI) on challenges and opportunities related to social determinants of health.  Submissions from the public are due by September 21.  More details on the RFI and Caucus itself can be viewed on the Caucus’ website.

CDC to Establish U.S. Public Health Pathogen Genomics Centers of Excellence in Fiscal Year 2022
The Centers for Disease Control and Prevention (CDC) shared details this week about its plans to establish a new U.S. Public Health Pathogen Genomics Centers of Excellence (CoE) program in fiscal year (FY) 2022.  This initiative, initially announced by President Biden in April 2021 as the Centers of Excellence in Genomic Epidemiology, is part of CDC’s efforts to improve surveillance of pathogens with the potential to become pandemic-level threats.  Details of the new CDC program emerged this week in a Grant Opportunity Forecast from CDC.  Dr. Greg Armstrong, Director of CDC’s Advanced Molecular Detection program, provided some additional context for the CoEs program during a webinar hosted by the American Society of Microbiology (ASM).

Following the success of the SPHERES (SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology, and Surveillance) program, an initiative which brought together clinical and public health laboratories, academic entities, and the private sector to collaborate on SARS-CoV-2 sequencing, the CDC is looking to continue similar types of collaborations to track the spread of existing and emerging infectious diseases.  The goal of the new CoEs program is to “foster innovation in pathogen genomics and molecular epidemiology in order to improve the control of and response to microbial threats of public-health importance” through partnerships between public health authorities and academic institutions.  This program is designed to be of mutual benefit to public health departments and academic organizations, where academia will help bring genomic and related technologies into public health, who will then help develop curricula to train new epidemiologists using virtual platforms. 

Each CoE will be composed of a governmental public health agency, at either the state or local level, and an academic partner, either a single entity or consortium, with expertise in microbial genomics, molecular epidemiology, or another relevant field.  The public health agency will be the primary recipient of the initial five-year research cooperative agreement, but groups will apply as partnerships.  The CoEs will be funded through a cooperative agreement that can be restructured to allow for additional funding if needed in the event of a public health emergency.  In the Grant Opportunity Forecast for this program (linked above), the CDC noted that it plans to dedicate $90 million to fund six CoEs in FY 2022.

CMS Releases Proposed CY 2022 Medicare Hospital Outpatient and Ambulatory Surgical Center Rule
This week, the Centers for Medicare and Medicaid Services (CMS) released their Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule for calendar year (CY) 2022.  For outpatient departments, CMS proposes an increase factor of 2.3 percent.  Total payments to providers would be approximately $82.7 billion, a $10.7 billion increase from CY 2021 estimated payments.  For Ambulatory Surgical Centers (ASC), CMS is proposing to increase payment rates by 2.3 percent to $5.1 billion, an increase of $20 million from the estimated CY 2021 payment.  Payments include beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix. 
 
CMS was seeking to increase penalties for non-compliance of the hospital price transparency final rule.  The agency is proposing to set a minimum civil monetary penalty of $300 per day for smaller hospitals with a bed count of 30 or fewer, and a penalty of $10 per bed per day for hospitals with a bed count greater than 30, for a maximum daily dollar amount of $5,500.  For a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.
 
With regard to the 340B program, CMS is proposing to maintain the payment rate at the average sales price minus a 22.5 percent rebate for certain separately payable drugs or biologicals.
 
In section 125 of the Consolidated Appropriations Act of 2021, Congress established a new provider type called Rural Emergency Hospitals (REHs).  To be eligible for this statue, REHs will be required to furnish emergency department services and observation care and may provide other outpatient medical and health services as specified by the Secretary through rulemaking.  In this proposed rule, CMS is requesting information to develop requirements that would apply to REHs.  This new designation was established to address the growing concern over the large number of hospital closures in rural communities. 
 
CMS is also seeking comment on the extent to which hospitals have been billing for telehealth services furnished to Medicare beneficiaries in their homes during the public health emergency, and whether they anticipate there being a continued demand for care in this way.  The agency is seeking comment on whether there are any changes that CMS should make, to account for changes in practice patterns, that rely on communication technology to provide mental health services to beneficiaries in their homes. CMS is interested in how much providers rely on the flexibility to allow for the presence of a physician for direct supervision requirements for pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services to include virtual presence through audio/video technology, to reduce exposure risks for the beneficiary or practitioner.  This flexibility is scheduled to expire at the end of the public health emergency or December 31, 2021.
 
With regard to the COVID-19 pandemic, CMS states in the proposed rule it is seeking input as to whether it should keep codes for specimen collection for severe acute respiratory syndrome coronavirus 2 active beyond the conclusion of the public health emergency, and whether it should extend or make permanent the Hospital Outpatient Prospective Payment System (OPPS) payment associated with specimen collection for COVID-19 tests after the end of the pandemic.
 

Non-NIH Grants OPPORTUNITY NUMBER OPPORTUNITY TITLE AGENCY NAME CLOSE DATE CDC-RFA-OT18-18020403SUPP21 Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nation's Health Centers for Disease Control - OSTLTS 8/9/2021 HRSA-22-004 Service Area Competition Health Resources and Services Administration 8/13/2021 EP-HIT-21-002 Enhance, Manage, and Promote the Medical Reserve Corps Training and Learning Management System via the TRAIN Learning Network (MRC-TRAIN) Assistant Secretary for Preparedness and Response 8/25/2021 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 HRSA-22-005 Service Area Competition Health Resources and Services Administration 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 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-21-164 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