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

November 5, 2021

Table of Contents

House Releases Revised Reconciliation Package; Vote Expected Soon

Senate HELP Committee Holds COVID-19 Update Hearing with Pandemic Response Leadership

Supreme Court Hears Arguments on Texas Abortion Case

OSHA and CMS Issue Regulations Requiring COVID-19 Vaccination for Health Care Workers

CMS Issues Final Hospital Outpatient Payment Rule

Non-NIH Grants

 

House Releases Revised Reconciliation Package; Vote Expected Soon 

The House of Representatives released a revised $1.75 trillion reconciliation package.  The House made changes to the budget and legislative framework that the Biden Administration released on October 28 focused on climate and clean energy, health care, education, childcare, and housing.  The most significant policy and funding changes included adding four weeks of paid family leave, raising the limit on the deduction for state and local income taxes, and a prescription drug price negotiation program.  With growing consensus and support for the reconciliation package from House Democrats, Speaker Nancy Pelosi (D-CA) may bring the reconciliation package, along with the bipartisan infrastructure bill, to the House floor for a vote in the next few days.  However, the reconciliation package will likely be amended significantly by Senators during their consideration of the bill.  The most recent draft of the legislation only reflects House Democrats’ priorities, and several Senators have already stated their opposition to certain provisions.  There is also a contingent of Members of Congress who would like to hold off on voting until the Congressional Budget Office (CBO) provides its independent analysis of the spending, revenue, and economic impact of the most recent package. 

Several changes to healthcare provisions in the revised package include: 

• An additional $1 billion, for a total of $2 billion, to support the construction and renovation of health centers and federally-qualified health center facilities. 
• $500 million for Schools of Medicine located in underserved areas, with a preference given to minority-serving institutions (MSIs), to support a variety of activities including the recruitment, enrollment, and retainment of individuals from disadvantaged backgrounds and underserved areas; curriculum development; construction; and infrastructure modernization efforts.  
• $500 million for Schools of Nursing located in underserved areas to support a variety of activities including recruitment, enrollment, and retainment of individuals from disadvantaged backgrounds and underserved areas; curriculum development; and infrastructure modernization efforts. 
• Increases in Graduate Medical Education slots from 1,000 as provided in the Consolidated Appropriations Act of 2021 to 4,000. 
• $500 million for the Nurse Corps, a $300 million increase over the previous draft. 
• $2 billion for the National Health Service Corps, a significant increase over the $650 million proposed in the previous draft. 
• Creation of a price negotiation program for prescription drugs in Medicare Parts B and D.  The number of drugs that would be subject to negotiation would be those which represent the highest by gross spending; which are single-source drugs outside of their initial exclusivity periods – nine years for small molecule drugs and 12 years for biologics; and insulin products.  The bill would provide the Department of Health and Human Services (HHS) Secretary with the authority to negotiate up to ten drugs for 2025, and then in each following year, up to 20 drugs for 2028 and beyond.  The bill would also limit out-of-pocket cost-sharing to $2,000, and additional cost-sharing assistance for insulin products by capping monthly co-pays at $35.  
• Modifications to the Medicare Part D prescription drug program by limiting out-of-pocket costs for beneficiaries by requiring insurers to pay 65 percent of the cost of brand-name drugs, and 75 percent of the cost of generic drugs.  When beneficiaries reach the catastrophic coverage gap, plans would be required to pay 60 percent of drug costs.  
• Improved access to vaccines for Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) beneficiaries. 

Lewis-Burke will continue to monitor reconciliation developments and provide updates. 

Senate HELP Committee Holds COVID-19 Update Hearing with Pandemic Response Leadership 

Pandemic response leaders from the Biden Administration returned to the Senate Health, Education, Labor, and Pensions (HELP) Committee to testify on COVID-19 response, testing capacity, vaccine uptake, and other issues.  Both Committee Chairwoman Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) expressed concerns about the Biden Administration’s ability to deliver the supply of rapid and at-home COVID-19 tests necessary to enable a return to work, allow for in-person learning, and prevent further spread of the virus.  Dr. Janet Woodcock, Acting Commissioner of the Food and Drug Administration (FDA), responded that the FDA recently approved several new test manufacturers and will prioritize consideration of future rapid test approvals to increase the supply of tests on the market.  Senators from both parties also expressed concern over rising cases in states with high vaccination rates, suggesting that Centers for Disease Control and Prevention (CDC) needs to improve its ability to publish accurate, relevant, and timely data on “breakthrough” COVID-19 cases.  When challenged on levels of protection for individuals with “natural immunity” via prior infection compared to vaccinated individuals, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), clarified that since antibody levels have shown to be higher for individuals who contracted COVID-19 and later received the vaccination than for individuals who only developed antibodies via one method, officials would continue to recommend vaccination for all eligible individuals.  The panel, which included Dr. Rochelle Walensky, Director of the CDC, and Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) Dawn O’Connell, also discussed support for school districts and localities on best use of testing resources, research initiatives on “long COVID,” mental health of care providers, “Test to Stay” strategies to keep students in schools, and other topics raised by the Committee. 
 

Supreme Court Hears Arguments on Texas Abortion Case  
The Supreme Court heard oral arguments on two cases involving SB 8, the controversial Texas abortion law prohibiting doctors from performing an abortion after the sixth week of pregnancy.  Opponents of the law argue that it violates the standard set by the Court in the Roe v. Wade and Planned Parenthood v. Casey cases establishing a constitutional right to an abortion up to the point a fetus becomes viable.  Viability is normally considered to occur around the 24th week of pregnancy.  The cases did not involve the constitutionality of abortion, but rather procedural aspects of the law. 

The first case was brought by a group of abortion providers who challenged the legality of the law’s enforcement mechanism, which was designed to evade a challenge in federal court.  The law was drafted in a way to not have the state enforce the law, but instead to rely on private individuals to sue those who violate the law.  The Justices can decide to rule as broadly as they would like.  However, if the Court finds in favor of the providers, the suit would most likely return to the lower courts for additional proceedings.  

The second case was brought by the Biden Administration after the Court voted five to four to deny a request by providers to place the law on hold.  The Administration argued that Texas created an enforcement mechanism to circumvent judicial review.  Solicitor General Elizabeth Prelogar argued that if a lawsuit to block a law like this one could not be brought, then no constitutional right is safe, and none of the Supreme Court’s decisions were safe.   

The Justices will hear oral arguments on December 1 in a challenge to a Mississippi law that bans almost all abortions after the 15th week of pregnancy.  This case is considered the first major challenge to the viability standard since it was set by the Court.  

OSHA and CMS Issue Regulations Requiring COVID-19 Vaccination for Health Care Workers 
The Department of Labor’s Occupational Safety and Health Administration (OSHA) released an Emergency Temporary Standard (ETS) interim rule for employers with more than 100 employees that will require employees to receive a COVID vaccination or to undergo regular testing as a means of protecting workers from COVID transmission.  The ETS will cover private and public sector employers, including state and local education employees, within the 26 states adhering to OSHA state plans.  Under the ETS, which is officially in the Federal Register as of November 5, large employers are expected to develop a vaccination policy and determine the vaccination status of its employees.  Unlike previously announced requirements for federal employees and contractors, the OSHA ETS will allow for weekly COVID testing and masking in lieu of vaccination.  The ETS also instructs employers to provide paid leave for vaccination and related sick time.  Employers are expected to begin compliance with most provisions within 30 days, but full vaccination, or compliance with testing for non-vaccinated employees, is expected within 60 days.  According to the FAQs released with the ETS, this rule preempts state or local requirements that ban or limit an employer’s authority to require vaccination or testing.  OSHA has posted many materials on a dedicated ETS website, including an on-demand webinar on the rule.  While going into immediate effect, OSHA will be accepting public comments to the ETS, due in 30 days.  

The rule issued by the Centers for Medicare and Medicaid Services (CMS) requires all health care employees at facilities that participate in the Medicare and/or Medicaid programs to be fully vaccinated.  Impacted facilities are required to establish a policy ensuring that all eligible staff receive their first dose of the Pfizer or Moderna vaccine, or the single-dose Johnson & Johnson vaccine, prior to providing care, treatment, or other services by December 5, 2021.  The rule also sets out a timeline for staff to be fully vaccinated by January 4, 2022.  According to CMS, the new rules will impact approximately 76,000 providers and cover over 17 million health care workers across the country.  The rule also applies to employees, regardless of whether their positions are clinical or non-clinical, and includes students, trainees, and volunteers who work at a covered facility receiving funding from Medicare or Medicaid.  It also includes individuals who provide treatment or other services for the facility under contract or other arrangements.  CMS indicated that they will monitor compliance of the rule through their established survey and enforcement processes.  Facilities are required to develop a process allowing for exemptions based on medical conditions or religious beliefs, observances, or practices.  

House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA) and Health Subcommittee Ranking Member Brett Guthrie (R-KY) issued a statement saying that they would review all options, including the Congressional Review Act, to nullify the rule. 
  
CMS Issues Final Hospital Outpatient Payment Rule 
The Centers for Medicare and Medicaid Services (CMS) issued the calendar year 2022 Medicare payment rates for hospital outpatient and ambulatory surgical center services (hospital outpatient rule).  The rule increased payments to hospitals that meet quality reporting requirements by two percent, and those that fail to meet quality reporting requirements face a two percent reduction.  According to the rule, the update is based on a projected hospital market basket increase of 2.7 percent, and a reduction of 0.7 percent for the productivity adjustment.  For ambulatory surgical center services, CMS is adjusting payment rates by two percent using the final productivity adjusted hospital market basket update.  

The hospital outpatient rule also increases civil penalties for non-compliance with the Hospital Price Transparency final rule.  The rule sets the minimum civil penalty at $300 per day for hospitals with 30 or fewer beds, and a penalty of $10 per bed per day for hospitals with more than 30 beds.  The penalties are capped at a maximum of $5,500 per day.  For a full year of non-compliance, the minimum total penalty would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500.  

With respect to the 340B program, the rule finalizes CMS’ proposal to continue the discounted payment of the average sales price (ASP) minus 22.5 percent for certain drugs or biologicals acquired through the program.  Rural sole community hospitals, children’s hospitals, and prospective payment system (PPS)-exempt cancer hospitals are still excluded from this policy. 

Regarding health equity, CMS acknowledged that persistent inequity continues to exist in care delivery, and that it continues to improve provider accountability, stating, “we are committed to achieving equity in health care outcomes for our beneficiaries by supporting providers in quality improvement activities to reduce health inequities, enabling them to make more informed decisions, and promoting provider accountability for health care inequities.” 
 

Non-NIH Grants OPPORTUNITY NUMBER OPPORTUNITY TITLE AGENCY NAME CLOSE DATE CDC-RFA-CE22-2202 E-Learning Collaborative for Sexual Violence and Intimate Partner Violence Prevention Centers for Disease Control - NCIPC 11/17/2021 RFA-FD-22-003 Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional Food and Drug Administration 11/29/2021 RFA-OH-22-004 World Trade Center Health Research related to WTC Survivors (U01-No Applications with Responders Accepted) Centers for Disease Control and Prevention - ERA 12/7/2021 RFA-OH-22-003 Occupational Safety and Health Training Project Grants Centers for Disease Control and Prevention - ERA 12/17/2021 CDC-RFA-DP22-2203 National Initiative to Advance Health Equity in K-12 Education by Preventing Chronic Disease and Promoting Healthy Behaviors Centers for Disease Control - NCCDPHP 1/10/2022 RFA-CK-22-005 Vector-Borne Disease Regional Centers of Excellence Centers for Disease Control and Prevention - ERA 1/18/2022 RFA-PS-22-004 Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era Centers for Disease Control and Prevention - ERA 1/18/2022 RFA-PS-22-001 Implementing Pre-exposure Prophylaxis for HIV Prevention in Syringe Service Programs Centers for Disease Control and Prevention - ERA 1/18/2022 RFA-DP-22-002 Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts Centers for Disease Control and Prevention - ERA 1/19/2022 HRSA-22-024 Ryan White HIV/AIDS Program (RWHAP) Access, Care, and Engagement Technical Assistance Center (ACE TA Center) Health Resources and Services Administration 1/21/2022 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 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 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