Alston & Bird Health Care Week in Review, August 27, 2021

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, the Food and Drug Administration (FDA) fully approved Pfizer-BioNTech’s COVID-19 Vaccine. Read more about this announcement and other news below. 

I. Regulations, Notices & Guidance

• On August 24, 2021, the Food and Drug Administration (FDA) issued a notice entitled, Data Standards; Specifications for the Electronic Common Technical Document Validation Criteria. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the date that FDA will begin rejecting submissions which fail Electronic Common Technical Document (eCTD) validations 1306 or 1323 that have been raised to high validation errors as described in the “Specifications for eCTD Validation Criteria.”
• On August 24, 2021, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Notice of Award of a Single-source Cooperative Agreement to Fund the Association of University Centers on Disability. The notice announces the award of approximately $3,190,000 in COVID-19 funding in response to an unsolicited application that has been submitted by the Association of University Centers on Disability (AUCD) to address vaccine hesitancy among people with disabilities, their families, and direct support professionals.
• On August 25, 2021, FDA issued draft guidance entitled, Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-Ligand 1 Blocking Antibodies for Treatment of Patients with Cancer. This draft guidance provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. This draft guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, and as such, does not address development of alternative dosing regimens for any other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products.
• On August 26, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; National Expansion Implementation for All Remaining States and Territories of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports. This notice announces the implementation dates for all remaining states and territories for the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports.
• On August 27, 2021, FDA issued a notice entitled, Data Standards; Specifications for Electronic Common Technical Document Validation Criteria. FDA’s Center for Drug Evaluation and Research (CDER) is announcing the date that FDA will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors as described in the Specifications for eCTD Validation Criteria. Validation errors 1551 and 1553 have been added to the Specifications for eCTD Validation Criteria.
• On August 27, 2021, FDA issued draft guidance entitled, Safety and Performance Based Pathway Device-Specific Guidances. FDA is announcing the availability of two draft device-specific guidance documents for the Safety and Performance Based Pathway--specifically, “Denture Base Resins--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff” and “Facet Screw Systems--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.”

Event Notices

• August 30-31, 2021: CDC issued an amended notice for the virtual public meeting of the Advisory Committee on Immunization Practices (ACIP). The virtual meeting is being amended to change the dates to August 30, 2021 and August 31, 2021, update meeting times and supplemental information.
• September 3, 2021: CMS announced a virtual public meeting of the Advisory Panel on Outreach and Education (APOE). APOE advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
• September 9, 2021: The National Institutes of Health (NIH) issued an amended notice for the meeting of the National Advisory Dental and Craniofacial Research Council. This meeting is being amended to change the times of the Open and Closed sessions. The Open session will be from 9:00 AM to 2:30 PM. The Closed session will be from 2:45 PM to 3:30 PM.
• September 13, 2021: NIH announced a virtual public meeting of the AIDS Research Advisory Committee of the National Institute of Allergy and Infectious Diseases. The meeting will include a report from the Division Director and Division Staff.
• September 13, 2021: NIH announced public meetings of the National Advisory Allergy and Infectious Diseases Council; National Advisory Allergy and Infectious Diseases Council Acquired Immune Deficiency Syndrome Subcommittee; National Advisory Allergy and Infectious Diseases Council Microbiology and Infectious Diseases Subcommittee; and National Advisory Allergy and Infectious Diseases Council Immunology and Transplantation Subcommittee of the National Institute of Allergy and Infectious Diseases.
• September 21-22, 2021: The Health Resources and Services Administration (HRSA) announced a virtual public meeting of the Advisory Committee on Infant Mortality (ACIM). The agenda is being finalized and may include the following topics: federal program updates; discussion of recommendations by ACIM to the Secretary; fatality review programs; health of indigenous mothers and infants; financing of care; and patient-physician racial concordance in health care.
• September 28, 2021: FDA announced a virtual public meeting entitled, Reauthorization of the Prescription Drug User Fee Act. The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027.
• September 30, 2021: FDA announced a virtual public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• October 20, 2021: FDA announced a virtual public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.
• October 22, 2021: CDC announced a virtual public meeting of the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). The Board is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS.
• November 2-3, 2021: FDA announced a virtual public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.

II. Congressional Hearings

U.S. House of Representatives

• On August 23, 2021, the House Committee on Rules held a business meeting entitled, Rules Committee Meeting on S. Con. Res. 14, H.R. 4 and H.R. 3684. The Committee discussed three pieces of legislation: S. Con. Res. 14, Setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031; H.R. 4, John R. Lewis Voting Rights Advancement Act of 2021; and H.R. 3684, INVEST in America Act.

III. Reports, Studies & Analyses

• On August 26, 2021, the Kaiser Family Foundation (KFF) released an issue brief entitled, How Have States Used Medicaid Emergency Authorities During COVID-19 and What Can We Learn? In response to the COVID-19 public health emergency, states and the federal government took a range of actions in Medicaid to enhance capacity to respond to the public health and economic crises. This brief summarizes how states have used Medicaid emergency authorities related to the COVID-19 PHE, providing potential lessons for future public health and economic crises.
• On August 27, 2021, KFF released an issue brief entitled, COVID-19 continues to be a leading cause of death in the U.S. in August 2021. The updated issue brief examines COVID-19’s effect on mortality rates, and finds that as of August 2021, COVID-19 has risen once again to number three on the list of the top ten leading causes of death in the U.S. As recently as January 2021, COVID was the number one leading cause of death, with an average of 3,066 people dying daily. Amid widespread availability of vaccines, that COVID rank had briefly dropped to the 8th leading cause of death in July 2021.

IV. Other Health Policy News

• On August 23, 2021, FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. More information about this approval can be found here.
• On August 24, 2021, CMS announced it is expanding opportunities for people to receive COVID-19 vaccinations in their home. To ensure Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach can receive the vaccination, healthcare providers can now receive additional payments for administering vaccines to multiple residents in one home setting or communal setting of a home. More information about the announcement can be found here.
• On August 25, 2021, CMS announced that the Affordable Care Act’s Shared Savings Program continues to improve quality of care while saving Medicare money during the COVID-19 pandemic. Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (Shared Savings Program) in 2020 earned performance payments (shared savings) totaling nearly $2.3 billion while saving Medicare approximately $1.9 billion, marking the fourth consecutive year of net savings for Medicare. More information about the announcement can be found here.
• On August 27, 2021, HHS awarded $10.7 million from the American Rescue Plan (ARP) to expand pediatric mental health care access by integrating telehealth services into pediatric care. The awards were made through the Health Resources and Services Administration (HRSA) to the Pediatric Mental Health Care Access Program. More information about this announcement can be found here.
• On August 27, 2021, HHS announced that the Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding $74.2 million in grants that will strengthen the structures that serve the mental health needs of our nation's youth. The first grant raises awareness of mental health issues for youths and trains school personnel. The second grant coordinates treatment for young people who have emotional disorders. More information on these grants can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.