Health Care Week in Review December 10, 2021

Alston & Bird Health Care Week in Review, December 10, 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, HHS announced several actions to improve maternal health outcomes, including awarding $82 million in ARP emergency home visiting funds. Read more about these actions and other news below.


I. Regulations, Notices & Guidance

Event Notices

  • January 19, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB). The meeting will feature a report from the Institute Director, Council Members, and other Institute Staff.
  • February 4, 2022: NIH announced a public meeting of the National Institute on Minority Health and Health Disparities. The meeting will feature opening remarks, administrative matters, the Director's Report, presentations, and other business of the Council.
  • February 10, 2022: FDA announced a public meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
  • Various Dates: The Department of Health and Human Services (HHS) announced various dates for public meetings of the Health Information Technology Advisory Committee (HITAC). The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator).

II. Congressional Hearings

U.S. House of Representatives

  • On December 8, 2021, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, The Future of Biomedicine: Translating Biomedical Research into Personalized Health Care. Witnesses present included: Dr. Amy Abernethy, President of Clinical Studies Platforms, Verily Life Sciences; Dr. Atul Butte, Distinguished Professor and Director of the Bakar Computational Health Sciences Institute, UCSF, and Chief Data Scientist, UC Health; Mr. Adolph Falcón, Executive Vice President, National Alliance for Hispanic Health; Dr. Leroy Hood, President, Institute for Systems Biology, Affiliate Professor of Immunology, University of Washington; and Dr. Lloyd Minor, Dean, Stanford University School of Medicine.
  • On December 10, 2021, the House Committee on Oversight and Reform held a hearing entitled, Unsustainable Drug Prices: Findings from the Committee’s Drug Pricing Investigation and the Need for Structural Reforms. Witnesses present included: Mindy Salango, Patient Advocate with Type 1 Diabetes, Morgantown, West Virginia; Dr. Reshma Ramachandran, Physician-Fellow, Yale National Clinician Scholars Program and Co-Chair, Doctors for America Drug Affordability Action Team; Rena Conti, PhD, Associate Professor, Department of Markets, Public Policy, and Law, Questrom School of Business, Boston University; and David Mitchell, President and Founder, Patients for Affordable Drugs.

III. Reports, Studies & Analyses

IV. Other Health Policy News

  • On December 7, 2021, HHS announced that U.S. Surgeon General Dr. Vivek Murthy issued a new Surgeon General’s Advisory to highlight the urgent need to address the nation’s youth mental health crisis. As the nation continues the work to protect the health and safety of America’s youth during this pandemic with the pediatric vaccine push amid concerns of the emerging omicron variant, the U.S. Surgeon General’s Advisory on Protecting Youth Mental Health outlines the pandemic’s unprecedented impacts on the mental health of America’s youth and families, as well as the mental health challenges that existed long before the pandemic. More information on this announcement can be found here.
  • On December 8, 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it is accepting applications for the first-ever SAMHSA Harm Reduction grant program and expects to issue $30 million in grant awards. This funding, authorized by the American Rescue Plan, will help increase access to a range of community harm reduction services and support harm reduction service providers as they work to help prevent overdose deaths and reduce health risks often associated with drug use. SAMHSA will accept applications from State, local, Tribal, and territorial governments, Tribal organizations, non-profit community-based organizations, and primary and behavioral health organizations. More information on this announcement can be found here.
  • On December 8, 2021, HHS and the Department of Housing and Urban Development (HUD) announced the expansion of a partnership established earlier this year to improve access to affordable, accessible housing and the critical services that make community living possible. The partners also announced the launch of a national Housing and Services Resource Center (HSRC) as the hub of this coordinated federal effort. More information on this partnership can be found here.
  • On December 9, 2021, CMS released a new monthly National Marketplace Open Enrollment report shows that, so far, nearly 4.6 million Americans have signed up for 2022 health coverage through HealthCare.gov and State-based Marketplaces since the start of the 2022 Open Enrollment Period on November 1. The assistance from the American Rescue Plan continues to drive affordability and accessibility of health coverage with the number of consumers getting coverage for $10 or less per month after tax credits nearly doubling compared to this time last year. Ninety five percent of consumers in HealthCare.gov states are receiving premium tax credits to lower the cost of their monthly premiums. More information on this report can be found here.
  • On December 9, 2021, FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. More information on this action can be found here.
  • On December 9, 2021, HHS Secretary Xavier Becerra launched the Biden-Harris Administration’s White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders (WHIAANHPI) and announced U.S. Trade Representative Ambassador Katherine Tai as his co-chair of both the White House Initiative and the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. More information on this initiative can be found here.
  • On December 10, 2021, HHS announced several actions it had taken this week to improve maternal health outcomes. In particular, on December 7, 2021, the White House hosted the first-ever Maternal Health Day of Action with a nationwide call-to-action to address maternal mortality and morbidity. CMS announced that it plans to establish a national “Birthing-Friendly” hospital designation to drive improvements in perinatal health outcomes and maternal health equity. It also issued guidance on states’ implementation of a new state plan option established by the American Rescue Plan (ARP), which will allow states to provide 12 months of extended postpartum coverage to pregnant individuals enrolled in Medicaid and CHIP, beginning April 1, 2022. Finally, HRSA awarded $82 million in ARP emergency home visiting funds to 56 states, jurisdictions, and nonprofit organizations to support children and families affected by the COVID-19 pandemic. This funding builds upon an initial investment of $40 million in ARP funds in May. The Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program supports the delivery of high quality, voluntary, evidence-based home visiting services to children and families living in communities at risk for poor maternal and child health outcomes. More information on these actions can be found here.

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