Alston & Bird Health Care Week In Review, September 24, 2021 – Food, Drugs, Healthcare, Life Sciences

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) authorized a
booster dose of the Pfizer-BioNTech COVID-19 vaccine for certain
populations. Read more about this authorization and other news
below.

I. Regulations, Notices & Guidance

• On September 20, 2021, the Department of Health and Human
  Services (HHS) and the Department of the Treasury issued a final
  rule entitled, Patient Protection and Affordable Care Act;
  Updating Payment Parameters, Section 1332 Waiver Implementing
  Regulations, and Improving Health Insurance Markets for 2022 and
  Beyond. This final rule sets forth revised 2022
  user fee rates for issuers offering qualified health plans (QHPs)
  through federally-facilitated Exchanges and State-based Exchanges
  on the Federal platform; repeals separate billing requirements
  related to the collection of separate payments for the portion of
  QHP premiums attributable to coverage for certain abortion
  services; expands the annual open enrollment period and Navigator
  duties; implements a new monthly special enrollment period for
  qualified individuals or enrollees, or the dependents of a
  qualified individual or enrollee, who are eligible for advance
  payments of the premium tax credit (APTC) and whose household
  income does not exceed 150 percent of the Federal poverty level,
  available during periods of time during which APTC benefits are
  available such that certain applicable taxpayers’ applicable
  percentage is set at zero, such as during tax years 2021 and 2022
  under the section 9661 of the American Rescue Plan Act of 2021;
  repeals the recent establishment of a Direct Enrollment option for
  Exchanges; and modifies regulations and policies related to section
  1332 waivers.




• On September 20, 2021, the Food and Drug Administration (FDA)
  issued a notice of availability entitled, Final Administrative Orders for
  Over-the-Counter Monographs. FDA is announcing certain
  final administrative orders, including for over-the-counter (OTC)
  drug monographs, that were deemed to be final orders by the
  Coronavirus Aid, Relief, and Economic Security Act (CARES Act),
  which added a new section to the Federal Food, Drug, and Cosmetic
  Act (FD&C Act). FDA is also announcing the process for making
  these final orders available. Finally, FDA is announcing its plan
  for withdrawing regulations that established final OTC drug
  monographs prior to the passage of the CARES act, and withdrawing
  or making technical changes to the procedures governing the OTC
  drug review.




• On September 22, 2021, FDA issued draft guidance entitled, Donor Eligibility for Animal Cells, Tissues,
  and Cell- and Tissue-Based Products. This
  guidance is for sponsors, firms, individuals, and establishments
  that participate in the manufacture of, or perform any aspect of,
  the donor eligibility determination for animal cells, tissues, and
  cell- and tissue-based products (ACTPs).




• On September 22, 2021, FDA issued draft guidance entitled, Good Manufacturing Practices for Animal Cells,
  Tissues, and Cell- and Tissue-Based Products.
  This guidance provides establishments that manufacture animal
  cells, tissues, and cell- and tissue-based products (ACTPs) meeting
  the definition of new animal drugs with recommendations for meeting
  requirements for current good manufacturing practices (CGMPs).




• On September 23, 2021, FDA issued a notice of availability
  entitled, Revocation of Three Authorizations of Emergency
  Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis
  of COVID-19. This notice announces the revocation of the
  Emergency Use Authorizations (EUAs) issued to Gravity Diagnostics,
  LLC for the Gravity Diagnostics COVID-19 Assay, Materials and
  Machines Corporation of America (DBA MatmaCorp, Inc.) for the
  MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. for the
  Guardant-19.




• On September 24, 2021, FDA issued a notice of availability
  entitled, Amending Over-the-Counter Monograph M020:
  Sunscreen Drug Products for Over-The-Counter Human Use; Over The
  Counter Monograph Proposed Order. FDA is issuing
  this proposed order to amend and revise the deemed final
  administrative order concerning nonprescription sunscreen drug
  products established by the enactment of the Coronavirus Aid,
  Relief, and Economic Security Act (CARES Act). This proposed order,
  if finalized, would replace the Deemed Final Order in its entirety
  with new conditions under which nonprescription sunscreen drug
  products would be determined to be generally recognized as safe and
  effective (GRASE) under the Federal Food, Drug, and Cosmetic Act
  (FD&C Act). It also sets forth certain characteristics that
  would establish that a sunscreen drug product is not GRASE.




• On September 24, 2021, the Health Resources and Services
  Administration (HRSA) issued a notice entitled, Criteria for Determining Maternity Care Health
  Professional Target Areas. HRSA is authorized by the HHS
  Secretary to establish the criteria which will be used to determine
  maternity care health professional target areas (MCTAs) in existing
  primary care Health Professional Shortage Areas (HPSAs). This
  notice sets forth the proposed criteria which will be used to
  identify and score MCTAs.

Event Notices

• October 13, 2021: The National
  Institutes of Health (NIH) announced a virtual public meeting of the
  Interagency Autism Coordinating Committee. The purpose of the IACC
  meeting is to discuss business, agency updates, and issues related
  to autism spectrum disorder (ASD) research and services
  activities.




• October 15, 2021: NIH announced a virtual public meeting of the
  Clinical Center Research Hospital Board. The meeting will include
  the CEO Update, Patient Safety and Clinical Quality Update, and
  discuss other business of the Board.




• October 20-21, 2021: The Centers for
  Disease Control and Prevention (CDC) announced a virtual public meeting of the
  Advisory Committee on Immunization Practices (ACIP). The committee
  is charged with advising the Director, CDC, on the use of
  immunizing agents. The agenda will include discussions on adult
  immunization schedule, child/adolescent immunization schedule,
  Ebola vaccine, hepatitis vaccines, herpes zoster vaccines,
  Orthopoxviruses vaccine, influenza vaccines, pneumococcal vaccine,
  cholera vaccine and tickborne encephalitis vaccine.




• October 22, 2021: NIH announced a virtual public meeting of the
  National Advisory Eye Council of the National Eye Institute. There
  will be a presentation of the NEI Director’s report and
  discussion of Data Sharing and Management as well as NEI programs.
  The meeting will also review and evaluate grant applications.




• October 26, 2021: NIH announced a virtual public meeting of the
  National Heart, Lung, and Blood Advisory Council. The meeting will
  discuss program policies and issues and review and evaluate grant
  applications.




• October 27, 2021: The Substance Abuse
  and Mental Health Services Administration (SAMHSA) announced a virtual public meeting of the
  Interdepartmental Serious Mental Illness Coordinating Committee
  (ISMICC). The meeting will address feedback from the ISMICC members
  regarding the final report to Congress and include information on
  federal efforts related to serious mental illness (SMI) and serious
  emotional disturbance (SED).




• November 2, 2021: FDA announced a virtual public meeting to discuss
  proposed recommendations for the reauthorization of the Biosimilar
  User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. The
  BsUFA authorizes FDA to collect user fees to support the process
  for the review of biosimilar biological product applications. The
  current legislative authority for BsUFA expires in September
  2022.




• November 2, 2021: CDC announced a virtual public meeting of the Board
  of Scientific Counselors, Center for Preparedness and Response
  (BSC, CPR). The Board is charged with providing advice and guidance
  to the Secretary, Department of Health and Human Services (HHS),
  the Assistant Secretary for Health (ASH), the Director, Centers for
  Disease Control and Prevention (CDC), and the Director, Center for
  Preparedness and Response (CPR), concerning strategies and goals
  for the programs and research within CPR, monitoring the overall
  strategic direction and focus of the CPR Divisions and Offices, and
  administration and oversight of peer review for CPR scientific
  programs.




• November 3, 2021: The Health
  Resources and Services Administration (HRSA) announced a virtual public meeting of the
  CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD
  Prevention and Treatment. The purpose of CHAC is to advise the
  Secretary of HHS, the Director of CDC, and the HRSA Administrator
  regarding objectives, strategies, policies, and priorities for HIV,
  viral hepatitis, and other STDs; prevention and treatment efforts,
  including surveillance of HIV infection, viral hepatitis, and other
  STDs, and related behaviors; epidemiologic, behavioral, health
  services, and laboratory research on HIV, viral hepatitis, and
  other STDs; identification of policy issues related to HIV/viral
  hepatitis/STD professional education, patient health care delivery,
  and prevention services; agency policies about prevention of HIV,
  viral hepatitis and other STDs; treatment, health care delivery,
  and research and training; strategic issues influencing the ability
  of CDC and HRSA to fulfill their missions of providing prevention
  and treatment services; programmatic efforts to prevent and treat
  HIV, viral hepatitis, and other STDs; and support to the CDC and
  HRSA in their development of responses to emerging health needs
  related to HIV, viral hepatitis, and other STDs.




• November 3, 2021: CDC announced a virtual public meeting of the
  Subcommittee on Procedures Reviews (SPR) of the Advisory Board on
  Radiation and Worker Health (ABRWH) for the National Institute for
  Occupational Safety and Health (NIOSH). The Advisory Board is
  charged with (a) providing advice to the Secretary, HHS, on the
  development of guidelines; (b) providing advice to the Secretary,
  HHS, on the scientific validity and quality of dose reconstruction
  efforts performed for this program; and (c) advise the Secretary on
  whether there is a class of employees at any Department of Energy
  facility who were exposed to radiation but for whom it is not
  feasible to estimate their radiation dose, and on whether there is
  reasonable likelihood that such radiation doses may have endangered
  the health of members of this class.




• November 8, 2021: NIH announced a virtual public meeting of the
  Diabetes Mellitus Interagency Coordinating Committee (DMICC). The
  topic for this meeting will be “Evolving Concepts in the
  Assessment and Management of Hypoglycemia.”




• December 2, 2021: FDA announced a virtual public advisory committee
  meeting of the Oncologic Drugs Advisory Committee. The general
  function of the committee is to provide advice and recommendations
  to FDA on regulatory issues.




• December 8, 2021: FDA announced a virtual public advisory committee
  meeting of the Cardiovascular and Renal Drugs Advisory Committee.
  The general function of the committee is to provide advice and
  recommendations to FDA on regulatory issues.




• December 14-15, 2021: CMS announced a virtual public Town Hall Meeting to
  discuss fiscal year (FY) 2023 applications for add-on payments for
  new medical services and technologies under the hospital inpatient
  prospective payment system (IPPS).

II. Congressional Hearings

U.S. Senate

• On September 22, 2021, the Senate Committee on Finance held a
  hearing entitled, Hearing to Consider the Nominations of Christi
  A. Grimm, of Colorado, to be Inspector General, Department of
  Health and Human Services and Neil Harvey MacBride, of Virginia, to
  be General Counsel for the Department of the Treasury.
  Witnesses present included Christi A. Grimm, United States
  Department of Health and Human Services; and Neil Harvey MacBride,
  United States Department of the Treasury.

U.S. House of Representatives

• On September 22, 2021, the House Committee on Energy and
  Commerce Subcommittee on Oversight and Investigations held a
  hearing entitled, Putting Kids First: Addressing COVID-19’s
  Impacts on Children. Witnesses present included: Lee Savio
  Beers, M.D., F.A.A.P., President, American Academy of Pediatrics
  (AAP); Margaret G. Rush, M.D., President, Monroe Carell Jr.
  Children’s Hospital at Vanderbilt; Arthur Evans, Jr., Ph.D.,
  Chief Executive Officer, American Psychological Association (APA);
  Kelly Danielpour, Founder, VaxTeen; and Tracy Beth Hoeg, M.D.,
  Ph.D., Epidemiologist and Public Health Expert, Physical Medicine
  and Rehabilitation Research Associate, University of California,
  Davis, and Private Practice Physician.




• On September 22, 2021, the House Select Subcommittee on the
  Coronavirus Crisis hearing entitled, Recognizing and Building on the Success of
  Pandemic Relief Programs. Witnesses present included:
  Indivar Dutta-Gupta, Co-Executive Director, Georgetown Center on
  Poverty & Inequality, on behalf of Georgetown University Law
  Center; Douglas Holtz-Eakin, President, American Action Forum; H.
  Luke Shaefer, Professor of Social Justice and Social Policy,
  Associate Dean for Research and Policy Engagement, Gerald R. Ford
  School of Public Policy, on behalf of University of Michigan; Diane
  Whitmore Schanzenbach, Professor of Human Development and Social
  Policy, Director, Institute for Policy Research, on behalf of
  Northwestern University; and Starsky Wilson President,
  Children’s Defense Fund.

III. Reports, Studies & Analyses

• On September 20, 2021, the Government Accountability Office
  (GAO) published a report entitled, Electronic Health Records: DOD Has Made
  Progress in Implementing a New System, but Challenges
  Persist. GAO’s objectives were to (1)
  determine what progress the Department of Defense (DOD) has made
  toward implementing a new electronic health record system, and (2)
  identify the challenges and key risks to MHS GENESIS implementation
  and what steps DOD is taking to address them.




• On September 20, 2021, the HHS Office of Inspector General
  (OIG) published a report entitled, Opportunities Exist To Strengthen Evaluation
  and Oversight of Telehealth for Behavioral Health in
  Medicaid. This data brief provides insight into State
  evaluations and oversight of telehealth for behavioral health
  services as of January and February 2020, before the expansion of
  telehealth due to the COVID-19 pandemic. As States consider making
  telehealth expansions permanent, States can use information in this
  data brief to help determine which services best support enrollees.
  This data brief is a companion report to a data brief that
  describes the challenges States reported with using telehealth to
  provide behavioral health services to Medicaid enrollees.




• On September 21, 2021, GAO published a report entitled, Supplemental Security Income: SSA Faces Ongoing
  Challenges with Work Incentives and Improper
  Payments. Prior and ongoing GAO work has
  identified issues with the Social Security Administration’s
  (SSA) efforts to reduce improper payments, including overpayments,
  to Supplemental Security Income (SSI) beneficiaries in general and
  beneficiaries who are working in particular. This testimony
  describes SSA’s challenges with (1) incentivizing employment
  for SSI recipients who wish to work, and (2) preventing improper
  payments to SSI recipients, including overpayments.




• On September 21, 2021, the Kaiser Family Foundation (KFF)
  published a report entitled, Dental, Hearing, and Vision Costs and Coverage
  Among Medicare Beneficiaries in Traditional Medicare and Medicare
  Advantage. KFF previously analyzed dental
  coverage, use, and out-of-pocket spending among Medicare
  beneficiaries and provided an in-depth look at coverage of dental
  services in Medicare Advantage plans. This brief builds on that
  prior work by analyzing hearing and vision use, out-of-pocket
  spending and cost-related barriers to care among beneficiaries in
  traditional Medicare and Medicare Advantage, incorporating
  top-level findings from our analysis of dental services to provide
  a comprehensive profile of dental, hearing, and vision benefits in
  Medicare Advantage plans.




• On September 23, 2021, GAO published a report entitled, Health Care Capsule: Racial and Ethnic Health
  Disparities. The “capsule” draws from
  several GAO reports to provide examples of these health
  disparities, such as COVID-19, maternal mortality, chronic health
  conditions, as well as disparities among veterans. GAO also offers
  policy considerations to help the federal government better
  understand health disparities and promote health equity.

IV. Other Health Policy News

• On September 17, 2021, HHS announced that beginning this year,
  consumers will have an extra 30 days to review and choose health
  plans through Open Enrollment, which will run from November 1, 2021
  through January 15, 2022, on HealthCare.gov. The Centers for
  Medicare & Medicaid Services (CMS) is also expanding services
  provided by Federally-facilitated Marketplace (FFM) Navigators and
  will re-launch its “Champions for Coverage” program. The
  program currently includes more than 1,000 local organizations that
  are active in providing outreach and education about the Health
  Insurance Marketplace and how consumers can enroll in coverage
  through HealthCare.gov, Medicaid, or the Children’s Health
  Insurance Program (CHIP). More information on this announcement can
  be found here.




• On September 17, 2021, HHS announced nearly $350 million in
  awards to every state across the nation to support safe pregnancies
  and healthy babies. Funding will expand home visiting services to
  families most in need, increase access to doulas, address health
  disparities in infant deaths, and improve data reporting on
  maternal mortality. The Health Resources and Services
  Administration (HRSA) awarded these funds. More information on this
  announcement can be found here.




• On September 17, 2021, HHS Secretary Xavier Becerra announced
  new resources and actions to protect reproductive health care for
  Texans, in response to President Joe Biden’s directive.
  Following the passage of SB 8, President Biden launched a
  whole-of-government response and directed HHS to explore options to
  bolster access to safe and legal abortions in Texas. Secretary
  Becerra is announcing measures HHS will take, including grant
  support for clinics, and resources that outline protections for
  health care personnel, and reinforcement of legal protections for
  pregnant individuals or persons experiencing pregnancy loss in
  Texas. More information on this announcement can be found here.




• On September 21, 2021, CMS awarded $15 million in planning
  grants to 20 states to support expanding community-based mobile
  crisis intervention services for Medicaid beneficiaries. The
  planning grants—funded by the ARP—provide financial
  resources for state Medicaid agencies to assess community needs and
  develop programs to bring crisis intervention services directly to
  individuals who are experiencing a substance use-related or mental
  health crisis outside a hospital or facility setting. These grants
  will help states integrate community-based mobile crisis
  intervention services into their Medicaid programs, a critical
  component of establishing a sustainable and public health-focused
  crisis support network. More information on this announcement can
  be found here.




• On September 21, 2021, CMS made it easier to check COVID-19
  vaccination rates for nursing home staff and residents with a new
  feature on Medicare.gov. It made vaccination data available in a
  user-friendly format to help people make informed decisions when
  choosing a nursing home for themselves or a loved one. CMS and CDC
  are also continuing to use this data to monitor vaccine uptake
  among residents and staff and to identify facilities that may need
  additional resources or assistance to respond to the pandemic. More
  information about this announcement can be found here.




• On September 22, 2021, FDA amended the emergency use
  authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to
  allow for use of a single booster dose, to be administered at least
  six months after completion of the primary series in: individuals
  65 years of age and older; individuals 18 through 64 years of age
  at high risk of severe COVID-19; and individuals 18 through 64
  years of age whose frequent institutional or occupational exposure
  to SARS-CoV-2 puts them at high risk of serious complications of
  COVID-19 including severe COVID-19. More information on this
  announcement can be found here.




• On September 22, 2021, HHS Office of the National Coordinator
  for Health Information Technology (ONC) awarded $73 million in
  cooperative agreements as part of its Public Health Informatics
  & Technology Workforce Development Program (PHIT Workforce
  Program). Announced earlier this year and funded through the
  American Rescue Plan, the program aims to strengthen U.S. public
  health information technology (IT) efforts, improve COVID-19 data
  collection, and increase representation of underrepresented
  communities within the public health IT workforce. ONC will support
  the overall administration of the program. More information about
  this announcement can be found here.




• On September 24, 2021, CMS announced that following FDA’s
  recent action that authorized a booster dose of the Pfizer COVID-19
  vaccine for certain high-risk populations and a recommendation from
  CDC, CMS will continue to provide coverage for this critical
  protection from the virus, including booster doses, without cost
  sharing. Beneficiaries with Medicare pay nothing for COVID-19
  vaccines or their administration, and there is no applicable
  copayment, coinsurance or deductible. In addition, thanks to the
  American Rescue Plan Act of 2021 (ARP), nearly all Medicaid and
  CHIP beneficiaries must receive coverage of COVID-19 vaccines and
  their administration, without cost-sharing. COVID-19 vaccines and
  their administration, including boosters, will also be covered
  without cost-sharing for eligible consumers of most issuers of
  health insurance in the commercial market. More information about
  this announcement can be found here.

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