December 9, 2022

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

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United States:

Alston & Bird Health Care Week In Review, September 24, 2021


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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

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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