Alston & Bird Health Care Week In Review, March 25, 2022 – Food, Drugs, Healthcare, Life Sciences



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Alston & Bird Health Care Week In Review, March 25, 2022


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Below is Alston & Bird’s Health Care Week in
Review
, which supplies a synopsis of the newest information in
healthcare rules, notices, and steering; federal laws
and congressional committee motion; experiences, research, and analyses;
and different well being coverage information.

Week in Review Highlight of the Week:

This week, HHS introduced greater than $413 million in Provider
Relief Fund (PRF) funds to greater than 3,600 suppliers throughout the
nation. Read extra about this announcement and different information
under.

I. Regulations, Notices & Guidance

  • On March 21, 2022, the Administration for Children and Families
    issued a request for info entitled, Technical Assistance Needs and Priorities on
    Implementation and Coordination of Early Childhood Development
    Programs in American Indian and Alaska Native Communities
    .
    Through this Request for Information (RFI), ACF seeks to additional
    the event, implementation, and coordination of early
    childhood growth packages in American Indian and Alaska Native
    (AI/AN) communities, by soliciting info and proposals
    from a broad array of people and organizations with information
    and experience across the context and desires of tribal communities
    and early childhood packages.

  • On March 21, 2022, the Food and Drug Administration (FDA)
    issued an Emergency Use Authorization (EUA) entitled, Certain Medical Devices During
    COVID-19
    . FDA is asserting the issuance of EUAs for
    sure medical gadgets associated to the Coronavirus Disease 2019
    (COVID-19) public well being emergency.

  • On March 22, 2022, FDA issued a ultimate steering
    entitled, Certain Ophthalmic Products, Policy Regarding
    Compliance
    This steering describes
    FDA’s compliance coverage with respect to the necessities of FDA
    rules that at the moment are relevant to ophthalmic medicine which might be
    packaged with eye cups, eye droppers, and different dispensers supposed
    for ophthalmic use.

  • On March 22, 2022, FDA issued a discover with a request for
    feedback entitled, Prioritizing the Addition of Maximum Daily
    Exposure Information and Removing Dosage Form Information From the
    Inactive Ingredient Database; Establishment of a Public Docket;
    Request for Comments
    . FDA is asserting the institution
    of a docket to solicit feedback that can help FDA in figuring out
    how finest to prioritize the addition of most every day publicity (MDE)
    info for inactive elements that don’t at present embrace
    MDE info within the Center for Drug Evaluation and
    Research’s Inactive Ingredient Database (IID) and whether or not to
    restructure the IID by eradicating dosage type info.

  • On March 22, 2022, the Occupational Safety and Health
    Administration (OSHA) issued a discover entitled, Occupational Exposure to COVID-19 in Healthcare
    Settings
    . OSHA is partially reopening the remark interval
    to permit for extra public touch upon particular matters and is
    scheduling a casual public listening to on its interim ultimate rule
    establishing an Emergency Temporary Standard (ETS),
    “Occupational Exposure to COVID-19.” The public listening to
    will start on April 27, 2022.

  • On March 24, 2022, the Department of Veterans Affairs (VA)
    issued an extension of remark interval for a proposed rule
    entitled, VA Pilot Program on Graduate Medical Education
    and Residency
    . The VA is extending the remark interval of
    the proposed rule “Pilot Program on Graduate Medical Education
    and Residency.” This motion is being taken in response to
    requests from stakeholders to permit further time for
    individuals to submit feedback on the proposed rule.

  • On March 25, 2022, the Health Resources and Services
    Administration (HRSA) issued a discover entitled, Solicitation of Nominations for Membership to
    Serve on the Advisory Committee on Heritable Disorders in Newborns
    and Children
    . HRSA is in search of nominations of certified
    candidates for consideration for appointment as members of the
    Advisory Committee on Heritable Disorders in Newborns and Children
    (ACHDNC or Committee). ACHDNC supplies recommendation, suggestions, and
    technical details about facets of heritable issues and
    new child and childhood screening to the Secretary of HHS.

  • On March 25, 2022, the Health Resources and Services
    Administration (HRSA) issued a discover entitled, Solicitation of Nominations for Organizational
    Representatives to the Advisory Committee on Heritable Disorders in
    Newborns and Children
    . HRSA is in search of nominations from
    organizations to ship representatives to be a liaison to the
    ACHDNC. Selections shall be primarily based on a evaluation of the
    group’s topic space of experience, mission, relevancy,
    and profit offered relative to the Committee’s goal. The
    organizational representatives are non-voting liaisons.

Event Notices

  • March 28-29, 2022:  The National
    Institutes of Health (NIH) introduced a public assembly of the National
    Cancer Institute Board of Scientific Advisors. The agenda will
    embrace the Director’s Report; RFA, RFP, and PAR Concept
    Reviews; and Scientific Presentations.

  • March 30, 2022:  The Department
    of Defense (DOD) introduced a public assembly of the Defense
    Health Board. The DHB supplies unbiased recommendation and
    suggestions to maximise the security and high quality of, in addition to
    entry to, well being look after DoD well being care beneficiaries. The
    goal of the assembly is to offer briefings to DHB members on
    present points associated to navy medication and upcoming DHB
    taskings.

  • April 5-7, 2022:  VA introduced a public assembly of the
    Veterans’ Rural Health Advisory Committee. The agenda will
    embrace updates from Department management; the Executive Director,
    VA Office of Rural Health; and the Committee Chair; in addition to
    shows by subject material specialists on basic rural well being
    care entry.

  • April 6, 2022:  FDA introduced a public advisory committee
    assembly of the Vaccines and Related Biological Products Advisory
    Committee (VRBPAC). The basic perform of the committee is to
    present recommendation and proposals to FDA on regulatory points.
    This assembly shall be held to debate concerns to be used of
    COVID-19 vaccine booster doses and the method for COVID-19 vaccine
    pressure choice to handle present and rising variants.

  • April 7, 2022:  The Centers for
    Medicare & Medicaid Services (CMS) introduced the subsequent assembly of the Advisory
    Panel on Outreach and Education (APOE). The Panel advises and makes
    suggestions to the Secretary of HHS and the Administrator of
    CMS on alternatives to reinforce the effectiveness of client
    training methods regarding the Health Insurance
    Marketplace®, Medicare, Medicaid, and the Children’s Health
    Insurance Program (CHIP).

  • April 7, 2022:  NIH issued an amended discover for a public
    assembly of the National Heart, Lung, and Blood Institute Sleep
    Disorders Research Advisory Board. The assembly is being amended to
    change the phone name in quantity.

  • April 27-28, 2022:  HHS introduced a public assembly of the
    Tick-Borne Disease Working Group. For this assembly, the TBDWG will
    be discussing and voting on suggestions for the 2022 TBDWG
    Report to the HHS Secretary and Congress.

  • May 2-3, 2022:  HHS introduced a public assembly of the Eunice
    Kennedy Shriver National Institute of Child Health and Human
    Development National Advisory Board on Medical Rehabilitation
    Research. The agenda will embrace the NICHD Director’s report;
    NCMRR Director’s report; Research discuss on Peripheral Nerve
    Regeneration; Concept Clearance; Mini Symposium on Assessments for
    Rehabilitation (neurophysiologic and medical measures).

  • Various Dates:  HRSA introduced a public assembly of the National
    Advisory Committee on Rural Health and Human Services (NACRHHS).
    NACRHHS will focus on two matters throughout the assembly: entry to
    Emergency Medical Services in Rural America and Rural Human
    Services Programs and Issues.

  • Various Dates:  The Federal
    Emergency Management Agency (FEMA) introduced that it’s holding conferences
    underneath the Plan of Action to Establish a National Strategy for the
    Manufacture, Allocation, and Distribution of Medical Devices to
    Respond to COVID-19 and the Plan of Action to Establish a National
    Strategy for the Manufacture, Allocation, and Distribution of Drug
    Products, Drug Substances, and Associated Medical Devices to
    Respond to COVID-19, with a purpose to implement the Voluntary Agreement
    for the Manufacture and Distribution of Critical Healthcare
    Resources Necessary to Respond to a Pandemic.

II. Congressional Hearings

U.S. Senate

  • On March 21, 2022 by March 24, 2022, the Senate Committee
    on the Judiciary held 4 hearings on the Nomination of Ketanji Brown Jackson to be an
    Associate Justice of the Supreme Court of the United
    States
    . Witnesses current included: the Honorable Ketanji
    Brown Jackson.

  • On March 23, 2022, the Senate Committee on Health, Education,
    Labor and Pensions (HELP) held a listening to entitled, Strengthening Federal Mental Health and
    Substance Use Disorder Programs: Opportunities, Challenges, and
    Emerging Issues
    Witnesses current
    included: Miriam E. Delphin-Rittmon, PhD, Assistant Secretary for
    Mental Health and Substance Use, Substance Abuse and Mental Health
    Services Administration (SAMSHA), Rockville, MD; Carole Johnson,
    Administrator, Health Resources and Services Administration (HRSA),
    Rockville, MD; Joshua A. Gordon, M.D., PHD, Director, National
    Institutes of Mental Health (NIMH), National Institutes of Health
    (NIH), Bethesda, MD; and Nora D. Volkov, M.D., Director, National
    Institute on Drug Abuse (NIDA), National Institutes of Health
    (NIH).

  • On March 23, 2022, the Senate Special Committee on Aging held a
    listening to entitled, An Economy That Cares: The Importance of
    Home-Based Services
    Witnesses current
    included: Ms. Lisa Harootunian, Associate Director, Health Program,
    Bipartisan Policy Center; Ms. Anne Tumlinson, CEO, ATI Advisory and
    Founder, Daughterhood; Mr. Brandon Kingsmore, Disability Advocate,
    Public Speaker and Accompanied by Ms. Lynn Weidner, Home Care
    Worker, United Homecare Workers of Pennsylvania – SEIU
    Healthcare PA; and Ms. Alene Shaheed, Home Care Recipient and
    Former Florida Health Justice Project Client.

III. Reports, Studies & Analyses

  • On March 21, 2022, Alston & Bird revealed an advisory
    entitled, Blockchain & Digital Assets Advisory:
    Breaking Down Key Areas of Biden’s Executive Order on Ensuring
    Responsible Development of Digital
    Assets
    . President’s Biden’s
    complete-of-authorities method is clear in his Executive Order
    managing the newest points surrounding digital property. In this
    advisory, Alston & Bird’s Blockchain and Digital Assets
    Team unravels the myriad authorized points throughout cybersecurity, the
    funds business, monetary companies, environmental considerations, and
    white collar crime.

  • On March 24, 2022, the Kaiser Family Foundation (KFF) revealed
    a problem transient entitled, How Does Use of Mental Health Care Vary by
    Demographics and Health Insurance Coverage?
    . In this challenge
    transient, KFF explores how the usage of psychological well being care diversified throughout
    populations reporting poor psychological well being earlier than the pandemic utilizing
    information from the National Health Interview Survey (NHIS) in 2019. In
    this evaluation, KFF finds that main as much as the pandemic, 8.5
    million adults reported reasonable to extreme signs of hysteria
    and/or melancholy however didn’t obtain remedy both by
    remedy or prescribed drugs up to now yr. Among adults
    reporting reasonable to extreme signs of hysteria and/or melancholy,
    receipt of psychological well being remedy was lowest amongst a number of
    demographic teams – together with younger adults, Black adults,
    males, and uninsured folks. These information present a helpful baseline for
    understanding disparities in psychological well being remedy that had been
    already current earlier than the pandemic, and should have been exacerbated
    by the general public well being disaster.

  • On March 24, 2022, KFF revealed a problem transient
    entitled, Out-of-pocket spending on insulin amongst folks
    with non-public insurance coverage
    Several legislative
    proposals in Congress suggest a $35 monthly cap on what folks
    with medical health insurance must pay out of pocket for insulin,
    a life-saving hormone taken usually by many individuals with diabetes
    to keep up their well being. In this evaluation, KFF seems at claims
    information from non-public well being plans to evaluate what number of insulin customers
    would possibly get monetary savings with a $35 month-to-month cap on out-of-pocket prices in
    the person, small group and huge group markets.
    This evaluation of insurance coverage claims information finds that such a
    cap may present monetary aid to a minimum of 1 out of 5 insulin
    customers with various kinds of non-public medical health insurance.

IV. Other Health Policy News

  • On March 18, 2022, HHS, by the Substance Abuse and Mental
    Health Services Administration (SAMHSA), introduced three funding
    alternatives to strengthen psychological well being and substance use
    companies for people in danger for or dwelling with HIV/AIDS.
    Totaling $43.7 million {dollars}, the funding alternatives mirror
    the Biden-Harris Administration’s dedication to offering
    accessible, proof-primarily based, culturally applicable substance use
    prevention, remedy and restoration companies to all as a part of
    HHS’s new Overdose Prevention Strategy. Funding shall be awarded
    within the fall. The grants, that are being deployed to assist
    underserved communities, are supported by the Minority AIDS
    Initiative and align with the Administration’s precedence of
    well being fairness. The funding targets areas of the nation with the
    best disparities in HIV-associated well being outcomes and aligns with
    the National HIV AIDS Strategy. More info on this funding
    could be discovered right here.

  • On March 22, 2022, HHS, by the Health Resources and
    Services Administration (HRSA), introduced greater than $413 million in
    Provider Relief Fund (PRF) funds to greater than 3,600 suppliers
    throughout the nation. This is the fourth spherical of PRF Phase 4
    funds, totaling practically $12 billion that has been distributed to
    greater than 82,000 suppliers in all 50 states, Washington D.C., and
    5 territories since November 2021. This is along with
    HRSA’s distribution of American Rescue Plan (ARP) Rural
    funds totaling practically $7.5 billion in funding to greater than
    44,000 suppliers throughout the nation over the previous 4 months. More
    info on this announcement could be discovered right here.

  • On March 23, 2022, HHS launched a brand new report highlighting information
    on the 2022 Open Enrollment Period and key well being care protection
    good points made underneath the Biden-Harris Administration. The “State
    of the ACA” report, revealed by CMS, exhibits that the
    Affordable Care Act is on the strongest it has ever been.
    Nationwide, 2.8 million extra customers are receiving tax credit in
    2022 in comparison with 2021. Nearly 6 million new customers signed up for
    protection by the Marketplaces nationwide throughout the 2021
    Special Enrollment Period (SEP) and this yr’s Open Enrollment
    Period (OEP). This consists of 2.8 million individuals who newly enrolled
    throughout the SEP and greater than 3 million who newly enrolled throughout
    the OEP. More info on this report could be discovered right here. The full report could be discovered right here.

  • On March 24, 2022, HHS, by SAMHSA, introduced two Certified
    Community Behavioral Health Clinics (CCBHCs) funding alternatives
    to broaden and enhance entry to proof-primarily based psychological well being and
    substance use companies for all Americans. This consists of offering
    important psychological well being companies—reminiscent of 24-hour cell
    disaster groups, screening, and case administration—to susceptible
    communities that may in any other case lack entry to companies. Totaling
    greater than $300 million, these funding alternatives mirror the
    Biden-Harris Administration’s commitments to addressing the
    nation’s psychological well being disaster and overdose epidemic as a part of
    the President’s Unity Agenda. More info on these
    bulletins could be discovered right here.

  • On March 24, 2022, HHS Secretary Xavier Becerra and U.S.
    Education Department (ED) Secretary Miguel A. Cardona reaffirmed
    their dedication to youngsters and youth by launching a
    joint-division effort to broaden faculty-primarily based well being companies,
    making certain youngsters have the well being companies and helps crucial
    to construct resilience and thrive. The COVID-19 pandemic has
    challenged the well being and wellbeing of the Nation’s youngsters
    and youth and additional exacerbated preexisting inequities. HHS and
    the ED have joined collectively to offer further technical
    help, sources and help to colleges that can present
    steering on the federal funding out there for college-primarily based bodily
    and behavioral well being companies, together with how Medicaid can help
    the supply of those companies; assist cut back federal administrative
    burden for states and localities, together with native academic
    companies, and limitations to the supply of college-primarily based bodily
    and behavioral well being companies; and enhance and strengthen entry
    to bodily and behavioral well being companies. More info on
    this effort could be discovered right here.

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