Health Care Week in Review May 6, 2022

Alston & Bird Health Care Week in Review, May 6, 2022

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care 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 $3 million in funding for the launch of the Maternal Mental Health Hotline and $25 million for school-based health services. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

Event Notices

  • May 13, 2022: HHS announced a public meeting of the Office of Global Affairs in preparation for the 75th World Health Assembly. The agenda includes a discussion of relevant topics that will be discussed at the World Health Assembly.
  • May 19, 2022: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on the use of COVID-19 vaccines. A recommendation vote is scheduled.
  • June 2, 2022: CDC announced a public meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following: the Healthcare Personnel Guideline Workgroup; Isolation Precautions Guideline Workgroup; and Neonatal Intensive Care Unit Workgroup.
  • June 7-8, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Mental Health Council. The agenda includes a presentation of the National Institute of Mental Health (NIMH) Director's Report and discussion of NIMH programs.
  • June 7-10, 2022: The Centers for Medicare & Medicaid Services (CMS) announced a series of public meetings for new revisions to the Healthcare Common Procedure Coding System (HCPCS) coding. The agenda will include discussions of CMS’ preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set. The June meetings will also include preliminary Medicare benefit category and payment determinations for codes effective January 1, 2020 to April 1, 2022, continuous glucose monitor and related supplies and accessories coding and payment determinations, and additional items added by CMS to address Medicare benefit category or payment determinations.
  • June 8, 2022: FDA announced a public meeting of the Pharmacy Compounding Advisory Committee. The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione.
  • June 15, 2022: NIH announced a public meeting of the National Heart, Lung, and Blood Institute. The meeting agenda will include a discussion of program policies and issues.
  • June 15-16, 2022: HHS announced a public meeting of the National Vaccine Advisory Committee. The agenda will include presentations on innovation for immunization, vaccine safety, and communication, and surveillance.
  • June 17, 2022: FDA announced a public meeting of the Psychopharmacologic Drugs Advisory Committee. The committee will discuss supplemental new drug applications 210793-s008 and 207318-s011, efficacy supplement resubmission for NUPLAZID (pimavanserin) tablets, submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.

II. Congressional Hearings

U.S. Senate

  • On May 4, 2022, the Senate Committee on Appropriations Subcommittee on Labor, Health and Humans Services, Education, and Related Agencies held a hearing entitled, A Review of the President’s FY 2023 Funding Request and Budget Justification for the Department of Health and Human. Witnesses present included: The Honorable Xavier Becerra, Secretary, HHS.
  • On May 5, 2022, the Senate Committee on Commerce, Science, & Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing entitled, Ensuring Fairness and Transparency in the Market for Prescription Drugs. Witnesses present included: David Balto, Antitrust Attorney, David A. Balto Law Offices; Robin Feldman, Professor and Researcher, UC Hastings College of Law; Craig Garthwaite, Professor and Director of the Program on Healthcare, Kellogg School of Management, Northwestern University; and JC Scott, President and CEO, Pharmaceutical Care Management Association.

III. Reports, Studies & Analyses

  • On May 3, 2022, the Kaiser Family Foundation (KFF) published a report entitled, An Overview of Medicaid Work Requirements: What Happened Under the Trump and Biden Administrations? KFF’s report details a recent history of Medicaid work requirements, which illustrates the tensions between states, changing presidential administrations, and the courts. This issue brief answers key questions about the history of Medicaid and work requirements, the impacts of Medicaid work requirements, and the current status and future of Medicaid work requirements.
  • On May 3, 2022, KFF published a report entitled, PrEP Access in the United States: The Role of Telehealth. This brief provides an overview of the tele-pre-exposure prophylaxis (PrEP) landscape, including how PrEP services (e.g., initial consults, lab work, prescribing, and ongoing monitoring) are provided and factors that facilitate its provision as well as barriers that remain. It is based on in-depth interviews conducted at the end of 2021 with representatives from the major national telehealth companies (those serving all or large portions of the U.S.) providing tele-PrEP and other select tele-PrEP programs. KFF also highlights two-state run programs – California and Iowa – and four community-based clinics that offer tele-PrEP programs. Collectively, the organizations included in this analysis are estimated to provide tele-PrEP services to over ten thousand clients.
  • On May 4, 2022, the Bipartisan Policy Center (BPC) published a report entitled, The Impact of COVID-19 on the Rural Health Care Landscape. BPC conducted a series of interviews over the last year with rural hospital leaders from eight states—Iowa, Minnesota, Montana, Nebraska, Nevada, North Dakota, South Dakota, and Wyoming—as well as with health policy experts from federal and state government, national organizations, provider organizations, and academia. The goal was to gain on-the-ground insights into today’s rural health care landscape, where the population is older, sicker, and less likely to be insured or seek preventive services than in urban areas.

IV. Other Health Policy New

  • On May 3, 2022, HHS announced nearly $25 million to improve and strengthen access to school-based health services in communities across the country. Awards will support local partnerships between schools and health centers to provide children and youth the comprehensive physical and mental health care they need. Health centers will use this funding to reduce disparities and improve access to care by increasing the number of young people receiving essential health care, including mental health services. Health centers will also use these funds for activities such as community and patient outreach, health education, and translation support. More information on this funding can be found here.
  • On May 4, 2022, HHS announced $55 million in funding for its Tribal Opioid Response (TOR) grant program. This program reflects HHS’ commitment to evidence-based programs addressing opioid and stimulant misuse in tribal communities, as well as the Biden-Harris Administration’s Unity Agenda item of combatting addiction. The TOR grant program addresses the overdose crisis in tribal communities by increasing access to FDA-approved medications for the treatment of opioid misuse, and supporting prevention, harm reduction, treatment, and recovery support services for opioid and stimulant misuse and co-occurring mental and substance use conditions. Funding will be provided each year for up to 150 grantees over a two-year project period, beginning late FY 2022. More information about this funding can be found here.
  • On May 6, 2022, the Health Resources and Services Administration (HRSA) announced the launch of the Maternal Mental Health Hotline, a new, confidential, toll-free hotline for expecting and new moms experiencing mental health challenges. With an initial $3 million investment, the hotline will launch on Mother’s Day, May 8, 2022, with counselors available to provide mental health support. President Biden’s Fiscal Year 2023 Budget would more than double this initial investment, allowing HRSA to expand the Maternal Mental Health Hotline’s expert staffing and build additional capacity in its future phases. Those who contact the hotline can receive a range of support, including brief interventions from trained counselors who are culturally and trauma-informed, as well as referrals to both community-based and telehealth providers as needed. Callers also will receive evidence-based information and referrals to support groups and other community resources. More information on this action can be found here.

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

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