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COVID-19: Post-PHE Planning; Pediatric Booster Authorized

In a May 10 letter, the Department of Health and Human Services (HHS) urged governors to ramp up their efforts to plan for Medicaid redeterminations and the end of the COVID-19 public health emergency (PHE).

The letter reviews current guidance and resources to support states’ return to normal Medicaid operations. HHS strongly recommends states use the entire 12-month unwinding period for Medicaid redeterminations to prevent improper coverage terminations. The department also urges state Medicaid agencies to review flexible options adopted during the PHE that are set to expire with the PHE to determine which ones they would like to maintain.

Further, HHS states the department does not know when the PHE will end but is committed to providing at least 60 days’ notice before the PHE expires. The latest PHE extension is effective April 16 through July 15.

CDC, ASPR to Hold Hospital Data Reporting Listening Sessions

The Centers for Disease Control and Prevention (CDC) and Office of the Assistant Secretary for Preparedness and Response (ASPR) will host two virtual listening sessions on the proposed hospital data reporting portion of the fiscal year 2023 Inpatient Prospective Payment System and Long-term Care Hospital Prospective Payment System proposed rule.

The Centers for Medicare & Medicaid Services will describe proposed hospital data reporting provisions for COVID-19 after the current PHE ends, along with future PHE declarations related to acute respiratory illness, SARS-CoV-2/COVID-19, and other viral and bacterial pathogens or infectious diseases. The agency will accept comments on the rule through June 17.

The May 24 listening session is geared toward state, territorial, local, and tribal public health and emergency response agencies. The May 25 listening session is geared toward hospitals, health systems, and associations that represent them. Both sessions will take place at 3 pm ET.

HRSA Extends PRF Reporting Extension Deadline

The Health Resources and Services Administration (HRSA) has extended from May 13 to May 18 the deadline for health care providers to request an extension for the second Provider Relief Fund reporting period. Providers may complete a request to report late due to extenuating circumstances form if they missed the March 31 reporting deadline due to:

  • severe illness or death of a provider;
  • natural disaster;
  • lack of receipt of reporting communications;
  • failure to click “submit;”
  • internal miscommunication or error; or
  • incomplete targeted distribution payments.

Providers will receive an email notification from UHG_HRSA@ProviderEmail.uhc.com if their request is approved and must submit their completed report within 10 days of approval. HRSA will not require non-compliant providers to return funds until after the request period has closed.

FDA Authorizes Pfizer-BioNTech Booster Vaccine in Children

The Food and Drug Administration (FDA) on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to authorize the use of a single booster dose in individuals ages 5 through 11. This population is eligible to receive the booster dose at least five months after completion of a primary series with the Pfizer vaccine.

In an ongoing, randomized, placebo-controlled trial, children who received a booster dose had a higher antibody level against the SARS-CoV-2 virus one month after the booster dose compared with the level before the booster dose.

FDA Authorizes Over-the-Counter Multianalyte Test

FDA on May 16 authorized the first multianalyte COVID-19 test available without a prescription. The Labcorp Seasonal Respiratory Virus Reverse Transcription Polymerase Chain Reaction Direct-to-Consumer test identifies multiple respiratory viruses at the same time, including influenza A and B, respiratory syncytial virus, and SARS-CoV-2, the virus that causes COVID-19. Users can collect a nasal swab at home and send the sample to Labcorp for testing; results are delivered through an online portal with follow-up from a health care provider in the event of positive or invalid test results.

FDA Approves Treatment for Hospitalized COVID-19 Patients

FDA on May 10 approved Olumiant (baricitinib) to treat COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.

Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. Primarily used to treat rheumatoid arthritis, the drug was authorized for use in combination with remdesivir in November 2020 and authorized for use alone in July 2021.

The agency cites data from two phase 3, randomized, double-blind trials, as well as the Randomised Evaluation of COVID-19 Therapy (RECOVERY) randomized, controlled, open-label trial. The drug is available for pediatric patients under emergency use authorization.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Julie Kozminski is a senior policy analyst at America's Essential Hospitals.

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