WHG - April 2021 Edition: Catalogue of Health Agency Guidance and Government Response to COVID-19

Summary

In response to the novel coronavirus (COVID-19) pandemic, U.S. government agencies have continued the frequent release of fact sheets and guidance documents for health care and public stakeholders. To help navigate the outpouring of information, the Wynne Health Group has maintained the attached and newly updated catalogue, intended to capture and organize the full array of relevant guidance for health care providers, insurers, state governments, public health agencies, and other stakeholders, as well as reflect the status of major actions by the White House and Congress, and pertinent funding opportunities. Within the attached document, you can follow hyperlinks to navigate to each section of the full compendium.

Reflecting a slowing of the pace at which new developments have arisen, we have been issuing the catalogue at a monthly, rather than biweekly, interval. Below, we have excerpted the pertinent developments that occurred during the month of April. This will be our final monthly catalogue update distribution.

Centers for Medicare & Medicaid Services

Benefits and Coverage

• *NEW* April 26: CMS announced that HHS is partnering with more than 20 national organizations to support Black American outreach and enrollment efforts during the ongoing special enrollment period (SEP).
• *NEW* April 7: CMS announced (press release; fact sheet) more than 528,000 individuals have signed up for coverage on the federal Marketplace since the Coronavirus-related special enrollment period opened on February 15. Numbers reflect enrollment through the end of March. (WHG client summary).
• *NEW* April 1: CMS announced that it began recouping payments for COVID-19 Accelerated and Advance Payments (CAAPs) on March 30, 2021. (WHG client summary).

Infection Control and Prevention

• *NEW* April 27: CMS released a revised memo that updates the COVID-19 Focused Survey Tool to assess compliance with new testing requirements and reflect other guidance updates.

Data

• *NEW* April 26: CMS released its monthly update detailing the impact of COVID-19 on Medicare beneficiaries.

Waivers and other Emergency Flexibilities

• *NEW* April 8: CMS announced it is ending certain long-term care COVID-19 emergency blanket waivers related to: notification of resident room or roommate changes, and transfer and discharge notification requirements; certain care planning requirements for residents transferred or discharged for cohorting purposes; and timeframe requirements for completing and transmitting resident assessment information.

Federal Communications Commission

Telehealth

• *NEW* April 16: The FCC announced it will begin accepting applications for Round 2 of the COVID-19 Telehealth Program beginning April 29, 2021 at noon ET (WHG client summary).

Food & Drug Administration

Treatments and Vaccines

• *NEW* April 23: The FDA and the CDC lift recommended pause on Johnson & Johnson COVID-19 vaccine use following safety review.

• *NEW* April 16: The FDA revoked the emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, as mild to moderate COVID-19 treatment.

• *NEW* April 13: The FDA released a new FDA Voices entitled “Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities.” (WHG client summary).

• *NEW* April 13: The FDA and the CDC issued a joint statement that the agencies are reviewing data involving six reported U.S. cases of a rare and severe blood clot in individuals after receiving the J&J vaccine. Until the review is complete, the agencies recommend pausing the use of the vaccine.

Personal Protective Equipment (PPE)

• *NEW* March 9: The FDA issued a letter to health care personnel and facilities recommending transition from use of decontaminated disposable respirators.

Diagnostic Testing

• *NEW* April 2: The FDA announced the launch of a new webpage titled SARS-CoV-2 viral mutations impact on COVID-19 tests.

• *NEW* March 31: The FDA authorized several over-the-counter (OTC) COVID-19 diagnostic tests to increase screening for asymptomatic individuals.

Department of Health and Human Services

• *NEW* April 27: HHS announced the availability of $1 billion for Health Resources and Services Administration (HRSA)- Health Center Program funded health centers to support major construction and renovation projects across the country.
• *NEW* April 22: HHS announced the launch of a new initiative entitled “We Can Do This: Live” to increase COVID-19 vaccine confidence.
• *NEW* April 19: HHS grants/view-opportunity.html?oppId=332930″>announced the availability of $150 million in grant funding to support approximately 100 Health Center Program look-alikes (LALs) to respond to and mitigate the spread of COVID-19 (WHG client summary).
• *NEW* April 19: HHS announced a series of commitments from national organizations to support outreach and support for Latinx communities to encourage greater enrollment during the COVID-19 SEP (WHG client summary).
• *NEW* April 16: The Assistant Secretary for Planning and Evaluation (ASPE) Office of Health Policy recently released a third issue brief about the availability of zero- and low-premium health plans in the HealthCare.gov Marketplace. (WHG client summary).
• *NEW* April 14: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released a report examining the unequal effects of economic need and program response during the COVID-19 pandemic.
• *NEW* April 14: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released an interactive map that depicts COVID-19 vaccine hesitancy estimates by Public-Use Microdata Areas.
• *NEW* April 13: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released a report highlighting the inequalities in the COVID-19-related employment crisis.
• *NEW* April 12: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released an issue brief examining Medicaid churn and continuity of care before and after the COVID-19 pandemic.
• *NEW* April 9: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released an issue brief examining the mental health consequences of COVID-19 and the role social determinants of health play.
• *NEW* April 7: HHS announced that all Health Resources and Services Administration (HRSA)-funded health centers and Health Center Program look-alikes (LALs) are now invited to participate in the Health Center COVID-19 Vaccine Program.
• *NEW* April 6: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released an issue brief examining the characteristics of homebound older adults and the potential barriers they face in accessing the COVID-19 vaccine.
• *NEW* April 6: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released an issue brief examining the impact of COVID-19 on Medicare beneficiaries with dementia.
• *NEW* April 6: The Assistant Secretary for Planning and Evaluation (ASPE) within HHS released estimates of COVID-19 vaccine hesitancy rates by geographic and sociodemographic characteristics.
• *NEW* April 1: HHS announced additional measures to increase vaccine confidence, including the launch of a nationwide network of trusted voices and a television advertisement campaign.
• *NEW* April 1: HHS Secretary Xavier Becerra announced that the reduced costs and expanded access for market health coverage under the American Rescue Plan are now available on HealthCare.gov.

Assistant Secretary for Preparedness and Response

• *NEW* April 21: Secretary Becerra renewed the public health emergency (PHE) declaration. This extends the PHE another 90 days to July 20, 2021.

Office of the Inspector General

• *NEW* April 15: HHS–OIG leadership issued a reminder about the COVID-19 vaccination program and provider compliance.
• *NEW* April 9: OIG reported new COVID-19 enforcement actions.
• *NEW* April 8: The OIG Principal Deputy Inspector General co-authored an op-ed about improving COVID-19 testing.

National Institutes of Health

• *NEW* April 23: The NIH announced a new study to assess how people with immune deficiencies respond to COVID-19 vaccines.

• *NEW* April 22: The NIH announced the launch of a Phase 3 clinical trial to test the safety and efficacy of therapeutics for COVID-19 patients with acute respiratory failure.

• *NEW* April 21: The NIH announced the launch of a Phase 2/3 clinical trial to evaluate a new fully-human polyclonal antibody therapeutic targeted at COVID-19.

• *NEW* April 19: The NIH announced a large clinical trial to study repurposed drugs to treat COVID-19 symptoms.

• *NEW* April 15: The NIH announced it is awarding up to $33 million over two years to fund projects on how to safely return to school for students, teachers, and support staff in vulnerable and underserved areas.

• *NEW* April 13: The NIH announced the launch of a clinical trial to test the safety and efficacy of investigational monoclonal antibody for treatments people who are hospitalized with respiratory disease and low blood oxygen due to COVID-19.

• *NEW* April 7: The NIH announced the launch of a clinical trial to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to Moderna or Pfizer COVID-19 vaccines.

• *NEW* March 31: The NIH and the CDC launched a community health initiative, known as “Say Yes! Covid Test” to test whether frequent self-administered COVID-19 tests help residents reduce community spread.

• *NEW* March 31: The NIH announced the launch of a clinical trial to evaluate Moderna COVID-19 variant vaccine.

Federal Emergency Management Agency

• *NEW* April 21: FEMA issued a COVID-19 response update which notes the application period for $110 million in supplemental Emergency Food and Shelter Program funding is now open
• *NEW* April 19: FEMA issued a COVID-19 response update which notes it has received more than 101,000 applications for funeral assistance
• *NEW* April 14: FEMA announced it is pausing administration of the Johnson & Johnson vaccine at its community vaccination centers and mobile vaccination clinics.
• *NEW* April 12: FEMA announced it has begun processing applications for COVID-19-related funeral assistance.
• *NEW* April 7: FEMA issued a COVID-19 response update describing its vaccine distribution support. The agency details the opening of several new federal vaccination centers and mobile vaccination units.
• *NEW* April 5: FEMA issued a COVID-19 response update describing its vaccine distribution support. The agency notes it has provided more than $4.5 billion in vaccination expenses.
• *NEW* April 2: FEMA issued a COVID-19 response update describing its vaccine distribution support. The agency notes it is continuing to open federal vaccination centers in communities across the country and has begun to roll out mobile vaccination units in select locations.
• *NEW* April 2: FEMA issued interim updated guidance for the Public Assistance (PA) program. The guidance responds to a White House memo that authorized FEMA to offer funding to PA Applicants for services and supplies that support the safe opening and operation of eligible facilities.
• *NEW* March 31: FEMA announced that federally-supported COVID-19 vaccination centers will receive help from a domestic Peace Corps deployment.

The White House

• *NEW* April 21: The White House issued a fact sheet announcing President Biden’s call to all U.S. employers to provide full paid time off (PTO) to employees for any time they require to receive a COVID-19 vaccination and any subsequent time needed for recovery (WHG client summary)
• *NEW* April 16: The White House announced it is distributing $1.7 billion in funding authorized by the American Rescue Plan Act of 2021 to support the Centers for Disease Control and Prevention (CDC) and state governments as they respond to the emergence of COVID-19 variants (WHG client summary).

Congressional Response

• *NEW* April 15: The House Select Subcommittee on the Coronavirus Crisis convened a hearing to examine ways to safely end the COVID-19 pandemic. (WHG client summary).