WHG - March 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 March.

Centers for Medicare & Medicaid Services

Benefits and Coverage

• *NEW* March 23: CMS announced it is extending the ongoing special enrollment period (SEP) for an additional three months (i.e., until August 15, 2021). (WHG client summary).
• *NEW* March 15: CMS released an updated toolkit on Coverage and Reimbursement of Vaccines, Vaccine Administration, and Cost Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program to reflect some of the changes made in the recently American Rescue Plan Act of 2021 (ARPA) (P.L. 117-2). (WHG client summary).
• *NEW* March 15: CMS announced an increase to the Medicare payment rates for COVID-19 vaccine administration. (WHG client summary).
• *NEW* March 12: CMS released a new fact sheet detailing the changes to financial assistance eligibility for Marketplace health plan enrollees that were effectuated through signing of the American Rescue Plan Act. The changes lower premiums for most people who are enrolled in health insurance through the exchanges. Increased premium tax credits will be available starting April 1, 2020 and CMS notes that current enrollees will need to submit a new application to receive increased assistance.
• *NEW* March 4: CMS announced that more than 206,000 individuals have signed up for Affordable Care Act coverage in the first two weeks of the Coronavirus-related special enrollment period which runs through May 15.

Infection Control and Prevention

• *NEW* March 26: CMS is resuming hospital survey activities following 30-day restrictions.
• *NEW* March 15: CMS released a graphic to help further explain its updated guidance on nursing home visitation.
• *NEW* March 10: CMS updated its guidance, in partnership with the CDC, for safe visitation in nursing homes during the COVID-19 public health emergency (press release; fact sheet). The changes reflect the impact of vaccinations on COVID-19 infections in nursing homes (WHG client summary).

Data

• *NEW* March 24: CMS released an updated data snapshot detailing the impact of COVID-19 on Medicare beneficiaries. (WHG client summary).

Waivers and other Emergency Flexibilities

• *NEW* March 1: CMS announced it is making $2.3 million available to support current Navigator grantees in Federally-facilitated Marketplace states. The funding is being made available to improve enrollment efforts for the Special Enrollment Period opened in response to the COVID-19 pandemic.

Telehealth & Provider Enrollment

• *NEW* March 23: The CMS From Coverage to Care (C2C) program released a set of resources to aid providers and patients as telehealth systems continue to be implemented in response to the COVID-19 pandemic. (WHG client summary).

Food & Drug Administration

Treatments and Vaccines

• *NEW* March 24: The FDA published a new webpage to provide information on the authorized COVID-19 vaccines.

• *NEW* February 27: The FDA issued emergency use authorization (EUA) for the single-dose Johnson & Johnson COVID-19 vaccine for individuals 18 years and older.

Diagnostic Testing

• *NEW* March 19: The FDA issued an emergency use authorization (EUA) for the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of SARS-CoV-2 infection.
• *NEW* March 5: The FDA issued emergency use authorization (EUA) for the T-Detect COVID test, which will aid in identifying individuals with recent or prior SARS-CoV-2 infection.
• *NEW* March 5: The FDA issued EUA for the first molecular non-prescription, at-home COVID-19 test
• *NEW* March 1: The FDA issued EUA for the Quidel QuickVue At-Home COVID-19 test, a antigen test that can be rapidly collected and tested at home.

Centers for Disease Control & Prevention

• *NEW* March 26: The complete breakdown of all COVID-19 funding made available by Congress and provided through various awards is available here.

Department of Health and Human Services

• *NEW* March 29: HHS announced $100 million in grants to the Aging and Disability Networks in every state and territory to expand access to COVID-19 vaccines for older adults and people with disabilities.
• *NEW* March 17: The Biden Administration announced that HHS is investing $150 million to increase access to COVID-19 monoclonal antibody therapeutic treatments for patients in underserved communities (WHG client summary).
• *NEW* March 12: HHS issued an amendment to the Public Readiness and Emergency Preparedness (PREP) Act to add additional categories of qualified people authorized to prescribe, dispense, and administer COVID-19 vaccines, including dentists, EMTs, midwives, optometrists, paramedics, physician assistants, podiatrists, respiratory therapists, and veterinarians.
• *NEW* March 12: HHS issued a fact sheet detailing how the American Rescue Plan reduces health care costs, expands access to insurance coverage, and addresses health care disparities.
• *NEW* March 11: HHS announced that an additional 700 Health Resources and Services Administration (HRSA)-supported health centers will be invited to join the Health Center COVID-19 Vaccine Program.
• *NEW* March 8: HHS announced $250 million for the Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 initiative to encourage COVID-19 safety and vaccination among underserved populations.

• *NEW* March 2: HHS announced a manufacturing collaboration between Merck and Johnson & Johnson to expand the production of the J&J one dose COVID-19 vaccine.

Office of the Inspector General

• *NEW* March 29: OIG reported new COVID-19 enforcement actions.
• *NEW* March 25: OIG updated its COVID-19 fraud alert information.
• *NEW* March 24: OIG released a report detailing how the COVID-19 pandemic has affected the ability of hospitals to deliver care. It provides an updated snapshot of hospital administrators’ views in February 2021, nearly a year after the first “pulse survey” in March 2020.
• *NEW* March 24: OIG updated FAQs about its administrative enforcement of arrangements connected to the COVID-19 public health emergency.
• *NEW* March 15: OIG revamped its COVID-19 portal and posted new COVID-19 work plan items.
• *NEW* March 8: OIG updated its COVID-19 fraud alert information.

Department of Labor

• *NEW* February 26: The Department of Labor, Treasury, and the Department of Health and Human Services (HHS) released guidance that requires plans to cover COVID diagnostic testing of asymptomatic patients without known exposure (WHG client summary).
• *NEW* February 26: The Employee Benefits Security Administration (EBSA) issued Guidance on Continuation of Relief for Employee Benefit Plans and Plan Participants and Beneficiaries Due to the COVID-19 (Novel Coronavirus) Outbreak (WHG client summary).

National Institutes of Health

• *NEW* March 24: The NIH announced new findings that SARS-CoV-2 infects mouth cells.

• *NEW* March 23: The Data and Safety Monitoring Board (DSMB) notified the National Institute of Allergy and Infectious Disease (NIAD), the Biomedical Advanced Research and Development Authority (BARDA) and AstraZeneca that is was concerned that AstraZeneca included outdated information from their investigational trial, which may have provided an incomplete view of the efficacy of the data.

• *NEW* March 22: The NIH announced that the AstraZeneca COVID-19 vaccine candidate is well tolerated and protects against symptomatic COVID-19 disease.

• *NEW* March 8: The NIH announced the launch of third clinical trial to test blood clotting treatments for COVID-19 as part of the  Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.

• *NEW* March 2: The NIH announced the suspension of a clinical trial evaluating the safety and effectiveness of COVID-19 convalescent plasma in patients with mild to moderate symptoms.

• *NEW* March 1: The NIH announced the launch of a study to assess the performance of usability of a smartphone app paired with the recently authorized Quidel QuickVue At-Home COVID-19 Test.

Office of the Inspector General

• *NEW* March 29: OIG reported new COVID-19 enforcement actions.
• *NEW* March 25: OIG updated its COVID-19 fraud alert information.
• *NEW* March 24: OIG released a report detailing how the COVID-19 pandemic has affected the ability of hospitals to deliver care. It provides an updated snapshot of hospital administrators’ views in February 2021, nearly a year after the first “pulse survey” in March 2020.
• *NEW* March 24: OIG updated FAQs about its administrative enforcement of arrangements connected to the COVID-19 public health emergency.
• *NEW* March 15: OIG revamped its COVID-19 portal and posted new COVID-19 work plan items.
• *NEW* March 8: OIG updated its COVID-19 fraud alert information.

Federal Emergency Management Agency

• *NEW* March 29: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $4.47 billion in vaccination expenses and is continuing to open new federal vaccination centers
• *NEW* March 25: FEMA amended all major disaster declarations for COVID-19 to pay 100% of total eligible costs (up from 75%) between Jan. 20, 2020 and Sept. 30, 2021, per an executive order issued Feb. 2.
• *NEW* March 24: FEMA issued a new interim policy on funeral assistance related to COVID-19 for individuals and households. The agency notes it will pay funeral costs up to $9,000 per COVID-19 death with a maximum of $35,500 allowed per applicant.
• *NEW* March 22: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $4.39 billion in vaccination expenses.
• *NEW* March 19: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency will soon open federal pilot community vaccination centers in Atlanta and Detroit.
• *NEW* March 17: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $4.38 billion in vaccination expenses.
• *NEW* March 9: FEMA announced that it has established a Civil Rights Advisory Group to evaluate FEMA’s COVID-19 vaccination policies, practices, strategies, and plans to ensure equitable vaccine access and administration.
• *NEW* March 8: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $4.24 billion in vaccination expenses.
• *NEW* March 5: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $4.13 billion in vaccination expenses and is operating more than 500 community and 70 mobile vaccination centers across the nation. Additionally, beginning next week, the weekly vaccine allocation to states, tribes, and territories will increase to 15.2 million doses.
• *NEW* March 3: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency is opening new pilot community vaccination centers at sites in Florida and New York and now has 55 mobile vaccination centers across the nation.
• *NEW* March 2: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $4.02 billion in vaccination expenses and has established or expanded more than 450 community and 47 mobile vaccination centers across the nation.
• *NEW* March 1: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes that effective this week, the weekly vaccine supply to states will increase to 14.5 million doses.
• *NEW* February 26: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $3.97 billion in vaccination expenses and has established or expanded more than 440 community vaccination centers across the nation.

The White House

• *NEW* March 29: The White House announced new actions to increase COVID-19 vaccinations. The Administration anticipates that by April 19, 90 percent of adults in the U.S. will be eligible for vaccination and 90 percent will be within five miles of a vaccination site. (WHG client summary).
• *NEW* March 25: The White House announced it is distributing $10 billion to expand access to COVID-19 vaccines, with a focus on improving vaccine confidence in high-risk communities. (WHG client summary).
• *NEW* March 11: The White House announced that all adult Americans will be eligible to receive a COVID-19 vaccination by May 1, 2021 (WHG client summary).

Congressional Response

Legislation

• *NEW* March 11: President Joe Biden signed the American Rescue Plan Act of 2021 (P.L. 117-2) into law. Congress approved the 1.9 trillion COVID-19 relief package along party lines – 220-211 in the House and 50-49 in the Senate using the budget reconciliation process. (WHG client summary).
• *NEW* March 4: The Senate adopted a motion to proceed to consideration of the American Rescue Plan Act of 2021 (H.R. 1319) by a 51-50 vote, with Vice President Kamala Harris breaking the tie. (WHF client summary).

Oversight and Other

• *NEW* March 17: The House E&C Subcommittee on Oversight and Investigations convened a hearing to examine the Biden Administration’s efforts to increase COVID-19 vaccination rates. (WHG client summary).
• *NEW* March 2: The House E&C Subcommittee on Health convened a hearing to discuss the future of telehealth reform in light of the recent, pandemic-driven expansions (WHG client summary).