House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Mnuchin are expected to continue negotiations on a coronavirus relief package this week. A deal before the election remains uncertain despite some concessions from both Democrats and Republicans over the last week. President Donald Trump’s COVID-19 prognosis continues to be a mystery, as the President, his medical team, and Chief of Staff... Read More
NAOM: Final COVID-19 Vaccine Allocation Framework Released with Recommendations to Apply the Framework
The National Academies of Science, Engineering, and Medicine (NASEM) Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released the finalized Framework for Equitable Allocation of COVID-19 Vaccine (press release). The framework finalizes four-phased approach that initially prioritizes a limited supply of vaccine doses for high-risk health workers, first responders, people with significant comorbid conditions, and older adults in... Read More
HHS: COVID-19 Public Health Emergency Declaration is Extended Until Jan. 23, 2021
Alex Azar, the Secretary for the Department of Health and Human Services (HHS), extended the public health emergency (PHE) declaration for the COVID-19 pandemic on Friday, October 2, 2020. The declaration will now expire on January 23, 2021 unless action is taken by the Secretary. This is the third extension of the PHE, which was officially declared on January 31,... Read More
House: HHS Secretary Azar Testifies Before the House Select Subcommittee on the Coronavirus Crisis; New Report Highlights 47 Incidents of Political Interference
The House Select Subcommittee on the Coronavirus Crisis convened a hearing with Department of Health and Human Services (HHS) Secretary Alex Azar to examine the Administration’s political interference in the COVID-19 pandemic response. Secretary Azar emphasized the importance of science driving all decisions made at the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the... Read More
HHS: $20B Phase 3 General Distribution of Provider Relief Funding is Announced; Applications Due Nov. 6
The Department of Health and Human Services (HHS) announced a Phase 3 General Distribution of $20 billion from the Provider Relief Fund (PRF). The funds will be open to previously ineligible providers (e.g., those who began practicing in 2020) and will permit those who have already received funds through previous distributions to apply for additional funding that reflects financial losses... Read More
FCC: Agency Extends Purchase and Implementation Deadline for COVID-19 Telehealth Program to Dec. 31, 2020
The Federal Communications Commission (FCC) released a brief announcement that it has extended the purchase and implementation deadline for funds received through its COVID-19 telehealth program. The original deadline for funding recipients to purchase eligible devices and implement eligible services was September 30, 2020. The FCC has now extended this deadline to December 31, 2020. The FCC states it did... Read More
CMS: Agency Loosens Nursing Home Testing Requirements
The Centers for Medicare & Medicare Services (CMS) announced that it is relaxing its nursing home testing requirements. In an August memo (details), CMS outlined on p. 5 the frequency at which nursing facilities must test staff. If a facility was in a county where positivity rate was less than five percent, the required minimum testing frequency was once per... Read More
WHG - September 2020 Edition: Catalogue of Health Agency Guidance and Government Response to COVID-19
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... Read More
Senate: Continuing Resolution Passed; President Trump Expected to Sign, Avert Government Shutdown
The Senate passed, by roll call vote (84-10), H.R. 8337, a bipartisan continuing resolution (CR) to extend federal government funding through December 11, 2020. The CR now heads to President Trump’s desk, where he is expected to sign the stopgap measure in order to avert a government shutdown. Overall, the CR would appropriate funding for fiscal year (FY) 2021 at... Read More
E&C: Experts Express Confidence in Prospective COVID-19 Vaccine Safety & Efficacy, Discuss Public Mistrust
The House Energy and Commerce (E&C) Subcommittee on Oversight and Investigations (O&I) convened a hearing to examine the safety and effectiveness of, access to, and the public’s trust in prospective COVID-19 vaccines. Throughout the hearing, Democrats criticized the Trump administration’s political interference at the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), noting that the... Read More
WHG - Chaotic First 2020 Presidential Debate Touches on ACA Supreme Court Case, Biden's Public Option Plan, Pandemic Response
Tuesday night, September 29, President Donald J. Trump faced former Vice President and Democratic presidential candidate Joseph R. Biden in the first of three 2020 general election debates. The event was hosted at the Sheila and Eric Samson Pavilion, part of a joint campus shared by Case Western Reserve University and the Cleveland Clinic. Cleveland Clinic is serving in the... Read More
NIH: Moderna Vaccine Candidate Generates Immune Response in Older Adults
The National Institutes of Health (NIH) announced that initial Phase 1 trial results from the Moderna vaccine candidate demonstrate that the vaccine is well-tolerated and generates a strong immune response in older adults. The Phase 1 trial was expanded to enroll older adults, who are more vulnerable to COVID-19 infections and are an important population for vaccination. The NIH notes... Read More
NIH: $239 Million Awarded to Increase COVID-19 Testing Among Underserved Population
The National Institutes of Health (NIH) awarded $239 million to improve COVID-19 testing for underserved and vulnerable populations, as part of the Rapid Acceleration of Diagnostics (RADx) Initiative Underserved Populations (RADx-UP). The funding will support 32 institutions and will focus on disproportionately affected populations, including African Americans, American Indians and Alaskan Native, Latinos and Latinas, Native Hawaiians, older adults, pregnant... Read More
CDC: Report on COVID-19 Cases in School-Aged Children
The Centers for Disease Control and Prevention (CDC) released a report that found that the incidence of COVID-19 cases in children aged 12-17 years nearly doubled the incidence of COVID-19 cases in children aged 5-11 years. School-aged children with at least one underlying medical condition were more likely to experience severe outcomes related to COVID-19. The CDC recommends schools and... Read More
House: Democrats' Updated Heroes Act
On September 28, House Democrats released an updated version of the Heroes Act – a $2.2 trillion package to provide additional coronavirus relief (press release; legislative text; summary; section-by-section). The updated Heroes Act is a marker bill that stakes out House Democrats’ starting position in renewed negotiations with Treasury Secretary Steven Mnuchin today. A vote on the slimmed-down updated version... Read More
HHS: Reporting Requirements for PRF Recipients Relies on Narrower Definition of Lost Revenue; Portal Opens Jan. 15
On Sept. 19, the Department of Health and Human Services (HHS) released long-awaited reporting requirements for funds obtained via the Provider Relief Fund (PRF). The newly released requirements contain significant changes from the guidance HHS previously released in July (WHG client summary), including a requirement that lost revenues be based on the difference between 2019 and 2020 net operating income... Read More
FDA: Guidance Issued on Common COVID-19-Related Symptoms for Clinical Trials of Drug and Biologicals to Treat COVID-19
The Food and Drug Administration issued final guidance on assessing COVID-19 related symptoms in outpatient adults and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment. The guidance is intended to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials. The FDA... Read More
MACPAC: Commissioners Discuss Need for Guidance on Eligibility Redetermination and Support Studying Telehealth
On September 24, 2020 the Medicaid Payment Advisory Commission (MedPAC) convened a session to reflect on the Medicaid response to COVID. Staff presented an update on actions taken since the Commission’s April meeting, including anecdotes from states related to telehealth use, substance use disorder (SUD) treatment, and home and community-based services (HCBS). Staff also provided an update on nursing facilities... Read More
MACPAC: Commissioners Consider Strategies to Increase the Vaccination Rate Among Adults
The Medicaid and CHIP Payment and Access Commission convened a session to examine Medicaid coverage of vaccines. MACPAC staff acknowledged that with a COVID-19 vaccine forthcoming, it is important to examine Medicaid coverage and ways to increase vaccination rates among adults. The presentation focused on current Medicaid coverage, which is dependent on eligibility, and how the adult vaccinate rate is... Read More
USDA: Agency Extends WIC COVID-19 Flexibilities for Duration of the COVID-19 Public Health Emergency
The USDA indicated that it has leveraged its ongoing emergency waiver authority – granted under the Families First Coronavirus Response Act (FFCRA) – to extend flexibilities for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Without the extension, the flexibilities would have expired on September 30. Instead, they are now in place for the duration of the... Read More
CDC: $200 Million Distributed for COVID-19 Vaccine Preparedness
The Centers for Disease Control and Prevention (CDC) announced the distribution of $200 million in funds made available under the CARES Act to the 64 awardees of the Vaccines for Children (VFC) Program and Section 317 grant program to support the planning and implementation of COVID-19 vaccination services. Grants were divided using a population-based formula. Jurisdiction-level allocations are available here... Read More
MACPAC: Commissioners Discuss Relief Funding for Medicaid Providers Affected by COVID-19
On September 24, 2020, the Medicaid Payment Advisory Commission (MACPAC) convened a session to discuss the COVID-19 relief funding Medicaid providers affected by the pandemic are eligible for and have received to date, as well as what further action should be taken by the Commission. The discussion follows letters sent by the Commission to Secretary Azar (here) and Administrator Verma... Read More
Education & Labor: Committee Democrats Examine Further Actions Needed to Address Child Hunger during the Pandemic
On Wednesday, September 23, the House Education and Labor Committee held a virtual briefing to examine the impact of the COVID-19 pandemic on child hunger and what the federal government can do to address the current child hunger crisis. Committee Chairman Bobby Scott (D-VA) noted that the briefing was not an official committee proceeding at that, though invited, Republican members... Read More
NIH: Expanded Clinical Trials Launched to Test Convalescent Plasma as COVID-19 Treatment
The National Institutes of Health (NIH) announced the expansion of clinical trials to evaluate convalescent plasma as treatment for hospitalized COVID-19 patients. The placebo-controlled clinical trials will enroll hospitalized patients across the country in order to generate sufficient data on whether convalescent plasma is effective and safe as a COVID-19 treatment. The Food and Drug Administration (FDA) recently issued emergency... Read More
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