The political stakes are high for the upcoming elections on Tuesday, November 3. American voters will choose between President Donald Trump and former Vice President Joe Biden and determine the makeup of the House and Senate amid the unprecedented circumstances surrounding a coronavirus pandemic, which has directly afflicted the President and others in the Administration and Congress. Meanwhile, a new... Read More
CMS: Agency Amends Payment Policies for High-Throughput COVID-19 Tests to Encourage Faster Results
The Centers for Medicare & Medicaid Services (CMS) announced it is updating its payment policies for high-throughput COVID-19 testing to encourage faster results. In April 2020, CMS first ruled that it would pay $100 for clinical diagnostic lab tests that use high-throughput technologies for detecting COVID-19 (details). In today’s updated ruling, CMS now states it will begin paying $100 only... Read More
CMS: Agency Adds 11 New Telehealth Services on Temporary Basis; Includes Additional Telehealth Resources for Medicaid & CHIP
The Centers for Medicare & Medicaid Services (CMS) announced it added 11 new services to the Medicare telehealth list. The agency did so using the expedited process for adding telehealth services outlined in its May interim final rule (details). These services are therefore temporarily added under the emergency authority granted to CMS during the COVID-19 public health emergency (PHE). The... Read More
WHG - Vice President Pence and Senator Kamala Harris Debate on Pandemic Response, Vaccine Confidence, Preexisting Conditions, and Roe vs. Wade
On Wednesday, October 7, Vice President Mike Pence and Sen. Kamala Harris (D-CA) met head-to-head in the first and only 2020 vice presidential debate. The candidates convened in Kingsbury Hall at the University of Utah in Salt Lake City. Debate moderator, Washington Bureau Chief Susan Page of USA Today, led the candidates through what were intended to be 10 minute... Read More
WHG - Issue Brief: COVID-19 Vaccine State of Play
As the United States surpasses 200,000 COVID-19 deaths and hovers around 40,000 new COVID-19 cases per day, the Trump administration and pharmaceutical manufacturers have sought to develop, manufacture, and distribute a safe and effective COVID-19 vaccine at an unprecedented pace. The likely limited supply of COVID-19 vaccines, at least initially, has also raised questions about who will receive the COVID-19... Read More
Other: New Paycheck Protection Program Loan Forgiveness Application for Loans of $50K or Less
The Small Business Administration (SBA), in consultation with the Treasury Department, recently released a new loan forgiveness application for Paycheck Protection Program (PPP) loans of $50,000 or less (press release; application; instructions). PPP borrowers can seek loan forgiveness for payroll costs incurred during the covered period, including cash compensation, employee benefits, and owner compensation. Borrowers can also seek loan forgiveness... Read More
CMS: Agency Announces New Repayment Terms for Advanced and Accelerated Payment Loans
The Centers for Medicare & Medicaid Services (CMS) announced new repayment terms for Accelerated and Advance Payments (AAP) issued to providers and suppliers during the COVID-19 pandemic (press release). These changes are pursuant to the Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). Beginning on March 27, 2020, CMS expanded the AAP program to provide additional financial supports... Read More
CMS: In New Guidance, Agency Details COVID-19 Hospital Reporting Requirements; Details Enforcement Process with Potential for Program Termination
The Centers for Medicare & Medicaid Services (CMS) released new guidance on hospital reporting requirements for COVID-19 as a condition for their participation in Medicare and Medicaid. CMS established these new reporting requirements through its August 26 interim final rule with comment period (details). In brief, CMS required through this rule that hospitals and critical access hospitals (CAHs) report data... Read More
FDA: Guidance Issued on Emergency Use Authorization Standards for COVID-19 Vaccine Candidates
The Food and Drug Administration (FDA) issued guidance on emergency use authorization (EUA) for COVID-19 vaccines (press release). The guidance is intended to provide recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an EUA for an investigational vaccine intended to prevent COVID-19. Overall, the guidance establishes that a COVID-19 vaccine candidate authorized... Read More
CDC: Update to How COVID is Spread
The Centers for Disease Control and Prevention (CDC) updated its "How COVID is Spread" webpage. The update reflects current science on the potential for airborne spread of COVID-19. Specifically, the webpage states: "Some infections can be spread by exposure to virus in small droplets and particles that can linger in the air for minutes to hours. These viruses may be... Read More
NIH: RADx Initiative Advances Six Additional COVID-19 Testing Technologies
The National Institutes of Health (NIH) announced a third round of awards to advanced new COVID-19 testing technologies through the Rapid Acceleration of Diagnostics (RADx) Initiative. The $98.35 million will advance six new technologies for point-of-care and other novel test approaches, including new modes of sample collection and the integration with smart devices. The following were recipients of the third... Read More
WH: President Trump Issues EO to Improve Mental Health Supports During COVID-19 Shutdowns
President Trump released an Executive Order (EO) to increase support for mental health needs, citing an increased need as COVID-related shutdowns continue across the country (fact sheet). In brief, the EO sets priority areas for work on mental health and establishes a workgroup to devise a response pandemic-driven mental health needs. A full summary of the EO’s major provisions follows... 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
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