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
NIH: Fourth COVID-19 Vaccine Phase 3 Clinical Trial Launched
The National Institutes of Health (NIH) announced the launch of the fourth Phase 3 clinical trial for a COVID-19 vaccine candidate sponsored by Janssen. The trial, which aim to enroll 60,000 individuals, will evaluate whether the one-dose vaccine candidate can prevent COVID-19 infection. While Janssen Pharmaceutical Companies of Johnson & Johnson is the leading regulatory sponsor, Janssen, the National Institutes... Read More
HELP: White House Coronavirus Task Force Discusses Vaccine Distribution, Agency Independence, and the Long-Term Impact of COVID-19
The Senate Health, Education, Labor & Pensions (HELP) Committee convened a hearing to examine the Trump Administration’s COVID-19 response efforts. Top officials from the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) testified about the separate agencies’ efforts to develop... Read More
House: Deal on Farm Assistance and Nutrition Funding Allows Continuing Resolution to Pass the House, Next to the Senate
Shortly ago, the House passed, by roll call vote (359-57), H.R. 8337, a modified continuing resolution (CR) to extend federal government funding through December 11, 2020. The CR now goes to the Senate, where it is expected to pass. Senate Majority Leader Mitch McConnell had previously slammed the bill for omitting farm bailout funding. Negotiations between House Speaker Nancy Pelosi... Read More
House Appropriations: Continuing Resolution to Fund Federal Government through Dec. 11 Introduced; Includes Health Care Extenders, Medicare Policy Changes
House Appropriations Committee Chairwoman Nita Lowey (D-NY) introduced H.R. 8319, a continuing resolution (CR) to extend federal government funding through December 11, 2020 and avoid a government shutdown (press release; legislative text; section-by-section). The House is expected to consider the CR later this week. House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin agreed to pass a “clean” CR... Read More
WHG - Weekly, September 21-25
The death of Supreme Court Justice Ruth Bader Ginsburg has reverberated throughout the country, igniting a new political debate with only 43 days until Election Day. President Trump is expected to announce his Supreme Court nominee, which he vowed would be a woman, this week. How quickly Senate Majority Leader Mitch McConnell will move to confirm the President’s nominee remains... Read More
CMS: New Nursing Home Visitation Guidance Released
Following the release of the Centers for Medicare and Medicaid Services (CMS) convened independent commission recommendations for nursing homes (WHG summary), the agency released new guidance for safe visitation in nursing homes during the COVID-19 public health emergency (press release). Overall, CMS advises that all visitors adhere to the core principles of COVID-19 infection prevention, which include practices such as... Read More
Oversight & Reform: Select Subcommittee on the Coronavirus Crisis Chair Clyburn Expresses Concern Over Weakened Public Health Recommendations
The House Select Subcommittee on the Coronavirus Crisis Chairman James Clyburn (D-SC) sent a letter to Vice President Mike Pence and Coronavirus Response Coordinator Dr. Deborah Birx, expressing concerns that the White House Coronavirus Task Force, under political pressure, weakened science-based public health recommendations (press release; letter). Chairman Clyburn also raised issue with the Trump Administration's failure to publicly release... Read More
NIH: $12 Million Awarded for Community Engagement COVID-19 Research
The National Institutes of Health (NIH) awarded $12 million to RTI International for outreach and engagement efforts in ethnic and racial minority communities disproportionately impacted by the COVID-19 pandemic. RTI International will support teams in 11 states as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. The goal of the CEAL teams will be to improve COVID-19... Read More
NIH: Seven Contracts Awarded to Develop Digital Health Technologies for COVID-19
The National Institutes of Health (NIH) awarded seven contracts to companies and academic institutions to develop digital health solutions, such as smartphone apps, wearable devices, and software, that can help address the COVID-19 pandemic. The NIH notes that these seven projects were selected from over 200 ideas and represent a broad range of solutions for immediate public health needs related... Read More
CMS: Independent Commission Outlines 27 Recommendations for Nursing Home COVID-19 Response
An independent commission convened by the Centers for Medicare & Medicaid Services (CMS) released its findings and recommendations on ensuring safety and quality in nursing homes during the COVID-19 response (press release). Convened by MITRE, CMS outlined for objectives for the Commission’s investigation: Identify best practices for facilities to enable rapid and effective identification of COVID-19 in nursing homes; Recommend... Read More
WH: Operation Warp Speed Outlines Plan for COVID-19 Vaccine Distribution, Administration, Monitoring, and Communications
The Trump Administration announced its plan for distributing and administering a COVID-19 vaccine once one becomes available. The release materials are two-fold, containing first a Report to Congress on its overall strategy, along with a complementary operational playbook for states. Overall, the plan discusses elements around plans for centrally distributing the vaccine; how state and local governments will be partners... Read More
Senate Appropriations: Subcommittee Examines Administration's COVID-19 Response; Testing Capacity, COVID-19 Vaccine Distribution, and COVID-19 Funds Discussed
The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies convened a hearing to examine the Trump Administration’s COVID-19 response efforts. Top officials from the Department of Health and Human Services (HHS) testified about efforts to increase testing capacity and the development of a COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) Director Dr... Read More
House: Problem Solvers Caucus Release Bipartisan Plan for COVID-19 Relief Package
The Problem Solvers Caucus, a 50-member bipartisan group in the House, released its “March To Common Ground” framework – a plan intended to “break the gridlock” in negotiations between Democrats and Republicans over a COVID-19 relief package. The proposal would provide approximately $1.5 trillion in federal aid – an overall price tag between Republicans’ latest $650 billion “skinny package” and... Read More
Other: Multi-Stakeholder Taskforce Offers Long-Term Recommendations on Telehealth
The Taskforce on Telehealth Policy (TTP) – convened by the National Committee for Quality Assurance, Alliance for Connected Care, and American Telemedicine Association – convened a public briefing on its findings and recommendations regarding the COVID-19 telehealth flexibility expansions (full report). First announced in June 2020 (details), the TTP was convened to study the effects of the rapid telehealth expansion... Read More
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