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
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
CMS: CY 2022 MA Part I Advance Notice; Comments Due Nov. 13
On September 14, 2020, the Centers for Medicare & Medicaid Services (CMS) released Part I of its Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part D Payment Policies for Calendar Year (CY) 2022 (press release; fact sheet). The announcement arrives ahead of the customary cycle in order to potentially publish the CY 2022 Rate Announcement... Read More
CDC: Comments Sought on National EHMR Strategy to Ease Demand on N95 Masks
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced a request for information regarding the use of “elastomeric half-mask respirators” healthcare settings during the COVID-19 pandemic. An elastomeric half-mask respirator (EHMR) is a an air-purifying respirator that “provide[s] at least the same level of protection as single-use N95 filtering facepiece... Read More
HELP: Senators Examine COVID-19 Vaccines; FDA Independence, Vaccine Confidence, Costs, and Distribution Discussed
On September 9, the Senate Health, Education, Labor & Pensions (HELP) Committee convened a hearing to examine the Administration’s efforts to develop a COVID-19 vaccine and increase uptake of regularly scheduled vaccines. The National Institutes of Health (NIH) Director Dr. Francis Collins testified about Operation Warp Speed (OWS) and the vaccine candidates currently under development. Surgeon General Dr. Jerome Adams... Read More
HHS: Administration Issues Guidance to Increase Access to Future COVID-19 Vaccine
On September 9, the Office of the Assistant Secretary for Health (OASH) within the Department of Health and Human Service (HHS) announced it had issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) that expands authorization for certain pharmacists to order and administer COVID-19 vaccinations. Specifically, the guidance authorizes state-licensed pharmacists to order and administer, and state-licensed... Read More
HHS: Administration Shares Plans for Provider Relief Fund Performance-Based Incentive Payments to Nursing Homes
On September 3, 2020 the Department of Health and Human Services (HHS) released details about the $2 billion Provider Relief Fund (PRF) performance-based incentive payments for nursing homes. To qualify, a facility must: Possess an active state certification as a nursing home or skilled nursing facility (SNF) and receive reimbursement from the Centers for Medicare & Medicaid Services (CMS) -... Read More
HHS: Department Releases RFI Seeking Information About Laboratory Surge Capacity for COVID Testing
The Office of the Assistant Secretary for Health (OASH) within the Department of Health and Human Services (HHS) released a request for information (RFI) on September 9, 2020. The RFI seeks information to assess whether Clinical Laboratory Improvement Amendments (CLIA)-certified/accredited laboratories are able to provide added COVID-19 testing if additional testing equipment from Thermo Fisher Scientific were made available. Specifically,... Read More
Senate: Senate Republicans Unveil "Targeted" COVID-19 Relief Bill ahead of Floor Vote later this Week
Senate Majority Leader Mitch McConnell (R-KY) unveiled a scaled-back coronavirus relief package containing approximately $500 billion in federal aid focused on health care, education, and the economy (legislative text). Leader McConnell announced he “will be moving immediately today [September 8] to set up a floor vote as soon as this week.” However, the legislation is unlikely to pass in the... Read More
FDA: Updated Consolidated List of Guidance Related to COVID-19
The Food and Drug Administration (FDA) updated the consolidated list of guidance documents available regarding the COVID-19 public health emergency (PHE). The FDA details that the agency will periodically publish a consolidated notice of availability (NOA) of the relevant COVID-19 documents. This update reflects new guidance documents and revisions made to existing guidance, including policies related to COVID-19 diagnostic testing, treatments, and medical... Read More
MedPAC: Commissioners Examine Impact of COVID-19 on Medicare Providers and Enrollees, Call for More Detailed Analysis of CARES Act Provider Funds
The Medicare Payment Advisory Commission (MedPAC) convened a session to discuss issues surrounding the uncertainty caused by the COVID-19 pandemic. These issues included the pandemic’s effects on beneficiaries and providers in Medicare, as well as eventual effects on costs, access, and providers’ financial performance. MedPAC staff noted that these obstacles, and their potential temporary and long-term impacts, are important considerations... Read More
MedPAC: Commissioners Support Policy Option for Part B Coverage for All Vaccines Without Cost Sharing
The Medicare Payment Advisory Commission (MedPAC) convened a session to examine potential policy options for Medicare coverage of vaccines. In the staff presentation, the existing Medicare policy for vaccine coverage was outlined, as well as Medicare spending on vaccines in Part B and Part D. The staff highlighted the government’s role in vaccination and specifically its support of COVID-19 vaccine... Read More
MedPAC: Commissioners Expresses Support for a Limited Telehealth Expansion After the COVID-19 Public Health Emergency
The Medicare Payment Advisory Commission (MedPAC) convened a session to examine the expansion of telehealth in Medicare during the COVID-19 public health emergency (PHE) and how to make some of the flexibilities permanent. MedPAC staff presented policy option in which providers who participate in advanced alternative payment models (A-APMs) are permitted to continue the telehealth flexibilities, while fee-for-services (FFS) providers... Read More
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