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 will now be issuing the catalogue at a monthly, rather than biweekly, interval. Below, we have excerpted the pertinent developments that occurred during the month of September.
Centers for Medicare & Medicaid Services
State-Specific Disaster Waiver Approvals
- September 30: CMS approved additional 1135 waiver flexibilities requested by Texas.
- September 21: CMS approved additional 1135 waiver flexibilities requested by Michigan.
- September 16: CMS approved additional 1135 waiver flexibilities requested by Oregon.
Infection Control and Prevention
- September 17: CMS released new guidance for safe visitation in nursing homes during the COVID-19 public health emergency (WHG client summary).
- September 16: 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; full report). (WHG client summary).
Telehealth & Provider Enrollment
- September 25: CMS released a new toolkit aimed at streamlining the process for receiving Clinical Laboratory Improvement Amendments (CLIA) certification for laboratories who want to administer COVID-19 tests.
Coding and Reimbursement
- September 18: CMS released details on the payment and codes for COVID-19 viral testing in Medicare, Medicaid and the uninsured, and private insurance.
Food & Drug Administration
Treatments and Vaccines
- September 28: The FDA 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 (WHG client summary).
- September 2: The FDA updated its guidance on investigational COVID-19 convalescent plasma to provide additional information related to the recently issued emergency use authorization (EUA).
- September 23: The FDA issued the first emergency use authorization (EUA) for a COVID-19 serology (antibody) point-of-care test. This will allow fingerstick blood samples to be tested in point-of-care settings, such as doctor’s office, urgent care centers, and emergency rooms.
Centers for Disease Control & Prevention
- September 29: 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. (WHG client summary).
- September 23: CDC announced $200 million in supplemental funding to 64 jurisdictions to support COVID-19 vaccine preparedness (WHG client summary).
- September 11: NIOSH, part of the CDC, announced a request for information regarding the use of “elastomeric half-mask respirators” in healthcare settings during the COVID-19 pandemic to “ease the demand for single-use N95 filtering facepiece respirators (FFRs). (WHG client summary).
- September 1: CDC issued an agency order effectuating a four-month temporary halt in residential evictions in the U.S., through on December 31, 2020. (WHG client summary).
Department of Health and Human Services
- September 23: HHS announced the CDC will provide $200 million to 64 jurisdictions (see details here) for COVID-19 vaccine preparedness as part of an existing Immunizations and Vaccines for Children cooperative agreement.
- September 19: 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).
- September 9: The Office of the Assistant Secretary for Health (OASH) 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 (WHG client summary).
- September 9: The Office of the Assistant Secretary for Health (OASH) released an RFI seeking information to assess whether CLIA-certified/accredited laboratories are able to provide additional COVID-19 testing if testing equipment from Thermo Fisher Scientific were made available (WHG client summary).
- September 3: HHS released details about the $2 billion Provider Relief Fund (PRF) performance-based incentive payment distribution to nursing homes (WHG client summary).
- September 2: HHS announced that assisted living facilities may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation (WHG client summary).
Assistant Secretary for Preparedness and Response
- September 24: BARDA announced it is continuing its partnership with Luminex Corporation on the development of a rapid, high-throughput COVID-19 test on the NxTAG® Respiratory Pathogen Panel, which will be submitted for both EUA and 510(k) approval.
- September 23: BARDA announced a partnership with Luminex Corporation to develop a cost effective, high throughput test that assesses the ability of antibodies in plasma to bind with and prevent SARS-CoV-2 from interacting with human cells.
- September 17: BARDA and DoD announced a partnership with Ology Bioservices that will expand domestic fill-finish capacity for COVID-19 vaccines and therapeutics under Operation Warp Speed.
Office of the Inspector General
- September 21: OIG posted new COVID-19 work plan items.
- September 3: OIG updated updated FAQs about its administrative enforcement of arrangements connected to the COVID-19 public health emergency.
National Institutes of Health
- September 30: 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) (WHG client summary).
- September 29: The 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 (WHG client summary).
- September 23: The NIH announced the launch of the fourth Phase 3 clinical trial for a COVID-19 vaccine candidate sponsored by Janssen (WHG client summary).
- September 22: The NIH announced the expansion of clinical trials to evaluate convalescent plasma as treatment for hospitalized COVID-19 patients (WHG client summary).
- September 16: The NIH awarded $12 million for outreach and engagement efforts in ethnic and racial minority communities disproportionately impacted by the COVID-19 pandemic (WHG client summary).
- September 15: The NIH announced seven contracts to companies and academic institutions to develop digital health solutions to help address the COVID-19 pandemic (WHG client summary).
- September 14: The NIH released study finds that reveal that people with substance use disorders are more susceptible to COVID-19 and its complications.
- September 1: The NIH announced the launch of a study to track the prevalence and impact of COVID-19 among pregnant women in low and middle-income countries.
U.S. Department of Agriculture (Food & Nutrition Service)
- September 29: USDA announced that more than 100 million food boxes have been distributed in support of American farmers and families affected by the COVID-19 pandemic through the agency’s Farmers to Families Food Box Program.
- September 21: 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 public health emergency (PHE). (WHG client summary).
Federal Emergency Management Agency
- September 2: FEMA released an interim policy to clarify eligible work under the Public Assistance program for the COVID-19 pandemic.
Administration for Community Living
The White House
- 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 candidates each addressed their records and plans for management of the COVID-19 pandemic. (WHG client summary).
- September 16: The Trump Administration announced its plan for distributing and administering a COVID-19 vaccine once one becomes available, which include a Report to Congress on its overall strategy, along with a complementary operational playbook for states (WHG client summary).
- 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). (WHG client summary).
- September 16: 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. (WHG client summary).
- September 8: 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). (WHG client summary).
Oversight and Other
- September 30: 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. (WHG client summary).
- September 24: At its September public meeting, MACPAC convened sessions on Medicaid provider relief funding for COVID-19 and Medicaid’s response to COVID-19. All WHG MACPAC session summaries are available here.
- 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. (WHG client summary).
- September 23: The Senate HELP Committee convened a hearing to examine the Trump Administration’s COVID-19 response efforts (WHG client summary).
- September 16: 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). (WHG client summary).
- September 16: 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 (WHG client summary).
- 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 (WHG client summary).
- September 4: At its September public meeting, MedPAC convened sessions on the impact of the Coronavirus pandemic on Medicare and Medicare providers and Medicare coverage for vaccines. All WHG MedPAC session summaries available here.