Summary
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 have been issuing the catalogue at a monthly, rather than biweekly, interval. Below, we have excerpted the pertinent developments that occurred during the month of October.
Centers for Medicare & Medicaid Services
Infection Control and Prevention
- *NEW* January 20: CMS released a memorandum to state survey agencies clarifying survey priorities for hospitals during the COVID-19 pandemic.
- *NEW* December 30: CMS released a memorandum to state survey agencies that revises the COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care.
- *NEW* December 17: CMS released a memorandum to state survey agencies providing guidance on COVID-19 infection control for psychiatric and intermediate care facilities for individuals with intellectual disabilities (ICFs/IID).
Data
- *NEW* January 15: CMS released its monthly update detailing the impact of COVID-19 on Medicare beneficiaries. The agency also released new data from the Medicare Current Beneficiary Survey about beneficiaries’ experiences.
Waivers and other Emergency Flexibilities
- *NEW* January 8: CMS released surveyor guidance for new and modified CLIA requirements related to SARSCoV-2 test result reporting.
- *NEW* December 30: CMS released a memorandum to state survey agencies permitting ASCs to keep medically stable patients for observation during the public health emergency.
State-Specific Disaster Waiver Approvals
- *NEW* January 12: CMS approved additional 1135 waiver flexibilities requested by Minnesota.
- *NEW* December 23: CMS approved additional 1135 waiver flexibilities requested by Massachusetts and Alaska.
- *NEW* December 18: CMS approved additional 1135 waiver flexibilities requested by Kentucky and Nevada.
- *NEW* December 9: CMS approved additional 1135 waiver flexibilities requested by Oregon.
- *NEW* December 2: CMS approved additional 1135 waiver flexibilities requested by Oregon.
Telehealth & Provider Enrollment
- *NEW* January 7: CMS updated the Medicare frequently asked questions (FAQs) on Medicare fee-for-service billing.
Food & Drug Administration
Treatments and Vaccines
- *NEW* January 15: The FDA issued three new guidance documents to address monoclonal antibody therapeutics, coagulation systems, and bioequivalence studies during the COVID-19 pandemic.
- *NEW* January 13: The FDA released a report on the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative, which reflects the FDA’s accomplishments to-date and potential prospective actions moving forward.
- *NEW* January 4: The FDA announced that providers administrating authorized COVID-19 vaccines should not change the authorized dosing or schedules.
- *NEW* December 18: The FDA issued emergency use authorization (EUA) for the Moderna COVID-19 vaccine. The vaccine is approved for use in individuals 18 years of age and older.
- *NEW* December 11: The FDA issued emergency use authorization (EUA) for the first COVID-19 vaccine, the Pfizer-BioNTech COVID-19 vaccine, for individuals 16 years of age and older.
- *NEW* December 8: The FDA posted background material for the upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) public meeting to review the Pfizer-BioNTech COVID-19 Vaccine.
- *NEW* December 1: The FDA announced it has scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 17 to examine the Moderna COVID-19 vaccine candidate.
Diagnostic Testing
- *NEW* December 9: The FDA issued an emergency use authorization (EUA) for the first direct-to-consumer COVID-18 test system.
- *NEW* December 4: The FDA issued the first emergency use authorization (EUA) for a diagnostic test for at home collection of patient sample to detect both COVID-19 and influenza A and B.
Centers for Disease Control & Prevention
- *NEW* December 8: CDC announced a grant opportunity (grants/view-opportunity.html?oppId=330280″>CDC-RFA-1P21-2016) aimed at increasing COVID-19 and flu vaccination coverage in racial and ethnic populations experiencing disparities in vaccination rates (WHG client summary).
Department of Health and Human Services
- *NEW* January 19: HHS announced it will exercise enforcement discretion and not impose penalties for violations of HIPAA Rules for providers in good faith using web-based platforms to schedule individual vaccination appointments for COVID-19.
- *NEW* January 19: HHS awarded $20 million in funds from the Coronavirus Aid, Relief, and Economic Security (CARES) Act to help increase data sharing between health information exchanges and immunization information systems.
- *NEW* January 15: HHS announced reporting updates for the Provider Relief Fund (WHG client summary).
- *NEW* January 13: HHS updated its guidance to hospitals for reporting COVID-19 data. Specifically, HHS is now requesting that hospitals report vaccine administration data once per week.
- *NEW* January 11: HHS announced the launch of a web-based COVID-19 outpatients treatment locator to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics.
- *NEW* January 6: HHS announced a series of actions out of the Centers for Disease Control and Prevention (CDC) to distribute over $22 billion in funding to support COVID-19 testing and vaccination distribution.
- *NEW* December 23: HHS announced the purchase of 100 million additional Pfizer COVID-19 doses.
- *NEW* December 18: HHS and the Department of Defense (DOD) announced a $356 million contract with Merck to support advanced development and large-scale manufacturing of their investigational COVID-19 treatment.
- *NEW* December 16: HHS announced it has completed review of Phase 3 applications for the Provider Relief Fund (PRF) and will distribute approximately $24.5 billion to over 70,000 providers (WHG client summary).
- *NEW* December 16: HHS announced sixteen winning designs from the HHS COVID-19 At-Anywhere Diagnostics Design-a-thon aimed to increase speed, quality, comprehensiveness, and utility of COVID-19 diagnostic test data.
- *NEW* December 15: HHS announced that the Centers for Disease Control and Prevention (CDC) will award $140 million for COVID-19 vaccine preparedness and $87 million for tracking and tracing to 64 jurisdictions.
- *NEW* December 11: HHS and DoD announced the purchase of an additional 100 million doses of Moderna’s COVID-19 vaccine candidate.
- *NEW* December 7: HHS announced the release of hospital COVID-19 capacity data at the facility level. Previously, data was only available at the state level.
- *NEW* December 7: HHS announced the release of $523 million in performance-based incentive payments to eligible nursing homes starting December 9 (WHG client summary).
- *NEW* December 3: HHS issued an amendment to the Public Readiness and Emergency Preparedness (PREP) Act to increase access to countermeasures, including COVID-19 tests via telehealth (WHG client summary).
- *NEW* December 3: HHS announced that all tribal health programs and Urban Indian Organizations (UIOs) have chosen their preferred method of receiving COVID-19 vaccines.
Assistant Secretary for Preparedness and Response
- *NEW* December 3: ASPR announced it is collaborating with Chembio Diagnostics on the development of two rapid point-of-care diagnostic tests to both detect antigens for COVID-19 and detect and differentiate Influenza from COVID-19.
- *NEW* December 2: ASPR announced the purchase of 650,000 additional treatment courses of Eli Lilly’s investigational monoclonal antibody therapeutic, bamlanivimab, to be delivered in December and January for treatment of non-hospitalized COVID-19 patients.
Office of the Inspector General
- *NEW* January 15: OIG posted new COVID-19 work plan items.
- *NEW* January 14: Multi-OIG report examines COVID-19 testing for six federal health care programs between February 1, 2020 and August 31, 2020.
- *NEW* December 17: OIG released a review of states’ onsite surveys of nursing homes during the COVID-19 pandemic, between March 23 and May 30, 2020.
- *NEW* December 15: OIG posted a new COVID-19 work plan item.
- *NEW* December 14: OIG updated FAQs about its administrative enforcement of arrangements connected to the COVID-19 public health emergency.
- *NEW* December 10: OIG updated FAQs about its administrative enforcement of arrangements connected to the COVID-19 public health emergency.
- *NEW* December 3: OIG updated its COVID-19 fraud alert information.
National Institutes of Health
- *NEW* January 26: The NIH announced the launch of database to track neurological symptoms associated with COVID-19.
- *NEW* January 5: The NIH announced the launch of a Phase 2/3 clinical trial to evaluate a combination investigational monoclonal antibody therapy for treatment of hospitalized COVID-19 patients.
- *NEW* December 30: The NIH published peer-review report on Moderna COVID-19 vaccine clinical effectiveness.
- *NEW* December 28: The NIH announced that the Phase 3 trial of the Novavax investigational COVID-19 vaccine has launched.
- *NEW* December 16: The NIH announced the launch of observational study to evaluate the short- and long-term outcomes of COVID-19 infection in children, including multisystem inflammatory syndrome in children (MIS-C).
- *NEW* December 11: The NIH announced that baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, have reduced time to recovery for people hospitalized with COVID-19 in recent clinical trials.
- *NEW* December 7: The NIH announced the launch of the COVID-19 Testing Impact Calculator, an online tool funded by the National Institute of Biomedical Imaging and Bioengineering that assists organizations on choosing a COVID-19 testing strategy that best suits their needs.
U.S. Department of Agriculture (Food & Nutrition Service)
- *NEW* January 4: USDA announced the U.S. Department of Agriculture (USDA) will purchase an additional $1.5 billion worth of food for nationwide distribution through the Farmers to Families Food Box Program.
- *NEW* December 31: USA announced that it approved Maine to participate in a pilot program to provide online purchasing of food for SNAP recipients. This brings the total number of states approved to participate in response to COVID-19 to 49 plus the District of Columbia. The pilot program, which was created under the 2014 Farm Bill, was previously operational in only six states: AL, IA, NE, NY, OR, and WA.
Federal Emergency Management Agency
- *NEW* January 27: FEMA released a fact sheet with information for exporters with a surplus of medical supplies and equipment.
- *NEW* January 26: FEMA announced it has released nearly $1 billion in funding through its Public Assistance grant program to support vaccinations.
- *NEW* January 25: FEMA issued a press release detailing how it is supporting vaccine distribution under the Biden administration.
- *NEW* January 15: FEMA published a fact sheet about a voluntary agreement established in August under the Defense Production Act that allows the federal government and the private sector to share more information than is typically allowed under antitrust laws.
- *NEW* December 31: FEMA extended its temporary final rule on domestic PPE prioritization.
- *NEW* December 14: FEMA issued a proposed rule to revise the “Estimated cost of the assistance,” which is one of the factors FEMA’s Public Assistance Program considers when evaluating requests from states for major disaster declarations and making recommendations to the President (WHG client summary).
Small Business Administration
- *NEW* January 8: SBA announced the re-opening of the Paycheck Protection Program for new borrowers and certain existing PPP borrowers on January 11 as well as the issuance of guidance on accessing capital for minority, underserved, veteran, and women-owned businesses, interim final rule on new PPP loans, and an interim final rule on second draw PPP loans.
The White House
- *NEW* January 21: President Joe Biden unveiled his administration’s “National Strategy for the COVID-19 Response and Pandemic Preparedness,” a roadmap to guide and centralize the federal government’s response to the pandemic (WHG client summary).
- *NEW* January 21: President Biden issued an executive order on requiring mask-wearing and an executive order organizing an effective COVID-19 response effort.
Congressional Response
- *NEW* December 21: Congress passed the fiscal year (FY) 2021 omnibus spending bill, which includes the Emergency Coronavirus Relief Act.