In response to the novel coronavirus (COVID-19) pandemic, U.S. government agencies have continued the rapid release of fact sheets and guidance documents on a daily basis. To help navigate the outpouring of information, this newly updated catalogue is intended to encapsulate and organize the relevant guidance for health care providers, insurers, state governments, public health agencies, and other stakeholders, as... Read More
HHS: 45-day Compliance Deadline Extension Granted for Providers Receiving Provider Relief Fund Payments
The Department of Health and Human Services (HHS) announced a 45-day deadline extension for providers to accept the Terms and Conditions for receiving payments from the Provider Relief Fund. HHS notes that providers are now granted 90 days from the date they receive a payment to accept the HHS Terms and Conditions, or return the funds. This announcement comes after... Read More
HHS: $500 Million Distributed to Tribal Hospitals, Clinics, and Urban Health Centers
The Department of Health and Human Services (HHS) announced the distribution of $500 million from the Provider Relief Fund to the Indian Health Services (IHS) and tribal hospitals, clinics, and urban health centers for COVID-19 response. HHS notes that the COVID-19 pandemic has disproportionately impacted IHS, creating an increased need for personal protective equipment (PPE) and labor. HHS details that... Read More
NIH: Peer-Reviewed Data Demonstrates Remdesivir Accelerates COVID-19 Recovery Time
The National Institutes of Health (NIH) announced that peer-reviewed data demonstrates that remdesivir improves the recovery time for patients with COVID-19, especially among those with severe cases. According to the report, which was published in the New England Journal of Medicine, remdesivir is "superior to the standard of care for the treatment of COVID-19." The analysis was based on data... Read More
E&C: Bipartisan Leaders Request National COVID-19 Vaccine Plan
House Energy and Commerce (E&C) Comittee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) sent a letter to White House Coronavirus Task Force Coordinator Dr. Deborah Birx urging the Trump administration to develop a national COVID-19 vaccine plan. In the... Read More
Senate: Democrats Release White Paper on Health Coverage Proposals for COVID-19 Response
Senate Democrats released a white paper outlining a series of proposals intended to expand health coverage in response to the COVID-19 pandemic, including expanding advance premium tax credit eligibility, providing a financial incentive for non-expansion states to expand Medicaid, and reversing various final rules and guidance related to the ACA marketplace promulgated by the Trump administration. The white paper also... Read More
FDA: Consolidated List of Guidance Related to COVID-19 Updated
The Food and Drug Administration (FDA) updated the consolidated list of guidance documents available on 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 revisions made to existing guidance, including policies related to COVID-19 diagnostic testing. All guidance documents can... Read More
HHS: $4.9 Billion to Be Distributed to Nursing Homes Impacted by COVID-19
The Department of Health and Human Services (HHS) announced the distribution of $4.9 billion in additional relief funds to skilled nursing facilities (SNFs). The funding is provided through Provider Relief Fund which was appropriated in the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. HHS details that each certified SNF with 6 or more beds will... Read More
Other: SBA Issues Interim Final Rule on Paycheck Protection Program; Extends Safe Harbor
The Small Business Administration (SBA) issued an interim final rule to extend the limited safe harbor with respect to certification concerning need for a Paycheck Protection Program loan request from May 14, 2020 to May 18, 2020. PPP applicants are required to certify in good faith that “[c]urrent economic uncertainty makes this loan request necessary to support the ongoing operations... Read More
FDA: 27 Antibody Tests to be Removed from the Market
The Food and Drug Administration announced the removal of 27 antibody tests from the “notification list” of tests being offered under the agency’s policy for COVID-19 diagnostic tests. Tests were either voluntarily removed by the manufacturer, the manufacturer failed to request an Emergency Use Authorization within 10 days, or a significant problem was identified with the test that could not... Read More
Senate: Special Committee on Aging Examines Protections for Seniors During COVID-19 Response; Challenges of Congregate Living, Need for Data, and Protections for Workers Discussed
Today, the Senate Special Committee on Aging convened a hearing to discuss what steps can be taken to better care for seniors during the COVID-19 crisis. Opening Statements In her opening statement, Chairman Susan Collins (R-ME) described the impact of COVID-19 on older adults, noting that nearly a third of COVID-19 deaths nationwide are nursing home residents. Chairman Collins also... Read More
Oversight & Reform: Select Subcommittee on the Coronavirus Crisis Examines Protections for Frontline Workers; Diagnostic Testing, Reopening Efforts, and PPE Discussed
The House Oversight and Reform Select Subcommittee on the Coronavirus Crisis convened a briefing on the impact of the COVID-19 pandemic on medical staff, first responders, grocery store workers, drivers, custodians, and other frontline workers. Opening Statements In his opening statement, Chairman James Clyburn (D-SC) commended the frontline workers who continue to work despite the risk of contracting of COVID-19... Read More
WH: President Trump Signs an Executive Order Encouraging Regulatory Flexibility to Spur Economic Recovery
President Trump signed an executive order directing federal agencies to waive, suspend, and eliminate any regulation that will impede economic recovery. Additionally, the President directed federal agencies to review existing waivers and flexibilities to determine if any would aid in economic recovery if made permanent beyond the public health emergency (PHE). Specifically, the executive order directs the heads of federal... Read More
CMS: Medicare Payment Factsheet for COVID-19 Diagnostic Tests Updated to Include Serology Tests
The Centers for Medicare and Medicaid Services (CMS) updated its Medicare payment factsheet for COVID-19 diagnostic tests to add additional codes that laboratories may bill Medicare for. The factsheet now includes CPT codes developed by the American Medical Association (AMA) for nucleic acid tests and serology tests. Prior to this update, laboratories could bill for COVID-19 diagnostic tests using the... Read More
HELP: Report to Congress on COVID-19 Health Disparities
The Department of Health and Human Services (HHS) submitted to select congressional committees a report of CDC’s COVID-19 testing data, including demographics, that was required by the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) (Public Law No: 116-139). Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and House Energy and Commerce (E&C) Committee... Read More
HHS: $11 Billion is Distributed to State, Territory, Local, and Tribal Govt. for COVID-19 Testing
The Department of Health and Human Services (HHS) announced (press release) it is delivering $11 billion in funding appropriated by the Paycheck Protection Program and Health Care Enhancement Act funding to support testing for COVID-19, which includes: $10.25 billion to states, territories, and local jurisdictions distributed by the Centers for Disease Control and Prevention (CDC) through its existing Epidemiology and... Read More
Senate: Bipartisan Bill to Provide Coronavirus Relief to States and Localities
Sens. Bill Cassidy (R-LA) and Bob Menendez (D-NJ) recently introduced the State and Municipal Assistance for Recovery and Transition (SMART) Act (S. 3752), which would establish the Coronavirus Local Community Stabilization Fund and provide $500 billion for FY 2020 (to remain available until expended) to state, local, and tribal governments. Similar to the Coronavirus Relief Fund, this newly created fund... Read More
CMS: Guidance Issued to Assist States in Reopening Nursing Homes Safely
The Centers for Medicare and Medicaid Services (CMS) issued guidance to assist State and local officials in reopening nursing homes safely (press release, FAQs). The guidance is intended to provide steps nursing homes and communities should take prior to relaxing restrictions. Criteria for Relaxing Certain Restrictions and Mitigating the Risk of Resurgence – CMS encourages State leaders to collaborate with... Read More
WHG - Weekly, May 18-22
Senate Republicans have no immediate plans to consider the HEROES Act (H.R. 6800) – the $3 trillion coronavirus relief package passed by House Democrats last Friday (May 15) – or present a counter offer to begin negotiations. Instead, the Senate will consider a slew of judicial nominees before adjourning for the Memorial Day recess. In the meantime, Democrats will continue... Read More
Other: SBA Releases Paycheck Protection Program Loan Forgiveness Application; Issues Interim Final Rules on Loan Increases, Safe Harbor
The Small Business Administration (SBA) released the Paycheck Protection Program Loan Forgiveness Instructions and Application for borrowers. As required by the CARES Act (Public Law No: 116-136), Paycheck Protection Program (PPP) loans will be fully forgiven if funds are used for eligible payroll costs incurred or paid during the eight-week covered period and other allowable expenses (including business mortgage interest... Read More
WHG - Chart: Compilation of Federal Telehealth Flexibilities
In light of the many changes to telehealth that have occurred since the beginning of the COVID-19 public health emergency, we have compiled the key telehealth changes and flexibilities at the federal level into one chart. The chart incorporates legislative changes, waivers, certain insurer flexibilities, and the Centers for Medicaid and Medicaid Services’ (CMS’) interim final rules with commend periods... Read More
USDA: Comment Period on SNAP E&T Proposed Rule Extended to June 17; Child Nutrition Waivers Extended to Aug. 31
The U.S. Department of Agriculture (USDA) extended the comment period on the proposed rule titled, “Employment and Training Opportunities in the Supplemental Nutrition Assistance Program (SNAP)” to June 17, 2020. Our summary of the proposed rule is appended below. In addition, USDA announced the extension of the following nationwide waivers through August 31, 2020: Non-congregate Feeding Waiver, which allows meals... Read More
House: Rules Committee Approves Manager's Amendment to Heroes Act
The House Rules Committee approved a manager’s amendment, to the Heroes Act, offered by Rep. Nita Lowey (D-NY), that will be included in the coronavirus relief package voted on this evening. Snapshot – The manager’s amendment includes several health-related provisions: The establishment of risk corridor programs for Medicare Advantage (MA) plans, issuers of individual or small group coverage, and self-insured... Read More
E&C: At COVID-19 Hearing, Reps. Discuss Whistleblower Complaint and Reliance on Foreign Suppliers for Medical Equipment
The House Energy and Commerce Subcommittee on Health convened a hearing to discuss the protection of scientific integrity during the nation’s COVID-19 response. The hearing featured two expert witnesses, Dr. Rick Bright, the former Director of the Biomedical Advanced Research and Development Authority (BARDA), and Michael Bowen, the Executive Vice President of Prestige Ameritech – the United States’ largest surgical... Read More
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