The Centers for Disease Control and Prevention (CDC) issued a Notice of Funding Opportunity (NOFO) (CDC-RFA-CK20-2003), “Improving Clinical and Public Health Outcomes through National Partnerships to Prevent and Control Emerging and Re-Emerging Infectious Disease Threats.” This NOFO is intended to establish an Approved-But-Unfunded (ABU) list of grantees, which will consist of organizations pre-identified and pre-approved for rapid funding by the... Read More
Senate: New Legislation would Tie FMAP Levels to State Unemployment
As the U.S. continues its response to COVID-19, Senator Bob Casey (D-PA) introduced new legislation that would tie the Medicaid Federal Medical Assistance Percentage (FMAP) to state unemployment levels. In times of crisis, this would trigger increases to the Medicaid FMAP when unemployment levels rise significantly. Under current law, states must await congressional action for federal aid to increase. The... Read More
E&C: Health Subcommittee Discusses Mental Health Legislation
The House Energy and Commerce Subcommittee on Health convened a legislative hearing to discuss 22 bills aimed at improving access to and quality of mental health care. Legislation, including bills with bipartisan support, covered an array of issues. They include Medicare, coverage parity, emergency departments and responders, federal grants, racial health disparities, suicide prevention, school resources, and research. Overall, members... Read More
FDA: Guidance Issued to Facilitate COVID-19 Vaccine Development
The Food and Drug Administration (FDA) issued guidance to help assist the development of COVID-19 vaccines (press release). The guidance is intended to provide recommendations regarding the data needed to facilitate clinical development and licensure of vaccines. The FDA notes that there are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine,... Read More
HELP: Trump Administration Officials Testify on Reopening Schools; Importance of Masks, Vaccines, Treatments, and Testing Capacity Addressed
The Senate Committee on Health, Education, Labor and Pensions (HELP) convened a hearing to discuss the necessary steps to safely reopen schools and the economy. Trump Administration officials from the National Institutes of Health (NIH), the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) testified about... Read More
WHG - Weekly, June 29-July 4
Democrats are seeking to draw a stark contrast with Republicans on health care, following the Trump administration’s call (in a brief to the Supreme Court) that the Affordable Care Act (ACA) in its entirety “must fall.” Today, the House is expected to pass the Patient Protection and Affordable Care Enhancement Act (H.R. 1425) – a bill to bolster health care... Read More
GAO: Report Examines Ways to Improve Federal Response to Pandemic Situations; Recommendations Include Automatic FMAP Adjustment During Downturns
The Government Accountability Office (GAO) released a report examining opportunities to improve the federal recovery efforts in response to COVID-19. After an analysis of obligation and expenditure data from federal agencies regarding the array of financial responses to the pandemic, the report identifies challenges and recommendations for improvement across the areas of viral testing, distribution of supplies, the Paycheck Protection... Read More
CMS: Agency to Begin Again Collecting Nursing Home Staffing Data; Quality Measures to be Held Constant
The Centers for Medicare & Medicaid Services (CMS) announced it is ending the emergency waiver that excused nursing homes from reporting staffing data through the Payroll-Based Journal (PBJ) system. CMS previously waived this requirement for nursing homes in response to the COVID-19 public health emergency (PHE) to relieve administrative burden. As a result, effective immediately, nursing homes will be required... Read More
CDC: Updated and Expanded List of People at Risk of Severe Illness from COVID-19
The Centers for Disease Control and Prevention (CDC) updated and expanded the list of people at risk for getting severely ill from COVID-19 (press release). Specifically, CDC removed the specific age threshold of 65 years and older. Instead, CDC states, “Among adults, the risk for severe illness from COVID-19 increases with age, with older adults at highest risk.” Regarding risks... Read More
HSGAC: Senate Committee on Homeland Security & Governmental Affairs Discusses Realigning the Goals of the Strategic National Stockpile and Decreasing Reliance on Foreign Manufacturers
The Senate Committee on Homeland Security & Governmental Affairs convened a hearing to discuss the Role of Strategic National Stockpile in Pandemic Response. Overall, Republicans pushed for a mission statement that defines what the Strategic National Stockpile is and clarifies the role of both federal and state governments. The hearing featured testimony from: Julie L. Gerberding, M.D., Former Director (2002-2009)... 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 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 new guidance documents and revisions made to existing guidance, including policies related to COVID-19 diagnostic testing, treatments, and medical device... Read More
HELP: Senators Consider COVID-19 Lessons Learned in Preparation for Future Pandemics
The Senate Committee on Health, Education, Labor, and Pensions (HELP) convened a hearing to discuss the lessons learned from the current COVID-19 pandemic response to begin preparing for the next pandemic. While Republicans were primarily interested in focusing attention on preparations for subsequent public health crises, Democrats were concerned that not enough attention was being placed on supporting the ongoing... Read More
FDA: Guidance Issued to Answer FAQs Regarding COVID-19 Impact on Meetings and Medical Device User Fee Applications
The Food and Drug Administration (FDA) issued guidance to answer frequently asked questions (FAQs) on the impact of the COVID-19 public health emergency (PHE) on formal meetings and user fee applications for medical devices. The guidance is intended to provide answers to FAQs about regulatory and policy issued related to device development during the COVID-19 PHE. Additional highlights from the... Read More
E&C: White House Coronavirus Task Force Members Testify; Spike in Cases, Testing Capacity, Vaccine Timeline, PPE, and Reopening Schools Discussed
The House Committee on Energy and Commerce convened a hearing to discuss the federal government’s response to the COVID-19 pandemic. Trump Administration officials from the National Institutes of Health (NIH), the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) testified about their agency’s efforts to support... Read More
Other: SBA and Treasury Announce Enhanced Transparency Regarding the Paycheck Protection Program
The Small Business Administration (SBA) and the Department of Treasury announced that details on PPP borrowers that receive loans above $150,000 will be made publicly available. Details include business names, addresses, NAICS codes, zip codes, business type, demographic data, non-profit information, jobs supported, and loan amount ranges. These categories account for nearly 75 percent of the loan dollars approved. For loans below $150,000, totals... Read More
Education & Labor: Racial Inequities Exacerbated by COVID-19; Health, Education, Workforce Discussed
The House Education and Labor Committee convened a hearing to discuss how Congress can address racial inequities exacerbated by COVID-19 in education, health, and the workforce. Overall, Democrats urged Republicans to support the House-passed Heroes Act (H.R. 6800; WHG summary), while Republicans pushed for states to continue to reopen their economies to help address racial disparities. The hearing featured testimony... Read More
WHG - Weekly, June 22-26
The House and Senate will convene hearings on the COVID-19 pandemic as negotiations on the next coronavirus relief package are still not likely to begin until after the 4th of July holiday followed by a vote before the August recess. In addition, House Democrats are expected to introduce legislation to strengthen the Affordable Care Act (ACA) the week of July... Read More
CMS: In Light of COVID-19 Hospitalization Data, Agency Calls for Greater Emphasis on SDOH in Value-Based Payment Programs
The Centers for Medicare & Medicaid Services (CMS) released new data detailing the cumulative impact of COVID-19 on Medicare CHIP beneficiaries (data; FAQ; CMS Administrator Seema Verma blog post). Overall, CMS states the data show that older individuals and those with chronic health conditions are at the highest risk for COVID-19. The data also speak to racial disparities in the... Read More
HHS: Provider Relief Fund Recipients Do Not Need to Submit Quarterly Reports
The Department of Health and Human Services (HHS) updated its Provider Relief Fund frequently asked questions (FAQs) to clarify that recipients are not required to submit a separate quarterly report to HHS or the Pandemic Response Accountability Committee. The agency notes that the Terms and Conditions for the Provider Relief Fund require recipients who receive at least $150,000 to submit... Read More
WHG - Updated (6/22/20): Catalogue of Health Agency Guidance and Government Response to COVID-19
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 near 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,... Read More
HELP: Updated Report on COVID-19 Demographic Data
The Trump administration submitted its updated report on COVID-19 demographic data to Congress, as required by the Paycheck Protection Program and Health Care Enhancement Act. Senate Health, Education, Labor and Pensions (HELP) Ranking Member Patty Murray (D-WA) described the report as “incomplete,” noting it is “still missing race and ethnicity data for over half of COVID-19 case reports.” On pp... Read More
Other: SBA Issues Interim Final Rules on Paycheck Protection Program; Eligibility Requirements Relating to Applicants with Past Felony Convictoins
The Small Business Administration (SBA) issued an interim final rule to supplement previously posted interim final rules on the Paycheck Protection Program (PPP) with additional guidance on eligibility requirements relating to applicants with past felony convictions. SBA shortens the timeframe under review from five years to one year for an applicant that has been convicted of a felony that does... Read More
WHG - Aligned Support on Legislative & Regulatory Changes to Extend COVID-19 Telehealth Flexibilities
The COVID-19 public health emergency has required a swift and monumental response across several federal agencies and Congress. Through a combination of emergency powers, federal agencies have collectively issued over 600 temporary flexibilities and regulatory changes intended to bolster the U.S. response to the pandemic. With respect to the Department of Health and Human Services (HHS), many of the deregulatory... Read More
E&C: Subcommittee on Health Examines COVID-19 Racial and Ethnic Health Disparities; Racism, COVID-19 Data, Vaccines, and Social Determinants of Health Discussed
The House Energy and Commerce Subcommittee on Health convened a hearing to discuss racial and ethnic health disparities during the COVID-19 pandemic, and more broadly, in the health care system. Witnesses representing the interest of minority groups testified about the disproportionate impact the COVID-19 pandemic has had on racial and ethnic groups and how the public health emergency (PHE) shone... Read More
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