COVID-19: Federal Update (5/13)
House Democrats introduced their sweeping $3 trillion “CARES 2.0” stimulus legislation (text; section-by-section; one pager; state and local fact sheet) yesterday following weeks of intraparty negotiations and assessments of current COVID-19 response efforts. If enacted, the Health Economic Recovery Omnibus Emergency Solutions (HEROES) Act would represent the largest federal response to the COVID-19 pandemic to date, with provisions that would provide another round of direct payments to individuals and families, additional funding for health care providers and COVID-19 testing, as well as nearly $1 trillion in aid to state and local governments. TRP’s instant, comprehensive analysis of this legislation can be read here.
Meanwhile, House Majority Leader Steny Hoyer (D-MD) announced that Members will convene this Friday to consider the HEROES Act, as well as a rule change that would facilitate remote Congressional work. The House plans to provide additional time in the vote series to promote sanitation and social distancing practices. Given these factors — as well as the numerous procedural votes expected throughout the next legislative business day — it’s expected that the vote on final passage will stretch into late Friday night and possibly into early Saturday morning. In the upper chamber, Senators will convene today to consider a bill that would reauthorize and reform the Foreign Intelligence Services Act (FISA).
In notable political news, House Republicans scored two key victories in special elections yesterday. In California, Republican Mike Garcia is on track to defeat Democrat Christy Smith special election to replace former Rep. Katie Hill (D-CA). Garcia’s expected victory in California’s 25th Congressional district will mark the first time since 1998 that Republicans were able to flip a Democratic-held congressional seat in The Golden State. In Wisconsin, Republican state Sen. Tom Tiffany beat Democrat Tricia Zunker in a special election to replace former Rep. Sean Duffy (R-WI).
COVID-19: What We’re Hearing
Liability. Majority Leader Mitch McConnell (R-KY) and Sen. John Cornyn (R-TX) are working on legislation that would limit the liabilities of health care workers, business owners, and employees from lawsuits pertaining to the COVID-19 outbreak. Leader McConnell emphasized that any future COVID-19 relief efforts must include these protections in order for the Senate to consider additional relief legislation. Democrats have been dismissive of this proposal, arguing that it would water down federal consumer protection efforts.
Provider Funding. HHS announced that it has extended the deadline for providers to attest to the receipt of payments and accept the terms and conditions from 30 days to 45 days. TRP’s comprehensive analysis of these distributions can be read here.
To date, HHS is providing a $50 billion general allocation for Medicare hospitals and providers, $10 billion for hospitals in highly impacted areas, $10 billion for rural providers, and $400 million for the Indian Health Service. It also establishes a program to fund COVID-19 care for the uninsured.
HHS has published a list of frequently asked questions pertaining to the $50 billion general allocation of the COVID-19 provider relief fund. In addition, providers receiving funds must agree to a set of terms and conditions, including reporting and documentation requirements, charging only in-network rates for COVID-19 care, and certifying that the funds will only be used to prevent, prepare for, and respond to the outbreak.
HRSA launched a separate portal allowing providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to request reimbursement.
HHS also cited providers who will receive further, separate funding, including skilled nursing facilities, dentists, and providers that solely take Medicaid.
Select Subcommittee on the Coronavirus Crisis. The newly-formed Select Subcommittee on the Coronavirus Crisis will hold its first briefing this afternoon, hearing from a panel of experts on their proposals to reopen the economy and the conditions under which it may be done safely. The briefing will be livestreamed here.
COVID-19: What’s Happened
SBA and Treasury Department updated their list of frequently asked questions on the PPP.
SBA announced yesterday that agricultural businesses are now eligible for SBA’s Economic Injury Disaster Loan (EIDL) and EIDL Advance programs.
SBA issued guidance on how to calculate PPP loans by business type.
SBA is temporarily restricting incoming applications for PPP loans to only those submitted by the country’s smallest lenders.
SBA published a list of all lenders participating in the PPP.
SBA issued a interim final rule clarifying the process of applying for PPP loans for individuals who report self-employed income on a 1040 Schedule C
SBA issued an interim final rule outlining additional guidance for the PPP. TRP’s comprehensive analysis of the small business provisions contained in COVID-19 response bills can be read here. The loan application form can be accessed here.
FDA. The Food and Drug Administration (FDA) published new guidance documents related to drugs being developed for COVID-19. The first guidance document provides general recommendations to sponsors to help prepare them for pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs. The second guidance document is intended to assist sponsors in the clinical development of drugs for treating or preventing COVID-19.
FDA issued an emergency use authorization for the first COVID-19 antigen test.
FDA published guidance on reporting requirements for medical device shortages.
FDA issued an emergency use authorization for the antiviral Remdesivir.
FDA issued guidance outlining an exemption and exclusion from certain requirements of the Drug Supply Chain Security Act during the public health emergency.
FDA issued guidance that will temporarily allow hospitals to compound certain sedatives used for COVID-19 patients during the public health emergency. Additional details on this policy from the FDA can be read here.
Legislative Response. TRP has published several in-depth policy memos that analyze actions that Congress and the federal government have taken to address the COVID-19 outbreak. Click here for the full list of memos.
Since the beginning of the COVID-19 outbreak, Congress and the Trump administration have issued a number of policies and waivers designed to lower restrictions on and encourage telehealth services. Click here to read TRP’s memo on these telehealth policies.
President Donald Trump signed the $483.4 billion “COVID-19 Phase 3.5” bill into law. TRP’s comprehensive analysis of the Phase 3.5 legislation can be read here.
TRP has published a memo explores the “health extenders” that the CARES Act reauthorized through Nov. 2020, what’s on the table for these programs in the fall, and the questions that will shape the conversation. Click here to read the memo.
CMS. CMS published a new tranche of frequently asked questions for state Medicaid and CHIP programs regarding COVID-19 response efforts. These FAQs cover a variety of topics, including: (1) emergency preparedness and response; (2) eligibility and enrollment flexibilities; (3) benefit flexibilities; (4) cost-sharing and financing flexibilities; (5) managed care flexibilities; and (6) information technology and data reporting.
CMS issued an interim final rule with comment period and blanket waivers under Section 1135 of the Social Security Act. These new flexibilities provide for Medicare coverage of serology tests, new coverage for services provided by pharmacists, and a waiver of the limitation on the types of practitioner that may furnish Medicare telehealth services.
CMS also gave hospitals and other inpatient facilities new flexibilities that are intended to increase acute care hospitals’ capacity during the pandemic, as well as permitting off-campus hospital outpatient departments to apply to temporarily receive reimbursement under Medicare’s hospital outpatient prospective payment system, rather than under the physician fee schedule. TRP’s memo on the new flexibilities is available here.
CMS announced a new independent commission that will assess safety and quality in nursing homes.
CMS has updated its information related to COVID-19 guidance document for Medicare Advantage, Part D, and Medicare-Medicaid plans.
CMS has issued additional blanket waivers to promote flexibility for Long-Term Care Hospitals (LTCH), Rural Health Clinics (RHC), Federally Qualified Health Centers (FQHC), and Intermediate Care Facilities.
CMS issued recommendations that outline how certain health care systems can resume non-essential surgeries and medical procedures in areas with low incidence of COVID-19.
CMS has proposed to permanently codify a change to its inpatient rehabilitation facility (IRF) policy that dispenses with the requirement that IRFs provide and document a post-admission physician evaluation within 24 hours of admission.
A full list of the 1135 waiver approval letters can be accessed here.
Treasury. The Treasury Department has released a list of frequently asked questions pertaining to the Employee Retention Credit.
The Fed. The Federal Reserve and other bank regulatory agencies published an interim final rule that modifies the Liquidity Coverage Ratio to support banking organizations’ participation in the Money Market Mutual Fund Liquidity Facility and the PPP Liquidity Facility.
The Federal Reserve will expand the scope and eligibility for the Main Street Lending Program.
The Federal Reserve expanded the scope and duration of its Municipal Liquidity Facility to offer up to $500 billion in lending to states and municipalities during the pandemic.
The Federal Reserve announced a series of emergency actions that would provide more than $2 trillion in COVID-19 loans to businesses, state, and local governments.
IRS. The Internal Revenue Service (IRS) published a list of frequently asked questions on COVID-related relief for retirement plans and IRAs.
FEMA. The Federal Emergency Management Agency (FEMA) published a fact sheet on how the agency will coordinate and distribute two shipments of PPE to 15,000 nursing homes across the country.
DOT. The Department of Transportation (DOT) announced more than $1 billion in grants to 439 airports across all 50 states.
DOT issued a final order on service obligations for air carriers receiving financial relief through the CARES Act.
DOT and the Federal Transit Administration (FTA) announced a total of $25 billion in federal funding allocations to help the public transit systems respond to the COVID-19 outbreak.
Testing. The Trump administration released a blueprint that seeks to bolster state testing plans and rapid response programs.
SAMHSA. The Substance Abuse and Mental Health Services Administration (SAMHSA) awarded grant funding to increase access and improve the quality of community mental and substance use disorder (SUD) treatment services through the expansion of Certified Community Behavioral Health Clinics (CCBHC).
FCC. The Federal Communications Commission (FCC) and the Department of Education announced efforts to promote the use of $16 billion in funding for the CARES Act’s Education Stabilization Fund for remote learning.
In a move aimed at expanding access to Wi-Fi throughout the country, the FCC voted to adopt a report and order that would make 1,200 megahertz of spectrum in the 6 GHz band available for unlicensed use.
NIH. The National Institutes of Health issued its first guidance on COVID-19 treatment options that are currently under review.
NIH and the Foundation for the NIH (FNIH) announced that they will launch a new public-private partnership with more than a dozen biopharmaceutical companies aimed at speeding COVID-19 vaccine and treatment options.