COVID-19: Federal Update (3/31)
Capitol Hill Update
Despite plans to avoid Washington for the forseeable future due to the COVID-19 outbreak, lawmakers are hard at work on the next round of legislative relief efforts as existing and emerging issues linger. Speaker Nancy Pelosi (D-CA) stated yesterday that Democrats have begun working in earnest on the next round of legislative COVID-19 relief efforts, forecasting a package that focuses on bolstering the recovery efforts. Speaker Pelosi also noted that the next round would continue to shore up health care priorities, while also tackling key policy priorities that enjoy bipartisan support. As of now, Congress is not expected back in Washington until Apr. 20 at the earliest. However, leadership could call members back at any time should votes on the next round of relief efforts get scheduled.
COVID-19: What We’re Hearing
COVID-19 Phase IV. Lawmakers on both sides of the aisle are floating potential priorities for the next round of COVID-19 response legislation.
Speaker Pelosi has been advocating for additional health care provider funding, resources for state and local governments, and stronger workforce protections. She also suggested repealing the 2017 tax law provision that caps the State and Local Tax (SALT) deduction.
House Democrats are seeking funding streams to address pressing infrastructure priorities. This includes new funding for water, school, and broadband infrastructure in addition to several existing needs.
Energy and Commerce Ranking Member Greg Walden (R-OR) expects another push for action on surprise billing in the next round of relief. During the Phase III negotiations, Chairman Frank Pallone (D-NJ) and Senate Health, Education, Labor, and Pensions (HELP) Chairman Lamar Alexander (R-TN) were actively trying to tack on their surprise billing legislation onto the package.
House Schedule. Majority Leader Steny Hoyer (D-MD)issued a “Dear Colleague” letter to members today asking them to remain flexible with their schedules for the balance of the 2020 work session. This includes the possibility coming into session during previously-scheduled district work periods and convening for five-day work weeks.
COVID-19 Response Guidance. With the Phase III bill signed into law, implementation guidance for certain provisions contained in this sweeping package, as well as other relevant federal guidance pertaining to COVID-19 response efforts, is expected trickle out in the coming days and weeks.
Treasury Secretary Steven Mnuchin stated that relevant documents and instructions for the small business pandemic loans will issued this week. The Secretary noted that the program will make these loans available starting this Friday.
TRP will keep clients apprised on the latest developments on the federal government’s implementation of COVID-19 response legislation. As always, please feel free to follow up with the TRP team with any specific questions or feedback.
ACA. Rumors out of the Centers for Medicare and Medicaid Services (CMS) suggest that the agency is considering reopening the enrollment period for the Affordable Care Act (ACA) in response to the COVID-19 emergency.
Buy American EO. The Trump administration is reportedly considering a “Buy American” executive order that seeks to exercise war powers to bolster manufacturing capacity.
A timeline for when the order could be issued is fluid. Reports indicate that there has been considerable push back on the policy within the White House.
Rumors speculate that the order would: (1) limit or prohibit exports of certain pharmaceutical and medical products aimed at protecting the U.S. drug supply chain; (2) promote dramatic expansions of the US Strategic and Active Pharmaceutical Ingredients (API) Stockpiles; and (3) crack down on companies from providing investigational medicines for emergency use to other countries.
COVID-19: What’s Happened
Legislative Response. TRP’s latest memo on the COVID-19 relief packages dives into how the pharmaceutical industry may be impacted by provisions on therapy and vaccine development, drug supply chain transparency, over-the counter drug regulation reform and more. Click here to read the memo.
President Donald Trump signed the Phase III legislation into law on last Friday. TRP’s analysis of the Phase III legislation can be read here. Our memo on the bill’s provisions pertaining to the Public Health and Social Services Emergency Fund (PHSSEF) can be read here.
The Phase II legislative response bill was signed into law on March 18, 2020. TRP’s full analysis of the Phase II bill can be read here.
An $8.3 billion emergency supplemental appropriations bill cleared both chambers and was signed into law on Mar. 6. TRP’s analysis of the Phase I legislation can be read here.
The Treasury Department and IRS announced the implementation of certain paid sick and family leave requirements mandated by the second COVID-19 legislative response package. TRP’s breakdown of the paid leave provisions can be found here.
Telehealth. The Federal Communications Commission (FCC) proposed a $200 million program aimed at bolstering telehealth services for health care providers.
CMS issued telehealth guidance that expands the list of eligible services and providers as well as waives HIPAA requirements. It also clarifies that states have the authority without guidance or approval from the agency to waive policies within the Medicaid program.
TRP’s full analysis of the COVID-19 telehealth policies can be read here.
CMS. The Centers for Medicare and Medicaid Services (CMS) has issued a series of regulatory changes that seek to provide flexibility and bolster the health care system to address the COVID-19 outbreak.
CMS sent a letter to hospitals on behalf of Vice President Mike Pence requesting they report data in connection with their efforts to fight the COVID-19.
CMS issued guidance over the weekend for health care providers regarding the expansion of the accelerated and advance payments program for providers and suppliers during COVID-19 emergency.
CMS approved Medicaid Section 1135 Waivers for states in response to the COVID-19 outbreak. A full list of the 1135 waiver approval letters can be accessed here.
CMS announced that it is taking steps to implement provisions of the Families First Coronavirus Response Act that provide states with additional Medicaid funding.
CMS released a new targeted plan for health care facility inspections in light of the outbreak.
CMS announced that it is granting exemptions from reporting requirements and granting extensions for clinicians, providers, and facilities participating in Medicare quality reporting programs.
CMS released a list of frequently asked questions regarding COVID-19 actions on provider enrollment and waiving certain screening requirements.
CMS posted a recording of its Mar. 17 “All-State” call with state Medicaid and CHIP agencies. Additionally, the agency launched a new Medicaid COVID-19 resource page that will contain the latest updates and relevant information.
CMS posted Frequently Asked Questions (FAQs) to aid state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their response to the outbreak.
HHS. The Department of Health and Human Services (HHS) issued an emergency use authorization declaration stating that circumstances exist to justify the authorization of emergency use of drugs and biological products during the COVID-19 outbreak.
FDA. The Food and Drug Administration (FDA) issued an update yesterday on steps the agency is taking to help mitigate supply interruptions of food and medical products.
FDA announced actions to increase U.S. supplies to support COVID-19 response efforts by providing instructions to manufacturers importing personal protective equipment (PPE) and other devices.
FDA has provided new guidance on patient access to certain Risk Evaluation and Mitigation Strategy (REMS)-requited drugs during the COVID-19 public health emergency.
FDA issued guidance allowing manufacturers of certain non-invasive, FDA-cleared devices to expand their use so that health care providers can use them to monitor patients remotely.
The Food and Drug Administration (FDA) is suspending routine surveillance inspections for food, drugs, medical devices and tobacco to protect its workers from COVID-19 and because of industry concerns about visitors. Inspections triggered by specific reasons, like contamination, outbreaks or other emergencies, will continue.
VA. In an internal memo, the Department of Veterans’ Affairs (VA) is placing a pause on offering non-urgent community care referrals to veterans due to infection risks and concern over stressing the health system during the outbreak.
VA Secretary Robert Wilkie announced that the VA is preparing to deploy 3,000 doctors, nurses and other emergency personnel — along with mobile hospitals and pharmacies — to bolster COVID-19 response efforts.
Social Distancing. President Trump announced that the administration will be extending its social distancing guidelines through Apr. 30.
The guidance outlines a series of steps — including avoiding social gatherings of 10 or more people — aimed at mitigating the spread of the virus.
Centers for Disease Control and Prevention (CDC) issued guidance on Mar. 16 recommending that Americans cancel or postpone gatherings of 50 more people for the next eight weeks.
EO on Medical Resources. President Trump signed an executive order that seeks to stymie hoarding of health and medical resources to respond to the spread of COVID-19.
President Trump issued an executive order on prioritizing and allocating resources to respond to the spread of COVID-19.
SEC. The Securities and Exchange Commission (SEC) has extended its conditional exemptions from reporting and proxy delivery requirements for public companies, funds, and investment advisers affected by the outbreak.
The Fed. On Mar. 24, The Federal Reserve will be scaling back its examination of banks to focus more intently on the potential risks that arise from the outbreak.
The Federal Reserve announced on Mar. 23 a series of emergency moves aimed at stemming the economic impact of the outbreak. These actions include three new emergency lending facilities, as well as a new program that will support lending to eligible small-and medium-sized businesses that support efforts by the Small Business Administration (SBA).
The Federal Reserve announced that it will establish a Primary Dealer Credit Facility to support dealers’ market-making as the economy continues to slow due to the COVID-19 pandemic.
The Federal Reserve, Federal Deposit Insurance Corporation (FDIC), and Office of the Comptroller of the Currency (OCC) outlined actions aimed at providing banks additional flexibility to support households and businesses during the outbreak. Details on these steps can be read here.
The Fed slashed interest rates to a range of 0-0.25 percent, and will buy hundreds of billions of dollars in bonds in an effort to stave off economic hardships.
REAL ID. President Trump announcedthat the federal government would be extending the compliance deadline for REAL ID, responding to concern from the travel industry as well as lawmakers, who have been increasingly worried that a rush to DMVs to meet the Oct. 1 deadline could put people at risk
Tech. The White House announced the launch of a new COVID-19 High Performance Computing Consortium aimed at providing researchers with access to computing resources needed to bolster scientific research on the virus.
The Trump administration issued a call to action urging the tech industry to collaborate and utilize data on COVID-19 and related viruses using artificial intelligence (AI). It includes curated articles and data compiled by the Allen Institute for AI. Additional information on this database can be found here.
USTR. The Office of the United States Trade Representative (USTR) opened a comment docket for members of the public, businesses, and government agencies to submit comments if they believe further modifications to the 301 tariffs may be necessary in response to the outbreak.
NIH. The National Institutes of Health (NIH) announced that it will be shifting all non-mission-critical laboratory operations to a maintenance phase as the agency looks to reduce the risk of COVID-19 transmission among staff. Activities that will continue include research for participants in non-elective critical trials, COVID-19 research, and urgent public health research recommended by NIH leadership.
IRS. Treasury Secretary Steven Mnuchin stated that the Internal Revenue Service (IRS) will push the tax filing deadline back three months from the April 15 date in response to the pandemic.
Travel Restrictions. President Trump tweeted that the U.S. will be closing the northern border to Canada to all non-essential traffic. Trade will not be effected.
President Trump announced that he would suspend all travel from Europe to the United States for the next 30 days in addition to existing travel restrictions from China and Iran.
National Emergency. President Trump declared a national emergency in response to the COVID-19 outbreak, invoking the Stafford Act that allows the administration to provide more federal aid for states and municipalities.
This declaration would allow the states to request a 75 percent federal cost-share from the Federal Emergency Management Agency (FEMA) for expenses related to the outbreak, including medical tests and supplies, vaccinations, emergency workers, etc.
The national emergency declaration will also allow CMS to utilize Section 1135 waivers to provide flexibility to health care providers and state agencies during the outbreak.
Supreme Court. SCOTUS announced that it will postpone its next two weeks of oral arguments — a move that could complicate the remainder of the court’s docket for this term.