COVID-19: Federal Update (4/3)

Capitol Hill Recap

Lawmakers have left Washington amid the COVID-19 outbreak, and are not expected back in Washington until Apr. 20 at the earliest. Despite their distance from Capitol Hill, members are continuing discussions on the next round of legislative relief efforts aimed at stemming emerging and existing issues from the outbreak. The NTC is working with industry partners to encourage North Texas lawmakers to prioritize an infrastructure package should a Phase IV relief bill move forward. Congressional leadership could call members back at any time should key votes get scheduled.

COVID-19: What We’re Hearing

  • COVID-19 Phase IV. Democrats are moving fast on producing legislative text for the next version of COVID-19 response legislation. Bill text on certain provisions could be available as soon as next week.
  • Democratic leadership reissued their “Moving Forward” infrastructure framework. Speaker Pelosi specifically pointed to increased funding for transit, water, rail, airports, and broadband infrastructure in the Phase IV package.
  • TRP’s analysis of the House Democrats’ infrastructure priorities can be read here. Our breakdown of Senate Environment and Public Works Chairman John Barrasso’s (R-WY) Surface Transportation Reauthorization bill can be read here.
  • 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 their surprise billing legislation onto the package.
  • Speaker Pelosi has also 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.
  • Appropriations. With Congress’s schedule in flux for the balance of the year, Appropriations leaders are delaying the start of their fiscal year (FY) 2020 funding work amid the uncertainty surrounding the COVID-19 outbreak. Congressional appropriators have pushed their expectations for completing FY 2020 spending work past the late spring-early summer dates that leadership targeted earlier this year.
  • House Schedule. Majority Leader Steny Hoyer (D-MD)issued a “Dear Colleague” letter to members asking them to remain flexible with their schedules for the balance of the 2020 work session. This includes the possibility of 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 to trickle out in the coming days and weeks.
  • The NTC and TRP will keep members 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 NTC and TRP team with any specific questions or feedback.
  • 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

  • SBA. The Small Business Administration (SBA) issued an interim final rule yesterday outlining additional guidance for the paycheck protection program. 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.
  • Legislative Response. TRP’s newest memo examines the provider-related provisions contained in the CARES Act. This includes critical funding for hospitals and providers impacted by the COVID-19 pandemic, greatly expanded flexibilities for providers to operate through the pandemic, and mandated coverage of coronavirus-related therapies and testing. Click here to read the memo.
  • TRP’s has published an analysis of the medical device-related provisions in the CARES Act, including new reporting requirements, a study on the security of the medical device supply chain, and storage requirements. Click here to read the memo.
  • TRP has published a memo on the Medicare and Medicaid provisions in the CARES Act and other COVID-19-related legislation. This analysis examines new telehealth policies, emergency payment provisions, new flexibilities on prescription drug fills, and more. Click here to read the memo.
  • TRP’s 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 Mar. 27. 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 Mar. 18. 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.
  • DOL. TheDepartment of Labor issued a temporary rule yesterday implementing the paid family and medical leave provisions of the Families First Coronavirus Response Act. TRP’s analysis of the rule can be read here.
  • The Trump administration offered a broad definition of “health care providers” that may be excluded from paid sick and family leave, as well as broad exceptions to family leave for companies with fewer than 50 workers in the rule. This led some Members of Congress to say that the rule veers away from what Congress intended when it passed the law.
  • HHS. The Department of Health and Human Services (HHS) announced yesterday that it will not penalize HIPAA-covered business associates for sharing patient information intended to assist the government combat COVID-19. 
  • 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.
  • DOT. The Department of Transportation (DOT) and Federal Transit Administration (FTA) announced a total of $25 billion in federal funding allocations to help the public transit systems respond to the COVID-29 outbreak.
  • HUD. The Department of Housing and Urban Affairs (HUD) has begun allocating $3 billion in funding for communities through the Community Development Block Grant, Emergency Solutions Grant, and Housing Opportunities for Persons With AIDS programs to address COVID-19 issues.
  • CMS. The Centers for Medicare and Medicaid Services (CMS) has published additional frequently asked questions for state Medicaid and CHIP agencies regarding COVID-19 response efforts.
  • 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. TRP’s analysis of the rule can be read here.
  • CMS posted a transcript of its Mar. 31 national stakeholder call. A full list of CMS call transcripts and recordings can be found here.
  • 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 posted Frequently Asked Questions to aid state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their response to the outbreak.
  • The Fed. The Federal Reserve and four other financial agencies announced they will consider comments on Volcker rule modifications until May 1.
  • The Federal Reserve announced that it will temporarily ease its backup capital requirements for banks, excluding deposits and Treasury securities from the calculation of the Fed’s supplementary leverage ratio.
  • 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.
  • Treasury. The Treasury Department issued a statement clarifying that Social Security recipients will not need to file an abbreviated tax return to receive direct payment relief.
  • The Treasury Department has issued guidance for airlines to apply for up to $58 billion in grants and loans as mandated by the Phase III COVID-19 legislative response bill.
  • CFPB. The Consumer Financial Protection Bureau (CFBP) issued guidance urging lenders to provide information to credit reporting agencies about the work they are doing to provide relief to consumers during the COVID-19 emergency.
  • Social Distancing. Surgeon General Jerome Adams stated that he anticipates the Trump administration’s social distancing guidelines to be extended past Apr. 30.
  • 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.
  • Telehealth. TRP has published a comprehensive analysis of the telehealth policies for the COVID-19 national emergency. Click here to read the telehealth memo.
  • The Federal Communications Commission (FCC) proposed a $200 million program aimed at bolstering telehealth services for health care providers.
  • USTR. The Office of the United States Trade Representative (USTR) published a list of exemptions on certain medical items from the tariffs imposed by President Donald Trump on Chinese goods.
  • 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. 
  • FDA. The Food and Drug Administration (FDA) issued an update 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.  
  • 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.
  • 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. 
  • 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 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.
  • 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.

COVID-19: Federal Update (4/2)

Capitol Hill Update

With Congress’s schedule in flux for the balance of the year, Appropriations leaders are delaying the start of their fiscal year (FY) 2020 funding work amid the uncertainty surrounding the COVID-19 outbreak. Congressional appropriators have pushed their expectations for completing FY 2020 spending work past the late spring-early summer dates that leadership targeted earlier this year. As of now, House lawmakers are aiming to clear spending bills by June, while Senators are eyeing markups and passage after the Fourth of July. Congress is not expected back in Washington until Apr. 20 at the earliest. However, leadership could call members back at any time should key votes get scheduled. 

COVID-19: What We’re Hearing

  • COVID-19 Phase IV. Democrats are moving fast on producing legislative text for the next version of COVID-19 response legislation. Bill text on certain provisions could be available as soon as next week.
  • Democratic leadership reissued their “Moving Forward” infrastructure framework on a conference call yesterday. Speaker Pelosi specifically pointed to increased funding for transit, water, rail, airports, and broadband infrastructure in the Phase IV package.
  • TRP’s analysis of the House Democrats’ infrastructure priorities can be read here. Our breakdown of Senate Environment and Public Works Chairman John Barrasso’s (R-WY) Surface Transportation Reauthorization bill can be read here.
  • 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 their surprise billing legislation onto the package.
  • Speaker Pelosi has also 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 Schedule. Majority Leader Steny Hoyer (D-MD)issued a “Dear Colleague” letter to members asking them to remain flexible with their schedules for the balance of the 2020 work session. This includes the possibility of 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.
  • 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.
  • 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

  • SBA. The Small Business Administration (SBA) and Treasury Department released relevant documents and instructions for the small business “Paycheck Protection Program.” 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.
  • Legislative Response. TRP’s latest memo analyzes the medical device-related provisions in the CARES Act, including new reporting requirements, a study on the security of the medical device supply chain, and storage requirements. Click here to read the memo.
  • TRP has published a memo on the Medicare and Medicaid provisions in the CARES Act and other COVID-19-related legislation. This analysis examines new telehealth policies, emergency payment provisions, new flexibilities on prescription drug fills, and more. Click here to read the memo.
  • TRP’s 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 Mar. 27. 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 Mar. 18. 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.
  • Treasury. The Treasury Department issued a statement last night clarifying that Social Security recipients will not need to file an abbreviated tax return to receive direct payment relief.
  • The Treasury Department has issued guidance for airlines to apply for up to $58 billion in grants and loans as mandated by the Phase III COVID-19 legislative response bill.
  • The Fed. The Federal Reserve announced yesterday that it will temporarily ease its backup capital requirements for banks, excluding deposits and Treasury securities from the calculation of the Fed’s supplementary leverage ratio.
  • 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.
  • CFPB. The Consumer Financial Protection Bureau (CFBP) issued guidance yesterday urging lenders to provide information to credit reporting agencies about the work they are doing to provide relief to consumers during the COVID-19 emergency.
  • Social Distancing. Surgeon General Jerome Adams stated yesterday that he anticipates the Trump administration’s social distancing guidelines to be extended past Apr. 30.
  • 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.
  • CMS. The Centers for Medicare and Medicaid Services (CMS) posted a transcript of its Mar. 31 national stakeholder call. A full list of CMS call transcripts and recordings can be found here.
  • 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. TRP’s analysis of the rule can be read here.
  • 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 Frequently Asked Questions (FAQs) to aid state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their response to the outbreak.
  • Telehealth. TRP’s has updated our comprehensive analysis of the telehealth policies for the COVID-19 national emergency. Click here to read the telehealth memo.
  • 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. 
  • USTR. The Office of the United States Trade Representative (USTR) published a list of exemptions on certain medical items from the tariffs imposed by President Donald Trump on Chinese goods.
  • 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. 
  • 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 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.
  • 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. 
  • 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 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.
  • 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.

COVID-19: Federal Update (4/1)

While Congress avoids Washington amid the COVID-19 outbreak, officials are continuing to outline policy priorities for the next round of response legislation. The chatter about bolstering the nation’s infrastructure grew louder yesterday after Speaker Nancy Pelosi (D-CA) and President Donald Trump each publicly expressed interest in tackling this in the “Phase IV” legislation. While Speaker Pelosi honed in on specific policy proposals such as water, school, and broadband infrastructure, President Trump called for $2 trillion in infrastructure spending in a tweet yesterday. Conversely, Senate Majority Leader Mitch McConnell (R-KY) threw cold water on the idea of increased infrastructure and social program spending, saying that he will not allow the Phase IV legislation to become a vehicle to carry Democratic policy priorities. Despite this sentiment, lawmakers on both sides of the aisle agree that another round of COVID-19 response legislation is inevitable as the government looks to stem emerging and existing issues pertaining to the outbreak.

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. Rumors suggest that bill text on certain provisions could start to circulate soon.
  • 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 their surprise billing legislation onto the package.
  • 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 Schedule. Majority Leader Steny Hoyer (D-MD)issued a “Dear Colleague” letter to members asking them to remain flexible with their schedules for the balance of the 2020 work session. This includes the possibility of coming into session during previously-scheduled district work periods and convening for five-day work weeks.
  • 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 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.
  • 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.
  • 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

  • SBA. Yesterday, the Small Business Administration (SBA) and Treasury Department released relevant documents and instructions for the small business “Paycheck Protection Program.” TRP’s comprehensive analysis of the small business provisions contained in COVID-19 response bills can be read here. Details on how to apply can be found on the SBA website.
  • Legislative Response. TRP has published a new memo on the Medicare and Medicaid provisions in the CARES Act and other COVID-19-related legislation. This analysis examines new telehealth policies, emergency payment provisions, new flexibilities on prescription drug fills, and more. Click here to read the memo.
  • TRP’s 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 Mar. 27. 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 Mar. 18. 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. TRP’s has updated our comprehensive analysis of the telehealth policies for the COVID-19 national emergency. Click here to read the telehealth memo.
  • 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. 
  • 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. TRP’s analysis of the rule can be read here.
  • 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.
  • Treasury. The Treasury Department has issued guidance for airlines to apply for up to $58 billion in grants and loans as mandated by the Phase III COVID-19 legislative response bill.
  • USTR. The Office of the United States Trade Representative (USTR) published a list of exemptions on certain medical items from the tariffs imposed by President Donald Trump on Chinese goods.
  • 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. 
  • 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.
  • 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 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.
  • 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.

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.

COVID-19 Federal Update (3/30)

Capitol Hill Update

Following passage and enactment of the Phase III COVID-19 response bill late last week, lawmakers have left Washington and are expected to be out of session until Apr. 20th at the earliest. Despite this extended absence, discussions among lawmakers on a ‘Phase IV’ coronavirus legislative package are expected to intensify in the coming weeks. Speaker Nancy Pelosi (D-CA) reiterated the necessity of additional COVID-19 response legislation during a speech on the House floor last Friday, advocating for additional health care provider funding, resources for state and local governments, and stronger workforce protections. Lawmakers have also identified technical corrections to the massive Phase III package as an avenue for Congress to pursue in future COVID-19 legislative efforts.

COVID-19: What We’re Hearing

  • 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 come out today.The Secretary noted that the program will make these loans available starting this Friday.
  • The Centers for Medicare and Medicaid Services (CMS) is preparing to issue an interim final rule that will address policies the agency cannot waive under its Section 1135 authority. The rule will take effect immediately but can still be revised and will have an open comment period.
  • 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. 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 latest 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.
  • Social Distancing. At a news conference yesterday, 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.
  • CMS. Yesterday, 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 six states in response to the COVID-19 outbreak. These states include: NY, CO, HI, ID, MA, and MD. 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.
  • 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.  
  • FDA issued emergency authorization for a rapid point-of-care test that can deliver results in 45 minutes.
  • 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.
  • FDA Commissioner Stephen Hahn announced that state public health departments across the country can now unilaterally authorize laboratories to test for COVID-19. FDA will also allow diagnostics manufacturers to distribute certain testing kits prior to the federal government granting emergency use authorizations.
  • 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.
  • 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.
  • Telehealth. 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.
  • 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.

COVID-19 Alert: House Passes ‘Phase III’ Coronavirus Response Measure

  • Bill clears by voice vote, set for POTUS signature at 4 PM.
  • Deal includes funding for small businesses, health care needs, and direct payment relief.
  • Speaker Pelosi emphasizes need for ‘Phase IV’ legislation

Today, House lawmakers passed a sweeping $2.3 trillion economic stimulus package (section-by-section) aimed at bolstering the response efforts and stemming the negative impacts of the novel coronavirus (COVID-19) outbreak. The bill passed with strong bipartisan support via voice vote despite an effort by Rep. Thomas Massie (R-KY) to requested a recorded vote on the legislation. The measure now heads to President Donald Trump’s desk for signature at 4:00 PM.

  • Next Steps. While Congress is expected to be out of session until Apr. 20th at the earliest, discussions among lawmakers on a ‘Phase IV’ legislative package are expected to intensify in the coming weeks. Speaker Nancy Pelosi (D-CA) reiterated the necessity of additional COVID-19 response legislation during a speech on the House floor today, advocating for additional health care provider funding, resources for state and local governments, and stronger workforce protections. Lawmakers have also identified technical corrections to the massive Phase III package as an avenue for Congress to pursue in future COVID-19 legislative efforts.

Key policies in the COVID-19 stimulus package include:

Protection for Workers and Consumers

  • Direct Payment Relief The deal provides $1,200 in direct cash payment relief to individuals, $2,400 for married couples, plus $500 per child. The full payment is available for individuals making up to $75,000 and $150,000 for married couples. The value begins decreasing and then phases out completely for those making over the full payment income cap.
  • Expanded UI Benefits — The expanded unemployment insurance (UI) program allocates $260 billion to provide a $600 increase for every recipient, with provisions that incentivize states to eliminate waiting periods. An additional 13 weeks unemployment insurance benefits are also prioritized in the revised bill. Additionally, part-time, self-employed, and gig economy workers will also have access to UI benefits under these provisions.
  • Food Support. — The bill allocates $200 million to the Department of Homeland Security (DHS) to support shelter, food, and supportive services to individual and families. It also provides$450 million for the Emergency Food Assistance Program (TEFAP)

Employee Retention by Small Businesses

  • Paycheck Protection Program —The legislation’s “Paycheck Protection Program” would allow SBA to provide eligible small businesses and 501(c)3’s with a guarantee on a loan up to $10 million. 
  • This loan could then be forgiven for up to eight weeks of payroll, rent, utilities, and other essential operating expenses. Forgiveness would be reduced proportionally to any layoffs, as well as any reductions in salary above 25%. 
  • Eligible organizations include those with 500 or fewer employees, those that meet industry-specific SBA thresholds, independent contractors, and sole proprietorships. Restaurants and hospitality locations are assessed the 500 employees on a per-location basis. 
  • Grants — An additional program would provide $10,000 emergency grants to eligible small businesses to offset certain operating costs.
  • Tax Credits — A tax credit would compensate employers for half of wages paid to workers (up to $10,000 in wages per worker).

Relief for Drastically Affected Sectors of the Economy

  • Funding ReliefThe legislation provides the Treasury Department with $500 billion for the purpose of making loans, issuing loan guarantees, and purchasing obligations to assist several distressed areas of the economy. 
  • $454 billion would be generally available to businesses, states, and municipalities affected by the crisis. 
  • Aviation — $61 billion will be allocated toward a mix of grants and loans to both passenger airlines cargo airlines and contractors on the ground. The actual split is $25 billion to passenger and $4 billion to cargo in both grant and loans ($58 billion) and an additional $3 billion for contractors on the ground.
  • RestrictionsBorrowers would be restricted from stock buybacks, dividends, executive bonuses, and executive raises until one year after the loan is paid back and expected to maintain employment levels “to the extent practicable.” 
  • WaiversAfter much back and forth as to waivers for these requirements, the Secretary of the Treasury would be allowed to some of these requirements in order to “protect the interests of the federal government” but would be subject to appearing before Congress to discuss their decision to do so.

Health Policy

  • Extenders — Medicare, Medicaid, and public health programs set to expire on May 22, 2020 will be reauthorized through November 30, 2020 — punting a long-term reauthorization and accompanying dealmaking on surprise billing and drug pricing until after the election.
  • Public Health and Social Service Emergency Fund — $100 billion will be allocated for reimbursing providers with expenses or lost revenue directly attributable to COVID-19. It also provides an additional $27 billion for other PHSSEF functions, including: (1) $16 billion for the Strategic National Stockpile; (2) $3.5 billion for BARDA for manufacturing, production, and purchase of vaccines, therapeutics, and diagnostics for COVID-19; (3) $289 million for mitigating issues in health professional shortage areas; and (4) at least $250 million for the Hospital Preparedness Program.
  • Medicare Hospital Funding — The bill establishes a 20 percent add-on payment for hospitals for COVID-19 patients and temporarily ends the Medicare sequester.
  • Shortage Reporting — The bill places additional requirements on drug manufacturers regarding reporting supply interruptions and to maintain contingency plans to ensure a backup supply of their products. The bill also requires medical device manufacturers to submit information about a medical device or component shortage at FDA’s request.
  • Vaccine Coverage —The bill mandates that plans cover forthcoming COVID-19 vaccines without cost-sharing within 15 days of receiving an “A” or “B” rating from the United States Preventative Services Task Force or a recommendation from the Advisory Committee on Immunization Practices. Furthermore, the bill provides for coverage of a COVID-19 vaccine through Part B with no cost sharing.
  • Telehealth and Rural Health — The bill reauthorizes and provides $180 million for HRSA rural health and telehealth initiatives, including funding for HRSA telehealth resource centers grant programs. It also provides $200 million for the Federal Communications Commission’s Connected Care Pilot Program, which supports providers rendering care through telehealth. The bill further relaxes Medicare telehealth requirements, removing any need for a telehealth provider to have seen the patient in the past three years. It also allows federally qualified health centers (FQHC) and rural health centers (RHC) to furnish telehealth to Medicare beneficiaries in their home and allow for many check-ups to be done via telehealth.
  • Part 2 and Other PHI — The bill aligns 42 CFR Part 2 regulations on substance use disorder records with the Health Insurance Portability and Accountability Act (HIPAA) with initial patient consent. Also requires HHS to issue guidance on patient record sharing during the COVID-19 emergency.
  • SAMHSA —$425 million will be allocated to Substance Abuse and Mental Health Services Administration (SAMHSA) for Health Surveillance and Program Support, including $250 million for Certified Community Behavioral Health Clinic expansion grants.
  • CMS —The bill provides $200 million for the Centers for Medicare and Medicaid Services to assist nursing homes with infection control.
  • OTC Reform — The bill would establish user fees for OTC-related work and make monograph issuance subject to administrative order, not notice-and-comment rulemaking. These long-awaited reforms have passed the House and Senate in various forms but their vehicle has never been signed into law.

Support for Children and Families

  • Healthy Start The bill reauthorizes the Healthy Start program to provide additional support for families during the COVID-19 emergency.
  • Head StartThe bill provides $750 million for Head Start to meet emergency staffing needs.
  • SNAPThe bill includes $15.5 billion in additional funding for the Supplemental Nutrition Assistance Program (SNAP).
  • Child Nutrition ProgramsThe bill allocates$8.8 billion in additional funding for Child Nutrition Programs in order to ensure children receive meals while school is not in session.
  • TANF — Funding for the Temporary Assistance for Needy Families (TANF) program will be extended through November 30, 2020.
  • Administration for Community LivingThe bill includes $955 million for the Administration for Community Living (ACL) to support nutrition programs, home and community-based services, support for family caregivers, and expand oversight and protections for seniors and individuals with disabilities.
  • Child Care Development Block GrantThe bill includes $3.5 billion to support child care and early education programs through Child Care Development Block Grant. 

State and Local Relief

  • Airports –$10 billion in Federal assistance is directed to help publicly-owned, commercial airports. These funds will help airport operators meet ongoing needs and manage current construction projects.
  • Community Development Block GrantThe bill provides $5 billion to the Community Development Block Grant (CDBG) program. This includes: (1) $2 billion for states and localities that received an allocation under the fiscal year 2020 CDBG formula; (2) $1 billion in direct funding to states to support a coordinated response across entitlement and non-entitlement communities; and (3) $2 billion for states and localities based on the prevalence and risk of COVID-19, as well as related economic and housing disruptions. 
  • Coronavirus Relief Fund – The bill provides $150 billion to State, Tribal and Local Governments (with a population that exceeds 500,000). 
  • Economic Development Administration (EDA) – The bill provides $1.5 billion for economic adjustment assistance to help revitalize local communities after the pandemic. 
  • Disaster Relief Fund – The bill allocates $45 billion to provide for the immediate needs of state, local, tribal, and territorial governments to protect citizens and help them recover from the overwhelming effects of COVID-19. 
  • Emergency Management Performance Grants – $100 million will be allocated for state, local, territorial, and tribal governments to support coordination, communications, and logistics efforts.
  • Department of Education – The bill includes $30.75 billion for an Education Stabilization Fund for states, school districts and institutions of higher education for costs related to COVID-19.
  • Community Services Block Grant (CSBG) – The bill includes $1 billion for CSBG to help communities address the consequences of increasing unemployment and economic disruption.

COVID-19 Federal Update (3/27)

Capitol Hill Update

House lawmakers have reconvened for legislative business as they look to swiftly clear the $2 trillion COVID-19 economic stimulus measure. The bill currently enjoys strong bipartisan support on both sides of the aisle after it overwhelmingly cleared the Senate on a 96-0 vote. While the House will try to pass the package by voice vote, reports suggest that Rep. Thomas Massie (R-KY) could try to block this from happening by requesting a roll call vote. Should any member exercise their right to call for an in-person, recorded vote, it could be delayed for as long as it takes for 216 lawmakers to come to the House floor for a quorum to be present. If a recorded vote is requested, the process could spill into the weekend if it takes longer-than-expected for members to return to Washington.

COVID-19: What We’re Hearing

  • Additional COVID-19 Legislation. Discussions are ongoing about additional COVID-19 response legislation that could be taken up during the balance of the 116th Congress.
  • House Majority Leader Steny Hoyer (D-MD) teased possible “Phase IV” and “Phase V” legislative packages that could be taken up later this year.
  • Speaker Nancy Pelosi (D-CA) noted that funding for food aid, stronger worker protections, and funding for pensions and state and local governments would be prioritized by Democrats in the next round of COVID-19 response legislation.
  • As the legislative text for Phase III continues to be analyzed, Senate Republicans are preparing to formulate a series of technical corrections to the Phase III legislation.
  • The next votes in the Senate are scheduled to occur on Monday, Apr. 20.
  • 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. The Treasury Department and IRS announced the immediate implementation of certain paid sick and family leave requirements mandated by the second COVID-19 legislative response package. TRP’s full analysis of the Phase II bill can be read here. A breakdown of the paid leave provisions can be found here.
  • TRP’s instant analysis of the Phase III legislation can be read here, and our new memo on the bill’s provisions pertaining to the Public Health and Social Services Emergency Fund (PHSSEF) 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.
  • CMS. The Centers for Medicare and Medicaid Services (CMS) approved Medicaid Section 1135 Waivers for six states in response to the COVID-19 outbreak. These states include: NY, CO, HI, ID, MA, and MD. 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.
  • 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.
  • FDA. The Food and Drug Administration (FDA) announced new 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.  
  • FDA issued emergency authorization for a rapid point-of-care test that can deliver results in 45 minutes.
  • 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.
  • FDA Commissioner Stephen Hahn announced that state public health departments across the country can now unilaterally authorize laboratories to test for COVID-19. FDA will also allow diagnostics manufacturers to distribute certain testing kits prior to the federal government granting emergency use authorizations.
  • 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. 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 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.
  • Telehealth. CMS released new 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.
  • 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.
  • Social Distancing. The Trump administration issued guidance that outlined a number of suggestions aimed at stemming the spread of COVID-19. The guidance outlines a series of steps — including avoiding social gatherings of 10 or more people — aimed at mitigating the spread of the virus over the course of the next 15 days.
  • Centers for Disease Control and Prevention (CDC) issued guidance recommending that Americans cancel or postpone gatherings of 50 more people for the next eight weeks.
  • Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), stated that Americans should be prepared to “hunker down significantly more” as the federal government ponders additional steps to stem the spread of the outbreak.
  • 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.

COVID-19 Federal Update (3/26)

Late last night, Senators overwhelmingly passed (96-0) a $2.2 trillion economic stimulus package aimed at bolstering the economy and response efforts amid the COVID-19 outbreak. The bill now heads to the House, where lawmakers are eyeing a voice vote passage of the measure during an abbreviated session tomorrow morning. The House Rules Committee is expected to convene today to develop a rule that will govern debate on the bill, as well as potential voting options should any lawmaker object to the voice vote. TRP’s instant analysis of the Phase III legislation can be read here.

COVID-19: What We’re Hearing

  • COVID-19 3.0. Rumors suggest that there are members on both sides of the aisle that could utilize procedural options to block a voice vote on the Phase III legislation.
  • Reps. Thomas Massie (R-KY) and Alexandria Ocasio-Cortez (D-NY) are on both parties’ respective watch lists pertaining to members that could block the expedited vote.
  • Should any member exercise their right to call for an in-person, recorded vote, Speaker Nancy Pelosi (D-CA) is expected to utilize a procedure for proxy voting for those members who are unable to return to Washington.
  • Additional COVID-19 Legislation. Discussions are ongoing about additional COVID-19 response legislation that could be taken up during the balance of the 116th Congress.
  • House Majority Leader Steny Hoyer (D-MD) teased possible “Phase IV” and “Phase V” legislative packages that could be taken up later this year.
  • As the legislative text for Phase III continues to be analyzed, Senate Republicans are preparing to formulate a series of technical corrections to the Phase III legislation.
  • The next votes in the Senate are scheduled to occur on Monday, Apr. 20.
  • 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. The Treasury Department and IRS announced the immediate implementation of certain paid sick and family leave requirements mandated by the second COVID-19 legislative response package. TRP’s full analysis of the Phase II bill can be read here. A breakdown of the paid leave provisions can be found 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.
  • CMS. The Centers for Medicare and Medicaid Services (CMS) approved Medicaid Section 1135 Waivers for seven states in response to the COVID-19 outbreak. These states include: KY, RI, IA, IN, KS, MO, and OR. 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.
  • 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.
  • FDA. The Food and Drug Administration (FDA) announced new 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.  
  • FDA issued emergency authorization for a rapid point-of-care test that can deliver results in 45 minutes.
  • 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.
  • FDA Commissioner Stephen Hahn announced that state public health departments across the country can now unilaterally authorize laboratories to test for COVID-19. FDA will also allow diagnostics manufacturers to distribute certain testing kits prior to the federal government granting emergency use authorizations.
  • 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. 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 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.
  • Telehealth. CMS released new 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.
  • 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.
  • Social Distancing. The Trump administration issued guidance that outlined a number of suggestions aimed at stemming the spread of COVID-19. The guidance outlines a series of steps — including avoiding social gatherings of 10 or more people — aimed at mitigating the spread of the virus over the course of the next 15 days.
  • Centers for Disease Control and Prevention (CDC) issued guidance recommending that Americans cancel or postpone gatherings of 50 more people for the next eight weeks.
  • Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), stated that Americans should be prepared to “hunker down significantly more” as the federal government ponders additional steps to stem the spread of the outbreak.
  • 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.

COVID-19 Federal Update (3/25)

Late last night, Senate Minority Leader Chuck Schumer (D-NY) and Treasury Secretary Steven Mnuchin struck a bipartisan agreement on a $2 trillion COVID-19 stimulus deal following days of intense negotiations. In a “Dear Colleague” letter to members, Leader Schumer outlined several funding streams Democrats were able to secure in the final bill, including: (1) $150 billion for a state, local, and tribal fund; (2) $100 billion in emergency funds for hospitals; and (3) $10 billion in small business grants up to $10,000 aimed at alleviating operating costs. The Democratic leader also lauded policy wins on unemployment insurance, direct payments to individuals, and oversight of the $500 billion allocated toward distressed industry relief.

Senate Majority Leader Mitch McConnell (R-KY) expressed confidence that the Senate would be able to pass the bill today, noting that the finalized bill text should be public around noon. While House leadership is eyeing passage of the bill via unanimous consent, it remains to be seen whether this strategy will pan out as some lawmakers on both sides of the aisle have expressed concerns about passing an economic stimulus bill by voice vote. As such, a concrete strategy and timing in the House remains in flux as of this point. The next “pro forma” session in the lower chamber is currently scheduled for 11 AM tomorrow morning.

COVID-19: What We’re Hearing

  • COVID-19 3.0. Once the updated bill text is released, the Senate is expected to vote on the Motion to Proceed to consideration of the bill, which requires support from 60 Senators.  
  • When the motion is adopted, the Senate will have up to 30 hours of debate at which point the Senate will vote on Cloture to end debate, also a 60 vote threshold. Final passage with a majority of the Senate would follow. 
  • After the Senate passes the stimulus deal, it will be sent to the House. There remains uncertainty about how the House will vote on the package. 
  • House Rules Committee Chairman James McGovern (D-MA) circulated a staff memorandum to lawmakers outlining two primary options: (1) convene for a “pro forma” session where they can pass the bill by unanimous consent; or (2) adopt a rule change and allow members to vote by proxy. 
  • We believe if members oppose the bill and want to be on record, the second option will be pursued.
  • Additional COVID-19 Legislation. House Majority Leader Steny Hoyer (D-MD) told Democrats yesterday that lawmakers will likely take up additional COVID-19 response legislation during the balance of the 116th Congress.
  • Leader Hoyer teased possible “Phase IV” and “Phase V” legislative packages that could be taken up later this year.
  • 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

  • FDA. The Food and Drug Administration (FDA) announced new 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.  
  • FDA issued emergency authorization for a rapid point-of-care test that can deliver results in 45 minutes.
  • 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.
  • FDA Commissioner Stephen Hahn announced that state public health departments across the country can now unilaterally authorize laboratories to test for COVID-19. FDA will also allow diagnostics manufacturers to distribute certain testing kits prior to the federal government granting emergency use authorizations.
  • CMS. The Centers for Medicare and Medicaid Services (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 approved Medicaid Section 1135 Waivers for 11 states in response to the COVID-19 outbreak. These states include: Alabama, Arizona, California, Illinois, Louisiana, Mississippi, New Hampshire, New Jersey, New Mexico, North Carolina, and Virginia
  • 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.
  • 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. 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 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 announced that 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.
  • Legislative Response. The Treasury Department and IRS announced the immediate implementation of certain paid sick and family leave requirements mandated by the second COVID-19 legislative response package. TRP’s full analysis of the bill can be read here. A breakdown of the paid leave provisions can be found here.
  • An $8.3 billion emergency supplemental appropriations bill, cleared both chambers and was signed into law on Mar. 6.
  • 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.
  • Telehealth. CMS released new 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.
  • VA. Veterans’ Affairs (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.
  • Funding Requests. The Trump administration, spearheaded by Secretary Mnuchin, submitted its $1 trillion stimulus request outlining priorities for the third phase of COVID-19 response legislation. 
  • OMB Acting Director Vought submitted a letter to Congressional appropriators with a request for $46 billion for agencies that have been stretched thin by the efforts to combat the outbreak.
  • 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.
  • Social Distancing. The Trump administration issued guidance that outlined a number of suggestions aimed at stemming the spread of COVID-19. The guidance outlines a series of steps — including avoiding social gatherings of 10 or more people — aimed at mitigating the spread of the virus over the course of the next 15 days.
  • Centers for Disease Control and Prevention (CDC) issued guidance recommending that Americans cancel or postpone gatherings of 50 more people for the next eight weeks.
  • Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), stated that Americans should be prepared to “hunker down significantly more” as the federal government ponders additional steps to stem the spread of the outbreak.
  • 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.

COVID-19 Federal Update (3/24)

White House officials and Congressional leaders are inching closer to an agreement on the “Phase III” COVID-19 response legislation following a tense day on the Senate floor that saw Majority Leader Mitch McConnell’s (R-KY) bill stall for a second time. Off the floor, Treasury Secretary Steven Mnuchin and Senate Minority Leader Chuck Schumer (D-NY) worked into the late hours last night and have signaled that they have narrowed the list of issues down to a handful of items — suggesting an agreement could be reached as soon as this morning. In a television interview moments ago, Speaker Nancy Pelosi (D-CA) stated that she thinks “there is real optimism that we could get something done in the next few hours.” Meanwhile, President Donald Trump urged Congress to approve the deal today as the White House scrambles to bolster the federal government’s response efforts.

COVID-19: What We’re Hearing

  • COVID-19 3.0. Once an agreement is reached, the Senate will again vote on the Motion to Proceed to consideration of the bill, which requires support from 60 Senators. 
  • If the motion is adopted, the Senate will have 30 hours of debate at which point the Senate will vote on Cloture to end debate, also a 60 vote threshold. Final passage with a majority of the Senate would follow. This process can be expedited through an agreement between Leader McConnell and Leader Schumer.
  • When the Senate passes the stimulus deal, it will be sent to the House. There remains uncertainty about how the House will vote on the package. 
  • House Rules Committee Chairman James McGovern (D-MA) circulated a staff memorandum yesterday to lawmakers outlining two primary options: (1) convene for a “pro forma” session where they can pass the bill by unanimous consent; or (2) adopt a rule change and allow members to vote by proxy. 
  • We believe if members oppose the bill and want to be on record, the second option will be pursued.
  • Meanwhile, Speaker Pelosi officially introduced the House Democrats’ version (summary) of the Phase III response legislation last night.
  • COVID-19 4.0. Congress will likely look to additional COVID-19 response legislation once a plan to return to Washington for legislative business is formulated.
  • Increased chatter about the development of a remote voting plan in light of the positive tests among three lawmakers suggests that leadership may look to develop an emergency offsite voting plan.
  • 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

  • CMS. The Centers for Medicare and Medicaid Services (CMS) approved Medicaid Section 1135 Waivers for 11 states in response to the COVID-19 outbreak. These states include: Alabama, Arizona, California, Illinois, Louisiana, Mississippi, New Hampshire, New Jersey, New Mexico, North Carolina, and Virginia
  • 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.
  • Defense Production Act. Federal Emergency Management Agency (FEMA) Director Peter Gaynor announced today that the Trump administration will formally implement the Defense Production Act (DPA) for the purposes of securing additional medical equipment.
  • REAL ID. President Trump announced that 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.
  • The Fed. In an aggressive new effort to boost the economy, the Federal Reserve announced 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.
  • FDA. The Food and Drug Administration (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.  
  • FDA issued emergency authorization for a rapid point-of-care test that can deliver results in 45 minutes.
  • 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.
  • FDA Commissioner Stephen Hahn announced that state public health departments across the country can now unilaterally authorize laboratories to test for COVID-19. FDA will also allow diagnostics manufacturers to distribute certain testing kits prior to the federal government granting emergency use authorizations.
  • Legislative Response. The Treasury Department and IRS announced the immediate implementation of certain paid sick and family leave requirements mandated by the second COVID-19 legislative response package. TRP’s full analysis of the bill can be read here. A breakdown of the paid leave provisions can be found here.
  • An $8.3 billion emergency supplemental appropriations bill, cleared both chambers and was signed into law on Mar. 6.
  • 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.
  • Telehealth. CMS released new 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.
  • VA. Veterans’ Affairs (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.
  • Funding Requests. The Trump administration, spearheaded by Secretary Mnuchin, submitted its $1 trillion stimulus request outlining priorities for the third phase of COVID-19 response legislation. 
  • OMB Acting Director Vought submitted a letter to Congressional appropriators with a request for $46 billion for agencies that have been stretched thin by the efforts to combat the outbreak.
  • EO on Medical Resources. President Trump issued an executive order on prioritizing and allocating resources to respond to the spread of COVID-19.
  • 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.
  • Social Distancing. The Trump administration issued guidance that outlined a number of suggestions aimed at stemming the spread of COVID-19. The guidance outlines a series of steps — including avoiding social gatherings of 10 or more people — aimed at mitigating the spread of the virus over the course of the next 15 days.
  • Centers for Disease Control and Prevention (CDC) issued guidance recommending that Americans cancel or postpone gatherings of 50 more people for the next eight weeks.
  • Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), stated that Americans should be prepared to “hunker down significantly more” as the federal government ponders additional steps to stem the spread of the outbreak.
  • 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.