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COVID-19: Federal Update (6/3)

Quick Takes

— HOUSE-PASSED PPP BILL HITS SNAG IN UPPER CHAMBER. Sens. Ron Johnson (R-WI) and Mike Lee (R-UT) have threatened to prevent unanimous consent passage of the bill.

— DEMOCRATS OFFER $494 BILLION TRANSPORT BILL TARGETING ECONOMY, CLIMATE. Democrats on the House Transportation and Infrastructure Committee unveiled a five-year, $494 billion surface transportation bill this morning.

— WHITE HOUSE WEIGHS OPTIONS FOR NEXT STIMULUS BILL. President Trump is planning to meet with his senior advisers as soon as this week to discuss policy options for the next coronavirus relief package.

— HHS ANNOUNCES $250 MILLION TO SUPPORT HEALTH CARE SYSTEMS RESPONDING TO COVID-19. This tranche of funding seeks to support hospitals and other health care entities that are treating patients and responding to the COVID-19 pandemic.

Capitol Hill Update

— HOUSE-PASSED PPP BILL HITS SNAG IN UPPER CHAMBER. The Senate will convene for legislative business today as lawmakers await next steps on consideration of a House-passed measure that seeks to provide Paycheck Protection Program (PPP) recipients with more time and flexibility in using these funds. While Senate Majority Leader Mitch McConnell’s (R-KY) comments earlier this week suggested that the upper chamber was satisfied with the underlying bill, two GOP senators —Sens. Ron Johnson (R-WI) and Mike Lee (R-UT) — have threatened to block expedited passage of the measure due to their preference to have the PPP expire in August rather than December. If senators cannot reach an agreement on unanimous consent passage, it’s likely that the bill would be brought to the floor for “regular order” consideration at some point over the course of these next few weeks.

— SENATE FLOOR ACTION FOCUSES ON NOMINATIONS. On the floor for today, Senators will resume clearing the queue of pending presidential nominations. This includes a vote on James Anderson’s nomination to be a Deputy Under Secretary of Defense. The Senate will also vote on Drew Tipton’s nomination to be a District Judge for the Southern District of Texas.

Washington Insider: What We’re Reading

Roll Call: Democrats Offer $494 Billion Transport Bill Targeting Economy, Climate

Democrats on the House Transportation and Infrastructure Committee unveiled a five-year, $494 billion surface transportation bill (text; fact sheet, summary, section-by-section) this morning. In all, the bill would offer surface transportation programs $494 billion over five years, including $411 billion over five years out of the Highway Trust Fund for highway, transit, safety and research programs, representing a 46 percent increase over current investment levels, according to documents released by the committee. Of that $494 billion, $319 billion would go to highways, $105 billion to transit, $4.6 billion for highway safety, $5.3 billion for motor carrier safety and $60 billion for rail

The Wall Street Journal: White House Weighs Options for Next Stimulus Bill ($)

President Trump is planning to meet with his senior advisers as soon as this week to discuss policy options for the next coronavirus relief package as the administration prepares for negotiations with Capitol Hill, according to a senior administration official. The president’s team has assembled a set of proposals meant to encourage the public to return to work and resume normal life, including going out to restaurants and taking vacations, in an effort to jump-start the ailing economy as quickly as possible. The size and scope of the final package, which White House aides predicted won’t be completed until July, will depend in part on the success of state-level reopening efforts and whether the economic downturn begins to reverse.

The Hill: USTR Launches Investigation into Countries’ Digital Taxes

The Office of the U.S. Trade Representative (USTR) on Tuesday announced that it is opening investigations into digital services taxes that have been adopted or are under consideration in a host of trading partners to determine whether they are discriminatory and burden U.S. commerce. The investigations, which will take place under Section 301 of the Trade Act of 1974, will examine taxes that have been adopted in Austria, India, Indonesia, Italy and Turkey and that are under consideration in Brazil, the Czech Republic, the European Union, Spain and the United Kingdom. Findings that the taxes are discriminatory and burdensome could result in the U.S. imposing tariffs.

The New York Times: Senate Confirms Inspector General to Oversee Virus Bailout Funds ($)

A divided Senate voted on Tuesday to confirm Brian D. Miller, a White House lawyer, to be the inspector general in charge of overseeing the Treasury Department’s $500 billion pandemic recovery fund. In the role, Mr. Miller will be required to monitor the flow of the funds and report any wrongdoing to Congress.

COVID-19: What We’re Hearing

APPROPRIATIONS UPDATE. As the COVID-19 pandemic continues to upend the Congressional schedule, lawmakers are adjusting their expectations for consideration of fiscal year (FY) 2020 spending bills.

  1. House. The lower chamber is expected to ramp up on the appropriations process in the coming weeks, with the goal of marking up and clearing all 12 measures by the end of July. Previously, Leader Hoyer had indicated that the House could complete the markup process by June.

  2. Senate. Senate Appropriations Chairman Richard C. Shelby (R-AL) indicated that his committee tentatively plans to mark up begin marking up spending bills during the third week of June.

— ‘CARES 2.0’ STATE OF PLAY. Senate Majority Leader Mitch McConnell (R-KY) stated yesterday that Congress will “probably” need to pass another round of COVID-19 relief legislation in the coming weeks — a pivot from his most recent stance that Congress must continue to analyze implementation of the CARES Act prior to moving additional stimulus relief. Key priorities that have emerged include:

  1. Budget Reform. A bipartisan group of House lawmakers penned a letter to Speaker Nancy Pelosi (D-CA) and Minority Leader Kevin McCarthy (R-CA) calling for provisions that address the federal debt and trust funds for Medicare and Social Security to be included in the next round of COVID-19 relief legislation.

  2. Surprise Billing. Reports out of the Trump administration suggest that the White House will push for action on surprise medical bills ahead of the next round of relief legislation.

  3. During the CARES Act 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.

  4. Liability. Leader McConnell and Sen. John Cornyn (R-TX) are working on legislation that would limit the liabilities of health care workers, business owners, and employees from lawsuits pertaining to the COVID-19 outbreak. Leader McConnell emphasized that any future COVID-19 relief efforts must include these protections in order for the Senate to consider additional relief legislation.

  5. House Democratic leadership appears open to negotiating a deal on liability protections. Leader Hoyer emphasized that these protections must not undermine the health and rights of workers but indicated that the issue is open for further discussion and negotiation.

  6. Unemployment Reform. Senate Republicans are spearheading efforts on reforming the enhanced unemployment benefits so that generous payments approved in the CARES Act don’t become an obstacle to rehiring workers.

  7. A key option on the table includes enhancing a tax credit that would give employers a tax break for keeping workers on the payroll.

  8. State and Local Governments. Funding for state and local governments is a key pillar of the Democrats’ next stimulus bill. While there is bipartisan agreement that more needs to be done to help stymie economic hardships for these entities, allocating additional funding has become a divisive issue within the Republican conference.

  9. It appears likely that some Senate Republicans — particularly those who are up for re-election — would coalesce behind a bipartisan proposal that would provide additional funding and flexibility to address needs at the state and local level.

COVID-19 Legislative & Regulatory Trackers

NEW TODAY…

— HHS ANNOUNCES $250 MILLION TO SUPPORT HEALTH CARE SYSTEMS RESPONDING TO COVID-19. The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS ASPR) announced it is allocating $250 million to aid U.S. health care systems treating patients and responding to the COVID-19 pandemic.

  1. This tranche of funding from the Hospital Preparedness Program seeks to support hospitals and other health care entities to train workforces, expand telemedicine and the use of virtual healthcare, procure supplies and equipment, and coordinate effectively across regional, state and jurisdictional, and local health care facilities to respond to COVID-19.

— CMS OUTLINES CHANGES TO CMMI MODELS DURING PUBLIC HEALTH EMERGENCY. The Centers for Medicare and Medicaid Services (CMS) published a “flexibilities table” that shows the changes the agency has made or will be making to Innovation Center models in response to the COVID-19 public health emergency.

— CMS ISSUES GUIDANCE ON OPTIONAL COVID-19 TESTING GROUP. CMS issued guidance to states addressing implementation of the Optional COVID-19 Testing (XXIII) Group.

RECENT DEVELOPMENTS…

— OCC LETTER TO MAYORS: EXTENDED SHUTDOWNS WILL HURT LENDERS. The Office of the Comptroller of the Currency (OCC) Acting Comptroller Brian Brooks penned a letter to the U.S. Conference of Mayors yesterday saying that extended COVID-19 shutdowns could hurt banks’ ability to lend.

— CMS ISSUES GUIDANCE FOR STATES ON RANGE OF COVID-RELATED POLICIES AND ACTIVITIES. The Centers for Medicare and Medicaid Services (CMS) issued guidance to states on COVID-19 survey activities, CARES Act funding, enhanced enforcement for infection control deficiencies, and quality improvement activities in nursing homes.

— CMS UNVEILS NEW ENFORCEMENT ACTIONS FOR NURSING HOMES. CMS unveiled new enforcement actions for nursing homes based on early trends in the most recent data regarding incidence of COVID-19 in residential care facilities. The enhanced enforcement targets facilities with persistent infection control violations, and CMS will also enforce lower-level violations to ensure greater attention to infection control practices.

— TREASURY PUBLISHES UPDATED FAQS ON CORONAVIRUS RELIEF FUND. The Treasury Department updated its list of frequently asked questions that provide examples of eligible and ineligible expenditures of the state, local, and tribal Coronavirus Relief Fund. TRP’s analysis of these new FAQs can be read here.

— HHS, BARDA ANNOUNCE NEW CDMO MANUFACTURING CONTRACT. The Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA) announced a $628 million contract with Emergent BioSolutions to advance manufacturing capabilities and capacity COVID-19 vaccines and therapeutics.

— SBA AND TREASURY ANNOUNCE $10 BILLION IN PPP FUNDING FOR CDFIs. The Small Business Administration (SBA) and Treasury Department announced they will set aside $10 billion in PPP funding for Community Development Financial Institutions.

— HHS UPDATES PROVIDER RELIEF FUNDING WEBSITE. HHS has updated its webpage outlining details on provider relief and related health funding.

  1. Click here for a list of extensive frequently asked questions on the fund.

  2. Click here for a detailed overview on all of the COVID-related provider funding.

— CMS PUBLISHES FACT SHEET ON PROGRAMS AND PAYMENT IN HOSPITAL ALTERNATE CARE SITES. The Centers for Medicare and Medicaid Services (CMS) published a fact sheet for state and local governments that outlines how these entities can seek payment for care in alternate care sites through CMS programs.

AS PREVIOUSLY REPORTED…

— HEROES ACT. The House passed the Democrats’ sweeping $3 trillion HEROES Act following weeks of intraparty negotiations and assessments of current COVID-19 response efforts. The bill is considered dead-on-arrival in the GOP-controlled Senate and White House. TRP’s comprehensive analysis of this legislation can be read here.

  1. As written, the bill would represent the largest federal response to the COVID-19 pandemic to date, with provisions that would provide another round of direct payments to individuals and families, additional funding for health care providers and COVID-19 testing, as well as nearly $1 trillion in aid to state and local governments.

— LEGISLATIVE RESPONSE. TRP has published several in-depth policy memos that analyze actions that Congress and the federal government have taken to address the COVID-19 outbreak. Click here for the full list of memos.

  1. Phase I. 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.

  2. Phase II. 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.

  3. Phase III. The CARES Act was signed into law on Mar. 27. TRP’s analysis of the Phase III legislation can be read here.

  4. Phase 3.5. President Donald Trump signed the $483.4 billion “COVID-19 Phase 3.5” bill into law on Apr. 24. TRP’s comprehensive analysis of the Phase 3.5 legislation can be read here.

— SMALL BUSINESSES. TRP’s comprehensive analysis of the small business provisions contained in COVID-19 response bills can be read here.

  1. PPP. SBA and Treasury Department have taken a piecemeal approach to implementing the PPP. While conducted with the aim of getting the emergency program up and running as quickly as possible, the government’s process of issuing FAQs and guidance as the program runs has created uncertainty in certain areas.

  2. The loan application form can be accessed here.

  3. On May 22, the agencies published a much-anticipated interim final rule on the PPP forgiveness process. That rule can be found here and the forgiveness application can be found here.

  4. The SBA and Treasury Department updated their running list of frequently asked questions on the PPP (May 27).

  5. SBA provided an update on its PPP loan data, as well as an updated state-by-state breakdown.

  6. SBA issued guidance on how to calculate PPP loans by business type.

  7. SBA published a list of all lenders participating in the PPP.

  8. SBA issued an interim final rule clarifying the process of applying for PPP loans for individuals who report self-employed income on a 1040 Schedule C.

  9. EIDL. Following overwhelming demand for Economic Injury Disaster Loans (EIDL) and accompanying $10,000 grants, SBA has limited eligibility for the program to agricultural businesses.

— FEDERAL RESERVE. Among other actions intended to mitigate an economic meltdown, the Fed has established 11 lending facilities intended to support the flow of credit to households, businesses, and municipalities. Many of these facilities are backed by Treasury funds provided under the CARES Act.

  1. Open Market Operations. At the onset of the pandemic, the Federal Open Market Committee (FOMC) lowered interest rates to 0-.25 percent in an effort to spur economic activity. Fed Chairman Jerome Powell, however, has indicated that the Fed is unlikely to pursue negative interest rates. The Fed is continuing to purchase Treasuries and mortgage-backed securities (MBS) with the aim of reducing strain on the financial sector.

  2. Main Street Lending Program. The Main Street Lending Program supports lending to small- and medium-sized businesses through the purchase of eligible commercial loans. More information on the program can be found here.

  3. Term Asset-Backed Securities Loan Facility (TALF). First created to deal with the liquidity crisis in the Asset-backed Securities (ABS) market in 2008-09, the Fed recently recreated this program to respond to COVID-19. Similar to the first version, TALF will allow issuers of ABS to effectively sell into a Fed backed Special Purpose Vehicle. More information on the program can be found here.

  4. Municipal Liquidity Facility (MLF). The Fed will purchase up to $500 billion in state and local debt with the intention of supporting cash-strapped municipal governments’ access to liquidity. More information on the program can be found here.

  5. Primary and Secondary Market Corporate Credit Facilities. The Fed will make loans to and purchase the bonds of investment-grade larger companies through two corporate credit facilities. More information on the program can be found here.

  6. Financial Markets. In addition to the above actions intended to support the flow of credit in the economy, the central bank has established several other facilities intended to facilitate the continued functioning of commercial paper markets, money markets, and primary dealer markets.

— TREASURY. The Treasury Department released a list of the payments that have been made to states and qualifying localities through the Coronavirus Relief Fund.

  1. Employee Retention Credit. The Treasury Department has released a list of frequently asked questions pertaining to the Employee Retention Credit.

— OVERSIGHT. The Congressional Oversight Commission has issued its first report outlining how it will review the Treasury Department and Federal Reserve’s efforts to implement Subtitle A of the CARES Act. This will include an analysis of the lending programs and facilities designed for businesses and municipalities.

— EO ON DEREGULATION. The Trump administration issued an executive order calling on agencies to target regulations “that may inhibit economic recovery” during the COVID-19 pandemic. Click here to read TRP’s analysis of this order.

— IRS. The Internal Revenue Service (IRS) published a list of frequently asked questions on COVID-related relief for retirement plans and IRAs (May 4).

— HHS. Among key initiatives led by the Department of Health and Human Services (HHS) at large:

  1. Testing. The Trump administration published a report on its national COVID-19 testing strategy as mandated by the “Phase 3.5” measure.

  2. HHS and the Health Resources and Services Administration (HRSA) allocated $225 million to Rural Health Clinics provided by the “Phase 3.5” legislation to bolster COVID-19 testing (May 20).

  3. Drug Manufacturing. HHS and the Biomedical Advanced Research and Development Authority (BARDA) announced a four-year, $354 million agreement with Phlow Corporation aimed at expanding U.S.-based pharmaceutical manufacturing for COVID-19 response (May 20). TRP’s analysis of the agreement can be read here.

  4. Drug Development. The Trump administration announced a framework and leadership for “Operation Warp Speed“— a national program aimed at accelerating the development, manufacturing, and distribution of COVID-19 diagnostics, treatments, and vaccines (May 15).

  5. Workforce, Telehealth. HHS and HRSA awarded $15 million in grant funding to 159 organizations across five health workforce programs to bolster telehealth capabilities in response to the COVID-19 pandemic (May 13).

— MEDICARE AND MEDICAID. The Centers for Medicare and Medicaid Services (CMS) has offered a series of regulatory flexibilities and guidances:

  1. Nursing Homes. CMS released guidance (press release) for state and local officials on reopening nursing homes which corresponds to the broader administration phases for opening up the U.S. (May 18).

  2. 1135 Waivers. A full list of the 1135 waiver approval letters can be accessed here (Updated Jun. 1).

  3. Medicaid Guidance. CMS released a new CMCS Informational Bulletin that provides states with guidance on how to temporarily modify certain provider payment methodologies and capitation rates under their Medicaid managed care contracts during the public health emergency (May 14).

  4. MA Plan FAQs. CMS updated its list frequently asked questions related to the public health emergency for Medicare Advantages plans (May 13).

  5. Interim Final Rule. CMS issued an interim final rule with comment period and blanket waivers under Section 1135 of the Social Security Act. These new flexibilities provide for Medicare coverage of serology tests, new coverage for services provided by pharmacists, and a waiver of the limitation on the types of practitioners that may furnish Medicare telehealth services (May 8).

  6. Medicaid, CHIP FAQs. CMS published a tranche of frequently asked questions for state Medicaid and CHIP programs regarding COVID-19 response efforts (May 5).

— HEALTH CARE PROVIDER FUNDING. TRP’s comprehensive analysis of these distributions can be read here.

  1. PHSSEF Distributions. To date, HHS is providing a $50 billion general allocation for Medicare hospitals and providers, $10 billion for hospitals in highly impacted areas, $10 billion for rural providers, $500 million for the Indian Health Service, and $4.9 billion for skilled nursing facilities. It also establishes a program to fund COVID-19 care for the uninsured. Additionally, HHS cited providers who will receive further, separate funding, including dentists and providers that solely take Medicaid.

  2. Compliance. HHS announced on May 22 that it would allow providers eligible to receive provider relief funding from the CARES Act an additional 45 days to accept the Terms & Conditions for such payments. Providers will now have a total of 90 days from receipt of payment to make the attestation to HHS.

— FDA. The Food and Drug Administration (FDA) has published several guidance documents related to drugs being developed for COVID-19, compounding, medical devices, and the supply chain.

  1. Testing. FDA posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (updated Jun. 2).

  2. Compounding. FDA issued guidance to temporarily allow pharmacies to compound drugs for hospitalized COVID-19 patients that are essentially copies of commercially-available drugs or provide such drugs to a hospital without a patient-specific prescription when certain conditions are met (Updated May 21).

  3. It also issued guidance to temporarily allow outsourcing facilities to compound a drug that is essentially a copy of an approved drug, use a bulk drug substance not on the 503B list, and not meet certain stability testing and expiration date requirements when certain conditions are met (Updated May 21).

  4. Drug Development. FDA published guidance documents related to drugs being developed for COVID-19.

  5. The first guidance document provides general recommendations to sponsors to help prepare them for pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs (May).

  6. The second guidance document is intended to assist sponsors in the clinical development of drugs for treating or preventing COVID-19 (May).

  7. Supply Chain Exemptions. FDA issued guidance outlining an exemption and exclusion from certain requirements of the Drug Supply Chain Security Act during the public health emergency (Updated May 11).

  8. Antigen Test. FDA issued an emergency use authorization for the first COVID-19 antigen test (May 8).

  9. Device Shortages. FDA published guidance on reporting requirements for medical device shortages (May).

  10. Remdesivir. FDA issued an emergency use authorization for the antiviral Remdesivir (May 1).

— CDC. The Centers for Disease Control and Prevention (CDC) published detailed guidelines for reopening schools and businesses that have been shut down amid the COVID-19 outbreak.

  1. CDC published guidance documents that offer decision-making tools for reopening schools, workplaces, child care programs, mass transit systems, bars and restaurants, as well as youth programs and camps.

— SAMHSA.

  1. The Substance Abuse and Mental Health Services Administration (SAMHSA) awarded grant funding to increase access and improve the quality of community mental and substance use disorder (SUD) treatment services through the expansion of Certified Community Behavioral Health Clinics (CCBHC) (Apr. 27).

  2. SAMHSA released $15 million in supplemental grant awards for tribal COVID-19 behavioral health response (May 1)

— NIH. National Institutes of Health (NIH) launched a study to investigate whether the COVID-19 pandemic has resulted in pregnancy-related health issues. The agency plans to incorporate this data into broader registry on how COVID-19 impacts maternal health.

  1. The National Institutes of Health issued its first guidance on COVID-19 treatment options that are currently under review (updated May 12).

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