Quick Takes
— CONGRESS SET TO CONSIDER DUELING POLICE REFORM PROPOSALS. House and Senate lawmakers will convene next week to consider the Democratic and Republican visions for comprehensive police reform.
— LOWER CHAMBER EYES JULY LEGISLATIVE BLITZ. House lawmakers have queued up votes on several key legislative items over the course of the next two weeks.
— HOUSE DEMS EYE DRUG PRICING AS ACA OFFSET. House Democrats are considering adding elements of H.R. 3 to their vote on the Affordable Care Act (ACA) the week of June 29.
— LOWEY UNVEILS HOUSE APPROPS SUBCOMMITTEE MARKUP SCHEDULE. Subcommittee markups will officially begin the week of Jul. 6.
— IRS ISSUES GUIDANCE ON CARES TELEHEALTH AND VIRTUAL CARE FLEXIBILITIES. The temporary flexibility applies to services provided on or after Jan. 1, 2020, for plan years beginning on or before Dec. 31, 2021.
Capitol Hill Update
— CONGRESS SET TO CONSIDER DUELING POLICE REFORM PROPOSALS. House and Senate lawmakers will convene next week to consider the Democratic and Republican visions for comprehensive police reform. After clearing The Justice in Policing Act out of the House Judiciary Committee on Wednesday, the lower chamber is eyeing a vote on the Democrats’ bill when lawmakers convene for votes next Thursday and Friday, while as Senate Republicans consider their Just and Unifying Solutions to Invigorate Communities Everywhere (JUSTICE) Act as well. While lawmakers have expressed a sense of urgency with respect to clinching meaningful reform, it remains to be seen whether lawmakers can clinch a bipartisan deal. For more on the state of play regarding these Congressional police reform efforts, click here to read TRP’s comprehensive memo.
— HOUSE PLANS ACA, DRUG PRICING VOTE. House Democrats are preparing a package of reforms to the Affordable Care Act (ACA) for a vote the week of June 29, likely including expansions of subsidies, restrictions on short-term plans, and a possible boost to Medicaid eligibility. The bill will likely include the Protecting Pre-existing Conditions and Making Health Care More Affordable Act (H.R. 1884, summary). To offset the cost of the legislation, Democratic leaders are looking to include Title I of H.R. 3, the sweeping drug pricing overhaul that passed the House in December of last year. That legislation directs the HHS Secretary to negotiate prices on at least, 50 and up to 250 brand-name, single-source drugs, with 120 percent of the average price in a basket of peer countries as an upper limit. While the bill is expected to pass the House, it has no prospects of being taken up by the Senate.
— LOWER CHAMBER EYES JULY LEGISLATIVE BLITZ. In addition to the Democrats’ police reform legislation and ACA bill, House lawmakers have queued up votes on several key legislative items over the course of the next two weeks. This includes: (1) legislation that would reform the Fair Credit Reporting Act (FCRA) to promote fair and accurate credit reporting; (2) the Senate-passed public lands measure; and (3) a comprehensive package of infrastructure legislation. Following the July 4 district work period, the House is also eyeing action on the fiscal year (FY) 2021 National Defense Authorization Act (NDAA) and appropriations bills.
Washington Insider: What We’re Reading
House Democrats unveiled a $1.5 trillion infrastructure plan Thursday that calls for a huge increase in funding to repair roads and bridges while expanding broadband access in rural areas. Democrats described the bill as the biggest legislative effort to fight climate change, with Speaker Nancy Pelosi (D-Calif.) saying the package would “make real the promise of building infrastructure in a green and resilient way.”
The Congressional Oversight Commission questioned whether the Federal Reserve’s emergency lending facilities have done enough to help smaller companies and workers during the coronavirus crisis, in a report released Thursday. The commission’s second report on the Fed and Treasury Department’s handling of the $500 billion Congress provided in March to inject liquidity into the economy applauded the help for large corporations but worried that others were being left behind.
President Trump said Friday that he will once again attempt to end a program designed to protect young immigrants from deportation, one day after the Supreme Court said his earlier efforts to do so were arbitrary and improper. In September 2017, Mr. Trump moved to terminate the Obama-era program known as Deferred Action for Childhood Arrivals, or DACA, making good on a 2016 campaign promise in which he called the program an illegal executive amnesty. On Thursday, the court said the administration had not followed the rules required to end the program, allowing it to remain in place for now.
While there is still $130 billion left unspent in the so-called Paycheck Protection Program, lobbyists say that’s because there were onerous restrictions — chiefly that businesses are prohibited from borrowing a second time, so if they’re out of money, they’re out of luck. Others say that many potential borrowers were largely left out of the process, including minority employers, who often don’t have relationships with bankers. Still others are looking for a longer-term solution: There is emerging bipartisan support for new government-backed lending that would last much longer than lawmakers first envisioned with the Paycheck Protection Program, which was designed to delay mass layoffs in the early days of the pandemic.
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) 2021 spending bills.
House. Chairwoman Nita Lowey (D-NY) has officially announced the House Appropriations Subcommittee markup schedule for the week of Jul. 6.
Jul. 6: State & Foreign Operations, Agriculture, Military Construction-VA
Jul. 7: Homeland Security, Interior-Environment, Legislative Branch, Energy-Water, Labor-HHS-Education
Jul. 8: Commerce-Science-Justice, Transportation-Housing and Urban Development, Financial Services and General Government, Defense.
Senate. Chairman Richard Shelby (R-AL) is planning to delay forthcoming markups ahead of the July 4 recess amid partisan disagreements over COVID-19 relief and police reform amendments that Democrats want to offer.
When the Appropriations Committee begins its markup process, appropriators will look to skip subcommittee markups for seven out of the FY 2021 spending bills, going straight to full committee markups instead. Senators on the panel are also expected to vote on the 302(b) funding allocations for each of the 12 bills ahead of the forthcoming markups.
— ‘CARES 2.0’ STATE OF PLAY. While Senate Majority Leader Mitch McConnell (R-KY) has indicated that Congress will likely need to pass another round of COVID-19 relief legislation, Republicans are pushing for a more narrowly-targeted relief package following better-than-expected jobs numbers for the month of May. Conversely, Congressional Democrats are remaining steadfast on their push for another robust stimulus package. As the public health emergency continues to unfold, lawmakers are mulling over several policy options for the next round of legislation, including:
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.
House Democratic leadership appears open to negotiating a deal on liability protections. House Majority Leader Steny Hoyer (D-MD) 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.
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.
A key option on the table includes enhancing a tax credit that would give employers a tax break for keeping workers on the payroll.
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.
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.
PPP. Following Congressional passage of the Paycheck Protection Program Flexibility Act, Lawmakers are eyeing further reforms to the PPP.
Prior to Senate passage of H.R. 7010, Sens. Ron Johnson (R-WI) and Mike Lee (R-UT) — who had expressed concerns and opposition to the House-passed bill — secured a letter from key Small Business Committee members in both chambers clarifying that the intent of the legislation is not to reauthorize the program through the end of the year without additional reforms.
Small Business Committee Chairman Marco Rubio (R-FL) and Sen. Susan Collins (R-ME) have also indicated they are working on a technical change to the legislation that would ensure businesses can have their loans forgiven in some form regardless of whether they reach the 60 percent threshold.
Additionally, there has been a bipartisan push in Congress to expand PPP eligibility to 501(c)6 organizations and other currently ineligible nonprofits in the next round of COVID-19 relief legislation.
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.
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.
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.
COVID-19 Legislative & Regulatory Trackers
NEW TODAY…
— IRS ISSUES GUIDANCE ON CARES TELEHEALTH AND VIRTUAL CARE FLEXIBILITIES. The IRS recently outlined flexibilities and issued guidance addressing the CARES safe harbor provision allowing high deductible health plans (HDHPs) with health savings accounts (HSAs) to cover telehealth and remote care before a patient reaches their deductible. The temporary flexibility applies to services provided on or after Jan. 1, 2020, for plan years beginning on or before Dec. 31, 2021.
RECENT DEVELOPMENTS…
— SBA, TREASURY ANNOUNCE NEW AND REVISED FORGIVENESS APPLICATION FOR PPP. The Small Business Administration (SBA) and Treasury Department posted a revised Paycheck Protection Program (PPP) forgiveness application as mandated by the PPP Flexibility Act.
SBA also published a new “EZ version” of the forgiveness application that applies to borrowers that: (1) are self-employed and have no employees; or (2) did not reduce the salaries or wages of their employees by more than 25 percent, nor the number of hours for their employees; or (3) experienced reductions in business activity as a result of of the pandemic, and did not reduce the salaries or wages of their employees by more than 25 percent.
— HOUSE CORONAVIRUS TASK FORCE LAUNCHES INVESTIGATION INTO COVID-19 DEATHS IN NURSING HOMES. The House Select Subcommittee on the Coronavirus Crisis officially launched an investigation into COVID-19 deaths in nursing homes. Click here to read the letter to the Centers for Medicare and Medicaid Services (CMS).
— SEC ISSUES NEW WAIVER FOR MUNICIPAL ADVISERS. The Securities and Exchange Commission (SEC) published a temporary waiver for municipal advisers that will allow them to solicit banks and credit unions for direct placements of securities through the end of the year, citing economic disruption from the COVID-19 public health emergency.
— SBA REOPENS EIDL AND EIDL ADVANCE PROGRAM. The SBA announced that it has reopened the Economic Injury Disaster Loan (EIDL) and EIDL Advance program portal to all eligible applicants experiencing economic impacts due to COVID-19.
— FEDERAL RESERVE TO EXPAND MAIN STREET LENDING PROGRAM TO NONPROFITS. The Federal Reserve announced it will be seeking feedback on a proposal to expand the Main Street Lending Program for nonprofit organizations.
The proposal would make loans available to 501(c)(3) and 501(c)(19) organizations with 50 to 15,000 employees, but 501(c)(6)s and nonprofits with endowments larger than $3 billion would not be eligible under the program.
— FED SET TO BEGIN PURCHASING CORPORATE DEBT. In a move aimed at slashing borrowing costs and stymieing COVID-related economic hardships, the Federal Reserve announced plans to begin purchasing debt from corporations.
— FDA ENDS EMERGENCY USE FOR ANTI-MALARIA MEDICINES. The Food and Drug Administration (FDA) withdrew its emergency use authorizations for hydroxychloroquine and chloroquine as COVID-19 treatment options. In a separate warning, the agency cautioned that the use of the anti-malaria medications could blunt the effectiveness of the antiviral Remdesivir.
— SBA, TREASURY ISSUE NEW GUIDANCE ON PPP FLEXIBILITY. Following the enactment of the Paycheck Protection Program Flexibility Act, the SBA and Treasury Department issued revised guidance for the PPP. Click to view the updated interim final rule, borrower application, and lender application.
— FED OPENS MAIN STREET LENDING PROGRAM FOR LENDER REGISTRATION. The Federal Reserve officially opened lender registration for its Main Street Lending Program. Click here to access the necessary registration documents.
— HHS ANNOUNCES $25 BILLION IN RELIEF FUNDING FOR MEDICAID PROVIDERS, SAFETY NET HOSPITALS. The Department of Health and Human Services (HHS) announced the allocation of $25 billion from the Provider Relief Fund, including $15 billion for Medicaid and CHIP providers, as well as $10 billion for safety net hospitals. TRP’s comprehensive analysis of the COVID-19 provider relief fund can be read here.
AS PREVIOUSLY REPORTED…
— PPP FLEXIBILITY ACT. President Donald Trump signed a bill giving PPP recipients more time and flexibility in using their loans. Click here to read TRP’s analysis of this legislation.
— 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.
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.
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.
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.
Phase III. The CARES Act was signed into law on Mar. 27. TRP’s analysis of the Phase III legislation can be read here.
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.
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.
The loan application form can be accessed here.
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.
The SBA and Treasury Department updated their running list of frequently asked questions on the PPP (May 27).
SBA provided an update on its PPP loan data, as well as an updated state-by-state breakdown.
SBA issued guidance on how to calculate PPP loans by business type.
SBA published a list of all lenders participating in the PPP.
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.
CDFI. SBA and Treasury Department announced they will set aside $10 billion in PPP funding for Community Development Financial Institutions (CDFI).
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.
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.
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.
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.
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.
The Federal Reserve announced that it is expanding the scope of cities that will be able to borrow money through its emergency program for state and local governments. This expansion will allow at least two cities or counties in every state to be eligible, regardless of population (Jun. 3).
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.
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 updated its list of frequently asked questions that provide examples of eligible and ineligible expenditures of the state, local, and tribal Coronavirus Relief Fund on May 28. TRP’s analysis of these new FAQs can be read here.
CRF. The Treasury Department released a list of the payments that have been made to states and qualifying localities through the Coronavirus Relief Fund.
Employee Retention Credit. The Treasury Department has released a list of frequently asked questions pertaining to the Employee Retention Credit (May 8).
— 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 (May 19).
— EO ON PERMITTING. The Trump administration issued an executive order calling on federal agencies to waive certain environmental and permitting requirements to expedite construction of highways and other energy infrastructure projects on federal lands (Jun. 4)
— IRS. The IRS announced that it will ease some of the requirements for the Opportunity Zone program to give taxpayers more time to meet specific deadlines due to the COVID-19 public health emergency. Click here to read the guidance in its entirety (Jun. 4).
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:
Testing. The Trump administration published a report on its national COVID-19 testing strategy as mandated by the “Phase 3.5” measure.
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).
Drug Manufacturing. 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 (Jun. 1).
HHS and the 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.
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).
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).
PREP ACT. HHS issued an amendment to its existing PREP Act declaration clarifying that covered countermeasures under the Declaration include qualified products that limit the harm COVID-19 might otherwise cause.
Resilience. HHS’ Office of the Assistant Secretary for Health (OASH) published a request for information on opportunities to strengthen the U.S. healthcare system over the long-term term, including policies and programs that can be improved to mitigate the risk of COVID-19 and avoid negative impacts on patient outcomes.
— MEDICARE AND MEDICAID. The Centers for Medicare and Medicaid Services (CMS) has offered a series of regulatory flexibilities and guidances:
In-Person Care. CMS published new guides for patients and health care facilities that provide recommendations on resuming in-person care (Jun. 8).
Flexibilities. 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 (Jun. 3).
State Fact Sheet. 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 (May 26).
State COVID Guidance. 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.
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).
CMS unveiled 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 (Jun. 1).
CMS published its first set of COVID-19 nursing home data and results from inspections conducted by the agency since Mar. 4, 2020 (May 31)
1135 Waivers. A full list of the 1135 waiver approval letters can be accessed here (Updated Jun. 1).
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).
MA Plan FAQs. CMS updated its list frequently asked questions related to the public health emergency for Medicare Advantages plans (May 13).
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).
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.
Website. HHS has updated its webpage outlining details on provider relief and related health funding.
PHSSEF Distributions. To date, HHS is providing a $50 billion general allocation for Medicare hospitals and providers, $12 billion for hospitals in highly impacted areas with another round currently pending, $10 billion for rural providers, $500 million for the Indian Health Service, $4.9 billion for skilled nursing facilities, and $15 billion for Medicaid and CHIP providers, and $10 billion for safety net hospitals. 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.
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.
Hospital Preparedness Fund. 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 (Jun. 2)
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.
— 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.
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).
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).
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).
Drug Development. FDA published guidance documents related to drugs being developed for COVID-19.
The first guidance document provides general recommendations to sponsors to help prepare them for pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs (May).
The second guidance document is intended to assist sponsors in the clinical development of drugs for treating or preventing COVID-19 (May).
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).
Antigen Test. FDA issued an emergency use authorization for the first COVID-19 antigen test (May 8).
Device Shortages. FDA published guidance on reporting requirements for medical device shortages (May).
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.
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. 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).
SAMHSA released $15 million in supplemental grant awards for tribal COVID-19 behavioral health response (May 1)
— NIH. The National Institutes for Health (NIH) has launched a study to evaluate drugs prescribed to treat COVID-19 in infants, children and adolescents across the country (Jun. 10).
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 (May 19).
The National Institutes of Health issued its first guidance on COVID-19 treatment options that are currently under review (updated May 12).