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COVID-19: Federal Update (7/8)


Quick Takes

— HOUSE WRAPS UP APPROPS SUBCOMMITTEE MARKUPS. Appropriators will meet to finish their subcommittee markups of fiscal year (FY) 2021 spending bills.


— CLASH LOOMS OVER NEXT CORONAVIRUS RELIEF BILL. Huge policy differences separate Democrats in the House from Republicans in the Senate.


— BIDEN WANTS US TO PRODUCE MORE OF ITS OWN PANDEMIC SUPPLIES. The presumptive Democratic presidential nominee’s campaign released a plan Tuesday to reinforce domestic stockpiles.


— HRSA POSTS FACT SHEET ON PROVIDER RELIEF FUND FOR MEDICAID AND CHIP PROVIDERS. The Health Resources and Services Administration (HRSA) has published a new fact sheet for Medicaid and CHIP providers on the Provider Relief Fund.


Capitol Hill Update


— HOUSE WRAPS UP APPROPS SUBCOMMITTEE MARKUPS. House appropriators will meet to finish their subcommittee markups of fiscal year (FY) 2021 spending bills. For today, Members will meet to consider the bills for Commerce-Science-Justice (CJS), Transportation-Housing and Urban Development (T-HUD), Financial Services and General Government (FSGG), and Defense. Meanwhile, the full Appropriations Committee will meet Thursday and Friday to begin consideration of spending bills that cleared the subcommittees earlier this week, as well as the lover chamber's official 302(b) subcommittee allocations for FY 2021. This includes the State-Foreign Operations(report), Agriculture-FDA (report), and Military Construction-VA (report) measures tomorrow, and the Interior-Environment and Legislative Branch bills on Friday


Washington Insider: What We’re Reading


The Hill: Clash Looms Over Next Coronavirus Relief Bill

Congressional leaders say there will be a fifth coronavirus relief bill approved by Congress, but how lawmakers get to the finish line is anyone’s guess. Huge policy differences separate Democrats in the House from Republicans in the Senate, and lawmakers have just weeks once they return to Washington to complete a bill before they are scheduled to leave again. Both parties have reasons to get to a deal given the intense pressure on Washington to provide relief for businesses and households amid double-digit unemployment and rising numbers of COVID-19 cases.


Associated Press: Biden Wants US to Produce More of its own Pandemic Supplies

Joe Biden is promising to shift production of medical equipment and other key pandemic-fighting products “back to U.S. soil,” creating jobs and bolstering a domestic supply chain he says has been exposed as inadequate and vulnerable by the coronavirus outbreak. The presumptive Democratic presidential nominee’s campaign released a plan Tuesday to reinforce stockpiles of a “range of critical products on which the U.S. is dangerously dependent on foreign suppliers” in places like China and Russia. That includes medical equipment and pharmaceuticals, but also energy and grid resilience technologies, semiconductors and key electronics, as well as telecommunications infrastructure and raw materials.


The Wall Street Journal: Recession Forces Spending Cuts on States, Cities Hit by Coronavirus ($)

State and local governments from Georgia to California are cutting money for schools, universities and other services as the coronavirus-induced recession wreaks havoc on their finances. Widespread job losses and closed businesses have reduced revenue from sales and income taxes, forcing officials to make agonizing choices in budgets for the new fiscal year, which started July 1 in much of the country.


The Hill: Court Rulings Deal Setbacks to Pipelines

A flurry of activity in courtrooms and boardrooms over a two-day period this week dealt significant blows to the oil and gas pipeline industry. Once the dust settled, two things were clear: the Atlantic Coast pipeline is no longer moving forward, and the Dakota Access pipeline is on hold. The onslaught of lawsuits by environmentalists and Native American tribes against pipeline projects in recent years has proven effective in creating hurdles for an administration and industry keen on rolling back regulations. This week’s rulings mark the latest obstacles.


COVID-19: What We’re Hearing


— 'CARES 2.0' STATE OF PLAY. Senate Majority Leader Mitch McConnell (R-KY) provided more details on the GOP priorities for the next round of COVID-19 relief legislation this week in a sign that another bill could be on the horizon toward the end of this month. Leader McConnell stated that he will be unveiling legislation in the forthcoming weeks that prioritizes health care, jobs, reopening schools and universities, and liability protections. A timeline for action on the forthcoming GOP legislation is expected to take place between Jul. 20 to Aug. 8, but it remains to be seen whether Senate Republicans, House Democrats, and the Trump administration can come to terms on an agreement. 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 stated that the GOP's liability provision would insulate stakeholders from lawsuits retroactive to Dec. 2019 through 2024, unless these entities are "grossly negligent or intentionally engaged in harmful behavior. He has continuously 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.

  • Surprise Billing. Reports out of the Trump administration suggest that the White House is prioritizing action on surprise medical billing in the next round of relief legislation. It is also looking to address price transparency for pharmaceuticals, as well as an adjustment in the reimbursement rate for telemedicine.

  • 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.

  • Stimulus Payments. In a recent interview, President Trump expressed openness to another round of direct economic impact payments, saying that he wants “larger numbers than the Democrats” have offered. Leader McConnell has also expressed openness for another round of stimulus payments that would be targeted toward individuals making $40,000 a year or less.

  • PPP. The Paycheck Protection Program (PPP) application process has officially been reopened thanks to swift action by Congress last week. House and Senate lawmakers were able to clinch unanimous consent agreements on a bill that that would reopen the application process for the roughly $134 billion remaining in the signature small business rescue program, pushing the application deadline from June 30 to August 18. lawmakers are already eyeing additional PPP reforms in the next round of COVID-19 relief legislation.

  • Small Business Committee Chairman Marco Rubio (R-FL) is drafting additional PPP legislation that would create new programs to expand the use of the remaining funds within the program, including a $25 billion set-aside for businesses with fewer than 10 employees.

  • Ranking Member Ben Cardin (D-MD) and Sen. Jeanne Shaheen (D-NH) have introduced a bill that would extend the PPP application deadline by six months and authorize new lending for businesses with fewer than 100 employees.

  • 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.

  • 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.

  • 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...

— HRSA POSTS FACT SHEET ON PROVIDER RELIEF FUND FOR MEDICAID AND CHIP PROVIDERS. The Health Resources and Services Administration (HRSA) has published a new fact sheet for Medicaid and CHIP providers on the Provider Relief Fund. 


RECENT DEVELOPMENTS…

— SBA, TREASURY OFFICIALLY DISCLOSE PPP RECIPIENTS. The Small Business Administration (SBA) and Treasury Department have officially disclosed the names of more than 650,000 recipients of the Paycheck Protection Program (PPP). Click here to access the database.

— TRUMP ADMINISTRATION ANNOUNCES NEW 'OPERATION WARP SPEED' INITIATIVES. The Department of Health and Human Services (HHS) and Department of Defense announced two new investments into COVID-19 vaccines and treatments as a part of the Trump administration's "Operation Warp Speed" initiative. This includes a $450 million contract with Regeneron Pharmaceuticals to manufacture an investigational anti-viral antibody treatment, as well as a $1.6 billion deal with Novavax to ramp up production of a potential vaccine.

—TRP SPECIAL REPORT: THE VIABILITY OF DRUG PRICING REFORMS DURING THE COVID-19 PANDEMIC. TRP's newest Special Report examines recent legislation tackling drug pricing reform or price controls for COVID-19 therapies and vaccines, provides a state-of-play on the larger debate on the Hill and within the administration, and explores perspectives on ensuring the affordability of coronavirus-targeted products from the biopharmaceutical industry and health stakeholders. 

— HHS TO HOLD WEBINAR ON MEDICAID/CHIP DISTRIBUTION FROM PROVIDER RELIEF FUND. HHS will hold a webinar for providers to learn more about the Medicaid and CHIP Distribution from the Provider Relief fund on July 8. Applications are due by July 20, 2020. 

— FDA ISSUES NEW EMERGENCY USE AUTHORIZATION FOR COMBINED COVID-19 DIAGNOSTIC TEST. The Food and Drug Administration (FDA) issued an emergency use authorization for a diagnostic test that can detect COVID-19 and multiple strains of influenza.

— FDIC, FEDERAL RESERVE TO REQUIRE COVID-RELATED ADDS TO BANK LIVING WILLS. The Federal Deposit Insurance Corporation (FDIC) and Federal Reserve announced new requirements for large financial institutions to provide details on how they’ve incorporated lessons from the COVID-19 pandemic into their plan for unwinding in the event of bankruptcy.

— OMB PUBLISHES SPRING UNIFIED REGULATORY AGENDA FOLLOWING PANDEMIC DELAY. The Office of Management and Budget (OMB) released its Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda) (OMB Page, HHS Agenda) this week following a lengthy delay due to the COVID-19 pandemic. Click here to read TRP's analysis on forthcoming rules from the Department of Health and Human Services (HHS). 

— FDA RELEASES GUIDANCE ON COVID-19 VACCINE AUTHORIZATIONS. The Food and Drug Administration (FDA) issued new guidance describing its expectations for potential COVID-19 vaccines that would be necessary to meet to receive approval. The agency describes acceptable primary and secondary endpoints for clinical trials, encourages standardization across clinical trials, and sets 50 percent efficacy as a primary endpoint. Efficacy may mean either preventing infection or preventing symptoms.

  • In addition, FDA raises the possibility of using so-called “challenge trials,” or deliberately exposing human subjects to infection, if it is not possible to demonstrate effectiveness through clinical disease endpoint efficacy studies. This guidance comes as stakeholders raise concerns about whether the public will trust a vaccine that has been rapidly developed to combat COVID-19.

CMS UPDATES MEDICAID FAQS. The Centers for Medicare and Medicaid Services (CMS) published a document addressing COVID-related questions from states and Medicaid stakeholders. The new frequently asked questions cover a broad range of topics, including financing changes and rate adjustments impacting providers, the optional COVID-19 testing group, and coverage of COVID-19 drugs and services among others. 

— TRP SPECIAL REPORT: COVID-19 EMERGENCY DECLARATIONS AND HEALTH POLICY. TRP has published a Special Report describing how emergencies are declared, how they end, the health-related flexibilities that were enabled by the declarations, and what will happen when the emergencies expire.

—TREASURY UPDATES CORONAVIRUS RELIEF FUND FAQS. The Treasury Department recently updated its list of frequently asked questions for the state, local, and tribal Coronavirus Relief Fund. New information includes non-federal match requirements under the Stafford Act, nonprofit eligibility, and flexibility on covering costs of public health and public safety employees.

— FED ISSUES NEW TERM SHEET FOR PMCCF. The Federal Reserve issued a new term sheet outlining pricing information for the Primary Market Corporate Credit Facility.

— HHS SECURES NEW SUPPLY OF KEY COVID-19 TREATMENT. HHS announced an agreement to secure more than 500,000 doses of the antiviral Remdesivir for U.S. hospitals from Gilead Sciences through September.


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