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Federal Health Policy Updates for the Week of July 20, 2020

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The Details

FY 2021 Appropriations process marches on in the House; Senate timetable unclear
The House Appropriations Committee, which has completed work on its versions of the twelve annual appropriations bills for FY 2021, has prepared a “minibus” spending package (H.R. 7614) combining seven of the bills for consideration on the House floor as soon as next week. The minibus includes the Labor-Health and Human Services (HHS)-Education and related agencies appropriations bill, which would provide a total of $47 billion for the National Institutes of Health (NIH) divided into $42 billion in annual appropriations and $5 billion in emergency funding.
 
The Senate has yet to begin work on its versions of the FY 2021 appropriations bills, and it may be early September following the August recess period before any details are released. Because of continued delays and the need for the House and Senate to eventually reconcile their spending bills, it is increasingly likely that a continuing resolution will be needed to keep the government funded beyond September 30.

House and Senate wrap up work on individual versions of the NDAA
The House and Senate have completed work on their individual versions of the FY 2021 National Defense Authorization Act (NDAA), an annual policy bill that, among other provisions, authorizes funding for the Department of Defense Medical Research Program. The House bill includes an amendment offered by Reps. Ayanna Pressley (D-MA) and Seth Moulton (D-MA) that would prevent the Trump Administration from attempting to impose rule changes that would bar international students in the U.S. from participating in programs offering only online courses during the COVID-19 health emergency.
 
Duke Health Government Relations continues to work with our Duke University government relations colleagues, professional associations, partners, and others to advocate on behalf of our international students and share their contributions to the medical workforce and research enterprise.
 
The House and Senate must now come to an agreement on final legislative language for the NDAA, but negotiations are not expected to finish before the November elections.
 
Energy and Commerce Subcommittee holds hearing on vaccine development
The House Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, "Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine." Subcommittee members heard from pharmaceutical companies including AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer about progress on COVID-19 vaccines and therapeutics.

During the hearing, Subcommittee members asked witnesses questions about the safety and efficacy surrounding the development of vaccines for COVID-19, as well as the cost of vaccines when they become available. Executive Vice President for BioPharmaceuticals R&D at AstraZeneca Dr. Mene Pangalos stated the agreement they have with the Biomedical Advanced Research and Development Authority (BARDA) is for 300 million doses to be sold to the government at no profit. When asked about the equitable distribution of vaccines once available, many of the witnesses indicated that they will be relying on the government in some way to help with distribution.
 
Telehealth proposals emerge in Congress
As more providers are developing expansive telehealth operations during the COVID-19 public health emergency, efforts are emerging among congressional leaders to make many of the temporary waivers and telehealth enhancements provided by the Centers for Medicare and Medicaid Services (CMS) permanent.

Duke Health previously joined over 340 organizations and health systems in signing on to a multi-stakeholder letter to congressional leaders outlining the actions necessary to ensure that CMS has the authority to make temporary enhanced telehealth services permanently available. Duke Health Government Relations is working in partnership with Duke leadership and the Duke Telehealth Office to ensure that beneficial telehealth policies are strengthened and maintained.
 
A bipartisan group of members of the Congressional Telehealth Caucus, including Reps. Mike Thompson (D-CA), David Schweikert (R-AZ), Bill Johnson (R-OH), Peter Welch (D-VT), and Doris Matsui (D-CA), introduced the Protecting Access to Post-COVID-19 Telehealth Act of 2020 (H.R. 7663). The legislation would remove geographic originating site restrictions on where a patient must be located in order to utilize telehealth services; make the home an eligible originating site; ensure federally qualified health centers and rural health centers can furnish telehealth services; and codify temporary waiver authority for the Secretary of Health & Human Services for future emergency periods and the 90 days after the expiration of a public health emergency period.

House Ways and Means Republicans, led by committee ranking member Kevin Brady (R-TX), released a draft discussion proposal that would, among other provisions, continue to allow Medicare beneficiaries to access telehealth services from their homes, including audio-only telehealth services, remove certain limits on the provision of telehealth services by rural health clinics, and to permanently allow physical therapists, speech pathologists, occupational therapists to deliver care via telehealth.

Senate Finance Committee ranking member Ron Wyden (D-OR) also introduced legislation (S. 4230) that would expand access to mental health services and certain evaluation and management services furnished through telehealth under the Medicare program.

The increased legislative urgency is due in part to Congress wanting to avoid a potential telehealth cliff where all policies revert back to pre-COVID-19 status, which would happen if Congress does not act to ensure that CMS has the proper authority beyond the public health emergency to make certain waivers permanent. The Trump Administration formally renewed the public health emergency on July 23, providing at least another 90 day buffer for Congress and CMS to make decisions about policies for potential permanence.

Negotiations taking shape on the next round of COVID-19 relief and stimulus
Senate Republican leadership and the White House have reached a tentative agreement on a proposal for the next round of comprehensive COVID-19 relief. The proposal is expected to serve as the Senate’s opening offer in negotiations with House Democrats, who passed their own “Phase IV” legislation, the HEROES Act (H.R. 6800), on May 15.
 
While final details have not been released, the Republican proposal, among other provisions, would reportedly provide:

  • Liability protections and reform for businesses, schools, and universities/colleges
  • $235 billion in supplemental funding for Labor-HHS-Education appropriations line
    • $25 billion for testing
    • $26 billion for vaccine research, distribution, and use
    • $1.3 billion for workplace training on social distancing
    • $15.5 billion – NIH labs/research
    • $25 billion for the hospital/provider fund (bringing the total to $200 billion)
    • $4.5 billion to SAMHSA for mental health, suicide prevention, and overdose response programs
    • $7.6 billion for Community Health Centers
    • $15 billion for child care
    • $105 billion for the Department of Education
  • Extension of current telehealth policies and reimbursements through 2021
  • Enhanced employee retention credit
  • Additional funding for the Paycheck Protection Program
  • Another round of direct payments to taxpayers
  • Scaled-back extension of expanded unemployment benefits

Despite a push from the White House, the package does not include a payroll tax cut for individuals or comprehensive reform for “surprise” medical billing. The $1 trillion proposal, which has faced criticism from some of the more conservative Republican members of the Senate, stands in contrast to the more expansive $3 trillion HEROES Act passed by the House, but also includes more funding in support of the research enterprise at NIH.
 
Given the tepid response of House Democratic leadership, as well as ongoing disagreements within the Senate Republican Caucus, negotiations on a final “Phase IV” package may push into early August.
 
Dr. Marion Broome, Dean of the Duke University School of Nursing, joined colleagues from nine of the top research-intensive schools of nursing in sending a letter to leadership on the Senate Appropriations Subcommittee on Labor-HHS-Education. The letter urged support for nursing research and workforce priorities in the upcoming COVID-19 relief legislation, including expanding loan forgiveness for nurses via the bipartisan “Strengthening America’s Health Care Readiness Act (S.4055) and supporting funding to ensure that nursing educators and students can access personal protective equipment (PPE) and durable medical equipment as they respond to the COVID-19 pandemic. 

In addition to these priorities, Duke Health Government Relations continues to advocate for at least $26 billion in emergency research funding to be included in the final “Phase IV” package, as well as additional relief for providers.

Sen. Tillis joins colleagues to introduce legislation in support of $26 billion for research
Duke's advocacy for additional emergency funding received a boost July 23 as Sen. Thom Tillis (R-NC), along with colleagues Sens. Ed Markey (D-MA), Gary Peters (D-MI), and Cory Gardner (R-CO), introduced the Senate version of the Research Investment to Spark the Economy (RISE) Act (S. 4286).

The legislation, a companion to the House RISE Act (H.R. 7308), which is cosponsored by NC Reps. GK Butterfield (D-NC-01) and David Rouzer (R-NC-07), authorizes approximately $26 billion in relief funding to support the nation’s research workforce and offset costs related to laboratory closures and lost research productivity resulting from COVID-19.

Duke Health supports the inclusion of the RISE Act in negotiations for additional COVID-19 relief.