The Headlines
- Read the latest health policy updates on Congress and the Administration.
- Duke experts meet virtually with congressional staff about the Pandemic Response Network.
- Fetal Tissue Advisory Board urged to consider medical significance of fetal tissue research.
Negotiations
Just one word, five syllables
Soaks up the O2
(COVID-19 relief bill haiku)
The Details
1. Federal health updates from Capitol Hill and the agencies
House wrapping up work on FY 2021 spending bills; Senate action not expected until September
By this evening, the House, in two separate “minibus” legislative packages, is expected to have passed ten of twelve of its versions of the FY 2021 appropriations bills. The first combined measure, approved on July 24, included the Military Construction,Veterans Affairs (VA), and related agencies appropriations bill, which would provide $840 million, an increase of $21 million above the FY 2020 level, for medical research at the VA.
The second package, consisting of six spending bills, is scheduled for a vote later today. It includes the Labor, Health and Human Services, Education (Labor-HHS) appropriations bill, which provides discretionary funding for many federal healthcare programs, and the Defense appropriations bill, which provides funding for the Congressionally Directed Medical Research Program (CDMRP) at the Department of Defense (DoD). The House FY 2021 Labor-HHS spending bill would provide increased funding for several of Duke Health’s priorities, including:
- $47 billion for the National Institutes of Health ($5 billion above the FY 2020 enacted level for one-time emergency spending)
- $512.5 million for Title VII health professions programs at the Health Resources and Services Administration (HRSA) ($38 million increase above the FY 2020 enacted level)
- $270 million for Title VIII Nursing Workforce Development programs at HRSA ($10 million above the FY 2020 enacted level)
- $342 million for the Agency for Healthcare Research and Quality (AHRQ) ($5 million above the FY 2020 enacted level)
Funding for the DoD’s CDMRP program was largely held steady at current levels and includes, among others, $12 million for the Reconstructive Transplant program and $110 million for prostate cancer research.
Two bills, which provide funding for the Department of Homeland Security and the Legislative Branch, respectively, were left out of the House’s minibus strategy and may not receive individual votes. The Senate is not expected to begin work on any of its versions of appropriations bills before Labor Day, increasing the likelihood that a short-term continuing resolution will be needed to keep the government funded after September 30 and likely through the November elections.
House and Senate reportedly “very far apart” on COVID-19 relief negotiations
After a brief delay to coalesce around details with the White House, Senate Republicans this week formally released a series of proposals that comprise the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act. The bill serves as the Senate Republican leadership’s opening offer in negotiations with House Democrats on the next round of COVID-19 relief. House Democrats passed their own “Phase IV” legislation, the HEROES Act (H.R. 6800), on May 15.
Among other provisions, the HEALS Act would provide:
- Federal liability reform and protections 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
- $705 million for the Defense Health Program
- Extension of current telehealth policies and reimbursements through 2021 or the end of the public health emergency, whichever is later
- Enhanced employee retention credit
- Additional funding for the Paycheck Protection Program
- Another round of direct payments to taxpayers following the March 2020 formula with expanded dependent eligibility
- Scaled-back extension of expanded federal unemployment benefits from $600 to $200 per week for 60 days; transition to a program offering up to 70 percent of wages earned prior to job loss
The $1 trillion proposal, which is facing scrutiny and criticism from some of the more conservative Republican members of the Senate, stands in contrast to the more expansive $3 trillion House-passed HEROES Act, but it also includes more funding in support of the research enterprise at NIH.
House Democratic leadership has thus far balked at a number of provisions in the Senate bill, and early reports from Administration officials indicate that Democrats and Republicans remain far apart on a final deal. Barring a surprise agreement, negotiations are expected to stretch through at least next week.
Marion Broome, PhD, Duke University Dean of the School of Nursing, and Mary Klotman, MD, Duke University Dean of the School of Medicine, have engaged in outreach to the North Carolina Congressional delegation expressing support for key priorities in the COVID-19 relief package.
Duke Health Government Relations continues to advocate for at least $26 billion in emergency research funding be included in the final “Phase IV” package, as well as additional relief for providers.
Duke Health leadership expresses appreciation for continued efforts to support research impacted by COVID-19
This week, Duke University Chancellor for Health Affairs and President and CEO for Duke University Health System Dr. Eugene Washington sent a letter to Senator Thom Tillis (R-NC) expressing support for his introduction of the Research Investment to Spark the Economy (RISE) Act in the Senate. This legislation would provide $26 billion for federal research agencies to support researchers impacted by the COVID-19 pandemic. Dr. Washington has also expressed his appreciation to Reps. Butterfield (D-NC-1) and David Rouzer (R-NC-7), who cosponsored a similar bill in the House.
Trump issues Executive Orders on drug pricing
On July 24, President Trump issued four executive orders on drug pricing. Three of the orders are essentially reboots of prior proposals that had not gained much traction in the past.
One would tie Medicare payments for Part B drugs to the International Pricing Index (IPI), which includes prices of a set of physician-administered drugs in 15 other developed nations. Utilizing the IPI would effectively cap payments in the U.S. based on an average of prices paid across the 15 nations for a selected number of Part B drugs.
The second would allow states and individuals to import lower cost drugs from Canada, including insulin. Individuals would have to be granted waivers in order to import drugs, so long as the importation would not pose a risk to public safety and would lower costs.
The third would ban the drug rebates that pharmacy benefit managers use to keep net prices stable while instead creating a safe harbor for point-of-sale discounts. The ban requires that premiums not increase, which may be an operational impossibility that threatens the efficacy of the order.
The fourth, and newest policy, would require health centers to provide patients with the significant discounts that health centers get on insulin and epinephrine through the 340B program. Federally Qualified Health Centers would be allowed to charge a small administration fee for the service.
House Subcommittee examines reauthorization of five Public health bills
The Energy and Commerce Subcommittee on Health held a hearing entitled, “Improving Access to Care: Legislation to Reauthorize Key Public Health Programs.” The hearing examined five reauthorization bills for public health programs, including the “Creating Hope Reauthorization Act" sponsored by Rep. G.K. Butterfield (D-NC-1) and other co-chairs of the Childhood Cancer Caucus. The bill would permanently extend Priority Review Vouchers to encourage treatments for children with cancer and other rare pediatric diseases. During his remarks, Rep. Butterfield referenced a Duke scientist that shared with his office that although brain tumors are the most common cause of death from cancer in children and infants, they are still considered rare and lack effective and safe therapies. Rep. Richard Hudson (R-NC-8) also sits on the Subcommittee and cosponsored the bill.
The Subcommittee also examined the Timely Reauthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies (TRANSPLANT) Act, which would reauthorize funding for the C.W. Bill Young Cell Transplantation program and the National Cord Blood Inventory that supports the work of the Carolinas Cord Blood Bank in the Duke University School of Medicine.
Subcommittee Chairwomen Anna Eshoo (D-CA-18) expressed her commitment to moving forward on legislation examined at the hearing, stating, “I stand ready to work with my colleagues to make sure these programs are reauthorized.”
2. Duke experts meet with congressional staff on the Pandemic Response Network (PRN)
Dr. Devdutta Sangvai, Suresh Balu, and Dr. Mark Sendak met virtually with Congressional staff this week for the offices of Rep. Butterfield, Rep. David Price and Senator Tillis about the Pandemic Response Network. The PRN is a network of health-based organizations, community-based organizations, state and federal agencies and associations, public and private employers, and religious organizations working together to connect people with the critical and supportive resources they need during the pandemic.
The meeting was an opportunity to inform Congressional offices about PRN’s work in communities and raise visibility about this important program. Learn more about PRN in a recent Duke Today article.
3. Stakeholders urge Fetal Tissue Advisory Board to consider medical significance of fetal tissue research
Duke University, with other stakeholders representing scientists, clinicians, and patients joined a letter to the newly formed NIH Human Fetal Tissue Research Ethics Advisory Board expressing strong support for the continued use of human fetal tissue in life-saving biomedical research. The letter states that research using human fetal tissue has been essential for scientific and medical advances that have saved millions of lives, and it remains a crucial resource for biomedical research. Signatories on the letter urged the new board to consider the scientific and medical significance of fetal tissue research and its crucial role in the development of new therapies.