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Federal Health Policy Updates for the Week of November 15, 2021

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Federal Health Policy Updates for the
Week of November 15 - November 19, 2021

 
We’re no Taylor Swift
But if Congress keeps it up
We’ll drop an album

Publication Notice:
Congress is taking a brief hiatus next week, and so are we! For breaking news, please follow us on Twitter @DukeGovRel. We'll be back the week of November 29th.
 

The Rundown

  • House poised to pass Build Back Better Act
  • Cures 2.0 introduced in the House
  • Update on the year-end legislative calendar
  • Butterfield joins Price in announcing retirement
  • The latest from our desks

Federal Updates

Reconciliation… reconciled?
We know better than getting ahead of ourselves when it comes to reconciliation, but House Democratic leaders seem poised to finally hold a vote today on the $1.7 trillion Build Back Better Act (BBBA) “human” infrastructure reconciliation package.

Following final passage of the bipartisan, “traditional” infrastructure package last week, the BBBA has been in limbo awaiting final cost estimates and revenue impacts in an evaluation from the Congressional Budget Office (CBO), a condition of proceeding on the bill for a group of House Democratic moderates, whose votes are needed for passage. CBO’s evaluation was delivered a day earlier than expected, which sets up the possibility of a vote before the weekend.

A vote on BBBA would allow the House to adjourn soon for next week’s Thanksgiving recess, avoiding a declaration from House Speaker Nancy Pelosi (D-CA) that the chamber would remain in session until passage of the legislation.

The BBBA includes significant investments in health care priorities, education and childcare, and support for working families and individuals. However, there are some problematic provisions related to the future of Medicare sequester cuts and Medicaid Disproportionate Share Hospital (DSH) payments that will require further attention in the Senate. Speaking of the Senate, it’s a safe bet to anticipate more changes to BBBA will be coming in the upper chamber and no guarantee that Senate Democrats will have their version ready by the end of this year.

We continue to monitor the situation closely and advocate for priorities important to Duke Health and the communities served by our institution.

Cures 2.0 introduced in the House
This week, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the much anticipated Cures 2.0 in the House. This legislation builds on the 21st Century Cures Act of 2016, which aimed to accelerate the approval of health care treatments and devices. There are elements of the old blending in with the new in the follow up legislation, including a provision to authorize $6.5 billion for the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H is modeled after the Defense Advanced Research Projects at the Department of Defense. In an update from a discussion draft released earlier this year, the current iteration of Cures 2.0 proposes housing ARPA-H at NIH to speed the development of treatments by supporting projects that could tackle challenges that require large-scale, sustained coordination for high-risk, high-reward research.

Among other notable provisions include:
  • Understand the implications of Long COVID. 
  • Require a national strategy, based off lessons learned and best practices developed as a result of the pandemic, that addresses testing, data sharing infrastructure, administration of vaccines and therapeutics, and medical supply readiness to mitigate future pandemics and public health emergencies.
  • Provide grant funding for educational programs and training for caregivers to learn skills which would allow them to augment a care team and complement a clinical visit (includes physical and mental support for caregivers).
  • Increase diversity in clinical trials.
  • Allow HHS to make permanent expanded telehealth services covered by Medicare, expand the types of providers eligible to provide these services (including PT, OT, and SLP), and remove geographic and originating site restrictions.
  • Explore innovative ways and incentives to foster the adoption of decentralized trials.
  • Provide guidance and strategies to states on effectively integrating telehealth into their Medicaid and CHIP programs.
  • Allow Medicare to cover the costs of their beneficiaries in PCORI-funded clinical trials.
The legislation also includes the “Precision Medicine Answers for Kids Today Act” to increase access to diagnostic testing by providing federal support for the use of genetic and genomic testing for pediatric patients with rare diseases, as well as the “Pioneering Antimicrobial Subscriptions to End Up Surging Resistance (PASTEUR) Act” to establish a subscription model to pay for novel antimicrobial drugs.

Our office coordinated feedback from Duke Health experts to Reps. DeGette and Upton as they developed this legislation. Our team also coordinated input from Duke Health leaders on the structure of ARPA-H. While the bill sponsors would like to see the legislation move quickly, a crowded year-end calendar and the expectation that relevant committees of jurisdiction will want to place their stamps on the bill likely means Cures 2.0 becomes a 2022 priority.

Year-end schedule update: A December to remember
It’s (hopefully) going to be a vote-a-thon (our apologies to Toyota) – and instead of discount prices on vehicles and other consumer products – we are dreaming of a December where Congress will take advantage of an ever-evolving schedule to take action on several must-pass priorities. We’ll likely have more details on the trajectories of any number of these issues following the Thanksgiving holiday, so for now, here’s a brief, updated summary of a few key issues we’re following:
  • FY 2022 federal spending – The current continuing resolution that has kept the government operating since October 1 will expire December 3. House and Senate negotiators appear to be nowhere close to a longer-term FY 2022 agreement. Another CR is inevitable, but for how long – a few weeks, a month or two? Democrats aren’t eager to kick the can much further down the road, and there isn’t much urgency yet from Republicans to strike a deal.
  • The debt limit – A short term expiration of the federal debt limit is set to expire in December, with default occurring as soon as December 15 absent extraordinary measures by the Treasury. Senate Republicans remain insistent that Democrats should address the issue unilaterally through reconciliation. Another standoff seems likely.
  • National Defense Authorization Act (NDAA) – The Senate is now considering its version of the NDAA, a major defense policy bill that would, among other provisions, authorize medical research programs at the Department of Defense. Senate Majority Leader Chuck Schumer (D-NY) is also hoping to attach Senate-passed anti-competitiveness legislation to the NDAA, but that effort faces hurdles. Congress has until December 31 to pass the authorizing legislation and hasn’t missed the deadline in nearly 60 years.
  • Medicare sequester and PAYGO cuts – Congress will need to pass a waiver and extension to ensure that potentially damaging cuts to Medicare providers do not go into effect on January 1, 2022.
Our office continues to advocate for Duke Health federal funding priorities and will be closely engaged with the NC congressional delegation and our partners in regional and national coalitions as the year-end process unfolds.

Rep. Butterfield joins Rep. Price in announcing retirement
In a somewhat surprising turn of events, two of the three individuals who have represented Duke University Hospital and the Durham community in the U.S. House of Representatives since 1993 have now announced their retirements within the past month.

Rep. G.K. Butterfield (D-NC-01) will not seek re-election in 2022. Rep. Butterfield represented Duke Health between 2013-2021 when the 1st congressional district was redrawn to include Durham County. Last month, Rep. David Price (D-NC-04) announced his retirement at the end of his current term. He has represented Duke Health in the years 1993-1995, 1997-2013, and since the start of the current Congress in 2021 as the 4th district was redrawn to include Durham. Both retirements will take effect at the swearing in of the 118th Congress in January 2023.

Current NC congressional delegation member Rep. Ted Budd (R-NC-13) is also not expected to return to the House next Congress as he is seeking to replace the retiring Senator Richard Burr (R-NC).

As noted in last week’s newsletter, the North Carolina House and Senate finalized another decennial redistricting process last week and approved new state and congressional district maps. As a result, congressional districts throughout the state have been altered, and the person who ultimately replaces Rep. Price to represent Duke and the Durham area will not do so from the 4th congressional district, but now in the redrawn 6th district.

From our desk(s): Duke Health GR this week
This week, our team monitored several congressional hearings.

On Wednesday, the House Energy and Commerce Committee held a markup of 12 pieces of legislation, including several health-related bills. A number of the bills that advanced are important to Duke Health, including the “Dr. Lorna Breen Health Care Provider Protection Act” (H.R. 1667), which would support the behavioral and mental health of health care professionals, residents, and students and passed the Senate earlier this year. The Committee also approved the “Accelerating Access to Critical Therapies for ALS Act” (H.R. 3537) to help patients take part in the Expanded Access program for experimental ALS drugs while providing a framework for the NIH and the FDA to benefit from patient data. The Committee also advanced the "Allied Health Workforce Diversity Act” to provide grants to accredited graduate education programs to increase diversity in the physical therapy, occupational therapy, respiratory therapy, audiology, and speech-language pathology professions.

The House and Senate Veterans’ Affairs (VA) Committees also held hearings this week with the Senate VA Committee examining over 20 Veteran’s legislative priorities on Wednesday, including access to mental health care, education, and housing benefits. The House VA Committee began a probe of the VA’s medical supply chain system on Thursday.

We held meetings with health system leadership to inform comments in response to the Biden administration’s rulemaking on the federal No Surprises Act; attended virtual meetings with colleagues to strategize on year-end priorities; and connected with staff of the NC congressional delegation on federal funding issues, telehealth expansion, and efforts around reconciliation.

Finally, we appreciated opportunities to meet with Duke Health colleagues to “talk shop” and provide updates on issues most relevant to their work. If your team would like to connect, we’d love to hear from you at govrelations@dm.duke.edu.