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Federal Health Policy Updates for the Week of June 21, 2021

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There’s joy in writing
To report, laugh, and inform
Our thanks for reading


Our sincere appreciation to everyone who shared their poetry talents with us this month. We were one submission short of completing the June cycle but want to say thank you for reading and engaging. It’s our privilege to do this every week – and we take it to heart.


Federal Updates
 
Believe it when you see it? Deal (reportedly) struck on infrastructure
We ask you to forgive our hedging, as sometimes even seemingly ironclad legislative deals are subject to wear and rust once the “elements” have an opportunity to make their presence known. How did we maybe, finally get here? Maybe it’s the cooler than average temperatures in D.C. right now. Perhaps it was the recent “strawberry” moon. Whatever the underlying reason, a long sought after bipartisan agreement on an infrastructure package appears to have arrived.

On Thursday, President Biden, joined by a group of bipartisan senators, announced that a deal has been reached on a “bipartisan infrastructure framework” that has the support of the administration and 21 senators in both parties. Yet, the devil is always in the details, and thus far we haven’t seen very many.

Here’s what we do know: under the negotiated framework, led by Senators Kyrsten Sinema (D-AZ) and Rob Portman (R-OH), more than $550 billion would be allocated in new spending on roads, bridges, and other traditional infrastructure projects, for a total of $974 billion over five years or $1.2 trillion over eight years. The sticking point has been how to pay for all the new spending, but that appears to no longer be a point of contention.

What is clear is that this deal focuses more on traditional infrastructure-related issues and less on the health care and family provisions outlined in the Biden administration’s American Families Plan. As a result, Senate Majority Leader Chuck Schumer (D-NY) has already announced that as far as he and House Speaker Nancy Pelosi (D-CA) are concerned, a comprehensive infrastructure plan is now on two parallel tracks: the first being the bipartisan framework, and the second using the budget reconciliation process to move ahead with those aspects of the American Families Plan and possibly other priorities that would not otherwise have enough Republican support to move forward.

It sounds like a plan – but the even harder part comes next as Democratic leaders will need to sell their caucuses on this strategy and try to hold together groups of moderates and progressives whose votes will be essential for either component to pass.

We will continue to monitor the release of proposals, legislation, and negotiations and share details as they become available. We are working with our partners, associations, other stakeholders, and Duke leadership to advocate for robust infrastructure investment in academic medical and research institutions, hospitals, clinical and research laboratories, and technological investments supporting the delivery of and greater access to health care.

FY 2022 is closer than it appears
The House Appropriations Committee began work on its versions of the twelve annual appropriations bills for FY 2022 this week, with subcommittee markups scheduled yesterday and today for the Financial Services, Military Construction and Veterans’ Affairs, and the Agriculture bills, the latter of which includes funding for the Food and Drug Administration (FDA). The Defense appropriations subcommittee will markup its bill, which provides funding for Defense medical research programs, on June 30, and subcommittee work on the Labor, Health and Human Services, and Education bill, which dedicates funding to numerous medical research programs and workforce programs, is set for July 12. As noted last week, the House’s “deeming” budget resolution has allowed House Appropriations Committee Chair Rosa DeLauro (D-CT) to schedule a more aggressive schedule with the goal of finalizing its work by the end of July.
 
The Senate’s path forward remains less certain. Democratic leaders have yet to settle on a budget resolution process to allow the Senate Appropriations Committee to kick off its formal work on individual bills. The likelihood of reconciliation for a secondary infrastructure package (as noted above) containing more of the administration’s favored infrastructure policies will play a role in how Senate Democrats ultimately decide on how to balance infrastructure priorities and regular spending for FY 2022. It’s a game of precision and timing with real opportunities to finalize increased investments in healthcare and research priorities – and one that gets harder (hello, debt ceiling) if a continuing resolution is needed this fall to buy more time on FY 2022 funding decisions.
 
Our office is actively engaged in the budget and appropriations process and will continue to advocate for sustained and strengthened funding for Duke Health priorities.
 
DeGette, Upton release revamped Cures 2.0 proposal
This week, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released an updated discussion draft of Cures 2.0, the follow up legislative effort to their 21st Century Cures Act passed by Congress in 2016.
 
While the initial framework proposed by DeGette and Upton last summer was heavily focused on care delivery, the latest iteration of Cures 2.0 has been influenced by the realities, challenges, and lessons learned during the COVID-19 public health emergency. Provisions have been added directing the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) to coordinate on pandemic preparedness planning, as well creating national testing and reporting strategies, and provide funding for public education campaigns on the importance of vaccinations.
 
The draft also includes an authorizing framework for the Advanced Research Projects Agency for Health (ARPA-H) proposal included in the Biden administration’s FY 2022 budget recommendation for the National Institutes of Health (NIH). The $6.5 billion ARPA-H program would be modeled after the Defense Department’s DARPA research program with the intent of pioneering new high-risk, high yield health and medical research initiations.
 
Among other investments proposed in the Cures 2.0 draft include language from the PASTEUR Act to provide increased support for innovations in antimicrobial research; drug development; telehealth integration under Medicaid, the Children’s Health Insurance Program (CHIP), and expansion under Medicare; genetic testing; precision medicine; and the Research Investment to Spark the Economy (RISE) Act, which would provide $25 billion to support the research enterprise.
 
DeGette and Upton signaled they intend to introduce a final draft bill by September and move Cures 2.0 through Congress this year, even though they will face some challenges on substance and a tight legislative calendar with a growing list of priorities along the way. The release this week also includes a request for information for stakeholders to offer their thoughts on the structure and scope of ARPA-H.
 
A section by section summary and full draft text are available for review.
 
Our office is evaluating the proposal and working with Duke Health experts and leadership on any feedback to provide to Reps. DeGette and Upton.
 
HELP (U.S.) get shots in arms: Senate hearing examines COVID-19 vaccine rollout and hesitancy
This week, the Senate Health, Education, Labor, and Pensions Committee, of which Senator Ruchard Burr (R-NC) serves as ranking member, held a hearing entitled “Vaccines: America’s Shot at Ending the COVID-19 Pandemic.” The discussion focused on ways to increase vaccine trust and outreach, particularly in communities where there are currently gaps in vaccination rates. Among the testifying witnesses was Curtis Chang, a consulting professor with the Duke Divinity School, who noted the need for increased and targeted outreach to the evangelical Christian community, which has relatively low COVID-19 vaccination rates. All of the witnesses testified in support of continued federal support to aid localized vaccine and education campaigns, and Senator Burr spoke favorably of public-private partnerships in North Carolina and other parts of the country that have been successful in addressing vaccine hesitancy. Burr suggested that “meeting people where they are” is the best way to ensure individuals have the appropriate context as to why the COVID vaccine is so important to their personal health, as well as to public health.
 
HELP continues pandemic preparedness work; LDT legislation introduced
As we’ve reported previously, the Senate HELP Committee has focused its efforts on improving the nation’s public health and medical preparedness and response programs, especially related to pandemic preparedness. Earlier this week, Chair Patty Murray (D-WA) and Ranking Member Burr (R-NC) directed HELP Committee staff to begin oversight and investigation aimed at identifying the barriers to vaccination among underserved communities, assessing the root causes of supply shortages within the Strategic National Stockpile during H1N1, Ebola, and COVID-19, and studying the origins of the virus that causes COVID-19 and how to improve the nation’s ability to assess the safety and security of biosafety laboratories.

Also this week, Senators Burr and Michael Bennet (D-CO) and Representatives DeGette (D-CO) and Larry Bucshon, M.D. (R-IN) introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This bipartisan legislation would modernize the review process for diagnostic testing, clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services (CMS), and limit duplication between the two agencies.

Our office will continue to work with the Senate HELP Committee on these efforts and will provide Duke expertise to help inform their work.
 
O-SH…A: New ETS for healthcare publishes and compliance deadlines loom
While the Occupational Health and Safety Administration (OSHA) within the Department of Labor (DOL) first issued a COVID-19 Emergency Temporary Standard (ETS) for health care settings on June 10, formal publication of the rule in the Federal Register was delayed until this week on Monday, June 21.

This means that the clock is now ticking for health care settings, including hospitals, to ensure they are in compliance with some provisions taking effect as soon as July 6 and others required to be in place by July 21.
 
Among other provisions, the ETS includes requirements for personal protective equipment, and barriers, social distancing, training, employee screening, paid leave, reporting, and providing resources and opportunities for employees to become vaccinated. While in many cases, hospitals and other health care settings likely have protocols in place that satisfy ETS requirements, concerns are emerging around the quick turnaround time for implementation and the need for clarification around some aspects of the rule.
 
The ETS, unless otherwise amended or rescinded, will remain in place for six months before the Biden administration will have to decide whether or not to formally propose a permanent standard. While the current ETS is not subject to the usual notice and comment rulemaking procedures before implementation, OSHA has opened a 30-day comment period for stakeholders to weigh in on whether any of the provisions should be made permanent after the six months.
 
OHSA has provided a number of resources, fact sheets, and indexed rule text on its website for reference.
 
The Duke Health leadership team is actively engaged in evaluating the ETS requirements and our office is working closely with the American Hospital Association, the North Carolina Healthcare Association, and other stakeholders on advocacy strategy.
 
From our desks(s): Duke Health GR this week
We’re inching closer to a short recess period, which means Congress is pushing through as much of its to-do list as possible.

This week, our office coordinated a meeting for Jacquelyn McMillian-Bohler, PhD, CNM, CNE, Assistant Professor in the Division of Health for Women, Children and Families in the School of Nursing, and her colleagues from UNC-Chapel Hill and Vanderbilt University with staff for HELP Committee Ranking Member Burr (R-NC) to discuss Black maternal health issues. Rep. Alma Adams (D-NC-12), co-chair of the Black Maternal Health Caucus with Rep. Lauren Underwood (D-IL), have reintroduced the Black Maternal Health Momnibus Act that aims to address every dimension of the maternal mortality crisis in our country.
 
We provided background and Duke Health expert feedback to the office of Rep. G.K. Butterfield (D-NC-01) on Black maternal health needs and Medicaid coverage modifications in advance of a House Energy and Commerce Health Subcommittee hearing focused largely on examining legislative proposals addressing social determinants of health. Members of our team also established connections with fellow advocates on animal research; maternal mental health; and making permanent through statutory changes waivers during the public health emergency that have allowed physical therapists, occupational therapists, and speech language therapists to be reimbursed for telehealth services provided under Medicare.

We were privileged to connect with Duke Health team members on advocacy and policy process issues; presented our work and role within Duke Health to the 2021 intern cohort for the Mary Ann Black Summer Internship Program; and helped coordinate the attendance of Duke Health team members to President Biden’s speech in Raleigh in honor of frontline vaccine workers.

Finally, we remain engaged in the FY 2022 federal appropriations process and routinely highlight Duke Health funding priorities with members of the North Carolina congressional delegation.

Register Now!
Town Hall: Leveraging Technology to Accelerate Innovation in Health Systems
On Tuesday, June 29 at 2:30pm, you are invited to join a virtual, public town hall conversation sponsored by Duke Health and UNC Health to discuss how federal policy, state policy, and public-private partnership opportunities can support advancing innovations in health to create pathways to opportunity and economic security. Topics will include addressing health equity, social determinants of health, and incentives for increased innovation.
 
The town hall will be led by the Future of Tech Commission, a private, independent and bipartisan working group developed in response to discussions with the White House and the Federal Communications Commission (FCC) to recommend a comprehensive tech policy agenda. The ideas and feedback generated from this event and diverse communities and groups across the country will be used to craft key tech policy measures, and set the stage to implement a robust tech agenda with bipartisan support.
 
Visit the event page to learn more and register!

Want to Join Team Advocacy?
Thanks to the PDC and our partners in the Duke State Relations office, Duke Health physicians and providers can engage with policymakers through the PDC Provider Advocacy Network.

By enrolling in the Phone2Action advocacy tool, individuals can join a powerful, collective voice on priority healthcare issues debated in Raleigh and Washington, D.C., including telehealth, workforce, drug pricing, and many more.

Learn more here. (NOTE: You must register and use a non-Duke email address to receive action alerts.)