Skip to main content

Federal Health Policy Updates for the Week of June 28, 2021

Duke Government Relations Logo

Progress feigns surprise
Sprints, now marathons; we’re just
Running to stand still


Publishing Note:
Congress is taking a brief recess next week – and so are we! While we won’t publish next Friday, please follow us on Twitter (@DukeGovRel) for any breaking federal policy news impacting Duke Health and our communities.

We’ll be back the week of July 12.
 

The Rundown

  • House appropriators propose funding allocations for FDA and VA medical research
  • Biden administration drops first surprise billing interim final rule
  • Duke Health comments on IPPS proposal for organ transplantation
  • Supreme Court denies challenge to site-neutral regulation
  • Democrats introduce a localized Medicaid expansion bill
  • Infrastructure is still unsettled
  • The latest from our desks
     

Federal Updates

House appropriations: on time and on schedule
The House Appropriations Committee approved FY 2022 appropriations bills this week that include funding for the Food and Drug Administration (FDA), nutrition and food security programs, and medical research at the Department of Veterans Affairs.
 
The Committee-passed Agriculture, Rural Development, FDA, and Related Agencies funding bill would, among other priorities, provide increased investments in rural broadband development, child and family nutrition programs, and additional support for FDA to combat the nation’s opioid crisis and surveillance of the medical supply chain, bringing FDA’s total allocation with user fees to over $6 billon for FY 2022. The Committee-passed Miltary Construction, Veterans Affairs, and Related Agencies bill, among other priorities, would allocate $902 million for the VA’s Medical and Prosthetic Research program, an increase of $15 million above President Biden’s FY 2022 budget request.
 
The Defense Appropriations Subcommittee held a closed-door mark up of its FY 2022 spending bill this week, which includes funding for Defense medical research programs. We will provide updates on line item specific programmatic allocations once the subcommittee report is made public the week of July 12 - which will also see the Committee kick off work on the Labor, Health and Human Services (HHS), and Education spending bill that provides funding for the National Institutes of Health and other key medical and clinical research programs.
 
While House Appropriations Chair Rosa DeLauro (D-CT) plans to have the committee’s work wrapped by July 16, there is still no immediate plan or path forward for FY 2022 appropriations in the Senate.
 
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.
 
Just in time – Biden administration announces initial interim final rule on surprise medical billing
On Thursday afternoon, the Departments of HHS, Labor, and Treasury, and the Office of Personnel Management (OPM), issued a surprise medical billing interim final rule (IFR) to implement provisions of the No Surprises Act, which was included in the December 2020 Consolidated Appropriations and Omnibus Act.

Among other provisions, the IFR, which is the first part of a series of rules to be developed by the Biden administration on surprise billing, bans: surprise billing for emergency services, high out-of-network cost-sharing for emergency and non-emergency services, out-of-network charges for ancillary care at an in-network facility, and other out-of-network charges without advance notice. This rule will also extend similar protections to Americans insured through employer-sponsored and commercial health plans.

Fact sheets are available here and here – and the full text of the unpublished IFR is available through CMS.

There will be a 60 day comment period that opens as soon as the IFR is published in the Federal Register.

Our office is coordinating with Duke Health leadership and our partners and stakeholders on any comments from the health system.

Duke Health weighs in on CMS’s FY 2022 IPPS proposed rule
Our apologies for the acronym heavy title. It is an occupational hazard of federal rulemaking.
 
This week, Duke Health submitted comments on the Centers for Medicare and Medicaid Services (CMS) FY 2022 Inpatient Prospective Payment System (IPPS) proposed rule. The comment letter primarily focused on a provision that would reduce Medicare payment for certain costs related to the organ acquisition process by reimbursing only for “organs transplanted into Medicare beneficiaries so that Medicare more accurately records and pays its share of organ acquisition costs.”
 
Duke Health, in consultation with Duke experts and the organ transplant community, responded that the proposed rule would have widespread and unintended consequences for patients, as “undermining the financial viability of organ procurement efforts is likely to reduce organ availability and lead to increased wait times for transplantation, resulting in greater acuity and possibly death.” Duke Health’s comments further request that CMS not finalize the transplant-related provisions of the rule and that HHS conduct a comprehensive policy analysis on the proposal’s potential impact on organ transplantation and procurement.
 
Duke Health also joined two community letters led by the American Society of Transplant Surgeons and a group of transplant hospitals from across the country, respectively, offering similar comments and recommendations.
 
As CMS reviews public comments to the proposed rule, our office is working in partnership with our leadership, fellow transplant hospitals, and other stakeholders to share our concerns with the NC congressional delegation and other key policymakers.

Supreme Court declines to hear challenge to site-neutral regulation
This week, the Supreme Court announced that it will not review a challenge from the American Hospital Association and other stakeholders on the Trump administration’s site-neutral regulation.

Under the policy issued in 2018, Medicare cut payments for basic outpatient medical evaluation visits in off-campus hospital-owned clinics by 60 percent to match the rates paid to independent doctors for the same service. Hospital groups won an initial case to invalidate the rule in federal district court, but the D.C. Circuit Court of Appeals sided with the Trump administration. While the Supreme Court’s decision ends the legal battle over the rule, legislative and rulemaking advocacy pathways remain open to hospitals opposing the rule – even though those efforts may face headwinds from Congress and the Biden administration.

The Court is still reviewing a separate challenge to a parallel policy in which Medicare cut reimbursements by nearly 30 percent to hospitals that receive drug manufacturer discounts through the 340B program. It is unclear when the Court will decide whether or not to proceed with that case.

All healthcare is local: new bill offers twist on Medicaid expansion
Rep. Lloyd Doggett (D-TX), chair of the House Ways and Means Subcommittee on Health, has introduced legislation to help aid Medicaid expansion in states where the state governments have declined. The Cover Outstanding Vulnerable Expansion-Eligible Residents Now (COVER Now) Act (H.R. 3961) would authorize CMS to work directly with counties, cities, and other political subdivisions to expand Medicaid coverage. Provisions include:

  • Authorizing CMS to contract directly with counties and other political subdivisions to establish demonstration projects expanding Medicaid coverage to their residents;
  • Allowing participating entities to receive the same deal previously made available to states: 100% federal funding for the first 3 years and a gradual reduction to 90% federal funding by year 7 and thereafter;
  • Allowing participating entities to apply individually or jointly if they wish to establish a regional expansion project;
  • Ensuring existing Medicaid rules and systems would remain in place and apply to the local expansion programs;
  • Requiring states to cooperate and authorize access to state Medicaid systems for participating entities, with additional federal administrative Medicaid funding for cooperation and subject to federal penalties for non-cooperation, and;
  • Ensuring that eligible beneficiaries enrolled in a local expansion program would be automatically enrolled into the state Medicaid program should a state decide to expand.

The legislation currently has over 40 cosponsors, including all 5 Democratic members of the North Carolina congressional delegation. Democratic leaders may work to position the bill as part of its reconciliation strategy for infrastructure or another healthcare priority.

We will monitor legislative developments closely.

Two steps forward, two steps back: infrastructure unsettled
There was a deal… then maybe not a deal… and then clarification of the previously announced deal… and now… we’re still waiting on all of the fine print.

As reported last week, the White House and a bipartisan group of 21 Senators reached a infrastructure framework agreement that would include more than $550 billion 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. This is progress – but the White House and less than a third of the Senate doesn’t necessarily speak for the whole Congress.

What we know now is that congressional Democrats still plan to move a separate budget reconciliation infrastructure bill that is expected to include much of the Biden administration’s American Families Plan agenda – and this plan seemingly has the support of swing Democratic votes in the Senate, including Senator Joe Manchin (D-WV).

The problem is that we still don’t have a lot of detail. The House has passed a $715 billion transportation and water infrastructure bill that Democrats are likely positioning to help round out the details of the bipartisan compromise, while other efforts are emerging to include more health care infrastructure initiatives in both potential packages. Costs and offsets, particularly proposed Medicare cuts, remain concerns for both sides. We’re close – but we’re not there yet – and a lot of parsing of details is expected behind the scenes during next week’s recess.

We continue to monitor the release of proposals and negotiations and 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.
 
From our desk(s): Duke Health GR this week
On Tuesday, Dr. Tony Moody, who co-leads the Centers for Research in Emerging Infectious Diseases (CREID) Coordinating Center, met with staff for Senator Richard Burr (R-NC) to share updates about the network of research centers and its work and goals. Senator Burr is the Ranking Republican for the Senate HELP Committee and is drafting legislation to address pandemic preparedness and response.

Our office met with congressional staff on the importance of continuing telehealth expansion in Medicare beyond the current public health emergency and coordinated with the Duke University School of Medicine Office of Physician Scientist Development to begin meeting with North Carolina congressional staff on the importance of a robust physician scientist workforce and pipeline.

Our team also met with Duke Health leaders about the health system’s work on its Hospital at Home program, which makes acute hospital-level care available to older adults in their homes, rather than in a traditional hospital setting.
 
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.