The courts want the say
When deference should apply
Because rules are rules
The Rundown
- Congress’ to-do list before the August recess includes appropriations and telehealth
- Committee update: Appropriations and medical debt
- Administration releases proposed rules on physician payment, outpatient services, and data sharing
- Supreme Court decisions may change approach to regulatory policy
- The latest from our desks
- Join the Duke Health Advocacy Network!
Federal Updates
Back in Business
Congress is back from its July 4th holiday recess and already looking ahead to the upcoming month-long August recess, which is scheduled to begin on August 2nd. During the August recess, members of Congress work in their home states and districts and engage in constituent meetings, town halls, and other community events. With 2024 being an election year, members are especially eager to get out of DC and head back home.
The approach of the August recess also shines a spotlight on everything that needs to get done between now and then, and Congress has plenty of healthcare-related items on its agenda. Some of the issues our office is monitoring include:
- Appropriations: The House Appropriations Committee marked up the FY 2025 Labor-HHS-Education (more on that below) and the Agriculture-FDA spending bills this week, while the Senate Appropriations Committee focused on the Agriculture-FDA package and the Military Construction, Veterans Affairs, and Related Agencies spending bill. While everyone is expecting a stopgap spending measure to avoid a government shutdown at the end of September, both chambers will continue working through these appropriations bills to help set the stage for negotiations after the elections.
- Telehealth: The House Energy and Commerce Committee was supposed to markup legislation that would extend loosened virtual care rules in Medicare for two years, but those plans were scrapped after negotiations on an unrelated privacy bill fell apart. Committee Chair Cathy McMorris Rodgers (R-WA) has said she hopes to advance a fully paid-for package before the August recess.
Heard on the Hill
Appropriations dominated the week, but a key Senate committee also examined the impact of medical debt.
House Appropriations Committee
This week, the House Appropriations Committee held a full committee markup of the FY 2025 spending bill for the Departments of Education, Health and Human Services, and Labor. The bill advanced with no Democratic support. The bill would provide $48.5 billion in total funding for the National Institutes of Health (NIH), which represents essentially level funding with inflationary adjustments, but it also outlines significant policy changes for restructuring and reorganizing NIH. At the markup, several members expressed concern with the proposed restructure, which is also being examined by Republicans on the House Energy and Commerce Committee, with a RFI currently open for feedback.
The bill also includes significant cuts to other agencies and important programs within the Department of Health and Human Services, including the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality. At the Subcommittee markup, Full Committee Chairman Tom Cole (R-OK) acknowledged that while the bill reflects many of the priorities of the Republican-led House, the bill will “bend toward the middle in the end because you’ve got to get 60 votes [for passage] in the United States Senate.”
Accompanying the full committee markup was the report that provided more insight into the spending in the bill, which also highlights support for some of Duke Health’s priorities.
Senate HELP Committee holds hearing on medical debt
On Thursday, the Senate Help, Education, Labor and Pensions (HELP) Committee held a hearing entitled, “What Can Congress Do to End the Medical Debt Crisis in America?” HELP Committee Chairman Senator Bernie Sanders (I-VT) discussed the prevalence and impact of medical debt. In May, Chairman Sanders introduced the Medical Debt Cancellation Act, which would eliminate all $220 billion in medical debt, wipe debt from credit reports, and drastically limit the accrual of future medical debt. Ranking Member Bill Cassidy, MD (R-LA) discussed the high cost of healthcare and noted the role hospitals play in medical debt. A full list of witnesses and testimony can be viewed at the link above.
It rules: regulatory updates
It’s July, which typically marks the busy season for key healthcare regulatory policy. It was that week for physician reimbursement, outpatient services patients, and healthcare data sharing.
CY 2025 Medicare Physician Fee Schedule
This week, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2025 Physician Fee Schedule (PFS) proposed rule. The rule proposes to cut the conversion factor by 2.8%, to $32.36 in CY 2025, as compared to $33.29 in CY 2024, reflecting the expiration of a 2.93% statutory payment increase for CY 2024. Other proposals include provisions designed to improve payment for and access to behavioral health care services and extension of certain expanded telehealth services and waivers through 2025, including those for virtual supervision and audio-only coverage of telehealth. However, CMS also makes clear that it does not believe it has full statutory authority to continue to grant other telehealth flexibilities, including the removal of geographic and site restrictions, unless Congress continues to grant extensions of public health emergency expansions or provides CMS with the power to make them permanent. Legislation is pending in Congress now that would extend for two additional years Medicare telehealth flexibilities, which are set to expire on December 31, 2024.
The proposed rule would also establish six new, optional Merit-based Incentive Payment Value System Value Pathways under the Quality Payment Program and update the Medicare Shared Savings Program.
Our team is continuing to evaluate the proposed rule and will work with Duke Health leadership and experts to coordinate any formal health system response. Comments are due September 9, 2024. More information, including fact sheets, is available here.
CY 2025 Outpatient Prospective Payment System
This week, CMS also released the CY 2025 Outpatient Prospective Payment System proposed rule. The proposed rule would increase Medicare hospital outpatient prospective payment system rates by a net 2.6% in calendar year 2025 compared to 2024. This includes a proposed 3.0% market basket update, offset by a 0.4 percentage point productivity cut.
It would also, among other provisions, provide separate payment for diagnostic radiopharmaceuticals with per-day costs above a threshold of $630, exclude certain qualifying cell and gene therapies from packaging under the comprehensive ambulatory payment classification policy, and pay for HIV pre-exposure prophylaxis in hospital outpatient departments. Further, new conditions of participation would be imposed on hospitals and critical access hospitals focused on obstetrical services and maternal care and hospitals would be required to have written policies and procedures for transferring patients under their care, including transfers both within and outside of the hospital.
Our team will work with Duke Health leadership and experts to coordinate any formal health system response. Comments are due September 9, 2024. More information, including fact sheets, is available here.
ONC Data Sharing Rule
The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) issued a proposed rule this week to improve health information sharing and interoperability during public health emergencies. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule calls for standardization of data transfer among public health departments and includes a digital framework for how health systems can more easily share data with public health officials.
ONC will hold an information session on the proposed rule next Wednesday, July 17.
We are coordinating with Duke Health experts on any potential health system response. The comment deadline is anticipated to be mid-September once the proposed rule is officially published in the Federal Register. Additional resources may be found here.
What’s the deference?
Shortly after our most recent publication ahead of last week’s July 4th recess, the US Supreme Court handed down two decisions that will impact processes for legislative and regulatory policy for healthcare – and potentially everything else.
One case, Loper Bright Enterprises, has dominated all of the headlines with the repeal of something known as the Chevron doctrine or Chevron deference. It was a 40-year-old judicially constructed precedent that allowed for agency discretion in implementing laws through rulemaking if the governing statutory language was otherwise ambiguous and Congress did not outline specifically how the agency should proceed. Chevron was steeped in judicial review but also recognized the importance of subject matter expertise and the limitations of Congress and the court system to resolve certain policy questions. Its absence alone means that purposeful ambiguity in legislation to account for possible changing circumstances in the future may be more readily challenged. Specificity and the clearest possible intent will be more necessary. And we’re going to need it in writing.
This particular shot also has a chaser. A few days after the Chevron decision, and on its last day of term, the Court issued a lesser-heralded ruling in Corner Post that expands the statute of limitations to challenge an agency rule or action to begin when the plaintiff alleges injury instead of from when the rule was instituted. This means that a rule that has been in place for decades could suddenly be called into question if a party claims there is a violation of rights or process.
Taken together, one can reasonably anticipate more litigation with respect to agency actions. The rulemaking process may get more difficult and subject to serious delays. How we advocate for legislation and its development may also require shifts in strategy, including the possibility that we may have to legislate more often to resolve questions that agencies once had the authority to determine.
But let’s also take a step back. Change is scary, and the unknown even more so. Some things we won’t know until we do, but we’ll be prepared as the landscape changes. It’s incredibly hard to bring a suit in federal court. It’s even harder to be successful in that effort. It’s likely a new standard of review will emerge, but it may take some time – and it might also be similar to Chevron, albeit under a different name and covering. Witness protection for former precedents.
Our team is following the after-effects closely, and we will be glad to answer your questions and direct you to any helpful resources as appropriate.
From our desk(s): Duke Health GR this week
Our team participated in stakeholder and coalition strategy calls on Duke Health policy priorities, including 340B, telehealth, trauma care and trauma centers, artificial intelligence in healthcare, and children’s mental health and trauma.
Our office participated in the Ad Hoc Group for Medical Research’s town hall to discuss the latest in FY 2025 appropriations, as well as other topics of interest to the medical research stakeholder community. Our team also participated in several monthly government relations calls to discuss strategy and hear updates on a range of issues including biomedical research, nursing education, and research policy.
This week our office coordinated a meeting with Rep. Ross’s office to discuss some of the issues relating to unauthorized enrollment or plan-switching.
Join the Duke Health Advocacy Network!
Looking for more opportunities to connect with fellow advocates and professionals interested in public policy across the health system? Join the Duke Health Advocacy Teams Channel! We’re growing leaps and bounds and hope you’ll consider joining us!
Managed and moderated by Duke Health Government Relations and Duke State Relations, the purpose of the platform is for you to connect with your colleagues throughout the health system who are engaged and/or interested in public policy advocacy. We hope the channel will be used as a space for sharing ideas, collaboration, and engaging with the government relations teams on the issues most important to your work.
We encourage you to explore the channel, as we will post relevant news items, policy updates, questions, advocacy resources, and opportunities for engagement. As importantly, this is your space to do the same and to help grow the community.
Click to Join
(Note: This is only open to Duke Health employees. By joining this teams channel, you acknowledge that the platform and your participation are intended for information sharing and connections/relationship building and is not an inducement by Duke Health Government Relations and Duke State Relations, or the channel’s participants, to act as an unauthorized advocacy and/or lobbying representative of Duke Health or Duke University).