Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various expiring provisions. Committee work on health care issues this Congress has been defined by both bipartisan collaboration as well as partisan developments. This summer saw a particularly busy stretch as Congress focused on a range of health fronts and held hearings and markups on many health-related bills. Yet, despite the high level of activity by the committees, few health bills have passed either the House and/or Senate, including bills that are considered "must pass" before the end of the current fiscal year (September 30) and have previously garnered overwhelming bipartisan support. Health stakeholders are closely watching to see how Congress will resolve outstanding health issues as August recess wraps up and the end of the fiscal year and calendar year approaches. This client alert highlights 10 health issues to watch as Congress returns from August recess.

  1. Fiscal Year (FY) 2024 Appropriations – Health stakeholders most closely watch two annual appropriations bills: the Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations bill and the Agriculture, Rural Development, and Food and Drug Administration, and Related Agencies (Ag-FDA) appropriations bill. While the Senate Appropriations Committee has approved all 12 annual appropriations bills, none of these bills have advanced through the full Senate. The House Appropriations Committee approved 10 of the annual appropriations bills, but due to timing constraints and controversial riders, the Labor-HHS bill and the Commerce-Justice-Science bill were not marked up at the full Committee level prior to the August recess. The House was successful in passing the Military Construction, Veterans Affairs, and Related Agencies appropriations bill in a party-line vote of 219-211 on July 27, but they had to pull the Ag-FDA bill, which had been scheduled to be on the House floor before the August recess. While the Senate's work on appropriations has been bipartisan, the House's work on these bills has played out entirely along party lines. These dynamics have set the stage for the FY 24 Appropriations to take top focus in September, with the end of the fiscal year (September 30) just weeks away and continued uncertainty about how Congress will address federal government funding for FY 24. Senate Majority Leader Chuck Schumer (D-NY) and House Speaker Kevin McCarthy (R-CA) have both expressed support for adopting a continuing resolution (CR) through early December to provide additional time for negotiations. Further complicating matters, the Biden administration has submitted to Congress a supplemental spending request (approximately $40 billion) for disaster relief, Ukraine aid and border security. The House Freedom Caucus responded in opposition to a "clean" CR, as well as a "blank check" for Ukraine, and underscored various policy demands for considering all 12 appropriations bills individually on the House floor at FY 22 funding levels. As for next steps, the House Rules Committee is expected to initially consider the Defense and Homeland Security appropriations bills the week of September 11, and the Senate may consider a "minibus" of several appropriations bills.

  2. FDA Animal Drug User Fee Acts – The Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) are up for reauthorization as these programs are set to expire at the end of the current fiscal year (September 30). The House bill (H.R. 1418) moved through the full Energy and Commerce Committee and House with bipartisan support. The Senate Health, Education, Labor and Pensions (HELP) Committee approved the Senate bill (S. 1844) in June. Stakeholders are watching to see if there will be UFA déjà vu and Congress will move a clean reauthorization ahead of the end of the fiscal year as happened last year with other FDA user fee programs.

  3. SUPPORT Act Reauthorization – The SUPPORT for Patients and Communities (SUPPORT) Act (P.L. 115-271) was a defining law in the effort to combat the opioid epidemic and was enacted with overwhelming bipartisan support five years ago. The Energy and Commerce Committee advanced legislation (H.R. 4531) by a vote of 49-0 in July to reauthorize expiring provisions in the 2018 law and add new provisions to account for the evolving nature of the fentanyl and opioid crisis, including provisions to schedule xylazine. While the Ranking Member of the Senate HELP Committee, Sen. Bill Cassidy (R-LA), has unveiled legislation to reauthorize the SUPPORT Act, the Senate HELP Committee has yet to move legislation to reauthorize the SUPPORT Act through the Committee, adding uncertainty to the timing and path ahead of reauthorizing the SUPPORT Act this fall.

  4. Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization – First enacted in 2006, bipartisanship has been an essential aspect of PAHPA and the law's reauthorizations in 2013 and 2019. PAHPA's provisions are set to expire at the end of the fiscal year. In July, the Senate HELP Committee approved S. 2333, the Pandemic and All-Hazards Preparedness and Response Act, with bipartisan support, but the full Senate has not taken up this bill. Also in July, the House Energy and Commerce Committee advanced two bills related to reauthorization along party lines (H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act, and H.R. 4420, Preparedness and Response Reauthorization Act) as the Committee's members disagreed over including medical product shortage related provisions as part of PAHPA reauthorization. It remains unclear how the House and Senate will reconcile the differences between their respective bills, but informal conference negotiations did commence over the August recess. Congress may pivot to take action on only the law's expiring authorities before the end of the fiscal year and address the programmatic authorizations at a later date.

  5. Drug Shortages – The Senate HELP Committee included drug shortage related provisions in its PAHPA reauthorization bill, but the inclusion of FDA medical product shortage related provisions has been a partisan sticking point in the House. There has been disagreement between the Democratic members of the Energy and Commerce Committee, who sought to include such provisions in the PAHPA reauthorization bills at both the Health Subcommittee and full Committee markups, and their Republican counterparts. Instead of including such provisions in the PAHPA reauthorization bills, in June, Chair Cathy McMorris Rodgers (R-WA) teamed up with Senate Finance Committee Ranking Member Mike Crapo (R-ID) to release a bicameral Request for Information (RFI) on drug shortages. In late July, Chair McMorris Rodgers released a legislative discussion draft focused on drug shortages and asked for stakeholder comments by August 25. While it is unclear if Congress will find bipartisan, bicameral agreement on these issues, given the impact drug shortages have on patients and public health, the congressional focus on these issues is expected to continue in the months ahead.

  6. Drug Pricing – August 16 marked the one-year anniversary of the enactment of the Inflation Reduction Act, which included sweeping drug pricing reforms. Drug pricing issues have been front and center during the 118th Congress. The focus on PBMs has been unprecedented with multiple Committees in the House and Senate holding hearings and marking up PBM legislation. In the days leading up to the August recess, the Senate Finance Committee advanced the Modernizing and Ensuring PBM Accountability Act by a vote of 26 to 1. While it remains to be seen when and how the House and Senate will come together on PBM legislation, it is clear that interest in moving bipartisan legislation on this issue is steadily gaining momentum as Congress looks toward September and beyond.

  7. Provider Price Transparency – The focus on transparency in health care has not been limited to PBMs, it has also extended to health care providers and consideration of new reporting requirements and site-neutral payments. Earlier this year, the House Energy and Commerce Committee approved H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 (the "PATIENT Act") by a unanimous, bipartisan vote of 49-0. In late July, the House Ways and Means Committee jumped on this legislative bandwagon advancing the Health Care Price Transparency Act of 2023 (H.R. 4822) by a vote of 23-17 and the Providers and Payers COMPETE Act (H.R. 3284) by a vote of 25-16. Stakeholders will be watching to see if the Senate takes up similar legislative reforms. Stakeholders will also be closely watching to see if these issues surface as part of any potential end of year health care package, and if so, how far Congress leans into reforms for health care providers and ownership by certain private equity funds, venture capital firms and other asset managers given the differences between the House bills.

  8. Telehealth Controlled Substance Prescribing – Throughout the COVID-19 Public Health Emergency (PHE), state and federal prescribing requirements were relaxed such that providers could prescribe scheduled substances without a need for in-person patient examinations or visits. With the end of the PHE, those rules were set to expire. In February this year, the Drug Enforcement Agency (DEA) proposed permanent rules that would have allowed practitioners to prescribe 30-day supplies of Schedule III-V non-narcotic medications as well as buprenorphine followed by an-person examination. The rule also allowed the prescription of any controlled medications where there has been a qualifying telemedicine referral from a practitioner who has conducted an in-person evaluation of the patient. Facing strong opposition, DEA extended the pandemic rules through November 2024 to allow time for further evaluation. Then, on August 4, DEA announced plans for stakeholder listening sessions on September 12 and 13 to consider relaxed rules that would allow providers to write prescriptions for controlled substances via telemedicine only. Congress previously instructed DEA back in 2008 to create a special registration process for providers to prescribe on a remote basis permanently, but DEA has not yet done so. These listening sessions could lead to a final rule that would permanently expand the ability of prescribers to issue scripts on a remote basis. This is another policy front that stakeholders will continue to closely watch given the patient impact implications and broader sustained interest in both telehealth and controlled substance issues.

  9. Remote Patient Monitoring – The pandemic accelerated a growing interest in remote patient monitoring (RPM) technology, and health care providers were able to use regulatory flexibilities during the PHE. Those flexibilities included the addition of remote therapeutic monitoring billing codes and expanded coverage by Medicare and commercial health plans. Now that the PHE has ended, many of those flexibilities are being pared back and, absent more permanent changes, may be eliminated. While providers have noted improvement in care, decreased hospital readmissions and support to telemedicine capabilities, they have also noted that reimbursement rates are insufficient to support widespread utilization. There is also uncertainty in the existing RPM reimbursement rules that limit how often certain codes can be utilized and how many days per month information needs to be assessed before it can be billed appropriately. Since many of the health benefits afforded by continuous remote telemonitoring come through analysis of longitudinal data, fee-for-service models and billing codes are often inappropriate and present challenges for the accurate capture of this data. Some stakeholders are arguing that these shortcomings must be addressed if the full promise of remote telemonitoring is to be realized. Stakeholders will continue to closely watch to see if this is another area of health policy on which Congress may weigh in.

  10. Diagnostics Reform – Diagnostics reform was a key area of legislative focus in the 117th Congress, yet to date enactment of bipartisan legislation (the VALID Act) has proven elusive. In late July, the Office of Information and Regulatory Affairs at the Office of Management and Budget showed a proposed rule on laboratory-developed tests (LDTs) under review raising expectations that a much-anticipated proposed rule by the Food and Drug Administration is forthcoming, the issuance of which would add yet another development to the closely watched diagnostics reform policy discussion.

The work on health care policy has not slowed down during the August recess. In recent days, the House Budget Committee Chair Jodey Arrington (R-TX) and Rep. Michael Burgess (R-TX) announced the launch of the Budget Committee Health Care Task Force with the stated goal of focusing on "bending the cost curve" of health care and examining key drivers of health care costs to the federal budget and proposals to reduce health care spending, while working to modernize and personalize the health care system, support innovation and increase patient access to quality and affordable care. In conjunction with this announcement and to inform related work, the Task Force members issued a request for information and have requested stakeholder feedback by October 15, 2023. This latest development further underscores the sustained interest in health care policy. There is no shortage of health issues awaiting congressional consideration as members return from August recess and look ahead to a sprint to the end of the fiscal year in the coming weeks and end of the calendar year in the months to follow. Health care issues have been a key area of bipartisan focus in both the House and Senate, and stakeholders will be closely watching to see how various legislative issues, including bills considered "must pass," are resolved in the days ahead.

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