THIS WEEK’S DOSE

• House Energy & Commerce Health Subcommittee Advances 21 Bills. The committee advanced legislation related to telehealth, Medicaid, workforce and rare diseases.
• Senate Finance Committee Holds Hearing on Rural Healthcare. The hearing discussed challenges in rural healthcare and solutions to support and improve healthcare for rural communities.
• HHS Secretary Becerra Testifies at House Education & Workforce Committee Hearing. The hearing was the latest in a series that focused on the fiscal year (FY) 2025 budget request for the US Department of Health and Human Services (HHS).
• Senate Bipartisan Working Group Releases Roadmap for AI Policy. The roadmap includes recommendations for federal policymaking related to artificial intelligence (AI), including the health sector.
• Senators Introduce Bipartisan Legislation Promoting Medicare Primary Care Payment Reform. The bill is accompanied by a request for information (RFI).
• FDA Holds Webinar on Laboratory Developed Tests (LDT) Final Rule. The webinar provided an overview of the final rule and answered questions about implementation.

CONGRESS

House Energy & Commerce Health Subcommittee Advances 21 Bills. The markup included legislation around telehealth, Medicaid, workforce and rare diseases. Of note, the subcommittee advanced a bill that included an extension of certain Medicare telehealth flexibilities through December 31, 2026, and a permanent extension of telehealth services for federally qualified health centers and rural health clinics. The telehealth bill also includes a new modifier for telehealth services for claims that are provided through a telehealth virtual platform or billed incident to a physician’s or practitioner’s professional service. While similar to the telehealth extension bill advanced by the House Ways and Means Committee last week, the bills are not identical, necessitating further work before a telehealth extension bill will reach the House floor for a vote.

More information on amendments and vote outcomes can be found here. Details on the outcomes of a few key bills can be found below:

• H.R. 7623, Telehealth Modernization Act of 2024, would extend certain telehealth flexibilities under the Medicare program through December 2026.
  • Advanced unanimously by a vote of 21-0.
• H.R. 8089, Medicare and Medicaid Fraud Prevention Act of 2024, would require certain additional provider screening under the Medicaid program.
  • Advanced unanimously by a vote of 22-0.
• H.R. 3433, Give Kids a Chance Act of 2023, would expand access to drugs for pediatric rare diseases.
  • Advanced by a vote of 16-11. Rep. Barragan was the only Democrat to vote yea.
• H.R. 3227, Ensuring Seniors’ Access to Quality Care Act, would modify requirements that prohibit a nursing home from running nurse aide trainings and competency evaluations when the nursing home has been subject to civil monetary penalties, so long as the facility has addressed deficiencies associated with the penalties and has not been found to have deficiencies related to patient harm or quality of care for more than two years.
  • Advanced by a vote of 13-12 along party lines with Republicans voting in support.
• H.R. 468, Building America’s Health Care Workforce Act, would extend waivers for nursing homes to retain temporary nurse aides for more than 120 days and would allow for competency requirement evaluations to be conducted at nursing homes where temporary nurse aides are employed.
  • Advanced by a vote of 14-8 along party lines with Republicans voting in support.

Senate Finance Committee Holds Hearing on Rural Healthcare. The hearing addressed challenges in rural healthcare and solutions to support and improve healthcare for rural communities. Witnesses discussed reimbursement and workforce issues. Witnesses and Senators emphasized the importance of telehealth flexibilities in increasing access to healthcare in rural communities. Many Senators emphasized the importance of increased graduate medical education slots and payments for rural communities. Senators and witnesses highlighted the lack of access to obstetric services in rural areas, creating maternity deserts.

HHS Secretary Becerra Testifies at House Education & Workforce Committee Hearing. The hearing focused on HHS’ FY 2025 budget request and other timely issues. Republican members expressed concern about unaccompanied children in the Office of Refugee Resettlement and the Biden administration’s efforts to protect gender-affirming care and women’s reproductive healthcare. Democratic representatives commended the administration’s efforts to advance access to health insurance. There was bipartisan support for further investments in mental and behavioral health services and supports.

Senate Bipartisan Working Group Releases Roadmap for AI Policy. The Bipartisan Senate AI Working Group roadmap provides high-level recommendations for federal legislative and regulatory actions for AI, discusses general areas for future engagement and includes summaries of roundtable discussions with stakeholders. The members of the working group include Senate Majority Leader Schumer (D-NY) and Senators Rounds (R-SD), Heinrich (D-NM) and Young (R-IN). The roadmap covers broad topics and includes recommendations for the following healthcare activity:

• Consider legislation that both supports further deployment of AI in healthcare and implements appropriate guardrails and safety measures to protect patients. This includes consumer protection, preventing fraud and abuse, and promoting the usage of accurate and representative data.
• Ensure that HHS has the proper tools to weigh the benefits and risks of AI-enabled products so that it can provide a predictable regulatory structure for product developers.
• Consider legislation that would provide transparency for providers and the public about the use of AI in medical products and clinical support services, including the data used to train the AI models.
• Consider policies to promote innovation of AI systems that meaningfully improve health outcomes and efficiencies in healthcare delivery. This should include examining the reimbursement mechanisms of the Centers for Medicare & Medicaid Services (CMS) and instituting guardrails to ensure accountability, appropriate use and broad application of AI across all populations.

Across the Capitol, a House AI working group is developing a similar document, though the House effort is not as far along. A one-pager outlining the Senate roadmap can be found here.

Senators Introduce Bipartisan Legislation and Issue RFI on Medicare Primary Care Payment Reform. As part of their ongoing work to address primary care challenges and reform physician payment models in Medicare, Senator Cassidy (R-LA) and Senator Whitehouse (D-RI), both members of the Senate Finance Committee, introduced S. 4338, the Pay PCPs Act. The bill is intended to better support and improve pay for high-quality primary care providers. It also encourages CMS to accelerate existing efforts to support value-based primary care and improve the adequacy of pay for primary care providers in Medicare.

In their press release, the senators noted that the bill serves as a marker for legislation in the primary care space. Their accompanying RFI offers stakeholders an opportunity to comment on the bill, including:

• How best to structure hybrid payments for primary care providers and what quality measures should apply to these payments,
• Appropriate beneficiary cost-sharing adjustments for primary care services, and
• Establishing a new technical advisory committee to help CMS determine fee schedule rate updates.

Stakeholders can submit feedback until July 15 via physician_payment@cassidy.senate.gov.

ADMINISTRATION

FDA Holds Webinar on LDT Final Rule. The webinar provided an overview of the LDT final rule, which made it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Presenters described the phaseout of the US Food and Drug Administration’s (FDA’s) general enforcement discretion approach to LDTs. During the webinar, the FDA discussed the provisions in the final rule and answered questions about enforcement discretion, the impact on tests currently being developed and FDA resources. The webinar presentation slides can be viewed here. The next scheduled webinar will be held on June 5, 2024. For more details about the final rule, read our +Insight.

QUICK HITS

• CISA, FBI, HHS and MS-ISAC Release Joint Cybersecurity Advisory. The Cybersecurity & Infrastructure Security Agency (CISA) issued a cybersecurity advisory, titled “#StopRansomware: Black Basta,” that includes tactics, techniques and procedures, as well as indicators of compromise used by known Black Basta ransomware affiliates, to help organizations protect against ransomware. Read the advisory here.
• HHS Announces National Strategy to Improve Maternal Mental Healthcare. Using recommendations developed by the Task Force on Maternal Mental Health, HHS released a national strategy to address maternal mental health and substance abuse. Read the report to Congress here, the national strategy here and the press release here.
• HHS Cuts Off Funding to EcoHealth Alliance. EcoHealth Alliance is a US-based nonprofit organization that conducted COVID-19 research. HHS cited EcoHealth on numerous research-related reporting lapses and accused the organization of not adequately monitoring the Wuhan Institute of Virology’s compliance with the terms of a National Institutes of Health grant that partly funded the work. EcoHealth has noted it will contest the funding cutoff.
• DOJ Notices Proposed Rule on Marijuana Scheduling. The US Department of Justice (DOJ) announced that they are taking steps to move marijuana from a schedule I to schedule III drug. The change in schedule would increase access for healthcare researchers seeking to treat patients with marijuana. Read the press release here.

NEXT WEEK’S DIAGNOSIS

Congress is in session next week, with healthcare activity expected at the committee level, including a Senate HELP Committee hearing on nutrition and a markup of several health bills, a House Energy & Commerce Health Subcommittee hearing on the FDA budget, a House Ways & Means Health Subcommittee hearing on challenges facing independent medicine and a House Budget Committee hearing on the effects of healthcare consolidation, among others.