THIS WEEK’S DOSE

• House Energy & Commerce Committee Hearing on FDA. The hearing examined the US Food & Drug Administration’s (FDA’s) regulation of drugs, biologics and devices.
• House Budget Committee Hearing on Healthcare Monopolies. The hearing examined the budgetary effects of healthcare consolidation.
• House Energy & Commerce Innovation, Data, and Commerce Subcommittee Markup of National Privacy Standard Discussion Draft. The subcommittee advanced the American Privacy Rights Act discussion draft to the full committee.
• House Ways & Means Committee Hearing on Private Practice. The hearing examined challenges facing independent medicine.
• Senate HELP Committee Markup of Health Bills. The markup considered seven bills related to public health.
• Senate Judiciary Committee Hearing on Competition in the Prescription Drug Market. The hearing focused on a series of bipartisan bills to enhance drug competition to increase affordability of prescription drugs in America.
• Senate HELP Committee Hearing on Food is Medicine. The committee discussed the vital role of nutrition in health and well-being.
• Senate Finance Committee Releases White Paper on Medicare Physician Pay Reform. The white paper broadly outlines policy concepts to reform physician Medicare payment, encourage participation in advanced payment models, reform quality reporting and meet the needs of those with chronic illness.
• ARPA-H Announces New Cybersecurity Program. The program is a cybersecurity effort to help protect healthcare facilities.

CONGRESS

House Energy & Commerce Health Subcommittee Hearing on FDA. The hearing examined the FDA’s regulation of drugs, biologics and devices, with a focus on the FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. Members and witnesses agreed that it is vital for the FDA to promote innovation while also protecting public health and safety. They also agreed on the importance of increasing the number of treatments available for rare diseases. Some members expressed concern with the recent laboratory-developed test final rule, including its potential impacts on slowing innovation. Some members also expressed concern about the lack of diversity within clinical trials for racial and ethnic minorities and pregnant people.

House Budget Committee Hearing on Healthcare Monopolies. The committee examined the budgetary effects of healthcare consolidation. There was bipartisan agreement that healthcare consolidation is a major driver of increased healthcare costs in the country. Several members and witnesses expressed concern on pharmaceutical market consolidation and its impact on patient access to care. Witnesses expressed support for solutions, such as passing legislation that includes Medicare site neutral payment reform and increasing price transparency, to address issues stemming from healthcare consolidation.

House Energy & Commerce Innovation, Data, and Commerce Subcommittee Markup of National Privacy Standard Discussion Draft. The Innovation, Data, and Commerce Subcommittee considered the American Privacy Rights Act, a bipartisan, bicameral discussion draft to establish a national privacy standard led by House Energy & Commerce Committee Chair McMorris Rodgers (R-WA) and Senate Commerce, Science, and Transportation Committee Chair Cantwell (D-WA). The markup considered an updated discussion draft that was made public a day prior and was revised to include provisions to carve out data protected by existing federal law, along with provisions to implement privacy protection for children.

During the markup, several members had amendments related to providing additional protections for Americans when their data is stolen, limiting foreign adversaries’ access to American information, clarifying state attorney general investigatory authority, and examining the definition of “small business.” While none of these amendments were brought to a vote, members urged they be adopted and discussed in the future. There was unanimous agreement that the bill still requires revisions, and it was noted that this would not be the last opportunity to refine and deliberate this draft. The subcommittee advanced the draft bill by a voice vote to the full committee for further consideration.

House Ways & Means Health Subcommittee Hearing on Private Practice. The subcommittee examined challenges facing independent medicine. Members agreed that it is important to preserve the practice of independent medicine in the United States. Many members expressed concern about increased consolidation in healthcare, including private equity firms acquiring independent private practices. Some witnesses highlighted that independent physicians face financial barriers to maintaining independent private practices because of rising operational costs and decreasing Medicare reimbursement rates. Witnesses and members both expressed concern about the increased administrative burden posed by prior authorization.

Senate HELP Committee Markup of Seven Health Bills. The committee held a markup to consider and advance seven bills related to public health. Six of the bills passed by wide bipartisan margins and one was advanced unanimously.

More information on the bills and amendments can be found here. Details on the outcomes can be found below:

• S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, would reauthorize education and awareness initiatives on mental health and substance use disorder services as well as reauthorize programs to promote mental health among the health professional workforce.
  • Passed with 19 yeas and 2 nays.
    • Sens. Paul (R-KY) and Braun (R-IN) voted nay.
• S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024, would reauthorize grants for emergency medical services for children.
  • Passed with 19 yeas and 2 nays.
    • Sens. Paul and Braun voted nay.
• S. 4351, a bill to amend the Public Health Service Act to reauthorize certain poison control programs.
  • Passed unanimously, with 21 yeas and 0 nays.
• S. 3775, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024, would provide an extension of programs with respect to Alzheimer’s Disease and related dementias.
  • Passed with 19 yeas and 2 nays.
    • Sens. Paul and Braun voted nay.
• S. 4325, a bill to amend the Public Health Service Act to reauthorize the program relating to lifespan respite care, and for other purposes.
  • Passed with 19 yeas and 2 nays.
    • Sens. Paul and Braun voted nay.
• S. 3757, Congenital Heart Futures Reauthorization Act of 2024, would reauthorize the congenital heart disease research, surveillance and awareness program of the Centers for Disease Control and Prevention.
  • Passed with 19 yeas and 2 nays.
    • Sens. Paul and Braun voted nay.
• S. 4045, East Palestine Health Impact Monitoring Act of 2024, would require a study on public health impacts as a consequence of the February 3, 2023, train derailment in East Palestine, Ohio.
  • Passed with 19 yeas and 2 nays.
    • Sens. Paul and Braun voted nay.

Senate Judiciary Committee Hearing on Competition in the Prescription Drug Market. The hearing examined competition in the drug market, particularly relating to anticompetitive patent practices. During the hearing, members were largely supportive of a series of bipartisan bills previously passed out of the committee with strong bipartisan support in 2023, which include:

• S. 150, the Affordable Prescriptions for Patients Act of 2023.
• S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.
• S. 148, the Stop STALLING Act.
• S. 79, the Interagency Patent Coordination and Improvement Act of 2023.

Senate HELP Primary Health and Retirement Security Subcommittee Hearing on Food is Medicine. The subcommittee held this hearing to hear from individuals about their work in “Food is Medicine” and its role in supporting health and reducing healthcare costs. There was bipartisan agreement about the importance of food and proper nutrition for health and well-being. Witnesses highlighted opportunities for congressional action, such as through passing legislation and authorizing funding for increased research to help integrate the benefits of Food is Medicine into the community.

Senate Finance Committee Releases White Paper on Medicare Physician Pay Reform. The white paper put forth by Chairman Wyden (D-OR) and Ranking Member Crapo (R-ID) broadly outlines a number of areas of interest that the committee sees as an opportunity for reform, including:

• Creating sustainable payment updates to ensure clinicians can own and operate their practices.
• Incentivizing alternative payment models that reward providing better care at a lower cost.
• Rethinking how Medicare measures quality care.
• Improving primary care.
• Supporting chronic care benefits in Medicare fee-for-service (FFS).
• Ensuring continued access to telehealth.

The policy concepts referenced or discussed in this white paper reflect preliminary areas of interest, rather than formalized proposals, and the committee has stated that it will continue to conduct outreach to stakeholders and experts to inform its legislative process.

While the white paper did not set a formal deadline for feedback, committee staff asks that stakeholders provide comments and responses by June 14, 2024.

ADMINISTRATION

ARPA-H Announces New Cybersecurity Program. The Advanced Research Projects Agency for Health (ARPA-H) announced the launch of the Universal PatchinG and Remediation for Autonomous DEfense (UPGRADE) program. This program is a cybersecurity effort that will invest more than $50 million to create tools for information technology teams to better defend hospital environments.

The role of the UPGRADE platform is to enable proactive evaluation of potential vulnerabilities by probing models of digital hospital environments for weaknesses in software. Through the platform, once a threat is detected, a remediation would be automatically developed, tested in the model environment and deployed with minimum interruption to the devices in use in a hospital.

The agency will host a Virtual Proposers’ Day on June 20, 2024. Participants must register by 3 pm EDT on June 18, 2024, here.

QUICK HITS

• CMS Launches New Option for Individuals to Report EMTALA Violations. The Centers for Medicare & Medicaid Services (CMS) launched a new option on CMS.gov to allow individuals to more easily file an Emergency Medical Treatment and Labor Act (EMTALA) complaint. In addition to reaching out to the state survey agency where the hospital is located, patients can fill out a simple online form.
• CMS Holds Webinar on Improving Health Equity for Dually Eligible Enrollees in Rural Areas. The webinar explored the health equity challenges facing rural communities, with a particular focus on dually eligible individuals. The speakers discussed innovative, evidence-based strategies that health plans can employ to address health equity disparities.

NEXT WEEK’S DIAGNOSIS

Congress will be in recess next week and will return to session the week of June 3, 2024. Because of this, we won’t publish Check-Up next week and will return to your inbox on June 7, 2024.