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:
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:
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:
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.
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.
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.
For more information, contact Debra Curtis, Kristen O’Brien, Julia Grabo, Priya Rathakrishnan or Erica Stocker.
To subscribe to the McDermottPlus Check-Up, please CLICK HERE.
