THIS WEEK’S DOSE

• Congress Begins Disaster Relief Efforts, Continues Organizing for 119th Congress. The first agenda items being tackled in the lame duck include developing an emergency supplemental disaster relief bill and electing House and Senate leadership.
• Senate Judiciary Committee Advances Patent Legislation. The PREVAIL Act, which would regulate patent reviews and challenges, passed by a vote of 11 – 10.
• Senate Bipartisan Cybersecurity Working Group Releases Legislation. The legislation aims to strengthen cybersecurity in the healthcare sector and improve cyberattack prevention and response.
• Trump Transition Continues. President-elect Donald Trump continued to make nominations for key Administration positions, including nominating Mehmet Oz, MD, to lead the Centers for Medicare & Medicaid Services.
• DEA Extends Flexibilities for Telemedicine Prescription of Certain Controlled Substances. The flexibilities are now scheduled to expire on December 31, 2025, while the US Drug Enforcement Administration (DEA) works on a more permanent framework.

CONGRESS

Congress Begins Disaster Relief Efforts, Continues Organizing for 119th Congress. In the aftermath of Hurricanes Helene and Milton, lawmakers are focused on funding an emergency supplemental disaster relief package. President Biden requested $98 billion for disaster relief efforts at agencies such as the Small Business Administration (SBA), the Federal Emergency Management Agency, and the US Department of Health and Human Services (HHS). A Senate vote to provide the SBA with $550 million was blocked by Sen. Rand Paul (R-KY) last week. The Senate Appropriations Committee held a hearing on disaster funding needs with Sen. Ossoff (D-GA), Sen. Tillis (R-NC), and leaders from federal agencies as witnesses.

House Democrats held their leadership elections and unanimously re-elected Hakeem Jeffries (D-NY) as minority leader. Senate Democrats have not yet announced a date for their leadership elections. Last week, Republicans elected Sen. Thune (R-ND) to be the new Senate majority leader, and Speaker Mike Johnson (R-LA) will officially face a full House vote next year to remain speaker.

While lawmakers’ focus has been on disaster relief and organizing the past two weeks, no progress has been made on a healthcare package. Key issues, such as extending the telehealth flexibilities, likely will be under consideration before the end of the year.

Senate Judiciary Committee Advances Patent Legislation. The markup included S. 2220, the PREVAIL Act, which would limit the ability of individuals and groups to request review of patents, require a higher evidentiary standard to overturn patents, and require patent challenges to occur only through the Patent Trial and Appeal Board or through the courts, rather than both. The legislation passed by a vote of 11 – 10. Sens. Whitehouse (D-RI), Padilla (D-CA), and Ossoff (D-GA) split from their party to vote no; Sens. Graham (R-SC), Tillis (R-NC), and Blackburn (R-TN) split from their party to vote yes.

Votes on this bill had been cancelled multiple times as legislators debated the policy. Previous iterations of the markup included an additional patent bill, S. 2140, the PERA Act, which was not voted on in this markup. The PERA Act would amend laws related to patent subject matter eligibility to establish that only specified subject matter is ineligible for patenting.

Senate Bipartisan Cybersecurity Working Group Releases Legislation. The working group was formed in 2023 and includes Senators Cassidy (R-LA), Warner (D-VA), Cornyn (R-TX), and Hassan (D-NH). The Health Care Cybersecurity and Resiliency Act of 2024 would provide grants to health entities to improve cyberattack prevention and response, require HHS to provide rural health clinics with best practices, improve coordination between HHS and the Cybersecurity and Infrastructure Security Agency, and require HHS to develop and implement a cybersecurity incident response plan. The working group aims to continue work on this legislation in the 119th Congress. Read more in the press release, which includes links to the bill text and a section-by-section summary.

ADMINISTRATION

Trump Transition Continues. President-Elect Trump nominated Mehmet Oz, MD, to be administrator of the Centers for Medicare & Medicaid Services (CMS). Oz previously ran for a Senate seat in Pennsylvania and lost to Sen. John Fetterman (D-PA). He served on the Council on Sports, Fitness, and Nutrition during the first Trump Administration. Trump also nominated entrepreneur and former SBA Administrator Linda McMahon to be secretary of education, and he nominated former Rep. Sean Duffy (R-WI), now a Fox News host, to be secretary of transportation. On November 21, 2024, former Rep. Matt Gaetz (R-FL) withdrew from consideration for attorney general. Trump then quickly nominated former Florida attorney general Pam Bondi to replace Gaetz. Of relevance to those of us focused on health policy, as Florida attorney general, Bondi joined the lawsuit, California v. Texas, that unsuccessfully tried to overturn the Affordable Care Act.

DEA Extends Flexibilities for Telemedicine Prescription of Certain Controlled Substances. This is the third time the DEA has extended flexibilities that allow providers to prescribe certain controlled substances through telemedicine without first requiring an in-person visit. The flexibilities began during the COVID-19 pandemic and were set to expire at the end of 2024, but they now extend through 2025. Further action is necessary for a longer-term solution. Read more in our Virtual Care Policy Update.

QUICK HITS

• CMS Issues Guidance on Medicaid Substance Use Disorder Coverage, MLR Policies. The guidance addresses policies passed in the Consolidated Appropriations Act, 2024, including permanent required coverage of medications for opioid use disorder and a permanent state plan option to cover individuals with a substance use disorder who reside in an institution for mental disease. The guidance also addresses a newly permanent medical loss ratio (MLR) remittance policy.
• GAO Releases Report on Private Health Insurer Market Concentration. The US Government Accountability Office (GAO) report found that market concentration in the individual, small-group, and large-group markets became more concentrated or remained concentrated from 2011 to 2022. The GAO did not make any recommendations.
• CMS Issues Guidance on Medicaid Eligibility and Enrollment Strategies. The guidance outlines which unwinding-related eligibility and enrollment strategies states can continue to use, which strategies will be required due to regulatory changes, and which flexibilities will expire a fter June 2025.
• AHRQ Holds National Advisory Council Meeting. The Agency for Healthcare Research and Quality (AHRQ) meeting agenda included updates on the AHRQ’s Patient-Centered Outcomes Research Trust Fund Extension Program, the Consumer Assessment of Healthcare Providers and Systems Vision and Strategy, and the National Action Alliance for Patient and Workforce Safety.
• CMS Releases Comprehensive Medicaid Integrity Plan. The plan is issued every five years and presents initiatives to combat fraud, waste, and abuse in Medicaid and the Children’s Health Insurance Program. Strategies include managed care oversight, data sharing and collaboration, and education and technical assistance on program integrity.
• CMS Hosts Two Rural Health Webinars. The CMS Office of Minority Health’s webinar highlighted the accomplishments of Augusta Health, winner of the 2024 CMS Health Equity Award, and how it is serving its rural communities. The Center for Medicare and Medicaid Innovation hosted a person-centered listening session on how to improve care experience, outcomes, and equity in rural communities.
• HRSA Launches Campaign for Maternal Mental Health Hotline. The Health Resources and Services Administration (HRSA) began a campaign to raise public awareness of the hotline. HRSA will work with organizations such as pharmacies, grocery stores, and hospitals to promote the hotline.
• CMS Holds Leadership National Call. Agency leaders highlighted accomplishments from the Biden Administration, including improvements in the Medicare Shared Savings Program, improved access to behavioral healthcare, reform of prior authorization practices, Medicaid coverage expansions, and minimum staffing standards for long-term care facilities.

NEXT WEEK’S DIAGNOSIS

Congress will be in recess next week for the Thanksgiving holiday. Lawmakers are set to return the week of December 2 with a packed agenda for the three remaining weeks of the 118th Congress. Legislators must fund the government (including a package of health extenders) before the current December 20 deadline, pass the National Defense Authorization Act (NDAA), and pass emergency supplemental disaster relief funding. Speaker Johnson (R-LA) has indicated that Congress likely will pass a short-term continuing resolution to punt the fiscal year 2025 funding debate to early next year, when Republicans will have full control of Congress and the presidency. Depending on the progress of work on various pieces, disaster relief funding and the NDAA could pass as standalone packages, or they could be combined into a final end-of-the-year package that also would be expected to include healthcare extenders.

With Congress out next week, the Check-Up will return on December 6. We wish you a Happy Thanksgiving.