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Congressional:
Senate Democrats Hold Leadership Elections for 119th Congress
On Tuesday, the Senate Democrats held leadership elections for the upcoming 119th Congress. The results of the election are below:
• Senate Democratic Leader and Chair of the Conference: Senator Chuck Schumer
• Democratic Whip: Senator Dick Durbin
• Chair of Steering and Policy Committee: Senator Amy Klobuchar
• Chair of Strategic Communications Committee: Senator Cory Booker
• Vice Chair of the Conference: Senator Elizabeth Warren
• Vice Chair of the Conference: Senator Mark Warner
• Chair of Outreach: Senator Bernie Sanders
• Senate Democratic Conference Secretary: Senator Tammy Baldwin
• Vice Chair of Outreach: Senator Catherine Cortez Masto
• Deputy Democratic Conference Secretary: Senator Brian Schatz
• Deputy Democratic Conference Secretary: Senator Chris Murphy
Senate HELP Committee Holds Hearing on FDA and Food and Beverage Industry
On Thursday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing to address the Food and Drug Administration’s (FDA) role in curbing the nation’s obesity and diabetes epidemics and what Chair Bernie Sanders (I-VT) described as the “greed of the food and beverage industry.” Witnesses included FDA Commissioner Robert Califf and Jim Jones, Deputy Commissioner of the Human Foods Program. During the hearing, Ranking Member Bill Cassidy (R-LA) stated, “The incoming Trump administration is indicating that combating obesity, promoting healthy foods is a top priority,” adding, “This is something I’ll examine as chair of the health committee in collaboration with the Trump administration.” Read the witness testimonies here.
House Select Subcommittee on the Coronavirus Pandemic Releases Two Final Reports on COVID-19 Pandemic
On Monday, the Select Subcommittee on the Coronavirus Pandemic Chair Brad Wenstrup (R-OH) released a final report titled “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward.” The report documents the panel's work investigating COVID-19's origins, government funding of gain-of-function research, scientific messaging, and the costs and benefits of different public health measures. The report also discussed the National Institutes of Health (NIH) and its connections to funding controversial research, notably its work with EcoHealth Alliance. In a statement on the report, Wenstrup stated, “The Covid-19 pandemic highlighted a distrust in leadership.” “Trust is earned. Accountability, transparency, honesty, and integrity will regain this trust.” Read the press release here and the report here.
On Tuesday, the Select Subcommittee on the Coronavirus Pandemic Democrats, led by ranking member Raul Ruiz (D-CA), released a separate report. The report cited that Republican’s dislike for the former NIH Director, Anthony Fauci, clouded their judgment on the pandemic's origins and the government’s handling of it. This report stated that COVID’s origins are still unknown and would never be known without more transparency from China. Read the press release here and the report here.
On Wednesday, the panel met and approved the report by voice vote. The report is entered into the Congressional Record to inform policies for future public health threats but contains no binding policies.
CBO Releases Report on Effects of Not Extending Expanded Premium Tax Credits
On Thursday, the Congressional Budget Office (CBO) released a report citing that the number of Americans without health insurance will rise by 2.2 million in 2026 if Congress does not extend enhanced premium subsidies provided in the American Rescue Plan Act of 2021 that are set to expire at the end of 2025. The CBO said that number will rise to 3.7 million in 2027 and by 3.8 million, on average, in each year over the 2026-2034 period. In addition, without a permanent extension, CBO projects that gross benchmark premiums would rise by 4.3 percent in 2026, 7.7 percent in 2027 and 7.9 percent on average between 2026 and 2034. Read the report here.
Reps. Krishnamoorthi, Carter, Ross, Bentz Author Letter Calling on DOJ to Investigate PBMs’ Role in Opioid Crisis
On Tuesday, November 26, Reps. Raja Krishnamoorthi (D-IL), Buddy Carter (R-GA), Deborah Ross (D-NC), and Cliff Bentz (R-OR) sent a bipartisan letter to Attorney General Merrick Garland calling on the Department of Justice (DOJ) to investigate what role pharmacy benefit managers (PBMs) played in exacerbating the opioid crisis. In the letter, the members cite investigative reports from Barron’s that found PBMs increased rebates if a health care plan covered higher amounts of OxyContin, leading to an increase in opioid sales that furthered the epidemic. “Recent reports, including confidential files and information from CVS Caremark, Express Scripts, and Optum Rx, suggests the three largest PBMs colluded and conspired to steer patients towards Oxycontin in exchange for $400 million… [and] at the expense of innocent American lives.” The members wrote in the letter. “The lack of transparency surrounding PBM’s rebate agreements and formulary decisions has allowed them to operate with little to no oversight, posing a significant threat to America’s public health. That is why we strongly urge the Department of Justice to investigate the role PBMs may have played in the opioid crisis and hold them accountable.” Read the letter here.
Notable Bills Introduced:
Reps. Garbarino, Suozzi, Harshbarger Introduce Bill To Protect Patient Access to Essential Medications and Support Small American Manufacturers
On Thursday, Reps. Andrew Garbarino (R-NY), Tom Suozzi (D-NY), and Diana Harshbarger (R-TN) introduced bipartisan legislation to maintain access to essential medications and provide relief for small domestic manufacturers. Specifically, the legislation would amend Title XVIII of the Social Security Act to exempt from the Medicare Part D Manufacturer Discount Program any orally administered medications that (1) was approved under an NDA pursuant to the FDA’s 1997 Federal Register Notice and (2) has been granted a “narrow exception” by CMS under the Medicaid Drug Rebate Program (MDRP). Read the press release here and the bill here.
Sens. Blackburn, Kelly Introduce Bill to Increase Primary Care Access and Lower Costs for Medicaid Recipients in Rural Communities
On Thursday, Marsha Blackburn (R-TN) and Mark Kelly (D-AZ) introduced the Medicaid Primary Care Improvement Act to grant state Medicaid programs the authority to explore and implement direct primary care arrangements for Medicaid beneficiaries. The bill would clarify that state Medicaid programs have the authority to explore and implement direct primary care (DPC) arrangements for Medicaid beneficiaries. Read the press release here and the bill here.
Reps. DelBene, Bucshon, Schrier, Miller Introduce Bill to Remove Financial Barriers for Living Organ Donors
On Wednesday, Reps. Suzan DelBene (D-WA), Larry Bucshon, MD (R-IN), Kim Schrier (D-WA), and Carol Miller (R-WV) introduced legislation to provide more support to living organ donors and address the increasingly high costs of donation. The Expanding Support for Living Donors Act would reauthorize the Living Organ Donation Reimbursement Program through 2035, increase the maximum reimbursement amount to $10,000, double the income eligibility to about $100,000 a year, and make reimbursement eligibility based on the donor’s income instead of the recipient. Read the press release here and the bill here.
Rep. LaHood Introduces Bipartisan, Bicameral Legislation to Strengthen and Protect Future Health Care Workforce
On Monday, November 25, Reps. Darin LaHood (R-IL), Angie Craig (D-MN), and Michelle Fischbach (R-MN) and Sens. Amy Klobuchar (D-MN) and Thom Tillis (R-NC) introduced the Rebuild America’s Health Care Schools Act, to help support and provide relief to hospital-based nursing schools and allied health education (NAHE) programs. The bill would allow hospital-based schools to provide clinical training and support to any hospital and/or other provider entity operating within the same health system and prohibit audits on payments to nursing and allied health education programs. Read the press release here and the bill here.
Sen. Cassidy, Colleagues Introduce Legislation to Strengthen Cybersecurity in Health Care Sector as Part of Bipartisan Working Group
On Friday, November 22, Senators Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Mark Warner (D-VA), John Cornyn (R-TX), and Maggie Hassan (D-NH) introduced legislation to strengthen cybersecurity in the health care sector and protect Americans’ health data. This legislation is a product of the senators’ health care cybersecurity working group launched last year. The legislation would strengthen cybersecurity in the health care sector by providing grants and training to health entities to improve cyberattack prevention and response. The bill would also improve coordination between the Department of Health and Human Services (HHS) and Cybersecurity and Infrastructure Security Agency (CISA) to better respond to cyberattacks in the health care sector. Read the press release here and the bill here.
Reps. Spanberger, Smith, & Sens. Kaine, Cotton Lead Bipartisan, Bicameral Effort to Address Drug Shortages
On Friday, November 22, Reps. Abigail Spanberger (D-VA) and Adrian Smith (R-NE) introduced the End Drug Shortages Act, bipartisan, bicameral legislation alongside Sens. Tim Kaine (D-VA) and Tom Cotton (R-AR). The legislation would improve communication between patients, healthcare professionals, the FDA, and drug manufacturers to identify when demand for a drug surges to prevent a potential shortage. The legislation would also help minimize shortages' impact when they occur. Read the press release here and the bill here.
Sens. Manchin, Collins Introduce Bipartisan Improving Access to Emergency Medical Services Act
On Friday, November 22, Senators Joe Manchin (I-WV) and Susan Collins (R-ME) introduced the Improving Access to Emergency Medical Services (EMS) Act. The legislation would create a pilot program to allow Medicare to reimburse for treat-in-place EMS services for certain medical issues. Read the press release here and the bill here.
Rep. Van Duyne, Colleagues Introduce Bipartisan, Bicameral Legislation to Improve Access to Diagnostic Services at Home
On Friday, November 22, Reps. Beth Van Duyne (R-TX), Brad Schneider (D-IL), Mariannette Miller-Meeks (R-IA), and Lori Trahan (D-MA) introduced the Portable Ultrasound Reimbursement Equity (PURE) Act, which would provide Medicare beneficiaries with more flexibility for care through an update to Medicare reimbursement for portable diagnostic services to include ultrasound procedures. The Senate companion bill was introduced by Sens. John Cornyn (R-TX) and Maggie Hassan (D-NH). Read the press release here and the bill here.
President-Elect Trump Transition:
Trump Nominates Jay Bhattacharya for NIH
On Wednesday, November 27, President-elect Trump nominated Jay Bhattacharya, a Stanford University physician and economist, to lead the National Institutes of Health (NIH). Trump stated in his announcement, “Jay and RFK Jr. will restore the NIH to a Gold Standard of Medical Research as they examine the underlying causes of, and solutions to, America’s biggest Health challenges, including our Crisis of Chronic Illness and Disease.” The position requires confirmation by the Senate.
Trump Nominates Jim O’Neill to Serve as HHS Deputy Secretary
On Wednesday, November 27, President-elect Trump nominated Jim O’Neill as Deputy Secretary of Health and Human Services (HHS). O’Neill previously served as HHS’ principal associate deputy secretary during the George W. Bush administration and was the former acting CEO of the Thiel Foundation. Trump stated in his announcement, “He will oversee all operations and improve Management, Transparency, and Accountability to Make America Healthy Again.”
Trump Nominates Dave Weldon as CDC Director
On Friday, November 22, President-elect Donald Trump nominated Dave Weldon to be director of the Centers for Disease Control and Prevention (CDC). Weldon is a former Republican congressman from Florida who served in the House from 1995 to 2009 and was a member of the Labor and HHS Appropriations Subcommittee working on accountability issues. The position requires confirmation by the Senate.
Trump Nominates Marty Makary as FDA Commissioner
On Friday, November 22, President-elect Donald Trump nominated Dr. Marty Makary as FDA commissioner. Makary is a surgeon, author, and Johns Hopkins University professor with a master’s degree in public health. He is also chief medical adviser to Nava, a benefits brokerage, and chief medical officer at Sesame. The position requires confirmation by the Senate.
Trump Nominates Janette Nesheiwat as Surgeon General
On Friday, November 22, President-elect Donald Trump nominated Dr. Janette Nesheiwat for Surgeon General. Nesheiwat is the medical director of CityMD, a network of urgent care centers in New York and New Jersey and is a former Fox News medical contributor. “Dr. Nesheiwat is a fierce advocate and strong communicator for preventive medicine and public health,” Trump said in a statement. “She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.” The position requires confirmation by the Senate.
Executive Branch:
Biden-Harris Administration Takes Next Steps to Increase Access to Sickle Cell Disease Treatments
On Wednesday, the Biden-Harris Administration announced that two drug manufacturers, LYFGENIA™ and CASGEVY™, with Food and Drug Administration-approved gene therapies for sickle cell disease have entered into agreements with the Centers for Medicare & Medicaid Services (CMS) to participate in the Cell and Gene Therapy Access Model. The voluntary model, led by the Center for Medicare and Medicaid Innovation, will test outcomes-based agreements for cell and gene therapies and will tie payments to whether the therapy improves health outcomes for people with Medicaid who receive these drugs. Read the press release here.
Biden-Harris Administration Announces Medicare Advantage and Medicare Part D Prescription Drug Proposals that Aim to Improve Care and Access for Enrollees
On Tuesday, November 26, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule in the Medicare Advantage (MA) and Medicare Part D prescription drug programs. The Contract Year (CY) 2026 MA and Part D proposed rule aims to hold MA and Part D plans more accountable for delivering high-quality coverage. In recognition of the prevailing medical consensus that obesity is a disease, CMS is proposing to reinterpret the statute to no longer exclude anti-obesity medications for the treatment of obesity from coverage under Medicare Part D and to require Medicaid programs to cover these medications when used to treat obesity. The proposed rule would also:
- Increase oversight of how Medicare Advantage insurers calculate their medical loss ratios.
- Prohibit insurers from including administrative costs as part of their quality improvements.
- Codify several provisions in the Inflation Reduction Act (IRA), including capped out-of-pocket costs in Medicare Part D and a capped insulin cost of $35 a month.
- Improve reporting requirements for CMS’ annual health equity analysis of insurers’ use of prior authorization.
- Propose guardrails for the use of artificial intelligence in decisions about medical care.
- Require Medicare Advantage insurers to improve their provider directory information.
- Expand oversight of Medicare Advantage and Part D plan marketing.
Comments on the proposed rule are open until January 27, 2025. Read the press release here and the fact sheet here.
Biden-Harris Administration Finalizes New Model to Improve Access to Kidney Transplants
On Tuesday, November 26, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), finalized a rule establishing a new, six-year mandatory model to increase access to kidney transplants while improving quality of care. The Increasing Organ Transplant Access Model provides participating transplant hospitals with a financial incentive to perform more transplants and a disincentive to perform fewer. Based on the final performance score, a participating transplant hospital will either receive a payment from CMS, fall in a neutral zone in which it neither receives nor owes a payment, or, beginning in performance year two, owe a payment back to CMS. These performance-based payments are in addition to the traditional Medicare fee-for-service payment. CMS is selecting half of the donation service areas (DSAs) in the country and all eligible kidney transplant hospitals within those DSAs to participate in the model, for a total of 103 kidney transplant hospitals. These hospitals will represent a range of geographic locations and experience with value-based care. Read the press release here and the final rule here.
Biden-Harris Administration Releases Final Rule Expanding Access to Organs for People with HIV
On Tuesday, November 26, the Department of Health and Human Services (HHS) announced a final rule that will expand access to kidney and liver transplants for people with HIV by removing clinical research requirements for these transplants. The final rule, which further implements the HIV Organ Policy Equity (HOPE) Act, removes the clinical research and institutional review board (IRB) approval requirements for kidney and liver transplants between donors with HIV and recipients with HIV. This change is based on research demonstrating the safety and effectiveness of kidney and liver transplants between donors and recipients with HIV. Read the press release here and the final rule here.
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