Top News
The Roundtable Responds to Senate Finance Committee RFI on Policy Options to Lower Drug Prices
On June 16, 2026, the Senate Finance Committee minority staff announced a Request for Information (RFI) titled “Commonsense Policy Options to Lower Drug Prices.” The RFI comes after Ranking Member Wyden (D-OR), along with Senators Cortez Masto (D-NV), Welch (D-VT), and Gallego (D-AZ), released a Dear Colleague letter to the Senate Democratic caucus on February 3, 2026. That letter outlined a three-pronged plan to build on the Inflation Reduction Act and further lower prescription drug prices. Several other Democratic senators, including Kelly (D-AZ), Baldwin (D-WI), Hassan (D-NH), Merkley (D-OR), Van Hollen (D-MD), Duckworth (D-IL), and Blumenthal (D-CT), have since joined the effort.
Following the release of the Dear Colleague letter, Finance Committee minority staff held listening sessions with more than 70 external organizations, including the Roundtable. The RFI builds on those conversations, seeking detailed feedback on policy options to lower manufacturer drug prices, reduce patient out-of-pocket costs, and support continued biopharmaceutical innovation.
The Roundtable submitted a formal response, which can be found here.
The Senate Finance Committee minority staff has also released a second RFI, titled “Health Coverage That Works For Everyone,” with responses due October 2. The Roundtable is currently evaluating whether to submit a response.
QPA Methodology Struck Down in IDR Process
The Fifth Circuit Court of Appeals sided with a group of providers by striking down the established methodology for calculating the qualifying payment amount (QPA) in the independent dispute resolution (IDR) process as part of the No Surprises Act (NSA). The QPA is a key benchmark used in initial negotiations, during which payers propose a payment amount that represents a median of in-network rates for a service. The court found that payers should not be allowed to include “ghost rates”, rates set for services they don’t actually provide, in the QPA calculation, since these rates tend to be artificially low (often $0 or $1) because insurers have no real incentive to negotiate them. While regulators had already agreed to exclude $0 ghost rates, the court said low but nonzero rates (like $1) also should not count. Additionally, the court ruled that payers cannot exclude bonus or incentive payments from QPA calculations, though it did agree that one-off contractual agreements can still be excluded.
The case was brought by the Texas Medical Association along with a hospital and a physician, after a federal district court initially sided with the providers and the government appealed. Federal officials had warned that striking down the methodology could leave patients facing surprise out-of-network bills in the interim, but the appellate judges noted that agencies have already been using enforcement discretion during the appeal and can continue doing so to avoid disruption.
Administrative Action
President Trump Issues Executive Order Updating Childhood Vaccine Schedule
On August 10th, President Trump issued an Executive Order “Delivering Gold Standard Childhood Vaccine Recommendations for Americans”, updating the recognized “Gold Standard Childhood Vaccine Recommendations” to reclassify hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza, and COVID-19 vaccinations as optional for children and adolescents based on shared clinical decision-making. Additionally, the executive order recommends that the measles, mumps, rubella (MMR) vaccine should be administered in three, separate single-disease shots rather than the widely utilized single administration route combining all three immunizations. Further, President Trump ordered recently confirmed Attorney General Todd Blanche to take appropriate measures to “…challenge State laws… related to parental authority, religious freedom, disability accommodations, and equal protection under the law… to provide religious and medical exemptions from childhood and adolescent immunization requirements.”
On December 5, 2025, President Trump issued a Presidential Memoranda Aligning U.S. Core Childhood Vaccine Recommendations with Best Practices from Peer, Developed Countries. Consequently, the Department of Health and Human Services (HHS) completed a scientific assessment that found that the U.S. recommends more childhood vaccines than peer nations. Subsequently, President Trump issued an Executive Order Realigning U.S. Core Childhood Vaccine Recommendations with Best Practices from Peer, Developed Countries which aimed to actualize HHS’s vaccine recommendations. However, the administration’s vaccine efforts have been delayed due to litigation over the composition of the Advisory Committee on Immunization Practices (ACIP). This most recent executive order reaffirms the administration’s position on childhood vaccines and expresses the administration’s support for parental choice over childhood vaccines congruent with “… the fundamental principles of personal autonomy and informed consent.”
ONDCP, HHS, and HUD Unveil “Treatment-First” Addiction Toolkit
The White House Office of National Drug Control Policy (ONDCP), the Department of Health and Human Services (HHS), and the Department of Housing and Urban Development (HUD) unveiled a “treatment-first” toolkit for homelessness and addiction, as part of the Great American Recovery initiative. This approach is a marked shift from the previous administration’s “housing-first” and harm-reduction approaches, which included syringe programs, overdose prevention sites, and fentanyl testing. The new framework ties housing to sobriety through a phased approach, emphasizes individual accountability and measurable outcomes, and frames relapse as an expected part of recovery rather than a dead end. It also calls for structured daily routines (e.g., wake times, job training, chores, treatment) and substance-free housing, with relapses triggering a return to a more intensive level of care rather than expulsion from the program.
The toolkit repeatedly highlights faith-based organizations as a key part of this model, citing survey data on Americans’ religious belief and arguing that spirituality strengthens recovery outcomes, even though many faith-based groups currently can’t access federal or state funding without changing their hiring, counseling, and curriculum practices. The toolkit also urges all recovery organizations, faith-based or not, to diversify funding beyond Medicaid, Health Resources and Services Administration (HRSA), and Substance Abuse and Mental Health Administration (SAMHSA) grants. In addition to these traditional funding streams, the toolkit points to philanthropy, work-therapy models, and in-house revenue sources like thrift stores as ways to reduce dependence on any single funding stream.
HHS Seeks Nominations for National Vaccine Advisory Committee Following New Executive Order
HHS is seeking nominations for the National Vaccine Advisory Committee (NVAC), with a Federal Register notice set to publish August 12, 2026, and nominations due within 30 days of publication. The solicitation follows a presidential executive order issued earlier last week directing changes to the federal childhood vaccine schedule.
NVAC is statutorily authorized for 17 members; the committee’s website currently lists eight members whose four-year terms have expired, allowing HHS to appoint an entirely new membership. NVAC advises HHS on vaccine research priorities, vaccine supply stability, and activities under the National Vaccine Program. The Advisory Committee on Immunization Practices (ACIP), which typically issues the Center for Disease Control and Prevention vaccine schedule recommendations, remains barred from meeting or making changes under existing court orders.
In July, HHS revised NVAC’s charter to direct the committee to consider “non-immunization strategies” for promoting health, including lifestyle initiatives, off-label uses of FDA-approved drugs, and dietary supplements. Recent ACIP membership changes, which added liaison organizations including the Association of American Physicians and Surgeons, Independent Medical Alliance, Medical Academy of Pediatrics and Special Needs, and Physicians for Informed Consent, could serve as a model for anticipated NVAC appointments.
CMS Outlines RAPID Coverage Pathway for New Devices in Medicare
On Friday, August 7, the Centers for Medicare and Medicaid Services (CMS) issued a proposed procedural notice outlining the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a mechanism for manufacturers to get new devices covered by Medicare faster. On April 23, 2026, CMS and the Food and Drug Administration (FDA) announced the RAPID pathway to accelerate beneficiaries’ access to eligible Class II FDA-designated Breakthrough Devices participating in FDA’s Toal Product Life Cycle Advisory Program (TAP) and eligible Class III FDA-designated Breakthrough Devices. The RAPID coverage pathway will allow CMS experts to engage with manufacturers early in the device manufacturing process to understand the clinical outcomes most relevant to the Medicare-eligible population. The coverage pathway would also ensure alignment between Medicare national coverage determinations (NCDs) and FDA market authorization, meaning national coverage could begin as soon as 60 days after FDA market authorization. The proposed procedural notice was posted on the Federal Register August 11 and comments are due on October 10.
HHS Announces $4 Million Initiative to Expand Rapid Syphilis Testing for Pregnant Women
On August 11, HHS unveiled a $4 million effort to bring rapid, on-site syphilis screening to more women. The initiative focuses on women seen in emergency rooms and other settings outside routine prenatal care. It responds to a steady climb in newborn syphilis infections over more than a decade. Case counts approached 4,000 in 2024, up roughly 700% from ten years prior. In 2023, 279 infant deaths or stillbirths were linked to the disease. Federal health officials estimate 83% of those cases were preventable with timely testing and treatment. The funding will move through CDC’s Division of STD Prevention, with roughly $3.25 million being distributed to health departments in areas hit hardest by the problem. It will run August 2026 through February 2027, with remaining funds supporting national technical assistance partners.
The announcement comes after CDC’s Division of STD Prevention underwent significant staffing reductions in 2025, including cuts to its laboratory and Disease Intervention and Response Branch, alongside broader reductions affecting most of the agency’s HIV program staff. Separately, in February, the administration cut CDC grants in California, Colorado, Illinois, and Minnesota, including $600 million in HIV and STI funding. These states believe the cuts were tied to their immigration policies. The matter remains in ongoing litigation.
Health Centers Receive an Increase in Funding
The U.S. Department of Health and Human Services (HHS), alongside the Health Resources and Services Administration (HRSA), announced on August 13 a $102 million investment in expanding the Health Center Program. The funding increases New Access Points awards and will support 158 new and existing health centers in establishing 415 new sites, extending comprehensive primary care to nearly 1 million more Americans. HHS Secretary Robert F. Kennedy Jr. and HRSA Administrator Tom Engels frame the investment as part of a broader push to strengthen preventive care, nutrition services, and access to mental health and substance use disorder treatment.
The announcement also noted HRSA’s parallel effort to help health centers source American-made medical supplies as part of the administration’s “America First” agenda. HRSA-funded health centers currently serve more than 32 million people at over 16,000 sites nationwide, including 1 in 8 children, 1 in 5 rural residents, and 1 in 15 older adults over the age of 65.
HHS Announces GRAS Notification Rule and Federal Definition of Ultra-Processed Foods
Health and Human Services (HHS) announced two food policy actions on August 11 as part of the administration’s Make America Healthy Again (MAHA) agenda. The Food and Drug Administration (FDA) proposed a rule requiring food and animal feed manufacturers to notify the agency when they determine a substance is Generally Recognized as Safe (GRAS), and HHS and US Department of Agriculture jointly submitted for final review the federal government’s first proposed definition of ultra-processed foods (UPFs).
Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to independently determine that a substance is safe under its intended use without notifying FDA. While FDA has operated voluntary notification programs, this proposal would make notification mandatory and expand the public inventory of submitted notices. For substances already on the market based on manufacturers’ own GRAS determinations, the rule would create a time-limited streamlined submission pathway allowing companies to report existing uses to FDA, intended to help the agency prioritize post-market safety reviews.
HHS stated that high UPF consumption is associated with chronic diseases including type 2 diabetes and heart disease and stated that the lack of a standardized federal definition has limited consistency in research to date. The proposed definition incorporates input from industry, consumer organizations, researchers, and the public. Secretary Kennedy cited a statistic that nearly 60% of the American diet consists of ultra-processed foods and that childhood obesity affects more than one in five American children.
Congressional Action
CBO Explains Inflation Reduction Act Projected Costs
On July 29, the Congressional Budget Office (CBO) responded to the Republican leadership’s request to explain CBO’s upward revision of Medicare Part D spending. On May 20, 2026, Committee on Budget Chairman Jodey C. Arrington (R-TX-19), Committee on Ways and Means Chairman Jason Smith (R-MO-08), and Committee on Energy and Commerce Chairman Brett Guthrie (R-KY-02) sent a letter to the CBO requesting clarification as to why the baseline budget technical revisions included a projected $700 billion increase in Medicare Part D outlays as compared to the initial scoring of the Inflation Reduction Act.
In the response, CBO stated that the increased projections are attributed to a combination of factors: smaller-than-expected Part D negotiation and rebate savings, faster-than-expected inflation raising rebate benchmarks, higher-than-expected costs from the Part D redesign, and higher-than-expected beneficiary utilization of prescription drugs. CBO also recognized structural market shifts, including the significant decline in standalone Part D plans and growth of Medicare Advantage prescription drug coverage. Total Part D outlays are currently projected at $2.1 trillion from 2026 through 2035, $1.5 trillion higher than projected last year.
Senators Issue Letter to CMS to Rescind LTC Voting Guidance
A group of 13 Democratic Senators, led by Senators Elizabeth Warren (D-MA) and Alex Padilla (D-CA), sent a letter on Wednesday to Centers for Medicare and Medicaid Services (CMS) Administrator Dr. Mehmet Oz raising concerns about new agency long-term care voting guidance and its potential to disenfranchise the nation’s 1.2 million nursing home residents. Existing memos released in October 2020 (under the first Trump administration) and September 2024 (under the Biden administration) had instructed nursing home staff to actively support residents’ voting rights, including specific instructions for assisting with absentee and mail-in ballots and transporting residents to polling places. However, in a CMS memo released in a July of this year, the agency removes earlier instructions on facilitating mail-in voting and instead warns nursing home staff about “undue influence” and cites two past voter fraud investigations, despite no fraudulent votes actually having been cast in either case.
The senators argue this shift could intimidate nursing home staff, many of whom are immigrants already facing scrutiny under the administration’s immigration policies, into avoiding assistance with the voting process altogether, effectively disenfranchising residents who depend on that help. They are calling on CMS to immediately rescind the July 2026 memo and reinstate the 2020 and 2024 guidance.
Industry News
KFF Reports: Hospital Mergers Drive Up Healthcare Costs
In a recently released article, KFF reports on how hospital mergers drive up healthcare prices, following a North Carolina woman’s experience with a knee surgery quote. The piece traces how a hospital’s history of consolidation led to sharply higher charges for the same procedures compared to nearby competitors, reflecting a broader national trend. Hospital systems announced 46 mergers and acquisitions last year alone, five of them “mega-mergers” valued at over $1 billion, including deals that merged 28 hospitals across Connecticut and New York and created a 56-hospital system spanning several Midwestern states. Federal oversight in this space has historically been limited: the FTC intervened in only about 1% of cases between 2002 and 2020, and last summer, President Trump revoked a 2021 Biden executive order that had directed federal agencies to more aggressively challenge mergers seen as harmful to consumers. Several states have since passed their own laws giving regulators more power to block or scrutinize hospital mergers, but none of this has slowed the overall consolidation trend.
Save the Date: 2026 Annual Conference
HealthCare Roundtable 22nd Annual Conference
November 4-6, 2026
The Mayflower Hotel
Washington, D.C.
