Insights

On November 4, 2026, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2027 Medicare Physician Fee Schedule (PFS) Final Rule.  The CMS press release can be found here.  A fact sheet from CMS is available here.  A separate fact sheet on the Medicare Shared Savings Program (MSSP) changes can be found here.  The policies generally take effect January 1, 2027, except where a different implementation date is specified.

Conversion Factor

As part of the rule, CMS finalizes a CY27 conversion factor (CF) of $32.95 for Qualifying Alternative Payment Model (APM) Participants (QPs), a 1.83% decrease from the CY26 QP CF of $33.57.  For non-qualifying participants (non-QPs), the final CF is $32.63, reflecting a 2.31% decrease from the CY26 non-QP CF of $33.40.  These amounts are below the proposed CFs of $33.17 and $32.84, respectively.  A summary of the components of those payment updates is below.

• Under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, the statutory update for CY27 is 0.75% for QPs and 0.25% for non-QPs. These are the same bifurcated statutory updates that first took effect in CY26 and that are intended to incentivize clinician participation in Advanced APMs.
• The one-year 2.50% CF increase provided by the One Big Beautiful Bill Act (OBBBA), which CMS refers to in the rule as the Working Families Tax Cut (WFTC) legislation, applies only to CY26 and expires at the end of this year. The final CY27 CFs therefore exclude that temporary increase.
• The final CFs also include a negative 0.12% budget neutrality adjustment associated with changes to relative value units (RVUs) and other payment policies, compared with the proposed positive 0.53% adjustment. The statutory updates, expiration of the WFTC increase, and final budget neutrality adjustment produce the net CF reductions described above.

E/M Visits Furnished During Global Surgical Periods

CMS finalizes a narrower payment reduction for separately identifiable office/outpatient evaluation and management (E/M) visits furnished on the same day as procedures with a 0-day global period.  The policy applies when the services are furnished by the same practitioner or practitioners of the same specialty in the same group practice.  The highest-valued service is paid at 100% of its rate, and the other affected services are paid at 80%.  The proposal would have paid those lower-valued services at 50% and also covered procedures with 10- or 90-day global periods.  CMS excludes those longer global periods from the final policy and reduces the payment adjustment to account for overlap already addressed through existing valuation processes.

E/M Visit Complexity Add-On (G2211)

In the CY21 PFS final rule, CMS finalized separate payment for the office/outpatient E/M visit complexity add-on code, HCPCS code G2211.  Implementation was delayed by statute and took effect for CY24.  For CY27, CMS finalizes two changes to this policy.

• CMS replaces G2211 with modifier B1 (identified as MOD1 in the proposal), appended to the associated E/M base code. As proposed, the modifier increases payment for the associated E/M code by 16% rather than providing a flat dollar amount, maintaining an equal percentage increase across all E/M levels.
• CMS also finalizes modifier B2 (identified as MOD2 in the proposal) for practitioners participating in a Medicare Shared Savings Program (MSSP) Accountable Care Organization (ACO) or serving as Participant Providers in a Long-term Enhanced ACO Design (LEAD) Model ACO. As proposed, B2 increases payment for the associated E/M visit by 32% to recognize additional longitudinal care costs, including total cost of care accountability and aligned quality reporting.  Use is voluntary and available for all beneficiaries served by the practitioner, not only ACO-assigned or ACO-aligned beneficiaries.  Claims submitted with B2 are included in MSSP beneficiary assignment calculations, historical benchmark expenditures, and performance year expenditures.

Practice Expense

CMS describes a multi-year effort to transition the practice expense (PE) methodology away from reliance on American Medical Association (AMA) survey data and toward what it argues will be a more objective, routinely updated, and auditable cost data.  The agency states that the surveys underlying current PE values suffer from low response rates and significant discrepancies with alternative empirical data sources.  The CY27 rule finalizes the following changes to that methodology.

• CMS finalizes the proposed phase-out of the indirect practice cost index (IPCI), which anchors aggregate specialty-level PE RVUs to practice expense per hour (PE/HR) survey data from 2007 or earlier. The transition applies half of the measured IPCI variation in CY27 and eliminates it in CY28.
• CMS finalizes the proposed PE stabilization adjustment, capping year-over-year increases or decreases in a code’s PE RVU at 5%. The cap excludes new, revised, newly nationally priced, and revalued codes.  It applies before the separate statutory phase-in that limits total RVU reductions to 19% per year.
• As proposed, CMS will allocate indirect PE using both work RVUs and clinical labor RVUs for all services except codes with 010- and 090-day global periods. Previously, that combined allocation approach applied only to services billable with professional and technical components.
• CMS finalizes equal facility and non-facility PE RVUs for nursing facility E/M visits (CPT codes 99304 through 99310, 99315, and 99316), as proposed. CMS notes this is being done to address an unintended consequence of the site of service differential finalized in the CY26 rule, under which payment varied based solely on whether the beneficiary was in a Part A skilled nursing facility stay.a
• CMS reviews comments on the broader facility versus non-facility differential, including whether the current 50% indirect PE allocation for facility-based services should be reduced for hospital-employed physicians, potentially to 0%, and whether a modifier should identify employed physicians. The agency does not finalize a further change to that differential in response to this solicitation.

Remote Monitoring

CMS finalizes several changes to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM).  Beginning in CY27, RTM must be furnished to established patients, and both RPM and RTM require an initiating visit with the billing practitioner, which may be in person or via Medicare-covered telehealth.  Patients already receiving these services before January 1, 2027, do not need a new initiating visit solely because of the policy change.  CMS also finalizes the requirement that clinical staff furnishing these services be directly employed by the practitioner or practice, but delays implementation until January 1, 2029.  The agency finalizes lower device-related valuations while retaining the existing direct PE inputs for six treatment-management codes, instead of adopting the proposed reductions to those inputs.  CMS does not finalize the potential consolidation of the RPM and RTM code families into four HCPCS G-codes, which was a comment solicitation.

Global Surgery Data Collection

CMS finalizes the proposed pause in global surgery data collection under section 523 of MACRA.  The agency states that collected data show fewer post-operative visits than assumed in 10- and 90-day global surgical packages, while acknowledging concerns about reporting limitations and burden.  CMS has posted a public-use file displaying imputed RVUs for post-operative visits using an arithmetic approach.  The final rule discusses comments on expanded data collection, alternative data sources, and revaluation strategies.  CMS does not finalize a broader revaluation of global surgical packages through this solicitation.

Limits on Medicare Eligibility for Certain Individuals

CMS finalizes regulations implementing section 71201 of the WFTC legislation (OBBBA), which amended the Social Security Act to limit Medicare eligibility to four groups.  Those groups are U.S. citizens or nationals, lawful permanent residents, individuals granted Cuban and Haitian entrant status, and individuals lawfully residing in the U.S. under a Compact of Free Association.  The regulations incorporate the newly specified eligibility groups, establish procedures for terminating coverage for individuals found ineligible, provide applicable appeal rights, and set out enrollment options for individuals who later gain or regain eligibility.

Medicare Prescription Drug Inflation Rebate Program

The rule finalizes updates to the Part B and Part D drug inflation rebate programs established under the Inflation Reduction Act of 2022 (IRA).  CMS clarifies which Consumer Price Index for All Urban Consumers (CPI-U) data apply when relevant monthly data are unavailable, the definition of “first marketed date,” and the treatment of certain skin substitutes as Part B rebatable drugs.  As proposed, providers and suppliers that are 340B covered entities must submit specified claim-level data to the Medicare Part D Claims Data 340B Repository for covered Part D drugs dispensed with a 340B discount beginning January 1, 2027.  CMS delays the first submission deadline from June 30 to September 30, 2027.  That deadline covers claims with dates of service from January through June 2027.

Clinical Laboratory Fee Schedule (CLFS)

CMS finalizes conforming regulatory changes implementing the Consolidated Appropriations Act, 2026 (CAA, 2026) amendments to the CLFS.  The changes address data collection and reporting for clinical diagnostic laboratory tests (CDLTs) and the phase-in of payment reductions based on private payor rates.  The reporting period for CDLTs that are not advanced diagnostic laboratory tests ran from May 1 through July 31, 2026, using information collected from January 1 through June 30, 2025.  As proposed, payment reductions based on those data are capped at 15% per year in CY27 through CY29.

Ambulatory Specialty Model (ASM)

The CY26 PFS final rule established the ASM, a mandatory alternative payment model administered through the CMS Innovation Center that focuses on specialists treating Medicare beneficiaries with heart failure and low back pain.  The model runs from 2027 through 2031, with the first performance year beginning January 1, 2027, and payment adjustments applied two years after each performance year.  Participating specialists are assessed individually (at the Taxpayer Identification Number (TIN)/National Provider Identifier (NPI) level) across four performance categories, which are quality, cost, improvement activities, and Promoting Interoperability.  Performance relative to peers treating the same condition determines two-sided adjustments to Medicare Part B payments ranging from -9% to +9% in the first two payment years (2029 and 2030) and gradually increasing to 12% by the final payment year (2033).

In the CY27 rule, CMS finalizes technical refinements for the model’s launch.  These include an administrative claims-based imaging quality measure for low back pain, replacement of the low back pain patient-reported outcome measure with a functional status outcome process measure, revised quality benchmarking and scoring, and a scoring incentive for voluntary patient-reported outcome data.  The rule adds a five-point rural scoring adjustment and aligns Promoting Interoperability requirements with the final MIPS changes.  CMS also finalizes exceptions for participants affected by TIN changes or specialty redesignations, authority to terminate participants under specified circumstances, an option to submit improvement activities data at the individual or group level, and revised collaborative care arrangement requirements.

Quality Payment Program (QPP)

The final rule includes significant changes to the QPP.  CMS sunsets traditional Merit-based Incentive Payment System (MIPS) reporting beginning with the CY31 performance period (2033 payment year), two years later than proposed.  At that point, MIPS Value Pathways (MVPs) become the only MIPS reporting option for clinicians not reporting through the APM Performance Pathway.  Additional final QPP policies include:

• Adding the three proposed MVPs focused on diabetic disease, hypertension, and hospitalist care, bringing the inventory to 30 pathways.
• Establishing the proposed CY27 quality measure inventory of 180 measures, reflecting 20 removals, 10 additions, and 43 substantive changes. CMS creates the “MIPS core measure” designation and replaces the outcome or high priority measure requirement with a requirement to report at least one core measure.  Small practices are exempt.  Other clinicians without an applicable core measure must attest to that fact and report another measure.
• Updating the improvement activities inventory as proposed by adding six activities, modifying five, and removing eleven. The additions include activities in the new Advancing Health and Wellness subcategory.
• Revising Promoting Interoperability as proposed, including removing the Security Risk Analysis measure and making the Electronic Prior Authorization measure optional for CY27, with 10 bonus points. That measure becomes required in CY28 alongside a new required Electronic Prior Authorization for Prescription Drugs measure.
• Applying QP status at the TIN/NPI level and modifying QP thresholds under the CAA, 2026. CMS adds a modification for clinicians whose QP or Partial QP status is determined individually: Partial QP status applies across their TIN reassignments, allowing a choice of whether to participate in MIPS.

Medicare Shared Savings Program (MSSP)

The CY27 PFS final rule includes numerous updates to the MSSP, including:

• Finalizing the proposed financial changes across risk tracks, including raising the shared savings rate for Level E of the BASIC track from 50% to 60%, lowering the maximum positive regional benchmark adjustment weight for ENHANCED track ACOs from 50% to 35%, raising the prior savings adjustment scaling factor from 50% to 75%, risk adjusting the 5% cap on upward benchmark adjustments, and adding a growth adjustment for bringing clinicians and beneficiaries new to value-based care into the program.
• Adding the proposed Accountable Care Prospective Trend (ACPT) guardrail for agreement periods beginning in 2027 or later, limiting the ACPT to no more than 1 percentage point below or 1.5 percentage points above observed national expenditure growth. The lower guardrail also applies to ACOs with 2024 through 2026 start dates for performance year 2025 and subsequent years in those agreements.  CMS has delayed 2025 financial reconciliation until November 2026 to implement the change.
• Allowing ACOs, with CMS approval of an implementation plan, to reduce or eliminate Part B cost sharing beginning April 1, 2027, as proposed. Durable medical equipment, prosthetics, orthotics, supplies, and prescription drugs are excluded.  CMS is ending the prepaid shared savings payment option, with participating ACOs receiving payments through December 31, 2027, and no new cohorts after the 2027 application cycle.
• Modifying beneficiary assignment for performance year 2028 and beyond, including excluding primary care charges billed through non-ACO taxpayer identification numbers by ACO professionals used in assignment.
• Streamlining quality and certified electronic health record technology (CEHRT) requirements as proposed, including extending the MIPS Clinical Quality Measures collection type and reporting incentive, creating Medicare electronic Clinical Quality Measures (eCQMs), and reducing the APP Plus measure set to eight measures. ACOs may meet CEHRT requirements through qualifying electronic quality reporting, quality reporting using Fast Healthcare Interoperability Resourse-based data, or attestation to an approved ACO CEHRT use metric.

Requests for Information (RFIs) and Comment Solicitations

The final rule discusses responses to the proposed rule’s RFIs and comment solicitations.  These requests did not themselves establish new payment policies.  CMS sought feedback on issues including:

• How CMS might redesign primary care valuation to support a shift toward preventive medicine, covering three topics, which are reconsidering relative primary care payment under the PFS, understanding the payment implications of incorporating technology into primary care, and establishing prospective primary care payment within the MSSP and potentially Original Medicare more broadly. Commenters broadly supported better valuation of primary care and voluntary hybrid prospective payments, while specialty groups opposed financing those changes through cuts to their services.
• How to address duplicate laboratory testing and imaging resulting from siloed diagnostic results, including potential actions to improve result sharing and interoperability across care settings. Commenters generally supported reducing unnecessary testing and improving result sharing, but some opposed payment denials when repeat tests are clinically necessary or prior results are unavailable.
• Whether and how the facility versus non-facility site of service differential should be refined, including the appropriate indirect PE allocation for hospital-employed physicians. CMS noted that commenters questioned place of service as a proxy for employment and generally sought better cost data, but disagreed on how to revise the differential.
• How to improve data collection and valuation accuracy for global surgical packages, including potential revaluation strategies for future rulemaking. Commenters generally supported the reporting pause, while many opposed expanded reporting and using incomplete post-operative visit data to revalue global packages.
• Whether the RPM and RTM code families should be restructured into bundled HCPCS G-codes. CMS acknowledges receiving comments but does not summarize support or opposition to bundling, and leaves potential changes for future rulemaking.
• The anticipated timeline, milestones, and implementation considerations for transitioning to FHIR-based digital quality reporting across the QPP and other CMS quality programs. CMS reports receiving many comments without summarizing their substance and leaves the transition timeline, technical requirements, and scoring policies for future rulemaking.
• The influence of the AMA’s CPT coding system and RUC valuation process on physician payment policy, including questions about the AMA’s licensing monopoly, conflicts of interest in service valuation, and potential alternatives for data collection and payment recommendations. Most feedback focused on RUC reforms, including better data, transparency, and representation, while many commenters cautioned against replacing CPT with competing coding standards.

On October 29, 2026, the Medicaid and CHIP Payment and Access Commission (MACPAC) opened its October meeting with a session on what drives hospital costs and how those cost factors are reflected in state Medicaid hospital payment methods and rates. The Commission then turned to an update on its monitoring of state implementation of Medicaid work requirements under the One Big Beautiful Bill Act (OBBBA). The meeting included a panel featuring the Medicaid directors of Indiana and Colorado and the head of Nebraska’s health center association.

HOSPITAL COST DRIVERS

The session began with MACPAC staff outlining their planned project related to hospital cost drivers, which will also include an update of MACPAC’s Inpatient and Outpatient Hospital Payment Compendia and a round of stakeholder interviews. Staff reviewed how states pay for inpatient and outpatient hospital services, including base payment methods and supplemental payments, which account for nearly half of Medicaid payments to hospitals. They also distinguished hospital costs, meaning the resources hospitals use to deliver care, from spending, meaning what payers pay for that care. They also shared findings from a literature review that identified labor, supplies, facilities, and overhead as the primary cost drivers, along with the volume, intensity, and location of services. Staff noted that evidence on cell and gene therapies, artificial intelligence, market concentration, ownership (including private equity acquisition), and cost containment policies such as price transparency was less conclusive.

Staff will return in January with findings from the payment policy compendium and a descriptive chapter for the 2027 Report to Congress. They asked Commissioners which cost drivers, payment policies, services, and hospital types to prioritize in stakeholder interviews.

Commissioner Discussion

Several Commissioners questioned how managed care fits into an analysis that centers on fee-for- service payment. One Commissioner asked what share of Medicaid hospital payments flow through fee-for-service. Staff pointed to a 2022 MACPAC issue brief that put the figure at roughly 48%, which they will confirm, and said the share has likely shifted as managed care has expanded. The Commissioner worried that leaving managed care out would miss a large portion of payments and limit the reach of any future recommendations. Another Commissioner built on that point, suggesting that in states where nearly all enrollees are in managed care, fee-for-service rates may not track hospital costs closely, and asked staff to explore the issue in interviews. The same Commissioner asked how state-directed payments (SDPs) would factor into a fee-for-service analysis. Staff said they would follow up but expected to consider SDPs to the extent they affect overall hospital operations.

One Commissioner praised staff for separating costs from spending and asked them to keep that distinction sharp. The Commissioner requested a sense of scale for each driver, such as how much cost growth comes from labor versus supplies. The Commissioner also asked staff to distinguish spending growth from rising prices, possibly tied to consolidation, from spending growth driven by utilization.

Another Commissioner, a former Washington, DC Medicaid director, said drivers of hospital costs require significant nuance and may be better analyzed at the state level than nationally. The Commissioner recommended the National Academy for State Health Policy’s hospital cost tool, which includes data through 2024, as something that could be helpful. The Commissioner also raised several points:

• Administrative costs include management fees that hospitals send to their parent health systems and transfers to affiliated foundations, which may not be captured, so staff should be clear whether they are examining hospital or system costs.
• Understanding why hospitals close is essential before making recommendations. In some non- expansion states, Medicaid is not a large payer and uncompensated care is the bigger problem.
• SDPs have become a major share of Medicaid hospital reimbursement and cannot be left out.
• States have several levers to keep a hospital open, including direct general fund support outside of Medicaid. When DC General Hospital closed despite the city’s efforts, DC created a program covering residents below 200% of the federal poverty level, illustrating the trade-off between preserving a facility and expanding coverage.

Commissioners also raised questions about how hospitals choose their service mix and where care is

delivered:

• One Commissioner asked staff to examine how hospital service line decisions relate to community need, noting a shift toward profitable, high-acuity services such as specialized cardiac units and away from maternity and mental health care.
• Another Commissioner noted declining use of some outpatient hospital services as competitors without facility fees emerge, and price transparency grows. This Commissioner then asked what share of costs and spending facility fees represent and for which services.
• A third Commissioner asked staff to look at off-campus outpatient clinics and freestanding emergency rooms that bill as hospitals without providing hospital services, including their costs and the revenue they generate.
• Another Commissioner asked staff to study how health professional shortage areas and weak primary care infrastructure push patients toward higher-acuity hospital care. The Commissioner also urged attention to small rural hospitals that are not critical access hospitals, as margins are just under 1%.

One Commissioner asked staff to consider how state regulations affect rural hospitals. As an example, this Commissioner pointed to staffing rules in California requiring a labor and delivery unit to keep specialists such as an anesthesiologist available around the clock. The Commissioner noted that these rules were even in effect at a rural hospital that handles only a few deliveries a month, until they were later loosened for rural hospitals in hopes of keeping their units open. The Commissioner also asked whether last-resort programs such as California’s distressed hospital loan program, run by the Department of Health Care Access and Information (HCAI), actually keep hospitals open or only delay closure. The Commissioner urged MACPAC to track what happens to rural hospitals as compliance dates under the new rules limiting SDPs arrive.

The Chair focused on market concentration and ownership. She asked how to interpret findings that private equity acquisitions lower operating costs while also reducing staffing and Medicaid discharges, and what evidence would separate genuine efficiency from reduced services or access for Medicaid patients. She also asked whether those effects differ for rural and safety net hospitals. The Vice Chair closed the discussion recommending that staff examine emergency department and inpatient boarding of both adults and children who remain in the hospital because outpatient services are unavailable, which adds costs for hospitals and payers. On AI, he suggested the lack of measurable savings from scribe tools may reflect physicians completing documentation during off hours, so the benefit shows up in quality of life rather than in hospital costs. He urged close attention to rural, safety-net, and children’s hospitals, noting that safety-net and children’s hospitals often have Medicaid shares of 50% to 75% or more and that Medicare benchmarks do not work well for them. He added that his state has seen private equity-owned hospitals fail after owners declined to invest in infrastructure and staffing.

MEDICAID WORK REQUIREMENTS: MONITORING STATE IMPLEMENTATION

MACPAC staff opened the session by announcing that the Commission will now use the term work requirements instead of community engagement, consistent with CMS’s messaging recommendations and federal and state outreach campaigns. Staff then presented findings from MACPAC’s monitoring of state readiness, medical frailty, beneficiary outreach, and federal and state reporting. Stakeholders said many states will keep updating their IT systems well into 2027 while implementing several other eligibility changes at once. Most states will rely on self-attestation in 2027 for activities and exclusions they cannot verify ex parte (without clarification from the individual) including medical frailty. Staff noted that CMS has not yet released a template for good faith exemption requests, and that five governors wrote to HHS on October 1, 2026, asking for a delay to the January 1, 2027, start date.

Staff also shared early data from Nebraska, which implemented work requirements on May 1, 2026. Call volume and average wait times rose between January and August, and most denied applications and renewals resulted from non-response rather than noncompliance. Staff closed with updates on two pending lawsuits challenging the interim final rule (IFR), including its medical frailty provisions, sharing that a hearing for a summary motion took place for one and no movement occurred for the other. Staff noted they will return in December with further monitoring updates.

Commissioner Discussion

Commissioners focused heavily on the Nebraska data. One Commissioner confirmed that non- response accounted for 83.7% of denied applications and 91.9% of denied renewals and asked how that compares with non-response in regular renewals. Staff said Nebraska’s data covered only the expansion population, so no comparison is possible yet. When asked how to distinguish people who do not meet the requirements from those who simply could not navigate the process, staff said stakeholders attributed much of the non-response to confusion, with many beneficiaries unaware they were subject to the requirements or assuming they would not qualify for Medicaid with the work requirements. Two Commissioners raised concerns about call center performance. One called an average wait of 24 minutes appalling and said Medicaid enrollees deserve better service. Another said the bigger concern was the gap between the state’s averages and the three-hour waits beneficiaries are reporting. She suggested MACPAC conduct secret shopper calls across states after the January rollout, push for clearer descriptions of how states calculate wait times, and encourage states to post live dashboards showing the best times to call.

Commissioners raised several other questions:

• One Commissioner asked how states will handle exceptions for counties with high unemployment, given that Bureau of Labor Statistics data are backward-looking. Staff said some states have begun requesting short-term hardship exceptions and will continue to monitor.
• Another Commissioner asked whether states are adjusting provider rates, particularly for rural hospitals, or managed care capitation rates to reflect changes in the enrolled population. Staff said they have not seen this publicly or in interviews but will look into it.
• The same Commissioner asked whether states are adopting newer, more consumer-friendly eligibility tools. Staff said CMS has focused mainly on adding data sources to the Federal Data Services Hub and that it is unclear how much CMS is helping states work with these vendors.
• One Commissioner cautioned against drawing firm conclusions from Nebraska’s small sample and asked how many states are hiring eligibility staff or assisters. Staff pointed to a KFF survey from March 2026, conducted before the IFR, and said that states adding capacity still face recruitment challenges and steep training demands.

Panel on Medicaid Work Requirements: State Implementation

The meeting included a panel featuring Audrey Frenzel, Medicaid Director and Director of the Office of Medicaid Policy and Planning at the Indiana Family and Social Services Administration; Adela Flores-Brennan, Medicaid Director for the Colorado Department of Health Care Policy and Financing; and Amy Behnke, Chief Executive Officer of the Health Center Association of Nebraska, which represents the state’s seven federally qualified health centers (FQHCs).

Ms. Frenzel explained that Indiana is implementing a state law that is more stringent than the OBBBA. Indiana will run quarterly compliance checks requiring enrollees to show compliance in each month of the quarter, conduct redeterminations every six months, and will not accept self-attestation. The state announced its medical frailty framework, which uses MARA, a structured claims-based tool developed by Milliman that replaces a tool the state has used since 2024. The tool looks at diagnosis codes, place of service, durable medical equipment, and the frequency of medication and treatment. Indiana has published roughly 4,200 Tier 1 diagnosis codes and will run the tool on all current members and notify them of the result before January 1, 2027. When the tool cannot confirm frailty, providers may submit clinical documentation under penalty of perjury.

Ms. Flores-Brennan said Colorado began systems integration and user acceptance testing and recently held a webinar for about 4,000 stakeholders. She named time, budget, and competing priorities as the state’s biggest challenges, along with preparing frontline workers while the system is still being tested. Ms. Behnke said Nebraska’s health centers engaged early with the state Department of Health and Human Services and still meet monthly. She credited the state for choosing the least restrictive options, such as requiring proof of compliance for only one month of the look-back period, and for being transparent that processes will evolve. She said implementing before the IFR created uncertainty, the decision not to hire more caseworkers has lengthened call wait times and application processing, and outreach groups have received only one round of state data as of the panel’s convening, released in mid-September.

Commissioners asked several questions about medical frailty determinations. One Commissioner asked how Indiana’s claims-based approach accounts for conditions such as major depressive disorder or PTSD, where barriers to care and the symptoms themselves may mean little claims history. Ms. Frenzel said Indiana runs Tier 1 (diagnosis codes) and Tier 2 (utilization, such as recent inpatient or outpatient treatment) at the same time, so a diagnosis alone does not establish frailty. She said an early run using the five federal domains without further rules would have deemed nearly the entire expansion population frail. She then noted that this example highlights the need to balance sensitivity and specificity. She expects to rely more on provider documentation for new enrollees with no claims history. Ms. Flores-Brennan said Colorado will accept self-attestation as a safety net and has adopted the Harvard methodology. She described people in her own life who had to quit their jobs because of their health but could not get a diagnosis for six months, and said Colorado plans an RFP for a vendor that could pull electronic health record data, since verification after 2028 remains an open question. When asked how many enrollees could be found frail ex parte, Ms. Flores-Brennan said the Harvard tool identified about 160,000 (plus or minus 5,000) of Colorado’s 377,000 modified adjusted gross income (MAGI) adults as medically frail, roughly 40%, out of 1.2 million total Medicaid enrollees. Ms. Behnke said Nebraska uses a roughly 300-page code document and a 12-month claims look-back for existing enrollees, with self-attestation for everyone else until 2028.

On new eligibility technology, both state Medicaid directors said limited time and system complexity have kept them from adopting new tools. Ms. Flores-Brennan said Colorado receives multiple vendor pitches a day but faces state procurement guidelines and plans to reprocure its eligibility system in the next few years. Colorado will not have short-term hardship exceptions in place at go-live because it ran out of time and capacity. Ms. Flores-Brennan added that Colorado had planned to use the federal tool CMS had been developing but backed away when it did not come to fruition. Ms. Frenzel said Indiana modified its integrated eligibility system through existing contracts but could not use the federal eligibility tool because the system is highly customized.

Another Commissioner asked about audit risk. Ms. Flores-Brennan said Colorado is very worried, noting the state is in the second cycle of Payment Error Rate Measurement (PERM) audits, which are set to begin in June or July 2027. Colorado is documenting its unanswered questions and plans to request PERM relief, as CMS granted during ACA implementation. She also noted that CMS released a multi-page mitigation strategy document the previous week, with a fillable form for states to identify the strategies they will use, such as broad social media outreach when direct notices are not possible.

One Commissioner noted that more than 80% of Nebraska’s denials stemmed from non-response, describing the situation as “unwinding 2.0” with greater complexity, and asked about outreach best practices. Panelists described the following approaches:

• Ms. Behnke (NE): Health centers simplify state materials (with state review and approval), coordinate with community partners so every organization uses the same language, and rely on social media, short videos, community meetings, one-on-one help, and a website that helps people find an assister.
• Ms. Flores-Brennan (CO): The state partnered with the Center for Advancing Consumer Participation, funded by a local foundation, to build a co-brandable toolkit of social media posts, newsletter content, flyers, lobby videos, and translated materials. Colorado also offers screener tools for work requirements and immigrant eligibility and will relaunch an ambassador program that gives mini- grants to community organizations to serve as trusted local messengers.
• Ms. Frenzel (IN): The state uses similar toolkits and screeners and tracks engagement, such as how many town hall viewers then check their status in the benefits portal and where viewers stop watching informational videos. Ms. Frenzel stressed that meeting notice requirements is not the same as changing behavior.

Another Commissioner asked Ms. Frenzel about Indiana’s fiscal analysis for its legislature. She said the state projects about $50 million in first-year costs to implement the OBBBA and Indiana’s state law, driven by 400 new eligibility staff, secure workspace, and mail costs tied to quarterly compliance checks. She said earlier Indiana data showed that adding eligibility staff improved timeliness and lowered the state’s PERM error rate. Indiana will track results against its projections and make them public, including through the State Budget Committee and the coming legislative session.

In response to staff questions, panelists described the following workforce and operational challenges:

• Ms. Behnke said Nebraska’s roughly 70,000 expansion enrollees cannot easily learn they are in the expansion group, and a portal update to show this is several months away. She called enrollment assisters the most valuable tool in implementation, since they often come from the same communities as patients, receive enrollees’ mail through authorized representative forms, and flag systemic problems.
• Ms. Behnke said two-hour call waits are common and that a system glitch disconnects callers after two hours, forcing them to call back, which accounts for the three- to four-hour waits reported. Application processing times have also grown, and one rural local office has begun referring walk-ins to the community health center.
• Ms. Flores-Brennan said Colorado’s eligibility workforce is administered by its 64 counties, which are developing staffing plans. The state holds Q&A sessions with county workers, maintains a resource web page, and will roll out formal training in November and early December, close to go-live.
• Ms. Frenzel said Indiana’s training is ongoing and will likely require additional FAQs as new issues emerge.

On partnerships with managed care organizations (MCOs) and providers, Ms. Frenzel said Indiana distributed a provider toolkit and that MCO claims history will be important for frailty determinations as the state sees churn from its delayed unwinding. Indiana is also exploring Kentucky’s practice of listing an enrollee’s next redetermination date on provider eligibility responses. Ms. Flores-Brennan said Colorado meets regularly with MCOs and is scheduling roundtables with primary care providers. Ms. Behnke said two of Nebraska’s three Medicaid MCOs are sharing data on attributed patients with health centers, and health centers are exploring access to denial data so they can follow up on procedural denials.

When asked what they would request with a magic wand, Ms. Flores-Brennan said more time and that even as a longtime Medicaid official she struggled to follow her own state’s webinar. Ms. Behnke asked for simplification, warning that young, relatively healthy people may walk away from coverage altogether. Ms. Frenzel said she supports work requirements for able-bodied adults philosophically, but wished policymakers understood “the math of Medicaid,” as disenrolling someone does not save Indiana general fund dollars when that person later shows up uninsured at a hospital, particularly given pressures on hospital assessment fees, SDPs, and provider taxes.

Commissioners closed the session with several broader concerns:

• One Commissioner asked how MACPAC could track the effect of look-back periods on people who could not work because of a newly diagnosed illness, such as cancer, so the evidence is not merely anecdotal. Staff said they would consider options.
• Another Commissioner asked whether anyone is tracking how many people gain jobs, since that would be the key metric if employment is the goal. She warned that claims-based frailty tools create a perverse incentive for people with serious depression or PTSD to visit the emergency department simply to generate a record of acuity, particularly in states that do not allow self-attestation.
• A third Commissioner worried that physician documentation of frailty could introduce bias against people with invisible disabilities and asked what criteria and training, such as trauma-informed care, physicians will receive.
• One Commissioner called for an evaluation of the cumulative impact of work requirements, SDP reductions, financing changes, and payment rate changes, to see the total effects of all policy changes.

On October 8, 2026, the Medicare Payment Advisory Commission (MedPAC) met for its second meeting of the 2026-2027 analytic cycle. During the meeting, Commissioners discussed several topics, including physician participation in Medicare Advantage (MA) networks, issues affecting the payment accuracy of the Physician Fee Schedule (PFS) and the Clinical Laboratory Fee Schedule (CLFS), and ways to improve clinician quality incentives in Fee-for-Service (FFS) Medicare.

PHYSICIAN PARTICIPATION IN MA PROVIDER NETWORKS: COMPARING PROVIDER DIRECTORIES WITH ENCOUNTER DATA

This session began with MedPAC staff providing an overview of MedPAC’s previous work on physician participation in MA networks and background information on provider directories. Staff then discussed physician participation in MA at the program level and beneficiaries’ use of services from physicians not listed in provider directories. Staff highlighted that over 95% of Medicare physicians provided care to MA enrollees in 2023; however, almost a third of MA encounters had a rendering physician not listed in the MA enrollee’s plan provider directory. Staff concluded the presentation with an overview of their interviews with National Cancer Institute (NCI) Designated Cancer Centers and MA plans, which covered contracting practices, coverage policies, payment rates, and prior authorization concerns.

Commissioner Discussion

Commissioners opened with clarifying questions about staff work. When asked who participated in the cancer center interviews, staff said most participants were payer strategy and finance staff. When asked about the data used in the analysis, staff explained that the program-wide participation analysis used a full year of encounters, while the plan-directory comparison used only February 2023 encounters to avoid lags in directory updates. Several Commissioners asked whether results differ between Health Maintenance Organizations (HMOs) and Preferred Provider Organizations (PPOs), since going out-of-network carries very different consequences in each. Staff confirmed that breakout of this data by plan type is underway, along with work using billing National Provider Identifiers (NPIs) and taxpayer identification numbers (TINs) to separate true out-of-network care from directory errors. Staff also confirmed that a physician’s participation status applies across all of Medicare, so a provider cannot participate in MA if they do not participate in FFS, and that non-participating providers can bill up to 115% of the FFS rate. Commissioners also discussed how to understand gaps in an MA provider directory. One Commissioner said plan explanations for outdated directories should be treated as problems to fix, not accepted as reasonable. Another said the industry should be held to high accuracy standards, suggesting plans could use artificial intelligence to reconcile directories with their contract databases. However, another Commissioner urged caution, arguing that directory inaccuracies should not be equated with barriers to care and that managed care’s value in coordinating care and controlling costs should be preserved. An additional Commissioner noted that a high participation rate overall does not guarantee network adequacy in a given local market.

Several Commissioners suggested treating physicians who practice at an in-network facility, such as emergency physicians, radiologists, anesthesiologists, and hospitalists, as in-network so beneficiaries are not surprised by a bill after choosing an in-network hospital. One Commissioner cautioned that a similar idea proved highly contentious in recent federal debates over surprise billing in the commercial insurance market.

The cancer center findings drew the most varied reactions. Some Commissioners suggested requiring plans to include an NCI-designated cancer center in their network, but others were skeptical. One noted there are not centers in every state and argued that a network requirement would give centers even more market power. It was also suggested centers may limit MA patients in favor of commercial patients who pay two to three times FFS rates. Another Commissioner noted that episode costs at these centers often run higher because of repeated imaging and testing. Others argued that modern cancer care is subspecialized, multimodal, and team-based, and that service-by-service prior authorization and site-of-service rules are fundamentally incompatible with that model. One Commissioner argued that the volume of single-case agreements points to a de facto contract that should simply be made a standing one. Another noted that one-time agreements often fail to cover the years of follow-up care that cancer patients need. MedPAC staff and the Chair reiterated that the interviews reflected what centers and plans reported and that the scope of this work is descriptive, not a review of network adequacy for cancer centers or any other sector.

Mid-year contract terminations were another recurring concern. One Commissioner called mid-year network changes unacceptable and a straightforward problem to fix by holding networks constant through the plan year. Another pointed out that switching plans mid-year resets out-of-pocket spending and suggested out-of-pocket spending should follow the beneficiary.

Several Commissioners pushed back on excluding nurse practitioner (NP) and physician assistant (PA) data from analysis, as they provide a growing share of primary care in rural, geriatric, and safety-net settings, and an increasing share of specialty care. Staff noted that MedPAC recommended direct billing for these clinicians in 2019, instead of billing under a supervising physician.

Commissioners requested the following additional analyses and context:

• A narrower encounter window to test whether timing explains some discrepancies
• A plan-level view showing what share of each plan’s directory physicians appear in its encounter data
• A beneficiary-level analysis of primary care physician relationships to see whether mismatches cluster among certain plans or enrollees
• A survey of access and appointment wait times at NCI Designated Cancer Centers for Medicare versus commercial patients
• More interviews with cancer center operations staff, additional MA plans, community cancer centers, and advocacy groups such as the American Cancer Society to understand potential harms beneficiaries experience as a result of fragmented cancer care
• More detail on how single-case agreements are approved and continuity of care protections
• Use of grievances, appeals, complaint tracking data, and disenrollment to measure how directory errors affect enrollees
• Exploration of policy options, including aligning contract cycles with the plan year, centralized provider directories, and counting directory accuracy toward Star Ratings

The Chair closed by emphasizing that this session’s work remains focused on fact-finding. The goal is to support informed beneficiary choice, separate from network adequacy and prior authorization, and MedPAC does not expect to make recommendations on this topic at the November meeting.

ISSUES AFFECTING THE PAYMENT ACCURACY OF THE PFS AND CLFS

MedPAC staff began this session with a background on the Commission’s previous work on payment accuracy for PFS and CLFS before explaining payment types such as global surgical services and “incident-to” billing, which is when providers bill under the NPI of a supervising physician. Staff then discussed telehealth billing under the PFS and the appropriateness of payment rates for those services. The last section of the presentation covered the CLFS, including recent developments from Congress, MedPAC, and private payers.

Commissioner Discussion

When asked about beneficiary cost sharing on global surgical services, staff said beneficiaries currently pay 20% coinsurance on the full bundle and would pay less under either reform option suggested in the June 2025 Report to Congress. Those options were to either convert 10- and 90-day global surgical services to 0-day services and let clinicians bill separately for postoperative visits, or keep the current payment structure but adjust valuations for 10- and 90-day global surgical services to reflect the postoperative services actually performed. Staff explained that postoperative visit assumptions come from specialty society surveys reviewed by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) and the Centers for Medicare and Medicaid Services (CMS). The Chair added that clinical guidance on the right number of postoperative visits is largely nonexistent and that care patterns have shifted since the bundles were designed. Staff also noted that RAND looked beyond the bundle for visits furnished by other clinicians and still found the assumed visits were simply not happening, and that postoperative visits by an NP or PA in the surgeon’s practice remain part of the bundle. On labs, staff said no cost data are available, that cost sharing was originally waived because tests were inexpensive, and that MA rates are included in the private payer data used to set CLFS rates.

On the reforms suggested in the June 2025 Report to Congress related to global surgical services, most Commissioners who weighed in favored keeping the bundle and lowering its valuation rather than converting to 0-day services. Several argued that unbundling could increase postoperative visits and run counter to efforts to coordinate care, and one Commissioner noted that keeping the bundle preserves the incentive for surgeons to find efficiencies. Commissioners supported phasing in any revaluation.

Commissioners reaffirmed the 2019 MedPAC recommendation to eliminate “incident-to” billing. Some Commissioners saw little need for more work on the topic, while others asked staff to identify which practices and patients still rely on incident-to billing where direct billing is allowed, and what barriers prevent practices from billing directly.

Telehealth drew the most interest, and several Commissioners called it a high priority, particularly with flexibilities set to expire at the end of 2027. One Commissioner said paying the same rate regardless of modality made little sense, while others disagreed. One Commissioner said that in close calls MedPAC should err on the side of access and avoid heavy regulation that could stifle care innovation. Another warned that lower telehealth payment could push more visits in person and strain access. In response to a question on audio-only telehealth visits, staff said audio-only visits now make up about 10% of FFS telehealth, that most telehealth occurs in the beneficiary’s home, and that Medicare does not require a telehealth clinician to communicate with a beneficiary’s primary care provider. Staff also confirmed that MedPAC has no mandated telehealth report and that the NP and PA scope of practice is governed by state law, not Medicare billing rules.

Commissioners requested the following additional analyses and context:

• Beneficiary out-of-pocket costs under each global surgical option
• Interviews with primary care physicians about surgeons shifting postoperative follow-up to primary care
• A closer look at postoperative care patterns for high-volume 10-day and 90-day procedures across all treating clinicians
• Analysis of the states where incident-to billing persists despite direct billing being allowed
• Separating clinician-assisted telehealth from telehealth delivered to beneficiaries at home
• Outcomes data comparing telehealth and in-person care, such as blood pressure and A1C control
• Monitoring of telehealth prescribing, including GLP-1 prescribing, for Medicare beneficiaries

The Chair closed by noting strong Commissioner interest in continuing the telehealth work, pointing out that the Commission already has standing recommendations on global surgical services, and saying staff will continue tracking incident-to billing.

CLINICIAN QUALITY INCENTIVES IN FFS MEDICARE

The session began with MedPAC staff offering a background on previous MedPAC work on quality measurement in Medicare and the 2 current incentive pathways: the Advanced Alternative Payment Models (A-APMs) and the Merit-based Incentive Payment System (MIPS). Staff then explained concerns with MIPS, which MedPAC previously recommended eliminating in 2018, including burdensome reporting requirements, physician eligibility concerns, and performance differences across physician types. Staff then gave an overview of published literature on ways to incentivize clinician quality and some suggestions of potential analytic work. These suggestions included further analysis of MIPS participation and performance data; stakeholder interviews about experiences with MIPS, including benefits and challenges; and lessons from other performance-incentive programs.

Commissioner Discussion

Commissioners were nearly unanimous in their criticism of MIPS. One Commissioner pointed out that the reporting burden on physicians does not justify the pay benefits and urged Medicare to measure far fewer indicators, focused on outcomes, patient experience, and avoidable utilization at the practice or accountable care organization (ACO) level. Another Commissioner argued that MIPS bonuses are financed by penalties on the small and solo practices that most need resources, said the program may be contributing to consolidation, criticized CMS for being slow to retire topped-out measures, and cautioned that larger incentives can drive gaming, as seen in MA Star Ratings. A third Commissioner called for dissolving MIPS rather than tweaking the program, describing up to tenfold variation in clinician performance within a network and proposed a mandatory program built on evidence-based guidelines with meaningful rewards for high performers and penalties, or removal from Medicare, for persistent low performers.

Another Commissioner noted that 88% of physicians received a positive adjustment in 2024, that the advanced APM bonus has fallen from 5% to 1.9%, and that research found nearly four out of five quality measures do not crosswalk across FFS, ACO, and MA. This Commissioner proposed a single Medicare-wide system with capped measures, three categories (population health, beneficiary and workforce satisfaction, and cost), star ratings graded in 0.1 increments, and comparisons at a common geographic level. Several other Commissioners also supported a unified quality framework across FFS, ACOs, and MA.

Other Commissioners suggested reframing what quality measurement is for. One argued that after 25 years of modest results, policymakers should stop expecting pay-for-performance to improve quality and instead use measurement to identify low-quality outliers, while rewarding measures tied to broad structural change. Another Commissioner proposed using existing patient surveys to flag physicians performing two standard deviations below the mean, citing a Vanderbilt program in which about 85% of outlier physicians improved after intervention. The Chair noted that identifying the lowest performers requires far smaller samples than distinguishing among clinicians in the middle of the distribution. Another Commissioner suggested scrapping MIPS for small practices, possibly keeping only an interoperability measure, while holding very large practices to a zero-sum program on a core measure set with a simple socioeconomic adjustment. Other proposals included using unplanned hospital admissions as a shared outcome measure, measuring teamwork and staffing, and having CMS field patient experience surveys directly rather than requiring practices to do so.

One Commissioner called for abandoning both MIPS and the current Medicare Shared Savings Program (MSSP) structure, arguing that ACO quality thresholds have been lowered so far that many ACOs report at about the 50% level, that payments per beneficiary have more than doubled, and that the program now rewards coding over care improvement. The Commissioner urged a return to Pre-Pathways to Success program rules and called for an all-payer claims database that patients can use directly to compare quality and cost.

Other Commissioners were more cautious. One cautioned that reliability at the individual clinician level can be as low as 6% and rarely exceeds 50% to 60%, compared with 70% to 90% at the group level, and urged staff to separate flaws specific to MIPS from challenges any replacement would face. The Chair clarified that any further analysis would inform future policy options, not judge whether MIPS works, since the Commission’s 2018 recommendation still stands.

Commissioners requested the following additional analyses and context:

A breakdown of the 764 MIPS measures by specialty

• A side-by-side comparison of MIPS Value Pathways (MVPs) and traditional MIPS scores for clinicians who report both, along with early experience from the heart failure MVP used in the Ambulatory Specialty Model beginning in January
• Measure-level performance distributions and collection types over time
• Analysis of persistent low performers, tested against other Medicare data and for sensitivity to patient mix and sample size
• Interviews on what practices actually do to improve scores on current measures
• An explanation of why Congress has not acted on the 2018 recommendation to eliminate MIPS
• An estimate of MSSP’s current net cost or savings to Medicare
• Policy options for replacing MIPS, including the feasibility of a unified quality framework across FFS, ACOs, and MA

On September 24, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the nomination of Dr. Heidi Overton to be Commissioner of the Food and Drug Administration (FDA). Much of the questioning focused on whether Dr. Overton would keep FDA product decisions independent from the White House, particularly after President Trump’s recent comments calling the Measles, Mumps, and Rubella (MMR) vaccine lethal. Dr. Overton said repeatedly that every vaccine on the U.S. market is safe and effective and that she would follow the statutory standards for safety and efficacy in reviewing individual products. Senators also pressed her on recent flavored vape authorizations, the ongoing mifepristone safety review, expedited approvals for rare disease treatments, oversight of clinical trials in China, and resources for FDA’s Human Foods Program.

OPENING STATEMENTS

• Committee Chair Bill Cassidy (R-LA)
• Committee Ranking Member Bernie Sanders (I-VT)

WITNESS TESTIMONY

• Dr. Heidi Overton, MD, PhD, Nominee for Commissioner of Food and Drugs

MEMBER DISCUSSION

Vaccines and FDA Independence

Members expressed concerns regarding Dr. Overton’s history of supporting President Trump’s vaccine statements and questioned her ability to make informed decisions regardless of his input. Chair Bill Cassidy (R-LA), Sen. Maggie Hassan (D-NH), and Sen. Ed Markey (D-MA) asked Dr. Overton about President Trump’s claim that the MMR vaccine is lethal. She said the vaccine is safe, 97% effective, and the best tool currently available to combat MMR. She also expressed confidence in the safety of every vaccine on the U.S. market given the FDA’s oversight of each product. Chair Cassidy, Ranking Member Bernie Sanders (I-VT) pressed her on what she would do if the president’s directions conflicted with FDA science or the law. She said she would follow the law and the statutory standards for safety and efficacy, and that while the president sets policy priorities, individual product reviews belong to FDA experts. Sen. Lisa Blunt Rochester (D-DE) and Sen. Markey asked about her role in the executive order on childhood vaccines and the proposal to split the MMR vaccine into three shots. Dr. Overton said she simply coordinated agency input and presented options to the president. She also confirmed that no separate MMR vaccines are currently available in the U.S. and said any new application would be reviewed against the same standards. Sen. Hassan also asked about the President’s claims that Tylenol causes autism, and Dr. Overton said she has not seen causal evidence linking the two.

Drug Development and Clinical Trials

Members focused on ways to improve drug development and clinical trial timelines in the U.S. Sen. Susan Collins (R-ME) asked how FDA could speed approval of safe, promising treatments for rare diseases where large trials are not feasible. Dr. Overton called it a key priority, pointed to the plausible mechanism pathway, and said FDA’s flexible, risk-based approach should be formalized into policy. Sen. Jim Banks (R-IN) asked about inspections of clinical trials in China and other countries. She said progress has been made, but more is needed to ensure data meets good clinical practice standards, and that her goal is to make it easier to develop and manufacture products in America. Sen. Chris Murphy (D-CT) asked her to restore disbanded advisory committees. She called them a critical part of FDA’s work and said she would review each one to ensure they are all fulfilling their purpose.

Tobacco and Vaping

There was bipartisan concern regarding the FDA’s recent flavored vape authorizations. Sen. Tommy Tuberville (R-AL) and Sen. Tammy Baldwin (D-WI) raised that the changes have allowed flavored vapes to continue to be marketed to children. Dr. Overton said protecting kids comes first, that the flavored vape decision reflected adult use under current law, and that the administration has asked Congress for more authority to fight illicit products. Sen. Ashley Moody (R-FL) asked Dr. Overton about current guidance allowing companies awaiting application approval to continue to sell their products on the market. She said the application backlog has fallen from about 300,000 in May to about 100,000, with 48 products approved, and committed to revisiting current guidance that lets products stay on the market while applications are pending. Sen. Murphy, Sen. Angela Alsobrooks (D-MD), and Sen. Tim Kaine (D-VA) questioned the timing of the policy change after a major tobacco company donated to and met with President Trump. Dr. Overton rejected the framing, said career officials made the recommendation, and said she has not been involved since her nomination.

Mifepristone and Reproductive Health

Sen. Patty Murray (D-WA), Sen. Baldwin, Sen. Banks, and Sen. Josh Hawley (R-MO) questioned Dr. Overton on mifepristone from opposing directions. She said the drug was approved as meeting FDA’s safety and efficacy standard under its current Risk Evaluation and Mitigation Strategies (REMS), but that an internal safety review of the changes to the REMS is ongoing and she could not prejudge whether the label should change. Sen. Hawley noted that FDA has said in court it will not stand behind the REMS adopted under the Biden administration. Sen. Banks asked her to accelerate the review, and she said it would be on her desk immediately, noting an FDA update due to a Louisiana court filing deadline on October 7.

Food Safety and Nutrition

Members also sought clarity on Dr. Overton’s plans to manage food safety and labeling, especially after the large number of recalls this summer. Sen. Murray, Sen. Banks, and Sen. Murkowski asked about resources for the Human Foods Program and state and local inspection partnerships. Dr. Overton said the program would need more resources and that FDA, which has 17,000 employees, is hiring. She did not know the program’s current staffing and, when asked which office monitors foodborne illness outbreaks, named the Food Safety and Inspection Center before Sen. Murray corrected her with the Coordinated Outbreak Response and Evaluation (CORE) Network. Sen. Baldwin and Sen. Murkowski asked about labeling for dairy names and genetically engineered foods, and Dr. Overton called accurate labeling a top priority. Ranking Member Sanders asked about legislation banning over-processed food ads targeted at kids, and she said she supports addressing childhood obesity and improving food quality.

Other Topics

In response to a question on drug prices, she told Ranking Member Sanders that prices have dropped under Most Favored Nation (MFN) policies.