Holland & Knight Health Dose: November 10, 2026

Looking Ahead

Both chambers of the U.S. Congress return to Washington, D.C., for the final legislative sprint of the 119th Congress following a midterm election in which Democrats captured majorities in both the U.S. House of Representatives and U.S. Senate. Several races remain outstanding – including Senate races in Alaska and Mississippi and more than 15 House races – but Democrats are on track to have at least 54 seats in the Senate and more than 250 seats in the House. Holland & Knight will publish a separate analysis of the 2026 midterm election results and their implications for healthcare policy. Newly elected Members of Congress are scheduled to be in Washington, D.C., this week and next for new member orientation.

The Senate is expected to continue processing outstanding healthcare nominees, potentially including Dr. Heidi Overton, the president's nominee to serve as U.S. Food and Drug Administration (FDA) commissioner, whose nomination remains pending following her September 24, 2026, confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions (HELP). Republicans will lose their Senate majority on January 3, 2027, which adds pressure to confirm the president's nominees this year.

Government funding remains on track to expire on December 11, 2026, without additional action by Congress. Meanwhile, the House will take up several nonhealthcare bills on the floor this week and is expected to consider articles of impeachment against U.S. Department of War Secretary Pete Hegseth.

Upcoming Events

Federal Agencies

November 10, 2026

• FDA and Focused Ultrasound Foundation – a public workshop on the development of transcranial ultrasound for neurological and psychiatric applications; the workshop will address safety, nonclinical testing, clinical trial design and regulatory considerations for technologies, including neuromodulation and blood-brain barrier opening

November 10-12, 2026

• National Institutes of Health (NIH) – 13th Annual 3Rs Symposium, focused on approaches to reduce, refine and replace the use of animals in biomedical research

November 12, 2026

• FDA – a public virtual workshop on maintenance treatment for ovarian cancer, focused on balancing treatment benefit and toxicity; the workshop runs through November 19

November 13, 2026

• NIH's Office of Research Infrastructure Programs (ORIP) – a pre-application webinar on its C06 Construction Programs funding opportunity for development of collaborative research and research-resource facilities.

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health AI Navigator is a centralized, interactive resource designed to help healthcare stakeholders track and interpret the rapidly evolving legal and regulatory landscape for artificial intelligence (AI) in healthcare. It provides regularly updated summaries of federal and state legislative, regulatory and executive activity, including developments from Congress, the U.S. Department of Health and Human Services (HHS) and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Personnel Updates

• Susie Wiles, chief of staff to President Donald Trump, has resigned from her position following the midterm elections. President Trump announced on November 6, 2026, that Stephen Miller would replace her as chief of staff.

Congressional Updates

Congress Returns for Lame-Duck Session

Attention during the remaining days of the 119th Congress will center on must-pass government funding – to include defense related items in the National Defense Authorization Act (NDAA) – pending nominations, and a narrower group of year-end healthcare provisions, including funding for community health centers (CHCs) and rural hospitals. Congress may also face renewed pressure to address Medicare physician reimbursement after the Centers for Medicare & Medicaid Services (CMS) finalized calendar year (CY) 2027 payment rates that will result in a net reduction for most clinicians, largely due to the expiration of the temporary 2.5 percent payment increase enacted as part of H.R. 1, which is only applicable to 2026. Any physician payment relief – or funding for any other healthcare program that is slated to expire – would need to weigh against the desire to extend funding for CHCs, rural health and other expiring healthcare provisions, all of which is frequently offset with reductions or by funding pulled from other sources. Complicating the path toward a larger health portion of a continuing resolution (CR) is the president's decision to utilize funding in the Medicare Improvement Fund (MIF) to send rebates to Medicare beneficiaries, which removed a potential pot of more than $2 billion from which Congress could have tapped at the end of the year.

The December 2026 spending measure is likely to be the final major legislative vehicle of the year and the principal opportunity to move any outstanding healthcare provisions. Congress may opt to advance another CR, potentially through the early months of 2027. The length of another potential CR may also be dependent upon whether Republicans and Democrats are able to reach a bipartisan path forward, such as clearing outstanding legislation that passed one chamber or the other, or whether Democrats – with a majority in both chambers on the horizon – opt to wait until 2027 to take significant new action, such as passing full-year appropriations bills or otherwise.

New Congress Yields Democrat Majorities in Both Chambers

Though much legislative work is needed before the end of 2026, activities related to 2027 and the beginning of the 120th Congress – one where Democrats will control both the House and the Senate with healthy margins – are actively underway. In November 2026, House Democrats and Republicans are slated to hold leadership elections to determine majority and minority leadership roles. Current Democratic Majority Leader Hakeem Jeffries (D-N.Y.) is expected to be elected Speaker of the House by the caucus; however, there are a number of members-elect who have committed or stated they will not support him in that race until certain assurances are provided about a potential Democratic agenda next Congress, while current Minority Whip Rep. Katherine Clark (D-Mass.) and current Chair of House Democratic Caucus Rep. Pete Aguilar (D-Calif.) are also expected to retain their positions. Current Speaker of the House Mike Johnson (R-La.) has said he does not intend to seek the position of Minority Leader in the next Congress, leaving Reps. Steve Scalise (R-La.), Jim Jordan (R-Ohio) and potentially others to vie for top slots in the House Republican leadership.

In the Senate, leadership elections are currently slated for late November 2026, with the possibility that the vote gets moved. It is currently expected that Senate Democratic Leader Chuck Schumer (D-N.Y.) is on track to retake the position as leader of the Democratic Senate Majority, with Sen. Brian Schatz (D-Hawaii) anticipated to be elected as the next Democratic Whip as he is running opposed to fill retiring Sen. Dick Durbin's (D-Ill.) post. Several incoming senators-elect have shared they also do not intend to support Sen. Schumer's bid to retake the helm as Senate Majority Leader, including Senators-Elect Peggy Flanagan (D-Minn.), Adam Hamilton (D-Kan.) and Annie Andrews (D-S.C.). Some, such as Senator-Elect Abdul El-Sayed (D-Mich.), have openly stated they would support another candidate – such as Sen. Chris Van Hollen (D-Md.) – for the role.

Elections to leadership elections in the House and Senate are expected to be completed prior to the assignment of committee leadership and membership positions to incoming and returning members. There will be significant change regardless of the new member assignments, with a number of members departing from healthcare committees of jurisdiction in both chambers due to either retirement or loss in a re-election race. The House Committee on Energy and Commerce will lose long-serving members on both sides of the dais due to retirements or re-election losses. Though committee leadership votes will take place towards the end of November 2026, Rep. Frank Pallone (D-N.J.) is expected to serve as Energy and Commerce chair, with Rep. Brett Guthrie (R-Ky.) as ranking member. The Health Subcommittee will have a new leader, with Reps. Doris Matsui (D-Calif.) and Kathy Castor (D-Fla.) set to have seniority to potentially select the committee as chair. At the time of writing, Rep. Matsui's re-election race has yet to be formally called, though she remains the lead vote-getter with additional votes still being tabulated. Rep. Morgan Griffith (R-Va.) is expected to remain the top Republican on the Health Subcommittee. The House Committee on Ways and Means will also see departures of several members on both sides of the dais, with Rep. Richard Neal (D-Mass.) expected to serve as chair and Rep. Jason Smith (R-Mo.) expected to serve as ranking member. Rep. Mike Thompson's (D-Calif.) re-election race remains uncalled at this time, though he was largely expected to take over the Health Subcommittee if re-elected.

In the Senate, Sen. Bernie Sanders (I-Vt.) is expected to serve as chair of the Senate HELP Committee. The ranking member slot is currently under discussion, as it is anticipated that current committee member Sen. Lisa Murkowski (R-Alaska) will pursue the top Republican slot on the Senate Committee on Appropriations following the loss of Sen. Susan Collins (R-Maine), leaving the top slot on the HELP Committee potentially to Sen. Rand Paul (R-Ky.). However, Sen. Paul could elect to remain the top Republican on the Senate Committee on Homeland Security and Governmental Affairs, potentially leaving open the top Republican spot on the HELP Committee open for Sen. Josh Hawley (R-Mo.). Sen. Ron Wyden (D-Ore.) is expected to remain the top Democrat on the Senate Committee on Finance, with Sen. Mike Crapo (R-Idaho) expected to remain the top Republican.

New Doctors Join Congressional Ranks

Several new doctors and healthcare professionals were elected to Congress and may vie for positions on healthcare committees of jurisdiction, including:

• Senator-Elect Andrews, trained as a pediatrician and worked at children's hospitals in Washington, D.C., and South Carolina
• Senator-Elect El-Sayed, who holds a medical degree and a doctorate in public health, worked as an epidemiologist and in leadership roles for the health departments in Detroit and for Wayne County, Michigan
• Representative-Elect Dr. Richard Pan (D-Calif.), pediatrician
• Representative-Elect Dr. Amish Shah (D-Ariz.), emergency medicine physician
• Representative-Elect Dr. John Cowan (R-Ga.), neurosurgeon
• Representative-Elect Mitchell Berman (D-Wis.), emergency room nurse
• Representative-Elect Dr. Adam Hamawy (D-N.J.), plastic and reconstructive surgeon

Rep. Mariannette Miller-Meeks (R-Iowa), a member of the GOP Doctors Caucus and the Energy and Commerce Health Subcommittee, lost her re-election race, while GOP Doctors Caucus leader Rep. Greg Murphy's (R-N.C.) race remains uncalled, with additional votes being tabulated.

Regulatory Updates: CMS

CMS Finalizes CY 2027 Medicare PFS

On November 4, 2026, CMS released the CY 2027 Medicare Physician Fee Schedule (PFS) final rule, establishing Medicare Part B payment and quality policies beginning January 1, 2027. CMS finalized conversion factors of $32.9548 for qualifying Advanced Alternative Payment Model (APM) participants and $32.6286 for other clinicians, decreases of approximately 1.85 percent and 2.31 percent, respectively, from CY 2026. The reductions largely reflect expiration of the temporary 2.5 percent payment increase that applies during 2026. CMS also finalized a narrower version of its proposed reduction for separately identifiable office and outpatient evaluation and management (E/M) services billed with Modifier -25 on the same day as a procedure. The reduction will apply only in connection with 0-day global procedures, rather than 0-, 10- and 90-day global procedures as proposed, and CMS reduced the payment adjustment from 50 percent to 20 percent. The highest-paid service will continue to be paid at 100 percent, with other applicable same-day services paid at 80 percent, with the reductions applying only to specific CPT codes related to patient visits.

The rule also advances several broader changes to Medicare payment and quality policy. CMS will transition the E/M visit complexity add-on code G2211 to percentage-based modifiers, including an enhanced modifier for clinicians participating in Medicare Shared Savings Program and Long-term Enhanced ACO Design (LEAD) Model Accountable Care Organizations (ACOs). For remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM), CMS finalized an established-patient requirement, a separately billable initiating visit and changes to code valuation, while delaying until January 1, 2029, the requirement that certain RPM and RTM services be furnished by clinical staff employed by the billing practice. CMS also finalized the transition from traditional Merit-based Incentive Payment System (MIPS) reporting to MIPS Value Pathways (MVPs), with traditional MIPS ending after the 2030 performance year. Electronic prior authorization will become mandatory under Promoting Interoperability in CY 2028, alongside a new electronic prior authorization for prescription drugs measure. Changes to the Medicare Shared Savings Program are projected to reduce Medicare Trust Fund expenditures by approximately $5.5 billion between 2027-2036.

CMS Finalizes CY 2027 Hospital Outpatient and ASC Payment Rule

CMS also released the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) final rule on November 4, 2026. CMS finalized a 2.3 percent payment update for hospitals and ASCs meeting applicable quality-reporting requirements. The rule makes several consequential changes to 340B reimbursement. Beginning January 1, 2027, CMS will generally pay ASP minus 28 percent for 340B-acquired drugs, rather than ASP minus 33.4 percent as proposed, while maintaining ASP plus 6 percent for drugs acquired outside the 340B Program. Rural sole community hospitals, children's hospitals and PPS-exempt cancer hospitals remain exempt from the 340B payment adjustment. CMS also accelerated recoupment of $7.8 billion associated with its prior 340B payment policy by applying a 2 percent reduction to the OPPS conversion factor for affected hospitals, up from the current 0.5 percent reduction but below the 3 percent reduction initially proposed.

CMS also expanded its site-neutral payment policy to certain imaging-without-contrast services furnished in most off-campus hospital outpatient departments, which CMS estimates will reduce Medicare Part B spending by approximately $260 million in CY 2027. The agency continued the phaseout of the inpatient-only list, removing 637 additional procedures, and expanded the ASC Covered Procedures List by more than 600 codes. Of particular significance for digital health companies, CMS established a more defined payment framework for Software as a Medical Service (SaMS). CMS designated 36 Healthcare Common Procedure Coding System (HCPCS) codes as SaMS technologies, established a new O1 payment status indicator and will continue separate APC payment for these services while developing a longer-term reimbursement methodology. Fourteen software analyses performed on laboratory tests will also move from the Clinical Laboratory Fee Schedule into New Technology APCs. CMS declined for now to extend the framework to non-device clinical decision support but indicated that it may further address the scope of SaMS in future rulemaking.

CMS Finalizes CY 2027 Home Health Payment and Medicare Program Integrity Changes

CMS separately finalized the CY 2027 Home Health Prospective Payment System rule on November 4, 2026. The rule increases aggregate home health payments by an estimated $415 million, or 2.4 percent, in CY 2027. CMS finalized a 2.1 percent annual payment update and a national standardized 30-day payment rate of $2,092.69. Although the agency did not apply an additional permanent behavioral adjustment, it finalized a temporary 3 percent reduction intended to recoup approximately $4.9 billion in prior payments associated with implementation of the Patient-Driven Groupings Model. CMS also recalibrated case-mix weights and other payment parameters using CY 2025 data and retained the existing 5 percent cap on annual decreases to the wage index.

The rule also contains a substantial package of Medicare program-integrity and Durable Medical Equipment, Prosthetic Devices, Prosthetics, Orthotics and Supplies (DMEPOS) policies. CMS finalized broader provider enrollment revocation and denial authorities, including new grounds addressing certain fraud-risk geographic concentrations, misdemeanor convictions, shared office arrangements and false enrollment information, while declining to finalize several of the broader authorities it had proposed. CMS also clarified that replacing a DMEPOS item with another item under the same HCPCS code requires a new written order but does not require a new face-to-face encounter. Beginning April 1, 2027, Medicare coverage for certain home infusion pumps will expand where FDA labeling requires administration or supervision by a healthcare professional in the home and other statutory conditions are met. CMS will also move forward through the Paperwork Reduction Act process with a proposal to collect and publicly report the country of origin for lead items supplied by DMEPOS competitive bidding contract suppliers.

Regulatory Updates: ONC

HHS Finalizes HTI-5 Rule Narrowing Health IT Certification Requirements

On October 26, 2026, HHS' Office of the National Coordinator for Health Information Technology (ONC) finalized the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) rule. The final rule removes 14 health IT certification criteria, revises seven and leaves 39 unchanged. It also removes certain AI transparency requirements established under HTI-1, including model-card requirements associated with the Decision Support Interventions certification criterion. ONC describes these changes as establishing a new foundation for future FHIR-based API requirements.

Significantly, ONC did not finalize the information-blocking changes included in the proposed rule, leaving the existing information-blocking framework and exceptions intact. HHS has indicated that it continues to consider comments on those proposals, leaving open the possibility that they could return in the anticipated HTI-6 rulemaking. CMS notes that future rulemaking is expected to focus on interoperability standards, API capabilities and emerging technologies, including AI-enabled interoperability.

Regulatory Updates: FDA

FDA Announces New Discussion Paper on Robotic Medical Devices

On November 6, 2026, the FDA's Center for Devices and Radiological Health (CDRH) released a new discussion paper for comment titled "Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities: Discussion Paper and Request for Feedback." The discussion paper seeks to lay out the FDA's potential thinking on what a robotic device system may be defined as, when a robotic device system may be considered to have autonomy and when a robotic device system may be operated remotely through teleoperation. The discussion paper asks a number of questions throughout, including risks that may arise when a robotic device system is autonomous, safety controls needed, risk mitigations and potential post-market activities.

The release of the discussion paper and RFI coincides with the FDA's upcoming December 2-3, 2026, hybrid public workshop on the topic. Comments on the RFI are due by January 5, 2027.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.