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CMS’ Calendar Year 2026 Medicare Physician Fee Schedule Final Rule

On October 31, 2025, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule. The CMS press release can be found here. A fact sheet from CMS can be found here. The rule takes full effect on January 1, 2026.

CONVERSION FACTOR

For CY26, CMS will implement two separate conversion factors (CFs). For Alternative Payment Model (APM) participants, known as Qualifying Participants (QPs), the aggregate final CF is set at $33.57, a 3.77% increase ($1.22) from the CY25 CF of $32.35. For non-qualifying participants (non-QPs), the aggregate final CF is $33.40, reflecting a 3.26% increase ($1.05) from the previous year. Notably, these aggregate updates represent a very slight reduction from the originally proposed updates (down from $33.59 or 3.8% for qualifying APMs and $33.42 or 3.3% for nonqualifying APMs – a $0.02 cut in the proposed aggregate update for both categories).

A summary of the various components of those aggregate payment updates is below.

  • The primary reason for the bifurcation of the CFs is the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, which reformed Medicare physician payments by replacing the outdated Sustainable Growth Rate (SGR) formula with the Quality Payment Program (QPP). Under MACRA, starting in CY26, a statutory update of 0.75% is provided for QPs that meet thresholds for participation in Advanced APMs (that emphasize quality and cost accountability) and 0.25% for non-QPs.

  • In addition to the MACRA updates, the final rule includes a one-year increase of 2.50% applicable to both QPs and non-QPs, as included in this year’s One Big Beautiful Bill Act (OBBBA). Enacted to address concerns over physician payment adequacy, the OBBBA’s 2.50% adjustment helps offset inflation and other economic factors while Congress considers longer-term/systemic reforms to the PFS (which were considered during the development of the OBBBA but were ultimately dropped from the bill due to a combination of cost concerns and a lack of broad Republican consensus).

  • Finally, the CF updates account for shifts in relative value units (RVUs), which are used to determine payment rates based on the resources required for services. CMS finalized a 0.49% adjustment to accommodate two broad-based changes in work and practice expense (PE) RVUs, as well ordinary shifts in RVUs (generally due to code values being revised). As discussed below, the broad-based modifications will have the practical effect of somewhat offsetting (in some instances, substantially) the positive CF update for certain specialties/services, particularly those delivered in the facility setting.

EFFICIENCY ADJUSTMENT

As noted above, CMS finalized two broad-based adjustments to RVUs as part of the CY26 rule. The first, an efficiency adjustment, will reduce the work component of the aggregate RVU calculations. The work RVU quantifies the physician’s professional effort in providing a service, encompassing factors such as time, skill, physical and mental effort, and psychological stress due to potential risks to the patient.

As with the proposed rule, CMS used the final rule to criticize its historical dependency on survey data from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC) for determining work RVUs. And the agency reiterated its concerns over the limited number of codes that undergo annual reevaluation and once again raised the notion that time assumptions in many PFS valuations are overstated.

CMS opted to largely finalize the efficiency adjustment as originally proposed. The adjustment will involve a broad-based -2.5% reduction to the intraservice physician time component of the work RVUs. The -2.5% is calculated as the sum of the Medicare Economic Index (MEI) productivity adjustments from the prior five years (CY21 through CY25). As with the proposed rule, the final rule does not apply the adjustment to time-based codes, such as evaluation and management (E/M) services, care management services, behavioral health services, services on the telehealth list, and maternity codes. However, in response to industry comments, CMS in the final rule opted to expand the list of exempt HCPCS codes, adding time-based physical medicine and rehabilitation (PM&R) services, remote therapeutic monitoring (RTM) services, time-based drug administration services (e.g., chemotherapy infusions), any new HCPCS codes for CY 2026, and certain codes involving high cost software inputs (e.g., CPT code 75577 for coronary atherosclerotic plaque assessment by CT).

Specialties most directly impacted by this change include cardiac surgery (-1% cut to work RVUs), colon and rectal surgery (-1%), interventional radiology (-1%), neurosurgery (-1%), nuclear medicine (-1%), pathology (-1%), plastic surgery (-1%), radiation oncology (-1%), radiology (-1%), and thoracic surgery (-1%).

PRACTICE EXPENSE

As part of CY26 proposed rule, CMS announced its intention to implement a second broad-based adjustment targeting the PE RVU. The PE RVU quantifies the non-physician costs associated with providing a medical service, including staff time, supplies, equipment, and indirect expenses like rent and administrative overhead. As outlined in both the proposed and final rules, CMS believes an adjustment to the PE RVU is necessary to address distortions in payment allocation resulting from the significant shift in physician practices from independent, non-facility settings to hospital-based or facility settings.

CMS largely finalized the PE RVU adjustment as originally proposed. CMS will adjust the indirect PE allocation methodology by reducing the facility indirect PE to half of the non-facility indirect PE for applicable services, calculated using a revised formula that scales down the indirect PE allocator for facility settings based on work RVUs or clinical labor inputs. This adjustment applies broadly to PFS services, excluding those without dual settings and those with specific exemptions, such as certain radiation oncology codes (which instead use Outpatient Prospective Payment System (OPPS) relative weights for PE valuation). In the aggregate, specialties most directly impacted by this change include cardiac surgery (-3% cut to aggregate PE RVUs), critical care (-5%), emergency medicine (-3%), gastroenterology (-3%), general surgery (-3%), infectious disease (-7%), neurosurgery (-5%), orthopedic surgery (-3%), and plastic surgery (-4%). Facility-based PE RVU cuts are, in some instances, much more dramatic (i.e., -10% or higher for many specialties).

SKIN SUBSTITUTES

Skin substitutes are currently reimbursed under the Medicare PFS in non-facility settings as separately payable items using the Average Sales Price (ASP) plus 6% methodology, with each product assigned a unique HCPCS Level II code and manufacturers required to report ASP data quarterly. Synthetic skin substitutes have been paid separately in physician offices since CY22, distinct from the application procedure codes (i.e., CPT 15271-15278). CMS has concerns with this approach, noting the increase in Medicare Part B spending on skin substitutes from $250 million in CY19 to $10 billion in CY24, while the beneficiary count has only doubled.

To address concerns about the potential overuse of skin substitute products, CMS finalized reclassifying skin substitutes as “incident-to” supplies rather than treating them as separately payable under the ASP + 6% methodology. In practice, “incident-to” classification means skin substitutes are considered integral but incidental components of the physician’s professional service during wound care. In place of the separate payment, the cost of such products will be “packaged” into the physicians’ PE RVU. As finalized, the PE RVU for such procedures will be adjusted to reflect a uniform OPPS-based rate of $127.28 per cm² for skin substitute products for CY26, representing up to a -90% reduction in aggregate per-service costs. Notably, that figure represents an increase relative to the proposed rate of $125.38 per cm².

In later years, CMS will differentiate the payment rates for skin substitute products in a manner consistent with their FDA regulatory status (i.e., distinct rates for products approved under the Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), Pre-Market Approvals (PMAs), or 510(k) pathways).

CHRONIC ILLNESS AND BEHAVIORAL HEALTH G-CODES

As part of the CY25 PFS final rule, CMS finalized three new G-codes for Advanced Primary Care Management (APCM) services. These codes – G0556 for non-complex APCM (requiring at least one serious condition and clinical staff time thresholds), G0557 for complex APCM (involving multiple conditions with significant staff involvement), and G0558 for APCM with direct physician or non-physician practitioner time thresholds – bundle elements from existing Chronic Care Management (CCM), Principal Care Management (PCM), and Communication Technology-Based Services (CTBS) into a single monthly payment structure. The intent was to reduce administrative burdens associated with fragmented billing requirements and increase access to coordinated care for beneficiaries with chronic or high-risk conditions.

In the CY26 PFS final rule, CMS built on that framework by finalizing three new add-on G-codes – GPCM1 (initial psychiatric Collaborative Care Model or CoCM, mirroring CPT 99492 for the first month of outreach, assessment, and treatment planning), GPCM2 (subsequent CoCM months, mirroring CPT 99493 for ongoing monitoring and adjustments), and GPCM3 (general Behavioral Health Integration or BHI services, mirroring CPT 99484 for at least 20 minutes of monthly care coordination) – which will be billed monthly alongside the base APCM codes.

TELEHEALTH

CMS finalized several updates to its PFS telehealth policies for CY 2026, including:

  • CMS streamlined additions to the telehealth services list by eliminating the “provisional” versus “permanent” categories and concentrating evaluations only on whether the service can be adequately provided through interactive two-way audio-video technology.

  • The agency permanently lifted limitations on the frequency of telehealth use for subsequent inpatient visits, subsequent nursing facility encounters, and critical care consultations.

  • For services needing direct supervision, CMS permanently allows virtual supervision via real-time interactive audio-video communications (excluding audio-only). This covers “incident-to” billing, diagnostic testing, pulmonary rehab, and cardiac or intensive cardiac rehab services, but excludes services with a global surgery indicator of 010 or 090.

  • In a change from the proposed rule, which did not extend the pandemic-era flexibility permitting teaching physicians to supervise residents virtually for billing purposes (instead proposing a return to the original mandate for physical presence during key parts of resident-delivered services), CMS finalized allowing teaching physicians to have a virtual presence in all teaching settings permanently, but only when the service is furnished virtually.

AMBULATORY SPECIALTY MODEL

CMS finalized the Ambulatory Specialty Model (ASM), a mandatory alternative payment model through the Innovation Center (CMMI) that targets beneficiaries with heart failure and low back pain. Starting January 1, 2027, the model holds specialists individually accountable through a two-sided risk payment adjustment on Medicare Part B fees, ranging roughly between –9% and +9% in the first payment year. Performance will be evaluated across four domains: quality (e.g., BP control, functional improvement), cost reduction, care-improvement activities (like patient engagement and social needs screening), and interoperability via certified EHRs. Specialists must treat at least 20 Medicare patients per condition annually and operate within selected Core-Based Statistical Areas (CBSA). CMS finalized the ASM as proposed, without significant changes. The agency will announce selected geographic areas/participant lists in late 2025 and early 2026.

QUALITY PAYMENT PROGRAM

CMS finalized several refinements to the Quality Payment Program (QPP), including maintaining the Merit-based Incentive Payment System (MIPS) performance threshold at 75 points for the 2028-2030 payment years, adding five new quality measures (i.e., transplant waitlist ratios) while removing 10 others (i.e., social drivers of health), and introducing six new Value Pathways (MVPs) for specialties like diagnostic radiology and podiatry. CMS finalized these refinements as proposed, without modifications.

MEDICARE SHARED SAVINGS PROGRAM (MSSP)

The CY26 PFS final rule includes several updates to the Medicare Shared Savings Program (MSSP), including:

  • Limiting participation in the BASIC track’s one-sided risk level to a maximum of five performance years during an ACO’s first agreement period in the glide path (if eligible), requiring ACOs to transition more quickly to two-sided risk models. This applies to periods beginning on January 1, 2027.

  • Increasing flexibility in eligibility and financial reconciliation requirements by allowing ACOs to have fewer than 5,000 assigned beneficiaries in benchmark years 1 or 2, provided they have at least 5,000 in benchmark year 3. Such ACOs are restricted to the BASIC track with capped shared savings and losses. This applies to agreement periods beginning on or after January 1, 2027.

  • Removing the health equity adjustment applied to an ACO’s quality score, beginning in performance year 2026 (instead of 2025). CMS finalized the revised start date in response to comments and made terminology revisions for performance years 2023 through 2025 (instead of 2023-2024).

  • Renaming the “health equity benchmark adjustment” to “population adjustment” for performance year 2025 and subsequent years, to better reflect its focus on beneficiaries enrolled in Medicare Part D low-income subsidy or dually eligible for Medicare and Medicaid.

  • Updating the APM Performance Pathway (APP) Plus quality measure set for performance year 2025 and subsequent years, including removing Quality ID: 487 Screening for Social Drivers of Health.

  • Expanding CAHPS survey modes to include a web-based option (web-mail-phone) beginning with performance year 2027, to increase response rates.

  • Extending Extreme and Uncontrollable Circumstances (EUC) protections to include cyberattacks (e.g., ransomware/malware) for quality and financial evaluations from performance year 2025 onward.

  • Revising the definition of a beneficiary eligible for Medicare Clinical Quality Measures (CQMs) for performance year 2025 and beyond, requiring one primary care service from specified providers.

  • Requiring ACOs to report changes during the performance year to their ACO participant list (Change of Ownership scenarios resulting in a new TIN) and SNF affiliate list.

  • Revising the definition of primary care services for beneficiary assignment to align with PFS changes, including new behavioral health integration and psychiatric collaborative care management add-on services when furnished with advanced primary care management, effective for performance year starting January 1, 2026. In a change from the proposed rule, CMS did not finalize the exclusion of HCPCS code G0136 (administration of a standardized, evidence-based Social Determinants of Health Risk Assessment tool), continuing to include it with its updated code descriptor.

  • Revising quality monitoring policies to track whether ACOs meet both the quality performance standard and the alternative quality performance standard for performance years beginning January 1, 2026, with extended actions (prior to termination or immediate termination) if an ACO fails either.

AGENCY REPLIES TO REQUESTS FOR INFORMATION (RFIS)

In the proposed rule, CMS issued several RFIs on a variety of issues. For some those RFIs, the CY26 final rule contains a summary of the stakeholder comments and CMS feedback on industry’s comments – a review of these specific RFIs is below. For most, however, CMS reiterated what it requested from stakeholders and noted that it had received significant feedback from industry but did not include a summary of those comments or feedback on the information it received (i.e., reducing regulatory burdens, enhancing payment for global surgeries, PDMP data integration, prevention and management of chronic disease, etc.).

  • How to handle cost-sharing for APCM services, and whether waiving or adjusting cost-sharing requirements for APCM services could enhance access and utilization: Commenters recommended eliminating cost-sharing for APCM services, arguing that cost-sharing could limit uptake. CMS responded that APCM does not fully align with preventive service categories but acknowledged similarities with “personalized prevention plan services” (e.g., health risk assessments, self-management oversight). CMS noted the complexity of APCM bundling both preventive and treatment services, solicited further comments on application and inclusions (e.g., Annual Wellness Visits), and stated it would consider the input for future rulemaking without specific actions in this rule.

  • Whether and how to standardize “core elements” within the MVP reporting requirements: Many commenters supported standardizing core elements to improve data comparability and reliability, but some expressed concerns that rigid standardization could limit flexibility for diverse patient populations. Suggestions included specific measures for core elements and mechanisms for updates. CMS reiterated its commitment to balancing standardization with flexibility and pledged to continue stakeholder engagement for future policy development without immediate changes.

  • Input on transitioning to digital quality measurement within the QPP and MSSP: Most commenters supported changes aligning beneficiary definitions, noting reduced confusion and burden in reporting, which aids the dQM transition. Some raised concerns about technical challenges (e.g., EHR incompatibilities, data deduplication, vendor limitations). One encouraged integrating dQM into ACO requirements. CMS thanked commenters and stated it would not address RFI comments in this rule but would consider them for future rulemaking.

A Prognosis of AI Regulation in Health Care

Even as the use of artificial intelligence (AI) in health care has been on the rise for years, federal policymakers are currently grappling with how to address the intersection of health care delivery, innovation, and AI regulation.

As AI becomes more integrated into health care operations and clinical decision-making, policymakers face the challenge of establishing frameworks that promote innovation while addressing concerns around bias, transparency, and accountability.

Through understanding the current federal landscape and the actions already taken, we can get a clearer picture of the direction policymakers and stakeholders are going and the implications for the health care system.

Federal Policy Actions

Recent federal involvement in AI policy is primarily driven by policymakers’ interest in:

  • addressing concerns about regulatory gaps for AI use;
  • establishing accountability measures for organizations that utilize the benefits of AI; and
  • and improving public trust in AI systems to encourage responsible AI use.

In Congress, the Senate HELP Committee recently held a hearing on AI’s potential to support patients, workers, children, and families. The hearing showcased both support for the positive impacts of AI in various work sectors and concerns about the need for proper oversight.

Various bills have also been introduced, including:

  • S.2997, the Right to Override Act, by Sen. Markey (D-MA)
  • H.R.5045, the Health AI Act, by Rep. Lieu (D-CA-36)
  • H.R.238, the Healthy Technology Act of 2025, by Rep. Schweikert (R-AZ-01)

These bills represent 3 different types of legislation related to AI and health care; those that seek to mitigate negative effects, those that seek to understand it better, and those that seek to utilize it to improve the health care system.

The Trump administration has also been active in the AI policy space, through its America’s AI Action Plan, which was published in July 2025. This plan encourages the development and use of new AI systems in health care.

Specifically, the Center for Medicare and Medicaid has proposed the WISeR Model, developed to review Medicare payments for certain services. Many stakeholders have concerns about the model, including the American Hospital Association (AHA), which recognizes the benefits of AI but is worried that the algorithm may ignore patient-specific care details without proper guardrails and human oversight.

Implications of Federal Actions

These actions represent early attempts at governing AI in health care and highlight the desire from policymakers to utilize AI to improve health care while negating potential adverse impacts. But how do these actions impact different stakeholders within health care?

Let’s start by looking at providers. We are already starting to see more AI platforms designed to increase efficiency for providers, but new regulations could require training modules and newly formed committees to monitor AI use in these settings, possibly increasing barriers to entry. Additionally, as AI use becomes more common in making care decisions, providers are raising concerns that regulations will not adequately protect their ability to use clinical judgement.

Drug manufacturers are seeing success with AI modeling to increase efficiency in the drug development process and could expand use to other aspects of manufacturing. The FDA has established the Center for Drug Evaluation and Research (CDER) AI Counsel to oversee these developments, however further guidance and action could bolster or limit AI use in the manufacturing process.

The AI Counsel has not finalized any guidance, as there are concerns about how AI is being defined, and how credibility and risk of different AI platforms can be established. Drug manufacturers have been supportive of AI use at the FDA so far, however there are concerns from within the industry about the technology providing incomplete and incorrect summaries which could lead to slowdowns in the approval process.

When it comes to patients, they are still skeptical about what health care in AI means for them. In a recent study published in JAMA, almost two-thirds of people surveyed reported distrust in their healthcare system’s use of AI and concern that AI could harm them.

This finding indicates a need for lawmakers to implement policies that increase confidence and trust in AI for patients to feel comfortable with ongoing AI use. This could require a change in approach from the Trump administration which has generally taken a view that stresses protecting AI innovation from overregulation.

Ongoing Policy Issues

While there has been movement regarding policies related to AI and health care, there are still some issues that will need to be addressed in the future.

  • Equity and Bias: Some stakeholders, like the AHA, have expressed concerns that AI tools could possibly be biased or discriminate against patients, providing substandard care.
  • Health Care Workforce: Both the AHA and the American Medical Association (AMA) have been supportive of expanded AI use to help address provider burnout, so long as it enhances providers’ work rather than replacing it.
  • Oversight: The Biotechnology Innovation Organization (BIO) has previously stated that the organization supports an incremental approach to oversight and regulation to allow sufficient time for adaptation. The AMA emphasizes that providers must be included in oversight conversations to ensure that the technology is supportive for care.

What’s Next

AI in health care is no longer just a possibility; policymakers are actively grappling with its deployment for providers and payers. Decisions made now will impact how AI is utilized and perceived implicating access, quality, and cost of care for patients for years to come.

Doctor Using AI Interface

Week Ahead: We’re Back – But Not for Long

After a whirlwind of votes and a stroke of a pen, the longest federal government shutdown in history has come to an end. However, the deal to reopen the government is only in effect for a few weeks and advance premium tax credits (APTCs) expiration is looming.  With only a few more days before leaving town again for Thanksgiving, can lawmakers make progress on their stalled agenda? There’s only one way to find out, so let’s get into it. Welcome back to the Week Ahead!

The Administration  

President Trump weighed in on the health care debate on Truth Social (where else!?), saying that Republicans in Congress should redirect the APTCs from the insurance companies directly to the people. The post offered no details on how exactly that would work, but one idea coming from Republican lawmakers and conservative think tanks, such as the Paragon Institute, would be to put the funding for APTC credits into health savings accounts (HSAs) for individual enrollees to use. Another option that has been suggested is to provide the APTC credits to enrollees through flexible spending accounts (FSAs). Beefing up HSAs and FSAs is not a new idea in Republican circles, but the President’s call to action doesn’t mean Republicans are ready to sub in HSAs for APTCs.

The debate over APTCs is not the only issue on the administration’s health care policy plate. There are also the 29 regulatory actions from the Department of Health and Human Services (HHS) currently at the Office of Management and Budget (OMB). These include the final rules for calendar year 2026 (CY 26) End-Stage Renal Disease Prospective Payment System (PPS), Hospital Outpatient PPS, and Home Health PPS. These rules go into effect January 1, and the Centers for Medicare and Medicaid Services (CMS) has already lost valuable time due to the shutdown.

The Senate  

The Senate has been in session throughout the shutdown, working on the continuing resolution (CR), which ultimately led to the reopening of the federal government. Now, after a short break, it’s right back to work for the upper chamber as Senate Majority Leader John Thune (R-SD) promised a vote “in mid-December” on APTCs to get enough Democratic votes to pass the CR. In addition to APTICs, there has also been discussion of a concurrent vote on a Republican health care “reform” bill. This may include reallocating funding for APTCs to HSAs or FSAs for enrollees to use. There have also been discussions about a proposal to extend the APTCs with reforms such as an income cap, guardrails to prevent improper payments, and stricter eligibility/oversight measures.

All of these discussions will come to a head when the Senate Finance Committee meets for a hearing on November 19 regarding the rising cost of health care. This will be an opportunity for Senators on the Committee that oversees APTCs to discuss the future of the subsidies. It’s a battle royale for health policy wonks when the conservative American Action Forum (AAF) and the Paragon Institute and the progressive Urban Institute square off on the idea of redirecting ACA subsidies to tax-free accounts. It’s especially interesting since AAF recently published a piece expressing concerns about the idea of redirecting APTCs to tax-free accounts. We expect Democratic members of the committee to generally emphasize the importance of extending the APTCs, but it will be important to monitor any signs that Democratic members are open to any reforms.

Other Health Care Hearings This Week

  • November 19: Senate Finance Committee executive session to vote on the nomination of Thomas Bell to be the Inspector General of HHS
  • November 19: Senate Aging Committee hearing on restoring trust in medicines

The House 

The House returned on November 13 after being out of session since the end of September, and the chamber faces a daunting to-do list. The House is reportedly going to consider legislation requiring the Department of Justice (DOJ) to release information related to the Jeffrey Epstein investigation on November 18. House Speaker Mike Johnson (R-LA) has also indicated he plans to bring forward a bill to repeal provisions of the recently passed CR that would allow for Senate offices to sue the federal government for unauthorized disclosure of Senate data.

Even with all this going on, House appropriators are also feeling pressure to make progress on FY 26 funding bills for those that were not included in the CR. According to our conversations with House Appropriations Committee staff, the Defense appropriations bill is rumored to be up next for consideration, and the plan would be to pair it with other appropriations bills. This lines up with conversations on the Senate side about advancing a minibus of appropriations bills, including for Defense. The Senate has yet to advance its version of the Defense appropriations bill, but our conversations on the hill indicate that it could be considered as soon as the week of November 17 or the week after Thanksgiving.

House Republicans will also face continued questioning about what they plan to do on APTCs. Speaker Johnson has not indicated that he would take up a bill to extend the enhanced ACA tax credits, but he may face political pressure, especially from House GOP members who are defending vulnerable seats in the 2026 midterm elections. On the other hand, bringing up a vote on extending the enhanced ACA tax credits could be divisive, since it would be something many members of his caucus would oppose, and he would need Democratic support to pass it.

 House Health Care Hearings this Week  

  • November 18: House Energy and Commerce Oversight Subcommittee hearing on AI chatbots
  • November 19: House Ways and Means Health Subcommittee hearing on preventing and treating chronic diseases

There You Have It  

Congratulations to the Washington Spirit, which will play in its second consecutive National Women’s Soccer League Championship game, and its fourth in club history, on November 22. Do you have a favorite fall sport? Let us know. Make it a great week!

Senate HELP Committee Hearing on the Future of Biotech

On October 29, 2025, the Senate HELP Committee held a hearing on the future of biotech. The members heard testimony on the current state of biotech in the United States as well as how to address coming challenges. There was strong bipartisan support of the need for domestic drug manufacturing and maintaining US competitiveness in the global arena.

Opening Statements

Witness Testimony

  • Lowell Schiller, JD, Nonresident Senior Scholar, USC Schaeffer Institute – Testimony
  • John F. Crowley, JD, MBA, President and CEO, Biotechnology Innovation Organization (BIO) – Testimony
  • Josh Makower, MBA, Yock Family Professor of Medicine and Bioengineering, Byers Family Director and Co-founder Stanford Mussallem Center for Biodesign, Stanford University Schools of Medicine and Engineering – Testimony
  • Aaron S. Kesselheim, JD, MPH, Professor of Medicine, Harvard Medical School/Bringham and Women’s Hospital – Testimony
  • Reshma Ramachandran, MPP, MHS, Assistant Professor of Medicine, Yale School of Medicine – Testimony

Member Discussion

Domestic Manufacturing

The most widespread concern from members, including Sens. Banks (R-IN), Blunt Rochester (D-DE), Kaine (D-VA), and Chairman Cassidy (R-LA), was how to encourage domestic manufacturing of biotech. Sen. Blunt Rochester highlighted the lack of a national comprehensive plan to address US biotech innovation and manufacturing. When asked by Sen. Banks about ways for the Food and Drug Administration (FDA) to improve manufacturing, Mr. Schiller indicated a need to update regulations for modern technology and processes as well as have parity between domestic and global inspection standards. Chairman Cassidy raised the potential of using robotics to support domestic manufacturing of generic drugs, but Mr. Schiller responded that the upfront capital needed to open a robotics-based plant makes it unobtainable for companies.

Funding and Staffing Changes

Sen. Murray (D-WA), along with Sens. Hickenlooper (D-CO) and Blunt Rochester (D-DE), expressed concerns that funding changes to the National Institutes of Health (NIH) will greatly reduce US competitiveness and innovation in biotech due to decreased research. All 5 witnesses agreed that the funding changes pose serious risks to innovation and continued drug development. Dr. Ramachandran specifically highlighted the negative impacts on patients due to the cancellation of clinical trials and the brain drain that is occurring as scientists find employment opportunities in other countries. Mr. Crowley emphasized the important role that the NIH plays in basic and translation research, which builds the foundation for startup biotech companies and encourages investment capital from academic institutions and private organizations.

Similar concerns were raised about layoffs at the FDA and the Centers for Disease Control and Prevention (CDC). Sen. Kim (D-NJ) asked about current challenges with FDA resources, to which Dr. Makower responded that vacancies needed to be filled at a one-to-one rate to keep up with the workload of approvals, manufacturing plant inspections, and questions from biotech developers. Dr. Ramachandran highlighted the need for CDC action and surveillance to address growing public health concerns, like drug resistant super bugs, that have biotech solutions, novel antibiotics.

Cost

Sen. Sanders (I-VT) was the first to raise the point of the high cost of pharmaceuticals, often out pricing patients who cannot afford their medications. Dr. Ramachandran shared her experiences where patients request to skip a month of one of their medications or choose not to fill a prescription after seeing the cost at a pharmacy. Sen. Hassan (D-NH) suggested biosimilars could be a way to decrease costs if they can be brought to market quickly. Dr. Kesselheim agreed but elaborated that efforts need to be made to encourage prescribing of biosimilars as well as regulatory guidance to allow them to be interchangeable with their counterparts at pharmacies.

Sen. Hickenlooper questioned if there have been any negative outcomes on negotiating drug prices under the Inflation Reduction Act (IRA). Dr. Kesselheim stated there have been no changes to innovation and the results have only showed drug prices can be decreased. Sen. Cassidy followed up, trying to understand if there has been a difference in investments by biotech companies because of the IRA. Mr. Crowley stated the largest result he has seen is the focus shift from small to large molecules.

Possible Regulations

Sen. Moody (R-FL) asked what regulatory improvements could be made to improve the FDA. Mr. Crowley expressed the need for faster, clearer guidance from the FDA through the approval process. He also suggested the consideration of surrogate endpoints or risk/benefit assessments for rare disease therapies.

Sen. Kaine wanted input from the panel about the Vaccine Injury Compensation Program and whether reform was needed. Dr. Kesselheim expressed support for the VICP, especially how it supports US production of vaccines. Mr. Crowley was also supportive of the program, stating that the system works and should be preserved and strengthened.

Chairman Cassidy led the conversation about the 3rd party review process for the FDA, questioning why the FDA will re-review approvals. Dr. Makower expressed the variable quality for 3rd party reviews and the need to implement a quality control process if there is a desire to increase 3rd party usage. Dr. Ramachandran echoed the point and discussed the need for greater oversight.

Meet Katie Meadows: Passionate Health Policy Professional

We recently welcomed Katie Meadows as Research Associate. We sat down with Katie to talk about her background, what she thinks are the biggest challenges in health policy right now, and how her skills and experience will be an asset to our clients.

Tell us a little about your background and how that background prepares you for this new role.

I’m a proud double Hoya with an MS in Health and the Public Interest and BS in Human Science and Public Health, both from Georgetown University. While completing my degrees, I interned at the Substance Abuse and Mental Health Services Administration and volunteered with a student-run health and science advocacy organization. These experiences gave me the chance to explore federal policy from multiple angles and gain experience working to accomplish shared goals. In my new role, I hope to leverage these skills and experiences to support the needs of Chamber Hill Strategies’ clients.

What drew you to join a government affairs firm with a health care focus?

I wanted to find a workplace that would enable me to explore many areas of health care policy and gain applicable experience. I was drawn to Chamber Hill Strategies due to the firm’s bipartisan focus and broad reach in areas such as Medicare/Medicaid reimbursement, rural health, and the health care workforce. Working for a firm with such a diverse group of clients will allow me to build a strong professional foundation.

What are the core areas of health care policy you’re most passionate about or experienced in?

One area of health care policy that I am very passionate about is mental health and well-being, especially for children and adolescents. While there has been a growing focus on the area, there are more steps to be taken to ensure that children receive the care they need. I am interested in gaining experience in the current health insurance landscape so I can better assist clients in navigating this space.

What do you see as the biggest challenges (and opportunities) in health care policy right now?

Some of the biggest challenges that I currently see in health care policy are ensuring access to quality care and addressing the growing health care workforce crisis. Many communities, such as those in rural or underserved areas, continue to face barriers to care due to high costs, hospital closures, provider shortages, and limited access to services. At the same time, many providers are experiencing high patient loads, burnout, and system-wide staffing shortages. These issues, both separately and combined, impact the timeliness of care and create roadblocks to improved population health.

What will your role at the firm entail — what are you looking forward to doing here?

I currently produce the firm’s daily health care policy report, PolicyCrush, along with the weekly report on upcoming events. I also analyze policy both in legislation and regulation.  I am looking forward to gaining experience and learning from my colleagues at Chamber Hill Strategies. The mentorship that I have already received has been invaluable. I am excited to continue to grow in my role and continue supporting the firm’s work on behalf of our clients.

How do you like to approach problem-solving in complex policy settings?

For complex issues, I think it is important to understand how different parties are approaching the problem and what their goals are. From there, I try to find commonalities between the different approaches to foster discussion on finding a shared way forward.

Outside of work, what motivates you or keeps you energized?

I love spending time with my friends and family, exploring all DC has to offer. Whether it is finding new coffee shops and restaurants to try or visiting the Smithsonian museums, I enjoy taking the time to connect with the people and world around me.

What else should your colleagues or clients know about you?

I am always looking for new book recommendations, both insightful and fun, as I find reading a good way to relax and escape for a bit while still learning. I also love to travel and explore new countries, especially trying local foods.

Do you have any book or travel recommendations for us?

One book I recently read was Everything is Tuberculosis by John Green, an author I grew up reading. I enjoyed seeing a new side of his writing and the way he highlighted a longstanding global health challenge. In terms of travel, one of my favorite cities I recently visited is Florence, Italy. I would love the chance to visit again.

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