Insights^

Find our analysis on legislation, regulations, MedPAC meetings, and more. 

House Ways and Means Health Subcommittee Hearing on Preventing and Treating Chronic Disease

On November 19, 2025, the House Ways and Means Health Subcommittee held a hearing on modernizing care coordination to prevent and treat chronic disease. There was discussion about ways to combat rising medical costs as well as preserving access to care, especially for populations in need.

OPENING STATEMENTS

WITNESS TESTIMONY

  • Dr. Michael Hoben, MD, Chief Medical Officer of Population Health Services, Novant Health – Testimony
  • Mrs. Allison Reichert, PharmD, Pharmacist, Bode Drug – Testimony
  • Dr. Ashish Parikh, MD, Chief Population Health Officer, Summit Health – Testimony
  • Mr. Brian Connell, Vice President of Federal Affairs, Blood Cancer United – Testimony

MEMBER DISCUSSION

Extension of the Advance Premium Tax Credits (APTCs)

The most repeated argument made by Democrats in attendance was the need to extend the APTCs for at least 1 more year. Reps. Mike Thompson (D-CA-04), Judy Chu (D-CA-28), and Danny Davis (D-IL-07) all argued that you cannot coordinate care for those without access to it. Subcommittee Ranking Member Lloyd Doggett (D-TX-37) questioned Mr. Connell on what would happen to patients with chronic diseases if their health insurance coverage lapsed due to unaffordable premiums, to which Mr. Connell replied that there is no self-pay option for cancer treatments, and health care costs will increase due to more frequent emergency room visits to manage chronic diseases. Rep. Kevin Hern (R-OK-01) pushed back, stating that costs need to be lowered for all populations, not just those who are on ACA marketplace plans.

The Democrats were also strongly against replacing APTCs with health savings accounts (HSAs). Ranking Member Lloyd Doggett argued that APTCs go directly to pay for health care costs while HSAs can be used to finance other purchases. Rep. Greg Murphy (R-NC-03) rebutted that HSAs give patients greater choice in their health care spending. Rep. Blake Moore (R-UT-01) conceded that HSAs are currently only available for high deductible insurance plans and advocated for the passage of H.R.955, which would allow expanded access to tax-advantaged health savings accounts.

Extension of Telehealth Services

There was bipartisan support for extending and expanding COVID-era telehealth services. Reps. Thompson, Hern, Brian Fitzpatrick (R-PA-01), and Moore all agreed that telehealth options improve access, especially in rural areas and among senior populations, while lowering the cost of care. Mr. Connell, Dr. Hoben, and Dr. Parikh agreed as well, saying that connecting increased care options with lower costs and better continuity of care would keep patients out of emergency rooms.

Expansion of Provider Licensing

Full Committee Chairman Adrian Smith (R-NE-03) expressed support for expanding care options for pharmacists through his legislation H.R.3164, which would allow pharmacists to test and treat for common diseases, such as influenza, without seeing a primary care provider. Dr. Reichert also agreed that including pharmacists as part of the broader care team would help address the needs of patients with chronic diseases. Dr. Reichert stated that federal recognition of pharmacists as providers would preserve access to care, especially for rural and senior populations. Rep. Greg Steube (R-FL-17) was in favor of a similar status for chiropractors, mentioning H.R.539, which would expand Medicare coverage to all chiropractic services, allowing chiropractors to be a larger part of a chronic pain care team.

Summary of Proposed Public Charge Rule

On November 19, the Department of Homeland Security (DHS) published in the Federal Register a propsoed rule rescinding the 2022 public charge ground of inadmissibility regulations. Public comments are due December 19, 2025. This memorandum presents a high-level summary of the pre-release version of the rule.

I. BACKGROUND AND REGULATORY CONTEXT

The proposed rule represents a significant shift away from the narrower 2022 public charge framework and moves toward a more expansive interpretation similar to the 2019 rule. If finalized, the rule will increase disenrollment, disrupt care, and place significant documentation burdens on Medicaid Plans and members. The proposed rule establishes a transition framework whereby applications filed before the final rule’s effective date follow the existing 2022 rule, and those filed after must comply with the new framework.

II. 8 CFR 103 – PROCEDURAL AMENDMENTS

The proposed rule updates procedural provisions governing DHS adjudications and introduces enhanced oversight structures for public charge bond monitoring and enforcement. The agency proposes revised notice procedures for bond breach, clarified timelines, and increased evidence submission options. These changes formalize the agency’s authority to request additional information regarding an applicant’s financial stability or benefit utilization.

III. 8 CFR 212.21 – DEFINITIONS

The proposed rule expands and clarifies multiple public charge–related definitions, including ‘public benefit’, ‘cash assistance for income maintenance’, and ‘long-term institutionalization’. Unlike the 2022 rule, which excluded most non-cash benefits, the proposed rule opens the door to including programs such as Medicaid, nutritional programs, housing vouchers, and other social supports. The agency requests comment on which non-cash benefits may be considered predictive of future dependence.

IV. 8 CFR 212.22 – PUBLIC CHARGE INADMISSIBILITY FRAMEWORK

The agency reinstates a broad, multi-factor totality-of-the-circumstances test aligned with section 212(a) (4) of the Immigration and Nationality Act. The agency proposes updated evidentiary standards that require detailed disclosures about income, assets, liabilities, credit history, health conditions, household size, and benefit use—including non-cash programs. Applications may be evaluated using weighted negative factors such as benefit receipt, poor health combined with lack of insurance, limited English proficiency, and limited financial reserves. Positive factors may include high income, private health insurance, strong employment history, and education or skills.

Fear of immigration consequences may cause members to disenroll from Medicaid or decline medically necessary services. This poses continuity-of-care risks, affects quality metric performance, and increases costs associated with preventable acute events.

A. Age

The proposed rule reintroduces age as a weighted factor. Applicants at extremes of age may be viewed as higher risk for future dependence. For health plans, this may reduce enrollment among older immigrants seeking Medicaid for chronic care or younger dependents requiring pediatric services.

B. Health

The proposed rule explicitly links negative weight to health conditions requiring ongoing medical treatment without adequate insurance coverage. This may incentivize immigrant members to avoid documenting chronic illnesses or seeking needed specialty care. Plans may see increased emergency utilization and unreported conditions.

C. Family Status

Larger households may be negatively evaluated if resource limitations are present. Immigrant families may avoid enrolling eligible children in Medicaid/CHIP to minimize the appearance of reliance on benefits.

D. Assets, Resources, and Financial Status

Expanded financial documentation may require applicants to disclose assets, debt, liabilities, and remittances. Immigrants may believe that using Medicaid indicates insufficient resources, prompting disenrollment.

E. Education and Skills

Lower education levels or limited English proficiency may be treated as negative predictors of future self-sufficiency. This may affect vulnerable immigrant groups and impact culturally competent outreach efforts by plans.

F. Benefit Use History

The proposed rule seeks comment on including non-cash benefits such as Medicaid, HCBS, WIC, SNAP, or housing assistance. If adopted, immigrant enrollees may fear any interaction with public benefits, disrupting continuity of care and leading to worse outcomes and higher costs.

V. 8 CFR 213 – PUBLIC CHARGE BONDS

The proposed rule revamps the public charge bond system. Bonds may be required where an applicant presents risk of future dependence. The agency defines breach more clearly: benefit receipt during the enforceable period, failure to meet financial obligations, or misreporting. Bond cancellation criteria are also updated, allowing cancellation upon attainment of LPR status, end of enforceability, or proof of financial stability.

VI. FORMS I-485, I-945, AND I-356

The proposed rule adds extensive information-collection requirements to Forms I-485, I-945, and I-356. Applicants must disclose detailed financial data, health insurance arrangements, household composition, and past benefit use. Members may request documentation from their Medicaid plan to prove insurance coverage or non-use of benefits.

Compliance Implication: Members may request documentation from health plans to prove insurance coverage or non-use of benefits. General Counsel should confirm that such documentation requests follow appropriate privacy and HIPAA channels, and that no misleading or legally risky explanations are provided to members about the rule or their benefit usage.

VII. COMMENT TOPICS THE AGENCY SEEKS INPUT ON

The agency seeks comments on the following areas.

A. Which Non-Cash Benefits Should Be Included

  1. Whether certain non-cash public benefits (e.g., health benefits, housing assistance, nutrition programs) should count toward a public-charge determination (and if so, which ones).
  2. How to define the threshold of benefit use (duration, frequency, value) that signals “dependence.”
  3. Whether receipt of benefits by other household members (rather than the applicant) should be considered.

B. Definition of “Public Charge” / “Dependence”

  1. How the term “likely at any time to become a public charge” should be defined or clarified.
  2. What weight should be given to “primary dependence on government support” versus other factors.
  3. How “dependence” should be operationalized (asset depletion, benefit use over time, lack of resources, etc.).

C. Evidence & Documentation Requirements

  1. What evidentiary standards applicants should meet (income, assets, liabilities, credit history, employment, insurance, benefit use).
  2. How far back and how detailed documentation needs to be (household composition, benefit history, insurance status).
  3. Whether and how private health insurance coverage should weigh in as a positive factor or offset other risks.

D. Factor Weighting in the Totality-of-Circumstances Test

  1. How to weigh negative factors (e.g., receipt of benefits, poor health, lack of insurance, limited skills/ education, large dependents) and positive factors (e.g., high income, significant assets, private insurance, strong employment history).
  2. Whether certain factors should be “heavily weighted” or carry presumptive significance.
  3. How to treat mixed factors (e.g., use of benefits + strong employment) in the balancing process.

E. Bond Regime / Public Charge Bonds

  1. Under what circumstances a public-charge bond should be required.
  2. What counts as “breach” of a bond, what are appropriate cancellation or release criteria, and what monitoring/enforcement mechanisms should apply.
  3. How sureties should function, and whether benefit receipt by the applicant should trigger automatic breach or discretionary review.

F. Information-Collection Burden / Form Revisions

  1. The estimated burden hours for applicants and sponsors in responding to new form requirements (e.g., expanded fields for assets, liabilities, benefit history, insurance).
  2. Whether the forms (e.g., I-485, I-945, I-356) appropriately capture the proposed data without unnecessary complexity.
  3. How to streamline or reduce duplication while maintaining integrity of the determinations.

G. Implementation & Transition Provisions

  1. How to transition from the current rule to the proposed rule for pending applications, benefit use records, and bond postings.
  2. Whether a phased implementation or grandfathering should apply, and how to treat applications filed before the effective date. 3.
  3. Whether exceptions or carve-outs should apply to vulnerable populations (e.g., children, immigrants with disabilities, older applicants).

H. Impact on Vulnerable Populations / Equity Considerations

  1. How the proposed rule might affect immigrant children, immigrants with disabilities, older individuals, or mixed-status households.
  2. Whether the rule would have disparate impact on certain racial/ethnic groups, or income/education strata, and how to mitigate such risks.
  3. How chilling effects (fear of benefit use) should be considered in regulatory design and public health/ health-insurance access contexts.

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.

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.

Senate HELP Committee Hearing on the 340B Program

On October 23, 2025, the Senate HELP Committee held a hearing to examine the 340B Program’s growth and impact on patients. The members heard testimony on how the program functions as well as some current challenges that have been identified. There was strong bipartisan support for the continuation of the program, but there were also calls from both sides of the aisle for careful regulations to ensure the program’s continuing success.

Opening Statements

Witness Testimony

  • Michelle Rosenberg, Director, Health Care, U.S. Government Accountability Office (GAO)– Testimony
  • Dr. Aditi Sen, Chief, Health Policy Studies Unit, Congressional Budget Office (CBO) – Testimony
  • William B. Feldman, Physician and Health Policy Researcher, University of California, Los Angeles – Testimony

Member Discussion

The most common line of questioning from members, including Sen. Tuberville (R-AL), Sen. Murkowski (R-AK), Sen. Kim (D-NJ), Sen. Collins (R-ME), and Sen. Banks (R-IN), was regarding how 340B Program facilities use the savings from the program in their operating budgets. Ms. Rosenberg responded each time that there are no specific requirements in the program on how to use the funds, and Dr. Sen elaborated that the CBO does not have the data required to have a full understanding of how different entities are using the funds. Sen. Hassan (D-NH) suggested that reporting requirements for revenue generated by the program could increase transparency and guide future regulations on its use.

Sen. Baldwin (D-WI), who is a member of a bipartisan 340B working group, raised concerns about the new 340B Rebate Model Pilot Program, which requires program participants to purchase pharmaceuticals at market price and receive a rebate later, creating greater upfront costs. Dr. Feldman shared these concerns and suggested a 3rd party clearing house could be a solution to ensure that pharmaceutical companies and health care providers are able to reach equitable agreements.

Sen. Marshall (R-KS) suggested that creating a definition of a patient under the program, considering factors such as recency or frequency of visits, could aid in regulating eligibility requirements. Dr. Sen agreed but cautioned that any narrowing of the definition would have implications that would need to be understood.

When asked by Sen. Kaine (D-VA) and Sen. Baldwin about recommendations for 340B program reforms, Ms. Rosenberg suggested the 15 recommendations GAO previously made to HRSA, through reports on June, 28 2018, January 10, 2020, and January 27, 2020, that have not been implemented. These include addressing duplicate discount policies, more auditing of contracts and hospital systems, and more data collection on cost savings and use. Sen Hickenlooper (D-CO) continued this line of questioning with the need for more HRSA oversight, which requires authorization to impose regulations and staffing levels to uphold them.

Sen. Kim, Sen. Murray (D-CT), Sen. Markey (D-MA), and Sen. Alsobrooks (D-MD) all discussed how stretched 340B hospital systems’ budgets are, and they raised concerns about how policy decisions such as not renewing advance premium tax credits (APTCs) could make things worse. Dr. Feldman agreed and stressed that any increase in the uninsured population would lead to providing more uncompensated care and a larger burden on the providers in those systems. Sen. Collins and Sen. Murkowski were concerned that regulations limiting 340B hospitals would have a disproportionate impact on rural hospitals that rely more heavily on the 340B program to provide care to their patients.

Subscribe to Us Now!

Be a DC insider by getting our updates straight to your inbox