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

Senate HELP Hearing on Making Health Care Affordable

On July 31, 2025, the Senate Health, Education, Labor, and Pension (HELP) Committee held a hearing titled making health care affordable to lower costs and empower patients. Members of the committee heard testimony regarding the impact of health care costs on patient care. There was bipartisan agreement that the cost of health care is too high and there must be a solution to lower the costs.

OPENING STATEMENTS

WITNESS TESTIMONY

  • Ms. Chris Deacon, Principal and Founder at VerSan Consulting – Testimony
  • Dr. Benedic Ippolito, Senior Fellow at American Enterprise Institute – Testimony
  • Dr. Brian Miller, Associate Professor of Medicine, Practicing Hospital Medicine Physician – Testimony
  • Mr. Wendell Potter, Center for Health and Democracy – Testimony
  • Dr. Adam Gaffney, Assistant Professor of Medicine at Harvard Medical School – Testimony

MEMBER DISCUSSION

Health Care Transparency

Chairman Bill Cassidy (R-LA) opened the discussion by asking how price transparency could reduce the cost of care. Ms. Deacon explained that while employers pay premiums on behalf of employees, they often lack the ability to control hospital costs. Transparency would allow insurers and patients to compare prices, identify the best deals, and better understand what is being paid for.

Sen. John Hickenlooper (D-CO) highlighted the importance of maintaining broad health coverage, noting that Medicare and Medicaid remain major revenue sources for providers. He characterized transparency as a central issue and inquired whether future legislation could expand it. Ms. Deacon expressed strong support, emphasizing that giving patients access to clear “price tags” could be transformative.

Sen. Roger Marshall (R-KS) further advocated for the concept, referencing his bipartisan Patients Deserve Price Tag Act with Sen. Hickenlooper, and asked how greater transparency could influence consumer decisions and overall health care costs. Ms. Deacon responded that patients would evaluate both cost and value when making choices. She added that if all members had access to this information, it would drive down costs and potentially lower insurance premiums.

Other witnesses echoed support for greater transparency. Dr. Miller stated that withholding price information is unethical, and Dr. Ippolito agreed that transparency would assist in making informed decisions. Mr. Potter added that transparency would be broadly helpful, while Dr. Gaffney cautioned that transparency alone would not prevent some individuals from becoming uninsured.

PBM Reform

Sen. Marshall raised concerns about pharmacy benefit managers (PBMs), referencing his bill to delink PBM’s and noting that PBMs often create formularies that can prevent patients from accessing generic drugs, emphasizing the importance of legislative oversight. Mr. Potter added that PBMs “suck so much money from the pharmacy supply chain,” highlighting their significant financial impact. Sen. Marshall then asked what value PBMs provide to patients. Dr. Miller explained that PBMs primarily serve as the constructor of formularies.

Sen. Andy Kim (D-NJ) shifted the discussion to retrospective reviews, asking Dr. Miller to elaborate. Miller responded that while the Federal Trade Commission (FTC) previously blocked some hospital mergers, PBM mergers were approved under the assumption that they would lower drug prices. In retrospect, Dr. Miller argued, this analysis was flawed, as PBM consolidation has not delivered the expected price reductions.

340B Drug Pricing Program

Sen. Jon Husted (R-OH) raised concerns about the effectiveness of the 340B drug pricing program, stating, that “340B is not working,” and asked for recommendations to improve it. Dr. Ippolito explained that the program’s original goal is to help hospitals afford care for vulnerable populations. He suggested that tying 340B subsidies more directly to patient care could better align the program with its intended purpose.

 

Calendar Year 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule

On July 15, 2025, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule. The CMS press release can be found here. A fact sheet from CMS can be found here. The 60-day comment period under the Administrative Procedure Act (APA) for the CY26 PFS proposed rule ends on September 15, 2025.

UPDATES TO OPPS & ASC PAYMENT RATES

As part of the rule, CMS proposes updating both OPPS and ASC payment rates for hospitals that meet applicable quality reporting requirements by 2.4%. This update is based on the projected hospital market basket increase of 3.2%, reduced by a -0.8% productivity adjustment.

Notably, CMS has opted to once again extend the use of the hospital market basket for setting ASC rates. In 2019, CMS initiated a five-year “test” of calculating the ASC conversion factor update using the hospital market basket instead of the CPI-U, with the intention of assessing whether this change would prompt a further migration of procedures from the hospital setting to ASCs. That test was initially set to run through CY23, but CMS has since opted to extend it on two occasions (most recently, in this proposed rule) through CY26, due to pandemic-era anomalies in volume that created difficulties in assessing the effect of the shift. Though CPI-U has been running higher than the hospital market basket in recent years (due to the pandemic and the higher-than-usual rates of inflation), the continued use of the hospital market basket would be a positive for ASCs over the long term, given that it has historically been higher than CPI-U (i.e., if/when inflation cools, using CPI-U would be a negative for ASCs relative to the updates experienced during this test).

PROSPECTIVE ADJUSTMENT TO PAYMENTS FOR NON-DRUG ITEMS AND SERVICES

During President Trump’s first term, beginning in CY18, CMS implemented a -28.5% cut to payments for most drugs purchased through the 340B Program and paid under OPPS, lowering the reimbursement amounts from average sales price (ASP) plus 6% to ASP minus 22.5%. The payment reduction was budgetneutral, meaning that savings from the 340B reductions were used to increase payments on other items and services paid under OPPS. Hospitals challenged this policy in federal court and prevailed before the Supreme Court. In 2023, CMS announced it would recoup those increased payments through a -0.5% annual reduction in the OPPS conversion factor beginning in CY26 and running through CY41 (totaling ~$7.8 billion in overpayment recoupments).

As part of the CY26 proposed rule, CMS has announced that it intends to accelerate the recoupment process, implementing a -2% reduction to the OPPS conversion factor through CY31. In practice, for OPPS only, this adjustment would result in an effective payment update for CY26 that is closer to 0.9%. There are, however, outstanding legal questions as to whether the recoupment is allowable on a retroactive basis.

MEDICARE OPPS DRUGS ACQUISITION COST SURVEY

As noted above, in CY18, the Trump administration instituted cuts to Medicare Part B payments for drugs acquired under the 340B program. Those, however, were deemed unlawful by the Supreme Court in the 2022 case American Hospital Association v. Becerra. The court’s decision, reversing a D.C. Circuit ruling that had upheld the cuts, centered on CMS exceeding its statutory authority under 42 U.S.C. §1395l(t)(14) (A)(iii), which outlines two reimbursement methodologies: one permitting rate variation by hospital group only if HHS conducts a survey of hospitals’ average acquisition costs, and a default method requiring uniform ASP-based rates without such variation if no survey is performed. Since HHS did not conduct the requisite acquisition cost survey, the agency lacked the authority to impose differential rates on 340B providers.

As part of the CY26 OPPS proposed rule – and in response to President Trump’s April 2025 drug pricing executive order (EO) – CMS has announced it intends to conduct a comprehensive survey by early calendar year 2026 to collect data on hospital acquisition costs for each separately payable drug acquired by all hospitals paid under the OPPS, with the results aimed at informing policymaking and potential payment rate adjustments beginning with the CY27 OPPS/ASC proposed rule. Although it is not stated in the proposed rule, this effort is likely an attempt by CMS to revisit 340B payment adjustments in a manner compliant with statutory requirements and prior court rulings.

SITE-NEUTRAL PAYMENTS FOR DRUG ADMINISTRATION

The Bipartisan Budget Act of 2015 established the existing site-neutral policies in effect today, aiming to eliminate payment differentials based on the site of service for certain outpatient services. That law stipulated that new off-campus outpatient departments would be paid lower PFS rates for certain services. However, many facilities were exempted from that law (i.e., ASCs, on-campus outpatient departments, off-campus departments that existed before November 2015). Because of these exemptions, the trend has been for hospitals to create new on-campus outpatient departments, purchase pre-2015 off-campus outpatient departments when they want to expand, or build or buy ASCs.

Congress has repeatedly failed to enact broader site-neutral payment reforms beyond the BBA of 2015, often due to opposition from hospital groups concerned about reduced access in underserved areas and the unique costs of hospital-based care. In recent years, bipartisan efforts have included proposals to expand site-neutrality to additional services, such as diagnostic imaging, ambulatory surgery, and drug administration, as well as eliminating grandfathering for existing off-campus PBDs and applying these policies to on-campus facilities. Most recently, as part of the recently enacted One Big Beautiful Bill Act (OBBBA) in 2025, Republican lawmakers debated incorporating comprehensive site-neutral provisions (i.e., eliminating grandfathering, applying site-neutral payments to on-campus departments). The House ultimately passed a proposal to apply site-neutral payments only in the context of drug administration, but that provision was stripped from the bill during Senate consideration.

In the CY26 OPPS proposed rule, CMS proposes to expand site-neutral payments specifically to drug administration services furnished in excepted off-campus outpatient departments, applying a PFSequivalent rate (approximately 40% of the OPPS rate) for services in APCs 5691 through 5694, which include 61 HCPCS codes such as those for chemotherapy infusions and injections. Exceptions include rural sole community hospitals, which will continue to receive 107.1% of OPPS rates for these services, as well as on-campus and non-excepted off-campus locations that are already subject to PFS rates. The agency estimates that this change would yield $280 million in federal savings for CY26, comprising $210 million in reduced Medicare expenditures and $70 million in lower beneficiary copayments.

INPATIENT-ONLY LIST (IPO) & ASC COVERED PROCEDURES LIST (CPL)

The IPO List, established in 2000 under the OPPS, comprises ~1,731 procedures that Medicare reimburses solely when performed in an inpatient setting due to their invasiveness, the need for extended postoperative recovery, and/or patient health risks. For CY26, CMS proposes a three-year phased elimination of the IPO list, entirely removing it by 2029, beginning with the removal of 285 procedures – primarily musculoskeletal services such as hip and knee revisions, osteotomies, amputations, and spinal fusions, along with 16 non-musculoskeletal procedures like cardiovascular interventions, lymphatic excisions, and digestive system repairs.

Relatedly, the ASC CPL outlines surgical procedures and ancillary services eligible for Medicare payment in ASCs – typically HCPCS codes for Category I and III CPT, Level II HCPCS, and items like brachytherapy sources, implantable devices, drugs, and radiology services that are separately payable under OPPS, not on the IPO list, and not unlisted or excluded under regulatory criteria emphasizing safety and minimal risk. For CY26, CMS proposes adding 276 surgery-like codes not currently on the IPO list and an additional 271 codes proposed for IPO removal, expanding the CPL to include spinal procedures (i.e., disc arthroplasty like 0095T and vertebral tethering like 0656T), orthopedic interventions (i.e., hip/knee revisions and osteotomies), general surgery (i.e., amputations like 20816 and tumor resections like 23200), and specialties such as cardiovascular, gynecological, and endovascular.

In practice, these proposals would encourage the migration of procedures to the outpatient setting, potentially lowering Medicare expenditures, reducing beneficiary copayments, and alleviating pressure on hospital inpatient capacity. However, as evidenced in recent years, such adjustments to the IPO and CPL are subject to administrative shifts and thus cannot be presumed to be permanent (i.e., during his f irst term, Trump pursued similar policy changes regarding the IPO and CPL, but those were rescinded through regulation by the Biden administration, with CMS citing safety concerns).

SKIN SUBSTITUTES

Currently, under the OPPS and ASC payment systems, skin substitute products are treated as surgical supplies and are bundled into the payment for the associated wound care procedures, such as application codes 15271-15278 for high-cost groups and C5271-C5278 for low-cost groups. This results in no separate reimbursement for the skin substitutes themselves unless a product has transitional passthrough payment status or qualifies under the Average Sales Price (ASP) + 6% methodology for certain biologicals with pass-through or non-pass-through status. According to CMS, a potential problem with this high-cost/low-cost construct is that it can incentivize manufacturers to set arbitrarily high launch prices to qualify for the more favorable high-cost group reimbursement, and providers may develop a bias toward products falling into that group.

For CY 2026, CMS proposes to unpackage skin substitutes from procedures and pay them separately as incident-to supplies in OPPS and ASCs (excluding Biologics License Application products, which continue under ASP rules). Under this proposal, CMS would group such products into three new Ambulatory Payment Classifications (APCs) based on FDA regulatory pathways – APC 6000 for Premarket Approval (PMA) products, APC 6001 for 510(k) or De Novo cleared items, and APC 6002 for 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – with new codes (QXXX1-QXXX3) for reporting.

The codes would receive an initial uniform payment rate of $125.38 per unit across all groups, derived from the highest volume-weighted ASP or Manufacturer’s Unadjusted Charge (MUC), updated annually (with fallbacks to Wholesale Acquisition Cost (WAC) or 89.6% of Average Wholesale Price (AWP) if ASP data is unavailable).

INTENSIVE OUTPATIENT PROGRAM (IOP) & PARTIAL HOSPITALIZATION PROGRAM (PHP)

IOPs are structured behavioral health treatment services designed for individuals with acute mental health disorders that provide at least nine hours of therapeutic services per week without requiring overnight stays or inpatient admission. These programs serve as an intermediate level of care between standard outpatient therapy and partial hospitalization. PHPs, in contrast, are intensive outpatient psychiatric services serving as an alternative to inpatient hospitalization for individuals with acute mental illnesses or substance use disorders, requiring at least 20 hours per week of structured therapeutic interventions such as group therapy, individual counseling, occupational therapy, and medication management.

For CY26, CMS proposes to maintain payment rates for hospital-based IOPs ($340.90 for three-service days (APC 5861) and $424.60 for four or more service days (APC 5862)). For Community Mental Health Center-based (CMHC) IOPs, CMS proposes applying a 40% PFS relativity adjuster to hospital rates to resolve cost inversions and stabilize payments, resulting in $136.36 for three-service days (APC 5851) and $169.84 for four or more service days (APC 5852). For CMHC-based PHPs, CMS proposes applying a 40% PFS relativity adjuster to hospital rates to address cost inversions and stabilize payments. This adjustment would result in APC 5853 being reimbursed at $136.36 for three or more service days and APC 5854 at $169.84 for four or more days.

HOSPITAL PRICE TRANSPARENCY

As part of the CY26 rule, CMS proposes a variety of changes to hospital price transparency requirements, including:

  • Replacing the affirmation with an attestation in the machine-readable file (MRF) stating that all standard charge information is true, accurate, and complete, encoded with the name of the CEO or senior official, effective December 31, 2025.
  • Offering a 35% reduction in civil monetary penalties (CMPs) for hospitals waiving an Administrative Law Judge hearing within 30 days, excluding core violations like failing to post the MRF or shoppable services list, with payment due within 60 days.
  • Adding definitions for the 10th percentile, median (50th percentile), and 90th percentile allowed amounts based on historical reimbursements from electronic remittance advice (ERA) data over a lookback period of up to 12 months.
  • Requiring disclosure of the 10th percentile, median, and 90th percentile allowed amounts, plus the count of allowed amounts, for percentage- or algorithm-based charges using EDI 835 ERA data, including info to derive dollar amounts.
  • Mandating the encoding of the organizational (Type 2) National Provider Identifier (NPI) in the MRF using taxonomy codes starting with ‘28’ or ‘27’ to enhance data comparability.

HOSPITAL QUALITY STAR RATING PROGRAM

CMS proposes updates to the Hospital Quality Star Rating methodology to address concerns that some hospitals can achieve high star ratings despite their poor performance in the Safety of Care measure group. The changes would add a final adjustment step after initial rating calculation (applying only to hospitals with at least three Safety of Care measures) and would be implemented in two stages.

  •  Stage 1 (CY 2026): Hospitals in the lowest quartile of Safety of Care performance that would otherwise receive five stars will be capped at four stars, preventing top ratings for those with subpar safety.
  • Stage 2 (beginning CY 2027, replacing Stage 1): Hospitals in the lowest quartile of Safety of Care will receive a blanket 1-star reduction, broadly penalizing poor safety across all rating levels.

HOSPITAL OUTPATIENT QUALITY REPORTING (OQR) PROGRAM

CMS proposes the following changes to the OQR Program:

  • Adding the Emergency Care Access & Timeliness eCQM, with voluntary reporting in CY 2027 and mandatory starting in CY 2028 (for CY 2030 payment determination).
  • Adding the Information Transfer PRO-PM, with voluntary reporting in CY 2027 and CY 2028, and mandatory starting in CY 2029 (for CY 2031 payment determination).
  • Modifying the Excessive Radiation Dose or Inadequate Image Quality for Diagnostic CT in Adults eCQM to voluntary reporting beginning in CY 2027 (for CY 2029 payment determination).
  • Removing several measures, including COVID-19 Vaccination Coverage Among Healthcare Personnel (effective CY 2024 reporting/CY 2026 payment); Hospital Commitment to Health Equity (effective CY 2025 reporting/CY 2027 payment); Screening for Social Drivers of Health and Screen Positive Rate for Social Drivers of Health (effective CY 2025 reporting); and Median Time from ED Arrival to ED Departure for Discharged ED Patients plus Left Without Being Seen (effective CY 2028 reporting/CY 2030 payment, contingent on Emergency Care Access & Timeliness eCQM adoption).

AMBULATORY SURGICAL CENTER QUALITY REPORTING (ASCQR) PROGRAM

CMS proposes the following changes to the ASCQR Program:

  • Adding the Patient Understanding of Key Information Related to Recovery After a Facility-Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure (Information Transfer PRO-PM), with voluntary reporting in CY 2027 and CY 2028, and mandatory starting in CY 2029 (for CY 2031 payment determination); ASCs must use the Hospital Quality Reporting (HQR) system for PRO-PM data submission.
  • Removing several measures, including COVID-19 Vaccination Coverage Among Healthcare Personnel (effective CY 2024 reporting/CY 2026 payment); Facility Commitment to Health Equity (effective CY 2025 reporting/CY 2027 payment); Screening for Social Drivers of Health and Screen Positive Rate for Social Drivers of Health (both effective CY 2025 reporting).

REQUESTS FOR INFORMATION (RFIS)

As part of the proposal, CMS issued several RFIs, seeking stakeholder feedback on issues including:

  • Ways to streamline Medicare regulations to reduce provider burdens and align those regulations with Executive Order 14192 (“Unleashing Prosperity Through Deregulation”)
  • Whether CMS should expand its site-neutral policies to include on-campus outpatient departments
  • Whether well-being and nutrition measures should be integrated into the OQR and ASCQR Programs

CMS’ Calendar Year 2026 Medicare Physician Fee Schedule Proposed Rule

On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule. The CMS press release can be found here. A fact sheet from CMS can be found here. The 60-day comment period ends on September 12, 2025.

CONVERSION FACTOR

As part of the rule, CMS proposes implementing two separate conversion factors (CFs). For Alternative Payment Model (APM) participants, known as Qualifying Participants (QPs), the aggregate conversion factor is set at $33.59, a 3.83% increase ($1.24) from the CY25 CF of $32.35. For non-qualifying participants (non-QPs), the aggregate proposed CF is $33.42, reflecting a 3.62% increase ($1.17) from the previous year. 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 significant participation in Advanced APMs that emphasize quality and cost accountability) and 0.25% for nonQPs. This differential aims to incentivize clinicians to shift toward value-based care delivery models.
  • In addition to the MACRA updates, the proposed rule includes a one-year increase of 2.50% applicable to both QPs and non-QPs, as included in the recently enacted 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 proposes an estimated 0.55% adjustment to accommodate two broad-based changes in work and practice expense (PE) RVUs. As discussed below in greater detail, the RVU modifications proposed by CMS as part of the CY26 rule will (if finalized) 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 is proposing broad-based adjustments to RVUs as part of the CY26 rule. The first, described as an efficiency adjustment, would have the practical effect of reducing 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, technical skill, physical effort, mental effort and judgment, and psychological stress due to potential risks to the patient. It constitutes approximately 51% of the total RVUs for a service, alongside practice expense (PE) and malpractice RVUs.

As part of the proposed rule, CMS notes that it has long depended on survey data from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC) to determine work RVUs. However, the agency raises concerns over the limited number of codes that undergo annual reevaluation and highlights third-party research suggesting time assumptions in many PFS valuations are significantly overstated.

The efficiency adjustment involves a broad-based -2.5% reduction applied 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). In the view of CMS, the use of MEI – which measures economy-wide productivity gains and is used here to proxy efficiency improvements in medical practices – for calculating broad-based work RVU adjustments provides a more accurate picture of shifts in efficiency as compared to “low-response rate” and “conflicted” industry surveys. Notably, the adjustment does not apply to time-based codes, such as evaluation and management (E/M) services, care management services, behavioral health services, services on the telehealth list, and specific maternity codes.

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

PRACTICE EXPENSE

As part of the CY26 proposed rule, CMS intends to pursue a second broad-based adjustment to the RVUs, this time targeting the PE RVU. The PE RVU quantifies the non-physician costs associated with providing a medical service, including clinical staff time, supplies, equipment, and indirect expenses like office rent and administrative overhead.

According to CMS, the PE RVU adjustment is necessary to address distortions in payment allocation resulting from evolving site-of-service trends and to promote payment stability amid healthcare consolidation. As noted by CMS, in recent years, there has been a significant shift in physician practices from independent, non-facility settings to hospital-based or facility settings, with private practice ownership decreasing from 72% to 35.4% over the past three decades. This consolidation into larger health systems means that many physicians no longer bear the full indirect costs in facility settings, where hospitals often cover these expenses, distorting payment incentives and contributing to higher Medicare expenditures without reflecting actual resource use.

The mechanics of the PE RVU shift involve adjusting 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).

Specialties most directly impacted by this proposal include cardiac surgery (-3% cut to aggregate PE RVUs), colon/rectal surgery (-2%), critical care (-5%), emergency medicine (-3%), gastroenterology (-3%), infectious disease (-7%), neurosurgery (-4%), plastic surgery (-3%), and thoracic surgery (-3%). 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 CY 2022, distinct from the application procedure codes (i.e., CPT 15271-15278). In contrast, under the Outpatient Prospective Payment System (OPPS), skin substitutes have been packaged into the payment for application procedures since CY 2014. CMS has significant concerns with the PFS approach, noting the dramatic increase in Medicare Part B spending on skin substitutes from $250 million in CY19 to $10 billion in CY24, while the number of beneficiaries treated has only doubled.

To address concerns about the potential overuse of skin substitute products, CMS proposes 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 would be “packaged” into the physicians’ PE RVU. Under this new construct, the PE RVU for such procedures would be adjusted to reflect a uniform OPPS-based rate of $125.38 per cm² for skin substitute products for CY26, representing up to a -90% reduction in aggregate per-service costs, yielding a projected $9.4 billion in savings for CY26. In the out-years, CMS intends to trifurcate the payment rates for skin substitute products in a manner consistent with their FDA regulatory status (i.e., resulting in distinct rates for products depending on whether they are approved under the Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), Pre-Market Approvals (PMAs), or 510(k) pathways).

Notably, for CY26, CMS is asserting that this change, which, in practice, shifts what was ordinarily a separately payable supply into the PE RVU of the underlying procedure, will not carry broader budget neutrality implications for RVUs or the CF. However, the agency notes that once this change is reflected in the CY26 claims data, there may be potential budget neutrality impacts in CY27 and beyond (i.e., future downward pressure on RVUs and/or the CF more broadly to account for the increase in PE RVUs for skin substitutes).

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 proposed rule, CMS is building on that framework by introducing 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 (if finalized) will be billed monthly alongside the base APCM codes. The intent is to further alleviate documentation burdens by eliminating time-tracking requirements, improve access to behavioral health in primary care environments (especially for underserved populations), and encourage holistic care management without duplicative billing.

While this policy change (if finalized) provides incremental reimbursement for primary care management, in CY27 and beyond, higher-than-anticipated utilization of these add-ons – reflected in CY 2026 claims data – could create downward pressure on PE RVUs for other PFS services or lead to reductions in the CF (as CMS redistributes resources to offset any net spending increases while maintaining aggregate PFS.

TELEHEALTH

CMS is proposing several updates to its PFS telehealth policies for CY26, including:

  • CMS plans to streamline 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 intends to permanently lift limitations on the frequency of telehealth use for follow-up inpatient visits, subsequent nursing facility encounters, and critical care consultations.
  • For procedures needing direct oversight, CMS proposes allowing permanent virtual supervision via real-time interactive audio-video communications (excluding audio-only). This would cover “incidentto” billing, diagnostic testing, pulmonary rehab, and cardiac or intensive cardiac rehab services.
  • CMS does not plan to extend the pandemic-era flexibility permitting teaching physicians to supervise residents virtually for billing purposes. Instead, it proposes returning to the original mandate for physical presence during key parts of resident-delivered services in urban Metropolitan Statistical Areas (MSAs), while preserving the exemption for rural areas.

AMBULATORY SPECIALTY MODEL

CMS proposes launching the Ambulatory Specialty Model (ASM) as a mandatory alternative payment model through the Innovation Center (CMMI), targeting beneficiaries with heart failure and low back pain. Starting January 1, 2027 (performance period through 2031, with payments tied from 2029 to 2023), 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 is evaluated across four domains: quality (e.g., BP control, functional improvement), cost reduction, careimprovement 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).

QUALITY PAYMENT PROGRAM

CMS proposes 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.

MEDICARE SHARED SAVINGS PROGRAM (MSSP)

The CY26 PFS proposed rule includes several updates to the MSSP, including:

  • Limiting participation in the BASIC track’s one-sided risk level to a maximum of five performance years (down from seven), requiring ACOs to transition more quickly to two-sided risk models
  • Renaming the health equity adjustment to “population adjustment” and removing it from scoring.
  • Updating the APM Performance Pathway Plus measure set, including removing the social determinants of health screening measure and expanding CAHPS survey modes to web-mail-phone in 2027.
  • Extending Extreme and Uncontrollable Circumstances (EUC) protections to include cybersecurity events for quality and financial evaluations from performance year 2025 onward.

REQUESTS FOR INFORMATION

As part of the proposed rule, CMS issued several Requests for Information (RFIs), seeking stakeholder feedback on issues including:

  • Ways to streamline Medicare regulations to reduce provider burdens and align those regulations with Executive Order 14192 (“Unleashing Prosperity Through Deregulation”)
  • How to enhance payment accuracy for global surgical packages
  • How to handle cost-sharing for APCM services, and whether waiving or adjusting cost-sharing requirements for APCM services could enhance access and utilization
  • Whether and how to standardize “core elements” within the MVP reporting requirements
  • How to integrate Prescription Drug Monitoring Program (PDMP) data into Medicare workflows to enhance opioid prescribing safety and reduce misuse
  • Input on transitioning to digital quality measurement within the QPP and MSSP
  • The timeline for implementing Fast Healthcare Interoperability Resources (FHIR)
  • Whether and how CMS can enhance its support for prevention and management of chronic disease through new “well-being” and “nutrition” service lines or quality metrics

House Ways and Means Health Subcommittee Hearing on the Role of Digital Health in Improving Patient Outcomes

On June 25, 2025, the House Ways and Means Health Subcommittee held a hearing on the role of digital health in improving patient outcomes. Members from both parties asked questions related to improving chronic disease, rural health, and data privacy and security. Ultimately, there was bipartisan agreement that digital health is vital for improving access to health care.

OPENING STATEMENTS

WITNESS TESTIMONY

  • Kristen Holmes, Ph.D. Global Head of Human Performance and Principal Scientist of WHOOP – Testimony
  • Josh Phelps, President of Winchester Metals Inc. – Testimony
  • Andrew Zengilowski, CEO and Co-Founder of CoachCare – Testimony
  • Dr. Jackie Gerhart, Chief Medical Officer and VP of Clinical Informatics Epic Systems – Testimony
  • Sabrina Corlette, Research Professor and Co-Director at the Center on Health Insurance Reforms, Georgetown University McCourt School of Public Policy – Testimony

MEMBER DISCUSSION

Rural Health Care

Rural access and infrastructure were central concerns during the hearing. Health Subcommittee Ranking Member Lloyd Doggett (D-TX) asked what sustained funding cuts would mean for providers under the House reconciliation bill. In response, Ms. Corlette explained that the bill would trigger annual 4% mandatory cuts to providers, placing rural hospitals under significant financial strain. She warned that repeated reductions would make it difficult for rural facilities to maintain operations and services.

Rep. Greg Steube (R-FL) expressed skepticism about the practical benefits of digital health technologies if rural hospitals lack the capacity to implement them. He asked what specific steps could be taken to support rural health providers. Dr. Gerhardt emphasized the need for continued innovation, noting that small and rural providers must be empowered to tailor digital solutions to their communities’ needs.

When Rep. Kevin Hern (R-OK) raised questions about bipartisan collaboration for Rep. David Kustoff (RTN) bill H.R. 3108 which addresses the impact of remote monitoring devices on patient outcomes, Mr. Zengilowski explained how providers contact patients directly when digital readings fall out of range. Still, he warned that many small practices simply cannot afford to absorb the financial loss of adopting new technologies without policy support.

Chronic Disease

Rep. Brian Fitzpatrick (R-PA) spotlighted the alarming prevalence of chronic disease, citing Centers for Medicare and Medicaid Services (CMS) data that 60% of Americans suffer from one or more chronic conditions. He asked how digital tools and data-sharing can enhance care coordination and outcomes. Dr. Gerhardt pointed to diabetes and prediabetes management as examples where digital monitoring has been especially effective. Dr. Gerhardt said that by regularly reviewing patients’ data, providers can make informed decisions more quickly and adjust treatment plans as needed.

Rep. Fitzpatrick also asked about the barriers doctors face in adopting digital tools in rural areas. Witnesses pointed to workflow challenges, limited reimbursement, and the steep learning curve for providers unfamiliar with technology integration. Without incentives and clear guidance, many providers struggle to fully incorporate digital solutions into their practice.

Data Privacy and Security

Data privacy emerged as another central concern throughout the hearing, with members from both sides voicing alarm over the increasing vulnerability of health records in the digital age. Rep. Judy Chu (DCA) raised concerns about the proliferation of wearable health devices, questioning whether companies collecting this data adequately safeguard users. She warned that as more patients are pushed toward digital tools, particularly in the wake of potential rollbacks to the Affordable Care Act (ACA) subsidies and health coverage, many may not fully understand how their information is being used or shared.

Ms. Corlette responded by emphasizing that when individuals lose access to health insurance, they are not only less likely to receive in-person care, but also less able or willing to engage with digital health solutions. This disengagement, she noted, carries implications for both health outcomes and privacy, as patients may resort to unregulated tools or delay care altogether. The issue of health data being collected by devices such as fitness trackers, mobile health apps, and wearable devices, outside of traditional Health Insurance Portability and Accountability Act (HIPAA) protections, was raised multiple times. Several witnesses highlighted that these platforms operate in a legal gray area, where user data is often shared with third parties for marketing or analytics purposes without the explicit consent of patients.

Rep. Brian Fitzpatrick (R-PA) asked whether HIPAA needs to be updated to reflect the current digital health ecosystem. Dr. Gerhart affirmed that while HIPAA still provides a baseline of protections, it does not adequately address the types of data now routinely gathered by consumer-facing technologies. She urged Congress to consider modernizing the law to extend protections beyond the walls of traditional clinical settings. This includes establishing clearer rules for data collection, use, and storage by thirdparty tech companies that are not classified as health care providers or insurers but still handle sensitive health information.

Rep. Mike Thompson (D-CA) questioned whether federal agencies outside of the Department of Health and Human Services (HHS)—such as the Department of Government Efficiency (DOGE) should have access to any form of health-related data. Though witnesses did not have insight into the specific agency reference, they echoed a broader concern about cross-agency data sharing without public transparency. Calls for comprehensive federal privacy legislation were repeatedly echoed throughout the hearing, with panelists warning that piecemeal regulations would not be sufficient to address emerging threats, such as hacking, unauthorized use of biometric data, and data aggregation from multiple sources.

House Budget Committee Hearing on Work Requirements in Federal Programs

On June 25, the House Budget Committee held a hearing on work requirements in federal programs, including Medicaid. This hearing takes place as the Senate prepares to consider its version of reconciliation legislation, following the House’s passage of its bill in May. The hearing included both sides accusing the other of misleading the public about the impact of the House reconciliation bill. Any person(s) or organization(s) wishing to submit written comments for the hearing record can do so by emailing Ryan.Bailey@mail.house.gov by the close of business on June 27, 2025.

OPENING STATEMENTS

WITNESS TESTIMONY

MEMBER QUESTIONS

The hearing provided Republicans an opportunity to defend provisions they argue will address waste, fraud, and abuse within federal programs. Republicans praised the provisions to strengthen eligibility verification, prevent undocumented immigrants from accessing federal benefits, and limit certain state f inancing options, such as provider taxes and state-directed payments, which they argued have been used by states like California to secure more Medicaid funding. They also argued the bill does not cut Medicaid but ensures the program can provide care to those who genuinely need it. Republicans, such as Chair Jodey Arrington (R-TX) and Rep. Ralph Northam (R-SC), also said that the bill could go further to address waste, fraud, and abuse in federal programs. Reps. Chip Roy (R-TX) and Andrew Clyde (RGA) expressed concerns that a Senate proposal to change the expanded Federal Medical Assistance Percentage (FMAP) for the Medicaid expansion population does not go far enough in addressing their concerns about spending in the program.

Democratic members responded to these arguments by stating that these Medicaid and SNAP work requirements will increase bureaucratic burden and will cause Americans to lose access to legitimate benefits in order to fund tax cuts for the wealthy, and that most people impacted by the bill will be citizens and legal residents. Additionally, Democrats argued that instead of enacting the work requirements in the House reconciliation bill, Congress should focus on eliminating what they see as real waste, fraud, and abuse, including examples they cited within the Trump administration. Notably, Rep. Lloyd Doggett (D-TX) and Pramila Jayapal (D-WA) argued that there should be an increased focus on provider and insurer fraud. Chairman Arrington noted that he and other Republicans have an interest in addressing concerns about fraud and abuse within the Medicare Advantage program. Reps. Jimmy Panetta (D-CA), John McGarvey (D-KY), Veronica Escobar (D-TX), and Marcy Kaptur (D-OH) also argued that Medicaid provisions in the House’s bill would lead to hospital closures, especially in rural and underserved areas.

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