September 12, 2025
RE: Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P)
Dear Administrator Oz,
On behalf of Accountable for Health, we appreciate the opportunity to provide comments on the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule.
Accountable for Health (A4H) is a non-partisan, national advocacy and policy organization accelerating the adoption of effective accountable care. We aim to support policymakers to advance the movement in the health care system toward accountable care that achieves better outcomes, improved care experiences, increased access and lower costs.
This proposed rule confirms this Administration’s commitment to accountable care. As outlined in more detail below, we support proposals to build and deepen accountable care relationships by requiring accountable care organizations (ACOs) in the Medicare Shared Savings Program (MSSP) to move to two-sided models after their first five-year performance proposal. We also applaud the Administration for responding to stakeholder requests for new specialty models by proposing the new Ambulatory Services Model (ASM) – a model that we believe is in line with Congress’ original intent in passing the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015. Finally, we support efforts to improve the underlying fee-for-service payment structure, including G2211 proposals and new payment proposal for skin substitutes, and urge CMS to work with Congress to ensure that providers in accountable care models remain appropriately incentivized for their efforts and results.
Our detailed recommendations are provided below.
Physician Payment Proposals
Conversion Factor
As required by statute, beginning in CY 2026, there will be two separate conversion factors: one for qualifying alternative payment model (APM) participants (QPs) and one for physicians and practitioners who are not QPs. QPs will receive a 0.75 increase to the conversion factor, while non-QPs get 0.25.
For CY 2026, CMS proposes a qualifying APM conversion factor of $33.59, an increase of $1.24 (3.83%) from the current conversion factor of $32.35, and a non-qualifying APM conversion factor of $33.42, a projected increase of $1.17 (3.62%). This accounts for the 2.5% PFS increase included in the One Big Beautiful Bill Act.
A4H strongly believes that Medicare payment structures should incentivize participation in accountable care models while disincentivizing fee-for-service payment in most instances. For that reason, we support the differential conversion factor as an incentive and benefit to QPs in Advanced APMs. We encourage CMS to consider how the increased conversion factor for QPs will interact with accountable care programs and models and may need to be addressed through a carve out or other adjustment.
Complexity Add On HCPCS Code G2211
In the CY 2024 PFS, CMS finalized separate payment for the office/outpatient evaluation and management (O/O E/M) visit complexity add-on code HCPCS code G2211. CMS now believes it is appropriate to extend the application of G2211 to home and residence E/M visits and proposes to allow HCPCS code G2211 to be billed as an add-on code with the home or residence evaluation and management visits code family (CPT codes 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350).
A4H strongly supports the proposal to allow home-based primary care (HBPC) providers to bill G2211. HCPCS code G2211 is designed to recognize the inherent complexity and additional resources associated with longitudinal continuous care. It was originally effective January 1, 2024, and is referred to as an “add on” because it is only eligible to be billed alongside an evaluation and management (E&M) service. While HBPC providers provide longitudinal primary care to some of the Medicare program’s sickest and most expensive patients, they have been prevented from billing G2211 alongside CPT codes 99340-99350 for reasons that are not entirely clear.
The 2026 PFS proposed rule fixes this gap in payment policy, and A4H strongly supports the proposal to allow HBPC providers to bill G2211 alongside CPT codes 99340-99350. We also support the proposed technical changes to the code descriptor that would effectuate this change. This policy change will support better access to home-based care for more Medicare beneficiaries in need. We thank CMS for its proposal and encourage you to finalize it without changes.
Payments for Skin Substitutes
Skin substitutes are coverings that are designed to help hard-to-heal wounds. Products can be commercialized under different FDA pathways – medical device (de novo classification, 510k), biologics (BLA), human cells, tissues and cellular and tissue-based products (HCT/Ps). The amount of FDA premarket evidence review varies significantly by pathway – there is essentially no clinical evidence review for HCT/Ps products – and we are aware of effectively zero “head-to-head” evidence demonstrating the clinical efficacy of one product versus another.
Today skin substitutes are coded and paid consistent with Part B Drugs. In ambulatory settings they are paid separately from the core professional service (e.g., product application) under the average sales price + 6% (ASP + 6%) methodology established in section 1847A of the Social Security Act. Providers bill Medicare for the product, and Medicare pays the ASP +6% amount, if ASP is available. The Office of Inspector General has indicated that there are problems with the ASP reporting from skin substitute manufacturers.1 Under the Outpatient Prospective Payment System (OPPS), the skin substitutes are packaged (status indicator = “N”) into the payment for the application procedure. These procedures are assigned to a small number of APCs (5053-5). This payment policy effectively caps the amount that Medicare will pay at each application in the hospital outpatient setting. And anecdotally we are seeing volume (and labor) shift away from the hospital setting, where payments are capped, into ambulatory and mobile wound clinics where payments are not capped and single applications that exceed $20,000-$40,000 are common.
Increases in Medicare spending on skin substitutes is unprecedented in its size and scope. Nationally total Medicare payments for skin substitutes grew from $250 million in 2019 to over $10 billion in 2024 and is now impacting Part B Premiums, MediGap premiums, and, we anticipate, payments to Medicare Advantage plans. One A4H member, which serves nearly 20,000 traditional Medicare patients annually, saw total wound care spending of over $106 million in 2024, with only 152 patients driving $92 million of the total.
We recognize that sharp increases in spending secondary to innovation should have their value assessed on an individual basis. The advent of certain immunotherapies that can increase quality of life and improve health outcomes for certain cancer patients, or direct acting antivirals for the treatment (and cure) of Hepatitis C, have increased spending in their applicable clinical categories since these kinds of treatments come with hefty price tags. But those spending increases are tied to clear and verifiable improvements in outcomes and even sometimes cures, reducing the need for additional care like hospitalizations or the need for other expensive interventions.
That is rarely the case with wound care and the skin substitute products. Rather, A4H member experiences align with national reports2 of poor outcomes and risks to patient safety. Most frequently, we see third party wound care providers opting to use skin substitutes, bill Medicare for exorbitant fees, and not address the underlying cause of the wound that, in many cases, would prevent the need for the use of skin substitutes in the first place.
Support for Proposed Medicare Payment Policy
A4H strongly supports the proposal to change the way skin substitutes are paid from the methodology used for drugs and biologics to treating them as incident-to supplies. This proposal will help stop the flood of waste, fraud and abuse, and improve the quality of care for hundreds of thousands of Medicare beneficiaries. Specifically:
- We support treating skin substitute products that are not drugs and biologicals as incident-to supplies.
- We are agnostic on the proposal to subdivide the products into three different payment categories based on their FDA regulatory pathway – PMA, 510(k), 361 H/CTP. We do not believe that adding subcategories or otherwise adding further granularity would lead to a more accurate reflection of resource costs. Rather, we believe greater aggregation within payment categories, including CMS’ recommended “synthetic” versus “non synthetic” option would be sufficient and potentially preferrable given the lack of differences (in clinical outcomes, supporting evidence and resource costs) across products.
- We strongly support the development of single payment rate across all non-BLA products regardless of their classification and we urge CMS to stick with this approach in the final rule and in the coming years.
- We strongly support the use of the hospital outpatient utilization data to inform the development of practice expense RVUs. In the proposed rule, to establish the initial payment rate of $125 per sq cm, CMS uses the highest volume weighted average from the 3 groups (the group with 361 HCP/T products). Instead of this we recommend CMS use the “pooled” payment rate that reflects an average across all products and would establish a rate of $65 per sq cm, which we believe will more accurately reflect resource costs and also further discourage the sort of “profiteering” and extreme growth in Medicare spending that CMS has identified as concerning.
We note that a recent Office of Inspector General Report stated that “action is urgently needed to rein in the massive increases in Medicare Part B spending for skin substitutes.” The report further called for the critical need for reforms to address fraud, waste and abuse in this area.3 A4H strongly supports CMS action in this important area.
Recommendations for ACOs
ACOs have been on the front lines identifying and reducing fraud, waste and abuse. The ACO community has also been first to signal to the Center for Medicare, the Center for Program Integrity and the Innovation Center circumstances where we see patterns indicative of suspect billing and/or fraud – for example: the DME catheter scam.4 We appreciate CMS acting to both address the fraud and create a process to remove “suspect and anomalous” billing from Medicare Shared Savings Program (MSSP) and ACO REACH.
Problematic billing for skin substitutes is far more layered than catheters. The catheter scam was “truly fraud”5, with bad actors billing for product that was never actually shipped to the patient, or billing for catheters sent to beneficiaries that never wanted/needed a catheter. For skin substitutes, A4H member experiences have been that it’s very hard to tell what is “truly fraud” as opposed to what fits in the “dark grey” area of waste – e.g., services that are clinically inappropriate and incentivized because of payment policy and lax coverage policy. Not all waste is necessarily illegal, especially when there is limited to no coverage policy for many types of wounds.6 The CMS Innovation Center has stated repeatedly that they do not believe that it is appropriate to apply the significant anomalous and high suspect (SAHS) billing policy that was developed in response to the catheter scam.
We strongly believe that ACOs have a role to play in identifying and reducing waste to deliver better care for beneficiaries. A4H members have invested significant resources in improving the quality of wound care for patients. The SAHS policy which, in general, removes the spend associated with fraud from both the benchmarks and medical spend, eliminates the incentives to address the “grey area” waste scenarios, but may be useful in some scenarios or for particular types of billing.
CMS could take steps to make it easier for potential fraud that’s identified by ACOs to be communicated to CMS, for CMS to take immediate action, and to ensure that ACOs are not being held accountable for true fraud. CMS could suspend payment to potentially fraudulent providers if the circumstance meets certain conditions and communicate the claims suspension to ACOs.
In addition, both REACH and MSSP ACOs should be able to re-open their settlements from two or three years prior if criminal proceedings are initiated against potentially fraudulent providers and those providers rendered services to ACO-aligned beneficiaries. We think this longer “re-opening” period would help account for the timing of Department of Justice and OIG investigations, which can take multiple years in some cases.
Finally, CMS could create a new stop loss policy that applies to skin substitutes claims. We would be pleased to discuss these solutions forward and to partner with the CMS fraud war room to develop strategies to address fraud and abuse.
Efficiency Adjustment & Site of Service Payment Differential
To consider changes in medical practice and better reflect the resources involved in furnishing services paid under the PFS, CMS proposes to establish an efficiency adjustment to the work relative value units (RVUs), as well as corresponding updates to the intraservice portion of physician time inputs for non-time-based services. CMS proposes to apply the efficiency adjustment using a look-back period of five years of the Medicare Economic Index (MEI) productivity adjustment percentage to calculate this efficiency adjustment, which would result in a proposed efficiency adjustment of -2.5% for CY 2026.
For each service valued in the facility setting under the PFS, CMS also proposes to reduce the portion of the facility (i.e., outpatient hospital settings and ambulatory surgery centers) Practice Expense (PE) RVUs allocated based on work RVUs to half the amount allocated to non-facility (e.g., office-based) PE RVUs beginning in CY 2026. This change aims to reduce hospital consolidation and ensure payment parity across care settings.
A4H supports both technical proposals, which we believe will increase access to care and make Medicare payments for ambulatory primary care providers more accurate and reflective of the “true” work and practice expense inputs.
Medicare Shared Savings Program (MSSP)
Supporting the Transition to Two-Sided Risk
In light of CMS’ current vision and strategic direction, it is revisiting MSSP policies on the amount of time an ACO can remain under a one-sided model, accelerating the progression to performance-based risk. Current policy allows ACOs to participate for up to seven performance years under a one-sided model. CMS proposes limiting the amount of time an ACO can participate under the BASIC track’s glide path to one agreement period and also limits the amount of time under a one-sided model to, at most, five performance years. A4H supports quicker transitions to two-sided risk and applauds the Administration for this proposed policy. Recent MSSP results continue to underscore that significant savings comes from two-sided risk arrangements. Requiring downside risk adoption must be coupled with an appropriate glidepath for incremental risk adoption to support providers in the transition to accountable care. We believe this proposal strikes the appropriate balance and urge the Administration to finalize as proposed.
ACO Eligibility and Related Financial Reconciliation Requirements
For agreement periods beginning on or after, January 1, 2027, CMS proposes changes to the eligibility requirements to allow for participation by ACOs with a minimum of 5,000 assigned beneficiaries in their third benchmark year (BY), even if the ACO has fewer than 5,000 assigned beneficiaries in BY 1 and/or BY2.
A4H supports policies that will increase participation in ACO models. This proposal will make it easier for new entrants to participate in MSSP, supporting the goals of expanding participation in accountable care. We applaud the Administration for this proposal and urge CMS to finalize as proposed.
APP Plus Quality Measure Set
CMS proposes that the APP Plus quality measure set for MSSP ACOs would include 10 measures (7 eCQMs/Medicare CQMs, 2 administrative claims-based measures, and the CAHPS for MIPS Survey measure) beginning with PY 2028 or the PY that is one year after the eCQM specification becomes available for Quality ID: 493 Adult Immunization Status, whichever is later.
Over the last several years, CMS has increasingly moved to overlay MIPS requirements onto advanced APM participants in ways that are inconsistent with the statutory vision of the Medicare Access and CHIP Reauthorization Act (MACRA). The original intent of the statute and accompanying regulations was to create two separate pathways and among the incentives for participating in advanced APMs, were reduced burdens and bonus payments. However, today, overlaid MIPS requirements have added burden to advanced APM participants and QPs, without providing any meaningful information for patients, providers, or the research community. We strongly urge CMS to decouple MSSP quality reporting from MIPS reporting and to revise the quality measure set for MSSP to be streamlined, reducing burden for ACOs and creating more meaningful information for doctors and their patients. We would be happy to follow up with specific recommendations for how to do this decoupling.
Request for Information Related to APCM and Prevention
CMS seeks comment on the advanced primary care management (APCM) bundle – a coding bundle that first became eligible for payment in CY 2025. APCM expands on Chronic Care Management (CCM) and Principal Care Management (PCM) and reflects essential elements of advanced primary care. The new code set bundled several existing care management and communication technology-based services. While APCM represents an improvement over CCM, there are still barriers that the agency could address related to this bundle.
APCM is a helpful stepping stone to risk. We believe that the attention to advanced primary care capabilities is important, and can help move providers to greater levels of clinical and financial capability over time. CMS should continue to monitor how the APCM bundle interacts with total cost of care models and evaluate for opportunities to continue to integrate across the portfolio.
Cost sharing continues to be a barrier to fully deploying APCM. CMS should explore whether the bundle can be further combined into annual wellness visits, which we believe could help to provide justification for waiving cost sharing.
Finally, the agency should consider creating an additional tier for beneficiaries with six or more chronic conditions.
A4H Supports the Proposed Ambulatory Specialty Model
CMS proposes a mandatory Ambulatory Specialty Model (ASM), which would hold certain specialists financially accountable for upstream management of low back pain and congestive heart failure, two areas of high fee-for-service Medicare spending with significant potential for cost savings. The two-sided risk model would be structured after the MIPS Value Pathway (MVP) framework. Risk adoption would incrementally increase from 9% in 2027 to 12% in in 2031.
ASM is designed to purposely overlap with Advanced APMs and ACOs to increase engagement of specialists, regardless of organizational structure. ASM participants would be required to establish collaborative care arrangements (CCAs) with primary care providers, which must include at least three of the following five elements: data sharing, co-management, transitions in care planning, closed-loop connections, and care coordination integration.
A4H supports the proposed mandatory ASM as a mechanism for enabling specialists to get on a glidepath to accountable care. The Merit-based Incentive Payment System (MIPS), passed by Congress as part of MACRA, was intended to include significant enough positive and negative payment adjustments as to encourage providers – including specialists – to participate in two-sided risk accountable care arrangements. Instead, MIPS today has become a largely “check the box” exercise that does not result in provider behavior change or encourage providers to move to accountable care. ASM, as we understand it in the proposed rule, adheres more closely to the original vision for MIPS – creating true accountability for care with increasing levels of payment “at risk” tied to quality, cost, interoperability and practice improvements. It articulates a defined set of measures for accountability rather than allowing providers to select measures to report. Finally, it purports to provide a true distribution of performance from -9% to +9% and increasing over time, a true differentiator from MIPS today where most providers are clustered with updates of 0-2%. We believe that all of these features are consistent with what was originally intended for the MIPS program and that this mandatory model could create a foundation for understanding how MIPS and MVPs work in the future.
CMS should consider how ASM relates to other payment structures and incentivizes participation in two-sided risk total cost of care models. We encourage the agency to think about how the significantly higher upward adjustments and distribution of payments in ASM could interact with the ACO financial methodology. Along these lines, we are seeking clarity as to whether the proposed financial bonuses and penalties impact the providers entire Part B reimbursement or only the services associated with this model.
In terms of overlap with Advanced APMs and ACOs, we recommend that CMS build in “off ramps” for specialists who meaningfully participate in ACOs. Consistent with the original vision for MIPS, Advanced APM QP status should exempt a specialist from mandatory participation in ASM. Participants in ACOs and other Advanced APMs are inherently already clinically and financially accountable for their patient population so holding them accountable for additional metrics and benchmarks is administratively burdensome.
RFI on Chronic Disease Prevention and Management
CMS solicits feedback to help better understand how it could enhance support management for prevention and management of chronic disease including certain services that address the root causes of disease, chronic disease management, or prevention; address social isolation or loneliness; or improve physical activity. CMS also solicits comment on technical solutions that would enhance the uptake of the annual wellness visit (AWV), whether it should create separate coding and payment for medically-tailored meals, among other topics.
Accountable care models can be extremely impactful in preventing and managing chronic disease, particularly when model waivers and other policies enable ACO participants to provide preventive care. Accountable care models encourage team-based care and care coordination, and provide financial stability needed to make longer term investments in services not covered by Medicare today such as lifestyle programs, social needs investments and more.
Below are several case studies demonstrating the power of accountable care models in supporting management of a range of chronic disease.
Case Study #1: Team-Based Care Models
A 5’8” elderly male with COPD, weighing 325 lbs, could not walk one block and had significant dyspnea ascending stairs. He was desperate for help to improve his pulmonary function and activities of daily living. At his pulmonologist’s suggestion, he began daily nebulizer treatments. While he saw some improvement after one month, it was less significant than he had hoped.
An A4H member brought together a respiratory therapist, health coach, or clinical pharmacist to consult on the patient’s care. His nebulizer medications and the frequency of use were modified. The patient initiated daily exercises and breathing techniques. Following guidance from the respiratory care team and his primary care provider, the patient reduced his food intake and maintained his daily exercise routine, incorporating some light weightlifting. The respiratory care team actively supported his progress with personalized, evidence-based care.
Case Study #2: Care Coordination
A 63-year old woman has advanced hepatic cirrhosis and chronic liver disease. The patient resides in a rural area that lacks transportation and other services for seniors. She struggles to take her medication as directed and does not qualify for state-funded caregiver support. By participating in MSSP, our member could afford to create a Clinical Excellence Team, consisting of Case Management, Clinical Pharmacists, Home Visits Team, and Social Workers. The team is dedicated to analyzing the data from patients who visit the ED frequently and identifying why it is happening. In this patient’s case, the team recognized that the patient needed additional support in getting her other health conditions under control to better position her to manage her chronic condition. By deploying a Home Visits Team Nurse Practitioner, the member could better manage her health, address her various needs, and support her with taking her medication.
Behavioral Health and Lifestyle Interventions
CMS is also seeking input on coding and payment for intensive lifestyle interventions. Our members believe that there is an important opportunity around behavioral health emergency response services and crisis stabilization services that could dramatically improve quality of life for Medicare beneficiaries. We would be pleased to discuss this further.
RFI on FHIR DQM
CMS solicits comment on its anticipated approach to the use of HL7 Fast Healthcare Interoperability Resources (FHIR) in electronic clinical quality measure (eCQM) reporting, noting its aim to transition over time to a fully digital quality measurement (dQM) landscape that promotes interoperability and increase the value of reporting quality measure data. CMS poses questions on a number of topics including eCQM FHIR conversion activities; data standardization for quality measurement and reporting; the timeline under consideration for FHIR-based eCQM reporting; and measure development and reporting tools.
Accountable care entities are generally comprised of many participant providers, each of whom has one or more electronic medical records (EMRs) and numerous other digital tools that collect and store information on a patient’s health and health care. To report eCQMs, quality information must be extracted, standardized and aggregated across participants by the accountable care entity. Accurate quality reporting – both of eCQMs now and dQMs in the future – rely on EMRs to function as expected. Real-world testing requirements should be preserved to ensure that EMRs do in fact function as expected in native technology environments, and new technologies such as Bulk FHIR and API infrastructure should further be preserved and expanded to enable reporting on larger populations such as those aligned to accountable care entities.
In addition, providers are at various states of utilizing and functionality of digital technology.
- CMS should consider implementing incentives which encourage all stakeholders to switch to modern data exchange technology, including the development and adoption of real-time FHIR based APIs.
- CMS should support public/private partnerships which bolster interoperable mechanisms for data access and sharing between patients, caregivers, providers, and payers.
- CMS should foster utilization of digital technologies which enhance workflows.
We offered additional comments on the questions posed in this RFI in our response to the FY 2026 IPPS proposed rule and would be happy to share additional information on the particular challenges for ACOs as desired by CMS.
Conclusion
Accountable for Health appreciates the opportunity to provide feedback on this proposed rule. Please do not hesitate to contact Mara McDermott, mmcdermott@accountableforhealth.org.if we can be a resource.
Sincerely,
Mara McDermott
CEO
Accountable for Health
Dr. Mehmet Oz
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Submitted via regulations.gov
September 12, 2025
RE: Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1832-P)
Dear Administrator Oz,
On behalf of Accountable for Health, we appreciate the opportunity to provide comments on the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule.
Accountable for Health (A4H) is a non-partisan, national advocacy and policy organization accelerating the adoption of effective accountable care. We aim to support policymakers to advance the movement in the health care system toward accountable care that achieves better outcomes, improved care experiences, increased access and lower costs.
This proposed rule confirms this Administration’s commitment to accountable care. As outlined in more detail below, we support proposals to build and deepen accountable care relationships by requiring accountable care organizations (ACOs) in the Medicare Shared Savings Program (MSSP) to move to two-sided models after their first five-year performance proposal. We also applaud the Administration for responding to stakeholder requests for new specialty models by proposing the new Ambulatory Services Model (ASM) – a model that we believe is in line with Congress’ original intent in passing the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015. Finally, we support efforts to improve the underlying fee-for-service payment structure, including G2211 proposals and new payment proposal for skin substitutes, and urge CMS to work with Congress to ensure that providers in accountable care models remain appropriately incentivized for their efforts and results.
Our detailed recommendations are provided below.
Physician Payment Proposals
Conversion Factor
As required by statute, beginning in CY 2026, there will be two separate conversion factors: one for qualifying alternative payment model (APM) participants (QPs) and one for physicians and practitioners who are not QPs. QPs will receive a 0.75 increase to the conversion factor, while non-QPs get 0.25.
For CY 2026, CMS proposes a qualifying APM conversion factor of $33.59, an increase of $1.24 (3.83%) from the current conversion factor of $32.35, and a non-qualifying APM conversion factor of $33.42, a projected increase of $1.17 (3.62%). This accounts for the 2.5% PFS increase included in the One Big Beautiful Bill Act.
A4H strongly believes that Medicare payment structures should incentivize participation in accountable care models while disincentivizing fee-for-service payment in most instances. For that reason, we support the differential conversion factor as an incentive and benefit to QPs in Advanced APMs. We encourage CMS to consider how the increased conversion factor for QPs will interact with accountable care programs and models and may need to be addressed through a carve out or other adjustment.
Complexity Add On HCPCS Code G2211
In the CY 2024 PFS, CMS finalized separate payment for the office/outpatient evaluation and management (O/O E/M) visit complexity add-on code HCPCS code G2211. CMS now believes it is appropriate to extend the application of G2211 to home and residence E/M visits and proposes to allow HCPCS code G2211 to be billed as an add-on code with the home or residence evaluation and management visits code family (CPT codes 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350).
A4H strongly supports the proposal to allow home-based primary care (HBPC) providers to bill G2211. HCPCS code G2211 is designed to recognize the inherent complexity and additional resources associated with longitudinal continuous care. It was originally effective January 1, 2024, and is referred to as an “add on” because it is only eligible to be billed alongside an evaluation and management (E&M) service. While HBPC providers provide longitudinal primary care to some of the Medicare program’s sickest and most expensive patients, they have been prevented from billing G2211 alongside CPT codes 99340-99350 for reasons that are not entirely clear.
The 2026 PFS proposed rule fixes this gap in payment policy, and A4H strongly supports the proposal to allow HBPC providers to bill G2211 alongside CPT codes 99340-99350. We also support the proposed technical changes to the code descriptor that would effectuate this change. This policy change will support better access to home-based care for more Medicare beneficiaries in need. We thank CMS for its proposal and encourage you to finalize it without changes.
Payments for Skin Substitutes
Skin substitutes are coverings that are designed to help hard-to-heal wounds. Products can be commercialized under different FDA pathways – medical device (de novo classification, 510k), biologics (BLA), human cells, tissues and cellular and tissue-based products (HCT/Ps). The amount of FDA premarket evidence review varies significantly by pathway – there is essentially no clinical evidence review for HCT/Ps products – and we are aware of effectively zero “head-to-head” evidence demonstrating the clinical efficacy of one product versus another.
Today skin substitutes are coded and paid consistent with Part B Drugs. In ambulatory settings they are paid separately from the core professional service (e.g., product application) under the average sales price + 6% (ASP + 6%) methodology established in section 1847A of the Social Security Act. Providers bill Medicare for the product, and Medicare pays the ASP +6% amount, if ASP is available. The Office of Inspector General has indicated that there are problems with the ASP reporting from skin substitute manufacturers.1 Under the Outpatient Prospective Payment System (OPPS), the skin substitutes are packaged (status indicator = “N”) into the payment for the application procedure. These procedures are assigned to a small number of APCs (5053-5). This payment policy effectively caps the amount that Medicare will pay at each application in the hospital outpatient setting. And anecdotally we are seeing volume (and labor) shift away from the hospital setting, where payments are capped, into ambulatory and mobile wound clinics where payments are not capped and single applications that exceed $20,000-$40,000 are common.
Increases in Medicare spending on skin substitutes is unprecedented in its size and scope. Nationally total Medicare payments for skin substitutes grew from $250 million in 2019 to over $10 billion in 2024 and is now impacting Part B Premiums, MediGap premiums, and, we anticipate, payments to Medicare Advantage plans. One A4H member, which serves nearly 20,000 traditional Medicare patients annually, saw total wound care spending of over $106 million in 2024, with only 152 patients driving $92 million of the total.
We recognize that sharp increases in spending secondary to innovation should have their value assessed on an individual basis. The advent of certain immunotherapies that can increase quality of life and improve health outcomes for certain cancer patients, or direct acting antivirals for the treatment (and cure) of Hepatitis C, have increased spending in their applicable clinical categories since these kinds of treatments come with hefty price tags. But those spending increases are tied to clear and verifiable improvements in outcomes and even sometimes cures, reducing the need for additional care like hospitalizations or the need for other expensive interventions.
That is rarely the case with wound care and the skin substitute products. Rather, A4H member experiences align with national reports2 of poor outcomes and risks to patient safety. Most frequently, we see third party wound care providers opting to use skin substitutes, bill Medicare for exorbitant fees, and not address the underlying cause of the wound that, in many cases, would prevent the need for the use of skin substitutes in the first place.
Support for Proposed Medicare Payment Policy
A4H strongly supports the proposal to change the way skin substitutes are paid from the methodology used for drugs and biologics to treating them as incident-to supplies. This proposal will help stop the flood of waste, fraud and abuse, and improve the quality of care for hundreds of thousands of Medicare beneficiaries. Specifically:
We note that a recent Office of Inspector General Report stated that “action is urgently needed to rein in the massive increases in Medicare Part B spending for skin substitutes.” The report further called for the critical need for reforms to address fraud, waste and abuse in this area.3 A4H strongly supports CMS action in this important area.
Recommendations for ACOs
ACOs have been on the front lines identifying and reducing fraud, waste and abuse. The ACO community has also been first to signal to the Center for Medicare, the Center for Program Integrity and the Innovation Center circumstances where we see patterns indicative of suspect billing and/or fraud – for example: the DME catheter scam.4 We appreciate CMS acting to both address the fraud and create a process to remove “suspect and anomalous” billing from Medicare Shared Savings Program (MSSP) and ACO REACH.
Problematic billing for skin substitutes is far more layered than catheters. The catheter scam was “truly fraud”5, with bad actors billing for product that was never actually shipped to the patient, or billing for catheters sent to beneficiaries that never wanted/needed a catheter. For skin substitutes, A4H member experiences have been that it’s very hard to tell what is “truly fraud” as opposed to what fits in the “dark grey” area of waste – e.g., services that are clinically inappropriate and incentivized because of payment policy and lax coverage policy. Not all waste is necessarily illegal, especially when there is limited to no coverage policy for many types of wounds.6 The CMS Innovation Center has stated repeatedly that they do not believe that it is appropriate to apply the significant anomalous and high suspect (SAHS) billing policy that was developed in response to the catheter scam.
We strongly believe that ACOs have a role to play in identifying and reducing waste to deliver better care for beneficiaries. A4H members have invested significant resources in improving the quality of wound care for patients. The SAHS policy which, in general, removes the spend associated with fraud from both the benchmarks and medical spend, eliminates the incentives to address the “grey area” waste scenarios, but may be useful in some scenarios or for particular types of billing.
CMS could take steps to make it easier for potential fraud that’s identified by ACOs to be communicated to CMS, for CMS to take immediate action, and to ensure that ACOs are not being held accountable for true fraud. CMS could suspend payment to potentially fraudulent providers if the circumstance meets certain conditions and communicate the claims suspension to ACOs.
In addition, both REACH and MSSP ACOs should be able to re-open their settlements from two or three years prior if criminal proceedings are initiated against potentially fraudulent providers and those providers rendered services to ACO-aligned beneficiaries. We think this longer “re-opening” period would help account for the timing of Department of Justice and OIG investigations, which can take multiple years in some cases.
Finally, CMS could create a new stop loss policy that applies to skin substitutes claims. We would be pleased to discuss these solutions forward and to partner with the CMS fraud war room to develop strategies to address fraud and abuse.
Efficiency Adjustment & Site of Service Payment Differential
To consider changes in medical practice and better reflect the resources involved in furnishing services paid under the PFS, CMS proposes to establish an efficiency adjustment to the work relative value units (RVUs), as well as corresponding updates to the intraservice portion of physician time inputs for non-time-based services. CMS proposes to apply the efficiency adjustment using a look-back period of five years of the Medicare Economic Index (MEI) productivity adjustment percentage to calculate this efficiency adjustment, which would result in a proposed efficiency adjustment of -2.5% for CY 2026.
For each service valued in the facility setting under the PFS, CMS also proposes to reduce the portion of the facility (i.e., outpatient hospital settings and ambulatory surgery centers) Practice Expense (PE) RVUs allocated based on work RVUs to half the amount allocated to non-facility (e.g., office-based) PE RVUs beginning in CY 2026. This change aims to reduce hospital consolidation and ensure payment parity across care settings.
A4H supports both technical proposals, which we believe will increase access to care and make Medicare payments for ambulatory primary care providers more accurate and reflective of the “true” work and practice expense inputs.
Medicare Shared Savings Program (MSSP)
Supporting the Transition to Two-Sided Risk
In light of CMS’ current vision and strategic direction, it is revisiting MSSP policies on the amount of time an ACO can remain under a one-sided model, accelerating the progression to performance-based risk. Current policy allows ACOs to participate for up to seven performance years under a one-sided model. CMS proposes limiting the amount of time an ACO can participate under the BASIC track’s glide path to one agreement period and also limits the amount of time under a one-sided model to, at most, five performance years. A4H supports quicker transitions to two-sided risk and applauds the Administration for this proposed policy. Recent MSSP results continue to underscore that significant savings comes from two-sided risk arrangements. Requiring downside risk adoption must be coupled with an appropriate glidepath for incremental risk adoption to support providers in the transition to accountable care. We believe this proposal strikes the appropriate balance and urge the Administration to finalize as proposed.
ACO Eligibility and Related Financial Reconciliation Requirements
For agreement periods beginning on or after, January 1, 2027, CMS proposes changes to the eligibility requirements to allow for participation by ACOs with a minimum of 5,000 assigned beneficiaries in their third benchmark year (BY), even if the ACO has fewer than 5,000 assigned beneficiaries in BY 1 and/or BY2.
A4H supports policies that will increase participation in ACO models. This proposal will make it easier for new entrants to participate in MSSP, supporting the goals of expanding participation in accountable care. We applaud the Administration for this proposal and urge CMS to finalize as proposed.
APP Plus Quality Measure Set
CMS proposes that the APP Plus quality measure set for MSSP ACOs would include 10 measures (7 eCQMs/Medicare CQMs, 2 administrative claims-based measures, and the CAHPS for MIPS Survey measure) beginning with PY 2028 or the PY that is one year after the eCQM specification becomes available for Quality ID: 493 Adult Immunization Status, whichever is later.
Over the last several years, CMS has increasingly moved to overlay MIPS requirements onto advanced APM participants in ways that are inconsistent with the statutory vision of the Medicare Access and CHIP Reauthorization Act (MACRA). The original intent of the statute and accompanying regulations was to create two separate pathways and among the incentives for participating in advanced APMs, were reduced burdens and bonus payments. However, today, overlaid MIPS requirements have added burden to advanced APM participants and QPs, without providing any meaningful information for patients, providers, or the research community. We strongly urge CMS to decouple MSSP quality reporting from MIPS reporting and to revise the quality measure set for MSSP to be streamlined, reducing burden for ACOs and creating more meaningful information for doctors and their patients. We would be happy to follow up with specific recommendations for how to do this decoupling.
Request for Information Related to APCM and Prevention
CMS seeks comment on the advanced primary care management (APCM) bundle – a coding bundle that first became eligible for payment in CY 2025. APCM expands on Chronic Care Management (CCM) and Principal Care Management (PCM) and reflects essential elements of advanced primary care. The new code set bundled several existing care management and communication technology-based services. While APCM represents an improvement over CCM, there are still barriers that the agency could address related to this bundle.
APCM is a helpful stepping stone to risk. We believe that the attention to advanced primary care capabilities is important, and can help move providers to greater levels of clinical and financial capability over time. CMS should continue to monitor how the APCM bundle interacts with total cost of care models and evaluate for opportunities to continue to integrate across the portfolio.
Cost sharing continues to be a barrier to fully deploying APCM. CMS should explore whether the bundle can be further combined into annual wellness visits, which we believe could help to provide justification for waiving cost sharing.
Finally, the agency should consider creating an additional tier for beneficiaries with six or more chronic conditions.
A4H Supports the Proposed Ambulatory Specialty Model
CMS proposes a mandatory Ambulatory Specialty Model (ASM), which would hold certain specialists financially accountable for upstream management of low back pain and congestive heart failure, two areas of high fee-for-service Medicare spending with significant potential for cost savings. The two-sided risk model would be structured after the MIPS Value Pathway (MVP) framework. Risk adoption would incrementally increase from 9% in 2027 to 12% in in 2031.
ASM is designed to purposely overlap with Advanced APMs and ACOs to increase engagement of specialists, regardless of organizational structure. ASM participants would be required to establish collaborative care arrangements (CCAs) with primary care providers, which must include at least three of the following five elements: data sharing, co-management, transitions in care planning, closed-loop connections, and care coordination integration.
A4H supports the proposed mandatory ASM as a mechanism for enabling specialists to get on a glidepath to accountable care. The Merit-based Incentive Payment System (MIPS), passed by Congress as part of MACRA, was intended to include significant enough positive and negative payment adjustments as to encourage providers – including specialists – to participate in two-sided risk accountable care arrangements. Instead, MIPS today has become a largely “check the box” exercise that does not result in provider behavior change or encourage providers to move to accountable care. ASM, as we understand it in the proposed rule, adheres more closely to the original vision for MIPS – creating true accountability for care with increasing levels of payment “at risk” tied to quality, cost, interoperability and practice improvements. It articulates a defined set of measures for accountability rather than allowing providers to select measures to report. Finally, it purports to provide a true distribution of performance from -9% to +9% and increasing over time, a true differentiator from MIPS today where most providers are clustered with updates of 0-2%. We believe that all of these features are consistent with what was originally intended for the MIPS program and that this mandatory model could create a foundation for understanding how MIPS and MVPs work in the future.
CMS should consider how ASM relates to other payment structures and incentivizes participation in two-sided risk total cost of care models. We encourage the agency to think about how the significantly higher upward adjustments and distribution of payments in ASM could interact with the ACO financial methodology. Along these lines, we are seeking clarity as to whether the proposed financial bonuses and penalties impact the providers entire Part B reimbursement or only the services associated with this model.
In terms of overlap with Advanced APMs and ACOs, we recommend that CMS build in “off ramps” for specialists who meaningfully participate in ACOs. Consistent with the original vision for MIPS, Advanced APM QP status should exempt a specialist from mandatory participation in ASM. Participants in ACOs and other Advanced APMs are inherently already clinically and financially accountable for their patient population so holding them accountable for additional metrics and benchmarks is administratively burdensome.
RFI on Chronic Disease Prevention and Management
CMS solicits feedback to help better understand how it could enhance support management for prevention and management of chronic disease including certain services that address the root causes of disease, chronic disease management, or prevention; address social isolation or loneliness; or improve physical activity. CMS also solicits comment on technical solutions that would enhance the uptake of the annual wellness visit (AWV), whether it should create separate coding and payment for medically-tailored meals, among other topics.
Accountable care models can be extremely impactful in preventing and managing chronic disease, particularly when model waivers and other policies enable ACO participants to provide preventive care. Accountable care models encourage team-based care and care coordination, and provide financial stability needed to make longer term investments in services not covered by Medicare today such as lifestyle programs, social needs investments and more.
Below are several case studies demonstrating the power of accountable care models in supporting management of a range of chronic disease.
Case Study #1: Team-Based Care Models
A 5’8” elderly male with COPD, weighing 325 lbs, could not walk one block and had significant dyspnea ascending stairs. He was desperate for help to improve his pulmonary function and activities of daily living. At his pulmonologist’s suggestion, he began daily nebulizer treatments. While he saw some improvement after one month, it was less significant than he had hoped.
An A4H member brought together a respiratory therapist, health coach, or clinical pharmacist to consult on the patient’s care. His nebulizer medications and the frequency of use were modified. The patient initiated daily exercises and breathing techniques. Following guidance from the respiratory care team and his primary care provider, the patient reduced his food intake and maintained his daily exercise routine, incorporating some light weightlifting. The respiratory care team actively supported his progress with personalized, evidence-based care.
Case Study #2: Care Coordination
A 63-year old woman has advanced hepatic cirrhosis and chronic liver disease. The patient resides in a rural area that lacks transportation and other services for seniors. She struggles to take her medication as directed and does not qualify for state-funded caregiver support. By participating in MSSP, our member could afford to create a Clinical Excellence Team, consisting of Case Management, Clinical Pharmacists, Home Visits Team, and Social Workers. The team is dedicated to analyzing the data from patients who visit the ED frequently and identifying why it is happening. In this patient’s case, the team recognized that the patient needed additional support in getting her other health conditions under control to better position her to manage her chronic condition. By deploying a Home Visits Team Nurse Practitioner, the member could better manage her health, address her various needs, and support her with taking her medication.
Behavioral Health and Lifestyle Interventions
CMS is also seeking input on coding and payment for intensive lifestyle interventions. Our members believe that there is an important opportunity around behavioral health emergency response services and crisis stabilization services that could dramatically improve quality of life for Medicare beneficiaries. We would be pleased to discuss this further.
RFI on FHIR DQM
CMS solicits comment on its anticipated approach to the use of HL7 Fast Healthcare Interoperability Resources (FHIR) in electronic clinical quality measure (eCQM) reporting, noting its aim to transition over time to a fully digital quality measurement (dQM) landscape that promotes interoperability and increase the value of reporting quality measure data. CMS poses questions on a number of topics including eCQM FHIR conversion activities; data standardization for quality measurement and reporting; the timeline under consideration for FHIR-based eCQM reporting; and measure development and reporting tools.
Accountable care entities are generally comprised of many participant providers, each of whom has one or more electronic medical records (EMRs) and numerous other digital tools that collect and store information on a patient’s health and health care. To report eCQMs, quality information must be extracted, standardized and aggregated across participants by the accountable care entity. Accurate quality reporting – both of eCQMs now and dQMs in the future – rely on EMRs to function as expected. Real-world testing requirements should be preserved to ensure that EMRs do in fact function as expected in native technology environments, and new technologies such as Bulk FHIR and API infrastructure should further be preserved and expanded to enable reporting on larger populations such as those aligned to accountable care entities.
In addition, providers are at various states of utilizing and functionality of digital technology.
We offered additional comments on the questions posed in this RFI in our response to the FY 2026 IPPS proposed rule and would be happy to share additional information on the particular challenges for ACOs as desired by CMS.
Conclusion
Accountable for Health appreciates the opportunity to provide feedback on this proposed rule. Please do not hesitate to contact Mara McDermott, mmcdermott@accountableforhealth.org.if we can be a resource.
Sincerely,
Mara McDermott
CEO
Accountable for Health
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