August 28, 2026

Mehmet Oz, MD
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment Rule (CMS-1850-P)

Dear Dr. Oz:

The American Urological Association (AUA) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule captioned above (Proposed Rule), which includes proposals to update payment rates and regulations affecting Medicare services furnished in hospital outpatient and Ambulatory Surgery Center (ASC) settings beginning in CY 2027.

The AUA is a leading advocate for the specialty of urology and has more than 24,000 members throughout the world. Our members represent the world's largest collection of expertise and insight into the treatment of urologic disease. Of the total AUA membership, more than 17,000 are based in the United States and provide invaluable support to the urologic community by fostering the highest standards of urologic care through education, research, and the formulation of health policy.

On behalf of our members, we actively engage in the development of health policy and regulation and routinely comment on regulatory proposals of the Department of Human and Health Services and its subagencies that affect our members and their patients. Our comments, which are explained in more detail below, can be summarized as follows:

1. The AUA recommends payment parity between CPT code 52282, cystourethroscopy with insertion of a permanent urethral stent (APC 5375), and Category III CPT codes 0941T, 0942T, and 0943T, cystourethroscopy with insertion and expansion of a prostatic urethral scaffold (APC 5376), given the clinical similarities in the devices, physician work, and resources required to perform these
2. AUA supports APC level 4 designation for integrated sacral neurostimulators under CPT code 0786T.
3. The AUA opposes CMS's proposed reduction of ASC reimbursement for CPT 64561 and 64590 due to lack of justification or meaningful change from CY 2026 to CY 2027.
4. AUA opposes codes 54400, 54401, 54405, and 54461 (Penile Prosthesis) being subject to ASC multiple procedure reduction.
5. The AUA opposes changes under the Inpatient Only List (IPO) without CMS formulating a fair reimbursement methodology that preserves physician practices. The proposed changes would disproportionately impact urological procedures (male genital, female genital and urinary).
6. AUA supports CMS's efforts to assign SaMS technologies to appropriate APC classifications and offers suggestions on how best to accomplish these goals.

I. Permanent Prostatic Urethral Stent, CPT® Code 52282 (APC 5375)

The American Urological Association (AUA) supports appropriate payment for the resources associated with CPT code 52282 and proposes that the associated permanent prostatic urethral stent devices be designated as "device-intensive." This designation would require device reporting and, importantly, facilitate appropriate payment for the procedure in the ambulatory surgical center (ASC) setting. For CY 2027, the AUA believes the device offset should be based on the manufacturer's invoice cost to ensure that payment appropriately reflects the actual cost of the device.

The AUA also supports parity in the treatment and payment of clinically comparable devices and procedures. Devices associated with Category III CPT codes 0941T, 0942T, and 0943T, which are assigned to APC 5376, involve cystourethroscopy with insertion and expansion of a prostatic urethral scaffold. These procedures require substantially similar work, effort, and resources as CPT code 52282. Accordingly, the AUA believes that comparable devices should receive consistent treatment under the OPPS, including consideration of device-intensive status and appropriate device-related payment.

CMS proposes to reassign CPT code 52282 (cystourethroscopy with insertion of a permanent urethral stent) from APC 53 74 (Level 4 Urology and Related Services), with a CY 2027 payment rate of$4,064, to APC 5375 (Level 5 Urology and Related Services), with a payment rate of $6,292. This proposed change would increase Medicare outpatient hospital department payment for the procedure by approximately 55%.

We urge CMS to consider these recommendations in finalizing the CY 2027 OPPS rule to ensure that payment accurately reflects the resources required to furnish these procedures and promotes appropriate payment parity among clinically similar technologies.

 

II. Integrated Sacral Neurostimulator, CPT Code 0786T

The AUA supports CMS's proposal to assign CPT code 0786T to an APC level 4 given the lack of claims data being available. CMS appropriately relied on clinical and resource homogeneity in proposing the Level 4 assignment, and we encourage CMS to finalize this APC assignment. The AUA is also engaged with an AMA workgroup that is currently developing additional definitions regarding integrated sacral neurostimulators, which we hope will help further define and provide clarity for our members regarding this procedure.

For CY 2027, CMS proposes to reassign CPT code 0786T (Insertion or replacement of percutaneous electrode array, sacral, with integrated neurostimulator, including imaging guidance, when performed) from APC 5463 (Level 3 Neurostimulator and Related Procedures) to APC 5464 (Level 4 Neurostimulator and Related Procedures). Since CPT code 0786T was not assigned to a clinical APC until January 1, 2026, there were no CY 2025 Medicare claims data available to inform the APC assignment at that time.

Without claims data to inform CMS on appropriate APC placement for 0786T, the agency instead compared the procedure to existing sacral and tibial neuromodulation procedures for bladder dysfunction and concluded that the resources and clinical effort are like those associated with APC 5464. CMS's proposed APC reassignment will increase payment for CPT code 0786T in 2027, from $12,673 to $22,150.

III. CPT 64590 & 64561 - Sacral Neuromodulation

The AUA opposes CMS's proposed reduction of ASC reimbursement for CPT codes 64561 and 64590 due to lack of justification or meaningful change from CY 2026 to CY 2027. CMS's proposes to reduce APC reimbursement by 50% when CPT codes 64590 and 64561 (sacral neuromodulation procedures) are performed in the same setting. Both procedures are device-intensive and require significant device-related resources. A 50% reduction in APC reimbursement would not adequately reflect the costs associated with these procedures and could make performing the combined procedure financially unviable.

The AUA is concerned that if CMS adopt this proposed change, patients will lose access to having these procedures performed in an ASC and shift the procedures into less accessible hospital outpatient departments, where scheduling and wait times may potentially increase, thereby delaying care.

CMS also proposes changes to the ASC Addendum AA that would make sacral nerve stimulation (SNS) procedures involving CPT codes 64561 [Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed] and 64590 [Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver] subject to multiple procedure reduction.

Under the CMS multiple procedure reduction rule, the highest-valued eligible procedure is paid at 100% of ASC payment rate, and subsequent procedures are paid at a reduced rate at 50% of the allowable rate when performed in the same operative session. While this methodology is intended to account for efficiencies when multiple procedures are performed together, it does not fully reflect the device resources associated with implantable neuromodulation procedures.

CPT code 64561 for example, represents a distinct lead placement procedure and a separate implantable electrode array that the ASC must acquire and furnish for the procedure. Reducing 64561 potentially by 50%, this could make the SNS procedures less viable in the ASC.

 

1. CPT 54400, 54401, 54405, 54410, & 54416- Penile Prosthesis

The AUA urges CMS not to implement the multiple procedure payment reduction (MPPR) policy for CPT codes 54400, 54401, 54405, 54410, & 54416. CMS proposes to dramatically reduce reimbursement for penile prosthesis procedures by applying the MPPR policy. This could create financial challenges for ASCs and limit physician clinical choice when choosing the appropriate site of care for a Medicare beneficiary. Insufficient ASC payment could inadvertently restrict patient access and create bottlenecks in hospital outpatient departments with the potential to undermine the quality of care, efficiency, and patient satisfaction.

Additionally, CMS revised the CY 2027 Addendum AA changing several penile prothesis CPT codes (as listed in the table below) from "No" to "Yes" indicating the services would be subject to the MPPR in the ASC. CMS has not provided a clear rationale for changing the longstanding treatment of these device-intensive codes which does not give stakeholders the opportunity to provide informed comments.

Code	Long Description	Status Indicator	Proposed CY 2027 Device Offset Percentage
54400	Insertion of penile prosthesis; non inflatable (semi rigid)	JS	67.35%
54401	Inflatable (self-contained)	JS	72.91%
54405	Insertion of multi component, inflatable penile prosthesis, including placement of pump, cylinders, and reservoir	JS	72.12%
54410	Removal and replacement of all component(s) of a multi-component, inflatable penile prosthesis at the same operative session	JS	6S.71%
54416	Removal and replacement of non-inflatable (semi rigid) or inflatable (self-contained) penile prosthesis at the same operative session.	JS	67.70%

Applying these reductions could create financial challenges for ASCs and limit physician clinical choice in the most appropriate site of care. Insufficient ASC payment could inadvertently restrict patient access and create bottlenecks in hospital outpatient departments with the potential to undermine the quality of care, efficiency, and patient satisfaction.

V. Proposed CY 2027 Changes to the Inpatient Only List

The AUA opposes changes under the Inpatient Only List (IPO) without CMS formulating a fair reimbursement methodology that preserves sustainable practices. The proposed changes would disproportionately impact urological procedures including (male genital, female genital and urinary tract procedures).

CMS proposes the continued elimination of the inpatient only (IPO) list with implementation of the second phase of the process by removing 637 procedures from the IPO in the following clinical families: auditory, digestive, endocrine, female genital, hemic and lymphatic systems, integumentary, male genital, maternity care and delivery, mediastinum and diaphragm, respiratory, and urinary.

Should urological procedures be eliminated from the IPO, there must be reimbursement parity between the inpatient setting and within outpatient setting sites of care, which include ASCs. Regardless of setting of care, the work, time, and intensity of these procedures would remain the same. In addition, as patient volume increases into the ASCs, more resources and overheads will be utilized, necessitating CMS to provide reimbursement rates that account for these significant shifts. While the AUA is broadly supportive of moving procedures impacting male genital, female genital and urinary care into outpatient settings of care, the AUA urges CMS to consult relevant stakeholders to formulate a fair reimbursement methodology that preserves sustainable practices.

 

VI. OPPS Payments for Software as a Medical Service (SaMS)

AUA supports CMS's continued efforts and engagement on SaMS and how to appropriately address payment for innovative technological services. CMS proposes an interim payment policy of assigning all service codes representing SaMS technologies to new technology APCs for CY 2027 while the agency contemplates a broader strategy for payment of these types of services.

Recognizing that there is wide variation between these technological medical services, AUA encourages CMS to consider payment strategies and methodologies for SaMS that adequately account for data complexity, collection, use, and updates by:

• Separately evaluating each new technology to determine the appropriate HCPCS coding, including whether a potential CPT code can be used to support payment for the separate and distinct service under the OPPS.
• Considering separately payable codes for SaMS where appropriate in circumstances when the cost of the AI/software would not be adequately covered if included in the bundled service.
• If not separately payable, considering whether a service should be assigned to a higher cost APC when use of SaMS results in discrete and incremental costs.

In addition, AUA believes CMS should factor the full range of AI/software costs into its payment rates/and bundles including unique costs for collecting data, conducting analyses that require significant computing power, and maintaining and updating systems (including cybersecurity). CMS should include the costs for updates to and maintenance of technologies over time (including FDA-required updates and technical updates) in determining changes in payment for separately payable or bundled codes for AI/software functions over time.

Thank you for your consideration of our comments. If you have any questions or would like additional information, please contact Irfan Khan, AUA's lead on payment policy and reimbursement strategy, at ikhan@auanet.org.

Sincerely,

Mark T. Edney, MD, MBA
Chair, AUA Public Policy Council

Anurag Das, MD
Chair, AUA Physician Payment & Reimbursement Committee