The Centers for Medicare and Medicaid Services (CMS) on November 2nd released the CY 2022 Medicare Physician Fee Schedule final rule. The final rule implements on January 1, 2022 a number of policies that impact urology. These policies include a reduction in the Medicare conversion factor from $34.8931 (2021) to $33.5983 (2022) and an update to direct practice expense clinical labor rates that CMS significantly modified based on AUA input.

• CY 2022 MPFS Impacts on Urology Codes Compared with CY 2021 Rates (Facility and Non-Facility Rates) [pdf]
• CY 2022 MPFS Impacts on Evaluation & Management Codes Compared with CY 2021 Rates (Facility and Non-Facility Rates) [pdf]

Direct Practice Expense Clinical Labor Rate Update

The revised direct practice expense clinical labor rate update modifies the policy to be phased in over four years and utilizes median Bureau of Labor Statistics (BLS) wage data (as opposed to mean BLS wage data) and the 2021 BLS fringe benefits multiplier of 1.296 (as opposed to the 2002 BLS fringe benefits multiplier of 1.366). The four-year phase in and revised BLS wage and fringe benefits inputs will mitigate the impacts of this policy and enable practices to better absorb its impacts.

“AUA strongly advocated against the clinical labor rate update as originally proposed and we are grateful to CMS for listening to our professional input and implementing a four-year phase in and modified BLS wage and fringe benefits data”, said Dr. Eugene Rhee, AUA Public Policy Council Chair. “While we still believe that a one-year delay of this proposal would have been appropriate, these modifications will mitigate the impacts of this policy change. Urologists must be able to provide care in the most appropriate setting to ensure that our patients – particularly those in rural and underserved communities – have access to the care that they need. The AUA will continue to work with CMS to ensure that we are able to do so.”

In our comment letter to CMS, AUA advocated a number of changes to this policy (four of which were accepted by CMS):

Accepted

• Phase the update in over a four year period
• Use the median instead of the mean BLS wage rate data
• Use a current and accurate fringe benefits multiplier
• Implement a more regular review process (e.g., every 5 years)

Not Accepted

• Delay the proposal for one year
• Implement a device offset

AUA was active on several fronts to ensure that the clinical labor rate update was not implemented in CY 2022 as proposed. In July, AUA staff began working with several other specialty societies as part of a Clinical Labor Coalition in order to address this issue with a unified front (and submitted a comment letter to CMS as part of this effort). On August 25, AUA met with CMS staff and raised the proposed clinical labor rate update issue. On October 7, AUA and the Clinical Labor Coalition met with the White House Domestic Policy Council and on October 25, AUA and the Clinical Labor Coalition met with the Office of Management and Budget (OMB) to discuss the proposal to update direct practice expense clinical labor rates. During these meetings, Dr. Thomas M.T. Turk spoke about urologic procedures performed in the non-facility office setting that require expensive devices.

Medicare Conversion Factor

CMS also finalized a reduction to the Medicare conversion factor from $34.8931 (2021) to $33.5983 (2022); this reduction is largely a result of the expiration of the 3.75 percent conversion factor increase for CY 2021 included in the Consolidated Appropriations Act, 2021 (CAA) in response to the COVID-19 public health emergency. CMS does not have statutory authority to avoid this reduction and any further increase in the conversion factor will require Congressional action; AUA continues to engage with Congress on this issue as part of the Surgical Coalition and has been active at the grassroots level.

Notably, on October 14, Representatives Ami Bera, MD (D-CA-07) and Larry Bucshon, MD (R-IN-08) finalized a congressional sign-on “Dear Colleague” letter sent to House leadership. The letter, which was signed by more than 245 lawmakers, outlines the breadth of potential payment cuts on the horizon. Specifically, the letter requests an extension of the 3.75 percent payment adjustment to the Medicare conversion factor under the CAA while considering a framework to ensure appropriate reimbursement and improve the Medicare payment system broadly.

Working with dozens of other physician groups, the AUA engaged its members in a grassroots effort to promote the effort and gather signatories from members of Congress, which resulted in 196 AUA members contacting 195 congressional offices on the topic.

Telehealth

CMS finalized with modifications a number of policies related to the provision of telehealth services. Many of these policies are either in response to the COVID-19 public health emergency (PHE) or telehealth provisions enacted through the CAA. AUA supported CMS’ thoughtful implementation of many of these telehealth policies in our comment letter in response to the CY 2022 proposed rule while advocating that CMS expand its definition of the word “home” as an originating site.

CMS finalized a policy to retain a number of Category III telehealth services through CY 2023 in order to collect data and facilitate proposals to keep services on telehealth list in CY 2024. CMS maintains a list of telehealth services for Medicare and places these services into three categories:

• Category 1 - Services that are determined to be similar to services on the existing Medicare telehealth services list for the roles of, and interactions among, the beneficiary, physician at the distant site and, if necessary, the telepresenter.
• Category 2 - Services that are not similar to those on the current Medicare telehealth list. Review includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the procedures demonstrated clinical benefit to the patient.
• Cateogry 3 - Services covered temporarily during the PHE, but for which CMS has not yet developed evidence sufficient to meet the requirements for permanent coverage.

CMS also finalized the implementation of policies around the provision of mental health services via telehealth, including the use of audio-only two-way communications systems when two-way audio-video is available to the provider but the patient either does not have access to video services or does not consent to utilize video services. CMS did not add CPT codes 99441-99443 to the Category 3 telehealth services list for the provision of mental health services because under the CY 2022 MPFS final rule, CPT codes 99202-99205 and 99211-99215 may be provided via audio-only for mental health services.

CMS finalized a timeframe for in-person visit for telehealth services for mental health services to once every 12 months (though more frequent visits are allowed) and will allow a clinician’s colleague in the same subspecialty in the same group to furnish the in-person, non-telehealth service to the beneficiary if the original practitioner is unavailable (CMS originally proposed requiring an in-person visit for these services once every 6 months).

CMS addressed AUA’s comments regarding the definition of the word “home” for the purposes of originating site (AUA felt that the proposed definition was too narrow and risked cutting beneficiaries off from care) and clarified that – as proposed in our comment letter – “home” can include temporary lodging such as hotels and homeless shelters as well as locations a short distance from the beneficiary's home.

Finally, CMS provides a definition of “audio-only telecommunications system” but reiterates that distant site physicians must still have the technical capability to use an interactive telecommunications system that includes two-way, real-time interactive audio and video communications at the time that an audio only service is furnished; this policy is only applicable to telehealth mental health services at this time; physicians must use a new modifier for services furnished using audio-only communications.

Split-Shared Evaluation & Management (E/M) Visits

CMS finalized its proposal for split (or shared) Evaluation & Management (E/M) visits with modifications. CMS finalized the definition of “substantive portion” of a split (or shared) E/M visit in the facility setting as more than half of the total time spent by the physician or non-physician practitioner (NPP) performing the split (or shared) visit.

CMS also finalized its definition of “substantive portion” for a split (or shared) visit as more than half the total time spent by the physician and NPP performing the split (or shared) visit beginning on January 1, 2023. However, for CY 2022, CMS will define the substantive portion as one of the three key components (history, exam, or medical decision making), or more than half of the total time spent by the physician and NPP performing the split (or shared) visit. Practitioners can still use MDM to select visit level for the E/M split (or shared) visit; however, when one of the three key components is used as the substantive portion for the E/M split (or shared) visit in CY 2022, the practitioner who bills the visit must perform that component in its entirety to bill.

AUA submitted comments opposing CMS’ proposal to exclusively use time to determine the substantive portion of a split (or shared) E/M visit, noting that this policy would require physicians and NPPs to further document time and increase administrative burden while also negating the recent updates to the CPT E/M guidelines to allow visit level selection based on either time or MDM. AUA advocated for allowing MDM when determining the substantive portion of the split (or shared) E/M visit.

Furthermore, split (or shared) E/M visits can be reported for new as well as established patients and for initial and subsequent visits. CMS will require a modifier on the claim to identify these services and documentation in the medical record must identify the two individuals who performed the visit; the individual who performed the substantive portion of the visit must sign and date the medical record.

Stark Law Regulations

CMS did not finalize proposed changes to Stark law regulations that would have impacted indirect compensation arrangements at § 411.354(c)(2)(ii)(A)(4). By not finalizing this proposal, CMS continues to take a more narrow approach – in line with its historical approach – to indirect compensation arrangements specifically with respect to lithotripsy procedures.

Other Urologic Payment Policies

CMS finalized proposals for 5 urology-specific CPT codes. CMS is finalizing Medicare contractor pricing – based on AMA Relative-Value Scale Update Committee (RUC) recommendations – for the following new CPT codes that describe periurethral balloon continence device procedures:

• 53451 Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance
• 53452 Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance
• 53453 Periurethral transperineal adjustable balloon continence device; removal, each balloon
• 53454 Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume

CMS also confirmed its assertion that CPT code 55880 Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance is not potentially misvalued (in response to a stakeholder submission) and that this CPT code will be reviewed by the AMA RUC in the coming year. AUA agreed with CMS’ determination with respect to CPT code 55880.

MIPS Value Pathways (MVPs) and the Quality Payment Program (QPP)

CMS finalized AUA’s preferred policy of delaying implementation of the MIPS Value Pathway (MVP) framework until the 2023 MIPS performance year. In the final rule, CMS reiterated that it does not believe that maintaining both MIPS and MVPs is a feasible long-term approach and that it is considering sunsetting traditional MIPS at the end of the CY 2027 performance period/2029 MIPS payment year. CMS did note, however, that these are planning statements and any formal proposal to mandate MVP reporting and sunsetting of MIPS would be made in future rulemaking. CMS also thanked organizations, like the AUA, for commenting on the inclusion of equity measures in the quality payment program and stated that this feedback would be incorporated in future rulemaking as appropriate.

For the 2023, 2024, and 2025 performance years, CMS will allow individual clinicians, single specialty groups, multispecialty groups, subgroups, and APM Entities to report MVPs. For the 2026 performance year and for future years, CMS will allow individual clinicians, single specialty groups, subgroups, and APM Entities to report MVPs. For the 2023, 2024, and 2025 MIPS performance years, CMS will define an MVP Participant as: Individual clinicians, Single specialty groups, Multispecialty groups, Subgroups, and APM Entities. Beginning in the 2026 performance year, multispecialty groups will be required to form subgroups to report MVPs.

Proposed MVPs

CMS finalized the seven proposed MVPs for the CY 2023 performance year:

• Rheumatology
• Stroke Care and Prevention
• Heart Disease
• Chronic Disease Management
• Emergency Medicine
• Lower Extremity Joint Repair
• Anesthesia

MVP Development Criteria

In the CY 2021 final rule, CMS established a specific set of criteria to be used in the development and selection of MVPs. In the CY 2022 final rule, CMS finalized the following additions to the MVP development criteria beginning with the CY 2022 performance year:

• MVPs must include at least one outcome measure that is relevant to the MVP topic.
• Each MVP that is applicable to more than one clinician specialty should include at least one outcome measure that is relevant to each clinician specialty included.
• In instances when outcome measures are not available, each MVP must include at least one high priority measure that is relevant to the MVP topic.
• Allow the inclusion of outcomes-based administrative claims measures within the quality component of an MVP.
• Each MVP must include at least one high priority measure that is relevant to each clinician specialty included.
• Allow the inclusion of outcomes-based administrative claims measures within the quality component of an MVP.
• To be included in an MVP, a qualified clinical data registry (QCDR) measure must be fully tested at the clinician level.

Finalized MVP Reporting Requirements

CMS finalized the following MVP reporting requirements for all MVP participants for the four MIPS performance categories:

• Quality Performance Category – An MVP Participant selects four quality measures, and one must be an outcome measure (or a high priority measure if an outcome is not available or applicable), declining AUA’s suggestion that a participant be permitted to select more than four quality measures.
• Improvement Activities Performance Category – The MVP Participant must select:
  • Two medium weighted improvement activities; or
  • One high weighted improvement activity; or
  • Participates in a certified or recognized patient-centered medical home (PCMH) or comparable specialty practice.
• Cost Performance Category – An MVP Participant is scored on the cost measures that are included in the MVP that they select and report.
• Foundational Layer
  • Population Health Measures – An MVP Participant selects one population health measure, at the time of MVP registration, to be scored on.
  • Promoting Interoperability (PI) Performance Category – An MVP Participant is required to meet the Promoting Interoperability performance category requirements.

In response to criticism by the AUA and others that population health measures may not be specialty-relevant, CMS noted that population measures capture outcomes important to patients and therefore provide meaningful information to clinicians so that they can improve their practices.

MVP Registration

To report an MVP, an MVP Participant and subgroup must register for the MVP between April 1 and November 30 of the performance year, or a later date as specified by CMS. To report the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey associated with an MVP, a group, subgroup, or APM Entity must complete their MVP registration by June 30 of the performance year to align with the CAHPS for MIPS Survey registration deadline. At the time of MVP registration, an MVP Participant would select: the MVP they intend to report; one population health measure included in the MVP; any outcomes-based administrative claims measure on which the MVP Participant intends to be scored, if available within the MVP. During registration an MVP Participant will not be able to submit or make changes to the MVP they select after the close of the registration period (November 30 of the performance year) and will not be allowed to report on an MVP for which they did not register.

MVP QDCR Meaures

To be included in an MVP, a qualified clinical data registry (QCDR) measure must be fully tested. In its final rule, CMS provided clarity on the inclusion of QCRD measures in MVPs. CMS encouraged QCDRs to share testing data for their fully tested QCDR measures at the time of MVP candidate submission. CMS also noted that, if a QCDR is unable to submit testing data to demonstrate that a QCDR measure is fully tested at the clinician level by the end of the self-nomination period or otherwise does not meet requirements, the QCDR measure will not be finalized within the MVP. In response to questions by the AUA and others as to what constitutes “fully tested at the clinician level,” CMS again referred commenters to the CMS Measures Management System Blueprint, as well as prior rulemaking.

MIPS Cost & Quality Performance Category Updates

CMS finalized a zero percent weight to the cost performance category for 2020 PY/CY 2022 payment year due to the ongoing public health emergency. CMS also finalized the proposal to remove end-to-end electronic reporting and the high-priority measure bonus points for the 2022 performance period and to remove the 3-point floor for scoring measures, with exceptions for small practices, beginning with the 2023 performance period. CMS declined to finalize the proposal to use performance period benchmarks exclusively for the 2021 performance period. CMS will create historical benchmarks for the 2022 performance period, using data submitted for the 2020 performance period.

Performance Category Weights

The 2022 performance year/2024 payment year performance weights, CMS finalized the weights specified in statute:

• 30% for the quality performance category;
• 30% for the cost performance category;
• 15% for the improvement activities performance category;
• 25% for the promoting interoperability category.

Newly Finalized & Removed Urology Measures

CMS also finalized a new urology process measure within the effective clinical care national quality strategy domain on intravesical BCG for non-muscle invasive bladder cancer. The measure, stewarded by Oregon Urology, would measure Percentage of patients initially diagnosed with non-muscle invasive bladder cancer and who received intravesical BCG within 6 months of initial diagnosis. CMS also finalized removal of the Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients) measure, the Pelvic Organ Prolapse: Preoperative Screening for Uterine Malignancy measure, and the Proportion of Patients Sustaining a Ureter Injury at the Time of Pelvic Organ Prolapse Repair measure.