On July 13, 2021, CMS released the calendar year (CY) 2022 Medicare Physician Fee Schedule (PFS) Proposed Rule. The rule in its entirety and the addenda (including Addendum B, which lists the proposed RVUs for each CPT code) can be found on CMS's website. The AUA will submit comments to CMS in response to the proposed rule prior to the comment submission deadline on September 13. (Note that the page numbers listed in this text refer to the PDF display copy of the proposed rule).

What You Need to Know

• The CY2022 proposed conversion factor will be reduced to $33.58, a $1.31 cut from CY2021.
• Based on the American Medical Association’s analysis, the proposed changes in the rule, including the conversion factor decrease, would result in -3.7 percent and -3.8 percent decreases for urology and general surgery, respectively.
• Changes to the calculation of payment for direct practice expense inputs result in significant decreases for some procedures commonly performed by urologists.
• CMS proposes Medicare contractor pricing for four new periurethral adjustable balloon continence devices as recommended by the Relative-Value Scale Update Committee (RUC).
• CMS is proposing the changes with respect to split/shared visits and highlighted their concerns with duplication of care and medical necessity of visits.
• The Merit-Based Incentive Payment System (MIPS) will be revised and phased-out and will move towards the MIPS Value Pathways (MVPs) system beginning in 2023.
• The overall impact of this proposed rule on an individual physician’s reimbursement will depend upon their case mix.

Combined Specialty Impact of Proposed Rule and Conversion Factor Reduction for CY 2022

CMS did not propose any work RVU changes to urology-specific codes under the resource-based relative value scale (RBRVS). CMS proposes Medicare contractor pricing for four new periurethral adjustable balloon continence devices as recommended by the Relative-Value Scale Update Committee (RUC) at the October 2020 RUC meeting: CPT codes 53XX1 Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance, 53XX2 Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance, 53XX3 Periurethral transperineal adjustable balloon continence device; removal, each balloon and 53XX4 Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume.

CMS discussed a stakeholder’s nomination of CPT code 55880 Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance as potentially misvalued as it has not been valued in the non-facility/office setting. CMS disagreed with the assertion that this service is misvalued and noted that CPT code 55880 was reviewed and valued in the CY 2021 PFS final rule (the first year for which this service existed in the CPT code book) and that the stakeholder did not provide necessary evidence that the service is misvalued. The AUA notes that this service is on the RUC’s new technology list and is flagged for RUC review in 2022 (for valuation for CY 2024).

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

Practice Expense Clinical Labor Pricing Update

In this proposed rule, CMS is proposing to update the clinical labor pricing for CY 2022 using the most current Bureau of Labor Statistics (BLS) data in conjunction with the final year of the supply and equipment pricing update. Table 5 (on page 17) includes the proposed clinical labor pricing updates.

The AUA will be working with other similarly impacted medical specialty societies to address procedures negatively impacted by this proposal.

Telehealth

CMS proposed several changes to its Medicare telehealth policies for the CY 2022 Physician Fee Schedule. CMS rejected requests to add the following urology-specific services to the telehealth list on a permanent basis:

• CPT code 51741 Complex uroflowmetry (e.g., calibrated electronic equipment)
• CPT code 90901 Biofeedback by any modality
• CPT code 90912 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient
• CPT code 90913 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; each additional 15 minutes of one-on-one physician or other qualified health care professional contact with the patient (List separately in addition to code for primary procedure)

CMS noted with respect to CPT code 51741 that the remote interpretation of diagnostic tests is not considered to be a telehealth service and that the technical component of this service would not meet the criterion to be added on a Category 1 basis because it is not like other services on the Medicare telehealth list. CMS also noted that they do not believe that the uroflowmetric information can be accurately and effectively collected using two-way, audio/visual communication technology to the degree that would make the results clinically useful.

CMS noted with respect to CPT codes 90901, 90912, and 90913 that they do not believe that these services are similar to Category 1 services on the Medicare telehealth list. CMS also noted that these services describe the application of electrodes directly to the patient’s skin and that they believe the proper application of electrodes would require the beneficiary and provider to be in the same physical location.

CMS is considering adding additional services to the Medicare telehealth services list under Category 3 designation, which was established in 2020 rulemaking to add services on a temporary basis following the end of the COVID-19 public health emergency. These are services likely to have a clinical benefit when furnished via telehealth, but there is not yet sufficient evidence for the agency to consider adding them to the telehealth list on a permanent basis.

The agency includes a separate list of services added to the telehealth list on an interim basis in response to the COVID-19 public health emergency, but not on a Category 3 basis (Table 11 on page 35); these services will be removed when the COVID-19 public health emergency expires and include hospital inpatient services (CPT codes 99221-3), observation care services (CPT codes 99218-20, 99234-6), and telephone evaluation & management visit services (CPT codes 99441-3).

Other notable telehealth provisions in the CY 2022 PFS proposed rule include:

• Soliciting information on whether the COVID-19 public health emergency-related flexibilities related to direct supervision should be made permanent by revising the definition of “direct supervision” to include immediate availability through the virtual presence of the supervising physician or practitioner using real-time, interactive audio/video communications technology without limitation.
• Proposing to permanently adopt and provide reimbursement for virtual check-in HCPCS code G2252 (Brief communication technology-based service, e.g., virtual check-in service, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11–20 minutes of medical discussion).
• The Chronic Care Management/Complex Chronic Care Management/Principal Care Management code family now includes five sets of codes, each set with a base code and an add-on code. The sets vary by the degree of complexity of care (that is, CCM, CCCM, or PCM), who furnishes the care (that is, clinical staff or the physician or non-physician practitioner), and the time allocated for the services. CMS is proposing to accept the work and PE values as recommended by the RUC (see Table 12 on page 73). CMS is also interested in understanding the process employed to get beneficiary consent for these services and asks for comment on this issue, specifically on what levels of supervision are necessary to obtain beneficiary consent when furnishing CCM services and will consider such comments in future rulemaking.

Evaluation & Management Split/Shared Visits

CMS is proposing significant changes to split (or shared) Evaluation & Management visits. A split/shared visit refers to an E/M visit that is performed (“split” or “shared”) by both a physician and a non-physician practitioner (NPP) who are in the same group. CMS needs to address whether and when a physician can bill for these visits because they are reimbursed at a higher rate than an NPP. In the office, physicians can bill for these services when the NPP’s services are “incident to” the physician’s professional services; however, the “incident to” rules do not apply in the facility setting. CMS sees the changes in the rule as distinguishing between split/shared visits and those services furnished incident to the professional services of a physician.

CMS is proposing the changes listed below with respect to split/shared visits and highlighted their concerns with duplication of care and medical necessity of visits:

• Definition of split/shared visits: In the facility setting, a split/shared visit is one performed in part by both a physician and a NPP who are the same group where “incident to” billing is prohibited and is furnished in accordance with applicable law and regulation, including conditions of coverage and payment, such that the E/M visit could be billed by either the physician or the NPP if it were furnished independently by only one of them in the facility setting.
• Physicians and NPPs can bill split/shared visits for both new and established patients and for critical care and certain SNF/NF E/M visits.
• Definition of “substantive portion”: Only the physician or NPP who performs the substantive portion of the visit would bill for it, so the agency proposes “substantive portion” to mean more than half of the total time spent by the physician and NPP performing the visit.
• Distinct time: The distinct time spent by each physician or NPP furnishing a split/shared visit would be summed to determine the total time and who provided the substantive portion.
• Qualifying time: CMS is proposing a listing of activities that could count toward total time for determining substantive portion (for services other than for critical care) including:
  • Preparing to see the patient (for example, review of tests).
  • Obtaining and/or reviewing separately obtained history.
  • Performing a medically appropriate examination and/or evaluation.
  • Counseling and educating the patient/family/caregiver.
  • Ordering medications, tests, or procedures.
  • Referring and communicating with other health care professionals (when not separately reported).
  • Documenting clinical information in the electronic or other health record.
  • Independently interpreting results (not separately reported) and communicating results to the patient/ family/caregiver.
  • Care coordination (not separately reported).
• CMS is proposing to revise its policy to allow a practitioner to bill for a prolonged E/M as a split/shared visit.
• CMS is proposing that the two individual practitioners who performed the visit must be documented in the medical record and the individual who performed the substantive portion would be required to sign and date the medical record.
• CMS is proposing to create a modifier to be billed with these visits to identify the visits as split/shared visits.

Quality Payment Program, MIPS, and MVPs

CMS is continuing to move forward with the development of MIPS Value Pathways (MVPs) and proposes to delay the transition to MVPs to the CY 2023 performance year. CMS is proposing the following MVP implementation timeline:

• CY 2023 performance period – the initial set of MVPs will be available for reporting and that reporting is voluntary.
• CY 2024-2027 performance periods – the MVP portfolio will be updated to include new MVPs that are available for reporting and MVP reporting is still voluntary.
• The end of the CY 2027 performance period – CMS will sunset traditional MIPS.
• CY 2028 performance period and subsequent years – CMS will require mandatory MVP reporting.

CMS plans to gradually implement MVPs for specialties and subspecialties that participate in the MVP program. For the CY 2023 performance year, CMS is proposing to implement the following MVPs:

1. Rheumatology
2. Stroke Care and Prevention
3. Heart Disease
4. Chronic Disease Management
5. Emergency Medicine
6. Lower Extremity Joint Repair
7. Anesthesia

Each proposed MVP includes a specific set of measures and activities from the quality performance category, improvement activities performance category, and the cost performance category. CMS also includes a “foundational layer” of measures which includes population health measurers and promoting interoperability performance category measures.

CMS is also proposing to retain one Large Urology Group Practice Association (LUGPA) stewarded urology measure – Urinary Symptom Score Change 6-12 Months After Diagnosis of Benign Prostatic Hyperplasia – in the Urology and Geriatrics MIPS measure sets.

Physician Self-referral

CMS is proposing to revise the regulation that sets forth the conditions for “indirect compensation arrangements.” Under this revision, an unbroken chain of financial relationships between a physician and an entity would be an indirect compensation arrangement for purposes of the physician self-referral law if the unit of compensation received by the physician (or immediate family member) is payment for anything other than services personally performed by the physician (or immediate family member). This would include an arrangement for the rental of office space or equipment.

Requiring Certain Manufacturers to Report Drug Pricing Information for Part B and Determination of ASP for Certain Self-Administered Drug Products

In November 2017, the Office of Inspector General (OIG) conducted a study¹ and found that CMS included non-covered, self-administered versions of Part B drugs when calculating payment amounts for two Part B drugs, Orencia and Cimzia, even though Part B generally does not cover drugs that are self-administered. OIG found that inclusion of these non-covered versions significantly increased Medicare expenditures. Since then, OIG has recommended that Congress pass legislation to give CMS the authority to determine when non-covered, self-administered versions of Part B drugs should be included in the calculation of the average sales price (ASP).

Congress directed the OIG to conduct periodic studies to identify non-covered, self-administered drugs or biologicals that are included in the calculation of payment. Further, the statute permits CMS to apply the “lesser of” methodology to applicable billing and payment codes. Specifically, the Medicare payment limit for a drug or biological billing and payment code in these circumstances would be the lesser of: (1) the payment limit determined using the current methodology where the calculation includes the ASPs of self-administered versions; or (2) the payment limit determined after excluding the non-covered, self-administered versions. CMS proposes to codify this methodology to be used for any drug or biological product identified by OIG. CMS states that they will not apply the “lesser-of” methodology if the drug is reported on the “Drug Shortage” list by the FDA.

¹https://oig.hhs.gov/oei/reports/oei-12-17-00260.pdf