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Proposed Rule on Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 (CMS-1799-P)

On June 28, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the proposed rule entitled, “Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023” (CMS-1799-P). This proposed rule is part of a larger strategy to address significant, anomalous, and highly suspect (SAHS) within ACO reconciliation, and additional information will be forthcoming in the Physician Fee Schedule.

This Fact Sheet summarizes the proposed changes to the Medicare Shared Savings Program (Shared Savings Program) that are included in this proposed rule. There will be a 30-day public comment period on the SAHS billing activity proposed rule. CMS encourages all interested members of the public, including Accountable Care Organizations (ACOs), providers, suppliers, and Medicare beneficiaries to submit comments so that CMS can consider them as we develop the final rule. The 30-day comment period closes on July 29, 2024. Comments can be submitted at: https://www.regulations.gov/ (in commenting please refer to file code CMS-1799-P).

CMS uses payment amounts on Medicare Parts A and B claims to calculate various factors used in Shared Savings Program financial calculations, including expenditures for beneficiaries assigned to an ACO, expenditures for the national assignable fee-for-service (FFS) population and the assignable population in an ACO’s regional service area, as well as in calculations used to determine ACO revenue status (high revenue or low revenue). Recently, CMS observed an increase in Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) billing to Medicare for selected intermittent urinary catheter supplies in CY 2023, which could, if unaddressed, adversely impact the accuracy, fairness, and integrity of Shared Savings Program financial calculations.

The observed DMEPOS billing volume in CY 2023 for Healthcare Common Procedure Coding System (HCPCS) codes A4352 (Intermittent urinary catheter; Coude (curved) tip, with or without coating (Teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each) and A4353 (Intermittent urinary catheter, with insertion supplies) represents SAHS billing activity. Generally, a HCPCS or Current Procedural Terminology (CPT) code exhibits SAHS billing activity when there is a significant increase in claims, either in volume or dollars, with national or regional impact, which represents a deviation from historical utilization trends that is unexpected and is not clearly attributable to reasonably explained changes in policy or the supply or demand for covered items or services. In this proposed rule, we propose to exclude payment amounts for the two HCPCS codes on DMEPOS claims submitted by any supplier from expenditure and revenue calculations used for: assessing performance year (PY) 2023 financial performance of Shared Savings Program ACOs, establishing benchmarks for ACOs starting agreement periods in 2024, 2025, and 2026, and calculating factors used to determine revenue status and repayment mechanism amounts in the application and change request cycles for ACOs applying to enter a new agreement period beginning on January 1, 2025, or continue their participation in the program in PY 2025, respectively.

The modifications to the Shared Savings Program financial methodology in this proposed rule, with a 30-day comment period, are anticipated to delay by up to six weeks issuance of initial determinations and disbursements of earned performance payments for PY 2023, and would allow us to maintain timely adjudication of certain determinations of applicant ACOs’ eligibility to participate under the advance investment payment option, or the ACO Primary Care Flex Model, for an agreement period beginning January 1, 2025, and timely finalization of repayment mechanism arrangements required for ACOs to enter or continue their participation in two-sided models for PY 2025. Furthermore, the modifications as proposed would delay the calculation of final historical benchmarks, and delivery of related reports, for ACOs that entered an agreement period beginning on January 1, 2024.