The Centers for Medicare & Medicaid Services (CMS) has unveiled its final rule for the Calendar Year (CY) 2025 Outpatient Prospective Payment System (OPPS) updates. This comprehensive rule, published in the Federal Register on November 27, 2024, outlines significant changes to payment rates, device pass-through payments, and quality reporting requirements. Amy Larson, RHIT, CCS-P, is the Senior Coding and Reimbursement Analyst at Meperia and here she provides a breakdown of the most impactful provisions:
Device Pass-Through Payment Applications: For CY 2025, CMS received 14 complete applications for OPPS device pass-through payment consideration. CMS has approved 10 of the 14 devices for pass-through payment. As noted in the Federal Register, the 10 devices detailed below have been approved for device pass-through payment for CY 2025.
Summary of new device applications, which received CMS approval for pass-through payment beginning CY2025:
- Precision GI EUS fine needle biopsy device for pancreatic biopsy, manufactured by Limaca Medical *
- Symplicity Spyral Catheter, multi-electrode RND catheter, manufactured by Medtronic *
- AGENT™ Paclitaxel-Coated Balloon Catheter, manufactured by Hemoteq AG/Boston Scientific *
- Aveir DR System, manufactured by Abbott (note: was already preliminarily approved for pass-through payment in July 2024)
- Detour System, manufactured by Endologix (note: was already preliminarily approved for pass-through payment in July 2024)
- Endosound (UDK-T component of EVS, manufactured by Endosound (note: was already preliminarily approved for pass-through payment in July 2024)
- IFuse Bedrock Granite, manufactured by SI Bone *
- Paradise Ultrasound RDN catheter, cartridge, and connector cable, manufactured by ReCor Medical *
- CANTURIO™ Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP®) System), manufactured by Canary Medical/Zimmer Biomet *
- PulseSelect™ Pulsed Field Ablation (PFA) System), manufactured by Medtronic *
(* new HCPC device category codes are pending)
Device Application Transparency has arrived!
Beginning with CY 2025, applications for transitional device pass-through payment (TPT) discussed in the OPPS/ASC proposed are posted publicly to increase transparency and enable increased stakeholder engagement. For additional information regarding this policy, please see the CY 2023 OPPS/ASC final rule (87 FR 71934 through 71938). Device pass-through application summaries can be found here: https://mearis.cms.gov/public/publications/device-ptp
OPPS Update: For CY 2025, we propose to increase the payment rates under the OPPS by an Outpatient Department (OPD) fee schedule increase factor of 2.6 percent. This increase factor is based on the proposed inpatient hospital market basket percentage increase of 3.0 percent for inpatient services paid under the hospital inpatient prospective payment system (IPPS) reduced by a proposed productivity adjustment of 0.4 percentage point. Based on this update, we estimate that total payments to OPPS providers (including beneficiary cost sharing and estimated changes in enrollment, utilization, and case mix) for calendar year (CY) 2025 would be approximately $88.2 billion, a proposed increase of approximately $5.2 billion compared to estimated CY 2024 OPPS payments.
We continue to implement the statutory 2.0 percentage point reduction in payments for hospitals that fail to meet the hospital outpatient quality reporting requirements by applying a reporting factor of 0.9805 to the OPPS payments and copayments for all applicable services.
ASC Payment Update (note: not OPPS): For CYs 2019 through 2023, we adopted a policy to update the ASC payment system using the hospital market basket update. In light of the impact of the COVID-19 PHE on healthcare utilization, we extended our policy to update the ASC payment system using the hospital market basket update an additional 2 years—through CYs 2024 and 2025. Using the hospital market basket methodology, for CY 2025, we propose to increase payment rates under the ASC payment system by 2.6 percent for ASCs that meet the quality reporting requirements under the ASCQR Program. This increase is based on a proposed hospital market basket percentage increase of 3.0 percent reduced by a productivity adjustment of 0.4 percentage points. Based on this proposed update, we estimate that total payments to ASCs (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case mix) for CY 2025 will be approximately $7.4 billion, an increase of approximately $202 million compared to the estimated CY 2024 Medicare payments.
Data Used in CY 2025 OPPS/ASC Ratesetting: To set OPPS and ASC payment rates, we normally use the most updated claims and cost report data available. The best available claims data is the most recent set of data which would be from two years prior to the calendar year that is the subject of rulemaking. Cost report data usually lags the claims data by a year, and we believe that using the most updated cost report extract available from the Healthcare Cost Report Information System (HCRIS) is appropriate for CY 2025 OPPS rate setting. Therefore, we are using our typical data process of using the most updated cost reports and claims data available for CY 2025 OPPS rate setting.
Changes to the List of ASC Covered Surgical Procedures and Ancillary Services Lists (note: Not OPPS): For CY 2025, we propose to add 20 medical and dental procedures to the ASC CPL and ancillary services lists based upon existing criteria at § 416.166.
Changes to the Inpatient Only (IPO) List: For CY 2025, we propose to add three services for which codes were newly created by the AMA CPT Editorial Panel for CY 2025 to the IPO list: CPT codes 0894T (Cannulation of the liver allograft in preparation for connection to the normothermic perfusion device and decannulation of the liver allograft following normothermic perfusion), 0895T (Connection of liver allograft to normothermic machine perfusion device, hemostasis control; initial 4 hours of monitoring time, including hourly physiological and laboratory assessments ( e.g., perfusate temperature, perfusate pH, hemodynamic parameters, bile production, bile pH, bile glucose, biliary), and 0896T (Connection of liver allograft to normothermic machine perfusion device, hemostasis control; each additional hour, including physiological and laboratory assessments ( e.g., perfusate temperature, perfusate pH, hemodynamic parameters, bile production, bile pH, bile glucose, biliary bicarbonate, lactate levels, macroscopic assessment)
Remote Services: For CY 2025, we are clarifying our policies for remotely furnished outpatient therapy services, Diabetes Self-Management Training and Medical Nutrition Therapy services and mental health services furnished remotely to beneficiaries in their homes by hospital staff to maintain alignment across payment systems.
All-Inclusive Rate (AIR) Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities: In CY 2024 OPPS/ASC rulemaking, due to health equity and beneficiary access concerns, we solicited comment from the public on whether Medicare should pay separately for certain high-cost drugs provided by IHS and tribal facilities and, if so, how we might do so. Based on the responses we received, we are proposing, starting January 1, 2025, to separately pay IHS and tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the AIR under the authorities used to calculate the AIR.
Clinical Trials Coding and Payment: We propose technical refinements to our Category B clinical trials coding and payment policy for devices and procedures. We are also proposing to extend our coding and payment policy to drugs and devices that meet CAG’s coverage and evidence development (CED) requirement for which there is a control arm.
Payment for HIV Pre-Exposure Prophylaxis (PrEP) in Hospital Outpatient Departments: For CY 2025, we are proposing to pay for HIV PrEP drugs covered as an additional preventive service and related services under the OPPS, if covered by CMS through a National Coverage Determination. We propose a site neutral policy where products are generally paid similar rates under the OPPS and Physician Fee Schedule.
Diagnostic Radiopharmaceuticals Separate Payment: We propose to pay separately for diagnostic radiopharmaceuticals with per-day costs above a threshold of $630, which is approximately two times the volume-weighted average cost amount currently associated with diagnostic radiopharmaceuticals. We also propose to update the $630 threshold in CY 2026 and subsequent years by the Producer Price Index (PPI) for Pharmaceutical Preparations. Finally, we propose to pay for separately payable diagnostic radiopharmaceuticals based on their Mean Unit Cost (MUC) derived from OPPS claims and seek comment on the use of Average Sales Price (ASP) for payment in future years.
Exclusion of Cell and Gene Therapies from Comprehensive Ambulatory Payment Classification (C-APC) Packaging: We propose to exclude qualifying cell and gene therapies from C-APC packaging and seek comment on whether there are other changes to the C-APC packaging policy we should consider for future years.
Add-on Payment for Radiopharmaceutical Technetium-99m (Tc-99m): For CY 2025, an add-on payment applies to radiopharmaceuticals that use Tc-99m produced without use of highly enriched uranium (HEU). We propose for CY 2026 that we would replace the add-on payment for radiopharmaceuticals produced without the use of Tc-99m derived from non-HEU sources with an add-on payment for radiopharmaceuticals that use Tc-99m derived from domestically produced Mo-99.
Changes to the Review Timeframes for the Hospital Outpatient Department (OPD) Prior Authorization Process: We are changing the current review time frame for prior authorization requests for OPD services from 10-business days to 7-calendar days for standard reviews.
Cross-Program Proposals for the Hospital Outpatient Quality Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR), and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs: We propose to: (1) adopt the Hospital Commitment to Health Equity (HCHE) measure in the Hospital OQR and REHQR Programs and the Facility Commitment to Health Equity (FCHE) measure in the ASCQR Program beginning with the CY 2025 reporting period/CY 2027 payment or program determination; (2) adopt the Screening for Social Drivers of Health (SDOH) measure in all three programs beginning with voluntary reporting for the CY 2025 reporting period followed by mandatory reporting beginning with the CY 2026 reporting period/CY 2028 payment or program determination; (3) adopt the Screen Positive Rate for SDOH measure in all three programs beginning with voluntary reporting for the CY 2025 reporting period followed by mandatory reporting beginning with the CY 2026 reporting period/CY 2028 payment or program determination; and (4) modify the Immediate Measure Removal policy for adopted Hospital OQR and ASCQR Program measures beginning with CY 2025.
Hospital Outpatient Quality Reporting (OQR) Program: In addition to the cross-program proposals, we propose to: (1) adopt the Patient Understanding of Key Information Related to Recovery After a Facility-Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure (Information Transfer PRO-PM) beginning with voluntary reporting for the CY 2026 reporting period followed by mandatory reporting beginning with the CY 2027 reporting period/CY 2029 payment determination; (2) remove the MRI Lumbar Spine for Low Back Pain measure beginning with the CY 2025 reporting period/CY 2027 payment determination; (3) remove the Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac, Low-Risk Surgery measure beginning with the CY 2025 reporting period/CY 2027 payment determination; (4) require electronic health record (EHR) technology to be certified to all electronic clinical quality measures (eCQMs) available to report beginning with the CY 2025 reporting period/CY 2027 payment determination; and (5) publicly report the Median Time from Emergency Department (ED) Arrival to ED Departure for Discharged ED Patients measure—Psychiatric/Mental Health Patients stratification on Care Compare beginning with CY 2025.
Rural Emergency Hospital Quality Reporting (REHQR) Program: In addition to the cross-program proposals, we propose to: (1) extend the reporting period for the Risk-Standardized Hospital Visits Within 7 Days After Hospital Outpatient Surgery measure from one year to two years beginning with the CY 2027 program determination; and (2) establish when, after status conversion, REHs would be required to report data under the REHQR Program.
Source: https://www.federalregister.gov/documents/2024/11/27/2024-25521/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical
About the Author
Amy Larson, RHIT, CCS-P, is the Senior Coding and Reimbursement Analyst at Meperia. Her primary goals are to identify items meeting the criteria for HCPC Level II codes, allowing for improved outpatient facility revenue capture and reimbursement. Amy is a credentialed coder through AHIMA for over 29 years, having worked in many sectors of health care including, level 1 trauma inpatient and outpatient hospital coder, managed care PHO assistant director, consulting and has held positions as adjunct faculty instructing courses related to medical coding and reimbursement.