CY 2025 Medicare Hospital Outpatient Prospective Payment System Final Rule Summary
On November 1, the Centers for Medicare & Medicaid Services released the final rule for the CY 2025 Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System. Additional information may be found in the fact sheet that accompanies the rule. Page numbers in this summary reflect the page number in the display copy of the final rule linked above.
Payment Rate Updates for OPPS and ASC Payment System – p. 887
The agency finalized an update to the payment rate for outpatient hospitals of 2.9%. Payment rates for outpatient hospitals are based on the hospital market basket update which is projected to increase by 3.4%. The rate is then reduced by 0.5% to account for a productivity adjustment. The payment update is the same for ASCs which will see an increase of 2.9% for services provided to Medicare beneficiaries. The detailed economic analyses and impact may be found on page 1,630 of the final rule.
Payment for Cell and Gene Therapies – p. 67
CMS finalized policy to exclude cell and gene therapy products from packaged payment. Generally, CMS provides a single payment for all the services that are included/bundled into a comprehensive ambulatory payment classification (C-APC). The C-APC provides payment for all services provided during a hospital outpatient visit that are integral, ancillary, supportive, dependent, or adjunctive to the primary service. The primary service is the main reason for the outpatient visit, such as a surgical procedure or a significant diagnostic test. Services included in the C-APC payment might include laboratory tests, imaging services, anesthesia, and other related care provided during the outpatient encounter.
The agency has stated that when a cell or gene therapy is administered to a patient “the therapies are the primary treatment being administered to a patient and thus, are not integral, ancillary, supportive, dependent, or adjunctive to any primary C-APC services.” Additionally, the therapies included in the policy are usually separately paid and priced using the ASP methodology, and the agency stated in the rule that “given the unique nature of these therapies, we do not believe they function as integral, ancillary, supportive, dependent, or adjunctive to any of the current C-APCs primary services.” Finally, the administration of cell and gene therapies are primary treatments and therefore do not support C-APC services. The following is a list of cell and gene therapies for which payment for the therapy will be paid separately from the C-APC. CMS did add one more therapy to the list that was proposed, Casgevy.
Cell and Gene Therapies Proposed for Exclusion from C-APC Packaging.
| Trade Name | HCPCS Code | Long Descriptor |
| Yescarta | Q2041 | Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Kymriah | Q2042 | Tisagenlecleucel, up to 600 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Provenge | Q2043 | Sipuleucel-t, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion |
| Tecartus | Q2053 | Brexucabtagene autoleucel, up to 200 million autologous anti-cd19car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Breyanzi | Q2054 | Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Abecma | Q2055 | Idecabtagene vicleucel, up to 510 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Carvytki | Q2056 | Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Luxturna | J3398 | Injection, voretigene neparvovec-rzyl, 1 billion vector genomes |
| Zolgensma | J3399 | Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector genomes |
| Casgevy | J3392 | Injection, exagamglogene autotemcel, per treatment |
Payment for Services Associated with Administration of CAR T-cell Therapies – p. 375
The Society and several stakeholders submitted comments in support of separate OPPS payment for services associated with CAR T-cell collection (38225), preparation to send the cells (38226), and receipt of and preparation to administer the cells (38227). However, CMS was not convinced by comments submitted and will continue its current policy not to pay separately for services associated with CAR T-cell collection, preparation to send the cells, and receipt of and preparation to administer the cells. The agency stated that it will not deviate from long-standing policy that “Medicare does not generally pay separately for each step used to manufacture a drug or biological product”.
The three CPT® codes that describe these services will continue to be assigned a status indicator of B, which means they are considered to be bundled and will not be paid separately. The CPT® code (38228) for CAR T-cell administration has a status indictor of S (paid under OPPS; separate APC payment under OPPS) with a national payment rate of $331.69.
New Category I codes will replace the current Category III beginning on January 1, 2025. Listed below are the descriptions for CAR T-cell therapy.
- 38225 - Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day
- 38226 - Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)
- 38227 - Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
- 38228- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous
Changes to the Review Timeframes for the Hospital Outpatient Department (OPD) Prior Authorization Process – p. 1,369
The agency finalized prior authorization (PA) review time requirements reducing the response time from 10-business days to 7-calendar days. This means that the Medicare Administrative Contractors have seven calendar days to review PA requests for the select services listed in the following paragraph. This change would align with the expedited time requirements finalized in the CMS Interoperability and Prior Authorization final rule.
In the CY 2020, the agency created policy that requires prior authorization (PA) for certain services when provided in the outpatient department. Generally, the Medicare fee-for-service payment system does not require PA, except in a few select instances. These include for the services of blepharoplasty, rhinoplasty, botulinum toxin injections, panniculectomy, vein ablation, cervical fusion with disc removal, implanted spinal neurostimulators, and facet joint interventions. Understanding that the services listed do not pertain to ASH members, we share this policy update to monitor and inform members on the evolution of Medicare fee-for-service PA policies. Over the past several years, CMS has continued to add services to the PA list under OPPS, and therefore it is important to follow this issue closely.
2025 Medicare Outpatient Prospective Payment System Final Rule
ASH Comment Comparison
| Submitted Comments | Final Rule Provision |
| Supported policy to not to package payment for the cell and gene therapy products when those therapies appear on the same claim as a primary comprehensive ambulatory payment classification (C-APC). | Policy was finalized. |
| Recommended CMS extend policy to not package payment for cell and gene therapy products for three years, as opposed to the one year proposed by CMS. | CMS finalized the policy for 2025 and subsequent years. |
| Commented that there is no accurate way to create a bundled payment policy for the whole group of cell and gene therapies. Each therapy has unique costs, protocols, and treatment plans; therefore, a new C-APC would not work. | CMS did not finalize any policy and will take comments received under advisement in future rulemaking. |
|
- Requested that CMS make separate payment for all the services associated with CAR T-cell therapy. - Supported status indicator of S (separate payment) for CAR T-cell administration (38228). - Supported the Advisory Panel on Hospital Outpatient Payment recommendation to assign payment status indicator of S to CPT codes for CAR T-cell collection (38225), preparation to transport the cells (38226), and receipt of and preparation to administer the cells (38227). |
- Finalized policy to bundle 38225, 38226, and 38227, and not make separate payment under the OPPS for these services, a continuation of longstanding agency policy. - CPT codes 38225, 38226, and 38227 assigned payment status indicator of B – bundled payment. - Finalized policy to make separate payment for CAR T-cell administration (38228) and assigned payment status of S – separate payment. |