Non-Opioid Treatments for Pain Relief
Section 4135 Non-Opioid Treatments for Pain Relief
Section 4135 of the Consolidated Appropriations Act, 2023 established eligibility criteria for temporary additional payments for certain non-opioid treatments for pain relief from January 1, 2026 through December 31, 2027 in the hospital outpatient department and ambulatory surgical center settings. The CY 2025 OPPS/ASC final rule with comment period finalized the criteria (89 FR 94343 through 94361). CMS also finalized regulation text at 42 CFR 416.174 and 42 CFR 419.43(k), which outline the payment for non-opioid pain management drugs, biologicals, and medical devices under both the ASC payment system and OPPS, respectively.
List of Qualifying Non-Opioid Treatments for Pain Relief under Section 4135, CAA
We fully evaluated applicable non-opioid treatments against the statutory eligibility criteria, and we determined the products in the table below meet the statutory definition of a non-opioid treatment for pain relief and should be paid according to the finalized policy.
| Brand Name | HCPCS Code | Descriptor | Effective Date |
|---|---|---|---|
| Exparel | J0666 (previously C9290) | Injection, bupivacaine liposome, 1mg | January 1, 2025 |
| Omidria | J1097 | Phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml | January 1, 2025 |
| Dextenza | J1096 | Dexamethasone, lacrimal ophthalmic insert, 0.1 mg | January 1, 2025 |
| Ketorolac tromethamine Injection | J1885 | Injection, ketorolac tromethamine, per 15 mg | January 1, 2025 |
| On-Q Pump | C9804 | Elastomeric infusion pump (e.g., ON-Q* Pump with Bolus), including catheter and all disposable system components, non-opioid medical device (must be a qualifying Medicare nonopioid medical device for postsurgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2025 |
| SPRINT | C9807 | Nerve stimulator, percutaneous, peripheral (e.g., SPRINT Peripheral Nerve Stimulation System), including electrode and all disposable system components, non-opioid medical device (must be a qualifying Medicare nonopioid medical device for postsurgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2025 |
| cryoICE, cryoSPHERE, cryoSPHERE MAX, cryoICE cryoSPHERE, cryoICE Cryo2 | C9808 | Nerve cryoablation probe (e.g., cryoICE, cryoSPHERE, cryoSPHERE MAX, cryoICE cryoSPHERE, cryoICE Cryo2), including probe and all disposable system components, non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2025 |
| ambIT Pump | C9806 | Rotary peristaltic infusion pump (e.g., ambIT Pump), including catheter and all disposable system components, non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2025 |
| Iovera System | C9809 | Cryoablation needle (e.g., iovera System), including needle/tip and all disposable system components, non-opioid medical device (must be a qualifying Medicare nonopioid medical device for postsurgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2025 |
| IceMan | C9810 | Water circulating motorized cold therapy device (e.g., IceMan) including all system components (e.g. pads, console, disposable parts), non-opioid medical device (must be a qualifying medicare non-opioid medical device for postsurgical pain relief in accordance with section 4135 of the caa, 2023) | January 1, 2026 |
| Sapphire Pump | C9811 | Electronic ambulatory infusion pump (e.g. Sapphire pump), including all pump components, including disposable components , non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 |
| SonoPlex, SonoBlock, SonoTap | C9812 | Echogenic nerve block needles (e.g. SonoPlex, SonoBlock, SonoTap), nonopioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 |
| InfiltraLong | C9813 | Perforated continuous infusion catheter set (e.g. InfiltraLong), including all components, non-opioid medical device (must be a qualifying Medicare nonopioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 |
| SonoLong, E-Cath | C9814 | Continuous anesthesia echogenic conduction catheter set (e.g. SonoLong, E-Cath), including all components, non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 *long descriptor revised to include E-Cath effective February 1, 2026 |
| CADD-Solis ambulatory infusion pump | C9815 | Linear peristaltic pain management infusion pump (e.g. CADD-Solis ambulatory infusion pump), and all disposable system components, nonopioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 |
| reusable ambIT Pump | C9816 | Rotary peristaltic infusion pump (e.g., reusable ambIT Pump) including all disposable system components, reusable non-opioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 |
| Game Ready® GRPro 2.1 System | C9817 | Electronic cryo-pneumatic compression, pain management system (e.g. Game Ready® GRPro 2.1 System), including control unit, anatomically correct wrap(s), and other system component(s), nonopioid medical device (must be a qualifying Medicare non-opioid medical device for post-surgical pain relief in accordance with Section 4135 of the CAA, 2023) | January 1, 2026 |
| Zynrelef | J0668 (Previously C9088) | Instillation, bupivacaine and meloxicam, 1 mg/0.03 mg | January 1, 2026 |
| Journavx | C9818 | suzetrigine, oral, 1 mg | January 23, 2026 |
Payment Limit Information
Section 1833(t)(16)(G)(iii) of the Social Security Act states that the separate payment amount specified in clause (ii) must not exceed the estimated average of 18% of the HOPD fee schedule amount for the HOPD service (or group of services) with which the non-opioid treatment for pain relief is provided, as determined by the HHS Secretary.
*Please see the next quarterly OPPS and ASC CRs for payment information.
Submitting Requests for New Non-Opioid Products
For more information on the process to submit information to request payment for eligible non-opioid products, please visit our downloads section.