The NOPAIN Act is among the most consistently misdescribed payment changes in pain medicine. Most coverage reads as though Medicare began paying clinicians more for choosing a non-opioid analgesic. It did not. Section 4135 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328, signed December 29, 2022) changed how facilities are paid: Medicare must stop packaging certain non-opioid treatments for pain relief into the procedure payment and must make a separate, additional payment for them, in the hospital outpatient department and the ambulatory surgical center. Those are the only two settings the authority reaches.
It is not a Physician Fee Schedule change. It does not create or raise anyone’s professional payment, and it does not extend separate payment to the physician office. If your interventional work happens in your own office, the direct effect on your revenue is probably nil. Worth establishing up front, because the opposite is written almost everywhere.
Everything regulatory below comes from the CY 2026 OPPS/ASC final rule with comment period (90 FR 53448, published November 25, 2025, CMS-1834-FC) and CMS’s qualifying-products page, both read September 17, 2026.
What section 4135 actually changed
CMS puts it plainly in the CY 2026 final rule: “Section 4135(a) and (b) of the CAA, 2023, titled Access to Non-Opioid Treatments for Pain Relief, amended section 1833(t)(16) and section 1833(i) of the Act, respectively, to provide for temporary additional payments for non-opioid treatments for pain relief.” Section 1833(t)(16) of the Social Security Act is the hospital outpatient prospective payment system; section 1833(i) is the ASC payment system. The implementing regulations are 42 CFR 419.43(k) and 42 CFR 416.174.
The mechanism matters more than the name. Under ordinary OPPS and ASC rules, most drugs, biologicals and single-use devices used during a procedure are packaged: the facility gets one payment and the supplies are assumed to be inside it, so a facility choosing a costlier non-opioid analgesic absorbs the difference. Section 4135 removes that packaging for qualifying products and directs a separate payment on top. The beneficiary is the facility that buys the product and bills the case, so whether it reaches you depends on your ownership position and where you operate.
The exact window and the exact cap
The statute is specific about timing: separate payment applies to a qualifying non-opioid treatment for pain relief “furnished on or after January 1, 2025, and before January 1, 2028.” CMS states the same window plainly — on a temporary basis from January 1, 2025 through December 31, 2027. The ASC-side authority, section 1833(i)(10), was added by section 4135(b) and applies to surgical services furnished in that identical window.
The cap is the figure most articles get wrong, usually by rounding it or calling it a share of the product’s cost. It is neither. Under section 1833(t)(16)(G)(iii) of the Act, the separate payment “shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or group of services) with which the non-opioid treatment for pain relief is furnished.” The ceiling tracks the payment for the associated service, not what the facility paid the manufacturer.
CMS operationalizes that 18 percent limitation using the volume-weighted average of the payment rates of the top five primary procedures, by volume, into which the product’s payment would otherwise have been packaged, applied per date of service billed — a method finalized in the CY 2025 final rule (89 FR 94349). Two caveats CMS states itself: the separate payments must be made in a budget neutral manner under section 1833(t)(2)(E), and product-specific payment limitations are revised annually, so the amount attached to a product is a moving number.
How a drug or device qualifies
Qualification is a label-and-evidence test, not a clinical-judgment test, and the two product classes are treated differently. For a drug or biological, section 1833(t)(16)(G)(iv)(I) requires an FDA-approved label indication “to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body’s opioid receptors.” The product must also not be receiving transitional pass-through payment, and must otherwise be packaged — there is nothing to unpackage if it is already paid separately.
For a medical device, section 1833(t)(16)(G)(iv)(II) requires that the device be used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia; that it be PMA-approved, 510(k)-cleared, or 510(k)-exempt; and that it have “demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal.”
That last clause has teeth, and CMS applies it procedurally: device eligibility is decided by reviewing literature submitted during the annual rule’s public comment period. In the agency’s words, “If there is no data or literature submitted for a medical device, or if the materials submitted do not demonstrate any ability of the medical device to replace, reduce, or avoid opioids, the medical device would not meet this evidence criterion.” A plausible opioid-sparing story with nothing submitted behind it does not make the list.
Where the qualifying list lives, and why you should not copy it
CMS maintains the current list on its Non-Opioid Treatments for Pain Relief page, in the hospital outpatient PPS section of cms.gov, as the “List of Qualifying Non-Opioid Treatments for Pain Relief under Section 4135, CAA.” For CY 2026 it was proposed as Table 82 of the proposed rule (90 FR 33746–33747) and republished as Table 134 in the final rule, with finalized product-specific payment limitations in Table 137.
Do not work from a copy of that table published in an article, including this one. CMS adds qualifying products between annual rules. On the CMS page read September 17, 2026, two products carried mid-2026 effective dates — Journavx (HCPCS C9818), effective January 23, 2026, and Caldolor (J1741), effective March 11, 2026 — and a block of devices carried January 1, 2026 effective dates. The page itself showed a last-modified date of September 1, 2026, which is why no product table appears here.
Find your product on the CMS page, note its HCPCS code and effective date, and then take the step almost nobody takes.
A HCPCS code and a payment rate are not coverage
This is the most useful sentence in the rule for anyone building a business case: CMS states that assignment of a HCPCS code and payment rate does not imply Medicare coverage. The rule’s wording: “HOPDs and ASCs only receive payment for qualifying drugs, biologicals, and medical devices when the appropriate MAC determines that the service meets the relevant conditions for coverage and payment.”
So a product can sit on the list, carry a code and a published payment limitation, and still be denied in your jurisdiction because your Medicare Administrative Contractor does not consider it covered for the case you billed. The list answers a narrow question — is separate payment available in principle? Your MAC’s local coverage determinations answer the one that funds your facility.
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The practical read for a practice
Strip the marketing away and the provision does three modest things.
It removes a packaging disincentive, for facilities, at the margin. If you hold an interest in an ASC, or influence purchasing in a hospital outpatient department, the change is real: a qualifying product that used to come out of the facility’s procedure payment now draws an additional, capped payment. Whether that closes the gap against acquisition cost is a per-product arithmetic question to run with your own numbers and the current limitation. Our look at what in-house NCV and EMG testing actually pays models that discipline.
It does not change your case mix, and it does not create a covered indication. Nothing in section 4135 makes a procedure newly appropriate, indicated or covered. It changes how a facility is paid for a product used in a case that was already going to happen, when the MAC agrees the case is covered. Building a service line around a payment change rather than patient selection is the wrong order of operations; our clinical reference on interventional pain management procedures organizes the field by anatomic target and evidence rather than billing.
It is not a reason to move a procedure’s site of service. Shifting office-based work into an HOPD or ASC to chase a capped, budget-neutral add-on payment is not a decision this provision supports. Site of service should turn on patient selection, equipment and staffing, facility access, coverage rules and your own cost structure. For most office-based interventional pain work — joint and soft-tissue injections, trigger point injections, diagnostic blocks — NOPAIN is not in the payment system you bill under at all. Empire’s analysis of which pain management procedures carry the highest return in a clinic is the better starting point on office economics, and our post on combining interventional and conservative pain management covers how the halves support each other.
The clinicians who see a direct financial effect are a narrow group: facility owners, ASC partners, and hospital departments making purchasing decisions. Everyone else gets something less tangible — a federal policy that treats opioid-sparing analgesia as worth paying for separately.
What to watch before the sunset
Plan as though the separate payment ends with services furnished on December 31, 2027, because that is what the statute says. Section 4135(c) of the CAA, 2023 requires a Report to Congress assessing the policy’s impact, which the CY 2026 final rule references; that report is the likely trigger for any extension debate. As of September 17, 2026 no extension had been enacted, and planning a purchase on the assumption of one would be speculation.
Read section XIII.F of each annual OPPS/ASC final rule when it publishes in the fall, and re-check the CMS page before committing to a product.
Keep all of this separate from your federal prescriber obligations: the DEA eight-hour training requirement is a different law with its own attestation, covered in our post on MATE Act compliance for pain physicians.
Frequently asked questions
What is the NOPAIN Act?
It is the common name for section 4135 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), signed December 29, 2022, which amended sections 1833(t)(16) and 1833(i) of the Social Security Act. It requires Medicare to unpackage and separately pay for qualifying non-opioid treatments for pain relief in two facility settings, temporarily. It is a payment provision, not a coverage mandate.
Which settings does it apply to?
The hospital outpatient department, under the OPPS, and the ambulatory surgical center, under the ASC payment system. Those are the only authorities CMS cites in the CY 2026 final rule, and CMS describes the policy as applying in those two settings. Status as of September 17, 2026.
Does it cover my office?
No. There is no physician-office or Physician Fee Schedule authority in the provision, and CMS does not extend separate payment under it to the office setting. If you perform procedures in your own office, this does not change what you are paid. It is the most common error in published coverage of the law.
Which treatments qualify?
Drugs and biologicals with an FDA-approved label indication to reduce postoperative pain or produce postsurgical or regional analgesia without acting on opioid receptors, and devices meeting an FDA approval or clearance pathway plus the statutory opioid-reduction evidence test. CMS publishes the current list by product and HCPCS code, with effective dates, on its Non-Opioid Treatments for Pain Relief page. Check that page, not a reproduction of it.
When does it sunset?
The authority covers qualifying treatments furnished on or after January 1, 2025 and before January 1, 2028 — it ends after December 31, 2027 unless Congress extends it. As of September 17, 2026 no extension had been enacted.
Where to build the procedural side of a non-opioid practice
Payment policy is downstream of capability. Reading a rule like this closely is really about deciding what your practice can offer without reaching for an opioid — a training question, not a billing one.
Empire’s Pain Management Training program, THE Pain Show, is accredited for 25.25 AMA PRA Category 1 Credits™, jointly provided by AKH, Inc, and Empire Medical Training, and anchors the wider pain management academy. If your interest sits at the biologic end of non-opioid care, ACP and Biologics for Pain Management is accredited for 7.0 AMA PRA Category 1 Credits™. Curriculum detail and accreditation statements sit on each course page; our guide to choosing an accredited pain management CME program sets out criteria worth applying to any of them.
Be clear-eyed about what accredited CME does and does not do. It produces the documented training a credentialing or privileging committee reviews alongside licensure, prior privileges and procedure logs, and it is how most clinicians add a procedure to an established practice. It does not confer subspecialty board eligibility or board certification in pain medicine, which at the ABPN and the ABPMR requires 12 months of ACGME-accredited pain medicine fellowship training. It does not grant hospital or ASC privileges, a facility governing-body decision. And it does not expand your legal scope of practice beyond what your state allows. Confirm scope with your board and privileges with your facility before you schedule a patient.
