2026 Rulemaking Increases Separate Reimbursement for Non-Opioid Alternatives

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2026 Rulemaking Increases Separate Reimbursement for Non-Opioid Alternatives

Second year of NOPAIN Act implementation expands Medicare beneficiary access

BY KARA NEWBURY | FEBRUARY 11, 2026

The 2026 final payment rule for ASCs and hospital outpatient departments (HOPD) expanded the number of codes eligible for reimbursement under the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act. As of January 2026, there are 18 non-opioid alternatives that are available for separate Medicare reimbursement under the act, an increase from 11 codes that were eligible for separate reimbursement in 2025.

Codes may be added quarterly, so ASCA will update members if additional codes become separately reimbursed during the year.

Enacted in 2022, the NOPAIN Act first went into effect in 2025. It provides Medicare beneficiaries with greater access to non-opioid postoperative alternatives.

Product Eligibility and Payment Indicator Designation

To qualify as a non-opioid treatment for pain relief and receive separate reimbursement, the product must have “a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body’s opioid receptors.”

Similarly, to qualify as a non-opioid treatment for pain relief, a medical device it must be “used to deliver a therapy to reduce postoperative pain, or produce post-surgical or regional analgesia” that has “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.” More specifics as to the FDA designation can be found in the Code of Federal Regulation § 416.174 Payment for non-opioid pain management drugs, biologicals, and medical devices.

The Centers for Medicare & Medicaid Services (CMS) considered establishing new payment indicators to designate non-opioid drugs or biologicals and devices. However, in 2025, CMS instead modified the payment indicator “L6,” which previously only included new technology intraocular lens (NTIOL). Now “L6” indicates a special payment for NTIOL or qualifying non-opioid devices.

Reimbursement

The amount of payment for a qualifying non-opioid treatment for pain relief is as follows.

  1. For a qualifying drug or biological, the amount of payment is the amount the drug or biological exceeds the applicable portion of the Medicare HOPD fee schedule amount for the primary code.
  2. For a qualifying medical device, the amount of payment is the amount of the hospital’s charges for the device, adjusted to cost, which exceeds the applicable portion of the Medicare HOPD fee schedule amount for the primary code.

For drugs, biologicals and medical devices, reimbursement cannot exceed 18 percent of the HOPD fee schedule amount of the volume-weighted average of the five highest-volume primary procedures into which the non-opioid treatment for pain relief would be packaged. Table 18 in the January 2026 Update of the Ambulatory Surgical Center [ASC] Payment System shows the payment limitations for eligible products.

Background

The NOPAIN Act was passed as Section 4135 of the Consolidated Appropriations Act (CAA), 2023, signed into law on December 29, 2022. The NOPAIN Act provides for temporary additional payments for non-opioid treatments for pain relief on or after January 1, 2025, and before January 1, 2028. The law states that the secretary of the US Department of Health and Human Services (HHS) “shall not package payment for the non-opioid treatment for pain relief into payment” for a covered procedure, and “shall make an additional payment for the non-opioid treatment for pain relief.”

Language outlining code eligibility was added to the Code of Federal Regulations for ASCs at § 416.174 Payment for non-opioid pain management drugs, biologicals, and medical devices.

The NOPAIN Act also requires the HHS secretary, acting through the CMS administrator, to submit a report to Congress identifying limitations, gaps or barriers to access and make recommendations to improve Medicare coverage and reimbursement for non-opioid alternatives. To date, this report has not yet been released.

Non-Opioid Quarterly Implementation Process

CMS welcomes submissions from the public recommending additional products that meet the qualifying criteria and should be paid according to the statute under this policy. Typically, these submissions are made by drug or device manufacturers, as they are the entities with the data necessary to meet the qualifying criteria. Interested parties can email OutpatientPPS@cms.hhs.gov with the product qualifies as a non-opioid treatment for pain relief along with any necessary supporting information. In the subject line of your email, include “Non-Opioid Treatment for Pain Relief Supporting Documentation.” For more information, visit the CMS page.

If approved, CMS will first post the approval on the CMS Hospital OPPS Website. If not approved, CMS will contact the submitter via email. It is possible that payment could be made retroactively effective to the date that CMS determines that a product meets the criteria. For example, for submissions made between February 2 and May 1, the earliest possible CMS implementation date is July 1 (Q3 2026), and payment may be retroactive to the date CMS determines the product met the criteria.

Advocacy

While the NOPAIN Act went into effect just last year, ASCA has been advocating for greater access to non-opioid alternatives for over a decade. ASCA has long partnered with Voices for Non-Opioid Choices (Voices), has signed on to letters to members of Congress and CMS, and gone to Capitol Hill to help advocate for better access to non-opioid alternatives through the NOPAIN Act and other avenues.

The NOPAIN Act is currently set to expire after 2027. ASCs using these non-opioid alternatives must include them on their claims so that CMS has accurate utilization data showing the full impact of the policy.

ASCA will continue to work with stakeholder groups, such as Voices, to ensure this policy is extended.

Write Kara Newbury with questions.