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Healthcare UpdateMedical PracticeMedicare Physician Fee Schedule
February 17, 2025
2025 PFS Final Rule: Miscellaneous Provisions

2025 PFS Final Rule: Miscellaneous Provisions

In English, we have a word that encapsulates the thematically bereft, a catch-all term that incorporates those items that don’t fit neatly into any particular category. But, like the Land of Misfit Toys, it’s a title that allows the random and unattached to have a home. We, of course, refer to that indispensable adjective, “miscellaneous.” And what better way to describe today’s topic? Weeks ago, we brought you alerts on the key provisions of the 2025 Medicare Physician Fee Schedule (PFS) final rule, from both the anesthesia and chronic pain perspective. Today’s article will focus on the rest of the story—the leftovers, if you like.

2025 PFS Final Rule: Miscellaneous Provisions

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Below are the final rule’s miscellaneous provisions. But don’t be fooled. The summary below, primarily gleaned from a fact sheet published by the Centers for Medicare and Medicaid Services (CMS), will have application to many within our readership.

Opioid Treatment Programs

Certain flexibilities for opioid use disorder (OUD) treatment services furnished by opioid treatment programs (OTPs) are allowed under the rule, so long as (a) all requirements are met, and (b) the use of these technologies is permitted under the applicable Substance Abuse and Mental Health Services (SAMHSA) and the Drug Enforcement Administration (DEA) requirements at the time the services are furnished, as follows:

    • CMS is making permanent its prior flexibility for furnishing periodic assessments via audio-only telecommunications beginning January 1, 2025, so long as all other applicable requirements are met.
    • CMS is allowing the OTP intake add-on code to be furnished via two-way audio-video communications technology when billed for the initiation of treatment with methadone (using HCPCS code G2076) if the OTP determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform.

The rule increases payment for social determinants of health (SDOH) risk assessments as part of intake activities within OUD treatment services furnished by OTPs, if medically reasonable and necessary to adequately reflect additional effort for OTPs, to identify a patient’s unmet health-related social needs (HRSNs) or the need and interest for harm reduction interventions and recovery support services that are critical to the treatment of an OUD. CMS is also updating payment for periodic assessments to include payment for SDOH risk assessments to reflect additional reassessments that OTPs may conduct throughout treatment, to monitor potential changes in a patient’s HRSNs or support services.

The rule finalizes payment for new opioid agonist and antagonist medications approved by the FDA. First, CMS is finalizing a new add-on code for nalmefene hydrochloride nasal spray, indicated for the emergency treatment of known or suspected opioid overdose. CMS is also finalizing payment for a new injectable buprenorphine product via (a) a new weekly bundled payment code for the weekly formulation of the new injectable buprenorphine product, and (b) including payment for the monthly formulation of the new injectable buprenorphine product into the existing code for monthly injectable buprenorphine. 

Lastly, CMS is clarifying a billing requirement that OTPs must append an OUD diagnosis code on claims for OUD treatment services, consistent with Medicare coverage and payment provisions under the Social Security Act.

Drugs and Biologicals

Requiring Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts

The rule finalizes clarifications to several policies implemented in the 2023 and 2024 PFS final rules, including exclusions of drugs, for which payment has been made under Part B for fewer than 18 months, from the definition of refundable single-dose container or single-use package drug, and identifying single-dose containers.

In addition, the rule requires that the JW modifier must be used if a billing supplier is not administering a drug but there are amounts discarded during the preparation process before supplying the drug to the patient.

Radiopharmaceuticals in the Office Setting

In an effort to provide clarity on which methodologies are available to Medicare Administrative Contractors (MACs) for pricing of radiopharmaceuticals in the physician office setting, CMS is finalizing a clarification that, for radiopharmaceuticals furnished in a setting other than a hospital outpatient department, MACs shall determine payment limits for radiopharmaceuticals based on any methodology used to determine payment limits for radiopharmaceuticals in place on or prior to November 2003. The methodology may include, but is not limited to, the use of invoice-based pricing.

For more information on these provisions of the final rule for 2025, please reach out to your account executive or you can visit the following link: Calendar Year (CY) 2025 Medicare Physician Fee Schedule Final Rule | CMS.