ACCESS TO NON-OPIOID TREATMENTS FOR PAIN RELIEF.

SEC. 4135. ACCESS TO NON-OPIOID TREATMENTS FOR PAIN RELIEF.(a) In General.—Section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)) is amended—(1) in paragraph (2)(E), by inserting “and temporary additional payments for non-opioid treatments for pain relief under paragraph (16)(G),” after “payments under paragraph (6)”; and (2) in paragraph (16), by adding at the end the following new subparagraph:“(G) Temporary additional payments for non-opioid treatments for pain relief.—“(i) In general.—Notwithstanding any other provision of this subsection, with respect to a non-opioid treatment for pain relief (as defined in clause (iv)) furnished on or after January 1, 2025, and before January 1, 2028, the Secretary shall not package payment for such non-opioid treatment for pain relief into a payment for a covered OPD service (or group of services), and shall make an additional payment as 136 STAT. 5922 specified in clause (ii) for such non-opioid treatment for pain relief. “(ii) Amount of payment.—Subject to the limitation under clause (iii), the amount of the payment specified in this clause is, with respect to a non-opioid treatment for pain relief that is—“(I) a drug or biological product, the amount of payment for such drug or biological determined under section 1847A that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or “(II) a medical device, the amount of the hospital’s charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device. “(iii) Limitation.—The additional payment amount specified in clause (ii) 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, as determined by the Secretary. “(iv) Definition of non-opioid treatment for pain relief.—In this subparagraph, the term ‘non-opioid treatment for pain relief’ means a drug, biological product, or medical device that—“(I) in the case of a drug or biological product, has 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; “(II) in case of a medical device, is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia, and has—“(aa) an application under section 515 of the Federal Food, Drug, and Cosmetic Act that has been approved with respect to the device, been cleared for market under section 510(k) of such Act, or is exempt from the requirements of section 510(k) of such Act pursuant to subsection (l) or (m) or section 510 of such Act or section 520(g) of such Act; and “(bb) 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; “(III) does not receive transitional pass-through payment under paragraph (6); and “(IV) has payment that is packaged into a payment for a covered OPD service (or group of services).” . (b) Ambulatory Surgical Center Payment System.—Section 1833(i) of the Social Security Act (42 U.S.C. 1395l(i)) is amended by adding at the end the following new paragraph:136 STAT. 5923 “(10) Temporary additional payments for non-opioid treatments for pain relief.—“(A) In general.—In the case of surgical services furnished on or after January 1, 2025, and before January 1, 2028, the payment system described in paragraph (2)(D)(i) shall provide, in a budget-neutral manner, for an additional payment for a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) furnished as part of such services in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection. “(B) Transition.—A drug or biological that meets the requirements of section 416.174 of title 42, Code of Federal Regulations (or any successor regulation) and is a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) shall receive additional payment in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.” . (c) Evaluation of Coverage and Payment for Non-opioid Therapies and Therapeutic Services for Pain Management.—(1) Report to congress.—Not later than January 1, 2028, the Secretary of Health and Human Services (in this subsection referred to as the “Secretary”) shall submit to Congress a report—(A) identifying limitations, gaps, barriers to access, or deficits in Medicare coverage or reimbursement for restorative therapies, behavioral approaches, and complementary and integrative health services that are identified in the Pain Management Best Practices Inter-Agency Task Force Report and that have demonstrated the ability to replace or reduce opioid consumption; (B) recommending actions to address the limitations, gaps, barriers to access, or deficits identified under subparagraph (A) to improve Medicare coverage and reimbursement for such therapies, approaches, and services; and (C) comparing, for the 12-month period following the first 6 months in which additional payment for non-opioid treatments for pain relief (as defined in clause (iv) of section 1833(t)(16)(G) of the Social Security Act, as added by subsection (a)) is made under such section 1833(t)(16)(G)—(i) with respect to Medicare beneficiaries who received a non-opioid treatment for pain relief (as so defined) as part of a covered OPD service, the quantity of opioids administered, dispensed, and prescribed for the same covered OPD service, including postoperative management; and (ii) with respect to Medicare beneficiaries who did not receive a non-opioid treatment for pain relief (as so defined) as part of the same covered OPD service in clause (i)), the quantity of opioids administered, dispensed, and prescribed for the same covered OPD service, including postoperative management. (2) Reporting standard and public consultation.—In developing the report described in paragraph (1), the Secretary shall compare results from nationally represented samples of 136 STAT. 5924 beneficiaries and consult with relevant stakeholders as determined appropriate by the Secretary. (3) Exclusive treatment.—Any drug, biological product, or medical device that is a non-opioid treatment for pain relief (as defined in section 1833(t)(16)(G)(iv) of the Social Security Act, as added by subsection (a)) shall not be considered a therapeutic service for purposes of the report under paragraph (1).