I 117th CONGRESS 1st Session H. R. 3259 IN THE HOUSE OF REPRESENTATIVES May 14, 2021 Ms. Sewell (for herself, Mr. McKinley , Ms. Kuster , and Mr. Fitzpatrick ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to combat the opioid crisis by promoting access to non-opioid treatments in the hospital outpatient setting.

1. Short title This Act may be cited as the Non-Opioids Prevent Addiction In the Nation Act or the NOPAIN Act . 2. Access to non-opioid treatments for pain (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 separate payments for non-opioid treatments under paragraph (16)(G), after payments under paragraph (6) ; and (2) in paragraph (16), by adding at the end the following new subparagraph: (G) Access to non-opioid treatments for pain (i) In general Notwithstanding any other provision of this subsection, with respect to a covered OPD service (or group of services) furnished on or after January 1, 2022, and before January 1, 2027, the Secretary shall not package, and shall make a separate payment as specified in clause (ii) for, a non-opioid treatment (as defined in clause (iii)) furnished as part of such service (or group of services). (ii) Amount of payment The amount of the payment specified in this clause is, with respect to a non-opioid treatment that is— (I) a drug or biological product, the amount of payment for such drug or biological determined under section 1847A; or (II) a medical device, the amount of the hospital’s charges for the device, adjusted to cost. (iii) Definition of non-opioid treatment A non-opioid treatment means— (I) a drug or biological product that is indicated to produce analgesia without acting upon the body’s opioid receptors; or (II) an implantable, reusable, or disposable medical device cleared or approved by the Administrator for Food and Drugs for the intended use of managing or treating pain, that has demonstrated the ability to replace, reduce, or avoid opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. . (b) Ambulatory surgical center payment system Section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ) is amended— (1) by aligning the margins of clause (v) with the margins of clause (iv); (2) by redesignating clause (vi) as clause (vii); and (3) by inserting after clause (v) the following new clause: (vi) In the case of surgical services furnished on or after January 1, 2022, and before January 1, 2027, the payment system described in clause (i) shall provide, in a budget-neutral manner, for a separate payment for a non-opioid treatment (as defined in clause (iii) of subsection (t)(16)(G)) furnished as part of such services in the amount specified in clause (ii) of such subsection. . (c) Evaluation of therapeutic services for pain management (1) Report to Congress Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (in this subsection referred to as the Secretary ), acting through the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a report identifying— (A) 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; and (B) recommendations 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. (2) Public consultation In developing the report described in paragraph (1), the Secretary shall 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 (as defined in section 1833(t)(16)(G)(iii) of the Social Security Act, as added by subsection (a)) shall not be considered a therapeutic service for the purpose of the report described in paragraph (1).