; (B) has an approved indication for the prevention, management, or treatment of a mental health or substance use disorder, including opioid use disorder; (C) uses behavioral treatment or modification to achieve its intended result; and (D) can only be dispensed pursuant to a prescription. (2) Relevant authority defined For purposes of paragraph (1), the term relevant authority means the following sections of the Federal Food, Drug, and Cosmetic Act: (A) Section 510(k) of such Act ( 21 U.S.C. 360(k) ). (B) Section 515 of such Act ( 21 U.S.C. 360e ). . (c) Payment for prescription digital therapeutics Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (x) Payment for prescription digital therapeutics (1) Separate payment The Secretary shall make a payment (separate from any payment that may otherwise be made under this title for a related service) in the amount established pursuant to paragraph (3) for a prescription digital therapeutic (as defined in section 1861(kkk)) that is furnished on or after January 1, 2021. (2) Payment recipient Payment under this subsection shall be made to any provider of services or supplier enrolled under this title that— (A) prescribes a prescription digital therapeutic (as defined in such subsection); (B) uses such prescription digital therapeutic as an integral part of a treatment for a related service