II 116th CONGRESS 2d Session S. 4640 IN THE SENATE OF THE UNITED STATES September 22, 2020 Mr. Bennet (for himself and Ms. Collins ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Controlled Substances Act to require physicians and other prescribers of controlled substances to complete training on treating and managing patients with opioid and other substance use disorders, which shall also satisfy certain training requirements to receive a waiver for dispensing narcotic drugs for maintenance or detoxification treatment, and for other purposes.

1. Short title This Act may be cited as the Medication Access and Training Expansion Act of 2020 or the MATE Act of 2020 . 2. Requiring prescribers of controlled substances to complete training on treating and managing patients with opioid and other substance use disorders (a) In general Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (l) Required training for prescribers on treating and managing patients with opioid and other substance use disorders (1) Applicability This subsection applies— (A) to any practitioner who is licensed under State law to prescribe controlled substances; and (B) beginning with the first registration or renewal of registration by the practitioner under this section that occurs on or after the date that is 90 days after the date of enactment of the Medication Access and Training Expansion Act of 2020 . (2) Training required As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any practitioner described in paragraph (1)(A) to meet the following conditions: (A) In the case of a practitioner who is a physician, the physician shall meet not less than 1 of the following conditions: (i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties. (ii) The physician holds an addiction certification or board certification from the American Society of Addiction Medicine or the American Board of Addiction Medicine. (iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association. (iv) The physician has completed not less than 8 hours of training on the treatment and management of patients with opioid and other substance use disorders that— (I) is provided through classroom situations, seminars at professional society meetings, electronic communication, or other means; (II) is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or another organization that the Secretary determines appropriate; and (III) includes content relating to— (aa) opioid maintenance and detoxification; (bb) the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; (cc) initial and periodic patient assessments, including substance use monitoring; (dd) individualized treatment planning, overdose reversal, and relapse prevention; (ee) counseling and recovery support services; (ff) staffing roles and considerations, including bias and anti-racism training to reduce racial and ethnic disparities; (gg) diversion control; and (hh) other best practices, such as addiction prevention, as identified by the Secretary after consultation with practitioners from a variety of medical specialties and who practice in different settings in which controlled substances are prescribed. (v) The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of the approved drug. (vi) The physician has other training or experience that the medical licensing board of the State where the physician will provide maintenance or detoxification treatment considers demonstrative of the ability of the physician to treat and manage patients with opioid and other substance use disorders. (vii) (I) The physician has other training or experience that the Secretary identifies, in a regulation promulgated in accordance with subclause (II), as demonstrative of the ability of the physician to treat and manage patients with opioid and other substance use disorders. (II) (aa) The Secretary may by regulation establish criteria for purposes of subclause (I). (bb) Subject to item (cc), any criteria established by the Secretary under item (aa) shall be effective for a 3-year period. (cc) During the 30-day period preceding the expiration of a 3-year period of effectiveness of criteria established under this subclause, the Secretary may extend the effectiveness of the criteria for an additional 3-year period by publishing a notice of the extension in the Federal Register. (viii) The physician— (I) graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period preceding the date of the first registration or renewal of registration by the physician described in paragraph (1)(B); and (II) has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that included— (aa) not less than 8 hours of training on treating and managing patients with opioid and other substance use disorders; and (bb) at a minimum— (AA) the training described in items (aa) through (hh) of clause (iv)(III); and (BB) training with respect to any other best practice the Secretary determines necessary, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. (B) In the case of a practitioner who is not a physician, the practitioner shall meet not less than 1 of the following conditions: (i) The practitioner has completed not less than 8 hours of initial training on the topics listed in subparagraph (A)(iv)(III) that— (I) is provided through classroom situations, seminars at professional society meetings, electronic communication, or other means; and (II) is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary determines appropriate. (ii) The practitioner has other training or experience that the Secretary identifies as demonstrative of the ability of the practitioner to treat and manage patients with opioid and other substance use disorders. (iii) The practitioner— (I) graduated in good standing from an accredited physician assistant school or school of advanced practice nursing in the United States during the 5-year period immediately preceding the date of the first registration or renewal of registration by the practitioner described in paragraph (1)(B); and (II) has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that includes— (aa) not less than 8 hours of training on treating and managing patients with opioid and other substance use disorders; and (bb) at a minimum— (AA) the training described in items (aa) through (hh) of subparagraph (A)(iv)(III); and (BB) training with respect to any other best practice the Secretary determines necessary, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. (3) Reciprocal treatment (A) Physicians (i) Meeting conditions for prescribing A physician who meets one or more of the conditions listed in paragraph (2)(A) shall be deemed to meet one or more of the conditions listed in subsection (g)(2)(G)(ii). (ii) Meeting conditions for waiver for dispensing A physician who meets one or more of the conditions listed in subsection (g)(2)(G)(ii) shall be deemed to meet one or more of the conditions listed in paragraph (2)(A). (B) Other practitioners (i) Meeting conditions for prescribing A practitioner who is not a physician, and who meets one or more of the conditions listed in paragraph (2)(B), shall be deemed to meet one or more of the conditions listed in subsection (g)(2)(G)(iv)(II). (ii) Meeting conditions for waiver for dispensing A practitioner who is not a physician, and who meets one or more of the conditions listed in subsection (g)(2)(G)(iv)(II), shall be deemed to meet one or more of the conditions listed in paragraph (2)(B). . (b) Training required (1) Physicians Section 303(g)(2)(G)(ii)(IV)(hh) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)(IV)(hh)) is amended by inserting after , as identified by the Secretary the following: , which may include best practices for addiction prevention . (2) Other practitioners Section 303(g)(2)(G)(iv)(II) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iv)(II) ) is amended— (A) in item (aa), by striking or at the end; (B) in item (bb), by striking the period at the end and inserting ; or ; and (C) by adding at the end the following: (cc) graduated in good standing from an accredited physician assistant school or school of advanced practice nursing in the United States during the 5-year period immediately preceding the date on which the practitioner submits to the Secretary a notification under subparagraph (B) and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that includes— (AA) not less than 8 hours of training on treating and managing opioid-dependent patients; (BB) the training described in items (aa) through (hh) of clause (ii)(IV); and (CC) training with respect to any other best practice the Secretary determines necessary, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. . (3) Technical corrections Section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended— (A) in clause (ii)— (i) by moving subclauses (I) and (II) 4 ems to the left; (ii) in subclause (VIII)— (I) in item (bb), by moving subitems (AA) and (BB) 2 ems to the right; and (II) by moving items (aa) and (bb) 2 ems to the right; and (iii) by moving subclause (VIII) 2 ems to the right; and (B) in clause (iv)(II)(bb), by striking has before such other training .