MATE Act of 2020

II 116TH CONGRESS 2D SESSION S. 4640 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. 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, Edu- cation, Labor, and Pensions A BILL To amend the Controlled Substances Act to require physi- cians 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4640 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Medication Access and 2 Training Expansion Act of 2020’’ or the ‘‘MATE Act of 3 2020’’. 4 SEC. 2. REQUIRING PRESCRIBERS OF CONTROLLED SUB- 5 STANCES TO COMPLETE TRAINING ON 6 TREATING AND MANAGING PATIENTS WITH 7 OPIOID AND OTHER SUBSTANCE USE DIS- 8 ORDERS. 9 (a) IN GENERAL.—Section 303 of the Controlled 10 Substances Act (21 U.S.C. 823) is amended by adding at 11 the end the following: 12 ‘‘(l) REQUIRED TRAINING FOR PRESCRIBERS ON 13 TREATING AND MANAGING PATIENTS WITH OPIOID AND 14 OTHER SUBSTANCE USE DISORDERS.— 15 ‘‘(1) APPLICABILITY.—This subsection ap- 16 plies— 17 ‘‘(A) to any practitioner who is licensed 18 under State law to prescribe controlled sub- 19 stances; and 20 ‘‘(B) beginning with the first registration 21 or renewal of registration by the practitioner 22 under this section that occurs on or after the 23 date that is 90 days after the date of enactment 24 of the Medication Access and Training Expan- 25 sion Act of 2020. 26 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4640 IS ‘‘(2) TRAINING REQUIRED.—As a condition on 1 registration under this section to dispense controlled 2 substances in schedule II, III, IV, or V, the Attorney 3 General shall require any practitioner described in 4 paragraph (1)(A) to meet the following conditions: 5 ‘‘(A) In the case of a practitioner who is 6 a physician, the physician shall meet not less 7 than 1 of the following conditions: 8 ‘‘(i) The physician holds a board cer- 9 tification in addiction psychiatry or addic- 10 tion medicine from the American Board of 11 Medical Specialties. 12 ‘‘(ii) The physician holds an addiction 13 certification or board certification from the 14 American Society of Addiction Medicine or 15 the American Board of Addiction Medicine. 16 ‘‘(iii) The physician holds a board cer- 17 tification in addiction medicine from the 18 American Osteopathic Association. 19 ‘‘(iv) The physician has completed not 20 less than 8 hours of training on the treat- 21 ment and management of patients with 22 opioid and other substance use disorders 23 that— 24 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4640 IS ‘‘(I) is provided through class- 1 room situations, seminars at profes- 2 sional society meetings, electronic 3 communication, or other means; 4 ‘‘(II) is provided by the American 5 Society of Addiction Medicine, the 6 American Academy of Addiction Psy- 7 chiatry, the American Medical Asso- 8 ciation, the American Osteopathic As- 9 sociation, the American Psychiatric 10 Association, or another organization 11 that the Secretary determines appro- 12 priate; and 13 ‘‘(III) includes content relating 14 to— 15 ‘‘(aa) opioid maintenance 16 and detoxification; 17 ‘‘(bb) the appropriate clin- 18 ical use of all drugs approved by 19 the Food and Drug Administra- 20 tion for the treatment of a sub- 21 stance use disorder; 22 ‘‘(cc) initial and periodic pa- 23 tient assessments, including sub- 24 stance use monitoring; 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4640 IS ‘‘(dd) individualized treat- 1 ment planning, overdose reversal, 2 and relapse prevention; 3 ‘‘(ee) counseling and recov- 4 ery support services; 5 ‘‘(ff) staffing roles and con- 6 siderations, including bias and 7 anti-racism training to reduce ra- 8 cial and ethnic disparities; 9 ‘‘(gg) diversion control; and 10 ‘‘(hh) other best practices, 11 such as addiction prevention, as 12 identified by the Secretary after 13 consultation with practitioners 14 from a variety of medical special- 15 ties and who practice in different 16 settings in which controlled sub- 17 stances are prescribed. 18 ‘‘(v) The physician has participated as 19 an investigator in one or more clinical 20 trials leading to the approval of a narcotic 21 drug in schedule III, IV, or V for mainte- 22 nance or detoxification treatment, as dem- 23 onstrated by a statement submitted to the 24 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4640 IS Secretary by the sponsor of the approved 1 drug. 2 ‘‘(vi) The physician has other training 3 or experience that the medical licensing 4 board of the State where the physician will 5 provide maintenance or detoxification 6 treatment considers demonstrative of the 7 ability of the physician to treat and man- 8 age patients with opioid and other sub- 9 stance use disorders. 10 ‘‘(vii)(I) The physician has other 11 training or experience that the Secretary 12 identifies, in a regulation promulgated in 13 accordance with subclause (II), as demon- 14 strative of the ability of the physician to 15 treat and manage patients with opioid and 16 other substance use disorders. 17 ‘‘(II)(aa) The Secretary may by regu- 18 lation establish criteria for purposes of 19 subclause (I). 20 ‘‘(bb) Subject to item (cc), any cri- 21 teria established by the Secretary under 22 item (aa) shall be effective for a 3-year pe- 23 riod. 24 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 4640 IS ‘‘(cc) During the 30-day period pre- 1 ceding the expiration of a 3-year period of 2 effectiveness of criteria established under 3 this subclause, the Secretary may extend 4 the effectiveness of the criteria for an addi- 5 tional 3-year period by publishing a notice 6 of the extension in the Federal Register. 7 ‘‘(viii) The physician— 8 ‘‘(I) graduated in good standing 9 from an accredited school of allopathic 10 medicine or osteopathic medicine in 11 the United States during the 5-year 12 period preceding the date of the first 13 registration or renewal of registration 14 by the physician described in para- 15 graph (1)(B); and 16 ‘‘(II) has successfully completed 17 a comprehensive allopathic or osteo- 18 pathic medicine curriculum or accred- 19 ited medical residency that included— 20 ‘‘(aa) not less than 8 hours 21 of training on treating and man- 22 aging patients with opioid and 23 other substance use disorders; 24 and 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 4640 IS ‘‘(bb) at a minimum— 1 ‘‘(AA) the training de- 2 scribed in items (aa) 3 through (hh) of clause 4 (iv)(III); and 5 ‘‘(BB) training with re- 6 spect to any other best prac- 7 tice the Secretary deter- 8 mines necessary, which may 9 include training on pain 10 management, including as- 11 sessment and appropriate 12 use of opioid and non-opioid 13 alternatives. 14 ‘‘(B) In the case of a practitioner who is 15 not a physician, the practitioner shall meet not 16 less than 1 of the following conditions: 17 ‘‘(i) The practitioner has completed 18 not less than 8 hours of initial training on 19 the topics listed in subparagraph 20 (A)(iv)(III) that— 21 ‘‘(I) is provided through class- 22 room situations, seminars at profes- 23 sional society meetings, electronic 24 communication, or other means; and 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 4640 IS ‘‘(II) is provided by the American 1 Society of Addiction Medicine, the 2 American Academy of Addiction Psy- 3 chiatry, the American Medical Asso- 4 ciation, the American Osteopathic As- 5 sociation, the American Nurses 6 Credentialing Center, the American 7 Psychiatric Association, the American 8 Association of Nurse Practitioners, 9 the American Academy of Physician 10 Assistants, or any other organization 11 that the Secretary determines appro- 12 priate. 13 ‘‘(ii) The practitioner has other train- 14 ing or experience that the Secretary identi- 15 fies as demonstrative of the ability of the 16 practitioner to treat and manage patients 17 with opioid and other substance use dis- 18 orders. 19 ‘‘(iii) The practitioner— 20 ‘‘(I) graduated in good standing 21 from an accredited physician assistant 22 school or school of advanced practice 23 nursing in the United States during 24 the 5-year period immediately pre- 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 4640 IS ceding the date of the first registra- 1 tion or renewal of registration by the 2 practitioner described in paragraph 3 (1)(B); and 4 ‘‘(II) has successfully completed 5 a comprehensive physician assistant 6 or advanced practice nursing cur- 7 riculum that includes— 8 ‘‘(aa) not less than 8 hours 9 of training on treating and man- 10 aging patients with opioid and 11 other substance use disorders; 12 and 13 ‘‘(bb) at a minimum— 14 ‘‘(AA) the training de- 15 scribed in items (aa) 16 through (hh) of subpara- 17 graph (A)(iv)(III); and 18 ‘‘(BB) training with re- 19 spect to any other best prac- 20 tice the Secretary deter- 21 mines necessary, which may 22 include training on pain 23 management, including as- 24 sessment and appropriate 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 4640 IS use of opioid and non-opioid 1 alternatives. 2 ‘‘(3) RECIPROCAL TREATMENT.— 3 ‘‘(A) PHYSICIANS.— 4 ‘‘(i) MEETING CONDITIONS FOR PRE- 5 SCRIBING.—A physician who meets one or 6 more of the conditions listed in paragraph 7 (2)(A) shall be deemed to meet one or 8 more of the conditions listed in subsection 9 (g)(2)(G)(ii). 10 ‘‘(ii) MEETING CONDITIONS FOR 11 WAIVER FOR DISPENSING.—A physician 12 who meets one or more of the conditions 13 listed in subsection (g)(2)(G)(ii) shall be 14 deemed to meet one or more of the condi- 15 tions listed in paragraph (2)(A). 16 ‘‘(B) OTHER PRACTITIONERS.— 17 ‘‘(i) MEETING CONDITIONS FOR PRE- 18 SCRIBING.—A practitioner who is not a 19 physician, and who meets one or more of 20 the conditions listed in paragraph (2)(B), 21 shall be deemed to meet one or more of the 22 conditions listed in subsection 23 (g)(2)(G)(iv)(II). 24 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 4640 IS ‘‘(ii) MEETING CONDITIONS FOR 1 WAIVER FOR DISPENSING.—A practitioner 2 who is not a physician, and who meets one 3 or more of the conditions listed in sub- 4 section (g)(2)(G)(iv)(II), shall be deemed 5 to meet one or more of the conditions list- 6 ed in paragraph (2)(B).’’. 7 (b) TRAINING REQUIRED.— 8 (1) PHYSICIANS.—Section 9 303(g)(2)(G)(ii)(IV)(hh) of the Controlled Sub- 10 stances Act (21 U.S.C. 823(g)(2)(G)(ii)(IV)(hh)) is 11 amended by inserting after ‘‘, as identified by the 12 Secretary’’ the following: ‘‘, which may include best 13 practices for addiction prevention’’. 14 (2) OTHER PRACTITIONERS.—Section 15 303(g)(2)(G)(iv)(II) of the Controlled Substances 16 Act (21 U.S.C. 823(g)(2)(G)(iv)(II)) is amended— 17 (A) in item (aa), by striking ‘‘or’’ at the 18 end; 19 (B) in item (bb), by striking the period at 20 the end and inserting ‘‘; or’’; and 21 (C) by adding at the end the following: 22 ‘‘(cc) graduated in good standing from an 23 accredited physician assistant school or school 24 of advanced practice nursing in the United 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 13 •S 4640 IS States during the 5-year period immediately 1 preceding the date on which the practitioner 2 submits to the Secretary a notification under 3 subparagraph (B) and has successfully com- 4 pleted a comprehensive physician assistant or 5 advanced practice nursing curriculum that in- 6 cludes— 7 ‘‘(AA) not less than 8 hours of train- 8 ing on treating and managing opioid-de- 9 pendent patients; 10 ‘‘(BB) the training described in items 11 (aa) through (hh) of clause (ii)(IV); and 12 ‘‘(CC) training with respect to any 13 other best practice the Secretary deter- 14 mines necessary, which may include train- 15 ing on pain management, including assess- 16 ment and appropriate use of opioid and 17 non-opioid alternatives.’’. 18 (3) TECHNICAL CORRECTIONS.—Section 19 303(g)(2)(G) of the Controlled Substances Act (21 20 U.S.C. 823(g)(2)(G)) is amended— 21 (A) in clause (ii)— 22 (i) by moving subclauses (I) and (II) 23 4 ems to the left; 24 (ii) in subclause (VIII)— 25 VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S4640.IS S4640 pamtmann on DSKBC07HB2PROD with BILLS 14 •S 4640 IS (I) in item (bb), by moving 1 subitems (AA) and (BB) 2 ems to the 2 right; and 3 (II) by moving items (aa) and 4 (bb) 2 ems to the right; and 5 (iii) by moving subclause (VIII) 2 ems 6 to the right; and 7 (B) in clause (iv)(II)(bb), by striking 8 ‘‘has’’ before ‘‘such other training’’. 9 Æ VerDate Sep 11 2014 19:34 Oct 05, 2020 Jkt 019200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6301 E:\BILLS\S4640.IS S4640 pamtmann o [Text truncated for display. 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