Sec. 303. MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM ADDICTION
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## SEC. 303 MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM ADDICTION ###
(a)In general ####
(1)In general Section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) is amended— #####
(A)in subparagraph (B), by striking clauses (i), (ii), and
(iii)and inserting the following: > > ###### “(i) > > The practitioner is a qualifying practitioner (as defined in subparagraph (G)). > > > ###### “(ii) > > With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary— > > > ###### “(I) > > all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and > > > ###### “(II) > > appropriate counseling and other appropriate ancillary services. > > > ###### “(iii) > > > ######
(I)> > The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30. > > > ###### “(II) > > The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. > > > ###### “(III) > > The Secretary may by regulation change such applicable number. > > > ###### “(IV) > > The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting.” > ; #####
(B)in subparagraph (D)— ######
(i)in clause (ii), by striking “Upon receiving a notification under subparagraph (B)” and inserting “Upon receiving a determination from the Secretary under clause
(iii)finding that a practitioner meets all requirements for a waiver under subparagraph (B)”; and ######
(ii)in clause (iii)— ######
(I)by inserting “and shall forward such determination to the Attorney General” before the period at the end of the first sentence; and ######
(II)by striking “physician” and inserting “practitioner”; #####
(C)in subparagraph (G)— ######
(i)by amending clause (ii)(I) to read as follows: > > ###### “(I) > > The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.” > ; ######
(ii)by amending clause (ii)(II) to read as follows: > > ###### “(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)in clause (ii)(III), by striking “subspecialty”; ######
(iv)by amending clause (ii)(IV) to read as follows: > > ###### “(IV) > > The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that 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 any other organization that the Secretary determines is appropriate for purposes of this subclause. Such training shall include— > > > ###### “(aa) > > opioid maintenance and detoxification; > > > ###### “(bb) > > appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid 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; > > > ###### “(gg) > > diversion control; and > > > ###### “(hh) > > other best practices, as identified by the Secretary.” > ; and ######
(v)by adding at the end the following: > > ###### “(iii) > > The term ‘qualifying practitioner’ means— > > > ##### “(I) > > a qualifying physician, as defined in clause (ii); or > > > ##### “(II) > > during the period beginning on the date of enactment of the Comprehensive Addiction and Recovery Act of 2016 and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv). > > > ###### “(iv) > > The term ‘qualifying other practitioner’ means a nurse practitioner or physician assistant who satisfies each of the following: > > > ###### “(I) > > The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain. > > > ###### “(II) > > The nurse practitioner or physician assistant has— > > > ###### “(aa) > > completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) 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 is appropriate for purposes of this subclause; or > > > ###### “(bb) > > has such other training or experience as the Secretary determines will demonstrate the ability of the nurse practitioner or physician assistant to treat and manage opiate-dependent patients. > > > ###### “(III) > > The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician. > > The Secretary may, by regulation, revise the requirements for being a qualifying other practitioner under this clause.” > ; and #####
(D)in subparagraph (H)— ######
(i)in clause (i), by inserting after subclause
(II)the following: > > ###### “(III) > > Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements.” > ; and ######
(ii)by amending clause
(ii)to read as follows: > > ###### “(ii) > > Not later than 18 months after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act, the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment.” > . ####
(2)Opioid defined Section 102(18) of the Controlled Substances Act (21 U.S.C. 802(18)) is amended by inserting “or ‘opioid’” after “The term ‘opiate’”. ####
(3)Reports to congress **[**[21 U.S.C. 823 note](/us/usc/t21/s823)**]** #####
(A)In general Not later than 3 years after the date of enactment of this Act and not later than 3 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall— ######
(i)perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and ######
(ii)submit a report to the Congress on the findings and conclusions of such review. #####
(B)Contents Each report under subparagraph
(A)shall include an assessment of— ######
(i)compliance with the requirements of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), as amended by this section; ######
(ii)the measures taken by the Secretary of Health and Human Services to ensure such compliance; ######
(iii)whether there is further need to increase or decrease the number of patients a practitioner, pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), is permitted to treat; ######
(iv)the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; ######
(v)access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services; ######
(vi)changes in State or local policies and legislation relating to opioid use disorder treatment; ######
(vii)the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver described in clause (iii); ######
(viii)the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in clause (vii); and ######
(ix)the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment. ###
(b)State Flexibility Section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) is amended by striking subparagraphs
(I)and (J), and inserting the following: > > ###### “(I) > > Notwithstanding section 708, nothing in this paragraph shall be construed to preempt any State law that— > > > ###### “(i) > > permits a qualifying practitioner to dispense narcotic drugs in schedule III, IV, or V, or combinations of such drugs, for maintenance or detoxification treatment in accordance with this paragraph to a total number of patients that is more than 30 or less than the total number applicable to the qualifying practitioner under subparagraph (B)(iii)(II) if a State enacts a law modifying such total number and the Attorney General is notified by the State of such modification; or > > > ###### “(ii) > > requires a qualifying practitioner to comply with additional requirements relating to the dispensing of narcotic drugs in schedule III, IV, or V, or combinations of such drugs, including requirements relating to the practice setting in which the qualifying practitioner practices and education, training, and reporting requirements.” > . ###
(c)Update Regulations **[**[21 U.S.C. 823 note](/us/usc/t21/s823)**]** Not later than 18 months after the date of enactment of this Act, the Attorney General and the Secretary of Health and Human Services, as appropriate, shall update regulations regarding practitioners described in subsection (a)(3)(B)(vii) (as amended by this section) to include nurse practitioners and physician assistants to ensure the quality of patient care and prevent diversion. # TITLE IV ADDRESSING COLLATERAL CONSEQUENCES
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