Sec. 7. Establishment of the Controlled Substances Clinical Standards Commission
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Part A of title V of the Public Health Service Act ( 42 U.S.C. 290aa et seq. ), as amended by section 3, is further amended by adding at the end the following: The Secretary shall establish a Controlled Substances Clinical Standards Commission (referred to in this section as the Commission ), to be composed of representatives from the Administration, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Pain Management Consortia of the National Institutes of Health, and other agencies that the Secretary may deem necessary, to develop— appropriate and safe dosing guidelines for all forms of methadone, including recommendations for maximum daily doses of all forms as provided for in subsection (b)(1); benchmark guidelines for the reduction of methadone abuse, as provided for in subsection (b)(2); appropriate conversion factors for use by health care providers in transitioning patients from one opioid to another; specific guidelines for initiating pain management with methadone that prescribing practitioners shall comply with in order to meet certification requirements set forth in part C of the Controlled Substances Act ( 21 U.S.C. 821 et seq. ); and patient and practitioner education guidelines for both methadone maintenance therapy and pain management that apply to safe and effective use and include detoxification.
Not later than 2 years after the date of enactment of this section, the Commission established under subsection
(a)shall publish in the Federal Register— safe and clinically appropriate dosing guidelines for all forms of methadone used for both pain management and opioid treatment programs, including recommendations for maximum daily doses of all forms, including recommendations for the induction process for patients who are newly prescribed methadone; requirements for individual patient care plans, including initial and follow-up patient physical examination guidelines, and recommendations for screening patients for chronic or acute medical conditions that may cause an immediate and adverse reaction to methadone; appropriate conversion factors for use by health care providers in transitioning patients from one opioid to another; specific guidelines for initiating pain management with methadone, that prescribing physicians or other clinicians shall comply with in order to meet Drug Enforcement Administration certification and re-certification requirements; and consensus guidelines for pain management with prescription opioid drugs. Not later than 3 years after the publication of guidelines under subparagraph (A), and at least every 3 years thereafter, the Commission shall update such guidelines. Not later than 3 years after the date of enactment of this section, the Commission established under subsection
(a)shall publish in the Federal Register— the initial benchmark guidelines for the reduction of methadone abuse to be used— by opioid treatment programs in providing methadone therapy; and by entities in the initial accreditation or certification, and the re-accreditation and re-certification, of such opioid treatment programs; a model policy for dispensing methadone to be used by pharmacists that dispense methadone, which should include education and training guidelines for such pharmacists; the continuing education guidelines that all prescribers shall comply with in order to meet Drug Enforcement Administration certification and re-certification requirements, as set forth in section 303(g)(3) of the Controlled Substances Act ( 21 U.S.C. 823(g)(3) ), which should include a minimum of 16 training hours at least every 3 years that include the integration of both addiction and pain management curricula; and patient education guidelines for both opioid treatment programs and pain management, including recommendations for patient counseling prior to and during opioid addiction treatment or treatment for pain. Not later than 1 year after the publication of guidelines under subparagraph (A), and at least annually thereafter, the Commission shall update the guidelines published under clauses
(iii)and
(iv)of such subparagraph. In developing and publishing the guidelines under this section, the Commission shall consult with relevant professional organizations with expertise in the area of addiction, relevant professional organizations with expertise in the area of pain management, physician groups, pharmacy groups (including the National Association of Boards of Pharmacy), patient representatives, and any other organization that the Secretary determines is appropriate for purposes of this section. Not later than 180 days after the date of enactment of this section, the Commission shall establish and operate a Commission website. Not later than 1 year after the date of enactment of this section, the Commission shall establish, and distribute to practitioners that are registered to prescribe or otherwise dispense methadone, a methadone toolkit. The Commission shall make the components of the toolkit that are available in electronic form available on the Commission website. The Commission shall develop a practitioner education program that shall be used for the practitioner education described in section 303(g)(3) of the Controlled Substances Act, and shall make such program available to providers of such practitioner education. There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2014 through 2018. .
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Sec. 7
Establishment of the Controlled Substances Clinical Standards Commission
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