Opioid addiction treatment modernization

(a)

In general

Section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) is amended— (1)by adding at the end the following:

(3)The standards under paragraph (1)(A) (for determining whether a practitioner is qualified to engage in the treatment with respect to which registration is sought) shall include a requirement for completion, every 2 years, of training— (A)provided (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) by an organization such as the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, the American Association for the Treatment of Opioid Dependence, the National Council for Behavioral Health, or any other organization that the Secretary determines is appropriate; and (B)addressing— (i)opioid detoxification; (ii)appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid addiction; (iii)the need for initial and periodic assessments of each patient; (iv)the development of an individualized treatment plan for each patient; and (v)the importance of providing overdose reversal and relapse prevention, and appropriate counseling and other services.

;

(2)in paragraph (2)(B), by inserting and annually thereafter, after before the initial dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxification treatment,; (3)by amending paragraph (2)(B)(ii) to read as follows:

(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 or by referral— (I)all drugs approved by the Food and Drug Administration for the treatment of opioid addiction, including, as available, opioid maintenance, detoxification, and overdose reversal and relapse prevention; and (II)appropriate counseling and ancillary services.

;

(4)by redesignating clause (iii) of paragraph (2)(B) as clause (iv); (5)after paragraph (2)(B)(ii), by inserting the following:

(iii)The practitioner maintains a diversion control plan that contains specific measures to reduce the likelihood of the diversion of controlled substances prescribed by the practitioner for the treatment of opioid addiction.

;

(6)by amending paragraph (2)(G)(ii) to read as follows:

(ii)The term qualifying physician means a physician who meets the following: (I)The physician is licensed under State law. (II)The physician meets one or more of the following conditions: (aa)The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties. (bb)The physician holds an addiction certification from the American Society of Addiction Medicine. (cc)The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association. (dd)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 or the approval of a drug for the treatment of opioid addiction, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug. (ee)The physician has such other training or experience as the State medical licensing board (of the State in which the physician will provide maintenance or detoxification treatment) considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients. (ff)The physician has such other training or experience as the Secretary considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients. Any criteria of the Secretary under this item shall be established by regulation. Any such criteria are effective only for 3 years after the date on which the criteria are promulgated, but may be extended for such additional discrete 3-year periods as the Secretary considers appropriate for purposes of this item. Such an extension of criteria may only be effectuated through a statement published in the Federal Register by the Secretary during the 30-day period preceding the end of the 3-year period involved. (iii)The physician completes, with respect to the treatment and management of opiate-dependent patients, not less than 8 hours of training described in paragraph (3) not less frequently than every 2 years. (iv)The physician obtains in writing from each patient a signed acknowledgment that the patient— (I)will be subject to medication adherence and substance use monitoring; (II)understands available treatment options, including drugs approved by the Food and Drug Administration for the treatment of opioid addiction and their potential risks and benefits; and (III)has an individualized treatment plan.

; and

(7)by amending paragraph (2)(H)(ii) to read as follows:

(ii)Not later than one year after the date of enactment of the Opioid Addiction Treatment Modernization Act, the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opiate-dependent patients. The Secretary shall update such protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration, and other substance abuse disorder professionals. Updates to the protocol shall be guided by science.

(b)

Inspection authority

The Secretary of Health and Human Services or the Attorney General of the United States may inspect persons that are registered under section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) to ensure compliance with the requirements in this Act (and the amendments made by this Act) with respect to which noncompliance may result in a revocation or suspension of the practitioner’s registration. (c)

Certification of compliance

Not later than 1 year after the date of enactment of this Act, all practitioners who, as of such date of enactment, are permitted to dispense narcotic drugs to individuals (for maintenance treatment or detoxification treatment) pursuant to paragraph (1) or (2) of section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) shall submit a certification to the Secretary of Health and Human Services of compliance with the provisions of such section 303(g), as amended by this Act. (d)

Reports to Congress

(1)

In general

Not later than 1 year after the date of enactment of this Act, and every 5 years thereafter, the Comptroller General of the United States shall— (A)perform a thorough review of the provision of opioid addiction treatment services in the United States; and (B)submit a report to the Congress on the findings and conclusions of such review. (2)

Contents

Each report under paragraph (1) shall include— (A)an assessment of compliance with the requirements of section 303(g) of the Controlled Substances Act, as amended by this Act; (B)a description of the measures taken by the Secretary of Health and Human Services to ensure such compliance; and (C)an assessment of— (i)whether the full range of science- and evidence-based treatment options for opioid addiction are fully integrated into treatment; and (ii)the circumstances surrounding medication diversion and misuse.