Opioid Addiction Treatment Modernization Act

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Opioid Addiction Treatment 
Modernization Act''.

SEC. 2. FINDINGS.

    The Congress finds that opioid addiction has become a public health 
epidemic that must be addressed by increasing awareness and access to 
all treatment options for opioid addiction, overdose reversal, and 
relapse prevention.

SEC. 3. 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.

Summary: Opioid Addiction Treatment Modernization Act  This bill amends the Controlled Substances Act to require a practitioner who administers or dispenses narcotic drugs for maintenance or detoxification treatment in an opioid treatment program to complete training every two years.   The legislation revises the waiver requirements for a physician who wants to administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment in an office-based opioid treatment program. Currently, such physician must notify the Department of Health and Human Services (HHS) and certify that he or she is a qualifying physician, has the capacity to refer patients for appropriate counseling and ancillary services, and will comply with a patient limit. This bill requires a physician to also certify that he or she maintains a diversion control plan and has the capacity to provide directly or by referral all drugs approved by the Food and Drug Administration for the treatment of opioid addiction.   The bill modifies the definition of a "qualifying physician." Currently, a qualifying physician must be licensed in a state and have expertise (such as relevant certification, training, or experience). This legislation requires a qualifying physician to also complete training every two years and obtain written consent from each patient regarding available treatment options.&nbsp;   It permits HHS or the Department of Justice to inspect registered practitioners who dispense narcotics to ensure compliance with the requirements of this Act.  All practitioners who are permitted to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment must submit to HHS a certification of compliance with the requirements of this Act.  The Government Accountability Office must review opioid addition treatment services in the United States and report findings to Congress every five years.