[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 636 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                 S. 636

             To reduce prescription drug misuse and abuse.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 3, 2015

   Mr. Udall introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
             To reduce prescription drug misuse and abuse.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Increasing the Safety of 
Prescription Drug Use Act of 2015''.

                         TITLE I--HHS PROGRAMS

SEC. 101. AMENDMENT TO PURPOSE.

    Paragraph (1) of section 2 of the National All Schedules 
Prescription Electronic Reporting Act of 2005 (Public Law 109-60) is 
amended to read as follows:
            ``(1) foster the establishment of State-administered 
        controlled substance monitoring systems in order to ensure 
        that--
                    ``(A) health care providers have access to the 
                accurate, timely prescription history information that 
                they may use as a tool for the early identification of 
                patients at risk for addiction in order to initiate 
                appropriate medical interventions and avert the tragic 
                personal, family, and community consequences of 
                untreated addiction; and
                    ``(B) appropriate law enforcement, regulatory, and 
                State professional licensing authorities have access to 
                prescription history information for the purposes of 
                investigating drug diversion and prescribing and 
                dispensing practices of errant prescribers or 
                pharmacists; and''.

SEC. 102. PRESCRIPTION DRUG MONITORING PROGRAM.

    (a) Controlled Substance Monitoring Program.--Section 399O of the 
Public Health Service Act (42 U.S.C. 280g-3) is amended--
            (1) in subsection (a)(1)--
                    (A) in subparagraph (A), by striking ``or'';
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by adding at the end the following:
                    ``(C) to maintain and operate an existing State-
                controlled substance monitoring program.'';
            (2) by amending subsection (b) to read as follows:
    ``(b) Minimum Requirements.--The Secretary shall maintain and, as 
appropriate, supplement or revise (after publishing proposed additions 
and revisions in the Federal Register and receiving public comments 
thereon) minimum requirements for criteria to be used by States for 
purposes of clauses (ii), (v), (vi), and (vii) of subsection 
(c)(1)(A).'';
            (3) in subsection (c)--
                    (A) in paragraph (1)(B)--
                            (i) in the matter preceding clause (i), by 
                        striking ``(a)(1)(B)'' and inserting 
                        ``(a)(1)(B) or (a)(1)(C)'';
                            (ii) in clause (i), by striking ``program 
                        to be improved'' and inserting ``program to be 
                        improved or maintained'';
                            (iii) by redesignating clauses (iii) and 
                        (iv) as clauses (iv) and (v), respectively;
                            (iv) by inserting after clause (ii), the 
                        following:
                            ``(iii) a plan to apply the latest advances 
                        in health information technology in order to 
                        incorporate prescription drug monitoring 
                        program data directly into the workflow of 
                        prescribers and dispensers to ensure timely 
                        access to patients' controlled prescription 
                        drug history;'';
                            (v) in clause (iv) (as so redesignated), by 
                        inserting before the semicolon the following: 
                        ``and at least one health information 
                        technology system such as electronic health 
                        records, health information exchanges, and e-
                        prescribing systems''; and
                            (vi) in clause (v) (as so redesignated), by 
                        striking ``public health'' and inserting 
                        ``public health or public safety'';
                    (B) in paragraph (3)--
                            (i) by striking ``If a State that submits'' 
                        and inserting the following:
                    ``(A) In general.--If a State that submits'';
                            (ii) by inserting before the period at the 
                        end ``and include timelines for full 
                        implementation of such interoperability. The 
                        State shall also describe the manner in which 
                        it will achieve interoperability between its 
                        monitoring program and health information 
                        technology systems, as allowable under State 
                        law, and include timelines for the 
                        implementation of such interoperability''; and
                            (iii) by adding at the end the following:
                    ``(B) Monitoring of efforts.--The Secretary shall 
                monitor State efforts to achieve interoperability, as 
                described in subparagraph (A).'';
                    (C) in paragraph (5)--
                            (i) by striking ``implement or improve'' 
                        and inserting ``establish, improve, or 
                        maintain''; and
                            (ii) by adding at the end the following: 
                        ``The Secretary shall redistribute any funds 
                        that are so returned among the remaining 
                        grantees under this section in accordance with 
                        the formula described in subsection 
                        (a)(2)(B).'';
            (4) in subsection (d)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by striking ``In implementing or 
                        improving'' and all that follows through 
                        ``(a)(1)(B)'' and inserting ``In establishing, 
                        improving, or maintaining a controlled 
                        substance monitoring program under this 
                        section, a State shall comply, or with respect 
                        to a State that applies for a grant under 
                        subparagraph (B) or (C) of subsection (a)(1)''; 
                        and
                            (ii) by striking ``public health'' and 
                        inserting ``public health or public safety''; 
                        and
                    (B) by adding at the end the following:
            ``(5) The State shall report on interoperability with the 
        controlled substance monitoring program of Federal agencies, 
        where appropriate, interoperability with health information 
        technology systems such as electronic health records, health 
        information exchanges, and e-prescribing, where appropriate, 
        and whether or not the State provides automatic, real-time or 
        daily information about a patient when a practitioner (or the 
        designee of a practitioner, where permitted) requests 
        information about such patient.'';
            (5) in subsection (e), by adding at the end the following:
            ``(5) The State shall--
                    ``(A) ensure that the database--
                            ``(i) is interoperable with the controlled 
                        substance monitoring program of other States 
                        and other Federal agencies and across 
                        appropriate State agencies, including health 
                        agencies, as determined by the Secretary;
                            ``(ii) is interoperable with electronic 
                        health records and e-prescribing, where 
                        appropriate; and
                            ``(iii) provides automatic, real-time or 
                        daily information about a patient when a 
                        practitioner (or the designee of a 
                        practitioner, where permitted) requests 
                        information about such patient;
                    ``(B) require practitioners to use State database 
                information to help determine whether to prescribe or 
                renew a prescription for a controlled substance; and
                    ``(C) require dispensers, or their designees, where 
                permitted, to enter data required by the Secretary, 
                including the name of the patient, the date, and 
                prescription dose, into the database for a controlled 
                substance.
            ``(6) Notwithstanding section 543 and any other provision 
        of law, the data required to be entered under paragraph (5)(C) 
        shall include information with respect to methadone that is 
        dispensed to a patient, if applicable.
            ``(7) The State shall ensure that--
                    ``(A) any person who receives patient information 
                through the database may disclose and use such 
                information only to carry out the official duties of 
                that person with regard to the patient; and
                    ``(B) notwithstanding subsection (f)(1)(B), no 
                information kept in accordance with a database 
                established, improved, or maintained through a grant 
                under this section may be used to conduct a criminal 
                investigation or substantiate any criminal charges 
                against a patient or to conduct any investigation of a 
                patient relating to methadone use of the patient.'';
            (6) in subsections (e), (f)(1), and (g), by striking 
        ``implementing or improving'' each place it appears and 
        inserting ``establishing, improving, or maintaining'';
            (7) in subsection (f)--
                    (A) in paragraph (1)(B) by striking ``misuse of a 
                schedule II, III, or IV substance'' and inserting 
                ``misuse of a controlled substance included in schedule 
                II, III, or IV of section 202(c) of the Controlled 
                Substance Act''; and
                    (B) by adding at the end the following:
            ``(3) Evaluation and reporting.--Subject to subsection (g), 
        a State receiving a grant under subsection (a) shall provide 
        the Secretary with aggregate data and other information 
        determined by the Secretary to be necessary to enable the 
        Secretary--
                    ``(A) to evaluate the success of the State's 
                program in achieving its purposes; or
                    ``(B) to prepare and submit the report to Congress 
                required by subsection (k)(2).
            ``(4) Research by other entities.--A department, program, 
        or administration receiving nonidentifiable information under 
        paragraph (1)(D) may make such information available to other 
        entities for research purposes.'';
            (8) by striking subsection (k);
            (9) by redesignating subsections (h) through (j) as 
        subsections (i) through (k), respectively;
            (10) in subsections (c)(1)(A)(iv) and (d)(4), by striking 
        ``subsection (h)'' each place it appears and inserting 
        ``subsection (i)'';
            (11) by inserting after subsection (g) the following:
    ``(h) Education and Access to the Monitoring System.--A State 
receiving a grant under subsection (a) shall take steps to--
            ``(1) facilitate prescriber and dispenser use of the 
        State's controlled substance monitoring system; and
            ``(2) educate prescribers and dispenser on the benefits of 
        the system both to them and society.'';
            (12) in subsection (k)(2)(A), as redesignated--
                    (A) in clause (ii), by striking ``or affected'' and 
                inserting ``, established or strengthened initiatives 
                to ensure linkages to substance use disorder services, 
                or affected''; and
                    (B) in clause (iii), by striking ``including an 
                assessment'' and inserting ``between controlled 
                substance monitoring programs and health information 
                technology systems, and including an assessment'';
            (13) in subsection (l)(1), by striking ``establishment, 
        implementation, or improvement'' and inserting ``establishment, 
        improvement, or maintenance'';
            (14) in subsection (m)(8), by striking ``and the District 
        of Columbia'' and inserting ``, the District of Columbia, and 
        any commonwealth or territory of the United States''; and
            (15) by amending subsection (n), to read as follows:
    ``(o) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $7,000,000 for each of fiscal 
years 2016 through 2020.''.
    (b) Confidentiality of Records.--Section 543(a) of the Public 
Health Service Act (42 U.S.C. 290dd-2(a)) is amended by inserting ``or, 
with respect to methadone, as required under section 399O(e)(6)'' 
before the period at the end.
    (c) Requirements for Federal Health Care Programs.--Health care 
practitioners (as defined in paragraph (7) of section 399O(m) of the 
Public Health Service Act (42 U.S.C. 280g-3(m))) and dispensers (as 
defined in paragraph (4) of such section) who participate in or are 
employed by a Federal health care program or federally funded health 
care program, including the Indian Health Service, the Department of 
Veterans Affairs, the Department of Defense, the Federal Bureau of 
Prisons, the Medicare program under title XVIII of the Social Security 
Act (42 U.S.C. 1395 et seq.), a State Medicaid plan under title XIX of 
the Social Security Act (42 U.S.C. 1396 et seq.), the Children's Health 
Insurance Program under title XXI of the Social Security Act (42 U.S.C. 
1397aa et seq.), and Federally qualified health centers, shall use the 
databases of the controlled substance monitoring programs under section 
399O of the Public Health Service Act (42 U.S.C. 280g-3), if such 
databases are available to the practitioner or dispenser.

SEC. 103. PILOT PROJECT.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall award grants 
to one or more States to carry out a 1-year pilot project to develop a 
standardized peer review process and methodology to review and evaluate 
prescribing and pharmacy dispensing patterns, through a review of 
prescription drug monitoring programs (referred to in this section as 
``PDMP'') in the States receiving such grants.
    (b) Methodology.--The recipients of a grant under this section 
shall develop a systematic, standardized methodology to identify and 
investigate questionable or inappropriate prescribing and dispensing 
patterns of substances on schedule II or III under section 202 of the 
Controlled Substances Act (21 U.S.C. 812). Such peer review methodology 
and prescribing and dispensing patterns shall be shared with the 
appropriate State health profession board.
    (c) Requirements.--A State receiving a grant under this section--
            (1) with respect to controlled substances for which a 
        prescriber is required to have a license issued by the Drug 
        Enforcement Administration in order to prescribe such 
        controlled substances, shall make the information with respect 
        to such controlled substances from the PDMP available to State 
        regulation and licensing boards; and
            (2) with respect to any other controlled substances, may 
        make the information with respect to such controlled substances 
        from the PDMP available to State regulation and licensing 
        boards.
    (d) Subgrantees.--A quality improvement organization with which the 
Secretary has entered into a contract under part B of title XI of the 
Social Security Act (42 U.S.C. 1320c et seq.) may serve as the 
subgrantee under this subsection to develop peer review processes as 
described in subsection (a).

SEC. 104. PRESCRIPTION DRUG AND OTHER CONTROLLED SUBSTANCE ABUSE 
              PREVENTION.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399V-6. PRESCRIPTION DRUG AND OTHER CONTROLLED SUBSTANCE ABUSE 
              PREVENTION.

    ``(a) Training Grants.--
            ``(1) In general.--The Secretary shall award 5-year grants 
        to eligible entities to facilitate training in order to 
        increase the capacity of health care providers to conduct 
        patient screening and brief interventions, such as in health 
        care settings, to prevent the abuse of prescription drugs and 
        other controlled substances. The grant program under this 
        section may be coordinated with the Screening Brief 
        Intervention and Referral to Treatment grant program of the 
        Substance Abuse and Mental Health Services Administration, or 
        other appropriate program.
            ``(2) Eligible entities.--In this subsection, the term 
        `eligible entity' includes--
                    ``(A) States;
                    ``(B) continuing education entities, such as health 
                profession boards or health accrediting bodies; and
                    ``(C) other appropriate health or professional 
                education organizations or institutions.
    ``(b) Federal Health Care Workers.--Health care providers who 
participate in or are employed by a Federal health care program, 
including the Indian Health Service, the Department of Veterans 
Affairs, the Department of Defense, the Federal Bureau of Prisons, the 
Medicare program under title XVIII of the Social Security Act (42 
U.S.C. 1395 et seq.), a State Medicaid plan under title XIX of the 
Social Security Act (42 U.S.C. 1396 et seq.), the State Children's 
Health Insurance Program under title XXI of the Social Security Act (42 
U.S.C. 1397aa et seq.), and Federally qualified health centers, shall 
screen patients for abuse of prescription drugs or other controlled 
substances, conduct brief interventions, and provide referrals for 
known or suspected abuse of prescription drugs or other controlled 
substances, as appropriate.
    ``(c) Expansion of Prescribing Authority.--The Secretary, acting 
through the Administrator of the Health Resources and Services 
Administration, shall award grants to States for the purpose of 
evaluating the prospect of the health professions board of such States 
reviewing and expanding prescribing authorities of providers, such as 
advance practice nurses and physician assistants, in order to control 
the abuse of prescription drugs or other controlled substances with 
respect to specific drugs and other controlled substances, as 
appropriate.''.

SEC. 105. PRESCRIPTION DRUG ABUSE TRAINING AND SCREENING PROGRAMS.

    (a) Continuing Education Grants.--The Secretary of Health and Human 
Services (referred to in this section as the ``Secretary'') shall award 
grants to States to develop continuing education criteria and review 
processes that allow State health profession boards or State agencies 
to certify appropriate education and training for informed and safe 
prescribing of opioids and other drugs on schedule II and III under 
section 202 of the Controlled Substances Act (21 U.S.C. 812).
    (b) Registration With DEA.--A practitioner who registers or renews 
a registration under section 303(f) of the Controlled Substances Act 
(21 U.S.C. 823(f)) shall, at the time of registering, certify to the 
Attorney General that such practitioner has completed continuing 
medical education or nursing continuing education, as applicable--
            (1) in the case of a practitioner registering for the first 
        time, with respect to prescription drug abuse; and
            (2) in the case of a practitioner renewing a registration, 
        with respect to medical understanding of the proper use of all 
        drugs listed in the schedules under section 202 of the 
        Controlled Substances Act (21 U.S.C. 812).
    (c) Screening Program.--The Attorney General shall require that a 
practitioner registered under section 303(f) of the Controlled 
Substances Act (21 U.S.C. 823(f)) conduct patient screening for 
potential drug misuse or abuse before prescribing a drug listed on 
schedule II or III under section 202 of the Controlled Substances Act 
(21 U.S.C. 812), according to standards established by the applicable 
State licensing body.

SEC. 106. FDA REVIEW OF NALOXONE.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall conduct a review of naloxone to 
consider whether naloxone should cease to be subject to section 
503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(b)(1)) and be available as a behind-the-counter drug, in order to 
increase access of such drug to community-based organizations and 
street outreach organizations.

SEC. 107. PRESCRIPTION DRUG DISPOSAL.

    The Secretary of Health and Human Services shall convene or 
coordinate with an existing entity an interagency working group to 
encourage States and local governments to increase opportunities for 
disposal of opiates, such as frequent ``take-back programs'' and fixed 
medicine disposal sites at law enforcement public buildings, and to 
reduce opportunities for abuse of opiates, such as establishing opioid 
dispensing limits at hospital emergency departments.

SEC. 108. GAO REPORT.

    The Comptroller General of the United States shall review 
prescription drug abuse programs and policies in Federal agencies and 
best practices with respect to prescription drug abuse programs of the 
States and, not later than 18 months after the date of enactment of 
this Act, shall issue a report to Congress on its findings and 
recommendations on ways to reduce prescription drug abuse.

                          TITLE II--TREAT ACT

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Recovery Enhancement for Addiction 
Treatment Act'' or the ``TREAT Act''.

SEC. 202. EXPANSION OF PATIENT LIMITS UNDER WAIVER.

    Section 303(g)(2)(B) of the Controlled Substances Act (21 U.S.C. 
823(g)(2)(B)) is amended--
            (1) in clause (i), by striking ``physician'' and inserting 
        ``practitioner'';
            (2) in clause (iii)--
                    (A) by striking ``30'' and inserting ``100''; and
                    (B) by striking ``, unless, not sooner'' and all 
                that follows through the end and inserting a period; 
                and
            (3) by inserting at the end the following new clause:
                    ``(iv) Not earlier than 1 year after the date on 
                which a qualifying practitioner obtained an initial 
                waiver pursuant to clause (iii), the qualifying 
                practitioner may submit a second notification to the 
                Secretary of the need and intent of the qualifying 
                practitioner to treat an unlimited number of patients, 
                if the qualifying practitioner--
                            ``(I)(aa) satisfies the requirements of 
                        item (aa), (bb), (cc), or (dd) of subparagraph 
                        (G)(ii)(I); and
                            ``(bb) agrees to fully participate in the 
                        Prescription Drug Monitoring Program of the 
                        State in which the qualifying practitioner is 
                        licensed, pursuant to applicable State 
                        guidelines; or
                            ``(II)(aa) satisfies the requirements of 
                        item (ee), (ff), or (gg) of subparagraph 
                        (G)(ii)(I);
                            ``(bb) agrees to fully participate in the 
                        Prescription Drug Monitoring Program of the 
                        State in which the qualifying practitioner is 
                        licensed, pursuant to applicable State 
                        guidelines;
                            ``(cc) practices in a qualified practice 
                        setting; and
                            ``(dd) has completed not less than 24 hours 
                        of training (through classroom situations, 
                        seminars at professional society meetings, 
                        electronic communications, or otherwise) with 
                        respect to the treatment and management of 
                        opiate-dependent patients for substance use 
                        disorders 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.''.

SEC. 203. DEFINITIONS.

    Section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 
823(g)(2)(G)) is amended--
            (1) by striking clause (ii) and inserting the following:
                    ``(ii) The term `qualifying practitioner' means the 
                following:
                            ``(I) A physician who is licensed under 
                        State law and who meets 1 or more of the 
                        following conditions:
                                    ``(aa) The physician holds a 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 board 
                                certification in addiction medicine 
                                from the American Osteopathic 
                                Association.
                                    ``(dd) The physician holds a board 
                                certification from the American Board 
                                of Addiction Medicine.
                                    ``(ee) The physician has completed 
                                not less than 8 hours of training 
                                (through classroom situations, seminar 
                                at professional society meetings, 
                                electronic communications, or 
                                otherwise) with respect to the 
                                treatment and management of opiate-
                                dependent patients for substance use 
                                disorders 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.
                                    ``(ff) The physician has 
                                participated as an investigator in 1 or 
                                more clinical trials leading to the 
                                approval of a narcotic drug in schedule 
                                III, IV, or V for maintenance or 
                                detoxification treatment, as 
                                demonstrated by a statement submitted 
                                to the Secretary by this sponsor of 
                                such approved drug.
                                    ``(gg) The physician has such other 
                                training or experience as the Secretary 
                                determines will demonstrate the ability 
                                of the physician to treat and manage 
                                opiate-dependent patients.
                            ``(II) A nurse practitioner or physician 
                        assistant who is licensed under State law and 
                        meets all of the following conditions:
                                    ``(aa) The nurse practitioner or 
                                physician assistant is licensed under 
                                State law to prescribe schedule III, 
                                IV, or V medications for pain.
                                    ``(bb) The nurse practitioner or 
                                physician assistant satisfies 1 or more 
                                of the following:
                                            ``(AA) Has completed not 
                                        fewer than 24 hours of training 
                                        (through classroom situations, 
                                        seminar at professional society 
                                        meetings, electronic 
                                        communications, or otherwise) 
                                        with respect to the treatment 
                                        and management of opiate-
                                        dependent patients for 
                                        substance use disorders 
                                        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.
                                            ``(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.
                                    ``(cc) The nurse practitioner or 
                                physician assistant practices under the 
                                supervision of a licensed physician who 
                                holds an active waiver to prescribe 
                                schedule III, IV, or V narcotic 
                                medications for opioid addiction 
                                therapy, and--
                                            ``(AA) the supervising 
                                        physician satisfies the 
                                        conditions of item (aa), (bb), 
                                        (cc), or (dd) of subclause (I); 
                                        or
                                            ``(BB) both the supervising 
                                        physician and the nurse 
                                        practitioner or physician 
                                        assistant practice in a 
                                        qualified practice setting.
                            ``(III) A nurse practitioner who is 
                        licensed under State law and meets all of the 
                        following conditions:
                                    ``(aa) The nurse practitioner is 
                                licensed under State law to prescribe 
                                schedule III, IV, or V medications for 
                                pain.
                                    ``(bb) The nurse practitioner has 
                                training or experience that the 
                                Secretary determines demonstrates 
                                specialization in the ability to treat 
                                opiate-dependent patients, such as a 
                                certification in addiction specialty 
                                accredited by the American Board of 
                                Nursing Specialties or the National 
                                Commission for Certifying Agencies, or 
                                a certification in addiction nursing as 
                                a Certified Addiction Registered 
                                Nurse--Advanced Practice.
                                    ``(cc) In accordance with State 
                                law, the nurse practitioner prescribes 
                                opioid addiction therapy in 
                                collaboration with a physician who 
                                holds an active waiver to prescribe 
                                schedule III, IV, or V narcotic 
                                medications for opioid addiction 
                                therapy.
                                    ``(dd) The nurse practitioner 
                                practices in a qualified practice 
                                setting.''; and
            (2) by adding at the end the following:
                    ``(iii) The term `qualified practice setting' means 
                1 or more of the following treatment settings:
                            ``(I) A National Committee for Quality 
                        Assurance-recognized Patient-Centered Medical 
                        Home or Patient-Centered Specialty Practice.
                            ``(II) A Centers for Medicaid & Medicare 
                        Services-recognized Accountable Care 
                        Organization.
                            ``(III) A clinical facility administered by 
                        the Department of Veterans Affairs, Department 
                        of Defense, or Indian Health Service.
                            ``(IV) A Behavioral Health Home accredited 
                        by the Joint Commission.
                            ``(V) A Federally-qualified health center 
                        (as defined in section 1905(l)(2)(B) of the 
                        Social Security Act (42 U.S.C. 1396d(l)(2)(B))) 
                        or a Federally-qualified health center look-
                        alike.
                            ``(VI) A Substance Abuse and Mental Health 
                        Services-certified Opioid Treatment Program.
                            ``(VII) A clinical program of a State or 
                        Federal jail, prison, or other facility where 
                        individuals are incarcerated.
                            ``(VIII) A clinic that demonstrates 
                        compliance with the Model Policy on DATA 2000 
                        and Treatment of Opioid Addiction in the 
                        Medical Office issued by the Federation of 
                        State Medical Boards.
                            ``(IX) A treatment setting that is part of 
                        an Accreditation Council for Graduate Medical 
                        Education, American Association of Colleges of 
                        Osteopathic Medicine, or American Osteopathic 
                        Association-accredited residency or fellowship 
                        training program.
                            ``(X) Any other practice setting approved 
                        by a State regulatory board or State Medicaid 
                        Plan to provide addiction treatment services.
                            ``(XI) Any other practice setting approved 
                        by the Secretary.''.

SEC. 204. GAO EVALUATION.

    Two years after the date on which the first notification under 
clause (iv) of section 303(g)(2)(B) of the Controlled Substances Act 
(21 U.S.C. 823(g)(2)(B)), as added by this title, is received by the 
Secretary of Health and Human Services, the Comptroller General of the 
United States shall initiate an evaluation of the effectiveness of the 
amendments made by this title, which shall include an evaluation of--
            (1) any changes in the availability and use of medication-
        assisted treatment for opioid addiction;
            (2) the quality of medication-assisted treatment programs;
            (3) the integration of medication-assisted treatment with 
        routine healthcare services;
            (4) diversion of opioid addiction treatment medication;
            (5) changes in State or local policies and legislation 
        relating to opioid addiction treatment;
            (6) the use of nurse practitioners and physician assistants 
        who prescribe opioid addiction medication;
            (7) the use of Prescription Drug Monitoring Programs by 
        waived practitioners to maximize safety of patient care and 
        prevent diversion of opioid addiction medication;
            (8) the findings of Drug Enforcement Agency inspections of 
        waived practitioners, including the frequency with which the 
        Drug Enforcement Agency finds no documentation of access to 
        behavioral health services; and
            (9) the effectiveness of cross-agency collaboration between 
        Department of Health and Human Services and the Drug 
        Enforcement Agency for expanding effective opioid addiction 
        treatment.
                                 <all>