```

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2645 Introduced in Senate (IS)]

113th CONGRESS
  2d Session
                                S. 2645

    To provide access to medication-assisted therapy, and for other 
                               purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 23, 2014

 Mr. Markey (for himself, Mrs. Feinstein, Mr. Rockefeller, Mr. Brown, 
 Ms. Hirono, and Mr. Durbin) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 A BILL

 
    To provide access to medication-assisted therapy, and for other 
                               purposes.

    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 ``Recovery Enhancement for Addiction 
Treatment Act'' or the ``TREAT Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Overdoses from opioids have increased dramatically in 
        the United States.
            (2) Deaths from drug overdose, largely from prescription 
        pain relievers, have tripled among men and increased five-fold 
        among women over the past decade.
            (3) Nationwide, drug overdoses now claim more lives than 
        car accidents.
            (4) Opioid addiction is a chronic disease that, untreated, 
        places a large burden on the healthcare system. Roughly 475,000 
        emergency room visits each year are attributable to the misuse 
        and abuse of opioid pain medication.
            (5) Effective medication-assisted treatment for opioid 
        addiction can decrease overdose deaths, be cost-effective, 
        reduce transmissions of HIV and viral hepatitis, and reduce 
        other social harms such as criminal activity.
            (6) Effective medication-assisted treatment programs for 
        opioid addiction should include multiple components, including 
        medications, cognitive and behavioral supports and 
        interventions, and drug testing.
            (7) Effective medication-assisted treatment programs for 
        opioid addiction may use a team of staff members, in addition 
        to a prescribing provider, to deliver comprehensive care.
            (8) Access to medication-assisted treatments, including 
        office-based buprenorphine opioid treatment, remains limited in 
        part due to current practice regulations and an insufficient 
        number of providers.
            (9) More than 10 years of experience in the United States 
        with office-based buprenorphine opioid treatment has informed 
        best practices for delivering successful, high quality care.

SEC. 3. 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. 4. 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. 5. 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 Act, 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 Act, 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>
```