[Congressional Record Volume 162, Number 33 (Tuesday, March 1, 2016)]
[Senate]
[Pages S1165-S1166]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 3381. Mr. MARKEY (for himself and Mr. Paul) submitted an amendment 
intended to be proposed by him to the bill S. 524, to authorize the 
Attorney General to award grants to address the national epidemics of 
prescription opioid abuse and heroin use; which was ordered to lie on 
the table; as follows:

       At the end, add the following:

                         TITLE VIII--TREAT ACT

     SEC. 801. SHORT TITLE.

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

     SEC. 802. 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, in combination with counseling and behavioral 
     therapies, 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. 803. 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. 804. 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, 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.
       ``(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, seminars at professional 
     society meetings, electronic communications, or otherwise) 
     with respect to the treatment and

[[Page S1166]]

     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. 805. 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 Administration 
     inspections of waived practitioners, including the frequency 
     with which the Drug Enforcement Administration 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 Administration for expanding effective opioid 
     addiction treatment.
                                 ______