II Calendar No. 441 114th CONGRESS 2d Session S. 1455 IN THE SENATE OF THE UNITED STATES May 22, 2015 Mr. Markey (for himself, Mr. Paul , Mrs. Feinstein , Mr. Durbin , Ms. Hirono , Mr. Brown , Ms. Baldwin , Mr. Franken , Mr. Casey , Mrs. Shaheen , Mr. King , Mr. Leahy , Mr. Sanders , Ms. Collins , Mr. Merkley , Mr. Reed , Mr. Murphy , Mr. Menendez , Mr. Hatch , and Mrs. Gillibrand ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions April 27, 2016 Reported by Mr. Alexander , with an amendment Strike out all after the enacting clause and insert the part printed in italic A BILL To provide access to medication-assisted therapy, and for other purposes.

1. Short title This Act may be cited as the Recovery Enhancement for Addiction Treatment Act or the TREAT Act . 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, 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. 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. . 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, 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 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. . 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 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.

1. Short title This Act may be cited as the Recovery Enhancement for Addiction Treatment Act or the TREAT Act . 2. 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 The total number and inserting (I) The total number ; (B) by striking 30 and inserting 100 ; (C) by striking , unless, not sooner and all that follows through of this subparagraph ; and (D) by adding at the end the following: (II) If a patient is referred by a qualifying practitioner that is a physician to another qualifying practitioner that is a physician that provides short-term services (such as induction or titration), the patient shall only be included in the total number of such patients of the qualifying physician that makes the referral. (III) In this clause, the term the total number of such patients shall not include a patient to whom a qualifying practitioner that is a physician meeting the requirements described in clause (iv)(I), or an authorized agent of such qualifying practitioner that is a physician, directly administers such drugs or combination drugs. ; and (4) by adding at the end the following: (iv) Not earlier than 1 year after the date on which a qualifying practitioner that is a physician obtained an initial waiver pursuant to clause (iii), such qualifying practitioner may submit a second notification to the Secretary of the need and intent of such qualifying practitioner to treat up to 500 patients, if such 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; and (cc) 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. (v) The qualifying practitioner shall maintain records relating to the dispensing of drugs or combinations of drugs to treat patients under this paragraph, including— (I) whether the qualifying practitioner provides counseling services on-site, and how frequently patients are using such services; (II) whether the qualifying practitioner referred patients for counseling services off-site, the percentage of the patients of the qualifying practitioner using such services, and how frequently the patients are using such services; and (III) the frequency with which patients being treated under this paragraph terminate the treatment against medical advice. . 3. Definitions Section 303(g)(2)(G) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G) ) is amended 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 or addiction medicine from the American Board of Medical Specialties. (bb) The physician holds an addiction certification from the American Society of Addiction Medicine or the American Board 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, after notice and the opportunity for comment. (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. (bb) The nurse practitioner or physician assistant 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 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, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary determines is appropriate for purposes of this subclause, after notice and opportunity for comment. (cc) If required by State law, the nurse practitioner or physician assistant prescribes opioid addiction therapy in collaboration with or under the supervision of, as applicable, a physician. . 4. State flexibility Section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is amended by striking subparagraphs (I) and (J), and inserting the following: (I) Notwithstanding section 708, nothing in this paragraph shall be construed to preempt any State law that— (i) permits a qualifying practitioner to dispense narcotic drugs in schedule III, IV, or V, or combinations of such drugs, for maintenance or detoxification treatment in accordance with this paragraph to a total number of patients that is more than 30 or less than the total number applicable to the qualifying practitioner under clause (iv) of subparagraph (B) if a State enacts a law modifying such total number and the Attorney General is notified by the State of such modification; or (ii) requires a qualifying practitioner to comply with additional requirements relating to the dispensing of narcotic drugs in schedule III, IV, or V, or combinations of such drugs, including requirements relating to the practice setting in which the qualifying practitioner practices and education, training, and reporting requirements. . 5. Update regulations Not later than 1 year after the date of enactment of this Act, the Attorney General shall update regulations regarding waived practitioners (as amended by this Act) to include nurse practitioners and physician assistants to ensure the quality of patient care and prevent diversion. 6. Evaluations (a) Definition In this section, the term appropriate committees of Congress means— (1) the Committee on Health, Education, Labor, and Pensions and the Committee on the Judiciary of the Senate; and (2) the Committee on Energy and Commerce and the Committee on the Judiciary of the House of Representatives. (b) HHS Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in coordination with the Attorney General, shall submit to the appropriate committees of Congress a report on the effect on the amendments made by this title on the availability of evidence-based treatment and any increased risk in diversion, including the impact of nurse practitioners and physician assistants as qualifying practitioners. (c) GAO (1) In general Four 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— (A) any changes in the availability and use of medication-assisted treatment for opioid addiction; (B) the quality of medication-assisted treatment programs; (C) the integration of medication-assisted treatment with routine healthcare services; (D) diversion of opioid addiction treatment medication; (E) changes in State or local policies and legislation relating to opioid addiction treatment; (F) the use of nurse practitioners and physician assistants who prescribe opioid addiction medication; (G) the use of Prescription Drug Monitoring Programs by waived practitioners to maximize safety of patient care and prevent diversion of opioid addiction medication; (H) 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 (I) the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Agency for expanding effective opioid addiction treatment. (2) Report The Comptroller General shall submit to the appropriate committees of Congress a report regarding the evaluation conducted under paragraph (1).

April 27, 2016 Reported with an amendment