Opioid Use Disorder Treatment Expansion and Modernization Act

Bill: 114-hr-4981
Sponsor: full_name: Rep. Bucshon, Larry [R-IN-8]
Introduced: 2016-04-18
Policy area: Health
Subjects: Congressional oversight

Drug therapy

Drug trafficking and controlled substances

Drug, alcohol, tobacco use

Government studies and investigations

Health personnel

Health promotion and preventive care

Licensing and registrations

Medical education

Prescription drugs
Latest action: action_date: 2016-05-12
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2016-04-18
action_desc: Introduced in House
text: <p><b>Opioid Use Disorder Treatment Expansion and Modernization Act</b></p> <p>This bill amends the Controlled Substances Act to revise the requirements for a practitioner to administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment in an office-based opioid treatment program.</p> <p>Currently, a practitioner must notify the Department of Health and Human Services (HHS) and certify that he or she is a qualifying physician (i.e., a state-licensed physician with certain expertise), has the capacity to refer patients for appropriate counseling and ancillary services, and will comply with a patient limit. The patient limit is how many patients the practitioner can treat under the office-based treatment program at one time.</p> <p>This legislation expands qualifying practitioners to include nurse practitioners and physician assistants who are licensed in a state, have expertise, and prescribe medications for opioid use disorder in collaboration with or under the supervision of a physician if required by state law. </p> <p>Additionally, it requires a qualifying practitioner to also certify that he or she will comply with reporting requirements and has the capacity to provide directly or by referral, or provide contact information of the nearest practitioner who can provide, all drugs approved by the Food and Drug Administration to treat opioid use disorder.</p> <p>Finally, the bill increases the patient limit for a qualifying physician who holds a specialized certification or completes specified training. A physician must additionally certify that he or she will maintain a diversion control plan and obtain written consent from each patient regarding available treatment options.</p> <p>HHS must update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings.</p> <p>HHS may recommend revoking or suspending the registration of a practitioner who fails to comply with the requirements of this Act.</p>

action_date: 2016-05-10
action_desc: Reported to House amended, Part I
text: <p><b>Opioid Use Disorder Treatment Expansion and Modernization Act</b></p> <p> (Sec. 3) This bill amends the Controlled Substances Act to revise the requirements for a practitioner to administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment in an office-based opioid treatment program. </p> <p>Currently, a practitioner must notify the Department of Health and Human Services (HHS) and certify that he or she is a qualifying physician (i.e., a state-licensed physician with certain expertise), has the capacity to refer patients for appropriate counseling and ancillary services, and will comply with a patient limit. The patient limit is how many patients the practitioner can treat under the office-based treatment program at one time. </p> <p>This legislation expands qualifying practitioners to include nurse practitioners and physician assistants who are licensed in a state, have expertise (such as relevant training or expertise), and prescribe medications for opioid use disorder in collaboration with or under the supervision of a qualifying physician if state law requires physician oversight of prescribing authority. </p> <p>Additionally, it requires a qualifying practitioner to also certify that he or she will comply with reporting requirements and has the capacity to provide directly or by referral, or in another manner prescribed by HHS, all drugs approved by the Food and Drug Administration to treat opioid use disorder. </p> <p>Finally, the bill increases from 100 to 250 the maximum patient limit for a qualifying physician who holds a specialized certification or completes specified training. A physician must additionally certify that he or she will maintain a diversion control plan and obtain written consent from each patient regarding available treatment options. </p> <p>HHS must update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. </p> <p>HHS may recommend revoking or suspending the registration of a practitioner who fails to comply with the requirements of this Act.</p>

action_date: 2016-05-11
action_desc: Passed House amended
text: <p><b>Opioid Use Disorder Treatment Expansion and Modernization Act</b></p> <p>(Sec. 3) This bill amends the Controlled Substances Act to revise the requirements for a practitioner to administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment in an office-based opioid treatment program.</p> <p>Currently, a practitioner must notify the Department of Health and Human Services (HHS) and certify that he or she is a qualifying physician (i.e., a state-licensed physician with certain expertise), has the capacity to refer patients for appropriate counseling and ancillary services, and will comply with a patient limit. The patient limit is how many patients the practitioner can treat under the office-based treatment program at one time.</p> <p>This legislation expands qualifying practitioners to include nurse practitioners and physician assistants who are licensed in a state, have expertise (such as relevant training or expertise), and prescribe medications for opioid use disorder in collaboration with or under the supervision of a qualifying physician if state law requires physician oversight of prescribing authority.</p> <p>Additionally, it requires a qualifying practitioner to also certify that he or she will comply with reporting requirements and has the capacity to provide directly or by referral, or in another manner prescribed by HHS, all drugs approved by the Food and Drug Administration to treat opioid use disorder.</p> <p>HHS may issue regulations to change the maximum patient limit for a qualifying practitioner. If HHS increases the limit, then a qualifying practitioner must additionally certify that he or she will obtain written consent from each patient regarding available treatment options.</p> <p>HHS must update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings.</p> <p>HHS may recommend revoking or suspending the registration of a practitioner who fails to comply with the requirements of this Act.</p> <p>(Sec. 4) The bill expresses the sense of Congress that HHS should consider raising from 100 to 250 the maximum patient limit for a qualifying physician.</p> <p>(Sec. 5) It amends the Controlled Substances Act to allow a pharmacist to partially fill a prescription for a schedule II controlled substance (such as a prescription opioid painkiller) if: (1) it is not prohibited by state law, (2) it is prescribed in accordance with existing laws and regulations, (3) it is requested by the patient or prescribing practitioner, and (4) the total quantity dispensed in partial fillings does not exceed the total quantity prescribed.</p> <p>Additionally, a pharmacist may partially fill a prescription for a schedule II controlled substance in other circumstances in accordance with existing Drug Enforcement Administration (DEA) regulations. (Current DEA regulations permit partial fills when a pharmacist cannot supply a full quantity, a patient resides in a long-term care facility, or a patient is terminally ill.)</p> <p>The remaining of a partially filled prescription may be filled within 30 days or, in the case of an emergency situation, within 72 hours.</p>

tv_txt: I 114th CONGRESS 2d Session H. R. 4981 IN THE HOUSE OF REPRESENTATIVES April 18, 2016 Mr. Bucshon (for himself and Mr. Tonko ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Controlled Substances Act to improve access to opioid use disorder treatment.

1. Short title This Act may be cited as the Opioid Use Disorder Treatment Expansion and Modernization Act . 2. Finding The Congress finds that opioid use disorder has become a public health epidemic that must be addressed by increasing awareness and access to all treatment options for opioid use disorder, overdose reversal, and relapse prevention. 3. Opioid use disorder treatment modernization (a) In general Section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is amended— (1) in subparagraph (B), by striking clauses (i), (ii), and (iii) and inserting the following: (i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)). (ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or by providing the contact information for the nearest applicable practitioner— (I) all schedule III, IV, and V drugs, as well as unscheduled medications approved by the Food and Drug Administration, for the treatment of opioid use disorder, including such drugs and medications for maintenance, detoxification, overdose reversal, and relapse prevention, as available; and (II) appropriate counseling and other appropriate ancillary services. (iii) (I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclauses (II) and (III), the applicable number is 30. (II) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. (III) The applicable number is 250 if the practitioner is a qualifying physician meeting the requirement of subclause (VI) and, not sooner than 1 year after the date on which the practitioner submitted a second notification under subclause (II), the practitioner submits a third notification to the Secretary of the need and intent of the practitioner to treat up to 250 patients. (IV) The Secretary may by regulation change such total number. (V) The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting. (VI) For purposes of subclause (III), a qualifying physician meets the requirement of this subclause if the practitioner or physician— (aa) holds a special certification in addiction psychiatry or addiction medicine as described in clause (ii) from the American Board of Medical Specialties, the American Board of Addiction Medicine, the American Osteopathic Association, the American Society of Addiction Medicine, or such other organization as the Secretary determines to be appropriate for purposes of this subclause; or (bb) completes at least 24 hours of training, with respect to the treatment and management of opiate-dependent patients, addressing the topics listed in subparagraph (G)(ii)(IV). The Secretary may review and update the requirements of this subclause. (iv) In the case of a third notification under clause (iii)(III), the practitioner maintains and implements a diversion control plan that contains specific measures to reduce the likelihood of the diversion of controlled substances prescribed by the practitioner for the treatment of opioid use disorder. (v) In the case of a third notification under clause (iii)(III), the practitioner obtains a written agreement from each patient, including the patient’s signature, that the patient— (I) will receive an initial assessment and treatment plan and periodic assessments and treatment plans thereafter; (II) will be subject to medication adherence and substance use monitoring; and (III) understands available treatment options, including all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including their potential risks and benefits. (vi) The practitioner will comply with the reporting requirements of subparagraph (D)(i)(IV). ; (2) in subparagraph (D)— (A) in clause (i), by adding at the end the following: (IV) The practitioner reports to the Secretary, at such times and in such manner as specified by the Secretary, such information and assurances as the Secretary determines necessary to assess whether the practitioner continues to meet the requirements for a waiver under this paragraph. ; (B) in clause (ii), by striking Upon receiving a notification under subparagraph (B) and inserting Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B) ; and (C) in clause (iii)— (i) by inserting and shall forward such determination to the Attorney General before the period at the end of the first sentence; and (ii) by striking physician and inserting practitioner ; (3) in subparagraph (G)— (A) by amending clause (ii)(IV) to read as follows: (IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is 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. Such training shall address— (aa) opioid maintenance and detoxification; (bb) appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; (cc) initial and periodic patient assessments (including substance use monitoring); (dd) individualized treatment planning; overdose reversal; relapse prevention; (ee) counseling and recovery support services; (ff) staffing roles and considerations; (gg) diversion control; and (hh) other best practices, as identified by the Secretary. ; and (B) by adding at the end the following: (iii) The term qualifying practitioner means— (I) a qualifying physician, as defined in clause (ii); or (II) a qualifying other practitioner, as defined in clause (iv). (iv) The term qualifying other practitioner means a nurse practitioner or physician assistant who satisfies each of the following: (I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain. (II) The nurse practitioner or physician assistant satisfies 1 or more of the following: (aa) Has completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminar at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, 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. (III) If required by State law, the nurse practitioner or physician assistant prescribes medications for the treatment of opioid use disorder in collaboration with or under supervision of a physician. The Secretary may review and update the requirements for being a qualifying other practitioner under this clause. ; and (4) in subparagraph (H)— (A) in clause (i), by adding at the end the following: (III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements. ; and (B) by amending clause (ii) to read as follows: (ii) Not later than one year after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act , the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment. . (b) Recommendation of revocation or suspension of registration in case of substantial noncompliance The Secretary of Health and Human Services may recommend to the Attorney General that the registration of a practitioner be revoked or suspended if the Secretary determines, according to such criteria as the Secretary establishes by regulation, that a practitioner who is registered under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is not in substantial compliance with the requirements of such section, as amended by this Act. (c) Opioid defined Section 102(18) of the Controlled Substances Act ( 42 U.S.C. 802(18) ) is amended by inserting or opioid after The term opiate . (d) Reports to Congress (1) In general Not later than 2 years after the date of enactment of this Act and not less than over every 5 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall— (A) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and non-specialty settings; and (B) submit a report to the Congress on the findings and conclusions of such review. (2) Contents Each report under paragraph (1) shall include an assessment of— (A) compliance with the requirements of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ), as amended by this Act; (B) the measures taken by the Secretary of Health and Human Services to ensure such compliance; (C) whether there is further need to increase or decrease the number of patients a waivered practitioner is permitted to treat, as provided for by the amendment made by subsection (a)(1); (D) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; (E) access to, and use of, other behavioral health and recovery supports; (F) changes in State or local policies and legislation relating to opioid use disorder treatment; (G) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ); (H) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in subparagraph (G); and (I) the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment.

tv_txt: I 114th CONGRESS 2d Session H. R. 4981 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend the Controlled Substances Act to improve access to opioid use disorder treatment.

1. Short title This Act may be cited as the Opioid Use Disorder Treatment Expansion and Modernization Act . 2. Finding The Congress finds that opioid use disorder has become a public health epidemic that must be addressed by increasing awareness and access to all treatment options for opioid use disorder, overdose reversal, and relapse prevention. 3. Opioid use disorder treatment modernization (a) In general Section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is amended— (1) in subparagraph (B), by striking clauses (i), (ii), and (iii) and inserting the following: (i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)). (ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary— (I) all schedule III, IV, and V drugs, as well as unscheduled medications approved by the Food and Drug Administration, for the treatment of opioid use disorder, including such drugs and medications for maintenance, detoxification, overdose reversal, and relapse prevention, as available; and (II) appropriate counseling and other appropriate ancillary services. (iii) (I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30. (II) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. (III) The Secretary may by regulation change such total number. (IV) The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting. (iv) If the Secretary by regulation increases the total number of patients which a qualifying practitioner is permitted to treat pursuant to clause (iii)(II), the Secretary shall require such a practitioner to obtain a written agreement from each patient, including the patient’s signature, that the patient— (I) will receive an initial assessment and treatment plan and periodic assessments and treatment plans thereafter; (II) will be subject to medication adherence and substance use monitoring; (III) understands available treatment options, including all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including their potential risks and benefits; and (IV) understands that receiving regular counseling services is critical to recovery. (v) The practitioner will comply with the reporting requirements of subparagraph (D)(i)(IV). ; (2) in subparagraph (D)— (A) in clause (i), by adding at the end the following: (IV) The practitioner reports to the Secretary, at such times and in such manner as specified by the Secretary, such information and assurances as the Secretary determines necessary to assess whether the practitioner continues to meet the requirements for a waiver under this paragraph. ; (B) in clause (ii), by striking Upon receiving a notification under subparagraph (B) and inserting Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B) ; and (C) in clause (iii)— (i) by inserting and shall forward such determination to the Attorney General before the period at the end of the first sentence; and (ii) by striking physician and inserting practitioner ; (3) in subparagraph (G)— (A) by amending clause (ii)(IV) to read as follows: (IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is 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. Such training shall address— (aa) opioid maintenance and detoxification; (bb) appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; (cc) initial and periodic patient assessments (including substance use monitoring); (dd) individualized treatment planning; overdose reversal; relapse prevention; (ee) counseling and recovery support services; (ff) staffing roles and considerations; (gg) diversion control; and (hh) other best practices, as identified by the Secretary. ; and (B) by adding at the end the following: (iii) The term qualifying practitioner means— (I) a qualifying physician, as defined in clause (ii); or (II) during the period beginning on the date of the enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act and ending on the date that is 3 years after such date of enactment, a qualifying other practitioner, as defined in clause (iv). (iv) The term qualifying other practitioner means a nurse practitioner or physician assistant who satisfies each of the following: (I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain. (II) The nurse practitioner or physician assistant satisfies one or more of the following: (aa) Has completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, 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. (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. (III) The nurse practitioner or physician assistant is supervised by or works in collaboration with a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician. The Secretary may review and update the requirements for being a qualifying other practitioner under this clause. ; and (4) in subparagraph (H)— (A) in clause (i), by inserting after subclause (II) the following: (III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements. ; and (B) by amending clause (ii) to read as follows: (ii) Not later than 1 year after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act , the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment. . (b) Recommendation of revocation or suspension of registration in case of substantial noncompliance The Secretary of Health and Human Services may recommend to the Attorney General that the registration of a practitioner be revoked or suspended if the Secretary determines, according to such criteria as the Secretary establishes by regulation, that a practitioner who is registered under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is not in substantial compliance with the requirements of such section, as amended by this Act. (c) Opioid defined Section 102(18) of the Controlled Substances Act ( 21 U.S.C. 802(18) ) is amended by inserting or opioid after The term opiate . (d) Reports to Congress (1) In general Not later than 2 years after the date of enactment of this Act and not less than over every 5 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall— (A) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and (B) submit a report to the Congress on the findings and conclusions of such review. (2) Contents Each report under paragraph (1) shall include an assessment of— (A) compliance with the requirements of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ), as amended by this Act; (B) the measures taken by the Secretary of Health and Human Services to ensure such compliance; (C) whether there is further need to increase or decrease the number of patients a waivered practitioner is permitted to treat, as provided for by the amendment made by subsection (a)(1); (D) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; (E) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services; (F) changes in State or local policies and legislation relating to opioid use disorder treatment; (G) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ); (H) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in subparagraph (G); and (I) the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment. 4. Sense of Congress It is the Sense of Congress that, with respect to the total number of patients that a qualifying physician (as defined in subparagraph (G)(iii) of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) can treat at any one time pursuant to such section, the Secretary of Health and Human Services should consider raising such total number to 250 patients following a third notification to the Secretary of the need and intent of the physician to treat up to 250 patients that is submitted to the Secretary not sooner than 1 year after the date on which the physician submitted to the Secretary a second notification to treat up to 100 patients. 5. Partial fills of schedule II controlled substances (a) In general Section 309 of the Controlled Substances Act ( 21 U.S.C. 829 ) is amended by adding at the end the following: (f) Partial fills of schedule II controlled substances (1) Partial fills (A) In general A prescription for a controlled substance in schedule II may be partially filled if— (i) it is not prohibited by State law; (ii) the prescription is written and filled in accordance with the Controlled Substances Act ( 21 U.S.C. 801 et seq. ), regulations prescribed by the Attorney General, and State law; (iii) the partial fill is requested by the patient or the practitioner that wrote the prescription; and (iv) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. (B) Other circumstances A prescription for a controlled substance in schedule II may be partially filled in accordance with section 1306.13 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Reducing Unused Medications Act of 2016 ). (2) Remaining portions (A) In general Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II— (i) may be filled; and (ii) shall be filled not later than 30 days after the date on which the prescription is written. (B) Emergency situations In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II— (i) may be filled; and (ii) shall be filled not later than 72 hours after the prescription is issued. . (b) Rule of construction Nothing in this section shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ) to be partially filled.

Passed the House of Representatives May 11, 2016. Karen L. Haas, Clerk.

tv_txt: IIB 114th CONGRESS 2d Session H. R. 4981 IN THE SENATE OF THE UNITED STATES May 12, 2016 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend the Controlled Substances Act to improve access to opioid use disorder treatment.

1. Short title This Act may be cited as the Opioid Use Disorder Treatment Expansion and Modernization Act . 2. Finding The Congress finds that opioid use disorder has become a public health epidemic that must be addressed by increasing awareness and access to all treatment options for opioid use disorder, overdose reversal, and relapse prevention. 3. Opioid use disorder treatment modernization (a) In general Section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is amended— (1) in subparagraph (B), by striking clauses (i), (ii), and (iii) and inserting the following: (i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)). (ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary— (I) all schedule III, IV, and V drugs, as well as unscheduled medications approved by the Food and Drug Administration, for the treatment of opioid use disorder, including such drugs and medications for maintenance, detoxification, overdose reversal, and relapse prevention, as available; and (II) appropriate counseling and other appropriate ancillary services. (iii) (I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30. (II) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. (III) The Secretary may by regulation change such total number. (IV) The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting. (iv) If the Secretary by regulation increases the total number of patients which a qualifying practitioner is permitted to treat pursuant to clause (iii)(II), the Secretary shall require such a practitioner to obtain a written agreement from each patient, including the patient’s signature, that the patient— (I) will receive an initial assessment and treatment plan and periodic assessments and treatment plans thereafter; (II) will be subject to medication adherence and substance use monitoring; (III) understands available treatment options, including all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including their potential risks and benefits; and (IV) understands that receiving regular counseling services is critical to recovery. (v) The practitioner will comply with the reporting requirements of subparagraph (D)(i)(IV). ; (2) in subparagraph (D)— (A) in clause (i), by adding at the end the following: (IV) The practitioner reports to the Secretary, at such times and in such manner as specified by the Secretary, such information and assurances as the Secretary determines necessary to assess whether the practitioner continues to meet the requirements for a waiver under this paragraph. ; (B) in clause (ii), by striking Upon receiving a notification under subparagraph (B) and inserting Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B) ; and (C) in clause (iii)— (i) by inserting and shall forward such determination to the Attorney General before the period at the end of the first sentence; and (ii) by striking physician and inserting practitioner ; (3) in subparagraph (G)— (A) by amending clause (ii)(IV) to read as follows: (IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is 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. Such training shall address— (aa) opioid maintenance and detoxification; (bb) appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; (cc) initial and periodic patient assessments (including substance use monitoring); (dd) individualized treatment planning; overdose reversal; relapse prevention; (ee) counseling and recovery support services; (ff) staffing roles and considerations; (gg) diversion control; and (hh) other best practices, as identified by the Secretary. ; and (B) by adding at the end the following: (iii) The term qualifying practitioner means— (I) a qualifying physician, as defined in clause (ii); or (II) during the period beginning on the date of the enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act and ending on the date that is 3 years after such date of enactment, a qualifying other practitioner, as defined in clause (iv). (iv) The term qualifying other practitioner means a nurse practitioner or physician assistant who satisfies each of the following: (I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain. (II) The nurse practitioner or physician assistant satisfies one or more of the following: (aa) Has completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, 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. (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. (III) The nurse practitioner or physician assistant is supervised by or works in collaboration with a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician. The Secretary may review and update the requirements for being a qualifying other practitioner under this clause. ; and (4) in subparagraph (H)— (A) in clause (i), by inserting after subclause (II) the following: (III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements. ; and (B) by amending clause (ii) to read as follows: (ii) Not later than 1 year after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act , the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment. . (b) Recommendation of revocation or suspension of registration in case of substantial noncompliance The Secretary of Health and Human Services may recommend to the Attorney General that the registration of a practitioner be revoked or suspended if the Secretary determines, according to such criteria as the Secretary establishes by regulation, that a practitioner who is registered under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is not in substantial compliance with the requirements of such section, as amended by this Act. (c) Opioid defined Section 102(18) of the Controlled Substances Act ( 21 U.S.C. 802(18) ) is amended by inserting or opioid after The term opiate . (d) Reports to Congress (1) In general Not later than 2 years after the date of enactment of this Act and not less than over every 5 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall— (A) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and (B) submit a report to the Congress on the findings and conclusions of such review. (2) Contents Each report under paragraph (1) shall include an assessment of— (A) compliance with the requirements of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ), as amended by this Act; (B) the measures taken by the Secretary of Health and Human Services to ensure such compliance; (C) whether there is further need to increase or decrease the number of patients a waivered practitioner is permitted to treat, as provided for by the amendment made by subsection (a)(1); (D) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; (E) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services; (F) changes in State or local policies and legislation relating to opioid use disorder treatment; (G) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ); (H) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in subparagraph (G); and (I) the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment. 4. Sense of Congress It is the Sense of Congress that, with respect to the total number of patients that a qualifying physician (as defined in subparagraph (G)(iii) of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) can treat at any one time pursuant to such section, the Secretary of Health and Human Services should consider raising such total number to 250 patients following a third notification to the Secretary of the need and intent of the physician to treat up to 250 patients that is submitted to the Secretary not sooner than 1 year after the date on which the physician submitted to the Secretary a second notification to treat up to 100 patients. 5. Partial fills of schedule II controlled substances (a) In general Section 309 of the Controlled Substances Act ( 21 U.S.C. 829 ) is amended by adding at the end the following: (f) Partial fills of schedule II controlled substances (1) Partial fills (A) In general A prescription for a controlled substance in schedule II may be partially filled if— (i) it is not prohibited by State law; (ii) the prescription is written and filled in accordance with the Controlled Substances Act ( 21 U.S.C. 801 et seq. ), regulations prescribed by the Attorney General, and State law; (iii) the partial fill is requested by the patient or the practitioner that wrote the prescription; and (iv) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. (B) Other circumstances A prescription for a controlled substance in schedule II may be partially filled in accordance with section 1306.13 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Reducing Unused Medications Act of 2016 ). (2) Remaining portions (A) In general Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II— (i) may be filled; and (ii) shall be filled not later than 30 days after the date on which the prescription is written. (B) Emergency situations In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II— (i) may be filled; and (ii) shall be filled not later than 72 hours after the prescription is issued. . (b) Rule of construction Nothing in this section shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act ( 21 U.S.C. 812(c) ) to be partially filled.

Passed the House of Representatives May 11, 2016. Karen L. Haas, Clerk

tv_txt: IB Union Calendar No. 435 114th CONGRESS 2d Session H. R. 4981 [Report No. 114–561, Part I] IN THE HOUSE OF REPRESENTATIVES April 18, 2016 Mr. Bucshon (for himself and Mr. Tonko ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned May 10, 2016 Additional sponsor: Mr. Rokita May 10, 2016 Reported from the Committee on Energy and Commerce with an amendment Strike out all after the enacting clause and insert the part printed in italic May 10, 2016 The Committee on the Judiciary discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed For text of introduced bill, see copy of bill as introduced on April 18, 2016 A BILL To amend the Controlled Substances Act to improve access to opioid use disorder treatment.

1. Short title This Act may be cited as the Opioid Use Disorder Treatment Expansion and Modernization Act . 2. Finding The Congress finds that opioid use disorder has become a public health epidemic that must be addressed by increasing awareness and access to all treatment options for opioid use disorder, overdose reversal, and relapse prevention. 3. Opioid use disorder treatment modernization (a) In general Section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is amended— (1) in subparagraph (B), by striking clauses (i), (ii), and (iii) and inserting the following: (i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)). (ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary— (I) all schedule III, IV, and V drugs, as well as unscheduled medications approved by the Food and Drug Administration, for the treatment of opioid use disorder, including such drugs and medications for maintenance, detoxification, overdose reversal, and relapse prevention, as available; and (II) appropriate counseling and other appropriate ancillary services. (iii) (I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclauses (II) and (III), the applicable number is 30. (II) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. (III) The applicable number is 250 if the practitioner is a qualifying physician meeting the requirement of subclause (VI) and, not sooner than 1 year after the date on which the physician submitted a second notification under subclause (II), the practitioner submits a third notification to the Secretary of the need and intent of the physician to treat up to 250 patients. (IV) The Secretary may by regulation change such total number. (V) The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting. (VI) For purposes of subclause (III), a qualifying physician meets the requirement of this subclause if the physician— (aa) holds a special certification in addiction psychiatry or addiction medicine as described in clause (ii) from the American Board of Medical Specialties, the American Board of Addiction Medicine, the American Osteopathic Association, the American Society of Addiction Medicine, or such other organization as the Secretary determines to be appropriate for purposes of this subclause; or (bb) has completed not fewer than 24 hours of training, with respect to the treatment and management of opiate-dependent patients, addressing the topics listed in subparagraph (G)(ii)(IV). The Secretary may review and update the requirements of this subclause. (iv) In the case of a third notification under clause (iii)(III), the qualifying physician maintains and implements a diversion control plan that contains specific measures to reduce the likelihood of the diversion of controlled substances prescribed by the physician for the treatment of opioid use disorder. (v) In the case of a third notification under clause (iii)(III), the qualifying physician obtains a written agreement from each patient, including the patient’s signature, that the patient— (I) will receive an initial assessment and treatment plan and periodic assessments and treatment plans thereafter; (II) will be subject to medication adherence and substance use monitoring; (III) understands available treatment options, including all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including their potential risks and benefits; and (IV) understands that receiving regular counseling services is critical to recovery. (vi) The practitioner will comply with the reporting requirements of subparagraph (D)(i)(IV). ; (2) in subparagraph (D)— (A) in clause (i), by adding at the end the following: (IV) The practitioner reports to the Secretary, at such times and in such manner as specified by the Secretary, such information and assurances as the Secretary determines necessary to assess whether the practitioner continues to meet the requirements for a waiver under this paragraph. ; (B) in clause (ii), by striking Upon receiving a notification under subparagraph (B) and inserting Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B) ; and (C) in clause (iii)— (i) by inserting and shall forward such determination to the Attorney General before the period at the end of the first sentence; and (ii) by striking physician and inserting practitioner ; (3) in subparagraph (G)— (A) by amending clause (ii)(IV) to read as follows: (IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is 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. Such training shall address— (aa) opioid maintenance and detoxification; (bb) appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; (cc) initial and periodic patient assessments (including substance use monitoring); (dd) individualized treatment planning; overdose reversal; relapse prevention; (ee) counseling and recovery support services; (ff) staffing roles and considerations; (gg) diversion control; and (hh) other best practices, as identified by the Secretary. ; and (B) by adding at the end the following: (iii) The term qualifying practitioner means— (I) a qualifying physician, as defined in clause (ii); or (II) a qualifying other practitioner, as defined in clause (iv). (iv) The term qualifying other practitioner means a nurse practitioner or physician assistant who satisfies each of the following: (I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain. (II) The nurse practitioner or physician assistant satisfies 1 or more of the following: (aa) Has completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, 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. (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. (III) The nurse practitioner or physician assistant is supervised by or works in collaboration with a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician. The Secretary may review and update the requirements for being a qualifying other practitioner under this clause. ; and (4) in subparagraph (H)— (A) in clause (i), by inserting after subclause (II) the following: (III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements. ; and (B) by amending clause (ii) to read as follows: (ii) Not later than one year after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act , the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment. . (b) Recommendation of revocation or suspension of registration in case of substantial noncompliance The Secretary of Health and Human Services may recommend to the Attorney General that the registration of a practitioner be revoked or suspended if the Secretary determines, according to such criteria as the Secretary establishes by regulation, that a practitioner who is registered under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ) is not in substantial compliance with the requirements of such section, as amended by this Act. (c) Opioid defined Section 102(18) of the Controlled Substances Act ( 21 U.S.C. 802(18) ) is amended by inserting or opioid after The term opiate . (d) Reports to Congress (1) In general Not later than 2 years after the date of enactment of this Act and not less than over every 5 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall— (A) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and (B) submit a report to the Congress on the findings and conclusions of such review. (2) Contents Each report under paragraph (1) shall include an assessment of— (A) compliance with the requirements of section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ), as amended by this Act; (B) the measures taken by the Secretary of Health and Human Services to ensure such compliance; (C) whether there is further need to increase or decrease the number of patients a waivered practitioner is permitted to treat, as provided for by the amendment made by subsection (a)(1); (D) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; (E) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services; (F) changes in State or local policies and legislation relating to opioid use disorder treatment; (G) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2) ); (H) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in subparagraph (G); and (I) the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment.

May 10, 2016 Reported from the Committee on Energy and Commerce with an amendment May 10, 2016 The Committee on the Judiciary discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed