II Calendar No. 440 114th CONGRESS 2d Session S. 480 IN THE SENATE OF THE UNITED STATES February 12, 2015 Mrs. Shaheen (for herself, Mr. Toomey , Mr. Durbin , Mr. Sessions , Mr. Brown , Mrs. Feinstein , Mrs. Gillibrand , Mr. Manchin , Mr. Markey , Mr. Schumer , Ms. Warren , Mr. Blumenthal , and Ms. Collins ) 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 amend and reauthorize the controlled substance monitoring program under section 399O of the Public Health Service Act.

1. Short title This Act may be cited as the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 . 2. Amendment to purpose Paragraph (1) of section 2 of the National All Schedules Prescription Electronic Reporting Act of 2005 ( Public Law 109–60 ) is amended to read as follows: (1) foster the establishment of State-administered controlled substance monitoring systems in order to ensure that— (A) health care providers have access to the accurate, timely prescription history information that they may use as a tool for the early identification of patients at risk for addiction in order to initiate appropriate medical interventions and avert the tragic personal, family, and community consequences of untreated addiction; and (B) appropriate law enforcement, regulatory, and State professional licensing authorities have access to prescription history information for the purposes of investigating drug diversion and prescribing and dispensing practices of errant prescribers or pharmacists; and . 3. Amendments to controlled substance monitoring program Section 399O of the Public Health Service Act ( 42 U.S.C. 280g–3 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A), by striking or ; (B) in subparagraph (B), by striking the period at the end and inserting ; or ; and (C) by adding at the end the following: (C) to maintain and operate an existing State-controlled substance monitoring program. ; (2) by amending subsection (b) to read as follows: (b) Minimum requirements The Secretary shall maintain and, as appropriate, supplement or revise (after publishing proposed additions and revisions in the Federal Register and receiving public comments thereon) minimum requirements for criteria to be used by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A). ; (3) in subsection (c)— (A) in paragraph (1)(B)— (i) in the matter preceding clause (i), by striking (a)(1)(B) and inserting (a)(1)(B) or (a)(1)(C) ; (ii) in clause (i), by striking program to be improved and inserting program to be improved or maintained ; (iii) by redesignating clauses (iii) and (iv) as clauses (iv) and (v), respectively; (iv) by inserting after clause (ii), the following: (iii) a plan to apply the latest advances in health information technology in order to incorporate prescription drug monitoring program data directly into the workflow of prescribers and dispensers to ensure timely access to patients’ controlled prescription drug history; ; (v) in clause (iv) (as so redesignated), by inserting before the semicolon the following: and at least one health information technology system such as electronic health records, health information exchanges, and e-prescribing systems ; and (vi) in clause (v) (as so redesignated), by striking public health and inserting public health or public safety ; (B) in paragraph (3)— (i) by striking If a State that submits and inserting the following: (A) In general If a State that submits ; (ii) by inserting before the period at the end and include timelines for full implementation of such interoperability. The State shall also describe the manner in which it will achieve interoperability between its monitoring program and health information technology systems, as allowable under State law, and include timelines for the implementation of such interoperability ; and (iii) by adding at the end the following: (B) Monitoring of efforts The Secretary shall monitor State efforts to achieve interoperability, as described in subparagraph (A). ; and (C) in paragraph (5)— (i) by striking implement or improve and inserting establish, improve, or maintain ; and (ii) by adding at the end the following: The Secretary shall redistribute any funds that are so returned among the remaining grantees under this section in accordance with the formula described in subsection (a)(2)(B). ; (4) in subsection (d)— (A) in the matter preceding paragraph (1)— (i) by striking In implementing or improving and all that follows through (a)(1)(B) and inserting In establishing, improving, or maintaining a controlled substance monitoring program under this section, a State shall comply, or with respect to a State that applies for a grant under subparagraph (B) or (C) of subsection (a)(1) ; and (ii) by striking public health and inserting public health or public safety ; and (B) by adding at the end the following: (5) The State shall report on interoperability with the controlled substance monitoring program of Federal agencies, where appropriate, interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, real-time or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient. ; (5) in subsections (e), (f)(1), and (g), by striking implementing or improving each place it appears and inserting establishing, improving, or maintaining ; (6) in subsection (f)— (A) in paragraph (1)(B) by striking misuse of a schedule II, III, or IV substance and inserting misuse of a controlled substance included in schedule II, III, or IV of section 202(c) of the Controlled Substance Act ; and (B) by adding at the end the following: (3) Evaluation and reporting Subject to subsection (g), a State receiving a grant under subsection (a) shall provide the Secretary with aggregate data and other information determined by the Secretary to be necessary to enable the Secretary— (A) to evaluate the success of the State’s program in achieving its purposes; or (B) to prepare and submit the report to Congress required by subsection (k)(2). (4) Research by other entities A department, program, or administration receiving nonidentifiable information under paragraph (1)(D) may make such information available to other entities for research purposes. ; (7) by striking subsection (k); (8) by redesignating subsections (h) through (j) as subsections (i) through (k), respectively; (9) in subsections (c)(1)(A)(iv) and (d)(4), by striking subsection (h) each place it appears and inserting subsection (i) ; (10) by inserting after subsection (g) the following: (h) Education and access to the monitoring system A State receiving a grant under subsection (a) shall take steps to— (1) facilitate prescriber and dispenser use of the State’s controlled substance monitoring system; and (2) educate prescribers and dispenser on the benefits of the system both to them and society. ; (11) in subsection (k)(2)(A), as redesignated— (A) in clause (ii), by striking or affected and inserting , established or strengthened initiatives to ensure linkages to substance use disorder services, or affected ; and (B) in clause (iii), by striking including an assessment and inserting between controlled substance monitoring programs and health information technology systems, and including an assessment ; (12) in subsection (l)(1), by striking establishment, implementation, or improvement and inserting establishment, improvement, or maintenance ; (13) in subsection (m)(8), by striking and the District of Columbia and inserting , the District of Columbia, and any commonwealth or territory of the United States ; and (14) by amending subsection (n), to read as follows: (o) Authorization of appropriations To carry out this section, there are authorized to be appropriated $7,000,000 for each of fiscal years 2016 through 2020. .

1. Short title This Act may be cited as the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 . 2. Amendment to purpose Paragraph (1) of section 2 of the National All Schedules Prescription Electronic Reporting Act of 2005 ( Public Law 109–60 ) is amended to read as follows: (1) foster the establishment of State-administered controlled substance monitoring systems in order to ensure that health care providers have access to the accurate, timely prescription history information that they may use as a tool for the early identification of patients at risk for addiction in order to initiate appropriate medical interventions and avert the tragic personal, family, and community consequences of untreated addiction; and . 3. Amendments to controlled substance monitoring program Section 399O of the Public Health Service Act ( 42 U.S.C. 280g–3 ) is amended— (1) in subsection (a)(1)— (A) in the matter preceding subparagraph (A), by inserting , in consultation with the Administrator of the Substance Abuse and Mental Health Services Administration and Director of the Centers for Disease Control and Prevention, after the Secretary ; (B) in subparagraph (A), by striking or ; (C) in subparagraph (B), by striking the period at the end and inserting ; or ; and (D) by adding at the end the following: (C) to maintain an existing State-controlled substance monitoring program. ; (2) by amending subsection (b) to read as follows: (b) Minimum requirements The Secretary shall maintain and, as appropriate, supplement or revise (after publishing proposed additions and revisions in the Federal Register and receiving public comments thereon) minimum requirements for criteria to be used by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A). ; (3) in subsection (c)— (A) in paragraph (1)(B)— (i) in the matter preceding clause (i), by striking (a)(1)(B) and inserting (a)(1)(B) or (a)(1)(C) ; (ii) in clause (i), by striking program to be improved and inserting program to be improved or maintained ; (iii) by redesignating clauses (iii) and (iv) as clauses (iv) and (v), respectively; (iv) by inserting after clause (ii), the following: (iii) a plan to apply the latest advances in health information technology, to the extent practicable, in order to incorporate prescription drug monitoring program data directly into the workflow of prescribers and dispensers to ensure timely access to patients’ controlled prescription drug history; ; (v) in clause (iv) (as so redesignated)— (I) by inserting before the semicolon the following: and at least one health information technology system such as electronic health records, health information exchanges, and e-prescribing systems ; and (II) by striking and after the semicolon; (vi) in clause (v) (as so redesignated)— (I) by striking public health and inserting public health or safety ; and (II) by striking the period and inserting ; and ; and (vii) by adding at the end the following: (vi) information, where applicable, on how the controlled substance monitoring program jointly works with the applicant’s respective State substance abuse agency to ensure information collected and maintained by the controlled substance monitoring program is used to inform the provision of clinically appropriate substance use disorder services to individuals in need. ; (B) in paragraph (3)— (i) by striking If a State that submits and inserting the following: (A) In general If a State that submits ; (ii) by inserting before the period at the end and include timelines for full implementation of such interoperability. The State shall also describe the manner in which it will achieve interoperability between its monitoring program and health information technology systems, as allowable under State law, and include timelines for the implementation of such interoperability ; and (iii) by adding at the end the following: (B) Monitoring of efforts The Secretary shall monitor State efforts to achieve interoperability, as described in subparagraph (A). ; and (C) in paragraph (5)— (i) by striking implement or improve and inserting establish, improve, or maintain ; and (ii) by adding at the end the following: The Secretary shall redistribute any funds that are so returned among the remaining grantees under this section in accordance with the formula described in subsection (a)(2)(B). ; (4) in subsection (d)— (A) in the matter preceding paragraph (1)— (i) by striking In implementing or improving and all that follows through (a)(1)(B) and inserting In establishing, improving, or maintaining a controlled substance monitoring program under this section, a State shall comply, or with respect to a State that applies for a grant under subparagraph (B) or (C) of subsection (a)(1) ; and (ii) by striking public health and inserting public health or safety ; and (B) by adding at the end the following: (5) The State shall report on interoperability with the controlled substance monitoring program of Federal agencies, where appropriate, interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient. ; (5) in subsections (e), (f)(1), and (g), by striking implementing or improving each place it appears and inserting establishing, improving, or maintaining ; (6) in subsection (f)— (A) in paragraph (1)— (i) in subparagraph (B), by striking misuse of a schedule II, III, or IV substance and inserting misuse of a controlled substance ; and (ii) in subparagraph (D)— (I) by inserting a State substance abuse agency, after State health department, ; and (II) by striking such department, program, or administration each place it appears and inserting such department, program, agency, or administration in each such place; and (B) by adding at the end the following: (3) Evaluation and reporting Subject to subsection (g), a State receiving a grant under subsection (a) shall provide the Secretary with aggregate data to enable the Secretary— (A) to evaluate the success of the State’s program in achieving its purposes; or (B) to prepare and submit the report to Congress required by subsection (k)(2). (4) Research by other entities A department, program, agency, or administration receiving nonidentifiable information under paragraph (1)(D) may make such information available to other entities for research purposes. ; (7) by striking subsection (k); (8) by redesignating subsections (h) through (j) as subsections (i) through (k), respectively; (9) in subsections (c)(1)(A)(iv) and (d)(4), by striking subsection (h) each place it appears and inserting subsection (i) ; (10) by inserting after subsection (g) the following: (h) Education and access to the monitoring system A State receiving a grant under subsection (a) shall take steps to— (1) facilitate prescriber and dispenser use of the State’s controlled substance monitoring system, to the extent practicable; and (2) educate prescribers and dispensers on the benefits of the system. ; (11) in subsection (k)(2)(A), as so redesignated— (A) in clause (ii), by striking or affected and inserting , established or strengthened initiatives to ensure linkages to substance use disorder services, or affected ; and (B) in clause (iii), by striking including an assessment and inserting and between controlled substance monitoring programs and health information technology systems, including an assessment ; (12) in subsection (l)(1), by striking establishment, implementation, or improvement and inserting establishment, improvement, or maintenance ; (13) in subsection (m)(8), by striking and the District of Columbia and inserting , the District of Columbia, and any commonwealth or territory of the United States ; and (14) by amending subsection (n) to read as follows: (n) Authorization of appropriations To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2017 through 2021. .

April 27, 2016 Reported with an amendment