[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 480 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 440
114th CONGRESS
  2d Session
                                 S. 480

 To amend and reauthorize the controlled substance monitoring program 
          under section 399O of the Public Health Service Act.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``National All Schedules 
Prescription Electronic Reporting Reauthorization Act of 
2015''.</DELETED>

<DELETED>SEC. 2. AMENDMENT TO PURPOSE.</DELETED>

<DELETED>    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:</DELETED>
        <DELETED>    ``(1) foster the establishment of State-
        administered controlled substance monitoring systems in order 
        to ensure that--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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''.</DELETED>

<DELETED>SEC. 3. AMENDMENTS TO CONTROLLED SUBSTANCE MONITORING 
              PROGRAM.</DELETED>

<DELETED>    Section 399O of the Public Health Service Act (42 U.S.C. 
280g-3) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(1)--</DELETED>
                <DELETED>    (A) in subparagraph (A), by striking 
                ``or'';</DELETED>
                <DELETED>    (B) in subparagraph (B), by striking the 
                period at the end and inserting ``; or''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(C) to maintain and operate an existing 
                State-controlled substance monitoring 
                program.'';</DELETED>
        <DELETED>    (2) by amending subsection (b) to read as 
        follows:</DELETED>
<DELETED>    ``(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).'';</DELETED>
        <DELETED>    (3) in subsection (c)--</DELETED>
                <DELETED>    (A) in paragraph (1)(B)--</DELETED>
                        <DELETED>    (i) in the matter preceding clause 
                        (i), by striking ``(a)(1)(B)'' and inserting 
                        ``(a)(1)(B) or (a)(1)(C)'';</DELETED>
                        <DELETED>    (ii) in clause (i), by striking 
                        ``program to be improved'' and inserting 
                        ``program to be improved or 
                        maintained'';</DELETED>
                        <DELETED>    (iii) by redesignating clauses 
                        (iii) and (iv) as clauses (iv) and (v), 
                        respectively;</DELETED>
                        <DELETED>    (iv) by inserting after clause 
                        (ii), the following:</DELETED>
                        <DELETED>    ``(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;'';</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (vi) in clause (v) (as so 
                        redesignated), by striking ``public health'' 
                        and inserting ``public health or public 
                        safety'';</DELETED>
                <DELETED>    (B) in paragraph (3)--</DELETED>
                        <DELETED>    (i) by striking ``If a State that 
                        submits'' and inserting the 
                        following:</DELETED>
                <DELETED>    ``(A) In general.--If a State that 
                submits'';</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (iii) by adding at the end the 
                        following:</DELETED>
                <DELETED>    ``(B) Monitoring of efforts.--The 
                Secretary shall monitor State efforts to achieve 
                interoperability, as described in subparagraph (A).''; 
                and</DELETED>
                <DELETED>    (C) in paragraph (5)--</DELETED>
                        <DELETED>    (i) by striking ``implement or 
                        improve'' and inserting ``establish, improve, 
                        or maintain''; and</DELETED>
                        <DELETED>    (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).'';</DELETED>
        <DELETED>    (4) in subsection (d)--</DELETED>
                <DELETED>    (A) in the matter preceding paragraph 
                (1)--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (ii) by striking ``public health'' 
                        and inserting ``public health or public 
                        safety''; and</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (5) in subsections (e), (f)(1), and (g), by 
        striking ``implementing or improving'' each place it appears 
        and inserting ``establishing, improving, or 
        maintaining'';</DELETED>
        <DELETED>    (6) in subsection (f)--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) to evaluate the success of the 
                State's program in achieving its purposes; or</DELETED>
                <DELETED>    ``(B) to prepare and submit the report to 
                Congress required by subsection (k)(2).</DELETED>
        <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (7) by striking subsection (k);</DELETED>
        <DELETED>    (8) by redesignating subsections (h) through (j) 
        as subsections (i) through (k), respectively;</DELETED>
        <DELETED>    (9) in subsections (c)(1)(A)(iv) and (d)(4), by 
        striking ``subsection (h)'' each place it appears and inserting 
        ``subsection (i)'';</DELETED>
        <DELETED>    (10) by inserting after subsection (g) the 
        following:</DELETED>
<DELETED>    ``(h) Education and Access to the Monitoring System.--A 
State receiving a grant under subsection (a) shall take steps to--
</DELETED>
        <DELETED>    ``(1) facilitate prescriber and dispenser use of 
        the State's controlled substance monitoring system; 
        and</DELETED>
        <DELETED>    ``(2) educate prescribers and dispenser on the 
        benefits of the system both to them and society.'';</DELETED>
        <DELETED>    (11) in subsection (k)(2)(A), as redesignated--
        </DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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'';</DELETED>
        <DELETED>    (12) in subsection (l)(1), by striking 
        ``establishment, implementation, or improvement'' and inserting 
        ``establishment, improvement, or maintenance'';</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (14) by amending subsection (n), to read as 
        follows:</DELETED>
<DELETED>    ``(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.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National All Schedules Prescription 
Electronic Reporting Reauthorization Act of 2016''.

SEC. 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''.

SEC. 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.''.
                                                       Calendar No. 440

114th CONGRESS

  2d Session

                                 S. 480

_______________________________________________________________________

                                 A BILL

 To amend and reauthorize the controlled substance monitoring program 
          under section 399O of the Public Health Service Act.

_______________________________________________________________________

                             April 27, 2016

                       Reported with an amendment