[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