[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5812 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 5812
To amend the Public Health Service Act to authorize the Director of the
Centers for Disease Control and Prevention to carry out certain
activities to prevent controlled substances overdoses, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 15, 2018
Mr. Griffith (for himself, Mr. Pallone, and Mr. Fitzpatrick) introduced
the following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to authorize the Director of the
Centers for Disease Control and Prevention to carry out certain
activities to prevent controlled substances overdoses, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Creating Opportunities that
Necessitate New and Enhanced Connections That Improve Opioid Navigation
Strategies Act of 2018'' or the ``CONNECTIONS Act''.
SEC. 2. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following new
section:
``SEC. 399V-7. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
``(a) Evidence-Based Prevention Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out any
evidence-based prevention activity described in
paragraph (2);
``(B) provide training and technical assistance to
States, localities, and Indian tribes for purposes of
carrying out any such activity; and
``(C) award grants to States, localities, and
Indian tribes for purposes of carrying out any such
activity.
``(2) Evidence-based prevention activities.--An evidence-
based prevention activity described in this paragraph is any of
the following activities:
``(A) With respect to a State, improving the
efficiency and use of the State prescription drug
monitoring program by--
``(i) encouraging all authorized users (as
specified by the State) to register with and
use the program and making the program easier
to use;
``(ii) enabling such users to access any
updates to information collected by the program
in as close to real-time as possible;
``(iii) providing for a mechanism for the
program to automatically flag any potential
misuse or abuse of controlled substances and
any detection of inappropriate prescribing
practices relating to such substances;
``(iv) enhancing interoperability between
the program and any electronic health records
system, including by integrating the use of
electronic health records into the program for
purposes of improving clinical decisionmaking;
``(v) continually updating program
capabilities to respond to technological
innovation for purposes of appropriately
addressing a controlled substance overdose
epidemic as such epidemic may occur and evolve;
``(vi) facilitating data sharing between
the program and the prescription drug
monitoring programs of neighboring States; and
``(vii) meeting the purpose of the program
established under section 399O, as described in
section 399O(a).
``(B) Achieving community or health system
interventions through activities such as--
``(i) establishing or improving controlled
substances prescribing interventions for
insurers and health systems;
``(ii) enhancing the use of evidence-based
controlled substances prescribing guidelines
across sectors and health care settings; and
``(iii) implementing strategies to align
the prescription of controlled substances with
the guidelines described in clause (ii).
``(C) Evaluating interventions to better understand
what works to prevent overdoses, including those
involving prescription and illicit controlled
substances.
``(D) Implementing projects to advance an
innovative prevention approach with respect to new and
emerging public health crises and opportunities to
address such crises, such as enhancing public education
and awareness on the risks associated with opioids.
``(b) Enhanced Surveillance of Controlled Substance Overdose
Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out any
controlled substance overdose surveillance activity
described in paragraph (2);
``(B) provide training and technical assistance to
States for purposes of carrying out any such activity;
``(C) award grants to States for purposes of
carrying out any such activity; and
``(D) coordinate with the Assistant Secretary for
Mental Health and Substance Use to collect data
pursuant to section 505(d)(1)(A) (relating to the
number of individuals admitted to the emergency rooms
of hospitals as a result of the abuse of alcohol or
other drugs).
``(2) Controlled substance overdose surveillance
activities.--A controlled substance overdose surveillance
activity described in this paragraph is any of the following
activities:
``(A) Enhancing the timeliness of reporting data to
the public, including data on fatal and nonfatal
overdoses of controlled substances.
``(B) Enhancing comprehensiveness of data on
controlled substances overdoses by collecting
information on such overdoses from appropriate sources
such as toxicology reports, autopsy reports, death
scene investigations, and other risk factors.
``(C) Using data to help identify risk factors
associated with controlled substances overdoses.
``(D) With respect to a State, supporting entities
involved in providing information to inform efforts
within the State, such as by coroners and medical
examiners, to improve accurate testing and reporting of
causes and contributing factors to controlled
substances overdoses.
``(E) Working to enable information sharing
regarding controlled substances overdoses among data
sources.
``(c) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled
substance' has the meaning given that term in section 102 of
the Controlled Substances Act.
``(2) Indian tribe.--The term `Indian tribe' has the
meaning given that term in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(d) Authorization of Appropriations.--For purposes of carrying
out this section and section 399O, there is authorized to be
appropriated $486,000,000 for each of fiscal years 2019 through
2023.''.
SEC. 3. PRESCRIPTION DRUG MONITORING PROGRAM.
Section 399O of the Public Health Service Act (42 U.S.C. 280g-3) is
amended to read as follows:
``SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM.
``(a) Program.--
``(1) In general.--Each fiscal year, the Secretary, in
consultation with the Director of National Drug Control Policy,
acting through the Director of the Centers for Disease Control
and Prevention, the Assistant Secretary for Mental Health and
Substance Use, and the National Coordinator for Health
Information Technology, shall support States for the purpose of
improving the efficiency and use of PDMPs, including--
``(A) establishment and implementation of a PDMP;
``(B) maintenance of a PDMP;
``(C) improvements to a PDMP by--
``(i) enhancing functional components to
work toward--
``(I) universal use of PDMPs among
providers and their delegates, to the
extent that State laws allow, within a
State;
``(II) more timely inclusion of
data within a PDMP;
``(III) active management of the
PDMP, in part by sending proactive or
unsolicited reports to providers to
inform prescribing; and
``(IV) ensuring the highest level
of ease in use and access of PDMPs by
providers and their delegates, to the
extent that State laws allow;
``(ii) improving the intrastate
interoperability of PDMPs by--
``(I) making PDMPs more actionable
by integrating PDMPs within electronic
health records and health information
technology infrastructure; and
``(II) linking PDMP data to other
data systems within the State,
including--
``(aa) the data of pharmacy
benefit managers, medical
examiners and coroners, and the
State's Medicaid program;
``(bb) worker's
compensation data; and
``(cc) prescribing data of
providers of the Department of
Veterans Affairs and the Indian
Health Service within the
State;
``(iii) improving the interstate
interoperability of PDMPs through--
``(I) sharing of dispensing data in
near-real time across State lines; and
``(II) integration of automated
queries for multistate PDMP data and
analytics into clinical workflow to
improve the use of such data and
analytics by practitioners and
dispensers; or
``(iv) improving the ability to include
treatment availability resources and referral
capabilities within the PDMP.
``(2) State legislation.--As a condition on the receipt of
support under this section, the Secretary shall require a State
to demonstrate that the State has enacted legislation or
regulations--
``(A) to provide for the implementation of the
PDMP; and
``(B) to permit the imposition of appropriate
penalties for the unauthorized use and disclosure of
information maintained by the PDMP.
``(b) PDMP Strategies.--The Secretary shall encourage a State, in
establishing, improving, or maintaining a PDMP, to implement strategies
that improve--
``(1) the reporting of dispensing in the State of a
controlled substance to an ultimate user so the reporting
occurs not later than 24 hours after the dispensing event;
``(2) the consultation of the PDMP by each prescribing
practitioner, or their designee, in the State before initiating
treatment with a controlled substance, or any substance as
required by the State to be reported to the PDMP, and over the
course of ongoing treatment for each prescribing event;
``(3) the consultation of the PDMP before dispensing a
controlled substance, or any substance as required by the State
to be reported to the PDMP;
``(4) the proactive notification to a practitioner when
patterns indicative of controlled substance misuse by a
patient, including opioid misuse, are detected;
``(5) the availability of data in the PDMP to other States,
as allowable under State law; and
``(6) the availability of nonidentifiable information to
the Centers for Disease Control and Prevention for
surveillance, epidemiology, statistical research, or
educational purposes.
``(c) Drug Misuse and Abuse.--In consultation with practitioners,
dispensers, and other relevant and interested stakeholders, a State
receiving support under this section--
``(1) shall establish a program to notify practitioners and
dispensers of information that will help to identify and
prevent the unlawful diversion or misuse of controlled
substances; and
``(2) may, to the extent permitted under State law, notify
the appropriate authorities responsible for carrying out drug
diversion investigations if the State determines that
information in the PDMP maintained by the State indicates an
unlawful diversion or abuse of a controlled substance.
``(d) Evaluation and Reporting.--As a condition on receipt of
support under this section, the State shall report on interoperability
with PDMPs of other States and Federal agencies, where appropriate,
intrastate 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.
``(e) Evaluation and Reporting.--A State receiving support under
this section shall provide the Secretary with aggregate nonidentifiable
information, as permitted by State law, to enable the Secretary--
``(1) to evaluate the success of the State's program in
achieving the purpose described in subsection (a); or
``(2) to prepare and submit to the Congress the report
required by subsection (i)(2).
``(f) Education and Access to the Monitoring System.--A State
receiving support under this section shall take steps to--
``(1) facilitate prescribers and dispensers, and their
delegates, as permitted by State law, to use the PDMP, to the
extent practicable; and
``(2) educate prescribers and dispensers, and their
delegates on the benefits of the use of PDMPs.
``(g) Electronic Format.--The Secretary may issue guidelines
specifying a uniform electronic format for the reporting, sharing, and
disclosure of information pursuant to PDMPs.
``(h) Rules of Construction.--
``(1) Functions otherwise authorized by law.--Nothing in
this section shall be construed to restrict the ability of any
authority, including any local, State, or Federal law
enforcement, narcotics control, licensure, disciplinary, or
program authority, to perform functions otherwise authorized by
law.
``(2) Additional privacy protections.--Nothing in this
section shall be construed as preempting any State from
imposing any additional privacy protections.
``(3) Federal privacy requirements.--Nothing in this
section shall be construed to supersede any Federal privacy or
confidentiality requirement, including the regulations
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law 104-191;
110 Stat. 2033) and section 543 of this Act.
``(4) No federal private cause of action.--Nothing in this
section shall be construed to create a Federal private cause of
action.
``(i) Progress Report.--Not later than 3 years after the date of
enactment of the CONNECTIONS Act, the Secretary shall--
``(1) complete a study that--
``(A) determines the progress of States in
establishing and implementing PDMPs consistent with
this section;
``(B) provides an analysis of the extent to which
the operation of PDMPs has--
``(i) reduced inappropriate use, abuse,
diversion of, and overdose with, controlled
substances;
``(ii) established or strengthened
initiatives to ensure linkages to substance use
disorder treatment services; or
``(iii) affected patient access to
appropriate care in States operating PDMPs;
``(C) determine the progress of States in achieving
interstate interoperability and intrastate
interoperability of PDMPs, including an assessment of
technical, legal, and financial barriers to such
progress and recommendations for addressing these
barriers;
``(D) determines the progress of States in
implementing near real-time electronic PDMPs;
``(E) provides an analysis of the privacy
protections in place for the information reported to
the PDMP in each State receiving support under this
section and any recommendations of the Secretary for
additional Federal or State requirements for protection
of this information;
``(F) determines the progress of States in
implementing technological alternatives to centralized
data storage, such as peer-to-peer file sharing or data
pointer systems, in PDMPs and the potential for such
alternatives to enhance the privacy and security of
individually identifiable data; and
``(G) evaluates the penalties that States have
enacted for the unauthorized use and disclosure of
information maintained in PDMPs, and the criteria used
by the Secretary to determine whether such penalties
qualify as appropriate for purposes of subsection
(a)(2); and
``(2) submit a report to the Congress on the results of the
study.
``(j) Advisory Council.--
``(1) Establishment.--A State may establish an advisory
council to assist in the establishment, improvement, or
maintenance of a PDMP consistent with this section.
``(2) Limitation.--A State may not use Federal funds for
the operations of an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP.
``(3) Sense of congress.--It is the sense of the Congress
that, in establishing an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP, a State
should consult with appropriate professional boards and other
interested parties.
``(k) Definitions.--For purposes of this section:
``(1) The term `controlled substance' means a controlled
substance (as defined in section 102 of the Controlled
Substances Act) in schedule II, III, or IV of section 202 of
such Act.
``(2) The term `dispense' means to deliver a controlled
substance to an ultimate user by, or pursuant to the lawful
order of, a practitioner, irrespective of whether the dispenser
uses the internet or other means to effect such delivery.
``(3) The term `dispenser' means a physician, pharmacist,
or other person that dispenses a controlled substance to an
ultimate user.
``(4) The term `interstate interoperability' with respect
to a PDMP means the ability of the PDMP to electronically share
reported information with another State if the information
concerns either the dispensing of a controlled substance to an
ultimate user who resides in such other State, or the
dispensing of a controlled substance prescribed by a
practitioner whose principal place of business is located in
such other State.
``(5) The term `intrastate interoperability' with respect
to a PDMP means the integration of PDMP data within electronic
health records and health information technology infrastructure
or linking of a PDMP to other data systems within the State,
including the State's Medicaid program, workers' compensation
programs, and medical examiners or coroners.
``(6) The term `nonidentifiable information' means
information that does not identify a practitioner, dispenser,
or an ultimate user and with respect to which there is no
reasonable basis to believe that the information can be used to
identify a practitioner, dispenser, or an ultimate user.
``(7) The term `PDMP' means a prescription drug monitoring
program that is State-controlled.
``(8) The term `practitioner' means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or
other person licensed, registered, or otherwise permitted, by
the United States or the jurisdiction in which the individual
practices or does research, to distribute, dispense, conduct
research with respect to, administer, or use in teaching or
chemical analysis, a controlled substance in the course of
professional practice or research.
``(9) The term `State' means each of the 50 States, the
District of Columbia, and any commonwealth or territory of the
United States.
``(10) The term `ultimate user' means a person who has
obtained from a dispenser, and who possesses, a controlled
substance for the person's own use, for the use of a member of
the person's household, or for the use of an animal owned by
the person or by a member of the person's household.
``(11) The term `clinical workflow' means the integration
of automated queries for prescription drug monitoring programs
data and analytics into health information technologies such as
electronic health record systems, health information exchanges,
and/or pharmacy dispensing software systems, thus streamlining
provider access through automated queries.''.
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