```

[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.''.
                                 <all>
```