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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4063 Engrossed in House (EH)]

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114th CONGRESS
  2d Session
                                H. R. 4063

_______________________________________________________________________

                                 AN ACT

 
 To improve the use by the Secretary of Veterans Affairs of opioids in 
               treating veterans, 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 ``Promoting Responsible Opioid 
Management and Incorporating Scientific Expertise Act'' or the ``Jason 
Simcakoski PROMISE Act''.

SEC. 2. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPARTMENT OF VETERANS 
              AFFAIRS.

    (a) Expansion of Opioid Safety Initiative.--
            (1) Inclusion of all medical facilities.--Not later than 
        180 days after the date of the enactment of this Act, the 
        Secretary of Veterans Affairs shall expand the Opioid Safety 
        Initiative of the Department of Veterans Affairs to include all 
        medical facilities of the Department.
            (2) Guidance.--The Secretary shall establish guidance that 
        each health care provider of the Department of Veterans 
        Affairs, before initiating opioid therapy to treat a patient as 
        part of the comprehensive assessment conducted by the health 
        care provider, use the Opioid Therapy Risk Report tool of the 
        Department of Veterans Affairs (or any subsequent tool), which 
        shall include information from the prescription drug monitoring 
        program of each participating State as applicable, that 
        includes the most recent information to date relating to the 
        patient that accessed such program to assess the risk for 
        adverse outcomes of opioid therapy for the patient, including 
        the concurrent use of controlled substances such as 
        benzodiazepines, as part of the comprehensive assessment 
        conducted by the health care provider.
            (3) Enhanced standards.--The Secretary shall establish 
        enhanced standards with respect to the use of routine and 
        random urine drug tests for all patients before and during 
        opioid therapy to help prevent substance abuse, dependence, and 
        diversion, including--
                    (A) that such tests occur not less frequently than 
                once each year; and
                    (B) that health care providers appropriately order, 
                interpret and respond to the results from such tests to 
                tailor pain therapy, safeguards, and risk management 
                strategies to each patient.
    (b) Pain Management Education and Training.--
            (1) In general.--In carrying out the Opioid Safety 
        Initiative of the Department, the Secretary shall require all 
        employees of the Department responsible for prescribing opioids 
        to receive education and training described in paragraph (2).
            (2) Education and training.--Education and training 
        described in this paragraph is education and training on pain 
        management and safe opioid prescribing practices for purposes 
        of safely and effectively managing patients with chronic pain, 
        including education and training on the following:
                    (A) The implementation of and full compliance with 
                the VA/DOD Clinical Practice Guideline for Management 
                of Opioid Therapy for Chronic Pain, including any 
                update to such guideline.
                    (B) The use of evidence-based pain management 
                therapies, including cognitive-behavioral therapy, non-
                opioid alternatives, and non-drug methods and 
                procedures to managing pain and related health 
                conditions including medical devices approved or 
                cleared by the Food and Drug Administration for the 
                treatment of patients with chronic pain and 
                complementary alternative medicines.
                    (C) Screening and identification of patients with 
                substance use disorder, including drug-seeking 
                behavior, before prescribing opioids, assessment of 
                risk potential for patients developing an addiction, 
                and referral of patients to appropriate addiction 
                treatment professionals if addiction is identified or 
                strongly suspected.
                    (D) Communication with patients on the potential 
                harm associated with the use of opioids and other 
                controlled substances, including the need to safely 
                store and dispose of supplies relating to the use of 
                opioids and other controlled substances.
                    (E) Such other education and training as the 
                Secretary considers appropriate to ensure that veterans 
                receive safe and high-quality pain management care from 
                the Department.
            (3) Use of existing program.--In providing education and 
        training described in paragraph (2), the Secretary shall use 
        the Interdisciplinary Chronic Pain Management Training Team 
        Program of the Department (or success program).
    (c) Pain Management Teams.--
            (1) In general.--In carrying out the Opioid Safety 
        Initiative of the Department, the director of each medical 
        facility of the Department shall identify and designate a pain 
        management team of health care professionals, which may include 
        board certified pain medicine specialists, responsible for 
        coordinating and overseeing pain management therapy at such 
        facility for patients experiencing acute and chronic pain that 
        is non-cancer related.
            (2) Establishment of protocols.--
                    (A) In general.--In consultation with the Directors 
                of each Veterans Integrated Service Network, the 
                Secretary shall establish standard protocols for the 
                designation of pain management teams at each medical 
                facility within the Department.
                    (B) Consultation on prescription of opioids.--Each 
                protocol established under subparagraph (A) shall 
                ensure that any health care provider without expertise 
                in prescribing analgesics or who has not completed the 
                education and training under subsection (b), including 
                a mental health care provider, does not prescribe 
                opioids to a patient unless that health care provider--
                            (i) consults with a health care provider 
                        with pain management expertise or who is on the 
                        pain management team of the medical facility; 
                        and
                            (ii) refers the patient to the pain 
                        management team for any subsequent 
                        prescriptions and related therapy.
            (3) Report.--
                    (A) In general.--Not later than 1 year after the 
                date of enactment of this Act, the director of each 
                medical facility of the Department shall submit to the 
                Under Secretary for Health and the director of the 
                Veterans Integrated Service Network in which the 
                medical facility is located a report identifying the 
                health care professionals that have been designated as 
                members of the pain management team at the medical 
                facility pursuant to paragraph (1).
                    (B) Elements.--Each report submitted under 
                subparagraph (A) with respect to a medical facility of 
                the Department shall include--
                            (i) a certification as to whether all 
                        members of the pain management team at the 
                        medical facility have completed the education 
                        and training required under subsection (b);
                            (ii) a plan for the management and referral 
                        of patients to such pain management team if 
                        health care providers without expertise in 
                        prescribing analgesics prescribe opioid 
                        medications to treat acute and chronic pain 
                        that is non-cancer related; and
                            (iii) a certification as to whether the 
                        medical facility--
                                    (I) fully complies with the 
                                stepped-care model of pain management 
                                and other pain management policies 
                                contained in Directive 2009-053 of the 
                                Veterans Health Administration, or 
                                successor directive; or
                                    (II) does not fully comply with 
                                such stepped-care model of pain 
                                management and other pain management 
                                policies but is carrying out a 
                                corrective plan of action to ensure 
                                such full compliance.
    (d) Tracking and Monitoring of Opioid Use.--
            (1) Prescription drug monitoring programs of states.--In 
        carrying out the Opioid Safety Initiative and the Opioid 
        Therapy Risk Report tool of the Department, the Secretary 
        shall--
                    (A) ensure access by health care providers of the 
                Department to information on controlled substances, 
                including opioids and benzodiazepines, prescribed to 
                veterans who receive care outside the Department 
                through the prescription drug monitoring program of 
                each State with such a program, including by seeking to 
                enter into memoranda of understanding with States to 
                allow shared access of such information between States 
                and the Department;
                    (B) include such information in the Opioid Therapy 
                Risk Report; and
                    (C) require health care providers of the Department 
                to submit to the prescription drug monitoring program 
                of each State information on prescriptions of 
                controlled substances received by veterans in that 
                State under the laws administered by the Secretary.
            (2) Report on tracking of data on opioid use.--Not later 
        than 18 months after the date of the enactment of this Act, the 
        Secretary shall submit to the Committee on Veterans' Affairs of 
        the Senate and the Committee on Veterans' Affairs of the House 
        of Representatives a report on the feasibility and advisability 
        of improving the Opioid Therapy Risk Report tool of the 
        Department to allow for more advanced real-time tracking of and 
        access to data on--
                    (A) the key clinical indicators with respect to the 
                totality of opioid use by veterans;
                    (B) concurrent prescribing by health care providers 
                of the Department of opioids in different health care 
                settings, including data on concurrent prescribing of 
                opioids to treat mental health disorders other than 
                opioid use disorder; and
                    (C) mail-order prescriptions of opioid prescribed 
                to veterans under the laws administered by the 
                Secretary.
    (e) Availability of Opioid Receptor Antagonists.--
            (1) Increased availability and use.--
                    (A) In general.--The Secretary shall maximize the 
                availability of opioid receptor antagonists approved by 
                the Food and Drug Administration, including naloxone, 
                to veterans.
                    (B) Availability, training, and distributing.--In 
                carrying out subparagraph (A), not later than 90 days 
                after the date of the enactment of this Act, the 
                Secretary shall--
                            (i) equip each pharmacy of the Department 
                        with opioid receptor antagonists approved by 
                        the Food and Drug Administration to be 
                        dispensed to outpatients as needed; and
                            (ii) expand the Overdose Education and 
                        Naloxone Distribution program of the Department 
                        to ensure that all veterans in receipt of 
                        health care under laws administered by the 
                        Secretary who are at risk of opioid overdose 
                        may access such opioid receptor antagonists and 
                        training on the proper administration of such 
                        opioid receptor antagonists.
                    (C) Veterans who are at risk.--For purposes of 
                subparagraph (B), veterans who are at risk of opioid 
                overdose include--
                            (i) veterans receiving long-term opioid 
                        therapy;
                            (ii) veterans receiving opioid therapy who 
                        have a history of substance use disorder or 
                        prior instances of overdose; and
                            (iii) veterans who are at risk as 
                        determined by a health care provider who is 
                        treating the veteran.
            (2) Report.--Not later than 120 days after the date of the 
        enactment of this Act, the Secretary shall submit to the 
        Committee on Veterans' Affairs of the Senate and the Committee 
        on Veterans' Affairs of the House of Representatives a report 
        on carrying out paragraph (1), including an assessment of any 
        remaining steps to be carried out by the Secretary to carry out 
        such paragraph.
    (f) Inclusion of Certain Information and Capabilities in Opioid 
Therapy Risk Report Tool of the Department.--
            (1) Information.--The Secretary shall include in the Opioid 
        Therapy Risk Report tool of the Department--
                    (A) information on the most recent time the tool 
                was accessed by a health care provider of the 
                Department with respect to each veteran; and
                    (B) information on the results of the most recent 
                urine drug test for each veteran.
            (2) Capabilities.--The Secretary shall include in the 
        Opioid Therapy Risk Report tool the ability of the health care 
        providers of the Department to determine whether a health care 
        provider of the Department prescribed opioids to a veteran 
        without checking the information in the tool with respect to 
        the veteran.
    (g) Notifications of Risk in Computerized Health Record.--The 
Secretary shall modify the computerized patient record system of the 
Department to ensure that any health care provider that accesses the 
record of a veteran, regardless of the reason the veteran seeks care 
from the health care provider, will be immediately notified whether the 
veteran--
            (1) is receiving opioid therapy and has a history of 
        substance use disorder or prior instances of overdose;
            (2) has a history of opioid abuse; or
            (3) is at risk of becoming an opioid abuser as determined 
        by a health care provider who is treating the veteran.
    (h) Definitions.--In this section:
            (1) The term ``controlled substance'' has the meaning given 
        that term in section 102 of the Controlled Substances Act (21 
        U.S.C. 802).
            (2) The term ``State'' means each of the several States, 
        territories, and possessions of the United States, the District 
        of Columbia, and the Commonwealth of Puerto Rico.

SEC. 3. STRENGTHENING OF JOINT WORKING GROUP ON PAIN MANAGEMENT OF THE 
              DEPARTMENT OF VETERANS AFFAIRS AND THE DEPARTMENT OF 
              DEFENSE.

    (a) In General.--Not later than 90 days after the date of enactment 
of this Act, the Secretary of Veterans Affairs and the Secretary of 
Defense shall ensure that the Pain Management Working Group of the 
Health Executive Committee of the Department of Veterans Affairs-
Department of Defense Joint Executive Committee (Pain Management 
Working Group) established under section 320 of title 38, United States 
Code, includes a focus on the following:
            (1) The opioid prescribing practices of health care 
        providers of each Department.
            (2) The ability of each Department to manage acute and 
        chronic pain among individuals receiving health care from the 
        Department, including training health care providers with 
        respect to pain management.
            (3) The use by each Department of complementary and 
        integrative health and complementary alternative medicines in 
        treating such individuals.
            (4) The concurrent use by health care providers of each 
        Department of opioids and prescription drugs to treat mental 
        health disorders, including benzodiazepines.
            (5) The practice by health care providers of each 
        Department of prescribing opioids to treat mental health 
        disorders.
            (6) The coordination in coverage of and consistent access 
        to medications prescribed for patients transitioning from 
        receiving health care from the Department of Defense to 
        receiving health care from the Department of Veterans Affairs.
            (7) The ability of each Department to identify and treat 
        substance use disorders among individuals receiving health care 
        from that Department.
    (b) Coordination and Consultation.--The Secretary of Veterans 
Affairs and the Secretary of Defense shall ensure that the working 
group described in subsection (a)--
            (1) coordinates the activities of the working group with 
        other relevant working groups established under section 320 of 
        title 38, United States Code;
            (2) consults with other relevant Federal agencies with 
        respect to the activities of the working group; and
            (3) consults with the Department of Veterans Affairs and 
        the Department of Defense with respect to, reviews, and 
        comments on the VA/DOD Clinical Practice Guideline for 
        Management of Opioid Therapy for Chronic Pain, or any successor 
        guideline, before any update to the guideline is released.
    (c) Clinical Practice Guidelines.--
            (1) In general.--Not later than 180 days after the date of 
        the enactment of this Act, the Secretary of Veterans Affairs 
        and the Secretary of Defense shall issue an update to the VA/
        DOD Clinical Practice Guideline for Management of Opioid 
        Therapy for Chronic Pain.
            (2) Matters included.--In conducting the update under 
        subsection (a), the Pain Management Working Group, in 
        coordination with the Clinical Practice Guideline VA/DOD 
        Management of Opioid Therapy for Chronic Pain Working Group, 
        shall examine whether the Clinical Practical Guideline should 
        include the following:
                    (A) Enhanced guidance with respect to--
                            (i) the coadministration of an opioid and 
                        other drugs, including benzodiazepines, that 
                        may result in life-limiting drug interactions;
                            (ii) the treatment of patients with current 
                        acute psychiatric instability or substance use 
                        disorder or patients at risk of suicide; and
                            (iii) the use of opioid therapy to treat 
                        mental health disorders other than opioid use 
                        disorder.
                    (B) Enhanced guidance with respect to the treatment 
                of patients with behaviors or comorbidities, such as 
                post-traumatic stress disorder or other psychiatric 
                disorders, or a history of substance abuse or 
                addiction, that requires a consultation or comanagement 
                of opioid therapy with one or more specialists in pain 
                management, mental health, or addictions.
                    (C) Enhanced guidance with respect to health care 
                providers--
                            (i) conducting an effective assessment for 
                        patients beginning or continuing opioid 
                        therapy, including understanding and setting 
                        realistic goals with respect to achieving and 
                        maintaining an expected level of pain relief, 
                        improved function, or a clinically appropriate 
                        combination of both; and
                            (ii) effectively assessing whether opioid 
                        therapy is achieving or maintaining the 
                        established treatment goals of the patient or 
                        whether the patient and health care provider 
                        should discuss adjusting, augmenting, or 
                        discontinuing the opioid therapy.
                    (D) Guidelines to govern the methodologies used by 
                health care providers of the Department of Veterans 
                Affairs and the Department of Defense to taper opioid 
                therapy when adjusting or discontinuing the use of 
                opioid therapy.
                    (E) Guidelines with respect to appropriate case 
                management for patients receiving opioid therapy who 
                transition between inpatient and outpatient health care 
                settings, which may include the use of care transition 
                plans.
                    (F) Guidelines with respect to appropriate case 
                management for patients receiving opioid therapy who 
                transition from receiving care during active duty to 
                post-military health care networks.
                    (G) Guidelines with respect to providing options, 
                before initiating opioid therapy, for pain management 
                therapies without the use of opioids and options to 
                augment opioid therapy with other clinical and 
                complementary and integrative health services to 
                minimize opioid dependence.
                    (H) Guidelines with respect to the provision of 
                evidence-based non-opioid treatments within the 
                Department of Veterans Affairs and the Department of 
                Defense, including medical devices and other therapies 
                approved or cleared by the Food and Drug Administration 
                for the treatment of chronic pain as an alternative to 
                or to augment opioid therapy.

SEC. 4. REVIEW, INVESTIGATION, AND REPORT ON USE OF OPIOIDS IN 
              TREATMENT BY DEPARTMENT OF VETERANS AFFAIRS.

    (a) Comptroller General Report.--
            (1) In general.--Not later than 2 years after the date of 
        the enactment of this Act, the Comptroller General of the 
        United States shall submit to the Committee on Veterans' 
        Affairs of the Senate and the Committee on Veterans' Affairs of 
        the House of Representatives a report on the Opioid Safety 
        Initiative of the Department of Veterans Affairs and the opioid 
        prescribing practices of health care providers of the 
        Department.
            (2) Elements.--The report submitted under paragraph (1) 
        shall include the following:
                    (A) Recommendations on such improvements to the 
                Opioid Safety Initiative of the Department as the 
                Comptroller General considers appropriate.
                    (B) Information with respect to--
                            (i) deaths resulting from sentinel events 
                        involving veterans prescribed opioids by a 
                        health care provider of the Department;
                            (ii) overall prescription rates and 
                        prescriptions indications of opioids to treat 
                        non-cancer, non-palliative, and non-hospice 
                        care patients;
                            (iii) the prescription rates and 
                        prescriptions indications of benzodiazepines 
                        and opioids concomitantly by health care 
                        providers of the Department;
                            (iv) the practice by health care providers 
                        of the Department of prescribing opioids to 
                        treat patients without any pain, including to 
                        treat patients with mental health disorders 
                        other than opioid use disorder; and
                            (v) the effectiveness of opioid therapy for 
                        patients receiving such therapy, including the 
                        effectiveness of long-term opioid therapy.
                    (C) An evaluation of processes of the Department in 
                place to oversee opioid use among veterans, including 
                procedures to identify and remedy potential over-
                prescribing of opioids by health care providers of the 
                Department.
                    (D) An assessment of the implementation by the 
                Secretary of the VA/DOD Clinical Practice Guideline for 
                Management of Opioid Therapy for Chronic Pain.
    (b) Quarterly Progress Report on Implementation of Comptroller 
General Recommendations.--Not later than 2 years after the date of the 
enactment of this Act, and not later than 30 days after the end of each 
quarter thereafter, the Secretary of Veterans Affairs shall submit to 
the Committee on Veterans' Affairs of the Senate and the Committee on 
Veterans' Affairs of the House of Representatives a progress report 
detailing the actions by the Secretary during the period covered by the 
report to address any outstanding findings and recommendations by the 
Comptroller General of the United States under subsection (a) with 
respect to the Veterans Health Administration.
    (c) Annual Review of Prescription Rates.--Not later than 1 year 
after the date of the enactment of this Act, and not less frequently 
than annually for the following 5 years, the Secretary shall submit to 
the Committee on Veterans' Affairs of the Senate and the Committee on 
Veterans' Affairs of the House of Representatives a report, with 
respect to each medical facility of the Department of Veterans Affairs, 
to collect and review information on opioids prescribed by health care 
providers at the facility to treat non-cancer, non-palliative, and non-
hospice care patients that contains, for the 1-year period preceding 
the submission of the report, the following:
            (1) The number of patients and the percentage of the 
        patient population of the Department who were prescribed 
        benzodiazepines and opioids concurrently by a health care 
        provider of the Department.
            (2) The number of patients and the percentage of the 
        patient population of the Department without any pain who were 
        prescribed opioids by a health care provider of the Department, 
        including those who were prescribed benzodiazepines and opioids 
        concurrently.
            (3) The number of non-cancer, non-palliative, and non-
        hospice care patients and the percentage of such patients who 
        were treated with opioids by a health care provider of the 
        Department on an inpatient-basis and who also received 
        prescription opioids by mail from the Department while being 
        treated on an inpatient-basis.
            (4) The number of non-cancer, non-palliative, and non-
        hospice care patients and the percentage of such patients who 
        were prescribed opioids concurrently by a health care provider 
        of the Department and a health care provider that is not health 
        care provider of the Department.
            (5) With respect to each medical facility of the 
        Department, information on opioids prescribed by health care 
        providers at the facility to treat non-cancer, non-palliative, 
        and non-hospice care patients, including information on--
                    (A) the prescription rate at which each health care 
                provider at the facility prescribed benzodiazepines and 
                opioids concurrently to such patients and the aggregate 
                such prescription rate for all health care providers at 
                the facility;
                    (B) the prescription rate at which each health care 
                provider at the facility prescribed benzodiazepines or 
                opioids to such patients to treat conditions for which 
                benzodiazepines or opioids are not approved treatment 
                and the aggregate such prescription rate for all health 
                care providers at the facility;
                    (C) the prescription rate at which each health care 
                provider at the facility prescribed or dispensed mail-
                order prescriptions of opioids to such patients while 
                such patients were being treated with opioids on an 
                inpatient-basis and the aggregate of such prescription 
                rate for all health care providers at the facility; and
                    (D) the prescription rate at which each health care 
                provider at the facility prescribed opioids to such 
                patients who were also concurrently prescribed opioids 
                by a health care provider that is not a health care 
                provider of the Department and the aggregate of such 
                prescription rates for all health care providers at the 
                facility.
            (6) With respect to each medical facility of the 
        Department, the number of times a pharmacist at the facility 
        overrode a critical drug interaction warning with respect to an 
        interaction between opioids and another medication before 
        dispensing such medication to a veteran.
    (d) Investigation of Prescription Rates.--If the Secretary 
determines that a prescription rate with respect to a health care 
provider or medical facility of the Department conflicts with or is 
otherwise inconsistent with the standards of appropriate and safe care, 
the Secretary shall--
            (1) immediately notify the Committee on Veterans' Affairs 
        of the Senate and the Committee on Veterans' Affairs of the 
        House of Representatives of such determination, including 
        information relating to such determination, prescription rate, 
        and health care provider or medical facility, as the case may 
        be; and
            (2) through the Office of the Medical Inspector of the 
        Veterans Health Administration, conduct a full investigation of 
        the health care provider or medical facility, as the case may 
        be.
    (e) Prescription Rate Defined.--In this section, the term 
``prescription rate'' means, with respect to a health care provider or 
medical facility of the Department, each of the following:
            (1) The number of patients treated with opioids by the 
        health care provider or at the medical facility, as the case 
        may be, divided by the total number of pharmacy users of that 
        health care provider or medical facility.
            (2) The average number of morphine equivalents per day 
        prescribed by the health care provider or at the medical 
        facility, as the case may be, to patients being treated with 
        opioids.
            (3) Of the patients being treated with opioids by the 
        health care provider or at the medical facility, as the case 
        may be, the average number of prescriptions of opioids per 
        patient.

SEC. 5. MANDATORY DISCLOSURE OF CERTAIN VETERAN INFORMATION TO STATE 
              CONTROLLED SUBSTANCE MONITORING PROGRAMS.

    Section 5701(l) of title 38, United States Code, is amended by 
striking ``may'' and inserting ``shall''.

SEC. 6. MODIFICATION TO LIMITATION ON AWARDS AND BONUSES.

    Section 705 of the Veterans Access, Choice, and Accountability Act 
of 2014 (Public Law 113-146; 38 U.S.C. 703 note) is amended to read as 
follows:

``SEC. 705. LIMITATION ON AWARDS AND BONUSES PAID TO EMPLOYEES OF 
              DEPARTMENT OF VETERANS AFFAIRS.

    ``The Secretary of Veterans Affairs shall ensure that the aggregate 
amount of awards and bonuses paid by the Secretary in a fiscal year 
under chapter 45 or 53 of title 5, United States Code, or any other 
awards or bonuses authorized under such title or title 38, United 
States Code, does not exceed the following amounts:
            ``(1) With respect to each of fiscal years 2017 through 
        2021, $230,000,000.
            ``(2) With respect to each of fiscal years 2022 through 
        2024, $360,000,000.''.

            Passed the House of Representatives May 10, 2016.

            Attest:

                                                                 Clerk.
114th CONGRESS

  2d Session

                               H. R. 4063

_______________________________________________________________________

                                 AN ACT

 To improve the use by the Secretary of Veterans Affairs of opioids in 
               treating veterans, and for other purposes.
```