I 114th CONGRESS 1st Session H. R. 2805 IN THE HOUSE OF REPRESENTATIVES June 17, 2015 Mrs. Brooks of Indiana (for herself, Mr. Kennedy , Mr. Carson of Indiana , Mrs. Walorski , Mr. Whitfield , and Mr. Messer ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To address prescription opioid abuse and heroin use.

1. Short title This Act may be cited as the Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 . 2. Findings Congress makes the following findings: (1) The Controlled Substances Act ( 21 U.S.C. 801 et seq. ) declares that many controlled substances have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the people of the United States. (2) Health care professionals, medical experts, researchers, and scientists have found pain to be a major national health problem. (3) The responsible treatment of pain is a high priority for our Nation and the needs of individuals with pain must be taken into careful consideration when taking steps to prevent prescription drug misuse and abuse. (4) When no longer needed or wanted for legitimate pain management or health treatment, prescription opioids are susceptible to diversion. Prescription opioids also may be abused by individuals who were not prescribed such drugs, or misused by individuals not taking such drugs as directed. (5) Approximately 4 out of 5 new heroin users report that they became addicted to prescription opioids before they used heroin for the first time. (6) According to the National Institute on Drug Abuse, heroin attaches to the same brain cell receptors as prescription opioids. (7) The low cost and high purity of currently available heroin has contributed to an increase in heroin use across the United States. (8) More people are using heroin, and are using heroin at a younger age. The National Survey on Drug Use and Health reports that new heroin users numbered 142,000 in 2010, and increased to 178,000 in 2011. In 2011, the average age at first use among heroin abusers between 12 and 49 years was 22.1 years. In 2009, the average age at first use among heroin abusers between 12 and 49 years was 25.5 years. (9) According to the Department of Health and Human Services, heroin use nationwide rose 79 percent between 2007 and 2012. (10) Deaths from heroin overdose have significantly increased in communities across the United States. According to the Centers for Disease Control and Prevention, the number of deaths involving heroin almost tripled between 2010 and 2013. From 2010 to 2013, the number of heroin deaths rose from 3,036 to 8,257. (11) The Edward Byrne Memorial Justice Assistance Grant Program under part E of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3750 et seq. ) is critical to fighting the prescription opioid abuse and heroin use epidemics, and should be reauthorized and fully funded. 3. Development of best prescribing practices (a) Inter-Agency task force Not later than 120 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), in cooperation with the Secretary of Veterans Affairs, the Secretary of Defense, and the Administrator of the Drug Enforcement Administration, shall convene a Pain Management Best Practices Inter-Agency Task Force (referred to in this section as the task force ). (b) Membership The task force shall be comprised of— (1) representatives of— (A) the Department of Health and Human Services, including the Centers for Disease Control and Prevention; (B) the Department of Veterans Affairs; (C) the Department of Defense; (D) the Drug Enforcement Administration; (E) the Office of National Drug Control Policy; and (F) the Institute of Medicine; and (2) the Director of the National Institutes of Health; (3) physicians, dentists, and non-physician prescribers; (4) pharmacists; (5) experts in the fields of pain research and addiction research; (6) representatives of— (A) pain management professional organizations; (B) the mental health treatment community; (C) the addiction treatment community; and (D) pain advocacy groups; (7) a person in recovery from addiction to medication for chronic pain; (8) a person with chronic pain; and (9) other stakeholders, as the Secretary determines appropriate. (c) Duties The task force shall— (1) not later than 180 days after the date on which the task force is convened, develop best practices for pain management and prescription pain medication prescribing practices, taking into consideration— (A) existing pain management research; (B) recommendations from relevant conferences; and (C) ongoing efforts at the State and local levels and by medical professional organizations to develop improved pain management strategies; (2) solicit and take into consideration public comment on the best practices developed under paragraph (1), amending such best practices if appropriate; and (3) develop a strategy for disseminating information about the best practices developed under paragraphs (1) and (2) to prescribers, pharmacists, State medical boards, educational institutions that educate prescribers and pharmacists, and other parties, as the Secretary determines appropriate. (d) Limitation The task force shall not have rulemaking authority. (e) Report Not later than 270 days after the date on which the task force is convened under subsection (a), the task force shall submit to Congress a report that includes— (1) the strategy for disseminating best practices developed under subsection (c); (2) the results of a feasibility study on linking best practices developed under paragraphs (1) and (2) of subsection (c) to receiving and renewing registrations under section 303(f) of the Controlled Substances Act ( 21 U.S.C. 823(f) ); and (3) recommendations on how to apply such best practices to improve prescribing practices at medical facilities, including medical facilities of the Veterans Health Administration. 4. 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)— (A) in paragraph (1)— (i) in subparagraph (A), by striking or ; (ii) in subparagraph (B), by striking the period at the end and inserting ; or ; and (iii) by adding at the end the following: (C) to maintain and operate an existing State-controlled substance monitoring program. ; and (B) in paragraph (3), by inserting by the Secretary after Grants awarded ; (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 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 redesignated, by inserting before the semicolon at the end and at least one health information technology system such as an electronic health records system, a health information exchange, or an e-prescribing system ; and (vi) in clause (v), as redesignated, by striking public health and inserting public health or public safety ; (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 striking the period at the end and inserting 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 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). ; (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 public safety ; and (B) by adding at the end the following: (5) The State shall report to the Secretary on— (A) as appropriate, interoperability with the controlled substance monitoring programs of Federal departments and agencies; (B) as appropriate, interoperability with health information technology systems such as electronic health records systems, health information exchanges, and e-prescribing systems; and (C) 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. ; (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 included in schedule II, III, or IV of section 202(c) of the Controlled Substance Act ; and (ii) in subparagraph (D), by inserting a State substance abuse agency, after a State health department, ; 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 and other information determined by the Secretary to be necessary 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 (l)(2). (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. ; (7) by redesignating subsections (h) through (n) as subsections (j) through (p), respectively; (8) in subsections (c)(1)(A)(iv) and (d)(4), by striking subsection (h) each place it appears and inserting subsection (j) ; (9) 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; (2) educate prescribers and dispensers on the benefits of the system both to them and society; and (3) facilitate linkage to the State substance abuse agency and substance abuse disorder services. (i) Consultation with Attorney General In carrying out this section, the Secretary shall consult with the Attorney General of the United States and other relevant Federal officials to— (1) ensure maximum coordination of controlled substance monitoring programs and related activities; and (2) minimize duplicative efforts and funding. ; (10) in subsection (l)(2)(A), as redesignated by paragraph (7)— (A) in clause (ii), by inserting ; established or strengthened initiatives to ensure linkages to substance use disorder services; before or affected patient access ; and (B) in clause (iii), by inserting and between controlled substance monitoring programs and health information technology systems, before , including an assessment ; (11) by striking subsection (m) (relating to preference), as redesignated by paragraph (7); (12) by redesignating subsections (m) through (o), as redesignated by paragraph (7), as subsections (l) through (o), respectively; (13) in subsection (m)(1), as redesignated by paragraph (12), by striking establishment, implementation, or improvement and inserting establishment, improvement, or maintenance ; (14) in subsection (n)— (A) in paragraph (5)— (i) by striking means the ability and inserting the following: means— (A) the ability ; (ii) by striking the period at the end and inserting ; or ; and (iii) by adding at the end the following: (B) sharing of State controlled substance monitoring program information with a health information technology system such as an electronic health records system, a health information exchange, or an e-prescribing system. ; (B) in paragraph (7), by striking pharmacy and inserting pharmacist ; and (C) in paragraph (8), by striking and the District of Columbia and inserting , the District of Columbia, and any commonwealth or territory of the United States ; and (15) by amending subsection (o), as redesignated by paragraph (12), to read as follows: (o) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years from 2016 through 2020. . 5. Reauthorization of byrne justice assistance grant program Section 508 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 42 U.S.C. 3758 ) is amended by striking 2006 through 2012 and inserting 2016 through 2020 . 6. Awareness campaigns (a) In general The Secretary of Health and Human Services shall advance the education and awareness of the public, providers, patients, and other appropriate stakeholders regarding the risk of abuse of prescription opioid drugs if such products are not taken as prescribed. (b) Drug-Free media campaign (1) In general The Office of National Drug Control Policy, in coordination with the Secretary of Health and Human Services and the Attorney General, shall establish a national drug awareness campaign. (2) Requirements The national drug awareness campaign under paragraph (1) shall— (A) take into account the association between prescription opioid abuse and heroin use; (B) emphasize the similarities between heroin and prescription opioids and the effects of heroin and prescription opioids on the human body; and (C) bring greater public awareness to the dangerous effects of fentanyl when mixed with heroin or abused in a similar manner. (3) Available funds Funds for the national drug awareness campaign may be derived from amounts appropriated to the Office of National Drug Control Policy and otherwise available for obligation and expenditure. 7. Naloxone demonstration grants (a) Definitions In this section— (1) the term eligible entity means a State, a unit of local government, or a tribal government; (2) the term first responder includes firefighters, law enforcement officers, paramedics, emergency medical technicians, and other individuals (including employees of legally organized and recognized volunteer organizations, whether compensated or not), who, in the course of professional duties, respond to fire, medical, hazardous material, or other similar emergencies; and (3) the term opioid overdose reversal drug means a drug that, when administered, reverses in whole or part the pharmacological effects of an opioid overdose in the human body. (b) Program authorized The Attorney General, in coordination with the Secretary of Health and Human Services and the Director of the Office of National Drug Control Policy, may make grants to eligible entities to create not more than 8 demonstration programs to allow properly trained first responders to prevent prescription opioid and heroin overdose death by administering an opioid overdose reversal drug to an individual who has experienced overdose or who has been determined to have likely experienced overdose. (c) Application (1) In general To be eligible to receive a grant under this section, an entity shall submit an application to the Attorney General, at such time, in such manner, and accompanied by such information as the Attorney General shall require, and— (A) that meets the criteria for selection under paragraph (2); and (B) that describes— (i) the evidence-based methodology and outcome measures that will be used to evaluate the program funded with a grant under this section, and specifically explain how such measurements will provide valid measures of the impact of the program; (ii) how the program could be broadly replicated if demonstrated to be effective; (iii) how the eligible entity will coordinate with their corresponding State substance abuse agency to identify protocols and resources that are available to victims and families, including information on treatment and recovery resources; and (iv) how the demonstration program will continue with State, local, or private funding after the expiration of the grant. (2) Criteria for selection The Attorney General may award grants to eligible entities that demonstrate an institutional need for technical support and lack existing infrastructure in order to implement and train first responders to carry out a demonstration program under paragraph (b). (3) Priority consideration In awarding grants under this section, the Attorney General shall give priority to an eligible entity located in a State that provides civil liability protection for first responders administering an opioid overdose reversal drug to counteract opioid overdoses by— (A) enacting legislation that provides such civil liability protection; and (B) providing a certification by the attorney general of the State that the attorney general has— (i) reviewed any applicable civil liability protection law to determine the applicability of the law with respect to first responders who may administer an opioid overdose reversal drug to individuals reasonably believed to be suffering from opioid overdose; and (ii) concluded that the law described in subparagraph (A) provides adequate civil liability protection applicable to such persons. (d) Use of funds An eligible entity shall use a grant received under this section to— (1) make an opioid overdose reversal drug, which may include naloxone, available to be carried and administered by first responders; (2) train and provide resources for first responders, on carrying and administrating such opioid overdose reversal drug for the prevention of prescription opioid and heroin overdose deaths; and (3) establish processes, protocols, and mechanisms for referral to treatment. (e) Technical support The Attorney General shall provide individualized technical support, as requested, to grant recipients under this section to assist with implementation of the demonstration program. (f) Grant duration A demonstration project grant shall be for a period of 3 years. (g) Evaluation Following the first grant year, a recipient of a grant awarded under this section shall report to the Attorney General on an annual basis — (1) the number of first responders equipped with an opioid overdose reversal drug for the prevention of fatal prescription opioid and heroin overdose; (2) the number of prescription opioid and heroin overdoses reversed by first responders; (3) the number of calls for service related to prescription opioid and heroin overdose; and (4) the extent to which overdose victims and families receive information about treatment services and available data describing treatment admissions. (h) Report to congress The Attorney General shall submit an annual report to the appropriate committees of Congress aggregating the data received from the grant recipients and evaluating the outcomes achieved by the demonstration projects funded under this section. 8. Offset It is the sense of Congress that the amounts expended to carry out this Act and the amendments made by this Act should be offset by a corresponding reduction in Federal non-defense discretionary spending.