I 113th CONGRESS 2d Session H. R. 4169 IN THE HOUSE OF REPRESENTATIVES March 6, 2014 Ms. Edwards (for herself, Ms. Bass , Mr. Carson of Indiana , Mr. Cummings , Mr. Ellison , Mr. Keating , Ms. Lee of California , Mr. Lynch , Mr. Michaud , Mr. Rangel , Mr. Ryan of Ohio , Ms. Schwartz , Mr. Serrano , Ms. Shea-Porter , Mr. Tierney , Mr. Tonko , Ms. Wilson of Florida , Mr. Foster , and Mr. Ben Ray Luján of New Mexico ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To prevent deaths occurring from drug overdoses.

1. Short title This Act may be cited as the Stop Overdose Stat Act or the S.O.S. Act . 2. Findings The Congress finds the following: (1) According to the Centers for Disease Control and Prevention (CDC), each day in the United States more than 100 people die from a drug overdose. Among people 25 to 64 years old, drug overdose caused more deaths than motor vehicle accidents. (2) The CDC reports that more than 38,000 people in the United States died from a drug overdose in 2010 alone. Seventy-eight percent of these deaths were due to unintentional drug overdoses, and many could have been prevented. (3) Deaths resulting from unintentional drug overdoses increased more than 400 percent between 1980 and 1999, and more than doubled between 1999 and 2010. (4) Ninety-one percent of all unintentional poisoning deaths are due to drugs. Since 1999, in the United States the population of Non-Hispanic Whites and the population of American Indians and Alaska Natives have seen the highest rates of unintentional drug poisoning deaths. (5) Opioid medications such as oxycodone and hydrocodone are involved in 55 percent of all unintentional drug poisoning deaths. (6) Between 1999 and 2010, opioid medication overdose fatalities increased by more than 400 percent among women and 265 percent among men. (7) Military veterans are at elevated risk of experiencing a drug overdose. Vietnam, Iraq, and Afghanistan veterans with combat injuries, post­trau­mat­ic stress disorder (PTSD), and other co-occurring mental health diagnoses are at elevated risk of fatal drug overdose from opioid medications. (8) Rural and suburban regions are disproportionately affected by opioid medication overdoses. Urban centers also continue to struggle with overdose, which is the leading cause of death among homeless adults. (9) In the year 2009 alone, estimated lost productivity and direct medical costs from opioid medication poisonings exceeded $20,000,000,000. (10) Both fatal and nonfatal overdoses place a heavy burden on public health and public safety resources, yet there is no coordinated cross-Federal agency response to prevent overdose fatalities. (11) Naloxone is a medication that rapidly reverses overdose from heroin and opioid medications. (12) In 2012, the Food and Drug Administration (FDA) held a public workshop in collaboration with the National Institute on Drug Abuse (NIDA) and the CDC, and with participation from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of National Drug Control Policy (ONDCP), to discuss making naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. (13) Lawmakers in California, Colorado, Connecticut, Illinois, Kentucky, Massachusetts, Maryland, New Jersey, New Mexico, New York, North Carolina, Oregon, Rhode Island, Vermont, Virginia, Washington, and the District of Columbia have removed legal impediments to increasing naloxone prescription and its use by bystanders who are in a position to respond to an overdose. (14) Health practitioners are often not fully aware of overdose symptoms and prevention methods, impacting their ability to adequately inform patients and caregivers on how to recognize symptoms, respond effectively by seeking emergency assistance, and provide naloxone and other first aid in order to save a life. (15) The American Medical Association (AMA), the Nation’s largest physician organization, supports further implementation of community-based programs that offer naloxone and other opioid overdose prevention services. (16) Community-based overdose prevention programs have successfully prevented deaths from opioid overdoses by making rescue trainings and naloxone available to first responders, parents, and other bystanders who may encounter an overdose. Over 50,000 potential bystanders have been trained by overdose prevention programs in the United States. A CDC report credits overdose prevention programs with saving more than 10,000 lives since 1996. (17) At least 188 local overdose prevention programs are operating in the United States, including in major cities such as Baltimore, Chicago, Los Angeles, New York City, Boston, San Francisco, and Philadelphia, and statewide in New Mexico, Massachusetts, and New York. Between 2006 and 2009, overdose prevention programs facilitated by the Massachusetts Department of Public Health trained nearly 3,000 people who reported more than 300 rescues. Since 2004, a program administered by the Baltimore City Health Department has trained more than 3,000 people who reported more than 220 rescues. Project Lazarus, an overdose prevention program in Wilkes County, North Carolina, reduced overdose deaths 69 percent between 2009 and 2011. (18) The ONDCP supports equipping first responders to help reverse overdoses. Police officers on patrol in Quincy, Massachusetts, have conducted 170 overdose rescues with naloxone since 2010. The police department has reported a 95-percent success rate with overdose rescue attempts by police officers. In Suffolk County, New York, police officers have saved more than 50 lives with naloxone. (19) Research shows that the cost per year of life gained by making naloxone available to reverse overdoses is within the range of what Americans usually pay for health treatments. (20) Overdose prevention programs are needed in correctional facilities, addiction treatment programs, and other places where people are at higher risk of overdosing after a period of abstinence. (21) People affected by drug overdose gather each year in communities nationwide on August 31st for Overdose Awareness Day to mourn and pay tribute to loved ones and raise awareness about overdose risk and prevention. 3. Overdose prevention grant program (a) Program authorized The Secretary, acting through the Director of the CDC, shall award grants or cooperative agreements to eligible entities to enable the eligible entities to reduce deaths occurring from overdoses of drugs. (b) Application (1) In general An eligible entity desiring a grant or cooperative agreement under this section shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (2) Contents An application under paragraph (1) shall include— (A) a description of the activities to be funded through the grant or cooperative agreement; and (B) a demonstration that the eligible entity has the capacity to carry out such activities. (c) Priority In awarding grants and cooperative agreements under subsection (a), the Secretary shall give priority to eligible entities that— (1) are a public health agency or community-based organization; and (2) have expertise in preventing deaths occurring from overdoses of drugs in populations at high risk of such deaths. (d) Eligible activities (1) Required activity As a condition on receipt of a grant or cooperative agreement under this section, an eligible entity shall agree to use the grant or cooperative agreement to purchase and distribute the drug naloxone. (2) Additional activities In addition to the activity described in paragraph (1), an eligible entity shall use a grant or cooperative agreement under this section to carry out one or more of the following activities: (A) Educating prescribers and pharmacists about overdose prevention and naloxone prescription. (B) Training first responders, other individuals in a position to respond to an overdose, and law enforcement and corrections officials on the effective response to individuals who have overdosed on drugs. Training pursuant to this subparagraph may include any activity that is educational, instructional, or consultative in nature, and may include volunteer trainings, awareness building exercises, outreach to individuals who are at-risk of a drug overdose, and distribution of educational materials. (C) Implementing and enhancing programs to provide overdose prevention, recognition, treatment, and response to individuals in need of such services. (D) Expanding activities described in paragraph (1). (E) Expanding activities described in subparagraph (A) or (B). (e) Coordinating center (1) Establishment The Secretary shall establish and provide for the operation of a coordinating center responsible for— (A) collecting, compiling, and disseminating data on the programs and activities under this section; (B) evaluating such data and, based on such evaluation, developing best practices for preventing deaths occurring from drug overdoses; and (C) making such best practices specific to the type of community involved. (2) Reports to center As a condition on receipt of a grant or cooperative agreement under this section, an eligible entity shall agree to prepare and submit, not later than 90 days after the end of the grant or cooperative agreement period, a report to such coordinating center and the Secretary describing the results of the activities supported through the grant or cooperative agreement. (f) Matching funds (1) In general As a condition on receipt of a grant or cooperative agreement under this section, an eligible entity shall agree that, with respect to the costs to be incurred by the eligible entity in carrying out the activities for which the grant or cooperative agreement is awarded, the eligible entity will make available non-Federal contributions in an amount equal to not less than 50 percent of the Federal funds provided through the grant or cooperative agreement. (2) Satisfying matching requirement The non-Federal contributions required under paragraph (1) may be— (A) in cash or in-kind, including services, fairly evaluated; and (B) from— (i) any private source; or (ii) a State, tribal, or local agency. (3) Waiver The Secretary may waive or reduce the non-Federal contribution required by paragraph (1) if the eligible entity involved demonstrates that the eligible entity cannot meet the contribution requirement due to financial hardship. (g) Duration The period of a grant or cooperative agreement under this section shall be 4 years. (h) Authorization of appropriations There are authorized to be appropriated $10,000,000 to carry out this section for each of the fiscal years 2014 through 2018. 4. Surveillance capacity building (a) Program authorized The Secretary, acting through the Director of the CDC, shall award grants or cooperative agreements to State, local, or tribal governments, or the National Poison Data System working in conjunction with State, local, or tribal governments, to improve fatal and nonfatal drug overdose surveillance and reporting capabilities, including the following: (1) Providing training to improve identification of drug overdose as the cause of death by coroners and medical examiners. (2) Establishing, in cooperation with the National Poison Data System, coroners, and medical examiners, a comprehensive national program for surveillance of, and reporting to an electronic database on, drug overdose deaths in the United States. (3) Establishing, in cooperation with the National Poison Data System, a comprehensive national program for surveillance of, and reporting to an electronic database on, fatal and nonfatal drug overdose occurrences, including epidemiological and toxicologic analysis and trends. (b) Application (1) In general A State, local, or tribal government or the National Poison Data System desiring a grant or cooperative agreement under this section shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (2) Contents The application described in paragraph (1) shall include— (A) a description of the activities to be funded through the grant or cooperative agreement; and (B) a demonstration that the State, local, or tribal government or the National Poison Data System has the capacity to carry out such activities. (c) Report As a condition on receipt of a grant or cooperative agreement under this section, a State, local, or tribal government or the National Poison Data System shall agree to prepare and submit, not later than 90 days after the end of the grant or cooperative agreement period, a report to the Secretary describing the results of the activities supported through the grant or cooperative agreement. (d) Authorization of appropriations There are authorized to be appropriated to carry out this section $5,000,000 for each of the fiscal years 2014 through 2018. 5. Reducing overdose deaths Part J of title III of the Public Health Service Act ( 42 U.S.C. 280b et seq. ) is amended by inserting after section 393D ( 42 U.S.C. 280b–1f ) the following: 393F. Reducing overdose deaths (a) Prevention of drug overdose Not later than 180 days after the date of the enactment of this section, the Secretary, in consultation with a task force comprised of stakeholders, shall develop a plan to reduce the number of deaths occurring from overdoses of drugs and shall submit the plan to Congress. The plan shall include— (1) a plan for implementation of a public health campaign to educate prescribers and the public about overdose prevention and naloxone prescription; (2) recommendations for improving and expanding overdose prevention programming; and (3) recommendations for such legislative or administrative action as the Secretary considers appropriate. (b) Task force representation (1) Required members The task force referred to in subsection (a) shall include at least one representative of each of the following: (A) Individuals directly impacted by drug overdose. (B) Direct service providers who engage individuals at risk of a drug overdose. (C) Drug overdose prevention advocates. (D) The NIDA. (E) The Center for Substance Abuse Treatment. (F) The CDC. (G) The Health Resources and Services Administration. (H) The Food and Drug Administration. (I) The Office of National Drug Control Policy. (J) The American Medical Association. (K) The American Association of Poison Control Centers. (L) The Bureau of Prisons. (M) The Centers for Medicare & Medicaid Services. (N) The Department of Justice. (2) Additional members In addition to the representatives required by paragraph (1), the task force referred to in subsection (a) may include other representatives of individuals or entities with expertise relating to drug overdoses. . 6. Overdose prevention research (a) Overdose research The Director of the NIDA shall prioritize and conduct or support research on drug overdose and overdose prevention. The primary aims of this research shall include— (1) examination of circumstances that contribute to drug overdose and identification of drugs associated with fatal overdose; (2) evaluation of existing overdose prevention methods; (3) pilot programs or research trials on new overdose prevention strategies or programs that have not been studied in the United States; (4) scientific research concerning the effectiveness of overdose prevention programs, including how to effectively implement and sustain such programs; and (5) comparative effectiveness research on overdose prevention programs. (b) Formulations of naloxone The Director of the NIDA shall support research on the development of formulations of naloxone and dosage delivery devices specifically intended to be used by lay persons or first responders for the prehospital treatment of unintentional drug overdose. (c) Authorization of appropriations There are authorized to be appropriated to carry out this section $5,000,000 for each of the fiscal years 2014 through 2018. 7. Offset of costs and personnel Notwithstanding any other provision of law, the Secretary shall— (1) eliminate such initiatives, positions, and programs as the Secretary deems necessary to ensure any and all costs incurred to carry out the provisions of this Act, and the amendments made by this Act, are entirely offset; (2) ensure no net increase in personnel are added to carry out the provisions of this Act, with any new full- or part-time employees or equivalents offset by eliminating an equivalent number of existing staff; (3) not later than 60 days after the date of the enactment of this Act, report to the Congress on the actions taken to ensure compliance with paragraphs (1) and (2), including the specific initiatives, positions, and programs that have been eliminated to ensure that the costs of carrying out this Act will be offset; and (4) not implement any other provision of this Act (other than paragraphs (1), (2), and (3)) or any amendment made by this Act until the Secretary has certified that the actions specified in paragraphs (1), (2), and (3) have been completed. 8. Definitions In this Act: (1) CDC The term CDC means the Centers for Disease Control and Prevention. (2) Drug The term drug — (A) means a drug (as that term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )); and (B) includes any controlled substance (as that term is defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 )). (3) Eligible entity The term eligible entity means an entity that is a State, local, or tribal government, a correctional institution, a law enforcement agency, a community agency, a professional organization in the field of poison control and surveillance, or a private nonprofit organization. (4) National poison data system The term National Poison Data System means the system operated by the American Association of Poison Control Centers, in partnership with the CDC, for real-time local, State, and national electronic reporting, and the corresponding database network. (5) NIDA The term NIDA means the National Institute on Drug Abuse. (6) ONDCP The term ONDCP means the Office of National Drug Control Policy. (7) Secretary The term Secretary means the Secretary of Health and Human Services. (8) State The term State means any of the several States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, the United States Virgin Islands, Guam, American Samoa, and any other territory or possession of the United States.