Protecting Patient Access to Emergency Medications Act of 2016

To amend the Controlled Substances Act with regard to the provision of emergency medical services. 1. Short title This Act may be cited as the Protecting Patient Access to Emergency Medications Act of 2016 2. Emergency medical services Section 303 of the Controlled Substances Act ( 21 U.S.C. 821 et seq. (1) by redesignating subsection (j) as subsection (k); and (2) by inserting after subsection (i) the following: (j) Emergency medical services that administer controlled substances (1) Registration For the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General— (A) shall register an emergency medical services agency if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and (B) may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection (f). (2) Option for single registration In registering an emergency medical services agency pursuant to paragraph (1), the Attorney General shall allow such agency the option of a single registration in each State where the agency administers controlled substances in lieu of requiring a separate registration for each location of the emergency medical services agency. (3) Hospital-based agency If a hospital-based emergency medical services agency is registered under subsection (f), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection. (4) Administration outside physical presence of medical director or authorizing medical professional Emergency medical services professionals of a registrant emergency medical services agency may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administration is— (A) authorized by the law of the State in which it occurs; and (B) pursuant to— (i) a standing order that is— (I) issued and adopted by 1 or more medical directors of the agency; or (II) developed by a specific State authority; or (ii) a verbal order that is— (I) issued in accordance with a policy of the agency; (II) provided by an authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient; (III) in the case of a mass casualty incident; or (IV) to ensure the proper care and treatment of a specific patient. (5) Delivery A registrant emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if— (A) the agency designates the unregistered location for such delivery; and (B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location. (6) Storage A registrant emergency medical services agency may store controlled substances— (A) at a registered location of the agency; (B) at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or (C) in an emergency medical services vehicle used by the agency that is— (i) traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or (ii) otherwise actively in use by the agency. (7) No treatment as distribution The delivery of controlled substances by a registrant emergency medical services agency pursuant to this subsection shall not be treated as distribution for purposes of section 308. (8) Restocking of emergency medical services vehicles at a hospital Notwithstanding paragraph (13)(J), a registrant emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of section 308, provided all of the following conditions are satisfied: (A) The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph (9). (B) The hospital maintains a record of such delivery to the agency in accordance with section 307. (C) If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances. (9) Maintenance of records (A) In general A registrant emergency medical services agency shall maintain records in accordance with subsections (a) and (b) of section 307 of all controlled substances that are received, administered, or otherwise disposed of pursuant to the agency's registration, without regard to subsection 307(c)(1)(B). (B) Requirements Such records— (i) shall include records of deliveries of controlled substances between all locations of the agency; and (ii) shall be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of. (10) Other requirements A registrant emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that— (A) all emergency medical services professionals who administer controlled substances using the agency's registration act in accordance with the requirements of this subsection; (B) the recordkeeping requirements of paragraph (9) are met with respect to a registered location and each designated location of the agency; (C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever controlled substances are stored by the agency in accordance with paragraph (6); and (D) the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph (9). (11) Regulations The Attorney General may issue regulations— (A) specifying, with regard to delivery of controlled substances under paragraph (5)— (i) the types of locations that may designated under such paragraph; and (ii) the manner in which a notification under paragraph (5)(B) must be made; (B) specifying, with regard to the storage of controlled substances under paragraph (6), the manner in which such substances must be stored at registered and designated locations, including in emergency medical service vehicles; and (C) addressing the ability of hospitals, registered locations, and designated locations to deliver controlled substances to each other in the event of— (i) shortages of such substances; (ii) a public health emergency; or (iii) a mass casualty event. (12) Rule of construction Nothing in this subsection shall be construed— (A) to limit the authority vested in the Attorney General by other provisions of this title to take measures to prevent diversion of controlled substances; or (B) to override the authority of any State to regulate the provision of emergency medical services. (13) Definitions In this section: (A) The term designated location (B) The term emergency medical services (C) The term emergency medical services agency (i) is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based; (ii) provides emergency medical services by ground, air, or otherwise; and (iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis. (D) The term emergency medical services professional (E) The term emergency medical services vehicle (F) The term hospital-based (G) The term medical director (H) The term medical oversight (I) The term medical professional (J) The term registered location (K) The term registrant emergency medical services agency (i) an emergency medical services agency that is registered pursuant to this subsection; or (ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (f). (L) The term specific State authority (M) The term standing order (N) The term verbal order . November 14, 2016 Reported from the Committee on Energy and Commerce November 14, 2016 The Committee on the Judiciary

Summary: Protecting Patient Access to Emergency Medications Act of 2016 (Sec. 2) This bill amends the Controlled Substances Act to direct the Drug Enforcement Administration (DEA) to register an emergency medical services (EMS) agency to administer controlled substances if the agency submits an application demonstrating that it is authorized to conduct such activity in the state in which the agency practices. The DEA may deny an application if it determines that the registration is inconsistent with the public interest. An EMS agency may obtain a single registration in each state instead of a separate registration for each location. A registered EMS agency may deliver, store, and receive controlled substances, subject to specified conditions. An EMS professional of a registered EMS agency may administer controlled substances in schedules II, III, IV, or V outside the physical presence of a medical director if such administration is authorized under state law and pursuant to a standing or verbal order, subject to specified conditions. The bill specifies that a hospital-based EMS agency (i.e., an EMS agency owned or operated by a hospital) may continue to administer controlled substances under the hospital's DEA registration.