I 114th CONGRESS 2d Session H. R. 4365 IN THE HOUSE OF REPRESENTATIVES January 12, 2016 Mr. Hudson (for himself, Mr. Butterfield , Mr. Cohen , Mr. Farenthold , Mr. Heck of Nevada , Mr. Ruiz , and Mr. Westerman ) 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 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. Findings The Congress finds as follows: (1) The use of controlled substances by emergency medical services agencies to administer medical care and medicines to individuals in the field is essential to save lives, manage pain, and improve health outcomes. (2) The unique nature of mobile emergency medical services is unlike other health care services governed by the Controlled Substances Act in that it requires the provision of time-sensitive and mobile medical care to individuals with critical injuries and illnesses in the field and movement of such individuals to definitive care. (3) Regulatory oversight to prevent diversion should not disrupt the current delivery model of providing medical care to individuals by emergency medical services practitioners under the supervision of a physician medical director. (4) Such oversight should also recognize the variety of emergency medical services agencies including governmental, nongovernmental, private, and volunteer emergency medical services agencies. 3. Emergency medical services Part C of the Controlled Substances Act ( 21 U.S.C. 821 et seq. ) is amended by adding at the end the following: 312. Emergency medical services (a) Registration (1) In general For the purpose of enabling emergency medical services practitioners to dispense controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services, the Attorney General shall, at the request of the emergency medical services agency employing such practitioners, register such emergency medical services agency under section 303(f) in lieu of registering the individual practitioners or one or more medical directors of such agency. (2) Single registration In registering an emergency medical services agency pursuant to paragraph (1), the Attorney General shall require a single registration per State, not a separate registration for each location of the emergency medical services agency. (b) Medical oversight Notwithstanding section 309: (1) A registrant emergency medical services agency shall have one or more medical directors responsible for medical oversight of the agency’s provision of emergency medical services. (2) Controlled substances in schedule II, III, IV, or V may be administered by the emergency medical services practitioners of a registrant emergency medical services agency in the course of providing emergency medical services pursuant to a standing order issued by one or more medical directors of such agency. A registrant emergency medical services agency shall keep any such standing order on file and make such standing order available to the Attorney General upon the Attorney General’s request. (3) In the case of administering a controlled substance pursuant to paragraph (2), the medical directors of the registrant emergency medical services agency shall not be required— (A) to be present; or (B) to provide a written or oral prescription with regard to a known individual before or at the time of such administering. (c) Receipt, movement, and storage of controlled substances (1) Receipt The registrant emergency medical services agency— (A) may receive controlled substances at any location of the agency designated by the agency for such receipt; and (B) may not receive controlled substances at any location not so designated. (2) Movement and delivery The registrant emergency medical services agency may move or deliver controlled substances within the possession of such agency between any locations of such agency. A registrant emergency medical services agency shall not be treated as a distributor of controlled substances under this Act by reason of such movement or distribution. (3) Storage Such agency— (A) may store controlled substances at any location of the agency designated by the agency for such storage; and (B) may not store controlled substances at any location not so designated. (d) Definitions In this section: (1) The term emergency medical services means emergency medical response, and emergency mobile medical services, provided outside of a medical facility. (2) The term emergency medical services agency means an organization providing emergency medical services, including such organizations that— (A) are governmental (including fire-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based; and (B) provide emergency medical services by ground, air, or otherwise. (3) The term emergency medical services practitioner means a health care practitioner (including nurse, paramedic, or emergency medical technician) licensed or certified by a State and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services to individuals within the scope of the practitioner’s State license or certification. (4) The term medical director means a physician providing medical oversight for an emergency medical services agency. (5) The term medical oversight means supervision of medical operations of an emergency medical services agency. (6) The term standing order means a written medical protocol in which a medical director prescribes in advance the medical criteria to be followed by emergency medical services practitioners in administering controlled substances to individuals in need of emergency medical services. .