II Calendar No. 46 115th CONGRESS 1st Session S. 916 IN THE SENATE OF THE UNITED STATES April 24, 2017 Mr. Cassidy (for himself, Mr. Bennet , Mr. Blunt , Mr. Franken , Mr. Alexander , Ms. Murkowski , and Mrs. Murray ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions May 1, 2017 Reported by Mr. Alexander , with an amendment Strike out all after the enacting clause and insert the part printed in italic 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 2017 . 2. Emergency medical services Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended— (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 registered 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 issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or (ii) a verbal order that is— (I) issued in accordance with a policy of the agency; and (II) provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient— (aa) in the case of a mass casualty incident; or (bb) to ensure the proper care and treatment of a specific patient. (5) Delivery A registered 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 registered 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 under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General. (7) No treatment as distribution The delivery of controlled substances by a registered 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 registered 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 registered 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 registered 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 be 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, emergency medical services agencies, 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 consistent with this subsection. (13) Definitions In this section: (A) The term authorizing medical professional means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant) who is— (i) registered under this Act; (ii) acting within the scope of the registration; and (iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders. (B) The term designated location means a location designated by an emergency medical services agency under paragraph (5). (C) The term emergency medical services means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. (D) The term emergency medical services agency means an organization providing emergency medical services, including such an organization that— (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. (E) The term emergency medical services professional means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional’s State license or certification. (F) The term emergency medical services vehicle means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations. (G) The term hospital-based means, with respect to an agency, owned or operated by a hospital. (H) The term medical director means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. (I) The term medical oversight means supervision of the provision of medical care by an emergency medical services agency. (J) The term registered location means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (f), which shall be where the agency receives controlled substances from distributors. (K) The term registered emergency medical services agency means— (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 means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors. (M) The term standing order means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services. (N) The term verbal order means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional. . 3. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general The Controlled Substance Act is amended by inserting after section 309 ( 21 U.S.C. 829 ) the following: 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this Act and the regulations issued by the Attorney General under this Act, for the purpose of administering of the controlled substance by the practitioner if— (1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this Act; (2) (A) in the case of administering of the controlled substance for the purpose of maintenance or detoxification treatment under section 303(g)(2)— (i) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and (ii) the controlled substance is to be administered by injection, implantation, or use of an intrathecal pump; or (B) in the case of administering of the controlled substance for a purpose other than maintenance or detoxification treatment, the controlled substance is to be administered by a practitioner through use of an intrathecal pump; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) the controlled substance is to be administered only to the patient named on the prescription not later than 7 days, or longer if extended by the Attorney General, after the date of receipt of the controlled substance by the practitioner; and (6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General. . (b) Technical and conforming amendment The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following: Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner. .

1. Short title This Act may be cited as the Protecting Patient Access to Emergency Medications Act of 2017 . 2. Emergency medical services Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended— (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 registered 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 issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or (ii) a verbal order that is— (I) issued in accordance with a policy of the agency; and (II) provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient— (aa) in the case of a mass casualty incident; or (bb) to ensure the proper care and treatment of a specific patient. (5) Delivery A registered 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 registered 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 under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General. (7) No treatment as distribution The delivery of controlled substances by a registered 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 registered 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 registered 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 registered 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 be 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, emergency medical services agencies, 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 consistent with this subsection. (13) Definitions In this section: (A) The term authorizing medical professional means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant) who is— (i) registered under this Act; (ii) acting within the scope of the registration; and (iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders. (B) The term designated location means a location designated by an emergency medical services agency under paragraph (5). (C) The term emergency medical services means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. (D) The term emergency medical services agency means an organization providing emergency medical services, including such an organization that— (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. (E) The term emergency medical services professional means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional’s State license or certification. (F) The term emergency medical services vehicle means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations. (G) The term hospital-based means, with respect to an agency, owned or operated by a hospital. (H) The term medical director means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. (I) The term medical oversight means supervision of the provision of medical care by an emergency medical services agency. (J) The term registered location means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (f), which shall be where the agency receives controlled substances from distributors. (K) The term registered emergency medical services agency means— (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 means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors. (M) The term standing order means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services. (N) The term verbal order means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional. . 3. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general The Controlled Substance Act is amended by inserting after section 309 (21. U.S.C. 829) the following: 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this Act and the regulations issued by the Attorney General under this Act, for the purpose of administering of the controlled substance by the practitioner if— (1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this Act; (2) (A) in the case of administering of the controlled substance for the purpose of maintenance or detoxification treatment under section 303(g)(2)— (i) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and (ii) the controlled substance is to be administered by injection, implantation, or through the use of an intrathecal pump; or (B) in the case of administering of the controlled substance for a purpose other than maintenance or detoxification treatment, the controlled substance is to be administered by a practitioner through use of an intrathecal pump; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and (6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General. (b) Modification of number of days before which controlled substance shall be administered (1) Initial 2-year period During the 2-year period beginning on the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will— (A) reduce the risk of diversion; or (B) protect the public health. (2) Modifications after submission of report After the date on which the report described in subsection (c) is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5). (3) Minimum number of days Any modification under this subsection shall be for a period of not less than 7 days. (c) Study and report Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection, implantation, or through the use of an intrathecal pump. . (b) Technical and conforming amendment The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following: Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner. .

May 1, 2017 Reported with an amendment