Protecting Patient Access to Emergency Medications Act of 2016

Bill: 114-hr-4365
Sponsor: full_name: Rep. Hudson, Richard [R-NC-8]
Introduced: 2016-01-12
Policy area: Health
Subjects: Drug trafficking and controlled substances

Emergency medical services and trauma care

Health information and medical records

Health personnel

Licensing and registrations
Latest action: action_date: 2016-11-15
text: Received in the Senate.

Summaries:
action_date: 2016-01-12
action_desc: Introduced in House
text: <p><b>Protecting Patient Access to Emergency Medications Act of 2016</b></p> <p>This bill amends the Controlled Substances Act to direct the Drug Enforcement Administration to register an emergency medical services (EMS) agency as an entity authorized to dispense controlled substances, instead of registering the individual practitioners or medical directors of the agency.</p> <p>A registered EMS agency must be overseen by one or more medical directors.</p> <p>The bill specifies that an EMS practitioner who is employed by a registered EMS agency may administer controlled substances under a standing order issued by a medical director. The standing order does not have to be specific to an individual patient.</p>

action_date: 2016-11-14
action_desc: Passed House amended
text: <p><b>Protecting Patient Access to Emergency Medications Act of 2016</b></p> <p>(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.</p> <p>An EMS agency may obtain a single registration in each state instead of a separate registration for each location.</p> <p>A registered EMS agency may deliver, store, and receive controlled substances, subject to specified conditions.</p> <p>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.</p> <p>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.</p> <p>

tv_txt: 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. .

tv_txt: IB Union Calendar No. 628 114th CONGRESS 2d Session H. R. 4365 [Report No. 114–804, Part I] 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 November 14, 2016 Additional sponsors: Mr. Blumenauer , Ms. Jenkins of Kansas , Mr. Peterson , Mr. Fitzpatrick , Mr. Harris , Mr. Schrader , Mr. David Scott of Georgia , Ms. Michelle Lujan Grisham of New Mexico , Mr. Ashford , Mr. Burgess , Mr. Long , Mrs. Brooks of Indiana , Mr. Kind , Mr. Cartwright , Mr. Bilirakis , Mr. Smith of Texas , Mr. Pocan , Mr. Sensenbrenner , Mr. Tipton , Mr. Young of Alaska , Mr. Zinke , Ms. Gabbard , Mr. Brendan F. Boyle of Pennsylvania , Mr. Walden , Mr. Westmoreland , Mr. Diaz-Balart , Ms. Eshoo , Mr. Langevin , Mr. Collins of New York , Mr. Abraham , Mr. Walz , Mr. Cramer , Mr. Clawson of Florida , Ms. Frankel of Florida , Mr. Nugent , Mr. Duncan of Tennessee , Mr. Graves of Missouri , Mr. Yoder , Mr. Luetkemeyer , Mr. DesJarlais , Mr. Mullin , Mr. Garrett , Mr. Roe of Tennessee , Mr. Blum , Mr. Culberson , Mr. DeFazio , Mr. Boustany , Ms. Pingree , Mrs. Blackburn , Mr. Fleming , Ms. Moore , Mr. Williams , Mrs. Kirkpatrick , Mr. Huelskamp , Mr. Allen , Mr. Lucas , Mr. Young of Iowa , Mr. Pompeo , Mr. Smith of Washington , Mr. Emmer of Minnesota , Ms. Bonamici , Mr. Costello of Pennsylvania , Mr. Rouzer , Mr. Joyce , Mr. Graves of Louisiana , Mr. Wenstrup , Mr. Bucshon , Mr. Graves of Georgia , Ms. Schakowsky , Mr. Jolly , Mr. Van Hollen , Mr. Beyer , Mr. Rigell , Mr. Brooks of Alabama , Mr. Marchant , Mr. Conyers , Mr. Barr , Mr. Lance , Mr. Roskam , Mrs. McMorris Rodgers , Mr. Carter of Texas , Mr. Forbes , Mrs. Wagner , Mr. Ted Lieu of California , Mr. Cummings , Mrs. Walorski , Ms. DelBene , Mr. Walberg , Mr. McCaul , Mr. Kilmer , Ms. Brownley of California , Mr. Dold , Mr. Donovan , Mr. Welch , Mr. Guinta , Mr. Richmond , Ms. Granger , Mr. Pittenger , Mr. Ellison , Ms. Herrera Beutler , Mr. Renacci , Mr. Labrador , Mr. Rogers of Kentucky , Mr. Paulsen , Mr. Babin , Mr. Stivers , Mr. Smith of Missouri , Ms. Castor of Florida , Mr. Bishop of Michigan , Ms. Graham , Mr. Gosar , Mr. McHenry , Mr. Rothfus , Mr. Duncan of South Carolina , Mrs. Beatty , Mr. Guthrie , Mrs. Noem , Mr. Brady of Pennsylvania , Ms. Hahn , Mrs. Ellmers of North Carolina , Mr. Stewart , Mr. Dent , Mrs. Bustos , Mr. Courtney , Mr. Lipinski , Miss Rice of New York , Mr. Schweikert , and Ms. McSally November 14, 2016 Reported from the Committee on Energy and Commerce with an amendment Strike out all after the enacting clause and insert the part printed in italic November 14, 2016 The Committee on the Judiciary discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed For text of introduced bill, see copy of bill as introduced on January 12, 2016 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. Emergency medical services Section 303 of the Controlled Substances Act ( 21 U.S.C. 821 et seq. ) 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 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 means a location designated by an emergency medical services agency under paragraph (5). (B) The term emergency medical services means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. (C) 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. (D) 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. (E) The term emergency medical services vehicle means an ambulance, fire apparatus, supervisor truck, or other vehicle owned or operated 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. (F) The term hospital-based means, with respect to an agency, owned or operated by a hospital. (G) The term medical director means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. (H) The term medical oversight means supervision of the provision of medical care by an emergency medical services agency. (I) The term medical professional means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant) whose scope of practice under a State license or certification includes the ability to provide verbal orders. (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 registrant 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 authorizing medical director. .

November 14, 2016 Reported from the Committee on Energy and Commerce with an amendment November 14, 2016 The Committee on the Judiciary discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: I 114th CONGRESS 2d Session H. R. 4365 IN THE HOUSE OF REPRESENTATIVES AN ACT 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. ) 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; (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 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. (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 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 means a location designated by an emergency medical services agency under paragraph (5). (B) The term emergency medical services means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. (C) 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. (D) 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. (E) 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. (F) The term hospital-based means, with respect to an agency, owned or operated by a hospital. (G) The term medical director means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. (H) The term medical oversight means supervision of the provision of medical care by an emergency medical services agency. (I) The term medical professional means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant) whose scope of practice under a State license or certification includes the ability to provide verbal orders. (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 authorizing medical director. .

Passed the House of Representatives November 14, 2016. Karen L. Haas, Clerk.

tv_txt: II 114th CONGRESS 2d Session H. R. 4365 IN THE SENATE OF THE UNITED STATES November 15, 2016 Received AN ACT 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. ) 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; (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 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. (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 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 means a location designated by an emergency medical services agency under paragraph (5). (B) The term emergency medical services means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. (C) 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. (D) 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. (E) 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. (F) The term hospital-based means, with respect to an agency, owned or operated by a hospital. (G) The term medical director means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. (H) The term medical oversight means supervision of the provision of medical care by an emergency medical services agency. (I) The term medical professional means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant) whose scope of practice under a State license or certification includes the ability to provide verbal orders. (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 authorizing medical director. .

Passed the House of Representatives November 14, 2016. Karen L. Haas, Clerk