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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4365 Engrossed in House (EH)]

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114th CONGRESS
  2d Session
                                H. R. 4365

_______________________________________________________________________

                                 AN ACT

 
To amend the Controlled Substances Act with regard to the provision of 
                      emergency medical services.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Patient Access to 
Emergency Medications Act of 2016''.

SEC. 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.

            Attest:

                                                                 Clerk.
114th CONGRESS

  2d Session

                               H. R. 4365

_______________________________________________________________________

                                 AN ACT

To amend the Controlled Substances Act with regard to the provision of 
                      emergency medical services.
```