[Congressional Record Volume 163, Number 178 (Thursday, November 2, 2017)]
[House]
[Pages H8421-H8422]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT OF 2017

  Mr. HUDSON. Mr. Speaker, I ask unanimous consent to take from the 
Speaker's table the bill (H.R. 304) to amend the Controlled Substances 
Act with regard to the provision of emergency medical services, with 
the Senate amendment thereto, and concur in the Senate amendment.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore (Mr. Hultgren). The Clerk will report the 
Senate amendment.
  The Clerk read as follows:
  Senate amendment:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Protecting Patient Access to 
     Emergency Medications Act of 2017''.

     SEC. 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 the agency--
       ``(A) 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

[[Page H8422]]

       ``(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)--
       ``(i) who is registered under this Act;
       ``(ii) who is 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 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).
       ``(K) 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.
       ``(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.''.

  Mr. HUDSON (during the reading). Mr. Speaker, I ask unanimous consent 
that the Senate amendment be considered as read.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from North Carolina?
  There was no objection.
  The SPEAKER pro tempore. Is there objection to the original request 
of the gentleman from North Carolina?
  There was no objection.
  A motion to reconsider was laid on the table.

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