[Congressional Record Volume 163, Number 171 (Tuesday, October 24, 2017)]
[Senate]
[Pages S6771-S6772]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 1577. Mr. McCONNELL (for Mr. Cassidy (for himself, Mr. Bennet, Mr.
Blunt, and Mr. Franken)) proposed an amendment to the bill H.R. 304, to
amend the Controlled Substances Act with regard to the provision of
emergency medical services; as follows:
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
``(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
[[Page S6772]]
``(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.''.
______