[Congressional Record Volume 162, Number 162 (Monday, November 14, 2016)]
[House]
[Pages H6118-H6120]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT OF 2016
Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 4365) to amend the Controlled Substances Act with regard to
the provision of emergency medical services, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 4365
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
[[Page H6119]]
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 1 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
[[Page H6120]]
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.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Texas (Mr. Burgess) and the gentlewoman from Illinois (Ms. Schakowsky)
each will control 20 minutes.
The Chair recognizes the gentleman from Texas.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
I rise in support of H.R. 4365, the Protecting Patient Access to
Emergency Medications Act, introduced by my colleagues from North
Carolina, Mr. Hudson and Mr. Butterfield.
H.R. 4365 would update the DEA registration process for emergency
medical services agencies with multiple locations, clarifying
recordkeeping requirements related to the transportation and storage of
controlled substances. Further, the bill would ensure that paramedics
and other EMS professionals are able to continue to administer pain and
antiseizure medications in emergency situations that are pursuant to
standing or verbal orders when certain conditions are met.
H.R. 4365 has over 130 cosponsors. It was reported out of the Energy
and Commerce Committee on a voice vote, and it is supported by over a
dozen EMS and trauma care organizations. Mr. Speaker, I urge my
colleagues to vote ``yes'' on H.R. 4365.
I reserve the balance of my time.
Ms. SCHAKOWSKY. Mr. Speaker, I yield myself such time as I may
consume.
I rise in support of H.R. 4365, the Protecting Patient Access to
Emergency Medications Act of 2016.
I thank Mr. Hudson for his leadership, as well as Mr. Butterfield's.
This bill is the result of a bipartisan effort, and it reflects input
from emergency medical services--EMS--professionals, hospitals, and law
enforcement. The bill strikes the right balance of ensuring that EMS
professionals have flexibility when responding to emergency situations
while preserving the Drug Enforcement Agency's ability to effectively
enforce U.S. laws and regulations that govern controlled substances.
H.R. 4365 would amend the Controlled Substances Act to, among other
things, clarify that EMS personnel can administer controlled substances
under a standing order from an EMS medical director who oversees
emergency care. This would codify what is current practice across the
U.S. and would help ensure that patients have access to important drugs
during emergency situations. H.R. 4365 would also streamline the EMS
registration process to allow for a single registration for an EMS
agency in a State rather than requiring each EMS medical director or
EMS agency location to register. In addition, H.R. 4365 makes EMS
agencies responsible for receiving, storing, and tracking controlled
substances to ensure that the DEA can better prevent the diversion or
misuse of controlled substances.
I thank my colleagues Mr. Butterfield and Mr. Hudson for their work
on this important legislation, and I urge all of my colleagues to vote
``yes'' on H.R. 4365.
I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
North Carolina (Mr. Hudson), the primary author of the bill and a
valuable member of the Energy and Commerce Committee.
Mr. HUDSON. Mr. Speaker, I rise to urge my colleagues to support my
bill, H.R. 4365, the Protecting Patient Access to Emergency Medications
Act.
What if your loved one were in a car accident or had a seizure, but
the EMS responder who was trained to help couldn't give him the
medicine he needed? Under current law, this could be a reality. This is
a huge problem, especially in rural communities where access to a
hospital is already a challenge.
That is why I introduced this commonsense bill with my colleague G.K.
Butterfield--to clarify existing law and allow emergency medical
responders to continue administering lifesaving medications. Without
this bill, patients could suffer simply because Washington hasn't kept
up with modern medicine. It is a prime example of government's getting
in the way and of the exact type of problem I came here to fix.
While today's bill may not be flashy, it solves a problem and it
saves lives. It is an example of how to get things done: finding common
ground and advancing bipartisan solutions to the problems that face us.
Congressional action is immediately needed, which is why I urge my
colleagues to support this commonsense legislation.
I thank my colleague and friend, Representative Butterfield, for
working with me on this in a bipartisan way. I also thank Chairman
Burgess, Chairman Upton, and the other leaders of the Energy and
Commerce Committee who have helped us bring this bill to the floor.
Ms. SCHAKOWSKY. Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
Georgia (Mr. Carter).
Mr. CARTER of Georgia. Mr. Speaker, I rise in support of H.R. 4365,
the Protecting Patient Access to Emergency Medications Act of 2016,
which amends the Controlled Substances Act and safeguards the
dispensing of controlled substances by emergency medical services
professionals.
In today's healthcare system, EMS providers often provide the first--
and sometimes only--medical treatment that a patient receives in the
event of an emergency. Due to their unique nature, there is routinely a
clinical need for EMS providers to administer controlled substance
medications in the practice of EMS medicine, ranging from pain
narcotics to epinephrine. This response is critical to providing timely
and lifesaving care, and, oftentimes, patients cannot survive delays in
the delivery of this care.
As the Representative of a rural district, many of my constituents
continue to face the consequences of the Drug Enforcement Agency
regulations that do not take into account the significant differences
between EMS practice and that of other healthcare entities that are
covered by the same regulations. H.R. 4365 would ensure that EMS
personnel can administer these emergency medications in a timely manner
and provide the needed care to patients.
I urge my colleagues to support this legislation.
Ms. SCHAKOWSKY. Mr. Speaker, I thank the sponsors and supporters.
I yield back the balance of my time.
General Leave
Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members
have 5 legislative days in which to revise and extend their remarks and
to insert extraneous materials in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. BURGESS. Mr. Speaker, I thank the sponsors of the bill for
bringing this important legislation to the floor.
I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Texas (Mr. Burgess) that the House suspend the rules and
pass the bill, H.R. 4365, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________