[Congressional Record Volume 163, Number 5 (Monday, January 9, 2017)]
[House]
[Pages H206-H208]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT OF 2017
Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 304) to amend the Controlled Substances Act with regard to
the provision of emergency medical services.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 304
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 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;
``(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 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, 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
[[Page H207]]
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.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Texas (Mr. Burgess) and the gentleman from Texas (Mr. Gene Green) each
will control 20 minutes.
The Chair recognizes the gentleman from Texas (Mr. Burgess).
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
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 yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 304, the Protecting
Patient Access to Emergency Medications Act, introduced by the
gentlemen from North Carolina, Mr. Hudson and Mr. Butterfield.
H.R. 304 would update the Drug Enforcement Administration
registration process for emergency medical services agencies with
multiple locations, clarifying recordkeeping requirements related to
the transportation and storage of controlled substances in the process.
Further, the bill would ensure that paramedics and other EMS
professionals are able to continue to administer pain and antiseizure
medications in emergency situations pursuant to standing or verbal
orders when certain conditions are met.
This commonsense measure is supported by over a dozen EMS and trauma
care organizations.
Mr. Speaker, I urge my colleagues to vote ``yes'' on H.R. 304, and I
reserve the balance of my time.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume.
I rise in support of H.R. 304, the Protecting Patient Access to
Emergency Medications Act of 2017.
Ensuring that we have access to the right medicine at the right time
is critically important in emergency situations. While controlled
substances have abuse and diversion potential, they also have
lifesaving potential. In fact, they are very often used by emergency
medical services--EMS--providers in situations where every minute
counts.
Currently, these providers must often administer controlled
substances during emergencies using a standing order. However, it is
unclear whether or not this is permissible under current law.
To help clarify the current law, H.R. 304 would amend the Controlled
Substances Act to make clear that EMS personnel can, in fact,
administer controlled substances in emergency situations under a
standing order from an EMS medical director.
This bill helps guarantee that patients will have timely access to
drugs they need during an emergency. It will also streamline the DEA's
emergency medical services registration process by allowing a single
registration for a State EMS agency as opposed to a separate
registration for each EMS agency location.
To help safeguard against diversion, the bill will hold registered
EMS agencies responsible for receiving, storing, and tracking all
controlled substances.
This bill passed the Energy and Commerce Committee and the House
floor last Congress, and it incorporates important feedback from a wide
range of stakeholders. I believe our efforts in this important bill
will ensure that EMS professionals have the flexibility that they need
to respond during emergencies, while preserving the DEA's ability to
enforce controlled substances laws and regulations.
I urge my colleagues to join me in supporting the passage of H.R.
304.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 4 minutes to the gentleman from
Oregon (Mr. Walden), the chairman of the full Committee on Energy and
Commerce.
Mr. WALDEN. Mr. Speaker, I thank my colleagues on the Energy and
Commerce Committee for this important piece of legislation, H.R. 304,
the Protecting Patient Access to Emergency Medications Act.
This is a bipartisan bill. It was introduced by two of our colleagues
from North Carolina, Representatives Hudson and Butterfield. It
previously passed the House by voice vote, no objection, back in
November; but, unfortunately, it was not taken up by the Senate before
the last Congress adjourned, meaning we have to be here today to
restart this process.
This, along with three other Energy and Commerce bills that we are
considering today, shows that the Energy and Commerce Committee is
picking right up where we left off, in a bipartisan way, to produce
quality legislation that will improve the public health.
Now, H.R. 304 is really an important bill because it enables our
Nation's emergency medical services professionals to continue to
provide quality emergency care by recognizing the unique nature of
their practice.
Specifically, as you may have heard, the bill clarifies that
paramedics and other EMS professionals can administer certain pain and
antiseizure medications in emergency situations pursuant to standing or
verbal orders. In other words, the doctor has said to the EMS person,
you can do these things in emergencies.
Now, think about this. You are in a car wreck. The EMT shows up in
the ambulance. They can't communicate with anybody because they are
down in a valley or somewhere where they don't have communication.
Without this legislation, it is uncertain now, because of this ruling
out of the administration, whether or not they can give you antiseizure
medication or pain relief medication until they can get in contact.
This is not what any of us wants, so this legislation fixes that.
During this process, when this decision was made a while back, I
heard from Dr. Paul Rostykus, an emergency physician in Jackson County,
Oregon. He said that this is really critical to saving lives and
reducing suffering, particularly in our remote and rural areas where
these emergency technicians, EMTs, may struggle to call in emergencies
and it can take much longer for patients to reach the nearest doctor.
I just implore you to talk to anybody that is running around the
ambulances, and they will tell you this is really, really important for
patients.
I had an ambulance driver tell me--an EMT tell me it is important for
them because sometimes in an accident, somebody is injured and they are
kind of out of control and have a seizure. Now, I am not a doctor. We
actually have one here who can tell us
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more. But they then are able to administer certain medications that
will calm the patient, prevent them from hurting themselves or hurting
the EMT.
So I urge my colleagues to support H.R. 304 as well as the other
bipartisan Energy and Commerce bills that are on the floor today.
Mr. Speaker, I call on my colleagues to pass these important bills.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume. I thank Congressman Hudson and Congressman Butterfield,
both great members of our committee on this very bipartisan bill.
I yield back the balance of my time.
Mr. BURGESS. Mr. Speaker, I urge my colleagues to vote ``yes'' on
H.R. 304, and 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. 304.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. BURGESS. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this motion will be postponed.
____________________