[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

[[Page H208]]

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.

                          ____________________