[Congressional Record (Bound Edition), Volume 162 (2016), Part 10]
[House]
[Pages 14100-14103]
[From the U.S. 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 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

[[Page 14101]]

     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 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.

[[Page 14102]]

  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.
  Ms. JACKSON LEE. Mr. Speaker, I rise to express my strong support for 
H.R. 4365 the bipartisan ``Protecting Patient Access to Emergency 
Medications Act of 2016.''
  H.R. 4365 would authorize a medical director, physician, and 
physician assistant or advanced practice registered nurse to authorize 
Emergency Medical Service, EMS, personnel to dispense controlled 
substances such seizure medications, narcotic painkillers and other 
controlled substances under an order from a registered doctor or 
agency.
  This bipartisan bill was passed by both the House Committee on Energy 
and Commerce and its Subcommittee on Health, each by unanimous consent.
  I support this bipartisan bill because it provides a vital solution 
for our emergency management personnel to provide lifesaving care to 
those requiring unique medical attention, such as in cases substance 
abuse overdose.
  Under this bill the Justice Department would be directed to approve 
the registration of qualified EMS agencies under the Controlled 
Substances Act and is empowered to deny registration based on an 
applicant's conviction record and other factors that could affect 
public health and safety.
  The bill authorizes emergency service providers to store substances 
in ambulances and other EMS vehicles and partner with local hospitals 
to restock medications and supplies.
  Each emergency services provider would be responsible for complying 
with requirements including recordkeeping and physical security.
  In Houston, Texas in 2015 alone, over 289,907 citizens relied upon 
the critical care emergency services of medical personnel, such as 
nurses, paramedics and technicians.

[[Page 14103]]

  Our EMS personnel throughout the nation must be equipped with every 
tool necessary to provide critical lifesaving measures during patients' 
most dire time of need.
  During the horrific terrorist attacks of September 11th, the 
lifesaving skills of our EMS providers were vital to saving countless 
American lives.
  Mr. Speaker, I support H.R. 4365 the ``Protecting Patient Access to 
Emergency Medications Act of 2016'' because it provides emergency 
medical personnel with a broad range of tools to provide lifesaving 
care to persons in need.
  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.

                          ____________________