PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT OF 2017; Congressional Record Vol. 164, No. 85
(Senate - May 23, 2018)

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[Pages S2882-S2884]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT OF 2017

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 46, S. 916.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The bill clerk read as follows:

       A bill (S. 916) to amend the Controlled Substances Act with 
     regard to the provision of emergency medical services.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof 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--
       ``(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 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:

[[Page S2883]]

       ``(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) who is--
       ``(i) registered under this Act;
       ``(ii) acting within the scope of the registration; and
       ``(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 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 medical 
     director or authorizing medical professional.''.

     SEC. 3. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO 
                   AN ADMINISTERING PRACTITIONER.

       (a) In General.--The Controlled Substance Act is amended by 
     inserting after section 309 (21. U.S.C. 829) the following:

     ``SEC. 309A. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY 
                   TO AN ADMINISTERING PRACTITIONER.

       ``(a) In General.--Notwithstanding section 102(10), a 
     pharmacy may deliver a controlled substance to a practitioner 
     in accordance with a prescription that meets the requirements 
     of this Act and the regulations issued by the Attorney 
     General under this Act, for the purpose of administering of 
     the controlled substance by the practitioner if--
       ``(1) the controlled substance is delivered by the pharmacy 
     to the prescribing practitioner or the practitioner 
     administering the controlled substance, as applicable, at the 
     location listed on the practitioner's certificate of 
     registration issued under this Act;
       ``(2)(A) in the case of administering of the controlled 
     substance for the purpose of maintenance or detoxification 
     treatment under section 303(g)(2)--
       ``(i) the practitioner who issued the prescription is a 
     qualifying practitioner authorized under, and acting within 
     the scope of that section; and
       ``(ii) the controlled substance is to be administered by 
     injection, implantation, or through the use of an intrathecal 
     pump; or
       ``(B) in the case of administering of the controlled 
     substance for a purpose other than maintenance or 
     detoxification treatment, the controlled substance is to be 
     administered by a practitioner through use of an intrathecal 
     pump;
       ``(3) the pharmacy and the practitioner are authorized to 
     conduct the activities specified in this section under the 
     law of the State in which such activities take place;
       ``(4) the prescription is not issued to supply any 
     practitioner with a stock of controlled substances for the 
     purpose of general dispensing to patients;
       ``(5) except as provided in subsection (b), the controlled 
     substance is to be administered only to the patient named on 
     the prescription not later than 14 days after the date of 
     receipt of the controlled substance by the practitioner; and
       ``(6) notwithstanding any exceptions under section 307, the 
     prescribing practitioner, and the practitioner administering 
     the controlled substance, as applicable, maintain complete 
     and accurate records of all controlled substances delivered, 
     received, administered, or otherwise disposed of under this 
     section, including the persons to whom controlled substances 
     were delivered and such other information as may be required 
     by regulations of the Attorney General.
       ``(b) Modification of Number of Days Before Which 
     Controlled Substance Shall Be Administered.--
       ``(1) Initial 2-year period.--During the 2-year period 
     beginning on the date of enactment of this section, the 
     Attorney General, in coordination with the Secretary, may 
     reduce the number of days described in subsection (a)(5) if 
     the Attorney General determines that such reduction will--
       ``(A) reduce the risk of diversion; or
       ``(B) protect the public health.
       ``(2) Modifications after submission of report.--After the 
     date on which the report described in subsection (c) is 
     submitted, the Attorney General, in coordination with the 
     Secretary, may modify the number of days described in 
     subsection (a)(5).
       ``(3) Minimum number of days.--Any modification under this 
     subsection shall be for a period of not less than 7 days.
       ``(c) Study and Report.--Not later than 2 years after the 
     date of enactment of this section,

[[Page S2884]]

     the Comptroller General of the United States shall conduct a 
     study and submit to Congress a report on access to and 
     potential diversion of controlled substances administered by 
     injection, implantation, or through the use of an intrathecal 
     pump.''.
       (b) Technical and Conforming Amendment.--The table of 
     contents for the Comprehensive Drug Abuse Prevention and 
     Control Act of 1970 is amended by inserting after the item 
     relating to section 309 the following:

``Sec. 309A. Delivery of a controlled substance by a pharmacy to an 
              administering practitioner.''.

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the 
committee-reported substitute amendment be withdrawn, the Cassidy 
substitute amendment at the desk be agreed to, the bill, as amended, be 
considered read a third time and passed, the Cassidy title amendment be 
agreed to, and the motions to reconsider be considered made and laid 
upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee-reported amendment in the nature of a substitute was 
withdrawn.
  The amendment (No. 2267) in the nature of a substitute was agreed to, 
as follows:

                (Purpose: In the nature of a substitute)

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Ensuring Patient Access to 
     Substance Use Disorder Treatments Act of 2018''.

     SEC. 2. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO 
                   BE ADMINISTERED BY INJECTION OR IMPLANTATION.

       (a) In General.--The Controlled Substances Act is amended 
     by inserting after section 309 (21 U.S.C. 829) the following:


``delivery of a controlled substance by a pharmacy to an administering 
                              practitioner

       ``Sec. 309A.  (a) In General.--Notwithstanding section 
     102(10), a pharmacy may deliver a controlled substance to a 
     practitioner in accordance with a prescription that meets the 
     requirements of this title and the regulations issued by the 
     Attorney General under this title, for the purpose of 
     administering of the controlled substance by the practitioner 
     if--
       ``(1) the controlled substance is delivered by the pharmacy 
     to the prescribing practitioner or the practitioner 
     administering the controlled substance, as applicable, at the 
     location listed on the practitioner's certificate of 
     registration issued under this title;
       ``(2) in the case of administering of the controlled 
     substance for the purpose of maintenance or detoxification 
     treatment under section 303(g)(2)--
       ``(A) the practitioner who issued the prescription is a 
     qualifying practitioner authorized under, and acting within 
     the scope of that section; and
       ``(B) the controlled substance is to be administered by 
     injection or implantation;
       ``(3) the pharmacy and the practitioner are authorized to 
     conduct the activities specified in this section under the 
     law of the State in which such activities take place;
       ``(4) the prescription is not issued to supply any 
     practitioner with a stock of controlled substances for the 
     purpose of general dispensing to patients;
       ``(5) except as provided in subsection (b), the controlled 
     substance is to be administered only to the patient named on 
     the prescription not later than 14 days after the date of 
     receipt of the controlled substance by the practitioner; and
       ``(6) notwithstanding any exceptions under section 307, the 
     prescribing practitioner, and the practitioner administering 
     the controlled substance, as applicable, maintain complete 
     and accurate records of all controlled substances delivered, 
     received, administered, or otherwise disposed of under this 
     section, including the persons to whom controlled substances 
     were delivered and such other information as may be required 
     by regulations of the Attorney General.
       ``(b) Modification of Number of Days Before Which 
     Controlled Substance Shall Be Administered.--
       ``(1) Initial 2-year period.--During the 2-year period 
     beginning on the date of enactment of this section, the 
     Attorney General, in coordination with the Secretary, may 
     reduce the number of days described in subsection (a)(5) if 
     the Attorney General determines that such reduction will--
       ``(A) reduce the risk of diversion; or
       ``(B) protect the public health.
       ``(2) Modifications after submission of report.--After the 
     date on which the report described in subsection (c) is 
     submitted, the Attorney General, in coordination with the 
     Secretary, may modify the number of days described in 
     subsection (a)(5).
       ``(3) Minimum number of days.--Any modification under this 
     subsection shall be for a period of not less than 7 days.''.
       (b) Study and Report.--Not later than 2 years after the 
     date of enactment of this section, the Comptroller General of 
     the United States shall conduct a study and submit to 
     Congress a report on access to and potential diversion of 
     controlled substances administered by injection or 
     implantation.
       (c) Technical and Conforming Amendment.--The table of 
     contents for the Comprehensive Drug Abuse Prevention and 
     Control Act of 1970 is amended by inserting after the item 
     relating to section 309 the following:

``Sec. 309A. Delivery of a controlled substance by a pharmacy to an 
              administering practitioner.''.

  The bill (S. 916), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.
  The amendment (No. 2268) was agreed to, as follows:

                     (Purpose: To amend the title)

       Amend the title so as to read: ``To amend the Controlled 
     Substances Act to provide for the delivery of a controlled 
     substance by a pharmacy to an administering practitioner.''.

                          ____________________