,,ii #aaeth ,,congress #ast ,session ,s4 #iaf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bd1 #bjag,mr4 ,cassidy 7for himself1 ,mr4 ,bennet1 ,mr4 ,blunt1 and ,mr4 ,franken7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,controlled ,substances ,act with regard to the provision of emergency medical services4 #a4 ,short title ,this ,act may be cited as the ,protecting ,patient ,access to ,emergency ,medications ,act of #bjag4 #b4 ,emergency medical services ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended-- 7#a7 by redesignating subsection 7j7 as subsection 7k72 and 7#b7 by inserting after subsection 7i7 the following3 7j7 ,emergency medical services that administer controlled substances 7#a7 ,registration ,for the purpose of enabling emergency medical services professionals to administer controlled substances in schedule ,,ii1 ,,iii1 ,,iv1 or ,v to ultimate users receiving emergency medical services in accordance with the requirements of this subsection1 the ,attorney ,general-- 7,a7 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 practices2 and 7,b7 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 7f74 7#b7 ,option for single registration ,in registering an emergency medical services agency pursuant to paragraph 7#a71 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 agency4 7#c7 ,hospital-based agency ,if a hospital-based emergency medical services agency is registered under subsection 7f71 the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection4 7#d7 ,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 ,,ii1 ,,iii1 ,,iv1 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-- 7,a7 authorized by the law of the ,state in which it occurs2 and 7,b7 pursuant to-- 7i7 a standing order that is issued and adopted by one or more medical directors of the agency1 including any such order that may be developed by a specific ,state authority2 or 7ii7 a verbal order that is-- 7,i7 issued in accordance with a policy of the agency2 and 7,,ii7 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-- 7aa7 in the case of a mass casualty incident2 or 7bb7 to ensure the proper care and treatment of a specific patient4 7#e7 ,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-- 7,a7 the agency designates the unregistered location for such delivery2 and 7,b7 notifies the ,attorney ,general at least #cj days prior to first delivering controlled substances to the unregistered location4 7#f7 ,storage ,a registered emergency medical services agency may store controlled substances-- 7,a7 at a registered location of the agency2 7,b7 at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency2 or 7,c7 in an emergency medical services vehicle used by the agency that is-- 7i7 traveling from1 or returning to1 a registered or designated location of the agency in the course of responding to an emergency2 or 7ii7 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 ,general4 7#g7 ,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 #cjh4 7#h7 ,restocking of emergency medical services vehicles at a hospital ,notwithstanding paragraph 7#ac77;,j71 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 response1 and without being subject to the requirements of section #cjh1 provided all of the following conditions are satisfied3 7,a7 ,the registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph 7#i74 7,b7 ,the hospital maintains a record of such delivery to the agency in accordance with section #cjg4 7,c7 ,if the vehicle is primarily situated at a designated location1 such location notifies the registered location of the agency within #gb hours of the vehicle receiving the controlled substances4 7#i7 ,maintenance of records 7,a7 ,in general ,a registered emergency medical services agency shall maintain records in accordance with subsections 7a7 and 7b7 of section #cjg of all controlled substances that are received1 administered1 or otherwise disposed of pursuant to the agency's registration1 without regard to subsection #cjg7;c77#a77;,b74 7,b7 ,requirements ,such records-- 7i7 shall include records of deliveries of controlled substances between all locations of the agency2 and 7ii7 shall be maintained1 whether electronically or otherwise1 at each registered and designated location of the agency where the controlled substances involved are received1 administered1 or otherwise disposed of4 7#aj7 ,other requirements ,a registered emergency medical services agency1 under the supervision of a medical director1 shall be responsible for ensuring that-- 7,a7 all emergency medical services professionals who administer controlled substances using the agency's registration act in accordance with the requirements of this subsection2 7,b7 the recordkeeping requirements of paragraph 7#i7 are met with respect to a registered location and each designated location of the agency2 7,c7 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 7#f72 and 7,d7 the agency maintains1 at a registered location of the agency1 a record of the standing orders issued or adopted in accordance with paragraph 7#i74 7#aa7 ,regulations ,the ,attorney ,general may issue regulations-- 7,a7 specifying1 with regard to delivery of controlled substances under paragraph 7#e7-- 7i7 the types of locations that may be designated under such paragraph2 and 7ii7 the manner in which a notification under paragraph 7#e77;,b7 must be made2 7,b7 specifying1 with regard to the storage of controlled substances under paragraph 7#f71 the manner in which such substances must be stored at registered and designated locations1 including in emergency medical service vehicles2 and 7,c7 addressing the ability of hospitals1 emergency medical services agencies1 registered locations1 and designated locations to deliver controlled substances to each other in the event of-- 7i7 shortages of such substances2 7ii7 a public health emergency2 or 7iii7 a mass casualty event4 7#ab7 ,rule of construction ,nothing in this subsection shall be construed-- 7,a7 to limit the authority vested in the ,attorney ,general by other provisions of this title to take measures to prevent diversion of controlled substances2 or 7,b7 to override the authority of any ,state to regulate the provision of emergency medical services consistent with this subsection4 7#ac7 ,definitions ,in this section3 7,a7 ,the term authorizing medical professional means an emergency or other physician1 or another medical professional 7including an advanced practice registered nurse or physician assistant7 who is-- 7i7 registered under this ,act2 7ii7 acting within the scope of the registration2 and 7iii7 whose scope of practice under a ,state license or certification includes the ability to provide verbal orders4 7,b7 ,the term designated location means a location designated by an emergency medical services agency under paragraph 7#e74 7,c7 ,the term emergency medical services means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility4 7,d7 ,the term emergency medical services agency means an organization providing emergency medical services1 including such an organization that-- 7i7 is governmental 7including fire-based and hospital-based agencies71 nongovernmental 7including hospital-based agencies71 private1 or volunteer-based2 7ii7 provides emergency medical services by ground1 air1 or otherwise2 and 7iii7 is authorized by the ,state in which the organization is providing such services to provide emergency medical care1 including the administering of controlled substances1 to members of the general public on an emergency basis4 7,e7 ,the term emergency medical services professional means a health care professional 7including a nurse1 paramedic1 or emergency medical technician7 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 certification4 7,f7 ,the term emergency medical services vehicle means an ambulance1 fire apparatus1 supervisor truck1 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 locations4 7,g7 ,the term hospital-based means1 with respect to an agency1 owned or operated by a hospital4 7,h7 ,the term medical director means a physician who is registered under subsection 7f7 and provides medical oversight for an emergency medical services agency4 7,i7 ,the term medical oversight means supervision of the provision of medical care by an emergency medical services agency4 7,j7 ,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 7f71 which shall be where the agency receives controlled substances from distributors4 7,k7 ,the term registered emergency medical services agency means-- 7i7 an emergency medical services agency that is registered pursuant to this subsection2 or 7ii7 a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection 7f74 7,l7 ,the term specific ,state authority means a governmental agency or other such authority1 including a regional oversight and coordinating body1 that1 pursuant to ,state law or regulation1 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 directors4 7,m7 ,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 services4 7,n7 ,the term verbal order means an oral directive that is given through any method of communication including by radio or telephone1 directly to an emergency medical services professional1 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 professional4 4 #c4 ,delivery of a controlled substance by a pharmacy to an administering practitioner 7a7 ,in general ,the ,controlled ,substance ,act is amended by inserting after section #cji 7#ba ,u4,s4,c4 #hbi7 the following3 #cji;,a4 ,delivery of a controlled substance by a pharmacy to an administering practitioner ,notwithstanding section #ajb7aj71 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 ,act1 for the purpose of administering of the controlled substance by the practitioner if-- 7#a7 the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance1 as applicable1 at the location listed on the practitioner's certificate of registration issued under this ,act2 7#b7 7,a7 in the case of administering of the controlled substance for the purpose of maintenance or detoxification treatment under section #cjc7;g77#b7-- 7i7 the practitioner who issued the prescription is a qualifying practitioner authorized under1 and acting within the scope of that section2 and 7ii7 the controlled substance is to be administered by injection1 implantation1 or use of an intrathecal pump2 or 7,b7 in the case of administering of the controlled substance for a purpose other than maintenance or detoxification treatment1 the controlled substance is to be administered by a practitioner through use of an intrathecal pump2 7#c7 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 place2 7#d7 the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients2 7#e7 the controlled substance is to be administered only to the patient named on the prescription not later than #g days1 or longer if extended by the ,attorney ,general1 after the date of receipt of the controlled substance by the practitioner2 and 7#f7 notwithstanding any exceptions under section #cjg1 the prescribing practitioner1 and the practitioner administering the controlled substance1 as applicable1 maintain complete and accurate records of all controlled substances delivered1 received1 administered1 or otherwise disposed of under this section1 including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the ,attorney ,general4 4 7b7 ,technical and conforming amendment ,the table of contents for the ,comprehensive ,drug ,abuse ,prevention and ,control ,act of #aigj is amended by inserting after the item relating to section #cji the following3 ,sec4 #cji;,a4 ,delivery of a controlled substance by a pharmacy to an administering practitioner4 4