Protecting Patient Access to Emergency Medications Act of 2016

Summary: Protecting Patient Access to Emergency Medications Act of 2016 This bill amends the Controlled Substances Act to direct the Drug Enforcement Administration (DEA) to register an emergency medical services (EMS) agency as an entity authorized to dispense controlled substances, instead of registering the individual practitioners or medical directors of the agency. A registered EMS agency must be overseen by one or more medical directors. The bill specifies that an EMS practitioner who is employed by a registered EMS agency may administer controlled substances under a standing order issued by a medical director. The standing order does not have to be specific to an individual patient. An EMS agency must keep the standing order on file and make it available to the DEA upon request. 

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Patient Access to 
Emergency Medications Act of 2016''.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1) the use of controlled substances by emergency medical 
        services agencies to administer medical care and medicines to 
        individuals in the field is essential to save lives, manage 
        pain, and improve health outcomes;
            (2) the unique nature of mobile emergency medical services 
        is unlike other healthcare services governed by the Controlled 
        Substances Act (21 U.S.C. 801 et seq.) in that it requires the 
        provision of time-sensitive and mobile medical care to 
        individuals with critical injuries and illnesses in the field 
        and movement of such individuals to definitive care;
            (3) there have been few investigations by the Drug 
        Enforcement Administration related to diversion in emergency 
        medical services;
            (4) one recent survey of large emergency medical services 
        agencies in the United States showed less than 20 diversions or 
        investigations for nearly 70,000 doses of controlled substances 
        administered;
            (5) regulatory oversight to prevent diversion is essential 
        in all health care settings, including emergency medical 
        services;
            (6) such oversight shall be carefully tailored to recognize 
        unique care delivery models, including the provision of medical 
        care to individuals by emergency medical services practitioners 
        under the supervision of a physician medical director; and
            (7) such oversight should further promote uniformity of 
        rules, application and enforcement to prevent diversion and 
        establish clear guidelines within emergency medical services 
        while also recognizing the variety of emergency medical 
        services agencies including governmental, nongovernmental, 
        private, and volunteer emergency medical services agencies.

SEC. 3. EMERGENCY MEDICAL SERVICES.

    Part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) is 
amended by adding at the end the following:

``SEC. 312. EMERGENCY MEDICAL SERVICES.

    ``(a) Definitions.--In this section--
            ``(1) the term `emergency medical services' means emergency 
        medical response, and emergency mobile medical services, 
        provided outside of a medical facility;
            ``(2) the term `emergency medical services agency' means an 
        organization providing emergency medical services, including an 
        organization that--
                    ``(A) is governmental (including a fire-based 
                agency), nongovernmental (including a hospital-based 
                agency), private, or volunteer-based; and
                    ``(B) provides emergency medical services by 
                ground, air, or otherwise;
            ``(3) the term `emergency medical services practitioner' 
        means a health care practitioner (including a nurse, a 
        paramedic, or an emergency medical technician) licensed or 
        certified by a State and credentialed by a medical director of 
        the respective emergency medical services agency to provide 
        emergency medical services to individuals within the scope of 
        the State license or certification of the practitioner;
            ``(4) the term `medical director' means a physician 
        providing medical oversight for an emergency medical services 
        agency;
            ``(5) the term `medical oversight' means supervision of 
        medical operations of an emergency medical services agency;
            ``(6) the term `standing order' means a written medical 
        protocol in which a medical director prescribes in advance the 
        medical criteria to be followed by emergency medical services 
        practitioners in administering a controlled substance to an 
        individual in need of emergency medical services;
            ``(7) the term `verbal order' means a verbal prescription 
        to be followed by an emergency medical services practitioner in 
        administering a controlled substance to an individual in need 
        of emergency medical services;
            ``(8) the term `online medical direction' means verbal 
        instructions provided by a physician to an emergency medical 
        services practitioner with regard to patient care and 
        treatment, including by radio or telephone; and
            ``(9) the term `registrant emergency medical services 
        agency' means an emergency medical services agency that 
        registers under subsection (b) or a hospital that--
                    ``(A) owns and operates an emergency medical 
                services agency; and
                    ``(B) is registered under its own hospital license.
    ``(b) Registration.--
            ``(1) In general.--For the purpose of enabling emergency 
        medical services practitioners to dispense controlled 
        substances in schedule II, III, IV, or V to ultimate users 
        receiving emergency medical services, the Attorney General 
        shall, at the request of the emergency medical services agency 
        employing such practitioners, register such emergency medical 
        services agency under section 303(f) in lieu of registering the 
        individual practitioners or 1 or more medical directors of such 
        agency.
            ``(2) Single registration.--In registering an emergency 
        medical services agency pursuant to paragraph (1), the Attorney 
        General shall require a single registration per State, not a 
        separate registration for each location of the emergency 
        medical services agency.
            ``(3) Guidance to registrants.--For purposes of providing 
        guidance to registrant emergency medical services agencies, the 
        Attorney General shall tailor such guidance to recognize--
                    ``(A) the existing delivery of medical care and 
                medical oversight to patients with emergency medical 
                conditions; and
                    ``(B) the variety of emergency medical service care 
                delivery models provided by emergency medical services 
                agencies.
    ``(c) Medical Oversight.--
            ``(1) In general.--Notwithstanding section 309--
                    ``(A) a registrant emergency medical services 
                agency shall have 1 or more medical directors 
                responsible for medical oversight of the provision of 
                emergency medical services by the agency;
                    ``(B) the medical director shall be a physician 
                licensed by the State in which the physician practices 
                medicine and in which the emergency medical services 
                agency is located;
                    ``(C) subject to the authority provided by the 
                State or a political subdivision or other delegated 
                authority of such State, the responsibilities of the 
                medical director may include--
                            ``(i) decisions with regard to 
                        transportation destination of patients;
                            ``(ii) approving all medical protocols, 
                        including standing orders;
                            ``(iii) overseeing patient care delivered 
                        by emergency medical services practitioners of 
                        the emergency medical services agency, 
                        including--
                                    ``(I) the evaluation, treatment, 
                                and interventions of patients;
                                    ``(II) online medical direction; 
                                and
                                    ``(III) establishing drug 
                                formularies and the dispensing and 
                                administering of all medications and 
                                controlled substances to patients;
                            ``(iv) overseeing medical education and 
                        training programs for emergency medical 
                        services practitioners; and
                            ``(v) overseeing quality improvement for 
                        the emergency medical services agency; and
                    ``(D) subject to the authority provided by the 
                State or a political subdivision or other delegated 
                authority of such State, controlled substances in 
                schedule II, III, IV, or V may be administered by the 
                emergency medical services practitioners of a 
                registrant emergency medical services agency in the 
                course of providing emergency medical services pursuant 
                to--
                            ``(i) a standing order issued by 1 or more 
                        medical directors of such agency; or
                            ``(ii) an online medical direction that 
                        includes a verbal order issued by 1 or more 
                        medical directors, or other licensed physician, 
                        in accordance with a policy of such agency 
                        under the following circumstances--
                                    ``(I) the emergency medical 
                                services practitioners request such an 
                                order with regard to a specific patient 
                                and the medical director verbally 
                                provides such an order;
                                    ``(II) the medical director 
                                provides verbal orders upon dispatching 
                                emergency medical services 
                                practitioners responding to an 
                                unanticipated mass casualty incident; 
                                or
                                    ``(III) other specific patient 
                                situations in which the medical 
                                director identifies a need to provide 
                                such an order to ensure proper care and 
                                treatment to patients.
            ``(2) Impermissible limitations on allowable 
        prescriptions.--In the case of administering a controlled 
        substance under paragraph (1), the medical directors of the 
        registrant emergency medical services agency shall not be 
        required--
                    ``(A) to be present; or
                    ``(B) to provide a written or oral prescription 
                with regard to a known individual before or at the time 
                of such administering.
            ``(3) Documentation.--
                    ``(A) In general.--A registrant emergency medical 
                services agency shall keep any such standing order on 
                file and make such standing order available to the 
                Attorney General upon the request of the Attorney 
                General.
                    ``(B) Policy.--A registrant emergency medical 
                services agency shall have a policy requiring 
                practitioners to document in the patient care chart a 
                verbal order was received from online medical direction 
                and a controlled substance was administered. Any such 
                administration of a controlled substance shall be 
                documented in the patient care chart as soon as 
                practicable and available to the Attorney General upon 
                the request of the Attorney General.
    ``(d) Receipt, Movement, and Storage of Controlled Substances.--
            ``(1) Receipt.--The registrant emergency medical services 
        agency--
                    ``(A) may receive controlled substances at any 
                location of the agency designated by the agency for 
                such receipt; and
                    ``(B) may not receive controlled substances at any 
                location not so designated.
            ``(2) Movement and delivery.--The registrant emergency 
        medical services agency may move or deliver controlled 
        substances within the possession of such agency between any 
        locations of such agency. A registrant emergency medical 
        services agency shall not be treated as a distributor of 
        controlled substances under this Act by reason of such movement 
        or distribution.
            ``(3) Storage.--Such agency--
                    ``(A) may store controlled substances at any 
                location of the agency designated by the agency for 
                such storage; and
                    ``(B) may not store controlled substances at any 
                location not so designated.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed to--
            ``(1) alter any requirements under titles XVIII or XIX of 
        the Social Security Act; or
            ``(2) limit the authority vested in the Attorney General to 
        enforce diversion of controlled substances otherwise provided 
        in this Act.''.