IN THE SENATE OF THE UNITED STATES
May 16, 2016
Mr. Cassidy introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
To amend the Controlled Substances Act with respect to the provision of emergency medical services.
This Act may be cited as the
Protecting Patient Access to Emergency Medications Act of 2016.
The Congress finds that—
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;
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;
there have been few investigations by the Drug Enforcement Administration related to diversion in emergency medical services;
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;
regulatory oversight to prevent diversion is essential in all health care settings, including emergency medical services;
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
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.
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:
Emergency medical services
In this section—
the term emergency medical services means emergency medical response, and emergency mobile medical services, provided outside of a medical facility;
the term emergency medical services agency means an organization providing emergency medical services, including an organization that—
is governmental (including a fire-based agency), nongovernmental (including a hospital-based agency), private, or volunteer-based; and
provides emergency medical services by ground, air, or otherwise;
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;
the term medical director means a physician providing medical oversight for an emergency medical services agency;
the term medical oversight means supervision of medical operations of an emergency medical services agency;
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;
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;
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
the term registrant emergency medical services agency means an emergency medical services agency that registers under subsection (b) or a hospital that—
owns and operates an emergency medical services agency; and
is registered under its own hospital license.
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.
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.
Guidance to registrants
For purposes of providing guidance to registrant emergency medical services agencies, the Attorney General shall tailor such guidance to recognize—
the existing delivery of medical care and medical oversight to patients with emergency medical conditions; and
the variety of emergency medical service care delivery models provided by emergency medical services agencies.
Notwithstanding section 309—
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;
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;
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—
decisions with regard to transportation destination of patients;
approving all medical protocols, including standing orders;
overseeing patient care delivered by emergency medical services practitioners of the emergency medical services agency, including—
the evaluation, treatment, and interventions of patients;
online medical direction; and
establishing drug formularies and the dispensing and administering of all medications and controlled substances to patients;
overseeing medical education and training programs for emergency medical services practitioners; and
overseeing quality improvement for the emergency medical services agency; and
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—
a standing order issued by 1 or more medical directors of such agency; or
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—
the emergency medical services practitioners request such an order with regard to a specific patient and the medical director verbally provides such an order;
the medical director provides verbal orders upon dispatching emergency medical services practitioners responding to an unanticipated mass casualty incident; or
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.
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—
to be present; or
to provide a written or oral prescription with regard to a known individual before or at the time of such administering.
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.
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.
Receipt, movement, and storage of controlled substances
The registrant emergency medical services agency—
may receive controlled substances at any location of the agency designated by the agency for such receipt; and
may not receive controlled substances at any location not so designated.
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.
may store controlled substances at any location of the agency designated by the agency for such storage; and
may not store controlled substances at any location not so designated.
Rule of construction
Nothing in this section shall be construed to—
alter any requirements under titles XVIII or XIX of the Social Security Act; or
limit the authority vested in the Attorney General to enforce diversion of controlled substances otherwise provided in this Act.