January 13, 2010, Introduced by Reps. Liss, Haugh, Constan, Ball, Marleau, Gonzales, Calley, Angerer, Segal, McDowell, Lahti, Nerat and Green and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 7333a (MCL 333.7333a), as added by 2001 PA 231.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 7333a. (1) The department shall establish, by rule, an
electronic system for monitoring schedule 2, 3, 4, and 5 controlled
substances dispensed in this state by veterinarians, and by
pharmacists and dispensing prescribers licensed under part 177 or
dispensed to an address in this state by a pharmacy licensed in
this state. The rules shall provide an appropriate electronic
format for the reporting of data including, but not limited to,
patient identifiers, the name of the controlled substance
dispensed, date of dispensing, quantity dispensed, prescriber, and
dispenser. The department shall require a veterinarian, pharmacist,
or dispensing prescriber to utilize the electronic data transmittal
process developed by the department or the department's contractor.
A veterinarian, pharmacist, or dispensing prescriber shall not be
required to pay a new fee dedicated to the operation of the
electronic monitoring system and shall not incur any additional
costs solely related to the transmission of data to the department.
The rules promulgated under this subsection shall exempt both of
the following circumstances from the reporting requirements:
(a) The administration of a controlled substance directly to a
patient.
(b) The dispensing from a health facility or agency licensed
under article 17 of a controlled substance by a dispensing
prescriber in a quantity adequate to treat a patient for not more
than 48 hours.
(2) Notwithstanding any practitioner-patient privilege, the
director of the department may provide data obtained under this
section to all of the following:
(a) A designated representative of a board responsible for the
licensure, regulation, or discipline of a practitioner, pharmacist,
or other person who is authorized to prescribe, administer, or
dispense controlled substances.
(b) An employee or agent of the department.
(c) A state, federal, or municipal employee or agent whose
duty is to enforce the laws of this state or the United States
relating to drugs.
(d) A state-operated medicaid program.
(e) A state, federal, or municipal employee who is the holder
of a search warrant or subpoena properly issued for the records.
(f) A practitioner or pharmacist who requests information and
certifies that the requested information is for the purpose of
providing medical or pharmaceutical treatment to a bona fide
current patient.
(g) An individual with whom the department has contracted
under subsection (9).
(3) Except as otherwise provided in this part, information
submitted under this section shall be used only for bona fide drug-
related criminal investigatory or evidentiary purposes or for the
investigatory or evidentiary purposes in connection with the
functions of a disciplinary subcommittee or 1 or more of the
licensing or registration boards created in article 15.
(4) A person who receives data or any report under subsection
(2) or (8) containing any patient identifiers of the system from
the department shall not provide it to any other person or entity
except by order of a court of competent jurisdiction.
(5) Except as otherwise provided in this subsection, reporting
under subsection (1) is mandatory for a veterinarian, pharmacist,
and dispensing prescriber. However, the department may issue a
written waiver of the electronic reporting requirement to a
veterinarian, pharmacist, or dispensing prescriber who establishes
grounds that he or she is unable to use the electronic monitoring
system. The department shall require the applicant for the waiver
to report the required information in a manner approved by the
department.
(6) In addition to the information required to be reported
annually under section 7112(3), the controlled substances advisory
commission shall include in the report information on the
implementation and effectiveness of the electronic monitoring
system.
(7) The department, in consultation with the controlled
substances advisory commission, the Michigan board of pharmacy, the
Michigan board of medicine, the Michigan board of osteopathic
medicine and surgery, the Michigan state police, and appropriate
medical professional associations, shall examine the need for and
may promulgate rules for the production of a prescription form on
paper that minimizes the potential for forgery. The rules shall not
include any requirement that sequential numbers, bar codes, or
symbols be affixed, printed, or written on a prescription form or
that the prescription form be a state produced prescription form.
In examining the need for rules for the production of a
prescription form on paper that minimizes the potential for
forgery, the department shall consider and identify the following:
(a) Cost, benefits, and barriers.
(b) Overall cost-benefit analysis.
(c) Compatibility with the electronic monitoring system
required under this section.
(8)
The department shall report its findings under subsection
(7)
to the members of the house and senate standing committees
having
jurisdiction over health policy issues not later than
October 1, 2002, and before the electronic monitoring system
required
under this section becomes operational.
(8) On or before January 1, 2010 and notwithstanding any
practitioner-patient privilege, the director of the department
shall provide direct access to the electronic monitoring system
established under subsection (1) to health care payment or benefit
providers for the purposes of ensuring patient safety and
investigating fraud and abuse. As used in this subsection, "health
care payment or benefit providers" means a person that provides
health benefits, coverage, or insurance in this state, including a
health insurance company, a nonprofit health care corporation, a
health maintenance organization, a multiple employer welfare
arrangement, a medicaid contracted health plan, or any other person
providing a plan of health benefits, coverage, or insurance subject
to state insurance regulation.
(9) The department may enter into 1 or more contractual
agreements for the administration of this section.
(10) The department, all law enforcement officers, all
officers of the court, and all regulatory agencies and officers, in
using the data for investigative or prosecution purposes, shall
consider the nature of the prescriber's and dispenser's practice
and the condition for which the patient is being treated.
(11) The data and any report containing any patient
identifiers obtained therefrom is not a public record, and is not
subject to the freedom of information act, 1976 PA 442, MCL 15.231
to 15.246.
(12) As used in this section, "department" means the
department
of consumer and industry services community health.