May 27, 2014, Introduced by Reps. LaVoy and Kivela 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 amended by 2012 PA
44.
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 must
provide an appropriate electronic
format
for the reporting of data information
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 information transmittal process developed by the
department
or the department's contractor. A The department shall
not require 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 or to incur
any
additional
costs solely related to the transmission of data
information to the department. The rules promulgated under this
subsection
shall must exempt both of the following circumstances
from the reporting requirements under this section:
(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 information 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.information.
(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 (8).
(h) A practitioner or other person who is authorized to
prescribe controlled substances for the purpose of determining if
prescriptions written by that practitioner or other person have
been dispensed.
(i) Until December 31, 2016, the health care payment or
benefit provider for the purposes of ensuring patient safety and
investigating fraud and abuse.
(j) A prescription monitoring program in another jurisdiction.
The director shall not transmit information under this subdivision
unless he or she has entered into an agreement with the
prescription monitoring system in the jurisdiction. The agreement
must provide for the mutual exchange of information and limit the
use of the information only as authorized in and subject to the
same restrictions of this section.
(3) Except as otherwise provided in this part, a person shall
use
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 information
or any report under
subsection
(2) containing any patient identifiers of the system
this section from the department that contains any patient
identifiers
shall not provide it that information 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 subsections (1) and
(12) is mandatory for a
veterinarian, pharmacist, prescriber, and dispensing prescriber, as
applicable. However, the department may issue a written waiver of
the electronic reporting requirement to a veterinarian, pharmacist,
prescriber, 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
must 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 may enter into 1 or more contractual
agreements for the administration of this section.
(9) The department, all law enforcement officers, all officers
of the court, and all regulatory agencies and officers, in using
the
data information 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.
(10)
The data information and any report containing any
patient
identifiers obtained from the data information are not
public records and are not subject to the freedom of information
act, 1976 PA 442, MCL 15.231 to 15.246.
(11) Beginning February 1, 2013 and through February 1, 2016,
the department may issue a written request to a health care payment
or benefit provider to determine if the provider has accessed the
electronic system as provided in subsection (2)(i) in the previous
calendar year and, if so, to determine the number of inquiries the
provider made in the previous calendar year and any other
information the department requests in relation to the provider's
access to the electronic system. A health care payment or benefit
provider shall respond to the written request on or before the
March 31 following the request. The department shall collaborate
with health care payment or benefit providers to develop a
reasonable request and reporting form for use under this
subsection.
(12) The department shall include in the electronic monitoring
system established under subsection (1) a system for monitoring
schedule 2 and schedule 3 controlled substances prescribed in this
state and, subject to subsection (2)(j), sharing that information
with prescription monitoring programs in other jurisdictions. The
department shall provide a format for prescribers who prescribe
schedule 2 or schedule 3 controlled substances for the reporting of
information including, but not limited to, patient identifiers, the
name of the schedule 2 or schedule 3 controlled substance
prescribed, date of prescribing, quantity prescribed, and
prescriber. The department shall require a prescriber to utilize
the electronic information transmittal process developed by the
department or the department's contractor. The department shall not
require a prescriber to pay a new fee dedicated to the operation of
the reporting requirements under this subsection or to incur any
additional costs solely related to the transmission of information
to the department. The department may promulgate rules it considers
necessary for the implementation and administration of this
subsection.
(13) (12)
As used in this section:
(a) "Department" means the department of licensing and
regulatory affairs.
(b) "Health care payment or benefit provider" 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.