Bill Text: MI HB4369 | 2011-2012 | 96th Legislature | Engrossed
Bill Title: Health; pharmaceuticals; electronic monitoring system for certain dispensed controlled substances; allow health care payment or benefit providers to access data until date certain and allow department to request access data. Amends sec. 7333a of 1978 PA 368 (MCL 333.7333a).
Spectrum: Slight Partisan Bill (Democrat 14-5)
Status: (Passed) 2012-03-08 - Assigned Pa 44'12 With Immediate Effect [HB4369 Detail]
Download: Michigan-2011-HB4369-Engrossed.html
HB-4369, As Passed Senate, October 18, 2011
SENATE SUBSTITUTE FOR
HOUSE BILL NO. 4369
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 7333a (MCL 333.7333a), as amended by 2011 PA
108.
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 (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, 2015, the health care payment or
benefit provider for the purposes of ensuring patient safety and
investigating fraud and abuse.
(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) 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 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 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 and any report containing any patient
identifiers
obtained therefrom is from
the data are not a public
record,
records and is 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 the Michigan association of health plans or its successor
agency to develop a reasonable request and reporting form for use
under this subsection.
(12) (11)
As used in this section: ,
"department"
(a)
"Department" means the
department of community health
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.
