November 29, 2018, Introduced by Senator SHIRKEY and referred to the Committee on Michigan Competitiveness.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 7109 and 7333a (MCL 333.7109 and 333.7333a),
section 7109 as amended by 2016 PA 383 and section 7333a as amended
by 2017 PA 252.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 7109. (1) "Person" means a person as defined in section
1106 or a governmental entity.
(2) "Poppy straw" means all parts, except the seeds, of the
opium poppy, after mowing.
(3) "Practitioner" means any of the following:
(a) A prescriber or pharmacist, a scientific investigator as
defined by rule of the administrator, or other person licensed,
registered, or otherwise permitted to distribute, dispense, conduct
research with respect to, or administer a controlled substance in
the course of professional practice or research in this state,
including an individual in charge of a dog pound or animal shelter
licensed or registered by the department of agriculture and rural
development under 1969 PA 287, MCL 287.331 to 287.340, or a class B
dealer licensed by the United States Department of Agriculture
under the animal welfare act, Public Law 89-544, 7 USC 2131 to
2147, 2149, and 2151 to 2159 and the department of agriculture and
rural development under 1969 PA 224, MCL 287.381 to 287.395, for
the limited purpose of buying, possessing, and administering a
commercially prepared, premixed solution of sodium pentobarbital to
practice euthanasia on animals.
(b) A pharmacy, hospital, or other institution or place of
professional practice licensed, registered, or otherwise permitted
to distribute, prescribe, dispense, conduct research with respect
to, or administer a controlled substance in the course of
professional practice or research in this state.
(4) "Prescriber" means that term as defined in section 17708.
(5) "Prescription form" means a printed form, that is
authorized and intended for use by a prescribing practitioner to
prescribe controlled substances or other prescription drugs and
that meets the requirements of rules promulgated by the
administrator, and all of the following requirements:
(a) Bears the preprinted, stamped, typed, or manually printed
name, address, and telephone number or pager number of the
prescribing practitioner.
(b) Includes the manually printed name of the patient, the
address of the patient, the prescribing practitioner's signature,
and the prescribing practitioner's drug enforcement administration
registration number.
(c) Includes the quantity of the prescription drug prescribed,
in both written and numerical terms.
(d) Includes the date the prescription drug was prescribed.
(e) Complies with any rules promulgated by the department
under
section 7333a(6).7333a(7).
(6) "Production" means the manufacture, planting, cultivation,
growing, or harvesting of a controlled substance.
(7) "Sign" means to affix one's signature manually to a
document or to use an electronic signature.
(8) "Ultimate user" means an individual who lawfully possesses
a controlled substance for personal use or for the use of a member
of the individual's household, or for administering to an animal
owned by the individual or by a member of the individual's
household.
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 must provide an appropriate electronic format
for the reporting of data including, but not limited to, patient
identifiers, and the name of the controlled substance dispensed,
the date of dispensing, the quantity dispensed, the prescriber, and
the 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. The department shall not require a veterinarian,
pharmacist, or dispensing prescriber to pay a new fee dedicated to
the operation of the electronic monitoring system or to incur any
additional costs solely related to the transmission of data to the
department. The dispensing of a controlled substance in any of the
following is exempt from the reporting requirements:
(a) A hospital that is licensed under article 17 that
administers the controlled substance to an individual who is an
inpatient.
(b) A health facility or agency licensed under article 17 if
the controlled substance is dispensed by a dispensing prescriber in
a quantity adequate to treat the patient for not more than 48
hours.
(c) A veterinary hospital or clinic that administers the
controlled substance to an animal that is an inpatient.
(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 that is authorized to prescribe, administer, or
dispense controlled substances.
(b) An employee or agent of the department.
(c)
A Subject to subsection
(4), 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 Subject to subsection
(4), 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 (7).(8).
(h) A practitioner or other person that is authorized to
prescribe controlled substances for the purpose of determining if
prescriptions written by that practitioner or other person have
been dispensed.
(i) 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, a person shall
use
information submitted obtained
from the department under this
section
subsection (2) 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) The director of the department shall provide a law
enforcement officer who is employed by the department of state
police with access to an application program interface for
monitoring schedule 2, 3, 4, and 5 controlled substances for the
purposes of the law enforcement access to Michigan automated
prescription system data act. Patient treatment information
provided through the application program interface under this
subsection must be deidentified and the application program
interface must disclose prescriber and dispenser data to the law
enforcement officer.
(5)
(4) A person that 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 except
by order of a court of competent jurisdiction.
(6) (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.
(7) (6)
The department, in consultation
with the Michigan
board of pharmacy, the Michigan board of medicine, the Michigan
board of osteopathic medicine and surgery, the department of 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 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) (7)
The department may enter into 1 or
more contractual
agreements for the administration of this section.
(9) (8)
The department, all law enforcement
officers, all
officers of the court, and all regulatory agencies and officers, in
using the data obtained under this section 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) (9)
The data and any report containing
any patient
identifiers obtained from the data obtained under this section are
not public records and are not subject to disclosure under the
freedom of information act, 1976 PA 442, MCL 15.231 to 15.246.
(11) (10)
The department may issue a written
request to a
health care payment or benefit provider to determine if the
provider has accessed the electronic monitoring 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 monitoring
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) (11)
Before dispensing or prescribing
buprenorphine, or a
drug containing buprenorphine or methadone, to a patient in a
substance use disorder program, a prescriber shall obtain and
review data concerning that patient from the department under
subsection (2). A prescriber dispensing buprenorphine, or a drug
containing buprenorphine or methadone, to a patient in a substance
use disorder program shall also report the data required in
subsection (1), if federal law does not prohibit the reporting of
data concerning the patient, to the department. As used in this
subsection:
(a) "Approved service program" means that term as defined in
section 100a of the mental health code, 1974 PA 258, MCL 330.1100a.
(b) "Substance use disorder program" means a program as that
term is defined in section 260 of the mental health code, 1974 PA
258, MCL 330.1260, an approved service program, a nonregulated
substance use disorder services program, a federal certified
substance use disorder services program, or a federally regulated
substance use disorder services program.
(12)
R 338.3162e of the Michigan Administrative Code is
rescinded.
(13) 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.
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.
Enacting section 2. This amendatory act does not take effect
unless Senate Bill No._1245
of the 99th Legislature is enacted into law.