Bill Text: MI HB5603 | 2013-2014 | 97th Legislature | Introduced

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Bill Title: Health; pharmaceuticals; electronic monitoring system of controlled substances; require department to establish system to report schedule 2 or 3 prescriptions and allow interstate sharing under certain circumstances. Amends sec. 7333a of 1978 PA 368 (MCL 333.7333a).

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Introduced - Dead) 2014-05-28 - Printed Bill Filed 05/28/2014 [HB5603 Detail]

Download: Michigan-2013-HB5603-Introduced.html

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HOUSE BILL No. 5603

 

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.