Bill Text: MI HB4284 | 2017-2018 | 99th Legislature | Introduced

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

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced - Dead) 2017-03-01 - Bill Electronically Reproduced 02/28/2017 [HB4284 Detail]

Download: Michigan-2017-HB4284-Introduced.html

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HOUSE BILL No. 4284

 

 

February 28, 2017, Introduced by Rep. Kosowski 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 2016 PA

 

383.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 7333a. (1) The department shall establish, by rule, an

 

electronic a prescription drug monitoring 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

 

information 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 use the electronic data

 

information 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 prescription drug

 

monitoring system or to incur any additional costs solely related

 

to the transmission of data information to the department. The

 

rules promulgated under this subsection 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 shall 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 that 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, prescription drug diversion, or health care

 

fraud.

 

     (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 (7).

 

     (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.

 

     (j) A prescription drug monitoring system in another

 

jurisdiction. The director shall not transmit information under

 

this subdivision unless he or she has entered into an agreement

 

with the prescription drug 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 only for bona fide

 

drug-related criminal, civil, or administrative investigatory or

 

evidentiary purposes relating to drugs, prescription drug

 

diversion, or health care fraud 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 that 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 except 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, prescription drug diversion, or health

 

care fraud or by order of a court of competent jurisdiction.

 

     (5) Except as otherwise provided in this subsection, reporting

 

Reporting under subsection subsections (1) and (11) 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, 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) 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 prescription drug

 

monitoring system required under this section.

 

     (7) The department may enter into 1 or more contractual

 

agreements for the administration of this section.

 

     (8) 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.

 

     (9) The data information and any report containing any patient

 

identifiers obtained from the data information 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.

     (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 prescription drug 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

 

prescription drug 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.

 

     (11) As used in this section:

 

     (11) The department shall include in the prescription drug

 

monitoring system established under subsection (1) a system for

 

monitoring controlled substances prescribed in this state and,

 

subject to subsection (2)(j), sharing that information with

 

prescription drug monitoring systems in other jurisdictions. The

 

department shall provide a format for prescribers who prescribe

 

controlled substances for reporting information, including, but not

 

limited to, patient identifiers, the name of the controlled

 

substance prescribed, the date of prescribing, the quantity

 

prescribed, and the prescriber. The department shall require a

 

prescriber to use 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. In addition to complying with

 

any rules promulgated under this subsection, a prescriber described

 

in this subsection shall use the electronic information transmittal

 

process as follows:

 

     (a) Before prescribing a controlled substance for the first

 

time for a patient, whether the patient is a new patient or an

 

existing patient.

 

     (b) Unless a more frequent utilization is required in this

 

subsection, at least annually before prescribing a controlled

 

substance for a patient.

 

     (c) At least once during every 12-week period before

 

prescribing a controlled substance for a patient if the prescriber

 

is treating a patient on a protracted basis. As used in this

 

subdivision, "protracted basis" means for a period in excess of 12

 

weeks.

 

     (d) Before prescribing a controlled substance for a patient

 

regardless of the utilization required under subdivisions (a) to

 

(c) if the patient exhibits behaviors of concern to the prescriber.

 

     (12) In addition to the general duty requirements applicable

 

to a prescriber under article 15, a prescriber who believes or has

 

reason to believe that a patient is abusing or diverting controlled

 

substances, based in part on whether the patient exhibits behaviors

 

of concern to the prescriber, shall use sound clinical judgment to

determine whether a controlled substance should be prescribed for

 

the patient under the circumstances. A violation of this subsection

 

or subsection (11) is considered a violation of a general duty

 

under section 16221(a). A prescriber who violates this subsection

 

or subsection (11) is subject to any penalty, remedy, or

 

administrative sanction applicable to that violation under article

 

15.

 

     (13) (12) As used in this section:

 

     (a) "Behaviors of concern" includes, but is not limited to,

 

any of the following:

 

     (i) Selling a prescription drug.

 

     (ii) Forging or altering a prescription form.

 

     (iii) Stealing or borrowing a controlled substance.

 

     (iv) Increasing the dosage of a controlled substance in an

 

amount that exceeds the prescribed amount.

 

     (v) Having a drug screen result that is inconsistent with the

 

treatment plan or refusing to participate in a drug screen.

 

     (vi) Having been arrested, having been convicted, or having

 

received diversion or intervention instead of conviction for a

 

drug-related offense while under the prescriber's care.

 

     (vii) Receiving controlled substances from multiple

 

prescribers.

 

     (viii) Having a family member, friend, law enforcement

 

officer, or health care professional express concern related to the

 

patient's use of illegal drugs or controlled substances.

 

     (ix) Having a known history of substance use disorder as that

 

term is defined in section 100d of the mental health code, 1974 PA

258, MCL 330.1100d.

 

     (x) Appearing impaired or overly sedated during an office

 

visit or examination.

 

     (xi) Requesting controlled substances by specific name, street

 

name, color, or identifying marks.

 

     (xii) Frequently requesting early refills of controlled

 

substances.

 

     (xiii) Frequently losing prescriptions for controlled

 

substances.

 

     (xiv) Sharing controlled substances with another individual.

 

     (xv) Recurring emergency department visits to obtain

 

controlled substances.

 

     (b) (a) "Department" means the department of licensing and

 

regulatory affairs.

 

     (c) (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.