Bill Text: MI HB4811 | 2015-2016 | 98th 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 7-0)

Status: (Introduced - Dead) 2015-08-19 - Printed Bill Filed 08/19/2015 [HB4811 Detail]

Download: Michigan-2015-HB4811-Introduced.html

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HOUSE BILL No. 4811

 

August 18, 2015, Introduced by Reps. LaVoy, Zemke, Darany, Schor, Irwin, Hovey-Wright and Chirkun and referred to the Committee on Regulatory Reform.

 

     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 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 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 prescription drug

 

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 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 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, prescription drug diversion, or health care

 

fraud.

 

     (d) A state-operated medicaid 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 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 shall be used 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 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 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 (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, 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 prescription

 

drug 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 prescription drug

 

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 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.

 

     (12) 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 the reporting of information, including,

 

but not limited to, patient identifiers, the name of the 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. In addition to complying with the requirements in rules

 

promulgated under this subsection, if any, a prescriber described

 

in this subsection shall utilize 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.

 

     (13) 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 (12) is considered a violation of a general duty

 

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

 

or subsection (12) is subject to any penalty, remedy, or

 

administrative sanction applicable to that violation under article

 

15.

 

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

 

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

 

any of the following:

 

     (i) Selling prescription drugs.

 

     (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 in lieu 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 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.