SB-0047, As Passed Senate, December 13, 2017

HOUSE SUBSTITUTE FOR

SENATE BILL NO. 47

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 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 rules promulgated under this subsection must 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.~~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.

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.

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 (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.

(3) Except as otherwise provided in this part, a person shall

use information submitted under this section 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 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.

(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) 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.

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 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 and any report containing any patient identifiers

obtained from the data 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 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.

(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) ~~(11)~~ 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.