HB-5735, As Passed House, June 30, 2010

SUBSTITUTE FOR

HOUSE BILL NO. 5735

A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending section 7333a (MCL 333.7333a), as added by 2001 PA 231.

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 provide an appropriate electronic

format for the reporting of data 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 transmittal

process developed by the department or the department's contractor.

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 incur any additional

costs solely related to the transmission of data to the department.

The rules promulgated under this subsection shall 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.

(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 who 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 ~~(9)~~ (8).

(h) The medical director of a medicaid contracted health plan

for the purposes of ensuring patient safety and investigating fraud

and abuse.

(3) Except as otherwise provided in this part, 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 or any report under subsection

(2) containing any patient identifiers of the system from the

department shall not provide it 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 (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) 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 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.

~~(8) The department shall report its findings under subsection~~

~~(7) to the members of the house and senate standing committees~~

~~having jurisdiction over health policy issues not later than~~

~~October 1, 2002, and before the electronic monitoring system~~

~~required under this section becomes operational.~~

(8) ~~(9)~~ The department may enter into 1 or more contractual

agreements for the administration of this section.

(9) ~~(10)~~ 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.

(10) ~~(11)~~ The data and any report containing any patient

identifiers obtained therefrom is not a public record, and is not

subject to the freedom of information act, 1976 PA 442, MCL 15.231

to 15.246.

(11) ~~(12)~~ As used in this section, "department" means the

department of ~~consumer and industry services~~ community health.