BillCam

SB-1247, As Passed Senate, December 6, 2018

SUBSTITUTE FOR

SENATE BILL NO. 1247

A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 7109 and 7333a (MCL 333.7109 and 333.7333a),

section 7109 as amended by 2016 PA 383 and section 7333a as amended

by 2017 PA 252.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

Sec. 7109. (1) "Person" means a person as defined in section

1106 or a governmental entity.

(2) "Poppy straw" means all parts, except the seeds, of the

opium poppy, after mowing.

(3) "Practitioner" means any of the following:

(a) A prescriber or pharmacist, a scientific investigator as

defined by rule of the administrator, or other person licensed,

registered, or otherwise permitted to distribute, dispense, conduct

research with respect to, or administer a controlled substance in

the course of professional practice or research in this state,

including an individual in charge of a dog pound or animal shelter

licensed or registered by the department of agriculture and rural

development under 1969 PA 287, MCL 287.331 to 287.340, or a class B

dealer licensed by the United States Department of Agriculture

under the animal welfare act, Public Law 89-544, 7 USC 2131 to

2147, 2149, and 2151 to 2159 and the department of agriculture and

rural development under 1969 PA 224, MCL 287.381 to 287.395, for

the limited purpose of buying, possessing, and administering a

commercially prepared, premixed solution of sodium pentobarbital to

practice euthanasia on animals.

(b) A pharmacy, hospital, or other institution or place of

professional practice licensed, registered, or otherwise permitted

to distribute, prescribe, dispense, conduct research with respect

to, or administer a controlled substance in the course of

professional practice or research in this state.

(4) "Prescriber" means that term as defined in section 17708.

(5) "Prescription form" means a printed form, that is

authorized and intended for use by a prescribing practitioner to

prescribe controlled substances or other prescription drugs and

that meets the requirements of rules promulgated by the

administrator, and all of the following requirements:

(a) Bears the preprinted, stamped, typed, or manually printed

name, address, and telephone number or pager number of the

prescribing practitioner.

(b) Includes the manually printed name of the patient, the

address of the patient, the prescribing practitioner's signature,

and the prescribing practitioner's drug enforcement administration

registration number.

in both written and numerical terms.

(d) Includes the date the prescription drug was prescribed.

(e) Complies with any rules promulgated by the department

under section 7333a(6).7333a(8).

(6) "Production" means the manufacture, planting, cultivation,

growing, or harvesting of a controlled substance.

(7) "Sign" means to affix one's signature manually to a

document or to use an electronic signature.

(8) "Ultimate user" means an individual who lawfully possesses

a controlled substance for personal use or for the use of a member

of the individual's household, or for administering to an animal

owned by the individual or by a member of the individual's

household.

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 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.

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 Subject to subsection (4), 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).(9).

(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 obtained from the department under this

section subsection (2) 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) The director of the department shall provide a law

enforcement officer who is employed by the department of state

police with access to an application program interface for

monitoring schedule 2, 3, 4, and 5 controlled substances for the

purposes of the law enforcement access to Michigan automated

prescription system data act. Patient treatment information

provided through the application program interface under this

subsection must be deidentified to protect the identity and privacy

of patients in accordance with federal and state law, including,

but not limited to, regulations promulgated under the health

insurance portability and accountability act of 1996, Public Law

104-191, related to deidentification and privacy standards but not

including data breach notifications or any other requirement. The

application program interface must disclose prescriber and

dispenser data to the law enforcement officer.

(5) The department, in consultation with the department of

state police, shall promulgate rules that it considers necessary

that ensure that any data provided by the director of the

department under subsection (2) is provided only to the extent

necessary, that minimize the inappropriate use of the data provided

under subsection (2), and that minimize the risk of a breach of the

data in the electronic monitoring system.

(6) (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.

(7) (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.

(8) (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.

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

agreements for the administration of this section.

(10) (8) The department, all law enforcement officers, all

officers of the court, and all regulatory agencies and officers, in

using the data obtained under this section 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.

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

identifiers obtained from the data obtained under this section 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.

(12) (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.

(13) (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.

(14) (13) 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.

Enacting section 2. This amendatory act does not take effect

unless Senate Bill No. 1245 of the 99th Legislature is enacted into

law.