Michigan Office of Administrative Hearings and Rules

611 W. Ottawa Street

Lansing, MI 48909

Phone: 517-335-8658 Fax: 517-335-9512

AGENCY REPORT TO THE

JOINT COMMITEE ON ADMNINISTRATIVE RULES (JCAR)

1. Agency Information

Agency name:

Licensing and Regulatory Affairs

Division/Bureau/Office:

Bureau of Professional Licensing

Name of person completing this form:

Andria Ditschman

Phone number of person completing this form:

517-290-3361

E-mail of person completing this form:

DitschmanA@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Elizabeth Arasim

2. Rule Set Information

MOAHR assigned rule set number:

2020-82 LR

Title of proposed rule set:

Pharmacy - Controlled Substances

3. Purpose for the proposed rules and background:

The purpose of the Pharmacy - Controlled Substances Rules is to regulate the schedules, licenses,

security, records, dispensing and administering, prescriptions, distributions, and administrative and

disciplinary procedures for controlled substances. The proposed rules will: clarify R 338.3135 and

require physician’s assistants to meet the opioid training requirements that apply to controlled

substances licensees because they hold a controlled substance license; expand the individuals who

must take the opioid training; require individuals to take the opioid training by July 1, 2022; exempt

an individual licensed under section 7303 of the code, MCL 333.7303, who prescribes or dispenses

controlled substances only for research on animals from taking the opioid training; clarify that R

338.3162b requires additional information to be submitted to the Prescription Drug Monitoring

Program (MAPS) database; clarify rules regarding electronic transmission of prescriptions pursuant

to section 17754a of the Public Health Code; update the controlled substances schedules; update rules

related to the opioid crisis; clarify licensing provisions; evaluate the need for a separate license to

treat a drug-dependent person; clarify when inventories and records are required; update prescription

requirements; clarify dispensing and distribution requirements; and clarify refilling of prescriptions.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

4. Summary of proposed rules:

The proposed revisions to the rules will: adopt the federal schedule of controlled substances; clarify

when a controlled substance license is required; modify the requirements for opioids and other

controlled substances training; modify the licensure requirements for prescribers who provide

maintenance or detoxification treatment in the course of their professional practice or who are

registered with the DEA to provide such treatment; clarify when a licensee may prescribe, dispense,

and administer a controlled substance to a drug dependent individual; clarify “significant” loss;

clarify when an inventory of controlled substances is required; modify record retention to two years

for most records and 5 years for an original prescription; provide the requirements for electronic

transmission of prescriptions; provide the process for a waiver from the mandate to electronically

transmit a prescription; and modify reporting to the electronic system for monitoring.

5. List names of newspapers in which the notice of public hearing was published and

publication dates:

Marquette Mining Journal – August 15, 2021; Flint Journal – August 15, 2021; Grand Rapids Press –

August 19, 2021

6. Date of publication of rules and notice of public hearing in Michigan Register:

9/1/2021

7. Date, time, and location of public hearing:

9/9/2021 01:00 PM at Location: G. Mennen Williams Building Auditorium , 525 W. Ottawa Street,

Lansing, Michigan

8. Provide the link the agency used to post the regulatory impact statement and cost-benefit

analysis on its website:

https://ARS.apps.lara.state.mi.us/Transaction/RFRTransaction?TransactionID=1208

9. List of the name and title of agency representative(s) attending public hearing:

Kerry Przybylo, Manager; Andria Ditschman, Senior Policy Analyst; and Stephanie Wysack, Board

Support.

10. Persons submitting comments of support:

The following persons submitted comments in support:

Adam Carlson, Vice President, Advocacy, Michigan Health & Hospital Association (MHA)

Deeb Eid, Advisor, Pharmacy Regulatory Affairs, CVS Health

Timothy Gammons, President, Michigan Society of Addiction Medicine (MISAM)

Julie Novak, Chief Executive Officer, Michigan State Medical Society (MSMS)

11. Persons submitting comments of opposition:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

The following persons sent comments in writing:

Rose Baran, PharmD

Barry Cargill, President & CEO, Michigan HomeCare and Hospice Association (MHHA)

Adam Carlson, Vice President, Advocacy, Michigan Health & Hospital Association (MHA)

Deeb Eid, Advisor, Pharmacy Regulatory Affairs, CVS Health

Timothy Gammons, President, Michigan Society of Addiction Medicine (MISAM)

Alicia Mankowski, Pharmacy Compliance Specialist, Meijer

Charlie Mollien

Julie Novak, Chief Executive Officer, Michigan State Medical Society (MSMS)

Brian Sapita, Director of Government Affairs, Michigan Pharmacists Association (MPA)

Kolinda Lambert and Lori Smoker Young, Hospice Care of Southwest Michigan, testified at the

public hearing.

12. Identify any changes made to the proposed rules based on comments received during the

public comment period:

Name &

Comments made at Written

Agency Rationale Rule number

Organization public hearing

Comments

for change

& citation

changed

1

Novak/MSMS

Subrules (3) and To provide clarity R 338.3132

(8) appear to be to the rule,

both duplicative activities requiring

and contradictory. a separate

(3) and (8)

For clarity

controlled

purposes, MSMS substance license,

suggests that

activities

requiring a

separate

controlled

substance

licenses be

included in

subrule (3), while

exceptions to that

requirement be

addressed in

subrule (8) and

(9).

will be included in

subrule (3), while

exceptions to that

requirement will

be addressed in

subrules (8) and

(9).

2

Novak/MSMS

and

Carlson/MHA

To help provide To provide clarity, R 338.3137

clarity, MHA

recommends

referencing the

the rule will be

modified to state

that the Drug

Drug Treatment Treatment

Program

Prescriber

Prescriber license

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

License, so

providers

is eliminated not

waived.

understand which

license is being

discussed.

MSMS believes

that the

Department

should eliminate

proposed Rule

37. With the

proposed

elimination of the

requirement to

have a separate

controlled

substance license

for prescribing,

dispensing, or

administering a

controlled

substance to a

drug dependent

person in a drug

treatment and

rehabilitation

program under

Rule 32,

proposed Rule 37

is both moot and

confusing. It is

also duplicative

of proposed Rule

63, which

requires

compliance with

federal law to

provide treatment

to a “drug-

dependent

individual.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

3

Baran

Other than the

beginning

To add clarity, the R 338.3151

phrase “at the

(5)

inventory the rule licensed location”

does not state the will be added to

annual inventory the rule.

must be kept at

the licensed

location. Add to

(5) “at the

licensed

location.”

4

Baran

As voided DEA For consistency

222 forms must with federal

R 338.3153

(a)

be kept at the

licensed location phrase “or voided”

pursuant to 21 will be added to

regulations, the

CFR 1305.17, “or the rule.

voided” should

be added to the

rule.

5

Eid/CVS

Health

The term “sales To clarify, the

R 338.3153

(c)

receipt” be

phrase “in

further defined to electronic or paper

provide clarity

and to explain

whether sales

receipts may be

stored

form” will be

added to (c).

electronically or

not.

6

Sapita/MPA

We feel that it is a The requirement R 338.3154

cumbersome

requirement to

have our

will be modified to (5)(h)(vi)

“identification”

instead of “name

and license

institutional

pharmacists input number.”

their license

number every

time they check

the machines. We

would like to see

the verbiage

requiring the

“license number”

to be removed

completely.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

7

Mankowski

For consistency, Effective

R 338.3162a

align the rule

with the Code

and the Pharmacy The Public Health

Date/Subrules (1) (1), (3), (4),

Novak/MSMS

Carlson/MHA

and (3):

and (5)

General Rules

which also

Code mandates

electronic

addresses

electronic

transmission of

prescriptions.

transmission of

prescriptions as of

October 1, 2021

but requires that

the Department

delay the

implementation

date of the

mandate to the

date established by

the Federal

Centers for

Medicare and

Medicaid Services

for electronic

transmission of

prescription for

controlled

substances.

Therefore, the

effective/enforced

date will be the

date the mandate

is enforced by the

Federal Centers

for Medicare and

Medicaid

Services.

The requirement

that a prescriber is

unable to meet the

requirements of

section 17754a(1)

or (2) of the

code /Subrule (4)

(b):

A typographical

error that requires

a prescriber to

meet both (1) and

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

(2) will be

changed to (1) or

(2) for consistency

with the Pharmacy

General Rules and

the Code.

A dispensing

prescriber/Subrule

(4)(b)(i):

In the Pharmacy

General Rules, the

basis for a waiver

that “the

prescriber and

dispensing

pharmacy are the

same entity” was

modified to “if the

prescription is

dispensed by a

dispensing

prescriber.” For

consistency, the

change will also

be made in the CS

rules.

CMS waiver is

automatic state

waiver/Subrule (4)

(a):

The Code requires

that if a CMS

waiver is granted

then the

Department shall

also grant a

waiver. Subrule

(5) will be

modified to allow

for a waiver

without meeting

other requirements

if the CMS waiver

has been granted.

Professional

judgment/Subrule

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

(1)(c):

The language in

(1)(c) will be

modified for

consistency with

the Code and

Pharmacy General

Rules by adding

“validity” and

deleting the last

sentence.

Delete Subrule

(5): The

Controlled

Substances Rules

include a

provision that is

duplicative of the

Code and is not

included in the

Pharmacy General

Rules. For

consistency it will

be deleted.

8

Novak/MSMS

and

Amend to

recognize the

The rule will

recognize the

R 338.3162a

(3)

Carlson/MHA

exceptions to the exceptions to

mandate by

electronic

adding, “unless transmissions

an exception

under section

17754 of the

Code, MCL

333.17754a,

applies, …”

permitted by MCL

333.17754a.

9

Novak/MSMS

Identify examples The exceptional

R 338.3162a

of qualifying

“exceptional

circumstances will (4)(b)(iii)(A)-

be further clarified (C)

circumstances as by adding

follows:

circumstances

(iv) The

suggested in A, C,

and D, however,

(A) will read

prescriber

demonstrates

attests to

“prescribing fewer

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

exceptional

than 100

circumstances

controlled

including, but not substances

limited to, the

following:

A. Prescribing

fewer than “X”

prescriptions

(combined

controlled and

non-controlled

substances) per

year.

prescriptions per

year or the number

of controlled

substances

prescriptions used

in the Federal

Centers for

Medicare and

Medicaid Services

waiver for

B. Utilizing

electronic

transmission of

transmission for prescriptions for

non-controlled

substances but

controlled

substances,

prescribing fewer whichever is

than “Y”

more.”

controlled

substance

prescriptions per

year. (Note: The

cost of the

enhanced e-

prescribing

software for

controlled

substances is not

fiscally

responsible for

some prescribers

who rarely

prescribe them.)

C. Intention to

cease practice

within the next

twelve months.

D. Limited

practice due to an

illness or other

unforeseen event.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 10

10

Carlson/MHA

Clarify that the

prescriber may

declare of

The rule will read R 338.3162a

“The prescriber

demonstrates by

(4)(b)(iii)

formally certify attesting to

in writing such as exceptional

with an circumstances

attestation as to including, but not

the exceptional

circumstances,

instead of having

to demonstrate

the exceptional

circumstances.

limited to, the

following: ….”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 11

11

Mollien

The rules do not The phrase “cash R 338.3162b

address or

provide clarity

discount cards are (1)(q)

considered cash

for a definition of transactions” will

what a “cash”

transaction is for

purposes of

be added.

reporting “the

prescription

payment type”

under R

338.3162b(1)(q).

The rule should

add a definition

or explain what

payment types

are considered

“cash” under the

ASAP 4.1

reporting

requirements,

which should

include cash

prices at U&C

and, only for

purposes of

reporting to

MAPS, any

discount card

used that is not

regulated under

the Insurance

Code (e.g.,

GoodRx, etc.)

Rule 63 be

eliminated or

significantly

12

Novak/MSMS

Pursuant to the

comments the

following changes

R 338.3163

revised for better are made to the

clarity and rule:

consistency with Drug dependent

federal law. This person:

proposed Rule is Throughout the

confusing and

uses terminology dependent person”

that is will be modified to

inconsistent with “individual with

rule “Drug

MCL 24.242 and 24.245

Agency Report to JCAR-Page 12

similar federal

laws regarding

the authorized

prescribing,

substance use

disorder.”

Practitioner:

Throughout the

administering and rule, the various

dispensing of

controlled

terms, licensee,

health

substances to an professional, and

individual for

treatment of

substance use

disorder.

prescriber, will be

modified for

consistency to

practitioner.

Furthermore, the Behavior

term “drug-

dependent

allowed/Subrule

(1):

individual” is not The rule will be

defined in the

Proposed Rule

Set and is not

modified to state

the behavior that is

allowed instead of

acknowledged by what is prohibited.

the Public Health “Drug treatment

Code. MSMS

questions whether program”/Subrules

there is a more (1)(b) and (3)(b):

appropriate and This term is not

person-first defined in the

and rehabilitation

reference to these Code. It will be

individuals than modified to

“drug-dependent “program” which

individual.”

is defined in the

Mental Health

Code, MCL

330.1260(1)(i).

Align with federal

regulations:

To further align

the rule with the

federal regulations

(b)(i) has been

divided into two

provisions (b) and

(c) to clarify that

the limitations of a

one-day supply of

medicine and no

more than 3 days

MCL 24.242 and 24.245

Agency Report to JCAR-Page 13

only apply to acute

withdrawal not

participation in a

program.

Further, (2) has

been modified for

consistency with

federal regulations

to refer to

“hospital or

similar setting.

13

Sapita/MPA

Regarding

“Dispensing

R 338.3165

R338.3165

subsection 2(c)

pharmacist” and

“pharmacist” will

which specifies be modified to

“dispensing

“pharmacy.”

pharmacist”. We

believe this

would cause

undue hardship

on our relief

pharmacists who

may work at

different

pharmacies each

day. Would the

dispensing relief

pharmacist have

to check each

place of work to

ensure

compliance with

this rule?

13.Date report completed:

10/6/2021

MCL 24.242 and 24.245