Current through Register Vol. 48, No. 39, March 25, 2024
Subpart 1.
Application.
This part applies to the use of oral, oral transmucosal,
buccal, and transdermal opioid analgesic medications and does not apply to the
use of parenteral or intrathecal opioid analgesic medications. The choice of
specific opioid analgesic medication is governed by part
5221.6105, subpart 3. For purposes
of this part, "long-term treatment with opioid analgesic medication" means
that:
A. a health care provider
documents a plan to initiate treatment for intractable pain by prescribing
opioid analgesic medication to be taken daily for at least 90 days;
or
B. a health care provider
continues prescribing opioid analgesic medication for a patient who has been
prescribed opioid analgesic medication to be taken daily for at least 90
days.
Subp. 2.
Indications and documentation.
Long-term treatment with opioid analgesic medication is not
indicated for treatment of workers compensation injuries unless the
requirements in this part are met. The prescribing health care provider must
document in the medical record the patient selection criteria, the assessments
performed, whether there are any potential contraindications to the long-term
prescription of opioid analgesics, the elements of the treatment program, the
written treatment contract, an objective assessment of the success of the
treatment program, and the results of periodic monitoring and testing.
Subp. 3.
Pain and function
assessment tools.
When a health care provider initiates a plan for long-term
treatment with opioid analgesic medication, the provider must assess the
patients level of pain and function using the following tools:
A. a tool validated in peer-reviewed
scientific literature for the assessment of pain. Examples are the Brief Pain
Inventory, the Chronic Pain Grade, the Neuropathic Pain Scale, the Visual
Analog Scale, the Numeric Rating Scale, or the Verbal Descriptive Scales;
and
B. a tool validated in
peer-reviewed scientific literature for the assessment of function. Examples
are the SF-36 Health Survey, the Quick DASH Outcome Measure, the Quality of
Life (QOL) Scale, the Oswestry Disability Index, the Neck Disability Index, or
the Short Musculoskeletal Function Assessment.
The results of these assessments provide the baseline for
determining the success of the treatment program as specified in subpart
8, item B.
Subp. 4.
Patient selection
criteria.
Before initiating a plan for long-term treatment with opioid
analgesic medication, the prescribing health care provider must determine that
all of the following criteria are met:
A. the patient cannot maintain function at
work, or in the activities of daily living, without long-term use of opioid
analgesic medication;
B. the
patient does not have a Somatic Symptom Disorder as defined in the fifth
edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5);
C. all other reasonable
medical treatment options have been exhausted as determined by either a pain
medicine specialist or a health care provider specializing in the treatment of
the area, system, or organ of the body identified as the source of the
pain;
D. the patient does not have
a history of failing to comply with treatment or failing to take medication as
prescribed;
E. the patient does not
have a current Substance Use Disorder as defined in the fifth edition of the
Diagnostic and Statistical Manual of Mental Disorders (DSM-5); and
F. a qualitative urine drug test confirms
that the patient is not using any illegal substances.
Subp. 5.
Potential
contraindications.
Items A and B apply to potential contraindications.
A. Before beginning long-term treatment with
opioid analgesic medication, the prescribing health care provider must assess
whether any of the following circumstances are present and, if present, whether
they constitute contraindications to the long-term treatment with opioid
analgesic medication:
(1) the patient has a
history of respiratory depression, or a condition that can cause respiratory
depression when taking opioid analgesic medications;
(2) the patient is pregnant or is planning to
become pregnant during the period of treatment with opioid analgesic
medications;
(3) the patient has a
Substance Use Disorder in remission as defined in the fifth edition of the
Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
(4) the patient has another mental disorder
referenced in the fifth edition of the Diagnostic and Statistical Manual of
Mental Disorders (DSM-5);
(5) the
patient is a suicide risk;
(6) the
patient has poor impulse control; and
(7) the patient regularly engages in an
activity that could be unsafe for a patient taking opioid analgesic
medications.
B. The
prescribing health care provider may obtain an appropriate specialty
consultation to assist with the assessments in this subpart or determine if the
long-term prescription of opioid analgesic medication is appropriate.
Subp. 6.
Opioid risk
assessment; program of treatment.
A.
Long-term treatment with opioid analgesic medication must be part of an
integrated program of treatment that complies with this subpart and that is
documented in the medical record.
B. The health care provider must complete an
opioid risk assessment using a tool validated in the peer-reviewed scientific
literature. Examples of this type of assessment tool are the Opioid Risk Tool;
the Diagnosis, Intractability, Risk, Efficacy Scale (DIRE); and the Screener
and Opioid Assessment for Patients with Pain - Revised (SOAPP-R). The provider
must disclose the results of the assessment to the patient.
(1) If the assessment shows the patient to be
at high risk of dependence or abuse, the provider must refer the patient to a
pain medicine specialist or addiction medicine specialist for a second opinion
before initiating long-term treatment with opioid analgesic
medication.
(2) Following the
second opinion, if long-term treatment with opioid analgesic medication is
initiated in a patient at high risk, the prescribing provider must:
(a) perform urine drug testing at least twice
a year;
(b) review the patients
prescription history in the Minnesota prescription monitoring program at each
visit; and
(c) see the patient in
clinic for follow-up every month for the first six months of treatment and
every three months thereafter.
C. The patient and the prescribing health
care provider must sign a formal written treatment contract that meets the
requirements of subpart
7.
D. All opioid analgesic medications must be
used in fixed schedules of dosing and prescribed in an amount sufficient to
preclude exhaustion of a prescription on a weekend, holiday, or vacation day
when the prescribing health care provider is not available.
E. Other treatment modalities are permitted
in conjunction with long-term treatment with opioid analgesic medication, to
the extent indicated by parts
5221.6010 to
5221.6600.
F. The prescribing health care provider must
have a written plan for treatment of episodic pain due to the injury being
treated, specifying the modality or medication to be used, the frequency and
scheduling of the modality or dosing of medication, the duration of use, the
circumstances for contacting the prescribing health care provider, and
treatment of possible side effects of the medications.
G. All prescriptions for long-term treatment
with opioid analgesic medication must be written only by the prescribing health
care provider or the designated proxy. The patient must agree to inform the
prescribing health care provider if short-term treatment with opioid analgesic
medications or other controlled drugs is prescribed by other health care
providers in the treatment of acute injuries or conditions so that overall care
can be properly coordinated. Examples of acute medical problems are dental
procedures, acute trauma, surgery, or emergency medical treatment. The patient
must also agree to inform the prescribing health care provider of any use of
medical cannabis permitted under Minnesota Statutes, sections
152.22 to
152.37.
H. The prescribing health care provider must
discuss with the patient the risks associated with the long-term treatment with
opioid analgesic medication, the specific medications to be used, and possible
side effects.
I. All medications
and other treatment modalities for the work-related injury must be prescribed
or provided on referral by the single health care provider party to the written
treatment contract or by a proxy designated in the medical record by the health
care provider party to the written treatment contract.
J. The prescribing health care provider must
document in the medical record the name of the drug prescribed, the dose, the
dosing schedule, the amount to be dispensed, and the number of refills allowed,
if any, for each opioid analgesic prescribed.
K. The prescribing health care provider must
establish a schedule of follow-up visits for monitoring the
treatment.
L. The prescribing
health care provider must provide written reports of work ability or
restrictions as required by part
5221.0410, subpart
6.
M. If long-term treatment with opioid
analgesic medication is discontinued, the prescribing health care provider must
prescribe a schedule of tapering dosages and ancillary medications as needed to
minimize symptoms of withdrawal, taking into account the type, dose, and
duration of the opioid medication being discontinued. The health care provider
must offer alternative pain management treatment or referral to another
provider.
Subp. 7.
Written treatment contract.
A patient receiving long-term treatment with opioid analgesic
medication must enter into a written treatment contract with the prescribing
health care provider as part of the integrated program of treatment. The
written contract must be made part of the patients medical record. A copy of
the contract must be provided to the patient. Except when discontinuance is
required by subpart 8,
items E and F, the prescribing health care provider has discretion to
discontinue treatment with opioid analgesic medication if the provider believes
that the patient has not complied with the terms of the contract.
Discontinuance must be according to a tapering schedule as described in subpart
6, item M. The contract must
include the following:
A. the goals of
long-term treatment with opioid analgesic medication; the program of treatment
identified in subpart
6, items D, G, H, I, K, L,
and M; and the monitoring described in subpart
8, items E, F, and
G;
B. an agreement by the patient
to comply with treatment prescribed in addition to the opioid analgesic
medication;
C. an agreement by the
patient that only one replacement refill or prescription is permitted in the
event of lost or stolen medication or prescription, but only the first time the
patient alleges that the prescription or medication was lost or stolen and only
at the discretion of the prescribing health care provider;
D. an agreement by the patient that
prescriptions or medications will not be renewed earlier than
scheduled;
E. an agreement by the
patient to notify all other health care providers of the treatment contract and
its stipulations before receiving any prescription medications and to notify
the prescribing health care provider party to the contract of medications
received from other health care providers;
F. an agreement by the prescribing health
care provider that arrangements must be made ahead of time to renew
prescriptions when the prescribing health care provider is on vacation or
otherwise unavailable;
G. an
agreement by the prescribing health care provider to be available or provide
coverage for episodic pain not responsive to planned interventions;
H. a statement that, except for the required
discontinuance provided in subpart
8, items E and F, the
prescribing health care provider has discretion to discontinue treatment with
opioid analgesics using a schedule of tapering dosages if the patient does not
comply with any of the agreements set out in the written treatment contract;
and that if opioid analgesics are discontinued the provider must offer
alternative pain management treatment or referral to another
provider;
I. an agreement by the
patient to:
(1) follow a schedule of regular
visits recommended by the prescribing health care provider and take the opioid
medication exactly as prescribed;
(2) abstain from all illegal
substances;
(3) cooperate with the
assessments and urine drug testing requested by the prescribing health care
provider;
(4) allow the prescribing
health care provider to access the prescription monitoring program and contact
any other health care provider who treats or has treated the patient to discuss
the patients use of opioid medication; and
(5) cooperate with referrals to other
providers, as requested by the prescribing health care provider; and
J. the dated signatures of the
patient and prescribing health care provider.
The commissioner shall develop a form for a model written
contract addressing items A to J. If a prescribing health care provider uses
the commissioners form, then the contract shall be deemed to meet the
requirements of this subpart once completed and made part of the patients
medical record. The patient and prescribing health care provider must enter
into a new written contract whenever it is deemed necessary by the prescribing
health care provider.
Subp.
8.
Monitoring long-term treatment with opioid analgesic
medications.
The prescribing health care provider who is party to the
treatment contract must monitor treatment that includes long-term prescription
of opioid analgesic medications. The prescribing health care provider must
document the monitoring in the medical record. Monitoring must include
everything in items A to G.
A. The
prescribing health care provider must schedule regular follow-up visits with
the patient. Visits must be at least quarterly in the first year of treatment
and no less than annually thereafter, except for patients taking more than 120
morphine-equivalent milligrams per day who must be seen at least every three
months, and except for patients at high risk of dependency or abuse under
subpart 6, item
B, who must be seen every month for the first six months and every three months
thereafter.
B. At each follow-up
visit, the prescribing health care provider must assess the success of the
program treatment in meeting its goals. The prescribing health care provider
must assess pain and function at each follow-up visit, using the same tools
chosen for the initial assessment in subpart 3. The program is considered
successful if there is improvement in both pain and function within six months
after long-term treatment with opioid analgesic medication is initiated, and
this improvement is at least maintained at subsequent follow-up
assessments.
C. At each follow-up
visit, the prescribing health care provider must assess the possible side
effects of treatment, misuse of medications, aberrant behaviors indicative of
addiction, or contraindications to continuing treatment.
D. At each follow-up visit, the prescribing
health care provider must assess the patients adherence to the entire program
of treatment.
E. At least
semiannually, the prescribing health care provider must review the patients
prescription history in the Minnesota prescription monitoring program to
validate correct medication usage, except that the prescription history must be
reviewed at every follow-up visit for each patient who is taking more than 120
morphine-equivalent milligrams per day or is at high risk for dependence or
abuse under subpart 6, item
B. If there is more than one instance of unreported opiate prescriptions from
other providers, the health care provider must discontinue opioid medications
using a schedule of tapering dosages as described in subpart
6, item M.
F. The prescribing health care provider has
discretion to order urine drug testing as part of a patients monitoring, except
that monitoring must include urine drug testing at least twice per year for
each patient who is taking more than 120 morphine-equivalent milligrams per day
or is at high risk for dependence or abuse under subpart
6, item B.
(1) Urine drug testing protocol is within the
discretion of the prescribing provider. After all tests requested by the
prescribing provider are completed, urine drug testing is failed if it shows
the presence of an illegal substance or if the results are inconsistent with
the opiate and dosage prescribed. If the urine drug testing is failed, opioid
medications must be discontinued using a schedule of tapering dosages as
described in subpart 6, item
M.
(2) If a urine sample is sent to
a laboratory for testing, the employer or insurer may designate the laboratory
so long as it is accredited by the College of American Pathologists under the
Forensic Urine Drug Testing Program.
G. The prescribing health care provider must
provide a referral to a pain medicine specialist for consultation under any of
the following circumstances:
(1) there is a
sudden or progressive increase in the dosage of opioid analgesic
required;
(2) the goals of the
treatment program are not met; or
(3) the patient requires more than 120
morphine-equivalent milligrams per day to meet or maintain the programs
treatment goals.
Subp.
9.
Notice and plan for compliance.
A prescribing providers failure to comply with any requirement
of this part is not a basis to deny payment for treatment with opioid
analgesics unless the insurer has previously sent the provider and the patient
a copy of this part and has given the provider at least 30 days to initiate a
plan to come into compliance. The insurer is required to send the provider and
patient the notice and provide 30 days to initiate a plan for compliance only
once.
Subp. 10.
Patients currently receiving treatment.
For a patient who is receiving long-term treatment with opioid
analgesic medication on the effective date of this part, the prescribing health
care provider must, within three months of receipt of written notice of this
part from the insurer to the provider and patient:
A. assess the patients current level of pain
and function using tools validated in peer-reviewed scientific literature as
required in subpart 3;
B. meet all
of the requirements of subpart
6, items C to M;
C. complete a written contract with the
patient that complies with the requirements of subpart
7; and
D. establish monitoring of the treatment that
complies with the requirements of subpart
8.
Subp. 11.
Incorporation by
reference.
The Diagnostic and Statistical Manual of Mental Disorders,
fifth edition (DSM-5), copyrighted by the American Psychiatric Association, is
incorporated by reference. It is not subject to frequent change, although the
American Psychiatric Association publishes DSM-5 errata and coding updates.
DSM-5 is published by American Psychiatric Publishing, Inc. (APPI), and may be
purchased from them by calling 800-368-5777 or by ordering online at the APPI
website. It is also available from other bookstores and online retailers. It is
available through the Minitex interlibrary loan system.
Statutory Authority: MS s
176.83