HF 1117

as introduced - 88th Legislature (2013 - 2014) Posted on 03/04/2013 01:50pm

A bill for an act
relating to human services; modifying provisions related to chemical and mental
health and human services licensing; establishing methadone treatment program
standards; modifying drug treatment provisions; amending Minnesota Statutes
2012, sections 254B.04, by adding a subdivision; 254B.05, subdivision 1b;
proposing coding for new law in Minnesota Statutes, chapter 245A.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

ARTICLE 1

LICENSING

Section 1.

new text begin [245A.192] PROVIDERS LICENSED TO PROVIDE TREATMENT
OF OPIOID ADDICTION.
new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin This section applies to services licensed under this chapter to
provide treatment for opioid addiction. In addition to the requirements under Minnesota
Rules, parts 9530.6405 to 9530.6505, a program licensed to provide treatment of opioid
addiction must meet the requirements in this section. Where a standard exceeds that in
administrative rule, the standards of this section apply.
new text end

new text begin Subd. 2. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the terms defined in this
subdivision have the meanings given them.
new text end

new text begin (b) "Diversion" means the use of a medication for the treatment of opioid addiction
being diverted from its intended use.
new text end

new text begin (c) "Medication used for the treatment of opioid addiction" means a medication
approved by the Food and Drug Administration for the treatment of opioid addiction.
new text end

new text begin (d) "Opioid treatment program" has the meaning given in Code of Federal
Regulations, title 42, section 8.12, and includes programs licensed under Minnesota Rules,
part 9530.6500.
new text end

new text begin (e) "Program" means an entity that is licensed under Minnesota Rules, part 9530.6500.
new text end

new text begin (f) "Unsupervised use" means the use of a medication for the treatment of opioid
addiction dispensed for use by a client outside of the program setting. This is also referred
to as a "take-home" dose.
new text end

new text begin (g) "Placing authority" has the meaning given in Minnesota Rules, part 9530.6605,
subpart 21a.
new text end

new text begin (h) "Minnesota health care programs" has the meaning given in section 256B.0636,
clause (3).
new text end

new text begin Subd. 3. new text end

new text begin Medication orders. new text end

new text begin Prior to the program administering or dispensing a
medication used for the treatment of opioid addiction:
new text end

new text begin (1) a client-specific order must be received by an appropriately credentialed
physician;
new text end

new text begin (2) the signed order must be documented in the client's record; and
new text end

new text begin (3) if the order is not directly issued by the physician, such as a verbal order, the
physician that issued the order must review the documentation and sign the order in the
client's record within 72 hours of the medication being administered or dispensed. The
physician must document whether the medication was administered or dispensed as
ordered. If the medication was not administered or dispensed as ordered, the license
holder must report the incident to the commissioner.
new text end

new text begin Subd. 4. new text end

new text begin Drug testing. new text end

new text begin Each client enrolled in the program must receive a minimum
of eight random drug abuse tests per 12 months of treatment. These tests must be
reasonably disbursed over the 12-month period. A license holder may elect to conduct
more drug abuse tests.
new text end

new text begin Subd. 5. new text end

new text begin Criteria for unsupervised use. new text end

new text begin (a) The medical director must determine
whether a client may be dispensed medication used for the treatment of opioid addiction
for unsupervised or take-home use outside of the program. The medical director must
consider the criteria in this paragraph in determining whether a client may be permitted
unsupervised or take-home use of such medications. The criteria must also be considered
when determining whether dispensing medication for a client's unsupervised use is
appropriate to increase or to extend the amount of time between visits to the program.
The criteria includes:
new text end

new text begin (1) absence of recent abuse of drugs including but not limited to opioids,
nonnarcotics, and alcohol;
new text end

new text begin (2) regularity of program attendance;
new text end

new text begin (3) absence of serious behavioral problems at the program;
new text end

new text begin (4) absence of known recent criminal activity such as drug dealing;
new text end

new text begin (5) stability of the client's home environment and social relationships;
new text end

new text begin (6) length of time in comprehensive maintenance treatment;
new text end

new text begin (7) reasonable assurance that take-home medication will be safely stored within the
client's home; and
new text end

new text begin (8) whether the rehabilitative benefit the client derived from decreasing the frequency
of program attendance outweighs the potential risks of diversion or unsupervised use.
new text end

new text begin (b) The determination, including the basis of the determination, must be consistent
with the criteria in paragraph (a) and must be documented in the client's medical record.
new text end

new text begin Subd. 6. new text end

new text begin Restrictions for unsupervised or take-home use. new text end

new text begin (a) In cases where it
is determined that a client meets the criteria in subdivision 5 and may be dispensed a
medication used for the treatment of opioid addiction, the restrictions in paragraphs (b)
to (g) must be followed.
new text end

new text begin (b) During the first 90 days of treatment, the take-home supply must be limited to
a maximum of a single dose each week and the client shall ingest all other doses under
direct supervision.
new text end

new text begin (c) In the second 90 days of treatment, the take-home supply must be limited to
two doses per week.
new text end

new text begin (d) In the third 90 days of treatment, the take-home supply must not exceed three
doses per week.
new text end

new text begin (e) In the remaining months of the first year, a client may be given a maximum
six-day supply of take-home medication.
new text end

new text begin (f) After one year of continuous treatment, a client may be given a maximum
two-week supply of take-home medication.
new text end

new text begin (g) After two years of continuous treatment, a client may be given a maximum
one-month supply of take-home medication, but must make monthly visits.
new text end

new text begin Subd. 7. new text end

new text begin Restriction exceptions. new text end

new text begin When a license holder has reason to accelerate
the number of unsupervised or take-home doses, the license holder must comply with
the requirements of Code of Federal Regulations, title 42, chapter 1, subchapter A, part
8, section 8.12, the criteria for unsupervised use in subdivision 5, and must use the
exception process provided by the federal Center for Substance Abuse Treatment Division
of Pharmacologic Therapies. For the purposes of enforcement of this subdivision, the
commissioner has the authority to monitor for compliance with these federal regulations
and may issue licensing actions according to sections 245A.05, 245A.06, and 245A.07
based on the commissioner's determination of noncompliance.
new text end

new text begin Subd. 8. new text end

new text begin Guest dosing. new text end

new text begin For purposes of this subdivision, "guest dosing" means the
practice of administering a medication used for the treatment of opioid addiction to a
person who is not a client of the program that is administering or dispensing the medication.
In order to receive a guest dose, the client must be enrolled in an opioid treatment program
elsewhere in the state or country and be receiving the medication on a temporary basis
because the client is not able to receive the medication at the program in which the client is
enrolled. Such arrangements shall not exceed 30 consecutive days in any one program and
must not be for the convenience or benefit of either program. Guest dosing may also occur
when the client's primary clinic is not open and the client is not receiving take-home doses.
new text end

new text begin Subd. 9. new text end

new text begin Data and reporting. new text end

new text begin The license holder must submit data concerning
medication used for the treatment of opioid addiction to a central registry. The data must
be submitted in a method determined by the commissioner and must be submitted for each
client at the time of admission and discharge. The program must document the date the
information was submitted. This requirement is effective upon implementation of changes
to the Drug and Alcohol Abuse Normative Evaluation System (DAANES) or development
of an electronic system by which to submit the data.
new text end

new text begin Subd. 10. new text end

new text begin Amount of treatment services. new text end

new text begin The program must provide at least
two individual or group therapy treatment services as defined in Minnesota Rules, part
9530.6430, subpart 1, item A, subitem (1), per week, or at least one treatment service per
month if more than one week of take-home medication is dispensed to the client. Each
treatment service must be at least 55 consecutive minutes in length.
new text end

new text begin Subd. 11. new text end

new text begin Prescription monitoring program. new text end

new text begin (a) The medical director or the
medical director's delegate must review data from the Minnesota Board of Pharmacy,
prescription monitoring program (PMP) established under section 152.126 prior to the
client being prescribed any controlled substance as defined under section 152.126,
subdivision 1, paragraph (b), including medications used for the treatment of opioid
addiction. The subsequent reviews of the PMP data must occur monthly and be
documented in the client's individual file. Additionally, any findings from the PMP data
that are relevant to the medical director's course of treatment for the client must be
documented in the client's individual file.
new text end

new text begin (b) In cases where the PMP data identifies that a client is receiving a medication that
may be contraindicated if the client is also prescribed a medication used for the treatment
of opioid addiction, the program must seek the client's consent to discuss the client's
opioid treatment with the other prescriber and must seek consent for the other prescriber
to disclose to the opioid treatment program's medical director the client's condition that
formed the basis of the other prescription.
new text end

new text begin (c) The commissioner shall pursue a waiver of, or exception to, Code of Federal
Regulations, title 42, part 2, to permit programs licensed under this section to be required
to meet the PMP reporting requirements under section 152.126 related to medications
prescribed for the treatment of opioid addiction. If the federal waiver is granted, the
commissioner, in consultation with the Minnesota Board of Pharmacy, shall propose
legislation directing the opioid treatment programs' participation in the PMP.
new text end

new text begin Subd. 12. new text end

new text begin Policies and procedures. new text end

new text begin (a) License holders must develop and maintain
the policies and procedures required in this subdivision. Where a standard exceeds that in
administrative rule, the standards of this subdivision apply.
new text end

new text begin (b) For programs that are not open every day of the year, the license holder must
maintain a policy and procedure that permits clients to receive a single unsupervised
use of medication used for the treatment of opioid addiction for days that the program
is closed for business, including, but not limited to, Sundays and state and federal
holidays. The criteria for unsupervised use in subdivision 5, paragraph (a), do not apply
to unsupervised use under this paragraph.
new text end

new text begin (c) The license holder must maintain a policy and procedure that includes specific
measures to reduce the possibility of medication used for the treatment of opioid addiction
being diverted from its intended treatment use. The policy and procedure must:
new text end

new text begin (1) specifically identify and define the responsibilities of the medical and
administrative staff for carrying out diversion control measures; and
new text end

new text begin (2) include a process for contacting no less than five percent of clients who have
unsupervised use of medication used for the treatment of opioid addiction to require them
to physically return to the program each month. The system must require clients to return
to the program within a stipulated time frame and turn in all medication containers related
to opioid addiction treatment. The license holder must document all related contacts on a
central log and the outcome of the contact for each client in the individual client's record.
new text end

new text begin (d) Medications used for the treatment of opioid addictions must be ordered,
administered, and dispensed according to applicable state and federal regulations and the
standards set by applicable accreditation entities. In addition, when an order requires
assessment by the person administering or dispensing the medication to determine
the amount to be administered or dispensed, the assessment must be completed by
an individual whose professional scope of practice permits such assessment. For the
purposes of enforcement of this paragraph, the commissioner has the authority to monitor
for compliance with these state and federal regulations and the relevant standards of
the license holder's accreditation agency and may issue licensing actions according to
sections 245A.05, 245A.06, and 245A.07 based on the commissioner's determination
of noncompliance.
new text end

new text begin (e) The program must maintain a policy to address the treatment needs of clients
for whom it is their first treatment episode for opioid addiction. For clients for whom the
opioid treatment is their first chemical dependency treatment, the program must provide
clients educational information concerning treatment alternatives to medication used for
the treatment of opioid addiction. The education must include the risk and benefits of the
alternatives and the clients' participation in the education must be documented. If a client
refuses the educational information, the program must attempt at least weekly for the first
six weeks of treatment to provide the education. This is in addition to providing education
according to Minnesota Rules, part 9530.6430, subpart 1, item A, subitem (1).
new text end

new text begin Subd. 13. new text end

new text begin Quality improvement plan. new text end

new text begin The license holder must develop and
maintain a quality improvement process and plan. The plan must:
new text end

new text begin (1) include evaluation of the services provided to clients with the goal of identifying
issues that may improve service delivery and client outcomes;
new text end

new text begin (2) include goals for the program to accomplish based on the evaluation;
new text end

new text begin (3) be reviewed annually by the management of the program to determine whether
the goals were met and if not, whether additional action is required;
new text end

new text begin (4) be updated at least annually to include new or continued goals based on an
updated evaluation of services; and
new text end

new text begin (5) identify two specific goal areas, in addition to others identified by the program
including:
new text end

new text begin (i) a goal concerning oversight and monitoring of the premises around and near the
exterior of the program to reduce the possibility of medication used for the treatment of
opioid addiction being inappropriately used by clients, including but not limited to the sale
or transfer of the medication to others; and
new text end

new text begin (ii) a goal concerning community outreach, including but not limited to
communications with local law enforcement and county human services agencies with
the goal of increasing coordination of services and identification of areas of concern to
be addressed in the plan.
new text end

new text begin Subd. 14. new text end

new text begin Placing authorities. new text end

new text begin Programs must provide certain notification and
client-specific updates to placing authorities for clients who are enrolled in Minnesota
health care programs. At the request of the placing authority, the program must provide
client-specific updates, including but not limited to informing the placing authority of
positive drug screenings and changes in medications used for the treatment of opioid
addiction ordered for the client.
new text end

ARTICLE 2

CHEMICAL AND MENTAL HEALTH

Section 1.

Minnesota Statutes 2012, section 254B.04, is amended by adding a
subdivision to read:

new text begin Subd. 2b. new text end

new text begin Eligibility for placement in opioid treatment programs.
new text end

new text begin Notwithstanding provisions of Minnesota Rules, part 9530.6622, subpart 5, related
to a placement authority's requirement to authorize services or service coordination
in a program that complies with Minnesota Rules, part 9530.6500, or Code of Federal
Regulations, title 42, part 8, a placement authority may authorize services or service
coordination or otherwise place an individual in an opioid treatment program.
new text end

Sec. 2.

Minnesota Statutes 2012, section 254B.05, subdivision 1b, is amended to read:

Subd. 1b.

Additional vendor requirements.

new text begin (a) new text end Vendors must comply with the
following duties:

(1) maintain a provider agreement with the department;

(2) continually comply with the standards in the agreement;

(3) participate in the Drug Alcohol Normative Evaluation System;

(4) submit an annual financial statement which reports functional expenses of
chemical dependency treatment costs in a form approved by the commissioner;

(5) report information about the vendor's current capacity in a manner prescribed
by the commissioner; and

(6) maintain adequate and appropriate insurance coverage necessary to provide
chemical dependency treatment services, and at a minimum:

(i) employee dishonesty in the amount of $10,000 if the vendor has or had custody
or control of money or property belonging to clients; and

(ii) bodily injury and property damage in the amount of $2,000,000 for each
occurrence.

new text begin (b) For vendors of opioid treatment services, the medical director or the medical
director's designee must review data from the prescription monitoring program (PMP)
established under section 152.126, and conduct monthly reviews of all prescriptions of
controlled substances dispensed to all clients served by their clinics. The client files
must include documentation of the reviews.
new text end