HF 1117

1st Engrossment - 88th Legislature (2013 - 2014) Posted on 03/13/2013 07:15pm

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 152.126, subdivision 6; 254B.04, by adding a subdivision;
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.1915] OPIOID ADDICTION TREATMENT EDUCATION
REQUIREMENT FOR PROVIDERS LICENSED TO PROVIDE CHEMICAL
DEPENDENCY TREATMENT SERVICES.
new text end

new text begin All programs licensed by the commissioner must provide educational information
concerning treatment options for opioid addiction, including the use of a medication for
the use of opioid addiction, to clients identified as having or seeking treatment for opioid
addiction. The commissioner shall develop educational materials that are supported by
research and updated periodically that must be used by programs to comply with this
requirement.
new text end

Sec. 2.

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 (a) 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.
new text end

new text begin (b) Where a standard in this section differs from a standard in an otherwise
applicable administrative rule, the standards of this section apply.
new text end

new text begin (c) When federal guidance or interpretations have been issued on federal standards
or requirements also required under this section, the federal guidance or interpretations
shall 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) To limit the potential for diversion
of medication used for the treatment of opioid addiction to the illicit market, any such
medications dispensed to patients for unsupervised use shall be subject to the following
requirements:
new text end

new text begin (1) any patient in an opioid treatment program may receive a single take-home dose
for a day that the clinic is closed for business, including Sundays and state and federal
holidays; and
new text end

new text begin (2) treatment program decisions on dispensing medications used to treat opioid
addiction to patients for unsupervised use beyond that set forth in paragraph (a), clause
(1), shall be determined by the medical director.
new text end

new text begin (b) The medical director must consider the criteria in paragraph (a) 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 (c) The determination, including the basis of the determination, must be consistent
with the criteria in paragraph (a), clause (2), 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 of methadone
hydrochloride. new text end

new text begin (a) In cases where it is determined that a client meets the criteria in
subdivision 5, paragraph (a), clause (2), and may be dispensed a medication used for the
treatment of opioid addiction, the restrictions in paragraphs (b) to (g) must be followed
when the medication to be dispensed is methadone hydrochloride.
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 of methadone hydrochloride, 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 Nonmedication treatment services; documentation. new text end

new text begin (a) The program
must provide at least one hour of individual or group therapy treatment services as defined
in Minnesota Rules, part 9530.6430, subpart 1, item A, subitem (1), per week for the
first ten weeks following admission, and at least one hour per month thereafter. The
program may provide additional levels of services when deemed clinically necessary.
Each treatment service must be at least 55 consecutive minutes in length.
new text end

new text begin (b) Notwithstanding the requirements of individual treatment plans set forth in
Minnesota Rules, part 9530.6425:
new text end

new text begin (1) treatment plan contents for maintenance clients are not required to include goals
the client must reach to complete treatment and have services terminated;
new text end

new text begin (2) treatment plans for clients in a taper or detox status must include goals the client
must reach to complete treatment and have services terminated;
new text end

new text begin (3) progress notes must be entered in a client's file at least weekly and be recorded in
each of the six dimensions for the initial ten weeks after admission for all new admissions,
readmissions, and transfers. Subsequently, the counselor must document progress no less
than one time monthly, recorded in the six dimensions, or when clinical need warrants
more frequent notations; and
new text end

new text begin (4) treatment plan reviews must occur weekly, or after each treatment service, which
is less frequent, for the first ten weeks of treatment for all new admissions, readmissions,
and transfers. Following the first ten weeks of treatment, treatment plan reviews may occur
monthly unless the client has needs that warrant more frequent revisions or documentation.
new text end

new text begin Subd. 11. new text end

new text begin Prescription monitoring program. new text end

new text begin (a) Upon admission to a methadone
clinic outpatient treatment program, clients shall be notified that the medical director
will monitor the prescription monitoring program to review the prescribed controlled
drugs the clients have received. 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 ordered 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. A
review of the PMP is not required for every medication dose adjustment.
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 in this section
differs from a standard in otherwise applicable 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
as required under subdivision 5, paragraph (a), clause (1). 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, excluding
those approved solely under subdivision 5, paragraph (a), clause (1), 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 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 (a)
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, and after taking into account an individual's preference for
placement in an opioid treatment program, a placement authority may, but is not required
to, authorize services or service coordination or otherwise place an individual in an opioid
treatment program. Prior to making a determination of placement for an individual, the
placing authority must consult with the current treatment provider, if any.
new text end

new text begin (b) Prior to placement of an individual who is determined by the assessor to require
treatment for opioid addiction, the assessor must provide educational information
concerning treatment options for opioid addiction, including the use of a medication
for the use of opioid addiction. The commissioner shall develop educational materials
supported by research and updated periodically that must be used by assessors to comply
with this requirement.
new text end

ARTICLE 3

CONTROLLED SUBSTANCES PRESCRIPTION MONITORING PROGRAM

Section 1.

Minnesota Statutes 2012, section 152.126, subdivision 6, is amended to read:

Subd. 6.

Access to reporting system data.

(a) Except as indicated in this
subdivision, the data submitted to the board under subdivision 4 is private data on
individuals as defined in section 13.02, subdivision 12, and not subject to public disclosure.

(b) Except as specified in subdivision 5, the following persons shall be considered
permissible users and may access the data submitted under subdivision 4 in the same or
similar manner, and for the same or similar purposes, as those persons who are authorized
to access similar private data on individuals under federal and state law:

(1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
delegated the task of accessing the data, to the extent the information relates specifically to
a current patient, to whom the prescriber is prescribing or considering prescribing any
controlled substance and with the provision that the prescriber remains responsible for the
use or misuse of data accessed by a delegated agent or employee;

(2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
delegated the task of accessing the data, to the extent the information relates specifically
to a current patient to whom that dispenser is dispensing or considering dispensing any
controlled substance and with the provision that the dispenser remains responsible for the
use or misuse of data accessed by a delegated agent or employee;

(3) an individual who is the recipient of a controlled substance prescription for
which data was submitted under subdivision 4, or a guardian of the individual, parent or
guardian of a minor, or health care agent of the individual acting under a health care
directive under chapter 145C;

(4) personnel of the board specifically assigned to conduct a bona fide investigation
of a specific licensee;

(5) personnel of the board engaged in the collection of controlled substance
prescription information as part of the assigned duties and responsibilities under this
section;

(6) authorized personnel of a vendor under contract with the board who are engaged
in the design, implementation, operation, and maintenance of the electronic reporting
system as part of the assigned duties and responsibilities of their employment, provided
that access to data is limited to the minimum amount necessary to carry out such duties
and responsibilities;

(7) federal, state, and local law enforcement authorities acting pursuant to a valid
search warrant; and

(8) personnel of the medical assistance program assigned to use the data collected
under this section to identify recipients whose usage of controlled substances may warrant
restriction to a single primary care physician, a single outpatient pharmacy, or a single
hospital.

For purposes of clause (3), access by an individual includes persons in the definition
of an individual under section 13.02.

(c) Any permissible user identified in paragraph (b), who directly accesses
the data electronically, shall implement and maintain a comprehensive information
security program that contains administrative, technical, and physical safeguards that
are appropriate to the user's size and complexity, and the sensitivity of the personal
information obtained. The permissible user shall identify reasonably foreseeable internal
and external risks to the security, confidentiality, and integrity of personal information
that could result in the unauthorized disclosure, misuse, or other compromise of the
information and assess the sufficiency of any safeguards in place to control the risks.

(d) The board shall not release data submitted under this section unless it is provided
with evidence, satisfactory to the board, that the person requesting the information is
entitled to receive the data.

(e) The board shall not release the name of a prescriber without the written consent
of the prescriber or a valid search warrant or court order. The board shall provide a
mechanism for a prescriber to submit to the board a signed consent authorizing the release
of the prescriber's name when data containing the prescriber's name is requested.

(f) The board shall maintain a log of all persons who access the data and shall ensure
that any permissible user complies with paragraph (c) prior to attaining direct access to
the data.

(g) Section 13.05, subdivision 6, shall apply to any contract the board enters into
pursuant to subdivision 2. A vendor shall not use data collected under this section for
any purpose not specified in this section.

new text begin (h) The commissioner of human services shall establish and implement a system
through which the Department of Human Services shall routinely access the data for
the purpose of determining whether any client enrolled in an opioid treatment program
licensed according to chapter 245A has been prescribed or dispensed a controlled
substance in addition to that administered or dispensed by the opioid treatment program.
When the commissioner determines there have been multiple prescribers or multiple
prescriptions of controlled substances, the commissioner shall:
new text end

new text begin (1) inform the medical director of the opioid treatment program only that the
commissioner determined the existence of multiple prescribers or multiple prescriptions of
controlled substances; and
new text end

new text begin (2) direct the medical director of the opioid treatment program to access the data
directly, review the effect of the multiple prescribers or multiple prescriptions, and
document the review.
new text end

new text begin If determined necessary, the commissioner of human services shall seek a federal waiver
of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
2.34, item (c), prior to implementing this paragraph.
new text end