Bill Text: MN HF1117 | 2013-2014 | 88th Legislature | Engrossed
Bill Title: Chemical and mental health and human service licensing provisions modified, methadone treatment program standards established, drug treatment provisions modified, and Schedule I controlled substances added to list.
Spectrum: Slight Partisan Bill (Democrat 3-1)
Status: (Passed) 2013-05-24 - Secretary of State Chapter 113 [HF1117 Detail]
Download: Minnesota-2013-HF1117-Engrossed.html
1.2relating to human services; modifying provisions related to chemical and mental
1.3health and human services licensing; establishing methadone treatment program
1.4standards; modifying drug treatment provisions; adding to the list of Schedule
1.5I controlled substances;amending Minnesota Statutes 2012, sections 152.01,
1.6subdivision 5a; 152.02, subdivision 2; 152.126, subdivision 6; 254B.04, by adding
1.7a subdivision; proposing coding for new law in Minnesota Statutes, chapter 245A.
1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.11 Section 1. [245A.1915] OPIOID ADDICTION TREATMENT EDUCATION
1.12REQUIREMENT FOR PROVIDERS LICENSED TO PROVIDE CHEMICAL
1.13DEPENDENCY TREATMENT SERVICES.
1.14All programs licensed by the commissioner must provide educational information
1.15concerning treatment options for opioid addiction, including the use of a medication for
1.16the use of opioid addiction, to clients identified as having or seeking treatment for opioid
1.17addiction. The commissioner shall develop educational materials that are supported by
1.18research and updated periodically that must be used by programs to comply with this
1.19requirement.
1.20 Sec. 2. [245A.192] PROVIDERS LICENSED TO PROVIDE TREATMENT OF
1.21OPIOID ADDICTION.
1.22 Subdivision 1. Scope. (a) This section applies to services licensed under this chapter
1.23to provide treatment for opioid addiction. In addition to the requirements under Minnesota
2.1Rules, parts 9530.6405 to 9530.6505, a program licensed to provide treatment of opioid
2.2addiction must meet the requirements in this section.
2.3(b) Where a standard in this section differs from a standard in an otherwise
2.4applicable administrative rule, the standards of this section apply.
2.5(c) When federal guidance or interpretations have been issued on federal standards
2.6or requirements also required under this section, the federal guidance or interpretations
2.7shall apply.
2.8 Subd. 2. Definitions. (a) For purposes of this section, the terms defined in this
2.9subdivision have the meanings given them.
2.10(b) "Diversion" means the use of a medication for the treatment of opioid addiction
2.11being diverted from its intended use.
2.12(c) "Guest dose or dosing" means the practice of administering a medication used
2.13for the treatment of opioid addiction to a person who is not a client of the program that is
2.14administering or dispensing the medication.
2.15(d) "Medical director" means a physician, licensed to practice medicine in the
2.16jurisdiction in which the opioid treatment program is located, who assumes responsibility
2.17for administering all medical services performed by the program, either by performing
2.18them directly or by delegating specific responsibility to authorized program physicians
2.19and health care professionals functioning under the medical director's direct supervision.
2.20(e) "Medication used for the treatment of opioid addiction" means a medication
2.21approved by the Food and Drug Administration for the treatment of opioid addiction.
2.22(f) "Opioid treatment program" has the meaning given in Code of Federal
2.23Regulations, title 42, section 8.12, and includes programs licensed under Minnesota Rules,
2.24part 9530.6500.
2.25(g) "Program" means an entity that is licensed under Minnesota Rules, part
2.269530.6500.
2.27(h) "Unsupervised use" means the use of a medication for the treatment of opioid
2.28addiction dispensed for use by a client outside of the program setting. This is also referred
2.29to as a "take-home" dose.
2.30(i) "Placing authority" has the meaning given in Minnesota Rules, part 9530.6605,
2.31subpart 21a.
2.32(j) "Minnesota health care programs" has the meaning given in section 256B.0636,
2.33clause (3).
2.34 Subd. 3. Medication orders. Prior to the program administering or dispensing a
2.35medication used for the treatment of opioid addiction:
3.1(1) a client-specific order must be received from an appropriately credentialed
3.2physician;
3.3(2) the signed order must be documented in the client's record; and
3.4(3) if the order is not directly issued by the physician, such as a verbal order, the
3.5physician that issued the order must review the documentation and sign the order in the
3.6client's record within 72 hours of the medication being administered or dispensed. The
3.7physician must document whether the medication was administered or dispensed as
3.8ordered. The license holder must report to the commissioner any medication error that
3.9endangers a patient's health, as determined by the medical director.
3.10 Subd. 4. Drug testing. Each client enrolled in the program must receive a minimum
3.11of eight random drug abuse tests per 12 months of treatment. These tests must be
3.12reasonably disbursed over the 12-month period. A license holder may elect to conduct
3.13more drug abuse tests.
3.14 Subd. 5. Criteria for unsupervised use. (a) To limit the potential for diversion
3.15of medication used for the treatment of opioid addiction to the illicit market, any such
3.16medications dispensed to patients for unsupervised use shall be subject to the following
3.17requirements:
3.18(1) any patient in an opioid treatment program may receive a single take-home dose
3.19for a day that the clinic is closed for business, including Sundays and state and federal
3.20holidays; and
3.21(2) treatment program decisions on dispensing medications used to treat opioid
3.22addiction to patients for unsupervised use beyond that set forth in paragraph (a), clause
3.23(1), shall be determined by the medical director.
3.24(b) The medical director must consider the criteria in paragraph (a) in determining
3.25whether a client may be permitted unsupervised or take-home use of such medications.
3.26The criteria must also be considered when determining whether dispensing medication
3.27for a client's unsupervised use is appropriate to increase or to extend the amount of time
3.28between visits to the program. The criteria includes:
3.29(1) absence of recent abuse of drugs including but not limited to opioids,
3.30nonnarcotics, and alcohol;
3.31(2) regularity of program attendance;
3.32(3) absence of serious behavioral problems at the program;
3.33(4) absence of known recent criminal activity such as drug dealing;
3.34(5) stability of the client's home environment and social relationships;
3.35(6) length of time in comprehensive maintenance treatment;
4.1(7) reasonable assurance that take-home medication will be safely stored within the
4.2client's home; and
4.3(8) whether the rehabilitative benefit the client derived from decreasing the frequency
4.4of program attendance outweighs the potential risks of diversion or unsupervised use.
4.5(c) The determination, including the basis of the determination, must be consistent
4.6with the criteria in paragraph (a), clause (2), and must be documented in the client's
4.7medical record.
4.8 Subd. 6. Restrictions for unsupervised or take-home use of methadone
4.9hydrochloride. (a) In cases where it is determined that a client meets the criteria in
4.10subdivision 5, paragraph (a), clause (2), and may be dispensed a medication used for the
4.11treatment of opioid addiction, the restrictions in paragraphs (b) to (g) must be followed
4.12when the medication to be dispensed is methadone hydrochloride.
4.13(b) During the first 90 days of treatment, the take-home supply must be limited to
4.14a maximum of a single dose each week and the client shall ingest all other doses under
4.15direct supervision.
4.16(c) In the second 90 days of treatment, the take-home supply must be limited to
4.17two doses per week.
4.18(d) In the third 90 days of treatment, the take-home supply must not exceed three
4.19doses per week.
4.20(e) In the remaining months of the first year, a client may be given a maximum
4.21six-day supply of take-home medication.
4.22(f) After one year of continuous treatment, a client may be given a maximum
4.23two-week supply of take-home medication.
4.24(g) After two years of continuous treatment, a client may be given a maximum
4.25one-month supply of take-home medication, but must make monthly visits.
4.26 Subd. 7. Restriction exceptions. When a license holder has reason to accelerate
4.27the number of unsupervised or take-home doses of methadone hydrochloride, the license
4.28holder must comply with the requirements of Code of Federal Regulations, title 42, chapter
4.291, subchapter A, part 8, section 8.12, the criteria for unsupervised use in subdivision 5,
4.30and must use the exception process provided by the federal Center for Substance Abuse
4.31Treatment Division of Pharmacologic Therapies. For the purposes of enforcement of
4.32this subdivision, the commissioner has the authority to monitor for compliance with
4.33these federal regulations and may issue licensing actions according to sections 245A.05,
4.34245A.06, and 245A.07 based on the commissioner's determination of noncompliance.
4.35 Subd. 8. Guest dosing. In order to receive a guest dose, the client must be enrolled
4.36in an opioid treatment program elsewhere in the state or country and be receiving the
5.1medication on a temporary basis because the client is not able to receive the medication
5.2at the program in which the client is enrolled. Such arrangements shall not exceed 30
5.3consecutive days in any one program and must not be for the convenience or benefit of
5.4either program. Guest dosing may also occur when the client's primary clinic is not open
5.5and the client is not receiving take-home doses.
5.6 Subd. 9. Data and reporting. The license holder must submit data concerning
5.7medication used for the treatment of opioid addiction to a central registry. The data must
5.8be submitted in a method determined by the commissioner and must be submitted for each
5.9client at the time of admission and discharge. The program must document the date the
5.10information was submitted. This requirement is effective upon implementation of changes
5.11to the Drug and Alcohol Abuse Normative Evaluation System (DAANES) or development
5.12of an electronic system by which to submit the data.
5.13 Subd. 10. Nonmedication treatment services; documentation. (a) The program
5.14must offer at least 50 consecutive minutes of individual or group therapy treatment services
5.15as defined in Minnesota Rules, part 9530.6430, subpart 1, item A, subitem (1), per week,
5.16for the first ten weeks following admission, and at least 50 consecutive minutes per month
5.17thereafter. As clinically appropriate, the program may offer these services cumulatively
5.18and not consecutively in increments of no less than 15 minutes over the required time
5.19period, and for a total of 60 minutes of treatment services over the time period, and must
5.20document the reason for providing services cumulatively in the client's record. The
5.21program may offer additional levels of service when deemed clinically necessary.
5.22(b) Notwithstanding the requirements of individual treatment plans set forth in
5.23Minnesota Rules, part 9530.6425:
5.24(1) treatment plan contents for maintenance clients are not required to include goals
5.25the client must reach to complete treatment and have services terminated;
5.26(2) treatment plans for clients in a taper or detox status must include goals the client
5.27must reach to complete treatment and have services terminated;
5.28(3) for the initial ten weeks after admission for all new admissions, readmissions, and
5.29transfers, progress notes must be entered in a client's file at least weekly and be recorded
5.30in each of the six dimensions upon the development of the treatment plan and thereafter.
5.31Subsequently, the counselor must document progress no less than one time monthly,
5.32recorded in the six dimensions or when clinical need warrants more frequent notations; and
5.33(4) upon the development of the treatment plan and thereafter, treatment plan
5.34reviews must occur weekly, or after each treatment service, whichever is less frequent,
5.35for the first ten weeks of treatment for all new admissions, readmissions, and transfers.
6.1Following the first ten weeks of treatment, treatment plan reviews may occur monthly,
6.2unless the client has needs that warrant more frequent revisions or documentation.
6.3 Subd. 11. Prescription monitoring program. (a) Upon admission to a methadone
6.4clinic outpatient treatment program, clients shall be notified that the Department of Human
6.5Services and the medical director will monitor the prescription monitoring program to
6.6review the prescribed controlled drugs the clients have received. The medical director or
6.7the medical director's delegate must review data from the Minnesota Board of Pharmacy,
6.8prescription monitoring program (PMP) established under section 152.126 prior to the
6.9client being ordered any controlled substance as defined under section 152.126, subdivision
6.101, paragraph (b), including medications used for the treatment of opioid addiction. The
6.11subsequent reviews of the PMP data must occur quarterly and be documented in the
6.12client's individual file. When the PMP data shows a recent history of multiple prescribers
6.13or multiple prescriptions for controlled substances, then subsequent reviews of the PMP
6.14data must occur monthly and be documented in the client's individual file. If, at any time,
6.15the medical director believes the use of the controlled substances places the client at risk
6.16of harm, the program must seek the client's consent to discuss the client's opioid treatment
6.17with other prescribers and must seek consent for the other prescriber to disclose to the
6.18opioid treatment programs' medical director the client's condition that formed the basis of
6.19the other prescriptions. Additionally, any findings from the PMP data that are relevant to
6.20the medical director's course of treatment for the client must be documented in the client's
6.21individual file. A review of the PMP is not required for every medication dose adjustment.
6.22(b) The commissioner shall collaborate with the Minnesota Board of Pharmacy
6.23to develop and implement an electronic system through which the commissioner shall
6.24routinely access the data from the Minnesota Board of Pharmacy prescription monitoring
6.25program established under section 152.126 for the purpose of determining whether
6.26any client enrolled in an opioid addiction treatment program licensed according to this
6.27section has also been prescribed or dispensed a controlled substance in addition to
6.28that administered or dispensed by the opioid addiction treatment program. When the
6.29commissioner determines there have been multiple prescribers or multiple prescriptions of
6.30controlled substances, the commissioner shall:
6.31(1) inform the medical director of the opioid treatment program only that the
6.32commissioner determined the existence of multiple prescribers or multiple prescriptions of
6.33controlled substances; and
6.34(2) direct the medical director of the opioid treatment program to access the data
6.35directly, review the effect of the multiple prescribers or multiple prescriptions, and
6.36document the review.
7.1(c) If determined necessary, the commissioner shall seek a federal waiver of, or
7.2exception to, any applicable provision of Code of Federal Regulations, title 42, part 2.34,
7.3item (c), prior to implementing this paragraph.
7.4 Subd. 12. Policies and procedures. (a) License holders must develop and maintain
7.5the policies and procedures required in this subdivision. Where a standard in this section
7.6differs from a standard in otherwise applicable administrative rule, the standards of this
7.7subdivision apply.
7.8(b) For programs that are not open every day of the year, the license holder must
7.9maintain a policy and procedure that permits clients to receive a single unsupervised use
7.10of medication used for the treatment of opioid addiction for days that the program is
7.11closed for business, including, but not limited to, Sundays and state and federal holidays
7.12as required under subdivision 5, paragraph (a), clause (1).
7.13(c) The license holder must maintain a policy and procedure that includes specific
7.14measures to reduce the possibility of medication used for the treatment of opioid addiction
7.15being diverted from its intended treatment use. The policy and procedure must:
7.16(1) specifically identify and define the responsibilities of the medical and
7.17administrative staff for carrying out diversion control measures; and
7.18(2) include a process for contacting no less than five percent of clients who have
7.19unsupervised use of medication used for the treatment of opioid addiction, excluding those
7.20approved solely under subdivision 5, paragraph (a), clause (1), to require them to physically
7.21return to the program each month. The system must require clients to return to the program
7.22within a stipulated time frame and turn in all unused medication containers related to
7.23opioid addiction treatment. The license holder must document all related contacts on a
7.24central log and the outcome of the contact for each client in the individual client's record.
7.25(d) Medications used for the treatment of opioid addictions must be ordered,
7.26administered, and dispensed according to applicable state and federal regulations and the
7.27standards set by applicable accreditation entities. In addition, when an order requires
7.28assessment by the person administering or dispensing the medication to determine
7.29the amount to be administered or dispensed, the assessment must be completed by
7.30an individual whose professional scope of practice permits such assessment. For the
7.31purposes of enforcement of this paragraph, the commissioner has the authority to monitor
7.32for compliance with these state and federal regulations and the relevant standards of
7.33the license holder's accreditation agency and may issue licensing actions according to
7.34sections 245A.05, 245A.06, and 245A.07 based on the commissioner's determination
7.35of noncompliance.
8.1 Subd. 13. Quality improvement plan. The license holder must develop and
8.2maintain a quality improvement process and plan. The plan must:
8.3(1) include evaluation of the services provided to clients with the goal of identifying
8.4issues that may improve service delivery and client outcomes;
8.5(2) include goals for the program to accomplish based on the evaluation;
8.6(3) be reviewed annually by the management of the program to determine whether
8.7the goals were met and if not, whether additional action is required;
8.8(4) be updated at least annually to include new or continued goals based on an
8.9updated evaluation of services; and
8.10(5) identify two specific goal areas, in addition to others identified by the program
8.11including:
8.12(i) a goal concerning oversight and monitoring of the premises around and near the
8.13exterior of the program to reduce the possibility of medication used for the treatment of
8.14opioid addiction being inappropriately used by clients, including but not limited to the sale
8.15or transfer of the medication to others; and
8.16(ii) a goal concerning community outreach, including but not limited to
8.17communications with local law enforcement and county human services agencies with
8.18the goal of increasing coordination of services and identification of areas of concern to
8.19be addressed in the plan.
8.20 Subd. 14. Placing authorities. Programs must provide certain notification and
8.21client-specific updates to placing authorities for clients who are enrolled in Minnesota
8.22health care programs. At the request of the placing authority, the program must provide
8.23client-specific updates, including but not limited to informing the placing authority of
8.24positive drug screenings and changes in medications used for the treatment of opioid
8.25addiction ordered for the client.
8.28 Section 1. Minnesota Statutes 2012, section 254B.04, is amended by adding a
8.29subdivision to read:
8.30 Subd. 2b. Eligibility for placement in opioid treatment programs. (a)
8.31Notwithstanding provisions of Minnesota Rules, part 9530.6622, subpart 5, related
8.32to a placement authority's requirement to authorize services or service coordination
8.33in a program that complies with Minnesota Rules, part 9530.6500, or Code of Federal
8.34Regulations, title 42, part 8, and after taking into account an individual's preference for
8.35placement in an opioid treatment program, a placement authority may, but is not required
9.1to, authorize services or service coordination or otherwise place an individual in an opioid
9.2treatment program. Prior to making a determination of placement for an individual, the
9.3placing authority must consult with the current treatment provider, if any.
9.4(b) Prior to placement of an individual who is determined by the assessor to require
9.5treatment for opioid addiction, the assessor must provide educational information
9.6concerning treatment options for opioid addiction, including the use of a medication
9.7for the use of opioid addiction. The commissioner shall develop educational materials
9.8supported by research and updated periodically that must be used by assessors to comply
9.9with this requirement.
9.12 Section 1. Minnesota Statutes 2012, section 152.01, subdivision 5a, is amended to read:
9.13 Subd. 5a. Hallucinogen. "Hallucinogen" means any hallucinogen listed in section
9.14152.02, subdivision 2
, clause (3) paragraph (d), or Minnesota Rules, part 6800.4210, item
9.15C, except marijuana and Tetrahydrocannabinols.
9.16EFFECTIVE DATE.This section is effective August 1, 2013, and applies to crimes
9.17committed on or after that date.
9.18 Sec. 2. Minnesota Statutes 2012, section 152.02, subdivision 2, is amended to read:
9.19 Subd. 2. Schedule I. (a) Schedule I consists of the substances listed in this
9.20subdivision.
9.21(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of
9.22the following substances, including their analogs, isomers, esters, ethers, salts, and salts
9.23of isomers, esters, and ethers, whenever the existence of the analogs, isomers, esters,
9.24ethers, and salts is possible:
9.25(1) acetylmethadol;
9.26(2) allylprodine;
9.27(3) alphacetylmethadol (except levo-alphacetylmethadol, also known as
9.28levomethadyl acetate);
9.29(4) alphameprodine;
9.30(5) alphamethadol;
9.31(6) alpha-methylfentanyl benzethidine;
9.32(7) betacetylmethadol;
9.33(8) betameprodine;
10.1(9) betamethadol;
10.2(10) betaprodine;
10.3(11) clonitazene;
10.4(12) dextromoramide;
10.5(13) diampromide;
10.6(14) diethyliambutene;
10.7(15) difenoxin;
10.8(16) dimenoxadol;
10.9(17) dimepheptanol;
10.10(18) dimethyliambutene;
10.11(19) dioxaphetyl butyrate;
10.12(20) dipipanone;
10.13(21) ethylmethylthiambutene;
10.14(22) etonitazene;
10.15(23) etoxeridine;
10.16(24) furethidine;
10.17(25) hydroxypethidine;
10.18(26) ketobemidone;
10.19(27) levomoramide;
10.20(28) levophenacylmorphan;
10.21(29) 3-methylfentanyl;
10.22(30) acetyl-alpha-methylfentanyl;
10.23(31) alpha-methylthiofentanyl;
10.24(32) benzylfentanyl beta-hydroxyfentanyl;
10.25(33) beta-hydroxy-3-methylfentanyl;
10.26(34) 3-methylthiofentanyl;
10.27(35) thenylfentanyl;
10.28(36) thiofentanyl;
10.29(37) para-fluorofentanyl;
10.30(38) morpheridine;
10.31(39) 1-methyl-4-phenyl-4-propionoxypiperidine;
10.32(40) noracymethadol;
10.33(41) norlevorphanol;
10.34(42) normethadone;
10.35(43) norpipanone;
10.36(44) 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);
11.1(45) phenadoxone;
11.2(46) phenampromide;
11.3(47) phenomorphan;
11.4(48) phenoperidine;
11.5(49) piritramide;
11.6(50) proheptazine;
11.7(51) properidine;
11.8(52) propiram;
11.9(53) racemoramide;
11.10(54) tilidine;
11.11(55) trimeperidine.
11.12(c) Opium derivatives. Any of the following substances, their analogs, salts, isomers,
11.13and salts of isomers, unless specifically excepted or unless listed in another schedule,
11.14whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
11.15(1) acetorphine;
11.16(2) acetyldihydrocodeine;
11.17(3) benzylmorphine;
11.18(4) codeine methylbromide;
11.19(5) codeine-n-oxide;
11.20(6) cyprenorphine;
11.21(7) desomorphine;
11.22(8) dihydromorphine;
11.23(9) drotebanol;
11.24(10) etorphine;
11.25(11) heroin;
11.26(12) hydromorphinol;
11.27(13) methyldesorphine;
11.28(14) methyldihydromorphine;
11.29(15) morphine methylbromide;
11.30(16) morphine methylsulfonate;
11.31(17) morphine-n-oxide;
11.32(18) myrophine;
11.33(19) nicocodeine;
11.34(20) nicomorphine;
11.35(21) normorphine;
11.36(22) pholcodine;
12.1(23) thebacon.
12.2(d) Hallucinogens. Any material, compound, mixture or preparation which contains
12.3any quantity of the following substances, their analogs, salts, isomers (whether optical,
12.4positional, or geometric), and salts of isomers, unless specifically excepted or unless listed
12.5in another schedule, whenever the existence of the analogs, salts, isomers, and salts of
12.6isomers is possible:
12.7(1) methylenedioxy amphetamine;
12.8(2) methylenedioxymethamphetamine;
12.9(3) methylenedioxy-N-ethylamphetamine (MDEA);
12.10(4) n-hydroxy-methylenedioxyamphetamine;
12.11(5) 4-bromo-2,5-dimethoxyamphetamine (DOB);
12.12(6) 2,5-dimethoxyamphetamine (2,5-DMA);
12.13(7) 4-methoxyamphetamine;
12.14(8) 5-methoxy-3, 4-methylenedioxy amphetamine;
12.15(9) alpha-ethyltryptamine;
12.16(10) bufotenine;
12.17(11) diethyltryptamine;
12.18(12) dimethyltryptamine;
12.19(13) 3,4,5-trimethoxy amphetamine;
12.20(14) 4-methyl-2, 5-dimethoxyamphetamine (DOM);
12.21(15) ibogaine;
12.22(16) lysergic acid diethylamide (LSD);
12.23(17) mescaline;
12.24(18) parahexyl;
12.25(19) N-ethyl-3-piperidyl benzilate;
12.26(20) N-methyl-3-piperidyl benzilate;
12.27(21) psilocybin;
12.28(22) psilocyn;
12.29(23) tenocyclidine (TPCP or TCP);
12.30(24) N-ethyl-1-phenyl-cyclohexylamine (PCE);
12.31(25) 1-(1-phenylcyclohexyl) pyrrolidine (PCPy);
12.32(26) 1-[1-(2-thienyl)cyclohexyl]-pyrrolidine (TCPy);
12.33(27) 4-chloro-2,5-dimethoxyamphetamine (DOC);
12.34(28) 4-ethyl-2,5-dimethoxyamphetamine (DOET);
12.35(29) 4-iodo-2,5-dimethoxyamphetamine (DOI);
12.36(30) 4-bromo-2,5-dimethoxyphenethylamine (2C-B);
13.1(31) 4-chloro-2,5-dimethoxyphenethylamine (2C-C);
13.2(32) 4-methyl-2,5-dimethoxyphenethylamine (2-CD);
13.3(33) 4-ethyl-2,5-dimethoxyphenethylamine (2C-E);
13.4(34) 4-iodo-2,5-dimethoxyphenethylamine (2C-I);
13.5(35) 4-propyl-2,5-dimethoxyphenethylamine (2C-P);
13.6(36) 4-isopropylthio-2,5-dimethoxyphenethylamine (2C-T-4);
13.7(37) 4-propylthio-2,5-dimethoxyphenethylamine (2C-T-7);
13.8(38) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
13.9(2-CB-FLY);
13.10(39) bromo-benzodifuranyl-isopropylamine (Bromo-DragonFLY);
13.11(40) alpha-methyltryptamine (AMT);
13.12(41) N,N-diisopropyltryptamine (DiPT);
13.13(42) 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT);
13.14(43) 4-acetoxy-N,N-diethyltryptamine (4-AcO-DET);
13.15(44) 4-hydroxy-N-methyl-N-propyltryptamine (4-HO-MPT);
13.16(45) 4-hydroxy-N,N-dipropyltryptamine (4-HO-DPT);
13.17(46) 4-hydroxy-N,N-diallyltryptamine (4-HO-DALT);
13.18(47) 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT);
13.19(48) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DiPT);
13.20(49) 5-methoxy-α-methyltryptamine (5-MeO-AMT);
13.21(50) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT);
13.22(51) 5-methylthio-N,N-dimethyltryptamine (5-MeS-DMT);
13.23(52) 5-methoxy-N-methyl-N-propyltryptamine (5-MeO-MiPT);
13.24(53) 5-methoxy-α-ethyltryptamine (5-MeO-AET);
13.25(54) 5-methoxy-N,N-dipropyltryptamine (5-MeO-DPT);
13.26(55) 5-methoxy-N,N-diethyltryptamine (5-MeO-DET);
13.27(56) 5-methoxy-N,N-diallytryptamine (5-MeO-DALT);
13.28(57) methoxetamine (MXE);
13.29(58) 5-iodo-2-aminoindane (5-IAI);
13.30(59) 5,6-methylenedioxy-2-aminoindane (MDAI).;
13.31(60) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine
13.32(25I-NBOMe).
13.33(e) Peyote. All parts of the plant presently classified botanically as Lophophora
13.34williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part
13.35of the plant, and every compound, manufacture, salts, derivative, mixture, or preparation
13.36of the plant, its seeds or extracts. The listing of peyote as a controlled substance in
14.1Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies
14.2of the American Indian Church, and members of the American Indian Church are exempt
14.3from registration. Any person who manufactures peyote for or distributes peyote to the
14.4American Indian Church, however, is required to obtain federal registration annually and
14.5to comply with all other requirements of law.
14.6(f) Central nervous system depressants. Unless specifically excepted or unless listed
14.7in another schedule, any material compound, mixture, or preparation which contains any
14.8quantity of the following substances, their analogs, salts, isomers, and salts of isomers
14.9whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
14.10(1) mecloqualone;
14.11(2) methaqualone;
14.12(3) gamma-hydroxybutyric acid (GHB), including its esters and ethers;
14.13(4) flunitrazepam.
14.14(g) Stimulants. Unless specifically excepted or unless listed in another schedule, any
14.15material compound, mixture, or preparation which contains any quantity of the following
14.16substances, their analogs, salts, isomers, and salts of isomers whenever the existence of
14.17the analogs, salts, isomers, and salts of isomers is possible:
14.18 (1) aminorex;
14.19(2) cathinone;
14.20(3) fenethylline;
14.21 (4) methcathinone;
14.22(5) methylaminorex;
14.23(6) N,N-dimethylamphetamine;
14.24(7) N-benzylpiperazine (BZP);
14.25(8) methylmethcathinone (mephedrone);
14.26(9) 3,4-methylenedioxy-N-methylcathinone (methylone);
14.27(10) methoxymethcathinone (methedrone);
14.28(11) methylenedioxypyrovalerone (MDPV);
14.29(12) fluoromethcathinone;
14.30(13) methylethcathinone (MEC);
14.31(14) 1-benzofuran-6-ylpropan-2-amine (6-APB);
14.32(15) dimethylmethcathinone (DMMC);
14.33(16) fluoroamphetamine;
14.34(17) fluoromethamphetamine;
14.35(18) α-methylaminobutyrophenone (MABP or buphedrone);
14.36(19) β-keto-N-methylbenzodioxolylpropylamine (bk-MBDB or butylone);
15.1(20) 2-(methylamino)-1-(4-methylphenyl)butan-1-one (4-MEMABP or BZ-6378);
15.2(21) naphthylpyrovalerone (naphyrone); and
15.3(22) any other substance, except bupropion or compounds listed under a different
15.4schedule, that is structurally derived from 2-aminopropan-1-one by substitution at the
15.51-position with either phenyl, naphthyl, or thiophene ring systems, whether or not the
15.6compound is further modified in any of the following ways:
15.7(i) by substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy,
15.8haloalkyl, hydroxyl, or halide substituents, whether or not further substituted in the ring
15.9system by one or more other univalent substituents;
15.10(ii) by substitution at the 3-position with an acyclic alkyl substituent;
15.11(iii) by substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl, or
15.12methoxybenzyl groups; or
15.13(iv) by inclusion of the 2-amino nitrogen atom in a cyclic structure.
15.14(h) Marijuana, tetrahydrocannabinols, and synthetic cannabinoids. Unless
15.15specifically excepted or unless listed in another schedule, any natural or synthetic material,
15.16compound, mixture, or preparation that contains any quantity of the following substances,
15.17their analogs, isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
15.18whenever the existence of the isomers, esters, ethers, or salts is possible:
15.19(1) marijuana;
15.20(2) tetrahydrocannabinols naturally contained in a plant of the genus Cannabis,
15.21synthetic equivalents of the substances contained in the cannabis plant or in the
15.22resinous extractives of the plant, or synthetic substances with similar chemical structure
15.23and pharmacological activity to those substances contained in the plant or resinous
15.24extract, including, but not limited to, 1 cis or trans tetrahydrocannabinol, 6 cis or trans
15.25tetrahydrocannabinol, and 3,4 cis or trans tetrahydrocannabinol;
15.26(3) synthetic cannabinoids, including the following substances:
15.27(i) Naphthoylindoles, which are any compounds containing a 3-(1-napthoyl)indole
15.28structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
15.29alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
15.302-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any
15.31extent and whether or not substituted in the naphthyl ring to any extent. Examples of
15.32naphthoylindoles include, but are not limited to:
15.33(A) 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM-678);
15.34(B) 1-Butul-3-(1-naphthoyl)indole (JWH-073);
15.35(C) 1-Pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081);
15.36(D) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
16.1(E) 1-Propyl-2-methyl-3-(1-naphthoyl)indole (JWH-015);
16.2(F) 1-Hexyl-3-(1-naphthoyl)indole (JWH-019);
16.3(G) 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
16.4(H) 1-Pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210);
16.5(I) 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
16.6(J) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201).
16.7(ii) Napthylmethylindoles, which are any compounds containing a
16.81H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom
16.9of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
16.101-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further
16.11substituted in the indole ring to any extent and whether or not substituted in the naphthyl
16.12ring to any extent. Examples of naphthylmethylindoles include, but are not limited to:
16.13(A) 1-Pentyl-1H-indol-3-yl-(1-naphthyl)methane (JWH-175);
16.14(B) 1-Pentyl-1H-indol-3-yl-(4-methyl-1-naphthyl)methan (JWH-184).
16.15(iii) Naphthoylpyrroles, which are any compounds containing a
16.163-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the
16.17pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
16.181-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
16.19further substituted in the pyrrole ring to any extent, whether or not substituted in the
16.20naphthyl ring to any extent. Examples of naphthoylpyrroles include, but are not limited to,
16.21(5-(2-fluorophenyl)-1-pentylpyrrol-3-yl)-naphthalen-1-ylmethanone (JWH-307).
16.22(iv) Naphthylmethylindenes, which are any compounds containing a
16.23naphthylideneindene structure with substitution at the 3-position of the indene
16.24ring by an allkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
16.251-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not further
16.26substituted in the indene ring to any extent, whether or not substituted in the naphthyl
16.27ring to any extent. Examples of naphthylemethylindenes include, but are not limited to,
16.28E-1-[1-(1-naphthalenylmethylene)-1H-inden-3-yl]pentane (JWH-176).
16.29(v) Phenylacetylindoles, which are any compounds containing a 3-phenylacetylindole
16.30structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
16.31alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
16.322-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
16.33any extent, whether or not substituted in the phenyl ring to any extent. Examples of
16.34phenylacetylindoles include, but are not limited to:
16.35(A) 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole (RCS-8);
16.36(B) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
17.1(C) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251);
17.2(D) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).
17.3(vi) Cyclohexylphenols, which are compounds containing a
17.42-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
17.5of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
17.61-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
17.7substituted in the cyclohexyl ring to any extent. Examples of cyclohexylphenols include,
17.8but are not limited to:
17.9(A) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP 47,497);
17.10(B) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
17.11(Cannabicyclohexanol or CP 47,497 C8 homologue);
17.12(C) 5-(1,1-dimethylheptyl)-2-[(1R,2R)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]
17.13-phenol (CP 55,940).
17.14(vii) Benzoylindoles, which are any compounds containing a 3-(benzoyl)indole
17.15structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
17.16alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
17.172-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
17.18any extent and whether or not substituted in the phenyl ring to any extent. Examples of
17.19benzoylindoles include, but are not limited to:
17.20(A) 1-Pentyl-3-(4-methoxybenzoyl)indole (RCS-4);
17.21(B) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694);
17.22(C) (4-methoxyphenyl-[2-methyl-1-(2-(4-morpholinyl)ethyl)indol-3-yl]methanone
17.23(WIN 48,098 or Pravadoline).
17.24(viii) Others specifically named:
17.25(A) (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
17.26-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (HU-210);
17.27(B) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
17.28-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (Dexanabinol or HU-211);
17.29(C) 2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]
17.30-1,4-benzoxazin-6-yl-1-naphthalenylmethanone (WIN 55,212-2).;
17.31(D) (1-pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);
17.32(E) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
17.33(XLR-11);
17.34(F) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide
17.35(AKB-48(APINACA));
18.1(G) N-((3s,5s,7s)-adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
18.2(5-Fluoro-AKB-48);
18.3(H) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22);
18.4(I) 8-quinolinyl ester-1-(5-fluoropentyl)-1H-indole-3-carboxylic acid (5-Fluoro
18.5PB-22).
18.6(i) A controlled substance analog, to the extent that it is implicitly or explicitly
18.7intended for human consumption.
18.8EFFECTIVE DATE.This section is effective August 1, 2013, and applies to crimes
18.9committed on or after that date.
18.10 Sec. 3. Minnesota Statutes 2012, section 152.126, subdivision 6, is amended to read:
18.11 Subd. 6. Access to reporting system data. (a) Except as indicated in this
18.12subdivision, the data submitted to the board under subdivision 4 is private data on
18.13individuals as defined in section13.02, subdivision 12 , and not subject to public disclosure.
18.14 (b) Except as specified in subdivision 5, the following persons shall be considered
18.15permissible users and may access the data submitted under subdivision 4 in the same or
18.16similar manner, and for the same or similar purposes, as those persons who are authorized
18.17to access similar private data on individuals under federal and state law:
18.18 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
18.19delegated the task of accessing the data, to the extent the information relates specifically to
18.20a current patient, to whom the prescriber is prescribing or considering prescribing any
18.21controlled substance and with the provision that the prescriber remains responsible for the
18.22use or misuse of data accessed by a delegated agent or employee;
18.23 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
18.24delegated the task of accessing the data, to the extent the information relates specifically
18.25to a current patient to whom that dispenser is dispensing or considering dispensing any
18.26controlled substance and with the provision that the dispenser remains responsible for the
18.27use or misuse of data accessed by a delegated agent or employee;
18.28 (3) an individual who is the recipient of a controlled substance prescription for
18.29which data was submitted under subdivision 4, or a guardian of the individual, parent or
18.30guardian of a minor, or health care agent of the individual acting under a health care
18.31directive under chapter 145C;
18.32 (4) personnel of the board specifically assigned to conduct a bona fide investigation
18.33of a specific licensee;
19.1 (5) personnel of the board engaged in the collection of controlled substance
19.2prescription information as part of the assigned duties and responsibilities under this
19.3section;
19.4 (6) authorized personnel of a vendor under contract with the board who are engaged
19.5in the design, implementation, operation, and maintenance of the electronic reporting
19.6system as part of the assigned duties and responsibilities of their employment, provided
19.7that access to data is limited to the minimum amount necessary to carry out such duties
19.8and responsibilities;
19.9 (7) federal, state, and local law enforcement authorities acting pursuant to a valid
19.10search warrant;and
19.11 (8) personnel of the medical assistance program assigned to use the data collected
19.12under this section to identify recipients whose usage of controlled substances may warrant
19.13restriction to a single primary care physician, a single outpatient pharmacy, or a single
19.14hospital.; and
19.15(9) personnel of the Department of Human Services assigned to access the data
19.16pursuant to paragraph (h).
19.17 For purposes of clause (3), access by an individual includes persons in the definition
19.18of an individual under section13.02 .
19.19 (c) Any permissible user identified in paragraph (b), who directly accesses
19.20the data electronically, shall implement and maintain a comprehensive information
19.21security program that contains administrative, technical, and physical safeguards that
19.22are appropriate to the user's size and complexity, and the sensitivity of the personal
19.23information obtained. The permissible user shall identify reasonably foreseeable internal
19.24and external risks to the security, confidentiality, and integrity of personal information
19.25that could result in the unauthorized disclosure, misuse, or other compromise of the
19.26information and assess the sufficiency of any safeguards in place to control the risks.
19.27 (d) The board shall not release data submitted under this section unless it is provided
19.28with evidence, satisfactory to the board, that the person requesting the information is
19.29entitled to receive the data.
19.30 (e) The board shall not release the name of a prescriber without the written consent
19.31of the prescriber or a valid search warrant or court order. The board shall provide a
19.32mechanism for a prescriber to submit to the board a signed consent authorizing the release
19.33of the prescriber's name when data containing the prescriber's name is requested.
19.34 (f) The board shall maintain a log of all persons who access the data and shall ensure
19.35that any permissible user complies with paragraph (c) prior to attaining direct access to
19.36the data.
20.1(g) Section13.05, subdivision 6 , shall apply to any contract the board enters into
20.2pursuant to subdivision 2. A vendor shall not use data collected under this section for
20.3any purpose not specified in this section.
20.4(h) With available appropriations, the commissioner of human services shall
20.5establish and implement a system through which the Department of Human Services shall
20.6routinely access the data for the purpose of determining whether any client enrolled in
20.7an opioid treatment program licensed according to chapter 245A has been prescribed or
20.8dispensed a controlled substance in addition to that administered or dispensed by the
20.9opioid treatment program. When the commissioner determines there have been multiple
20.10prescribers or multiple prescriptions of controlled substances, the commissioner shall:
20.11(1) inform the medical director of the opioid treatment program only that the
20.12commissioner determined the existence of multiple prescribers or multiple prescriptions of
20.13controlled substances; and
20.14(2) direct the medical director of the opioid treatment program to access the data
20.15directly, review the effect of the multiple prescribers or multiple prescriptions, and
20.16document the review.
20.17If determined necessary, the commissioner of human services shall seek a federal waiver
20.18of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
20.192.34, item (c), prior to implementing this paragraph.
1.3health and human services licensing; establishing methadone treatment program
1.4standards; modifying drug treatment provisions; adding to the list of Schedule
1.5I controlled substances;amending Minnesota Statutes 2012, sections 152.01,
1.6subdivision 5a; 152.02, subdivision 2; 152.126, subdivision 6; 254B.04, by adding
1.7a subdivision; proposing coding for new law in Minnesota Statutes, chapter 245A.
1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.11 Section 1. [245A.1915] OPIOID ADDICTION TREATMENT EDUCATION
1.12REQUIREMENT FOR PROVIDERS LICENSED TO PROVIDE CHEMICAL
1.13DEPENDENCY TREATMENT SERVICES.
1.14All programs licensed by the commissioner must provide educational information
1.15concerning treatment options for opioid addiction, including the use of a medication for
1.16the use of opioid addiction, to clients identified as having or seeking treatment for opioid
1.17addiction. The commissioner shall develop educational materials that are supported by
1.18research and updated periodically that must be used by programs to comply with this
1.19requirement.
1.20 Sec. 2. [245A.192] PROVIDERS LICENSED TO PROVIDE TREATMENT OF
1.21OPIOID ADDICTION.
1.22 Subdivision 1. Scope. (a) This section applies to services licensed under this chapter
1.23to provide treatment for opioid addiction. In addition to the requirements under Minnesota
2.1Rules, parts 9530.6405 to 9530.6505, a program licensed to provide treatment of opioid
2.2addiction must meet the requirements in this section.
2.3(b) Where a standard in this section differs from a standard in an otherwise
2.4applicable administrative rule, the standards of this section apply.
2.5(c) When federal guidance or interpretations have been issued on federal standards
2.6or requirements also required under this section, the federal guidance or interpretations
2.7shall apply.
2.8 Subd. 2. Definitions. (a) For purposes of this section, the terms defined in this
2.9subdivision have the meanings given them.
2.10(b) "Diversion" means the use of a medication for the treatment of opioid addiction
2.11being diverted from its intended use.
2.12(c) "Guest dose or dosing" means the practice of administering a medication used
2.13for the treatment of opioid addiction to a person who is not a client of the program that is
2.14administering or dispensing the medication.
2.15(d) "Medical director" means a physician, licensed to practice medicine in the
2.16jurisdiction in which the opioid treatment program is located, who assumes responsibility
2.17for administering all medical services performed by the program, either by performing
2.18them directly or by delegating specific responsibility to authorized program physicians
2.19and health care professionals functioning under the medical director's direct supervision.
2.20(e) "Medication used for the treatment of opioid addiction" means a medication
2.21approved by the Food and Drug Administration for the treatment of opioid addiction.
2.22(f) "Opioid treatment program" has the meaning given in Code of Federal
2.23Regulations, title 42, section 8.12, and includes programs licensed under Minnesota Rules,
2.24part 9530.6500.
2.25(g) "Program" means an entity that is licensed under Minnesota Rules, part
2.269530.6500.
2.27(h) "Unsupervised use" means the use of a medication for the treatment of opioid
2.28addiction dispensed for use by a client outside of the program setting. This is also referred
2.29to as a "take-home" dose.
2.30(i) "Placing authority" has the meaning given in Minnesota Rules, part 9530.6605,
2.31subpart 21a.
2.32(j) "Minnesota health care programs" has the meaning given in section 256B.0636,
2.33clause (3).
2.34 Subd. 3. Medication orders. Prior to the program administering or dispensing a
2.35medication used for the treatment of opioid addiction:
3.1(1) a client-specific order must be received from an appropriately credentialed
3.2physician;
3.3(2) the signed order must be documented in the client's record; and
3.4(3) if the order is not directly issued by the physician, such as a verbal order, the
3.5physician that issued the order must review the documentation and sign the order in the
3.6client's record within 72 hours of the medication being administered or dispensed. The
3.7physician must document whether the medication was administered or dispensed as
3.8ordered. The license holder must report to the commissioner any medication error that
3.9endangers a patient's health, as determined by the medical director.
3.10 Subd. 4. Drug testing. Each client enrolled in the program must receive a minimum
3.11of eight random drug abuse tests per 12 months of treatment. These tests must be
3.12reasonably disbursed over the 12-month period. A license holder may elect to conduct
3.13more drug abuse tests.
3.14 Subd. 5. Criteria for unsupervised use. (a) To limit the potential for diversion
3.15of medication used for the treatment of opioid addiction to the illicit market, any such
3.16medications dispensed to patients for unsupervised use shall be subject to the following
3.17requirements:
3.18(1) any patient in an opioid treatment program may receive a single take-home dose
3.19for a day that the clinic is closed for business, including Sundays and state and federal
3.20holidays; and
3.21(2) treatment program decisions on dispensing medications used to treat opioid
3.22addiction to patients for unsupervised use beyond that set forth in paragraph (a), clause
3.23(1), shall be determined by the medical director.
3.24(b) The medical director must consider the criteria in paragraph (a) in determining
3.25whether a client may be permitted unsupervised or take-home use of such medications.
3.26The criteria must also be considered when determining whether dispensing medication
3.27for a client's unsupervised use is appropriate to increase or to extend the amount of time
3.28between visits to the program. The criteria includes:
3.29(1) absence of recent abuse of drugs including but not limited to opioids,
3.30nonnarcotics, and alcohol;
3.31(2) regularity of program attendance;
3.32(3) absence of serious behavioral problems at the program;
3.33(4) absence of known recent criminal activity such as drug dealing;
3.34(5) stability of the client's home environment and social relationships;
3.35(6) length of time in comprehensive maintenance treatment;
4.1(7) reasonable assurance that take-home medication will be safely stored within the
4.2client's home; and
4.3(8) whether the rehabilitative benefit the client derived from decreasing the frequency
4.4of program attendance outweighs the potential risks of diversion or unsupervised use.
4.5(c) The determination, including the basis of the determination, must be consistent
4.6with the criteria in paragraph (a), clause (2), and must be documented in the client's
4.7medical record.
4.8 Subd. 6. Restrictions for unsupervised or take-home use of methadone
4.9hydrochloride. (a) In cases where it is determined that a client meets the criteria in
4.10subdivision 5, paragraph (a), clause (2), and may be dispensed a medication used for the
4.11treatment of opioid addiction, the restrictions in paragraphs (b) to (g) must be followed
4.12when the medication to be dispensed is methadone hydrochloride.
4.13(b) During the first 90 days of treatment, the take-home supply must be limited to
4.14a maximum of a single dose each week and the client shall ingest all other doses under
4.15direct supervision.
4.16(c) In the second 90 days of treatment, the take-home supply must be limited to
4.17two doses per week.
4.18(d) In the third 90 days of treatment, the take-home supply must not exceed three
4.19doses per week.
4.20(e) In the remaining months of the first year, a client may be given a maximum
4.21six-day supply of take-home medication.
4.22(f) After one year of continuous treatment, a client may be given a maximum
4.23two-week supply of take-home medication.
4.24(g) After two years of continuous treatment, a client may be given a maximum
4.25one-month supply of take-home medication, but must make monthly visits.
4.26 Subd. 7. Restriction exceptions. When a license holder has reason to accelerate
4.27the number of unsupervised or take-home doses of methadone hydrochloride, the license
4.28holder must comply with the requirements of Code of Federal Regulations, title 42, chapter
4.291, subchapter A, part 8, section 8.12, the criteria for unsupervised use in subdivision 5,
4.30and must use the exception process provided by the federal Center for Substance Abuse
4.31Treatment Division of Pharmacologic Therapies. For the purposes of enforcement of
4.32this subdivision, the commissioner has the authority to monitor for compliance with
4.33these federal regulations and may issue licensing actions according to sections 245A.05,
4.34245A.06, and 245A.07 based on the commissioner's determination of noncompliance.
4.35 Subd. 8. Guest dosing. In order to receive a guest dose, the client must be enrolled
4.36in an opioid treatment program elsewhere in the state or country and be receiving the
5.1medication on a temporary basis because the client is not able to receive the medication
5.2at the program in which the client is enrolled. Such arrangements shall not exceed 30
5.3consecutive days in any one program and must not be for the convenience or benefit of
5.4either program. Guest dosing may also occur when the client's primary clinic is not open
5.5and the client is not receiving take-home doses.
5.6 Subd. 9. Data and reporting. The license holder must submit data concerning
5.7medication used for the treatment of opioid addiction to a central registry. The data must
5.8be submitted in a method determined by the commissioner and must be submitted for each
5.9client at the time of admission and discharge. The program must document the date the
5.10information was submitted. This requirement is effective upon implementation of changes
5.11to the Drug and Alcohol Abuse Normative Evaluation System (DAANES) or development
5.12of an electronic system by which to submit the data.
5.13 Subd. 10. Nonmedication treatment services; documentation. (a) The program
5.14must offer at least 50 consecutive minutes of individual or group therapy treatment services
5.15as defined in Minnesota Rules, part 9530.6430, subpart 1, item A, subitem (1), per week,
5.16for the first ten weeks following admission, and at least 50 consecutive minutes per month
5.17thereafter. As clinically appropriate, the program may offer these services cumulatively
5.18and not consecutively in increments of no less than 15 minutes over the required time
5.19period, and for a total of 60 minutes of treatment services over the time period, and must
5.20document the reason for providing services cumulatively in the client's record. The
5.21program may offer additional levels of service when deemed clinically necessary.
5.22(b) Notwithstanding the requirements of individual treatment plans set forth in
5.23Minnesota Rules, part 9530.6425:
5.24(1) treatment plan contents for maintenance clients are not required to include goals
5.25the client must reach to complete treatment and have services terminated;
5.26(2) treatment plans for clients in a taper or detox status must include goals the client
5.27must reach to complete treatment and have services terminated;
5.28(3) for the initial ten weeks after admission for all new admissions, readmissions, and
5.29transfers, progress notes must be entered in a client's file at least weekly and be recorded
5.30in each of the six dimensions upon the development of the treatment plan and thereafter.
5.31Subsequently, the counselor must document progress no less than one time monthly,
5.32recorded in the six dimensions or when clinical need warrants more frequent notations; and
5.33(4) upon the development of the treatment plan and thereafter, treatment plan
5.34reviews must occur weekly, or after each treatment service, whichever is less frequent,
5.35for the first ten weeks of treatment for all new admissions, readmissions, and transfers.
6.1Following the first ten weeks of treatment, treatment plan reviews may occur monthly,
6.2unless the client has needs that warrant more frequent revisions or documentation.
6.3 Subd. 11. Prescription monitoring program. (a) Upon admission to a methadone
6.4clinic outpatient treatment program, clients shall be notified that the Department of Human
6.5Services and the medical director will monitor the prescription monitoring program to
6.6review the prescribed controlled drugs the clients have received. The medical director or
6.7the medical director's delegate must review data from the Minnesota Board of Pharmacy,
6.8prescription monitoring program (PMP) established under section 152.126 prior to the
6.9client being ordered any controlled substance as defined under section 152.126, subdivision
6.101, paragraph (b), including medications used for the treatment of opioid addiction. The
6.11subsequent reviews of the PMP data must occur quarterly and be documented in the
6.12client's individual file. When the PMP data shows a recent history of multiple prescribers
6.13or multiple prescriptions for controlled substances, then subsequent reviews of the PMP
6.14data must occur monthly and be documented in the client's individual file. If, at any time,
6.15the medical director believes the use of the controlled substances places the client at risk
6.16of harm, the program must seek the client's consent to discuss the client's opioid treatment
6.17with other prescribers and must seek consent for the other prescriber to disclose to the
6.18opioid treatment programs' medical director the client's condition that formed the basis of
6.19the other prescriptions. Additionally, any findings from the PMP data that are relevant to
6.20the medical director's course of treatment for the client must be documented in the client's
6.21individual file. A review of the PMP is not required for every medication dose adjustment.
6.22(b) The commissioner shall collaborate with the Minnesota Board of Pharmacy
6.23to develop and implement an electronic system through which the commissioner shall
6.24routinely access the data from the Minnesota Board of Pharmacy prescription monitoring
6.25program established under section 152.126 for the purpose of determining whether
6.26any client enrolled in an opioid addiction treatment program licensed according to this
6.27section has also been prescribed or dispensed a controlled substance in addition to
6.28that administered or dispensed by the opioid addiction treatment program. When the
6.29commissioner determines there have been multiple prescribers or multiple prescriptions of
6.30controlled substances, the commissioner shall:
6.31(1) inform the medical director of the opioid treatment program only that the
6.32commissioner determined the existence of multiple prescribers or multiple prescriptions of
6.33controlled substances; and
6.34(2) direct the medical director of the opioid treatment program to access the data
6.35directly, review the effect of the multiple prescribers or multiple prescriptions, and
6.36document the review.
7.1(c) If determined necessary, the commissioner shall seek a federal waiver of, or
7.2exception to, any applicable provision of Code of Federal Regulations, title 42, part 2.34,
7.3item (c), prior to implementing this paragraph.
7.4 Subd. 12. Policies and procedures. (a) License holders must develop and maintain
7.5the policies and procedures required in this subdivision. Where a standard in this section
7.6differs from a standard in otherwise applicable administrative rule, the standards of this
7.7subdivision apply.
7.8(b) For programs that are not open every day of the year, the license holder must
7.9maintain a policy and procedure that permits clients to receive a single unsupervised use
7.10of medication used for the treatment of opioid addiction for days that the program is
7.11closed for business, including, but not limited to, Sundays and state and federal holidays
7.12as required under subdivision 5, paragraph (a), clause (1).
7.13(c) The license holder must maintain a policy and procedure that includes specific
7.14measures to reduce the possibility of medication used for the treatment of opioid addiction
7.15being diverted from its intended treatment use. The policy and procedure must:
7.16(1) specifically identify and define the responsibilities of the medical and
7.17administrative staff for carrying out diversion control measures; and
7.18(2) include a process for contacting no less than five percent of clients who have
7.19unsupervised use of medication used for the treatment of opioid addiction, excluding those
7.20approved solely under subdivision 5, paragraph (a), clause (1), to require them to physically
7.21return to the program each month. The system must require clients to return to the program
7.22within a stipulated time frame and turn in all unused medication containers related to
7.23opioid addiction treatment. The license holder must document all related contacts on a
7.24central log and the outcome of the contact for each client in the individual client's record.
7.25(d) Medications used for the treatment of opioid addictions must be ordered,
7.26administered, and dispensed according to applicable state and federal regulations and the
7.27standards set by applicable accreditation entities. In addition, when an order requires
7.28assessment by the person administering or dispensing the medication to determine
7.29the amount to be administered or dispensed, the assessment must be completed by
7.30an individual whose professional scope of practice permits such assessment. For the
7.31purposes of enforcement of this paragraph, the commissioner has the authority to monitor
7.32for compliance with these state and federal regulations and the relevant standards of
7.33the license holder's accreditation agency and may issue licensing actions according to
7.34sections 245A.05, 245A.06, and 245A.07 based on the commissioner's determination
7.35of noncompliance.
8.1 Subd. 13. Quality improvement plan. The license holder must develop and
8.2maintain a quality improvement process and plan. The plan must:
8.3(1) include evaluation of the services provided to clients with the goal of identifying
8.4issues that may improve service delivery and client outcomes;
8.5(2) include goals for the program to accomplish based on the evaluation;
8.6(3) be reviewed annually by the management of the program to determine whether
8.7the goals were met and if not, whether additional action is required;
8.8(4) be updated at least annually to include new or continued goals based on an
8.9updated evaluation of services; and
8.10(5) identify two specific goal areas, in addition to others identified by the program
8.11including:
8.12(i) a goal concerning oversight and monitoring of the premises around and near the
8.13exterior of the program to reduce the possibility of medication used for the treatment of
8.14opioid addiction being inappropriately used by clients, including but not limited to the sale
8.15or transfer of the medication to others; and
8.16(ii) a goal concerning community outreach, including but not limited to
8.17communications with local law enforcement and county human services agencies with
8.18the goal of increasing coordination of services and identification of areas of concern to
8.19be addressed in the plan.
8.20 Subd. 14. Placing authorities. Programs must provide certain notification and
8.21client-specific updates to placing authorities for clients who are enrolled in Minnesota
8.22health care programs. At the request of the placing authority, the program must provide
8.23client-specific updates, including but not limited to informing the placing authority of
8.24positive drug screenings and changes in medications used for the treatment of opioid
8.25addiction ordered for the client.
8.28 Section 1. Minnesota Statutes 2012, section 254B.04, is amended by adding a
8.29subdivision to read:
8.30 Subd. 2b. Eligibility for placement in opioid treatment programs. (a)
8.31Notwithstanding provisions of Minnesota Rules, part 9530.6622, subpart 5, related
8.32to a placement authority's requirement to authorize services or service coordination
8.33in a program that complies with Minnesota Rules, part 9530.6500, or Code of Federal
8.34Regulations, title 42, part 8, and after taking into account an individual's preference for
8.35placement in an opioid treatment program, a placement authority may, but is not required
9.1to, authorize services or service coordination or otherwise place an individual in an opioid
9.2treatment program. Prior to making a determination of placement for an individual, the
9.3placing authority must consult with the current treatment provider, if any.
9.4(b) Prior to placement of an individual who is determined by the assessor to require
9.5treatment for opioid addiction, the assessor must provide educational information
9.6concerning treatment options for opioid addiction, including the use of a medication
9.7for the use of opioid addiction. The commissioner shall develop educational materials
9.8supported by research and updated periodically that must be used by assessors to comply
9.9with this requirement.
9.12 Section 1. Minnesota Statutes 2012, section 152.01, subdivision 5a, is amended to read:
9.13 Subd. 5a. Hallucinogen. "Hallucinogen" means any hallucinogen listed in section
9.15C, except marijuana and Tetrahydrocannabinols.
9.16EFFECTIVE DATE.This section is effective August 1, 2013, and applies to crimes
9.17committed on or after that date.
9.18 Sec. 2. Minnesota Statutes 2012, section 152.02, subdivision 2, is amended to read:
9.19 Subd. 2. Schedule I. (a) Schedule I consists of the substances listed in this
9.20subdivision.
9.21(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of
9.22the following substances, including their analogs, isomers, esters, ethers, salts, and salts
9.23of isomers, esters, and ethers, whenever the existence of the analogs, isomers, esters,
9.24ethers, and salts is possible:
9.25(1) acetylmethadol;
9.26(2) allylprodine;
9.27(3) alphacetylmethadol (except levo-alphacetylmethadol, also known as
9.28levomethadyl acetate);
9.29(4) alphameprodine;
9.30(5) alphamethadol;
9.31(6) alpha-methylfentanyl benzethidine;
9.32(7) betacetylmethadol;
9.33(8) betameprodine;
10.1(9) betamethadol;
10.2(10) betaprodine;
10.3(11) clonitazene;
10.4(12) dextromoramide;
10.5(13) diampromide;
10.6(14) diethyliambutene;
10.7(15) difenoxin;
10.8(16) dimenoxadol;
10.9(17) dimepheptanol;
10.10(18) dimethyliambutene;
10.11(19) dioxaphetyl butyrate;
10.12(20) dipipanone;
10.13(21) ethylmethylthiambutene;
10.14(22) etonitazene;
10.15(23) etoxeridine;
10.16(24) furethidine;
10.17(25) hydroxypethidine;
10.18(26) ketobemidone;
10.19(27) levomoramide;
10.20(28) levophenacylmorphan;
10.21(29) 3-methylfentanyl;
10.22(30) acetyl-alpha-methylfentanyl;
10.23(31) alpha-methylthiofentanyl;
10.24(32) benzylfentanyl beta-hydroxyfentanyl;
10.25(33) beta-hydroxy-3-methylfentanyl;
10.26(34) 3-methylthiofentanyl;
10.27(35) thenylfentanyl;
10.28(36) thiofentanyl;
10.29(37) para-fluorofentanyl;
10.30(38) morpheridine;
10.31(39) 1-methyl-4-phenyl-4-propionoxypiperidine;
10.32(40) noracymethadol;
10.33(41) norlevorphanol;
10.34(42) normethadone;
10.35(43) norpipanone;
10.36(44) 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);
11.1(45) phenadoxone;
11.2(46) phenampromide;
11.3(47) phenomorphan;
11.4(48) phenoperidine;
11.5(49) piritramide;
11.6(50) proheptazine;
11.7(51) properidine;
11.8(52) propiram;
11.9(53) racemoramide;
11.10(54) tilidine;
11.11(55) trimeperidine.
11.12(c) Opium derivatives. Any of the following substances, their analogs, salts, isomers,
11.13and salts of isomers, unless specifically excepted or unless listed in another schedule,
11.14whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
11.15(1) acetorphine;
11.16(2) acetyldihydrocodeine;
11.17(3) benzylmorphine;
11.18(4) codeine methylbromide;
11.19(5) codeine-n-oxide;
11.20(6) cyprenorphine;
11.21(7) desomorphine;
11.22(8) dihydromorphine;
11.23(9) drotebanol;
11.24(10) etorphine;
11.25(11) heroin;
11.26(12) hydromorphinol;
11.27(13) methyldesorphine;
11.28(14) methyldihydromorphine;
11.29(15) morphine methylbromide;
11.30(16) morphine methylsulfonate;
11.31(17) morphine-n-oxide;
11.32(18) myrophine;
11.33(19) nicocodeine;
11.34(20) nicomorphine;
11.35(21) normorphine;
11.36(22) pholcodine;
12.1(23) thebacon.
12.2(d) Hallucinogens. Any material, compound, mixture or preparation which contains
12.3any quantity of the following substances, their analogs, salts, isomers (whether optical,
12.4positional, or geometric), and salts of isomers, unless specifically excepted or unless listed
12.5in another schedule, whenever the existence of the analogs, salts, isomers, and salts of
12.6isomers is possible:
12.7(1) methylenedioxy amphetamine;
12.8(2) methylenedioxymethamphetamine;
12.9(3) methylenedioxy-N-ethylamphetamine (MDEA);
12.10(4) n-hydroxy-methylenedioxyamphetamine;
12.11(5) 4-bromo-2,5-dimethoxyamphetamine (DOB);
12.12(6) 2,5-dimethoxyamphetamine (2,5-DMA);
12.13(7) 4-methoxyamphetamine;
12.14(8) 5-methoxy-3, 4-methylenedioxy amphetamine;
12.15(9) alpha-ethyltryptamine;
12.16(10) bufotenine;
12.17(11) diethyltryptamine;
12.18(12) dimethyltryptamine;
12.19(13) 3,4,5-trimethoxy amphetamine;
12.20(14) 4-methyl-2, 5-dimethoxyamphetamine (DOM);
12.21(15) ibogaine;
12.22(16) lysergic acid diethylamide (LSD);
12.23(17) mescaline;
12.24(18) parahexyl;
12.25(19) N-ethyl-3-piperidyl benzilate;
12.26(20) N-methyl-3-piperidyl benzilate;
12.27(21) psilocybin;
12.28(22) psilocyn;
12.29(23) tenocyclidine (TPCP or TCP);
12.30(24) N-ethyl-1-phenyl-cyclohexylamine (PCE);
12.31(25) 1-(1-phenylcyclohexyl) pyrrolidine (PCPy);
12.32(26) 1-[1-(2-thienyl)cyclohexyl]-pyrrolidine (TCPy);
12.33(27) 4-chloro-2,5-dimethoxyamphetamine (DOC);
12.34(28) 4-ethyl-2,5-dimethoxyamphetamine (DOET);
12.35(29) 4-iodo-2,5-dimethoxyamphetamine (DOI);
12.36(30) 4-bromo-2,5-dimethoxyphenethylamine (2C-B);
13.1(31) 4-chloro-2,5-dimethoxyphenethylamine (2C-C);
13.2(32) 4-methyl-2,5-dimethoxyphenethylamine (2-CD);
13.3(33) 4-ethyl-2,5-dimethoxyphenethylamine (2C-E);
13.4(34) 4-iodo-2,5-dimethoxyphenethylamine (2C-I);
13.5(35) 4-propyl-2,5-dimethoxyphenethylamine (2C-P);
13.6(36) 4-isopropylthio-2,5-dimethoxyphenethylamine (2C-T-4);
13.7(37) 4-propylthio-2,5-dimethoxyphenethylamine (2C-T-7);
13.8(38) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4-yl)ethanamine
13.9(2-CB-FLY);
13.10(39) bromo-benzodifuranyl-isopropylamine (Bromo-DragonFLY);
13.11(40) alpha-methyltryptamine (AMT);
13.12(41) N,N-diisopropyltryptamine (DiPT);
13.13(42) 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT);
13.14(43) 4-acetoxy-N,N-diethyltryptamine (4-AcO-DET);
13.15(44) 4-hydroxy-N-methyl-N-propyltryptamine (4-HO-MPT);
13.16(45) 4-hydroxy-N,N-dipropyltryptamine (4-HO-DPT);
13.17(46) 4-hydroxy-N,N-diallyltryptamine (4-HO-DALT);
13.18(47) 4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT);
13.19(48) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DiPT);
13.20(49) 5-methoxy-α-methyltryptamine (5-MeO-AMT);
13.21(50) 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT);
13.22(51) 5-methylthio-N,N-dimethyltryptamine (5-MeS-DMT);
13.23(52) 5-methoxy-N-methyl-N-propyltryptamine (5-MeO-MiPT);
13.24(53) 5-methoxy-α-ethyltryptamine (5-MeO-AET);
13.25(54) 5-methoxy-N,N-dipropyltryptamine (5-MeO-DPT);
13.26(55) 5-methoxy-N,N-diethyltryptamine (5-MeO-DET);
13.27(56) 5-methoxy-N,N-diallytryptamine (5-MeO-DALT);
13.28(57) methoxetamine (MXE);
13.29(58) 5-iodo-2-aminoindane (5-IAI);
13.30(59) 5,6-methylenedioxy-2-aminoindane (MDAI)
13.31(60) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine
13.32(25I-NBOMe).
13.33(e) Peyote. All parts of the plant presently classified botanically as Lophophora
13.34williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part
13.35of the plant, and every compound, manufacture, salts, derivative, mixture, or preparation
13.36of the plant, its seeds or extracts. The listing of peyote as a controlled substance in
14.1Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies
14.2of the American Indian Church, and members of the American Indian Church are exempt
14.3from registration. Any person who manufactures peyote for or distributes peyote to the
14.4American Indian Church, however, is required to obtain federal registration annually and
14.5to comply with all other requirements of law.
14.6(f) Central nervous system depressants. Unless specifically excepted or unless listed
14.7in another schedule, any material compound, mixture, or preparation which contains any
14.8quantity of the following substances, their analogs, salts, isomers, and salts of isomers
14.9whenever the existence of the analogs, salts, isomers, and salts of isomers is possible:
14.10(1) mecloqualone;
14.11(2) methaqualone;
14.12(3) gamma-hydroxybutyric acid (GHB), including its esters and ethers;
14.13(4) flunitrazepam.
14.14(g) Stimulants. Unless specifically excepted or unless listed in another schedule, any
14.15material compound, mixture, or preparation which contains any quantity of the following
14.16substances, their analogs, salts, isomers, and salts of isomers whenever the existence of
14.17the analogs, salts, isomers, and salts of isomers is possible:
14.18 (1) aminorex;
14.19(2) cathinone;
14.20(3) fenethylline;
14.21 (4) methcathinone;
14.22(5) methylaminorex;
14.23(6) N,N-dimethylamphetamine;
14.24(7) N-benzylpiperazine (BZP);
14.25(8) methylmethcathinone (mephedrone);
14.26(9) 3,4-methylenedioxy-N-methylcathinone (methylone);
14.27(10) methoxymethcathinone (methedrone);
14.28(11) methylenedioxypyrovalerone (MDPV);
14.29(12) fluoromethcathinone;
14.30(13) methylethcathinone (MEC);
14.31(14) 1-benzofuran-6-ylpropan-2-amine (6-APB);
14.32(15) dimethylmethcathinone (DMMC);
14.33(16) fluoroamphetamine;
14.34(17) fluoromethamphetamine;
14.35(18) α-methylaminobutyrophenone (MABP or buphedrone);
14.36(19) β-keto-N-methylbenzodioxolylpropylamine (bk-MBDB or butylone);
15.1(20) 2-(methylamino)-1-(4-methylphenyl)butan-1-one (4-MEMABP or BZ-6378);
15.2(21) naphthylpyrovalerone (naphyrone); and
15.3(22) any other substance, except bupropion or compounds listed under a different
15.4schedule, that is structurally derived from 2-aminopropan-1-one by substitution at the
15.51-position with either phenyl, naphthyl, or thiophene ring systems, whether or not the
15.6compound is further modified in any of the following ways:
15.7(i) by substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy,
15.8haloalkyl, hydroxyl, or halide substituents, whether or not further substituted in the ring
15.9system by one or more other univalent substituents;
15.10(ii) by substitution at the 3-position with an acyclic alkyl substituent;
15.11(iii) by substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl, or
15.12methoxybenzyl groups; or
15.13(iv) by inclusion of the 2-amino nitrogen atom in a cyclic structure.
15.14(h) Marijuana, tetrahydrocannabinols, and synthetic cannabinoids. Unless
15.15specifically excepted or unless listed in another schedule, any natural or synthetic material,
15.16compound, mixture, or preparation that contains any quantity of the following substances,
15.17their analogs, isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
15.18whenever the existence of the isomers, esters, ethers, or salts is possible:
15.19(1) marijuana;
15.20(2) tetrahydrocannabinols naturally contained in a plant of the genus Cannabis,
15.21synthetic equivalents of the substances contained in the cannabis plant or in the
15.22resinous extractives of the plant, or synthetic substances with similar chemical structure
15.23and pharmacological activity to those substances contained in the plant or resinous
15.24extract, including, but not limited to, 1 cis or trans tetrahydrocannabinol, 6 cis or trans
15.25tetrahydrocannabinol, and 3,4 cis or trans tetrahydrocannabinol;
15.26(3) synthetic cannabinoids, including the following substances:
15.27(i) Naphthoylindoles, which are any compounds containing a 3-(1-napthoyl)indole
15.28structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
15.29alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
15.302-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any
15.31extent and whether or not substituted in the naphthyl ring to any extent. Examples of
15.32naphthoylindoles include, but are not limited to:
15.33(A) 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM-678);
15.34(B) 1-Butul-3-(1-naphthoyl)indole (JWH-073);
15.35(C) 1-Pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081);
15.36(D) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
16.1(E) 1-Propyl-2-methyl-3-(1-naphthoyl)indole (JWH-015);
16.2(F) 1-Hexyl-3-(1-naphthoyl)indole (JWH-019);
16.3(G) 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
16.4(H) 1-Pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210);
16.5(I) 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
16.6(J) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201).
16.7(ii) Napthylmethylindoles, which are any compounds containing a
16.81H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom
16.9of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
16.101-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further
16.11substituted in the indole ring to any extent and whether or not substituted in the naphthyl
16.12ring to any extent. Examples of naphthylmethylindoles include, but are not limited to:
16.13(A) 1-Pentyl-1H-indol-3-yl-(1-naphthyl)methane (JWH-175);
16.14(B) 1-Pentyl-1H-indol-3-yl-(4-methyl-1-naphthyl)methan (JWH-184).
16.15(iii) Naphthoylpyrroles, which are any compounds containing a
16.163-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the
16.17pyrrole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
16.181-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
16.19further substituted in the pyrrole ring to any extent, whether or not substituted in the
16.20naphthyl ring to any extent. Examples of naphthoylpyrroles include, but are not limited to,
16.21(5-(2-fluorophenyl)-1-pentylpyrrol-3-yl)-naphthalen-1-ylmethanone (JWH-307).
16.22(iv) Naphthylmethylindenes, which are any compounds containing a
16.23naphthylideneindene structure with substitution at the 3-position of the indene
16.24ring by an allkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
16.251-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not further
16.26substituted in the indene ring to any extent, whether or not substituted in the naphthyl
16.27ring to any extent. Examples of naphthylemethylindenes include, but are not limited to,
16.28E-1-[1-(1-naphthalenylmethylene)-1H-inden-3-yl]pentane (JWH-176).
16.29(v) Phenylacetylindoles, which are any compounds containing a 3-phenylacetylindole
16.30structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
16.31alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
16.322-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
16.33any extent, whether or not substituted in the phenyl ring to any extent. Examples of
16.34phenylacetylindoles include, but are not limited to:
16.35(A) 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole (RCS-8);
16.36(B) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
17.1(C) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251);
17.2(D) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).
17.3(vi) Cyclohexylphenols, which are compounds containing a
17.42-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
17.5of the phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl,
17.61-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group whether or not
17.7substituted in the cyclohexyl ring to any extent. Examples of cyclohexylphenols include,
17.8but are not limited to:
17.9(A) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP 47,497);
17.10(B) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
17.11(Cannabicyclohexanol or CP 47,497 C8 homologue);
17.12(C) 5-(1,1-dimethylheptyl)-2-[(1R,2R)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]
17.13-phenol (CP 55,940).
17.14(vii) Benzoylindoles, which are any compounds containing a 3-(benzoyl)indole
17.15structure with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl,
17.16alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or
17.172-(4-morpholinyl)ethyl group whether or not further substituted in the indole ring to
17.18any extent and whether or not substituted in the phenyl ring to any extent. Examples of
17.19benzoylindoles include, but are not limited to:
17.20(A) 1-Pentyl-3-(4-methoxybenzoyl)indole (RCS-4);
17.21(B) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694);
17.22(C) (4-methoxyphenyl-[2-methyl-1-(2-(4-morpholinyl)ethyl)indol-3-yl]methanone
17.23(WIN 48,098 or Pravadoline).
17.24(viii) Others specifically named:
17.25(A) (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
17.26-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (HU-210);
17.27(B) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)
17.28-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol (Dexanabinol or HU-211);
17.29(C) 2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]
17.30-1,4-benzoxazin-6-yl-1-naphthalenylmethanone (WIN 55,212-2)
17.31(D) (1-pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);
17.32(E) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
17.33(XLR-11);
17.34(F) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide
17.35(AKB-48(APINACA));
18.1(G) N-((3s,5s,7s)-adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
18.2(5-Fluoro-AKB-48);
18.3(H) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22);
18.4(I) 8-quinolinyl ester-1-(5-fluoropentyl)-1H-indole-3-carboxylic acid (5-Fluoro
18.5PB-22).
18.6(i) A controlled substance analog, to the extent that it is implicitly or explicitly
18.7intended for human consumption.
18.8EFFECTIVE DATE.This section is effective August 1, 2013, and applies to crimes
18.9committed on or after that date.
18.10 Sec. 3. Minnesota Statutes 2012, section 152.126, subdivision 6, is amended to read:
18.11 Subd. 6. Access to reporting system data. (a) Except as indicated in this
18.12subdivision, the data submitted to the board under subdivision 4 is private data on
18.13individuals as defined in section
18.14 (b) Except as specified in subdivision 5, the following persons shall be considered
18.15permissible users and may access the data submitted under subdivision 4 in the same or
18.16similar manner, and for the same or similar purposes, as those persons who are authorized
18.17to access similar private data on individuals under federal and state law:
18.18 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
18.19delegated the task of accessing the data, to the extent the information relates specifically to
18.20a current patient, to whom the prescriber is prescribing or considering prescribing any
18.21controlled substance and with the provision that the prescriber remains responsible for the
18.22use or misuse of data accessed by a delegated agent or employee;
18.23 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
18.24delegated the task of accessing the data, to the extent the information relates specifically
18.25to a current patient to whom that dispenser is dispensing or considering dispensing any
18.26controlled substance and with the provision that the dispenser remains responsible for the
18.27use or misuse of data accessed by a delegated agent or employee;
18.28 (3) an individual who is the recipient of a controlled substance prescription for
18.29which data was submitted under subdivision 4, or a guardian of the individual, parent or
18.30guardian of a minor, or health care agent of the individual acting under a health care
18.31directive under chapter 145C;
18.32 (4) personnel of the board specifically assigned to conduct a bona fide investigation
18.33of a specific licensee;
19.1 (5) personnel of the board engaged in the collection of controlled substance
19.2prescription information as part of the assigned duties and responsibilities under this
19.3section;
19.4 (6) authorized personnel of a vendor under contract with the board who are engaged
19.5in the design, implementation, operation, and maintenance of the electronic reporting
19.6system as part of the assigned duties and responsibilities of their employment, provided
19.7that access to data is limited to the minimum amount necessary to carry out such duties
19.8and responsibilities;
19.9 (7) federal, state, and local law enforcement authorities acting pursuant to a valid
19.10search warrant;
19.11 (8) personnel of the medical assistance program assigned to use the data collected
19.12under this section to identify recipients whose usage of controlled substances may warrant
19.13restriction to a single primary care physician, a single outpatient pharmacy, or a single
19.14hospital
19.15(9) personnel of the Department of Human Services assigned to access the data
19.16pursuant to paragraph (h).
19.17 For purposes of clause (3), access by an individual includes persons in the definition
19.18of an individual under section
19.19 (c) Any permissible user identified in paragraph (b), who directly accesses
19.20the data electronically, shall implement and maintain a comprehensive information
19.21security program that contains administrative, technical, and physical safeguards that
19.22are appropriate to the user's size and complexity, and the sensitivity of the personal
19.23information obtained. The permissible user shall identify reasonably foreseeable internal
19.24and external risks to the security, confidentiality, and integrity of personal information
19.25that could result in the unauthorized disclosure, misuse, or other compromise of the
19.26information and assess the sufficiency of any safeguards in place to control the risks.
19.27 (d) The board shall not release data submitted under this section unless it is provided
19.28with evidence, satisfactory to the board, that the person requesting the information is
19.29entitled to receive the data.
19.30 (e) The board shall not release the name of a prescriber without the written consent
19.31of the prescriber or a valid search warrant or court order. The board shall provide a
19.32mechanism for a prescriber to submit to the board a signed consent authorizing the release
19.33of the prescriber's name when data containing the prescriber's name is requested.
19.34 (f) The board shall maintain a log of all persons who access the data and shall ensure
19.35that any permissible user complies with paragraph (c) prior to attaining direct access to
19.36the data.
20.1(g) Section
20.2pursuant to subdivision 2. A vendor shall not use data collected under this section for
20.3any purpose not specified in this section.
20.4(h) With available appropriations, the commissioner of human services shall
20.5establish and implement a system through which the Department of Human Services shall
20.6routinely access the data for the purpose of determining whether any client enrolled in
20.7an opioid treatment program licensed according to chapter 245A has been prescribed or
20.8dispensed a controlled substance in addition to that administered or dispensed by the
20.9opioid treatment program. When the commissioner determines there have been multiple
20.10prescribers or multiple prescriptions of controlled substances, the commissioner shall:
20.11(1) inform the medical director of the opioid treatment program only that the
20.12commissioner determined the existence of multiple prescribers or multiple prescriptions of
20.13controlled substances; and
20.14(2) direct the medical director of the opioid treatment program to access the data
20.15directly, review the effect of the multiple prescribers or multiple prescriptions, and
20.16document the review.
20.17If determined necessary, the commissioner of human services shall seek a federal waiver
20.18of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
20.192.34, item (c), prior to implementing this paragraph.
