| 1 | 1 | | 1.1 A bill for an act |
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| 2 | 2 | | 1.2 relating to state government; changing provisions in the prescription monitoring |
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| 3 | 3 | | 1.3 program; amending Minnesota Statutes 2024, section 152.126, subdivisions 1, 1a, |
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| 4 | 4 | | 1.4 2, 4, 5, 6, 11. |
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| 5 | 5 | | 1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: |
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| 6 | 6 | | 1.6 Section 1. Minnesota Statutes 2024, section 152.126, subdivision 1, is amended to read: |
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| 7 | 7 | | 1.7 Subdivision 1.Definitions.(a) For purposes of this section, the terms defined in this |
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| 8 | 8 | | 1.8subdivision have the meanings given. |
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| 9 | 9 | | 1.9 (b) "Board" means the Minnesota State Board of Pharmacy established under chapter |
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| 10 | 10 | | 1.10151. |
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| 11 | 11 | | 1.11 (c) "Controlled Reportable substances" means those substances listed in section 152.02, |
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| 12 | 12 | | 1.12subdivisions 3 to 6, and those substances defined by the board pursuant to section 152.02, |
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| 13 | 13 | | 1.13subdivisions 7, 8, and 12. For the purposes of this section, controlled Reportable substances |
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| 14 | 14 | | 1.14includes butalbital and, gabapentin, and opioid antagonists approved for use by the Food |
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| 15 | 15 | | 1.15and Drug Administration (FDA) as opioid overdose reversal agents. |
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| 16 | 16 | | 1.16 (d) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision |
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| 17 | 17 | | 1.1730. Dispensing does not include the direct administering of a controlled reportable substance |
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| 18 | 18 | | 1.18to a patient by a licensed health care professional. |
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| 19 | 19 | | 1.19 (e) "Dispenser" means a person authorized by law to dispense a controlled reportable |
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| 20 | 20 | | 1.20substance, pursuant to a valid prescription. For the purposes of this section, a dispenser does |
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| 21 | 21 | | 1.21not include a licensed hospital pharmacy that distributes controlled reportable substances |
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| 22 | 22 | | 1Section 1. |
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| 23 | 23 | | 25-00405 as introduced01/10/25 REVISOR EB/DG |
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| 24 | 24 | | SENATE |
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| 25 | 25 | | STATE OF MINNESOTA |
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| 26 | 26 | | S.F. No. 2806NINETY-FOURTH SESSION |
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| 27 | 27 | | (SENATE AUTHORS: MOHAMED) |
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| 28 | 28 | | OFFICIAL STATUSD-PGDATE |
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| 29 | 29 | | Introduction and first reading03/20/2025 |
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| 30 | 30 | | Referred to Health and Human Services 2.1for inpatient hospital care or a veterinarian who is dispensing prescriptions under section |
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| 31 | 31 | | 2.2156.18. |
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| 32 | 32 | | 2.3 (f) "Prescriber" means a licensed health care professional who is authorized to prescribe |
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| 33 | 33 | | 2.4a controlled substance under section 152.12, subdivision 1 or 2. |
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| 34 | 34 | | 2.5 (g) "Prescription" has the meaning given in section 151.01, subdivision 16a. |
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| 35 | 35 | | 2.6 Sec. 2. Minnesota Statutes 2024, section 152.126, subdivision 1a, is amended to read: |
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| 36 | 36 | | 2.7 Subd. 1a.Treatment of intractable pain.This section is not intended to limit or interfere |
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| 37 | 37 | | 2.8with the legitimate prescribing of controlled reportable substances for pain. No prescriber |
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| 38 | 38 | | 2.9shall be subject to disciplinary action by a health-related licensing board for prescribing a |
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| 39 | 39 | | 2.10controlled reportable substance according to the provisions of section 152.125. |
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| 40 | 40 | | 2.11 Sec. 3. Minnesota Statutes 2024, section 152.126, subdivision 2, is amended to read: |
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| 41 | 41 | | 2.12 Subd. 2.Prescription electronic reporting system.(a) The board shall establish by |
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| 42 | 42 | | 2.13January 1, 2010, an electronic system for reporting the information required under subdivision |
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| 43 | 43 | | 2.144 for all controlled reportable substances dispensed within the state. |
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| 44 | 44 | | 2.15 (b) The board may contract with a vendor for the purpose of obtaining technical assistance |
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| 45 | 45 | | 2.16in the design, implementation, operation, and maintenance of the electronic reporting system. |
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| 46 | 46 | | 2.17 Sec. 4. Minnesota Statutes 2024, section 152.126, subdivision 4, is amended to read: |
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| 47 | 47 | | 2.18 Subd. 4.Reporting requirements; notice.(a) Each dispenser must submit the following |
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| 48 | 48 | | 2.19data to the board or its designated vendor: |
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| 49 | 49 | | 2.20 (1) name of the prescriber; |
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| 50 | 50 | | 2.21 (2) national provider identifier of the prescriber; |
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| 51 | 51 | | 2.22 (3) name of the dispenser; |
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| 52 | 52 | | 2.23 (4) national provider identifier of the dispenser; |
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| 53 | 53 | | 2.24 (5) prescription number; |
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| 54 | 54 | | 2.25 (6) name of the patient for whom the prescription was written; |
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| 55 | 55 | | 2.26 (7) address of the patient for whom the prescription was written; |
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| 56 | 56 | | 2.27 (8) date of birth of the patient for whom the prescription was written; |
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| 57 | 57 | | 2.28 (9) date the prescription was written; |
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| 58 | 58 | | 2Sec. 4. |
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| 59 | 59 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 3.1 (10) date the prescription was filled; |
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| 60 | 60 | | 3.2 (11) name and strength of the controlled reportable substance; |
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| 61 | 61 | | 3.3 (12) quantity of controlled reportable substance prescribed; |
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| 62 | 62 | | 3.4 (13) quantity of controlled reportable substance dispensed; and |
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| 63 | 63 | | 3.5 (14) number of days supply. |
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| 64 | 64 | | 3.6 (b) The dispenser must submit the required information by a procedure and in a format |
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| 65 | 65 | | 3.7established by the board. The board may allow dispensers to omit data listed in this |
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| 66 | 66 | | 3.8subdivision or may require the submission of data not listed in this subdivision provided |
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| 67 | 67 | | 3.9the omission or submission is necessary for the purpose of complying with the electronic |
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| 68 | 68 | | 3.10reporting or data transmission standards of the American Society for Automation in |
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| 69 | 69 | | 3.11Pharmacy, the National Council on Prescription Drug Programs, or other relevant national |
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| 70 | 70 | | 3.12standard-setting body. |
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| 71 | 71 | | 3.13 (c) A dispenser is not required to submit this data for those controlled reportable substance |
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| 72 | 72 | | 3.14prescriptions dispensed for: |
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| 73 | 73 | | 3.15 (1) individuals residing in a health care facility as defined in section 151.58, subdivision |
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| 74 | 74 | | 3.162, paragraph (b), when a drug is distributed through the use of an automated drug distribution |
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| 75 | 75 | | 3.17system according to section 151.58; |
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| 76 | 76 | | 3.18 (2) individuals receiving a drug sample that was packaged by a manufacturer and provided |
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| 77 | 77 | | 3.19to the dispenser for dispensing as a professional sample pursuant to Code of Federal |
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| 78 | 78 | | 3.20Regulations, title 21, part 203, subpart D; and |
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| 79 | 79 | | 3.21 (3) individuals whose prescriptions are being mailed, shipped, or delivered from |
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| 80 | 80 | | 3.22Minnesota to another state, so long as the data are reported to the prescription drug monitoring |
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| 81 | 81 | | 3.23program of that state. |
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| 82 | 82 | | 3.24 (d) A dispenser must provide notice to the patient for whom the prescription was written, |
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| 83 | 83 | | 3.25or to that patient's authorized representative, of the reporting requirements of this section |
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| 84 | 84 | | 3.26and notice that the information may be used for program administration purposes. |
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| 85 | 85 | | 3.27 (e) The dispenser must submit the required information within the time frame specified |
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| 86 | 86 | | 3.28by the board; if no reportable prescriptions are dispensed or sold on any day, a report |
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| 87 | 87 | | 3.29indicating that fact must be filed with the board. |
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| 88 | 88 | | 3.30 (f) The dispenser must submit accurate information to the database and must correct |
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| 89 | 89 | | 3.31errors identified during the submission process within seven calendar days. |
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| 90 | 90 | | 3Sec. 4. |
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| 91 | 91 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 4.1 (g) For the purposes of this paragraph, the term "subject of the data" means the individual |
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| 92 | 92 | | 4.2reported as being the patient, the practitioner reported as being the prescriber, the client |
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| 93 | 93 | | 4.3when an animal is reported as being the patient, or an authorized agent of these individuals. |
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| 94 | 94 | | 4.4The dispenser must correct errors brought to its attention by the subject of the data within |
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| 95 | 95 | | 4.5seven calendar days, unless the dispenser verifies that an error did not occur and the data |
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| 96 | 96 | | 4.6were correctly submitted. The dispenser must notify the subject of the data that either the |
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| 97 | 97 | | 4.7error was corrected or that no error occurred. |
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| 98 | 98 | | 4.8 Sec. 5. Minnesota Statutes 2024, section 152.126, subdivision 5, is amended to read: |
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| 99 | 99 | | 4.9 Subd. 5.Use of data by board.(a) The board shall develop and maintain a database of |
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| 100 | 100 | | 4.10the data reported under subdivision 4. The board shall maintain data that could identify an |
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| 101 | 101 | | 4.11individual prescriber or dispenser in encrypted form. Except as otherwise allowed under |
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| 102 | 102 | | 4.12subdivision 6, the database may be used by permissible users identified under subdivision |
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| 103 | 103 | | 4.136 for the identification of: |
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| 104 | 104 | | 4.14 (1) individuals receiving prescriptions for controlled reportable substances from |
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| 105 | 105 | | 4.15prescribers who subsequently obtain controlled reportable substances from dispensers in |
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| 106 | 106 | | 4.16quantities or with a frequency inconsistent with generally recognized standards of use for |
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| 107 | 107 | | 4.17those controlled reportable substances, including standards accepted by national and |
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| 108 | 108 | | 4.18international pain management associations; and |
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| 109 | 109 | | 4.19 (2) individuals presenting forged or otherwise false or altered prescriptions for controlled |
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| 110 | 110 | | 4.20reportable substances to dispensers. |
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| 111 | 111 | | 4.21 (b) No permissible user identified under subdivision 6 may access the database for the |
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| 112 | 112 | | 4.22sole purpose of identifying prescribers of controlled reportable substances for unusual or |
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| 113 | 113 | | 4.23excessive prescribing patterns without a valid search warrant or court order. |
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| 114 | 114 | | 4.24 (c) No personnel of a state or federal occupational licensing board or agency may access |
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| 115 | 115 | | 4.25the database for the purpose of obtaining information to be used to initiate a disciplinary |
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| 116 | 116 | | 4.26action against a prescriber. |
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| 117 | 117 | | 4.27 (d) Data reported under subdivision 4 shall be made available to permissible users for |
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| 118 | 118 | | 4.28a 12-month period beginning the day the data was received and ending 12 months from the |
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| 119 | 119 | | 4.29last day of the month in which the data was received, except that permissible users defined |
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| 120 | 120 | | 4.30in subdivision 6, paragraph (b), clauses (7) and (8), may use all data collected under this |
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| 121 | 121 | | 4.31section for the purposes of administering, operating, and maintaining the prescription |
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| 122 | 122 | | 4.32monitoring program and conducting trend analyses and other studies necessary to evaluate |
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| 123 | 123 | | 4.33the effectiveness of the program. |
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| 124 | 124 | | 4Sec. 5. |
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| 125 | 125 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 5.1 (e) Data reported during the period January 1, 2015, through December 31, 2018, may |
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| 126 | 126 | | 5.2be retained through December 31, 2019, in an identifiable manner. Effective January 1, |
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| 127 | 127 | | 5.32020, data older than 24 months must be destroyed. Identifiable data reported for |
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| 128 | 128 | | 5.4prescriptions dispensed on or after January 1, 2020, must be destroyed no later than 12 |
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| 129 | 129 | | 5.5months from the date the prescription was reported as dispensed except that deidentified |
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| 130 | 130 | | 5.6data may be maintained for the purposes described in paragraph (d) that are carried out by |
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| 131 | 131 | | 5.7the permissible users defined in subdivision 6, paragraph (b), clauses (7) and (8). |
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| 132 | 132 | | 5.8 Sec. 6. Minnesota Statutes 2024, section 152.126, subdivision 6, is amended to read: |
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| 133 | 133 | | 5.9 Subd. 6.Access to reporting system data.(a) Except as indicated in this subdivision, |
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| 134 | 134 | | 5.10the data submitted to the board under subdivision 4 is private data on individuals as defined |
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| 135 | 135 | | 5.11in section 13.02, subdivision 12, and not subject to public disclosure. |
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| 136 | 136 | | 5.12 (b) Except as specified in subdivision 5, the following persons shall be considered |
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| 137 | 137 | | 5.13permissible users and may access the data submitted under subdivision 4 in the same or |
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| 138 | 138 | | 5.14similar manner, and for the same or similar purposes, as those persons who are authorized |
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| 139 | 139 | | 5.15to access similar private data on individuals under federal and state law: |
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| 140 | 140 | | 5.16 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has |
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| 141 | 141 | | 5.17delegated the task of accessing the data, to the extent the information relates specifically to |
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| 142 | 142 | | 5.18a current patient, to whom the prescriber is: |
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| 143 | 143 | | 5.19 (i) prescribing or considering prescribing any controlled reportable substance; |
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| 144 | 144 | | 5.20 (ii) providing emergency medical treatment for which access to the data may be necessary; |
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| 145 | 145 | | 5.21 (iii) providing care, and the prescriber has reason to believe, based on clinically valid |
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| 146 | 146 | | 5.22indications, that the patient is potentially abusing a controlled reportable substance; or |
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| 147 | 147 | | 5.23 (iv) providing other medical treatment for which access to the data may be necessary |
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| 148 | 148 | | 5.24for a clinically valid purpose and the patient has consented to access to the submitted data, |
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| 149 | 149 | | 5.25and with the provision that the prescriber remains responsible for the use or misuse of data |
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| 150 | 150 | | 5.26accessed by a delegated agent or employee; |
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| 151 | 151 | | 5.27 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has |
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| 152 | 152 | | 5.28delegated the task of accessing the data, to the extent the information relates specifically to |
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| 153 | 153 | | 5.29a current patient to whom that dispenser is dispensing or considering dispensing any |
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| 154 | 154 | | 5.30controlled reportable substance and with the provision that the dispenser remains responsible |
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| 155 | 155 | | 5.31for the use or misuse of data accessed by a delegated agent or employee; |
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| 156 | 156 | | 5Sec. 6. |
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| 157 | 157 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 6.1 (3) a licensed dispensing practitioner or licensed pharmacist to the extent necessary to |
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| 158 | 158 | | 6.2determine whether corrections made to the data reported under subdivision 4 are accurate; |
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| 159 | 159 | | 6.3 (4) a licensed pharmacist who is providing pharmaceutical care for which access to the |
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| 160 | 160 | | 6.4data may be necessary to the extent that the information relates specifically to a current |
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| 161 | 161 | | 6.5patient for whom the pharmacist is providing pharmaceutical care: (i) if the patient has |
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| 162 | 162 | | 6.6consented to access to the submitted data; or (ii) if the pharmacist is consulted by a prescriber |
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| 163 | 163 | | 6.7who is requesting data in accordance with clause (1); |
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| 164 | 164 | | 6.8 (5) an individual who is the recipient of a controlled reportable substance prescription |
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| 165 | 165 | | 6.9for which data was submitted under subdivision 4, or a guardian of the individual, parent |
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| 166 | 166 | | 6.10or guardian of a minor, or health care agent of the individual acting under a health care |
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| 167 | 167 | | 6.11directive under chapter 145C. For purposes of this clause, access by individuals includes |
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| 168 | 168 | | 6.12persons in the definition of an individual under section 13.02; |
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| 169 | 169 | | 6.13 (6) personnel or designees of a health-related licensing board listed in section 214.01, |
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| 170 | 170 | | 6.14subdivision 2, or of the Office of Emergency Medical Services, assigned to conduct a bona |
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| 171 | 171 | | 6.15fide investigation of a complaint received by that board or office that alleges that a specific |
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| 172 | 172 | | 6.16licensee is impaired by use of a drug for which data is collected under subdivision 4, has |
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| 173 | 173 | | 6.17engaged in activity that would constitute a crime as defined in section 152.025, or has |
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| 174 | 174 | | 6.18engaged in the behavior specified in subdivision 5, paragraph (a); |
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| 175 | 175 | | 6.19 (7) personnel of the board engaged in the collection, review, and analysis of controlled |
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| 176 | 176 | | 6.20reportable substance prescription information as part of the assigned duties and |
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| 177 | 177 | | 6.21responsibilities under this section; |
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| 178 | 178 | | 6.22 (8) authorized personnel under contract with the board, or under contract with the state |
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| 179 | 179 | | 6.23of Minnesota and approved by the board, who are engaged in the design, evaluation, |
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| 180 | 180 | | 6.24implementation, operation, or maintenance of the prescription monitoring program as part |
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| 181 | 181 | | 6.25of the assigned duties and responsibilities of their employment, provided that access to data |
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| 182 | 182 | | 6.26is limited to the minimum amount necessary to carry out such duties and responsibilities, |
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| 183 | 183 | | 6.27and subject to the requirement of de-identification and time limit on retention of data specified |
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| 184 | 184 | | 6.28in subdivision 5, paragraphs (d) and (e); |
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| 185 | 185 | | 6.29 (9) federal, state, and local law enforcement authorities acting pursuant to a valid search |
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| 186 | 186 | | 6.30warrant; |
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| 187 | 187 | | 6.31 (10) personnel of the Minnesota health care programs assigned to use the data collected |
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| 188 | 188 | | 6.32under this section to identify and manage recipients whose usage of controlled reportable |
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| 189 | 189 | | 6.33substances may warrant restriction to a single primary care provider, a single outpatient |
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| 190 | 190 | | 6.34pharmacy, and a single hospital; |
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| 191 | 191 | | 6Sec. 6. |
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| 192 | 192 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 7.1 (11) personnel of the Department of Human Services assigned to access the data pursuant |
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| 193 | 193 | | 7.2to paragraph (k); |
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| 194 | 194 | | 7.3 (12) personnel of the health professionals services program established under section |
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| 195 | 195 | | 7.4214.31, to the extent that the information relates specifically to an individual who is currently |
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| 196 | 196 | | 7.5enrolled in and being monitored by the program, and the individual consents to access to |
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| 197 | 197 | | 7.6that information. The health professionals services program personnel shall not provide this |
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| 198 | 198 | | 7.7data to a health-related licensing board, except as permitted under section 214.33, subdivision |
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| 199 | 199 | | 7.83; |
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| 200 | 200 | | 7.9 (13) personnel or designees of a health-related licensing board other than the Board of |
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| 201 | 201 | | 7.10Pharmacy listed in section 214.01, subdivision 2, assigned to conduct a bona fide |
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| 202 | 202 | | 7.11investigation of a complaint received by that board that alleges that a specific licensee is |
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| 203 | 203 | | 7.12inappropriately prescribing controlled reportable substances as defined in this section. For |
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| 204 | 204 | | 7.13the purposes of this clause, the health-related licensing board may also obtain utilization |
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| 205 | 205 | | 7.14data; and |
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| 206 | 206 | | 7.15 (14) personnel of the board specifically assigned to conduct a bona fide investigation |
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| 207 | 207 | | 7.16of a specific licensee or registrant. For the purposes of this clause, the board may also obtain |
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| 208 | 208 | | 7.17utilization data. |
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| 209 | 209 | | 7.18 (c) By July 1, 2017, every prescriber licensed by a health-related licensing board listed |
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| 210 | 210 | | 7.19in section 214.01, subdivision 2, practicing within this state who is authorized to prescribe |
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| 211 | 211 | | 7.20controlled reportable substances for humans and who holds a current registration issued by |
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| 212 | 212 | | 7.21the federal Drug Enforcement Administration, and every pharmacist licensed by the board |
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| 213 | 213 | | 7.22and practicing within the state, shall register and maintain a user account with the prescription |
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| 214 | 214 | | 7.23monitoring program. Data submitted by a prescriber, pharmacist, or their delegate during |
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| 215 | 215 | | 7.24the registration application process, other than their name, license number, and license type, |
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| 216 | 216 | | 7.25is classified as private pursuant to section 13.02, subdivision 12. |
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| 217 | 217 | | 7.26 (d) Notwithstanding paragraph (b), beginning January 1, 2021, a prescriber or an agent |
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| 218 | 218 | | 7.27or employee of the prescriber to whom the prescriber has delegated the task of accessing |
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| 219 | 219 | | 7.28the data, must access the data submitted under subdivision 4 to the extent the information |
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| 220 | 220 | | 7.29relates specifically to the patient: |
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| 221 | 221 | | 7.30 (1) before the prescriber issues an initial prescription order for a Schedules II through |
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| 222 | 222 | | 7.31IV opiate controlled reportable substance to the patient; and |
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| 223 | 223 | | 7.32 (2) at least once every three months for patients receiving an opiate for treatment of |
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| 224 | 224 | | 7.33chronic pain or participating in medically assisted treatment for an opioid addiction. |
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| 225 | 225 | | 7Sec. 6. |
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| 226 | 226 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 8.1 (e) Paragraph (d) does not apply if: |
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| 227 | 227 | | 8.2 (1) the patient is receiving palliative care, or hospice or other end-of-life care; |
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| 228 | 228 | | 8.3 (2) the patient is being treated for pain due to cancer or the treatment of cancer; |
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| 229 | 229 | | 8.4 (3) the prescription order is for a number of doses that is intended to last the patient five |
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| 230 | 230 | | 8.5days or less and is not subject to a refill; |
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| 231 | 231 | | 8.6 (4) the prescriber and patient have a current or ongoing provider/patient relationship of |
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| 232 | 232 | | 8.7a duration longer than one year; |
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| 233 | 233 | | 8.8 (5) the prescription order is issued within 14 days following surgery or three days |
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| 234 | 234 | | 8.9following oral surgery or follows the prescribing protocols established under the opioid |
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| 235 | 235 | | 8.10prescribing improvement program under section 256B.0638; |
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| 236 | 236 | | 8.11 (6) the controlled reportable substance is prescribed or administered to a patient who is |
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| 237 | 237 | | 8.12admitted to an inpatient hospital; |
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| 238 | 238 | | 8.13 (7) the controlled reportable substance is lawfully administered by injection, ingestion, |
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| 239 | 239 | | 8.14or any other means to the patient by the prescriber, a pharmacist, or by the patient at the |
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| 240 | 240 | | 8.15direction of a prescriber and in the presence of the prescriber or pharmacist; |
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| 241 | 241 | | 8.16 (8) due to a medical emergency, it is not possible for the prescriber to review the data |
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| 242 | 242 | | 8.17before the prescriber issues the prescription order for the patient; or |
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| 243 | 243 | | 8.18 (9) the prescriber is unable to access the data due to operational or other technological |
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| 244 | 244 | | 8.19failure of the program so long as the prescriber reports the failure to the board. |
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| 245 | 245 | | 8.20 (f) Only permissible users identified in paragraph (b), clauses (1), (2), (3), (4), (7), (8), |
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| 246 | 246 | | 8.21(10), and (11), may directly access the data electronically. No other permissible users may |
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| 247 | 247 | | 8.22directly access the data electronically. If the data is directly accessed electronically, the |
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| 248 | 248 | | 8.23permissible user shall implement and maintain a comprehensive information security program |
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| 249 | 249 | | 8.24that contains administrative, technical, and physical safeguards that are appropriate to the |
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| 250 | 250 | | 8.25user's size and complexity, and the sensitivity of the personal information obtained. The |
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| 251 | 251 | | 8.26permissible user shall identify reasonably foreseeable internal and external risks to the |
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| 252 | 252 | | 8.27security, confidentiality, and integrity of personal information that could result in the |
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| 253 | 253 | | 8.28unauthorized disclosure, misuse, or other compromise of the information and assess the |
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| 254 | 254 | | 8.29sufficiency of any safeguards in place to control the risks. |
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| 255 | 255 | | 8.30 (g) The board shall not release data submitted under subdivision 4 unless it is provided |
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| 256 | 256 | | 8.31with evidence, satisfactory to the board, that the person requesting the information is entitled |
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| 257 | 257 | | 8.32to receive the data. |
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| 258 | 258 | | 8Sec. 6. |
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| 259 | 259 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 9.1 (h) The board shall maintain a log of all persons who access the data for a period of at |
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| 260 | 260 | | 9.2least three years and shall ensure that any permissible user complies with paragraph (c) |
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| 261 | 261 | | 9.3prior to attaining direct access to the data. |
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| 262 | 262 | | 9.4 (i) Section 13.05, subdivision 6, shall apply to any contract the board enters into pursuant |
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| 263 | 263 | | 9.5to subdivision 2. A vendor shall not use data collected under this section for any purpose |
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| 264 | 264 | | 9.6not specified in this section. |
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| 265 | 265 | | 9.7 (j) The board may participate in an interstate prescription monitoring program data |
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| 266 | 266 | | 9.8exchange system provided that permissible users in other states have access to the data only |
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| 267 | 267 | | 9.9as allowed under this section, and that section 13.05, subdivision 6, applies to any contract |
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| 268 | 268 | | 9.10or memorandum of understanding that the board enters into under this paragraph. |
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| 269 | 269 | | 9.11 (k) With available appropriations, the commissioner of human services shall establish |
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| 270 | 270 | | 9.12and implement a system through which the Department of Human Services shall routinely |
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| 271 | 271 | | 9.13access the data for the purpose of determining whether any client enrolled in an opioid |
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| 272 | 272 | | 9.14treatment program licensed according to chapter 245A has been prescribed or dispensed a |
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| 273 | 273 | | 9.15controlled reportable substance in addition to that administered or dispensed by the opioid |
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| 274 | 274 | | 9.16treatment program. When the commissioner determines there have been multiple prescribers |
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| 275 | 275 | | 9.17or multiple prescriptions of controlled reportable substances, the commissioner shall: |
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| 276 | 276 | | 9.18 (1) inform the medical director of the opioid treatment program only that the |
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| 277 | 277 | | 9.19commissioner determined the existence of multiple prescribers or multiple prescriptions of |
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| 278 | 278 | | 9.20controlled reportable substances; and |
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| 279 | 279 | | 9.21 (2) direct the medical director of the opioid treatment program to access the data directly, |
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| 280 | 280 | | 9.22review the effect of the multiple prescribers or multiple prescriptions, and document the |
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| 281 | 281 | | 9.23review. |
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| 282 | 282 | | 9.24If determined necessary, the commissioner of human services shall seek a federal waiver |
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| 283 | 283 | | 9.25of, or exception to, any applicable provision of Code of Federal Regulations, title 42, section |
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| 284 | 284 | | 9.262.34, paragraph (c), prior to implementing this paragraph. |
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| 285 | 285 | | 9.27 (l) The board shall review the data submitted under subdivision 4 on at least a quarterly |
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| 286 | 286 | | 9.28basis and shall establish criteria, in consultation with the advisory task force, for referring |
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| 287 | 287 | | 9.29information about a patient to prescribers and dispensers who prescribed or dispensed the |
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| 288 | 288 | | 9.30prescriptions in question if the criteria are met. |
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| 289 | 289 | | 9.31 (m) The board shall conduct random audits, on at least a quarterly basis, of electronic |
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| 290 | 290 | | 9.32access by permissible users, as identified in paragraph (b), clauses (1), (2), (3), (4), (7), (8), |
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| 291 | 291 | | 9.33(10), and (11), to the data in subdivision 4, to ensure compliance with permissible use as |
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| 292 | 292 | | 9Sec. 6. |
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| 293 | 293 | | 25-00405 as introduced01/10/25 REVISOR EB/DG 10.1defined in this section. A permissible user whose account has been selected for a random |
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| 294 | 294 | | 10.2audit shall respond to an inquiry by the board, no later than 30 days after receipt of notice |
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| 295 | 295 | | 10.3that an audit is being conducted. Failure to respond may result in deactivation of access to |
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| 296 | 296 | | 10.4the electronic system and referral to the appropriate health licensing board, or the |
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| 297 | 297 | | 10.5commissioner of human services, for further action. The board shall report the results of |
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| 298 | 298 | | 10.6random audits to the chairs and ranking minority members of the legislative committees |
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| 299 | 299 | | 10.7with jurisdiction over health and human services policy and finance and government data |
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| 300 | 300 | | 10.8practices. |
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| 301 | 301 | | 10.9 (n) A permissible user who has delegated the task of accessing the data in subdivision |
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| 302 | 302 | | 10.104 to an agent or employee shall audit the use of the electronic system by delegated agents |
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| 303 | 303 | | 10.11or employees on at least a quarterly basis to ensure compliance with permissible use as |
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| 304 | 304 | | 10.12defined in this section. When a delegated agent or employee has been identified as |
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| 305 | 305 | | 10.13inappropriately accessing data, the permissible user must immediately remove access for |
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| 306 | 306 | | 10.14that individual and notify the board within seven days. The board shall notify all permissible |
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| 307 | 307 | | 10.15users associated with the delegated agent or employee of the alleged violation. |
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| 308 | 308 | | 10.16 (o) A permissible user who delegates access to the data submitted under subdivision 4 |
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| 309 | 309 | | 10.17to an agent or employee shall terminate that individual's access to the data within three |
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| 310 | 310 | | 10.18business days of the agent or employee leaving employment with the permissible user. The |
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| 311 | 311 | | 10.19board may conduct random audits to determine compliance with this requirement. |
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| 312 | 312 | | 10.20 (p) Access to reportable data on opioid antagonists is restricted to those permissible |
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| 313 | 313 | | 10.21users defined in paragraph (b), clauses (7) and (8). |
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| 314 | 314 | | 10.22Sec. 7. Minnesota Statutes 2024, section 152.126, subdivision 11, is amended to read: |
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| 315 | 315 | | 10.23 Subd. 11.Patient information on record access.A patient who has been prescribed a |
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| 316 | 316 | | 10.24controlled reportable substance may access the prescription monitoring program database |
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| 317 | 317 | | 10.25in order to obtain information on access by permissible users to the patient's data record, |
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| 318 | 318 | | 10.26including the name and organizational affiliation of the permissible user and the date of |
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| 319 | 319 | | 10.27access. In order to obtain this information, the patient must complete, notarize, and submit |
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| 320 | 320 | | 10.28a request form developed by the board. The board shall make this form available to the |
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| 321 | 321 | | 10.29public on the board's website. |
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| 322 | 322 | | 10Sec. 7. |
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| 323 | 323 | | 25-00405 as introduced01/10/25 REVISOR EB/DG |
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