1.1 A bill for an act 1.2 relating to state government; changing provisions in the prescription monitoring 1.3 program; amending Minnesota Statutes 2024, section 152.126, subdivisions 1, 1a, 1.4 2, 4, 5, 6, 11. 1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 1.6 Section 1. Minnesota Statutes 2024, section 152.126, subdivision 1, is amended to read: 1.7 Subdivision 1.Definitions.(a) For purposes of this section, the terms defined in this 1.8subdivision have the meanings given. 1.9 (b) "Board" means the Minnesota State Board of Pharmacy established under chapter 1.10151. 1.11 (c) "Controlled Reportable substances" means those substances listed in section 152.02, 1.12subdivisions 3 to 6, and those substances defined by the board pursuant to section 152.02, 1.13subdivisions 7, 8, and 12. For the purposes of this section, controlled Reportable substances 1.14includes butalbital and, gabapentin, and opioid antagonists approved for use by the Food 1.15and Drug Administration (FDA) as opioid overdose reversal agents. 1.16 (d) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision 1.1730. Dispensing does not include the direct administering of a controlled reportable substance 1.18to a patient by a licensed health care professional. 1.19 (e) "Dispenser" means a person authorized by law to dispense a controlled reportable 1.20substance, pursuant to a valid prescription. For the purposes of this section, a dispenser does 1.21not include a licensed hospital pharmacy that distributes controlled reportable substances 1Section 1. REVISOR EB/DG 25-0040501/10/25 State of Minnesota This Document can be made available in alternative formats upon request HOUSE OF REPRESENTATIVES H. F. No. 2624 NINETY-FOURTH SESSION Authored by Bierman03/20/2025 The bill was read for the first time and referred to the Committee on Health Finance and Policy 2.1for inpatient hospital care or a veterinarian who is dispensing prescriptions under section 2.2156.18. 2.3 (f) "Prescriber" means a licensed health care professional who is authorized to prescribe 2.4a controlled substance under section 152.12, subdivision 1 or 2. 2.5 (g) "Prescription" has the meaning given in section 151.01, subdivision 16a. 2.6 Sec. 2. Minnesota Statutes 2024, section 152.126, subdivision 1a, is amended to read: 2.7 Subd. 1a.Treatment of intractable pain.This section is not intended to limit or interfere 2.8with the legitimate prescribing of controlled reportable substances for pain. No prescriber 2.9shall be subject to disciplinary action by a health-related licensing board for prescribing a 2.10controlled reportable substance according to the provisions of section 152.125. 2.11 Sec. 3. Minnesota Statutes 2024, section 152.126, subdivision 2, is amended to read: 2.12 Subd. 2.Prescription electronic reporting system.(a) The board shall establish by 2.13January 1, 2010, an electronic system for reporting the information required under subdivision 2.144 for all controlled reportable substances dispensed within the state. 2.15 (b) The board may contract with a vendor for the purpose of obtaining technical assistance 2.16in the design, implementation, operation, and maintenance of the electronic reporting system. 2.17 Sec. 4. Minnesota Statutes 2024, section 152.126, subdivision 4, is amended to read: 2.18 Subd. 4.Reporting requirements; notice.(a) Each dispenser must submit the following 2.19data to the board or its designated vendor: 2.20 (1) name of the prescriber; 2.21 (2) national provider identifier of the prescriber; 2.22 (3) name of the dispenser; 2.23 (4) national provider identifier of the dispenser; 2.24 (5) prescription number; 2.25 (6) name of the patient for whom the prescription was written; 2.26 (7) address of the patient for whom the prescription was written; 2.27 (8) date of birth of the patient for whom the prescription was written; 2.28 (9) date the prescription was written; 2Sec. 4. REVISOR EB/DG 25-0040501/10/25 3.1 (10) date the prescription was filled; 3.2 (11) name and strength of the controlled reportable substance; 3.3 (12) quantity of controlled reportable substance prescribed; 3.4 (13) quantity of controlled reportable substance dispensed; and 3.5 (14) number of days supply. 3.6 (b) The dispenser must submit the required information by a procedure and in a format 3.7established by the board. The board may allow dispensers to omit data listed in this 3.8subdivision or may require the submission of data not listed in this subdivision provided 3.9the omission or submission is necessary for the purpose of complying with the electronic 3.10reporting or data transmission standards of the American Society for Automation in 3.11Pharmacy, the National Council on Prescription Drug Programs, or other relevant national 3.12standard-setting body. 3.13 (c) A dispenser is not required to submit this data for those controlled reportable substance 3.14prescriptions dispensed for: 3.15 (1) individuals residing in a health care facility as defined in section 151.58, subdivision 3.162, paragraph (b), when a drug is distributed through the use of an automated drug distribution 3.17system according to section 151.58; 3.18 (2) individuals receiving a drug sample that was packaged by a manufacturer and provided 3.19to the dispenser for dispensing as a professional sample pursuant to Code of Federal 3.20Regulations, title 21, part 203, subpart D; and 3.21 (3) individuals whose prescriptions are being mailed, shipped, or delivered from 3.22Minnesota to another state, so long as the data are reported to the prescription drug monitoring 3.23program of that state. 3.24 (d) A dispenser must provide notice to the patient for whom the prescription was written, 3.25or to that patient's authorized representative, of the reporting requirements of this section 3.26and notice that the information may be used for program administration purposes. 3.27 (e) The dispenser must submit the required information within the time frame specified 3.28by the board; if no reportable prescriptions are dispensed or sold on any day, a report 3.29indicating that fact must be filed with the board. 3.30 (f) The dispenser must submit accurate information to the database and must correct 3.31errors identified during the submission process within seven calendar days. 3Sec. 4. REVISOR EB/DG 25-0040501/10/25 4.1 (g) For the purposes of this paragraph, the term "subject of the data" means the individual 4.2reported as being the patient, the practitioner reported as being the prescriber, the client 4.3when an animal is reported as being the patient, or an authorized agent of these individuals. 4.4The dispenser must correct errors brought to its attention by the subject of the data within 4.5seven calendar days, unless the dispenser verifies that an error did not occur and the data 4.6were correctly submitted. The dispenser must notify the subject of the data that either the 4.7error was corrected or that no error occurred. 4.8 Sec. 5. Minnesota Statutes 2024, section 152.126, subdivision 5, is amended to read: 4.9 Subd. 5.Use of data by board.(a) The board shall develop and maintain a database of 4.10the data reported under subdivision 4. The board shall maintain data that could identify an 4.11individual prescriber or dispenser in encrypted form. Except as otherwise allowed under 4.12subdivision 6, the database may be used by permissible users identified under subdivision 4.136 for the identification of: 4.14 (1) individuals receiving prescriptions for controlled reportable substances from 4.15prescribers who subsequently obtain controlled reportable substances from dispensers in 4.16quantities or with a frequency inconsistent with generally recognized standards of use for 4.17those controlled reportable substances, including standards accepted by national and 4.18international pain management associations; and 4.19 (2) individuals presenting forged or otherwise false or altered prescriptions for controlled 4.20reportable substances to dispensers. 4.21 (b) No permissible user identified under subdivision 6 may access the database for the 4.22sole purpose of identifying prescribers of controlled reportable substances for unusual or 4.23excessive prescribing patterns without a valid search warrant or court order. 4.24 (c) No personnel of a state or federal occupational licensing board or agency may access 4.25the database for the purpose of obtaining information to be used to initiate a disciplinary 4.26action against a prescriber. 4.27 (d) Data reported under subdivision 4 shall be made available to permissible users for 4.28a 12-month period beginning the day the data was received and ending 12 months from the 4.29last day of the month in which the data was received, except that permissible users defined 4.30in subdivision 6, paragraph (b), clauses (7) and (8), may use all data collected under this 4.31section for the purposes of administering, operating, and maintaining the prescription 4.32monitoring program and conducting trend analyses and other studies necessary to evaluate 4.33the effectiveness of the program. 4Sec. 5. REVISOR EB/DG 25-0040501/10/25 5.1 (e) Data reported during the period January 1, 2015, through December 31, 2018, may 5.2be retained through December 31, 2019, in an identifiable manner. Effective January 1, 5.32020, data older than 24 months must be destroyed. Identifiable data reported for 5.4prescriptions dispensed on or after January 1, 2020, must be destroyed no later than 12 5.5months from the date the prescription was reported as dispensed except that deidentified 5.6data may be maintained for the purposes described in paragraph (d) that are carried out by 5.7the permissible users defined in subdivision 6, paragraph (b), clauses (7) and (8). 5.8 Sec. 6. Minnesota Statutes 2024, section 152.126, subdivision 6, is amended to read: 5.9 Subd. 6.Access to reporting system data.(a) Except as indicated in this subdivision, 5.10the data submitted to the board under subdivision 4 is private data on individuals as defined 5.11in section 13.02, subdivision 12, and not subject to public disclosure. 5.12 (b) Except as specified in subdivision 5, the following persons shall be considered 5.13permissible users and may access the data submitted under subdivision 4 in the same or 5.14similar manner, and for the same or similar purposes, as those persons who are authorized 5.15to access similar private data on individuals under federal and state law: 5.16 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has 5.17delegated the task of accessing the data, to the extent the information relates specifically to 5.18a current patient, to whom the prescriber is: 5.19 (i) prescribing or considering prescribing any controlled reportable substance; 5.20 (ii) providing emergency medical treatment for which access to the data may be necessary; 5.21 (iii) providing care, and the prescriber has reason to believe, based on clinically valid 5.22indications, that the patient is potentially abusing a controlled reportable substance; or 5.23 (iv) providing other medical treatment for which access to the data may be necessary 5.24for a clinically valid purpose and the patient has consented to access to the submitted data, 5.25and with the provision that the prescriber remains responsible for the use or misuse of data 5.26accessed by a delegated agent or employee; 5.27 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has 5.28delegated the task of accessing the data, to the extent the information relates specifically to 5.29a current patient to whom that dispenser is dispensing or considering dispensing any 5.30controlled reportable substance and with the provision that the dispenser remains responsible 5.31for the use or misuse of data accessed by a delegated agent or employee; 5Sec. 6. REVISOR EB/DG 25-0040501/10/25 6.1 (3) a licensed dispensing practitioner or licensed pharmacist to the extent necessary to 6.2determine whether corrections made to the data reported under subdivision 4 are accurate; 6.3 (4) a licensed pharmacist who is providing pharmaceutical care for which access to the 6.4data may be necessary to the extent that the information relates specifically to a current 6.5patient for whom the pharmacist is providing pharmaceutical care: (i) if the patient has 6.6consented to access to the submitted data; or (ii) if the pharmacist is consulted by a prescriber 6.7who is requesting data in accordance with clause (1); 6.8 (5) an individual who is the recipient of a controlled reportable substance prescription 6.9for which data was submitted under subdivision 4, or a guardian of the individual, parent 6.10or guardian of a minor, or health care agent of the individual acting under a health care 6.11directive under chapter 145C. For purposes of this clause, access by individuals includes 6.12persons in the definition of an individual under section 13.02; 6.13 (6) personnel or designees of a health-related licensing board listed in section 214.01, 6.14subdivision 2, or of the Office of Emergency Medical Services, assigned to conduct a bona 6.15fide investigation of a complaint received by that board or office that alleges that a specific 6.16licensee is impaired by use of a drug for which data is collected under subdivision 4, has 6.17engaged in activity that would constitute a crime as defined in section 152.025, or has 6.18engaged in the behavior specified in subdivision 5, paragraph (a); 6.19 (7) personnel of the board engaged in the collection, review, and analysis of controlled 6.20reportable substance prescription information as part of the assigned duties and 6.21responsibilities under this section; 6.22 (8) authorized personnel under contract with the board, or under contract with the state 6.23of Minnesota and approved by the board, who are engaged in the design, evaluation, 6.24implementation, operation, or maintenance of the prescription monitoring program as part 6.25of the assigned duties and responsibilities of their employment, provided that access to data 6.26is limited to the minimum amount necessary to carry out such duties and responsibilities, 6.27and subject to the requirement of de-identification and time limit on retention of data specified 6.28in subdivision 5, paragraphs (d) and (e); 6.29 (9) federal, state, and local law enforcement authorities acting pursuant to a valid search 6.30warrant; 6.31 (10) personnel of the Minnesota health care programs assigned to use the data collected 6.32under this section to identify and manage recipients whose usage of controlled reportable 6.33substances may warrant restriction to a single primary care provider, a single outpatient 6.34pharmacy, and a single hospital; 6Sec. 6. REVISOR EB/DG 25-0040501/10/25 7.1 (11) personnel of the Department of Human Services assigned to access the data pursuant 7.2to paragraph (k); 7.3 (12) personnel of the health professionals services program established under section 7.4214.31, to the extent that the information relates specifically to an individual who is currently 7.5enrolled in and being monitored by the program, and the individual consents to access to 7.6that information. The health professionals services program personnel shall not provide this 7.7data to a health-related licensing board, except as permitted under section 214.33, subdivision 7.83; 7.9 (13) personnel or designees of a health-related licensing board other than the Board of 7.10Pharmacy listed in section 214.01, subdivision 2, assigned to conduct a bona fide 7.11investigation of a complaint received by that board that alleges that a specific licensee is 7.12inappropriately prescribing controlled reportable substances as defined in this section. For 7.13the purposes of this clause, the health-related licensing board may also obtain utilization 7.14data; and 7.15 (14) personnel of the board specifically assigned to conduct a bona fide investigation 7.16of a specific licensee or registrant. For the purposes of this clause, the board may also obtain 7.17utilization data. 7.18 (c) By July 1, 2017, every prescriber licensed by a health-related licensing board listed 7.19in section 214.01, subdivision 2, practicing within this state who is authorized to prescribe 7.20controlled reportable substances for humans and who holds a current registration issued by 7.21the federal Drug Enforcement Administration, and every pharmacist licensed by the board 7.22and practicing within the state, shall register and maintain a user account with the prescription 7.23monitoring program. Data submitted by a prescriber, pharmacist, or their delegate during 7.24the registration application process, other than their name, license number, and license type, 7.25is classified as private pursuant to section 13.02, subdivision 12. 7.26 (d) Notwithstanding paragraph (b), beginning January 1, 2021, a prescriber or an agent 7.27or employee of the prescriber to whom the prescriber has delegated the task of accessing 7.28the data, must access the data submitted under subdivision 4 to the extent the information 7.29relates specifically to the patient: 7.30 (1) before the prescriber issues an initial prescription order for a Schedules II through 7.31IV opiate controlled reportable substance to the patient; and 7.32 (2) at least once every three months for patients receiving an opiate for treatment of 7.33chronic pain or participating in medically assisted treatment for an opioid addiction. 7Sec. 6. REVISOR EB/DG 25-0040501/10/25 8.1 (e) Paragraph (d) does not apply if: 8.2 (1) the patient is receiving palliative care, or hospice or other end-of-life care; 8.3 (2) the patient is being treated for pain due to cancer or the treatment of cancer; 8.4 (3) the prescription order is for a number of doses that is intended to last the patient five 8.5days or less and is not subject to a refill; 8.6 (4) the prescriber and patient have a current or ongoing provider/patient relationship of 8.7a duration longer than one year; 8.8 (5) the prescription order is issued within 14 days following surgery or three days 8.9following oral surgery or follows the prescribing protocols established under the opioid 8.10prescribing improvement program under section 256B.0638; 8.11 (6) the controlled reportable substance is prescribed or administered to a patient who is 8.12admitted to an inpatient hospital; 8.13 (7) the controlled reportable substance is lawfully administered by injection, ingestion, 8.14or any other means to the patient by the prescriber, a pharmacist, or by the patient at the 8.15direction of a prescriber and in the presence of the prescriber or pharmacist; 8.16 (8) due to a medical emergency, it is not possible for the prescriber to review the data 8.17before the prescriber issues the prescription order for the patient; or 8.18 (9) the prescriber is unable to access the data due to operational or other technological 8.19failure of the program so long as the prescriber reports the failure to the board. 8.20 (f) Only permissible users identified in paragraph (b), clauses (1), (2), (3), (4), (7), (8), 8.21(10), and (11), may directly access the data electronically. No other permissible users may 8.22directly access the data electronically. If the data is directly accessed electronically, the 8.23permissible user shall implement and maintain a comprehensive information security program 8.24that contains administrative, technical, and physical safeguards that are appropriate to the 8.25user's size and complexity, and the sensitivity of the personal information obtained. The 8.26permissible user shall identify reasonably foreseeable internal and external risks to the 8.27security, confidentiality, and integrity of personal information that could result in the 8.28unauthorized disclosure, misuse, or other compromise of the information and assess the 8.29sufficiency of any safeguards in place to control the risks. 8.30 (g) The board shall not release data submitted under subdivision 4 unless it is provided 8.31with evidence, satisfactory to the board, that the person requesting the information is entitled 8.32to receive the data. 8Sec. 6. REVISOR EB/DG 25-0040501/10/25 9.1 (h) The board shall maintain a log of all persons who access the data for a period of at 9.2least three years and shall ensure that any permissible user complies with paragraph (c) 9.3prior to attaining direct access to the data. 9.4 (i) Section 13.05, subdivision 6, shall apply to any contract the board enters into pursuant 9.5to subdivision 2. A vendor shall not use data collected under this section for any purpose 9.6not specified in this section. 9.7 (j) The board may participate in an interstate prescription monitoring program data 9.8exchange system provided that permissible users in other states have access to the data only 9.9as allowed under this section, and that section 13.05, subdivision 6, applies to any contract 9.10or memorandum of understanding that the board enters into under this paragraph. 9.11 (k) With available appropriations, the commissioner of human services shall establish 9.12and implement a system through which the Department of Human Services shall routinely 9.13access the data for the purpose of determining whether any client enrolled in an opioid 9.14treatment program licensed according to chapter 245A has been prescribed or dispensed a 9.15controlled reportable substance in addition to that administered or dispensed by the opioid 9.16treatment program. When the commissioner determines there have been multiple prescribers 9.17or multiple prescriptions of controlled reportable substances, the commissioner shall: 9.18 (1) inform the medical director of the opioid treatment program only that the 9.19commissioner determined the existence of multiple prescribers or multiple prescriptions of 9.20controlled reportable substances; and 9.21 (2) direct the medical director of the opioid treatment program to access the data directly, 9.22review the effect of the multiple prescribers or multiple prescriptions, and document the 9.23review. 9.24If determined necessary, the commissioner of human services shall seek a federal waiver 9.25of, or exception to, any applicable provision of Code of Federal Regulations, title 42, section 9.262.34, paragraph (c), prior to implementing this paragraph. 9.27 (l) The board shall review the data submitted under subdivision 4 on at least a quarterly 9.28basis and shall establish criteria, in consultation with the advisory task force, for referring 9.29information about a patient to prescribers and dispensers who prescribed or dispensed the 9.30prescriptions in question if the criteria are met. 9.31 (m) The board shall conduct random audits, on at least a quarterly basis, of electronic 9.32access by permissible users, as identified in paragraph (b), clauses (1), (2), (3), (4), (7), (8), 9.33(10), and (11), to the data in subdivision 4, to ensure compliance with permissible use as 9Sec. 6. REVISOR EB/DG 25-0040501/10/25 10.1defined in this section. A permissible user whose account has been selected for a random 10.2audit shall respond to an inquiry by the board, no later than 30 days after receipt of notice 10.3that an audit is being conducted. Failure to respond may result in deactivation of access to 10.4the electronic system and referral to the appropriate health licensing board, or the 10.5commissioner of human services, for further action. The board shall report the results of 10.6random audits to the chairs and ranking minority members of the legislative committees 10.7with jurisdiction over health and human services policy and finance and government data 10.8practices. 10.9 (n) A permissible user who has delegated the task of accessing the data in subdivision 10.104 to an agent or employee shall audit the use of the electronic system by delegated agents 10.11or employees on at least a quarterly basis to ensure compliance with permissible use as 10.12defined in this section. When a delegated agent or employee has been identified as 10.13inappropriately accessing data, the permissible user must immediately remove access for 10.14that individual and notify the board within seven days. The board shall notify all permissible 10.15users associated with the delegated agent or employee of the alleged violation. 10.16 (o) A permissible user who delegates access to the data submitted under subdivision 4 10.17to an agent or employee shall terminate that individual's access to the data within three 10.18business days of the agent or employee leaving employment with the permissible user. The 10.19board may conduct random audits to determine compliance with this requirement. 10.20 (p) Access to reportable data on opioid antagonists is restricted to those permissible 10.21users defined in paragraph (b), clauses (7) and (8). 10.22Sec. 7. Minnesota Statutes 2024, section 152.126, subdivision 11, is amended to read: 10.23 Subd. 11.Patient information on record access.A patient who has been prescribed a 10.24controlled reportable substance may access the prescription monitoring program database 10.25in order to obtain information on access by permissible users to the patient's data record, 10.26including the name and organizational affiliation of the permissible user and the date of 10.27access. In order to obtain this information, the patient must complete, notarize, and submit 10.28a request form developed by the board. The board shall make this form available to the 10.29public on the board's website. 10Sec. 7. REVISOR EB/DG 25-0040501/10/25