Minnesota 2025-2026 Regular Session

Minnesota House Bill HF2624 Latest Draft

Bill / Introduced Version Filed 03/20/2025

                            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​
1​Section 1.​
REVISOR EB/DG 25-00405​01/10/25 ​
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 Bierman​03/20/2025​
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;​
2​Sec. 4.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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.​
3​Sec. 4.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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.​
4​Sec. 5.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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;​
5​Sec. 6.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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;​
6​Sec. 6.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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.​
7​Sec. 6.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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.​
8​Sec. 6.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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​
9​Sec. 6.​
REVISOR EB/DG 25-00405​01/10/25 ​ 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.​
10​Sec. 7.​
REVISOR EB/DG 25-00405​01/10/25 ​