SF 2806

Introduction - 94th Legislature (2025 - 2026)

Posted on 03/21/2025 10:30 a.m.

A bill for an act
relating to state government; changing provisions in the prescription monitoring
program; amending Minnesota Statutes 2024, section 152.126, subdivisions 1, 1a,
2, 4, 5, 6, 11.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2024, section 152.126, subdivision 1, is amended to read:

Subdivision 1.

Definitions.

(a) For purposes of this section, the terms defined in this
subdivision have the meanings given.

(b) "Board" means the Minnesota State Board of Pharmacy established under chapter
151.

(c) " deleted text begin Controlled deleted text end new text begin Reportable new text end substances" means those substances listed in section 152.02,
subdivisions 3 to 6, and those substances defined by the board pursuant to section 152.02,
subdivisions 7, 8, and 12. deleted text begin For the purposes of this section, controlled deleted text end new text begin Reportable new text end substances
includes butalbital deleted text begin and deleted text end new text begin , new text end gabapentin new text begin , and opioid antagonists approved for use by the Food
and Drug Administration (FDA) as opioid overdose reversal agents new text end .

(d) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision
30. Dispensing does not include the direct administering of a deleted text begin controlled deleted text end new text begin reportable new text end substance
to a patient by a licensed health care professional.

(e) "Dispenser" means a person authorized by law to dispense a deleted text begin controlled deleted text end new text begin reportable new text end
substance, pursuant to a valid prescription. For the purposes of this section, a dispenser does
not include a licensed hospital pharmacy that distributes deleted text begin controlled deleted text end new text begin reportable new text end substances
for inpatient hospital care or a veterinarian who is dispensing prescriptions under section
156.18.

(f) "Prescriber" means a licensed health care professional who is authorized to prescribe
a controlled substance under section 152.12, subdivision 1 or 2.

(g) "Prescription" has the meaning given in section 151.01, subdivision 16a.

Sec. 2.

Minnesota Statutes 2024, section 152.126, subdivision 1a, is amended to read:

Subd. 1a.

Treatment of intractable pain.

This section is not intended to limit or interfere
with the legitimate prescribing of deleted text begin controlled deleted text end new text begin reportable new text end substances for pain. No prescriber
shall be subject to disciplinary action by a health-related licensing board for prescribing a
deleted text begin controlled deleted text end new text begin reportable new text end substance according to the provisions of section 152.125.

Sec. 3.

Minnesota Statutes 2024, section 152.126, subdivision 2, is amended to read:

Subd. 2.

Prescription electronic reporting system.

(a) The board shall establish by
January 1, 2010, an electronic system for reporting the information required under subdivision
4 for all deleted text begin controlled deleted text end new text begin reportable new text end substances dispensed within the state.

(b) The board may contract with a vendor for the purpose of obtaining technical assistance
in the design, implementation, operation, and maintenance of the electronic reporting system.

Sec. 4.

Minnesota Statutes 2024, section 152.126, subdivision 4, is amended to read:

Subd. 4.

Reporting requirements; notice.

(a) Each dispenser must submit the following
data to the board or its designated vendor:

(1) name of the prescriber;

(2) national provider identifier of the prescriber;

(3) name of the dispenser;

(4) national provider identifier of the dispenser;

(5) prescription number;

(6) name of the patient for whom the prescription was written;

(7) address of the patient for whom the prescription was written;

(8) date of birth of the patient for whom the prescription was written;

(9) date the prescription was written;

(10) date the prescription was filled;

(11) name and strength of the deleted text begin controlled deleted text end new text begin reportable new text end substance;

(12) quantity of deleted text begin controlled deleted text end new text begin reportable new text end substance prescribed;

(13) quantity of deleted text begin controlled deleted text end new text begin reportable new text end substance dispensed; and

(14) number of days supply.

(b) The dispenser must submit the required information by a procedure and in a format
established by the board. The board may allow dispensers to omit data listed in this
subdivision or may require the submission of data not listed in this subdivision provided
the omission or submission is necessary for the purpose of complying with the electronic
reporting or data transmission standards of the American Society for Automation in
Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
standard-setting body.

(c) A dispenser is not required to submit this data for those deleted text begin controlled deleted text end new text begin reportable new text end substance
prescriptions dispensed for:

(1) individuals residing in a health care facility as defined in section 151.58, subdivision
2, paragraph (b), when a drug is distributed through the use of an automated drug distribution
system according to section 151.58;

(2) individuals receiving a drug sample that was packaged by a manufacturer and provided
to the dispenser for dispensing as a professional sample pursuant to Code of Federal
Regulations, title 21, part 203, subpart D; and

(3) individuals whose prescriptions are being mailed, shipped, or delivered from
Minnesota to another state, so long as the data are reported to the prescription drug monitoring
program of that state.

(d) A dispenser must provide notice to the patient for whom the prescription was written,
or to that patient's authorized representative, of the reporting requirements of this section
and notice that the information may be used for program administration purposes.

(e) The dispenser must submit the required information within the time frame specified
by the board; if no reportable prescriptions are dispensed or sold on any day, a report
indicating that fact must be filed with the board.

(f) The dispenser must submit accurate information to the database and must correct
errors identified during the submission process within seven calendar days.

(g) For the purposes of this paragraph, the term "subject of the data" means the individual
reported as being the patient, the practitioner reported as being the prescriber, the client
when an animal is reported as being the patient, or an authorized agent of these individuals.
The dispenser must correct errors brought to its attention by the subject of the data within
seven calendar days, unless the dispenser verifies that an error did not occur and the data
were correctly submitted. The dispenser must notify the subject of the data that either the
error was corrected or that no error occurred.

Sec. 5.

Minnesota Statutes 2024, section 152.126, subdivision 5, is amended to read:

Subd. 5.

Use of data by board.

(a) The board shall develop and maintain a database of
the data reported under subdivision 4. The board shall maintain data that could identify an
individual prescriber or dispenser in encrypted form. Except as otherwise allowed under
subdivision 6, the database may be used by permissible users identified under subdivision
6 for the identification of:

(1) individuals receiving prescriptions for deleted text begin controlled deleted text end new text begin reportable new text end substances from
prescribers who subsequently obtain deleted text begin controlled deleted text end new text begin reportable new text end substances from dispensers in
quantities or with a frequency inconsistent with generally recognized standards of use for
those deleted text begin controlled deleted text end new text begin reportable new text end substances, including standards accepted by national and
international pain management associations; and

(2) individuals presenting forged or otherwise false or altered prescriptions for deleted text begin controlled deleted text end new text begin
reportable new text end substances to dispensers.

(b) No permissible user identified under subdivision 6 may access the database for the
sole purpose of identifying prescribers of deleted text begin controlled deleted text end new text begin reportable new text end substances for unusual or
excessive prescribing patterns without a valid search warrant or court order.

(c) No personnel of a state or federal occupational licensing board or agency may access
the database for the purpose of obtaining information to be used to initiate a disciplinary
action against a prescriber.

(d) Data reported under subdivision 4 shall be made available to permissible users for
a 12-month period beginning the day the data was received and ending 12 months from the
last day of the month in which the data was received, except that permissible users defined
in subdivision 6, paragraph (b), clauses (7) and (8), may use all data collected under this
section for the purposes of administering, operating, and maintaining the prescription
monitoring program and conducting trend analyses and other studies necessary to evaluate
the effectiveness of the program.

(e) Data reported during the period January 1, 2015, through December 31, 2018, may
be retained through December 31, 2019, in an identifiable manner. Effective January 1,
2020, data older than 24 months must be destroyed. new text begin Identifiable new text end data reported for
prescriptions dispensed on or after January 1, 2020, must be destroyed no later than 12
months from the date the prescription was reported as dispensed new text begin except that deidentified
data may be maintained for the purposes described in paragraph (d) that are carried out by
the permissible users defined in subdivision 6, paragraph (b), clauses (7) and (8) new text end .

Sec. 6.

Minnesota Statutes 2024, section 152.126, subdivision 6, is amended to read:

Subd. 6.

Access to reporting system data.

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

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

(1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
delegated the task of accessing the data, to the extent the information relates specifically to
a current patient, to whom the prescriber is:

(i) prescribing or considering prescribing any deleted text begin controlled deleted text end new text begin reportable new text end substance;

(ii) providing emergency medical treatment for which access to the data may be necessary;

(iii) providing care, and the prescriber has reason to believe, based on clinically valid
indications, that the patient is potentially abusing a deleted text begin controlled deleted text end new text begin reportable new text end substance; or

(iv) providing other medical treatment for which access to the data may be necessary
for a clinically valid purpose and the patient has consented to access to the submitted data,
and with the provision that the prescriber remains responsible for the use or misuse of data
accessed by a delegated agent or employee;

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

(3) a licensed dispensing practitioner or licensed pharmacist to the extent necessary to
determine whether corrections made to the data reported under subdivision 4 are accurate;

(4) a licensed pharmacist who is providing pharmaceutical care for which access to the
data may be necessary to the extent that the information relates specifically to a current
patient for whom the pharmacist is providing pharmaceutical care: (i) if the patient has
consented to access to the submitted data; or (ii) if the pharmacist is consulted by a prescriber
who is requesting data in accordance with clause (1);

(5) an individual who is the recipient of a deleted text begin controlled deleted text end new text begin reportable new text end substance prescription
for which data was submitted under subdivision 4, or a guardian of the individual, parent
or guardian of a minor, or health care agent of the individual acting under a health care
directive under chapter 145C. For purposes of this clause, access by individuals includes
persons in the definition of an individual under section 13.02;

(6) personnel or designees of a health-related licensing board listed in section 214.01,
subdivision 2, or of the Office of Emergency Medical Services, assigned to conduct a bona
fide investigation of a complaint received by that board or office that alleges that a specific
licensee is impaired by use of a drug for which data is collected under subdivision 4, has
engaged in activity that would constitute a crime as defined in section 152.025, or has
engaged in the behavior specified in subdivision 5, paragraph (a);

(7) personnel of the board engaged in the collection, review, and analysis of deleted text begin controlled deleted text end new text begin
reportable new text end substance prescription information as part of the assigned duties and
responsibilities under this section;

(8) authorized personnel under contract with the board, or under contract with the state
of Minnesota and approved by the board, who are engaged in the design, evaluation,
implementation, operation, or maintenance of the prescription monitoring program as part
of the assigned duties and responsibilities of their employment, provided that access to data
is limited to the minimum amount necessary to carry out such duties and responsibilities,
and subject to the requirement of de-identification and time limit on retention of data specified
in subdivision 5, paragraphs (d) and (e);

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

(10) personnel of the Minnesota health care programs assigned to use the data collected
under this section to identify and manage recipients whose usage of deleted text begin controlled deleted text end new text begin reportable new text end
substances may warrant restriction to a single primary care provider, a single outpatient
pharmacy, and a single hospital;

(11) personnel of the Department of Human Services assigned to access the data pursuant
to paragraph (k);

(12) personnel of the health professionals services program established under section
214.31, to the extent that the information relates specifically to an individual who is currently
enrolled in and being monitored by the program, and the individual consents to access to
that information. The health professionals services program personnel shall not provide this
data to a health-related licensing board, except as permitted under section 214.33, subdivision
3;

(13) personnel or designees of a health-related licensing board other than the Board of
Pharmacy listed in section 214.01, subdivision 2, assigned to conduct a bona fide
investigation of a complaint received by that board that alleges that a specific licensee is
inappropriately prescribing deleted text begin controlled deleted text end new text begin reportable new text end substances as defined in this section. For
the purposes of this clause, the health-related licensing board may also obtain utilization
data; and

(14) personnel of the board specifically assigned to conduct a bona fide investigation
of a specific licensee or registrant. For the purposes of this clause, the board may also obtain
utilization data.

(c) By July 1, 2017, every prescriber licensed by a health-related licensing board listed
in section 214.01, subdivision 2, practicing within this state who is authorized to prescribe
deleted text begin controlled deleted text end new text begin reportable new text end substances for humans and who holds a current registration issued by
the federal Drug Enforcement Administration, and every pharmacist licensed by the board
and practicing within the state, shall register and maintain a user account with the prescription
monitoring program. Data submitted by a prescriber, pharmacist, or their delegate during
the registration application process, other than their name, license number, and license type,
is classified as private pursuant to section 13.02, subdivision 12.

(d) Notwithstanding paragraph (b), beginning January 1, 2021, a prescriber or an agent
or employee of the prescriber to whom the prescriber has delegated the task of accessing
the data, must access the data submitted under subdivision 4 to the extent the information
relates specifically to the patient:

(1) before the prescriber issues an initial prescription order for a Schedules II through
IV opiate deleted text begin controlled deleted text end new text begin reportable new text end substance to the patient; and

(2) at least once every three months for patients receiving an opiate for treatment of
chronic pain or participating in medically assisted treatment for an opioid addiction.

(e) Paragraph (d) does not apply if:

(1) the patient is receiving palliative care, or hospice or other end-of-life care;

(2) the patient is being treated for pain due to cancer or the treatment of cancer;

(3) the prescription order is for a number of doses that is intended to last the patient five
days or less and is not subject to a refill;

(4) the prescriber and patient have a current or ongoing provider/patient relationship of
a duration longer than one year;

(5) the prescription order is issued within 14 days following surgery or three days
following oral surgery or follows the prescribing protocols established under the opioid
prescribing improvement program under section 256B.0638;

(6) the deleted text begin controlled deleted text end new text begin reportable new text end substance is prescribed or administered to a patient who is
admitted to an inpatient hospital;

(7) the deleted text begin controlled deleted text end new text begin reportable new text end substance is lawfully administered by injection, ingestion,
or any other means to the patient by the prescriber, a pharmacist, or by the patient at the
direction of a prescriber and in the presence of the prescriber or pharmacist;

(8) due to a medical emergency, it is not possible for the prescriber to review the data
before the prescriber issues the prescription order for the patient; or

(9) the prescriber is unable to access the data due to operational or other technological
failure of the program so long as the prescriber reports the failure to the board.

(f) Only permissible users identified in paragraph (b), clauses (1), (2), (3), (4), (7), (8),
(10), and (11), may directly access the data electronically. No other permissible users may
directly access the data electronically. If the data is directly accessed electronically, the
permissible user shall implement and maintain a comprehensive information security program
that contains administrative, technical, and physical safeguards that are appropriate to the
user's size and complexity, and the sensitivity of the personal information obtained. The
permissible user shall identify reasonably foreseeable internal and external risks to the
security, confidentiality, and integrity of personal information that could result in the
unauthorized disclosure, misuse, or other compromise of the information and assess the
sufficiency of any safeguards in place to control the risks.

(g) The board shall not release data submitted under subdivision 4 unless it is provided
with evidence, satisfactory to the board, that the person requesting the information is entitled
to receive the data.

(h) The board shall maintain a log of all persons who access the data for a period of at
least three years and shall ensure that any permissible user complies with paragraph (c)
prior to attaining direct access to the data.

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

(j) The board may participate in an interstate prescription monitoring program data
exchange system provided that permissible users in other states have access to the data only
as allowed under this section, and that section 13.05, subdivision 6, applies to any contract
or memorandum of understanding that the board enters into under this paragraph.

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

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

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

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

(l) The board shall review the data submitted under subdivision 4 on at least a quarterly
basis and shall establish criteria, in consultation with the advisory task force, for referring
information about a patient to prescribers and dispensers who prescribed or dispensed the
prescriptions in question if the criteria are met.

(m) The board shall conduct random audits, on at least a quarterly basis, of electronic
access by permissible users, as identified in paragraph (b), clauses (1), (2), (3), (4), (7), (8),
(10), and (11), to the data in subdivision 4, to ensure compliance with permissible use as
defined in this section. A permissible user whose account has been selected for a random
audit shall respond to an inquiry by the board, no later than 30 days after receipt of notice
that an audit is being conducted. Failure to respond may result in deactivation of access to
the electronic system and referral to the appropriate health licensing board, or the
commissioner of human services, for further action. The board shall report the results of
random audits to the chairs and ranking minority members of the legislative committees
with jurisdiction over health and human services policy and finance and government data
practices.

(n) A permissible user who has delegated the task of accessing the data in subdivision
4 to an agent or employee shall audit the use of the electronic system by delegated agents
or employees on at least a quarterly basis to ensure compliance with permissible use as
defined in this section. When a delegated agent or employee has been identified as
inappropriately accessing data, the permissible user must immediately remove access for
that individual and notify the board within seven days. The board shall notify all permissible
users associated with the delegated agent or employee of the alleged violation.

(o) A permissible user who delegates access to the data submitted under subdivision 4
to an agent or employee shall terminate that individual's access to the data within three
business days of the agent or employee leaving employment with the permissible user. The
board may conduct random audits to determine compliance with this requirement.

new text begin (p) Access to reportable data on opioid antagonists is restricted to those permissible
users defined in paragraph (b), clauses (7) and (8).
new text end

Sec. 7.

Minnesota Statutes 2024, section 152.126, subdivision 11, is amended to read:

Subd. 11.

Patient information on record access.

A patient who has been prescribed a
deleted text begin controlled deleted text end new text begin reportable new text end substance may access the prescription monitoring program database
in order to obtain information on access by permissible users to the patient's data record,
including the name and organizational affiliation of the permissible user and the date of
access. In order to obtain this information, the patient must complete, notarize, and submit
a request form developed by the board. The board shall make this form available to the
public on the board's website.