SF 2122

as introduced - 91st Legislature (2019 - 2020) Posted on 03/08/2019 08:28am

A bill for an act
relating to health; modifying the prescription monitoring program; amending
Minnesota Statutes 2018, section 152.126, subdivisions 1, 3, 4, 6.

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

Section 1.

Minnesota Statutes 2018, 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 deleted text begin State deleted text end Board of Pharmacy established under chapter
151.

(c) "Controlled 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. For the purposes of this section, controlled substances includes butalbital and
gabapentin.

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

(e) "Dispenser" means a person authorized by law to dispense a controlled substance,
pursuant to a valid prescription. For the purposes of this section, a dispenser does not include
a licensed hospital pharmacy that distributes controlled 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 2018, section 152.126, subdivision 3, is amended to read:

Subd. 3.

Prescription Monitoring Program Advisory Task Force.

(a) The board shall
appoint deleted text begin an deleted text end new text begin a multidisciplinary new text end advisory task force consisting of at least one deleted text begin representative
of deleted text end new text begin member from each of the following categories new text end :

deleted text begin (1) the Department of Health;
deleted text end

deleted text begin (2) the Department of Human Services;
deleted text end

deleted text begin (3) each health-related licensing board that licenses prescribers;
deleted text end

deleted text begin (4) a professional medical association, which may include an association of pain
management and chemical dependency specialists;
deleted text end

deleted text begin (5) a professional pharmacy association;
deleted text end

deleted text begin (6) a professional nursing association;
deleted text end

deleted text begin (7) a professional dental association;
deleted text end

deleted text begin (8) a consumer privacy or security advocate;
deleted text end

deleted text begin (9) a consumer or patient rights organization; and
deleted text end

deleted text begin (10) an association of medical examiners and coroners.
deleted text end

new text begin (1) prescribers in active practice, in good standing with their applicable licensing board,
who specialize in each of the following:
new text end

new text begin (i) emergency medicine;
new text end

new text begin (ii) family practice;
new text end

new text begin (iii) pain management;
new text end

new text begin (iv) addiction medicine;
new text end

new text begin (v) obstetrics; or
new text end

new text begin (vi) dentistry;
new text end

new text begin (2) pharmacists in active practice and in good standing with the board;
new text end

new text begin (3) licensed substance abuse addiction counselors, in good standing with their applicable
licensing board, who provide services for a state licensed substance abuse addiction treatment
program;
new text end

new text begin (4) medical examiners or coroners, in active practice, who utilize the prescription
monitoring program and are in good standing with their applicable licensing board or local
appointing board;
new text end

new text begin (5) representatives of the Department of Human Services, including at least one individual
with responsibility for substance abuse prevention and treatment policy;
new text end

new text begin (6) representatives of the Department of Health, including at least one individual with
responsibility for injury and violence prevention policy; and
new text end

new text begin (7) law enforcement officials whose duty includes the enforcement of state controlled
substances or prescription drug laws.
new text end

(b) The advisory task force shall deleted text begin advise the board on the development and operation of
the prescription monitoring program, including, but not limited to deleted text end :

deleted text begin (1) technical standards for electronic prescription drug reporting;
deleted text end

deleted text begin (2) proper deleted text end new text begin (1) provide expertise in new text end analysis and interpretation of prescription monitoring
data;

deleted text begin (3) an evaluation process for the program; and
deleted text end

new text begin (2) provide recommendations for program evaluation and improvements;
new text end

new text begin (3) assist in defining content for monthly, quarterly, and annual program reports;
new text end

(4) new text begin recommend new text end criteria for the unsolicited provision of prescription monitoring data by
the board to prescribers and dispensers.

(c) The task force is governed by section 15.059. Notwithstanding any other provisions
of law to the contrary, the task force shall not expire.

Sec. 3.

Minnesota Statutes 2018, 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 controlled substance;

(12) quantity of controlled substance prescribed;

(13) quantity of controlled 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.

new text begin (c) The dispenser must submit the required information no later than one business day
after the prescription is dispensed. If no reportable prescriptions are dispensed on any day,
a report indicating that fact must be filed with the board.
new text end

new text begin (d) The dispenser must submit accurate information to the database, and must correct
errors identified during the submission process within seven calendar days.
new text end

new text begin (e) 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 was correctly submitted. The dispenser must notify the subject of the data that either
the error was corrected or that no error occurred. For the purposes of this paragraph, "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.
new text end

deleted text begin (c) deleted text end new text begin (f) new text end A dispenser is not required to submit this data for those controlled 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; deleted text begin and
deleted text end

(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 deleted text begin . deleted text end new text begin ; and
new text end

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

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

Sec. 4.

Minnesota Statutes 2018, 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 controlled 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 controlled 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
controlled 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 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);

(4) an individual who is the recipient of a controlled 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 new text begin . For purposes of this clause, access by an individual includes persons in the
definition of an individual under section 13.02 new text end ;

(5) personnel or designees of deleted text begin a deleted text end new text begin other new text end health-related licensing deleted text begin board deleted text end new text begin boards new text end listed in
section 214.01, subdivision 2, or of the Emergency Medical Services Regulatory Board,
assigned to conduct a bona fide investigation of a complaint received by that board 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);

(6) personnel of the board engaged in the collection, review, and analysis of controlled
substance prescription information as part of the assigned duties and responsibilities under
this section;

(7) authorized personnel of a vendor under contract with the state of Minnesota who are
engaged in the design, implementation, operation, and 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);

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

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

(10) personnel of the Department of Human Services assigned to access the data pursuant
to paragraph deleted text begin (i) deleted text end new text begin (j) new text end ;

(11) 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 or the Emergency Medical Services Regulatory
Board, except as permitted under section 214.33, subdivision 3 deleted text begin . deleted text end new text begin ;
new text end

deleted text begin For purposes of clause (4), access by an individual includes persons in the definition of
an individual under section 13.02; and
deleted text end

(12) personnel or designees of deleted text begin a deleted text end new text begin other new text end health-related licensing deleted text begin board deleted text end new text begin boards new text end 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
controlled substances as defined in this section deleted text begin . deleted text end new text begin ; and
new text end

new text begin (13) personnel of the board specifically assigned to conduct a bona fide investigation
of a specific licensee or registrant.
new text end

(c) new text begin The commissioner of health shall have access to de-identified data for statistical,
research, or educational purposes related to public health and safety.
new text end

deleted text begin By July 1, 2017, deleted text end new text begin (d) new text end 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
controlled 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.

deleted text begin (d) deleted text end new text begin (e) new text end Only permissible users identified in paragraph (b), clauses (1), (2), (3), (6), (7),
(9), and (10), 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.

deleted text begin (e) deleted text end new text begin (f) new text end 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.

deleted text begin (f) deleted text end new text begin (g) new text end 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 deleted text begin (c) deleted text end new text begin
(d) new text end prior to attaining direct access to the data.

deleted text begin (g) deleted text end new text begin (h) new text end 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.

deleted text begin (h) deleted text end new text begin (i) new text end 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.

deleted text begin (i) deleted text end new text begin (j) new text end 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
controlled 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 controlled 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
controlled 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.

deleted text begin (j) deleted text end new text begin (k) new text end 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.