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SF 991

as introduced - 90th Legislature (2017 - 2018) Posted on 03/02/2018 10:06am

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health; providing certain agencies access to the Minnesota prescription
monitoring program to identify and investigate inappropriate prescribing or
dispensing of controlled substances; amending Minnesota Statutes 2016, section
152.126, subdivisions 5, 6.

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

Section 1.

Minnesota Statutes 2016, 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 controlled substances from prescribers who
subsequently obtain controlled substances from dispensers in quantities or with a frequency
inconsistent with generally recognized standards of use for those controlled substances,
including standards accepted by national and international pain management associations;
and

(2) individuals presenting forged or otherwise false or altered prescriptions for controlled
substances to dispensers.

(b) deleted text begin No permissible user identified under subdivision 6 may access the database for the
sole purpose of identifying prescribers of controlled substances for unusual or excessive
prescribing patterns without a valid search warrant or court order.
deleted text end new text begin The board and its designees
are authorized to access the database for the purpose of identifying prescribers or dispensers
engaged in patterns of unusual or excessive prescribing or dispensing of controlled
substances, or other conduct affecting public health or safety.
new text end

(c) deleted text begin 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.
deleted text end

deleted text begin (d)deleted text end 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 (6) and (7), 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.

deleted text begin (e)deleted text end new text begin (d)new text end 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. Data reported on or after January 1,
2020, must be destroyed no later than 12 months from the date the data was received.

Sec. 2.

Minnesota Statutes 2016, 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;

(5) personnel or designees of a health-related licensing board 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 (i);

(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.

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

(12) personnel or designees of a health-related licensing board 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 sectiondeleted text begin .deleted text end new text begin ; and
new text end

new text begin (13) personnel or designees of the Department of Human Services for the purpose of
identifying potential inappropriate prescribing or dispensing of controlled substances,
fraudulent billing of government programs, or other conduct affecting public health or
safety.
new text end

(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
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.

(d) 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.

(e) 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.

(f) 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.

(g) 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.

(h) 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.

(i) 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.

(j) 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.