HF 3980

as introduced - 92nd Legislature (2021 - 2022) Posted on 03/17/2022 05:30pm

A bill for an act
relating to health; modifying reporting, access, and other requirements related to
the prescription monitoring program; amending Minnesota Statutes 2020, section
152.126, subdivisions 4, 5, 6, 9.

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

Section 1.

Minnesota Statutes 2020, 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 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.
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 the dispenser's 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, 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.
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 drug 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 that patient's authorized representative, new text end of the reporting
requirements of this section and deleted text begin notice deleted text end that the information may be used for program
administration purposes.

Sec. 2.

Minnesota Statutes 2020, 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) 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.

(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 deleted text begin data was received deleted text end new text begin prescription was reported as
dispensed new text end and ending 12 months from the deleted text begin last day of the month in which the data was
received deleted text end new text begin day the prescription was reported as dispensed new text end , except that permissible users defined
in subdivision 6, paragraph (b), clauses deleted text begin (6) deleted text end new text begin (7) new text end and deleted text begin (7) deleted text end new text begin (8) new text end , may use all data collected under
this section for the purposes of administering, operating, and maintaining the prescription
monitoring program deleted text begin and deleted text end new text begin or new text end 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. Data reported new text begin as dispensed new text end on or after
January 1, deleted text begin 2020 deleted text end new text begin 2021 new text end , must be destroyed no later than 12 months from the date the data
was deleted text begin received deleted text end new text begin reported as dispensed, except that de-identified 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. 3.

Minnesota Statutes 2020, 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;

new text begin (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;
new text end

deleted text begin (3) deleted text end new text begin (4) new text end 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);

deleted text begin (4) deleted text end new text begin (5) new text end 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. For purposes of this clause, access by individuals includes persons in the
definition of an individual under section 13.02;

deleted text begin (5) deleted text end new text begin (6) new text end 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);

deleted text begin (6) deleted text end new text begin (7) new text end 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;

deleted text begin (7) deleted text end new text begin (8) new text end authorized personnel deleted text begin of a vendor deleted text end under contract with the state of Minnesota new text begin or
the board new text end who are engaged in the design, new text begin evaluation, new text end implementation, operation, deleted text begin and deleted text end new text begin or new text end
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);

deleted text begin (8) deleted text end new text begin (9) new text end federal, state, and local law enforcement authorities acting pursuant to a valid
search warrant;

deleted text begin (9) deleted text end new text begin (10) new text end 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;

deleted text begin (10) deleted text end new text begin (11) new text end personnel of the Department of Human Services assigned to access the data
pursuant to paragraph (k);

deleted text begin (11) deleted text end new text begin (12) new text end 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 and
deleted text end

deleted text begin (12) deleted text end new text begin (13) new text end personnel or designees of a health-related licensing board new text begin other than the Board
of Pharmacy 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. new text begin For the purposes
of this clause, the health-related licensing board may also obtain utilization data; and
new text end

new text begin (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.
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) 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 controlled 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 controlled substance is prescribed or administered to a patient who is admitted
to an inpatient hospital;

(7) the controlled 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), deleted text begin (6) deleted text end new text begin (4) new text end , (7),
deleted text begin (9), and deleted text end (10), new text begin and (11), new text end may directly access the data electronically. new text begin Permissible users
identified in paragraph (b), clause (8), may directly access the data electronically only as
permitted by the board. new text end 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
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.

(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), deleted text begin (6) deleted text end new text begin (4) new text end , (7),
deleted text begin (9), and deleted text end (10), new text begin and (11), new text end 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.

Sec. 4.

Minnesota Statutes 2020, section 152.126, subdivision 9, is amended to read:

Subd. 9.

Immunity from liability deleted text begin ; no requirement to obtain information deleted text end .

(a) A
pharmacist, prescriber, or other dispenser making a report to the program in good faith under
this section is immune from any civil, criminal, or administrative liability, which might
otherwise be incurred or imposed as a result of the report deleted text begin , or on the basis that the pharmacist
or prescriber did or did not seek or obtain or use information from the program deleted text end .

(b) new text begin Except as required by subdivision 6, paragraph (d), new text end nothing in this section shall
require a pharmacist, prescriber, or other dispenser to obtain information about a patient
from the program, and the pharmacist, prescriber, or other dispenser, if acting in good faith,
is immune from any civil, criminal, or administrative liability that might otherwise be
incurred or imposed for requesting, receiving, or using information from the program.