HF 4176

as introduced - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am

A bill for an act
relating to health; modifying the prescription electronic reporting system;
amending Minnesota Statutes 2007 Supplement, section 152.126.

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

Section 1.

Minnesota Statutes 2007 Supplement, section 152.126, is amended to read:

152.126 SCHEDULE II AND III CONTROLLED SUBSTANCES
PRESCRIPTION ELECTRONIC REPORTING SYSTEM.

Subdivision 1.

Definitions.

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

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

(b) "Controlled substances" means those substances listed in section 152.02,
subdivisions 3 and 4, and those substances defined by the board pursuant to section
152.02, subdivisions 7, 8, and 12.

(c) "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.

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

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

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

new text begin Subd. 1a. new text end

new text begin Treatment of intractable pain. new text end

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

Subd. 2.

Prescription electronic reporting system.

(a) The board shall establish by
January 1, deleted text begin 2009 deleted text end new text begin 2010 new text end , an electronic system for reporting the information required under
subdivision 4 for all controlled substances dispensed within the state. deleted text begin Data for controlled
substance prescriptions that are dispensed in a quantity small enough to provide treatment
to a patient for a period of 48 hours or less need not be reported.
deleted text end

(b) The board may contract with a vendor for the purpose of obtaining technical
assistance in the design, implementation, and maintenance of the electronic reporting
system. The vendor's role shall be limited to providing technical support to the board
concerning the software, databases, and computer systems required to interface with the
existing systems currently used by pharmacies to dispense prescriptions and transmit
prescription data to other third parties.

Subd. 3.

Prescription Electronic Reporting Advisory Committee.

(a) The
board shall convene an advisory committee. The committee must include at least one
representative of:

(1) the Department of Health;

(2) the Department of Human Services;

(3) each health-related licensing board that licenses prescribers;

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

(5) a professional pharmacy association;

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

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

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

deleted text begin (7) deleted text end new text begin (9) new text end a consumer or patient rights organization.

(b) The advisory committee shall advise the board on the development and operation
of the electronic reporting system, including, but not limited to:

(1) technical standards for electronic prescription drug reporting;

(2) proper analysis and interpretation of prescription monitoring data; and

(3) an evaluation process for the program.

(c) The Board of Pharmacy, after consultation with the advisory committee, shall
present recommendations and draft legislation on the issues addressed by the advisory
committee under paragraph (b), to the legislature by December 15, 2007.

Subd. 4.

Reporting requirements; notice.

(a) Each dispenser must submit the
following data to the board or its designated vendor, subject to the notice required under
paragraph (d):

(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) new text begin prescription number;
new text end

new text begin (6) new text end name of the patient for whom the prescription was written;

new text begin (7) address of the patient for whom the prescription was written;
new text end

deleted text begin (6) deleted text end new text begin (8) new text end date of birth of the patient for whom the prescription was written;

deleted text begin (7) deleted text end new text begin (9) new text end date the prescription was written;

deleted text begin (8) deleted text end new text begin (10) new text end date the prescription was filled;

deleted text begin (9) deleted text end new text begin (11) new text end name and strength of the controlled substance;

deleted text begin (10) deleted text end new text begin (12) new text end quantity of controlled substance prescribed; deleted text begin and
deleted text end

deleted text begin (11) deleted text end new text begin (13) new text end quantity of controlled substance dispensed new text begin ; and
new text end

new text begin (14) number of days supply new text end .

(b) The dispenser must submit the required information by a procedure and in a
format established by the board. new text begin 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 end

(c) A dispenser is not required to submit this data for those controlled substance
prescriptions dispensed for:

(1) individuals residing in licensed skilled nursing or intermediate care facilities;

(2) individuals receiving assisted living services under chapter 144G or through a
medical assistance home and community-based waiver;

(3) individuals receiving medication intravenously;

(4) individuals receiving hospice and other palliative or end-of-life care; and

(5) individuals receiving services from a home care provider regulated under chapter
144A.

(d) A dispenser must not submit data under this subdivision unless a conspicuous
notice of the reporting requirements of this section is given to the patient for whom the
prescription was written.

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. 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 new text begin generally recognized new text end standards new text begin of use for those controlled
substances, including standards new text end accepted by national and international pain management
associations deleted text begin of dosage for those controlled substances deleted text end ; 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 or
substantiate a disciplinary action against a prescriber.

(d) Data reported under subdivision 4 shall be retained by the board in the database
for a 12-month period, and shall be removed from the database 12 months from the date
the data was received.

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, to the extent the information relates specifically to a current patient
deleted text begin of the prescriber deleted text end , to whom the deleted text begin practitioner deleted text end new text begin prescriber new text end is prescribing or considering
prescribing any controlled substance;

(2) a dispenser, to the extent the information relates specifically to a current patient
to whom that dispenser is dispensing or considering dispensing any controlled substance;

(3) 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;

(4) personnel of the board specifically assigned to conduct a bona fide investigation
of a specific licensee;

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

(6) authorized personnel of a vendor under contract with the board who are engaged
in the design, implementation, and maintenance of the electronic reporting system as part
of the assigned duties and responsibilities of their employment, provided that access to data
is limited to the minimum amount necessary to test and maintain the system databases;

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

(8) personnel of the medical assistance program assigned to use the data collected
under this section to identify recipients whose usage of controlled substances may warrant
restriction to a single primary care physician, a single outpatient pharmacy, or a single
hospital.

For purposes of clause (3), access by an individual includes persons in the definition
of an individual under section 13.02.

(c) Any permissible user identified in paragraph (b), who directly accesses
the data electronically, 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.

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

(e) The board shall not release the name of a prescriber without the written consent
of the prescriber or a valid search warrant or court order. The board shall provide a
mechanism for a prescriber to submit to the board a signed consent authorizing the release
of the prescriber's name when data containing the prescriber's name is requested.

(f) The board shall maintain a log of all persons who access the data and shall ensure
that any permissible user complies with paragraph (c) prior to attaining direct access to
the data.

Subd. 7.

Disciplinary action.

(a) A dispenser who knowingly fails to submit data to
the board as required under this section is subject to disciplinary action by the appropriate
health-related licensing board.

(b) A prescriber or dispenser authorized to access the data who knowingly discloses
the data in violation of state or federal laws relating to the privacy of health care data
shall be subject to disciplinary action by the appropriate health-related licensing board,
and appropriate civil penalties.

Subd. 8.

Evaluation and reporting.

(a) The board shall evaluate the prescription
electronic reporting system to determine if the system deleted text begin is cost-effective and whether it deleted text end is
negatively impacting appropriate prescribing practices of controlled substances. The
board may contract with a vendor to design and conduct the evaluation.

(b) The board shall submit the evaluation of the system to the legislature by January
15, deleted text begin 2010 deleted text end new text begin 2011 new text end .

Subd. 9.

Immunity from liability; no requirement to obtain information.

(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, or on the basis that the
pharmacist or prescriber did or did not seek or obtain or use information from the program.

(b) 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.