HF 3264

as introduced - 84th Legislature (2005 - 2006) Posted on 12/15/2009 12:00am

A bill for an act
relating to health; establishing a controlled substances reporting program;
providing for disciplinary action; proposing coding for new law in Minnesota
Statutes, chapter 152.

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

Section 1.

[152.126] ALL SCHEDULES PRESCRIPTION ELECTRONIC
REPORTING PROGRAM.

Subdivision 1.

Definitions.

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

(a) "Advisory committee" means the Prescription Electronic Reporting Advisory
Committee established under subdivision 3.

(b) "Board" means the Minnesota State 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.

(d) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision
30.

(e) "Dispenser" means a person authorized by law to dispense, pursuant to a valid
prescription, a controlled substance. A dispenser does not include a licensed hospital
pharmacy that distributes controlled substances for inpatient hospital care.

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

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

Subd. 2.

Establishment of a prescription electronic reporting program.

(a) The
board shall establish by January 1, 2008, an electronic system for reporting the information
required under subdivision 4 for all controlled substances dispensed within the state.

(b) The board may contract with a vendor to establish and maintain the electronic
reporting system.

Subd. 3.

Prescription Electronic Reporting Advisory Committee.

(a) The
advisory committee consists of seven members appointed by the board to three-year
terms. The board shall 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; and

(6) 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;

(3) standards for clinically appropriate prescribing and dispensing of controlled
substances; and

(4) an evaluation process for the program.

Subd. 4.

Reporting requirements.

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

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

(7) date the prescription was written;

(8) date the prescription was filled;

(9) name and strength of the controlled substance;

(10) quantity of controlled substance prescribed;

(11) quantity of controlled substance dispensed;

(12) days supply based on the directions for use listed on the prescription; and

(13) any other information deemed necessary by the board.

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

(c) A dispenser is not required to submit this data for those controlled substance
prescriptions dispensed for individuals residing in licensed skilled nursing or intermediate
care facilities.

Subd. 5.

Use and analysis of data by board.

The board shall develop and maintain
a database of the data reported under subdivision 4 and shall use the database for the
identification of:

(1) prescribing practices and patterns of prescribing and dispensing controlled
substances;

(2) prescribers who may be prescribing controlled substances in an unprofessional or
unlawful manner;

(3) dispensers who may be dispensing controlled substances in an unprofessional or
unlawful manner;

(4) 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 dosage for those controlled
substances; and

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

Subd. 6.

Access to prescription electronic reporting program data.

(a) Except as
indicated in paragraphs (b), (c), and (d), the data submitted to the board under subdivision
4 is private data on individuals as defined in section 13.02, subdivision 12.

(b) If in the course of reviewing data submitted under subdivision 4, the board
determines there is reasonable cause to believe that a violation of law or a breach of
professional standards has occurred, the board shall notify the appropriate law enforcement
and professional licensing, certification, or regulatory authorities, and provide all relevant
data to the appropriate authority.

(c) The board may provide data submitted under subdivision 4 for public research,
policy or education purposes, to the extent that any information that is likely to reveal the
identity of the patient or other person who is the subject of the data has been removed.

(d) The following persons 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
of the prescriber, to whom the practitioner 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;

(4) personnel of the board specifically assigned to conduct investigations related to
controlled substances laws under the jurisdiction of the board;

(5) personnel of the board engaged in the collection and analysis of controlled
substance prescription information as part of the assigned duties and responsibilities of
their employment;

(6) authorized personnel of a vendor under contract to the board who are engaged in
the collection and analysis of the data collected under subdivision 4 as part of the assigned
duties and responsibilities of their employment;

(7) a designated representative of a health-related licensing board responsible for the
licensure, regulation, or discipline of prescribers or dispensers provided that the requested
data relates to a bona fide investigation of a specific licensee;

(8) federal, state, and local law enforcement authorities engaged in a bona fide
investigation of a specific person; and

(9) 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.

(e) 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.

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 healthcare data shall
be subject to disciplinary action by the appropriate health-related licensing board.

Subd. 8.

Evaluation and reporting.

(a) The board, in consultation with the
advisory committee, shall evaluate the prescription electronic reporting program to
determine if the program is cost-effective. The board may contract with a vendor to
design and conduct the evaluation.

(b) The board shall submit the evaluation of the program to the legislature by
January 15, 2009.

Subd. 9.

Rules.

The board may promulgate rules necessary to implement the
provisions of this section.

EFFECTIVE DATE.

This section is effective July 1, 2006, or upon receiving
sufficient nonstate funds to implement the prescription electronic reporting program,
whichever is later. In the event that nonstate funds are not secured by the Board of
Pharmacy to adequately fund the implementation of the prescription electronic reporting
program, the board is not required to implement section 1, without a subsequent
appropriation from the legislature.

Sec. 2. FEDERAL GRANTS.

The Board of Pharmacy shall apply for any applicable federal grants or other nonstate
funds to establish and fully implement the prescription electronic reporting program.

EFFECTIVE DATE.

This section is effective the day following final enactment.