Bill Text: MN SF2134 | 2013-2014 | 88th Legislature | Engrossed
Bill Title: Prescription monitoring program modifications
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2014-03-24 - Comm report: To pass and re-referred to Finance [SF2134 Detail]
Download: Minnesota-2013-SF2134-Engrossed.html
1.2relating to health; making changes to the Minnesota prescription monitoring
1.3program;amending Minnesota Statutes 2012, section 152.126, as amended.
1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.5 Section 1. Minnesota Statutes 2012, section 152.126, as amended by Laws 2013,
1.6chapter 113, article 3, section 3, is amended to read:
1.7152.126CONTROLLED SUBSTANCES PRESCRIPTION ELECTRONIC
1.8REPORTING SYSTEM PRESCRIPTION MONITORING PROGRAM.
1.9 Subdivision 1. Definitions. (a) For purposes of this section, the terms defined in
1.10this subdivision have the meanings given.
1.11(a) (b) "Board" means the Minnesota State Board of Pharmacy established under
1.12chapter 151.
1.13(b) (c) "Controlled substances" means those substances listed in section
152.02 ,
1.14subdivisions 3 to5 6, and those substances defined by the board pursuant to section
1.15152.02, subdivisions 7
, 8, and 12. For the purposes of this section, controlled substances
1.16includes tramadol and butalbital.
1.17(c) (d) "Dispense" or "dispensing" has the meaning given in section
151.01,
1.18subdivision 30 . Dispensing does not include the direct administering of a controlled
1.19substance to a patient by a licensed health care professional.
1.20(d) (e) "Dispenser" means a person authorized by law to dispense a controlled
1.21substance, pursuant to a valid prescription. For the purposes of this section, a dispenser
1.22does not include a licensed hospital pharmacy that distributes controlled substances for
1.23inpatient hospital care, a licensed pharmacy, located on the same premises as a residential
1.24hospice, when the licensed pharmacy is dispensing controlled substances to be used
2.1by an individual who is a resident of the hospice or a veterinarian who is dispensing
2.2prescriptions under section156.18 .
2.3(e) (f) "Prescriber" means a licensed health care professional who is authorized to
2.4prescribe a controlled substance under section152.12, subdivision 1 or 2.
2.5(f) (g) "Prescription" has the meaning given in section
151.01, subdivision 16 .
2.6 Subd. 1a. Treatment of intractable pain. This section is not intended to limit or
2.7interfere with the legitimate prescribing of controlled substances for pain. No prescriber
2.8shall be subject to disciplinary action by a health-related licensing board for prescribing a
2.9controlled substance according to the provisions of section152.125 .
2.10 Subd. 2. Prescription electronic reporting system. (a) The board shall establish
2.11by January 1, 2010, an electronic system for reporting the information required under
2.12subdivision 4 for all controlled substances dispensed within the state.
2.13 (b) The board may contract with a vendor for the purpose of obtaining technical
2.14assistance in the design, implementation, operation, and maintenance of the electronic
2.15reporting system.
2.16 Subd. 3. PrescriptionElectronic Reporting Monitoring Program Advisory
2.17Committee Task Force. (a) The board shall convene may appoint an advisory committee.
2.18The committee must include task force consisting of at least one representative of:
2.19 (1) the Department of Health;
2.20 (2) the Department of Human Services;
2.21 (3) each health-related licensing board that licenses prescribers;
2.22 (4) a professional medical association, which may include an association of pain
2.23management and chemical dependency specialists;
2.24 (5) a professional pharmacy association;
2.25 (6) a professional nursing association;
2.26 (7) a professional dental association;
2.27 (8) a consumer privacy or security advocate;and
2.28 (9) a consumer or patient rights organization.; and
2.29 (10) an association of medical examiners and coroners.
2.30 (b) The advisorycommittee task force shall advise the board on the development and
2.31operation of theelectronic reporting system prescription monitoring program, including,
2.32but not limited to:
2.33 (1) technical standards for electronic prescription drug reporting;
2.34 (2) proper analysis and interpretation of prescription monitoring data;and
2.35 (3) an evaluation process for the program; and
3.1 (4) criteria for the unsolicited provision of prescription monitoring data by the
3.2board to prescribers and dispensers.
3.3(c) The task force is governed by section 15.059. Notwithstanding section 15.059,
3.4subdivision 5, the task force shall not expire.
3.5 Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the
3.6following data to the board or its designated vendor, subject to the notice required under
3.7paragraph (d):
3.8 (1) name of the prescriber;
3.9 (2) national provider identifier of the prescriber;
3.10 (3) name of the dispenser;
3.11 (4) national provider identifier of the dispenser;
3.12 (5) prescription number;
3.13 (6) name of the patient for whom the prescription was written;
3.14 (7) address of the patient for whom the prescription was written;
3.15 (8) date of birth of the patient for whom the prescription was written;
3.16 (9) date the prescription was written;
3.17 (10) date the prescription was filled;
3.18 (11) name and strength of the controlled substance;
3.19 (12) quantity of controlled substance prescribed;
3.20 (13) quantity of controlled substance dispensed; and
3.21 (14) number of days supply.
3.22 (b) The dispenser must submit the required information by a procedure and in a
3.23format established by the board. The board may allow dispensers to omit data listed in this
3.24subdivision or may require the submission of data not listed in this subdivision provided
3.25the omission or submission is necessary for the purpose of complying with the electronic
3.26reporting or data transmission standards of the American Society for Automation in
3.27Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
3.28standard-setting body.
3.29 (c) A dispenser is not required to submit this data for those controlled substance
3.30prescriptions dispensed for:
3.31(1) individuals residing in licensed skilled nursing or intermediate care facilities;
3.32(2) individuals receiving assisted living services under chapter 144G or through a
3.33medical assistance home and community-based waiver;
3.34(3) individuals receiving medication intravenously;
3.35(4) individuals receiving hospice and other palliative or end-of-life care; and
4.1(5) individuals receiving services from a home care provider regulated under chapter
4.2144A.
4.3 (1) individuals residing in a health care facility as defined in section 151.58,
4.4subdivision 2, paragraph (b), when a drug is distributed through the use of an automated
4.5drug distribution system according to section 151.58; and
4.6 (2) individuals receiving a drug sample that was packaged by a manufacturer and
4.7provided to the dispenser for dispensing as a professional sample pursuant to Code of
4.8Federal Regulations, title 21, section 203, subpart D.
4.9 (d) A dispenser mustnot submit data under this subdivision unless provide to the
4.10patient for whom the prescription was written a conspicuous notice of the reporting
4.11requirements of this sectionis given to the patient for whom the prescription was written
4.12 and notice that the information may be used for program administration purposes.
4.13 Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
4.14of the data reported under subdivision 4. The board shall maintain data that could identify
4.15an individual prescriber or dispenser in encrypted form. Except as otherwise allowed
4.16under subdivision 6, the database may be used by permissible users identified under
4.17subdivision 6 for the identification of:
4.18 (1) individuals receiving prescriptions for controlled substances from prescribers
4.19who subsequently obtain controlled substances from dispensers in quantities or with a
4.20frequency inconsistent with generally recognized standards of use for those controlled
4.21substances, including standards accepted by national and international pain management
4.22associations; and
4.23 (2) individuals presenting forged or otherwise false or altered prescriptions for
4.24controlled substances to dispensers.
4.25 (b) No permissible user identified under subdivision 6 may access the database
4.26for the sole purpose of identifying prescribers of controlled substances for unusual or
4.27excessive prescribing patterns without a valid search warrant or court order.
4.28 (c) No personnel of a state or federal occupational licensing board or agency may
4.29access the database for the purpose of obtaining information to be used to initiate or
4.30substantiate a disciplinary action against a prescriber when the disciplinary action relates
4.31to allegations involving unusual or excessive prescribing of the drugs for which data
4.32is collected under subdivision 4.
4.33 (d) Data reported under subdivision 4 shall beretained by the board in the
4.34databasefor a 12-month period, and shall be removed from the database no later than 12
4.35months from the last day of the month during which the data was received. made available
4.36to permissible users for a 12-month period beginning the day the data was received and
5.1ending 12 months from the last day of the month in which the data was received, except
5.2that permissible users defined in subdivision 6, paragraph (b), clauses (6) and (7), may
5.3use all data collected under this section for the purposes of administering, operating, and
5.4maintaining the prescription monitoring program and conducting trend analyses and other
5.5studies necessary to evaluate the effectiveness of the program.
5.6(e) The board shall not retain data reported under subdivision 4 for a period longer
5.7than five years from the date the data was received.
5.8 Subd. 6. Access to reporting system data. (a) Except as indicated in this
5.9subdivision, the data submitted to the board under subdivision 4 is private data on
5.10individuals as defined in section13.02, subdivision 12 , and not subject to public disclosure.
5.11 (b) Except as specified in subdivision 5, the following persons shall be considered
5.12permissible users and may access the data submitted under subdivision 4 in the same or
5.13similar manner, and for the same or similar purposes, as those persons who are authorized
5.14to access similar private data on individuals under federal and state law:
5.15 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
5.16delegated the task of accessing the data, to the extent the information relates specifically to
5.17a current patient, to whom the prescriber is prescribing or considering prescribing any
5.18controlled substance or to whom the prescriber is providing other medical treatment for
5.19which access to the data may be necessary and with the provision that the prescriber remains
5.20responsible for the use or misuse of data accessed by a delegated agent or employee;
5.21 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
5.22delegated the task of accessing the data, to the extent the information relates specifically
5.23to a current patient to whom that dispenser is dispensing or considering dispensing any
5.24controlled substance and with the provision that the dispenser remains responsible for the
5.25use or misuse of data accessed by a delegated agent or employee;
5.26 (3) a licensed pharmacist who is providing pharmaceutical care for which access to
5.27the data may be necessary to the extent that the information relates specifically to a current
5.28patient for whom the pharmacist is providing pharmaceutical care;
5.29(3) (4) an individual who is the recipient of a controlled substance prescription for
5.30which data was submitted under subdivision 4, or a guardian of the individual, parent or
5.31guardian of a minor, or health care agent of the individual acting under a health care
5.32directive under chapter 145C;
5.33(4) (5) personnel of the a health-related licensing board specifically listed in section
5.34214.01, subdivision 2, or the Emergency Medical Services Regulatory Board, assigned to
5.35conduct a bona fide investigation of a complaint received by that board alleging that a
5.36 specific licensee is impaired by use of a drug for which data is collected under subdivision
6.14, has engaged in activity that would constitute a crime as defined in section 152.025, or
6.2has engaged in the behavior specified in section 152.126, subdivision 5, paragraph (a);
6.3(5) (6) personnel of the board engaged in the collection, review, and analysis
6.4 of controlled substance prescription information as part of the assigned duties and
6.5responsibilities under this section;
6.6(6) (7) authorized personnel of a vendor under contract with the board state of
6.7Minnesota who are engaged in the design, implementation, operation, and maintenance of
6.8theelectronic reporting system prescription monitoring program as part of the assigned
6.9duties and responsibilities of their employment, provided that access to data is limited to
6.10the minimum amount necessary to carry out such duties and responsibilities;
6.11(7) (8) federal, state, and local law enforcement authorities acting pursuant to a
6.12valid search warrant;
6.13(8) (9) personnel of the medical assistance program Minnesota health care programs
6.14assigned to use the data collected under this section to identify and manage recipients
6.15whose usage of controlled substances may warrant restriction to a single primary care
6.16physician provider, a single outpatient pharmacy, or and a single hospital; and
6.17(9) (10) personnel of the Department of Human Services assigned to access the
6.18data pursuant to paragraph (h).;
6.19(11) a coroner or medical examiner, or an agent or employee of the coroner or
6.20medical examiner to whom the coroner or medical examiner has delegated the task of
6.21accessing the data, conducting an investigation pursuant to section 390.11, and with the
6.22provision that the coroner or medical examiner remains responsible for the use or misuse
6.23of data accessed by a delegated agent or employee; and
6.24(12) personnel of the health professionals services program established under
6.25section 214.31, to the extent that the information relates specifically to an individual who
6.26is currently enrolled in and being monitored by the program. The health professionals
6.27services program personnel shall not provide this data to a health-related licensing board
6.28or the Emergency Medical Services Regulatory Board, except as permitted under section
6.29214.33, subdivision 3.
6.30 For purposes of clause(3) (4), access by an individual includes persons in the
6.31definition of an individual under section13.02 .
6.32 (c)Any A permissible user identified in paragraph (b), who clauses (1), (2), (3), (6),
6.33(7), (9), (10), and (11) may directlyaccesses access the data electronically,. If the data
6.34is directly accessed electronically, the permissible user shall implement and maintain a
6.35comprehensive information security program that contains administrative, technical,
6.36and physical safeguards that are appropriate to the user's size and complexity, and the
7.1sensitivity of the personal information obtained. The permissible user shall identify
7.2reasonably foreseeable internal and external risks to the security, confidentiality, and
7.3integrity of personal information that could result in the unauthorized disclosure, misuse,
7.4or other compromise of the information and assess the sufficiency of any safeguards in
7.5place to control the risks.
7.6 (d) The board shall not release data submitted underthis section subdivision 4 unless
7.7it is provided with evidence, satisfactory to the board, that the person requesting the
7.8information is entitled to receive the data.
7.9(e) The board shall not release the name of a prescriber without the written consent
7.10of the prescriber or a valid search warrant or court order. The board shall provide a
7.11mechanism for a prescriber to submit to the board a signed consent authorizing the release
7.12of the prescriber's name when data containing the prescriber's name is requested.
7.13(f) (e) The board shall maintain a log of all persons who access the data for a period
7.14of at least three years and shall ensure that any permissible user complies with paragraph
7.15(c) prior to attaining direct access to the data.
7.16(g) (f) Section
13.05, subdivision 6 , shall apply to any contract the board enters into
7.17pursuant to subdivision 2. A vendor shall not use data collected under this section for
7.18any purpose not specified in this section.
7.19(g) The board may participate in an interstate prescription monitoring program data
7.20exchange system provided that permissible users in other states have access to the data
7.21only as allowed under this section, and that section 13.05, subdivision 6, applies to any
7.22contract or memorandum of understanding that the board enters into under this paragraph.
7.23(h) With available appropriations, the commissioner of human services shall
7.24establish and implement a system through which the Department of Human Services shall
7.25routinely access the data for the purpose of determining whether any client enrolled in
7.26an opioid treatment program licensed according to chapter 245A has been prescribed or
7.27dispensed a controlled substance in addition to that administered or dispensed by the
7.28opioid treatment program. When the commissioner determines there have been multiple
7.29prescribers or multiple prescriptions of controlled substances, the commissioner shall:
7.30(1) inform the medical director of the opioid treatment program only that the
7.31commissioner determined the existence of multiple prescribers or multiple prescriptions of
7.32controlled substances; and
7.33(2) direct the medical director of the opioid treatment program to access the data
7.34directly, review the effect of the multiple prescribers or multiple prescriptions, and
7.35document the review.
8.1If determined necessary, the commissioner of human services shall seek a federal waiver
8.2of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
8.32.34
, item (c), prior to implementing this paragraph.
8.4(i) The board may provide data submitted under subdivision 4 for public research,
8.5policy, or education purposes, but only after the removal of any information that is likely
8.6to reveal the identity of the patient, prescriber, or dispenser who is the subject of the data.
8.7(j) The board shall review the data submitted under subdivision 4 on at least a
8.8quarterly basis and shall establish criteria, in consultation with the advisory task force,
8.9for referring information about a patient to prescribers and dispensers who prescribed or
8.10dispensed the prescriptions in question if the criteria are met.
8.11 Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
8.12the board as required under this section is subject to disciplinary action by the appropriate
8.13health-related licensing board.
8.14 (b) A prescriber or dispenser authorized to access the data who knowingly discloses
8.15the data in violation of state or federal laws relating to the privacy of health care data
8.16shall be subject to disciplinary action by the appropriate health-related licensing board,
8.17and appropriate civil penalties.
8.18Subd. 8. Evaluation and reporting. (a) The board shall evaluate the prescription
8.19electronic reporting system to determine if the system is negatively impacting appropriate
8.20prescribing practices of controlled substances. The board may contract with a vendor to
8.21design and conduct the evaluation.
8.22(b) The board shall submit the evaluation of the system to the legislature by July
8.2315, 2011.
8.24 Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
8.25pharmacist, prescriber, or other dispenser making a report to the program in good faith
8.26under this section is immune from any civil, criminal, or administrative liability, which
8.27might otherwise be incurred or imposed as a result of the report, or on the basis that the
8.28pharmacist or prescriber did or did not seek or obtain or use information from the program.
8.29 (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
8.30to obtain information about a patient from the program, and the pharmacist, prescriber,
8.31or other dispenser, if acting in good faith, is immune from any civil, criminal, or
8.32administrative liability that might otherwise be incurred or imposed for requesting,
8.33receiving, or using information from the program.
8.34 Subd. 10. Funding. (a) The board may seek grants and private funds from nonprofit
8.35charitable foundations, the federal government, and other sources to fund the enhancement
8.36and ongoing operations of the prescriptionelectronic reporting system monitoring
9.1program established under this section. Any funds received shall be appropriated to the
9.2board for this purpose. The board may not expend funds to enhance the program in a way
9.3that conflicts with this section without seeking approval from the legislature.
9.4(b) Notwithstanding any other section, the administrative services unit for the
9.5health-related licensing boards shall apportion between the Board of Medical Practice, the
9.6Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
9.7Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to
9.8be paid through fees by each respective board. The amount apportioned to each board
9.9shall equal each board's share of the annual appropriation to the Board of Pharmacy
9.10from the state government special revenue fund for operating the prescriptionelectronic
9.11reporting system monitoring program under this section. Each board's apportioned share
9.12shall be based on the number of prescribers or dispensers that each board identified in
9.13this paragraph licenses as a percentage of the total number of prescribers and dispensers
9.14licensed collectively by these boards. Each respective board may adjust the fees that the
9.15boards are required to collect to compensate for the amount apportioned to each board by
9.16the administrative services unit.
9.17 Sec. 2. STUDY REQUIRED; PRESCRIPTION MONITORING PROGRAM
9.18DATABASE.
9.19The Board of Pharmacy, in collaboration with the Prescription Monitoring Program
9.20Advisory Task Force, shall study the issue of mandatory use of the prescription monitoring
9.21program database and report to the chairs and ranking minority members of the senate
9.22health and human services policy and finance division and the house of representatives
9.23health care and human services policy and finance division by December 15, 2014, with
9.24recommendations on whether or not to require the use of the prescription monitoring
9.25program database by prescribers when prescribing or considering prescribing, and
9.26pharmacists when dispensing or considering dispensing, a controlled substance as defined
9.27in Minnesota Statutes, section 152.126, subdivision 1, paragraph (c).
1.3program;amending Minnesota Statutes 2012, section 152.126, as amended.
1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.5 Section 1. Minnesota Statutes 2012, section 152.126, as amended by Laws 2013,
1.6chapter 113, article 3, section 3, is amended to read:
1.7152.126
1.8
1.9 Subdivision 1. Definitions. (a) For purposes of this section, the terms defined in
1.10this subdivision have the meanings given.
1.11
1.12chapter 151.
1.13
1.14subdivisions 3 to
1.16includes tramadol and butalbital.
1.17
1.18subdivision 30
1.19substance to a patient by a licensed health care professional.
1.20
1.21substance, pursuant to a valid prescription. For the purposes of this section, a dispenser
1.22does not include a licensed hospital pharmacy that distributes controlled substances for
1.23inpatient hospital care, a licensed pharmacy, located on the same premises as a residential
1.24hospice, when the licensed pharmacy is dispensing controlled substances to be used
2.1by an individual who is a resident of the hospice or a veterinarian who is dispensing
2.2prescriptions under section
2.3
2.4prescribe a controlled substance under section
2.5
2.6 Subd. 1a. Treatment of intractable pain. This section is not intended to limit or
2.7interfere with the legitimate prescribing of controlled substances for pain. No prescriber
2.8shall be subject to disciplinary action by a health-related licensing board for prescribing a
2.9controlled substance according to the provisions of section
2.10 Subd. 2. Prescription electronic reporting system. (a) The board shall establish
2.11by January 1, 2010, an electronic system for reporting the information required under
2.12subdivision 4 for all controlled substances dispensed within the state.
2.13 (b) The board may contract with a vendor for the purpose of obtaining technical
2.14assistance in the design, implementation, operation, and maintenance of the electronic
2.15reporting system.
2.16 Subd. 3. Prescription
2.17
2.18
2.19 (1) the Department of Health;
2.20 (2) the Department of Human Services;
2.21 (3) each health-related licensing board that licenses prescribers;
2.22 (4) a professional medical association, which may include an association of pain
2.23management and chemical dependency specialists;
2.24 (5) a professional pharmacy association;
2.25 (6) a professional nursing association;
2.26 (7) a professional dental association;
2.27 (8) a consumer privacy or security advocate;
2.28 (9) a consumer or patient rights organization
2.29 (10) an association of medical examiners and coroners.
2.30 (b) The advisory
2.31operation of the
2.32but not limited to:
2.33 (1) technical standards for electronic prescription drug reporting;
2.34 (2) proper analysis and interpretation of prescription monitoring data;
2.35 (3) an evaluation process for the program; and
3.1 (4) criteria for the unsolicited provision of prescription monitoring data by the
3.2board to prescribers and dispensers.
3.3(c) The task force is governed by section 15.059. Notwithstanding section 15.059,
3.4subdivision 5, the task force shall not expire.
3.5 Subd. 4. Reporting requirements; notice. (a) Each dispenser must submit the
3.6following data to the board or its designated vendor
3.7
3.8 (1) name of the prescriber;
3.9 (2) national provider identifier of the prescriber;
3.10 (3) name of the dispenser;
3.11 (4) national provider identifier of the dispenser;
3.12 (5) prescription number;
3.13 (6) name of the patient for whom the prescription was written;
3.14 (7) address of the patient for whom the prescription was written;
3.15 (8) date of birth of the patient for whom the prescription was written;
3.16 (9) date the prescription was written;
3.17 (10) date the prescription was filled;
3.18 (11) name and strength of the controlled substance;
3.19 (12) quantity of controlled substance prescribed;
3.20 (13) quantity of controlled substance dispensed; and
3.21 (14) number of days supply.
3.22 (b) The dispenser must submit the required information by a procedure and in a
3.23format established by the board. The board may allow dispensers to omit data listed in this
3.24subdivision or may require the submission of data not listed in this subdivision provided
3.25the omission or submission is necessary for the purpose of complying with the electronic
3.26reporting or data transmission standards of the American Society for Automation in
3.27Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
3.28standard-setting body.
3.29 (c) A dispenser is not required to submit this data for those controlled substance
3.30prescriptions dispensed for:
3.31
3.32
3.33
3.34
3.35
4.1
4.2
4.3 (1) individuals residing in a health care facility as defined in section 151.58,
4.4subdivision 2, paragraph (b), when a drug is distributed through the use of an automated
4.5drug distribution system according to section 151.58; and
4.6 (2) individuals receiving a drug sample that was packaged by a manufacturer and
4.7provided to the dispenser for dispensing as a professional sample pursuant to Code of
4.8Federal Regulations, title 21, section 203, subpart D.
4.9 (d) A dispenser must
4.10patient for whom the prescription was written a conspicuous notice of the reporting
4.11requirements of this section
4.12 and notice that the information may be used for program administration purposes.
4.13 Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
4.14of the data reported under subdivision 4. The board shall maintain data that could identify
4.15an individual prescriber or dispenser in encrypted form. Except as otherwise allowed
4.16under subdivision 6, the database may be used by permissible users identified under
4.17subdivision 6 for the identification of:
4.18 (1) individuals receiving prescriptions for controlled substances from prescribers
4.19who subsequently obtain controlled substances from dispensers in quantities or with a
4.20frequency inconsistent with generally recognized standards of use for those controlled
4.21substances, including standards accepted by national and international pain management
4.22associations; and
4.23 (2) individuals presenting forged or otherwise false or altered prescriptions for
4.24controlled substances to dispensers.
4.25 (b) No permissible user identified under subdivision 6 may access the database
4.26for the sole purpose of identifying prescribers of controlled substances for unusual or
4.27excessive prescribing patterns without a valid search warrant or court order.
4.28 (c) No personnel of a state or federal occupational licensing board or agency may
4.29access the database for the purpose of obtaining information to be used to initiate or
4.30substantiate a disciplinary action against a prescriber when the disciplinary action relates
4.31to allegations involving unusual or excessive prescribing of the drugs for which data
4.32is collected under subdivision 4.
4.33 (d) Data reported under subdivision 4 shall be
4.34
4.35
4.36to permissible users for a 12-month period beginning the day the data was received and
5.1ending 12 months from the last day of the month in which the data was received, except
5.2that permissible users defined in subdivision 6, paragraph (b), clauses (6) and (7), may
5.3use all data collected under this section for the purposes of administering, operating, and
5.4maintaining the prescription monitoring program and conducting trend analyses and other
5.5studies necessary to evaluate the effectiveness of the program.
5.6(e) The board shall not retain data reported under subdivision 4 for a period longer
5.7than five years from the date the data was received.
5.8 Subd. 6. Access to reporting system data. (a) Except as indicated in this
5.9subdivision, the data submitted to the board under subdivision 4 is private data on
5.10individuals as defined in section
5.11 (b) Except as specified in subdivision 5, the following persons shall be considered
5.12permissible users and may access the data submitted under subdivision 4 in the same or
5.13similar manner, and for the same or similar purposes, as those persons who are authorized
5.14to access similar private data on individuals under federal and state law:
5.15 (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
5.16delegated the task of accessing the data, to the extent the information relates specifically to
5.17a current patient, to whom the prescriber is prescribing or considering prescribing any
5.18controlled substance or to whom the prescriber is providing other medical treatment for
5.19which access to the data may be necessary and with the provision that the prescriber remains
5.20responsible for the use or misuse of data accessed by a delegated agent or employee;
5.21 (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
5.22delegated the task of accessing the data, to the extent the information relates specifically
5.23to a current patient to whom that dispenser is dispensing or considering dispensing any
5.24controlled substance and with the provision that the dispenser remains responsible for the
5.25use or misuse of data accessed by a delegated agent or employee;
5.26 (3) a licensed pharmacist who is providing pharmaceutical care for which access to
5.27the data may be necessary to the extent that the information relates specifically to a current
5.28patient for whom the pharmacist is providing pharmaceutical care;
5.29
5.30which data was submitted under subdivision 4, or a guardian of the individual, parent or
5.31guardian of a minor, or health care agent of the individual acting under a health care
5.32directive under chapter 145C;
5.33
5.34214.01, subdivision 2, or the Emergency Medical Services Regulatory Board, assigned to
5.35conduct a bona fide investigation of a complaint received by that board alleging that a
5.36 specific licensee is impaired by use of a drug for which data is collected under subdivision
6.14, has engaged in activity that would constitute a crime as defined in section 152.025, or
6.2has engaged in the behavior specified in section 152.126, subdivision 5, paragraph (a);
6.3
6.4 of controlled substance prescription information as part of the assigned duties and
6.5responsibilities under this section;
6.6
6.7Minnesota who are engaged in the design, implementation, operation, and maintenance of
6.8the
6.9duties and responsibilities of their employment, provided that access to data is limited to
6.10the minimum amount necessary to carry out such duties and responsibilities;
6.11
6.12valid search warrant;
6.13
6.14assigned to use the data collected under this section to identify and manage recipients
6.15whose usage of controlled substances may warrant restriction to a single primary care
6.16
6.17
6.18data pursuant to paragraph (h)
6.19(11) a coroner or medical examiner, or an agent or employee of the coroner or
6.20medical examiner to whom the coroner or medical examiner has delegated the task of
6.21accessing the data, conducting an investigation pursuant to section 390.11, and with the
6.22provision that the coroner or medical examiner remains responsible for the use or misuse
6.23of data accessed by a delegated agent or employee; and
6.24(12) personnel of the health professionals services program established under
6.25section 214.31, to the extent that the information relates specifically to an individual who
6.26is currently enrolled in and being monitored by the program. The health professionals
6.27services program personnel shall not provide this data to a health-related licensing board
6.28or the Emergency Medical Services Regulatory Board, except as permitted under section
6.29214.33, subdivision 3.
6.30 For purposes of clause
6.31definition of an individual under section
6.32 (c)
6.33(7), (9), (10), and (11) may directly
6.34is directly accessed electronically, the permissible user shall implement and maintain a
6.35comprehensive information security program that contains administrative, technical,
6.36and physical safeguards that are appropriate to the user's size and complexity, and the
7.1sensitivity of the personal information obtained. The permissible user shall identify
7.2reasonably foreseeable internal and external risks to the security, confidentiality, and
7.3integrity of personal information that could result in the unauthorized disclosure, misuse,
7.4or other compromise of the information and assess the sufficiency of any safeguards in
7.5place to control the risks.
7.6 (d) The board shall not release data submitted under
7.7it is provided with evidence, satisfactory to the board, that the person requesting the
7.8information is entitled to receive the data.
7.9
7.10
7.11
7.12
7.13
7.14of at least three years and shall ensure that any permissible user complies with paragraph
7.15(c) prior to attaining direct access to the data.
7.16
7.17pursuant to subdivision 2. A vendor shall not use data collected under this section for
7.18any purpose not specified in this section.
7.19(g) The board may participate in an interstate prescription monitoring program data
7.20exchange system provided that permissible users in other states have access to the data
7.21only as allowed under this section, and that section 13.05, subdivision 6, applies to any
7.22contract or memorandum of understanding that the board enters into under this paragraph.
7.23(h) With available appropriations, the commissioner of human services shall
7.24establish and implement a system through which the Department of Human Services shall
7.25routinely access the data for the purpose of determining whether any client enrolled in
7.26an opioid treatment program licensed according to chapter 245A has been prescribed or
7.27dispensed a controlled substance in addition to that administered or dispensed by the
7.28opioid treatment program. When the commissioner determines there have been multiple
7.29prescribers or multiple prescriptions of controlled substances, the commissioner shall:
7.30(1) inform the medical director of the opioid treatment program only that the
7.31commissioner determined the existence of multiple prescribers or multiple prescriptions of
7.32controlled substances; and
7.33(2) direct the medical director of the opioid treatment program to access the data
7.34directly, review the effect of the multiple prescribers or multiple prescriptions, and
7.35document the review.
8.1If determined necessary, the commissioner of human services shall seek a federal waiver
8.2of, or exception to, any applicable provision of Code of Federal Regulations, title 42, part
8.4(i) The board may provide data submitted under subdivision 4 for public research,
8.5policy, or education purposes, but only after the removal of any information that is likely
8.6to reveal the identity of the patient, prescriber, or dispenser who is the subject of the data.
8.7(j) The board shall review the data submitted under subdivision 4 on at least a
8.8quarterly basis and shall establish criteria, in consultation with the advisory task force,
8.9for referring information about a patient to prescribers and dispensers who prescribed or
8.10dispensed the prescriptions in question if the criteria are met.
8.11 Subd. 7. Disciplinary action. (a) A dispenser who knowingly fails to submit data to
8.12the board as required under this section is subject to disciplinary action by the appropriate
8.13health-related licensing board.
8.14 (b) A prescriber or dispenser authorized to access the data who knowingly discloses
8.15the data in violation of state or federal laws relating to the privacy of health care data
8.16shall be subject to disciplinary action by the appropriate health-related licensing board,
8.17and appropriate civil penalties.
8.18
8.19
8.20
8.21
8.22
8.23
8.24 Subd. 9. Immunity from liability; no requirement to obtain information. (a) A
8.25pharmacist, prescriber, or other dispenser making a report to the program in good faith
8.26under this section is immune from any civil, criminal, or administrative liability, which
8.27might otherwise be incurred or imposed as a result of the report, or on the basis that the
8.28pharmacist or prescriber did or did not seek or obtain or use information from the program.
8.29 (b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
8.30to obtain information about a patient from the program, and the pharmacist, prescriber,
8.31or other dispenser, if acting in good faith, is immune from any civil, criminal, or
8.32administrative liability that might otherwise be incurred or imposed for requesting,
8.33receiving, or using information from the program.
8.34 Subd. 10. Funding. (a) The board may seek grants and private funds from nonprofit
8.35charitable foundations, the federal government, and other sources to fund the enhancement
8.36and ongoing operations of the prescription
9.1program established under this section. Any funds received shall be appropriated to the
9.2board for this purpose. The board may not expend funds to enhance the program in a way
9.3that conflicts with this section without seeking approval from the legislature.
9.4(b) Notwithstanding any other section, the administrative services unit for the
9.5health-related licensing boards shall apportion between the Board of Medical Practice, the
9.6Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
9.7Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to
9.8be paid through fees by each respective board. The amount apportioned to each board
9.9shall equal each board's share of the annual appropriation to the Board of Pharmacy
9.10from the state government special revenue fund for operating the prescription
9.11
9.12shall be based on the number of prescribers or dispensers that each board identified in
9.13this paragraph licenses as a percentage of the total number of prescribers and dispensers
9.14licensed collectively by these boards. Each respective board may adjust the fees that the
9.15boards are required to collect to compensate for the amount apportioned to each board by
9.16the administrative services unit.
9.17 Sec. 2. STUDY REQUIRED; PRESCRIPTION MONITORING PROGRAM
9.18DATABASE.
9.19The Board of Pharmacy, in collaboration with the Prescription Monitoring Program
9.20Advisory Task Force, shall study the issue of mandatory use of the prescription monitoring
9.21program database and report to the chairs and ranking minority members of the senate
9.22health and human services policy and finance division and the house of representatives
9.23health care and human services policy and finance division by December 15, 2014, with
9.24recommendations on whether or not to require the use of the prescription monitoring
9.25program database by prescribers when prescribing or considering prescribing, and
9.26pharmacists when dispensing or considering dispensing, a controlled substance as defined
9.27in Minnesota Statutes, section 152.126, subdivision 1, paragraph (c).
