SF 1440

Conference Committee Report - 89th Legislature (2015 - 2016) Posted on 05/21/2016 09:39pm

1.1CONFERENCE COMMITTEE REPORT ON S.F. No. 1440

1.2A bill for an act

1.3relating to health; making changes to the Minnesota prescription monitoring
1.4program;amending Minnesota Statutes 2014, section 152.126, subdivisions 1, 3,
1.55, 6; repealing Laws 2014, chapter 286, article 7, section 4.
1.6May 21, 2016
1.7The Honorable Sandra L. Pappas
1.8President of the Senate
1.9The Honorable Kurt L. Daudt
1.10Speaker of the House of Representatives
1.11We, the undersigned conferees for S.F. No. 1440 report that we have agreed upon
1.12the items in dispute and recommend as follows:
1.13That the House recede from its amendments and that S.F. No. 1440 be further
1.14amended as follows:
1.15Delete everything after the enacting clause and insert:

"1.16    Section 1. Minnesota Statutes 2014, section 152.126, subdivision 1, is amended to read:
1.17    Subdivision 1. Definitions. (a) For purposes of this section, the terms defined in
1.18this subdivision have the meanings given.
1.19    (b) "Board" means the Minnesota State Board of Pharmacy established under
1.20chapter 151.
1.21    (c) "Controlled substances" means those substances listed in section 152.02,
1.22subdivisions 3 to 6, and those substances defined by the board pursuant to section 152.02,
1.23subdivisions 7 , 8, and 12. For the purposes of this section, controlled substances includes
1.24tramadol and butalbital and gabapentin.
1.25    (d) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision
1.2630 . Dispensing does not include the direct administering of a controlled substance to a
1.27patient by a licensed health care professional.
1.28    (e) "Dispenser" means a person authorized by law to dispense a controlled substance,
1.29pursuant to a valid prescription. For the purposes of this section, a dispenser does not
2.1include a licensed hospital pharmacy that distributes controlled substances for inpatient
2.2hospital care or a veterinarian who is dispensing prescriptions under section 156.18.
2.3    (f) "Prescriber" means a licensed health care professional who is authorized to
2.4prescribe a controlled substance under section 152.12, subdivision 1 or 2.
2.5    (g) "Prescription" has the meaning given in section 151.01, subdivision 16 16a.

2.6    Sec. 2. Minnesota Statutes 2014, section 152.126, subdivision 3, is amended to read:
2.7    Subd. 3. Prescription Monitoring Program Advisory Task Force. (a) The board
2.8shall appoint an advisory task force consisting of at least one representative of:
2.9    (1) the Department of Health;
2.10    (2) the Department of Human Services;
2.11    (3) each health-related licensing board that licenses prescribers;
2.12    (4) a professional medical association, which may include an association of pain
2.13management and chemical dependency specialists;
2.14    (5) a professional pharmacy association;
2.15    (6) a professional nursing association;
2.16    (7) a professional dental association;
2.17    (8) a consumer privacy or security advocate;
2.18    (9) a consumer or patient rights organization; and
2.19    (10) an association of medical examiners and coroners.
2.20    (b) The advisory task force shall advise the board on the development and operation
2.21of the prescription monitoring program, including, but not limited to:
2.22    (1) technical standards for electronic prescription drug reporting;
2.23    (2) proper analysis and interpretation of prescription monitoring data;
2.24    (3) an evaluation process for the program; and
2.25    (4) criteria for the unsolicited provision of prescription monitoring data by the
2.26board to prescribers and dispensers.
2.27(c) The task force is governed by section 15.059. Notwithstanding any other
2.28provisions of law to the contrary, the task force shall not expire.

2.29    Sec. 3. Minnesota Statutes 2014, section 152.126, subdivision 5, is amended to read:
2.30    Subd. 5. Use of data by board. (a) The board shall develop and maintain a database
2.31of the data reported under subdivision 4. The board shall maintain data that could identify
2.32an individual prescriber or dispenser in encrypted form. Except as otherwise allowed
2.33under subdivision 6, the database may be used by permissible users identified under
2.34subdivision 6 for the identification of:
3.1    (1) individuals receiving prescriptions for controlled substances from prescribers
3.2who subsequently obtain controlled substances from dispensers in quantities or with a
3.3frequency inconsistent with generally recognized standards of use for those controlled
3.4substances, including standards accepted by national and international pain management
3.5associations; and
3.6    (2) individuals presenting forged or otherwise false or altered prescriptions for
3.7controlled substances to dispensers.
3.8    (b) No permissible user identified under subdivision 6 may access the database
3.9for the sole purpose of identifying prescribers of controlled substances for unusual or
3.10excessive prescribing patterns without a valid search warrant or court order.
3.11    (c) No personnel of a state or federal occupational licensing board or agency may
3.12access the database for the purpose of obtaining information to be used to initiate or
3.13substantiate a disciplinary action against a prescriber.
3.14    (d) Data reported under subdivision 4 shall be made available to permissible users for
3.15a 12-month period beginning the day the data was received and ending 12 months from the
3.16last day of the month in which the data was received, except that permissible users defined
3.17in subdivision 6, paragraph (b), clauses (6) and (7), may use all data collected under this
3.18section for the purposes of administering, operating, and maintaining the prescription
3.19monitoring program and conducting trend analyses and other studies necessary to evaluate
3.20the effectiveness of the program. Data retained beyond 24 months must be de-identified.
3.21(e) The board shall not retain data reported under subdivision 4 for a period longer
3.22than four years from the date the data was received.
3.23(e) Data reported during the period January 1, 2015, through December 31, 2018,
3.24may be retained through December 31, 2019, in an identifiable manner. Effective January
3.251, 2020, data older than 24 months must be destroyed. Data reported on or after January 1,
3.262020, must be destroyed no later than 12 months from the date the data was received.

3.27    Sec. 4. Minnesota Statutes 2014, section 152.126, subdivision 6, is amended to read:
3.28    Subd. 6. Access to reporting system data. (a) Except as indicated in this
3.29subdivision, the data submitted to the board under subdivision 4 is private data on
3.30individuals as defined in section 13.02, subdivision 12, and not subject to public disclosure.
3.31    (b) Except as specified in subdivision 5, the following persons shall be considered
3.32permissible users and may access the data submitted under subdivision 4 in the same or
3.33similar manner, and for the same or similar purposes, as those persons who are authorized
3.34to access similar private data on individuals under federal and state law:
4.1    (1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
4.2delegated the task of accessing the data, to the extent the information relates specifically to
4.3a current patient, to whom the prescriber is:
4.4    (i) prescribing or considering prescribing any controlled substance;
4.5    (ii) providing emergency medical treatment for which access to the data may be
4.6necessary; or
4.7    (iii) providing care, and the prescriber has reason to believe, based on clinically valid
4.8indications, that the patient is potentially abusing a controlled substance; or
4.9    (iii) (iv) providing other medical treatment for which access to the data may be
4.10necessary for a clinically valid purpose and the patient has consented to access to the
4.11submitted data, and with the provision that the prescriber remains responsible for the use
4.12or misuse of data accessed by a delegated agent or employee;
4.13    (2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
4.14delegated the task of accessing the data, to the extent the information relates specifically
4.15to a current patient to whom that dispenser is dispensing or considering dispensing any
4.16controlled substance and with the provision that the dispenser remains responsible for the
4.17use or misuse of data accessed by a delegated agent or employee;
4.18(3) a licensed pharmacist who is providing pharmaceutical care for which access
4.19to the data may be necessary to the extent that the information relates specifically to a
4.20current patient for whom the pharmacist is providing pharmaceutical care: (i) if the patient
4.21has consented to access to the submitted data; or (ii) if the pharmacist is consulted by a
4.22prescriber who is requesting data in accordance with clause (1);
4.23    (4) an individual who is the recipient of a controlled substance prescription for
4.24which data was submitted under subdivision 4, or a guardian of the individual, parent or
4.25guardian of a minor, or health care agent of the individual acting under a health care
4.26directive under chapter 145C;
4.27    (5) personnel or designees of the a health-related licensing board specifically listed
4.28in section 214.01, subdivision 2, or of the Emergency Medical Services Regulatory Board,
4.29assigned to conduct a bona fide investigation of a complaint received by that board that
4.30alleges that a specific licensee is impaired by use of a drug for which data is collected
4.31under subdivision 4, has engaged in activity that would constitute a crime as defined in
4.32section 152.025, or has engaged in the behavior specified in subdivision 5, paragraph (a);
4.33    (6) personnel of the board engaged in the collection, review, and analysis
4.34of controlled substance prescription information as part of the assigned duties and
4.35responsibilities under this section;
5.1    (7) authorized personnel of a vendor under contract with the state of Minnesota who
5.2are engaged in the design, implementation, operation, and maintenance of the prescription
5.3monitoring program as part of the assigned duties and responsibilities of their employment,
5.4provided that access to data is limited to the minimum amount necessary to carry out such
5.5duties and responsibilities, and subject to the requirement of de-identification and time
5.6limit on retention of data specified in subdivision 5, paragraphs (d) and (e);
5.7    (8) federal, state, and local law enforcement authorities acting pursuant to a valid
5.8search warrant;
5.9    (9) personnel of the Minnesota health care programs assigned to use the data
5.10collected under this section to identify and manage recipients whose usage of controlled
5.11substances may warrant restriction to a single primary care provider, a single outpatient
5.12pharmacy, and a single hospital;
5.13(10) personnel of the Department of Human Services assigned to access the data
5.14pursuant to paragraph (h) (i); and
5.15(11) personnel of the health professionals services program established under section
5.16214.31 , to the extent that the information relates specifically to an individual who is
5.17currently enrolled in and being monitored by the program, and the individual consents to
5.18access to that information. The health professionals services program personnel shall not
5.19provide this data to a health-related licensing board or the Emergency Medical Services
5.20Regulatory Board, except as permitted under section 214.33, subdivision 3.
5.21    For purposes of clause (4), access by an individual includes persons in the definition
5.22of an individual under section 13.02.; and
5.23    (12) personnel or designees of a health-related licensing board listed in section
5.24214.01, subdivision 2, assigned to conduct a bona fide investigation of a complaint
5.25received by that board that alleges that a specific licensee is inappropriately prescribing
5.26controlled substances as defined in this section.
5.27    (c) By July 1, 2017, every prescriber licensed by a health-related licensing board
5.28listed in section 214.01, subdivision 2, practicing within this state who is authorized to
5.29prescribe controlled substances for humans and who holds a current registration issued
5.30by the federal Drug Enforcement Administration, and every pharmacist licensed by the
5.31board and practicing within the state, shall register and maintain a user account with the
5.32prescription monitoring program. Data submitted by a prescriber, pharmacist, or their
5.33delegate during the registration application process, other than their name, license number,
5.34and license type, is classified as private pursuant to section 13.02, subdivision 12.
5.35    (d) A Only permissible user users identified in paragraph (b), clauses (1), (2), (3), (6),
5.36(7), (9), and (10), may directly access the data electronically. No other permissible users
6.1may directly access the data electronically. If the data is directly accessed electronically,
6.2the permissible user shall implement and maintain a comprehensive information
6.3security program that contains administrative, technical, and physical safeguards that
6.4are appropriate to the user's size and complexity, and the sensitivity of the personal
6.5information obtained. The permissible user shall identify reasonably foreseeable internal
6.6and external risks to the security, confidentiality, and integrity of personal information
6.7that could result in the unauthorized disclosure, misuse, or other compromise of the
6.8information and assess the sufficiency of any safeguards in place to control the risks.
6.9    (d) (e) The board shall not release data submitted under subdivision 4 unless it
6.10is provided with evidence, satisfactory to the board, that the person requesting the
6.11information is entitled to receive the data.
6.12    (e) (f) The board shall maintain a log of all persons who access the data for a period
6.13of at least three years and shall ensure that any permissible user complies with paragraph
6.14(c) prior to attaining direct access to the data.
6.15(f) (g) Section 13.05, subdivision 6, shall apply to any contract the board enters into
6.16pursuant to subdivision 2. A vendor shall not use data collected under this section for
6.17any purpose not specified in this section.
6.18(g) (h) The board may participate in an interstate prescription monitoring program
6.19data exchange system provided that permissible users in other states have access to the
6.20data only as allowed under this section, and that section 13.05, subdivision 6, applies
6.21to any contract or memorandum of understanding that the board enters into under this
6.22paragraph. The board shall report to the chairs and ranking minority members of the senate
6.23and house of representatives committees with jurisdiction over health and human services
6.24policy and finance on the interstate prescription monitoring program by January 5, 2016.
6.25(h) (i) With available appropriations, the commissioner of human services shall
6.26establish and implement a system through which the Department of Human Services shall
6.27routinely access the data for the purpose of determining whether any client enrolled in
6.28an opioid treatment program licensed according to chapter 245A has been prescribed or
6.29dispensed a controlled substance in addition to that administered or dispensed by the
6.30opioid treatment program. When the commissioner determines there have been multiple
6.31prescribers or multiple prescriptions of controlled substances, the commissioner shall:
6.32(1) inform the medical director of the opioid treatment program only that the
6.33commissioner determined the existence of multiple prescribers or multiple prescriptions of
6.34controlled substances; and
7.1(2) direct the medical director of the opioid treatment program to access the data
7.2directly, review the effect of the multiple prescribers or multiple prescriptions, and
7.3document the review.
7.4If determined necessary, the commissioner of human services shall seek a federal waiver
7.5of, or exception to, any applicable provision of Code of Federal Regulations, title 42,
7.6section 2.34, paragraph (c), prior to implementing this paragraph.
7.7(i) (j) The board shall review the data submitted under subdivision 4 on at least a
7.8quarterly basis and shall establish criteria, in consultation with the advisory task force,
7.9for referring information about a patient to prescribers and dispensers who prescribed or
7.10dispensed the prescriptions in question if the criteria are met. The board shall report
7.11to the chairs and ranking minority members of the senate and house of representatives
7.12committees with jurisdiction over health and human services policy and finance on the
7.13criteria established under this paragraph and the review process by January 5, 2016. This
7.14paragraph expires August 1, 2016.

7.15    Sec. 5. REPEALER.
7.16Laws 2014, chapter 286, article 7, section 4, is repealed.
"

8.1	We request the adoption of this report and repassage of the bill.
8.2	Senate Conferees:
8.3	.....		.....
8.4	Julie A. Rosen		Kathy Sheran
8.5	.....
8.6	Michelle R. Benson
8.7	House Conferees:
8.8	.....		.....
8.9	Dave Baker		Tina Liebling
8.10	.....
8.11	Nick Zerwas