Chapter CSB 4

CSB 4.10(3) (3) The board shall conduct the review at its next regularly scheduled meeting and notify the dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator of the time and place of the review.

CSB 4.10(4) (4) No discovery is permitted.

CSB 4.10(5) (5) The board shall preside over the review. The review shall be recorded by audio tape unless otherwise specified by the board.

CSB 4.10(6) (6) The board shall provide the dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator with an opportunity to submit written documentation, make a personal appearance before the board and present a statement. The board may establish a time limit for making a presentation. Unless otherwise determined by the board, the time for making a personal appearance shall be 20 minutes.

CSB 4.10(7) (7) If the dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator fails to appear for a review, or withdraws the request for a review, the board may note the failure to appear in the minutes and affirm its original decision without further action.

CSB 4.10 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction in (1) (b) made under s. 13.92 (4) (b) 7., Stats., Register February 2014 No. 698; CR 14-003: am. (1) (intro.), (2) (intro.), (b), (3), (6), (7) Register August 2014 No. 704, eff. 9-1-14; correction in (1) (a) to (c) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; CR 15-101: am. (1) (c), (2) (a) Register June 2016 No. 726, eff. 7-1-16; s. 35.17 correction in (1) (c), Register June 2016 No. 726; EmR1706: emerg. am. (1) (intro.), r. (1) (a), am. (1) (c), (2) (intro.), (a), (3), (6), (7), eff. 4-1-17; CR 17-028: am. (1) (intro.), r. (1) (a), am. (1) (c), (2) (intro.), (a), (3), (6), (7) Register December 2017 No. 744, eff. 1-1-18; correction in (1) (c) made under s. 13.92 (4) (b) 7., Stats., December 2017 No. 744.

CSB 4.105 CSB 4.105 Practitioners’ requirement to review monitored prescription drug history reports.

CSB 4.105(1) (1) A practitioner, or a practitioner delegate assisting the practitioner in accordance with the standards of practice for the practitioner’s profession, shall review the monitored prescription drug history report about a patient before the practitioner issues a prescription order for the patient unless any of the following conditions are met:

CSB 4.105(1)(a) (a) The patient is receiving hospice care, as defined in s. 50.94 (1) (a).

CSB 4.105(1)(b) (b) The prescription order is for a number of doses that is intended to last the patient 3 days or less and is not subject to refill.

CSB 4.105(1)(c) (c) The monitored prescription drug is lawfully administered to the patient.

CSB 4.105(1)(d) (d) The practitioner is unable to review the patient’s monitored prescription drug history reports before issuing a prescription order for the patient due to an emergency.

CSB 4.105(1)(e) (e) The practitioner is unable to review the patient’s records under their program because the PDMP system is not operational or due to other technological failure that the practitioner reports to the board.

CSB 4.105(2) (2) Reviews of reports or other information not provided by the board as part of the program that summarize or analyze PDMP data do not satisfy the requirement to review a monitored prescription drug history report under sub. (1).

CSB 4.105(3) (3) The board may refer a practitioner that fails to review a monitored prescription drug history report about a patient prior to issuing a prescription order for that patient to the appropriate licensing or regulatory board for discipline.

CSB 4.105 History History: EmR1706: emerg. cr., eff. 4-1-17; CR 17-028: cr. Register December 2017 No. 744, eff. 1-1-18.

CSB 4.11 CSB 4.11 Methods of obtaining monitored prescription drug history reports.

CSB 4.11(1) (1) The board shall disclose the monitored prescription drug history report about a patient to the patient if he or she does all of the following:

CSB 4.11(1)(a) (a) Appears in person at the department with two forms of valid proof of identity, one of which is valid government-issued photographic identification or mails to the department copies of two forms of valid proof of identity, one of which is valid government-issued photographic identification.

CSB 4.11(1)(b) (b) Makes a request for the monitored prescription drug history reports about the patient on a form provided by the board. If the request is mailed, the form shall be notarized.

CSB 4.11(2) (2) The board shall disclose the monitored prescription drug history report about a patient to a person authorized by the patient if the person authorized by the patient does all of the following:

CSB 4.11(2)(a) (a) Appears in person at the department with two forms of valid proof of identity, one of which is valid government-issued photographic identification.

CSB 4.11(2)(b) (b) Provides proof sufficient to the board of the authorization or delegation from the patient.

CSB 4.11(2)(c) (c) Makes a request for the monitored prescription drug history report on a form provided by the board.

CSB 4.11(5) (5) The board shall disclose the minimum necessary amount of information in a monitored prescription drug history report about a patient, patient address, practitioner, or dispenser to designated staff of a federal or state governmental agency in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the designated staff does all of the following:

CSB 4.11(5)(a) (a) Creates an account with the PDMP system.

CSB 4.11(5)(b) (b) Provides proof sufficient to the board that the federal or state governmental agency is entitled to the information under s. 146.82 (2) (a) 5., Stats.

CSB 4.11(5)(c) (c) Makes a request for the monitored prescription drug history report through its PDMP system account.

CSB 4.11(5)(d) (d) If the PDMP system is unable to fulfill a request from designated staff through their account with the PDMP system, the board may disclose the minimum necessary amount of information necessary to designated staff of a federal or state governmental agency upon written request that cites the agency’s specific authorization to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records.

CSB 4.11(6) (6) The board shall disclose the minimum necessary amount of PDMP data or information in a monitored prescription drug history report about a patient, patient address, practitioner, or dispenser to designated staff of the department who is charged with investigating dispensers, dispenser delegates, pharmacists, pharmacist delegates, practitioners, and practitioner delegates in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the designated staff does all of the following:

CSB 4.11(6)(a) (a) Creates an account with the PDMP system.

CSB 4.11(6)(b) (b) Provides proof sufficient to the board that the department is entitled to the information under s. 146.82 (2) (a) 5., Stats.

CSB 4.11(6)(c) (c) Makes a request for the monitored prescription drug history report through its PDMP system account.

CSB 4.11(7) (7) The board shall disclose the minimum necessary amount of information in a monitored prescription drug history report about a patient or patient address to a prisoner’s health care provider, the medical staff of a prison or jail in which a prisoner is confined, the receiving institution intake staff at a prison or jail to which a prisoner is being transferred or a person designated by a jailer to maintain prisoner medical records or designated staff of the department of corrections in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following:

CSB 4.11(7)(a) (a) Creates an account with the PDMP system.

CSB 4.11(7)(b) (b) Provides proof sufficient to the board that the person is entitled to the information under s. 146.82 (2) (a) 21., Stats.

CSB 4.11(7)(c) (c) Makes a request for the monitored prescription drug history report through its PDMP system account.

CSB 4.11(8) (8) The board shall disclose the minimum necessary amount of information in a monitored prescription drug history report about a patient to a coroner, deputy coroner, medical examiner, or medical examiner’s assistant following the death of a patient in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following:

CSB 4.11(8)(a) (a) Creates an account with the PDMP system.

CSB 4.11(8)(b) (b) Provides proof sufficient to the board that the person is entitled to the information under s. 146.82 (2) (a) 18., Stats.

CSB 4.11(8)(c) (c) Makes a request for the monitored prescription drug history report through its PDMP system account with the board.

CSB 4.11(9) (9) The board may disclose PDMP data without personally identifiable information that could be reasonably used to identify any patient, healthcare professional, practitioner delegate, pharmacist delegate, or dispenser for public health and scientific research purposes. The board may require evidence of institutional review board approval.

CSB 4.11(10) (10) The board shall disclose the minimum necessary amount of information in a monitored prescription drug history report about a patient, patient address, practitioner, or dispenser to designated staff of a law enforcement agency or prosecutorial unit if the designated staff does all of the following:

CSB 4.11(10)(a) (a) Creates an account with the PDMP system.

CSB 4.11(10)(b) (b) Provides documentation demonstrating the law enforcement agency or prosecutorial unit is engaged in one of the following activities:

CSB 4.11(10)(b)1. 1. An active and specific investigation or prosecution of a violation of any state or federal law involving a monitored prescription drug and that the information being requested is reasonably related to that investigation or prosecution.

CSB 4.11(10)(b)2. 2. The monitoring of a patient as part of a drug court, as defined in s. 165.955 (1).

CSB 4.11(10)(c) (c) Makes a request for the monitored prescription drug history report through its account with the PDMP system.

CSB 4.11 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: r. (3), (4), am. (6) (intro.), renum. (9) (intro.) to (9) and am., r. (9) (a) to (c) Register August 2014 No. 704, eff. 9-1-14; correction in (5) (intro.), (6) (intro.), (7) (intro.), (8) (intro.), (10) (intro.) Register September 2015 No. 717; CR 15-101: am. (1) (intro.), (b), (2) (intro.), (c), (7) (intro.), (c), (8) (intro.), (c) Register June 2016 No. 726, eff. 7-1-16; EmR1706: emerg. am (Title), (1), (2) (intro.), (c), (5) (intro.), (a), (c), cr. (d), am. (6) (intro.), (a), (c), (7) (intro.), (a), (c), (8) (intro.), (a), (c), (9), (10) eff. 4-1-17; CR 17-028: (Title), (1), (2) (intro.), (c), (5) (intro.), (a), (c), cr. (d), am. (6) (intro.), (a), (c), (7) (intro.), (a), (c), (8) (intro.), (a), (c), (9), (10) Register December 2017 No. 744, eff. 1-1-18; CR 19-156: am. (9) Register August 2020 No. 776, eff. 9-1-20.

CSB 4.12 CSB 4.12 Use of PDMP data by the board and department.

CSB 4.12(1) (1) The board shall develop and maintain a PDMP database to store dispensing data and PDMP data in a secure environment and an encrypted format.

CSB 4.12(2m) (2m) The board shall develop and maintain a PDMP system to facilitate all of the following:

CSB 4.12(2m)(a) (a) The submission of dispensing data to the PDMP database.

CSB 4.12(2m)(b) (b) The creation of monitored prescription drug history reports about specific patients, practitioners, and dispensers.

CSB 4.12(2m)(c) (c) The access to and the obtaining of monitored prescription drug history reports, prescribing metrics reports, and audit trails.

CSB 4.12(3) (3) The board shall maintain audit trails that contain all of the following information:

CSB 4.12(3)(a) (a) A log of dispensing data submitted to the PDMP database by each dispenser.

CSB 4.12(3)(b) (b) A log of persons to whom the Board has granted direct access to the PDMP system under ss. CSB 4.09 or 4.093 and a log of each time a person attempts to access PDMP data or a monitored prescription drug history report.

CSB 4.12(3)(c) (c) A log of prescription monitoring programs operated by a relevant agency in another jurisdiction with which the board exchanges PDMP data pursuant to s. CSB 4.14 and a log of each time a person from another jurisdiction attempts to access PDMP data.

CSB 4.12(3)(d) (d) A log of pharmacies or other entities at which pharmacists dispense or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person from a pharmacy or other entity attempts to access PDMP data or a monitored prescription drug history report.

CSB 4.12(3)(e) (e) A log of hospitals or other entities at which practitioners prescribe, dispense, or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person from a hospital or other entity attempts to access PDMP data or a monitored prescription drug history report.

CSB 4.12(3)(f) (f) A log of monitored prescription drug history reports and PDMP data disclosed pursuant to s. CSB 4.11, including the name of the person to whom the information was disclosed.

CSB 4.12(3)(g) (g) A log of requests for PDMP data or monitored prescription drug history reports even when no information was disclosed.

CSB 4.12(6) (6) Staff assigned administrative duties over the PDMP, vendors, contractors, and other agents of the board shall only have access to the minimum amount of PDMP data necessary for all of the following purposes:

CSB 4.12(6)(a) (a) The design, implementation, operation, and maintenance of the program, including the PDMP database, PDMP system, the disclosure of information via other entities pursuant to s. CSB 4.09 (4), and the exchange of information pursuant to s. CSB 4.15 as part of the assigned duties and responsibilities of their employment.

CSB 4.12(6)(am) (am) The operation of an analytics platform that provides data cleansing and standardization, data integration, advanced analytics, and alert management capabilities as part of the PDMP database and PDMP system.

CSB 4.12(6)(b) (b) The collection of dispensing data as part of the assigned duties and responsibilities under s. 961.385, Stats., and this chapter.

CSB 4.12(6)(c) (c) Evaluating and responding to legitimate requests for monitored prescription drug history reports, audit trails, and PDMP data.

CSB 4.12(6)(cg) (cg) Preparing monitored prescription drug history reports, audit trails, and PDMP data for the board to determine whether suspicious or critically dangerous conduct or practices has occurred or is occurring pursuant to s. CSB 4.15.

CSB 4.12(6)(cr) (cr) Conducting a review of the program as required by s. 961.385 (5), Stats.

CSB 4.12(6)(d) (d) Other legally authorized purposes.

CSB 4.12 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (4), cr. (4g), (4r) Register August 2014 No. 704, eff. 9-1-14; correction in (6) (b) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; EmR1706: emerg. am. (title), (1), r. (2), cr. (2m), r. and recr. (3), r. (4), (4g), (4r), (5), am. (6) (intro.), (a), cr. (6) (am), am. (6) (c), cr. (6) (cg), (cr), eff. 4-1-17; CR 17-028: am. (title), (1), r. (2), cr. (2m), r. and recr. (3), r. (4), (4g), (4r), (5), am. (6) (intro.), (a), cr. (6) (am), am. (6) (c), cr. (6) (cg), (cr), Register December 2017 No. 744, eff. 1-1-18; ; correction in (3) (b) made under s. 13.92 (4) (b) 7., Stats., December 2017 No. 744.

CSB 4.13 CSB 4.13 Confidentiality of PDMP records.

CSB 4.13(1) (1) The dispensing data, PDMP data, audit trails, monitored prescription drug history reports, and prescribing metrics reports maintained, created, or stored as a part of the program are not subject to inspection or copying under s. 19.35, Stats.

CSB 4.13(2) (2) A person who discloses or a person whose delegate discloses dispensing data, PDMP data, audit trails, monitored prescription drug history reports, or prescribing metrics reports in violation of s. 146.82 or 961.385, Stats., this chapter, or other state or federal laws or regulations relating to the privacy of patient health care records, may be referred to the appropriate licensing or regulatory board for discipline, or the appropriate law enforcement agency for investigation and possible prosecution if the board determines that a criminal violation may have occurred.

CSB 4.13 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction in (2) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; EmR1706: emerg. am., eff. 4-1-17; CR 17-028: am. Register December 2017 No. 744, eff. 1-1-18.

CSB 4.14 CSB 4.14 Exchange of PDMP data.

CSB 4.14(1) (1) The board may exchange monitored prescription drug history reports and PDMP data with a prescription monitoring program operated by a relevant agency in another state or jurisdiction if the prescription monitoring program satisfies all of the following conditions:

CSB 4.14(1)(a) (a) The prescription monitoring program is compatible with the program.

CSB 4.14(1)(b) (b) The relevant agency operating the prescription monitoring program agrees to exchange similar information with the program.

CSB 4.14(2) (2) In determining the compatibility of a prescription monitoring program to the program, the board may consider any of the following:

CSB 4.14(2)(a) (a) The safeguards for privacy of patient records and the prescription monitoring program’s success in protecting patient privacy.

CSB 4.14(2)(b) (b) The persons authorized to access the information stored by the prescription monitoring program.

CSB 4.14(2)(c) (c) The schedules of controlled substances monitored by the prescription monitoring program.

CSB 4.14(2)(d) (d) The information required by the agency to be submitted regarding the dispensing of a prescription drug.

CSB 4.14(2)(e) (e) The costs and benefits to the board of sharing information.

CSB 4.14(3) (3) The board may assess a prescription monitoring program’s continued compatibility with the program at any time.

CSB 4.14 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (1) (intro.) Register August 2014 No. 704, eff. 9-1-14; EmR1706: emerg. am. (title), (1) (intro.), eff. 4-1-17; CR 17-028: am. (title), (1) (intro.) Register December 2017 No. 744, eff. 1-1-18.

CSB 4.15 CSB 4.15 Disclosure of suspicious or critically dangerous conduct or practices.