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S.F. No. 1484 - Licensing Provisions (2nd Engrossment)
 
Author: Senator Kathy Sheran
 
Prepared By:
 
Date: April 28, 2014



 

ARTICLE 1

HEALTH-RELATED LICENSING BOARDS

Section 1 (148.261) authorizes the Board of Nursing to bring disciplinary action against a licensee who has been discharged from the Health Professionals Services Program or any other alternative monitoring or diversion program for reasons other than satisfactory completion of the program.

Section 2 (148.261, subd. 1a) requires the Board of Nursing to deny a license or automatically revoke a license if the applicant or licensee has been convicted of a felony level criminal sexual conduct offense.

Section 3 (148.261, subd. 4) makes a technical change.

Sections 4, 5, 6, 8, 9, 10, 13 (150A.01, subd. 8a; 150A.06, subd. 1; 150A.06, subd. 1a;) removes reference to the American Dental Association when referring to the Commission on Dental  Accreditation.

Section 7 (150A.06, subd. 1c) permits the Board of Dentistry to grant one or more specialty licenses and makes conforming changes.

Section 11 (150A.06, subd. 2d) clarifies that the CPR certification must be from the American Heart Association health care provider course or the American Red Cross.

Section 12 (150A.06, subd. 3) eliminates the ability of the Board of Dentistry to waive the clinical examination for an applicant who meets the other requirements and has satisfactorily completed an accredited postdoctoral general dentistry residency program located outside of Minnesota.

Section 14 (150A.091, subd. 3) eliminates the ability to submit a separate prorated initial license or permit fee.

Section 15 (150A.091, subd. 8) makes a wallet size license and renewal certificate available for $15.

Section 16 (150A.091, subd. 16) increases the fee that a licensee would be charge if the licensee failed two professional development portfolio audits (currently the fee cannot exceed $250 if the licensee fails two consecutive audits).  Also authorizes the board to initiate a complaint process to address multiple failed audits.

Section 17 (150A.10) makes minor changes to the allied dental personnel section.

Subd. 1a clarifies that the CPR certification for a restorative dental hygienist must be from the American Heart Association healthcare provider course or the American Red Cross professional rescuer course.

Subd. 2 makes a technical change.

Subd. 4 includes the restorative procedures that certain dental hygienists and dental assistants can perform the ability to place, contour, and adjust class II supragingival composite restorations on primary teeth.

Section 18 (214.09) increases the compensation rate to $75 a day for members of health-related licensing boards when conducting board activities.  (Currently the rate is $55 a day.)

Section 19 (214.32) authorizes health-related licensing boards to temporarily suspend the license of any licensee who has been discharged from the health professionals services program based on allegations that the regulated person has engaged in conduct that might cause risk to the public.  The license may be suspended until the completion of a disciplinary investigation.  If the board suspends alliance, the board is required to complete the investigation within 60 days of receiving the report of discharge from the health professionals services program, unless the licensee requests a delay in the proceedings in which case the license will be suspended until completion of the investigation.

Section 20 (214.330, subd. 3) requires the program manager of the Health Professional Services Program to report to the appropriate health licensing board a regulated person who:

  1. is discharged from the program, except upon successful completion of the program;
  2. is subject to the provisions of section 214.17 to 214.25;
  3. causes identifiable patient harm;
  4. unlawfully substitutes or adulterates medications;
  5. writes a prescription in the name of a person other than the prescriber, or a veterinary patient for the personal use of the prescriber;
  6. alters a prescription for the purpose of obtaining a drug for personal use; or
  7. unlawfully uses a controlled or mood-altering substance or uses alcohol while providing patient care or otherwise on duty, if current use is the reason for participation in the program or the use occurs while the person is participating in the program.

Section 21 (364.09) specifies that chapter 364 does not apply to any license that has been denied or revoked by the Board of Nursing due to a conviction of a felony-level criminal sexual conduct offense.

Section 22 appropriates money to the health-related licensing boards for the increase in board member compensation and the Board of Nursing for licensing activities.

ARTICLE 2

BOARD OF PHARMACY

Section 1 (151.01) modifies the definitions of pharmacy, drug, director, commercial purposes, manufacturing, manufacturer, pharmacist intern, prescription drug order, legend drug, label, pharmacist in charge, legend drug, label, practitioner, practice of pharmacy, veterinary legend drug, legend medical gas, and. dispense or dispensing.  This section also adds the following new definitions:  prescription, chart order, protocol, collaborative practice, collaborative practice agreement, compounding, anticipatory compounding, extemporaneous compounding, and compounding positron emission tomography drug.

Section 2 (151.06) modifies the duties of the Board of Pharmacy.  Creates the ability to issue a cease and desist order and to enforce any cease and desist orders.

Section 3 (151.071) creates a new section that specifies disciplinary action, grounds for disciplinary action, automatic suspension, conditions on a reissued license, temporary suspension of license, evidence, mental examination and access to medical data, tax clearance certificate, and limitations on board proceedings.

Section 4 (151.072) establishes reporting requirements for persons who have knowledge of conduct that may be grounds for disciplinary action, pharmacies employing pharmacists, pharmacist interns, or pharmacy technicians; for licensees and registrants who have personal knowledge of any conduct by another licensee or registrant that may be grounds for disciplinary action; and for licensees to self-report to the board any personal action that would require a report be filed with the board.  Establishes deadlines for reporting and gives the board subpoena power for the reduction of reports or related documents.

Section 5 (151.073) provides immunity from civil liability for any person, facility, business or organization that makes a good faith report to the board alleging violations of this chapter.  This section also classifies the reports as investigative data.  This section also provides immunity from civil and criminal liability for any board member, board employee, or person who, within the scope of their duties, is participating or testifying regarding violations of this chapter.  Individuals who maintain records or make reports regarding adverse care events are immune from criminal and civil liability.

Section 6 (151.074) requires licensees and registrants to cooperate with the board if they are the subject of a board investigation.  Requires the board to maintain any records obtained pursuant to this section as investigative data.

Section 7 (151.075) requires the court reviewing any board disciplinary action taken under this chapter to seal the administrative record with the exception of the board’s final decision.

Section 8 (151.211) requires prescription drug orders to be retained at the location that dispensed the drug for at least two years.  This section also requires prescription drugs orders that are electronically prescribed to be kept on file in the format that they were received.  Requires electronic systems used to process and store prescription drug orders to be compliant with this chapter.  Prescription orders that are stored electronically may be stored in an electronic format and kept on file at a remote location provided the location is readily and securely accessible.  This section also adds electronic prescriptions to the refill requirements of this chapter.

Section 9 (151.251) establishes compounding requirements.

Subdivision 1 specifies that the manufacturing licensure requirements do not apply to a practitioner or a pharmacy when a pharmacist is engaged in extemporaneous compounding, anticipatory compounding, or compounding not done pursuant to a prescription drug order when permitted by this chapter.

Subdivision 2 specifies the circumstances under which a drug product may be compounded by a practitioner or pharmacist.

Subdivision 3 specifies that this section does not apply to compounded positiron emission tomography drugs or radiopharmaceuticals.

Section 10 (151.252, subd.1a) requires any person seeking to act as an outsourcing facility to apply and obtain a license from the board and pay the applicable manufacturer licensing fee.  This section also requires the facility to provide the board with proof that the outsourcing facility is registered with the FDA and in compliance with all laws and rules; requires a facility that is physically located in other states to be licensed or registered in that state; requires a separate license for each outsourcing facility; and requires the facility to pass an inspection conducted by a representative of the board.

Section 11 (151.34) Clarifies that this chapter does not apply to or interfere with the dispensing of a legend drug, including a controlled substance, that is packaged by the manufacturer and provided to the dispenser for dispensing as a professional sample, so long as the federal regulations are followed.  This section also states that the exceptions provided in this section do not apply to any compound or substance that is not approved for human consumption by the FDA or under Minnesota law, and that when introduced into the body induces a similar effect as a Schedule I or II controlled substance, regardless of whether the substance is marketed for human consumption.

Section 12 (151.34) makes it unlawful to sell any compound, substance, or derivative that is not approved for human consumption by the FDA or specifically permitted for human consumption under Minnesota law if when introduced into the body induces an effect similar to that of a Schedule I or II controlled substance.

Section 13 (151.35) states that a drug shall be considered adulterated if it is produced in a facility that was not registered by the FDA or licensed by the board.

Section 14 (151.361, subd. 2) strikes obsolete language.

Section 15 (151.37) makes a number of changes to this section regarding who may prescribe and possess prescription drugs.

Subdivision 2 makes a conforming change to prescription drug orders. 

Subdivision 4 specifies that a pharmacy may compound drugs for research studies if applicable standards regarding nonsterile and sterile compounding are followed. 

Subdivision 10a specifies that this chapter does not prohibit the purchase, possession, or use of a legend drug by an entity acting in accordance with an emergency use authorization issued by the FDA if the entity is specifically assigned in a public health response plan to perform critical functions necessary to perform critical functions necessary to support the response to a public health incident or event.

Subdivision 11 specifies that this section does not prohibit an accredited public or private postsecondary school from possessing a legend drug that is not a controlled substance listed in section 152.02, provided that certain factors are met.

Section 16 (151.44) modifies “repackers” to “repackagers” and the definition of “manufacturers” to refer to the meaning in section 151.01.

Section 17 (151.58, subd. 2) modifies the definition of “health care facility” by striking “community behavioral health hospital” within the automated drug distribution system section.

Section 18 (151.58, subd. 3) specifies that a pharmacy may use an automated drug distribution system to fill prescription drugs for patients of a health care facility provided that the policies and procedures required by this section are approved by the board.

Section 19 (151.58, subd. 5) specifies that a pharmacist employed by or working at a pharmacy that is acting as a central services pharmacy for the managing pharmacy may review, interpret, and approve all prescription drug orders before a drug is distributed from an automated drug distribution system.

Section 20 (152.02, subd. 2) adds several synthetic drugs to the Schedule I controlled substances list.

Section 21 (152.02, subd. 8b) under current law, the board may use expedited rulemaking to add a substance to the Schedule I list if that substance has a high potential of being abused, has no accepted medical use, lacks an accepted safety use under medical supervision, has unknown adverse health effects, and is currently available for use within the state.  This section strikes the language that states that the scheduling of such a substance expires the day after the adjournment of the legislative session, immediately following the substance’s scheduling, unless the legislature ratifies the addition by law.  This section also strikes the language that requires the board to notify the appropriate chairs and ranking minority members of the action and the reason for it.  This section also strikes the expiration date for the subdivision thereby permitting the board through expedited rulemaking to add certain substances to the Schedule I list.

Section 22 (152.126 subd. 1) changes the name of the program to the Prescription Monitoring  Program.  Also makes the following changes to the definitions of the program:

Adds to the definition of “controlled substances” for purposes of this program, tramadol and butalbital.

Excludes a licensed pharmacy located on the same premises as a residential hospice when the pharmacy is dispensing   controlled substances to residents of the hospice. 

Adds veterinarians to the definition of “prescriber.”

Subdivision 3 gives the board the authority to convene an advisory task force changing it from a requirement.  Also adds to the task force a representative of medical examiners and coroners.  Also requires the task force to advise the board on criteria for the unsolicited provision of prescription monitoring data by the board to prescribers and dispensers, and on the annual evaluation of drugs of concern that may warrant being reported to the program.  Specifies that the task force expiration and that the compensation and removal of the members are controlled under section 15.059.

Subdivision 4 specifies that a dispenser is not required to submit the required data for controlled substance prescriptions dispensed for individuals residing in a health care facility when a drug is distributed through an automated drug distribution system and individuals receiving a drug sample that was packaged by a manufacturer and provided to the dispenser for dispensing as a professional sample.   Requires a dispenser to submit data for those prescription drugs dispensed for individuals residing in licensed skilled nursing and intermediate care facilities; individuals receiving assisted living services under chapter 144G or through a medical assistance home and community based waiver;  individuals receiving medication intravenously; individuals receiving hospice and other palliative or end of life care; and individuals receiving services from a home care provider regulated under chapter 144G.

Subdivision 5 specifies that a state or federal occupational licensing board or agency may not access the database for the purpose of obtaining information to be used to initiate or substantiate a disciplinary action against a prescriber if the disciplinary action related to allegations involving unusual or excessive prescribing of the drugs for which data is collected.  Permits the data to be used after the 12-month period by certain permissible users for the purposes of administering, operating, and maintaining the program and conducting trend analyses and other studies necessary to evaluate the effectiveness of the program.  States that the board may not retain the data reported for a period longer than 5 years from the date the data was received by the board.

Subdivision 6, paragraph (b), makes changes to who is a permissible user and may access the data by including the following:  a prescriber to the extent the data relates to a current patient to whom the prescriber is providing other medical treatment for which access to the data may be necessary; a dispenser to the extent the data relates to a current patient to whom that dispenser is providing other pharmaceutical care for which access to the data may be necessary; a licensed pharmacist who is providing pharmaceutical care for which access to the data may be necessary or when consulted by a prescriber who is requesting data; personnel of a health-related licensing board or the emergency medical services regulatory board assigned to conduct a bona fide investigation of a complaint received by that board that alleges that a licensee is impaired by use of a drug for which data is collected, has engaged in activity that would constitute a crime under section 152.025, or has engaged in the behavior specified in section 151.126, subdivision 5, paragraph (a); a coroner or medical examiner conducting an investigation; personnel of the health professionals services program to the extent the data relates to an individual who is enrolled and being monitored by the program, but cannot be provided to a health-related licensing board, except as permitted under section 214.33, subdivision 3.

Strikes paragraph (e) that specified that the board cannot release the name of a prescriber without the written consent of the prescriber.

Paragraph (f) specifies that the board is required to maintain a log of all persons who access the data for a period of at least three years.

Adds a new paragraph authorizing the board to participate in an interstate prescription monitoring program data exchange system under certain conditions.

Adds a new paragraph permitting the board to provide data for public research, policy, or education purposes, but only if information that identifies the patient, prescriber, and dispenser has been removed.

Subdivision 8 is repealed (evaluation and reporting requirement that was required to be submitted to the legislature by July 15, 2011).

Subdivision 10 adds the Board of Veterinary Medicine to the health-related licensing boards in which the administrative services unit apportions the cost to the board for operating the program.

Section 23 requires the Board of Pharmacy to study the issue of mandatory use of the prescription monitoring program data base and report to the legislature by December 15, 2014, with recommendations on whether or not to (1) require the use of the database by prescribers when prescribing or considering to prescribe, and pharmacists when dispensing or considering dispensing a controlled substance; and (2) allow the use of the database to identify potentially inappropriate prescribing of controlled substances.

Section 24 appropriates money to the Board of Pharmacy for cease and desist authority and the prescription monitoring program.

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