HSB 173 (LSB 2645YC (3) 87)

HOUSE FILE _____ 

BY  (PROPOSED COMMITTEE ON HUMAN RESOURCES BILL BY CHAIRPERSON FRY)

A BILL FOR

An Act relating to telepharmacy requirements, and including effective date provisions.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  Section 155A.13, subsection 3, Code 2017, is amended to read as follows:
   3.  a.  The board may issue a special or limited-use pharmacy license based upon special conditions of use imposed pursuant to rules adopted by the board for cases in which the board determines that certain requirements may be waived.
   b.  The board shall adopt rules for the issuance of issue a special or limited-use pharmacy license to a telepharmacy site that meets the minimum requirements established by the board by rule. The rules shall address:
   (1)  Requirements for establishment and operation of a telepharmacy site, including but not limited to physical requirements and required policies and procedures.
   (a)  Telepharmacy site requirements for patient notification shall require that a pharmacist speak with the patient over an audiovisual link only when a new prescription is delivered to a patient at a telepharmacy site, not when a prescription refill is delivered to a patient.
   (b)  A telepharmacy site shall not be required to provide services in addition to those otherwise required to be provided by a licensed pharmacy.
   (2)  Requirements for being a managing pharmacy.
   (3)  Requirements governing operating agreements between telepharmacy sites and managing pharmacies.  The rules shall require that a copy of the written contract, between a telepharmacy site and a managing pharmacy that are not jointly owned, shall be submitted to the board with the initial application for licensure of the telepharmacy site and at any time there is a substantial change in any of the terms of the contract, but the written contract shall not be subject to approval of the board.
   (4)  Training and experience required for certified pharmacy technicians working at a telepharmacy site.  The rules shall require that before practicing in a telepharmacy site, a certified pharmacy technician shall meet all of the following requirements:
   (a)  Have successfully passed a pharmacy technician certification examination accredited by the national commission for certifying agencies.
   (b)  Have completed a minimum of two thousand hours of practice experience as a certified pharmacy technician working in a licensed pharmacy, at least one thousand hours of which shall have been completed practicing in an Iowa-licensed pharmacy and at least eighty hours of which shall have been completed practicing in the managing pharmacy.
   (5)  Requirements for a pharmacist providing services to and supervising a telepharmacy site.
   (6)  Any other health and safety concerns associated with a telepharmacy site. including but not limited to all of the following:
   (a)  With regard to monthly inspections, minimum on-site pharmacist staffing shall be no less than eight hours per month to adequately complete on-site inspections of the telepharmacy site and to perform clinical services for patients.
   (b)  With regard to security, a telepharmacy site shall employ methods to prevent unauthorized access to prescription drugs, devices, and pharmacy and patient records. Such methods may include an alarm system. Alarm systems and entry system locks shall be disarmed when the telepharmacy site is staffed and open to the public. Minimum security methods shall include all of the following: 
   (i)  The use of an electronic keypad or other electronic entry system into the telepharmacy site or the pharmacy department that requires and records the unique identification of the individual accessing the telepharmacy site or pharmacy department, including the date and time of access. Complete access records shall be maintained for a minimum of two years from the date of the access.
   (ii)  Secure storage such as a safe.
   (iii)  Controlled access to computer records.
   (iv)  A continuous system of video surveillance and recording of the pharmacy department that includes maintenance of recordings for a minimum of sixty days following the date of the recording. 
   (c)  (i)  With regard to controlled substances, a telepharmacy site that dispenses controlled substances shall maintain a perpetual inventory record of the controlled substances.
   (ii)  The perpetual inventory record format and other requirements applicable to a pharmacy pursuant to rules adopted by the board shall apply to the telepharmacy site’s perpetual inventory record of controlled substances with the following exceptions:
   (A)  The perpetual inventory record requirement shall apply to all controlled substances maintained and dispensed by the telepharmacy site and shall not be limited to only schedule II controlled substances.
   (B)  Audit of the perpetual inventory record shall be completed and the physical and perpetual inventories shall be reconciled each month, rather than no less frequently than annually, as part of the inspection of the telepharmacy site.
   (d)  With regard to verification of prescriptions, a pharmacist shall verify a prescription before the prescription is dispensed.
   c.  The board shall not issue a special or limited-use pharmacy license to a proposed telepharmacy site if a licensed pharmacy that dispenses prescription drugs to outpatients is located within ten miles by the shortest driving distance of the proposed telepharmacy site unless the
   (1)  A managing pharmacy shall not be required to demonstrate to the board that there is a limited access to pharmacy services in the community where the telepharmacy site is located. However, if the distance between the proposed telepharmacy site and the nearest currently licensed pharmacy is less than ten miles, the board shall not issue a special or limited-use pharmacy license to a proposed telepharmacy site unless the managing pharmacy submits a request for a waiver of the distance requirement. The distance requirement shall not apply under any of the following circumstances:
   (a)  The proposed telepharmacy site is located on property owned, operated, or leased by the state or unless the. 
   (b)  The proposed telepharmacy site is located within a hospital campus and is limited to inpatient dispensing. The mileage requirement does not apply to a 
   (c)  The telepharmacy site that has been was approved by the board and is was operating as a telepharmacy prior to July 1, 2016.
   d.  An applicant seeking a special or limited-use pharmacy license for a proposed telepharmacy site that does not meet the mileage requirement established in paragraph “c” and is not statutorily exempt from the mileage requirement may apply to the board for a waiver of the mileage requirement. A waiver request shall only be granted if the applicant can demonstrate to the board that the proposed telepharmacy site is located in an area where there is limited access to pharmacy services and can establish the existence of compelling circumstances that justify waiving the mileage requirement.
   (2)  The board’s decision to grant or deny a waiver request shall be a proposed decision subject to mandatory review by the director of public health. The director shall review a proposed decision and shall have the power to approve, modify, or veto a proposed decision. The director’s decision on a waiver request shall be considered final agency action subject to judicial review under chapter 17A.
   e.  The board shall issue a special or limited-use pharmacy license to a telepharmacy site that meets the minimum requirements established by the board by rule.
    Sec. 2.  EFFECTIVE UPON ENACTMENT.  This Act, being deemed of immediate importance, takes effect upon enactment.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill relates to telepharmacy requirements. The bill amends provisions relating to the issuance by the board of pharmacy of a special or limited-use pharmacy license to a telepharmacy site. The bill provides that if a telepharmacy site meets the minimum requirements established by the board by rule, the telepharmacy shall be issued the license. The bill eliminates the prohibition against the board issuing a license to an applicant seeking a special or limited-use pharmacy license for a proposed telepharmacy site if a licensed pharmacy that dispenses prescription drugs to outpatients is located within 10 miles by the shortest driving distance of the proposed telepharmacy site, unless the proposed telepharmacy meets the conditions of one of the exemptions. Instead, the bill provides that a managing pharmacy shall not be required to demonstrate to the board that there is a limited access to pharmacy services in the community where the telepharmacy site is located, but that if the distance between the proposed telepharmacy site and the nearest currently licensed pharmacy is less than 10 miles, the board shall not issue a special or limited-use pharmacy license to a proposed telepharmacy site unless the managing pharmacy submits a request for a waiver of the distance requirement. 
   The bill also addresses requirements for rules to be adopted by the board of pharmacy, to include specific rules that are to be adopted in the areas of: requirements for establishment and operation of a telepharmacy site relating to patient notification and the services required to be provided by a telepharmacy; the written contract between a telepharmacy site and a managing pharmacy, to provide that if they are not jointly owned, the contract is not subject to approval of the board of pharmacy; the requirements for a certified pharmacy technician practicing in a telepharmacy; and health and safety concerns associated with a telepharmacy site including those relating to monthly inspections, security, controlled substances, and verification of a prescription.
   The bill takes effect upon enactment.