House Study Bill 173 - Introduced HOUSE FILE _____ BY (PROPOSED COMMITTEE ON HUMAN RESOURCES BILL BY CHAIRPERSON FRY) A BILL FOR An Act relating to telepharmacy requirements, and including 1 effective date provisions. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 2645YC (3) 87 pf/rj

H.F. _____ Section 1. Section 155A.13, subsection 3, Code 2017, is 1 amended to read as follows: 2 3. a. The board may issue a special or limited-use pharmacy 3 license based upon special conditions of use imposed pursuant 4 to rules adopted by the board for cases in which the board 5 determines that certain requirements may be waived. 6 b. The board shall adopt rules for the issuance of issue a 7 special or limited-use pharmacy license to a telepharmacy site 8 that meets the minimum requirements established by the board by 9 rule . The rules shall address: 10 (1) Requirements for establishment and operation of a 11 telepharmacy site, including but not limited to physical 12 requirements and required policies and procedures. 13 (a) Telepharmacy site requirements for patient notification 14 shall require that a pharmacist speak with the patient over an 15 audiovisual link only when a new prescription is delivered to a 16 patient at a telepharmacy site, not when a prescription refill 17 is delivered to a patient. 18 (b) A telepharmacy site shall not be required to provide 19 services in addition to those otherwise required to be provided 20 by a licensed pharmacy. 21 (2) Requirements for being a managing pharmacy. 22 (3) Requirements governing operating agreements between 23 telepharmacy sites and managing pharmacies. The rules 24 shall require that a copy of the written contract, between 25 a telepharmacy site and a managing pharmacy that are not 26 jointly owned, shall be submitted to the board with the initial 27 application for licensure of the telepharmacy site and at any 28 time there is a substantial change in any of the terms of the 29 contract, but the written contract shall not be subject to 30 approval of the board. 31 (4) Training and experience required for certified pharmacy 32 technicians working at a telepharmacy site. The rules shall 33 require that before practicing in a telepharmacy site, a 34 certified pharmacy technician shall meet all of the following 35 -1- LSB 2645YC (3) 87 pf/rj 1/ 6

H.F. _____ requirements: 1 (a) Have successfully passed a pharmacy technician 2 certification examination accredited by the national commission 3 for certifying agencies. 4 (b) Have completed a minimum of two thousand hours of 5 practice experience as a certified pharmacy technician working 6 in a licensed pharmacy, at least one thousand hours of which 7 shall have been completed practicing in an Iowa-licensed 8 pharmacy and at least eighty hours of which shall have been 9 completed practicing in the managing pharmacy. 10 (5) Requirements for a pharmacist providing services to and 11 supervising a telepharmacy site. 12 (6) Any other health and safety concerns associated with 13 a telepharmacy site . including but not limited to all of the 14 following: 15 (a) With regard to monthly inspections, minimum on-site 16 pharmacist staffing shall be no less than eight hours per month 17 to adequately complete on-site inspections of the telepharmacy 18 site and to perform clinical services for patients. 19 (b) With regard to security, a telepharmacy site shall 20 employ methods to prevent unauthorized access to prescription 21 drugs, devices, and pharmacy and patient records. Such methods 22 may include an alarm system. Alarm systems and entry system 23 locks shall be disarmed when the telepharmacy site is staffed 24 and open to the public. Minimum security methods shall include 25 all of the following: 26 (i) The use of an electronic keypad or other electronic 27 entry system into the telepharmacy site or the pharmacy 28 department that requires and records the unique identification 29 of the individual accessing the telepharmacy site or pharmacy 30 department, including the date and time of access. Complete 31 access records shall be maintained for a minimum of two years 32 from the date of the access. 33 (ii) Secure storage such as a safe. 34 (iii) Controlled access to computer records. 35 -2- LSB 2645YC (3) 87 pf/rj 2/ 6

H.F. _____ (iv) A continuous system of video surveillance and 1 recording of the pharmacy department that includes maintenance 2 of recordings for a minimum of sixty days following the date 3 of the recording. 4 (c) (i) With regard to controlled substances, a 5 telepharmacy site that dispenses controlled substances shall 6 maintain a perpetual inventory record of the controlled 7 substances. 8 (ii) The perpetual inventory record format and other 9 requirements applicable to a pharmacy pursuant to rules adopted 10 by the board shall apply to the telepharmacy site’s perpetual 11 inventory record of controlled substances with the following 12 exceptions: 13 (A) The perpetual inventory record requirement shall apply 14 to all controlled substances maintained and dispensed by the 15 telepharmacy site and shall not be limited to only schedule II 16 controlled substances. 17 (B) Audit of the perpetual inventory record shall be 18 completed and the physical and perpetual inventories shall be 19 reconciled each month, rather than no less frequently than 20 annually, as part of the inspection of the telepharmacy site. 21 (d) With regard to verification of prescriptions, a 22 pharmacist shall verify a prescription before the prescription 23 is dispensed. 24 c. The board shall not issue a special or limited-use 25 pharmacy license to a proposed telepharmacy site if a licensed 26 pharmacy that dispenses prescription drugs to outpatients is 27 located within ten miles by the shortest driving distance of 28 the proposed telepharmacy site unless the 29 (1) A managing pharmacy shall not be required to demonstrate 30 to the board that there is a limited access to pharmacy 31 services in the community where the telepharmacy site is 32 located. However, if the distance between the proposed 33 telepharmacy site and the nearest currently licensed pharmacy 34 is less than ten miles, the board shall not issue a special or 35 -3- LSB 2645YC (3) 87 pf/rj 3/ 6

H.F. _____ limited-use pharmacy license to a proposed telepharmacy site 1 unless the managing pharmacy submits a request for a waiver of 2 the distance requirement. The distance requirement shall not 3 apply under any of the following circumstances: 4 (a) The proposed telepharmacy site is located on property 5 owned, operated, or leased by the state or unless the . 6 (b) The proposed telepharmacy site is located within a 7 hospital campus and is limited to inpatient dispensing. The 8 mileage requirement does not apply to a 9 (c) The telepharmacy site that has been was approved by the 10 board and is was operating as a telepharmacy prior to July 1, 11 2016. 12 d. An applicant seeking a special or limited-use pharmacy 13 license for a proposed telepharmacy site that does not meet the 14 mileage requirement established in paragraph “c” and is not 15 statutorily exempt from the mileage requirement may apply to 16 the board for a waiver of the mileage requirement. A waiver 17 request shall only be granted if the applicant can demonstrate 18 to the board that the proposed telepharmacy site is located in 19 an area where there is limited access to pharmacy services and 20 can establish the existence of compelling circumstances that 21 justify waiving the mileage requirement. 22 (2) The board’s decision to grant or deny a waiver request 23 shall be a proposed decision subject to mandatory review by 24 the director of public health. The director shall review a 25 proposed decision and shall have the power to approve, modify, 26 or veto a proposed decision. The director’s decision on a 27 waiver request shall be considered final agency action subject 28 to judicial review under chapter 17A . 29 e. The board shall issue a special or limited-use pharmacy 30 license to a telepharmacy site that meets the minimum 31 requirements established by the board by rule. 32 Sec. 2. EFFECTIVE UPON ENACTMENT. This Act, being deemed of 33 immediate importance, takes effect upon enactment. 34 EXPLANATION 35 -4- LSB 2645YC (3) 87 pf/rj 4/ 6

H.F. _____ The inclusion of this explanation does not constitute agreement with 1 the explanation’s substance by the members of the general assembly. 2 This bill relates to telepharmacy requirements. The bill 3 amends provisions relating to the issuance by the board of 4 pharmacy of a special or limited-use pharmacy license to a 5 telepharmacy site. The bill provides that if a telepharmacy 6 site meets the minimum requirements established by the board 7 by rule, the telepharmacy shall be issued the license. The 8 bill eliminates the prohibition against the board issuing 9 a license to an applicant seeking a special or limited-use 10 pharmacy license for a proposed telepharmacy site if a licensed 11 pharmacy that dispenses prescription drugs to outpatients is 12 located within 10 miles by the shortest driving distance of the 13 proposed telepharmacy site, unless the proposed telepharmacy 14 meets the conditions of one of the exemptions. Instead, the 15 bill provides that a managing pharmacy shall not be required 16 to demonstrate to the board that there is a limited access 17 to pharmacy services in the community where the telepharmacy 18 site is located, but that if the distance between the proposed 19 telepharmacy site and the nearest currently licensed pharmacy 20 is less than 10 miles, the board shall not issue a special or 21 limited-use pharmacy license to a proposed telepharmacy site 22 unless the managing pharmacy submits a request for a waiver of 23 the distance requirement. 24 The bill also addresses requirements for rules to be adopted 25 by the board of pharmacy, to include specific rules that are 26 to be adopted in the areas of: requirements for establishment 27 and operation of a telepharmacy site relating to patient 28 notification and the services required to be provided by a 29 telepharmacy; the written contract between a telepharmacy 30 site and a managing pharmacy, to provide that if they are not 31 jointly owned, the contract is not subject to approval of the 32 board of pharmacy; the requirements for a certified pharmacy 33 technician practicing in a telepharmacy; and health and 34 safety concerns associated with a telepharmacy site including 35 -5- LSB 2645YC (3) 87 pf/rj 5/ 6

H.F. _____ those relating to monthly inspections, security, controlled 1 substances, and verification of a prescription. 2 The bill takes effect upon enactment. 3 -6- LSB 2645YC (3) 87 pf/rj 6/ 6