WSR 16-15-053 PROPOSED RULES DEPARTMENT OF HEALTH [Filed July 15, 2016, 11:34 a.m.]
Original Notice.
Title of Rule and Other Identifying Information: WAC 246-907-0302 Hospital pharmacy associated clinics—Fees and renewal cycle (new), proposing new fees to cover the costs of regulation and inspection of hospital pharmacy licenses that include individual practitioner offices and multi-practitioner clinics owned, operated or under the common control of a hospital. The proposed rule is needed to implement SSB 6558 (chapter 118, Laws of 2016). The pharmacy quality assurance commission (commission) is adopting licensing rules for this new subcategory of hospital pharmacy licenses under a separate rule making.
Hearing Location(s): Department of Health, Town Center 2, 111 Israel Road S.E., Room 158, Tumwater, WA 98501, on August 23, 2016, at 1:00 p.m.
Date of Intended Adoption: August 30, 2016.
Submit Written Comments to: Sherry Thomas, Policy Coordinator, Washington State Department of Health, P.O. Box 47850, Olympia, WA 98504-7850, e-mail https://fortress.wa.gov/doh/policyreview, fax (360) 236-4626, by August 23, 2016.
Assistance for Persons with Disabilities: Contact Sherry Thomas by August 9, 2016, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will allow the department of health (department) and commission to cover credentialing, inspection and other costs of regulation for hospital pharmacy associated clinics (HPAC) that receive drugs transferred from the parent hospital pharmacy. The rule creates two fee categories: One for clinics that receive drugs but do not perform compounding; and one for clinics that receive drugs and perform sterile or nonsterile compounding. The categories and fee amounts were developed in coordination with the commission and affected stakeholders.
Reasons Supporting Proposal: The proposed rule sets the parent hospital pharmacy licensing fees for HPACs that are necessary to implement SSB 6558. RCW 43.70.250 requires the department to set license fees at sufficient levels to defray the costs of the licensing program. The proposed fees cover the estimated costs of administering the new credentials based on the level of work required for each category of HPAC, which includes inspection, discipline, and credentialing costs. The department plans to monitor revenues and expenditures for this new license subcategory to determine if future adjustments are needed.
Statutory Authority for Adoption: RCW 43.70.250.
Statute Being Implemented: SSB 6558 (chapter 118, Laws of 2016).
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of health, governmental.
Name of Agency Personnel Responsible for Drafting: Sherry Thomas, 111 Israel Road S.E., Tumwater, WA 98503, (360) 236-4692; Implementation and Enforcement: Steven Saxe, 111 Israel Road S.E., Tumwater, WA 98503, (360) 236-2903.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(f), a small business economic impact statement is not required for proposed rules that set or adjust fees or rates pursuant to legislative standards.
A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 (5)(b)(vi) exempts rules that set or adjust fees or rates pursuant to legislative standards.
July 15, 2016
John Wiesman, DrPH, MPH
Secretary
NEW SECTION
WAC 246-907-0302 Hospital pharmacy associated clinics licensing periods and fees—Fees and renewal cycle.
(1) Parent hospital pharmacy licenses with one or more hospital pharmacy associated clinics (HPAC) expire on June 1st of each year.
(2) A parent hospital pharmacy must submit fees for HPACs in addition to fees set in WAC 246-907-030(4). HPAC fees are due annually, except as provided under subsection (3)(d) of this section.
(3) A parent hospital pharmacy must submit the following nonrefundable fees based on category and number of HPACs as defined in WAC 246-873A-020(3) added to the parent hospital pharmacy license.
(a) Category 1 HPAC. A parent hospital pharmacy must submit the Category 1 HPAC fee according to the number of Category 1 HPACs under the parent hospital pharmacy license.
(b) Category 2 HPAC. A parent hospital pharmacy must submit the Category 2 HPAC fee for each Category 2 HPAC under the parent hospital pharmacy license.
(c) The department charges a processing fee of fifty-five dollars for an amended license to change the number of HPACs.
(d) If at any time a parent hospital pharmacy submits an addendum increasing the number of HPACs on the parent hospital pharmacy license, which changes the applicable HPAC tier to a higher fee amount, the parent hospital pharmacy shall submit the difference in fees with the addendum.
(e) The department will not refund fees when a tier reduction occurs between renewal periods.
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