WSR 18-07-102
[Filed March 20, 2018, 6:25 p.m., effective April 20, 2018]
Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-310-715, 246-310-720, 246-310-725 and 246-310-745, the adopted rules amend existing certificate of need percutaneous coronary intervention (PCI) program volume standards for institutions from three hundred to two hundred, and for individual practitioners from seventy-five to fifty to promote safe and effective elective PCI programs based on the most recent clinical research and literature.
Citation of Rules Affected by this Order: Amending WAC 246-310-715, 246-310-720, 246-310-725, and 246-310-745.
Statutory Authority for Adoption: RCW 70.38.135.
Other Authority: RCW 70.38.115.
Adopted under notice filed as WSR 18-01-097 on December 18, 2017.
A final cost-benefit analysis is available by contacting Katherine Hoffman, 111 Israel Road S.E., P.O. Box 47852, Tumwater, WA 98501, phone 360-236-2979, fax 360-236-2321, TTY 360-833-6388 or 711, email, web site
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 4, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 4, Repealed 0.
Date Adopted: March 13, 2018.
John Wiesman, DrPH, MPH
AMENDATORY SECTION (Amending WSR 09-01-113, filed 12/19/08, effective 12/19/08)
WAC 246-310-715 General requirements.
The applicant hospital must:
(1) Submit a detailed analysis of the impact that their new adult elective PCI services will have on the Cardiovascular Disease and Interventional Cardiology Fellowship Training programs at the University of Washington, and allow the university an opportunity to respond. New programs may not reduce current volumes at the University of Washington fellowship training program.
(2) Submit a detailed analysis of the projected volume of adult elective PCIs that it anticipates it will perform in years one, two and three after it begins operations. All new elective PCI programs must comply with the state of Washington annual PCI volume standards of (((three)) two hundred) by the end of year three. The projected volumes must be sufficient to assure that all physicians working only at the applicant hospital will be able to meet volume standards of ((seventy-five)) fifty PCIs per year. If an applicant hospital fails to meet annual volume standards, the department may conduct a review of certificate of need approval for the program under WAC 246-310-755.
(3) Submit a plan detailing how they will effectively recruit and staff the new program with qualified nurses, catheterization laboratory technicians, and interventional cardiologists without negatively affecting existing staffing at PCI programs in the same planning area.
(4) Maintain one catheterization lab used primarily for cardiology. The lab must be a fully equipped cardiac catheterization laboratory with all appropriate devices, optimal digital imaging systems, life sustaining apparati, intra-aortic balloon pump assist device (IABP). The lab must be staffed by qualified, experienced nursing and technical staff with documented competencies in the treatment of acutely ill patients.
(5) Be prepared and staffed to perform emergent PCIs twenty-four hours per day, seven days per week in addition to the scheduled PCIs.
(6) If an existing CON approved heart surgery program relinquishes the CON for heart surgery, the facility must apply for an amended CON to continue elective PCI services. The applicant must demonstrate ability to meet the elective PCI standards in this chapter.
AMENDATORY SECTION (Amending WSR 09-01-113, filed 12/19/08, effective 12/19/08)
WAC 246-310-720 Hospital volume standards.
(1) Hospitals with an elective PCI program must perform a minimum of ((three)) two hundred adult PCIs per year by the end of the third year of operation and each year thereafter.
(2) The department shall only grant a certificate of need to new programs within the identified planning area if:
(a) The state need forecasting methodology projects unmet volumes sufficient to establish one or more programs within a planning area; and
(b) All existing PCI programs in that planning area are meeting or exceeding the minimum volume standard.
AMENDATORY SECTION (Amending WSR 09-01-113, filed 12/19/08, effective 12/19/08)
WAC 246-310-725 Physician volume standards.
Physicians performing adult elective PCI procedures at the applying hospital must perform a minimum of ((seventy-five)) fifty PCIs per year. Applicant hospitals must provide documentation that physicians performed ((seventy-five)) fifty PCI procedures per year for the previous three years prior to the applicant's CON request.
AMENDATORY SECTION (Amending WSR 09-01-113, filed 12/19/08, effective 12/19/08)
WAC 246-310-745 Need forecasting methodology.
For the purposes of the need forecasting method in this section, the following terms have the following specific meanings:
(1) "Base year" means the most recent calendar year for which December 31 data is available as of the first day of the application submission period from the department's CHARS reports or successor reports.
(2) "Current capacity" means the sum of all PCIs performed on people (aged fifteen years of age and older) by all ((CON)) certificate of need approved adult elective PCI programs, or department grandfathered programs within the planning area. To determine the current capacity for those planning areas where a new program has operated less than three years, the department will measure the volume of that hospital as the greater of:
(a) The actual volume; or
(b) The minimum volume standard for an elective PCI program established in WAC 246-310-720.
(3) "Forecast year" means the fifth year after the base year.
(4) "Percutaneous coronary interventions" means cases as defined by diagnosis related groups (DRGs) as developed under the Centers for Medicare and Medicaid Services (CMS) contract that describe catheter-based interventions involving the coronary arteries and great arteries of the chest. The department will exclude all pediatric catheter-based therapeutic and diagnostic interventions performed on persons fourteen years of age and younger are excluded. The department will update the list of DRGs administratively to reflect future revisions made by CMS to the DRG to be considered in certificate of need definitions, analyses, and decisions. The DRGs for calendar year 2008 applications will be DRGs reported in 2007, which include DRGs 518, 555, 556, 557 and 558.
(5) "Use rate" or "PCI use rate," equals the number of PCIs performed on the residents of a planning area (aged fifteen years of age and older), per one thousand persons.
(6) "Grandfathered programs" means those hospitals operating a certificate of need approved interventional cardiac catheterization program or heart surgery program prior to the effective date of these rules, that continue to operate a heart surgery program. For hospitals with jointly operated programs, only the hospital where the program's procedures were approved to be performed may be grandfathered.
(7) The data sources for adult elective PCI case volumes include:
(a) The comprehensive hospital abstract reporting system (CHARS) data from the department, office of hospital and patient data;
(b) The department's office of certificate of need survey data as compiled, by planning area, from hospital providers of PCIs to state residents (including patient origin information, i.e., patients' zip codes and a delineation of whether the PCI was performed on an inpatient or outpatient basis); and
(c) Clinical outcomes assessment program (COAP) data from the foundation for health care quality, as provided by the department.
(8) The data source for population estimates and forecasts is the office of financial management medium growth series population trend reports or if not available for the planning area, other population data published by well-recognized demographic firms.
(9) The data used for evaluating applications submitted during the concurrent review cycle must be the most recent year end data as reported by CHARS or the most recent survey data available through the department or COAP data for the appropriate application year. The forecasts for demand and supply will be for five years following the base year. The base year is the latest year that full calendar year data is available from CHARS. In recognition that CHARS does not currently provide outpatient volume statistics but is patient origin-specific and COAP does provide outpatient PCI case volumes by hospitals but is not currently patient origin-specific, the department will make available PCI statistics from its hospital survey data, as necessary, to bridge the current outpatient patient origin-specific data shortfall with CHARS and COAP.
(10) Numeric methodology:
Step 1. Compute each planning area's PCI use rate calculated for persons fifteen years of age and older, including inpatient and outpatient PCI case counts.
(a) Take the total planning area's base year population residents fifteen years of age and older and divide by one thousand.
(b) Divide the total number of PCIs performed on the planning area residents over fifteen years of age by the result of Step 1 (a). This number represents the base year PCI use rate per thousand.
Step 2. Forecasting the demand for PCIs to be performed on the residents of the planning area.
(a) Take the planning area's use rate calculated in Step 1 (b) and multiply by the planning area's corresponding forecast year population of residents over fifteen years of age.
Step 3. Compute the planning area's current capacity.
(a) Identify all inpatient procedures at ((CON)) certificate of need approved hospitals within the planning area using CHARS data;
(b) Identify all outpatient procedures at ((CON)) certificate of need approved hospitals within the planning area using department survey data; or
(c) Calculate the difference between total PCI procedures by ((CON)) certificate of need approved hospitals within the planning area reported to COAP and CHARS. The difference represents outpatient procedures.
(d) Sum the results of (a) and (b) or sum the results of (a) and (c). This total is the planning area's current capacity which is assumed to remain constant over the forecast period.
Step 4. Calculate the net need for additional adult elective PCI procedures by subtracting the calculated capacity in Step 3 from the forecasted demand in Step 2. If the net need for procedures is less than ((three)) two hundred, the department will not approve a new program.
Step 5. If Step 4 is greater than ((three)) two hundred, calculate the need for additional programs.
(a) Divide the number of projected procedures from Step 4 by ((three)) two hundred.
(b) Round the results down to identify the number of needed programs. (For example: ((575/300 = 1.916)) 375/200 = 1.875 or 1 program.)