Current through Register Vol. 24-18, September 15, 2024
(1) A pediatric cardiac surgery and
interventional treatment center is a hospital providing comprehensive pediatric
cardiology care, including medical and surgical diagnosis and
treatment.
(2) Pediatric cardiac
surgery and interventions includes, but is not limited to: All pediatric
surgery of the heart (excluding organ transplantation) and the great vessels in
the chest; all pediatric catheter-based nonsurgical therapeutic and diagnostic
interventions in the heart and great vessels in the chest; and invasive
pediatric electrophysiologic procedures.
(3) Pediatric cardiac surgery and
interventional procedure is a tertiary service as listed in WAC
246-310-020. To be granted a
certificate of need for a pediatric cardiac surgery and interventional
treatment center, a hospital must meet the standards in this section in
addition to applicable review criteria in WAC
246-310-210,
246-310-220,
246-310-230, and
246-310-240.
(4) The department must review new pediatric
cardiac surgery and interventional center applications using the concurrent
review cycle in this section.
(a) Applicants
must submit letters of intent between the first working day and last working
day of August of each year.
(b)
Initial applications must be submitted between the first working day and last
working day of September of each year.
(c) The department shall screen initial
applications for completeness by the last working day of October of each
year.
(d) Responses to screening
questions must be submitted by the last working day of November of each
year.
(e) The public review and
comment period for applications begins on December 16 of each year. If December
16 is not a working day in any year, then the public review and comment period
begins on the first working day after December 16.
(f) The public comment period is limited to
ninety days, unless extended according to the provisions of WAC
246-310-120(2)(d).
The first sixty days of the public comment period shall be reserved for
receiving public comments and conducting a public hearing, if requested. The
remaining thirty days shall be for the applicant or applicants to provide
rebuttal statements to written or oral statements submitted during the first
sixty-day period. Any interested person that:
(i) Is located or resides within the
applicant's health service area;
(ii) Testified or submitted evidence at a
public hearing; and
(iii) Requested
in writing to be informed of the department's decision, must also be provided
the opportunity to provide rebuttal statements to written or oral statements
submitted during the first sixty-day period.
(g) The final review period is limited to
sixty days, unless extended according to the provisions of WAC
246-310-120.
(5) The department may convert the review of
an application that was initially submitted under the concurrent review cycle
to a regular review process if the department determines that the application
does not compete with another application.
(6) Any letter of intent or certificate of
need application submitted for review in advance of this schedule, or
certificate of need application under review as of the effective date of this
section, shall be held by the department for review according to the schedule
in this section.
(7) Standards.
(a) A minimum of one hundred pediatric
cardiac surgical procedures (seventy-five with extracorporeal circulation) per
year and a minimum of one hundred fifty catheterizations must be performed at a
hospital with a pediatric cardiac surgery and interventional treatment center
by the third year of operation and each year thereafter.
(b) Hospitals applying for a pediatric
cardiac surgery and interventional center certificate of need must demonstrate
that they can meet one hundred ten percent of the minimum volume standards. The
applicant hospital must provide data from CHARS demonstrating:
(i) The zip codes served by the applying
hospital;
(ii) The percentage of
the total hospital admissions for children ages zero through nineteen served by
the applying hospital in each of the applicable zip codes during the most
recent available three years data. Expired patients will not be
counted;
(iii) The number of
pediatric heart surgeries, number of therapeutic and diagnostic interventions
and invasive electrophysiologic procedures performed in these zip codes during
the most recent available three years data. The percentage established in
(b)(ii) of this subsection shall then be applied to the number of pediatric
heart surgeries, interventions and invasive electrophysiologic procedures. This
number must be equal to or greater than one hundred ten percent of the minimum
volume standards.
(c)
The department will not grant a certificate of need to a new center if:
(i) The new center will reduce any existing
center below one hundred ten percent of any one of the minimum volume
standards; or
(ii) Reduces the
volumes of any existing center that has not yet met any one of the minimum
volume standards; or
(iii) Fails to
meet any one of the center's minimum volume standards.
(d) At time of initiating the program, and
thereafter, the director of the pediatric cardiac surgery and interventional
center must be a U.S. board certified pediatric cardiologist.
(e) At time of initiating the program, and
thereafter, pediatric cardiac surgery and interventional centers must have at
least two U.S. board certified or board eligible cardiac surgeons on the staff.
At least one of the required surgeons must be certified by the American Board
of Thoracic Surgery. Board eligible status must not extend beyond five
years.
(f) The program must provide
twenty-four hour coverage.
(g)
Hospitals with a pediatric cardiac surgery and interventional center must have
plans for facilitating emergency access to heart surgery services at all times
for the population they serve. These plans should, at minimum, include
arrangements for addressing peak volume periods (such as joint agreements with
other programs, the capacity to temporarily increase staffing, etc.), and the
maintenance of or affiliation with emergency transportation services (including
contingency plans for poor weather and known traffic congestion
problems).
(h) Hospitals with a
pediatric cardiology surgery and interventional center must provide a copy of
the hospital's QI plan that includes/incorporates a section specific to the
pediatric cardiac surgery and interventional center.
(i) If a certificate of need is issued, it
will be conditioned, at a minimum, to require ongoing compliance with the
certificate of need standards. Failure to meet the conditioned standards may be
grounds for revocation or suspension of a hospital's certificate of need, or
other appropriate licensing or certification action.
(j) In the event two or more centers are
competing to meet the same forecasted net need, the department shall consider
the following factors when determining which proposal best meets forecasted
need:
(i) The most appropriate improvement in
geographic access;
(ii) The most
cost efficient service;
(iii)
Minimizing impact on existing programs;
(iv) Providing the greatest breadth and depth
of pediatric cardiovascular and support services; and
(v) Facilitating emergency access to
care.
(k) Hospitals
granted a certificate of need have three years from the date of initiating the
program to meet the center procedure volume standards.
(l) These standards should be reevaluated
every three years.
(8)
Need forecasting method. The data used for evaluating applications submitted
during the concurrent review cycle will be the most recent three years CHARS
data available at the close of the application submittal period for that review
cycle. Separate forecasts are to be made for heart surgery, interventions and
electrophysiological procedures.
(a) Step 1.
Compute the planning area's current capacity. When a new center is being
established, the assumed volume of that center will be the greater of the
actual volume or the minimum volume standards or the estimated volumes
described in the approved application, including any adjustments made by the
department in the course of review and approval.
(b) Step 2. Compute the percent of
out-of-state use of the area's hospitals.
(c) Step 3. Compute the planning area's
average age-specific use rates.
(d)
Step 4. Multiply the planning area's age-specific use rates by the area's
corresponding forecast year population. The sum of these figures equals the
forecasted number of pediatric cardiac surgical and interventional procedures
expected to be performed on Washington pediatric residents.
(e) Step 5. Increase the number of pediatric
cardiac surgical and interventional procedures expected to occur within the
planning area in accordance with the percent of procedures calculated as
occurring in those hospitals on out-of-state residents, based on the average of
the last three years. This figure equals the total forecasted number of
procedures expected to occur within the hospital's planning area.
(f) Step 6. Calculate the net need for
additional pediatric cardiac centers by subtracting the current capacity from
the total forecasted pediatric cardiac surgical and interventional
procedures.
(g) Step 7. The
department will not grant a certificate of need for a new center if the need is
less than the minimum volume standards. An exception may be made and a
certificate of need granted if (g)(i) and (ii) of this subsection can be met:
(i) The applying hospital can meet all the
other certificate of need criteria for a pediatric cardiac surgery and
interventional treatment center (including documented evidence of capability of
achieving the minimum volume standard); and
(ii) At least eighty percent of the results
identified in subsection (7)(b)(iii) of this section for pediatric cardiac
services received pediatric cardiac services more than seventy-five miles
away.
(9) For
the purposes of the forecasting method in this section, the following terms
have the following specific meanings:
(a)
Age-specific categories. The categories used in computing age-specific values
will be zero through fourteen, fifteen through nineteen year olds.
(b) Current capacity. The planning area's
current capacity for pediatric cardiac surgical and interventional procedures
equals the sum of the highest reported annual volume for each hospital with an
approved pediatric cardiac surgical and interventional center within the
planning area. When a new center is being established, the assumed volumes of
that center will be the greater of the actual volume or minimum volume
standards or the estimated volumes described in the approved application,
including any adjustments made by the department in the course of review and
approval.
(c) Forecast year.
Pediatric cardiac surgery and interventional service needs shall be based on
forecasts for the fourth year after the certificate of need pediatric cardiac
surgery and interventional concurrent review process.
(d) Pediatric cardiac surgery and
intervention. Pediatric cardiac surgery and intervention means diagnosis
related groups (DRGs) 104-111 and 115-116, as developed under the Centers for
Medicare and Medicaid Services (CMS) contract. All adult cardiac procedures
(ages twenty-one and over) are excluded. The department will update the list of
codes administratively to reflect future revisions made by CMS to the DRGs to
be considered in certificate of need definitions, analyses and decisions. The
department's updates to DRGs will be based on the definition of pediatric heart
surgery contained in subsection (2) of this section.
(e) Out-of-state use of planning area
hospitals. The percent of out-of-state use of hospitals within the planning
area will equal the percent of total pediatric cardiac surgery and
interventional procedures occurring within the planning area's hospitals that
were performed on patients from out-of-state (or on patients whose reported zip
codes are invalid). The most recent available three years data will be used to
compute out-of-state use of Washington hospitals.
(f) Planning area. For the purpose of
pediatric cardiac surgery and intervention, the planning area is the state of
Washington.
Use rate. The pediatric cardiac surgery and interventional
use rate equals the number of procedures performed on the pediatric residents
of the planning area.
(10) The data source for pediatric cardiac
surgery and interventional procedures is the comprehensive hospital abstract
reporting system (CHARS), office of hospital and patient data, department of
health.
(11) The data source for
population estimates and forecasts is the office of financial management
population trends reports.
Statutory Authority: Chapter 70.38 RCW and State Court of
Appeals, Case # 23480-7-11. 04-24-016, § 246-310-263, filed 11/22/04,
effective 12/23/04.
