PROPOSED RULES
Original Notice.
Preproposal statement of inquiry was filed as WSR 00-08-097.
Title of Rule: Adult heart surgery standards and need forecasting method; adult elective coronary interventions standards and need forecasting method; and pediatric cardiac surgery and diagnostic treatment center standards and need forecasting method.
Purpose: To reduce many regulatory requirements prohibiting the establishment of heart surgery and interventional cardiology programs and increase access to those services while still maintaining high quality programs.
Other Identifying Information: Chapter 59, Laws of 2000.
Statutory Authority for Adoption: Chapter 70.38 RCW.
Statute Being Implemented: Chapter 70.38 RCW.
Summary: Amends WAC 246-310-261 Open heart surgery standards and need forecasting methods, amends WAC 246-310-262 Nonemergent interventional cardiology standard, and creates a new section, WAC 246-310-263 Pediatric cardiac surgery and diagnostic treatment center standards and need forecasting methods.
Reasons Supporting Proposal: This proposed rule is consistent with recommendations forwarded by the 2000 Heart Surgery Advisory Committee, a panel of top cardiac practitioners and hospitals. These changes will decrease the regulatory burden on applicants and increase access to cardiac services while still maintaining high quality programs.
Name of Agency Personnel Responsible for Drafting and Implementation: Bart Eggen, 2725 Harrison Avenue N.W, Suite 500, Olympia, WA 98504-7852, (360) 705-6658; and Enforcement: Gary Bennett, 2725 Harrison Avenue N.W., Suite 500, Olympia, WA 98504-7852, (360) 705-6652.
Name of Proponent: 2000 Heart Surgery Advisory Committee, Department of Health, governmental.
Rule is necessary because of state court decision, 23480-7-II (WAC 246-310-263).
Explanation of Rule, its Purpose, and Anticipated Effects: Amends WAC 246-310-261 Open heart surgery standards and need forecasting methods, to revise definitions to reflect technological changes in adult heart surgery; reduce the minimum volume standards for applying hospitals and individual surgeons, and make other changes which reduce the regulatory burden on applicants. These changes should result in increased access to adult heart surgery services.
Amends WAC 246-310-262 Nonemergent interventional cardiology standard, to remove the requirement that all nonemergent interventional cardiology procedures be performed in hospitals with on-site open heart surgery programs; specifically define "adult elective coronary interventions"; require a separate certificate of need for these programs; establish standards for applying programs; and develop a need forecasting method. These changes should result in increased access to adult elective coronary interventions and provide improved treatment options.
As required through a August 1999 court decision, creates a new section, WAC 246-310-263 Pediatric cardiac surgery and diagnostic treatment center standards and need forecasting methods consistent with the definitions and standards in the American Academy of Pediatrics, Guidelines for Pediatric Cardiology Diagnostic and Treatment Centers and the adult heart surgery need forecasting method. This places in rule guidelines the department has been utilizing since the court decision, clarifying for applicants the standards and methods the department will use in their decision making.
Proposal Changes the Following Existing Rules: WAC 246-310-261, updates definitions, places requirements for the concurrent review process in this section, reduces minimum volume standards for hospitals and surgeons, changes the process applicants use to demonstrate they can meet the minimum volume, changes the requirements for board certified surgeons and twenty-four hour coverage, requires institutions to address the heart surgery program in their quality improvement plan, and require ongoing compliance with the certificate of need standards.
WAC 246-310-262, removes the requirement that all nonemergent interventional cardiology procedures be performed in hospitals with on-site open heart surgery programs, defines "adult elective coronary interventions," requires a separate certificate of need for adult elective coronary intervention programs, establishes a concurrent review process for these programs, develops institutional and staff volume requirements, requires institutions to address the adult elective coronary intervention program in their quality improvement plan, requires ongoing compliance with the certificate of need standards, and develops a need forecasting method.
No small business economic impact statement has been prepared under chapter 19.85 RCW. None of the facilities subject to this rule fall under the definition of a small business.
RCW 34.05.328 applies to this rule adoption. The proposed rules are significant because they set standards for certificate of need for health care facilities under RCW 34.05.328 (5)(iii)(B).
Hearing Location: Department of Health, 1101 Eastside Street, Room 6, Olympia, WA 98504-7890, on February 5, 2003, at 9:30 a.m.
Assistance for Persons with Disabilities: Contact Yvette Harrison by January 27, 2003, TDD (800) 833-6388 or (360) 705-6661.
Submit Written Comments to: Yvette Harrison, Department of Health, Facilities and Services Licensing, P.O. Box 47852, Olympia, WA 98504-7852, phone (360) 705-6661, e-mail yvette.harrison@doh.wa.gov, by February 5, 2003.
Date of Intended Adoption: February 20, 2003.
December 17, 2002
M. C. Selecky
Secretary
OTS-4833.5
AMENDATORY SECTION(Amending Order 274, filed 5/26/92,
effective 6/26/92)
WAC 246-310-261
((Open)) Adult heart surgery standards
and need forecasting method.
(1) ((Open)) Heart surgery means
a specialized surgical procedure of the heart and great
vessels in the chest (excluding organ transplantation) ((which
utilizes a heart-lung bypass machine and is intended to
correct congenital and acquired cardiac and coronary artery
disease)).
(2) ((Open)) Heart surgery is a tertiary service as
listed in WAC 246-310-020. To be granted a certificate of
need, ((an open)) a heart surgery program ((shall)) 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. If granted a certificate of need for adult heart
surgery, a hospital is not required to obtain another
certificate of need for adult elective coronary intervention
as defined in WAC 246-310-262.
(3) The department shall review new adult heart surgery applications using the concurrent review cycle in this subsection.
(a) Applicants must submit letters of intent between the first working day and last working day of July of each year.
(b) Initial applications must be submitted between the first working day and last working day of August of each year.
(c) The department shall screen initial applications for completeness by the last working day of September of each year.
(d) Responses to screening questions must be submitted by the last working day of October of each year.
(e) The public review and comment period for applications must begin on November 16 of each year. If November 16 is not a working day in any year, then the public review and comment period must begin on the first working day after November 16.
(f) The public comment period is limited to ninety days, unless extended under WAC 246-310-120 (2)(d). The first sixty days of the public comment period must be reserved for receiving public comments and conducting a public hearing, if requested. The remaining thirty days must 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, shall 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 may not exceed sixty days, unless extended under WAC 246-310-120 (2)(d).
(4) 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.
(((3))) (5) Standards.
(a) A minimum of two hundred ((fifty open)) heart surgery
procedures per year ((shall)) must be performed at
institutions with an ((open)) adult heart surgery program.
(b) Hospitals applying for a certificate of need
((shall)) must demonstrate that they can meet one hundred ten
percent of the minimum volume standard. To do so, the
applicant hospital must provide ((written documentation, which
is verifiable, of open heart surgeries performed on patients
referred by active medical staff of the hospital. The volume
of surgeries counted must be appropriate for the proposed
program (i.e., pediatric and recognized complicated cases
would be excluded))) data from CHARS demonstrating:
(i) The zip codes served by the applying hospital;
(ii) The applying hospital's percentage of total adult hospital admissions in the applicable zip codes during the most recent available three years data. Expired patients will not be counted;
(iii) The number of heart surgeries performed on patients from these zip codes during the most recent available three years data. The percentage established in (ii) of this subsection must then be applied to the number of heart surgeries. This number must be equal to or greater than two hundred twenty (one hundred ten percent of the minimum volume).
(c) ((No new program shall be established which will
reduce an existing program)) The department shall not grant a
certificate of need to a new program if the new program would
cause the procedures at an existing program to drop below
((the minimum volume standard)) two hundred fifty procedures
per year.
(d) ((Open)) Heart surgery programs ((shall)) must have
at least ((two)) one U.S. board certified cardiac surgeon((s,
one of whom shall be available for emergency surgery)) or
cardio-thoracic surgeon. The program must provide twenty-four
hour((s a day)) coverage. ((The practice of these surgeons
shall be concentrated in a single institution and arranged so
that)) Each surgeon must perform((s)) a minimum of one hundred
((twenty-five open)) heart surgery procedures per year ((at
that institution)).
(e) Institutions with ((open)) heart surgery programs
((shall)) must have plans for facilitating emergency access to
((open)) 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))).
(f) Institutions with heart surgery programs must provide a copy of the hospital's QI plan that includes/incorporates a section specific to the heart surgery program.
(g) When a certificate of need is issued, failure to operate the heart surgery program in accordance with certificate of need standards may be grounds for revocation or suspension of a facility's certificate of need, or other appropriate licensing or certification action.
(h) In the event two or more hospitals 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 cardiovascular and support services; and
(v) Facilitating emergency access to care.
(((g))) (i) Hospitals granted a certificate of need have
three years from the date the program is initiated to
establish the program and meet these standards.
(((h))) (j) These standards should be reevaluated in at
least three years.
(((4))) (6) Steps in the need forecasting method. The
department will develop a forecast of need for ((open)) heart
surgery every year using the following procedures.
(a) Step 1. Based upon the most recent three years volumes reported for the hospitals within each planning area, compute the planning area's current capacity and the percent of out-of-state use of the area's hospitals. In those planning areas where a new program is being established, the assumed volume of that institution will be the greater of either the minimum volume standard or the estimated volume described in the approved application and adjusted by the department in the course of review and approval.
(b) Step 2. Patient origin adjust the three years of
((open)) heart surgery data, and compute each planning area's
age-specific use rates and market shares.
(c) Step 3. 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 surgeries expected to be performed on the residents of each planning area.
(d) Step 4. Apportion the forecasted surgeries among the planning areas in accordance with each area's average market share for the last three years of the four planning areas. This figure equals the forecasted number of state residents' surgeries expected to occur within the hospitals in each planning area. In those areas where a newly approved program is being established, an adjustment will be made to reflect anticipated market share shifts consistent with the approved application.
(e) Step 5. Increase the number of surgeries expected to occur within the hospitals in each planning area in accordance with the percent of surgeries 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 surgeries expected to occur within the hospitals in each planning area.
(f) Step 6. Calculate the net need for additional
((open)) heart surgery services by subtracting the current
capacity from the total forecasted surgeries.
(g) Step 7. ((If the net need is less than the minimum
volume standard, no new programs shall be assumed to be needed
in the planning area. However, hospitals may be granted
certificate of need approval even if the forecasted need is
less than the minimum volume standard, provided:)) The
department will not grant a certificate of need to new
programs if the net need is less than the minimum volume
standard, except for an applicant hospital that meets (g)(i)
and either (ii) or (iii) of this subsection:
(i) The applying hospital can meet all the other
certificate of need criteria for ((an open)) a heart surgery
program (including documented evidence of capability of
achieving the minimum volume standard); and
(ii) There is documented evidence that at least eighty
percent of the patients referred for ((open)) heart surgery by
the medical staff of the applying hospital are referred to
institutions more than seventy-five miles away; or
(iii) Existing programs within the same planning area could maintain volumes of two hundred fifty or more procedures.
(((5))) (7) 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 fifteen to forty-four year olds, forty-five to sixty-four year olds, sixty-five to seventy-four year olds, and seventy-five and older.
(b) Current capacity. A planning area's current capacity
for ((open)) heart surgeries equals the sum of the highest
reported annual volume for each hospital within the planning
area during the most recent available three years data.
(c) Forecast year. ((Open)) Heart surgery service needs
shall be based on forecasts for the fourth year after the
certificate of need ((open)) heart surgery concurrent review
process. ((The 1992 reviews will be based on forecasts for
1996.))
(d) Market share. The market share of a planning area represents the percent of a planning area's total patient origin adjusted surgeries that were performed in hospitals located in that planning area. The most recent available three years data will be used to compute the age-specific market shares for each planning area.
(e) ((Open)) Heart surgeries. ((Open)) Heart surgeries
are defined as diagnosis related groups (DRGs) 104 through
((108, inclusive)) 111 as developed under the Centers for
Medicare and Medicaid Services (CMS) contract. The department
will reflect any future revisions made by CMS to the DRGs in
the appropriate certificate of need definitions, analyses and
decisions. All pediatric surgeries (ages fourteen and under)
are excluded.
(f) Out-of-state use of planning area hospitals. The percent of out-of-state use of hospitals within a planning area will equal the percent of total surgeries 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 planning area hospitals.
(g) Patient origin adjustment. A patient origin
adjustment of ((open)) heart surgeries provides a count of
surgeries performed on the residents of a planning area
regardless of which planning area the surgeries were performed
in. (Surgeries can be patient origin adjusted by using the
patient's zip code reported in the CHARS data base.)
(h) Planning areas. Four regional health service areas
will be used as planning areas for forecasting ((open)) heart
surgery service needs.
(i) Health service area "one" includes the following counties: Clallam, Island, Jefferson, King, Kitsap, Pierce, San Juan, Snohomish, Skagit, and Whatcom.
(ii) Health service area "two" includes the following counties: Cowlitz, Clark, Grays Harbor, Klickitat, Lewis, Mason, Pacific, Skamania, Thurston, and Wahkiakum.
(iii) Health service area "three" includes the following counties: Benton, Chelan, Douglas, Franklin, Grant, Kittitas, Okanogan, and Yakima.
(iv) Health service area "four" includes Adams, Asotin, Columbia, Ferry, Garfield, Lincoln, Pend Oreille, Stevens, Spokane, Walla Walla, and Whitman.
(v) Use rate. The ((open)) heart surgery use rate equals
the number of surgeries performed on the residents of a
planning area divided by the population of that planning area.
The most recent available three years data is used to compute
an averaged annual age-specific use rate for the residents of
each of the four planning areas.
(((6))) (8) The data source for ((open)) heart surgeries
is the comprehensive hospital abstract reporting system
(CHARS), office of hospital and patient data, department of
health.
(((7))) (9) The data source for population estimates and
forecasts is the office of financial management population
trends reports.
[Statutory Authority: RCW 70.38.135(3). 92-12-015 (Order 274), § 246-310-261, filed 5/26/92, effective 6/26/92.]
(2) Adult elective coronary interventions are tertiary services as listed in WAC 246-310-020. To be granted a certificate of need, an adult elective coronary intervention program 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.
(3) The department shall review new adult elective coronary intervention services using the concurrent review cycle in subsections (4) through (6) of this section.
(4) Certificate of need applications must be submitted and reviewed according to the following schedule and procedures.
(a) Applicants must submit letters of intent between the first working day and last working day of September of each year.
(b) Initial applications must be submitted between the first working day and last working day of October of each year.
(c) The department shall screen initial applications for completeness by the last working day of November of each year.
(d) Responses to screening questions must be submitted by the last working day of December of each year.
(e) The public review and comment period for applications begins on January 16 of each year. If January 16 is not a working day in any year, then the public review and comment period must begin on the first working day after January 16.
(f) The public comment period is limited to ninety days, unless extended under 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 must 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, shall 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 may not exceed sixty days, unless extended under WAC 246-310-120 (2)(d).
(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) Institutional volume requirements.
(i) A minimum of two hundred therapeutic catheter-based interventions per year must be performed in institutions with an adult elective coronary intervention program by the end of the third year of operation and for each year thereafter.
(ii) During the first year of operation, a minimum of one hundred therapeutic catheter-based interventions must be performed. Allowing one hundred procedures per year during the first year of operation will allow institutions to consider the complexity of cases performed during that first year.
(iii) No new program shall be established which will reduce an existing program below the minimum institutional volume standard.
(b) Staff certification requirements.
(i) Director of interventional cardiology. The director of interventional cardiology at the adult elective coronary intervention program must become U.S. board certified in general cardiology at the time of application and become U.S. board certified in interventional cardiology within two years.
(ii) Established cardiologists. Established cardiologists are defined as cardiologists out of fellowship for more than two years as of the effective date of this section. Established cardiologists must be U.S. board certified or board prepared in interventional cardiology at time of application. Board prepared status must not extend beyond five years. Cardiologists certified in general cardiology at time of application must be U.S. Interventional Cardiology Board certified within five years.
(iii) New cardiologists. New cardiologists means those cardiologists out of fellowship for less than two years. New cardiologists must be U.S. board certified or board prepared in interventional cardiology at the time of application and must maintain certification. Board prepared status may not extend beyond two years.
(c) Staff volume requirements.
(i) Established cardiologists. Established cardiologists (including the director of interventional cardiology) must perform a minimum of seventy-five catheter-based therapeutic interventions per year, except for those established cardiologists who have performed a minimum of five hundred post-training cases during his/her career. The minimum volume requirement for these cardiologists is fifty procedures per year.
(ii) New cardiologists. New cardiologists must perform a minimum of fifty catheter-based therapeutic interventions per year until they have been in practice for two or more years. After this time period, the minimum volume requirement is seventy-five procedures per year.
(d) Institutions with adult elective coronary intervention programs must have plans for facilitating safe and swift emergency access to heart surgery services at all times for the population they serve. These plans must include, at a minimum:
(i) A formal written transfer agreement for emergency medical/surgical management with at least one hospital that provides heart surgery services, that can be reached expeditiously from the program by available emergency transport within a reasonable amount of time (never to exceed two hours) and that provides the greatest assurance of patient safety;
(ii) A plan for conferences between representatives from the heart surgery program(s) and the elective coronary intervention program to be held at least quarterly, in which a significant number of preoperative and postoperative cases are reviewed, including all transport cases;
(iii) Arrangements for addressing peak volume periods (such as joint agreements with other programs, the capacity to temporarily increase staffing, etc.); and
(iv) The maintenance of, or affiliation with, emergency transportation services (including contingency plans for poor weather and known traffic congestion problems).
(e) Institutions with adult elective coronary intervention programs must provide a copy of the hospital's QI plan that includes/incorporates a section specific to the adult elective coronary intervention program.
(f) If a certificate of need is issued, it will be conditioned 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 facility's certificate of need, or other appropriate licensing or certification actions.
(g) If two or more hospitals 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 adult coronary intervention programs;
(iv) Providing the greatest breadth and depth of cardiovascular and support services; and
(v) Facilitating emergency access to care.
(h) Hospitals granted a certificate of need have three years from the date the program is initiated to establish the program and meet these standards.
(i) These standards should be reevaluated in at least three years.
(8) Steps in the need forecasting method. The department will develop a forecast of need for adult elective coronary interventions every year using the following procedures.
(a) Step 1. Based upon the most recent three years volumes reported for the hospitals within each planning area, compute the planning area's current capacity and the percent of out-of-state use of the area's hospitals. In those planning areas where a new program has operated less than three years, the assumed volume of that institution will be the greater of either the minimum volume standard or the estimated volume described in the approved application and adjusted by the department in the course of review and approval.
(b) Step 2. Patient origin adjust the three years of adult elective coronary intervention data and compute each planning area's age-specific use rates and market shares.
(c) Step 3. 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 catheter-based therapeutic interventions expected to be performed on the residents of each planning area.
(d) Step 4. Apportion the forecasted catheter-based therapeutic interventions among the planning areas in accordance with each area's average market share for the last three years of the planning areas. This figure equals the forecasted number of state residents' interventions expected to occur within the hospitals in each planning area. In those areas where a newly approved program is being established, an adjustment will be made to reflect anticipated market share shifts consistent with the approved application.
(e) Step 5. Increase the number of catheter-based therapeutic interventions expected to occur within the hospitals in each planning area in accordance with the percent of catheter-based therapeutic interventions 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 catheter-based therapeutic interventions expected to occur within the hospitals in each planning area.
(f) Step 6. Calculate the net need for additional adult elective coronary intervention services by subtracting the current capacity from the total forecasted interventions.
(g) Step 7. The department will not grant a certificate of need to new programs if the net need is less than the minimum volume standard, except for an applicant hospital that meets (g) (i) and either (ii) or (iii) of this subsection:
(i) The applying hospital meets all the other certificate of need criteria for an adult elective coronary intervention program (including documented evidence of capability of achieving the minimum volume standard); and
(ii) There is documented evidence that at least eighty percent of the patients referred for catheter-based therapeutic interventions by the medical staff of the applying hospital are referred to institutions more than seventy-five miles away; or
(iii) Existing programs within the same planning area could maintain volumes of two hundred fifty or more procedures.
(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 fifteen to forty-four year olds, forty-five to sixty-four year olds, sixty-five to seventy-four year olds, and seventy-five and older.
(b) Current capacity. A planning area's current capacity for adult elective coronary interventions equals the sum of the highest reported annual volume for each hospital within the planning area during the most recent available three years data.
(c) Forecast year. Adult elective coronary intervention service needs must be based on forecasts for the fourth year after the certificate of need adult elective coronary intervention concurrent review process.
(d) Market share. The market share of a planning area represents the percent of a planning area's total patient origin adjusted catheter-based therapeutic interventions that were performed in hospitals located in that planning area. The most recent available three years data will be used to compute the age-specific market shares for each planning area.
(e) Adult elective coronary interventions. Adult elective coronary interventions means diagnosis related groups (DRGs) 112, 115, and 116 as developed under the Centers for Medicare and Medicaid Services (CMS) contract. All pediatric catheter-based therapeutic and diagnostic interventions (ages fourteen and under) are excluded. The department will reflect any revisions made by CMS to the DRGs in the appropriate certificate of need definitions, analyses, and decisions.
(f) Out-of-state use of planning area hospitals. The percent of out-of-state use of hospitals within a planning area will equal the percent of total catheter-based therapeutic interventions 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 planning area hospitals.
(g) Patient origin adjustment. A patient origin adjustment of catheter-based therapeutic interventions provides a count of interventions performed on the residents of a planning area regardless of which planning area the interventions were performed in. (Interventions can be patient origin adjusted by using the patient's zip code reported in the CHARS data base.)
(h) Planning areas. Planning area means each individual county designated by the department as the smallest geographic area for which adult coronary interventions are projected.
(i) Use rate. The adult elective coronary intervention use rate equals the number of catheter-based therapeutic interventions performed on the residents of a planning area divided by the population of that planning area. The most recent available three years data is used to compute an averaged annual age-specific use rate for the residents of each of the four planning areas.
(10) The data source for adult elective coronary interventions 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. 96-24-052, § 246-310-262, filed 11/27/96, effective 12/28/96. Statutory Authority: RCW 70.38.135(3). 92-12-015 (Order 274), § 246-310-262, filed 5/26/92, effective 6/26/92.]
(2) Pediatric cardiac surgery and diagnosis includes, but is not limited to: All pediatric surgery of the heart 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 diagnosis is a tertiary service as listed in WAC 246-310-020. To be granted a certificate of need, a pediatric cardiac surgery and diagnostic treatment center 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 diagnostic services using the concurrent review cycle in this section.
(5) Certificate of need applications must be submitted and reviewed according to the following schedule and procedures.
(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 begin on December 16 of each year. If December 16 is not a working day in any year, then the public review and comment period must begin 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 must 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 (2)(d).
(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 pediatric cardiac surgery and diagnostic treatment centers.
(b) Pediatric cardiology diagnostic and treatment centers applying for a certificate of need must demonstrate that they can meet one hundred ten percent of the minimum volume standard. To do so, the applicant center 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 0-21 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 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. This number must be equal to or greater than one hundred ten (one hundred ten percent of the minimum volume);
(c) A new center may not be established if it will reduce an existing program below the minimum volume standard.
(d) Pediatric cardiology diagnostic and treatment centers must have at least two U.S. board certified or board prepared cardiac surgeons on the staff. Board prepared status must not extend beyond five years. At least one surgeon must be certified by the American Board of Thoracic Surgery. The program must provide twenty-four hour coverage.
(e) Institutions with pediatric cardiology diagnostic and treatment centers 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).
(f) Institutions with pediatric cardiology diagnostic and treatment centers must provide a copy of the hospital's QI plan that includes/incorporates a section specific to the pediatric cardiac surgery and diagnostic treatment center.
(g) If a certificate of need is issued, it will be conditioned 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 facility's certificate of need, or other appropriate licensing or certification action.
(h) 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.
(i) Centers granted a certificate of need have three years from the date the program is initiated to establish the program and meet these standards.
(j) These standards should be reevaluated in at least three years.
(8) Steps in the need forecasting method. The department will develop a forecast of need for pediatric cardiac surgical and diagnostic procedures every year using the following procedures.
(a) Step 1. Based upon the most recent three years volumes reported for the hospitals within the planning area, compute the planning area's current capacity and the percent of out-of-state use of the area's hospitals. When a new program is being established, the assumed volume of that institution will be the greater of either the minimum volume standard or the estimated volume described in the approved application and adjusted by the department in the course of review and approval.
(b) Step 2. Patient origin adjust the three years of pediatric cardiac surgical and diagnosis data, and compute the planning area's age-specific use rates and market shares.
(c) Step 3. 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 diagnostic procedures expected to be performed on Washington pediatric residents.
(d) Step 4. Apportion the forecasted pediatric cardiac surgical and diagnostic procedures among the planning areas in accordance with Washington's average market share for the last three years. This figure equals the forecasted number of state pediatric residents' procedures expected to occur within the hospitals in the planning area. In those areas where a newly approved program is being established, an adjustment will be made to reflect anticipated market share shifts consistent with the approved application.
(e) Step 5. Increase the number of pediatric cardiac surgical and diagnostic procedures expected to occur within the hospitals in 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 hospitals in the planning area.
(f) Step 6. Calculate the net need for additional pediatric cardiac services by subtracting the current capacity from the total forecasted pediatric cardiac surgical and diagnostic procedures.
(g) Step 7. The department will not grant a certificate of need to new programs if the need is less than the minimum volume standard, except for an applicant hospital that meets the requirements in this subsection:
(i) The applying hospital can meet all the other certificate of need criteria for a pediatric cardiac surgery and diagnostic treatment center (including documented evidence of capability of achieving the minimum volume standard); and
(ii) There is documented evidence that at least eighty percent of the patients referred for pediatric cardiac services by the medical staff of the applying hospital are referred to institutions 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 0-14, 15-19 year olds.
(b) Current capacity. The planning area's current capacity for pediatric cardiac surgical and diagnostic procedures equals the sum of the highest reported annual volume for each hospital within the planning area during the most recent available three years data.
(c) Forecast year. Pediatric cardiac surgery and diagnosis service needs shall be based on forecasts for the fourth year after the certificate of need heart surgery concurrent review process.
(d) Market share. The market share of the planning area represents the percent of a planning area's total patient origin adjusted procedures that were performed in hospitals located in Washington. The most recent available three years data will be used to compute the age-specific market shares for Washington.
(e) Pediatric cardiac surgery and diagnosis. Pediatric cardiac surgery and diagnosis 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.
(f) 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 diagnosis 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.
(g) Patient origin adjustment. A patient origin adjustment of pediatric cardiac surgical and diagnostic procedures provides a count of procedures performed on the residents of the planning area regardless of where the surgeries were performed. (Procedures can be patient origin adjusted by using the patient's zip code reported in the CHARS data base.)
(h) Planning area. For the purpose of pediatric cardiac surgery and diagnosis, the planning area is the state of Washington.
(i) Use rate. The pediatric cardiac surgery and diagnostic use rate equals the number of procedures performed on the pediatric residents of the planning area. The most recent available three years data is used to compute an averaged annual age-specific use rate for the pediatric residents.
(10) The data source for pediatric cardiac surgery and diagnosis 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.
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The following section of the Washington Administrative Code is repealed:
| WAC 246-310-132 | Open heart surgery concurrent review cycle. |