BILL REQ. #:  S-0855.1 

Read first time 01/25/2007.   Referred to Committee on Health & Long-Term Care.

     AN ACT Relating to improving the cardiac delivery system in the state of Washington by creating a new statutory certificate of need category for adult nonemergent interventional cardiology for hospitals without on-site open heart surgery programs; adding new sections to chapter 70.38 RCW; and creating a new section.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

NEW SECTION.  Sec. 1   The legislature finds that:
     (1) Cardiovascular disease is the second leading cause of death in Washington state, accounting for approximately twenty-four percent of all deaths, many of which occur in individuals under the age of sixty-five. Through the work of the blue ribbon commission, the governor and legislature have called for improving the health status of Washington citizens through the use of evidence-based medicine. The current system in this state of allowing hospitals without on-site open heart surgery programs to perform adult emergency but not nonemergent coronary interventions is an inefficient system that is not consistent with evidence-based medicine.
     (2) Appropriate and timely access to coronary interventions for both emergency and nonemergent patients is an effective means of reducing the rate of premature deaths or morbidity from cardiovascular disease. In many communities, timely access is not available and the current system negatively impacts all cardiac delivery such that access, quality, and outcomes are adversely impacted. Negative consequences include:
     (a) Severe restrictions on access to the right cardiac care at the right time resulting in adverse health outcomes, even death;
     (b) Provider shortages due to communities' inability to recruit or retain an adequate supply of cardiologists and related providers, which affects not only access but also the quality of both emergency and nonemergent cardiac care; and
     (c) Unnecessary patient transfer and duplication of diagnostic tests, evaluations, and other procedures, which leads to increased patient risk as well as higher costs.
     (3) Advancements in technology have expanded the ability to safely and effectively perform adult nonemergent coronary interventions in hospitals that do not have on-site open heart surgery programs. Published literature demonstrates that these interventions can be safely performed in hospitals without on-site surgical back-up as long as certain volume levels and other quality controls are met. The number of states allowing hospitals to perform these interventions without on-site open heart surgery programs continues to grow in the United States such that Washington state is now in the minority of states.
     (4) Current department of health certificate of need rules, in effect since 1992, require hospitals to have an on-site open heart surgery program in order to perform nonemergent coronary interventions. Emergency coronary interventions are not subject to certificate of need review in Washington, and therefore any hospital can perform these procedures.
     (5) Over the past fourteen years, technological advances have affected the methods used and safety of these cardiac interventions. The current rule limits patient access unreasonably.
     (6) As recently as December 2001, the department of health released the report of the advisory committee on certificate of need heart surgery methodology review. The committee's report, required by legislation passed in 2000, recommended the creation of a separate certificate of need category for adult nonemergent interventional cardiology that did not require a hospital to have on-site open heart surgery.
     In order to improve the cardiac delivery system in this state, the legislature intends to allow hospitals without on-site open heart surgery programs the opportunity to perform adult nonemergent coronary interventions by applying for a separate certificate of need for these services. This change will significantly improve the cardiac delivery system in the state. It will strengthen the delivery of both emergency and nonemergent cardiac care by assuring that more Washington residents get the right cardiac care at the right time.

NEW SECTION.  Sec. 2   A new section is added to chapter 70.38 RCW to read as follows:
     (1) Adult nonemergent coronary interventions are tertiary services and shall be performed only in hospitals licensed pursuant to chapter 70.41 RCW that have obtained a certificate of need from the department pursuant to rules adopted by the department. The department's rules for granting a certificate of need to a licensed hospital to provide adult nonemergent coronary interventions shall not require the hospital to have an on-site open heart surgery program. If a hospital has an existing open heart surgery program, the hospital shall not be required to obtain a separate certificate of need to provide adult nonemergent coronary interventions.
     (2) For purposes of this section and section 3 of this act, "adult nonemergent coronary interventions" means catheter-based nonsurgical interventions in the coronary arteries performed on individuals age eighteen or older. These interventions include insertion of coronary artery stents and percutaneous transluminal coronary angioplasty.
     (3) Nothing in this section or section 3 of this act is to be interpreted as requiring a hospital to obtain a certificate of need prior to performing emergency coronary interventions.

NEW SECTION.  Sec. 3   A new section is added to chapter 70.38 RCW to read as follows:
     (1) The department of health shall adopt by rule, no later than April 1, 2008, a separate certificate of need methodology and standards implementing this section and section 2 of this act. The department shall begin accepting nonemergent coronary intervention certificate of need applications no later than May 1, 2008.
     (2) In developing the standards under this section, the department shall:
     (a) Include evidence-based minimum volume standards for both the applicant hospital and the performing cardiologists, taking into consideration that standards may need to be different for rural areas and other communities with special populations in order to provide adequate access;
     (b) Include standards to ensure that new adult nonemergent coronary intervention programs do not adversely impact the ability of hospitals currently performing these procedures to operate at volume levels noted in (a) of this subsection;
     (c) Establish standards to ensure that adult nonemergent coronary intervention volumes at the University of Washington academic medical center are maintained at levels required for training of cardiologists consistent with applicable accreditation requirements;
     (d) Establish standards to ensure that both emergency and nonemergent adult coronary intervention volumes are included in the count of volumes needed to attain the volume levels noted in (a) of this subsection;
     (e) Require applying hospitals to develop and maintain an agreement with a hospital that has an on-site open heart surgery program for transfer, case selection, and quality assurance review;
     (f) Use geographic areas no larger than the hospital subplanning areas defined in the 1987 Washington state health plan as the planning areas for evaluating need;
     (g) Require approved hospitals to submit outcome data to the American college of cardiology-national cardiovascular data registry.
     (3) Following the initial implementation of the rules, the department shall convene an expert panel at least every three years to review and recommend appropriate revision to these rules based on advances in technology and treatment.