Title: An act relating to Washington state participation in the Johns Hopkins University Atlantic cardiovascular patient outcomes research team elective angioplasty study to determine, through evidence-based medicine, whether nonemergency percutaneous coronary interventions can be performed safely and effectively at hospitals without on-site open heart surgery programs.

Brief Description: Authorizing Washington state participation in the Johns Hopkins University Atlantic cardiovascular patient outcomes research team elective angioplasty study to determine, through evidence-based medicine, whether nonemergency percutaneous coronary interventions can be performed safely and effectively at hospitals without on-site open heart surgery programs.

Sponsors: Senators Kastama, Eide, Keiser, Roach, Johnson, Regala, Fraser, Haugen, Kline, Hewitt, Swecker, Finkbeiner, McAuliffe, Poulsen and Spanel.

Brief History:

Committee Activity: Health & Long-Term Care: 1/25/06, 2/2/06 [DPS, DNP].

SENATE COMMITTEE ON HEALTH & LONG-TERM CARE

Majority Report: That Substitute Senate Bill No. 6632 be substituted therefor, and the substitute bill do pass.Signed by Senators Keiser, Chair; Thibaudeau, Vice Chair; Brandland, Johnson, Kastama, Kline and Parlette.

Minority Report: Do not pass.Signed by Senator Benson.

Staff: Edith Rice (786-7444)

Background: Washington Administrative Code 246-310-262 provides that non-emergency angioplasty and stent placements or percutaneous coronary interventions may only be performed in institutions which have an on-site open heart surgery program, capable of performing emergency open heart surgery. However, these same procedures can be performed on an emergency basis at hospitals without an on-site open heart surgery program.

Angioplasty is a procedure in which a tiny balloon is inflated and used to widen a blocked artery which has narrowed from the buildup of cholesterol-laden plaque. Most states' health care regulations limit the availability of angioplasty to emergencies such as during a heart attack because, in some instances, the procedure has led to a tear in a vessel or closing of an artery rather than opening it, thus necessitating emergency heart bypass surgery. National guidelines from the American Heart Association and the American College of Cardiology have for the past 20 years maintained a requirement for on-site cardiac surgery to back up angioplasty.

The Johns Hopkins cardiovascular patient outcome research team elective angioplasty study is comparing these procedures as they are performed at hospitals with and without on-site open heart surgery programs to determine if they can be performed safely and effectively.

Summary of Substitute Bill: Washington State hospitals are allowed to participate in the Johns Hopkins study to ensure that decisions regarding cardiac care in Washington are made on evidence-based data, and, if possible, based upon data specific to Washington State. The Department of Health will waive specific certificate of need review requirements for hospitals accepted to participate in the study, only for the purpose and duration of the study. No hospital may be approved to participate in the study if participation would reduce the number of emergency and non-emergency percutaneous coronary interventions at any hospital with an existing open heart surgery program to below levels specified in the bill. The Department of Health will not approve any hospital to participate in the study if a hospital within a two mile radius submits a written objection. The Department of Health will monitor the outcomes of the study and provide reports to the House of Representatives and Senate health committees. If the department finds that the study is endangering the health or safety of Washington citizens, participation can be terminated. Participation is limited to three Washington hospitals.

Substitute Bill Compared to Original Bill: Department of Health criteria for participation now include requirements that any hospital selected: currently have ability to do emergency interventions, an agreement with another hospital that has an existing open heart surgery program to accept transfers, and the ability to perform at least 200 interventions per year. Department of Health will not approve a hospital's participation if it would reduce the number of interventions below a certain number per year. The Department of Health will not approve any hospital to participate in the study if a hospital within a two mile radius submits a written objection. Participation is limited to three Washington hospitals.

Appropriation: None.

Fiscal Note: Available.

Committee/Commission/Task Force Created: No.

Effective Date: Ninety days after adjournment of session in which bill is passed.

Testimony For: Patients in areas where these services are not available are not being protected, and are affected adversely. Washington should participate in this rigorously supervised study. This is an opportunity we should not miss. We need evidence-based data. Is it safer to not provide this service?

Testimony Against: This will endanger patients. Department of Health has already done an extensive study and pilot rules; both have been rejected. This is an unconstitutional delegation of authority. Patients will be subjected to inferior standards of care. This will reduce our level of competency and jeopardize funding. It is unsafe.

Who Testified: PRO: Jody Carona, Health Facilities Planning Development; Gregg Davidson, CEO, Skagit Valley Hospital; Rubin Maidan, MD, Eastside Cardiology Assn.; Matt Crockett, Highline Medical Center.

CON: Linda Hull, Providence; Peter Erhlichman, Dorsey Whitney, Howard Lewis, Swedish Medical Center; Kurt Miller, St. Peter Hospital, Olympia, WA.

Signed in, Unable to Testify & Submitted Written Testimony: Marcel Loh, Swedish Medical Center; Jim Leonard, Providence St Peter Hospital, Jackie Der, University of Washington Medical Center.