Before certain health care facilities, including hospitals, may be constructed, renovated, or sold, the Department of Health (DOH) must issue a certificate of need. A certificate of need is also required for any new tertiary health services that are offered by a health care facility if the services were not offered on a regular basis within the previous 12-month period. A tertiary health service is a specialized service that meets complicated medical needs of people and requires sufficient patient volume to optimize provider effectiveness, quality of service, and improved outcomes.
Under rules adopted by the DOH, adult elective percutaneous coronary interventions (PCI) are tertiary services subject to the certificate of need requirement. Percutaneous coronary interventions are invasive but nonsurgical mechanical procedures or devices used for the revascularization of obstructed coronary arteries.
The DOH calculates the projections for PCI needs using individual geographic areas designed in rule. When submitting an application for a certificate of need for PCI, the applicant hospital must include a variety of information, including an analysis of the impact of the services on training programs at the University of Washington, projected volumes for PCI in the first three years of operations, and a plan detailing how the hospital will recruit and staff the new program. The hospital must also maintain one catheterization lab used primarily for cardiology and be prepared and staffed to perform emergent PCI 24-hours per day. Hospitals providing PCI are also subject to requirements relating to volume, staffing, partnering with other hospitals, and quality assurance.
Elective percutaneous coronary interventions provided in a hospital owned or operated by a state entity are exempt from certificate of need requirements.
(In support) The certificate of need process for percutaneous coronary interventions (PCIs) can be lengthy. Hospitals that can perform emergency PCIs are unable to perform elective PCIs, which creates inequity and access issues. Vulnerable and marginalized patients have to wait to receive a stent, which risks complications. Some patients even die while waiting. The Department of Health (DOH) is engaged in a rulemaking process, but the process is taking a long time. This bill will allow state-operated hospitals to provide comprehensive care and take care of vulnerable populations.
(Opposed) There should not be a special carve-out for a single hospital. There is ongoing and rigorous work being done with the DOH rulemaking. A special carve-out would unfairly prioritize the needs of one stakeholder in that rulemaking. The new rulemaking will wrap up soon and will lead to more equitable access. The existing process should not be bypassed.
(Other) Certificate of need requirements should be updated in a way that helps communities. Hospitals can do emergency PCIs but not elective ones, which does not make sense. A solution is needed that serves vulnerable communities and fits the needs of hospitals.
(In support) Rashi Gupta; and Michael Chen, MD, Harborview Medical Center Division of Cardiology.