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From Health Law Daily, September 1, 2015

Regulations are clear: not enough procedures, no certificate

By Kayla R. Bryant, J.D.

A health system’s certificate of need (CON) request was properly denied by the state Department of Health because its programs did not meet the minimum volume standard. The Court of Appeals of the State of Washington upheld Swedish Health Services’ (Swedish) CON denial because it did not meet one of the primary regulatory criteria. The criteria did not allow for consideration of special circumstances or other exemptions (Swedish Health Services v. Department of Health of the State of Washington, August 31, 2015, Cox, J.).

CON. Swedish operates two hospitals within close proximity of one another: First Hill and Cherry Hill. The cardiology program is located in Cherry Hill, so First Hill patients in need of cardiac care are transferred. After deciding to reestablish First Hill’s cardiology department, Swedish applied for a CON to perform elective percutaneous coronary interventions (PCIs) in the new department. PCIs are invasive nonsurgical procedures that can be either elective or non-elective. A CON is necessary for a hospital to perform elective PCIs.

Planning area. Washington’s Department of Health regulations prohibit granting a CON to a new program for this purpose if existing programs “in the identified planning area perform fewer than 300 PCI procedures as year” (WAC 246-310-720). In Swedish’s planning area, the programs at the University of Washington Medical Center and Northwest Hospital performed fewer than 300 PCIs each year. In Swedish’s appeal, it argued that although it failed to meet the regulatory criteria, the Department should have considered special circumstances.

Regulations. Swedish pointed to regulations governing the requirements for obtaining a CON for other procedures, arguing that they contain numerous exceptions and exemptions and therefore, PCI certificates should be issued even if all of the governing criteria is not met. The court of appeals held that the Department’s regulations governing the standards a hospital must meet to obtain a CON for elective PCIs were properly promulgated, interpreted, and applied. The minimum volume standards provision is mandatory, and the existence of exemptions in other regulations is irrelevant. There are no regulations that allow the Department to consider any other circumstances and waive the requirements, and the Department properly denied Swedish’s CON.

The case is No. 72312-9-I.

Attorneys: Brian William Grimm (Perkins Coie LLP) for Swedish Health Services. Richard Arthur McCartan, Washington Attorney General’s Office, for Department of Health of the State of Washington.

Companies: Swedish Health Services; First Hill; Cherry Hill; University of Washington Medical Center; Northwest Hospital; Department of Health of the State of Washington

MainStory: TopStory IPPSNews CONNews OPPSNews WashingtonNews

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