YAKIMA VALLEY MEMORIAL HOSPITAL, a Washington nonprofit corporation, Plaintiff-Appellant,
WASHINGTON STATE DEPARTMENT OF HEALTH; Mary C. Selecky, in her official capacity as Secretary of the Washington State Dept. of Health, Defendants-Appellees, and Yakima HMA, LLC, dba Yakima Regional Medical and Cardiac Center, Intervenor-Defendant.
Argued and Submitted June 4, 2013.
James L. Phillips (argued), Miller Nash LLP, Seattle, WA, for Plaintiff-Appellant.
Pamela Anderson (argued) and Richard A. McCartan, Assistant Attorneys General, Olympia, WA, for Defendants-Appellees.
Appeal fro the United States District Court for the Eastern District of Washington, Edward F. Shea, District Judge, Presiding. D.C. No. 2:09-cv-03032-EFS.
Before: M. MARGARET McKEOWN and SANDRA S. IKUTA, Circuit Judges, and CORMAC J. CARNEY, District Judge.[*]
McKEOWN, Circuit Judge:
This appeal involves a constitutional challenge under the Commerce Clause to Washington State Department of Health (" Department" ) Certificate of Need (" Certificate" ) regulations. In particular, the challenge targets regulations related to scheduled, or " elective," percutaneous coronary interventions (" PCIs" ), which are nonsurgical procedures used to treat coronary heart disease. Hospitals without on-site cardiac surgical facilities may perform elective PCIs only if they obtain a Certificate demonstrating sufficient need in the region to support an annual minimum volume. Yakima Valley Memorial Hospital (" Memorial" ) claims the requirement that elective PCIs be performed only at hospitals that have a minimum annual volume of 300 procedures lacks a reasonable basis and that its putative benefits, including safety, are outweighed by the burdens it places on interstate commerce, thus violating the dormant Commerce Clause. We disagree. The impact on interstate commerce, if any, is highly attenuated, and does not outweigh the safety benefits of the regulations. We affirm the district court's dismissal of Memorial's claims at summary judgment.
PCI, a nonsurgical procedure used to treat coronary heart disease, includes balloon stenting and angioplasty. The procedure involves removing arterial plaque, thereby clearing out obstructed coronary arteries and ameliorating the effects of heart disease. Elective PCIs are performed when the patient is stable and no medical emergency requires immediate action. Washington law requires healthcare providers to obtain a Certificate  in order
to offer certain facilities and services, including elective PCIs. Wash. Rev.Code § 70.38.105. Before 2007, only hospitals that had on-site surgical facilities were permitted to perform elective PCIs. In 2007, the state legislature directed the Department to promulgate elective PCI regulations for hospitals that, like Memorial, do not otherwise perform on-site cardiac surgery. Id. § 70.38.128. Factors to be considered included, among others, " access to care, patient safety, [and] quality outcomes...." Id.
The Department worked with Health Management Associates (" HMA" ), an operator of acute-care hospitals, on an " independent evidence-based review of the circumstances under which elective [PCIs] should be allowed in Washington at hospitals that do not otherwise provide on-site surgery." The September 2007 HMA report stated that " [e]lective PCI[s] should not be performed in hospitals without on-site surgery," and recommended limiting approval to " program[s] that serve[ ] a community or population with a fully documented pattern of unmet need." The report also recommended that elective PCIs should be performed only at hospitals that had a minimum annual volume of 300 procedures, noting that the " optimal" annual volume was 400 or more. The report recognized, however, that " [p]ublications suggest or recommend minimum volumes ranging from > 200, 400, 500, to even 600."
After receiving the HMA report, the Department met with numerous additional stakeholders, who advised the Department that hospitals with on-site surgery facilities preferred a 400-PCI minimum, while those without on-site facilities favored a 200-PCI minimum. The final regulations elected the midpoint between the two positions: only hospitals that can demonstrate that they will perform at least 300 PCIs annually will receive a Certificate permitting them to perform elective PCIs. Wash. Admin. Code § 246-310-720(1). The regulations apply statewide and do not single out or target particular facilities.
Only one hospital in the Yakima Valley area has on-site surgery facilities: Yakima Regional Medical and Cardiac Care Center (" Regional" ). Regional is a for-profit hospital owned by a Florida corporation. As a holder of a PCI Certificate, it performs both elective and emergency PCIs. Regional requires a 20-30% prepayment before performing an elective PCI, and it will not perform an elective PCI without adequate reimbursement. In contrast, Memorial is a nonprofit hospital that serves both uninsured and insured residents of Yakima Valley. Unlike Regional, Memorial would ...