Download this Paper Open PDF in Browser

Agency Imprimatur & Health Reform Preemption

75 Pages Posted: 18 Jul 2017  

Elizabeth Y. McCuskey

University of Toledo College of Law; Center for Health Law Studies

Date Written: June 29, 2017


At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating – state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but also exacerbates them. This Article identifies an inventive waiver structure in the Affordable Care Act – the § 1332 “State Innovation” waiver – that may defuse some health reform preemption problems.

The ACA’s individual and employer mandates, health insurance exchanges, and insurance coverage standards established a federal baseline of health insurance regulation that preempts conflicting state rules. Yet the ACA also quietly permits states to apply for a waiver of all these major provisions, if they promise to enact state legislation with equivalent protections. Through this waiver provision, the implementing agencies may sanction state variations if the agencies find suitable evidence that the variations will further the goals of the federal baselines and offer equivalent protections. The new administration has encouraged states to apply for these waivers.

The ACA’s combination of express preemption and guided waiver raises a novel confluence of “big waiver” theory and preemption doctrine. This Article posits that this confluence offers an “agency imprimatur” model with great potential for managing health law federalism issues. At its best, the agency imprimatur model offers advantages over preemption doctrine in expertise, transparency, and communicative federalism. These potential advantages, however, hinge on the presence of meaningful waiver standards that preserve the statute’s priorities and require reliance on agencies’ substantive expertise. The § 1332 wavier is not without its pitfalls. But the recently proposed revisions to this provision would erode the waiver’s standards and thereby erode these potential benefits.

Keywords: preemption, big waiver, health law, health reform, health care, health, regulation, federalism, affordable care act, ACA, BCRA, supremacy clause, state innovation, 1332 waiver, institutional competence, waiver

JEL Classification: I13

Suggested Citation

McCuskey, Elizabeth Y., Agency Imprimatur & Health Reform Preemption (June 29, 2017). Ohio State Law Journal, Vol. 89, No. 1, 2017. Available at SSRN:

Elizabeth McCuskey (Contact Author)

University of Toledo College of Law ( email )

2801 W. Bancroft Street
Toledo, OH 43606
United States


Center for Health Law Studies ( email )

100 N. Tucker Blvd.
St. Louis, MO 63101
United States

Paper statistics

Abstract Views