OPINION
The Washington State Department of Health (Department) will not license Yakima Valley Memorial Hospital (Memorial) to perform certain procedures known as elective percutaneous coronary interventions (PCI), which are used to treat diseased arteries of the heart. Examples of such procedures include stent implantation and laser angioplasty. 1 Although Memorial already performs PCI in emergencies (no license required), it cannot perform “elective” procedures without a license that is required as part of the state’s broader “certificate of need” regulatory regime. See Wash. Admin. Code § 246-310-700. 2 According to the Department, the community Memorial serves does not need another PCI provider.
The concept of certificate of need regimes, which many states enforce, is to avoid private parties making socially inefficient investments in health-care resources they might make if left unregulated. A certificate of need program corrects the market by requiring preapproval for certain investments and, in theory, thereby ensures that providers will make only necessary investments in health care. One type of investment the state of Washington regulates is the capacity to perform “tertiary health services,” which are specialized health-care services including PCI.
See
Wash. Rev.Code § 70.38.105(4)(f).
3
Congress made certificate of need regimes part of the federal government’s national
In 2007, the Washington legislature passed a law directing the Department to promulgate regulations requiring a certificate of need for elective PCI. See Wash. Rev.Code § 70.38.128. The Department responded in 2008 by promulgating the PCI regulations Memorial now challenges. See Wash. Admin. Code §§ 246-310-700-755. The PCI regulations, which are explained in detail below, (a) require that a licensed hospital perform at least 300 elective PCI procedures per year; and (b) provide that the Department shall issue a certificate of need only if projected demand in an applicant’s geographic market exceeds the ca-parity of incumbent certificate holders by at least 300 procedures. Under this formula, Memorial has no hope of receiving a certificate of need in the near future. Memorial operates a single nonprofit hospital in Yakima, Washington. The surrounding market is already served by the for-profit Yakima Regional Medical and Cardiac Center, which holds an elective PCI certificate and is the only competing hospital in the city of Yakima. The Department does not contest Memorial’s assertion that the market’s “need” will not exceed 300 procedures until 2022.
Memorial sued the Department after it promulgated the PCI regulations, arguing that the certificate of need requirement violates the dormant Commerce Clause by unreasonably burdening interstate commerce. Memorial also claimed that the Department’s methodology for defining “need” is anticompetitive and preempted by § 1 of the Sherman Act because it allows incumbent certificate holders to expand their capacity and preclude new certificates. The Department moved to dismiss the case for failure to state a claim and lack of standing to raise a dormant Commerce Clause challenge. Although the district court held that Memorial had standing, it dismissed the ease on the pleadings pursuant to Federal Rule of Civil Procedure 12(c).
See Yakima Valley Mem’l Hosp. v. Wash. State Dept. of Health,
The district court held that Memorial failed to state a claim of antitrust preemption, holding that the PCI regulations were a unilateral restraint of trade not barred by the Sherman Act. With regard to the dormant Commerce Clause, the district
Discussion
The district court ruled on the pleadings under Federal Rule of Civil Procedure 12(c), so we assume the facts alleged in the complaint are true and review de novo whether Memorial stated a claim under the Sherman Act or dormant Commerce Clause.
See United States ex rel. Cafasso v. Gen. Dynamics C4 Sys., Inc.,
A. The Sherman Act
1. Antitrust Preemption Requires a Per Se Violation
Memorial argues that the PCI regulations are preempted by Sherman Act § 1, which declares “[e]very contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade ... to be illegal.” 15 U.S.C. § 1. There are two primary modes of analysis under Sherman Act § 1:
The Supreme Court has repeatedly recognized that by the language of the Sherman Act, “ ‘Congress intended to outlaw only unreasonable restraints.’ ” Texaco Inc. v. Dagher,547 U.S. 1 , 5,126 S.Ct. 1276 ,164 L.Ed.2d 1 (2006) (quoting State Oil Co. v. Khan,522 U.S. 3 , 10,118 S.Ct. 275 ,139 L.Ed.2d 199 (1997)). “[M]ost antitrust claims are analyzed under a ‘rule of reason,’ according to which the finder of fact must decide whether the questioned practice imposes an unreasonable restraint on competition, taking into account a variety offactors.... ” State Oil, 522 U.S. at 10 ,118 S.Ct. 275 ....
“Some types of restraints, however, have such predictable and pernicious anticompetitive effect, and such limited potential for proeompetitive benefit, that they are deemed unlawful per se.” State Oil,522 U.S. at 10 ,118 S.Ct. 275 . Such restraints “ ‘are conclusively presumed to be unreasonable and therefore illegal without elaborate inquiry as to the precise harm they have caused or the business excuse for their use.’ ” Nw. Wholesale Stationersl Inc. v. Pac. Stationery and Printing Co.], 472 U.S. [284,] 289,105 S.Ct. 2613 ,86 L.Ed.2d 202 [ (1985) ](quoting N. Pac. Ry. Co. v. United States,356 U.S. 1 , 5,78 S.Ct. 514 ,2 L.Ed.2d 545 (1958)).
California ex rel. Harris v. Safeway, Inc.,
The distinction between the rule of reason and per se analysis is important for federal preemption, which requires “an irreconcilable conflict between the federal and state regulatory schemes.”
Rice v. Norman Williams Co.,
To determine whether a regulation facially conflicts with Sherman Act § 1, we first consider whether the challenged regulation involves (1) unilateral action by the state and is thus not subject to preemption (because there is no concerted action),
see id.
at 266-67,
In contrast, a hybrid restraint “may be attacked under [Sherman Act] § 1” as per se unreasonable.
824 Liquor Corp. v. Duffy,
In light of the foregoing principles, we must decide whether the PCI regulations go beyond the anticompetitive tendencies of a licensing requirement and actually delegate a degree of regulatory power to incumbent licensees.
10
Memorial argues
2. The PCI Regulations Impose a Barrier to Entry
The Washington legislature ordered the Department to promulgate a certificate of need requirement for elective PCI addressing, “at a minimum, factors related to access to care, patient safety, quality outcomes, costs, and the stability of Washington’s cardiac care delivery system and of existing cardiac care providers.” Wash. Rev.Code § 70.38.128 (2007). In response, the Department promulgated regulations setting forth a variety of requirements for an elective PCI certificate of need. See Wash. Admin. Code §§ 246-310-700-755. Memorial challenges only the PCI regulations’ methodology for calculating a community’s need for an additional elective PCI provider. See Wash. Admin. Code § 246-310-745. As is apparent from the regulations, once the Department grants a hospital a certificate of need to perform elective PCI, the requirement that there be an unmet demand for 300 procedures before granting another certificate of need creates a barrier to entry for potential competing hospitals.
The Department calculates need based on dividing the state into 14 geographical markets (planning areas). See id. §§ 246-310-705(5), -745(10). A hospital applies for a certificate of need to serve a particular planning area. The Department then forecasts whether the planning area will have unmet demand for elective PCI procedures within five years. See id. § 246-310-745(10) (explaining a five-step numeric methodology). A planning area “needs” another provider of elective PCI only if projected demand exceeds current capacity by 300 procedures. See id. (Steps 4-5). 11
Projected demand is based on the planning area’s current “use rate” (procedures per 1,000 residents) in the “base year” and the planning area’s estimated population in the “forecast year,” five years into the future. Id. §§ 246-310-745(1), (3), (5) & (10) (Steps 1-2). Assuming a constant use rate, the Department projects demand in the forecast year. That is, the projected demand is the current “use rate” multiplied by the forecasted population. If the projected demand sufficiently exceeds the planning area’s current capacity, the Department will issue a certificate of need.
Current capacity is based on the volume of procedures performed by the planning area’s existing certified PCI providers in the base year. The planning area’s current capacity is “assumed to remain constant over the forecast period.”
Id.
§ 246-310-745(10) (Step 3). The Department calculates the planning area’s net need for an additional provider by subtracting the current capacity from the projected demand.
See id.
(Step 4). If the difference exceeds 300 procedures, the Department will issue one certificate of need for every 300 excess procedures. That is, if there is excess demand from 301 to 599 procedures, the Department will issue only a
3. The PCI Regulations are a Unilateral Restraint Not Subject to Preemption
Memorial’s challenge focuses on Step 3, which relies on incumbent certificate holders’ “current capacity” to define whether need exists for an additional licensee. Memorial argues that, because incumbent hospitals can expand their current capacity to meet demand, they can forestall entry of a competing PCI provider.
Memorial mistakes the barrier to entry created by the licensing requirement, and its attendant anticompetitive effects, for a hybrid restraint. The Department licenses the first certificate of need holder in a planning area to perform as many PCI procedures as it wishes. The logical and intended result of the PCI regulations is that the Department will issue a second certificate of need only if the incumbent does not expand its capacity to meet growing demand. The PCI regulations create market power, but that is different from a hybrid regulation that delegates regulatory power.
That the Department leaves open the number of procedures that an incumbent licensee may perform does not mean it delegates regulatory power to licensees. The restraint of trade is the licensing requirement — a barrier to entry — and it is complete upon enactment. The state imposes the licensing requirements. The state decides what the licensing requirements will be and whether they are met. The state does not delegate any aspect of need calculation to private parties. Admittedly, the state takes notice of whether incumbent providers are meeting the needs of the planning area, but that responsiveness to private activity does not amount to a hybrid restraint.
See Fisher,
Rather, the Department has decided that monopoly is preferable in the market for elective PCI; otherwise it would grant a second certificate when a planning area’s demand exceeded 600 procedures annually — that is, when the market would support two competing providers both able to perform the minimum 300 procedures annually. That a licensee meets the Department’s expectation and supplies all demand is the logical and intended consequence of the PCI regulations, not a delegation of regulatory power to the incumbent. Entry is prohibited by the Department’s decision to grant an unlimited license and then withhold additional licenses until the incumbent can no longer meet demand, not the incumbent’s natural inclination to capitalize on the market power the licensing requirement creates.
Moreover, an incumbent provider’s discretion to increase supply unilaterally to meet demand is neither per se illegal nor recognizable as an element of a per se illegal agreement.
12
The only facet
Although this case deals with a barrier to entry, the ease law on hybrid and unilateral restraints involving price-fixing is instructive. For instance, horizontal price fixing is per se illegal.
See Dagher,
If the state fixes the price, however, the requirement that private parties adhere to the fixed price is a unilateral restraint. For example, in
Fisher,
the Supreme Court held that a regulation requiring private landlords to adhere to a maximum rent ceiling fixed by the state was a unilateral restraint.
See Fisher,
Memorial argues that incumbent certificate holders’ control over their PCI capacity makes them like the wholesalers in
Costco
(who were free to set their own
We made a similar distinction in
Costco,
which in addition to holding that a post- and-hold regulation was a hybrid restraint, held that a regulation requiring wholesalers to charge at least a 10-percent markup was a unilateral restraint. Although the minimum mark-up regulation “gave” private parties discretion to mark up higher than the minimum, the state did not create that discretion. Wholesalers could already mark up their prices unilaterally. The regulation simply created a floor on price competition without allowing private parties any role in setting what the floor would be. The regulated market was less competitive, but the restraint of trade was complete upon enactment of the regulation. Significantly, the state did not grant “to private parties a means to manipulate, and therefore control, the pricing decisions of other firms,” in contrast to post-and-hold regulations.
Costco,
In sum, “[t]he distinction between unilateral and concerted action is critical here” because the state unilaterally imposes the barrier to entry and unilaterally determines when to issue a new PCI license.
Fisher,
B. The Dormant Commerce Clause
Memorial’s complaint alleges that the PCI regulations violate the dormant Commerce Clause by placing an undue burden on interstate commerce.
16
If it were not for the licensing requirement, Memorial would offer elective PCI to out-of-state patients, as well as hire out-of-state doctors and import medical supplies from out-of-state to perform the procedures. There is no allegation of intentional discrimination against interstate commerce, but “[e]ven laws that are applied even-handedly and impose only an incidental burden on interstate commerce can be unconstitutional.”
Shamrock Farms Co. v. Veneman,
We must decide whether Memorial has standing to raise a dormant Commerce Clause challenge under Pike, and if so, whether the PCI regulations are immunized by congressional authorization. The ultimate question of whether the PCI regulations survive Pike scrutiny is not before us.
1. Memorial has standing to raise a dormant Commerce Clause challenge
Standing includes two components: Article III constitutional standing and prudential standing. See
City of L.A. v. Cnty. of Kern,
“The chief purpose underlying [the Commerce] Clause is to limit ‘the power of the States to erect barriers against interstate trade.’ ”
Washoe Cnty.,
“As the name implies, the zone of interests test turns on the
interest
sought to be protected, not the
harm
suffered by the plaintiff.”
Id.
at 848. Any alleged injury “must somehow be tied to a barrier imposed on interstate commerce.”
Id.
Here, the barrier to interstate commerce is the requirement of a certificate of need to offer elective PCI to
all
patients, in
The Department contends that Memorial lacks standing because it operates only an in-state hospital. The Commerce Clause, however, protects the vitality of the national market for goods and services, not the location of a particular participant, and thus a state burdens the rights of its own residents as well as those of other states when it burdens interstate commerce. Although the dormant Commerce Clause primarily targets discrimination against out-of-state economic activity, under
Pike
it prohibits all unjustifiable burdens on interstate commerce.
See Kleemvell Biohazard Waste and Gen. Ecology Consultants, Inc. v. Nelson,
2. Congress has not authorized the 2008 PCI regulations
“It is well established that Congress may authorize the States to engage in regulation that the Commerce Clause would otherwise forbid.”
Maine v. Taylor,
The district court granted judgment on the pleadings to the Department because it concluded Congress had authorized certificate of need programs in the National Health Planning and Resources Development Act of 1974 (NHPRDA).
See supra
n. 4. Although recognizing that the NHPRDA had been repealed in 1986 before the Department promulgated the challenged regulations in 2008, the district court accepted the repealed statute as a prima facie authorization and erroneously put the burden on Memorial to prove the significance of repeal. We reverse because the Department has failed to show that the NHPRDA, a statute repealed without a savings clause, provides the requisite clear statement of authorization for the 2008 PCI regulations.
18
We do not decide whether the NHPRDA is sufficient
The Department argues that the NHPRDA was a clear statement of authorization for certificate of need regimes because the statute made them a condition of federal funding. Memorial disputes whether this suffices as a sufficiently clear statement of authorization, but we need not decide the question. Whatever the NHPRDA authorized prior to 1986, after Congress repealed the statute there was no NHPRDA left to authorize a regulation promulgated in 2008. For more than a century, “the general rule ... [has been] that when an act of the legislature is repealed, it must be considered, except as to transactions past and closed, as if it never existed.”
Ex Parte McCardle,
Had Congress meant to perpetuate its alleged authorization for certificate of need programs, it could have included a savings clause in the repeal.
19
The savings clause would then itself be an unmistakably clear statement of authorization. Savings clauses can be used to preserve state authority from implied preemption when Congress passes a statute.
See, e.g., Telesaurus VPC, LLC v. Power,
It is also with great pleasure that I can finally lay to rest the Federal health planning authorities. I have sought their repeal since I assumed office. These authorities, while perhaps well-intentioned when they were enacted in the 1970’s, have only served to insert the Federal Government into a process that is best reserved to the marketplace. Healthplanning has proved to be a process that was costly to the Federal Government, in the last analysis without benefit, and even detrimental to the rational allocation of economic resources for health care.
CONCLUSION
We hold that there is no antitrust preemption because the PCI regulations are a unilateral restraint of trade not subject to preemption. We also hold that Memorial has standing to raise a dormant Commerce Clause challenge under Pike, because the PCI regulations burden the free flow of commerce to Memorial’s financial detriment. We reverse judgment on the dormant Commerce Clause claim, however, because the Department failed to prove congressional authorization for its PCI certificate of need regulations. We remand for further proceedings on Memorial’s dormant Commerce Clause claim consistent with this opinion. The parties shall bear their own costs.
AFFIRMED IN PART, REVERSED IN PART, REMANDED.
Notes
. See Wash. Admin Code § 246-310-705(4) (defining PCI as including, but not limited to, seven “mechanical procedures and devices that are used by cardiologists for the revascularization of obstructed coronary arteries”); see also id. § 246-310-745(4) (defining PCI by reference to "diagnosis related groups” developed under a Centers for Medicare and Medicaid Services contract).
. See Wash. Admin. Code § 246-310-705(2) (defining "elective” to mean "a PCI performed on a patient with cardiac function that has been stable in the days or weeks prior to the operation,” which is "usually scheduled at least one day prior to the surgical procedure”). The licensing requirement only applies to “adult” procedures, see id. § 246-310-700, which includes only those "performed on the planning area residents over fifteen years of age,” Id. § 246-310-745(10) (Step lb).
.For a statement of purpose,
see
Wash. Rev. Code §§ 70.38.015(2), 115; Wash. Admin. Code § 246-310-001;
Overtake Hosp. Ass'n v. Dep't of Health,
. See Pub.L. 93-641, 88 Stat. 2225, §§ 1-3 (1975) (formerly codified at 42 U.S.C. § 300k-300n-5) (repealed by Pub.L. 99-660, title VII, § 701(a), 100 Stat. 3743, 3799 (1986)).
. Washington, along with 23 other states, had a certificate of need program prior to 1979. However, Washington enacted its current program in direct response to Congress’ enactment of the NHPRDA.
. In granting the Rule 12(c) motion, the district court declined to consider two expert reports submitted by Memorial months after briefing and argument on the motion had concluded, because the reports were outside of the pleadings. Memorial appeals that decision, but the argument merits little discussion. Judgment on the pleadings is limited to material included in the pleadings.
See Schneider v. California Dept. of Corrections,
.
See also Hoover v. Rortwin,
. A hybrid regulation is only
potentially
preempted because the private discretionary conduct it incorporates may not "in all cases [be] a
per se
violation.”
Sanders,
Even a per se illegal hybrid restraint may be saved from preemption by the "state action” immunity doctrine.
See Fisher,
. General statements that a restraint is hybrid because "the federal anti-trust laws pre-empt state laws authorizing or compelling private parties to engage in anticompetitive behavior,”
324 Liquor,
.
See Rebel Oil Co. v. Atlantic Richfield Co.,
. See also Wash. Admin. Code §§ 246-310-010(58), -715(2). If a planning area's net need is negative, the Department may revoke existing certificates of need. See Wash. Admin. Code §§ 246-310-715(2), -755(a).
. At worst, capacity expansion, if motivated by a specific intent to monopolize with a dangerous probability of success, might be attempted monopolization under Sherman Act § 2, but that could not be decided on a facial challenge and thus could not warrant preemption.
See Fisher,
. Horizontal market division is a "classic per se antitrust violation.”
United States v. Brown,
. The Supreme Court reached a similar result in holding preempted a regulation that compelled vertical resale price maintenance but allowed wholesalers to fix the price.
See 324 Liquor,
. Memorial complains that by rejecting its allegation that the PCI regulations are a hybrid restraint of trade, the district court did not construe the facts alleged in the complaint in its favor. Whether a regulation is a hybrid restraint of trade is a question of law,
see
Phillip E. Areeda & Herbert Hovenkamp, Antitrust Law, vol. XI ¶ 1909b (2d ed.2000) (explaining that identification of per se illegal restraints is a question of law, citing
Arizona v. Maricopa Cnty. Med. Soc’y,
. The Commerce Clause of the Constitution explicitly grants Congress authority to regulate interstate commerce.
See
U.S. Const, art. I, § 8, cl. 3. As a corollary, the Commerce Clause implicitly limits the regulatory authority of the states over interstate commerce. This inference is commonly referred to as the dormant Commerce Clause.
See Nat’l Ass’n of Optometrists & Opticians LensCrafters, Inc.
v.
Brown,
. Recognizing that Article III standing is jurisdictional and can neither be waived by the parties nor ignored by the court, we are independently satisfied that Memorial has Article III standing under
Lujan v. Defenders of Wildlife,
. The burden did not fall on Memorial to rebut the alleged clear statement in the
. The repeal stated:
Sec. 701. Repeal of Title XV (a) Repeal — Title XV of the Public Health Services Act is repealed effective January 1, 1987.
(b) Funds — The repeal made by subsection (a) shall not affect any funds obligated for the purposes of title XV of the Public Health Service Act before January 1, 1987.
Pub.L. No. 99-660, tit. VII, § 701, 100 Stat. 3743, 3799 (1986).
. President Reagan said:
