Court Opinion

ID: 9770638
Source: CourtListenerOpinion
Date Created: 2023-08-29 16:15:36.207241+00
Date Added: 2024-06-11T15:37:23.777978
License: Public Domain

MARTIN, J., delivered the opinion of the court, in which SUTTON, J., and GRAHAM, D.J., concurred as to Parts I (background) and II (subject matter jurisdiction) and in which SUTTON, J., concurred in the judgment. SUTTON, J. (pp. 549-66), delivered the opinion of the court as to Part I (taxing power) of his opinion, in which GRAHAM, D.J., joins. GRAHAM, D.J. (pp. 566-73), delivered a separate opinion concurring in part and dissenting in part.
OPINION
BOYCE F. MARTIN, JR., Circuit Judge.
This is an appeal from the district court’s determination that the minimum coverage provision of the Patient Protection and Affordable Care Act1 is constitutionally sound. Among the Act’s many changes to the national markets in health care delivery and health insurance, the minimum coverage provision requires all applicable individuals to maintain minimum essential health insurance coverage or to pay a penalty. 26 U.S.C. § 5000A.
Plaintiffs include Thomas More Law Center, a public interest law firm, and four individuals: Jann DeMars, John Ceci, Steven Hyder, and Salina Hyder.2 The individual plaintiffs are United States citizens, Michigan residents, and federal taxpayers who claim that the minimum coverage provision unconstitutionally compels them to purchase health insurance. Thomas More does not assert any injury to itself as an organization or employer, but rather objects to the provision on behalf of its members.
*534Plaintiffs sought a declaration that Congress lacked authority under the Commerce Clause to pass the minimum coverage provision, and alternatively a declaration that the penalty is an unconstitutional tax. The district court held that the minimum coverage provision falls within Congress’s authority under the Commerce Clause for two principal reasons: (1) the provision regulates economic decisions regarding how to pay for health care that have substantial effects on the interstate health care market; and (2) the provision is essential to the Act’s larger regulation of the interstate market for health insurance. Because the district court found the provision to be authorized by the Commerce Clause, it declined to address whether it was a permissible tax under the General Welfare Clause. The district court denied plaintiffs’ motion for a preliminary injunction, and they appeal.
This opinion is divided into several parts. First, it provides background on the Affordable Care Act and the minimum coverage provision. Second, it addresses this Court’s jurisdiction. Third, it considers whether the provision is authorized by the Commerce Clause of the Constitution. Fourth, it declines to address whether the provision is authorized by the General Welfare Clause. We find that the minimum coverage provision is a valid exercise of legislative power by Congress under the Commerce Clause and therefore AFFIRM the decision of the district court.
I. BACKGROUND
Congress found that the minimum coverage provision is an essential cog in the Affordable Care Act’s comprehensive scheme to reform the national markets in health care delivery and health insurance. The Act contains five essential components designed to improve access to the health care and health insurance markets, reduce the escalating costs of health care, and minimize cost-shifting. First, the Act builds upon the existing nationwide system of employer-based health insurance. It establishes tax incentives for small businesses to purchase health insurance for their employees, 26 U.S.C. § 45R, and requires certain large employers to offer health insurance to their employees, id. § 4980H. Second, the Act provides for the creation of state-operated “health benefit exchanges.” These exchanges allow individuals and small businesses to leverage their collective buying power to obtain price-competitive health insurance. 42 U.S.C. § 18031. Third, the Act expands federal programs to assist the poor with obtaining health insurance. For eligible individuals who purchase insurance through an exchange, the Act offers federal tax credits for payment of health insurance premiums, 26 U.S.C. § 36B, and authorizes federal payments to help cover out-of-pocket expenses, 42 U.S.C. § 18071. The Act also expands eligibility for Medicaid. Id. § 1396a(a)(10)(A)(i)(VIH). Fourth, the Act bars certain practices in the insurance industry that have prevented individuals from obtaining and maintaining health insurance. The guaranteed issue requirement bars insurance companies from denying coverage to individuals with preexisting conditions, id. §§ 300gg-l(a), 300gg-3(a), and the community rating requirement prohibits insurance companies from charging higher rates to individuals based on their medical history, id. § 300gg.
Finally, the Act’s “Requirement to Maintain Minimum Essential Coverage,” 26 U.S.C. § 5000A, takes effect in 2014 and requires every “applicable individual” to obtain “minimum essential coverage” for each month. The Act directs the Secretary of Health and Human Services in coordination with the Secretary of the *535Treasury to define the required essential health benefits, which must include at least ten general categories of services. 42 U.S.C. § 18022(b)(1).
Applicable individuals who fail to obtain minimum essential coverage must include with their annual federal tax payment a “shared responsibility payment,” which is a “penalty” calculated based on household income. 26 U.S.C. § 5000A(b), (c). The Act exempts from its penalty provision certain individuals, including those deemed to suffer a hardship with respect to their capability to obtain coverage. Id. § 5000A(e).
A number of Congressional findings accompany the minimum coverage requirement. Congress determined that “the Federal Government has a significant role in regulating health insurance,” and “[t]he requirement is an essential part of this larger regulation of economic activity.” 42 U.S.C. § 18091(a)(2)(H). Congress found that without the minimum coverage provision, other provisions in the Act, in particular the guaranteed issue and community rating requirements, would increase the incentives for individuals to “wait to purchase health insurance until they needed care.” Id. § 18091(a)(2)(I). This would exacerbate the current problems in the markets for health care delivery and health insurance. See id. Conversely, Congress found that “[b]y significantly reducing the number of the uninsured, the [minimum coverage] requirement, together with the other provisions of this Act, will lower health insurance premiums.” Id. § 18091(a)(2)(F). Congress concluded that the minimum coverage provision “is essential to creating effective health insurance markets in which improved health insurance products that are guaranteed issue and do not exclude coverage of pre-existing conditions can be sold.” Id. § 18091(a)(2)®.
II. DOES THIS COURT HAVE JURISDICTION OVER PLAINTIFFS’ CLAIM?
A. Standing and Ripeness
Our first duty is to determine whether this is a “case or controversy” within the meaning of Article III of the Constitution such that we have judicial power to review this issue. Nat'l Rifle Ass’n of Am. v. Magaw, 132 F.3d 272, 279 (6th Cir.1997). “We review issues of justiciability pursuant to Article III de novo.” Id. at 278. Standing requires plaintiffs to demonstrate “actual present harm or a significant possibility of future harm.” Id. at 279. “[T]he presence of one party with standing is sufficient to satisfy Article Ill’s case-or-controversy requirement.” Rumsfeld v. Forum for Academic & Institutional Rights, Inc., 547 U.S. 47, 52 n. 2, 126 S.Ct. 1297, 164 L.Ed.2d 156 (2006). An issue must be ripe, or ready for review, before we act. “Ripeness requires that the injury in fact be certainly impending.” Nat’l Rifle Ass’n of Am., 132 F.3d at 280 (internal quotation marks and citation omitted).
Article III gives claimants standing to file a lawsuit in federal court if they establish injury, causation, and redressability. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). There is little to talk about with respect to the last two requirements: The United States caused the alleged injury by enacting the minimum coverage provision, and a favorable decision would redress the injury by invalidating the provision. There is more to talk about with respect to the injury requirement.
There are two potential theories of injury — “actual” present injury and “imminent” future injury, id. at 560, 112 S.Ct. 2130 — and plaintiffs satisfy both of them. *536As to actual injury, the declarations of Ceci and Steven Hyder show that the impending requirement to buy medical insurance on the private market has changed their present spending and saving habits. See John Ceci May 27, 2011 Decl. ¶¶ 7-8; Steven Hyder May 28, 2011 Deck ¶ 8.
Ceci and Steven Hyder filed these declarations, it is true, after a third plaintiff, Jann DeMars, obtained private insurance during this appeal. These new declarations do not contradict anything that Ceci and Steven Hyder said in their earlier declarations, and there is nothing exceptional, or for that matter surprising, about the contents of them, which largely parallel the original DeMars declaration. The United States concedes that the original DeMars declaration established injury, Gov’t Letter Br. to this Court, at 3-5, as the district court concluded and we agree.
That leaves the objection to our consideration of the new declarations that they were filed during the pendency of this appeal. This development, however, occurred in response to another development during the appeal — the United States’s motion to dismiss filed in the aftermath of DeMars’s disclosure that she had obtained medical insurance. Out of an abundance of caution, we could remand the case to the district court to permit testimony and cross-examination about the contents of the declarations. However, the United States offers no reason to believe that anything in the declarations is untrue, and we cannot think of any such reason ourselves. The Federal Rules of Appellate Procedure permit the filing of affidavits on appeal, particularly in response to a motion filed by an opposing party, and so do court decisions in settings similar to this one. See Fed. RApp. P. 10(e); Ouachita Watch League v. Jacobs, 463 F.3d 1163, 1170-71 (11th Cir.2006); Cabalceta v. Standard Fruit Co., 883 F.2d 1553, 1554-55, 1560 (11th Cir.1989); cf. United States v. Murdock, 398 F.3d 491, 500 (6th Cir.2005).
Summers v. Earth Island Institute, 555 U.S. 488, 129 S.Ct. 1142, 173 L.Ed.2d 1 (2009), does not change matters. There, “[ajfter the District Court had entered judgment, and after the Government had filed its notice of appeal, respondents submitted additional affidavits to the District Court.” Id. at 1150 n. *. The Court did not consider the affidavits because “respondents had not met the challenge to their standing at the time of judgment [and] could not remedy the defect retroactively.” Id. No such problem arose here. In this case, the plaintiffs “met the challenge to their standing at the time of judgment,” and indeed the United States did not challenge that judgment on appeal. Only after DeMars purchased insurance and after the appeal had been filed did the United States file its motion to dismiss.
In addition to establishing a present actual injury, plaintiffs have shown imminent injury — “that the threatened injury is certainly impending.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 190, 120 S.Ct. 693, 145 L.Ed.2d 610 (2000). Imminence is a function of probability. And probabilities can be measured by many things, including the certainty that an event will come to pass. The uncertainty that the event will come to pass may be based on developments that may occur during a gap in time between the filing of a lawsuit and a threatened future injury. See 520 S. Mich. Ave. Assocs., Ltd. v. Devine, 433 F.3d 961, 962 (7th Cir.2006) (“Standing depends on the probability of harm, not its temporal proximity.”).
On March 23, 2010, Congress passed a law that goes into effect on January 1, 2014. As the plaintiffs see it, the law requires them to do something that *537the Constitution prohibits: require that they buy and maintain a minimum amount of medical insurance. When the plaintiff is an object of the challenged action “there is ordinarily little question that the action or inaction has caused him injury.” Defenders of Wildlife, 504 U.S. at 561-62, 112 S.Ct. 2130.
The only developments that could prevent this injury from occurring are not probable and indeed themselves highly speculative. Plaintiffs, true enough, could leave the country or die, and Congress could repeal the law. But these events are hardly probable and not the kinds of future developments that enter into the imminence inquiry. Riva v. Massachusetts, 61 F.3d 1003, 1011 (1st Cir.1995) (“The demise of a party or the repeal of a statute will always be possible in any case of delayed enforcement, yet it is well settled that a time delay, without more, will not render a claim of statutory invalidity unripe if the application of the statute is otherwise sufficiently probable.”).
Plaintiffs also could buy insurance between the passage of the law and its effective date. This is less speculative, as underscored by the reality that one of the individual plaintiffs purchased insurance during the last year. But it makes no difference to the imminence inquiry because one of plaintiffs’ theories is that Congress may not force individuals to buy or maintain private insurance.
Plaintiffs also could become exempt from the requirement because their income could fall below the tax filing threshold or a disaster could befall them, making them eligible for the hardship exception. This, too, is not probable, particularly when it comes to all three individual plaintiffs, to say nothing of all of the members of Thomas More Law Center.
In settings like this one, the Supreme Court has permitted plaintiffs to challenge laws well before their effective date. The Court has allowed challenges to go forward even though the complaints were filed almost six years and roughly three years before the laws went into effect. See New York v. United States, 505 U.S. 144, 153-54, 112 S.Ct. 2408, 120 L.Ed.2d 120 (1992); Pierce v. Soc’y of Sisters, 268 U.S. 510, 530, 536, 45 S.Ct. 571, 69 L.Ed. 1070 (1925); see also Village of Bensenville v. Fed. Aviation Admin., 376 F.3d 1114, 1119 (D.C.Cir.2004) (over thirteen years). While the point does not come up often, as most laws have immediate effective dates, these decisions establish that a lawsuit filed roughly three and a half years before the effective date of the law is not out of the ordinary.
Although Pierce and New York speak of justiciability only in terms of ripeness, their reasoning applies equally to standing here. At least in this context, where the only Article III question concerns the imminence of the plaintiffs’ injury, standing analysis parallels ripeness analysis. See Duke Power Co. v. Carolina Envtl. Study Grp., Inc., 438 U.S. 59, 81, 98 S.Ct. 2620, 57 L.Ed.2d 595 (1978) (“To the extent that issues of ripeness involve, at least in part, the existence of a live ‘Case or Controversy,’ our conclusion that appellees will sustain immediate injury ... and that such injury would be redressed by the relief requested would appear to satisfy this requirement.” (internal quotation marks omitted)); Warth v. Seldin, 422 U.S. 490, 499 n. 10, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975) (“The standing question ... bears close affinity to questions of ripeness — whether the harm asserted has matured sufficiently to warrant judicial intervention. ...”). Indeed if a defendant’s “ripeness arguments concern only” the “requirement that the injury be imminent rather than conjectural or hypothetical” then “it follows that our analysis of [the *538defendant’s] standing challenge applies equally and interchangeably to its ripeness challenge.” Brooklyn Legal Servs. Corp. v. Legal Servs. Corp., 462 F.3d 219, 225 (2d Cir.2006). Whether viewed through the lens of standing or of ripeness, the plaintiffs’ challenge meets the requirements of Article III, especially in the context of a pre-enforcement facial challenge.
In view of the probability, indeed virtual certainty, that the minimum coverage provision will apply to the plaintiffs on January 1, 2014, no function of standing law is advanced by requiring plaintiffs to wait until six months or one year before the effective date to file this lawsuit. There is no reason to think that plaintiffs’ situation will change. And there is no reason to think the law will change. By permitting this lawsuit to be filed three and one-half years before the effective date, as opposed to one year before the effective date, the only thing that changes is that all three layers of the federal judiciary will be able to reach considered merits decisions, as opposed to rushed interim (e.g., stay) decisions, before the law takes effect. The former is certainly preferable to the latter, at least in the current setting of this case.
Nor is their claim insufficiently “concrete and particularized.” Defenders of Wildlife, 504 U.S. at 560, 112 S.Ct. 2130. While “ ‘some day’ intentions” to travel somewhere or to do something that might implicate a federal law “do not support a finding of the ‘actual or imminent’ injury” that the cases demand, id. at 564,112 S.Ct. 2130, plaintiffs’ situations are not nearly so ephemeral. There is no trip that must be taken, no ticket that must be purchased, before the injury occurs. See id. at 564 n. 2, 112 S.Ct. 2130. The plaintiffs claim a constitutional right to be free of the minimum coverage provision, and the only thing saving them from it at this point is two and a half more years and an exceedingly concrete “some day”: January 1, 2014. See 26 U.S.C. § 5000A(a).
McConnell v. Federal Election Commission, 540 U.S. 93, 124 S.Ct. 619, 157 L.Ed.2d 491 (2003), does not undermine this conclusion. There the Court ruled that several plaintiffs did not have standing to challenge a provision of the Bipartisan Campaign Reform Act because their “alleged injury ... [was] too remote temporally.” Id. at 226, 124 S.Ct. 619. The McConnell plaintiffs filed a lawsuit in March 2002, 251 F.Supp.2d 176, 206 (D.D.C.2003), and “the earliest day [McConnell] could be affected by [the challenged provision was] 45 days before the Republican primary in 2008.” 540 U.S. at 226, 124 S.Ct. 619. The Court, however, could not know whether the plaintiffs would even suffer an injury six years later. Id. The challenged provision would affect the McConnell plaintiffs only if the following things happened in an election six years later: (1) a challenger ran in the primary or election; (2) the plaintiff created an advertisement mentioning the challenger; (3) the advertisement did not identify the plaintiff by name; and (4) the broadcasters attempted to charge McConnell more than their lowest unit rate for his ads. Id. at 224-25, 124 S.Ct. 619. A candidate cannot guarantee (much less prove) that another person will run against him six years down the road or that a broadcaster will offer him a less than favorable price, and it is unknowable what type of political advertisements the candidate will run when the time comes.
The plaintiffs have no similar problem in this case. The Act itself proves they will be required to purchase insurance and maintain it when the time comes. Unlike the McConnell plaintiffs, who had not taken any action that would subject them to the Act, the plaintiffs need not do anything to become subject to the Act. That, indeed, *539is their key theory — that mere “existence” should not be a basis for requiring someone to buy health insurance on the private market. Plaintiffs have standing to bring this claim.
B. Anti-Injunction Act
The United States and the plaintiffs now agree that the Anti-Injunction Act does not bar this action. Yet because this limitation goes to the subject matter jurisdiction of the federal courts, the parties’ agreement by itself does not permit us to review this challenge. 26 U.S.C. § 7421(a); see Arbaugh v. Y & H Corp., 546 U.S. 500, 515-16 & n. 11, 126 S.Ct. 1235, 163 L.Ed.2d 1097 (2006).
The Anti-Injunction Act says that “no suit for the purpose of restraining the assessment or collection of any tax shall be maintained in any court.” 26 U.S.C. § 7421(a). In language “at least as broad as the Anti-Injunction Act,” Bob Jones Univ. v. Simon, 416 U.S. 725, 732 n. 7, 94 S.Ct. 2038, 40 L.Ed.2d 496 (1974), the Declaratory Judgment Act forbids declaratory judgment actions “with respect to Federal taxes.” 28 U.S.C. § 2201(a).
The relevant terminology suggests that we may hear this action. While the Anti-Injunction Act applies only to “tax[es],” 26 U.S.C. § 7421(a), Congress called the shared-responsibility payment a “penalty.” See id. § 5000A. In many contexts, the law treats “taxes” and “penalties” as mutually exclusive. See, e.g., United States v. Reorganized CF & I Fabricators of Utah, Inc., 518 U.S. 213, 220, 116 S.Ct. 2106, 135 L.Ed.2d 506 (1996) (determining whether, under section 507(a)(7) of the Bankruptcy Code, a particular exaction was “a ‘tax’ [ ]as distinct from a ... penalty”); Dep’t of Revenue of Mont. v. Kurth Ranch, 511 U.S. 767, 784, 114 S.Ct. 1937, 128 L.Ed.2d 767 (1994) (determining that a provision labeled a “tax” was a penalty and therefore barred by the Double Jeopardy Clause); Bailey v. Drexel Furniture Co., 259 U.S. 20, 38, 42 S.Ct. 449, 66 L.Ed. 817 (1922) (construing Congress’s taxing power under Article I, § 8, cl. 1, based on “[t]he difference between a tax and a penalty”). Congress’s choice of words — barring litigation over “tax[es]” in section 7421 but imposing a “penalty” in section 5000A — suggests that the former does not cover the latter.
Other provisions of the Internal Revenue Code, to be sure, show that some “penalties” amount to “taxes” for purposes of the Anti-Injunction Act. Not surprisingly, for example, chapter 68 of the Revenue Code imposes “penalties” on individuals who fail to pay their “taxes.” 26 U.S.C. § 6651. Less obviously, but to similar effect, subchapter B of chapter 68 of the Revenue Code imposes other “penalties” related to the enforcement of traditional taxes. See, e.g., id. § 6676 (penalty for erroneously claiming refunds); id. § 6704 (penalty for failing to keep certain records). Under section 6671, “any reference in this title to ‘tax’ imposed by this title shall be deemed also to refer to the penalties and liabilities provided by [subchapter B of chapter 68].” See also id. §§ 6201; 6665(a)(2). All of these “penalties” thus count as “taxes,” including for purposes of the Anti-Injunction Act. See Herring v. Moore, 735 F.2d 797, 798 (5th Cir.1984) (per curiam); Souther v. Mihlbachler, 701 F.2d 131, 132 (10th Cir.1983) (per curiam); Prof'l Eng’rs, Inc. v. United States, 527 F.2d 597, 599 (4th Cir.1975). Otherwise, the recalcitrant tax protester could sue to preempt collection of a substantial monetary charge (accumulated penalties and interest) but not what will often be a smaller charge (the tax owed).
None of this affects the shared-responsibility payment, a penalty triggered by failure to comply with the minimum coverage *540provision. Section 5000A is not a penalty “provided by” chapter 68 of the Revenue Code. Congress placed the penalty in chapter 48 of the Revenue Code, and it did not include a provision treating the penalty as a “tax” in the title, as it did with penalties provided in chapter 68. Distinct words have distinct meanings. Congress said one thing in sections 6665(a)(2) and 6671(a), and something else in section 5000A, and we should respect the difference. That is particularly so where, as here, Congress had a reason for creating a difference: Unlike the penalties listed in chapter 68, the shared responsibility payment has nothing to do with tax enforcement. Cf. Mobile Republican Assembly v. United States, 353 F.3d 1357, 1362 n. 5 (11th Cir.2003) (holding that “tax penalties imposed for substantive violations of laws not directly related to the tax code” do not implicate the Anti-Injunction Act).
Section 5000A(g)(l), it is true, says that “[t]he penalty provided by this section shall be paid upon notice and demand by the Secretary, and ... shall be assessed and collected in the same manner as an assessable penalty under subchapter B of chapter 68.” 26 U.S.C. § 5000A(g)(l) (emphasis added). The assessable penalties under subchapter B in turn “shall be paid upon notice and demand by the Secretary, and shall be assessed and collected in the same manner as taxes.” Id. § 6671(a). In the context of a shared-responsibility payment to the United States for failing to buy medical insurance, however, the most natural reading of the provision is that the “manner” of assessment and collection mentioned in sections 5000A(g)(l) and 6671(a) refers to the mechanisms the Internal Revenue Service employs to enforce penalties, not to the bar against pre-enforcement challenges to taxes.
The same is true of other provisions in the Code treating penalties as taxes. All that section 6665(a)(2) and section 6671(a) show is that Congress intended to treat certain penalties as “taxes” in certain contexts. To read these provisions loosely to suggest that every penalty is a “tax” would render each particular provision superfluous. That conclusion makes all the more sense in the context of the Affordable Care Act, which prohibits the Internal Revenue Service from using the customary tools available for collecting taxes and penalties, the very tools the Anti-Injunction Act was enacted to protect. See Bob Jones Univ., 416 U.S. at 736, 94 S.Ct. 2038. In collecting the health care penalty, the Internal Revenue Service may not impose liens on an individual’s property, place levies on an individual’s pay, or bring criminal charges. 26 U.S.C. § 5000A(g)(2)(B). All that the Internal Revenue Service may do is one of two things. It may deduct past-due penalties from future tax refunds, a form of enforcement exceedingly unlikely to implicate the Anti-Injunction Act. Or it may bring a collection action, which most individuals would be unlikely to preempt — in truth invite — by bringing their own lawsuit. Last of all, because the minimum coverage provision does not come into effect until 2014 (and the penalty could not be assessed or collected until at least a year later), this lawsuit will hardly interfere with the “Government’s need to assess and collect taxes as expeditiously as possible.” Bob Jones Univ., 416 U.S. at 736, 94 S.Ct. 2038. Here, the Anti-Injunction Act does not remove our jurisdiction to consider this claim.
III. IS THE MINIMUM COVERAGE PROVISION A CONSTITUTIONAL EXERCISE OF CONGRESS’S COMMERCE POWER?
The question squarely presented here is whether the minimum coverage provision is consistent with the Commerce *541Clause of the Constitution. We review de novo plaintiffs’ constitutional challenge to the provision. See United States v. Bowers, 594 F.3d 522, 527 (6th Cir.2010). At the outset, it is important to note that our elected officials and the public hotly debated the merits and weaknesses of the Act before Congress voted, and will undoubtedly continue to in the future. However, it is not this Court’s role to pass on the wisdom of Congress’s choice. See, e.g., Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 197, 6 L.Ed. 23 (1824) (“The wisdom and the discretion of Congress, their identity with the people, and the influence which their constituents possess at elections[] are ... the sole restraints on which they have relied, to secure them from its abuse.”). We consider only whether the Constitution grants Congress the power to enact this legislation.
The minimum coverage provision, like all congressional enactments, is entitled to a “presumption of constitutionality,” and will be invalidated only upon a “plain showing that Congress has exceeded its constitutional bounds.” United States v. Morrison, 529 U.S. 598, 607, 120 S.Ct. 1740, 146 L.Ed.2d 658 (2000). The presumption that the minimum coverage provision is valid is “not a mere polite gesture. It is a deference due to deliberate judgment by constitutional majorities of the two Houses of Congress that an Act is within their delegated power....” United States v. Five Gambling Devices, 346 U.S. 441, 449, 74 S.Ct. 190, 98 L.Ed. 179 (1953).
A. The Supreme Court’s Commerce Clause Jurisprudence
In our dual system of government, the federal government is limited to its enumerated powers, while all other powers are reserved to the states or to the people. U.S. Const, amend. X. States have authority under their general police powers to enact minimum coverage provisions similar to the one in the Affordable Care Act. See Mass. Gen. Laws Ann. ch. 111M, § 2 (West 2011). However, the federal government has no police power and may enact such a law only if it is authorized by one of its enumerated powers. See, e.g., United States v. Lopez, 514 U.S. 549, 566, 115 S.Ct. 1624, 131 L.Ed.2d 626 (1995). Our task is to review the district court’s conclusion that Congress properly relied on its authority under the Commerce Clause to enact the minimum coverage provision.
Recognizing that uniform federal regulation is necessary in some instances, the Commerce Clause of the Constitution grants Congress the power “[t]o regulate commerce with foreign Nations, and among the several States, and with the Indian Tribes.” U.S. Const. Art. I, § 8, cl. 3. The Supreme Court has held that Congress has broad authority to regulate under the Commerce Clause. From 1937 to 1994 it did not invalidate a single law as unconstitutional for exceeding the scope of Congress’s Commerce Power. The Court has explained that Congress’s Commerce Clause power encompasses three broad spheres: (1) “the use of the channels of interstate commerce”; (2) “the instrumentalities of interstate commerce, or persons or things in interstate commerce”; and (3) “those activities having a substantial relation to interstate commerce, ... i.e., those activities that substantially affect interstate commerce.” Lopez, 514 U.S. at 558-59,115 S.Ct. 1624.
Because the United States does not contend that the minimum coverage provision falls within either of the first two categories, we proceed to consider whether the provision falls within Congress’s power to regulate activities that substantially affect interstate commerce. Current Supreme Court jurisprudence reveals that Congress *542may use this category of its Commerce Power to regulate two related classes of activity. First, it has long been established that Congress may regulate economic activity, even if wholly intrastate, if it substantially affects interstate commerce. See Gonzales v. Raich, 545 U.S. 1, 25, 125 S.Ct. 2195, 162 L.Ed.2d 1 (2005); Morrison, 529 U.S. at 610, 120 S.Ct. 1740; Lopez, 514 U.S. at 560, 115 S.Ct. 1624.
Second, Congress may also regulate even non-economic intrastate activity if doing so is essential to a larger scheme that regulates economic activity. For example, in Wickard v. Filburn, 317 U.S. 111, 63 S.Ct. 82, 87 L.Ed. 122 (1942), the Court upheld regulations limiting the amount of wheat that farmers could grow, even for non-commercial purposes. Even though producing and consuming homegrown wheat is non-economic intrastate activity, Congress rationally concluded that the failure to regulate this class of activities would undercut its broader regulation of the interstate wheat market. Id. at 127-28, 63 S.Ct. 82. This is because individuals would be fulfilling their own demand for wheat rather than resorting to the market, which would thwart Congress’s efforts to stabilize prices. Id. at 128-29, 63 S.Ct. 82. Similarly, in Gonzales v. Raich, the Court held that the federal Controlled Substances Act could be applied to prohibit the local cultivation and possession of marijuana authorized under California law. 545 U.S. at 19, 125 S.Ct. 2195. Leaving home-grown and home-consumed marijuana outside federal control would undercut Congress’s broader regulation of interstate economic activity. Id. Thus, Wickard and Raich establish that “Congress can regulate purely intrastate activity that is not itself ‘commercial,’ in that it is not produced for sale, if it concludes that failure to regulate that class of activity would undercut the regulation of the interstate market in that commodity.” Id. at 18,125 S.Ct. 2195.
Despite the Supreme Court’s broad interpretation of the Commerce Power, it has emphasized in two recent cases that this power is subject to real limits. In United States v. Lopez and United States v. Morrison, the Court struck down single-subject criminal statutes as beyond Congress’s power under the Commerce Clause. The Supreme Court held that the statutes at issue in these cases, the Gun Free School Zones Act and the Violence Against Women Act, exceeded Congress’s Commerce Clause power based on four main factors: (1) the statutes regulated non-economic, criminal activity and were not part of a larger regulation of economic activity; (2) the statutes contained no jurisdictional hook limiting their application to interstate commerce; (3) any Congressional findings regarding the effects of the regulated activity on interstate commerce were not sufficient to sustain constitutionality of the legislation; and (4) the link between the regulated activity and interstate commerce was too attenuated. See Morrison, 529 U.S. at 601-15, 120 S.Ct. 1740; Lopez, 514 U.S. at 561-67, 115 S.Ct. 1624. The Court found that accepting Congress’s proffered reasons for the statutes would have paved the way for Congress to regulate those quintessentially local actions that the Constitution left within the purview of the states. Morrison, 529 U.S. at 615-16,120 S.Ct. 1740.
B. Whether the Minimum Coverage Provision is a Valid Exercise of the Commerce Power under Lopez, Morrison, and Raich
In applying this jurisprudence, our first duty is to determine the class of activities that the minimum coverage provision regulates. See, e.g., Perez v. United States, 402 U.S. 146, 153-54, 91 S.Ct. 1357, *54328 L.Ed.2d 686 (1971) (directing courts to determine first whether the class of activities regulated by a statute is within the reach of Congress’s power). There is debate over whether the provision regulates activity in the market of health insurance or in the market of health care. In the most literal, narrow sense, the provision might be said to regulate conduct in the health insurance market by requiring individuals to maintain a minimum level of coverage. However, Congress’s intent and the broader statutory scheme may help to illuminate the class of activities that a provision regulates. See, e.g., Swift & Co. v. United States, 196 U.S. 375, 398, 25 S.Ct. 276, 49 L.Ed. 518 (1905) (“[C]ommerce among the states is not a technical legal conception, but a practical one, drawn from the course of business.”); United States v. Ambert, 561 F.3d 1202, 1212 (11th Cir.2009) (“Congress did not focus on individual local registration as an end in itself, but rather as part of its goal to create a system to track and regulate the movement of sex offenders from one jurisdiction to another.”). The Act considered as a whole makes clear that Congress was concerned that individuals maintain minimum coverage not as an end in itself, but because of the economic implications on the broader health care market. Virtually everyone participates in the market for health care delivery, and they finance these services by either purchasing an insurance policy or by self-insuring. Through the practice of self-insuring, individuals make an assessment of their own risk and to what extent they must set aside funds or arrange their affairs to compensate for probable future health care needs.3 Thus, set against the Act’s broader statutory scheme, the minimum coverage provision reveals itself as a regulation on the activity of participating in the national market for health care delivery, and specifically the activity of self-insuring for the cost of these services.
Plaintiffs challenge the minimum coverage provision on its face as an unconstitutional exercise of congressional authority. They accept the class of activities that the provision purports to reach: participating in the national market for health care services without maintaining insurance that meets the minimum coverage requirement. Unlike the plaintiffs in Raich, they do not attempt to carve out a subset class of activities and to deny that their conduct has substantial effects on interstate commerce. Rather, like the plaintiffs in Lopez and Morrison, they claim that the entire class of activities that the provision attempts to reach is beyond Congress’s power to regulate.4 In this Circuit, “[fjacial invalidation of a statute ... is reserved only for when there are no set of circumstances in which the statute’s application would be constitutional.” *544United States v. Faasse, 265 F.3d 475, 487 n. 10 (6th Cir.2001) (en banc); see also United States v. Salerno, 481 U.S. 739, 745, 107 S.Ct. 2095, 95 L.Ed.2d 697 (1987).
By regulating the practice of self-insuring for the cost of health care delivery, the minimum coverage provision is facially constitutional under the Commerce Clause for two independent reasons. First, the provision regulates economic activity that Congress had a rational basis to believe has substantial effects on interstate commerce. In addition, Congress had a rational basis to believe that the provision was essential to its larger economic scheme reforming the interstate markets in health care and health insurance.
1. The minimum coverage provision regulates economic activity with a substantial effect on interstate commerce
Congress may regulate economic activity, even if wholly intrastate, that substantially affects interstate commerce. See Raich, 545 U.S. at 25, 125 S.Ct. 2195; Morrison, 529 U.S. at 610, 120 S.Ct. 1740; Lopez, 514 U.S. at 560, 115 S.Ct. 1624. Additionally, “[w]e need not determine whether [the] activities, taken in the aggregate, substantially affect interstate commerce in fact, but only whether a ‘rational basis’ exists for so concluding.” Raich, 545 U.S. at 22, 125 S.Ct. 2195 (citing Lopez, 514 U.S. at 557, 115 S.Ct. 1624). Thus, our task is to determine whether self-insuring for the cost of health care services is an economic activity, and whether Congress had a rational basis to conclude that, in the aggregate, this activity substantially affects interstate commerce.
The minimum coverage provision regulates activity that is decidedly economic. In Raich, the Supreme Court explained that “ ‘[ejconomics’ refers to ‘the production, distribution, and consumption of commodities.’ ” Id. at 25,125 S.Ct. 2195 (quoting Webster’s Third New International Dictionary 720 (1966)). Consumption of health care falls squarely within Raich’s definition of economics, and virtually every individual in this country consumes these services. Individuals must finance the cost of health care by purchasing an insurance policy or by self-insuring, cognizant of the backstop of free services required by law. By requiring individuals to maintain a certain level of coverage, the minimum coverage provision regulates the financing of health care services, and specifically the practice of self-insuring for the cost of care. The activity of foregoing health insurance and attempting to cover the cost of health care needs by self-insuring is no less economic than the activity of purchasing an insurance plan. Thus, the financing of health care services, and specifically the practice of self-insuring, is economic activity.
Furthermore, Congress had a rational basis to believe that the practice of self-insuring for the cost of health care, in the aggregate, substantially affects interstate commerce. An estimated 18.8% of the non-elderly United States population (about 50 million people) had no form of health insurance for 2009. U.S. Census Bureau, Income, Poverty, and Health Insurance Coverage in the United States: 2009, at 23, table 8 (2010). Virtually everyone requires health care services at some point, and unlike nearly all other industries, the health care market .is governed by federal and state laws requiring institutions to provide services regardless of a patient’s ability to • pay. The uninsured cannot avoid the need for health care, and they consume over $100 billion in health care services annually. Families *545USA, Hidden Health Tax: Americans Pay a Premium, at 2 (2009). The high cost of health care means that those who self-insure, as a class, are unable to pay for the health care services that they receive. Congress found that the aggregate cost of providing uncompensated care to the uninsured in 2008 was $43 billion. 42 U.S.C. § 18091(a)(2)(F). Congress also determined that the cost of uncompensated care is passed on from providers “to private insurers, which pass on the cost to families.” Id. This cost-shifting inflates the premiums that families must pay for their health insurance “by on average over $1,000 a year.” Id. Rising premiums push even more individuals out of the health insurance market, further increasing the cost-of health insurance and perpetuating the cycle. See 17 Million and Counting: Why the Health Care Marketplace Is Broken: Hearing Before the S. Comm, on Finance, 110th Cong. 49 (2008) (Statement of Mark A. Hall). Thus, the practice of self-insuring substantially affects interstate commerce by driving up the cost of health care as well as by shifting costs to third parties.
Self-insuring for the cost of health care directly affects the interstate market for health care delivery and health insurance. These effects are not at all attenuated as were the links between the regulated activities and interstate commerce in Lopez and Morrison. Similar to the causal relationship in Wickard, self-insuring individuals are attempting to fulfill their own demand for a commodity rather than resort to the market and are thereby thwarting Congress’s efforts to stabilize prices. Therefore, the minimum coverage provision is a valid exercise of the Commerce Power because Congress had a rational basis for concluding that, in the aggregate, the practice of self-insuring for the cost of health care substantially affects interstate commerce.
2. The minimum coverage provision is an essential part of a broader economic regulatory scheme
Alternatively, even if self-insuring for the cost of health care were not economic activity with a substantial effect on interstate commerce, Congress could still properly regulate the practice because the failure to do so would undercut its regulation of the larger interstate markets in health care delivery and health insurance. In Raich, the Supreme Court explained that Congress can regulate non-commercial intrastate activity if it concludes that it is necessary in order to regulate a larger interstate market. 545 U.S. at 18, 125 S.Ct. 2195. The Court found relevant that unlike the single-subject criminal statutes at issue in Morrison and Lopez, the classification of marijuana at issue in Raich was “merely one of many ‘essential part[s] of a larger regulation of economic activity, in which the regulatory scheme could be undercut unless the intrastate activity were regulated.’ ” Id. at 24-25, 125 S.Ct. 2195 (alteration in original) (quoting Lopez, 514 U.S. at 561, 115 S.Ct. 1624). The Raich Court highlighted two aspects of Congress’s broad power under the Commerce Clause. First, Congress may aggregate the effects of non-commercial activity and assess the overall effect on the interstate market. Id. at 22, 125 S.Ct. 2195. Second, the rational basis test applies to Congress’s judgment that regulating intrastate non-economic activity is essential to its broader regulatory scheme. Id. at 19, 125 S.Ct. 2195. Thus, where Congress comprehensively regulates interstate economic activity, it may regulate non-economic intrastate activity if it rationally believes that, in the aggregate, the failure to do so would undermine the effectiveness of the *546overlying regulatory scheme.5
We have applied this doctrine to uphold laws prohibiting intrastate possession of child pornography and intrastate transfer of firearms that are part of broader economic regulatory schemes. See, e.g., Bowers, 594 F.3d at 529 (“Raich indicates that Congress has the ability to regulate wholly intrastate manufacture and possession of child pornography, regardless of whether it was made or possessed for commercial purposes, that it rationally believes, if left unregulated in the aggregate, could work to undermine Congress’s ability to regulate the larger interstate commercial activity.”); United States v. Rose, 522 F.3d 710, 719 (6th Cir.2008) (“Congress had a rational basis for concluding that the intrastate transfer of firearms would undercut its regulation of the interstate firearms market. ...”). In addition, our sister circuits have applied this rationale in upholding laws requiring sex offender registration. See, e.g., United States v. Gould, 568 F.3d 459, 475 (4th Cir.2009) (“Requiring all sex offenders to register is an integral part of Congress’ regulatory effort and the regulatory scheme could be undercut unless the intrastate activity were regulated.” (internal quotation marks and citation omitted)); Ambert, 561 F.3d at 1211; United States v. Howell, 552 F.3d 709, 717 (8th Cir.2009). Similarly, Congress had a rational basis to conclude that failing to regulate those who self-insure would undermine its regulation of the interstate markets in health care delivery and health insurance.
As plaintiffs concede, Congress has the power under the Commerce Clause to regulate the interstate markets in health care delivery and health insurance. It has long been settled that “Congress plainly has power to regulate the price of [products] distributed through the medium of interstate commerce ... [and] it possesses every power needed to make that regulation effective.” United States v. Wrightwood Dairy Co., 315 U.S. 110, 118-19, 62 S.Ct. 523, 86 L.Ed. 726 (1942); see United States v. South-Eastern Underwriters Ass’n, 322 U.S. 533, 552-53, 64 S.Ct. 1162, 88 L.Ed. 1440 (1944). In doing so, Congress may decide “to give protection to sellers or purchasers or both.” Currin v. Wallace, 306 U.S. 1, 11, 59 S.Ct. 379, 83 L.Ed. 441 (1939). The Act uses this power to regulate prices and protect purchasers by banning certain practices in the insurance industry that have prevented individuals from obtaining and maintaining insurance coverage. Under the process of “medical underwriting,” insurance companies review each applicant’s medical history and health status to determine eligibility and premium levels. As a result of this practice, approximately thirty-six percent of applicants in the market for individual health insurance are denied coverage, charged a substantially higher premium, or offered only limited coverage that excludes pre-existing conditions. Department of Health and Human Services, Coverage Denied: How the Current Health Insurance System Leaves Millions Behind, at 1 (2009). The Act bans this practice through a guaranteed issue requirement, which bars insurance companies from denying coverage to individuals with preexisting conditions; and a community rating requirement, which prohibits insurance *547companies from charging higher rates to individuals based on their medical history. 42 U.S.C. §§ 300gg, 300gg-l(a), 300gg-3(a). No one denies that Congress properly enacted these reforms as part of its power to regulate the interstate markets in health care delivery and health insurance.
Furthermore, Congress had a rational basis for concluding that leaving those individuals who self-insure for the cost of health care outside federal control would undercut its overlying economic regulatory scheme. Congress found that without the minimum coverage provision, the guaranteed issue and community rating provisions would increase existing incentives for individuals to delay purchasing health insurance until they need care. Id. § 18091(a)(2)(I). The legislative record demonstrated that the seven states that had enacted guaranteed issue reforms without minimum coverage provisions suffered detrimental effects to their insurance markets, such as escalating costs and insurance companies exiting the market. In contrast, Congress found that “[i]n Massachusetts, a [minimum coverage] requirement has strengthened private employer-based coverage: despite the economic downturn, the number of workers offered employer-based coverage has actually increased.” Id. § 18091(a)(2)(D). It was reasonable for Congress to conclude that failing to regulate those who self-insure would “leave a gaping hole” in the Act. Cf. Raich, 545 U.S. at 22, 125 S.Ct. 2195 (holding that Congress had a rational basis to conclude that failing to regulate intrastate manufacture and possession of marijuana would “leave a gaping hole” in the Controlled Substances Act). Congress rationally found that the minimum coverage provision “is essential to creating effective health insurance markets in which improved health insurance products that are guaranteed issue and do not exclude coverage of pre-existing conditions can be sold.” 42 U.S.C. § 18091(a)(2)(I). Congress had a rational basis for concluding that the minimum coverage requirement is essential to its broader reforms to the national markets in health care delivery and health insurance. Therefore, the minimum coverage provision is a valid exercise of the Commerce Clause power.
C. Whether the Minimum Coverage Provision Impermissibly Regulates Inactivity
Thomas More argues that the minimum coverage provision exceeds Congress’s power under the Commerce Clause because it regulates inactivity. However, the text of the Commerce Clause does not acknowledge a constitutional distinction between activity and inactivity, and neither does the Supreme Court. Furthermore, far from regulating inactivity, the provision regulates active participation in the health care market.
As long as Congress does not exceed the established limits of its Commerce Power, there is no constitutional impediment to enacting legislation that could be characterized as regulating inactivity. The Supreme Court has never directly addressed whether Congress may use its Commerce Clause power to regulate inactivity, and it has not defined activity or inactivity in this context. However, it has eschewed defining the scope of the Commerce Power by reference to flexible labels, and it consistently stresses that Congress’s authority to legislate under this grant of power is informed by “broad principles of economic practicality.” Lopez, 514 U.S. at 571, 115 S.Ct. 1624 (Kennedy, J., concurring); see Wickard, 317 U.S. at 120, 63 S.Ct. 82 (explaining that Congress’s power cannot be determined “by reference to any formula which would give controlling force to nomenclature such as ‘production’ and ‘in*548direct’ and foreclose consideration of the actual effects of the activity in question upon interstate commerce”).
Similarly, this Court has also refused to focus on imprecise labels when determining whether a statute falls within Congress’s Commerce Power. For example, we rejected the argument that the Child Support Recovery Act is unconstitutional because it regulates an individual’s failure to place an item in commerce. Instead, we held that Congress had a rational basis for concluding that a non-custodial spouse’s failure to send court-ordered child support payments across state lines substantially affects interstate commerce. Faasse, 265 F.3d at 490-91; accord United States v. Black, 125 F.3d 454, 462 (7th Cir.1997); United States v. Parker, 108 F.3d 28, 30 (3d Cir.1997); United States v. Hampshire, 95 F.3d 999, 1004 (10th Cir.1996). Focusing on the broader economic landscape of the legislation revealed the unworkability of relying on inexact labels because there was “no principled distinction between the parent who fails to send any child support through commerce and the parent who sends only a fraction of the amount owed.” Faasse, 265 F.3d at 487 n. 9. Here, too, the constitutionality of the minimum coverage provision cannot be resolved with a myopic focus on a malleable label. Congress had a rational basis for concluding that the practice of self-insuring for the cost of health care has a substantial effect on interstate commerce, and that the minimum coverage provision is an essential part of a broader economic regulatory scheme. Thus, the provision is constitutional notwithstanding the fact that it could be labeled as regulating inactivity.
Furthermore, far from regulating inactivity, the minimum coverage provision regulates individuals who are, in the aggregate, active in the health care market. The Supreme Court has stated that “when it is necessary in order to prevent an evil to make the law embrace more than the precise thing to be prevented [Congress] may do so.” Westfall v. United States, 274 U.S. 256, 259, 47 S.Ct. 629, 71 L.Ed. 1036 (1927). The vast majority of individuals are active in the market for health care delivery because of two unique characteristics of this market: (1) virtually everyone requires health care services at some unpredictable point; and (2) individuals receive health care services regardless of ability to pay.
Virtually everyone will need health care services at some point, including, in the aggregate, those without health insurance. Even dramatic attempts to protect one’s health and minimize the need for health care will not always be successful, and the health care market is characterized by unpredictable and unavoidable needs for care. The ubiquity and unpredictability of the need for medical care is born out by the statistics. More than eighty percent of adults nationwide visited a doctor or other health care professional one or more times in 2009. Centers for Disease Control and Prevention National Center for Health Statistics, Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2009, table 35 (2010). Additionally, individuals receive health care services regardless of whether they can afford the treatment. The obligation to provide treatment regardless of ability to pay is imposed by the Emergency Medical Treatment and Active Labor Act, 42 U.S.C. § 1395dd, state laws, and many institutions’ charitable missions. The unavoidable need for health care coupled with the obligation to provide treatment make it virtually certain that all individuals will require and receive health care at some point. Thus, although there is no firm, constitutional bar that prohibits Congress from placing regulations on what could be described as inactivity, even if there were *549it would not impact this case due to the unique aspects of health care that make all individuals active in this market.
IV. IS THE MINIMUM COVERAGE PROVISION A CONSTITUTIONAL EXERCISE OF CONGRESS’S TAXING POWER?
In light of the conclusion that the minimum coverage provision is a valid exercise of Congress’s power under the Commerce Clause, it is not necessary to resolve whether the provision could also be sustained as a proper exercise of Congress’s power to tax and spend under the General Welfare Clause, U.S. Const. Art. I, § 8, cl. 1.
V. CONCLUSION
Congress had a rational basis for concluding that, in the aggregate, the practice of self-insuring for the cost of health care substantially affects interstate commerce. Furthermore, Congress had a rational basis for concluding that the minimum coverage provision is essential to the Affordable Care Act’s larger reforms to the national markets in health care delivery and health insurance. Finally, the provision regulates active participation in the health care market, and in any case, the Constitution imposes no categorical bar on regulating inactivity. Thus, the minimum coverage provision is a valid exercise of Congress’s authority under the Commerce Clause, and the decision of the district court is AFFIRMED.

. Pub.L. No. 111-148, 124 Stat. 119 (2010), amended by the Health Care and Education Reconciliation Act of 2010, Pub.L. No. 111-152, 124 Stat. 1029.

. Jann DeMars and Steven Hyder are members of Thomas More, while John Ceci and Salina Hyder are not.

. We use the term self-insurance for ease of discussion. We note, however, that it is actually a misnomer because no insurance is involved, and might be better described as risk retention.

. If a group of plaintiffs brought an as-applied challenge, in contrast, they would claim that their conduct does not have substantial effects on interstate commerce, either because they never access the health care market or because they are fully capable of paying for any health care services that they consume. We have no occasion to address these situations in detail but note only that if the minimum coverage provision is facially constitutional, then it is difficult to imagine a circumstance under which an as-applied Commerce Clause challenge to the provision would succeed. See, e.g., United States v. Maxwell, 446 F.3d 1210, 1215 n. 5 (11th Cir.2006) ("[Raich] leaves some doubt as to whether, in the Commerce Clause context, an as-applied challenge may ever be sustained so long as Congress may constitutionally regulate the broader class of activities of which the intrastate activity is a part....”).

. The Supreme Court has applied this larger regulatory scheme doctrine only in Raich, which addressed an as-applied challenge, while this case involves a facial challenge. However, because the larger regulatory scheme doctrine was articulated in Lopez, which addressed a facial challenge, it applies to facial challenges as well. See Lopez, 514 U.S. at 561, 115 S.Ct. 1624 ("[The Gun-Free School Zones Act] is not an essential part of a larger regulation of economic activity, in which the regulatory scheme could be undercut unless the intrastate activity were regulated.”).