Whether 42 U.S.C. 405(h), incorporated into the Medicare Act by 42 U.S.C. 1395ii, permits skilled nursing facilities participating in the Medicare program to bring anticipatory, pre-enforcement lawsuits under 28 U.S.C. 1331 and 1346 (1994 & Supp. III 1997) to challenge the validity of Medicare program enforcement regulations and guidelines notwithstanding the Medicare Act's provision of an express, post-enforcement mechanism for administrative and judicial review.






In the Supreme Court of the United States

No. 98-1109
DONNA E. SHALALA, SECRETARY OF HEALTH AND
HUMAN SERVICES, ET AL., PETITIONERS

v.

ILLINOIS COUNCIL ON LONG TERM CARE, INC.

ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE SEVENTH CIRCUIT

BRIEF FOR THE PETITIONERS

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-12a) is reported at 143 F.3d 1072. The memorandum and order of the district court (Pet. App. 13a-21a) is unreported.

The judgment of the court of appeals was entered on May 8, 1998. A petition for rehearing was denied on August 13, 1998 (Pet. App. 22a-23a). On November 2 and December 4, 1998, Justice Stevens extended the time within which to file a petition for a writ of certiorari, first to December 12, 1998, and then to January 10, 1999, a Sunday. The petition was filed on Monday, January 11, 1999, and was granted on April 19, 1999. The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1).

STATUTORY AND REGULATORY PROVISIONS INVOLVED
Pertinent statutory and regulatory provisions are set forth in the appendix to this brief.

The Health Insurance for the Aged Act, commonly known as the Medicare Act, Pub. L. No. 89-97, 79 Stat. 290, codified as amended, 42 U.S.C. 1395 et seq., provides insurance for covered in-patient hospital and post-hospital services, 42 U.S.C. 1395x(m), including skilled nursing care. 42 U.S.C. 1395f(b)(1), 1395i-3, 1395x(v)(1)(A).1 To receive payment for services provided to Medicare beneficiaries, a skilled nursing facility must enter into a provider agreement with the Secretary of Health and Human Services (HHS), and meet "requirements of participation" relating to beneficiary health, safety, and care. See 42 U.S.C. 1395i-3(a) to (d). Respondent, a trade association that represents nursing facilities participating in the Medicare program in Illinois, brought this suit to challenge the methods by which the Secretary assesses compliance with Medicare's health, safety, and quality-of-care requirements and selects remedies when noncompliance is detected. The question before the Court is whether a federal district court may entertain such a pre-enforcement challenge under the general grant of federal-question jurisdiction contained in 28 U.S.C. 1331, notwithstanding the Medicare Act's provision of express post-enforcement mechanisms for judicial review.
1. The Social Security Act was passed in 1935 to provide retirement and related benefits for the elderly. See ch. 531, 49 Stat. 620. Four years later, Congress amended the Act by adding express provisions for administrative and judicial review. See Social Security Act Amendments of 1939, ch. 666, 53 Stat. 1360; see S. Rep. No. 734, 76th Cong., 1st Sess. 51 (1939); H.R. Rep. No. 728, 76th Cong., 1st Sess. 42 (1939). Those provisions now appear (as amended) at 42 U.S.C. 405(b), (g) and (h).
Section 405(b) provides that any individual who is dissatisfied with an agency determination is entitled to "notice and opportunity for a hearing with respect to" the determination. 42 U.S.C. 405(b). Section 405(g), in turn, provides that anyone dissatisfied with a "final decision * * * made after a hearing to which he was a party may * * * obtain a review of such decision by" filing an action in district court. 42 U.S.C. 405(g). Finally, 42 U.S.C. 405(h) renders the administrative and judicial review procedures under Section 405(b) and (g) exclusive. It declares:
The findings and decisions of the Commissioner of Social Security after a hearing shall be binding upon all individuals who were parties to such hearing. No findings of fact or decision of the Commissioner of Social Security shall be reviewed by any person, tribunal, or governmental agency except as herein provided. No action against the United States, the Commissioner of Social Security, or any officer or employee thereof shall be brought under sections 1331 or 1346 of title 28 to recover on any claim arising under this subchapter.
42 U.S.C. 405(h). (Section 1331 of Title 28 accords federal courts general federal-question jurisdiction, and 28 U.S.C. 1346 provides jurisdiction over cases in which the United States is a defendant.)
In 1965, Congress amended the Social Security Act by adding Title XVIII-the Medicare Act-to furnish medical insurance for the elderly and disabled. Pub. L. No. 89-97, § 102, 79 Stat. 291, codified as amended at 42 U.S.C. 1395 et seq.; see p. 1, supra. Rather than enact separate provisions for review of Medicare claims, Congress incorporated the hearing and judicial review mechanisms of 42 U.S.C. 405(b), (g), and (h) into the Medicare program.2 For example, 42 U.S.C. 1395ff(a) and (b) provide that any "individual dissatisfied with" the determination by the Secretary of Health and Human Services respecting either his "entitle[ment]" to or the "amount" of benefits under Medicare is entitled to "a hearing thereon * * * to the same extent as is provided in Section 405(b) * * * and to judicial review of the Secretary's final decision after such hearing as is provided in Section 405(g)." 42 U.S.C. 1395ff(a) and (b).
The Medicare Act makes those same hearing and judicial review provisions applicable to decisions affecting institutions, such as skilled nursing facilities, that provide services to Medicare beneficiaries. For example, nursing facilities may receive reimbursement under Medicare only if they have a provider agreement with the Secretary and they meet statutory requirements relating to patient health, safety, and care; they must be certified as meeting statutory requirements on average once a year. 42 U.S.C. 1395i-3(b) to (d), 1395cc. If a provider wishes to dispute a determination concerning compliance or certification-or termination or non-renewal of its provider agreement-42 U.S.C. 1395cc(h) provides that it may do so through the hearing and review procedures under 42 U.S.C. 405(b) and (g).3 It thus states:
[A]n institution or agency dissatisfied with a determination by the Secretary that it is not a provider of services or a determination described in subsection (b)(2) of this section shall be entitled to a hearing thereon by the Secretary (after reasonable notice) to the same extent as provided in section 405(b) [of Title 42], and to judicial review of the Secretary's final decision after such hearing as is provided in section 405(g) [of Title 42].
42 U.S.C. 1395cc(h). The determinations "described in subsection (b)(2)" include, among other things, a determination "that the provider fails to comply substantially with the provisions of [its provider agreement or] with the provisions of [the Medicare Act] and regulations thereunder."4 Different provisions of the Medicare Act added after 1965 similarly channel other decisions affecting Medicare providers, including decisions determining provider reimbursement or imposing civil money penalties for violations, through specific statutory mechanisms for administrative and judicial review.5
Finally, the Medicare Act makes 42 U.S.C. 405(h)-the provision of Title II of the Social Security Act that declares the Secretary's decisions to be binding, prohibits review of any decision except as provided in the Act itself, and deprives federal courts of jurisdiction under 28 U.S.C. 1331 and 1346-applicable to the Medicare program. Specifically, Section 1395ii declares that "[t]he provisions of * * * subsections (a), (d), (e), (h), (i), (j), (k), and (l) of section 405 of this title, shall also apply with respect to this subchapter to the same extent as they are applicable with respect to [Title II]."

2. Notwithstanding the Medicare program's health and safety requirements for provider participation, a 1986 survey by the Institute of Medicine of the National Academy of Sciences found that, in many "government certified nursing homes, individuals * * * receive very inadequate -sometimes shockingly deficient-care that is likely to hasten the deterioration of their physical, mental, and emotional health." H.R. Rep. No. 391, 100th Cong., 1st Sess., Pt. 1, at 452 (1987). A Government Accounting Office survey also reported widespread deficiencies, ibid., and testimony before Congress confirmed (sometimes in grim detail) extensive problems, such as unsanitary conditions, pervasive neglect, and instances of serious abuse. See generally 1 Nursing Home Care-The Unfinished Agenda: Hearing Before the Senate Special Comm. on Aging, 99th Cong., 2d Sess. (1986) (1986 Hearing).6 As one observer summarized, Medicare's compliance regime had "failed, * * * somewhat dismally, to assure a decent level of patient care" to nursing facility residents. Id. at 2. That failure, Congress concluded, was in part the product of a system that focused on the facility's theoretical capacity to provide care, i.e., paper qualifications and physical characteristics, rather than on the actual care provided to beneficiaries. H.R. Rep. No. 391, supra, Pt. 1, at 466-467. And it resulted in part from the limited effectiveness of the only enforcement remedy available to the Secretary-termination of the provider agreement permitting the facility to participate in the Medicare program. That regime led to a "yo-yo" effect, under which facilities with serious health, safety, and quality-of-care deficiencies would remedy them just in time to avoid termination, but fall into noncompliance once again immediately thereafter. Id. at 471.7
Congress responded in 1987 by comprehensively reforming the requirements of participation for skilled nursing facilities, altering the manner in which compliance is enforced, and expanding the range of available remedies. See Omnibus Budget Reconciliation Act of 1987 (OBRA), Pub. L. No. 100-203, §§ 4201-4218, 101 Stat. 1330-160 to 1330-221. Among other things, OBRA requires that skilled nursing facilities be subjected to inspection without prior notice on average once a year. 42 U.S.C. 1395i-3(g)(2)(A)(i) and (iii). Although surveys are generally under the control of state agencies, 42 U.S.C. 1395i-3(g)(1)(A),8 federal law governs the qualifications of survey team members, prescribes survey methods and procedures, and requires the use of federal forms. 42 U.S.C. 1395i-3(g)(2)(C); see also 42 C.F.R. 488.26(c), 488.314. Survey information must be made available to the public, 42 U.S.C. 1395i-3(g)(5)(A), and information about some types of substandard care must be provided to certain state officials, licensing boards, and physicians, 42 U.S.C. 1395i-3(g)(5)(B) to (C); see also 42 C.F.R. 488.325. The statute also directs the Secretary to develop enforcement criteria and to minimize the time between the detection of deficiencies and the imposition of a remedy. 42 U.S.C. 1395i-3(h)(2)(B).
When a survey agency detects a deficiency, it must recommend a remedy to the Secretary, who can approve the remedy or select a different one. 42 U.S.C. 1395i-3(h)(1). If the facility substantially complies with health, safety, and quality of care requirements-that is, if "any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm," 42 C.F.R. 488.301-no remedy is imposed.9 Where substantial compliance is not found, however, the Secretary may impose a remedy from an expanded list of options; she may direct the creation of a plan for correcting violations, impose civil money penalties, deny further reimbursement for services rendered after the deficiency is discovered, appoint temporary management, or terminate a facility's right to participate in Medicare. 42 U.S.C. 1395i-3(h)(2); 42 C.F.R. 488.406. In general, the remedies selected depend on the seriousness of the violations. See 42 U.S.C. 1395i-3(h)(2)(B); see also 42 C.F.R. 488.408 (grouping violations into 3 categories). Thus, the Secretary's regulations require survey agencies to determine whether the violations have already resulted in actual harm to residents, the potential for harm the violations pose, the degree of that potential harm, and whether the violations place residents in "immediate jeopardy," i.e., whether the violations have "caused, or [are] likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. 488.301, 488.404(b)(1). The survey agency also must consider whether the violations are isolated, form a pattern, or are widespread. 42 C.F.R. 488.404(b)(2). Other factors relevant to remedy selection include the relationship among deficiencies and the facility's compliance history. 42 C.F.R. 488.404(c). In general, the Secretary is expected to use available enforcement mechanisms to "bring substandard facilities into compliance with [federal] quality of care requirements or to exclude them from the program." H.R. Rep. No. 391, supra, Pt. 1, at 452.
Where relatively serious violations grouped under the heading "substandard quality of care" are found,10 the agency must evaluate the facility's operations in greater depth and identify the policies and procedures that caused the deficiency. 42 U.S.C. 1395i-3(g)(2)(B). Nursing facilities that are subjected to such an extended survey because of substandard care lose their eligibility to conduct a certified nurse-aide training program for two years, 42 U.S.C. 1395i-3(f)(2)(B)(iii), and three consecutive findings of substandard quality of care trigger automatic sanctions, such as a denial of payment for new admissions until the facility achieves, and can demonstrate that it is able to maintain, substantial compliance, 42 U.S.C. 1395i-3(h)(2)(E); 42 C.F.R. 488.414.
Nursing homes must be afforded written notice of deficiencies noted in any survey, of the remedy (if any) to be imposed, and of appeal rights. 42 C.F.R. 488.330, 488.402(f). A facility that disagrees with the survey may invoke an informal dispute-resolution process before the survey agency. That process must afford the nursing facility a prompt and meaningful opportunity to refute any findings of deficient care. 42 C.F.R. 488.331.11 Whether or not the facility invokes the informal dispute resolution process, any facility subjected to a remedy for noncompliance is entitled to a hearing before an administrative law judge (ALJ). See 42 U.S.C. 1395cc(h); 42 C.F.R. 498.1(a)-(b), 498.3(a), 498.3(b)(12). At that hearing, the facility may be represented by counsel, call witnesses, and present evidence. 42 C.F.R. 498.40-498.78. Any nursing facility dissatisfied with the resulting "decision may request Departmental Appeals Board review." 42 C.F.R. 498.5(c). Where civil money penalties are imposed, the decision of the Departmental Appeals Board is subject to judicial review through a petition to the court of appeals. 42 U.S.C. 1395i-3(h)(2)(B)(ii); 42 U.S.C. 1320a-7a(e); see also 42 U.S.C. 1395cc(h)(2). In all other cases, "judicial review of the Secretary's final decision" is available in district court as provided in 42 U.S.C. 405(g). 42 U.S.C. 1395cc(h)(1). See generally pp. 4-6 & n.5, supra.

3. Respondent filed this action in the United States District Court for the Northern District of Illinois in 1996 seeking injunctive and declaratory relief with respect to the implementing regulations the Secretary issued in 1995. The complaint does not challenge the Secretary's substantive standards governing resident health, safety, and care. J.A. 17, 22, 36-37 (¶¶ 1, 16, 64). Instead, respondent broadly challenges the procedures and remedies used in enforcing those standards.
More specifically, respondent alleges that the Secretary's regulations concerning the characterization of the seriousness of violations are unconstitutionally vague. J.A. 18, 29-32, 43-45 (¶¶ 3B, 37-50, 84-88). According to respondent, critical terms such as "minimal harm," "immediate jeopardy," "pattern," and "widespread," are not defined with sufficient particularity. See J.A. 30-31 (¶¶ 42-44). Respondent further claims that, because of that asserted vagueness, remedies are not imposed in a consistent fashion. J.A. 18, 36-38, 45, 46 (¶¶ 3C, 64-68, 89-91, 94).
Respondent also alleges that the Secretary's regulations are inconsistent with due process because they limit the scope of administrative review. J.A. 18-19, 32-36, 47-49 (¶¶ 3D-3E, 51-63, 95-101). In particular, respondent complains that administrative review of survey findings is not available if no remedy is imposed, J.A. 34-35, 48-49 (¶¶ 59, 99, 101), or as to matters such as the surveyors' characterization of the level of noncompliance (except where it affects the permissible range of civil penalties) and the remedy selected, J.A. 34, 48-49 (¶¶ 57-58, 101). See generally 42 C.F.R. 498.3(b)(12) and (13), (d)(10) and (11). Respondent also protests the absence of a prior hearing before certain remedies, such as termination of the provider agreement, are imposed. J.A. 18-19 (¶ 3D).12 Finally, the complaint alleges that a manual used by state survey inspectors to review facilities for compliance-the State Operations Manual or SOM-is a substantive rule that was promulgated outside the notice-and-comment rulemaking process required by the Administrative Procedure Act (APA), 5 U.S.C. 553. J.A. 18, 26-28, 46 (¶¶ 3A, 30-36, 92-94).
Respondent seeks an order declaring that (1) the Secretary's regulations are unconstitutionally vague, (2) the State Operations Manual was promulgated in violation of the APA, and (3) the administrative appeal procedures provided under the current regulations are inadequate. J.A. 51 (¶¶ A, C, D). Respondent also seeks an injunction precluding the Secretary from (1) disclosing survey results where "substandard quality of care" is found; (2) imposing or collecting civil money penalties; and (3) imposing "upon [respondent's] Medicare members any ban on payment as a remedy for any deficiency." J.A. 52 (¶¶ E, F, G). Subject matter jurisdiction is premised on 28 U.S.C. 1331, 1346, and 2201. J.A. 22 (¶ 14); Pet. App. 13a, 15a.
The district court dismissed the complaint for lack of subject matter jurisdiction. Pet. App. 13a-21a. The court pointed out that, under 42 U.S.C. 405(h), a federal district court may not assert jurisdiction under 28 U.S.C. 1331 or 1346 with respect to claims arising under the Medicare Act. In this case, the court reasoned, respondent's claims clearly arise under the Medicare Act, and it therefore could not assert jurisdiction under 28 U.S.C. 1331 and 1346. Pet. App. 15a-18a.
The district court also rejected respondent's reliance on Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667 (1986). See Pet. App. 18a-19a. In Michigan Academy, this Court held that 28 U.S.C. 1331 gave a federal district court jurisdiction over a facial challenge to the validity of Medicare regulations governing the methodology for calculating payments under Part B of the Medicare program. At the time Michigan Academy was decided, the Medicare Act (through 42 U.S.C. 1395ff (1982)) provided for a hearing and judicial review, under 42 U.S.C. 405(b) and (g), of decisions regarding the amount of payment (if any) due for particular services under Part A of the Medicare program, but not under Part B, see 476 U.S. at 674 n.5, and the Court had already held in United States v. Erika, Inc., 456 U.S. 201, 207-208 (1982), that Congress thereby had completely foreclosed judicial review of administrative decisions concerning the amount of benefits payable under Part B. In Michigan Academy, however, the Court, relying on the "strong presumption that Congress intends judicial review of administrative action," held that the Medicare Act does not preclude "challenges mounted against the method by which [the] amounts [of Part B benefits] are to be determined rather than [challenges to] the [amount] determinations themselves." 476 U.S. at 670, 675.
In light of the statutory framework and this Court's analysis, the district court in this case concluded that Michigan Academy was premised on the fact that the plaintiffs there had "no other avenue of judicial review" to challenge the Secretary's regulations. Pet. App. 18a. Here, in contrast, the Medicare Act itself provides an avenue through which respondent's members can challenge the relevant enforcement procedures any time they are applied to the members themselves. Ibid. Moreover, the district court continued, Congress amended the Medicare Act shortly after the Court's decision in Michigan Academy, and the amendment now provides administrative and judicial review under 42 U.S.C. 405(b) and (g) for the sort of Part B methodology challenges that were at issue in that case. See Omnibus Budget Reconciliation Act of 1986, Pub. L. No. 99-509, § 9341(a)(1), 100 Stat. 2037 (codified at 42 U.S.C. 1395ff(1)). Because both Part A and Part B participants "now have an avenue of judicial review," the district court explained, "the concern * * * in Michigan Academy"-that agency action would be altogether immune from judicial review-"no longer exists." Pet. App. 18a.
The district court further found that respondent had not satisfied the prerequisites for judicial review under 42 U.S.C. 405(g) (as made applicable here by 42 U.S.C. 1395cc(h)(1)), including the non-waivable requirement that all claims be presented to the Secretary, and the waivable requirement that administrative remedies be exhausted. Pet. App. 18a-19a. Here, the court observed, respondent "ha[d] not alleged or shown any attempt at presentment of [its] claims to the Secretary." Id. at 19a.13

4. The court of appeals vacated and remanded. Pet. App. 1a-12a. It acknowledged that this Court's decisions in Heckler v. Ringer, 466 U.S. 602 (1984), and Weinberger v. Salfi, 422 U.S. 749 (1975), "treat th[e] language [of 42 U.S.C. 405(h)] as channeling all claims to benefits through the administrative forum, no matter what legal theory underlies the claim." Pet. App. 4a. Relying on Michigan Academy, however, the court of appeals concluded that Section 405(h) addresses only provider claims relating to a "request for reimbursement," ibid., and does not apply to an "anticipatory challenge to implementing regulations," id. at 5a.
The court of appeals agreed that "the 1986 amendments [to Part B]," which now provide an avenue of judicial review of Part B amount determinations and regulations through Section 405(g), might well "remove the practical support" for a distinction between "pre-enforcement challenges to Medicare regulations * * * and requests for reimbursement." Pet. App. 5a. It also recognized that "Michigan Academy [had] emphasized * * * the presumption that Congress has allowed some avenue of judicial review, and the Justices [had] read the statutes then in effect with that presumption in mind." Ibid. But the court of appeals noted that Congress had not amended 42 U.S.C. 405(h) or 1395ii. The court therefore considered itself "obliged to follow" Michigan Academy, which it read as permitting pre-enforcement review of regulations notwithstanding 42 U.S.C. 405(h), even where (unlike in Michigan Academy) Congress has provided for judicial review under 42 U.S.C. 405(g). See Pet. App. 6a-7a.14
The Secretary's petition for rehearing with suggestion of rehearing en banc was denied, although three judges voted to grant rehearing en banc. Pet. App. 22a-23a & n.2.

A. The Medicare Act establishes detailed mechanisms for obtaining judicial review of claims that arise under the Act. Of particular significance here, it provides for judicial review of a regulation after the regulation has been applied to the party seeking to challenge it, the party has presented its claim to the Secretary, and the Secretary has issued a final decision. Where the Act itself provides an express mechanism for obtaining judicial review, that mechanism is exclusive. That is clear not merely from the reticulated nature of the Act's review mechanisms, but also from the text of 42 U.S.C. 405(h), which, as incorporated into the Medicare program by 42 U.S.C. 1395ii, declares that "[n]o findings of fact or decision of the [Secretary] shall be reviewed by any person, tribunal, or governmental agency except as * * * provided" in the Medicare Act itself, and that "[n]o action against the United States, the [Secretary], or any officer or employee thereof shall be brought under sections 1331 or 1346 of title 28 to recover on any claim arising under this subchapter." As the Senate Report accompanying the Medicare Act explained, "[i]t is intended that the remedies provided by these review procedures shall be exclusive." S. Rep. No. 404, 89th Cong., 1st Sess., Pt. 1, at 55 (1965).
B. The court of appeals' decision permitting federal-question jurisdiction over "pre-enforcement" challenges to the validity of Medicare regulations under 28 U.S.C. 1331, notwithstanding the availability of post-enforcement review, is at odds with the plain language of Section 405(h) and is inconsistent with Heckler v. Ringer, 466 U.S. 602 (1984); Weinberger v. Salfi, 422 U.S. 749 (1975), and Mathews v. Eldridge, 424 U.S. 319 (1976). Those precedents hold that where, as here, the plaintiff's standing and the substantive basis for the plaintiff's suit are based on the Social Security Act (including its Medicare title), review is available only as provided by the Act itself.
Nor is the court of appeals' decision supported by Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667 (1986). Unlike this case, Michigan Academy involved Medicare claims for which there was no avenue of judicial review under the Medicare Act. As a result, precluding general federal-question jurisdiction over those claims would have left the plaintiffs with no means of securing judicial review of substantial questions concerning the administration of the Medicare program-a result that the Court found to be inconsistent with the strong presumption that Congress intends final agency action to be subject to judicial review. Thus, contrary to the decision below, Michigan Academy does not authorize federal-question jurisdiction over pre-enforcement challenges to Medicare regulations where, as here, the Medicare Act itself affords fully adequate means of judicial review.
C. Although respondent attempts to justify bypass of the Medicare Act's otherwise exclusive mechanisms by claiming that its statutory and constitutional claims cannot be raised in administrative proceedings, those claims can be raised on judicial review of the Secretary's final decision. This Court, moreover, has repeatedly rejected the suggestion that a party can bypass the otherwise exclusive mechanisms for review provided by the Social Security Act simply because it raises constitutional or other issues that would not ordinarily be addressed in the administrative process. "[T]he plain words of the third sentence of 405(h) do not preclude constitutional challenges. They simply require that [the challenges] be brought under jurisdictional grants contained in the Act, and thus in conformity with the same standards which are applicable to nonconstitutional claims arising under the Act." Salfi, 422 U.S. at 762.

RESPONDENT'S PRE-ENFORCEMENT JUDICIAL CHALLENGE TO THE SECRETARY'S ENFORCEMENT GUIDELINES AND REMEDIES IS BARRED BY THE MEDICARE ACT
By incorporating 42 U.S.C. 405(g) and (h) into the Medicare Act through 42 U.S.C. 1395cc(h) and 1395ii, Congress established a specific and exclusive mechanism for obtaining judicial review of claims "arising under" the Medicare Act. Those provisions require a nursing facility or other participant in the Medicare program to challenge the Secretary's regulations and policies after they have been applied to that participant, thereby ensuring that challenges are of manageable proportions and are framed by a concrete, factual setting. And they route all challenges through the administrative process as a pre-condition to judicial review, thereby permitting the development of a factual record, allowing for refinement of legal issues, enabling the agency to apply its expertise to the specific issues raised, and affording the Secretary the opportunity to resolve the dispute on other grounds.
In this case, respondent seeks to bypass Medicare's established mechanisms for obtaining review by bringing an anticipatory challenge under 28 U.S.C. 1331 to the Secretary's regulations in the abstract, without reference to any specific enforcement action. That effort, however, cannot be reconciled with the Medicare "statute's language, structure, * * * purpose, [and] legislative history," especially given that the Act itself provides an opportunity for "meaningful review." Thunder Basin Coal Co. v. Reich, 510 U.S. 200, 207 (1994). Indeed, the text of Section 405(h) prohibits such an effort in unmistakeable terms.

A. WHERE THE MEDICARE ACT PROVIDES A MECHANISM FOR OBTAINING JUDICIAL REVIEW, THAT MECHANISM IS EXCLUSIVE

1. a. The Medicare Act provides a highly "reticulated statutory scheme, which carefully details the forum and limits of review" of the Secretary's determinations. Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 675 (1986). With respect to each of a number of categories of claims, the Act channels the claims through administrative and then judicial review after the Secretary has taken action (reimbursement, enforcement, etc.) directed at the person seeking review. Thus, individuals who are dissatisfied with entitlement and payment determinations, 42 U.S.C. 1395ff(a) and (b), providers aggrieved by reimbursement decisions, 42 U.S.C. 1395oo(a) and (f), and entities subjected to civil money penalties, 42 U.S.C. 1320a-7a(c)(2) and (e), all are afforded the opportunity for a hearing after the Secretary's initial determination, and for judicial review once the Secretary reaches a final decision. See also pp. 3-6, supra.
That same general scheme applies to nursing facilities seeking to challenge the Secretary's guidelines and remedies for enforcing the Medicare program's requirements for participation. In particular, any nursing facility or other provider "dissatisfied with a determination by the Secretary that it is not a provider of services" or a determination that it does not "substantially comply" with the Secretary's health, safety, and quality-of-care requirements "is entitled to a hearing thereon by the Secretary (after reasonable notice) to the same extent as provided in section 405(b) * * * and to judicial review of the Secretary's final decision after such hearing as is provided in section 405(g) [of Title 42]." 42 U.S.C. 1395cc(h)(1) and (b)(2); see pp. 4-5, supra. Likewise, under 42 U.S.C. 1395i-3(h)(2)(B)(ii), a facility against which civil penalties have been assessed is entitled to a hearing, and judicial review in the court of appeals, as provided by 42 U.S.C. 1320a-7a(c)(2) and (e).
The provision of such a "detailed structure" for post-enforcement administrative and judicial review is, by itself, strong evidence that Congress intended to make that structure exclusive. See Thunder Basin, 510 U.S. at 207; United States v. Erika, Inc., 456 U.S. 201, 208 (1982) (concluding that evidence of exclusivity is particularly strong "[i]n the context of" the Medicare Act's "precisely drawn provisions"). See also Board of Governors of the Fed. Reserve Sys. v. MCorp Fin., Inc., 502 U.S. 32, 43-44 (1991); United States v. Fausto, 484 U.S. 439, 448-449 (1988); Whitney Nat'l Bank v. Bank of New Orleans & Trust Co., 379 U.S. 411, 420 (1965). By contrast, when Congress intends to permit pre-enforcement review notwithstanding specific post-enforcement review mechanisms, it typically enacts express statutory provisions so providing. See, e.g., Harrison v. PPG Indus., 446 U.S. 578, 592-593 (1980). It has not done so here.15
b. Congress, in any event, has expressly provided that the post-enforcement mechanisms for judicial review in the Medicare Act are exclusive. When Congress provided for judicial review of Social Security decisions by enacting 42 U.S.C. 405(g), it paired that provision with 42 U.S.C. 405(h) to preclude judicial review by other means. And when Congress made 42 U.S.C. 405(g) applicable to compliance determinations under the Medicare program in 1965, it also made Section 405(h) applicable by enacting 42 U.S.C. 1395ii. As incorporated into the Medicare Act, Section 405(h) provides:
The findings and decisions of the [Secretary] after a hearing shall be binding on all individuals who were parties to such hearing. No findings of fact or decision of the [Secretary] shall be reviewed by any person, tribunal, or governmental agency except as herein provided. No action against the United States, the [Secretary], or any officer or employee thereof shall be brought under sections 1331 or 1346 of title 28 to recover on any claim arising under this subchapter.
As this Court has observed, "the first two sentences of § 405(h) * * * assure that administrative exhaustion will be required," Weinberger v. Salfi, 422 U.S. 749, 757 (1975), while the third sentence "provides that § 405(g), to the exclusion of 28 U.S.C. § 1331, is the sole avenue for judicial review for all 'claim[s] arising under' the Medicare Act." Heckler v. Ringer, 466 U.S. 602, 614-615 (1984) (emphasis added). Section 405(h) thus "require[s] the exhaustion of available administrative procedures, * * * foreclose[s] jurisdiction under the general grant of federal-question jurisdiction, 28 U.S.C. § 1331, and * * * route[s] review through § [405(g)]." Califano v. Sanders, 430 U.S. 99, 103 n.3 (1977); see also id. at 110 (Stewart, J., concurring) ("I can see no reason in this case why the second sentence of § [405(h)] should not be read to mean exactly what it says-that the decision before us is reviewable under § [405(g)] or not at all.").16
c. To the extent the text and structure of the Medicare Act could leave any doubt, the legislative history erases it. The 1965 Senate Report that accompanied the Medicare Act, immediately after discussing the various methods for obtaining administrative and judicial review under the Act, declares: "It is intended that the remedies provided by these review procedures shall be exclusive." S. Rep. No. 404, 89th Cong., 1st Sess., Pt. 1, at 54-55 (1965) (emphasis added). A clearer expression of Congress's intent is difficult to imagine.
d. Finally, requiring nursing facilities like respondent's members to seek judicial review under Section 405(g) after first seeking relief in the administrative process is fair and sensible. It does not deny nursing facilities the opportunity for judicial review; it merely postpones review until such time as the claim has arisen in a specific, factual context, the matter has been presented to the Secretary, and the Secretary has issued a final decision. See Salfi, 422 U.S. at 762. Moreover, channeling Medicare claims through the statutorily-provided mechanisms for administrative and judicial review serves important policy goals. First, by requiring that challenges be brought in the context of a specific enforcement action, the Act ensures that "the scope of the controversy [will be] reduced to more manageable proportions, and its factual components fleshed out, by some concrete action applying the regulation to the claimant's situation in a fashion that harms or threatens to harm him." Lujan v. National Wildlife Fed'n, 497 U.S. 871, 891 (1990); see Reno v. Catholic Soc. Servs., Inc., 509 U.S. 43, 58-59 (1993) (noting, for similar reasons, that mere passage of a statute and issuance of regulations do not give a complainant a ripe claim absent agency action "applying the regulation to him"). Second, the process required by Section 405(g) and (h) promotes the interest in administrative efficiency by protecting the agency from the "potential for overly casual * * * judicial intervention in an administrative process" that is responsible not only for protecting the health and safety of thousands of Medicare beneficiaries residing in nursing homes, but also for resolving "millions of claims" a year. Ringer, 466 U.S. at 627; see also Salfi, 422 U.S. at 765.
Third, channeling claims through the administrative process promotes judicial economy. It permits the agency "to correct its own errors, to afford the parties and the courts the benefit of its experience and expertise, and to compile a record which is adequate for judicial review." Salfi, 422 U.S. at 765; accord Ringer, 466 U.S. at 619 n.12. Further, it may avert the need for judicial review altogether, as it "assures the Secretary the opportunity prior to * * * litigation to ascertain, for example, that the particular claims involved are neither invalid for other reasons nor allowable under other provisions of the Social Security Act." Salfi, 422 U.S. at 762.

2. Consistent with the text, structure, history, and purposes of the Social Security Act's review provisions, the Court repeatedly has recognized that, where those provisions create a mechanism for judicial review, that mechanism is exclusive. In Salfi, for example, the Court held that a federal district court lacked jurisdiction under 28 U.S.C. 1331 to hear a constitutional challenge to a provision of the Social Security Act that rendered the plaintiffs ineligible for certain benefits. The language of Section 405(h), the Court held, is "sweeping and direct"; it states "that no action shall be brought under § 1331" with respect to any claim "arising under" the Social Security Act. 422 U.S. at 757. The Court in Salfi also rejected the argument that Section 405(h) does not apply if the suit can be characterized as "arising under" the Constitution. Where "the Social Security Act * * * provides both the standing and the substantive basis for the presentation of their constitutional contentions," the Court held, the plaintiffs' action is a suit "arising under" the Act within the meaning of Section 405(h), even if the suit could be said to arise under the Constitution as well. 422 U.S. at 760-761. Consequently, where such claims are asserted, Section 405(h) precludes federal courts from exercising jurisdiction over them pursuant to 28 U.S.C. 1331; instead, judicial review is available only through the mechanisms provided by the Social Security Act itself. 422 U.S. at 760-761.
Seven years later, the Court again stressed the exclusivity of the Act's review mechanisms in United States v. Erika, Inc., 456 U.S. 201 (1982). There, a company that had provided services to Medicare beneficiaries sought to challenge the amount of reimbursement it received under Part B of the Medicare program. At that time, the Act provided for judicial review of decisions under both Part A and Part B where the "dispute relates to * * * eligibility to participate," but provided for judicial review of determinations concerning the "amount" of payment only with respect to claims under Part A. See 456 U.S. at 207-208. "In the context of the statute's precisely drawn provisions" and supporting legislative history, the Court explained, the omission of an express provision for judicial review of Part B "amount determinations" furnished "persuasive evidence that Congress deliberately intended to foreclose further review" of such determinations. Id. at 208. Thus, even though treating the Medicare program's review provisions as exclusive in Erika rendered the administrative determination at issue there completely unreviewable, the Court held them to be exclusive.
More recently, in Heckler v. Ringer, 466 U.S. 602 (1984), this Court once again concluded that 42 U.S.C. 405(g) provides the exclusive mechanism for obtaining judicial review of the Secretary's implementation and enforcement of the Medicare Act. In Ringer, one of the named plaintiffs, Freeman Ringer, sought to challenge an agency rule that precluded reimbursement for an operation he wished to undergo. Because Ringer had not undergone that procedure, he could not file a claim for reimbursement and challenge the Secretary's decision denying the claim under 42 U.S.C. 405(g). Accordingly, he brought a "pre-enforcement" action in district court requesting a declaratory judgment that the pertinent Medicare regulation was invalid. 466 U.S. at 621-623. This Court held that the Medicare Act itself, in 42 U.S.C. 405(g) (as incorporated by 42 U.S.C. 1395ff(b)), affords the exclusive basis for obtaining jurisdiction over such a claim, and that federal courts could not exercise jurisdiction under 28 U.S.C. 1331. The Court stated: "The third sentence of 42 U.S.C. § 405(h), made applicable to the Medicare Act by 42 U.S.C. § 1395ii, provides that § 405(g), to the exclusion of 28 U.S.C. § 1331, is the sole avenue for judicial review for all 'claim[s] arising under' the Medicare Act." 466 U.S. at 614-615 (emphasis added; footnote omitted).
Finally, just last Term, in Your Home Visiting Nurse Services, Inc. v. Shalala, 119 S. Ct. 930, 935 (1999), this Court reaffirmed its holding in Ringer, again declining to permit judicial review of claims under the Medicare program except as provided in the Act itself. There, a provider sought judicial review of a refusal to reopen its reimbursement claim. "[J]udicial review under the federal-question statute, 28 U.S.C. § 1331," the Court explained, "is precluded by 42 U.S.C. § 405(h), applicable to the Medicare Act by operation of § 1395ii, which provides that '[n]o action against . . . the [Secretary] or any officer or employee thereof shall be brought under section 1331 . . . of title 28 to recover on any claim arising under this subchapter." 119 S. Ct. at 935. The provider's claim, the Court further concluded, "'arises under' the Medicare Act within the meaning of [Section 405(h)] because 'both the standing and the substantive basis for the presentation' of the claim are the Medicare Act." Ibid. (quoting Ringer, 466 U.S. at 615 (some internal quotation marks omitted)).

3. The exclusivity of the review procedures established by Section 405(g) is further reinforced by the Administrative Procedure Act (APA), 5 U.S.C. 702-704. Section 10(b) of the APA states that, where Congress has provided a "special statutory review proceeding relevant to the subject matter," complainants must use that "form of proceeding for judicial review," unless it is "inadequa[te]." 5 U.S.C. 703. Moreover, Section 10(c) of the APA bars resort to its general provisions for judicial review of agency action unless "there is no other adequate remedy in a court." 5 U.S.C. 704.
As Attorney General Clark explained shortly after the APA's enactment, "[t]he net effect [of Section 10], clearly intended by the Congress, is to provide for a dovetailing of the general provisions of the [APA] with the particular statutory provisions which the Congress has moulded for special situations." Attorney General's Manual on the Administrative Procedure Act 95 (1947).17 The APA thus "'does not provide additional judicial remedies in situations where the Congress has provided special and adequate review procedures.'" Bowen v. Massachusetts, 487 U.S. 879, 903 (1988) (quoting Attorney General's Manual, supra, at 101).

4. The foregoing principles foreclose respondent's suit here. Respondent seeks to challenge the Secretary's regulations and guidelines governing the enforcement of Medicare's health, safety, and quality-of-care requirements for nursing homes. But respondent does not seek review of a specific, concrete "determination" or application of those regulations. See J.A. 22 (¶ 16) (Respondent "does not challenge the specific application of the 1995 Regulations and the SOM to any one facility, but challenges instead their lawfulness and their use" generally). Nor does respondent assert that jurisdiction is proper under the mechanisms for judicial review provided by the Medicare Act itself. To the contrary, respondent omits any reference to those provisions in its complaint, relying only on the more general jurisdictional grants contained in 28 U.S.C. 1331 and 1346. J.A. 22 (¶ 14).
Respondent thus is attempting to bypass the express statutory mechanisms for judicial review provided by the Medicare Act. But such a bypass is precisely what Section 405(h) prohibits, for it makes Section "405(g) * * * the sole avenue for judicial review for all 'claim[s] arising under' the Medicare Act." Ringer, 466 U.S. at 615 (emphasis added). Respondent nowhere disputes that its claims "arise under" the Act within the meaning of Section 405(h).18
Permitting respondent to bypass the mechanisms for review provided by the Medicare Act in this case, moreover, would give rise to the very dangers that the Medicare Act seeks to avoid. Because respondent seeks to raise its claims in the abstract rather than in connection with a specific application of the regulations, "the scope of the controversy" has not been "reduced to more manageable proportions," Lujan, 497 U.S. at 891; instead, it remains unwieldy and unmanageable, a broad-ranging attack on virtually every aspect of the Secretary's compliance regime. The correspondingly broad relief respondent seeks also creates a serious risk that premature judicial interference could have devastating consequences for the program. In essence, respondent asks the district court to invalidate the Secretary's entire compliance enforcement program, J.A. 51 (¶¶ A-D), and to bar the Secretary from assessing civil penalties, withholding payments, or imposing other sanctions, even where blatant and dangerous violations of the program's health, safety, and quality-of-care criteria are detected, J.A. 52 (¶¶ F-H). That relief would deprive the Secretary of access to the very remedies Congress thought necessary when it enacted OBRA to reform enforcement in 1987, and would bring enforcement to a virtual standstill in Illinois. See pp. 6-9, supra. Requiring respondent's members to challenge a discrete instance of enforcement of the regulations under the Medicare Act's review provisions will dramatically reduce the risk of such a grave intrusion on a federal program critical to the health of thousands of Medicare beneficiaries. See Ringer, 466 U.S. at 627 (Medicare Act remedies protect the agency from the "potential for overly casual * * * judicial intervention in" important administrative processes); Salfi, 422 U.S. at 765 (review mechanisms avoid "premature interference with agency processes, so that the agency may function efficiently").
Likewise, because respondent's challenge is purely anticipatory, it suffers from the absence of a factual record and concrete context that would make it fit for judicial review. Indeed, for that reason, the court of appeals held that respondent's void-for-vagueness claim was not "ripe" under ordinary APA principles. See Pet. App. 10a-11a. Compare Salfi, 422 U.S. at 765 (administrative process helps create a record and thereby render the case "fit" for judicial review); Ringer, 466 U.S. at 619 (similar). A similar absence of requisite facts-such as the nature of the nursing patient interests at stake in individual cases, e.g., whether there is immediate jeopardy to their lives requiring prompt action-makes adjudication of respondent's procedural due process claims cumbersome, if not impossible, as well. J.A. 32-46 (¶¶ 51-63).
Nor can it be claimed that there is a need here for immediate review outside of ordinary processes. Respondent does not assert that its members are required by allegedly improper regulations to refrain from engaging in otherwise lawful conduct. Cf. Lujan, 497 U.S. at 891 (rules requiring the complainant "to adjust [its] conduct immediately" may be ripe). To the contrary, respondent disavows any challenge to the substantive health, safety, and quality-of-care standards that govern its members' day-to-day operations. Instead, respondent claims that its members cannot tell what sanction, if any, otherwise clearly proscribed conduct will draw. See pp. 11-12, supra. Such an argument hardly provides compelling grounds for bypassing the express post-enforcement review process provided by the Medicare Act. Would-be criminals normally cannot bring declaratory judgment actions seeking to halt enforcement of criminal laws simply because they cannot tell in advance what their sentence will be if they commit a crime; any arbitrariness in sentencing must be raised through ordinary criminal processes only after an allegedly arbitrary sentence is imposed. The same should be true of would-be violators of the (unchallenged) substantive health, safety, and quality-of-care requirements that protect Medicare beneficiaries from abuse and injury.

B. MICHIGAN ACADEMY DOES NOT PERMIT FEDERAL COURTS TO EXERCISE GENERAL FEDERAL-QUESTION JURISDICTION OVER RESPONDENT'S SUIT

The court of appeals disputed none of the preceding analysis. Nowhere did the court dispute that the text, structure, purposes and legislative history of the Medicare Act all demonstrate that, where the Act provides a mechanism for obtaining judicial review, that mechanism is exclusive. Nor did the court of appeals express any doubt that respondent's members would be able to obtain judicial review of their claims-in a concrete factual setting-through the procedures provided by the Medicare Act itself. Indeed, the court of appeals agreed that, in a long line of cases stretching from Salfi to Ringer, this Court has rejected efforts to bypass the mechanisms for judicial review provided by the Medicare Act, and has held that 42 U.S.C. 405(h) precludes federal courts from exercising jurisdiction with respect to such claims under 28 U.S.C. 1331. See Pet. App. 2a-3a.
1. Nonetheless, the court of appeals concluded that Michigan Academy allowed the district court to exercise jurisdiction over respondent's pre-enforcement action. In Michigan Academy, the plaintiffs challenged the validity of reimbursement regulations under Part B of the Medicare program. At that time, the relevant provision of the Medicare Act, 42 U.S.C. 1395ff(b)(1) (1982), expressly provided for judicial review of disputes concerning the "amount" of reimbursement (if any) payable under Part A, but not under Part B. See 476 U.S. at 674-675. And in Erika, the Court had held that that omission, together with the relevant legislative history, established that Congress had intended to preclude judicial review of Part B claims challenging the amount of reimbursement. See 456 U.S. at 207-208.
In Michigan Academy, the government argued that Congress's failure to include a provision for judicial review of Part B claims, other than those relating to basic eligibility under the program, indicated that Congress intended to preclude judicial review of all issues under Part B except those relating to eligibility. Relying on the "strong presumption that Congress did not mean to prohibit all judicial review" of agency decisions, 476 U.S. at 672, the Court rejected that argument. While the Court found evidence that Congress had deliberately foreclosed any challenge to the amount of benefits awarded in a particular case, it found no evidence that Congress intended to preclude more general "challenges mounted against the method by which [the] amounts [of Part B benefits] are to be determined rather than [challenges to] the [amount] determinations themselves." Id. at 675. In particular, the legislative history provided "specific evidence of Congress' intent to foreclose review" with respect to "amount determinations," i.e., claims concerning the monetary sum of benefits due, but provided no indication of a similar intent to foreclose judicial review of more general "methodology" claims, which might involve "statutory and constitutional challenges to the Secretary's administration of Part B of the Medicare program." Id. at 680. Because the government had not produced "clear and convincing evidence" sufficient to overcome the "strong presumption that Congress did not mean to preclude judicial review" entirely, id. at 681, the Court held that "methodology" claims were not precluded even though "amount" claims were.
In this case, the court of appeals read Michigan Academy as broadly "hold[ing] that [42 U.S.C.] § 1395ii," which incorporates 42 U.S.C. 405(h) into the Medicare program, "does not foreclose Medicare providers' anticipatory challenge[s] to implementing regulations" under 28 U.S.C. 1331. Pet. App. 4a, 6a. In particular, the court of appeals interpreted Michigan Academy as holding that Section 405(h) "addresses only 'amount determinations' * * * -that is, calculations of reimbursements.'" Pet. App. 4a; see also id. at 6a. Thus, in the court of appeals' view, pre-enforcement challenges are permissible under Michigan Academy whether or not such claims could be adjudicated after a final administrative decision under the mechanisms for judicial review provided by the Medicare Act itself. That reading of Michigan Academy is incorrect.
a. Whatever the continuing vitality of Michigan Academy in the particular context in which it arose, in light of later amendments to the Medicare Act (see pp. 36-37, infra), that decision has no bearing where, as here, the question is not whether judicial review will be available, but when it will be available. See National Kidney Patients Ass'n v. Sullivan, 958 F.2d 1127, 1133 (D.C. Cir. 1992) ("[T]he Court in Michigan Academy was concerned not with timing, but with reviewability vel non."), cert. denied, 506 U.S. 1049 (1993). The Court's reasoning in Michigan Academy literally begins with, 476 U.S. at 670, ends with, id. at 681, and is steeped throughout with, see id. at 672, the presumption that Congress intends judicial review to be available. See also id. at 681 n.12 (noting that finding review to be available "avoids the 'serious constitutional question' that would arise if [the Court] construed § 1395ii to deny a judicial forum for constitutional claims arising under Part B"). That presumption, however, is not "implicate[d]" where, as here, the Medicare Act itself provides for judicial review of a regulation once it is applied in a concrete, factual context. See Thunder Basin, 510 U.S. at 207 n.8, 212-214 ("Because court of appeals review is available, this case does not implicate the strong presumption that Congress did not mean to prohibit all judicial review. Bowen v. Michigan Academy."); MCorp, 502 U.S. at 44 n.16 (similar analysis). See also McNary v. Haitian Refugee Ctr., Inc., 498 U.S. 479, 498 (1991) ("Inherent in our [Michigan Academy] analysis was the concern that * * * [there] would be 'no review at all of substantial statutory and constitutional challenges to the Secretary's administration of Part B of the Medicare program.'") (quoting Michigan Academy, 476 U.S. at 680).
Moreover, Michigan Academy relied heavily on the legislative history of the relevant statutory provision, which provided "specific evidence" that Congress intended to foreclose judicial review entirely only with respect to so-called "amount" determinations under Part B. 476 U.S. at 680. But whether or not Congress intended judicial review to be available at all for Part B benefit "amount" determinations has no bearing on the question here, which is merely the timing of judicial review of nursing home regulations under Part A. The relevant legislative history in this context, moreover, makes it abundantly clear that, while Congress did not intend to foreclose judicial review of claims like respondent's entirely, it did intend that such review would occur exclusively through the post-enforcement mechanisms provided in the Medicare Act itself. Immediately after describing the mechanisms for judicial review provided by the Medicare Act, the Senate Report states: "It is intended that the remedies provided by these review procedures shall be exclusive." S. Rep. No. 404, supra, Pt. 1, at 55.
Finally, the distinction between post-decision "amount" claims on the one hand and pre-enforcement actions on the other has no logical place in the context of enforcement actions under 42 U.S.C. 1395cc(h). The Court's opinion in Michigan Academy drew that distinction based on the language of 42 U.S.C. 1395ff (1982), which addressed review of "amount" claims under Part A, but was (at that time) silent about review of such claims under Part B. 476 U.S. at 674-675. Here, the relevant provision of the Medicare Act is not 42 U.S.C. 1395ff, but 42 U.S.C. 1395cc(h), which incorporates 42 U.S.C. 405(b) and (g). Unlike Section 1395ff, Section 1395cc(h) does not mention "amount" claims, and in fact it does not deal with reimbursement requests or such "amount" claims at all. Instead, it addresses challenges to noncompliance determinations. (Reimbursement or "amount" claims relating to nursing facilities would arise instead under 42 U.S.C. 1395oo.) It simply makes no sense to incorporate an amount/methodology distinction from Michigan Academy into Section 1395cc(h), which deals with neither reimbursement amounts nor the method by which they are calculated.
Thus, neither Michigan Academy's reasoning, nor the statutory language and legislative history it cited, has any bearing on cases like this one, in which barring review under 28 U.S.C. 1331 would not preclude judicial review altogether, but rather would channel it through the specific mechanisms provided by the Medicare Act. It therefore should be unsurprising that every court of appeals to have considered the matter-with the exception of the panel decision below-has concluded that Michigan Academy does not permit pre-enforcement judicial review under 28 U.S.C. 1331 where the Medicare Act itself provides for post-enforcement review. See, e.g., National Kidney Patients Ass'n, 958 F.2d at 1133 (because Michigan Academy rested "largely on the presumption of reviewability," it does not govern where agency action "will not go unreviewed," but review instead "simply awaits initial administrative determination in a concrete setting"); St. Francis Med. Ctr. v. Shalala, 32 F.3d 805, 812 (3d Cir. 1994) ("Since a provider seeking Part A payments has these avenues of review available under the Medicare Act, the presumption that Congress did not intend to foreclose judicial review, which was central to the decision in Michigan Academy, is inapplicable."), cert. denied, 514 U.S. 1016 (1995); Michigan Ass'n of Homes & Servs. for the Aging, Inc. v. Shalala, 127 F.3d 496, 501 (6th Cir. 1997) (Michigan Academy permits review despite 405(h) "when there is no other avenue of judicial review.").
b. Reading Michigan Academy as the court of appeals did here-as drawing a program-wide distinction between pre-enforcement suits challenging regulations on the one hand, and suits seeking to challenge "amount" determinations on the other-would also place Michigan Academy in irreconcilable conflict with the Court's prior decision in Ringer, which held that "§ 405(g), to the exclusion of 28 U.S.C. § 1331, is the sole avenue for judicial review for all 'claim[s] arising under' the Medicare Act." Ringer, 466 U.S. at 615 (emphasis added). As we have pointed out above (see pp. 24-25, supra), one of the named plaintiffs in Ringer sought pre-decisional, declaratory relief with respect to a Medicare rule. Moreover, the plaintiff in Ringer did not challenge a determination concerning the "amount" of reimbursement (if any) he was due for a particular claim. Instead, he sought to challenge a rule that, if he had submitted a claim, might have required denial of that claim. See 466 U.S. at 613. The Court nevertheless held that Section 405(h) precluded the exercise of general federal-question jurisdiction over such a pre-enforcement challenge. The Court reached an identical result in Salfi. There, the plaintiffs sought injunctive relief prohibiting the Secretary from relying on allegedly unconstitutional provisions (App. at 12-13, Weinberger v. Salfi, 422 U.S. 439 (1975) (No. 74-214)). But the Court held that Section 405(h) precluded federal district courts from entertaining their challenges under 28 U.S.C. 1331, and required that they instead file a claim and seek review through the mechanisms provided by the Social Security Act itself. 422 U.S. at 764.
Consequently, if the court of appeals' construction of Michigan Academy were correct-that it limits Section 405(h)'s preclusive effect to "amount" determinations and prevents its application to pre-enforcement regulatory challenges-then Michigan Academy would have overruled Ringer and Salfi sub silentio. That reading, we submit, is implausible given the seminal and far-reaching significance of Salfi and Ringer, as well as the strong presumption, rooted in considerations of stare decisis, that where this Court intends to overrule precedents it says so expressly. See Rodriguez de Quijas v. Shearson/American Express, Inc., 490 U.S. 477, 484 (1989); Agostini v. Felton, 521 U.S. 203, 237 (1997). For the same reason, the courts of appeals have uniformly refused to conclude that Michigan Academy overruled Ringer and Salfi. Instead, they have concluded that Michigan Academy controls over Ringer and Salfi only where-unlike here-the Medicare statute itself provides no mechanism for judicial review and, as a result, applying 42 U.S.C. 405(h) to bar suit under 28 U.S.C. 1331 would preclude judicial review altogether. National Kidney Patients Ass'n, 958 F.2d at 1132; Farkas, 24 F.3d at 860; American Academy of Dermatology, 118 F.3d at 1500.19
c. For similar reasons, subsequent statutory amendments have eliminated the basis for continuing application of the result in Michigan Academy even in the specific context in which it arose: challenges to the methods used to calculate the amount of reimbursement due on claims under Part B of the Medicare program. As the district court explained below, Pet. App. 18a, Congress amended Section 1395ff in 1986 (months after Michigan Academy was decided) to provide for administrative and judicial review (under 42 U.S.C. 405(b) and (g)) of carrier determinations concerning "amount" determinations under Part B. Pub. L. No. 99-509, § 9341(a)(1)(B), 100 Stat. 2037. In light of that amendment and its legislative history, the courts of appeals have uniformly agreed that district courts now lack jurisdiction under 28 U.S.C. 1331 to review all benefit-related claims arising under Part B, including the type of "methodology" disputes at issue in Michigan Academy. Instead, all such claims, like their counterparts under Part A, must be brought through the review mechanisms provided by the Medicare Act itself. See National Kidney Patients Ass'n, 958 F.2d at 1132 ("[T]he special treatment of part B [methodology claims], based on the pre-October 1986 statutory differences, cannot survive the elimination of those differences."); American Academy of Dermatology, 118 F.3d at 1500 ("[T]he amount/methodology distinction established in Michigan Academy is no longer viable."); Martin v. Shalala, 63 F.3d 497, 503 (7th Cir. 1995) ("[T]he Michigan Academy distinctions drawn between 'amount of payment' and 'validity of the statute and regulations' challenges are no longer meaningful or necessary."); Farkas, 24 F.3d at 860 (amount/methodology distinction no longer "good law"); Abbey v. Sullivan, 978 F.2d 37, 42 (2d Cir. 1992) (Michigan Academy's distinction "relegat[ed] to irrelevancy").

2. Although conceding the lack of "practical support" for the result it reached, Pet. App. 5a, the court of appeals nonetheless read Part III of the Court's opinion in Michigan Academy-the only portion addressed to 42 U.S.C. 1395ii, which incorporates 42 U.S.C. 405(h) into the Medicare program-as providing a broadly applicable limit on the preclusive scope of Section 405(h). In particular, the court of appeals interpreted Part III as holding that Section 405(h), as incorporated into Medicare, precludes review of "only 'amount determinations.'" Pet. App. 6a. That reasoning is flawed from premise to conclusion.
As an initial matter, the construction of Sections 1395ii and 405(h) the court of appeals purported to draw from Michigan Academy is not supported by that decision. This Court did not hold that Section 405(h) has no effect on any claim other than one involving the amount of reimbursement. Rather, again relying on the presumption that Congress intends agency action to be reviewable, 476 U.S. at 680, 681, the Court simply rejected the "extreme position" that Congress, by incorporating 42 U.S.C. 405(h) into the Medicare Act, "intended no review at all of substantial statutory and constitutional challenges to the Secretary's administration of Part B of the Medicare program." 476 U.S. at 680. Nowhere did the Court reject the distinctly more moderate position that, in those circumstances where the Medicare Act does provide mechanisms for judicial review, Section 405(h) channels all challenges to the Secretary's actions through those mechanisms.
In fact, far from offering a broadly applicable construction of Section 405(h), the Court in Michigan Academy expressly declined to "pass on the meaning of § 405(h) in the abstract," instead choosing to decide only that Section 405(h) "d[id] not apply" to preclude review of the particular claims at issue there. And to the extent the Court did identify generally applicable constructions of Section 405(h), both of the constructions it identified would bar the pre-enforcement action respondent seeks to bring here. The broader of the two interpretations (which represented the government's position in that case) was that Section 405(h) "by its terms prevents any resort to the grant of general federal-question jurisdiction contained in 28 U.S.C. 1331." 476 U.S. at 679. That construction would surely bar respondent's claim, which rests explicitly on 28 U.S.C. 1331. The narrower view identified by the Court was that Congress enacted Section 405(h) "to make clear that whatever specific procedures it provided for judicial review of final action by the Secretary were exclusive, and could not be circumvented by resort to the general jurisdiction of the federal courts." 476 U.S. at 679. That position too-although previously rejected by this Court in Salfi as excessively narrow20-would bar respondent's suit here, since the issues respondent seeks to raise on behalf of its members all may be raised after enforcement action is taken against a member, under the "specific procedures * * * for judicial review" provided by the Medicare Act.

3. Nor does the court of appeals' decision find support in the text of 42 U.S.C. 405(h). The court of appeals found it significant that the third sentence of 42 U.S.C. 405(h) bars the exercise of general federal-question jurisdiction over suits "to recover" on a claim arising under the Medicare Act, apparently reading "to recover" as meaning to obtain a monetary recovery. See Pet. App. 6a. That reasoning, however, does not take respondent's suit outside of Section 405(h).
a. To begin with, the court of appeals' reading of the phrase "to recover" is unnecessarily starchy. "Section 405(h) does not apply on its own terms" to challenges to the Secretary's enforcement of health, safety and quality-of-care requirements, "but instead is incorporated mutatis mutandis"-that is, with necessary changes in details and meaning, Black's Law Dictionary 1019 (6th ed. 1990)-"by § 1395ii." Michigan Academy, 476 U.S. at 680. In legal contexts, moreover, the phrase "to recover" does not refer only to the recovery of a monetary award. Instead, it means "to prevail" or "to obtain relief." See Black's Law Dictionary 1275-1276 (6th ed. 1990) ("In a narrower sense, to be successful in a suit, * * * to have judgment, to obtain a favorable or final judgment."); Webster's Third New International Dictionary 1898 (1981) ("to gain by legal process; to obtain a final judgment in one's favor: to succeed in a lawsuit or proceeding"); Random House Dictionary of the English Language 1613 (2d ed. 1987) ("to obtain by judgment in a court of law or by legal proceedings").
That Congress used the words "to recover" in that broader sense in Section 405(h)-and did not by that phrase intend to limit Section 405(h)'s application to "amount" determinations-is evident from the fact that Congress incorporated Section 405(h) into numerous parts of the Medicare program where "amount" determinations, as such, do not arise. For example, Congress expressly incorporated Section 405(h) into 42 U.S.C. 1320a-7 and 1320c-5, which address the circumstances under which Medicare providers can or must be excluded from the program. See 42 U.S.C. 1320a-7(f)(3). Since neither of those provisions deals with "amount" determinations-instead, like 42 U.S.C. 1395cc(h) here, they deal with eligibility to participate in Medicare-it would be illogical to construe Section 405(h) as "affect[ing]" only "amount determinations" of claims for reimbursement. Congress cannot be presumed to have specifically incorporated Section 405(h) in that setting with the understanding that so doing would have no effect at all.21
Construing Section 405(h) as "affect[ing] only 'amount determinations,'" Pet. App. 6a, moreover, would make the second sentence in Section 405(h) mere surplusage. An amount determination is by its very nature a reimbursement decision by the Secretary. Judicial review of such amount determinations through means other than those provided by the Medicare Act itself, however, is already precluded by the second sentence of Section 405(h), which states that "[n]o * * * decision of the [Secretary] shall be reviewed by any person, tribunal, or governmental agency except as herein provided." The court of appeals' construction thus makes the third sentence of Section 405(h) superfluous in light of the second sentence.
The court of appeals' ruling ignores the text and purpose of the second sentence of Section 405(h) in another respect as well. Whatever the words "to recover" might mean in the third sentence of Section 405(h), those words do not appear in the second sentence, which bars "any person, tribunal or governmental agency" from reviewing any "decision" of the Secretary, except as provided in the Medicare Act.22
b. In any event, respondent's suit is a suit "to recover" under Medicare even if some nexus to monetary recovery were necessary to trigger Section 405(h). By this suit, respondent seeks to preclude enforcement of the requirements that govern its members' participation in Medicare, and thus their eligibility for payment. See 42 U.S.C. 1395i-3(a) to (d); 42 C.F.R. 483.1-483.75; pp. 2, 12, supra. Respondent even prays for an injunction prohibiting the Secretary from imposing "upon [respondent's] Medicare members any ban on payment as a remedy for any deficiency." J.A. 52 (¶¶G, H). As the district court aptly observed (Pet. App. 17a):
[A]t the heart of [respondent's] case, is a claim for benefits. This is evidenced by the relief sought by [respondent]. [Respondent] seeks continuation of Medicare payments and reimbursement for past due payments incurred by the patients at the nursing homes. Thus, the issue here is whether or not the nursing homes are entitled to benefits.
For that reason, respondent's claim is essentially indistinguishable from the lead plaintiff's claim in Ringer and Salfi. Just as Freeman Ringer sought to bring a pre-enforcement challenge to the Secretary's rule barring payment for the treatment he wanted, Ringer, 466 U.S. at 614-615, respondent here brought a pre-enforcement challenge to regulations that could deny payments to its members if noncompliance is found. See p. 41, supra. And just as Salfi sought (as an alternative to monetary relief) a declaratory judgment that the statutory provisions were unconstitutional and injunctive relief prohibiting the Secretary from applying those provisions to deny him payment in administrative proceedings (App. at 12-13, Weinberger v. Salfi, supra), respondent makes an identical request with respect to the regulations at issue here. Since Ringer's and Salfi's anticipatory lawsuits challenging payment-barring statutes and regulations under 28 U.S.C. 1331 were precluded by Section 405(h) as suits "to recover on a claim arising under" the Act, respondent's action must be barred by Section 405(h) as well.23
Even as an original matter, moreover, the court of appeals' theory would place an implausible gloss on the statutory scheme as a whole. It ignores the fact that Congress deliberately paired Section 405(g) with Section 405(h), with the obvious purpose of excluding through the latter, at a minimum, all issues that could be raised under the former. And it turns the normal priorities for access to judicial review on their head. Under the court of appeals' approach, the party with the least need for immediate access to judicial review-the party bringing an abstract, facial challenge to regulations that may not be applied to it-has immediate access to the courts, while the party with a greater need, i.e., a party to whom the regulations have actually been applied and that is facing imminent enforcement proceedings and remedies, cannot bring suit until it exhausts administrative remedies. It is singularly unlikely that Congress intended to allocate access to the courts in that manner.

C. RESPONDENT'S CLAIMS CONCERNING THE ADEQUACY OF THE MEDICARE ACT'S REVIEW MECHANISMS ARE WITHOUT MERIT

In its brief in opposition, respondent attempted to defend the judgment of the court of appeals on different grounds. In particular, respondent argued that the issues it sought to raise in district court do not fall within Section 405(h)'s preclusive scope because they would not be addressed in a hearing under 42 U.S.C. 405(b); given that no such hearing is available, respondent argued, providing judicial review only after exhaustion of administrative remedies "is the practical equivalent of total denial of judicial review." See Br. in Opp. 13; see also id. at 9-10. The court of appeals did not address those arguments, and they are, in any event, without merit.
1. Respondent is, as an initial matter, incorrect in asserting that its members can obtain no relief at all with respect to any of its claims. For example, respondent contends that the State Operations Manual, which is used by survey agencies when reviewing nursing facilities for compliance, is invalid because it was "promulgated without the required notice and comment procedures required by the Administrative Procedures Act for substantive regulations." J.A. 18, 27-28, 46 (¶¶ 3A, 32-36, 94A-94B); see Br. in Opp. 2. Any nursing facility that is subjected to a remedy for a violation because of the Manual, however, can challenge the finding of a violation in administrative proceedings. Because ALJs and the Departmental Appeals Board are not bound by the Manual, see Shalala v. Guernsey Mem'l Hosp., 514 U.S. 87, 99 (1995),24 such a nursing home could obtain complete relief. Moreover, a claim of a violation of the APA's notice-and- comment requirements can in any event be addressed on judicial review, after exhaustion, under 42 U.S.C. 405(g). See Ringer, 466 U.S. at 614-616 (claim that regulations and instructions to intermediaries violate APA notice-and-comment requirements reviewable under Section 405(g) after exhaustion of administrative remedies).25
To be sure, some of the other issues respondent seeks to raise, such as its constitutional contentions and its challenges to the Secretary's regulations, ordinarily would not be the subject of an administrative hearing. Neither the Departmental Appeals Board nor individual ALJs are free to depart from statutory and regulatory requirements. But that does not mean that Section 405(h) ceases to apply. To the contrary, Section 405(h) requires all claims "arising under" the Medicare Act to be brought through the mechanisms provided by the Medicare Act itself; nowhere does it exclude individual issues that would not be addressed in the administrative process. That, in fact, is precisely the holding of Salfi, 422 U.S. at 760-762. There, the plaintiffs sought to challenge the constitutionality of a provision of the Social Security Act, a challenge that could not be resolved in the administrative process. This Court held that the language of Section 405(h), "which is sweeping and direct," does not limit its preclusive effect "to decisions of the Secretary on issues of law or fact. Rather, it extends to any 'action' seeking 'to recover on any * * * claim'-irrespective of whether resort to judicial processes is necessitated by discretionary decisions of the Secretary or by * * * nondiscretionary application of allegedly unconstitutional statutory restrictions." Id. at 757, 762. As the Court summarized: "[T]he plain words of the third sentence of § 405(h) do not preclude constitutional challenges. They simply require that [the challenges] be brought under jurisdictional grants contained in the Act, and thus in conformity with the same standards which are applicable to nonconstitutional claims arising under the Act." Id. at 762.
This Court likewise has applied Section 405(h) to preclude federal courts from exercising federal-question jurisdiction over procedural and due process claims like respondent's. In Ringer, for example, the Court "disagree[d] in particular with [the court of appeals'] apparent conclusion that simply because a claim somehow can be construed as 'procedural,' it is cognizable in federal district court by way of federal-question jurisdiction." 466 U.S. at 614. Instead, "the inquiry in determining whether § 405(h) bars federal-question jurisdiction must be whether the claim 'arises under' the Act, not whether it lends itself to a 'substantive' rather than a 'procedural' label." Id. at 615.
Finally, in Mathews v. Eldridge, 424 U.S. 319 (1976), the plaintiff alleged that the procedures the Secretary employed under the Act violated procedural due process. Even though the plaintiff's claims were "collateral" to the merits-they challenged the process provided, not the substantive result -and the plaintiff made a colorable claim that the post-deprivation review provided through administrative remedies would be inadequate, this Court held that "[t]he only avenue for judicial review" of such claims "is 42 U.S.C. 405(g)." Id. at 327. Section 405(g), the Court explained, permits adequate review of even completely collateral claims so long as the "final decision" requirement is properly applied.26

2. The text and structure of the Medicare Act confirm the correctness of that result. As the Court recognized in Ringer and Salfi, nothing in Section 405(h) limits its application to issues that might be addressed by an ALJ in the administrative process; its sweeping language instead extends to "all 'claim[s] arising under' the Medicare Act." Ringer, 466 U.S. at 615. Nor can such a limit be inferred from the scope of review provided by Section 405(g). Whereas the hearing provided by Section 405(b) might have a limited scope, the review provided by Section 405(g) is not limited to those issues cognizable before an ALJ. For example, far from restricting the reviewing court to an examination of whether "the findings * * * as to any fact" are "supported by substantial evidence," 42 U.S.C. 405(g), Section 405(g) expressly permits the reviewing court to address "the validity of [the] regulations" themselves, ibid.-an issue an ALJ could not address.
Other provisions of the Medicare Act, moreover, confirm that Congress intended to channel all claims through the administrative process as a prerequisite to judicial review under Section 405(g) and parallel Medicare provisions, even where individual legal issues bearing on those claims- including challenges to the Act or regulations-would not be addressed in the administrative process. For example, 42 U.S.C. 1395oo(f)(1) permits the Provider Reimbursement Review Board (PRRB) to facilitate judicial review on an expedited basis by certifying "that it is without authority to decide" a "question of law or regulations relevant to the matters in controversy." Once such a certification is made in a case otherwise properly before the PRRB, 42 U.S.C. 1395oo(a), an action for judicial review on that question may be filed immediately; it need not await the PRRB's resolution of issues that are within its competence to decide, as would otherwise be required by Salfi and Ringer. See 42 U.S.C. 1395oo(f)(1); Bethesda Hosp. Ass'n v. Bowen, 485 U.S. 399, 406-407 (1988). If matters outside the PRRB's competence to decide were not required to be channeled into the special statutory procedure for administrative and judicial review together with issues that are-and such issues instead could be presented outside that procedure in district court under 28 U.S.C. 1331-the expedited review provision in 42 U.SC. 1395oo(f)(1) would be entirely unnecessary. It is, of course, inappropriate to construe a statute so as to make any of its provisions superfluous. Moskal v. United States, 498 U.S. 103, 109-110 (1990). Similarly, in the case of individuals who seek administrative and judicial review of individual benefit claims under 42 U.S.C. 1395ff(b) (which incorporates 42 U.S.C. 405(g)), the Act specifically contemplates that judicial review of national coverage determinations of general applicability will be available under 42 U.S.C. 405(g), even though such determinations cannot be reviewed by an ALJ. See 42 U.S.C. 1395ff(b)(3).27

3. Because even issues that would not be addressed in a hearing can be reviewed by a court under 42 U.S.C. 405(g) after exhaustion, respondent's reliance on Thunder Basin, 510 U.S. at 207, is misplaced. Quoting Thunder Basin, respondent notes that whether "a statute is intended to preclude initial judicial review" depends in part on "whether the claims can be afforded meaningful review" through the mechanisms provided by statute. Br. in Opp. 13. Respondent then contends that the issues it seeks to raise "cannot be meaningfully addressed or reviewed in the administrative process." Br. in Opp. 13. But the question is not whether its contentions will be "meaningfully addressed * * * in the administrative process." It is whether they will be meaningfully addressed through the statutory mechanism for administrative and judicial review as a whole, with an emphasis on the latter. See 510 U.S. at 212-213 (inquiry particularly important "where a finding of preclusion could foreclose all meaningful judicial review") (emphasis added). In fact, in Thunder Basin itself, this Court held that the statutory review mechanism was meaningful, adequate, and exclusive "[e]ven if" the administrative agency would not or could not adjudicate the statutory and constitutional claims at issue there, because those issues ultimately would "be meaningfully addressed" on judicial review. Id. at 215. The same is true of the issues respondent seeks to raise here.

4. At bottom, respondent's suit for anticipatory relief is nothing more than an effort to bypass the reticulated mechanisms for administrative and judicial review provided by the Medicare Act itself. Seeking to avoid the necessity of bringing challenges in the context of specific violations, and attempting to evade the requirements that individual claims be presented to the Secretary and administrative remedies be exhausted, respondent filed the current facial challenge to the Secretary's regulations in an effort to obtain far-reaching and intrusive relief. But it was precisely such circumvention of the statutory processes (and the resulting potential for unnecessary and damaging intrusion into the administration of programs affecting millions of people) that this Court rejected in Salfi, in Mathews, and in Ringer, and that Sections 405(g) and 405(h) were designed to prevent. Those provisions simply do not permit a nursing facility to split off one legal issue bearing on the merits of a challenge to a compliance determination and present that issue in an independent action for declaratory or injunctive relief under 28 U.S.C. 1331. Of course, "[i]n the best of all worlds, immediate judicial access * * * might be desirable" for particular challenges in particular cases. Ringer, 466 U.S. at 627. But this is not such a case and, even if it were, "Congress, in § 405(g) and § 405(h), struck a different balance, refusing declaratory relief and requiring that administrative remedies be exhausted before judicial review of the Secretary's decisions takes place." Ibid. Because the court of appeals' judgment fails to respect that statutory balance, it should be reversed.