Heckler v. Ringer

Justice Rehnquist

delivered the opinion of the Court.

Respondents are individual Medicare claimants who raise various challenges to the policy of the Secretary of Health and Human Services (Secretary) as to the payment of Medi*605care benefits for a surgical procedure known as bilateral carotid body resection (BCBR). The United States District Court for the Central District of California dismissed the action for lack of jurisdiction, finding that in essence respondents are claiming entitlement to benefits for the BCBR procedure and therefore must exhaust their administrative remedies pursuant to 42 U. S. C. § 405(g), before pursuing their action in federal court. The Court of Appeals for the Ninth Circuit reversed and remanded for consideration on the merits. 697 F. 2d 1291 (1982). We granted certiorari to sort out the thorny jurisdictional problems which respondents’ claims present, 463 U. S. 1206 (1983), and we now reverse as to all respondents.

I

Title XVIII of the Social Security Act, 79 Stat. 291, as amended, 42 U. S. C. § 1395 et seq., commonly known as the Medicare Act, establishes a federally subsidized health insurance program to be administered by the Secretary. Part A of the Act, 42 U. S. C. § 1395c et seq., provides insurance for the cost of hospital and related posthospital services, but the Act precludes reimbursement for any “items or services . . . which are not reasonable and necessary for the diagnosis or treatment of illness or injury.” § 1395y(a)(l). The Medicare Act authorizes the Secretary to determine what claims are covered by the Act “in accordance with the regulations prescribed by him.” § 1395ff(a). Judicial review of claims arising under the Medicare Act is available only after the Secretary renders a “final decision” on the claim, in the same manner as is provided in 42 U. S. C. § 405(g)1 for old age and disability claims arising under Title II of the Social Security Act. 42 U. S. C. § 1395ff(b)(l)(C).

*606Pursuant to her rulemaking authority, see 42 U. S. C. §§1395hh, 1395Ü (incorporating 42 U. S. C. § 405(a)), the Secretary has provided that a “final decision” is rendered on a Medicare claim only after the individual claimant has pressed his claim through all designated levels of administrative review.2 First, the Medicare Act authorizes the Secretary to enter into contracts with fiscal intermediaries providing that the latter will determine whether a particular medical service is covered by Part A, and if so, the amount of the reimbursable expense for that service. 42 U. S. C. § 1395h; 42 CFR § 405.702 (1983). If the intermediary determines that a particular service is not covered under Part A, the claimant can seek Teconsideration by the Health Care Financing Administration (HCFA) in the Department of Health and Human Services. 42 CFR §§405.710-405.716 (1983). If denial of the claim is affirmed after reconsideration and if the claim exceeds $100, the claimant is entitled to a hearing before an administrative law judge (AL J) in the same manner as is provided for claimants under Title II of the Act. 42 U. S. C. §§ 1395ff(b)(l)(C), (b)(2); 42 CFR §405.720 (1983). *607If the claim is again denied, the claimant may seek review in the Appeals Council. 42 CFR §§405.701(c), 405.724 (1983) (incorporating 20 CFR §404.967 (1983)). If the Appeals Council also denies the claim and if the claim exceeds $1,000, only then may the claimant seek judicial review in federal district court of the “Secretary’s final decision.” 42 U. S. C. §§ 1395ff(b)(l)(C), (b)(2).

In January 1979, the Secretary through the HCFA issued an administrative instruction to all fiscal intermediaries, instructing them that no payment is to be made for Medicare claims arising out of the BCBR surgical procedure when performed to relieve respiratory distress. See 45 Fed. Reg. 71431-71432 (1980) (reproducing the instruction).3 Relying on information from the Public Health Service and a special Task Force of the National Heart, Lung and Blood Institute of the National Institutes of Health, id., at 71426, the HCFA explained that BCBR has been “shown to lack [the] general acceptance of the professional medical community” and that “controlled clinical studies establishing the safety and effectiveness of this procedure are needed.” Id., at 71431. It concluded that the procedure “must be considered investiga-tional” and not “reasonable and necessary” within the meaning of the Medicare Act. Ibid.

Many claimants whose BCBR claims were denied by the intermediaries as a result of the instruction sought review of the denial before ALJs, who were not bound by the Secretary’s instructions to the intermediaries. Until October *6081980, ALJs were consistently ruling in favor of individual BCBR claimants. The Appeals Council also authorized payment for BCRB Part A expenses in a consolidated case involving numerous claimants, see In re Ferguson, No. 126-12-3830 (HHS Appeals Council, Oct. 18, 1979), while stressing that its decision applied only to the claimants involved in that case and was not to be cited as precedent in future cases.

In response to the rulings of the ALJs and the Appeals Council, on October 28, 1980, the Secretary through the HCFA issued a formal administrative ruling, intended to have binding effect on the ALJs and the Appeals Council, see 20 CFR §422.408 (1983), prohibiting them in all individual cases from ordering Medicare payments for BCBR operations occurring after that date. 45 Fed. Reg. 71426-71427 (1980). In the ruling the Secretary noted that she had examined the proceedings in In re Ferguson, had consulted with the Public Health Service, and again had concluded that the BCBR procedure was not “reasonable and necessary” within the meaning of the Medicare Act. Ibid.

On September 18, 1980, respondents in this case filed a complaint in the District Court for the Central District of California, raising numerous challenges focused on the Secretary’s January 1979 instructions to her intermediaries precluding payment for BCBR surgery.4 On November 7,1980, *609after the Secretary issued the formal ruling binding on the ALJs and the Appeals Council as well as the intermediaries, respondents amended their complaint to challenge that ruling as well. Respondents relied on 28 U. S. C. § 1381 (federal question), 28 U. S. C. §1361 (mandamus against a federal official), and 42 U. S. C. § 405(g) (Social Security Act), to establish jurisdiction in the District Court.

The individuals named in the amended complaint, who are respondents before this Court,5 are four individual Medicare claimants. Their physician, Dr. Benjamin Winter,6 who has developed a special technique for performing BCBR surgery and who has performed the surgery over 1,000 times, prescribed BCBR surgery for all four respondents to relieve their pulmonary problems. Respondents Sanford Holmes, Norman Webster-Zieber, and Jean Vescio had the surgery before October 28, 1980, and all three filed a claim for reimbursement with their fiscal intermediary. At the time *610that the amended complaint was filed, none of the three had exhausted their administrative remedies, and thus none had received a “final decision” on their claims for benefits from the Secretary. The fourth respondent, Freeman Ringer, informally inquired of the Secretary and learned that BCBR surgery is not covered under the Medicare Act. Thus he has never had the surgery, claiming that he is unable to afford it. App. 32.

The essence of their amended complaint is that the Secretary has a constitutional and statutory obligation to provide payment for BCBR surgery because overwhelmingly her ALJs have ordered payment when they have considered individual BCBR claims. Id., at 9-10. According to the complaint, the Secretary’s instructions to the contrary to her intermediaries violate constitutional due process and numerous statutory provisions in that they force eligible Medicare claimants who have had BCBR surgery to pursue individual administrative appeals in order to get payment, even though ALJs overwhelmingly have determined that payment is appropriate. Id., at 16-22. Regarding the Secretary’s formal administrative ruling, the complaint asserts that the ruling merely reaffirms the instructions and creates an “additional administrative barrier” to Medicare beneficiaries desiring the BCBR treatment, and that it also is unlawful on numerous substantive and procedural grounds. Id., at 23-25.7 The *611complaint seeks a declaration that the Secretary’s refusal to find that BCBR surgery is “reasonable and necessary” under the Act is unlawful, an injunction compelling the Secretary to instruct her intermediaries to provide payment for BCBR claims, and an injunction barring the Secretary from forcing claimants to pursue individual administrative appeals in order to obtain payment. Id., at 9-10, 25-27.

The District Court dismissed the complaint in its entirety for lack of jurisdiction.8 It concluded that “[t]he essence of [respondents’ claim]... is a claim of entitlement [to] benefits for the BCBR procedure,” and that any challenges respondents raise to the Secretary’s procedures are “inextricably intertwined” with their claim for benefits. App. to Pet. for Cert. 14a. Thus the court concluded that 42 U. S. C. § 405(g) with its administrative exhaustion prerequisite provides the sole avenue for judicial review. Relying on our decision in Mathews v. Eldridge, 424 U. S. 319, 330-332 (1976), the court concluded that none of respondents’ claims are so “collateral” to their overall claim for benefits that the *612exhaustion requirement should be waived as to those claims. Because none of the named respondents have satisfied the exhaustion prerequisite of § 405(g), the court dismissed the complaint.

On appeal the Court of Appeals for the Ninth Circuit reversed. It concluded that the thrust of respondents’ claim is that “the Secretary’s presumptive rule that the BCBR operation is not reasonable and necessary was an unlawful administrative mechanism for determining awards of benefits.” 697 F. 2d, at 1294. The Court of Appeals concluded that to the extent that respondents are seeking to invalidate the Secretary’s 'procedure for determining entitlement to benefits, those claims are cognizable without the requirement of administrative exhaustion under the federal-question statute, 28 U. S. C. §1331, and the mandamus statute, 28 U. S. C. § 1361. 697 F. 2d, at 1294.

The Court of Appeals agreed with the District Court that respondents also had raised substantive claims for benefits, in that they had sought an injunction requiring the Secretary to declare that BCBR is reasonable and necessary under the Act. In the Court of Appeals’ view, the fact that respondents had not sought an actual award of benefits in their complaint did not alter the court’s characterization of a portion of their claim as essentially a claim for benefits. Ibid. Acknowledging that § 405(g) with its exhaustion prerequisite provides the only jurisdictional basis for seeking judicial review of claims for benefits, the court nonetheless concluded that the District Court had erred in requiring respondents to exhaust their administrative remedies in this case. Relying on our opinions in Weinberger v. Salfi, 422 U. S. 749 (1975), and Mathews v. Eldridge, supra, the Court of Appeals concluded that exhaustion would be futile for respondents and that it may not fully compensate them for the injuries they assert because they seek payment without the prejudice— and the necessity of appeal — resulting from the existence of the instructions and the rule. 697 F. 2d, at 1294-1296. Because we disagree with the Court of Appeals’ characteriza*613tion of the claims at issue in this case and its reading of our precedents, we now reverse.

HH I — i

Preliminarily, we must point out that, although the Court of Appeals seemed not to have distinguished them, there are in fact two groups of respondents in this case. Respondents Holmes, Vescio, and Webster-Zieber constitute one group of respondents, those who have had BCBR surgery before October 28, 1980, and who have requested reimbursement at some, but not all, levels of the administrative process. Although the Court of Appeals did not seem to realize it, there is no dispute that the Secretary’s formal administrative ruling simply does not apply to those three respondents’ claims for reimbursement for their BCBR surgery.9 Their claims only make sense then if they are understood as challenges to the Secretary’s instructions to her intermediaries, instructions which resulted in those respondents’ having to pursue administrative remedies in order to get payment. They have standing to challenge the formal ruling as well only because, construing their complaint liberally, they argue that the existence of the formal rule creates a presumption *614against payment of their claims in the administrative process, even though the rule does not directly apply to bar their claims. The relief respondents request is that the Secretary change her policy so as to allow payment for BCBR surgery so that respondents simply will not have to resort to the administrative process.

It seems to us that it makes no sense to construe the claims of those three respondents as anything more than, at bottom, a claim that they should be paid for their BCBR surgery. Arguably respondents do assert objections to the Secretary’s “procedure” for reaching her decision — for example, they challenge her decision to issue a generally applicable rule rather than to allow individual adjudication, and they challenge her alleged failure to comply with the rulemaking requirements of the APA in issuing the instructions and the rule. We agree with the District Court, however, that those claims are “inextricably intertwined” with respondents’ claims for benefits. Indeed the relief that respondents seek to redress their supposed “procedural” objections is the invalidation of the Secretary’s current policy and a “substantive” declaration from her that the expenses of BCBR surgery are reimbursable under the Medicare Act. We conclude that all aspects of respondents’ claim for benefits should be channeled first into the administrative process which Congress has provided for the determination of claims for benefits. We, therefore, disagree with the Court of Appeals’ separation of the particular claims here into “substantive” and “procedural” elements. We disagree in particular with its 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.

The third sentence of 42 U. S. C. § 405(h),10 made applicable to the Medicare Act by 42 U. S. C. § 1B95Ü, provides *615that § 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. See Weinberger v. Salfi, supra, at 760-761. Thus, to be true to the language of the statute, 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. See Mathews v. Eldridge, 424 U. S., at 327 (recognizing that federal-question jurisdiction is barred by 42 U. S. C. § 405(h) even in a case where claimant is challenging the administrative procedures used to terminate welfare benefits).

In Weinberger v. Salfi, supra, at 760-761, we construed the “claim arising under” language quite broadly to include any claims in which “both the standing and the substantive basis for the presentation” of the claims is the Social Security Act. In that case we held that a constitutional challenge to the duration-of-relationship eligibility statute pursuant to which the claimant had been denied benefits, was a “claim arising under” Title II of the Social Security Act within the meaning of 42 U. S. C. § 405(h), even though we recognized that it was in one sense also a claim arising under the Constitution.

Under that broad test, we have no trouble concluding that all aspects of respondents Holmes’, Vescio’s, and Webster-Zieber’s challenge to the Secretary’s BCBR payment policy “aris[e] under” the Medicare Act. It is of no importance that respondents here, unlike the claimants in Weinberger v. Salfi, sought only declaratory and injunctive relief and not an actual award of benefits as well. Following the declaration which respondents seek from the Secretary — that BCBR surgery is a covered service — only essentially ministerial details will remain before respondents would receive reimburse*616ment. Had our holding in Weinberger v. Salfi turned on the fact that claimants there did seek retroactive benefits, we might well have done as the dissent in that case suggested and held that § 405(h) barred federal-question jurisdiction only over claimants’ specific request for benefits, and not over claimants’ declaratory and injunctive claims as well. See 422 U. S., at 798-799, and n. 13 (Brennan, J., dissenting). Thus we hold that the Court of Appeals erred in concluding that any portion of Holmes’, Vescio’s, or Webster-Zieber’s claims here can be channeled into federal court by way of federal-question jurisdiction.

The Court of Appeals also relied on the mandamus statute as a basis for finding jurisdiction over a portion of those three respondents’ claims. We have on numerous occasions declined to decide whether the third sentence of § 405(h) bars mandamus jurisdiction over claims arising under the Social Security Act, either because we have determined that jurisdiction was otherwise available under § 405(g), see Califano v. Yamasaki, 442 U. S. 682, 698 (1979); Mathews v. Eldridge, supra, at 332, n. 12, or because we have determined that the merits of the mandamus claim were clearly insubstantial, Norton v. Mathews, 427 U. S. 524, 528-533 (1976). We need not decide the effect of the third sentence of § 405(h) on the availability of mandamus jurisdiction in Social Security cases here either.

Assuming without deciding that the third sentence of § 405(h) does not foreclose mandamus jurisdiction in all Social Security cases, see generally Dietsch v. Schweiker, 700 F. 2d 865, 867-868 (CA2 1983); Ellis v. Blum, 643 F. 2d 68, 78-82 (CA2 1981), the District Court did not err in dismissing respondents’ complaint here because it is clear that no writ of mandamus could properly issue in this case. The common-law writ of mandamus, as codified in 28 U. S. C. § 1361, is intended to provide a remedy for a plaintiff only if he has exhausted all other avenues of relief and only if the defendant owes him a clear nondiscretionary duty. See Kerr v. United *617States District Court, 426 U. S. 394, 402-403 (1976) (discussing 28 U. S. C. § 1651); United States ex rel. Girard Trust Co. v. Helvering, 301 U. S. 540, 543-544 (1937).

Here respondents clearly have an adequate remedy in § 405(g) for challenging all aspects of the Secretary’s denial of their claims for payment for the BCBR surgery, including any objections they have to the instructions or to the ruling if either ultimately should play a part in the Secretary’s denial of their claims. The Secretary’s decision as to whether a particular medical service is “reasonable and necessary” and the means by which she implements her decision, whether by promulgating a generally applicable rule or by allowing individual adjudication, are clearly discretionary decisions. See 42 U. S. C. §1395ff(a); see also Heckler v. Campbell, 461 U. S. 458, 467 (1983).

Thus § 405(g) is the only avenue for judicial review of respondents’ Holmes’, Vescio’s, and Webster-Zieber’s claims for benefits, and, when their complaint was filed in District Court, each had failed to satisfy the exhaustion requirement that is a prerequisite to jurisdiction under that provision. We have previously explained that the exhaustion requirement of § 405(g) consists of a nonwaivable requirement that a “claim for benefits shall have been presented to the Secretary,” Mathews v. Eldridge, 424 U. S., at 328, and a waivable requirement that the administrative remedies prescribed by the Secretary be pursued fully by the claimant. Ibid. All three respondents satisfied the nonwaivable requirement by presenting a claim for reimbursement for the expenses of their BCBR surgery, but none satisfied the waivable requirement.

Respondents urge us to hold them excused from further exhaustion and to hold that the District Court could have properly exercised jurisdiction over their claims under § 405(g). We have held that the Secretary herself may waive the exhaustion requirement when she deems further exhaustion futile, Mathews v. Diaz, 426 U. S. 67, 76-77 (1976); *618Weinberger v. Salfi, 422 U. S., at 766-767. We have also recognized that in certain special cases, deference to the Secretary’s conclusion as to the utility of pursuing the claim through administrative channels is not always appropriate. We held that Mathews v. Eldridge, supra, at 330-332, was such a case, where the plaintiff asserted a procedural challenge to the Secretary’s denial of a pretermination hearing, a claim that was wholly “collateral” to his claim for benefits, and where he made a colorable showing that his injury could not be remedied by the retroactive payment of benefits after exhaustion of his administrative remedies.

The latter exception to exhaustion is inapplicable here where respondents do not raise a claim that is wholly “collateral” to their claim for benefits under the Act, and where they have no colorable claim that an erroneous denial of BCBR benefits in the early stages of the administrative process will injure them in a way that cannot be remedied by the later payment of benefits. And here, it cannot be said that the Secretary has in any sense waived further exhaustion. In the face of the Secretary’s vigorous disagreement, the Court of Appeals concluded that the Secretary’s formal ruling denying payment for BCBR claims rendered further exhaustion by respondents futile. But as we have pointed out above, the administrative ruling is not even applicable to respondents’ claims because they had their surgery before October 28, 1980. We therefore agree with the Secretary that exhaustion is in no sense futile for these three respondents and that the Court of Appeals erred in second-guessing the Secretary’s judgment.11

*619Respondents also argue that there would be a presumption against them as they pursue their administrative appeals because of the very existence of the Secretary’s instructions and her formal ruling and thus that exhaustion would not fully vindicate their claims. The history of this litigation as recited to us by respondents belies that conclusion. Indeed, according to respondents themselves, in every one of 170 claims filed with ALJs between the time of the Secretary’s instructions to her intermediaries and the filing of this lawsuit, before the formal ruling became effective, ALJs allowed recovery for BCBR claims. Brief for Respondents 3. In promulgating the formal ruling, the Secretary took pains to exempt from the scope of the ruling individuals in respondents’ position who may have had the surgery relying on the favorable ALJ rulings. 45 Fed. Reg. 71427 (1980). Although respondents would clearly prefer an immediate appeal to the District Court rather than the often lengthy administrative review process, exhaustion of administrative remedies is in no sense futile for these respondents, and they, therefore, must adhere to the administrative procedure which Congress has established for adjudicating their Medicare claims.12

*6201 — 1 1 — I

Respondent Ringer is in a separate group from the other three respondents in this case. He raises the same challenges to the instructions and to the formal ruling as are raised by the other respondents. His position is different from theirs, however, because he wishes to have the operation and claims that the Secretary's refusal to allow payment for it precludes him from doing so. Because Ringer’s surgery, if he ultimately chooses to have it, would occur after the effective date of the formal ruling, Ringer’s claim for reimbursement, unlike that of the others, would be covered by the formal ruling. Ringer insists that, just as in the case of the other three respondents, the only relief that will vindicate his claim is a declaration that the formal ruling, and presumably the instructions as well, are invalid and an injunction compelling the Secretary to conclude that BCBR surgery is “reasonable and necessary” within the meaning of the Medicare Act. It is only after that declaration and injunction, Ringer insists, that he will be assured of payment and thus only then that he will be able to have the operation.

Again, regardless of any arguably procedural components, we see Ringer’s claim as essentially one requesting the payment of benefits for BCBR surgery, a claim cognizable only under § 405(g). Our discussion of the unavailabilty of mandamus jurisdiction over the claims of the other three respondents is equally applicable to Ringer. As to § 1331 jurisdiction, as with the other three respondents, all aspects of Ringer’s claim “aris[e] under” the Medicare Act in that the Medicare Act provides both the substance and the standing for Ringer’s claim, Weinberger v. Salfi, 422 U.S., at 760-761. Thus, consistent with our decision with respect to the other three respondents, we hold that §§1331 and 1361 are not *621available as jurisdictional bases for vindicating Ringer’s claim.

Ringer’s situation does differ from that of the other three respondents in one arguably significant way. Because he has not yet had the operation and thus has no reimbursable expenses, it can be argued that Ringer does not yet have a "claim” to present to the Secretary and thus that he does not have a “claim arising under” the Medicare Act so as to be subject to § 405(h)’s bar to federal-question jurisdiction. The argumént is not that Ringer’s claim does not “arise under” the Medicare Act as we interpreted that term in Weinberger v. Salfi; it is rather that it has not yet blossomed into a “claim” cognizable under § 405(g). We find that argument superficially appealing but ultimately unavailing.

Although it is true that Ringer is not seeking the immediate payment of benefits, he is clearly seeking to establish a right to future payments should he ultimately decide to proceed with BCBR surgery. See Attorney Registration & Disciplinary Comm’n v. Schweiker, 715 F. 2d 282, 287 (CA7 1983). The claim for future benefits must be construed as a “claim arising under” the Medicare Act because any other construction would allow claimants substantially to undercut Congress’ carefully crafted scheme for administering the Medicare Act.

If we allow claimants in Ringer’s position to challenge in federal court the Secretary’s determination, embodied in her rule, that BCBR surgery is not a covered service, we would be inviting them to bypass the exhaustion requirements of the Medicare Act by simply bringing declaratory judgment actions in federal court before they undergo the medical procedure in question. Ibid. Congress clearly foreclosed the possibility of obtaining such advisory opinions from the Secretary herself, requiring instead that a claim could be filed for her scrutiny only after the medical service for which payment is sought has been furnished. See 42 U. S. C. §§ 1395d(a), 1395f(a); 42 CFR §§405.1662-495.1667 (1983). Under the *622guise of interpreting the language of § 405(h), we refuse to undercut that choice by allowing federal judges to issue such advisory opinions. Thus it is not the case that Ringer has no “claim” cognizable under § 405(g); it is that he must pursue his claim under that section in the manner which Congress has provided. Because Ringer has not given the Secretary an opportunity to rule on a concrete claim for reimbursement, he has not satisfied the nonwaivable exhaustion requirement of § 405(g). The District Court, therefore, had no jurisdiction as to respondent Ringer.

With respect to our holding that there is no jurisdiction pursuant to § 1331, the dissent argues that § 405(h) is not a bar to § 1331 jurisdiction because Ringer’s challenge to the Secretary’s rule is “arising under” the Administrative Procedure Act, not the Medicare Act. Post, at 633. But the dissent merely resurrects an old argument that has already been raised and rejected before by this Court in Weinberger v. Salfi, supra. As we have already noted earlier, supra, at 615, the Court rejected the argument that the claimant in Salfi could bring his constitutional challenge to a Social Security Act provision in federal court pursuant to § 1331 because the claim was “arising under” the Constitution, not the Social Security Act. Ringer’s claim may well “aris[e] under” the APA in the same sense that Salfi’s claim arose under the Constitution, but we held in Salfi that the constitutional claim was nonetheless barred by § 405(h). It would be anomalous indeed for this Court to breathe life into the dissent’s already discredited statutory argument in order to give greater solicitude to an APA claim than the Court thought the statute allowed it to give to the constitutional claim in Salfi.

The dissent suggests that Salfi is distinguishable on two grounds. First, it seems to suggest that Salfi is distinguishable because, after rejecting the claim that there was jurisdiction under § 1331, the Court in Salfi went on to conclude that there was jurisdiction under § 405(g). Post, at 633-635. We fail to see how the Court’s conclusion that the claimants in Salfi had satisfied all of the prerequisites to jurisdiction *623under § 405(g) has anything at all to do with the proper construction of § 405(h). If the dissent is suggesting that the meaning of § 405(h) somehow shifts depending on whether a court finds that the waivable and nonwaivable requirements of § 405(g) are met in any given case, that suggestion is simply untenable.

Second, the dissent seems to suggest that Salfi is distinguishable because the claimants there appended a claim for benefits to their claim for declaratory and injunctive relief as to the unconstitutionality of the statute. Post, at 685-637. Again, as we have already pointed out in text, supra, at 615-616, there is no indication in Salfi that our holding in any way depended on the fact that the claimants there sought an award of benefits. Furthermore, today we explicitly hold that our conclusion that the claims of Holmes, Vescio, and Webster-Zieber are barred by § 405(h) is in no way affected by the fact that those respondents did not seek an award of benefits. Supra, at 615-616. If the dissent finds that the fact that Ringer does not expressly ask that he be paid benefits for his future surgery18 is crucial to its conclusion that his claims are not barred under § 405(h), it is difficult to see why the dissent also does not conclude that the claims of the other three respondents are not barred by § 405(h) for the same reason.

The crux of the dissent’s position as to § 1331 jurisdiction then seems to be that Ringer’s claims do not “arise under” the Medicare Act so as to be barred by § 405(h) because Ringer and his surgeon have not yet filed, and indeed cannot yet file, a concrete claim for reimbursement because Ringer has not yet had BCBR surgery. Thus, in the dissent’s view, if a clamaint wishes to claim entitlement to benefits in ad-*624vanee of undergoing the procedure for which payment is sought, his claim does not “arise under” the Medicare Act and hence he is not precluded by § 405(h) from resorting to federal-question jurisdiction. But that argument amounts to no more than an assertion that the substance of Ringer’s claim somehow changes and “arises under” another statute simply because he has not satisfied the procedural prerequisites for jurisdiction which Congress has prescribed in § 405(g).

The substance of Ringer’s claim is identical to the substance of the claims of the other three respondents, claims whose substance and standing we have earlier concluded are derived from the Medicare Act. Supra, at 615-616. As we have earlier noted, supra, at 620, the fairest reading of the rather confusing amended complaint is that all respondents, including Ringer, wish both to invalidate the Secretary’s rule and her instructions and to replace them with a new rule that allows them to get payment for BCBR surgery. While it is true that all of the respondents complain about the presumptive nature of the Secretary’s current rule, it is equally true that they all — including Ringer — complain about the burden of exhaustion of administrative remedies and that they all seek relief that will allow them to receive benefits yet bypass that administrative process altogether. App. 9-10; n. 13, supra. With respect to the other three respondents, we hold today that all their claims — identical to Ringer’s— are inextricably intertwined with what we hold is in essence a claim for benefits and that § 1331 jurisdiction over all their claims is barred by § 405(h). Supra, at 614-616. We decline to hold that the same claim asserted by Ringer should somehow be characterized in a different way for the purpose of §1331 jurisdiction simply because Ringer has not satisfied the prerequisites for jurisdiction under § 405(g).

With respect to our holding that Ringer has not satisfied the nonwaivable requirement of § 405(g), the dissent adopts the remarkable view that the Secretary’s promulgation of a *625rule regarding BCBR surgery satisfies that nonwaivable requirement. The dissent would thus open the doors of the federal courts in the first instance to everyone — those who can and those who cannot afford to pay their surgeons without reliance on Medicare — who thinks that he might be eligible to participate in the Medicare program, who thinks that someday he might wish to have some kind of surgery, and who thinks that this surgery might somehow be affected by a rule that the Secretary has promulgated. Of course, it is of no great moment to the dissent that after adjudicating his claim in federal court, that individual may simply abandon his musings about having surgery. And it is of no great moment to the dissent that Congress, who surely could have provided a scheme whereby claimants could obtain declaratory judgments about their entitlement to benefits, has instead expressly set up a scheme that requires the presentation of a concrete claim to the Secretary.

The dissent’s declaratory judgment notion effectively ignores the scheme which Congress has created and does nothing less than change the whole character of the Medicare system. The dissent argues that its frustration of Congress’ scheme can be limited to the situation where the Secretary has promulgated a rule, or in the dissent’s words, where she has “already issued an advisory opinion” about a certain surgical procedure in the form of a generally applicable rule. Post, at 642-643. Such a quest for restraint is admirable, but the logic of the dissent’s position makes the quest futile. The dissent’s concern in this case is with those perhaps millions of people, like Ringer, who desire some kind of controversial operation but who are unable to have it because their surgeons will not perform the surgery without knowing in advance whether they will be victorious in challenging the Secretary’s rule in the administrative or later in the judicial process. Post, at 629-630, 643. But that concern exists to the same degree with any claimant, even in the absence of a generally applicable ruling by the Secretary. For example, a *626surgeon called upon to perform any kind of surgery for a prospective claimant would, in the best of all possible worlds, wish to know in advance whether the surgery is “reasonable and necessary” within the meaning of the Medicare Act. And indeed some such surgeons may well decline to perform the requested surgery because of fear that the Secretary will not find the surgery “reasonable and necessary” and thus will refuse to reimburse them. The logic of the dissent’s position leads to the conclusion that those individuals, as well as Ringer, are entitled to an advance declaration so as to ensure them the opportunity to have the surgery that they desire.

Furthermore, the solution that the dissent provides for Ringer — allowing him to challenge the Secretary’s rule in federal court — hardly solves the problem that the dissent identifies. It is mere speculation to assume, as the dissent does, post, at 636-637, that a surgeon who is unwilling to perform surgery because of the existence of a rule will all of a sudden be willing to perform the surgery if the rule is struck down. That surgeon still faces a risk of not being paid in the administrative process, a risk that may well cause him to refuse to perform the surgery. The only sure way to ensure that all people desiring surgery are able to have it is to allow all of them to go into federal court or into the administrative process in advance of their surgery and get declarations of entitlement. Surely not even the dissent could sanction such a wholesale restructuring of the Medicare system in the face of clear congressional intent to the contrary.

IV

We hold that the District Court was correct in dismissing the complaint as to all respondents. Respondents urge affirmance of the Court of Appeals because “elderly, ill and disabled citizens who [sic] Congress intended to benefit from Social Security Act programs actually have suffered financially as well as physically” from the Secretary’s conclusion that BCBR surgery is never “reasonable and neces*627sary. ” Brief for Respondents 31. But respondents Holmes, Webster-Zieber, and Vescio are not subject to the Secretary’s formal ruling and stood the chance of prevailing in administrative appeals. Respondent Ringer has not undergone the procedure and could prevail only if federal courts were free to give declaratory judgments to anyone covered by Medicare as to whether he would be entitled to reimbursement for a procedure if he decided later to undergo it.

In the best of all worlds, immediate judicial access for all of these parties might be desirable. But 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. Congress must have felt that cases of individual hardship resulting from delays in the administrative process had to be balanced against the potential for overly casual or premature judicial intervention in an administrative system that processes literally millions of claims every year.14 If the balance is to be struck anew, the decision must come from Congress and not from this Court.

The judgment of the Court of Appeals is accordingly

Reversed.

Title 42 U. S. C. § 405(g) provides in part as follows:

“Any individual, after any final decision of the Secretary made after a hearing to which he was a party, irrespective of the amount in controversy, may obtain a review of such decision by a civil action commenced within sixty days after the mailing to him of notice of such decision or within such further time as the Secretary may allow. Such action shall be brought in *606the district court of the United States for the judicial district in which the plaintiff resides, or has his principal place of business, or, if he does not reside or have his principal place of business within any such judicial district, in the United States District Court for the District of Columbia. . . . The court shall have power to enter, upon the pleadings and transcript of the record, a judgment affirming, modifying, or reversing the decision of the Secretary, with or without remanding the cause for a rehearing. The findings of the Secretary as to any fact, if supported by substantial evidence, shall be conclusive. . . . The judgment of the court shall be final except that it shall be subject to review in the same manner as a judgment in other civil actions.”

The Secretary has recognized one exception which is not applicable here. She has provided by regulation that when the facts and her interpretation of the law are not in dispute and when the only factor precluding an award of benefits is a statutory provision which the claimant challenges as unconstitutional, the claimant need not exhaust his administrative remedies beyond the reconsideration stage. 42 CFR §§ 405.718-405.718e (1983); 20 CFR §§404.923-404.928 (1983).

BCBR, first performed in this country in the 1960’s, involves the surgical removal of the carotid bodies, structures the size of a rice grain which are located in the neck and which control the diameter of the bronchial tubes. Proponents of the procedure claim that it reduces the symptoms of pulmonary diseases such as asthma, bronchitis, and emphysema. Although the Secretary concluded that BCBR for that purpose is not “reasonable and necessary” within the meaning of the Medicare Act, she did note that the medical community had accepted the procedure as effective for another purpose, the removal of a carotid body tumor in the neck. 45 Fed. Reg. 71431 (1980).

Respondents objected to the denial of reimbursement for Part B as well as the Part A expenses of BCBR surgery. Part B of the Medicare Act, 42 U. S. C. § 1395j et seq., establishes a voluntary program of supplemental medical insurance covering expenses not covered by the Part A program, such as reasonable charges for physicians’ services, medical supplies, and laboratory tests. Payments for Part B expenses are made by private insurance carriers under contract to the Department of Health and Human Services, 42 U. S. C. § 1395u, and the claimant is entitled to reconsideration of the carrier’s initial denial of those claims. 42 CFR §§ 405.807-405.860 (1983). Congress has not, however, provided for judicial review of the denial of Part B claims. See Schweiker v. McClure, 456 U. S. 188 (1982); United States v. Erika, Inc., 456 U. S. 201 (1982). Thus respond*609ents seem to concede that to the extent that their claims are characterized as claims for Part B benefits, there is no judicial review of those claims under McClure and Erika. Brief for Respondents 1, n. 1. Respondents do argue, however, that to the extent that their claims can be characterized as collateral constitutional challenges, see n. 7, infra, those constitutional challenges are properly before us. In light of our characterization of respondents' claims essentially as claims for benefits, see text at 614, and the fact that whatever constitutional claims respondents assert are clearly too insubstantial to support subject-matter jurisdiction, see Hagans v. Lavine, 415 U. S. 528, 536-538 (1974), we view this case as involving only respondents’ Part A claims.

Respondents requested certification of a class, App. 12, but the District Court dismissed the complaint before ruling on the class certification question.

Dr. Winter is also named as a plaintiff in the amended complaint, but he is pressing no claims on his own behalf before this Court, serving instead as a representative of BCBR claimants pursuant to 20 CFR § 404.1700 et seq. (1983); Brief for Respondents 6, n. 4. Because we find that there is no jurisdiction as to the BCBR claimants whose claims are before this Court, there is of course no jurisdiction as to their representative, Dr. Winter.

In particular respondents contend that the instructions and the formal ruling barring payment for BCBR surgery violate the requirement in 42 U. S. C. § 1395y(a)(l) that payment be made for “reasonable and necessary” medical services and that the policy is arbitrary and capricious under the Administrative Procedure Act (APA), 5 U. S. C. § 706(2), under the provision in 42 U. S. C. § 405(a) authorizing the Secretary to issue “reasonable” rules, and under the Due Process Clause of the Fifth Amendment. They contend that requiring them to pursue administrative remedies in order to obtain BCBR payment violates their rights to prompt administrative action under 5 U. S. C. § 555(b) and §706(2)(A). Finally, they argue that the Secretary violated the rulemaking requirements of the APA, 5 U. S. C. § 553, in issuing the 1979 instructions and the 1980 formal *611ruling. The complaint also stated objections, not pressed before this Court, to the assignment of BCBR claims to an ALJ other than the one who usually considers Dr. Winter’s patients’ claims, and to the Secretary’s assertion of control over the practice of medicine allegedly in violation of constitutional and statutory provisions.

Amici point out that the District Court failed to grant respondents leave to amend their complaint to challenge the formal ruling, and that the District Court did not in fact consider the issues raised in the amended complaint. Brief for the Alliance of Social Security Disability Recipients and the Gray Panthers as Amici Curiae 7-8, n. 1. The amended complaint, however, merely attacked the new ruling on the same grounds as had been asserted to attack the instructions, and the District Court’s finding of no jurisdiction fairly can be read to apply to the issues raised in the amended complaint as well. It is unclear whether respondents contested the District Court’s apparent failure formally to grant the amendment, but in any event, the Court of Appeals explicitly considered the issues raised in the amended complaint. The Solicitor General has not objected in this Court to the Court of Appeals’ nor to our consideration of those issues, and we will thus regard any possible objection to have been waived.

The Secretary’s formal ruling states:

“Effective Date: As explained above, we have previously issued [a] policy in manual instructions excluding this service from Medicare coverage. However, since ALJs and the Appeals Council have ruled in several cases that claims for these services are payable, it is possible that some beneficiaries, relying on these rulings, have proceeded to have the operation performed in expectation of Medicare payment. In fairness to those beneficiaries, we are making the ruling effective for services furnished after the date of publication [October 28, 1980].” 45 Fed. Reg. 71427 (1980).
One ALJ already expressly has held that the regulation is inapplicable to claimants whose BCBR surgery was performed before October 28, 1980. In re Benjamin Winter, M. D., Representative for 132 Claimants (SSA Office Hearing App., Feb. 27, 1982). Dr. Winter pursued that case administratively during the pendency of this litigation on behalf of several of the named respondents and other BCBR claimants. See n. 12, infra. See also Tr. of Oral Arg. 16-17.

That provision reads as follows:

“The findings and decisions of the Secretary after a hearing shall be binding upon all individuals who were parties to the hearing. No findings of fact or decision of the Secretary shall be reviewed by any person, tribunal, *615or governmental agency except as herein provided. No action against the United States, the Secretary, or any officer or employee thereof shall be brought under section 1331 or 1346 of title 28 to recover on any claim arising under this subchapter.” 42 U. S. C. § 405(h).

Respondents’ reliance on Mathews v. Diaz, 426 U. S. 67 (1976), is unavailing. In that case, plaintiffs challenged the constitutionality of the duration of residency requirement for enrollment in the Part B Medicare Program. We concluded that the Secretary had waived further exhaustion because he had stipulated that the plaintiffs’ applications would be denied on the basis of the challenged provision, and because he had stipulated that the only issue before the courts was the constitutionality of the *619provision, an issue beyond the Secretary’s competence. Id., at 76-77. Here, however, the disputed question of coverage for BCBR surgery is peculiarly within the Secretary’s competence, and the formal ruling, which respondents liken to the stipulated denial of plaintiffs’ applications in Diaz, is not even applicable to their claims.

We noted in Weinberger v. Salfi, 422 U. S. 749, 765 (1975), that the purpose of the exhaustion requirement is to prevent “premature interference with agency processes” and to give the agency a chance “to compile a record which is adequate for judicial review.” This case aptly demonstrates the wisdom of Congress’ exhaustion scheme. Several respondents in this case pursued their administrative remedies during the pendency of this litigation, see n. 9, supra, and the claims of respondents Holmes and Webster-Zieber were denied on grounds not even related to the instructions and rule which they now seek to challenge in federal court. Further, the ALJ determined that the formal rule was not even applicable to re*620spondent Vescio’s claim because of the date of her surgery, and he thus concluded that additional evidence was necessary to determine whether she was entitled to payment.

Of course, as we have pointed out, Ringer and the other respondents come quite close to asking just that in asking the federal court to invalidate the Secretary’s rule and to compel the Secretary to declare BCBR surgery “reasonable and necessary” within the meaning of the Medicare Act. Supra, at 610-611, 614, 620; Brief for Respondents 1, 10; App. 25-26.

In 1982 there were 48 million claims filed under Part A of the Medicare Program. Bureau of Program Operations, HCFA, U. S. Department of Health and Human Services, B. P. O. Part A, Intermediary Workload Report (May 1983).