MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., PETITIONERS v. EULA B. STARNES, ET AL. No. 83-1149 In the Supreme Court of the United States October Term, 1983 The Solicitor General, on behalf of the Secretary of Health and Human Services and two insurance carriers that administer the Part B Medicare Program on behalf of the Secretary, petitions for a writ of certiorari to review the judgment of the United States Court of Appeals for the Fourth Circuit in this case. Petition for a Writ of Certiorari to the United States Court of Appeals for the Fourth Circuit PARTIES TO THE PROCEEDING In addition to the Secretary of Health and Human Services, the petitioners are Blue Cross and Blue Shield of South Carolina, Inc., and Prudential Insurance Company of America, which have contracted with the Secretary to administer the Part B Medicare Program on her behalf. They were named in the complaint as representatives of a defendant class consisting of all Medicare Part B carriers (C.A. App. 11), but the district court did not certify a defendant class. The named respondents are: (1) Eula B. Starnes, Johnnie Kaye Lloyd, Nettie E. Clarkson, Jayne E. Dunlap, and Mae T. Sanders, who are individuals enrolled under Part B of the Medicare Program; (2) Julian Adams, O. Rhett Talbert, Fred H. Allen, Jr., and William H. Stuart, who are physicians who utilize computerized tomography (CT) scanners in connection with medical services furnished to Medicare beneficiaries; and (3) Trident Neuro-Imaging Laboratory (a South Carolina general partnership in which Talbert is a partner), CT Scanlab (a North Carolina limited partnership in which Allen is a partner), and Atlanta Neurological Clinic, P.C. (a Georgia corporation in which Stuart is a shareholder), each of which owns and operates CT scanner equipment used in furnishing services to Medicare beneficiaries. Respondents Starnes, Lloyd, Clarkson, Dunlap, and Sanders represent a class of all Medicare beneficiaries who are enrolled in Part B and who have sought or would like to receive Medicare benefits for CT scan services. The other named respondents represent a class of all physicians and physician-directed clinics that own, operate, and use CT scanners in providing services to Medicare Part B beneficiaries. App., infra, 30a-31a. TABLE OF CONTENTS Opinions below Jurisdiction Statutory provisions involved Statement Reasons for granting the petition Conclusion Appendix OPINIONS BELOW The opinion of the court of appeals (App., infra, 1a-18a) is reported at 715 F.2d 134. The March 4, 1980 order of the district court entering a preliminary injunction (App., infra, 20a-28a), the October 19, 1981 order of the district court regarding class certification (App., infra, 29a-31a), and the April 15, 1982 order of the district court denying the motion to dismiss and certifying the jurisdictional issue for interlocutory appeal to the court of appeals pursuant to 28 U.S.C. 1292(b) (App., infra, 32a-40a) are not reported. JURISDICTION The judgment of the court of appeals was entered on August 16, 1983 (App., infra, 19a). On November 10, 1983, the Chief Justice extended the time within which to file a petition for a writ of certiorari to and including January 13, 1984. The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1). STATUTORY PROVISIONS INVOLVED 28 U.S.C. (Supp. V) 1331 and 28 U.S.C. 1361 and relevant provisions of the Social Security Act are reproduced at App., infra, 41a-42a. QUESTION PRESENTED Whether the district court had jurisdiction under 28 U.S.C. (& Supp. V) 1331 or 1361 to entertain respondents' challenge to the amount of benefits payable for a particular medical procedure under Part B of the Medicare Program, notwithstanding the jurisdictional bar in 42 U.S.C. 405(h) and 1395ff. STATEMENT This case concerns the jurisdiction of a federal district court to entertain a challenge to administrative guidelines affecting the amount of benefits to be paid under Part B of the Medicare Program for a particular medical service. 1. The Medicare Program is divided into two parts. Part A of the Act (42 U.S.C. (& Supp. V) 1395c et seq.) provides insurance for the reasonable cost of hospital and related post-hospital services. 42 U.S.C. (& Supp. V) 1395c and 1395d. Part B of the Act (42 U.S.C. (& Supp. V) 1395j et seq.), at issue here, establishes a voluntary program of supplementary medical insurance covering, in general, 80% of the "reasonable charge" for physicians' services, medical supplies, and radiology, pathology, and diagnostic testing services. 42 U.S.C. (& Supp. V) 1395k, 1395l and 1395x(s). Under 42 U.S.C. (& Supp. V) 1395u, the Secretary of Health and Human Services is authorized to enter into contracts with private insurance carriers to administer the payment of Part B claims on behalf of the Secretary. Schweiker v. McClure, 456 U.S. 188, 190 (1982). Under these contracts, the carriers determine whether particular services are covered by Part B and the amount of the "reasonable charge" for such services. These determinations are made in accordance with regulations and policy guidelines issued by the Secretary, through the Health Care Financing Administration (HCFA) in the Department of Health and Human Services. 42 C.F.R. 405.502(d). /1/ The Secretary is expressly authorized to issue such rules and regulations and to establish procedures to carry out the provisions of the Medicare Program. See 42 U.S.C. 405(a), as made applicable to the Medicare Program by 42 U.S.C. 1395ii; Heckler v. Campbell, No. 81-1983 (May 16, 1983), slip op. 7-8. If the carrier finds that the services are not covered by Part B or determines that the payment due is less than the amount claimed, the beneficiary or his assignee is entitled to have the claim reconsidered by the carrier. 42 C.F.R. 405.807-405.812. If the claim again is denied and the amount remaining in controversy is $100 or more, the claimant is entitled to an oral evidentiary hearing conducted by the carrier. 42 U.S.C. 1395u(b)(3)(C); see Schweiker v. McClure, 456 U.S. at 191. Under 42 U.S.C. 1395ff(b)(1)(C) and (2), an individual is entitled to judicial review of the "amount of benefits under part A" of the Medicare Program if the amount in controversy after completion of administrative review of a particular claim is $1,000 or more. /2/ There is, however, no comparable provision in 42 U.S.C. 1395ff for judicial review of the "amount of benefits" determined to be payable on a claim under Part B of the Medicare Program. In United States v. Erika, Inc., 456 U.S. 201, 206-211 (1982), this Court held that the text and legislative history of 42 U.S.C. 1395ff showed that Congress "deliberately intended to foreclose further review of such claims" (456 U.S. at 208). 2.a. This case involves a challenge to the amount determined to be the "reasonable charge" under Part B of the Medicare Program for particular medical services: computerized tomography (CT) scans. Head scans using approved models of equipment have been covered by the Medicare Program since September 1976, and body scans have been covered since August 1978 (C.A. App. 31). Because CT scans were new and relatively expensive diagnostic techniques when they were first approved for coverage under Medicare, they had been the subject of several studies regarding their effectiveness, utilization, and cost. In June 1977, the Regional Medicare Director for Region IV of the Medicare Bureau (the predecessor to HCFA) sent letters to carriers in that Region informing them of these studies and expressing concern about the increasing variance in charges allowed by carriers in processing claims for CT head scans (id. at 27-28). The letters also proposed to include in the next "allowable charge update (fiscal year 1978)" a $150 "reimbursement ceiling" on CT head scans (id. at 28). In December 1977, the Medicare Bureau issued a memorandum to all Regional Medicare Directors stressing the importance of assuring that carriers, when processing claims for CT scans, take into account not only the customary and prevailing charge for the service but also provisions of the Medicare regulations requiring that the charge for a specific service by "inherently reasonable" (C.A. App. 29-30), See 42 C.F.R. 405.502(a)(4) (1977). Subsequently, in September 1978, HCFA issued a formal Intermediary Letter 78-38 to all Medicare carriers to provide "direction and guidance to carriers as to how they should proceed when applying the reasonable charge methodology to develop screens for new and costly medical services and diagnostic procedures, such as CT scans" (C.A. App. 31). The Letter cited several studies concluding that the average charges for CT scan services were excessive (id. at 33) and noted that the National Guidelines for Health Planning issued in March 1978 "established 2,500 scans per year as the minimum operating standard" for each equipment unit (id. at 32). At that level of service, the Letter explained, a study by the Blue Cross Association had concluded that the technical component of each scan would generally cost less than $115 (ibid.) and a study by the National Academy of Sciences had concluded that a $35 limit on the physician's interpretation fee would be appropriate (id. at 33). Against this background, the Intermediary Letter "strongly recommend(ed)" that carriers implement charge screens reflecting overall limits of $157.50 for CT head scans and $178.50 for CT body scans, covering both the technical component and the physicians' interpretation fee (C.A. App. 33). The Letter contemplated that there would be future adjustments to the recommended limitations "to take into account evolving program experience, changing technology, or other relevant factors" (id. at 35). It also stated that an allowance above the recommended limits should be permitted "in individual claims involving unusual medical complications or circumstances" (ibid.) or in situations in which a CT scan unit had been approved by the state or local health planning agency but could not achieve normal utilization because of its location in a sparsely populated area (id. at 36). b. The instant suit was filed in the United States District Court for the District of South Carolina on November 27, 1979, challenging the amount of Part B benefits payable for CT scan services as a result of the 1977 agency memoranda and the 1978 Intermediary Letter. The named plaintiffs, the named respondents herein, are three medical clinics that own and operate CT head scanning equipment, four physicians who are affiliated with such clinics, and five Medicare Part B beneficiaries who have received services at one of the clinics (App., infra, 3a). The district court certified two nationwide classes represented by the plaintiffs: (1) a class of all past, present and future beneficiaries enrolled in the Part B Program who "have sought or desire to secure Medicare reimbursement for CT head scan services * * * "; and (2) a class of "all physicians and physician-directed clinics which now (or in the future) own, operate and use CT scanners in rendering head scan services to Medicare patients enrolled under Part B * * * ." App., infra, 30a-31a. The complaint alleged that the 1977 agency memoranda and the 1978 Intermediary Letter were promulgated in violation of the notice and comment rulemaking requirements of the Administrative Procedure Act (APA), 5 U.S.C. 553, and violate the provisions of the Medicare statute and regulations governing the determination of the reasonable charge for services under Part B. The complaint further alleged that the memoranda and Intermediary Letter violate the plaintiffs' rights to due process and equal protection under the Fifth Amendment because they were issued without notice and comment and were arbitrary and capricious and because the determination of the limitations differed from that applicable to other Part B services, differed from the method of reimbursement for CT scans under Part A of the Medicare Program, and (insofar as Region IV was concerned) differed from reasonable charge calculations for other regions in the country. C.A. App. 15-17. On October 6, 1980, the district court entered a preliminary injunction barring enforcement of the limitations on payments for CT head scans until such time as the Secretary promulgated regulations authorizing the Department to set specific reimbursement levels for the service (App., infra, 27a). The court concluded that "'(t)here can be no disputing the Secretary's statutory authority to define by regulation the method of computing (the reasonable charge)'" (id. at 21a, quoting Fairfax Hospital Ass'n v. Califano, 585 F.2d 602, 605 (4th Cir. 1978)). But the court nevertheless entered a preliminary injunction because of its concern that the Secretary had not followed the notice and comment procedures of the APA when he issued instructions to carriers regarding the calculation of the reasonable charge for CT scans (App., infra, 21a). In its order entering the preliminary injunction, the district court concluded that it had jurisdiction over the case under 28 U.S.C. 1331 notwithstanding the third sentence of 42 U.S.C. 405(h), /3/ which provides that "(n)o action" shall be brought against the Secretary under 28 U.S.C. 1331 "to recover on any claim arising under" the Medicare Act. The court reasoned that this Court's decision in Weinberger v. Salfi, 422 U.S. 749 (1975), holding that Section 405(h) bars the exercise of jurisdiction under 28 U.S.C. 1331 over any claim arising under the Social Security Act, is inapplicable where the claim is not otherwise reviewable under the Social Security Act (App., infra, 24a). The district court adhered to this view in a subsequent order dated April 16, 1982, but certified the question of subject matter jurisdiction for interlocutory appeal pursuant to 28 U.S.C. 1292(b) (App., infra, 39a-40a). c. The court of appeals granted leave to appeal (C.A. App. 163) and affirmed the district court's jurisdictional ruling (App., infra, 1a-18a). The court of appeals recognized that this Court had held in United States v. Erika, Inc., 456 U.S. 201 (1982), that in view of the precisely drawn provisions for judicial review in 42 U.S.C. 1395ff and the legislative history of those provisions, Congress had foreclosed judicial review of a carrier's determination of the amount of benefits payable under Part B for a particular service. App., infra, 7a. It further recognized that this preclusion of review applies even where the carrier's determination was based on instructions issued by the Secretary regarding the calculation of the reasonable charge, as in Erika itself. Id. at 9a. The court held, however, that although 42 U.S.C. 1395ff and the decision in Erika bar a judicial challenge to a past benefit determination, they do not bar a plaintiff from seeking prospective relief from the Secretary's actions in administering Part B through the issuance of such instructions. App., infra, 9a-10a. /4/ Similarly, the court of appeals concluded that 42 U.S.C. 405(h) does not preclude the exercise of jurisdiction under 28 U.S.C. 1331 over a challenge to a ruling by the Secretary that affects the amount of benefits payable under Part B where the ruling is alleged to violate the APA, the Medicare Act, or the Constitution, so long as the plaintiff does not actually seek an award of benefits from the district court. The court stated (App., infra, 15a (footnote omitted)): As we view plaintiffs' complaint, the gravamen of their action with respect to the alleged violation of (the) APA, the alleged violation of the Medicare Act and the alleged violation of their constitutional rights, is to redress those violations. Of course a well-founded complaint in that regard has a secondary effect on the benefits and payments due them. It may well be true that the effect of the preliminary injunction suspending enforcement of the caps granted by the district court entitles plaintiffs to be paid more than they would receive were the caps being enforced. But we do not perceive the suit (as) essentially one to recover benefits; it is a suit to enforce lawful conduct on the part of the Secretary. Cf. Ringer v. Schweiker, 684 F.2d 643, 646 (9 Cir. 1982). The court of appeals acknowledged that in holding that the district court had jurisdiction under 28 U.S.C. 1331, it was deciding a "close case" and that a "higher reviewing court" might conclude that it had misconstrued 42 U.S.C. 405(h) and 1395ff (App., infra, 15a). But it determined that if Section 1331 does not provide jurisdiction, then respondents' challenge could be heard under the mandamus statute, 28 U.S.C. 1361. In the court's view, this conclusion was not contrary to the purpose of 42 U.S.C. 405(h), because that section was intended only to prevent circumvention of the express judicial review provisions in the Social Security Act itself and not to preclude all judicial review of determinations under the Act. The court found no inconsistency with Section 405(h) here because the Act does not provide for judicial review of benefit amount determinations under Part B of the Medicare Program. App., infra, 16a-17a. REASONS FOR GRANTING THE PETITION The decision of the court of appeals, holding that the district court had jurisdiction under 28 U.S.C. 1331 and 1361 to review respondents' challenge to benefit amount determinations under Part B of the Medicare Act, is flatly inconsistent with this Court's rulings in United States v. Erika, Inc., 456 U.S. 201 (1982), and Weinberger v. Salfi, 422 U.S. 749 (1975). Moreover, the issues in this case are closely related to those presented in Heckler v. Ringer, cert. granted, No. 82-1772 (June 27, 1983). The petition therefore should be held pending the Court's decision in Ringer. 1. Respondents brought this suit to challenge the amount of benefits payable for CT scans under Part B of the Medicare Program as a result of the 1977 agency memoranda and the 1978 Intermediary Letter issued to carriers regarding the excessive charges for those services. As this Court held in Erika, however, Congress has foreclosed judicial review of the amount of benefits payable under Part B. In 42 U.S.C. 1395ff(a), Congress provided that "the determination of the amount of benefits under part A (of the Medicare Program), shall be made by the Secretary in accordance with regulations prescribed by (her)." The Secretary is authorized to enter into contracts with fiscal intermediaries to make these initial determinations on her behalf. See 42 U.S.C. (& Supp. V) 1395h. An individual who is dissatisfied with the initial determination of the "amount of benefits under Part A" is entitled to an evidentiary hearing before an administrative law judge in HHS if the amount in controversy is $100 or more and to judicial review as provided in 42 U.S.C. 405(g) if the amount remaining in controversy on the particular claim after the hearing is $1,000 or more. 42 U.S.C. 1395ff(b)(1)(C) and (2). On judicial review under 42 U.S.C. 405(g), the individual may contend that he is entitled to receive a greater amount of benefits under Part A than was awarded at the administrative level because the Secretary relied upon an invalid regulation in her "final decision" denying or limiting the amount of benefits. See Weinberger v. Salfi, 422 U.S. at 762. Determinations and evidentiary hearings with respect to the amount of benefits on a particular claim under Part B are conducted by private insurance carriers under contract with the Secretary. As this Court noted in Erika (456 U.S. at 208), 42 U.S.C. 1395ff conspicuously fails to authorize judicial review of the "amount of benefits" under Part B, even though it expressly authorizes such review under Part A. In light of the statute's "precisely drawn provisions," the Court in Erika found this omission persuasive evidence that Congress had "deliberately * * * foreclosed" judicial review of benefit amount determinations under Part B. 456 U.S. at 208. The Court found this indication confirmed by the legislative history of Section 1395ff, which evidenced a congressional intent to remove from the courts what were expected to be relatively minor disputes over the amount of benefits under Part B. 456 U.S. at 208-210. Moreover, as the court below recognized (App., infra, 8a-9a), this foreclosure of judicial review under Part B was intended to apply even where the plaintiff challenges an instruction issued by the Secretary that has the effect of limiting the amount of benefits payable on an individual claim. In Erika itself the plaintiff's claim to increased benefits was based in part on a challenge to instructions issued by the Secretary that limited the amount of benefits that could be awarded by the carrier. Erika, Inc. v. United States, 634 F.2d. 580, 589 (Ct. Cl. 1980). This conclusion also is evident from the structure of 42 U.S.C. 1395ff. Congress has authorized judicial review of the "amount of benefits under part A" and, as we have said, such review may include a challenge to regulations that establish benefit amounts or guide fiscal intermediaries in computing those amounts. The corresponding foreclosure of judicial review of the amount of benefits under Part B accordingly must extend to challenges to instructions or regulations issued by the Secretary that have the effect of limiting the amount of benefits determined by a carrier. Yet the court of appeals would permit a beneficiary to avoid this foreclosure of review simply by filing a suit challenging the Secretary's directives that limit the amount of benefits payable on his Part B claim before he has received a final decision from the carrier on that claim. This result would largely vitiate the Court's unanimous holding in Erika. Nor can respondents circumvent this preclusion of judicial review and the decision in Erika under the guise of seeking only "prospective relief" with respect to the amount payable on future claims under the Secretary's directives, rather than the reopening of carrier determinations on past claims (see App., infra, 7a-10a). Such a suit is still one seeking judicial review of the "amount of benefits," which 42 U.S.C. 1395ff authorizes in limited circumstances under Part A but not under Part B. Indeed, the court of appeals recognized that the effect of respondents' challenge to the Secretary's directives is to increase the amount of benefits awarded by the carrier (App., infra, 15a (quoted at pages 9-10, supra)), and respondents would need to have a claim for increased benefits in order to have standing and a substantive basis for their suit. See Weinberger v. Salfi, 422 U.S. at 760-761. The legislative history relied upon by the Court in Erika does not suggest a less comprehensive foreclosure of judicial review under Part B than is indicated by the text of 42 U.S.C. 1395ff. 456 U.S. at 208-210. To the contrary, the Conference Report on the 1972 amendments to 42 U.S.C. 1395ff states that those amendments were added to make clear that there is "no authorization * * * for judicial review on matters solely involving amounts of benefits under Part B" (H.R. Conf. Rep. 92-1605, 92d Cong., 2d Sess. 61 (1972)). /5/ Respondents' attempt to obtain judicial review of agency directives setting limits on Part B benefit payments for particular services plainly is one "involving amounts of benefits under Part B" and therefore is inconsistent with this expression of congressional intent. In this regard, the procedure Congress mandated for judicial review of benefit amount determinations under Part A is again significant. It is clear that a Medicare beneficiary cannot circumvent the terms of the Act that limit judicial review under Part A to suits brought pursuant to 42 U.S.C. 1395ff -- which provides for review only after the Secretary has rendered a "final decision" on an individual claim and only if there is $1000 or more remaining in controversy -- by confining his claim to "prospective" relief. It necessarily follows that a beneficiary cannot circumvent the complete foreclosure of judicial review under Part B in this manner. 2. The correctness of the result indicated by 42 U.S.C. 1395ff standing alone -- that judicial review of the amount of benefits under Part B is foreclosed because it is not expressly authorized -- is confirmed by 42 U.S.C. 405(h). /6/ The second sentence of Section 405(h) embodies a general rule under the Social Security Act that judicial review is unavailable except where and in the manner such review is expressly authorized under that Act. The second sentence provides that "(n)o findings of fact or decision by the Secretary shall be reviewed by any person, tribunal, or governmental agency except as herein provided" (emphasis added). Because carriers make determinations on claims for benefits under Part B on behalf of the Secretary (see Schweiker v. McClure, 456 U.S. at 190), this preclusion of review applies equally to findings and decisions by the carriers under Part B. Moreover, to the extent respondents' challenge is confined to the limitations on payment for CT scans contained in the 1977 agency memoranda and 1978 Intermediary Letter issued by the Secretary on the basis of factual studies of CT scans, respondents actually seek review in a judicial "tribunal" of "findings of fact or decision" of the Secretary, which is expressly barred by the second sentence of Section 405(h). The third sentence of 42 U.S.C. 405(h) further provides that "(n)o action" shall be brought against the Secretary under 28 U.S.C. 1331 "to recover on any claim arising under" the Medicare Act. The court of appeals' holding that the district court had jurisdiction over this suit under 28 U.S.C. 1331 directly contravenes this jurisdictional bar as well. It is similar to the Ninth Circuit's holding in Ringer v. Schweiker, 684 F.2d 643 (1982), cert. granted, No. 82-1772 (June 27, 1983), that the third sentence of Section 405(h) does not bar jurisdiction under 28 U.S.C. 1331 over a "procedural" challenge to a regulation prohibiting the payment of benefits for a particular medical procedure under the Medicare Program. In Ringer, as here, the respondents challenged the regulation on the grounds that it was promulgated in violation of the notice and comment requirements of the APA, was inconsistent with the Medicare Act, and violated the respondents' due process rights. See 82-1772 Pet. Br. 10. We have argued in Ringer (82-1772 Pet. Br. 20-37) /7/ that the Ninth Circuit's holding conflicts with this Court's decision in Weinberger v. Salfi, supra, that the "sweeping" bar in 42 U.S.C. 405(h) cannot be circumvented by characterizing the challenge as "procedural" or by seeking only prospective relief, that the preclusion of review in Section 405(h) applies even where the plaintiff does not seek an actual award of benefits in district court, and that the "APA" claim in fact arises under the Medicare Act rather than the APA and cannot in any event be brought under 28 U.S.C. 1331. Our submission in Ringer applies equally here. We therefore suggest that the Court hold the petition in this case pending a decision in Ringer regarding the scope of Section 405(h) and then dispose of the petition in light of that decision. 3. The court of appeals recognized that a "higher reviewing court" might disagree with its construction of 42 U.S.C. 1395ff and 405(h), and it therefore concluded that the district court also had jurisdiction over this case under the mandamus statute, 28 U.S.C. 1361 (App., infra, 15a-18a). The question of the existence of mandamus jurisdiction over claims arising under the Medicare Act is involved in Ringer as well, because the Ninth Circuit there held that the district court had jurisdiction under 28 U.S.C. 1361 over the respondents' "procedural" claims. 684 F.2d at 645-646, 648. We have argued in Ringer (82-1772 Pet. Br. 32-36) that Section 405(h) bars mandamus jurisdiction over cases arising under the Medicare Act and that, in any event, the exercise of mandamus jurisdiction was precluded in that case because, inter alia, the Secretary did not owe the respondents a "clear duty" to act in the manner they sought to compel. Those arguments apply equally here to bar the exercise of mandamus jurisdiction. /8/ This additional similarity between the two cases further indicates that the petition in this case should be held pending a decision in Ringer. CONCLUSION The petition for a writ of certiorari should be held pending the Court's decision in Heckler v. Ringer, No. 82-1772, and then be disposed of in light of that decision. Respectfully submitted. REX E. LEE Solicitor General RICHARD K. WILLARD Acting Assistant Attorney General KENNETH S. GELLER Deputy Solicitor General EDWIN S. KNEEDLER Assistant to the Solicitor General WILLIAM KANTER ELOISE E. DAVIES Attorneys JANUARY 1984 /1/ 42 C.F.R. 405.502(d) provides: Responsibility of Administration and carriers. Determinations by carriers of reasonable charge are not reviewed on a case-by-case basis by the Health Care Financing Administration, although the general procedures and performance of functions by carriers are evaluated. In making determinations, carriers apply the provisions of the law under broad principles issued by the Health Care Financing Administration. These principles are intended to assure overall consistency among carriers in their determinations of reasonable charge. The principles in Sections 405.503-405.507 establish the criteria for making such determinations in accordance with the statutory provisions. /2/ Under 42 U.S.C. 1395ff(b)(1)(A) and (B), an individual who is dissatisfied with the Secretary's determination of his eligibility to participate in the Part A or Part B Program also is entitled to judicial review. These provisions are not at issue here. /3/ As made applicable to the Medicare Program by 42 U.S.C. 1395ii. /4/ The court of appeals also concluded that 42 U.S.C. 1395ff and the decision in Erika do not bar judicial review of a carrier's decision on an individual benefit claim if that decision is challenged on constitutional grounds (App., infra, 9a-10a). However, the court rejected as "frivolous" one aspect of respondents' constitutional claim on the merits: that they had a constitutional right to notice and an opportunity to comment in connection with the promulgation of rules of general applicability. App., infra, 15a n.4 (citing Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 542 n.16 (1978)). /5/ See also Erika, 456 U.S. at 208 (quoting S. Rep. 404, 89th Cong., 1st Sess. 55 (1965)) (the bill "did not provide for judicial review of 'a determination concerning the amount of benefits under (P) art B'"); 456 U.S. at 209 n.11 (quoting S. Rep. 404, supra, at 55 (emphasis added by the Court)) ("'the remedies provided by (the statutory) review procedures (are) exclusive'"). /6/ 42 U.S.C. 405(h) is made applicable to the Medicare Program by 42 U.S.C. 1395ii. We have furnished respondents with a copy of our brief in Ringer. /8/ The Ninth Circuit appeared to be of the view in Ringer that whenever the bar in Section 405(h) does apply, it extends to mandamus jurisdiction as well as federal question jurisdiction. 684 F.2d at 645, 646 & n.2, 648. The court below, by contrast, believed that mandamus jurisdiction would lie even if federal question jurisdiction is barred. App., infra, 15a. APPENDIX APPENDIX MATERIAL IS NOT AVAILABLE ON JURIS