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No. 98-1307


In the Supreme Court of the United States
OCTOBER TERM, 1998

ILLINOIS COUNCIL ON LONG TERM CARE, INC.,
CROSS-PETITIONER

v.

DONNA E. SHALALA, SECRETARY OF HEALTH
AND HUMAN SERVICES, ET AL.

ON CROSS-PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE SEVENTH CIRCUIT

BRIEF FOR THE CROSS-RESPONDENTS
IN OPPOSITION




HARRIET S. RABB
General Counsel
SHEREE R. KANNER
Associate General Counsel
JEFFREY GOLLAND
Attorney
Department of Health
and Human Services
Washington, D.C. 20201
SETH P. WAXMAN
Solicitor General
Counsel of Record
DAVID W. OGDEN
Acting Assistant Attorney General
BARBARA C. BIDDLE
JEFFREY CLAIR
Attorneys
Department of Justice
Washington, D.C. 20530-0001
(202) 514-2217


QUESTION PRESENTED
Whether cross-petitioner's pre-enforcement "void-for-vagueness" challenge to regulations governing the enforcement of Medicare and Medicaid nursing home standards is ripe for adjudication.







In the Supreme Court of the United States
OCTOBER TERM, 1998

No. 98-1307
ILLINOIS COUNCIL ON LONG TERM CARE, INC.,
CROSS-PETITIONER

v.

DONNA E. SHALALA, SECRETARY OF HEALTH
AND HUMAN SERVICES, ET AL.

ON CROSS-PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE SEVENTH CIRCUIT

BRIEF FOR THE CROSS-RESPONDENTS
IN OPPOSITION

OPINIONS BELOW
The opinion of the court of appeals (Pet. App. 1a-12a1) is reported at 143 F.3d 1072. The opinion of the district court (Pet. App. 13a-21a) is unreported.
JURISDICTION
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). The Secretary of Health and Human Services filed a petition for a writ of certiorari on January 11, 1999, which was docketed on January 12, 1999. Cross-petitioner filed a conditional cross-petition for a writ of certiorari on February 11, 1999. The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1).
STATUTORY AND REGULATORY PROVISIONS INVOLVED
The provisions of 42 U.S.C. 1395-i(3)(h) and 42 U.S.C. 1396r(h) are reproduced in the appendix to this brief, App., infra, 1a-20a. The provisions of 42 C.F.R. 488.301, 488.400-488.456, are also reproduced in the appendix to this brief, App., infra, 21a- 66a.
STATEMENT
To participate in Medicare and Medicaid, a nursing home must comply with standards designed to ensure resident beneficiary health and safety. 42 U.S.C. 1395i-3(a) to (d) (Medicare); 42 U.S.C. 1396r(a)-(d) (Medicaid). In this case, the court of appeals held that 42 U.S.C. 405(h), incorporated into the Medicare Act by 42 U.S.C. 1395ii, does not preclude cross-petitioner from bringing a pre-enforcement challenge to regulations issued by the Secretary of Health and Human Services to govern the enforcement of nursing home standards for Medicare. The Secretary has filed a petition for a writ of certiorari (No. 98-1109), asking this Court to review that decision. The cross-petition for a writ of certiorari asks this Court to decide a different question-whether cross-petitioner's void-for-vagueness challenge to certain Medicare and Medicaid regulations is ripe for constitutional adjudication.
1. The regulations cross-petitioner seeks to challenge as unconstitutionally vague were adopted pursuant to the Omnibus Budget Reconciliation Act of 1987 (1987 Act), Pub L. No. 100-203, 101 Stat. 1330. See 59 Fed. Reg. 56,116 (1994). Before the 1987 Act, the Medicare and Medicaid regulatory scheme governing nursing homes focused on theoretical capacity to provide care; evaluations were based on sources such as the provider's written policies and procedures, the qualifications of its staff, and the characteristics of its physical facilities. H.R. Rep. No. 391, 100th Cong., 1st Sess., pt. 1, at 466 (1987). Because Congress concluded that such a system did not adequately protect nursing home residents, it amended the Medicare and Medicaid statutes in 1987 to focus them on the adequacy of care actually delivered to individual residents, and to expand available enforcement remedies. Id. at 466-467; see also 42 U.S.C. 1395i-3(b)(2) (requiring facility to "attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident") (Medicare); 42 U.S.C. 1396r(b)(2) (same) (Medicaid); 42 C.F.R. 483.25 (declaring that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with [a] comprehensive assessment and plan of care").
The resulting statute and implementing regulations set forth detailed requirements for patient admission, transfer, and discharge; the protection of resident rights; the scope and quality of health care and other services; the qualifications of the facility's staff and health care professionals; and the facility's physical environment. 42 C.F.R. 483.1-483.75. The statute also sets forth detailed procedures for ensuring compliance, including inspection and enforcement requirements. At intervals of no less than 15 months (and on average at least once a year), each skilled nursing facility is subject to a standard survey that must be conducted without prior notice. 42 U.S.C. 1395i-3(g)(2)(A)(i) and (iii) (Medicare); 42 U.S.C. 1396r(g)(2)(A)(i) and (iii) (Medicaid). The survey must examine the quality of care furnished to a representative sample of patients, and must generally investigate the facility's compliance with statutory provisions protecting each resident's right to choose his or her attending physician, to be free from physical or chemical restraint, and to exer- cise other individual rights guaranteed by statute. 42 U.S.C. 1395i-3(g)(2)(A)(ii) (Medicare); 42 U.S.C. 1396r(g)(2)(A)(ii) (Medicaid); see also 42 C.F.R. 488.305.
Although surveys are generally under the control of state agencies, 42 U.S.C. 1395i-3(g)(1)(A) (Medicare); 42 U.S.C. 1396r(g)(1)(A) (Medicaid),2 federal law requires that each survey be conducted by a multidisciplinary team of professionals following federally prescribed methods and procedures and using federally mandated forms. 42 U.S.C. 1395i-3(g)(2)(C) (Medicare); 42 U.S.C. 1396r(g)(2)(C) (Medicaid); see also 42 C.F.R. 488.26(c), 488.314. If the survey agency finds relatively serious violations, i.e., evidence that a nursing facility has provided "substandard quality of care,"3 the agency must conduct a more extensive evaluation of the facility's operations and identify the policies and procedures that resulted in the deficiency. 42 U.S.C. 1395i-3(g)(2)(B) (Medicare); 42 U.S.C. 1396r(g)(2)(B) (Medicaid). Congress has required the Secretary and the States to make survey information available to the public, 42 U.S.C. 1395i-3(g)(5), 1396r(g)(5), and some survey information must be provided, as a matter of course, to certain state officials, licensing boards, and physicians. 42 C.F.R. 488.325.
Where deficiencies are detected, the pertinent regulatory agency must identify an appropriate remedy. 42 U.S.C. 1395i-3(h) (Medicare); 42 U.S.C. 1396r(h) (Medicaid).4 Regulatory officials are empowered to direct a plan for correcting violations, to impose civil money penalties, to deny further reimbursement for services rendered after the deficiency is discovered, to appoint temporary management, to terminate a facility's right to participate in Medicare or Medicaid, or to transfer residents and close the facility. 42 U.S.C. 1395i-3(h)(2) (Medicare); 42 U.S.C. 1396r(h)(2) (Medicaid); 42 C.F.R. 488.406. Regulators are expected to use those 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.
Congress also vested federal and state officials with substantial (but not unbridled) remedial discretion. The statute provides:
The Secretary shall specify criteria, as to when and how each of such remedies is to be applied, the amounts of any fines, and the severity of each of these remedies * * *. Such criteria shall be designed so as to minimize the time between the identification of violations and final imposition of the remedies and shall provide for the imposition of incrementally more severe fines for repeated or uncorrected deficiencies.
42 U.S.C. 1395i-3(h)(2)(B) (Medicare); see also 42 U.S.C. 1396r(h)(2)(A) (Medicaid). Pursuant to that mandate, the Secretary has promulgated regulations that calibrate the enforcement remedy to the scope and severity of the nursing home's deficiencies. 42 C.F.R. 488.400-488.430. In particular, the choice of remedies depends on the degree of actual or potential harm to resident health or safety, and the extent to which the identified deficiencies reflect isolated occurrences or pervasive problems. 42 C.F.R. 488.404, 488.408. For example, regulators will not impose any remedy if they conclude that a nursing home "substantially" complies with statutory requirements, i.e., if the care, though technically falling short of a statutory standard, has not resulted in any harm to residents and poses no more than a risk of minimal harm in the future. 42 C.F.R. 488.301, 488.408(f)(2). More serious violations, such as those that have resulted in actual harm to a resident or that are sufficiently widespread or serious to have the potential to cause more than minimal harm, may result in significant sanctions, including civil money penalties or the denial of payment for new nursing home admissions. 42 C.F.R. 488.408(d). And violations that place the health or safety of residents in immediate jeopardy may result in the appointment of temporary management, closure of the facility, or termination of the facility's right to participate in Medicare or Medicaid. 42 C.F.R. 488.408(e).
2. Cross-petitioner Illinois Council on Long Term Care, Inc., a trade association of nursing facilities in Illinois, filed a complaint challenging the Secretary's regulations concerning enforcement of Medicare and Medicaid nursing home standards, and objecting to certain provisions of a manual that is used in surveying nursing care facilities. Cross-petitioner alleged that the regulatory standards governing the imposition of nursing home remedies are unconstitutionally vague; that they exceed the Secretary's statutory authority; that they violate the Due Process Clause by failing to provide a constitutionally adequate opportunity to contest enforcement actions; and that the manual used in the implementation of the survey and inspection program was improperly promulgated without use of the "notice and comment" rulemaking procedures provided by 5 U.S.C. 553.
The district court dismissed the complaint for lack of subject matter jurisdiction. Pet. App. 13a-21a. Cross-petitioner could not rest jurisdiction on 42 U.S.C. 405(g) (as incorporated by 42 U.S.C. 1395cc(h)) because it had not exhausted applicable administrative remedies. Nor could cross-petitioner obtain jurisdiction by relying on 28 U.S.C. 1331 or 1346 instead, because 42 U.S.C. 405(h) bars federal courts from asserting jurisdiction under those provisions. Pet. App. 15a-19a.
3. The court of appeals reversed in part and affirmed in part. Pet. App. 1a-12a. As explained in greater detail in the Secretary's petition for a writ of certiorari in No. 98-1109 (at 7-8), the court of appeals held that 42 U.S.C. 405(h) does not preclude federal courts from exercising general federal question jurisdiction (pursuant to 28 U.S.C. 1331 and 1346) over non-monetary claims arising under the Medicare or Medicaid Programs, including cross-petitioner's claims for pre-enforcement review of Medicare regulations. Nonetheless, the court of appeals affirmed dismissal of most of cross-petitioner's claims on alternative grounds.
As relevant here, the court of appeals held that cross-petitioner's challenge to the Secretary's regulations on vagueness grounds is not ripe for judicial review. Pet. App. 10a-11a. Vagueness challenges which do not involve First Amendment freedoms, the court of appeals reasoned, must be based on a specific application of the law to the plaintiff; they may not be based on the alleged vagueness of the law as applied to the conduct of others. Id. at 10a. Such challenges therefore must be brought and adjudicated "in the light of the facts of the case at hand." Ibid. (quoting United States v. Mazurie, 419 U.S. 544, 550 (1975)).
Cross-petitioner, the court of appeals observed, had sought to avoid the jurisdictional limitations of 42 U.S.C. 405(h) by framing its pre-enforcement challenge as a facial attack on the validity of the agency's regulations, a highly abstract claim. Because cross-petitioner had chosen to frame its attack in such general terms-rather than await and challenge a specific application of the regulations-cross-petitioner "finds itself with no 'facts of the case at hand' and therefore without any hope of success on a claim that the regulations are unconstitutionally vague." Pet. App. 10a. Accordingly, the court of appeals held that cross-petitioner's vagueness challenge is not ripe for decision and had been properly dismissed. Id. at 11a.
ARGUMENT
The decision below correctly applies well-established ripeness principles to cross-petitioner's void-for-vagueness claim. The case-specific holding challenged by cross-petitioner is consistent with this Court's precedents, does not conflict with other appellate decisions, and does not otherwise raise any issue of exceptional importance. It is, moreover, separate and discrete from the statutory jurisdictional issue raised by the Secretary's petition for a writ of certiorari in No. 98-1109. Consequently, the Secretary's petition-which cross-petitioner agrees should be granted, 98-1109 Br. in Opp. at 16-can be fully adjudicated without considering the ripeness issue presented in the conditional cross-petition.
1. The ripeness doctrine has its origins both in Article III and in judicially-developed rules governing the exercise of jurisdiction. Reno v. Catholic Social Servs., Inc., 509 U.S. 43, 57 n.18 (1993). At its core, the doctrine is designed "to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties." Abbott Labs. v. Gardner, 387 U.S. 136, 148-149 (1967). Accordingly, in deciding whether or not an agency's decision is ripe for judicial review, the Court has examined both the "fitness of the issues for judicial decision" and the "hardship to the parties of withholding court consideration." Id. at 149; Ohio Forestry Ass'n v. Sierra Club, 118 S. Ct. 1665, 1670 (1998).
a. Under those established standards, cross-petitioner's void-for-vagueness claim is premature. The essence of a void-for-vagueness claim is that the challenged criminal or regulatory prohibition fails to articulate standards with sufficient clarity to permit the claimant to conform his conduct to law. See Grayned v. City of Rockford, 408 U.S. 104, 108 (1972) ("[B]ecause we assume that man is free to steer between lawful and unlawful conduct, we insist that laws give the person of ordinary intelligence a reasonable opportunity to know what is prohibited, so that he may act accordingly."). "A plaintiff who engages in some conduct that is clearly proscribed," however, "cannot complain of the vagueness of the law as applied to the conduct of others." Village of Hoffman Estates v. Flipside, Hoffman Estates, Inc., 455 U.S. 489, 495 (1982). As a result, a vagueness challenge that is not based on the First Amendment must identify the claimant's specific conduct (the propriety of which is allegedly unclear), and the court must "examine the complainant's conduct before analyzing other hypothetical applications of the law." Ibid. Thus, "[v]agueness challenges to statutes which do not involve First Amendment freedoms must be examined in the light of the facts of the case at hand." Id. at 495 n.7 (quoting United States v. Mazurie, 419 U.S. 544, 550 (1975)).
Because cross-petitioner's vagueness challenge neither involves First Amendment freedoms, nor arises out of a specific set of facts-indeed, it does not even identify the specific conduct in which cross-petitioner or its members propose to engage-it is not currently "fit" for judicial review. See, e.g., Catholic Social Servs., 509 U.S. at 58-59 (mere passage of statute and issuance of regulations do not give complainant a ripe claim absent agency action "applying the regulation to him"); Lujan v. National Wildlife Fed'n, 497 U.S. 871, 891 (1990) ("[A] regulation is not ordinarily considered the type of agency action 'ripe' for judicial review under the APA until the scope of the controversy has been 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."). Thus, this is not a case involving a "formalized" administrative decision the "effects" of which have been "felt in a concrete way by the challenging part[y]." Abbott Labs., 387 U.S. at 148-149. It is instead an anticipatory challenge seeking generalized review of regulations outside of the context of a specific application. For that reason, cross-petitioner is incorrect to assert that requiring it and its members to await and challenge specific applications of the regulations amounts to a "heightened" pleading requirement. See Cross-Pet. 12-13. The question is not one of pleading; it is a question of timing. Under fundamental principles of justiciability, only challenges to specific and identifiable applications of the allegedly vague regulations-and not the general and highly abstract allegation that the pertinent standards are unclear-are "fit[] for judicial decision." Abbott Labs., 387 U.S. at 149.
b. Nor can cross-petitioner show that the "hardship" of "withholding court consideration" weighs in favor of immediate, pre-enforcement review. Indeed, cross-petitioner cannot show that "withholding * * * consideration" of its challenge will cause it or its members any "hardship" at all. Abbott Labs., 387 U.S. at 149. This is not a case in which cross-petitioner or its members will be forced, as a result of vague regulatory standards, to change their conduct or face a severe penalty. See Lujan, 497 U.S. at 891 (rules requiring the complainant "to adjust [its] conduct immediately" may be ripe); Catholic Social Servs., 509 U.S. at 58 (challenge to regulation not ripe where "the impact" of the regulation cannot "be said to be felt immediately by those subject to it in conducting their day-to-day affairs") (internal quotation marks omitted). To the contrary, cross-petitioner does not challenge any conduct-governing standards at all. Instead, it limits its void-for-vagueness challenge to the regulations governing the penalty or remedy that will be imposed once a violation is discovered.
Petitioner thus disavows any challenge to the extensive and detailed regulations applicable to the day-to-day operation of its members' facilities.5 Instead, it focuses the vagueness attack solely on the scope and severity factors that are used to determine the appropriate remedy for an actual violation. See Amended Compl. ¶¶ 43-50; Cross-Pet. 3-5. Cross-petitioner, for example, alleges that the term "substantial compliance," which is the standard that must be met before no penalty will be imposed despite the existence of some violations, is unconstitutionally vague, see Amended Compl. ¶ 43A;6 and it likewise challenges the adequacy of the definition of the term "substandard quality of care," which is a condition that, if found, will result in additional investigations and more severe penalties, see id. ¶ 43B.7 As the Amended Complaint summarizes, cross-petitioner claims that relevant legal sources do not "provide [its] members with any meaningful guidance for determining whether their conduct is in 'substantial compliance,'"-which would permit them to avoid penalties despite actual violations-"or for distinguishing between deficiencies which result in a finding of 'substandard quality of care,' and those which trigger lesser findings and enforcement penalties." Id. ¶ 46. See also id. ¶ 44 (alleging that terms such as "actual harm," "minimal harm," "isolated," "pattern," and "widespread," which are used to define "substantial compliance" and "substandard quality of care," are unduly vague). Uncertainty as to the remedies that will be used to ensure compliance with lawful substantive standards, however, is not the sort of undue hardship that warrants pre-enforcement review. Cf. Texas v. United States, 118 S. Ct. 1257, 1259-1260 (1998); Toilet Goods Ass'n v. Gardner, 387 U.S. 158, 163-164 (1967).
c. Seeking to avoid that result, cross-petitioner asserts (at 10-11) that a "systemic" challenge to the entire regulatory regime can be brought before the regulations are applied and enforced in a concrete setting. The ordinary rule, however, is that a regulation is not considered "ripe" for judicial review under the Administrative Procedure Act (APA) until it has been applied to a particular claimant and its effects are manifested in a concrete way. Lujan, 497 U.S. at 891. As this Court has explained:
The case-by-case approach that this requires is understandably frustrating to an organization such as respondent, which has as its objective across-the-board protection * * *. But this is the traditional, and remains the normal, mode of operation of the courts. Except where Congress explicitly provides for our correction of the administrative process at a higher level of generality, we intervene in the administration of the laws only when, and to the extent that, a specific "final agency action" has an actual or immediately threatened effect.
Id. at 894.8
Alternatively, cross-petitioner argues that its vagueness challenge should be considered "fit" for review now because administrative review would not improve the "fitness" of the issues it seeks to raise. In particular, cross-petitioner argues that administrative review will add little because administrative law judges cannot pass upon the validity of the regulations or overturn the choice of enforcement remedy. Cross-Pet. 5, 9-10, 12. Contrary to cross-petitioner's claim, an administrative record will demonstrate how the Secretary or state enforcement officials are tailoring enforcement remedies to the particular facts of the case, and may well document the enforcement agency's reasons and justifications for imposing the chosen sanction or corrective action, significantly aiding judicial review. Cf. Toilet Goods Ass'n, 387 U.S. at 163-164; Ohio Forestry Ass'n, 118 S. Ct. at 1671-1672.
Finally, cross-petitioner asserts that it might be able to render its claims more concrete by "provid[ing] multiple examples of how the regulations have been randomly applied against its members." Cross-Pet. 12. That proposal, however, is likewise foreclosed by this Court's precedents:
[I]t is at least entirely certain that the flaws in the entire "program"-consisting principally of the many individual actions referenced in the complaint, and presumably actions yet to be taken as well-cannot be laid before the courts for wholesale correction under the APA, simply because one of them that is ripe for review adversely affects one of respondent's members.
Lujan, 497 U.S. at 892-893. Simply put, if any of cross- petitioner's members is aggrieved by a specific application of the regulations, then its individual claim may be ripe for judicial review and may be brought once statutory exhaustion requirements are met. But that does not make the myriad potential (and as of now, purely hypothetical) future applications of the regulatory scheme ripe for immediate pre-enforcement review.
2. Nor is the question presented in the cross-petition related to, or necessary to, the resolution of the question presented in the Secretary's petition for a writ of certiorari in No. 98-1109.
The Secretary's petition seeks review of whether 42 U.S.C. 405(h), as incorporated into the Medicare Act by 42 U.S.C. 1395ii, prevents federal courts from asserting general federal question jurisdiction over any part of cross-petitioner's pre-enforcement challenge to the Secretary's Medicare nursing home regulations. That question is analytically distinct from the question on which cross-petitioner seeks review, which is whether its void-for-vagueness challenge is sufficiently concrete to be "fit[] for judicial decision," in light of any "hardship" that might result from withholding review. See Abbott Labs., 387 U.S. at 149. The former is a question of statutory construction; the latter is an application of the criteria this Court articulated in Abbott Laboratories.9
Notwithstanding the facial dissimilarity of the two issues, cross-petitioner asserts that this Court's decision in Reno v. Catholic Social Services, Inc., supra, demonstrates them to be related. Cross-petitioner is mistaken. That case concerned an Immigration and Naturalization Service (INS) policy that ostensibly called for INS personnel to reject some aliens' applications for legalization before the aliens even filed them -a practice called "front-desking," because the application would be rejected at the front desk of the INS office. The Court held that any alien subjected to that practice had a "ripe" claim. Such an alien had been subjected to the effects of the INS's substantive policy in a concrete and adverse manner (thus enhancing the fitness of the issue for judicial review); and, because the otherwise exclusive mechanism for review did not apply to aliens who had never filed an application, withholding review would leave such an alien without any means for obtaining judicial review (making the hardship of withholding review severe). See Catholic Social Servs., 509 U.S. at 61-63. Indeed, declaring the claim to be "unripe," the Court concluded, would contravene the presumption that Congress generally intends judicial review to be available. Ibid.
Here, cross-petitioner's claim is decidedly unripe, and the construction of Section 405(h) at issue in the Secretary's petition for a writ of certiorari in No. 98-1109 will not alter that conclusion. Whether or not Section 405(h) requires claims like cross-petitioner's to be channeled through the administrative process established by the Medicare Act, cross-petitioner's current vagueness claim is too abstract because, rather than challenging a specific and concrete application of the regulations to a particular entity, it launches a broad attack based on an alleged lack of clarity overall. Likewise, even if Section 405(h) requires presentment of such claims and exhaustion of administrative remedies under Section 405(g), as the Secretary contends in her petition for a writ of certiorari in No. 98-1109 (at 10-14), any party aggrieved by a specific application of the regulations will be able to obtain judicial review after such presentment and exhaustion occurs. See 98-1109 Pet. at 3-4 & n.4; 98-1109 Reply Br. at 8-9 n.4. The resolution of the question presented in No. 98-1109 thus will not alter the ripeness analysis that cross-petitioner asks this Court to address.10
3. Finally, also relying on Catholic Social Services, cross-petitioner argues (at 12-13) that the court of appeals erred in failing to remand for further factual development. There are, however, no further material facts to be developed. In Catholic Social Services, there was no record evidence demonstrating that the challenged practice of "front-desking" in fact had been applied to any member of the plaintiff class. "[B]ecause * * * the front-desking of a particular class member is not only sufficient to make [a class-member's] legal claims ripe, but necessary to do so," the Court found it appropriate to "remand * * * for proceedings to determine which class members were front-desked." 509 U.S. at 66-67.
Here, in contrast, there is no doubt that the regulations at issue have been applied to some of cross-petitioner's members. The only question is whether cross-petitioner may bring an immediate and across-the-board pre-enforcement challenge to the regulations on the grounds that they are unclear, or whether any challenge to those regulations should instead be raised in the context of a specific and concrete application. The answer to that question does not require further fact-finding by the district court, and has been provided by the court of appeals in accordance with legal principles established in this Court's decisions.
CONCLUSION
For the foregoing reasons, the conditional cross-petition for a writ of certiorari should be denied, without regard to the disposition of the Secretary's petition for a writ of certiorari in No. 98-1109.
Respectfully submitted.



HARRIET S. RABB
General Counsel
SHEREE R. KANNER
Associate General Counsel
JEFFREY GOLLAND
Attorney
Department of Health
and Human Services
SETH P. WAXMAN
Solicitor General
DAVID W. OGDEN
Acting Assistant Attorney General
BARBARA C. BIDDLE
JEFFREY CLAIR
Attorneys

MARCH 1999

1 "Pet. App." refers to the Appendix to the petition for a writ of certiorari in Shalala v. Illinois Council on Long Term Care, Inc., No. 98-1109 (filed Jan. 11, 1999).
2 In Medicare, which is a federally administered program, the surveys are conducted pursuant to contracts with the State. See 42 U.S.C. 1395aa (1994 & Supp. II 1996), 1395i-3(g)(1)(A). In Medicaid, which is a "cooperative federalism" program jointly administered by the federal and state governments, the State must make provision for the conduct of the survey program as part of its "State plan." 42 U.S.C. 1396r(g)(1)(A). Although the States thus have principal responsibility for surveying nursing homes participating in either Medicare or Medicaid, the Secretary retains the authority to survey public nursing facilities operated by state, county, or municipal governments. The Secretary may also conduct a survey of any facility if she has reason to question the facility's compliance with the statute, 42 U.S.C. 1395i-3(g)(3)(D), 1396r(g)(3)(D), or if necessary to assess the state survey agency's performance, 42 U.S.C. 1395i-3(g)(3)(A), 1396r(g)(3)(A).
3 Substandard care is a relatively serious violation of the statutory requirements most directly related to the quality of care and the residents' quality of life. See 42 C.F.R. 488.301. By statute, any finding of substandard care must trigger a more detailed follow-up survey, and also results in an automatic, two-year loss of eligibility to conduct a nurse aide training program for facility employees. 42 U.S.C. 1395i-3(f)(2)(B)(iii) (Medicare); 42 U.S.C. 1396r(f)(2)(B)(iii) (Medicaid).
4 In the federally-administered Medicare program, the state survey agency recommends an appropriate remedy and the Secretary makes the final decision. 42 U.S.C. 1395i-3(h)(1). In Medicaid, remedial powers are primarily vested in the State. 42 U.S.C. 1396r(h)(1).
5 See Cross-Pet. C.A. Br. 3 (cross-petitioner "does not seek to overturn or modify the new health, safety, and resident rights standards" established by the 1987 statutory amendments); Amended Compl. ¶ 1 (similar).
6 "Substantial compliance" is defined as "a level of compliance with the requirements of participation such that 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; Amended Compl. ¶ 43A.
7 "Substandard quality of care" is defined as "one or more deficiencies related to [certain] participation requirements" that (1) "[create] immediate jeopardy to resident health or safety," (2) "[constitute] a pattern of or widespread actual harm that is not immediate jeopardy," or (3) "[engender] widespread potential for more than minimal harm, but less than immediate jeopardy, [where] no actual harm" has yet occurred. 42 C.F.R. 488.301; Amended Compl. ¶ 43B.
8 Congress may, by statute, specifically provide for immediate review of a regulation to further interests in national uniformity or prompt resolution of a disputed matter. See, e.g., Harrison v. PPG Indus., 446 U.S. 578, 592-593 (1980). Congress has not done so here.
9 Of course, the ripeness doctrine and the statutory provisions governing judicial review may both point toward postponing judicial review until the Secretary's policies are applied in a concrete setting. But whether Congress has chosen to delay judicial review and channel it through certain mechanisms under Section 405(h), as it has plenary authority to do, see Weinberger v. Salfi, 422 U.S. 749, 762 (1975), is a separate question from whether a particular claim meets the constitutional and prudential requirements for justiciability.
10 The opportunity for judicial review exists even if some of cross-petitioner's claims are not ones that the agency itself would adjudicate in the first instance, since judicial review will still be available after presentment and exhaustion. Cf. Weinberger, 422 U.S. at 760-762 (challenge to constitutionality of a provision of Medicare Act, which cannot be resolved in the administrative process, must be brought through administrative process and cannot be subject of pre-enforcement action under 28 U.S.C. 1331).