Full opinion text
MEMORANDUM OPINION ROYCE C. LAMBERTH, Chief Judge. I. INTRODUCTION In 2003, as part of the Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L. No. 108-173, 117 Stat. 2066 (2003) or “MMA,” Congress directed the Department of Health and Human Services (“HHS”) and the Center for Medicaid and Medicare Services (“CMS”) to transition payment for Durable Medical Equipment (“DME”) under Medicare Part B from a fee schedule to a competitive bidding process by 2009. As part of this new law, Congress declared that CMS could not issue contracts to DME suppliers unless those entities met financial standards specified by the Secretary of HHS. The Secretary, along with an advisory group created by the MMA, held several public meetings on this new program— which included discussions on appropriate financial standards — and published a proposed rule in the Federal Register that, inter alia, described the purposes for collecting a supplier’s financial information and gave examples of financial metrics that CMS would consider. In 2007, the Secretary published a final rule outlining the competitive process (the “DME Bidding Program”). The final rule stated that bidders would need to submit certain financial documentation, and directed interested parties to a website for the Program describing ten financial metrics CMS would use to evaluate potential DME suppliers. Before the initial implementation of the DME Bidding Program, Congress amended the statute via the Medicare Improvements for Patients and Providers Act. Pub.L. No. 110-275, 122 Stat. 2494 (2008) (“MIPPA”). These changes pushed back the target dates for implementation, and the Secretary subsequently promulgated an interim final rule incorporating the statutory changes and proceeded with the revised DME Bidding Program. But before the results of the revised Program could be announced, plaintiffs — a DME supplier and an industry group — filed suit challenging the Secretary’s financial standards. The gravamen of plaintiffs’ complaint is that the standards lack the specificity required by statute, leaving potential DME suppliers in the dark when bidding for contracts. The DME Bidding Program has not yet been implemented, however, and so plaintiffs’ suit focuses on the procedures used by the Secretary in designing the Program. Specifically, plaintiffs allege that the generality with which the Secretary’s rulemaking process discussed financial standards renders the notice-and-eomment process required by both the MMA and the Administrative Procedure Act (“APA”) insufficient, that the absence of any published formula for financial viability violates the Freedom of Information Act (“FOIA”), and that the lack of a defined method for determining a supplier’s soundness implies that CMS is acting arbitrarily, and the defendants are acting ultra vires. Defendants now move to dismiss plaintiffs’ complaint, arguing that judicial review of these questions are precluded by the plain text of the MMA, that plaintiffs lack standing, and that the complaint fails to state a claim upon which relief may be granted. Plaintiffs oppose defendants’ request, and have sought several times to amend their original complaint. For the reasons set forth below, the Court finds that it lacks subject-matter jurisdiction over this matter and that, in any event, the Secretary’s rulemaking process was legally sufficient. The Court will therefore dismiss this action in its entirety. II. BACKGROUND A. Statutory and Regulatory Background Medicare is an “insurance program” that “provides basic protection against the costs of hospital, related post-hospital, home health services, and hospice care.” 42 U.S.C. § 1395c. Those eligible for the program include individuals over the age of 65, qualified individuals who have less than two years until they reach age-based eligibility, and certain other individuals afflicted with particular medical conditions. Id. Most drugs, medical equipment, and medical services are covered by Medicare, which pays for a significant proportion of the cost in accordance with fee schedules that are published and revised by HHS and CMS — a process that has traditionally applied to the purchase of DME for Medicare beneficiaries. In the late 1990s Congress — in the wake of “[njumerous studies conducted by the HHS Office and the Inspector General as well as GAO havfing] found the government-determined fee schedule for durable medical equipment (DME) too high for certain items,” H.R.Rep. No. 108-178(11), at 192 (2003) — authorized the Secretary to undertake several demonstration projects implementing a competitive bidding process for setting DME prices. The basic structure of the process is straightforward: Rather than have the Secretary set prices directly, CMS invites all suppliers in a geographical area to submit bid prices at which they would be willing to furnish particular DME products. After receiving bids and removing those entities ineligible under accreditation, financial or other standards, CMS adds up the proposed market shares — starting with the lowest bidder — until the entire market is covered, and awards exclusive contracts to those selected bidders at the median proposed price among the winners. A 1997 law “authorized the Secretary to conduct up to five demonstration projects to test competitive bidding as a way for Medicare to price and pay for” DME. H.R.Conf.Rep. No. 108-391, at 572 (2003). Three demonstrations were ultimately conducted — two in Polk County, Florida and one in the fine city of San Antonio, Texas. Id. The consensus following these pilot programs was, and remains, that the introduction of competitive bidding into the DME market was a resounding success. As Congress would later observe: “The DME competitive bidding demonstration has been a success. The taxpayers and beneficiaries saved significantly and quality standards • were higher under the demonstration.” H.R.Rep. No. 108-178(11), at 192. And HHS concurred: “The demonstration led to lower Medicare fees for almost every item in almost every product category in each round of bidding .... resulting in a nearly 20 percent overall savings at each site.” 71 F.R. 25654, 25657 (2006); see also Hearing on Medicare’s DMEPOS Competitive Bidding Program: Hearing before the Subcomm. On Health of the H. Comm. On Ways and Means, 110th Cong. 82 (2008), at 33 (statement of Mr. Hoerger) (“2008 Hearing Tr.”) (expert testimony that demonstrations “produced lower prices” while having “relatively little effect on beneficiary access, quality and product selection”). Satisfied with the demonstration results, Congress included in the MMA instructions for the Secretary to implement the DME Bidding Program nationwide. Codified at 42 U.S.G. § 1395w-3, the relevant statutory provision directs the Secretary to establish the DME Bidding Program, id. § 1395w-3(a), describes the conditions that must be met by suppliers before any contracts may be awarded, id. § 1395w-3(b)(2), establishes the terms that must be included in any contract, id. § 1395w-3(b)(3), and sets forth the process for payment. Id. § 1395w-3(b)(5). Congress envisioned implementation of the DME Bidding Program over several phases, with “10 of the largest metropolitan statistical areas in 2007; 80 ... in 2009; and remaining areas after 2009.” H.R.Rep. No. 108-391, at 575. The MMA sets forth conditions to be satisfied before CMS may award a contract under the DME Bidding Program, including that the supplier “meets applicable financial standards specified by the Secretary.” 42 U.S.C. § 1395w-3(b)(2)(A)(1)(ii); see also H.R.Rep. No. 108-391, at 576 (explaining that CMS may not award contracts unless “entities meet financial standards specified by the Secretary, taking into account the needs of small providers”). To determine the appropriate financial standards, the MMA created a Program Advisory and Oversight Committee (“PAOC”), 42 U.S.C. § 1395w-3(c), to “provide advice to the Secretary regarding the implementation of the program, data collection requirements, proposals for efficient interaction among manufacturers and distributors of the items and services providers and beneficiaries, the establishment of quality standards, and other functions specified by the Secretary.” H.R.Rep. No. 108-391, at 577; see also 42 U.S.C. § 1395w-3(c)(3)(A)(ii). In 2004, the Secretary published notice in the Federal Register of public meetings hosted by PAOC on replacement of “the current DME payment methodology for certain items with a competitive acquisition process to improve the effectiveness of Medicare’s methodology for setting DME payment amounts.” 69 F.R. 52723, 52723 (2004). That notice explained that PAOC’s role involved, inter alia, advising the Secretary on “financial standards for suppliers under the program.” Id. The notice requested any written comments or questions, and announced that a summary of the meeting would be made publicly available. Id. After this and other public discussions were held, which included discussion on the “[f]inancial capabilities of bidding suppliers,” the Secretary published a proposed rule in May 2006. 71 F.R. at 25658. In the proposed rule, the Secretary explained that the purpose of evaluating financial standards is to assist CMS “in assessing the expected quality of suppliers, estimating the total potential capacity of selected suppliers, and ensuring that selected suppliers are able to continue to serve market demand for the duration of their contracts.” Id. at 25675. The preamble further noted that CMS learned from the demonstrations that “general financial conditions, adequate financial ratios, positive credit history, adequate insurance documentation, adequate business capacity, and line of credit, net worth, and solvency, were important considerations for evaluating financial stability.” Id. Thus, the Secretary indicated that the requests for bids “will identify the specific information” required of suppliers, and suggested that such information might include “a supplier’s bank reference ... credit history, insurance documentation, business capacity and line of credit.” Id. In addition to the specific rules, the Secretary announced the creation of a public website, which would provide “access to all PAOC presentations, minutes, and updates for the” DME Bidding Program. Id. at 25658. The Secretary also set forth the role of financial standards in the Program, explaining that CMS would (1) look to all bidders to calculate the competitive bid range, then (2) eliminate those bidders that did not meet applicable financial standards, and finally (3) award contracts to the remaining bidders in sufficient number to provide for the entire market. Id. at 25677-78. Having set forth the purposes of the financial standards and the documentation involved, the Secretary “welcome[d] comments on the financial standards” and “the most appropriate documents that will support these standards.” Id. at 25675. After nearly a year passed, the Secretary promulgated a final rule establishing the DME Bidding Program. 72 F.R. 17992 (2007). In the preamble to that rule, the Secretary responded to a number of comments concerning financial standards and documentation. See generally id. at 18037-39. For example, in response to concerns about onerous documentation requirements, the Secretary announced that CMS would require only submission of “certain schedules from ... tax returns, a copy of the 10K filing report from the immediate 3 years prior ... certain specified financial statement reports, such as cash flow statements, and a copy of [a] current credit report,” id. at 18037, and explained that such information would allow CMS “to determine financial ratios, such as a supplier’s debt-to-equity ratio, and credit worthiness, which will allow [it] to assess a supplier’s financial viability.” Id. Some commenters also focused on particular financial indicators that they believed should be included in the Program, such as the debt-to-equity ratio, the EBITDA-to-equity ratio, the quick ratio and a Dunn and Bradstreet accounts payable rating. Id. at 18037-38. In response to these comments, the Secretary stated that CMS “will use appropriate financial ratios,” and listed examples such as “a supplier’s debt-to-equity ratio and a financial credit worthiness score from a reputable financial services company.” Id. at 18038. At the same time, the Secretary cautioned that CMS “will be reviewing all financial information in the aggregate and will not be basing [its] decision on one ratio but rather overall financial soundness.” Id. A subsequent announcement on the DME Bidding Program website explained that CMS would use ten particular financial ratios to evaluate a supplier’s viability. See Center for Medicaid and Medicare Services, CMS Announces Financial Measures for the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program, June 1, 2007, available at www. medicarenhic.com/dme/articles/060107_ comp_bid.pdf (last visited Sep. 5, 2011) (“CMS Financial Measures”). As to the specific regulation, the Secretary promulgated a rule requiring any bidding supplier to “submit along with its bid the applicable covered documents” to ensure that the candidate meets required financial standards. 42 C.F.R. § 414.414(d)(1). Covered documents were defined elsewhere as any “financial, tax, or other document required to be submitted by a bidder as part of an original bid submission under a competitive acquisition program in order to meet the required financial standards.” Id. § 414.402. Together, these regulations establish that “[i]n order to be considered for a contract award, each DMEPOS supplier is required to meet applicable quality and financial standards.” All Fla. Network Corp. v. United States, 82 Fed.Cl. 468, 470 (Fed.Cl.2008). CMS proceeded with Round 1 of the DME Bidding Program in the first 10 geographical areas, but in 2008 — -just before the results were announced — the House Committee on Ways and Means held a hearing “to review the development and execution of the ‘Durable Medical Equipment Competitive Bidding Program’ mandated in [the] MMA.” 2008 Hearting Tr. at 6 (statement of Rep. Stark). The hearing was called “because of the concern from [members of Congress] who [were] hearing from the suppliers in their communities,” prompting the need for, as one member put it, “oversight.” Id. Though recognizing that the initial demonstrations had successfully reduced prices, id. (noting estimated savings of 26%), and combated fraud, id. (applauding “the accreditation process” as method to combat “excessive fraud and abuse”), the Committee reviewed a number of complaints from industry and beneficiary advocates, and several members expressed their desire to alter or eliminate the DME Bidding Program. See generally id. at 6-9. During the 2008 Hearing, a colloquy between Kerry Weems, then director of CMS, and several representatives concerning the transparency of the Program and the disqualification of a large number of suppliers in Round 1 for lack of proper financial documentation took place. See, e.g., id. at 16 (statement of Mr. Weems) (acknowledging “that there is a problem with the fact that certain financial documentation was not supplied”); id. at 17 (statement of Mr. Weems) (discussing use of “certain financial rations [sic ] that ... tell [CMS] the financial strength of’ particular bidders); id. at 24 (statement of Mr. Weems) (admitting that CMS “ha[s] not disclosed as a matter of the bid process ... exactly how [CMS] use[s] the financial rations [sic ] in judging the financial viability of each bidder”). The statute creating the DME Bidding Program was largely unaffected following this hearing, 74 F.R. 2873, 2875 (2009)— likely because of the Program’s expected savings. See 2008 Hearing Tr. at 34-35 (statement of Rep. Stark) (“[T]o the extent we’re going to change [the DME Bidding Program], the Congressional Budget Office, who is a fiddler to whom we have to dance here, has said that a one-year delay in round one would lose $3.5 billion in projected savings, ... Over five years, the current program is north of $6 billion over the next five years.... [I]f we are going to solve this legislatively, and we may not, we’re going to have [to] come up with 6 billion bucks over five years.”). But the MIPPA did amend the statute in two ways that are collaterally relevant: first, Congress directed the Secretary to delay implementation of the program, such that a Round 1 rebid would be conducted in 2009 and Round 2 would be delayed until 2011, 74 F.R. at 2875; and second, Congress created a mechanism for supplier feedback that requires the Secretary to provide notice of any missing financial documents and an opportunity to supplement the bid. 42 U.S.C. § 1395w-3(a)(1)(F). Following passage of the MIPPA, the Secretary promulgated an interim final rule to integrate changes to various laws— including the DME Bidding Program — affected by that Act. 74 F.R. 2873. As the Secretary explained, the MIPPA made “certain limited changes” to the DME Bidding Program. Id. at 2875. Noting that these changes “are largely self-implementing,” the Secretary re-adopted the same methodologies (including the consideration of financial standards) that she had previously articulated. Id. at 2875-76; see also id. at 2876 (“The [requests for bid] issued for the Round 1 rebid will require suppliers to submit the same categories of financial documents as we requested for the previous Round 1 competition.”). In light of the MIPPA’s “new paragraph ... set[ting] forth a process for supplier feedback on missing financial documents,” id. at 2875, however, the Secretary amended the applicable regulations to provide a method for suppliers to obtain feedback concerning incomplete submissions. 42 C.F.R. § 414.414(d)(2). CMS then proceeded with the Round 1 rebid. B. Factual and Procedural History Before the results of the Round 1 rebid could be announced, plaintiffs filed suit in this Court. Complaint, May 10, 2010[1], The stated purposes of this action are to compel HHS and CMS “(1) [to] comply with the Medicare provisions ... by specifying financial standards that [DME] suppliers must meet, taking into consideration the needs of small providers, (2) to comply with the APA and the Medicare provisions of the Social Security Act by providing proper notice and opportunity for public comment in proposing and specifying such financial standards, and (3) to publish in the Federal Register, or otherwise provide to Plaintiffs, the ‘financial standards’ [they are] applying to qualify such DME suppliers, if in fact they exist.” Id. at ¶ 1. The Complaint centers around a host of alleged deficiencies in the processes used by the Secretary and the Director of CMS in developing the DME Bidding Program, including that “[t]he [2006] proposed rule did not contain any further information on the substance of the proposed financial standards,” id. at ¶ 14, the preamble to the final rule “did not specify the ‘appropriate financial ratios’ to be used” by defendants, id. at ¶ 15, the substantive adopted regulation “did' not specify financial standards that would be applied,” id. at ¶ 16, “[n]o-where in the [2009] interim final rule did Defendants specify the financial standards to be used,” id. at ¶ 18, and that — despite numerous requests — defendants have not allowed DME suppliers to “comment on proposed financial standards” following the interim final rule. Id. at ¶ 23. In light of these purported shortcomings, plaintiffs allege that DME suppliers participating in the Round 1 rebid “do not know whether or not they have been determined by Defendants to be qualified bidders under whatever financial standards or judgments are, or have been, applied.” Id. at ¶ 20. Plaintiffs further allege, “[o]n information and' belief,” that HHS and CMS are “evaluating the financial soundness of ... bidders without having specified financial standards, ... as required by statute, and are evaluating ‘covered documents’ for the financial soundness of providers on an ad hoc basis, without application of specified financial standards and without any specific means for considering the financial needs of small providers.” Id. at ¶24. Based on these allegations, plaintiffs assert that HHS and CMS have violated § 553 of the APA and § 1395hh of the Medicare Act by failing to make the financial standards publicly available and provide a meaningful opportunity for comment, id. at ¶¶ 25-34 (Counts I & II), violated § 552(a)(1)(C) of FOIA by failing to publish the applicable financial standards in the Federal Register, id. at ¶¶ 35-39 (Count III), and violated § 706(2) of the APA by failing to rely upon specified financial standards and thus acting ultra vires. Id. at ¶¶ 40-41. Defendants subsequently moved to dismiss plaintiffs’ complaint. Motion to Dismiss, July 23, 2010[9] (“MTD”). Defendants’ motion sets forth three general bases for dismissal: first, that the MMA precludes judicial review of the Secretary’s choice of financial standards, and thus this Court lacks subject-matter jurisdiction, id. at 18-24; second, that the Court lacks jurisdiction because the Complaint does not sufficiently allege the elements necessary to establish plaintiffs’ standing, id. at 25-29; and finally, that the Complaint fails to state any claim upon which relief may be granted and therefore must be dismissed under Federal Rule of Civil Procedure 12(b)(6). Id. at 29-37. Several months after defendants’ motion was fully briefed, plaintiffs moved to amend their Complaint following completion of the Round 1 rebid. Motion for Leave to File First Amended Complaint, Jan. 10, 2011[15]. Defendants opposed plaintiffs’ motion on the grounds that plaintiffs failed to comply with Local Rule 7(m) requiring the parties to meet and confer, and that the new allegations did not alter the three bases for dismissal— rendering amendment futile. Opposition to Motion for Leave, Jan. 12, 2011[16]. Three months later, plaintiffs moved a second time to amend the Complaint, asserting a need to incorporate allegations concerning Round 2 bidding under the DME Program, Motion for Leave to File Second Amended Complaint, Apr. 12, 2011 [18], and defendants opposed this request on the same grounds. And just last week, plaintiffs again moved to amend — and defendants again opposed — this time because (1) areas of Texas covered by Texas Alliance’s members are part of Round 2 of the DME Bidding Program and (2) plaintiffs wish to add a Medicare beneficiary as a plaintiff. Motion for Leave to File Third Amended Complaint, Aug. 29, 2011[23]. Having reviewed the full record, as well as the applicable law, the Court, for the reasons set forth below, will dismiss plaintiffs’ suit for want of jurisdiction and for failure to state a claim, and will deny plaintiffs’ requests to amend the Complaint as futile. III. STANDARD A. 12(b)(1) Motion to Dismiss for Lack of Subject Matter Jurisdiction Federal district courts are courts of limited jurisdiction, Kokkonen v. Guardian Life Ins. Co., 511 U.S. 375, 377, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994), and a Rule 12(b)(1) motion for dismissal presents a threshold challenge to a court’s jurisdiction. Haase v. Sessions, 835 F.2d 902, 906 (D.C.Cir.1987). In evaluating such a motion, the Court must “accept as true all of the factual allegations contained in the complaint,” Wilson v. District of Columbia, 269 F.R.D. 8, 11 (D.D.C.2010) (citing Leatherman v. Tarrant Cty. Narcotics Intel. & Coordination Unit, 507 U.S. 163, 164, 113 S.Ct. 1160, 122 L.Ed.2d 517 (1993)), and should review the complaint liberally while accepting all inferences favorable to the plaintiff. Barr v. Clinton, 370 F.3d 1196, 1199 (D.C.Cir.2004). At the same time, the Court may consider relevant materials outside the pleadings, Settles v. U.S. Parole Comm’n, 429 F.3d 1098, 1107 (D.C.Cir.2005), and must remain cognizant that “the plaintiffs factual allegations in the complaint will bear closer scrutiny in resolving a 12(b)(1) motion than in resolving a 12(b)(6) motion for failure to state a claim.” Wilson, 269 F.R.D. at 11 (quotations omitted). In defending against a Rule 12(b)(1) motion, the plaintiff bears the burden of demonstrating that jurisdiction exists. Khadr v. United States, 529 F.3d 1112, 1115 (D.C.Cir.2008). B. 12(b)(6) Motion to Dismiss for Failure to State a Claim A motion to dismiss under Rule 12(b)(6) tests the legal sufficiency of a complaint. Browning v. Clinton, 292 F.3d 235, 242 (D.C.Cir.2002). To satisfy this test, a complaint must contain “a short and plain statement of the claim showing that the pleader is entitled to relief, in order to give the defendant fair notice of what the ... claim is and the grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). “[W]hen ruling on a defendant’s motion to dismiss, a judge must accept as true all of the factual allegations contained in the complaint,” Atherton v. District of Columbia, 567 F.3d 672, 681 (D.C.Cir.2009), and grant a plaintiff “the benefit of all inferences that can be derived from the facts alleged.” Kowal v. MCI Commc’ns Corp., 16 F.3d 1271, 1276 (D.C.Cir.1994). At the same time, a court may not “accept inferences drawn by plaintiffs if such inferences are unsupported by the facts set out in the complaint.” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009). In other words, “only a complaint that states a plausible claim for relief survives a motion to dismiss.” Id.; see also Atherton, 567 F.3d at 681 (holding that complaint must plead “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged”). IV. ANALYSIS A. Statutory Preclusion The Secretary’s primary argument for dismissal is that judicial review of implementation of the DME Bidding Program — at least with respect to the Secretary’s choice of financial standards — is precluded. The relevant statutory provision reads, in its entirety: There shall be no administrative or judicial review under section 1869, section 1878, or otherwise, of— (A) the establishment of payment amounts under paragraph (5); (B) the awarding of contracts under this section; (C) the designation of competitive acquisition areas under subsection (a)(1)(A) and the identification of areas under subsection (a)(1)(D)(iii); (D) the phased-in implementation under subsection (a)(1)(B) and implementation of subsection (a)(1)(D); (E) the selection of items and services for competitive acquisition under subsection (a)(2); (F) the bidding structure and number of contractors selection under this section; or (G) the implementation of the special rule described in paragraph (10). 42 U.S.C. § 1395w-3(b)(11). Relying on subsections (b)(11)(B) and (b)(11)(F), defendants argue that “[t]he Secretary’s promulgation and application of financial standards is inextricably intertwined with ‘the awarding of contracts,’ just as the Secretary’s requirement that suppliers must provide certain financial documentation as a prerequisite for consideration is part of the ‘bidding process.’ ” MTD at 22. The Court agrees. In evaluating whether Congress intended to preempt judicial review of the Secretary’s actions, the Court begins, as it must, “with the strong presumption that Congress intends judicial review of administrative action.” Bowen v. Mich. Academy of Family Physicians, 476 U.S. 667, 670, 106 S.Ct. 2133, 90 L.Ed.2d 623 (1986). But this presumption, “like all presumptions used in interpreting statutes, may be overcome by, inter alia, specific language or specific legislative history that is a reliable indicator of congressional intent, or a specific congressional intent to preclude judicial review that is fairly discernible in the detail of the legislative scheme.” Id. at 673, 106 S.Ct. 2133. In particular, the presumption of judicial review of agency action may be overcome “ ‘upon a showing of clear and convincing evidence of a contrary legislative intent [to] restrict access to judicial review.’” Id. at 671, 106 S.Ct. 2133 (quoting Abbott Laboratories v. Gardner, 387 U.S. 136, 141, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967)); see also Bartlett v. Bowen, 816 F.2d 695, 699 (D.C.Cir.1987) (“It is axiomatic that this presumption can be overcome only by ‘clear and convincing evidence’ that Congress intended to restrict access to judicial review.”). This standard — which is not applied “in the strict evidentiary sense” — “serves as a useful reminder to courts that, where substantial doubt about the congressional intent exists, the general presumption favoring judicial review of administrative action is controlling.” Boiven, 476 U.S. at 672 n. 3, 106 S.Ct. 2133. To determine whether the statute precludes judicial review, the Court “turns to the statute’s ‘language, structure and purpose, its legislative history, and whether the claims can be afforded meaningful review.’ ” Amgen Inc. v. Smith, 357 F.3d 103, 112 (D.C.Cir.2004) (quoting Thunder Basin Coal Co. v. Reich, 510 U.S. 200, 206, 114 S.Ct. 771, 127 L.Ed.2d 29 (1994)). In particular, the presumption against preclusion “may be overcome by the language of the statute.” All Fla. Network, 82 Fed.Cl. at 473 (citing McNary v. Haitian Refugee Ctr., Inc., 498 U.S. 479, 498-99, 111 S.Ct. 888, 112 L.Ed.2d 1005 (1991)). Alternatively, the presumption “does not control in cases [where] the congressional intent to preclude judicial review is ‘fairly discernable’ in the detail of the legislative scheme.” Block v. Cmty. Nutrition Inst., 467 U.S. 340, 351, 104 S.Ct. 2450, 81 L.Ed.2d 270 (1984). The Court finds that both the plain language of § 1395w-3(b)(11) and the statutory scheme, read in its entirety, foreclose judicial review of the Secretary’s challenged actions. 1. The Language of §§ 1395w-3(b)(11)(B) & (F) “It is a ‘familiar canon of statutory construction that the starting point for interpreting a statute is the language of the statute itself.’ ” All Fla. Network, 82 Fed.Cl. at 472 (quoting Consumer Prod. Safety Comm’n v. GTE Sylvania, Inc., 447 U.S. 102, 108, 100 S.Ct. 2051, 64 L.Ed.2d 766 (1980)). The Secretary points to two phrases in the judicial-review provision to support her argument that review is precluded in this instance: first, that judicial review of the “awarding of contracts” is foreclosed; and second, that judicial review of “the bidding structure” is not permitted. MTD at 19-20. The Court discusses each of these subsections in turn. With respect to the “awarding of contracts,” § 1395w-3 expressly ties the development and application of appropriate financial standards to the Secretary’s decision to grant or deny a contract under the DME Bidding Program. Indeed, the only statutory reference to financial standards is found in the section entitled “Conditions for awarding contracts,” which provides that the Secretary “may not award a contract to any entity ... unless the Secretary finds [that] ... [t]he entity meets applicable financial standards specified by the Secretary.” 42 U.S.C. § 1395w-3(b)(2)(A)(ii). And while plaintiffs argue that the preclusion language is directed towards the act of awarding contracts— indicating congressional intention to preclude only post-bid review, Opposition to Motion to Dismiss 11, Aug. 6, 2010[10] (“MTD Opp.”) — it is well established that a statutory bar against bid protests also precludes “review of the administrative decisions leading up to the procurement.” Corel Corp. v. United States, 165 F.Supp.2d 12, 28-29 (D.D.C.2001) (collecting cases). Plaintiffs’ additional contention that “[a] reasonable and common-sense reading [of the phrase ‘awarding of contracts’] is that Congress did not want the courts and HHS to be bogged down with a plethora of fact-intensive lawsuits brought by individual bidders or contractors,” MTD Opp. at 11, is also undermined by the Supreme Court’s latest pronouncement on statutory preclusion, in which it explained that distinctions based upon “the ‘potential future’ versus the ‘actual present’ nature of the claim, the ‘general legal’ versus the ‘fact-specific’ nature of the challenge, the ‘collateral’ versus ‘non-collateral’ nature of the issues, or the ‘declaratory’ versus ‘injunctive’ nature of the relief sought” are without merit. Shalala v. Illinois Council on Long Term Care, Inc., 529 U.S. 1, 13-14, 120 S.Ct. 1084, 146 L.Ed.2d 1 (2000). In other words, the fundamental inquiries for the Court in this case — what financial standards the Secretary articulated, whether they are sufficiently specific or adequate to promote the underlying statutory goals, and whether the Secretary is complying with them — are the same as in any post-bid challenge. See All Fla. Network, 82 Fed.Cl. at 473 (remarking, in reviewing § 1395w-3(b)(11), that “eligibility determinations are part of the overall award scheme”). In this instance, there is simply “no reason to distinguish” among standards of eligibility, on the one hand, and the awarding of a contract, on the other. Atl. Urological Assocs., P.A. v. Leavitt, 549 F.Supp.2d 20, 30 (D.D.C.2008) (citing Illinois Council, 529 U.S. at 14, 120 S.Ct. 1084). Turning to the “bidding structure” for the DME Bidding Program, the Court finds that this provision forecloses preimplementation challenges to the Secretary’s specifications of appropriate financial standards. Unlike subsection (b)(11)(B)’s “awarding of contracts” language, this provision does not involve particular action undertaken by the Secretary, but precludes review of “the bidding structure” itself. 42 U.S.C. § 1395w-3(b)(11)(F). The “structure” of the DME Bidding Program is “the way in which the parts of something are put together or organized.” Webster’s Third New Int’l Dictionary 2267 (1965). And section (b)(2) provides a list of the “parts” that the Secretary is to compile into the DME Bidding Program — including the methods to determine whether a bidder “meets applicable quality standards,” “meets applicable financial standards,” whether “[t]he total amounts to be paid ... are expected to be less than the total amounts that would otherwise be paid,” and whether the “[access of individuals to a choice of multiple suppliers in the area is maintained.” 42 U.S.C. § 1395w-3(b)(2)(A)(i)-(iv). And while plaintiffs insist that the financial standards cannot be considered part of the bidding structure, MTD Opp. at 17, they offer no other part of the DME Bidding Program to which this language refers. Indeed, the Court can conceive of no clearer means of precluding review of these aspects of the DME Bidding Program than that used in the preclusion provision — save, perhaps, the listing of each individual piece of that structure. Permitting plaintiffs to “pars[e] the categories of decisions precluded from judicial review into challengeable sub-components would frustrate Congress’ intent and potentially hamstring the Secretary’s ability” to implement the- DME Bidding Program. All Fla. Network, 82 Fed.Cl. at 470 (quotations omitted). Accordingly where, as here, the preclusion provision shields a particular agency decision from review — in this instance the structure for the bidding process — it also shields the subcomponents of that process, which includes the financial standards. Carolina Med. Sales, Inc. v. Leavitt, 559 F.Supp.2d 69, 78 (D.D.C.2008) (citing Am. Medical Ass’n v. Thompson, No. 99 Civ. 7850, 2001 WL 619510 (N.D.Ill. May 29, 2001)). Another court in this district has relied upon similar principles to find review precluded under § 1395w-3(b)(11). In Carolina Med., the district court dismissed a complaint alleging that HHS and CMS promulgated rules governing certain aspects of the D ME Bidding Program without adhering to notice-and-comment procedures, 559 F.Supp.2d at 72, finding — in reliance on the express language in § 1395w-3(b)(10)(E) — that the preclusion provision “is broad, unqualified, and clear,” and expresses Congress’ intent to bar judicial review. Id. at 77. In doing so, the Carolina Med. Court rejected the argument — identical to plaintiffs’ position here — that the omission of the particular challenged agency action from § 1395w-3(b)(11)’s list was dispositive. See id. (“The absence of any mention of delivery method .... does not detract from this conclusion.... [There is] no reason why Congress would — after imbuing the Secretary with unreviewable discretion ...— decide to carve out an isolated patch for judicial review.”). Finally, plaintiffs’ reliance on Sharp Healthcare v. Leavitt, which held that § 1395w-3(b)(11) does not preclude certain claims under the DME Bidding Program, 555 F.Supp.2d 1121, 1125 (S.D.Cal.2008), is flawed for several reasons. Beyond the obvious — that this Court is not bound to that decision — and the less obvious but more compelling — that this decision has been subsequently vacated, Order, Sharp, No. 08 Civ. 170, July 22, 2010 [53], thus “voiding] the effect of [that] prior legal determination,” United States ex rel. Miller v. Bill Harbert Int’l Constr., — F.Supp.2d —, —, No. 95 Civ. 1231, 2011 WL 3796135, at *4, 2011 U.S. Dist. LEXIS 96236, at *14 (D.D.C. Aug. 29, 2011) — this Court takes issue with various aspects of the reasoning, which are conveyed in a few scant paragraphs. Most fundamentally, the Sharp Court relies on the Supreme Court’s interpretation of another Medicare preclusion statute in Bowen without accounting for critical differences between § 1395w-3(b)(11) and the statute at issue in Bowen. 555 F.Supp.2d at 1124; see also infra. In addition, the Sharp Court relies heavily on its concern that the Secretary might act contrary to statutory commands, id. at 1125, without due regard for the well-established exception to preclusion in the case of ultra vires actions. See infra. Sharp thus does little to alter the Court’s finding that §§ 1395w-3(b)(11)(B) & (F) preclude challenges to the Secretary’s articulation of financial standards for the DME Bidding Program. 2. The Statutory Scheme In addition to the specific statutory language, the Court may also “examine th[e] statutory scheme to determine whether Congress precluded all judicial review.” Block, 467 U.S. at 846, 104 S.Ct. 2450; see also id. at 349, 104 S.Ct. 2450 (“[T]he presumption favoring judicial review of administrative action may be overcome by inferences of intent drawn from the statutory scheme as a whole.”). Reading § 1395w-3 in its entirety and along with the preclusion provision, a clear narrative emerges: Congress precluded from administrative and judicial review all aspects of the DME Bidding Program concerning its design and implementation, but left open challenges to post-bid conduct. For instance, Congress precluded review of acceptable payment amounts, 42 U.S.C. § 1395w-3(b)(11)(A), the factors that the Secretary would consider in awarding contracts, id. § 1395w-3(b)(11)(B), the designation of areas where the Program is to be implemented, id. § 1395w-3(b)(11)(C), the timing of implementation, id. § 1395w-3(b)(11)(D), the choice of which DME would be included, id. § 1395w-3(b)(11)(E), the structure of the Program, id. § 1395w-3(b)(11)(F), and the implementation of any special rules for particular types of DME. Id. § 1395w-3(b)(11)(G). By contrast, the preclusion provision does not foreclose review of the precise terms to be included in a contract once bidders are chosen, id. § 1395w-3(b)(3)(B), disclosures to be made by DME suppliers once a contract has been entered into, id. § 1395w-3(b)(3)(C), the process of paying the winning bidders, id. § 1395w-3(b)(6), or challenges to the Secretary’s decision to terminate a contract before it expires. See 42 C.F.R. § 414.423 (setting forth process for administrative review of pre-term cancellation). In light of the clear division between review of the initial implementation of the DME Bidding Program — which is precluded — and review of post-bidding actions — which often is nob — the Federal Circuit recently observed that “Congress clearly intended that Medicare could proceed with these initial administrative processes without risk of litigation blocking the execution of the program.” Cardiosom, L.L.C. v. United States, 656 F.3d 1322, 1326 (Fed.Cir.2011); see also Carolina Med., 559 F.Supp.2d at 76 (“[T]he provision clearly indicates that Congress contemplated a detailed, scheduled deployment of the competitive bidding program and imbued the Secretary with the authority — immune from judicial review — to economize by accelerating the introduction of cost-effective items and services.”). The Court agrees, and also concurs with the Federal Circuit’s observation that “[t]he purpose of withholding judicial review in these instances is to insulate these management decisions by the Medicare Administration from the potential of inordinate delays that would transpire if every such management decision were open to an upfront challenge by some disappointed group.” Cardiosom, 656 F.3d at 1326 (citing H.R.Rep. No. 108-391, at 576-77). The Secretary’s choice of appropriate financial standards to apply in the DME Bidding Process is just such a management decision, and thus the Court finds that review of this action is precluded. Rather than address these structural arguments, plaintiffs place heavy reliance on the Supreme Court’s statement in Bowen that “prohibition of judicial review of benefit payments under Medicare ‘simply does not speak to challenges mounted against the method by which such amounts are to be determined rather than the determinations themselves.’ ” MTD Opp. at 14 (quoting Bowen, 476 U.S. at 675, 106 S.Ct. 2133). This reliance is misplaced, however, as Bowen was decided under a different statutory regime. Specifically, the relevant provision in Bowen provided that “the determination of the amount of benefits under part A, shall be made by the Secretary in accordance with regulations prescribed by him,” and “[a]ny individual dissatisfied with any determination ... shall be entitled to a hearing thereon by the Secretary ... and to judicial review of the Secretary’s final decision.” 476 U.S. at 674 n. 5, 106 S.Ct. 2133 (quoting portion of 42 U.S.C. § 1395ff as written at time). Beyond the obvious fact that § 1395w-3(b)(11) expressly precludes judicial review, while the provision at issue in Bowen “is an explicit authorization of judicial review, not a bar,” id. at 674, 106 S.Ct. 2133, the statutory scheme in Bowen undermines any attempt to apply the quoted language to this case. The provision at issue in Bowen references §§ 405(g) & (h) of the Social Security Act, which create an administrative process of review — followed by appeals to the courts — and render all findings of the Secretary final and immune from review, respectively. The government in Bowen argued that the provision’s reference to these sections required the Court to adhere to an earlier line of precedent holding that a fair reading of §§ 405(g) & (h) is that general federal jurisdiction was barred over any challenges to the procedures used by the Secretary. The Court declined this invitation, however, observing that the statutory reference to § 405(g) was only for “the determination of the amount of benefits”— thereby distinguishing between method and determination review in the manner quoted by plaintiffs, Bowen, 476 U.S. at 674-75 & n. 5, 106 S.Ct. 2133 — and explaining that because the legislative history of the statute before it “provides specific evidence of Congress’ intent to foreclose review only of ‘amount determinations,’ ” id. at 680, 106 S.Ct. 2133 (emphasis added), the general bar on such procedural claims under the Social Security Act did not apply to claims under Medicare Part B. Id. at 679-80, 106 S.Ct. 2133. This brief discussion should serve to illuminate the distinct differences between the circumstances in Bowen and those here. First, unlike the statute in Bowen, § 1395w-3(b)(11) contains both a provision concerning the actual CMS action — the “awarding of contracts” — and a provision concerning the broader design of the DME Bidding Program — the “bidding structure.” Supra. Thus, Bowen’s reasoning concerning the distinction between method and determination — if it remains good law — is inapplicable where the statute at issue, such as § 1395w-3(b)(11), precludes judicial review of both the “method” and the “determination.” Second, also unlike in Bowen, plaintiffs point to nothing in the record or legislative history — save speculation and innuendo — to suggest that Congress did not intend to bar judicial review of the entirety of the Secretary’s development of the DME Bidding Program. Moreover, a few months after the Bowen decision was issued, Congress amended the relevant provisions of the Medicare Act to make §§ 405(g) & (h) applicable to challenges under Part B “to the same extent as it applies” to Part A. Illinois Coun cil, 529 U.S. at 8, 120 S.Ct. 1084. Applying this new provision, the Illinois Council Court stated: [Our prior decisions] foreclose distinctions based upon the ‘potential future’ versus the ‘actual present’ nature of the claim, the ‘general legal’ versus the ‘fact-specific’ nature of the challenge, the ‘collateral’ versus ‘non-collateral’ nature of the issues, or the ‘declaratory’ versus ‘injunctive’ nature of the relief sought. Nor can the Court accept a distinction that limits § 405(h)’s scope to claims for monetary benefits or that involve ‘amounts,’ as neither the language nor the purposes of § 405 support such a distinction. Id. at 13-14, 120 S.Ct. 1084; see also Atl. Urological Assocs., 549 F.Supp.2d at 30 (noting that subsequent decisions disavowed the ‘amount’ versus ‘method’ dichotomy). The Illinois Council Court thus limited Bowen to circumstances in which there would be “no review at all” of constitutional challenges to agency action under Medicare part B, 529 U.S. at 19, and held that preclusion “applies to disputes over the methods used to determine reimbursement just as it applies to disputes over reimbursement amount determinations.” Am. Med. Techs. v. Johnson, 598 F.Supp.2d 78, 81 (D.D.C.2009). 3. The Court Lacks Subject-Matter Jurisdiction Having found that judicial review of the Secretary’s choice and promulgation of financial standards is precluded, the Court concludes that it lacks subject-matter jurisdiction over each of plaintiffs’ claims. Courts have routinely upheld the denial of administrative or judicial review of HHS actions where the relevant Medicare provision states that “[t]here shall be no administrative or judicial review.” Am. Soc’y of Dermatology v. Shalala, 962 F.Supp. 141,145-47 (D.D.C.1996); see also Amgen, 357 F.3d at 111-12 (holding that where preclusion language is clear, absence of alternative outlets for review is “unsurprising”). Accordingly, consideration of any claim under § 1395w-3(b)(11) is plainly precluded. See Carolina Med., 559 F.Supp.2d at 74-78 (precluding review of alleged violation of § 1395hh where § 1395w-3(b)(11) prohibited review of the substance of agency’s decision). And the APA, which forms the underlying remedial platform for all of plaintiffs’ claims, contains a specific provision withdrawing jurisdiction where “statutes preclude judicial review.” 5 U.S.C. § 701(a)(1); see Block, 467 U.S. at 345, 104 S.Ct. 2450 (observing that APA “confers a general cause of action upon persons ‘adversely affected or aggrieved by agency action within the meaning of a relevant statute,’ ” but “withdraws that cause of action to the extent the relevant statute ‘precludes judicial review’ ”) (quoting APA §§ 701(a)(1) & 702); Amgen, 357 F.3d at 113 (“If a no-review provision shields particular types of administrative action, a court may not inquire whether a challenged agency decision is arbitrary, capricious, or procedurally defective.”); see also Aid Ass’n for Lutherans v. USPS, 321 F.3d 1166, 1173 (D.C.Cir.2003) (finding that preclusion provision “exempts [agency] from the strictures of the APA in eases involving the APA’s procedural requirements”). One exception remains. “[T]he case law in this circuit is clear that judicial review is available when an agency acts ultra vires.” Aid Ass’n for Lutherans, 321 F.3d at 1173. Thus, “to the extent that statutes preclude judicial review,” APA § 701(a)(1) “does not repeal the review of ultra vires actions.... When an executive acts ultra vires, courts are normally available to reestablish the limits on his authority.” Dart v. United States, 848 F.2d 217, 224 (D.C.Cir.1988). This doctrine rests on the presumption of judicial review, which is “particularly strong that Congress intends judicial review of agency action taken in excess of delegated authority.” Amgen, 357 F.3d at 111. And in order to determine whether review is precluded, the Court must look briefly to the merits of plaintiffs’ allegations to determine whether the question is jurisdictionally barred. See id. at 113 (“[T]he determination of whether the court has jurisdiction is intertwined with the question of whether the agency has authority for the challenged action, and the court must address the merits to the extent necessary to determine whether the challenged agency action falls within the scope of the preclusion on judicial review.”). In this instance, this is a relatively straightforward task — as discussed at greater length infra, plaintiffs’ allegations of ultra vires action on behalf of HHE and CMS, which includes no details or basis to support such an inference, is plainly conclusory, and will be disregarded by the Court. See Am. Med. Techs., 598 F.Supp.2d at 80 (“ ‘[T]he court need not accept inferences drawn by plaintiffs if such inferences are unsupported by the allegations set out in the complaint. Nor must the court accept legal conclusions cast in the form of factual allegations.’ ”) (quoting Kowal, 16 F.3d at 1276). Accordingly, the Court finds that all of plaintiffs’ claims in this instance are precluded by § 1395w-3(b)(11) of the MMA and MIPPA. Having concluded that it lacks subject-matter jurisdiction, the Court’s consideration of this matter would normally be at an end. See All Fla. Network, 82 Fed.Cl. at 472 (“Jurisdiction is a prerequisite which must be met prior to considering any substantive issues.”). But in light of the dearth of clear law interpreting § 1395w-3, the Court — out of an abundance of caution — will proceed to consider defendants’ remaining arguments. B. Standing In addition to express statutory preclusion, defendants assert that “the Court also lacks jurisdiction because Plaintiffs’ alleged injuries are insufficient to confer Article III jurisdiction.” MTD at 25. This Court, like all Article III tribunals, is one of limited jurisdiction and “cannot decide cases that [it] lack[s] constitutional authority to decide.” Ctr. for Law & Educ. v. DOE, 396 F.3d 1152, 1156 (D.C.Cir.2005). “The core component of standing is an essential and unchanging part of the ease-or-controversy requirement of Article III,” Cty. of Del. v. DOT, 554 F.3d 143, 147 (D.C.Cir.2009), which “defines with respect to the Judicial Branch the idea of separate of powers on which the Federal Government is founded.” Allen v. Wright, 468 U.S. 737, 750, 104 S.Ct. 3315, 82 L.Ed.2d 556 (1984); see also Warth v. Seldin, 422 U.S. 490, 498, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975) (“[Standing] is founded in concern about the proper — and properly limited — role of the courts in a democratic society.”). “In essence the question of standing is whether a litigant is entitled to have the court decide the merits of the dispute or of particular issues.” Warth, 422 U.S. at 498, 95 S.Ct. 2197. “The party invoking federal jurisdiction bears the burden of establishing” standing. Lujan v. Defenders of Wildlife, 504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). In this instance, plaintiffs’ claims are not based on any denial of benefits within the DME Bidding Program, but rather on prospective claims concerning purported inadequacies in the procedures employed by the Secretary. In such circumstances, plaintiffs must rely on their purported procedural injury, which may confer standing “provided that [the procedural] requirement ‘was designed to protect some threatened concrete interest’ of the litigant.” Cty. of Del., 554 F.3d at 147 (quoting Lujan, 504 U.S. at 573 n. 8,112 S.Ct. 2130). This test, while different in some sense from the typical standing inquiry, requires both that a concrete injury exist and that the injury is caused by the alleged procedural defect. Ctr. for Law, 396 F.3d at 1157. The Court finds each element of plaintiffs’ standing lacking. 1. Concrete Interest With respect to a concrete interest, plaintiffs generally allege that defendants’ purported procedural failures “cause a distinct risk of harm to Plaintiffs’ concrete Medicare DME supplier interests.” Complaint ¶ 7. Reading plaintiffs’ subsequent proposed amended complaints, along with their opposition to defendants’ motion to dismiss, the Court identifies three possible injuries: (1) an increased risk that plaintiffs or their members will not receive contracts under the DME Bidding Program, (2) the cost of applying to the DME Bidding Program, and (3) a risk to DME beneficiaries of increases in costs or decreases in quality of services. These latter two interests may be easily dispatched. As to the costs of application, a supplier’s decision to apply or not apply to the DME Bidding Program belongs to the supplier alone — in either case, the choice is not without risk (whether through the inability to obtain a contract by not participating or through the costs of unsuccessful participation.) Such risks, however, are insufficient to confer standing on the party. See Nat’l Family Planning & Reproductive Health Ass’n v. Gonzales, 468 F.3d 826, 831 (D.C.Cir.2006) (explaining that Circuit Court has “consistently held that self-inflicted harm doesn’t satisfy the basic requirements for standing”). Moreover, procedural injury standing extends only to concrete risks that the procedural requirement in question was designed to protect. Cty. of Del., 554 F.3d at 147; see also Ctr. for Law, 396 F.3d at 1157 (“Not all procedural-rights violations are sufficient for standing; a plaintiff must show that ‘the procedures in question are designed to protect some threatened concrete interest of his that is the ultimate basis of his standing.’ ”) (quoting Lujan, 504 U.S. at 573 n. 8, 112 S.Ct. 2130; emphasis in original). As the Secretary explained in her proposed rulemaking, the financial standards are used for several purposes, fileluding “assessing the expected quality [and] total potential capacity of suppliers,” and “ensuring that selected suppliers are able to continue to serve market demand.” 71 F.R. at 25675. None of these purposes, however, extends to protection of potential suppliers bidding for contracts in the DME Bidding Program — nor do plaintiffs point to any statutory provision or legislative history suggesting otherwise. See Cal. Forestry Ass’n v. Thomas, 936 F.Supp. 13, 21 (D.D.C.1996) (“A plaintiff whose interests are marginally related to ... the purposes implicit in the statute lacks standing to sue.”) (quotations omitted). Finally, the risks involved both to DME suppliers and to Medicare beneficiaries are far too speculative to sustain the Court’s exercise of its jurisdiction. To successfully establish standing, plaintiffs must show that the purported failure to conduct notice-and-comment rulemaking has “created a ‘demonstrably increased risk’ that ‘actually threatens the plaintiffs particular interests.’ ” Ctr. for Law, 396 F.3d at 1161 (quoting Fla. Audubon Soc’y v. Bentsen, 94 F.3d 658, 667 (D.C.Cir.1996) (en banc); emphasis in original). With respect to the costs of application, plaintiffs’ standing argument is that (1) under the current financial standards certain suppliers would be ruled ineligible for the DME Bidding Process, but (2) proper notice-and-comment rulemaking would have altered the standards used by the Secretary, and (3) under the new financial standards those suppliers would be found eligible. Similarly, the argument concerning harm to beneficiaries is that (1) under the current financial standards the Medicare beneficiary would obtain a rate and quality of care that (2) would be altered by new financial standards (whatever they might be) and (3) would lead to higher costs or lower-quality services. These highly attenuated scenarios are insufficient to confer Article I II standing. See Jacobrown v. United States, 764 F.Supp.2d 221, 227 (D.D.C.2011) (holding that standing does not exist “where the court ‘would have to accept a number of very speculative inferences and assumptions in any endeavor to connect the alleged injury with the challenged conduct’ ”) (quoting Winpisinger v. Watson, 628 F.2d 133, 139 (D.C.Cir.1980)). 2. Causation Turning to plaintiffs’ only remaining injury — the risk of rejection in the DME Bidding Process — “to establish a so-called procedural injury, the plaintiff must ... show that it is ‘substantially probable that the procedural breach will cause the essential injury to the plaintiffs own interest.’” Cty. of Del., 554 F.3d at 147 (quoting Fla. Audubon Soc’y v. Bentsen, 94 F.3d 658, 665 (D.C.Cir.1996) (en banc)). Under this standard, the procedural violation, assuming one exists, must be “fairly traceable” to the alleged injury. Ctr. for Law, 396 F.3d at 1161. Plaintiffs allege three types of procedural violations — that the Secretary failed to offer concrete financial standards for notice and comment, failed to publish those standards, and disregards those standards in implementing the DME Bidding Program. MTD Opp. at 18. The first two fail to establish causation, while the latter is unsupported by the administrative record. As to the alleged failures to publish and offer for notice and comment, plaintiffs cannot explain how the lack of specification of such standards could alter the result of the DME Bidding Process. Even assuming that the Secretary gave no notice of the proposed standards, the fundamental issue — whether plaintiffs could receive a contract — is not determined by the publication of those standards, but whether a supplier meets the underlying viability requirements. “In order to establish causation sufficient for standing, a plaintiff asserting procedural injuries must demonstrate that there is a ‘substantial probability that the substantive agency action that disregarded a procedural requirement created a demonstrable risk ... of injury to the particularized interests of the plaintiff.’ ” Cty. of Del., 554 F.3d at 148 (quoting Fla. Audubon Soc’y v. Bentsen, 94 F.3d 658, 669 (D.C.Cir.1996) (en banc)). Nothing about the publication of particular financial standards, however, is capable of altering a supplier’s actual financial condition. If a bidder will meet published standards, they would also meet those standards if they were unpublished, and thus no harm derives from the lack of publication. Similarly, if a bidder will not meet some unpublished standards, no publication of such standards will alter this result — unless that bidder was to manipulate its financial records (a possibility the Court obviously does not consider.) “A prospective plaintiff must demonstrate that the defendant caused the particularized injury, and not just the alleged procedural violation.” Ctr. for Law, 396 F.3d at 1159 (quotations omitted; emphasis in original). In Ctr. For Law, the Circuit Court dismissed for lack of standing where the plaintiffs speculated as to their increased risk, but “offered th[e] Court no actual demonstration of increased risk.” Id. at 1161. Plaintiffs do no better here, and therefore lack standing under applicable law. Finally, plaintiffs’ ultra vires allegation — that CMS is not adhering to any financial standards at a