Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-11-05265/USCOURTS-caDC-11-05265-0/pdf.json

Parties Involved:
Dallas Oxygen Corporation
Appellant
Kathleen Sebelius
Appellee
Marilyn Tavenner
Appellee
Texas Alliance For Home Care Services
Appellant

Document Text:

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued April 18, 2012 Decided June 1, 2012

No. 11-5265

TEXAS ALLIANCE FOR HOME CARE SERVICES AND DALLAS

OXYGEN CORPORATION,

APPELLANTS

v.

KATHLEEN SEBELIUS, IN HER OFFICIAL CAPACITY AS

SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND

HUMAN SERVICES, AND MARILYN TAVENNER, IN HER

OFFICIAL CAPACITY AS ACTING ADMINISTRATOR, CENTERS

FOR MEDICARE AND MEDICAID SERVICES,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 1:10-cv-00747)

William G. Kelly Jr. argued the cause for the appellants.

Brendan J. Klaproth was on brief. 

Sharon Swingle, Attorney, United States Department of

Justice, argued the cause for the appellees. Tony West, Assistant

Attorney General, Ronald C. Machen, Jr., United States

Attorney, and Michael S. Raab, Attorney, were on brief. R.

Craig Lawrence, Assistant United States Attorney, entered an

appearance.

USCA Case #11-5265 Document #1376533 Filed: 06/01/2012 Page 1 of 15
2

Before: HENDERSON, TATEL and KAVANAUGH, Circuit

Judges.

Opinion for the Court filed by Circuit Judge HENDERSON.

KAREN LECRAFT HENDERSON, Circuit Judge: The Texas

Alliance for Home Care Services, a trade association

representing suppliers of durable medical equipment,1

prosthetics, orthotics and supplies (DMEPOS), and the Dallas

Oxygen Corporation, an individual DMEPOS supplier,

(collectively, Suppliers) appeal the district court’s dismissal of

their action against the Secretary of the United States

Department of Health and Human Services (Secretary) and the

Administrator of the Centers for Medicare and Medicaid

Services (CMS).2

 The Suppliers challenge a regulation

addressing the “applicable financial standards” that a DMEPOS

supplier must meet to be eligible for a Medicare contract under

the competitive bidding process established in 42 U.S.C.

§ 1395w-3 (DMEPOS Statute). The district court dismissed the

complaint on three grounds: (1) it is precluded by subsection

(b)(11) of the DMEPOS Statute, 42 U.S.C. § 1395w-3(b)(11);

(2) the Suppliers lack constitutional standing and (3) the

regulation is authorized and otherwise valid. Texas Alliance for

Home Care Servs. v. Sebelius, 811 F. Supp. 2d 76 (D.D.C.

2011). Because we agree that subsection (b)(11) expressly

1

“The term ‘durable medical equipment’ includes iron lungs,

oxygen tents, hospital beds, and wheelchairs . . . and includes

blood-testing strips and blood glucose monitors for individuals with

diabetes.” 42 U.S.C. § 1395x(n).

2

CMS administers the Medicare program on behalf of the

Secretary. St. Luke’s Hosp. v. Sebelius, 611 F.3d 900, 901 (D.C. Cir.

2010).

USCA Case #11-5265 Document #1376533 Filed: 06/01/2012 Page 2 of 15
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precludes judicial review of the challenged regulation, we affirm

the district court’s dismissal on this ground.3

I.

In 1965, the Congress enacted the Medicare Act as Title

XVIII of the Social Security Act, 42 U.S.C. §§ 1395 et seq., to

establish a federally funded health insurance program for the

elderly and disabled. Thomas Jefferson Univ. v. Shalala, 512

U.S. 504, 506 (1994). The Medicare Act authorizes the

Secretary to issue regulations “defining reimbursable costs and

otherwise giving content to the broad outlines of the Medicare

statute.” Id. at 506-07 (citing 42 U.S.C. § 1395x(v)(1)(A)). 

Before 2003, Medicare reimbursed the cost of DMEPOS

pursuant to a fixed fee schedule for each class of covered items. 

In 1997, the Congress authorized the Secretary to conduct up to

five demonstration projects to test competitive bidding (in lieu

of the fixed schedules) to price and award contracts for

Medicare Part B services, including the provision of DMEPOS.4

Balanced Budget Act of 1997, Pub. L. No. 105-33, § 4319, 111

Stat. 251, 392 (codified at 42 U.S.C. § 1395w-3 (1998)). The

subsequent demonstration projects, conducted in Polk County,

Florida and San Antonio, Texas, proved successful; competitive

bidding significantly reduced DMEPOS costs, while

maintaining quality standards and beneficiary satisfaction. See

H.R. Rep. No. 108-178(II), at 192 (July 15, 2003). Accordingly,

in 2003, the Congress instituted a competitive bidding process

3

Accordingly, we do not reach the Suppliers’ standing vel non or

the regulation’s validity.

4

Medicare Part B covers “outpatient items and services, including

durable medical equipment and certain prescription medications.”

Hays v. Sebelius, 589 F.3d 1279, 1280 (D.C. Cir. 2009).

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for DMEPOS purchases by enacting the DMEPOS Statute as

part of the Medicare Prescription Drug, Improvement, and

Modernization Act, Pub. L. No. 108-173, title III, § 302(b)(1),

117 Stat. 2224 (2003) (codified in relevant part at 42 U.S.C.

§ 1395w-3, as amended). The DMEPOS Statute directed the

Secretary to “establish and implement programs under which

competitive acquisition areas are established throughout the

United States for contract award purposes for the furnishing . . .

of competitively priced items and services.” 42 U.S.C.

§ 1395w-3(a)(1)(A) (2004). The Secretary was to implement

the programs in three phases, beginning in 2007 with the 10

largest metropolitan areas in the United States. Id. § 1395w3(a)(1)(B)(i)(I).5

Under the DMEPOS Statute, no payment may be made for

a covered item unless the contractor submits a bid “to furnish an

item or service for a particular price and time period that

includes, where appropriate, any services that are attendant to

the furnishing of the item or service” and the Secretary awards

a contract to the supplier for such item or service. Id. § 1395w3(b)(6)(A)-(B). In addition, the Secretary “may not award a

contract to any entity under the competition conducted in a

competitive acquisition area . . . to furnish such items or services

unless the Secretary finds,” inter alia, that “[t]he entity meets

applicable financial standards specified by the Secretary, taking

into account the needs of small providers.” Id. § 1395w3(b)(2)(A)(ii).6

 The Secretary is further directed to form a

5

The second and third phases extended the program, respectively,

to 80 of the largest metropolitan statistical areas in 2009 and to

“additional areas” after 2009. 42 U.S.C. § 1395w-3(a)(1)(B)(i)(II)-

(III) (2004).

6

The Secretary must also find that (1) the entity “meets applicable

quality standards specified by the Secretary,” (2) total payments to

area contractors will decrease and (3) beneficiaries will retain access

USCA Case #11-5265 Document #1376533 Filed: 06/01/2012 Page 4 of 15
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“Program Advisory and Oversight Committee” (PAOC) to

“provide advice” on several enumerated functions, including the

“establishment of financial standards for purposes of subsection

(b)(2)(A)(ii).” Id. § 1395w-3(c)(A)(i)-(iii).

In August 2004, the Secretary published in the Federal

Register a notice of a public meeting of PAOC on October 6,

2004 “to consider issues related to competitive bidding for

DMEPOS items and to furnish advice to the Secretary regarding

these issues.” Medicare Program; Public Meeting of the

Program Advisory and Oversight Committee (PAOC) for

Quality Standards and Competitive Acquisition of Certain

[DMEPOS], 69 Fed. Reg. 52,723, 52,723 (Aug. 27, 2004). The

notice solicited written comments “addressing topics discussed

at the meeting” to be submitted no later than October 13, 2004.

Id. During the October 6, 2004 meeting and two subsequent

ones, CMS presented to the public and to PAOC material on

topics that included the “[f]inancial capabilities of bidding

suppliers” before publishing a proposed DMEPOS rule in May

2006. Medicare Program; Competitive Acquisition for Certain

[DMEPOS] and Other Issues, 71 Fed. Reg. 25,654, 25,658 (May

1, 2006). 

The proposed DMEPOS rule included the following

provision regarding financial standards:

(d) Financial standards. All suppliers must meet

the applicable financial standards specified in the

request for bids.

71 Fed. Reg. at 25,700 (emphasis added). The proposed rule’s

preamble elaborated:

[A]s part of the bid selection process, the [Request

for Bids] will identify the specific information we will

to multiple suppliers. Id. § 1395w-3(b)(2)(A)(i), (iii)-(iv).

USCA Case #11-5265 Document #1376533 Filed: 06/01/2012 Page 5 of 15
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require to evaluate suppliers, which may include: a

supplier’s bank reference that reports general financial

condition, credit history, insurance documentation,

business capacity and line of credit to successfully

fulfill the contract, net worth, and solvency. We

welcome comments on the financial standards, in

particular the most appropriate documents that will

support these standards.

We found that in the demonstration, general

financial condition, 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.

As we develop our methodology for financial

standards, we will further consider which individual

measures should be required so that we can obtain as

much information as possible while minimizing the

burden on bidding suppliers and the bid evaluation

process.

Id. at 25,675. In addition, the preamble announced that CMS

had created a website “specifically for the public to have access

to all PAOC presentations, minutes, and updates for the

Medicare DMEPOS Competitive Bidding Program.” Id. at

25,658. 

The Secretary published the final rule in April 2007.

Medicare Program; Competitive Acquisition for Certain

[DMEPOS] and Other Issues, 72 Fed. Reg. 17,992 (Apr. 10,

2007). Its financial standards provision stated:

(d) Financial standards. Each supplier must

submit along with its bid the applicable financial

documentation specified in the request for bids.

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Id. at 18,088 (42 C.F.R. § 414.414(d) (2008)). The final rule’s

preamble, responding to comments, clarified the proposed rule

in two respects. First, it explained that “in order to obtain a

sufficient amount of information about each supplier while

minimizing the burden on both bidding suppliers and the bid

evaluation process,” CMS intended to require for the initial

round of competition that suppliers submit only “certain

schedules from their tax returns, a copy of the 10K filing report

from the immediate 3 years . . . [,] certain specified financial

statement reports, such as cash flow statements, and a copy of

their current credit report.” Id. at 18,037. These documents, the

preamble explained, would enable CMS to “determine financial

ratios, such as a supplier’s debt-to-equity ratio, and credit

worthiness” and, from those determinations, “to assess a

supplier’s financial viability.” Id. Second, the preamble

explained that CMS planned to “review[] all financial

information in the aggregate and [] not [] bas[e its] decision on

one ratio but rather overall financial soundness.” Id. at 18,038.

On March 22, 2007, CMS posted on the DMEPOS website the

ten financial ratios it intended to use, along with a supplier’s

credit history, in evaluating the supplier’s financial health.7

After evaluating the bids, CMS awarded over 329 contracts to

implement the program beginning July 1, 2008.

Meanwhile, the Ways and Means Committee of the United

States House of Representatives convened a hearing on the

bidding process culminating in the Medicare Improvements for

7

Initially, the ten ratios were: (1) current ratio, (2) collection

period, (3) accounts payable to sales, (4) quick ratio, (5) current

liabilities to net worth, (6) return on sales, (7) sales to inventory, (8)

working capital, (9) quality of earnings and (10) operating cash flow

to sales. Tex. Alliance for Home Care Servs., 811 F. Supp. 2d at 83;

see CMS Announces Financial Measures for the [DMEPOS]

Competitive Bidding Program, June 1, 2007 (available at http://www.

medicarenhic.com/dme/articles/060107_comp_bid.pdf).

USCA Case #11-5265 Document #1376533 Filed: 06/01/2012 Page 7 of 15
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Patients and Providers Act of 2008, Pub. L. No. 110-275, 122

Stat. 2494 (2008) (MIPPA). MIPPA amended the DMEPOS

Statute, inter alia, to terminate all contracts awarded pursuant to

the 2007 bid and mandate they be rebid in 2009 (postponing the

second bidding round to 2011), thereby effectively reinstating

the previous Medicare fee schedule for DMEPOS. 42 U.S.C.

§ 1395w–3(a)(1)(D).

In January 2009, in order to implement MIPPA, the

Secretary published a new “interim final rule,” which amended

42 C.F.R. § 414.414(d) to read in relevant part:

(1) General rule. Each supplier must submit along

with its bid the applicable covered documents (as

defined in § 414.402) specified in the request for bids.

Medicare Program; Changes to the Competitive Acquisition of

Certain [DMEPOS] by Certain Provisions of [MIPPA], 74 Fed.

Reg. 2873, 2880 (Jan. 16, 2009). Section 414.402 defines

“covered documents” broadly as “a 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.” 42 C.F.R.

§ 414.402.

The Secretary opened the round 1 rebidding on October, 21,

2009 and closed it on December 21, 2009. The resulting

contracts, announced in November 2010, went into effect on

January 1, 2011.8 Unsuccessful bidders were so notified by

letter, with a chart attached indicating by check marks the

reasons for their rejection—financial ineligibility, high bid, lack

of accreditation or licensure, etc. See, e.g., Letter from

Competitive Bidding Implementation Contractor Palmetto GBA

8

CMS issued a final rule in November 2011 which did not change

or even address 42 C.F.R. § 414.414(d), the regulation the Suppliers

now challenge. 76 Fed. Reg. 70,228 (Nov. 10, 2011). 

USCA Case #11-5265 Document #1376533 Filed: 06/01/2012 Page 8 of 15
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to Bidder Dallas Oxygen Corp. (dated Nov. 3, 2010) (Dallas

Oxygen Corp. Rejection Letter). 

Meanwhile, the plaintiffs filed this action on May 10, 2010,

alleging that the Secretary’s evaluation of bidders’ financial

eligibility without first “specify[ing]” by regulation the

“applicable financial standards” (1) violated the notice and

comment requirement of the Administrative Procedure Act

(APA), 5 U.S.C. § 553(b)-(c); the separate Medicare notice and

comment requirement, 42 U.S.C. § 1395hh(b), and the APA’s

Federal Register publication requirement, 5 U.S.C.

§ 552(a)(1)(D); and (2) should be set aside under the APA as

ultra vires, arbitrary and capricious, an abuse of discretion and

otherwise not in accordance with law, 5 U.S.C. § 706(2).

The Secretary and CMS moved to dismiss the complaint on

three alternative grounds: (1) subsection (b)(11) of the

DMEPOS Statute precludes judicial review; (2) the Suppliers

lacked constitutional standing to initiate the action; and (3) the

complaint fails to state a claim. The district court granted the

motion to dismiss on all three grounds and the Suppliers timely

appealed. 

II.

We review the district court’s dismissal de novo. Kim v.

United States, 632 F.3d 713, 715 (D.C. Cir. 2011). The

Suppliers invoked the district court’s federal question

jurisdiction under 28 U.S.C. § 1331 and sought review under the

APA. The APA generally “establishes a cause of action for

those ‘suffering legal wrong because of agency action, or

adversely affected or aggrieved by agency action.’ ” Koretoff v.

Vilsack, 614 F.3d 532, 536 (D.C. Cir. 2010) (quoting 5 U.S.C.

§ 702). The APA does not apply, however, “to the extent that

. . . statutes preclude judicial review.” 5 U.S.C. § 701(a). The

district court concluded that subsection (b)(11) of the DMEPOS

Statute precludes judicial review of the Secretary’s regulation on

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financial standards and therefore deprived the district court of

jurisdiction. See Amgen, Inc. v. Smith, 357 F.3d 103 (D.C. Cir.

2004) (court lacks jurisdiction over complaint precluded by 42

U.S.C. § 1395l(t)(12)(A)). We agree. 

“In determining whether a statute precludes judicial review,

the court must heed the APA’s ‘basic presumption of judicial

review’ that ‘will not be cut off unless there is persuasive reason

to believe that such was the purpose of Congress.’ ” Banzhaf

v. Smith, 737 F.2d 1167, 1168-69 (D.C. Cir. 1984) (en banc)

(quoting Abbott Labs. v. Gardner, 387 U.S. 136, 140 (1967)).

“The presumption favoring judicial review of administrative

action,” however, “is just that—a presumption” and, “like all

presumptions used in interpreting statutes, may be overcome by

specific language or specific legislative history that is a reliable

indicator of congressional intent.” Block v. Cmty. Nutrition

Inst., 467 U.S. 340, 349 (1984). The presumption of

reviewability here is overcome by the specific and emphatic

statutory language prohibiting judicial review of the competitive

bidding procedure. 

Subsection (b)(11) of the DMEPOS Statute sweepingly

states:

There shall be no administrative or judicial review

under section 1395ff of this title, section 1395oo of this

title, 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); 

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(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) of this section; 

(F) the bidding structure and number of

contractors selected under this section; or 

(G) the implementation of the special

rule described in paragraph (10). 

42 U.S.C. § 1395w-3(b)(11). The mandate that there be “no

administrative or judicial review” under the two cited statutes

“or otherwise” unequivocally precludes review of the

Secretary’s actions addressing the seven aspects of the

competitive bidding program enumerated in subsections

(b)(11)(A)-(G) (emphases added). See Amgen, 357 F.3d at 111

(virtually identical preclusive language in 42 U.S.C.

§ 1395l(t)(12)(A) precluded review of Medicare payment

classification system adjustments); cf. Banzhaf, 737 F.2d at

1168-69 (statutory language “shall not be reviewable in any

court” effectively precluded review of Attorney General’s

decision not to investigate particular allegations or seek

appointment of independent counsel). This language, combined

with the broad range of subjects expressly immunized from

review, manifest the Congress’s intent to “proceed with these

initial administrative processes without risk of litigation

blocking the execution of the program.” Cardiosom, LLC v.

United States, 656 F.3d 1322, 1326 (Fed. Cir. 2011) (noting

“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”); see also

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Carolina Med. Sales, Inc. v. Leavitt, 559 F. Supp. 2d 69 (D.D.C.

2008) (“The scope of the other areas of preclusion indicate a

scheme to insulate the entire program from review, as does the

broad, general language used.”). Moreover, as we explain

below, two of the enumerated subject areas encompass the

Secretary’s specification of “applicable financial standards”

pursuant to subsection (b)(2)(A)(ii) so as to insulate the

Secretary’s challenged regulation from any judicial review. See

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, but it must determine whether the

challenged agency action is of the sort shielded from review.”) 

First, the financial standards regulation is unreviewable

under subsection (b)(11)(B), which states that there is to be “no

administrative or judicial review . . . of . . . the awarding of

contracts under [section 1395w-3].” As the district court

observed, the DMEPOS Statute itself “ties the development and

application of appropriate financial standards to the Secretary’s

decision to grant or deny a contract” because the financial

standards requirement “is found in the section entitled

‘Conditions for awarding contracts,’ ” 42 U.S.C. § 1395w-3(b).

Texas Alliance, 811 F. Supp. 2d at 88. Indeed, under the

DMEPOS Statute, financial standards are indispensable to “the

awarding of contracts” as such standards determine whether or

not a contract may be awarded to a bidder based on the financial

documents submitted with its bid. If a bidder is found

financially ineligible, its bid is rejected in a notice advising that

CMS “is unable to offer [the bidder] a contract.” Dallas Oxygen

Corp. Rejection Letter at 1. 

The Suppliers claim the statutory language was meant to

preclude only review of “individual contracts.” Appellants’ Br.

18. The statutory language, however, is not so narrow. By its

terms, subsection (b)(11)(B) applies not to the awarding of a

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single contract but to “the awarding of contracts” generally,

which, under the DMEPOS Statute, requires the formulation and

application of financial standards. Nor does it make sense that

the Congress would intend to preclude a bidder deemed

financially ineligible from challenging the disqualifying

financial standards and yet allow a non-bidder to seek review of

the same standards. In either case, permitting review would

delay the costs savings the Congress sought to realize through

DMEPOS competitive bidding. Moreover, the United States

Supreme Court has rejected just the sort of distinction the

Suppliers seek to draw.

In Shalala v. Illinois Council on Long Term Care, Inc., 529

U.S. 1 (2000), the Court considered the preclusive effect of a

statutory channeling scheme, which prohibits direct review of

Medicare claim determinations under 28 U.S.C. § 1331 and

requires instead that a challenge proceed initially through a

statutory “special Medicare review route, [] set forth in a

complex set of statutory provisions,” with judicial review

available only afterward under the Medicare Act. 529 U.S. at 7-

8; see 42 U.S.C. § 1395ii (incorporating 42 U.S.C. § 405(h)

(“The findings and decision of the Commissioner of Social

Security after a hearing shall be binding upon all individuals

who were parties to such hearing. . . . No action . . . shall be

brought under section 1331 . . . to recover on any claim arising

under [Medicare].”)). There, as here, a trade association

mounted a direct attack in the district court under 28 U.S.C.

§ 1331, challenging Medicare regulations governing “how to

impose remedies after inspectors find that a nursing home has

violated substantive standards.” 529 U.S. at 6. The Court

concluded that the section 1331 bar applies not only to review

of the denial of monetary benefits but also to review of “a

policy, regulation, or statute that might later bar recovery of that

benefit.” Id. at 10. The Court explained that it could not

“accept a distinction that limits the scope of [the statutory bar]

to claims for monetary benefits”: 

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Claims for money, claims for other benefits, claims of

program eligibility, and claims that contest a sanction

or remedy may all similarly rest upon individual

fact-related circumstances, may all similarly dispute

agency policy determinations, or may all similarly

involve the application, interpretation, or

constitutionality of interrelated regulations or statutory

provisions. There is no reason to distinguish among

them in terms of the language or in terms of the

purposes of [the bar].

Id. at 14. Likewise here, we do not distinguish between an upfront attack on the financial standards by suppliers not yet

injured by them and a challenge brought after-the-fact by a

frustrated bidder who has been found to be financially

ineligible.9

 Under Illinois Council, review is precluded in both

cases. 

The Secretary’s financial standard is also immune from

review under subsection (b)(11)(F)’s ban on any challenge to

“the bidding structure and number of contractors selected.” The

financial standards, as eligibility criteria, are integral to the

9

The Suppliers argue that Illinois Council in fact supports

reviewability because the Court there acknowledged that in Bowen v.

Michigan Academy of Family Physicians, 476 U.S. 667 (1986), the

Court concluded the channeling provision did not apply because the

result would be no review at all—the same result that will occur, they

claim, if section 1395w-3(b)(11)(B) is applied to preclude their

challenge here. See Appellants’ Br. 20-21. In Michigan Academy,

however, the Court found “persuasive evidence of legislative intent”

to foreclose review only of “amount determinations” and therefore

concluded the presumption of reviewability had not been

“surmounted.” 476 U.S. at 680-81. As explained supra, here the

presumption is surmounted—by the broad and unequivocally

preclusive language of section § 1395w-3(b)(11), which manifests the

Congress’s intent to foreclose all review of the listed subjects.

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bidding structure the Secretary has erected. The standards are

identified in each individual Request for Bids, which lists the

financial documentation to be submitted; the bidder submits the

financial documents to CMS along with its bid; and the bidder

learns if it fails the standards in the notice of rejection of the bid. 

Financial eligibility under the applicable standards, then, is

inextricably intertwined with the bidding structure and review

thereof is therefore expressly precluded by subsection (b)(11)(F). 

For the foregoing reasons, we conclude that subsection

(b)(11) of the DMEPOS Statute precludes judicial review of the

Secretary’s financial standards regulation and that the district

court therefore lacked subject matter jurisdiction. Accordingly,

we affirm the district court’s judgment of dismissal under

Federal Rule of Civil Procedure 12(b)(1).

So ordered.

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