                           UNITED STATES DISTRICT COURT
                           FOR THE DISTRICT OF COLUMBIA
                                                 )
AMERICAN ORTHOTIC &                              )
PROSTHETIC ASSOCIATION, INC.                     )
          Plaintiff,                             )
                                                 )
       v.                                        )   Civil No. 13-697 (RCL)
                                                 )
KATHLEEN SEBELIUS, Secretary of the              )
Department of Health and Human Services,         )
             Defendant.                          )
                                                 )

                                 MEMORANDUM OPINION

       Plaintiff—the American Orthotic & Prosthetic Association, Inc. (“AOPA”)—is an

association of individual suppliers of prosthetic devices to Medicare patients who have lost limbs

to disease or injury. Consistent with its mission to secure “favorable treatment of the orthotic

and prosthetic business in laws, regulations, and services,” Compl. ¶ 11, AOPA filed the present

action seeking declaratory, injunctive, and mandamus relief against Kathleen Sebelius, Secretary

of the Department of Health and Human Services (“HHS”), for violations of Title XVIII of the

Social Security Act, 42 U.S.C. §§ 1395–1395iii (“the Medicare Act”); the Administrative

Procedure Act, 5 U.S.C. §§ 701 et seq. (“APA”); the Medicare, Medicaid, and SCHIP Benefits

Improvement and Protection Act of 2000 (“BIPA”); and the Regulatory Flexibility Act, 5 U.S.C.

§§ 601 et seq. (“RFA”). Currently before the Court is the defendant’s Motion to Dismiss [7] the

Complaint for lack of subject matter jurisdiction and failure to state a claim upon which relief

can be granted. Upon consideration of the Motion [7], the plaintiff’s Opposition thereto [8], the

defendant’s Reply [9], and supplemental briefs submitted by both parties [14, 15, 16], the Court

GRANTS the defendant’s Motion to Dismiss.
       I.      BACKGROUND

       The Medicare Act provides that payment or reimbursement for prosthetic devices is

permitted only where it is “reasonable and necessary for the diagnosis or treatment of illness or

injury or to improve the functioning of a malformed body member.”             42 U.S.C. § 1395y

(a)(1)(A). To assist with the millions of payment claims received by HHS annually, the Act

authorizes the Secretary to delegate certain functions to contractors, including the development

of local coverage determinations (“LCDs”) as to whether particular medical products or services

are covered by Medicare. Hays v. Sebelius, 589 F.3d 1279, 1280 (D.C. Cir. 2009); see also 42

U.S.C. § 1395kk-1(a)(4); 42 U.S.C. § 1395ff(f)(2)(B). The Act also allows the Secretary, at her

discretion, to employ contractors to make initial decisions on whether medical services or

products are reasonable and necessary. 42 U.S.C. § 1395kk-1(a)(4).

       The Secretary has designated four contractors to perform these functions with respect to

claims for durable medical equipment, including prostheses. 42 C.F.R. § 421.210. These

contractors are known as Durable Medical Equipment Medicare Administrative Contractors

(“DME MACs”) and are responsible for four separate geographic regions. In making payment

and coverage determinations, including whether payment for prosthetic devices should be

authorized, the DME MACs are guided by statutes, regulations, and the Medicare Program

Integrity Manual (“MPIM” or “the Manual”). The Manual provides that, as a prerequisite to

Medicare coverage for durable medical equipment, “the patient’s medical record must contain

sufficient documentation of the patient’s medical condition,” including, but not limited to, the

“duration of the patient’s condition, clinical course (worsening or improvement), prognosis,

nature and extent of functional limitations, other therapeutic interventions and results, [and] past

experience with related items.” Def.’s Mot. to Dismiss., Ex. 2 (MPIM), at § 5.7. Moreover, the



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“patient’s medical record is not limited to the physician’s office records. It may include hospital,

nursing home, or [home health agency] records and records from other health care

professionals.” Id. Standing alone, “neither a physician’s order . . . nor a supplier prepared

statement . . . provides sufficient documentation of medical necessity.” Id. “There must be

information in the patient’s medical record that supports the medical necessity for the item.” Id.

Finally, the Manual makes clear that the burden is on the supplier to “obtain as much

documentation from the patient’s medical record as they determine they need to assure

themselves that coverage criteria for an item have been met.” Id. at § 5.8. This is key because,

with certain exceptions not relevant here, the supplier is liable for the cost of the prosthesis if a

claim is rejected because the information in the patient’s medical record does not adequately

support the medical necessity for the item. Id. The LCDs echo the Manual’s directives, stating

that the patient’s medical record must sufficiently document the medical necessity for a

prosthetic device and reflect the patient’s functional ability based on the reasonable expectation

of the prosthetist and treating physician. Def.’s Mot. to Dismiss., Ex. 5 (LCDs).

       In August 2011, the Office of the Inspector General for the Department of Health &

Human Services completed an investigation of questionable billing by suppliers of lower limb

prostheses. The study was prompted by the fact that between 2005 and 2009, Medicare spending

for prostheses increased by 27% while the number of Medicare beneficiaries receiving

prostheses decreased by 2.5%. Def.’s Mot. to Dismiss, Ex. 1 (Questionable Billing by Suppliers

of Lower Limb Prostheses, Aug. 2011), at i [hereinafter OIG Rep.]. The Inspector General

found that in 2009, Medicare inappropriately paid $43 million for prostheses that were not

reasonable and necessary and an additional $61 million for beneficiaries with no claims from




                                                 3
their treating physicians. Id. at ii. The investigation also revealed questionable billing practices

by at least 267 prosthesis suppliers. Id.

       In response to the report, and pursuant to their statutory authority to provide “education

and technical assistance” to medical providers and suppliers, 42 U.S.C. § 1395kk-1(a)(4)(F), the

DME MACs distributed a letter to physicians on August 11, 2011 (“Dear Physician Letter”). It

is this letter that forms the basis of AOPA’s Complaint.

       The Dear Physician Letter, posted on each of the DME MAC’s websites, stated that

               Since the prosthetist is a supplier, the prosthetist’s records must be
               corroborated by the information in your patient’s medical record. It
               is the treating physician’s records, not the prosthetist’s, which are
               used to justify payment.

Def.’s Mot. to Dismiss., Ex. 3 (Dear Physician Letter, Aug. 11, 2011), at 1 [hereinafter Dear

Physician Letter]. The letter also directed physicians to detail each patient’s rehabilitation

potential and other diagnostic information in order to provide a full record of each patient’s

physical condition. Id. And, in keeping with the Inspector General’s recommendations, the

DME MAC’s also increased scrutiny and auditing of claims for prostheses. Prior to the report

and the Dear Physician Letter, AOPA claims that almost 100% of such claims were approved.

Compl. ¶ 76. By contrast, one DME MAC reported an 86% denial rate in November 2011, with

96% of those denials attributed to inadequate physician documentation. Id.

       AOPA argues that the Dear Physician Letter “changed the standards for validating

Medicare claims for prosthetic devices” because “no longer would prosthetist notes be accepted

to determine the medical necessity of the prosthetic device.” Pl.’s Opp’n to Def.’s Mot. to

Dismiss, ECF No. 8, at 1 [hereinafter Pl.’s Opp’n]. And because the letter was issued outside of

the formal rulemaking process, AOPA charges that the Secretary has violated the Medicare Act

and a host of other statutes.


                                                 4
       The Secretary moves to dismiss the Complaint under Federal Rules of Civil Procedure

12(b)(1), because this Court lacks subject matter jurisdiction, and 12(b)(6) because AOPA has

failed to state a claim for which relief can be granted. For the reasons stated herein, the Court

holds that AOPA has failed to establish that this Court has jurisdiction over its claims and

therefore finds it unnecessary to reach the Secretary’s 12(b)(6) motion.

       II.     LEGAL PRINCIPLES

       “Federal courts are courts of limited jurisdiction. They possess only that power

authorized by Constitution and statute, which is not to be expanded by judicial decree. It is to be

presumed that a cause lies outside this limited jurisdiction, and the burden of establishing the

contrary rests upon the party asserting jurisdiction.” Kokkonen v. Guardian Life Ins. Co. of Am.,

511 U.S. 375, 377 (1994) (internal citations omitted). A Rule 12(b)(1) motion tests whether this

burden has been met and “imposes on the court an affirmative obligation to ensure that it is

acting within the scope of its jurisdictional authority.” Grand Lodge of Fraternal Order of

Police v. Ashcroft, 185 F. Supp. 2d 9, 13–14 (D.D.C. 2001). As such, “the plaintiff’s 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.” Id. (internal alterations and citations

omitted). In undertaking this scrutiny, “the court need not limit itself to the allegations of the

complaint” and “may consider such materials outside the pleadings as it deems appropriate to

resolve the question whether it has jurisdiction in the case.” Id.

       III.    ANALYSIS

       The Secretary advances two arguments in support of her 12(b)(1) motion: (1) that the

plaintiff’s claims are not redressible by judicial action, and thus, the plaintiff lacks standing

under Article III of the Constitution; and (2) that the plaintiff has failed to properly present its



                                                  5
claims and exhaust administrative remedies as required by the Medicare Act. The Court will

address each of these arguments in turn.

               A. Redressability

       Article III, § 2, of the Constitution limits federal court jurisdiction to cases and

controversies. Raines v. Byrd, 521 U.S. 811, 818 (1997). Demonstrating the existence of a case

or controversy, or standing, requires that the plaintiff establish (1) an “injury in fact” that is (2)

“fairly traceable to the challenged action of the defendant” and is (3) likely to be “redressed by a

favorable decision.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560–61 (1992) (internal

quotations and citations omitted). The third element, redressability, requires an examination of

“whether the relief sought, assuming that the court chooses to grant it, will likely alleviate the

particularized injury alleged.” Cnty. of Delaware, Pa. v. Dep’t of Transp., 554 F.3d 143, 149

(D.C. Cir. 2009). Here, Counts I through IV of the plaintiff’s complaint allege that AOPA

members have suffered increased audits and denials of prostheses claims as a result of the Dear

Physician Letter. The question whether AOPA’s injury is redressible therefore turns upon

whether invalidation of the letter would alleviate the audits and claim denials.

       The Secretary argues that because the guidance provided in the Dear Physician Letter

merely restates standards previously set forth in the MPIM and LCDs, nullifying the letter would

have no effect on the processing of prostheses claims. AOPA makes three arguments in support

of the opposite position—that the letter drastically changed the standards for evaluated

prostheses claims.

       First, AOPA argues that “prior to August 2011 nothing in the MPIM, LCDs, or Supplier

Manuals called for corroboration of the prosthetist’s records beyond the physician’s signature on

the prescription and work order for the prosthesis.” Pl.’s Opp’n at 10. Not so. The importance



                                                  6
of the treating physician’s records is clear from the MPIM, which requires a full and complete

medical record of the patient’s diagnosis, clinical course, prognosis, and other therapeutic

interventions. MPIM § 5.7. The creation of such records requires the judgment and expertise of

physicians—not simply suppliers. AOPA draws much of the fuel for its argument from the

manual’s apparent effort to encourage a holistic evaluation of each patient by not limiting the

record to the treating physician’s records. See id. (“The patient’s medical record is not limited to

the physician’s office records. It may include hospital, nursing home, or HHA records and

records from other health care professionals.”). The creation of an inclusive medical record does

not, however, diminish the importance of the treating physician’s input and certainly does not

reduce the physician’s role to a mere signatory or rubber stamp. As further evidence that the

MPIM required more extensive records from the physician—over and above what the physician

shared with the supplier—the manual notes that the “documentation in the patient’s medical

record does not have to be routinely sent to the supplier . . . . However, the DME MACs . . . may

request this information in selected cases.” Id. This defeats AOPA’s argument that prior to the

Dear Physician Letter, prosthetist records alone were sufficient to prove medical necessity. Even

before the Dear Physician Letter—and indeed even if the letter did not exist—the Secretary

reserved the right to demand more medical documentation from the physician.

       Next, AOPA points to language in the LCDs and MPIM that addresses the prosthetist’s

duty to obtain and retain records supporting the medical necessity of prostheses. See, e.g., LCDs

at 5 (“Coverage is extended only if there is sufficient clinical documentation of functional need

for the technologic or design feature of a given type of [prosthesis]. This information must be

retained in the physician’s or prosthetist’s files.”) (emphasis added). In AOPA’s view, this

language means that the LCDs treat the “prosthetist as interchangeable with the physician and



                                                 7
the prosthetist records as equivalent to the physician’s.” Pl.’s Opp’n at 11. Again, this is not so.

The MPIM undoubtedly requires both physicians and prosthetists to keep adequate records. But

it does not follow that those records are interchangeable or that the physician’s records are

wholly irrelevant. Moreover, the MPIM explicitly places the onus on the supplier to maintain

appropriate records from the treating physician and directs the supplier to “obtain as much

documentation from the patient’s medical record as they determine they need to assure

themselves that the coverage criteria for an item have been met.” MPIM § 5.8. This makes

sense given that it is the supplier who submits the Medicare claim and, in the event of an audit or

denial of a claim, it is the supplier that is liable for the cost of the prosthesis. Id. at § 5.7. Thus,

the language pinpointed by AOPA does not mean that, prior to the Dear Physician Letter,

prosthetists were interchangeable with physicians; rather, it means that the suppliers bore the

greatest responsibility of—and had the greatest financial interest in—retaining adequate records.

See id. at § 5.8 (directing the suppliers to retain medical records for seven years).

        Third, AOPA points to the LCDs’ statement that “a determination of the type of

[foot/knee] for the prosthesis will be made by the treating physician and/or the prosthetist based

on the functional needs of the patient.” LCDs at 5; see also id. (“There must be information

about the patient’s history and current condition which supports the designation of the functional

level by the prosthetist.”). This statement simply recognizes that the prosthetist is an appropriate

expert to determine the type of prosthesis that is best for a patient. It does not amount to a

pronouncement that the prosthetist alone can determine the medical necessity of a prosthesis in

the first instance.

        The insufficiency of prosthetist records to establish medical necessity is apparent from

the LCDs and MPIM as they existed prior to the Dear Physician Letter. In January 2013,



                                                   8
however, the LCDs were revised to make this even more explicit. Because standing is “assessed

as of the time a suit commences,” Del Monte Fresh Produce Co. v. United States, 570 F.3d 316,

324 (D.C. Cir. 2009), the Court may consider the revised LCDs—which were produced before

the Complaint was filed in May 2013—in its determination. The revised LCDs state that

“[r]ecords from suppliers or healthcare professionals with a financial interest in the claim

outcome are not considered sufficient by themselves for the purpose of determining that an item

is reasonable and necessary.” Def.’s Supp. Br. in Supp. of Mot. to Dismiss, Ex. 1 (Revised

LCDs), at 7.

       It is therefore clear that, even in the absence of the Dear Physician Letter, claims

submitted without adequate physician records or solely on the basis of a supplier

recommendation would be properly subject to denial or audit. The agency admits that it has

“focused more resources on claims for prosthetic devices . . . to more effectively tamp down

waste, fraud, and abuse.” Def.’s Mot. at 21. A decision to increase enforcement of existing

standards is entirely within the agency’s discretion—see, e.g., Heckler v. Chaney, 470 U.S. 821,

831 (1985)—and HHS would be free to exercise this discretion with or without the Dear

Physician Letter. Accordingly, the Court holds that the violations alleged in Counts I through IV

of the Complaint are incapable of redress by a favorable judicial decision and are therefore

dismissed.     Even if plaintiff’s claims were redressible, the Court alternatively finds that

jurisdiction is lacking because the plaintiff failed to satisfy the Medicare Act’s prerequisites to

judicial review.

                B. Presentment & Exhaustion

       The Medicare Act places strict limits on the jurisdiction of federal courts to decide “any

claims arising under” the Act. 42 U.S.C. § 405(h). A claim arises under the Medicare Act where



                                                9
the provisions of the Act provide “both the standing and the substantive basis” for the complaint.

Weinberger v. Salfi, 422 U.S. 749, 761 (1975). And, significantly for the present case, the

jurisdiction-limiting provisions of the Medicare Act apply even where the plaintiff raises

Medicare-based claims under other statutes. Heckler v. Ringer, 466 U.S. 602, 620–22 (1984)

(federal question jurisdiction and the APA are not alternative jurisdictional bases for judicial

review of claims arising under the Medicare Act); Action Alliance of Senior Citizens v. Leavitt,

483 F.3d 852, 858 (D.C. Cir. 2007) (“[T]he existence of an administrative remedy under [the

Medicare Act] precludes the exercise of mandamus, which is available only if no other adequate

remedy [is] available to plaintiff.”). As all of AOPA’s claims are substantively based in the

Medicare Act, satisfaction of the Act’s conditions regarding judicial review is required.

         There are two prerequisites to federal jurisdiction over claims arising under the Medicare

Act. First, the plaintiff must meet the “nonwaivable requirement that a claim for benefits shall

have been presented to the Secretary.” Heckler, 466 U.S. at 617. The second requirement, that

the plaintiff exhaust all remedies available under the Act, may be waived by the Secretary, or by

the Court “in certain special cases.”             Id. at 618.      AOPA argues that it has met the first

requirement and urges the Court to waive the second.

         As to presentment, AOPA argues that it satisfied this requirement by submitting general

complaints regarding the Dear Physician Letter. 1 Compl. ¶¶ 74–78. In support of its contention

that such generalized complaints are sufficient to satisfy the presentment requirement, AOPA

cites Action Alliance of Senior Citizens v. Johnson, 607 F. Supp. 2d 33, 40 (D.D.C. 2009).



1
  In its Complaint, AOPA also avers that individual AOPA members have challenged the denial of claims before the
agency, Compl. § 81; however, the Complaint does not reveal whether those appeals presented the same questions
presented here. And, in response to the presentment arguments raised by the Secretary’s motion, AOPA did not
argue that these individual appeals satisfied the presentment requirement. In any event, because the Court also finds
that AOPA has not exhausted all administrative remedies, dismissal for lack of subject matter jurisdiction is
appropriate even if the individual appeals constitute proper presentment.

                                                         10
There, the district court, without explanation, declared that an association’s letters to the agency

established presentment. Id. In affirming the district court’s decision, the Circuit summarily

noted that a prior jurisdictional defect had been cured but offered no opinion on whether and why

generalized letters were sufficient. Action Alliance of Senior Citizens v. Sebelius, 607 F.3d 860,

862 n.1 (D.C. Cir. 2010). The lack of explanation in both cases is likely because the precise

question presented here—whether generalized grievance letters rather than discrete claims are

sufficient to satisfy presentment—was not raised by the parties in Action Alliance, and the Court

therefore questions the precedential value of those opinions. See, e.g., Arizona Christian Sch.

Tuition Org. v. Winn, 131 S. Ct. 1436, 1448 (2011) (“When a potential jurisdictional defect is

neither noted nor discussed in a federal decision, the decision does not stand for the proposition

that no defect existed.”). However, even if the Circuit’s opinion in Action Alliance were binding

on this Court, it is easily distinguishable from the case-at-hand because, unlike AOPA’s letters,

the letters relied upon by Action Alliance presented HHS with factually detailed letters regarding

discrete claims on behalf of individuals. In this way, the Action Alliance letters were closer to

the “concrete claim for reimbursement” that the Supreme Court has held is required for proper

presentment. Heckler, 466 U.S. at 622; see also id. at 625 (“Congress . . . has . . . expressly set

up a scheme that requires the presentation of a concrete claim to the Secretary.”). Because they

were not tied to any concrete claims, AOPA’s self-described “detailed critiques of the ‘Dear

Physician’ letter,” Pl.’s Opp’n at 18, are insufficient to establish presentment.

       AOPA has likewise failed to establish exhaustion. Exhaustion is a common principle of

administrative law that requires channeling of legal challenges through the agency before

seeking recourse with the federal courts. In ordinary challenges to agency action, the exhaustion

requirement “may be waived only in the most exceptional circumstances.”               UDC Chairs



                                                 11
Chapter, Am. Ass’n of Univ. Professors v. Bd. of Trustees of Univ. of D.C., 56 F.3d 1469, 1475

(D.C. Cir. 1995). Courts have often waived exhaustion upon a finding that agency review would

be futile; however, such a finding requires certainty—not simply probability—that the claim will

be denied by the agency. Id. And, in cases arising under the Medicare Act, the requirement for

“exceptional cases” and certainty are even more stringent because “the bar of § 405(h) reaches

beyond ordinary administrative law principles [such as] exhaustion of administrative remedies”

and “demands the channeling of virtually all legal attacks through the agency.” Shalala v.

Illinois Council on Long Term Care, Inc., 529 U.S. 1, 13 (2000); see also Tataranowicz v.

Sullivan, 959 F.2d 268, 274 (D.C. Cir. 1992) (noting that the Act’s requirement of a final

decision is “more than simply a codification of the judicially developed doctrine of exhaustion,

and may not be dispensed with merely by a judicial conclusion of futility.”). This is consistent

with Congress’s intent to assure “the agency greater opportunity to apply, interpret, or revise

policies, regulations, or statutes without possibly premature interference by different individual

courts applying ripeness and exhaustion exceptions case by case.” Id.

        Against this background, AOPA has presented this Court with a complaint that fails to

cite even a single supplier out of its 816 members that has exhausted all of the administrative

remedies available through the agency. 2 AOPA asks the Court to waive the exhaustion

requirement because any administrative appeal would be “unquestionably futile.” Pl.’s Opp’n at

23. This claim of futility is belied by the facts detailed in the Complaint, which states that

“AOPA members have challenged the denial of claims for artificial limbs in administrative

appeals [and] have won a significant percentage of those appeals.” Compl. ¶ 81. Proving futility


2
  AOPA attached an affidavit from Sara Beck, an employee of a prosthetic supplier represented by AOPA, to its
response to defendant’s supplemental brief. Ms. Beck avers that she has appealed claim denials through the ALJ
stage but has yet to present her issues to the Medicare Appeals Council, which is the final decision maker for claims
arising under the Medicare Act. 42 U.S.C. § 405.904(a)(2).

                                                         12
requires demonstration that defeat is certain, which the plaintiff cannot demonstrate if its

members are succeeding in appeals before the agency. In addition, this fact is sufficient to

distinguish this case from the futility case relied upon by AOPA, Tataranowicz v. Sullivan, 959

F.2d 268 (1992). In Tataranowicz, the Circuit waived exhaustion in a case arising under the

Medicare Act where there was “no reason to believe that the agency machinery might accede to

the plaintiff’s claims.” Id. at 274. And Tataranowicz relied heavily upon the Supreme Court’s

waiver of exhaustion in Mathews v. Diaz, 426 U.S. 67 (1976) after the Secretary averred to the

Court that the petitioner’s claim would certainly be denied based upon the challenged statutory

provision, which the Court held was “tantamount to . . . a waiver of the exhaustion

requirements,” id. at 76–77. None of this can be said about the present case. The Secretary has

neither promised the denial of AOPA members’ claims nor waived the exhaustion requirements;

rather, she has pressed her statutory right to resolve these issues in the context of discrete claims

that proceed through the proper administrative channels. And given the significant success of

AOPA’s members’ appeals, there is, unlike in Tataranowicz, reason to believe that the “agency

machinery might accede to the plaintiff’s claims.” 959 F.2d at 274. In addition to its reliance on

Tataranowicz, AOPA points to its “limited” administrative options, Pl.’s Opp’n at 21, and the

hardship suffered by prostheses suppliers while awaiting a final decision from the agency, id. at

15. To the first point, the Act permits several layers of administrative review for suppliers,

including redetermination, 42 C.F.R. § 405.940; reconsideration by a qualified independent

contractor, 42 C.F.R. § 405.904(a)(2); a hearing before an administrative law judge, 42 C.F.R. §

405.1000(a); and final review by the Medicare Appeals Council, 42 U.S.C. § 405.904(a)(2). The

Court therefore disagrees with AOPA’s characterization of suppliers’ appeal options as

“limited.” And further, even if AOPA’s characterization were apt, there is no exception to



                                                 13
exhaustion due to limited options—even limited options, however imperfect, must be exhausted

before a federal court can interfere with the Secretary’s right to apply, interpret, and/or revise

agency regulations and policies in the context of concrete factual claims. AOPA’s second point

was addressed in Illinois Council, where the Supreme Court held that “delay-related hardship”

was the price to be paid for the agency review required by Congress. 529 U.S. at 13.

       The Court therefore holds that the plaintiff has failed to demonstrate that it has fully

exhausted administrative remedies. The Complaint is dismissed in its entirety.

       A separate Order consistent with this Memorandum Opinion shall issue this date.

       Signed by Royce C. Lamberth, United States District Judge, on August 4, 2014.




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