Fresenius Kabi USA, LLC v. United States of America

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

FRESENIUS KABI USA, LLC,

Plaintiff,

v. Civil Action No. 25-375 (TJK)

UNITED STATES OF AMERICA, et al.,

Defendants.

MEMORANDUM OPINION

Fresenius Kabi USA, LLC is a manufacturer of injectable drug products that participates

in the Medicaid Drug Rebate Program administered by the Centers for Medicare and Medicaid

Services, or CMS. Through that program, it pays rebates to states based on a drug’s classification

and, in exchange, that drug is eligible for Medicaid coverage. In general, manufacturers pay higher

rebates for “innovator” drugs than for “noninnovator”—or generic—drugs. In 2021, Fresenius

Kabi petitioned CMS to reclassify several of its drugs as noninnovators, so it would pay lower

rebates. In September 2024, CMS denied the request, but informed Fresenius Kabi that it could

respond within a month to supplement or clarify its position, but if it did not, the decision would

be final. Fresenius Kabi timely responded, then followed up by suing CMS, the Department of

Health and Human Services, and relevant officials, alleging that the decision was arbitrary, capri-

cious, and contrary to law under the Administrative Procedure Act. Defendants move to dismiss

under Federal Rule of Civil Procedure 12(b)(6), asserting that CMS’s decision was not final agency

action, so Fresenius Kabi lacks a cause of action. The Court agrees, so it will grant the motion and

dismiss the case.

I. Background

A. Statutory and Regulatory Framework

“Medicaid is a cooperative federal-state program that provides federal funding for state

medical services to the poor.” Frew ex rel. Frew v. Hawkins, 540 U.S. 431, 433 (2004). Congress

created the Medicaid Drug Rebate Program “to offset Medicaid costs incurred by the federal gov-

ernment and the states for outpatient drugs provided to Medicaid recipients.” Council on Radio-

nuclides & Radiopharmaceuticals, Inc. v. Azar, 18-cv-633 (RBW), 2019 WL 5960142, at *2

(D.D.C. Nov. 13, 2019). For a drug to be eligible for Medicaid reimbursement, the manufacturer

must enter into a rebate agreement with the Department of Health and Human Services to pay

rebates to states. 42 U.S.C. §§ 1396r-8(a)(1), (c)(1)(A), (c)(3)(A). The rebate rate for a drug

depends on its classification as either: (1) “single source” (2) “innovator multiple source” or (3)

“noninnovator multiple source”—a generic drug. See id. §§ 1396r-8(c)(1), (3); id. § 1396r-

8(k)(7)(A). Rebate rates for noninnovator drugs are lower than those for single source and inno-

vator drugs. See id. § 1396r-8(c). In 2016, CMS established a “narrow exception” process through

which, under certain circumstances, drug manufacturers could apply to have an innovator drug

treated as a noninnovator for purposes of calculating rebate liability. See ECF No. 1 ¶ 69; see also

42 C.F.R. § 447.502. The process was intended “to ensure that drugs that are or were required to

be marketed under an original new drug application for technical reasons would not be erroneously

classified as innovators.” ECF No. 1 ¶ 69 (citation omitted).

B. Procedural Background

Fresenius Kabi is a global health care company and drug manufacturer. ECF No. 1 ¶ 9.

One of the drugs it manufactures is heparin, a common anticoagulant. Id. ¶¶ 1–2, 75. Fresenius

Kabi’s heparin products come in many forms, including vials, prefilled syringes, and—relevant

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here—pre-mixed intravenous bags. Id. ¶ 2. In June 2021, Fresenius Kabi requested a narrow

exception for several heparin products—including four types of premixed heparin bags and one

type of prefilled heparin syringe. Id. ¶ 96. Between February and March 2024, CMS granted

narrow exceptions for some of these products, including heparin vials and prefilled syringes. Id.

¶¶ 100–101.

On September 30, 2024, though, CMS sent Fresenius Kabi a letter denying the company’s

request for a narrow exception for four of its heparin bag products. See generally ECF No. 1-8.

The letter informed Fresenius Kabi that CMS had “decline[d] to . . . grant a narrow exception and

den[ied] [its] request to report the drugs . . . as noninnovator multiple source . . . drugs.” Id. at 2.

CMS further advised Fresenius Kabi that “[i]f [it] ha[d] any questions or concerns” about the letter,

it should “respond within 30 days . . . with any supplements to or clarifications of [its] positions in

[its] request” and to “include detailed supporting documentation if available.” Id. at 5. Moreover,

the letter provided that “[i]f [CMS] does not receive any written response by 30 days, then the

decision in this letter is final.” Id.

On October 29, 2024, Fresenius Kabi responded with its own letter, challenging CMS’s

decision as both outside its legal authority and in violation of “CMS guidance and precedent.”

ECF No. 19-5 at 3. The letter also advised that, unless the agency rescinded the decision by De-

cember 2, 2024, Fresenius Kabi intended “to amend its complaint in . . . pending litigation . . . to

establish that all of the heparin products marketed by Fresenius Kabi are . . . noninnovator drugs

. . . entitled to narrow exceptions.” Id. (emphasis in original).1 Fresenius Kabi included with its

1

In March 2024, Fresenius Kabi filed a separate lawsuit seeking to clarify the effective

date of narrow exceptions granted for drugs not at issue here. See Fresenius Kabi USA, LLC v.

United States, 24-cv-676 (TJK) (D.D.C. Oct. 11, 2024) (“Fresenius Kabi I”).

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letter a 30-page white paper “setting forth more fully [its] intended legal challenge.” See id. at 5.2

CMS has not yet responded. See ECF No. 25 at 11.

Rather than amend its pending complaint, however, Fresenius Kabi filed this lawsuit on

February 7, 2025, against the United States, the Department of Health and Human Services, the

Centers for Medicare and Medicaid Services, and officials in charge of these agencies. It alleges

that CMS’s decision declining to classify the four heparin bag products as noninnovators was ar-

bitrary, capricious, and contrary to law under the Administrative Procedure Act (“APA”). See

ECF No. 1 at 31–37. Defendants move to dismiss, arguing that CMS’s decision was not final

agency action reviewable under the APA, so Fresenius Kabi lacks a cause of action. ECF No. 19.3

II. Legal Standard

To survive a motion under Rule 12(b)(6), a plaintiff must have pleaded “enough facts to

state a claim to relief that is plausible on its face and to nudge [its] claims across the line from

conceivable to plausible.” Abbas v. Foreign Pol’y Grp., 783 F.3d 1328, 1338 (D.C. Cir. 2015)

(internal quotations omitted). To meet this standard, a plaintiff must plead “factual content that

allows the court to draw the reasonable inference that the defendant[s] [are] liable for the

2

The Court may consider Fresenius Kabi’s response letter and white paper, attached as an

exhibit to Defendants’ motion to dismiss, see ECF No. 19-5, as documents “referred to in the

complaint,” Langeman v. Garland, 88 F.4th 289, 292 (D.C. Cir. 2023) (internal quotations omit-

ted); see also ECF No. 1 ¶ 21 (“Fresenius Kabi subsequently asked CMS on October 29, 2024 to

rescind its decision in the hope of avoiding litigation.”).

3

Defendants also move for relief from Local Rule 7(n). ECF No. 20. That rule generally

requires an agency to “file a certified list of the contents of the administrative record with the Court

within 30 days following service of the answer to the complaint or simultaneously with the filing

of a dispositive motion, whichever occurs first.” LCvR 7(n)(1). Because the Court concludes,

based on the pleadings and documents incorporated by reference, that the decision is not final

agency action, consideration of the entire administrative record is unnecessary. See Connecticut

v. Dep’t of Interior, 344 F. Supp. 3d 279, 294 (D.D.C. 2018). Thus, the Court will grant Defend-

ants’ motion to waive compliance with Local Rule 7(n).

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misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). “Threadbare recitals of the

elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. When

evaluating such a motion, a court must “treat the complaint’s factual allegations as true and must

grant the plaintiff the benefit of all reasonable inferences from the facts alleged.” Trudeau v. FTC,

456 F.3d 178, 193 (D.C. Cir. 2006) (cleaned up).

III. Analysis

Defendants argue that CMS’s decision was not final agency action reviewable under the

APA, and so Fresenius Kabi lacks a cause of action. They are right that “where there is no final

agency action, a plaintiff has no cause of action under the APA.” Aracely v. Nielsen, 319 F. Supp.

3d 110, 138 (D.D.C. 2018). “Thus, although the absence of final agency action would not cost

[the Court its] jurisdiction,” it would cost Fresenius Kabi its “APA cause of action.” Trudeau, 456

F.3d at 188–89; see Oryszak v. Sullivan, 576 F.3d 522, 525 n.2 (D.C. Cir. 2009). As explained

below, the Court agrees that CMS’s decision was not final agency action under the APA.

The finality inquiry is governed by the two-prong test set forth in Bennett v. Spear, which

states that to be final, agency action must (1) “mark the consummation of the agency’s deci-

sionmaking process” and (2) be an action “by which rights or obligations have been determined,

or from which legal consequences will flow.” 520 U.S. 154, 177–78 (1997) (internal citations and

quotation marks omitted). The Supreme Court has instructed lower courts to “apply the finality

requirement in a ‘flexible’ and ‘pragmatic’ way.” Ciba-Geigy Corp. v. EPA, 801 F.2d 430, 435

(D.C. Cir. 1986) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 149–50 (1967)). The CMS

decision outlined in its September 30, 2024 letter to Fresenius Kabi fails Bennett’s first prong—it

does not mark the consummation of the agency’s decisionmaking process—for two reasons: it

premised finality on a future, contingent event that did not occur and it permitted Fresenius Kabi

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to submit additional material in support of its position, thereby triggering further agency consid-

eration that may obviate the need for judicial review. Thus, the Court need not consider Bennett’s

second prong to conclude that CMS’s decision was not final agency action.

First, the CMS decision was not final because it premised finality on a future, contingent

event—Fresenius Kabi’s nonresponse—that did not occur. “To mark the consummation of the

agency’s decision making, the action must mark a definitive position, rather than being merely

tentative or interlocutory.” Or. Health & Sci. Univ. v. Engels, 24-cv-2184 (RC), 2025 WL

1707630, at *5 (D.D.C. June 17, 2025), appeal dismissed sub nom. Mainegeneral Med. Ctr. v.

Engels, No. 25-5297, 2025 WL 2982893 (D.C. Cir. Oct. 21, 2025) (citation modified). When

considering the first Bennett prong, the D.C. Circuit has looked to the relevant language of the

challenged agency decision. See Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940,

944 (D.C. Cir. 2012). The Court turns to that language.

The letter states, under the heading “Decision,” that the agency “declines to exercise [its]

discretion to grant a narrow exception and den[ies] [Fresenius Kabi’s] request to report the drugs

. . . as noninnovator[s].” ECF No. 25 at 13 (quoting ECF No. 1-8 at 2) (emphasis as quoted). In

Fresenius Kabi’s view, this definitive language—which is “neither preliminary nor tentative”—

shows the decision’s finality. ECF No. 25 at 13. But in assessing finality, the Court must consider

the agency “document as a whole.” ForUsAll, Inc. v. Dep’t of Lab., 691 F. Supp. 3d 14, 31 (D.D.C.

2023). And that includes the later paragraph advising Fresenius Kabi that, if it did not respond

“with any supplements to or clarification of [its] positions” and “supporting documentation” within

30 days, “then the decision in this letter is final.” ECF No. 1-8 at 5 (emphasis added).

For their part, Defendants argue that the letter “states on its face” that the decision “would

only become final if CMS did not receive a timely response,” and, because Fresenius Kabi did

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timely respond, it is “clearcut” that the decision did not mark the consummation of the agency’s

decisionmaking process. ECF No. 19-1 at 12, 14. Fresenius Kabi disagrees, noting that “[t]he

word ‘only’ does not appear” in the decision. ECF No. 25 at 18. Thus, Fresenius Kabi argues,

“the language simply cautions that if [it] did not request reconsideration within 30 days, it might

miss the opportunity to do so.” Id. Defendants have the better argument.

The CMS letter’s use of “then” indicates that its finality was contingent on Fresenius

Kabi’s failure to respond within 30 days. See Then, Merriam Webster’s Dictionary (“[A]s a nec-

essary consequence.”), https://perma.cc/MAG2-ZKXF. Agency “statements and conclusions” that

are “tentative, open to further consideration, or conditional on future agency action” do not mark

the consummation of the agency’s decisionmaking process. City of Dania Beach, Fla. v. FAA,

485 F.3d 1181, 1188 (D.C. Cir. 2007). As here, finality can also depend on an action or event

outside the agency’s control. See Vill. of Bensenville v. FAA, 457 F.3d 52, 69 (D.C. Cir. 2006)

(holding that an FAA letter was not “final” because it was “contingent,” in part, “on congressional

appropriation” and a municipality’s filing of a grant application). And there is no dispute that the

contingent event that would have triggered finality—Fresenius Kabi’s nonresponse—did not hap-

pen. See ECF No. 1¶ 21. Rather, Fresenius Kabi responded to the letter within 30 days. So, “by

its own terms,” the letter “does not constitute the consummation of [CMS’s] decisionmaking pro-

cess.” Soundboard Ass’n v. FTC, 888 F.3d 1261, 1263 (D.C. Cir. 2018).

Fresenius Kabi dismisses this language as mere administrative “boilerplate,” which, it ar-

gues, cannot render CMS’s decision nonfinal for purposes of judicial review. ECF No. 25 at 15.

Not so. True, the “mere possibility that an agency might reconsider in light of ‘informal discus-

sion’ and invited contentions of inaccuracy does not suffice to make an otherwise final agency

action nonfinal.” Sackett v. EPA, 566 U.S. 120, 127 (2012) (emphasis added). But that argument

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puts the cart before the horse by assuming that CMS’s decision was final agency action in the first

place. As Defendants point out, the cases cited by Fresenius Kabi to support this argument involve

otherwise final agency action. See ECF No. 27 at 10–12.

Start with the Supreme Court’s decision in Sackett v. EPA. In that case, the plaintiff land-

owners challenged an order issued by the Environmental Protection Agency (“EPA”) concluding

that they had violated the Clean Water Act. See Sackett, 566 U.S. at 123. Although the order

invited the plaintiffs to “engage in informal discussion of the terms and requirements of the order

with the EPA and to inform the agency of any allegations therein which they believed to be inac-

curate,” the Court held that the order satisfied Bennett’s first prong and was final agency action.

Id. at 127 (citation modified). But there, unlike here, the plaintiffs requested a hearing to challenge

the agency’s findings and, when EPA denied that request, the plaintiffs learned that the order was

“not subject to further Agency review.” Id. That “alone sufficiently distinguishes [CMS’s deci-

sion] in this case from the [EPA’s] enforcement order in Sackett.” Soundboard, 888 F.3d at 1269.

Here, by contrast, CMS disclaimed finality if Fresenius Kabi timely responded to the letter, which

it did.

Fresenius Kabi’s reliance on the D.C. Circuit’s opinions in Safari Club International v.

Jewell, Appalachian Power Company v. EPA, and Friedman v. FAA is equally misplaced. In

Safari Club, the Circuit held that a ban on elephant trophy imports issued by the Fish and Wildlife

Service constituted final agency action notwithstanding the “possibility that the Service may revise

its decision based on new information.” Safari Club Int’l v. Jewell, 842 F.3d 1280, 1289 (D.C.

Cir. 2016) (citation modified). But there, “[t]he Service ha[d] made abundantly clear that it would

grant no [import] permits for 2014.” Id. at 1289–90. By contrast, here CMS has not closed off

further consideration of Fresenius Kabi’s request for a narrow exception. Rather, CMS invited

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Fresenius Kabi to submit further documentation in support of its position and withheld deeming

its decision final if the company did so. Appalachian Power is inapposite for similar reasons. In

that case, the Circuit rejected the EPA’s argument that its nationwide emission-source monitoring

guidance was nonfinal simply because it was “subject to change.” Appalachian Power Co. v. EPA,

208 F.3d 1015, 1022 (D.C. Cir. 2000). But, unlike CMS’s letter here, EPA’s guidance did not

invite regulated entities to submit further material challenging the agency’s position. Indeed,

CMS’s decision is nonfinal not just because it may change “as all laws are subject to change,” id.,

but because the agency invited Fresenius Kabi to submit material to support its position, withheld

finality if the manufacturer did so, and accepted the additional material for further consideration.

Finally, Friedman v. FAA does not compel a different outcome. In that case, a pilot seeking

a commercial license from the Federal Aviation Administration (“FAA”) refused multiple requests

to provide required medical records. See Friedman v. FAA, 841 F.3d 537, 542 (D.C. Cir. 2016).

After the applicant missed multiple deadlines to submit those records, the FAA told him that, alt-

hough his application “remain[ed] under consideration,” the agency was “unable to proceed with

[a] further determination.” Id. But the agency’s statement that it could not—and thus would not—

reach a determination on the application was the key to the court’s conclusion that the agency had

given its final word on the matter: “Where an agency has clearly communicated it will not reach

a determination on a petitioner’s submission due to petitioner’s recalcitrance but simultaneously

refuses to deny the petitioner’s submission on those grounds, it has engaged in final agency ac-

tion.” Id. (emphasis added). Here, however, CMS has not said that it cannot or will not reach a

final determination on Fresenius Kabi’s request. None of the facts Fresenius Kabi alleges in its

complaint “suggest[] that [the agency] is not seriously considering the additional materials and

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arguments [it] timely submitted to the agency” in response to CMS’s letter. ECF No. 27 at 15.4

The second reason CMS’s decision was not final is because it permitted Fresenius Kabi to

submit additional material in support of its position, thereby triggering ongoing agency consider-

ation that may obviate the need for judicial review. “In assessing whether a particular agency

action qualifies as final for purposes of judicial review, [the D.C. Circuit] and the Supreme Court

have looked to the way in which the agency subsequently treats the challenged action.” Sw. Air-

lines Co. v. United States Dep’t of Transp., 832 F.3d 270, 275 (D.C. Cir. 2016) (collecting cases).

Relatedly, “‘the extent to which [a] [party] may challenge’ an action before the agency may also

indicate how definitive the determination is.” Or. Health & Sci., 2025 WL 1707630, at *5 (quoting

Fed. Trade Comm’n v. Standard Oil Co., 449 U.S. 232, 241 (1980)).

Here, CMS invited Fresenius Kabi to submit additional materials in support of its posi-

tion—which it did with its own letter and white paper. See ECF No. 19-5. When an “agency has

been presented with new evidence that may alter the outcome of its . . . decision, the . . . denial

does not mark the consummation of the agency’s decisionmaking process and the APA does not

provide a vehicle for its review.” O’Sullivan v. U.S. Dep’t of Health & Hum. Servs., 22-cv-1189

(CRC), 2024 WL 1071045, at *5 (D.D.C. Mar. 12, 2024) (citation modified), appeal dismissed

sub nom., No. 24-5117, 2024 WL 4394815 (D.C. Cir. Sept. 30, 2024). CMS has not yet responded

to Fresenius Kabi’s letter. ECF No. 25 at 11. Thus, the agency’s consideration of Fresenius Kabi’s

request, and the additional material it submitted, remains “[o]ngoing,” which makes CMS’s

4

Fresenius Kabi also cites the Supreme Court’s decision in U.S. Army Corps of Engineers

v. Hawkes Co. to support its argument that CMS’s decision is final agency action subject to this

Court’s review. See ECF No. 25 at 16 (quoting 578 U.S. 590, 598 (2016)). But there, the Army

Corps conceded that the determination at issue marked the consummation of its decision-making

process and thus did not dispute that Bennett’s first prong had been satisfied. See Hawkes, 578

U.S. at 598.

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decision “non-final and judicial review premature.” Marcum v. Salazar, 694 F.3d 123, 128 (D.C.

Cir. 2012). Indeed, “all that judicial review would do at this stage is disrupt the agency’s process.”

Scotts Valley Band of Pomo Indians v. Burgum, 808 F. Supp. 3d 1, 14 (D.D.C. 2025), dismissed,

No. 25-5472, 2026 WL 230024 (D.C. Cir. Jan. 27, 2026) (citation modified).

In assessing whether CMS’s decision was final agency action fit for judicial review, Me-

diNatura, Inc. v. FDA is instructive. 998 F.3d 931 (D.C. Cir. 2021). There, the Circuit affirmed

the dismissal of an APA challenge to an FDA publication because the plaintiff failed to plausibly

allege that the publication marked the consummation of the agency’s decisionmaking. See gener-

ally id. In that case, MediNatura, a distributor of homeopathic drugs, challenged an FDA “Import

Alert” barring importation of the plaintiff’s products. Id. at 937. Before issuing the alert, FDA

sent MediNatura a letter “explain[ing] that it considered the Products ‘unapproved new drugs’ . . .

that . . . could not be distributed without approval.” Id. A few days later, FDA issued an Import

Alert formally banning importation of the drugs. Id. MediNatura argued, much like Fresenius

Kabi does here, that the Import Alert marked the consummation of the FDA’s decisionmaking

process because the “FDA ‘unambiguously stated’ that the Products [were] unapproved new

drugs.” Id. at 940. Still, the Circuit noted that, “[a]fter the addition of a product to the Import

Alert,” MediNatura could still “submit evidence to establish the drug’s admissibility” at a hearing.

Id. at 939. Though CMS has not afforded Fresenius Kabi a hearing, what matters is that Fresenius

Kabi “still enjoy[ed] an opportunity to convince the agency to change its mind” by submitting

additional materials. Id. (citation omitted). Thus, as the MediNatura court noted, “treating [CMS’s

letter] as final agency action would not allow [CMS] ‘an opportunity to apply its expertise and

correct its mistakes.’” Id. (citation omitted).

Moreover, “[s]hould [Fresenius Kabi] succeed in convincing [CMS] that its products are

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[noninnovators],” that would “obviate the need for judicial review.” MediNatura, 998 F.3d at 939

(citation omitted). Indeed, Fresenius Kabi alleges that it responded to the letter in the “hope . . .

that CMS might decide, as it has previously, to reverse course and grant Fresenius Kabi the relief

it seeks,” ECF No. 25 at 19, and in so doing “avoid unnecessary litigation,” id. at 17. CMS may

yet provide it that relief. Of course, Fresenius Kabi does not allege that CMS never reverses course

when a regulated entity responds to a denial letter. To the contrary, it acknowledges that CMS has

“previously” reversed a drug’s classification upon receipt of new information, id. at 19, and it has

not alleged nor asserted any plausible reason why CMS may not do so here.5 But rather than let

that process play out, Fresenius Kabi sued four months after responding to CMS’s decision. Be-

cause “completion of [CMS’s] processes may obviate the need for judicial review,” its decision is

best characterized as nonfinal. DRG Funding Corp. v. Sec’y of Hous. & Urb. Dev., 76 F.3d 1212,

1215 (D.C. Cir. 1996). To be sure, if Fresenius Kabi “is unhappy with the outcome of that process

once it has ended, it may seek judicial review then.” Id. at 1216.

In response, Fresenius Kabi argues that Section 704 of the APA forecloses any assertion

that its response rendered CMS’s decision nonfinal. See ECF No. 1 ¶ 21. Not so. That section

provides that

Except as otherwise expressly required by statute, agency action otherwise final is

final for the purposes of this section whether or not there has been presented or

determined an application for a declaratory order, for any form of reconsideration,

or, unless the agency otherwise requires by rule and provides that the action mean-

while is inoperative, for an appeal to superior agency authority.

5

Citing a joint status report filed in Fresenius Kabi I, Fresenius Kabi asserts that “CMS

stated that the agency did not intend to timely respond” to its “pre-suit letter.” ECF No. 25 at 11

(citing Fresenius I, ECF No. 25 ¶¶ 5–6). Not quite. In that report, filed less than two weeks after

Fresenius Kabi’s response letter, CMS said that it was “evaluating Fresenius Kabi’s written re-

sponse” and had “informed Fresenius Kabi that CMS [was] unable to issue a response by Decem-

ber 2, 2024, as requested by Fresenius Kabi.” Fresenius Kabi I, ECF No. 25 ¶¶ 5–6 (emphasis

added). Thus, all CMS told Fresenius Kabi was that it could not respond within Fresenius Kabi’s

preferred timeframe.

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5 U.S.C. § 704. This provision merely relieves a party from seeking reconsideration or adminis-

trative appeal of an “otherwise final” agency action before seeking review in district court. Id.

(emphasis added); see Interstate Com. Comm’n v. Bhd. of Locomotive Eng’rs, 482 U.S. 270, 284–

85 (1987). But for all the reasons already explained, CMS’s decision was not “otherwise final”

agency action. And so, also for the reasons already explained, Fresenius Kabi’s response was not

a request for reconsideration, but a submission of additional information which triggered ongoing

agency review. Thus, Section 704 does not aid Fresenius Kabi.6

6

Even if the Court accepted Fresenius Kabi’s argument that CMS’s decision was final

because it marked the consummation of the agency’s process, its APA challenge would still be

unfit for judicial review. That is so because its response would then be a request for reconsidera-

tion—which would render its present APA challenge premature. See O’Sullivan, 2024 WL

1071045, at *5 (“[R]egardless of how the []submission is characterized,” what matters is that a

party is “in fact seeking reconsideration and modification of the agency’s prior decision, which

renders that decision non-final.”) (citation modified). And “[i]f a party asks an agency to recon-

sider its prior decision, the request ‘renders an agency’s otherwise final action non-final with re-

spect to the requesting party,’ and therefore unreviewable.” Vanda Pharms. Inc. v. FDA, 23-cv-

2812 (CRC), 2024 WL 4133623, at *6 (D.D.C. Sept. 10, 2024) (quoting Clifton Power Corp. v.

FERC, 294 F.3d 108, 110 (D.C. Cir. 2002)); see O’Sullivan, 2024 WL 1071045, at *3 (“The law

is ‘well-established that a party may not simultaneously seek both agency reconsideration and

judicial review of an agency’s order.’”) (quoting Tenn. Gas Pipeline Co. v. FERC, 9 F.3d 980, 980

(D.C. Cir. 1993) (per curiam); see also e.g., Perry v. DOE, 20-cv-2003 (JEB), 2021 WL 289358,

at *1 (D.D.C. Jan. 28, 2021) (“In now moving to dismiss, Defendants point out that [the agency]

is currently reconsidering its denial decision; as a result, there is no final agency action that could

undergird an Administrative Procedure Act suit.”). In this case, Section 704 would not provide

Fresenius Kabi an avenue for judicial review either. That provision “has long been construed by

this and other courts merely to relieve parties from the requirement of petitioning for rehearing

before seeking judicial review . . . but not to prevent petitions for reconsideration that are actually

filed from rendering the orders under reconsideration nonfinal.” Interstate Com. Comm’n, 482

U.S. at 284–85.

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IV. Conclusion

For all these reasons, the Court will grant Defendants’ motion and dismiss the case. A

separate order will issue.

/s/ Timothy J. Kelly

TIMOTHY J. KELLY

United States District Judge

Date: March 30, 2026

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