RUDOLPH CONTRERAS, United States District Judge.
This action concerns whether the Department of Health and Human Services ("HHS") acted lawfully when it reduced Medicare payments worth billions of dollars to private institutions, to correct what it views as a fundamental misalignment of Medicare programs. Plaintiffs, a group of hospital associations and non-profit hospitals,
Presently before this Court are Plaintiffs' motion for a preliminary or permanent injunction and Defendants' motion to dismiss. Among other relief, Plaintiffs ask the Court to vacate the Secretary's rate reduction, require the Secretary to apply previous reimbursement rates for the remainder of this year, and require the Secretary to pay Plaintiffs the difference between the reimbursements they have received this year under the new rates and the reimbursements they would have received under the previous rates. Defendants contest the Court's ability to hear the case, arguing that Congress has shielded the Secretary's action from judicial review, that the Secretary's boundless discretion precludes review, and that Plaintiffs' failure to exhaust their administrative remedies is fatal. Defendants also argue that the Secretary's action was well within his statutory authority.
For the reasons stated below, the Court concludes that it has jurisdiction to provide relief in this case and that Plaintiffs are entitled to such relief. While in certain circumstances the Secretary could implement the rate reduction at issue here, he did not have statutory authority to do so under the circumstances presented. Moreover, because the parties have fully and vigorously debated the merits of Plaintiffs' claims, which turn on questions of law, not fact, the Court concludes that further merits briefing would be redundant and inefficient. However, while Plaintiffs are entitled to some relief, the potentially drastic impact of this Court's decision on Medicare's complex administration gives the Court pause. Accordingly, the Court grants Plaintiffs' motion for a permanent injunction and orders supplemental briefing on the question of a proper remedy.
Medicare is a federal health insurance program for the elderly and disabled, established by Title XVIII of the Social Security Act. See 42 U.S.C. §§ 1395-1395lll. Medicare Part A provides insurance coverage for inpatient hospital care, home health care, and hospice services. Id. § 1395c. Medicare Part B provides supplemental coverage for other types of care, including outpatient hospital care. Id. §§ 1395j, 1395k. HHS's Outpatient Prospective Payment System ("OPPS"), which directly reimburses hospitals for providing outpatient services and pharmaceutical drugs to Medicare beneficiaries, is a component of Medicare Part B. See id. at 1395l(t). OPPS requires "payments for out-patient hospital care to be made based on predetermined rates." Amgen, Inc. v. Smith, 357 F.3d 103, 106 (D.C. Cir. 2004). Under this system, HHS—through the Centers for Medicare and Medicaid Services ("CMS")—sets annual OPPS reimbursement rates prospectively, before a given year, rather than retroactively based on covered hospitals' actual costs during that year.
In 1992, Congress established what is now commonly referred to as the "340B Program." Veterans Health Care Act of 1992, Pub L. No. 102-585, § 602, 106 Stat. 4943, 4967-71. The 340B Program allows participating hospitals and other health care providers ("covered entities") to purchase certain "covered outpatient drugs" from manufacturers at or below the drugs' "maximum" or "ceiling" prices, which are dictated by a statutory formula and are typically significantly discounted from those drugs' average manufacturer prices. See 42 U.S.C. § 256b(a)(1)-(2).
The statutory provision governing OPPS, codified at 42 U.S.C. § 1395l(t), imposes the framework by which HHS must set prospective Medicare reimbursement rates. Among other requirements under that provision, HHS must determine how much it will pay for "specified covered outpatient drugs" ("SCODs") provided by hospitals to Medicare beneficiaries. 42 U.S.C. § 1395l(t)(14)(A). SCODS are a subset of "separately payable drugs," which are not bundled with other Medicare Part B outpatient services and are therefore reimbursed on a drug-by-drug basis. See id. § 1395l(t)(14)(B). And as noted, the 340B Program covers certain separately payable drugs, some of which are SCODs and some of which are not. 82 Fed. Reg. at 52,496; Defs.' Mot. to Dismiss ("Defs.' Mot.") at 5, ECF No. 14.
Congress has authorized two potential methodologies for setting SCOD rates.
As explained above, hospitals participating in the 340B Program purchase 340B drugs at steeply discounted rates, and when those hospitals prescribe the 340B drugs to Medicare beneficiaries they are reimbursed by HHS at OPPS rates. Before 2018, the relevant OPPS rate for 340B drugs was ASP plus 6%. See, e.g., 77 Fed. Reg. at 68,387. This rate resulted in a significant gap between what hospitals paid for 340B drugs and what they received in Medicare reimbursements for those drugs, because the 340B Program allowed participating hospitals to buy the drugs at a far lower rate than ASP plus 6%. See 82 Fed. Reg. at 52,495 (citing an Office of Inspector General report finding that this margin "allowed covered entities to retain approximately $1.3 billion in 2013"). Plaintiffs allege that the revenues derived from this payment gap have "helped [Plaintiffs] provide critical services to their communities, including underserved populations in those communities." Pls.' Mem. Supp. Mot. Prelim. & Permanent Inj. ("Pls.' Mem.") at 31 (citing Aff. of Tony Filer ("Northern Light Aff.") ¶ 13, Pls.' Mot. Prelim. & Permanent Inj. ("Pls.' Mot.") Ex. V, ECF No. 2-25; Aff. of Robin Damschroder ("Henry Ford Aff.") ¶¶ 15-18, Pls.' Mot. Ex. W, ECF No. 2-26; Aff. of Wendi Barber ("Park Ridge Aff.") ¶¶ 15-17, Pls.' Mot. Ex. X, ECF No. 2-27), ECF No. 2-1. They further allege that the narrowing of this gap "threatens these critical services" because Plaintiffs may be unable to fund the services with lower reimbursement amounts. Id. (citing Northern Light Aff. ¶¶ 14-19; Henry Ford Aff. ¶¶ 19-20; Park Ridge Aff. ¶¶ 18-19).
In mid-2017, HHS proposed reducing the Medicare reimbursement rates for SCODs and other separately payable drugs acquired through the 340B Program from ASP plus 6% to ASP minus 22.5%. Medicare Program: Hospital Outpatient
Thus, HHS concluded that lowering the Medicare reimbursement rates for 340B Program drugs would "make Medicare payment for separately payable drugs more aligned with the resources expended by hospitals to acquire such drugs[,] while recognizing the intent of the 340B program to allow covered entities, including eligible hospitals to stretch scarce resources while continuing to provide access to care." Id. HHS, however, did not have the data necessary to "precisely calculate the price paid by 340B hospitals for [any] particular covered outpatient drug." Id. at 33,634. For that reason, HHS estimated 340B hospitals' drug acquisition costs based on those hospitals' average 340B discount. See id. Specifically, HHS proposed applying the average 340B discount estimated by the Medicare Payment Advisory Commission ("MedPAC")—22.5% of a covered drug's average sales price—to govern the 340B drug reimbursement rates. See id. HHS believed that MedPAC's estimate was appropriate and, in fact, conservative because the "actual average discount experienced by 340B hospitals is likely much higher than 22.5[%]." Id.
In addition to explaining its rationale and methodology for reducing the 340B reimbursement rates to ASP minus 22.5%, HHS stated its purported statutory basis for taking that action. Because HHS did not "have hospital acquisition cost data for 340B drugs," 82 Fed. Reg. at 33,634, it could not invoke its express authority under 42 U.S.C. § 1395l(t)(14)(A)(iii)(I) to set rates according to the drugs' average acquisition costs. Instead, HHS invoked its authority under § 1395l(t)(14)(A)(iii)(II), "which states that if hospital acquisition cost data are not available, the payment for an applicable drug shall be the average price for the drug ... as calculated and adjusted by the Secretary as necessary." 82 Fed. Reg. at 33,634. HHS would thus "adjust the applicable payment rate as necessary" for separately payable drugs acquired under the 340B program, "to ASP minus 22.5[%]." Id. HHS stated that the adjustment was necessary because ASP minus 22.5% "better represents the average acquisition cost for [340B] drugs and biologicals." Id.
Plaintiffs strongly opposed the proposed 2018 340B reimbursement rates, and they voiced their opposition in comments to the proposed rule. Plaintiffs argued primarily
Nevertheless, in November 2017, HHS adopted the proposed 340B reimbursement rate reduction. See 82 Fed. Reg. at 52,362. In issuing its final rule, HHS responded to Plaintiffs' arguments about its authority to change Medicare reimbursement rates for 340B drugs. See id. at 52,499. HHS argued that the Secretary's authority under § 1395l(t)(14)(A)(iii)(II) to "calculate and adjust" drug payments "as necessary for purposes of this paragraph" gave the Secretary broad discretion, including discretion to adjust Medicare payment rates according to whether or not certain drugs were acquired at a significant discount. Id. HHS also disagreed with commenters that the authority to "calculate and adjust" drug rates as necessary was limited to "minor changes"; it saw "no evidence in the statute to support that position." Id. at 52,500. Accordingly, HHS used its purported authority "to apply a downward adjustment that is necessary to better reflect acquisition costs of [340B] drugs." Id. The 340B reimbursement rates dictated by this rule, and its ASP minus 22.5% methodology, became effective on January 1, 2018. Id. at 52,356.
In late 2017, Plaintiffs raised an Administrative Procedure Act ("APA") challenge to the 2018 OPPS Rule's 340B provisions. See generally Compl., Am. Hosp. Ass'n v. Hargan ("AHA I"), No. 17-2447, ECF No. 1 (D.D.C.). However, this Court dismissed the action because Plaintiffs failed "to present any concrete claim for reimbursement to the Secretary for a final decision[,]" which is "a fundamental jurisdictional impediment to judicial review under 42 U.S.C. § 405(g)." AHA I v. Hargan, 289 F.Supp.3d 45, 55 (D.D.C. 2017).
Plaintiffs allege that the Secretary's reimbursement rate reduction for 340B drugs violates the APA and the Social Security Act because it is "arbitrary and capricious and contrary to law, and in excess of the Secretary's authority under the Medicare provisions of the Social Security Act." Compl. ¶¶ 68-69 (citing 42 U.S.C. §§ 405(g), 1395ii, 1395l(t)(14)(A)(iii); 5 U.S.C. § 706(2)). In conjunction with filing their complaint, Plaintiffs have moved for either a preliminary injunction or a permanent injunction under Rule 65 of the Federal Rules of Civil Procedure. Pls.' Mot. at 1, ECF No. 2. Plaintiffs request that this Court direct the Secretary to:
Pls.' Mem. at 35. The government has opposed Plaintiffs' motion and filed a motion to dismiss the action pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). See generally Defs.' Mot. The parties' motions are fully briefed and ripe for this Court's consideration.
A motion to dismiss under Federal Rule of Civil Procedure 12(b)(1) "presents a threshold challenge to the Court's jurisdiction." Curran v. Holder, 626 F.Supp.2d 30, 32 (D.D.C. 2009) (quoting Agrocomplect, AD v. Republic of Iraq, 524 F.Supp.2d 16, 21 (D.D.C. 2007)). "It is to be presumed that a cause lies outside [the federal courts'] 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, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994) (citing McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 182-83, 56 S.Ct. 780, 80 S.Ct. 1135 (1936); Turner v. Bank of N.A., 4 U.S. (4 Dall.) 8, 11, 1 S.Ct. 718 (1799)). In determining whether the plaintiff has met this burden, a court must accept "the allegations of the complaint as true," Banneker Ventures, LLC v. Graham, 798 F.3d 1119, 1129 (D.C. Cir. 2015), and "construe the complaint `liberally,' granting the plaintiff `the benefit of all inferences that can be derived from the facts alleged,'" Barr v. Clinton, 370 F.3d 1196, 1199 (D.C. Cir. 2004) (quoting Kowal v. MCI Commc'ns. Corp., 16 F.3d 1271, 1276 (D.C. Cir.1994)). However, "the [p]laintiff'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." Grand Lodge of Fraternal Order of Police v. Ashcroft, 185 F.Supp.2d 9, 13-14 (D.D.C. 2001) (internal quotation marks omitted) (citing 5A Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 1350).
The Court must confirm its jurisdiction for each type of claim brought before it, including APA challenges. Indeed, while 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," the "APA does not apply ... to the extent that ... statutes preclude judicial review." Tex. All. for Home Care Servs. v. Sebelius, 681 F.3d 402, 408 (D.C. Cir. 2012) (internal quotation marks omitted) (quoting 5 U.S.C. § 701(a)(1); Koretoff v. Vilsack, 614 F.3d 532, 536 (D.C. Cir. 2010)). Similarly, courts lack jurisdiction over claims brought under the Social Security Act until the claimants have exhausted their administrative remedies and received final decisions from the Secretary regarding the issues underlying those claims. 42 U.S.C. § 405(g).
The Federal Rules of Civil Procedure require that a complaint contain "a short and plain statement of the claim" to give the defendant fair notice of the claim and the grounds upon which it rests. Fed. R. Civ. P. 8(a)(2); accord Erickson v. Pardus, 551 U.S. 89, 93, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007) (per curiam). A motion to dismiss under Rule 12(b)(6) does not test a plaintiff's ultimate likelihood of
To survive a motion to dismiss, a complaint need not contain all elements of a prima facie case. See Swierkiewicz v. Sorema N.A., 534 U.S. 506, 511-14, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002); Bryant v. Pepco, 730 F.Supp.2d 25, 28-29 (D.D.C. 2010). However, the "complaint must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). This means that a plaintiff's factual allegations "must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact)." Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (citations omitted). "Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements," are therefore insufficient to withstand a motion to dismiss. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. A court need not accept a plaintiff's legal conclusions as true, see id., nor must a court presume the veracity of legal conclusions couched as factual allegations, see Twombly, 550 U.S. at 555, 127 S.Ct. 1955.
The APA governs the conduct of federal administrative agencies. See 5 U.S.C. §§ 101-913. It permits a court to "compel agency action unlawfully withheld or unreasonably delayed," id. § 706(1), and to "hold unlawful and set aside agency action, findings, and conclusions found to be ... arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," id. § 706(2)(A). It provides for judicial review of a "final agency action for which there is no other adequate remedy in a court[,]" id. § 704, except when "statutes preclude judicial review" or the "agency action is committed to agency discretion by law[,]" id. § 701(a).
By and large, the Secretary's arguments for dismissal concern whether this Court has jurisdiction to hear Plaintiffs' allegations. First, the Secretary argues that Plaintiffs' failure to exhaust their administrative remedies forecloses judicial review. Second, the Secretary argues that certain Medicare provisions preclude the Court's review. Third, the Secretary argues that the decision to reduce 340B drug reimbursement rates was "committed to agency discretion by law," and therefore out-side the scope of APA review. Fourth, the Secretary argues that he had clear statutory authority to "adjust" 340B drug reimbursement rates. The Court addresses each argument in turn and concludes that the potential jurisdictional obstacles are not fatal here, and that the Secretary's action exceeded his authority to "adjust" rates. Accordingly, Plaintiffs are entitled to relief, to be determined after the Court considers the parties' supplemental briefing.
The Secretary argues that the Court lacks jurisdiction because Plaintiffs failed to exhaust their administrative remedies prior to filing suit. In evaluating this
Section 405(g)'s review channeling mechanism contains two elements. First, the provision contains a jurisdictional, non-waivable "requirement that a claim for benefits shall have been presented to the Secretary." Eldridge, 424 U.S. at 328, 96 S.Ct. 893. Second, the provision contains a non-jurisdictional "requirement that the administrative remedies prescribed by the Secretary be exhausted." Id. This requirement may be waived by the agency or a court.
"A court may waive the exhaustion requirements of § 405(g) when: (1) the issue raised is entirely collateral to a claim for payment; (2) plaintiffs show they would be irreparably injured were the exhaustion requirement enforced against them; [or] (3) exhaustion would be futile." Triad at Jeffersonville I, LLC v. Leavitt, 563 F.Supp.2d 1, 16 (D.D.C. 2008) (citing Bowen v. City of New York, 476 U.S. 467, 483-85, 106 S.Ct. 2022, 90 L.Ed.2d 462 (1986)); see also Tataranowicz v. Sullivan, 959 F.2d 268, 274 (D.C. Cir. 1992). In such situations, a "district court may, in its discretion, excuse exhaustion if `the litigant's interests in immediate judicial review out-weigh the government's interests in the efficiency or administrative autonomy that the exhaustion doctrine is designed to further.'" Avocados Plus Inc. v. Veneman, 370 F.3d 1243, 1247 (D.C. Cir. 2004) (quoting McCarthy v. Madigan, 503 U.S. 140, 146, 112 S.Ct. 1081, 117 L.Ed.2d 291 (1992)).
Here, Plaintiffs rely solely on what they claim is the futility of exhausting their administrative remedies. "Futility may serve as a ground for excusing exhaustion, either on its own or in conjunction with [the] other factors ...." Nat'l Ass'n for Home Care & Hospice, Inc. v. Burwell, 77 F.Supp.3d 103, 110 (D.D.C. 2015); see also Tataranowicz, 959 F.2d at 274 (waiving the plaintiffs' § 405(g) exhaustion requirement as futile, without recourse to other factors). That said, the ordinary standard for futility in administrative law cases is inapplicable in Medicare cases. See Weinberger v. Salfi, 422 U.S. 749, 766, 95 S.Ct. 2457, 45 L.Ed.2d 522 (1975) (stating that § 405(g) 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"). Instead, the Court must consider whether judicial resolution of the issue will interfere with the agency's efficient functioning, deny the agency the ability to self-correct, or deprive the Court of the benefits of the agency's expertise and an adequate factual record. Tataranowicz, 959 F.2d at 275 (citing Salfi, 422 U.S. at 765, 95 S.Ct. 2457).
Applying these principles, the futility of requiring Plaintiffs to exhaust their administrative remedies in this case is readily apparent. The Secretary does not argue that proceeding with Plaintiffs' lawsuit would somehow "interfere with the agency's efficient functioning."
In fact, as Plaintiffs point out and the Secretary does not dispute, because the 2018 OPPS Rule is final, it appears that no administrative review body would even have authority to alter or deviate from its requirements, due to the Rule's binding nature on HHS. Indeed, HHS regulations provide that "[a]ll laws and regulations pertaining to the Medicare and Medicaid programs ... are binding on ALJs and attorney adjudicators, and the [Medicare Appeals] Council." 42 C.F.R. § 405.1063(a) (emphasis added); see also HHS Expedited Access to Judicial Review Ruling at 6, ECF No. 19-1 (stating that "neither the ALJ nor the [Medicare Appeals] Council has the authority to find the 2018 OPPS Rule invalid").
When faced with similar circumstances, the Supreme Court and other courts in this jurisdiction have waived the Social Security Act's exhaustion requirement.
The Secretary also argues that the Court is precluded by certain Medicare provisions from hearing Plaintiffs' suit. Again, the precise mechanism by which Plaintiffs have brought this suit is key to the Court's analysis. Although, as discussed above, this Court has jurisdiction under § 405(g) to hear Plaintiffs' action, Plaintiffs ultimately seek relief not under § 405(g), but under the APA. See Compl. ¶¶ 68-69. And under the APA, litigants may seek review of agency action, "except to the extent that [a] statute[ ] preclude[s] judicial review." 5 U.S.C. § 701(a)(1).
"There is a `strong presumption that Congress intends judicial review of administrative action.'" Amgen, 357 F.3d at 111 (quoting Bowen v. Mich. Acad. of Family Physicians, 476 U.S. 667, 670, 106 S.Ct. 2133, 90 L.Ed.2d 623 (1986)). This presumption weighs "particularly strong[ly]" in favor of "judicial review of agency action taken in excess of delegated authority," as alleged here. Id. at 111-12 (citing Leedom v. Kyne, 358 U.S. 184, 190, 79 S.Ct. 180, 3 L.Ed.2d 210 (1958); Aid Ass'n for Lutherans v. USPS, 321 F.3d 1166, 1173 (D.C. Cir. 2003)). To overcome the presumption, there must be "`clear and convincing evidence' of a contrary legislative intent." Abbott Labs. v. Gardner, 387 U.S. 136, 141, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967) (quoting Rusk v. Cort, 369 U.S. 367, 380, 82 S.Ct. 787, 7 L.Ed.2d 809 (1962)), overruled on other grounds by Califano v. Sanders, 430 U.S. 99, 107, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977). This analysis requires that the Court look to the statute's "express language ... the structure of the statutory schemes, its objectives, its legislative history, and the nature of the administrative action involved." Block v. Cmty. Nutrition Inst., 467 U.S. 340, 345, 104 S.Ct. 2450, 81 L.Ed.2d 270 (1984).
The Secretary contends that three Medicare provisions preclude this Court's review of Plaintiffs' suit: 42 U.S.C. § 1395l(t)(12)(A), (t)(12)(C), and (t)(12)(E). Defs.' Mot. at 17. Subsection (t)(12)(A) states:
42 U.S.C. § 1395l(t)(12)(A) (emphasis added). Subsection (t)(12)(C) states that "[t]here shall be no administrative or judicial review under section 1395ff of this title, 1395oo of this title, or otherwise of... periodic adjustments made under paragraph [9]."
Id. § 1395l(t)(12)(E) (emphasis added).
It is uncontested that none of these subsections explicitly preclude judicial review of rate adjustments made under subsection (t)(14). See Pls.' Opp'n Defs.' Mot. ("Pls.' Opp'n") at 3, ECF No. 16. And Plaintiffs argue that without this explicit reference, there is no "clear and convincing evidence" that subsection (t)(12) is intended to preclude judicial review of the subsection (t)(14) rate adjustment at issue here. Id. a 3-4. The Secretary, on the other hand, argues that the separately payable drugs addressed by subsection (t)(14) fall within the OPPS payment "classification system" established under subsection (t)(2). Defs.' Mot. at 19. Therefore, according to the Secretary, adjustments to those drugs' reimbursement rates are "adjustments" described in subsection (t)(2), made to the agency's "fee schedule amount associated with particular ... drugs," review of which are precluded by subsections (t)(12)(A) and (t)(12)(E). Id. at 19-21; Reply Supp. Defs.' Mot. ("Defs.' Reply") at 4-5, ECF No. 20. The Secretary further argues that in finalizing the 2018 OPPS Rule, the Secretary explicitly invoked his subsection (t)(9) authority to periodically revise relative payment rates, review of which is precluded by subsection (t)(12)(C). Defs.' Mot. at 20 (citing 82 Fed. Reg. at 52,356); Defs.' Reply at 7-8.
The parties' preclusion arguments notwithstanding, because Plaintiffs claim that the Secretary acted in excess of his statutory authority—that he acted ultra vires—the Court need not resolve the parties' conflicting interpretations of subsection (t)(12). "[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 (citing Chamber of Commerce v. Reich, 74 F.3d 1322, 1327-28 (D.C. Cir. 1996)). Thus, "the APA's stricture barring judicial review `to the extent that statutes preclude judicial review,' `does not repeal the review of ultra vires actions' ...." Id. (quoting 5 U.S.C. § 701(a)(1); Dart v. United States, 848 F.2d 217, 224 (D.C. Cir. 1988)). Put simply, if the Secretary's 340B drug reimbursement rate reduction was an "adjustment" under subsection (t)(14), review of that adjustment is arguably precluded by subsection (t)(12). But if the Secretary's action was not an "adjustment," the Court may review it. See Amgen, 357 F.3d at 112 (section 1395l(t)(12)(A) prevents "review only of those `other adjustments' that the Medicare Act authorizes the Secretary to make; in other words, the preclusion on review of `other adjustments' extends no further than the Secretary's statutory authority to make them.").
Accordingly, to determine whether Plaintiffs raise an ultra vires claim falling outside the scope of subsection (t)(12)'s preclusion provisions, the Court must consider that claim's merits. 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."); Organogenesis Inc. v. Sebelius, 41 F.Supp.3d 14, 20-21 (D.D.C. 2014) ("[I]f Apligraf qualifies as a SCOD, this Court may hear the case under the ultra vires doctrine of review," but "if Apligraf does not qualify as a SCOD, 42 U.S.C. § 1395l (t)(12)(A) precludes this Court's review.");
Having waded through the potential impediments to its jurisdiction, the Court may consider Plaintiffs' core allegation; that the Secretary acted ultra vires in "adjusting" the 340B drug reimbursement rates from ASP plus 6% to ASP minus 22.5%. "To challenge agency action on the ground that it is ultra vires, [a plaintiff] must show a `patent violation of agency authority.'" Fla. Health Scis. Ctr., Inc. v. Sec'y of HHS, 830 F.3d 515, 522 (D.C. Cir. 2016) (quoting Indep. Cosmetic Mfrs. & Distribs., Inc. v. U.S. Dep't of Health, Educ. & Welfare, 574 F.2d 553, 555 (D.C. Cir. 1978)). "A violation is `patent' if it is `[o]bvious' or `apparent.'" Id. (quoting Black's Law Dictionary (10th ed. 2014)). "Such ultra vires review is `quite narrow.'" H. Lee Moffitt Cancer Center & Research Inst. Hosp., Inc. v. Azar, 324 F.Supp.3d 1, 11 (D.D.C. 2018) (quoting Mittleman v. Postal Regulatory Comm'n, 757 F.3d 300, 307 (D.C. Cir. 2014)).
Plaintiffs' ultra vires argument here turns on the scope of the Secretary's discretion under 42 U.S.C. § 1395l(t)(14)(A)(iii)(II) to alter the statutory benchmark drug reimbursement rates. As noted, under that provision, a given drug's reimbursement rate "shall be equal ... [to] the average price for the drug in the year established under ... section 1395w-3a of this title ... as calculated and adjusted by the Secretary as necessary for purposes of this paragraph." Id. (emphasis added). And the parties agree that § 1395w-3a sets a default payment rate of ASP plus 6%, which HHS implemented for several years preceding the 2018 OPPS Rule. Defs.' Mot. at 6; Pls.' Mem. at 3-4; 77 Fed. Reg. at 68,387.
Thus, the principle dispute among the parties is whether the Secretary acted within his authority to "calculate[ ] and adjust[ ]" the statutory benchmark rate of ASP plus 6% when he reduced that rate to ASP minus 22.5% based on his estimation of 340B hospitals' drug acquisition costs, rather than the drugs' average sales prices. 82 Fed. Reg. at 52,496. The Secretary argues that the authority to "adjust" reimbursement rates is essentially a plenary power to change rates according to any methodology, so long as the rates are expressed as a function of average drug prices. See Defs.' Mot. at 34. This argument relies on the premise that the statute's text does not impose any limits on the Secretary's authority to adjust rates. See id. at 31. This is plainly wrong.
In fact, the statute's plain text does limit the Secretary's "adjust[ment]" authority. The D.C. Circuit held as much under nearly identical circumstances in Amgen. In that case, the Circuit considered the Secretary's authority to adjust reimbursement rates under a different, but related, Medicare provision: 42 U.S.C. § 1395l(t)(2)(E). Amgen, 357 F.3d at 107.
Amgen's logic applies equally here. First, "identical words and phrases within the same statute should normally be given the same meaning." Powerex Corp. v. Reliant Energy Servs., Inc., 551 U.S. 224, 232, 127 S.Ct. 2411, 168 L.Ed.2d 112 (2007). Thus, because Congress did not intend for the term "adjust" to confer unbridled authority in the context of subsection (t)(2)(E), there is good reason to believe that Congress did not intend to confer such authority in the context of subsection (t)(14)(A)(iii)(II). But more fundamentally, the structure of subsection (t)(14)(A)(iii)(II) necessitates this conclusion. That provision commands that SCOD reimbursement rates "shall" be set "equal" to a rate specified in certain other statutory provisions; here, each drug's average sales price plus 6%. 42 U.S.C. § 1395l (t)(14)(A)(iii)(II). This clear directive is qualified only by the Secretary's authority to "adjust" those rates. Id. Notably, the Medicare subsection at issue in Amgen followed this very same structure by articulating a clear requirement and then qualifying that requirement with the modest authority to adjust rates. Thus, like in Amgen, the language and structure of subsection (t)(14)(A)(iii)(II) make clear that the Secretary may not make "basic and fundamental changes" under the purported auspices of making mere "adjustments" to the rates statutorily imposed by that subsection.
Amgen also answers another critical question: whether an abuse of the Secretary's adjustment authority might form the basis of an ultra vires action. That is to say, whether a court could find, under some set of circumstances, that the Secretary has "patent[ly]" violated his authority to "adjust" payment rates. Fla. Health Scis. Ctr., 830 F.3d at 522. Amgen suggests that such a finding is possible. The D.C. Circuit explained that, although the Secretary's equitable adjustment authority permitted "the adjustment of OPPS payments otherwise set by the Medicare Act," it did not "give the Secretary the absurdly broad power to make drastic adjustments, such as the elimination of the entire pass-through program, and term it an `equitable adjustment,' thereby undermining the mandatory nature of the pass-through payment system while evading judicial review." Amgen, Inc., 357 F.3d at 117 (emphasis added). Rather, if the Secretary makes "basic and fundamental changes in the scheme ... the Secretary would, in that event, exceed his statutory authority [to make adjustments] under § (t)(2)(E) [and] the preclusion on judicial review in § (t)(12)(A) would not apply." Id. (emphasis added). In other words, judicial review would be permitted because the Secretary's purported "adjustment" would be, in fact, an ultra vires act (i.e. a patent violation of his authority).
The question for the Court, then, is whether the change at issue here—reducing the default 340B drug reimbursement rate of ASP plus 6% to ASP minus 22.5%—is so substantial as to be a patent violation of the Secretary's § (t)(14)(A)(iii)(II) adjustment authority. Although similar arguments have been raised in this jurisdiction, no court has held that the Secretary acted outside of his authority to make "adjustments" to any Medicare reimbursement rates. For example, in Amgen, the D.C. Circuit had "no occasion to engage in line drawing to determine when `adjustments' cease being `adjustments'" because the rate adjustment at issue there involved "only the payment amount for a single drug, [which] does not work `basic and fundamental changes in the scheme' Congress created in the Medicare Act ...." Amgen, Inc., 357 F.3d at 117 (quoting MCI, 512 U.S. at 225, 114 S.Ct. 2223). Likewise, in other cases, courts have found that payment reductions of 0.2% and 2.9% were not significant enough to warrant a finding that the Secretary exceeded his adjustment authority. See Shands Jacksonville Med. Ctr. v. Burwell, 139 F.Supp.3d 240, 260 (D.D.C. 2015) (citing Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 700 (D.C. Cir. 2014)).
But the circumstances here are quite different than those previously presented in this jurisdiction. The Secretary's rate adjustment at issue here does not affect a single drug or even a handful of drugs, but rather potentially thousands of pharmaceutical products found in the 340B Program. See 82 Fed. Reg. at 52,494 (discussing the number of 340B "covered products" available to 340B covered entities). Moreover, the changes that the Secretary imposed are not modest. Indeed, by changing the formula from the statutory default of ASP plus 6% to ASP minus 22.5%, the Secretary is imposing a nearly 30% reduction from the formula that Congress expressly set as the standard. When viewed together, the rate reduction's magnitude and its wide applicability inexorably lead to the conclusion that the Secretary fundamentally altered the statutory scheme established by Congress for determining SCOD reimbursement rates, thereby exceeding the Secretary's authority to "adjust[ ]" SCOD rates under § (t)(14)(A)(iii)(II).
Here, the Secretary eschewed the use of subsection (I) because the required acquisition cost data was not available. 82 Fed. Reg. at 52,496. And the statutory scheme is clear that if the Secretary does not have that data, he must calculate reimbursement rates by reference to the drugs' average sales prices. 42 U.S.C. § (t)(14)(A)(iii)(II). While the Secretary is permitted to make "adjust[ments]" to those rates for whatever reasons he deems "necessary," adjustments are all he can make.
For these reasons, the Court concludes that the Secretary acted ultra vires.
Having resolved that this Court has jurisdiction over this matter and that, on the merits, the Secretary's action was ultra vires, the Court must now consider the proper way forward. Plaintiffs urge the Court to "[a]dvanc[e] a decision on the merits" under Federal Rule of Civil Procedure 65(a)(2). Pls.' Mem. at 34. Rule 65(a)(2) states that "[b]efore or after beginning [a] hearing on a motion for a preliminary injunction, the court may advance the trial on the merits and consolidate it with the hearing." Fed. R. Civ. P. 65(a)(2); accord Teva Pharm. USA, Inc. v. FDA, 398 F.Supp.2d 176, 181 n.1 (D.D.C. 2005) ("This type of consolidation is a procedural tool designed to conserve the resources of the Court and the parties by avoiding duplicative efforts." (citing NOW v. Operation Rescue, 747 F.Supp. 760, 768 (D.D.C. 1990))), vacated on other grounds by 441 F.3d 1 (D.C. Cir. 2006). In determining whether a decision on the merits is appropriate, a court must consider whether, at this stage, "the record is sufficient for a determination on the merits under the summary judgment standard, or, where reliance on the record is unnecessary, under the motion to dismiss standard."
The Secretary has had every opportunity and incentive to argue the merits of Plaintiffs' claim, and he was aware that the Court may enter judgment on the merits at this stage. Indeed, the Secretary urged this Court to decide this case on the merits, asserting that "[b]ecause Plaintiffs' APA claims raise pure legal questions regarding the scope of the Secretary's statutory authority, the Court may reach the merits of those claims on a Rule 12(b)(6) motion."
Consequently, in their briefing, both parties argued at length about the Secretary's authority to implement the Medicare rate reduction at issue. Moreover, the Secretary did not oppose, or even address, Plaintiffs' request that the Court render a judgment on the merits. And the Secretary gave no reason to believe that he might present different or additional legal arguments at some later stage in the litigation.
The typical remedy for an agency rule promulgated contrary to law is to vacate the rule. See Humane Soc'y of U.S. v. Zinke, 865 F.3d 585, 614 (D.C. Cir. 2017) (citing Sugar Cane Growers Co-op. of Fla. v. Veneman, 289 F.3d 89, 97 (D.C. Cir. 2002)); St. Lawrence Seaway Pilots Ass'n, Inc. v. U.S. Coast Guard, 85 F.Supp.3d 197, 208 (D.D.C. 2015). As noted, Plaintiffs seek that relief and its logical consequences, including that the Court require HHS to apply the 2017 OPPS drug reimbursement methodology—ASP plus 6%—to 340B drug payments made for the remainder of 2018,
Here, vacatur and the other relief sought by Plaintiffs are likely to be highly
Under the budget neutrality requirement, reducing 2018 340B reimbursement rates allowed the Secretary to increase reimbursements for other drugs and services covered under Medicare Part B; increasing 340B reimbursement rates would likewise require the Secretary to reduce reimbursements elsewhere in the program. For instance, in finalizing the 2018 OPPS Rule, the Secretary stated that "the reduced payments for separately payable drugs purchased through the 340B Program w[ould] increase payment rates for other non-drug items and services paid under the OPPS by an offsetting aggregate amount." 82 Fed. Reg. at 52,623. The Secretary could thus "increase OPPS payment rates for non-drug items and services by approximately 3.2[%]." Id. The retroactive OPPS payments that Plaintiffs seek here would presumably require similar offsets elsewhere; a quagmire that may be impossible to navigate considering the volume of Medicare Part B payments made in 2018.
The D.C. Circuit and other circuits have recognized the "havoc that piecemeal review of OPPS payments could bring about" in light of the budget neutrality requirement. Amgen, 357 F.3d at 112 (citing Am. Soc'y of Cataract & Refractive Surgery v. Thompson, 279 F.3d 447, 454 (7th Cir. 2002) (noting the "disruptive" impact of requiring Medicare Part B payment adjustments); Skagit Cty. Pub. Hosp. Dist. No. 2 v. Shalala, 80 F.3d 379, 386-87 (9th Cir. 1996)); see also Paladin Cmty. Mental Health Ctr. v. Sebelius, 684 F.3d 527, 531 n.3 (5th Cir. 2012) ("Judicial determinations forcing the Secretary to retroactively alter payment rates for various covered services—e.g., payment rates that are adjusted annually and are required to remain budget neutral—would likely wreak havoc on the already complex administration of Medicare Part B's outpatient prospective payment system." (citation omitted)). In the interest of avoiding that havoc, and because neither party thoroughly addressed the question of remedies in their briefs,
For the foregoing reasons, Plaintiffs' Motion for a Preliminary Injunction (ECF No. 2) is
An order consistent with this Memorandum Opinion is separately and contemporaneously issued.
42 U.S.C. § 405(g) (emphasis added).
42 U.S.C. § 405(h) (emphasis added). The Supreme Court has interpreted § 405(h) to require that Medicare claims be pursued through the special review system laid out in § 405(g), rather than through other judicial mechanisms that may otherwise be available. Shalala v. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 8-15, 120 S.Ct. 1084, 146 L.Ed.2d 1 (2000). 42 U.S.C. § 1395ii expressly applies § 405(h) to claims arising under the Medicare provisions of the Social Security Act, and the D.C. Circuit has reasoned that "expressly incorporating the judicial-review bar in § 405(h) also effectively incorporates the exception `herein provided' in § 405(g)." Am. Hosp. Ass'n v. Azar ("AHA II"), 895 F.3d 822, 825 (D.C. Cir. 2018) (citing United States v. Blue Cross & Blue Shield of Ala., Inc., 156 F.3d 1098, 1103 (11th Cir. 1998) ).