University of Colorado Health at Memorial Hospital et al v. Burwell

MOTION for Partial Summary Judgment

D.D.C.February 9, 2017

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA UNIVERSITY OF COLORADO HEALTH AT MEMORIAL HOSPITAL, f/k/a MEMORIAL HOSPITAL OF COLORADO SPRINGS, et al., Plaintiffs, v. SYLVIA M. BURWELL, Secretary, Department of Health and Human Services, Defendant. Civil Action No. 14-1220-RC DEFENDANT’S MOTION FOR PARTIAL SUMMARY JUDGMENT ON PLAINTIFFS’ CHALLENGES TO THE FISCAL YEARS 2008 AND 2011 FIXED LOSS THRESHOLDS AND THE 2003 OUTLIER PAYMENT REGULATION AMENDMENTS, AND MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT Pursuant to Rule 56(a) of the Federal Rules of Civil Procedure, the Defendant, Sylvia M. Burwell, Secretary of Health and Human Services (“the Secretary”), respectfully moves for summary judgment on the challenges to the fiscal years (“FY”) 2008 and 2011 fixed loss thresholds and the 2003 amendments to the outlier payment regulations that are asserted by Plaintiffs in this action that are also plaintiffs in Lee Memorial Health Systems v. Burwell, No. 13-cv-643-RMC (D.D.C.). Res judicata bars those claims. BACKGROUND On September 7, 2016, this Court in Lee Memorial entered summary judgment and final judgment in the Secretary’s favor on all of the plaintiffs’ claims against her. Lee Memorial v. Burwell, slip op. (D.D.C. Sept. 7, 2016) (Collyer, J.) (Ex. A). Those claims included challenges to the fixed loss threshold determinations in FYs 2008 and 2011 and the 2003 amendments to the outlier payment regulations. Id. at 28–45. Plaintiffs in this action purport to assert those same Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 1 of 8 2 claims. See ECF No. 41 ¶¶ 72–76 (challenging fixed loss thresholds in effect during, inter alia, FYs 2008 and 2011); id. ¶ 77 (challenging 2003 amendments to outlier payment regulations). All but two of the Plaintiffs in this action are also plaintiffs in Lee Memorial.1 Both forms of res judicata—claim preclusion and issue preclusion—bar those Plaintiffs from pursuing the same claims and arguments in this action that they pursued and lost in Lee Memorial.2 ARGUMENT Rule 56(a) of the Federal Rule of Civil Procedure provides for summary judgment “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Accord, e.g., Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). “Res judicata bars relitigation of claims and issues that were or could have been litigated in a prior action.” Alaska Forest Ass’n v. Vilsack, 883 F. Supp. 2d 136, 141-42 (D.D.C. 2012) (citing Taylor v. Sturgell, 553 U.S. 880, 892 (2008)). “The preclusive effect of a judgment is defined by claim preclusion and issue preclusion, which are collectively referred to as ‘res judicata.’” Canonsburg Gen. Hosp. v. Sebelius, 989 F. Supp. 2d 8, 16 (D.D.C. 2013) (quoting Taylor v. Sturgell, 553 U.S. 880, 892 (2008)); accord Angelex Ltd. v. United States, 123 F. Supp. 3d 66, 76 (D.D.C. 2015). Both claim preclusion and issue precusion preclude Plaintiffs 1 The only Plaintiffs in this action that are not plaintiffs in Lee Memorial are Banner Mesa Medical Center and Cabell Huntington Hospital. Compare Fourth Am. Compl., ECF No. 41 (June 16, 2015) with Fourth Am. Compl., Lee Memorial (June 17, 2015) (Ex. B). 2 The Secretary has also asserted the res judicata defense as to certain Plaintiffs’ challenge to the FY 2007 fixed loss threshold rulemaking based on this Court’s final judgment in Banner Health v. Sebelius, No. 10-cv-1638. See Def.’s Mem. in Support of her Mot. for Summ. J. at 18–19, ECF No. 66 (May 24, 2016); Def.’s Reply in Support of her Mot. for Summ. J. at 6–11, ECF No. 74 (July 22, 2016). The arguments in support of the res judicata defense to the FY 2007 rulemaking challenge are similar to the arguments in support of the res judicata defense to the challenges to the FYs 2008 and 2011 rulemakings and the 2003 outlier payment regulation amendments. Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 2 of 8 3 who were party to Lee Memorial from relitigating in this action claims and issues that they have already litigated. 1. Claim Preclusion Bars Relitigation of Challenges to the FYs 2008 and 2011 Fixed Loss Thresholds and the 2003 Outlier Payment Regulation Amendments By Plaintiffs Who Also Were Party to Lee Memorial. Under the res judicata principle of claim preclusion, “a final judgment forecloses successive litigation of the very same claim, whether or not relitigation of the claim raises the same issues as the earlier suit.” Angelex Ltd., 123 F. Supp. 3d at 76 (qouting Taylor, 553 U.S. at 892) (internal quotation marks omitted). Claim preclusion applies where “there has been prior litigation (1) involving the same claims or cause of action, (2) between the same parties or their privies, and (3) there has been a final, valid judgment on the merits, (4) by a court of competent jurisdiction.” Alaska Forest Ass’n, 883 F. Supp. 2d at 141-42 (quoting NRDC v. EPA, 513 F.3d 257, 260 (D.C. Cir. 2008)); accord Angelex Ltd., 123 F. Supp. 3d at 77 (quoting Smalls v. United States, 471 F.3d 186, 192 (D.C. Cir. 2006)). Here, the first claim preclusion criterion is satisfied because the causes of action concerning the FYs 2008 and 2011 fixed loss threshold rulemakings and the 2003 outlier payment regulation amendments in this case and Lee Memorial are the same. “‘Whether two cases implicate the same cause of action turns on whether they share the same nucleus of facts.’” Alaska Forest Ass’n, 883 F. Supp. 2d. at 142 (quoting Apotex, Inc. v. FDA, 393 F.3d 210, 217 (D.C. Cir. 2002)). The plaintiffs both here and in Lee Memorial sought judicial review based on Administrative Procedure Act (“APA”) standards. See Fourth Am. Compl. ¶ 3, ECF No. 41 (June 16, 2015); id. at 38 (Request for Relief ¶ 1); Lee Memorial, slip op. at 17–18. Thus, the administrative record for each challenged rulemaking constitutes the relevant nucleus of fact in each case. See 5 U.S.C. § 706 (in conducting APA review, “the court shall review the whole Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 3 of 8 4 record or those parts of it cited by a party”); accord, e.g., Citizens to Pres. Overton Park v. Volpe, 401 U.S. 402, 420 (1971). Accordingly, in both cases the relevant nucleus of fact for the challenge to the FY 2008 fixed loss threshold rulemaking is the administrative record for the FY 2008 rulemaking; the relevant nucleus of fact for the challenge to the FY 2011 fixed loss threshold rulemaking is the administrative record for the FY 2011 rulemaking; and the relevant nucleus of fact for the challenge to the 2003 amendments to the outlier payment regulations is the administrative record for the 2003 amendments.3 Because the relevant nucleus of fact for each challenge is the same in each case, the causes of action are the same. See Alaska Forest Ass’n, 883 F. Supp. 2d. at 142. Indeed, the D.C. Circuit has recognized that claim preclusion bars successive challenges to the same agency decision. See Nat’l Res. Def. Council v. EPA, 513 F.3d 257, 260–61 (D.C. Cir. 2008) (claim preclusion barred plaintiff from challenging the same agency decisions that it had challenged and lost in previous action against agency). The second claim preclusion criterion is satisfied with respect to the hospitals that are plaintiffs in both this action and Lee Memorial. As set forth above, all but two hospitals in this action are plaintiffs in both actions. And the Secretary of Health and Human Services is the defendant in both cases. The third criterion is likewise satisfied. The Lee Memorial Court has entered summary judgment and final judgment in favor of the Secretary on the merits of the plaintiffs’ challenges to the FY 2008 and 2011 fixed loss threshold rulemakings and the 2003 amendments to the outlier payment regulations. 3 The parties agreed that the administrative records for the FYs 2008 and 2011 fixed loss threshold rulemakings and for the 2003 outlier payment regulation amendments that were produced to the plaintiffs in Lee Memorial would constitute the administrative records for those rulemakings in this action. Jt. Proposed Schedule ¶ 2, ECF No. 21 (Dec. 1, 2014); Certification of the Administrative R. at 3, ECF No. 52 (Dec. 14, 2015). Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 4 of 8 5 The fourth criterion is also satisfied as the Lee Memorial Court is a court of competent jurisdiction. See Gharb v. Mitsubishi Elec. Corp., 148 F. Supp. 3d 44, 49–51 (D.D.C. 2015) (“a United States district court is a court of competent jurisdiction for res judicata purposes”). All four criteria for claim preclusion thus are present with respect to the hospitals that are Plaintiffs in both this case and in Lee Memorial. Application of res judicata principles to preclude duplicative litigation concerning the FYs 2008 and 2011 rulemakings and the 2003 outlier payment regulation amendments will promote efficient resolution of the claims of those Plaintiffs who brought the same challenges in Lee Memorial, even though the defense does not apply to every Plaintiff before the Court. Again, all but two of Plaintiffs here were also plaintiffs in Lee Memorial. Because many of the hospital Plaintiffs regularly challenge the rules governing their outlier payments,4 a ruling that they may not relitigate the same claim in multiple actions will promote the efficient and just allocation of judicial resources and government resources in the future. Accordingly, the Court should enter summary judgment in favor of the Secretary and against Plaintiffs that are also plaintiffs in Lee Memorial as to the challenges to the FYs 2008 and 2011 fixed loss threshold rulemakings and the 2003 amendments to the outlier payment regulations. 2. Issue Preclusion Bars Relitigation of Challenges to the FYs 2008 and 2011 Fixed Loss Thresholds By Plaintiffs Who Also Were Party to Lee Memorial. Issue preclusion, previously called collateral estoppel, “bars ‘successive litigation of an issue of fact or law actually litigated and resolved in a valid court determination essential to the 4 As set forth in Defendant’s motion for summary judgment, many of the Plaintiffs here are also plaintiffs in Banner Health. Several are also plaintiffs in Charleston Area Medical Center v. Sebelius, No. 15-cv-2031-JEB, another pending outlier payments challenge. Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 5 of 8 6 prior judgment.’” Canonsburg Gen. Hosp., 989 F. Supp. 2d at 16 (quoting Taylor, 553 U.S. at 892), aff’d sub nom. Canonsburg Gen. Hosp. v. Burwell, 807 F.3d 295 (D.C. Cir. 2015). Issue preclusion applies to preclude litigation of an issue on which final judgment has been entered where three elements are satisfied: (1) “‘the same issue now being raised must have been contested by the parties and submitted for judicial determination in the prior case’”; (2) “‘the issue must have been actually and necessarily determined by a court of competent jurisdiction in that prior case’”; and (3) “‘preclusion in the second case must not work a basic unfairness to the party bound by the first determination.’” Id. at 16–17 (quoting Martin v. Dep’t of Justice, 488 F.3d 446, 454 (D.C. Cir. 2007)); accord Angelex Ltd., 123 F. Supp. 3d at 78. “The overriding goal of the issue preclusion doctrine is to ‘avert needless relitigation and disturbance of repose, without inadvertently inducing extra litigation or unfairly sacrificing a person’s day in court.’” Id. at 17 (quoting Otherson v. U.S. Dep’t of Justice, 711 F.2d 267, 273 (D.C. Cir. 1983)). The first and second elements of issue preclusion are satisfied as to hospitals that are plaintiffs to both this action and Lee Memorial with respect to their challenges to the FYs 2008 and 2011 fixed loss threshold rulemakings and the 2003 outlier payment regulation amendments. In Lee Memorial, the parties litigated and the Court determined the same issues concerning each of those rulemakings that Plaintiffs purport to assert in this action. Compare Lee Memorial slip op. at 28–45 with Pls.’ Mem. in Supp. of Mot. for Summ J. at 38–73, ECF No. 64 (Apr. 25, 2016). And, as previsouly stated, the Lee Memorial Court is a court of competent jurisdiction. See Gharb, 148 F. Supp. 3d at 49–51. The third element of issue preclusion is also satified. Precluding the Plaintiffs here who were also plaintiffs in Lee Memorial from relitigating the issues that they have already litigated in that case will work no unfairness to those Plaintiffs. They have already had a full and fair Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 6 of 8 7 opportunity to argue those issues, and they did so under the representation of the same counsel who are representing them here. See Lee Memorial, Fourth Am. Compl. at 38 (Ex. B) (listing same counsel as represent Plaintiffs here). All three elements for issue preclusion are thus satisfied as to those Plaintiffs that were also plaintiffs in Lee Memorial with respect to their arguments that the FYs 2008 and 2011 fixed loss threshold rulemakings and the 2003 outlier payment regulation amendments violated the APA. Accordingly, those individual Plaintiffs should not be permitted to relitigate those issues in this action. The Court therefore should enter summary judgment in favor of the Secretary and against the Plaintiffs that were plaintiffs in Lee Memorial with respect to the FYs 2008 and 2011 fixed loss threshold rulemakings and the 2003 outlier payment regulation amendments. CONCLUSION For the foregoing reasons, the Court should enter summary judgment in the Secretary’s favor as to the Plaintiffs’ challenges to the FYs 2008 and 2011 fixed loss threshold rulemakings and the 2003 amendments to the outlier payment regulations. Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 7 of 8 8 Respectfully submitted, BENJAMIN C. MIZER Principal Deputy Assistant Attorney General CHANNING D. PHILLIPS United States Attorney JENNIFER RICKETTS Director, Federal Programs Branch JOEL McELVAIN Assistant Director, Federal Programs Branch /s/ Caroline Lewis Wolverton CAROLINE LEWIS WOLVERTON Senior Trial Counsel U.S. Department of Justice Civil Division, Federal Programs Branch P.O. Box 883 Washington DC 20044 Tel: (202) 514-0265 Fax: (202) 616-8470 E-mail: caroline.lewis-wolverton@usdoj.gov D.C. Bar No. 496-433 Attorneys for Defendant Case 1:14-cv-01220-RC Document 92 Filed 02/09/17 Page 8 of 8 EXHIBIT A Case 1:14-cv-01220-RC Document 92-1 Filed 02/09/17 Page 1 of 49 1 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA __________________________________ ) LEE MEMORIAL HEALTH SYSTEM ) f/b/o LEE MEMORIAL HOSPITAL, ) et al., ) ) Plaintiffs, ) ) v. ) Civil Action No. 13-cv-643 (RMC) ) SYLVIA M. BURWELL, Secretary of the ) U.S. Department of Health & Human ) Services ) ) Defendant. ) _________________________________ ) OPINION In these consolidated cases, Plaintiff hospitals challenge the methods used by the Department of Health & Human Services to calculate the “fixed-loss threshold,” a term integral to reimbursement under the Medicare program. Because the Center for Medicare and Medicaid Services, a constituent agency of HHS, followed the notice and comment rulemaking process and is entitled to a highly deferential standard of review, the Court cannot say that it has acted arbitrarily or capriciously. The regulations will stand. I. FACTS Plaintiffs, a group of non-profit organizations that own and operate acute care hospitals participating in the Medicare program (Hospitals),1 contend that the Center for 1 Plaintiffs are: Billings Clinic, Charleston Area Medical Center, Good Samaritan Hospital, Sarasota Memorial Hospital, Valley View Hospital, West Virginia University Hospital, Lee Memorial Health System, Banner Health, Halifax Community Health System, University of Colorado Health at Memorial Hospital, Allina Health, Denver Health Medical Center, Billings Clinic Hospital, Parkview Medical Center, Good Samaritan Hospital, and Boulder Community Hospital. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 1 of 464 1220 C Document 92-1 2 9 7 2 9 2 Medicare and Medicaid Services (CMS), led by Secretary Sylvia Burwell (the Secretary), has underpaid them for Medicare services provided during the fiscal years ending in 2008, 2009, 2010, and 2011. Plaintiffs challenge CMS’s administration of the outlier payment system, which pays eligible hospitals a percentage of their costs above the typical threshold for treating a Medicare patient. Plaintiffs challenge the “fixed loss threshold” rulemakings promulgated in fiscal years 2008 through 2011, as well as the 2003 amendment to the outlier payment regulations. Presently before the Court are Defendant’s Motion to Dismiss or, in the alternative, for Summary Judgment, Dkt. 73, and Plaintiffs’ Motion for Summary Judgment, Dkt. 74. A. Statutory Background Medicare is a federal program that provides health insurance to the elderly and the disabled. See generally 42 U.S.C. §§ 1395 et seq. Generally speaking, hospitals provide care to Medicare beneficiaries and then seek reimbursement from CMS. Reimbursement is not a precise exercise. Instead of reimbursing the providers dollar for dollar, CMS pays fixed rates through the Inpatient Prospective Payment System (IPPS).2 Under IPPS, inpatient services are divided into categories called “diagnosis related groups” or “DRGs.” See 42 U.S.C. § 1395ww(d). Each DRG merits a standard payment rate, intended to reflect the estimated average cost of treating the service(s) provided. See id. 2 The program originally reimbursed hospitals for the “reasonable costs” of services provided to Medicare patients. Cnty. of L.A. v. Shalala, 192 F.3d 1005, 1008 (D.C. Cir. 1999). That system deteriorated over time because it provided “little incentive for hospitals to keep costs down,” since “[t]he more they spent, the more they were reimbursed.” Id. (internal quotations and citations omitted). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 2 of 464 1220 C Document 92-1 2 9 7 3 9 3 Because these DRGs correspond to the given patient’s diagnosis upon discharge, the rates may vary from the costs actually incurred by the provider. In some cases, the rates may drastically understate a hospital’s costs. To compensate providers for exceptionally costly cases, Congress established the “outlier” payment system. See generally 42 U.S.C. § 1395ww(d)(5)(A). If the cost of health care in a given case exceeds the DRG payment “plus a fixed dollar amount determined by the Secretary,” then the hospital is eligible for an outlier payment. Id. § 1395ww(d)(5)(A)(ii).3 Taken together, the DRG plus the “fixed dollar amount determined by the Secretary” represents the “outlier threshold.” 42 U.S.C. § 1395ww(d)(5)(A)(ii); see also Cnty. of L.A., 192 F.3d at 1010. If a case qualifies, the provider receives 80% of the costs that exceed the outlier threshold. 42 C.F.R. § 412.84(k). This 80% is called the “additional payment” or “outlier payment.” E.g., id. §§ 412.80(a)(3), (c).4 3 The cost must also exceed “any amounts payable under subparagraphs (B) and (F).” 42 U.S.C. § 1395ww(d)(5)(A)(ii). Those subparagraphs generally cover additional payments to compensate for indirect costs of medical education (often abbreviated as IME); and for serving a significantly disproportionate number of low-income and urban populations (often abbreviated as DSH). See generally 42 U.S.C. §§ 1395ww(d)(5)(B), (F). These provisions need not be parsed for the purposes of this case; the questions presented here can be answered by considering the outlier threshold as a combination of the DRG rate and the “fixed dollar amount.” 4 The D.C. Circuit has succinctly summarized this process in a hypothetical: Assume that the Secretary sets the fixed loss threshold at $10,000. Assume also that a hospital treats a Medicare patient for a broken bone and that the DRG rate for the treatment is $3,000. The Medicare patient required unusually extensive treatment which caused the hospital to impose $23,000 in cost-adjusted charges. If no other statutory factor is triggered, the hospital is eligible for an outlier payment of $8,000, which is 80% of the difference between its cost-adjusted charges ($23,000) and the outlier threshold ($13,000). Dist. Hosp. Partners, L.P. v. Burwell, 786 F.3d 46, 50-51 (D.C. Cir. 2015). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 3 of 464 1220 C Document 92-1 2 9 7 4 9 4 The key phrase for present purposes is the “fixed dollar amount,” which is to be “determined by the Secretary” and “specified by CMS.” 42 U.S.C. § 1395ww(d)(5)(A)(ii); 42 C.F.R. § 412.80(a)(3). The parties refer to this as the “fixed-loss threshold” or “FLT.” The Fixed Loss Threshold functions as an “insurance deductible” of sorts. Boca Raton Cmty. Hosp., Inc. v. Tenet Health Care Corp., 582 F.3d 1227, 1229 (11th Cir. 2009). When the cost of care exceeds the predetermined DRG payment, the provider must absorb the entire Fixed Loss Threshold amount before it can recoup any outlier payments from CMS. The parties’ interests are thus diametrically opposed: CMS benefits from a higher Fixed Loss Threshold and the Hospitals benefit from a lower Fixed Loss Threshold. Finally, the Medicare Act requires that in any fiscal year “[t]he total amount of the [outlier] payments . . . may not be less than 5 percent nor more than 6 percent of the total payments projected or estimated to be made based on DRG prospective payment rates for discharges in that year.” 42 U.S.C. § 1395ww(d)(5)(A)(iv). Thus, although the Fixed Loss Threshold is “determined by the Secretary,” she must set a Fixed Loss Threshold high enough to ensure that projected outlier payments do not exceed 6% of the projected DRG payments, but not so high that projected outlier payments are less than 5% of the projected DRG.5 Although the statute’s command is unequivocal, Fixed Loss Threshold rulemakings are predictive. Id. (requiring outlier payments to be within 5-6 “percent of the total payments projected or estimated to be made based on DRG prospective payment rates for discharges”) (emphasis added); 42 C.F.R. § 412.80(c) (“CMS will issue threshold criteria for determining outlier 5 The numbers are inversely proportional. As the Fixed Loss Threshold rises, so does the outlier threshold. The result is a decrease in an outlier payment, which is 80% of what exceeds the outlier threshold. So as the Fixed Loss Threshold rises, outlier payments decrease, and vice versa. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 4 of 464 1220 C Document 92-1 2 9 7 5 9 5 payment in the annual notice of the prospective payment rates published in accordance with § 412.8(b).”). As a result, there is no obvious way for CMS to guarantee that annually prescribed rates and thresholds will yield outlier payments that are between 5% and 6% of total DRG payments in the next federal fiscal year. Nor must it take corrective action if its predictions fall short. See Cnty. of L.A., 192 F.3d at 1020. The D.C. Circuit has upheld this practice. See Dist. Hosp. Partners, 786 F.3d at 51. B. Regulatory Background 2003 was a watershed year for the outlier-payment system. The system had been manipulated in the late 1990s by some hospitals which exploited certain regulatory vulnerabilities, arising from “the time lag between the current charges on a submitted bill and the cost-to-charge ratio taken from the most recent settled cost report,” which predated current charges. Notice of Proposed Rulemaking, 68 Fed. Reg. 10,420, 10,423 (Mar. 5, 2003) (3/5/03 NPRM). The outlier payment system depends on calculating “charges, adjusted to cost,” including overhead and capital costs. 42 U.S.C. § 1395ww(d)(5)(A)(ii) (emphasis added). That adjustment is made using the “cost-to-charge ratio” (CCR) mentioned in the Notice of Proposed Rulemaking. Because hospitals knew that CCRs were based on past cost reports, some hospitals increased their charges for patient care between past cost reports and current reimbursement requests, yielding a CCR that would “be too high” and thus “overestimate the hospital’s costs.” 3/5/2003 NPRM at 10,423. Some 123 hospitals were found to have increased their charges by 70 percent, while only decreasing their CCRs by two percent. Id. at 10,424. This became known as “turbo-charging.” Dist. Hosp. Partners, 786 F.3d at 51 (describing turbochargers). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 5 of 464 1220 C Document 92-1 2 9 7 6 9 6 1. The February 2003 Draft Interim Final Rule The Hospitals rely heavily on a Draft Interim Final Rule proposed in February 2003—before the Notice of Proposed Rulemaking cited above—and obtained by them through a Freedom of Information Act (FOIA) request. Hosp. Mot. [Dkt. 74] at 11 (citing AR S3595- S3659) (Draft); see also Joint Appendix, Ex. 4 [Dkt. 81-4] at 97-161 (same). The 63-page Draft included a number of findings and proposed various solutions.6 The Draft found that turbocharging caused “nearly all of the increase in the FY 2003 threshold from FY 2002 ($21,025 to $33,560).” AR S3610. It also described the effect of turbocharging on the Fixed Loss Threshold: “Because the fixed-loss threshold is determined based on hospitals’ historical charge data, hospitals that have been inappropriately maximizing their outlier payments have caused the threshold to increase dramatically for FY 2003.” AR S3610. To prevent future turbocharging, the Draft said that CMS “need[ed] to make revisions to [its] outlier payment methodology,” primarily by “updating cost-to-charge ratios [CCRs].” 3/5/2003 NPRM at 10,421, 10,423. See also generally AR S3612-15. More specifically, the Draft proposed to amend CMS’s payment regulations so that “fiscal intermediaries”—insurance companies who examine Medicare payment claims under contract with CMS—could “use either the most recent settled or the most recent tentative settled cost report, whichever is from the latest cost reporting period.” AR S3614. But reducing the lag time alone would not be enough, because some hospitals could still “increase charges much faster 6 The Court will ascribe the findings and recommendations to “the Draft” and not to “CMS.” While the Hospitals argue that the Draft was CMS’s “first official act” in the rulemaking process, Hosp. Mot. at 11, a draft rule that is circulated internally and then abandoned does not constitute anything but a discarded first effort. Although the Court previously ordered that the Draft be added to the Administrative Record—a decision that was upheld by the D.C. Circuit in a related appeal, Dist. Hosp. Partners, 786 F.3d at 55 n.3—the Draft never became an official proposal by CMS. See generally id. at 58. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 6 of 464 1220 C Document 92-1 2 9 7 7 9 7 than costs during the time between the tentative settled cost report period and the time when the claim is processed. . . . [T]here will still be a lag of 1 to 2 years.” AR S3614-15. To counter this possibility, the Draft proposed a new regulatory provision that would allow CMS to increase a hospital’s CCR if “more recent charge data indicate that a hospital’s charges have been increasing at an excessive rate (relative to the rate of increase among other hospitals).” AR S3615. The hospitals could also have requested a modified CCR if they presented substantial evidence that the ratios were inaccurate. AR S3615. Further, the Draft reconsidered CMS’s previous policy “that payment determinations [were] made on the basis of the best information available at the time a claim is processed and [were] not revised, upward or downward, based upon updated data.” AR S3620. Acknowledging that “some hospitals have taken advantage of the current outlier policy,” AR S3620, the Draft resolved to reconcile processed payments with hospital cost reports once they were ultimately settled. AR S3621; see also AR 3626 (“[W]e believe the only way to eliminate the potential for such overpayments is to provide a mechanism for final settlement of outlier payments using actual cost-to-charge ratios from final, settled cost reports.”). That proposal would trigger another problem, however: “in the event of a decline in the [CCR], some cases would no longer qualify for any outlier payments while other cases would qualify for lower outlier payments.” AR S3622 (emphasis added). In other words, the reconciliation might show that an instance of patient treatment was never eligible for an outlier payment to begin with. And because CMS must predict the “total amount” of outlier payments before the fiscal year begins to comply with the 5-6% requirement, “the only way to accurately determine the net effect of a decrease in [CCRs] on a hospital’s total outlier payments is to assess the impact on a claim-by- Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 7 of 464 1220 C Document 92-1 2 9 7 8 9 8 claim basis.” Id. The Draft admitted candidly that CMS was “still assessing the procedural changes necessary to implement this change.” Id. The proposed amendments to the outlier payment scheme would have also made it “necessary,” according to the Draft, to lower the Fixed Loss Threshold. AR S3629. After excluding the 123 offending turbochargers from the CCR pool; applying actual CCRs (from settled cost reports) to the hospitals that were previously assigned statewide averages; extrapolating future CCRs from the national progression over the previous three years; and reestimating charge inflation without the 123 turbochargers, the Draft recommended reducing the Fixed Loss Threshold from $33,560 to $20,760. See AR S3629-33. 2. FY 2003 Proposed and Final Rules Amending Payment Regulation The Draft was never published. Although the Hospitals suggest that CMS “bow[ed] to pressure from [the Office of Management and Budget],” Hosp. Mot. at 11, that proposition finds no support in the record and may be inconsequential since both agencies are in the Executive Branch and headed by presidential appointees exercising their discretion. Whatever the reason, the Draft was abandoned. Instead, CMS on March 5, 2003 published a Notice of Proposed Rulemaking, 3/5/03 NPRM, 68 Fed. Reg. 10,420-29. The NPRM contained the same modifications listed above to the outlier payment scheme, but did not propose a corresponding reduction in Fixed Loss Threshold. After comments, the Final Rule was largely unchanged. See Final Rule, 68 Fed. Reg. 34,494 (June 9, 2003) (Final Rule). “Many commenters recommended that [CMS] lower the outlier threshold.” Final Rule at 34,505. CMS acknowledged having “reestimated the fixed- loss threshold reflecting the changes implemented in this final rule that will be in effect during a Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 8 of 464 1220 C Document 92-1 2 9 7 9 9 9 portion of FY 2003.” Id. Specifically, CMS inflated charges in the FY 2002 Medical Provider Analysis and Review (MedPAR) file7 by the two-year average annual rate of change in charges. Id. Had its analysis stopped there, the Fixed Loss Threshold would have been $42,300. Id. “However, after accounting for the changes implemented in this final rule, we estimate the threshold would be only slightly higher than the current threshold (by approximately $600).” Id. (emphasis added). Nonetheless, despite concluding that the Fixed Loss Threshold should be higher, CMS found it “appropriate not to change the FY 2003 outlier threshold at this time” because “[c]hanging the threshold for the remaining few months of the fiscal year could disrupt the hospitals’ budgeting plans and would be contrary to the overall prospectivity of the [inpatient prospective payment system].” Id. at 34,506. The Fixed Loss Threshold stayed at $33,560 for the remainder of FY 2003. Id. 3. The FY 2004 Regulations By the time CMS set the Fixed Loss Threshold for FY 2004, the changes to the outlier payment regulations were fully in effect. See generally Final Rule, 68 Fed. Reg. 45,346 (Aug. 1, 2003) (FY 2004 FLT Reg.). Extrapolating from 2002 MedPAR data, CMS applied “the 2-year average annual rate of change in charges per case,” as opposed to costs per case, “to establish the FY 2004 threshold.” Id. at 45,476. CMS then took three steps to update the CCR: [1] for each hospital, we matched charges-per-case to costs-per-case from the most recent cost reporting year; [2] we then divided each hospital’s costs by its charges to calculate the cost-to-charge ratio for each hospital; and [3] we multiplied charges from each case in 7 The MedPAR file “contains data from claims for services provided to beneficiaries admitted to Medicare certified inpatient hospitals and skilled nursing facilities.” CMS.gov, Medicare Provider Analysis and Review (MEDPAR) File (Feb. 18, 2015 5:11 PM), https://www.cms.gov/ Research-Statistics-Data-and-Systems/Files-for-Order/IdentifiableDataFiles/MedicareProvider AnalysisandReviewFile.html. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 9 of 46Case 1:14-cv-01220-RC Document 92-1 Filed 02/09/17 Page 10 of 49 10 the FY 2002 MedPAR (inflated to FY 2004) by this cost-to-charge ratio to calculate the cost per case. Id. The FY 2004 Fixed Loss Threshold regulation also reviewed and evaluated the reconciliation process established by the 2003 amendment to the outlier payment threshold.8 68 Fed. Reg. at 45,476-77. The novel reconciliation process had presented a roadblock. See id. (“Without actual experience with the reconciliation process, it is difficult to predict the number of hospitals that will be reconciled.”). CMS resolved to “assess the appropriate number of hospitals to be reconciled” once “later data bec[a]me available.” Id. CMS did identify, however, 50 of the turbocharging hospitals as likely subjects of reconciliation. Id. at 45,476-77. Based on all of this, CMS set an FY 2004 Fixed Loss Threshold of $31,000. Id. at 45,477. 4. The FY 2005-2007 Fixed Loss Threshold Regulations This pattern largely repeated itself until the years challenged in this case. See generally 69 Fed. Reg. 48,916, 49,276, 49,278 (Aug. 11, 2004) (FY 2005 FLT Reg.) (lowering the Fixed Loss Threshold to $25,800, after initially proposing $35,085, in response to comments suggesting that CMS revise its methodology); 70 Fed. Reg. 47,278, 47,493-94 (Aug. 12, 2005) (FY 2006 FLT Reg.) (lowering the Fixed Loss Threshold to $23,600, after initially proposing $26,675, by using the same methodology but updated data); 71 Fed. Reg. 47,870, 48,151 (Aug. 18, 2006) (FY 2007 FLT Reg.) (raising the Fixed Loss Threshold to $24,475, after initially 8 The FY 2003 amendment to the Payment Regulations instituted a process to reconcile outlier payments for hospitals that were overpaid due to the “time lag in updating their cost-to-charge ratios.” 68 Fed. Reg. at 34,504. Outlier “[p]ayments will be processed throughout the year using the appropriate historical . . . cost-to-charge ratios” and after “the cost report is settled,” outlier payments can be reconciled using the cost-to-charge ratio determined at the time the report is settled. Id. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 10 of 464 1220 C Document 92-1 2 9 7 1 9 11 proposing $25,530). To sum up: the Fixed Loss Threshold was set at $25,800 in FY 2005; $23,600 in FY 2006; and $24,475 in FY 2007. Throughout these rulemakings, commenters continually complained that the Fixed Loss Thresholds were too high, both out of self-interest and a concern over statutory compliance by CMS. E.g., FY 2005 FLT Reg. at 49,276 (“Some commenters explained that this increase to the threshold would make it more difficult for hospitals to qualify for outlier payments and put them at greater risk when treating high cost cases. . . . The commenters further noted that, in the proposed rule, [CMS] estimated total outlier payments for FY 2004 to be 4.4 percent of all inpatient payments.”); FY 2006 FLT Reg. at 47,974; FY 2007 FLT Reg. at 48,149. Commenters cited previous years’ outlier payments, which had not fallen within the 5-6% statutory window. E.g., FY 2007 FLT Reg. at 48,149 (“The commenters noted that total estimated outlier payments in FY 2004 and FY 2005 were well under the 5.1 percent target.”). CMS conceded this as a factual matter. Id. at 48,150 (“As the commenters noted, the outlier thresholds we have projected in the last several years have resulted in payments below the 5.1 percent target.”). CMS also noted that in earlier years, payments had been significantly higher than 5.1% because of turbocharging. Id. (“[I]n the early years of th[e] decade, outlier payments were significantly higher than the 5.1 percent target we projected.”). More specifically, commenters decried CMS’s failure to (1) apply an adjustment factor to the CCRs; or (2) account for the effect of reconciliation. E.g., FY 2006 FLT Reg. at 47,494 (“Several commenters suggested an alternative to the methodology we proposed”: CMS “should adjust cost-to-charge ratios that will be used to calculate the FY 2006 outlier threshold.”); FY 2005 FLT Reg. at 49,277 (“One of the commenters also noted that none of the Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 11 of 464 1220 C Document 92-1 2 9 7 2 9 12 calculations above factored in the impact of reconciliation that would result in an even lower outlier threshold.”). On the first point, CMS eventually relented. See FY 2007 FLT Reg. at 48,150 (“[W]e now agree with the commenters that it is appropriate to apply an adjustment factor to the CCRs so that the CCRs we are using in our simulation more closely reflect the CCRs that will be used in FY 2007.”). CMS agreed to “apply only a one year adjustment factor” of 99.73%. Id. The Hospitals refer to this as a “negative 0.27%.” Hosp. Mot. at 14. On the second point, CMS held firm and did not account for the potential effect of reconciliation when setting the outlier threshold. FY 2007 FLT Reg. at 48,149 (“As we did in establishing the FY 2006 outlier threshold, in our projection of FY 2007 outlier payments, we proposed not to make an adjustment for the possibility that hospitals’ CCRs and outlier payments may be reconciled upon cost report settlement.”) (citation omitted). 5. The FY 2008-2011 Fixed Loss Threshold Regulations We come now to the Fixed Loss Threshold regulations at issue in this case. Cf. Hosp. Mot. at 15 (“In Each of FYs 2008-2011 Here at Issue . . . .”). The Hospitals allege generally that CMS “continued to use the flawed FLT model that had resulted in substantial underpayment in FY 2007.” Id. With the benefit of hindsight, CMS has reported that the total outlier payments (as a percentage of total DRG payments) were 4.8% for FY 2008, see 74 Fed. Reg. at 44,012 (AR 7084); 5.3% for FY 2009, see 75 Fed. Reg. 50,042, 50,431 (Aug. 16, 2010) (AR 10187)9; 4.7% for FY 2010, see 76 Fed. Reg. 51,476, 51,795-96 (Aug. 18, 2011); and 4.8% for FY 2011, see 77 Fed. Reg. 53,258, 53,697 (Aug. 31, 2012). 9 The Hospitals dispute this figure, claiming that commenters have since showed outlier payments totaled only 4.9 %. Hosp. Mot. at 15 (citing AR 9473). The reference is to a June 2010 memorandum from the Federation of American Hospitals. See AR 9420-79 [Dkt. 81-3 at Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 12 of 464 1220 C Document 92-1 2 9 7 3 9 13 a. FY 2008 For FY 2008, CMS used the same methodology as it had used for FY 2007 to calculate the outlier threshold. See 72 Fed. Reg. 47,130, 47,417 (Aug. 22, 2007) (FY 2008 FLT Reg.). The agency applied a one-year CCR adjustment factor (99.12%) to the CCRs in the October 2006 update to the hospitals’ Provider Specific File, which is a file for each provider that contains the unique information relevant to that provider that is used by CMS to compute payments and repayments for services provided. CMS also artificially inflated (by 15.04%) the 2006 MedPAR claims by two years. Id. The result was a proposed Fixed Loss Threshold of $23,015. Id. Several commenters thought that amount was too high. See generally id. at 47,417-18. These commenters noted that outlier payments had been only 4.63% of overall FY 2007 payments; faulted CMS for not using more recent CCR data; and suggested applying the CCR adjustment factor over different periods of time (longer or shorter than one year). Id. CMS did not budge. See id. at 47,418 (“Because we are not making any changes to our methodology for this final rule with comment period, for FY 2008, we are using the same methodology we proposed to calculate the outlier threshold.”). It did use more recent data, however, which resulted in a lower final Fixed Loss Threshold of $22,635. Id. at 47,419.10 One commenter implored CMS to use even more recent data. Id. at 47,418 (“The commenter urged CMS to use the June 2007 update [to the hospital CCRs] instead of the March 2007 update for the final rule.”). CMS declined because the June CCR update would not be ready until the end 130-38]. The Federation cites an accompanying Vaida Health Data Consultants study that concluded: “The actual FY 2009 outlier payment level was estimated at 4.9 percent; the CMS estimate published in the Proposed Rule is 5.3 percent.” AR 9480. 10 A notable product of the updated data was the swing in CCR adjustment factor, from a negative in the proposed rule (0.9912) to a positive in the final rule (1.0027). Id. at 47,418. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 13 of 464 1220 C Document 92-1 2 9 7 4 9 14 of July, “which is beyond the timetable necessary for us to compute the outlier threshold and publish this final rule with comment period by August 1st.” Id. b. FY 2009 The process was the same for FY 2009. See 73 Fed. Reg. 48,434, 48,763 (Aug. 19, 2008) (FY 2009 FLT Reg.) (“For FY 2009, we proposed to continue to use the same methodology used for FY 2008 to calculate the outlier threshold.”) (citation omitted). CMS again proposed a one-year CCR adjustment factor (99.2%) to CCRs calculated from the previous December’s Provider Specific File update. Id. Once again, the previous year’s MedPAR data were extrapolated out by two years. Id. The result was a proposed Fixed Loss Threshold of $21,025. Id. This proposal found a slightly more welcoming reception than its predecessors. Id. at 48,764 (“The commenters commended CMS for making refinements such as applying an adjustment factor to CCRs when computing the outlier threshold but noted that, because CMS is still not reaching the 5.1 percent target, there is still room for improvement.”). Commenters again called the CCR adjustment calculation “unnecessarily complicated”; again urged CMS to use more recent, historical, and industry-wide rates of change; again asked CMS to vary the CCR adjustment factor to more or less than one year; and again asked CMS to apply the June Provider Specific File update instead of the March version. Id. Once again, CMS was implacable. See generally id. (providing largely the same reasons as in FY 2008). Applying the same methodology as in the proposed rule—but with more recent data—CMS settled on a Fixed Loss Threshold of $20,185. Id.11 As it had done 11 This was later revised, for unrelated reasons, to $20,045. See 73 Fed. Reg. 57,888, 57,891 (Oct. 3, 2008). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 14 of 464 1220 C Document 92-1 2 9 7 5 9 15 previously, CMS refused to make “any adjustments for the possibility that hospitals’ CCRs and outlier payments may be reconciled upon cost report settlement.” Id. at 48,765. c. FY 2010 “For FY 2010, [CMS] proposed to continue to use the same methodology used for FY 2009 to calculate the outlier threshold.” 74 Fed. Reg. 43,754, 44,007 (Aug. 27, 2009) (FY 2010 FLT Reg.) (citation omitted). The previous year’s MedPAR files were used, and a one- year CCR adjustment factor (98.4%) was applied to the CCRs as contained in the previous December’s Provider Specific File update. See generally id. at 44,007-08. CMS proposed a Fixed Loss Threshold of $24,240, which represented a 21% increase from the previous fiscal year. Id. at 44,008. The FY 2010 proposed increase spurred further protest. See generally id. Commenters could not understand why—when CMS had met its target in FY 2009—there should be any change. Id. at 44,009. Others accused CMS of purposefully erring on the low end of the 5-6% target or below it altogether. Id. Another asked CMS to make a mid-year change to the Fixed Loss Threshold if it appeared that the 5-6% target would not be met. Id. Still others repeated the requests to use June data instead of March data in the Final Rule, to account for reconciliation. Id. at 44,009-10. CMS insisted in its response that it had “use[d] the most recent data available to set the outlier threshold.” Id. at 44,009. A mid-year course correction was rejected. Id. (citing 70 Fed. Reg. at 47,495). All other suggestions were denied for the same reasons as in previous years. See generally FY 2010 FLT Reg. at 44,010. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 15 of 464 1220 C Document 92-1 2 9 7 6 9 16 d. FY 2011 Fiscal year 2011—the last at issue in this case—proved to be no different. See 75 Fed. Reg. 50,042, 50,427 (FY 2011 FLT Reg.) (Aug. 16, 2010) (“For FY 2011, [CMS] proposed to continue to use the same methodology used for FY 2009 to calculate the outlier threshold.”) (citation omitted). CMS proposed a one-year CCR adjustment factor of 98.9% with a resulting Fixed Loss Threshold of $24,165, a 4.5% increase from the previous year. Id. at 50,428. Commenters again pointed out that the previous year had missed the mark (outlier payments were merely 4.7% of total payments) and reiterated the previous years’ suggestions about how to fix that. See generally id. at 50,428-29. Commenters also made several discrete suggestions, addressed in the analysis below. See infra at 38-39. CMS rejected each of the suggestions. FY 2011 FLT Reg. at 50,429 (“Because we are not making any changes to our methodology for this final rule, for FY 2011, we are using the same methodology we proposed to calculate the outlier threshold.”). Applying that methodology to the updated data yielded a final Fixed Loss Threshold of $23,075. Id. at 50,430. C. Procedural History Hospitals can challenge the payments they receive as reimbursements for Medicare services by appealing to the Medicare Provider Reimbursement Review Board (PRRB). See 42 U.S. C. § 1395oo(a), (b) (allowing consolidated appeals by multiple hospitals). When raising questions of law challenging the validity of a regulation, hospitals can request that the PRRB authorize expedited judicial review in federal district court. Id. § 1395oo(f)(1). During an appeal to the PRRB, Plaintiffs requested expedited judicial review of the following question pertaining to the Threshold Regulations during FY 2008 through FY 2011 and the 2003 amendments to the Payment Regulations: Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 16 of 464 1220 C Document 92-1 2 9 7 7 9 17 Whether the specific regulations governing Outlier Case Payments as set forth in the two regulatory sources—the Outlier Payment Regulations and the fixed loss threshold (“FLT”) Regulations (collectively, the “Medicare Outlier Regulations”)—as promulgated by the Secretary of Health and Human Services (“HHS” or the “Secretary”) and the Centers for Medicare and Medicaid Services (“CMS”), and in effect for the appealed years are contrary to the Outlier Statute and/or are otherwise substantively or procedurally invalid? PRRB R 87 (Case No. 13-0593GC) [Dkt. 81-1]. The PRRB granted expedited review and Plaintiffs filed this action on May 3, 2013. See Compl. [Dkt. 1]. On September 2, 2014, this case was consolidated with three others. See Order Consolidating Cases [Dkt. 25] (consolidating this case with Allina Health v. Burwell, Case No. 13-cv-775; Allina Health v. Burwell, Case No. 13-cv-776; and Denver Health Medical Center v. Burwell, Case No. 14-cv-553). Plaintiffs have since amended the operative complaint in Dkt. 65, see Fourth Amended Complaint, [Dkt. 65], and the parties have filed cross motions for summary judgment. Plaintiffs’ Mot. for Summary Judgment [Dkt. 74] (Hosp. Mot.); Gov’t Mot. for Summary Judgment [Dkt. 73] (Gov’t Mot.).12 II. LEGAL STANDARD The Medicare statute incorporates the standards of the Administrative Procedure Act, 5 U.S.C. §§ 551 et seq. (APA). See 42 U.S.C. § 1395oo(f)(1) (“Such action[s] . . . shall be tried pursuant to the applicable provisions under chapter 7 of Title 5.”). “[W]hen a party seeks review of agency action under the APA, the district judge sits as an appellate tribunal. The ‘entire case’ on review is a question of law.” Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001). This Court will review CMS’s actions under the APA and decide 12 The Court also previously ruled on Plaintiffs’ Motion to Compel the Administrative Record, Dkt. 51, granting in part and denying in part. See Lee Mem’l Hosp. v. Burwell, 109 F. Supp. 3d 40, 51 (D.D.C. 2015). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 17 of 464 1220 C Document 92-1 2 9 7 8 9 18 “whether as a matter of law the agency action is supported by the administrative record and is otherwise consistent with the APA standard of review.” Se. Conference v. Vilsack, 684 F. Supp. 2d 135, 142 (D.D.C. 2010). This Court will uphold CMS’s actions unless they are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). “An agency decision is arbitrary and capricious if it ‘relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.’” Cablevision Sys. Corp. v. Fed. Commc’ns Comm’n, 649 F.3d 695, 714 (D.C. Cir. 2011) (quoting Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). Under the APA, an agency must “examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made.” Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43 (internal quotation and citation omitted). “Moreover, an agency cannot ‘fail[] to consider an important aspect of the problem’ or ‘offer [] an explanation for its decision that runs counter to the evidence’ before it.” Dist. Hosp. Partners, 786 F.3d at 57 (quoting Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43)). The Court’s review is “narrow[,] as courts defer to the agency’s expertise,” Ctr. For Food Safety v. Salazar, 898 F. Supp. 2d 130, 138 (D.D.C. 2012) (quoting Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43)), and the reviewing court must not “substitute its judgment for that of the agency.” Id. (quoting Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43)). However, a court may uphold agency action that is not fully explained “if the agency’s path may reasonably be discerned.” Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S. 281, 286 (1974). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 18 of 464 1220 C Document 92-1 2 9 7 9 9 19 A. Motion to Dismiss for Lack of Subject Matter Jurisdiction Federal Rule of Civil Procedure 12(b)(1) allows a defendant to move to dismiss a complaint, or any portion thereof, for lack of subject matter jurisdiction. Fed. R. Civ. P. 12(b)(1). No action of the parties can confer subject matter jurisdiction on a federal court because subject matter jurisdiction is both a statutory requirement and an Article III requirement. Akinseye v. District of Columbia, 339 F.3d 970, 971 (D.C. Cir. 2003). The party claiming subject matter jurisdiction bears the burden of demonstrating that such jurisdiction exists. Khadr v. United States, 529 F.3d 1112, 1115 (D.C. Cir. 2008); see Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994) (noting that federal courts are courts of limited jurisdiction and “[i]t 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”) (internal citations omitted). When reviewing a motion to dismiss for lack of jurisdiction under Rule 12(b)(1), a court must review 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). Nevertheless, “the Court need not accept factual inferences drawn by plaintiffs if those inferences are not supported by facts alleged in the complaint, nor must the Court accept plaintiffs’ legal conclusions.” Speelman v. United States, 461 F. Supp. 2d 71, 73 (D.D.C. 2006). A court may consider materials outside the pleadings to determine its jurisdiction. Settles v. U.S. Parole Comm’n, 429 F.3d 1098, 1107 (D.C. Cir. 2005); Coal. for Underground Expansion v. Mineta, 333 F.3d 193, 198 (D.C. Cir. 2003). A court has “broad discretion to consider relevant and competent evidence” to resolve factual issues raised by a Rule 12(b)(1) motion. Finca Santa Elena, Inc. v. U.S. Army Corps of Eng’rs, 873 F. Supp. 2d 363, 368 (D.D.C. 2012) (citing 5B Charles Wright & Arthur Miller, Fed. Prac. & Pro., Civil § 1350 (3d ed. 2004)); see also Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 19 of 464 1220 C Document 92-1 2 9 7 20 9 20 Macharia v. United States, 238 F. Supp. 2d 13, 20 (D.D.C. 2002), aff’d, 334 F.3d 61 (2003) (in reviewing a factual challenge to the truthfulness of the allegations in a complaint, a court may examine testimony and affidavits). In these circumstances, consideration of documents outside the pleadings does not convert the motion to dismiss into one for summary judgment. Al-Owhali v. Ashcroft, 279 F. Supp. 2d 13, 21 (D.D.C. 2003). B. Motions for Summary Judgment Under Federal Rule of Civil Procedure 56, summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). Moreover, summary judgment is properly granted against a party who “after adequate time for discovery and upon motion . . . fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). In ruling on a motion for summary judgment, the court must draw all justifiable inferences in the nonmoving party’s favor and accept the nonmoving party’s evidence as true. Anderson, 477 U.S. at 255. When evaluating cross-motions for summary judgment, each motion is reviewed “separately on its own merits to determine whether [any] of the parties deserves judgment as a matter of law.” Family Trust of Mass., Inc. v. United States, 892 F. Supp. 2d 149, 154 (D.D.C. 2012) (internal quotation and citation omitted). Neither party is deemed to “concede the factual assertions of the opposing motion.” CEI Wash. Bureau, Inc. v. Dep’t of Justice, 469 F.3d 126, 129 (D.C. Cir. 2006) (citation omitted)). “[T]he court shall grant summary judgment only if one of the moving parties is entitled to judgment as a matter of law upon material facts that are not Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 20 of 464 1220 C Document 92-1 2 9 7 1 9 21 genuinely disputed.” GCI Health Care Centers, Inc. v. Thompson, 209 F. Supp. 2d 63, 67 (D.D.C. 2002). A genuine issue exists only where “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson, 477 U.S. at 248. III. ANALYSIS The Hospitals cite “five flaws” in the Threshold Regulations described above for FYs 2008 through 2011. Hosp. Mot. at 27. First, the Hospitals accuse CMS of employing merely a “token CCR adjustment factor,” a miniscule amount compared to the true decline in CCRs nationally. Id. Second, the Hospitals find it anomalous that CMS’s positive, substantial inflation factors resulted in decreased Fixed Loss Thresholds. Third, the Hospitals impugn CMS’s modeling of historical outlier payments, which were “represented as having been made in prior FYs.” Id. Fourth, the Hospitals say it is “[c]ontrary to its established past practices” for CMS to have ignored prior years’ underpayments. Id. And fifth, the Hospitals say that CMS violated its own regulations and guidance when it failed to consider reconciliation when setting the Fixed Loss Threshold and failed to respond to comments urging the same. With the exception of the second argument, which is not advanced against the FY 2010 Threshold Regulation, all five arguments apply to all four years at issue. The Court will therefore address them categorically instead of taking each year in turn. The Hospitals also argue that the Payment Regulations, amended in 2003, are invalid both because they were promulgated in violation of the APA’s procedural requirements (under 5 U.S.C. § 553) and because, as applied, they are arbitrary, capricious or otherwise not in accordance with law (under 5 U.S.C. § 706). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 21 of 464 1220 C Document 92-1 2 9 7 2 9 22 A. Applicable Case Law 1. District Hospital Partners, L.P. v. Burwell (Dist. Hosp. Partners II) This Court does not paint on a blank canvas. In District Hospital Partners, L.P. v. Burwell, the D.C. Circuit recently rejected several challenges to rulemakings concerning Fixed Loss Thresholds. 786 F.3d 46 (D.C. Cir. 2015) (Dist. Hosp. Partners II). In that case, 186 hospitals challenged the Fixed Loss Thresholds for FYs 2004, 2005, and 2006. Id. at 48. The Circuit rejected the broad proposition “that the Secretary was obligated to use the best available data in formulating the outlier thresholds,” id. at 56, because the court could find no statute, regulation, or precedent to support it. See generally id. at 56-57; but see id. at 56 (“To be clear, agencies do not have free rein to use inaccurate data.”) (emphasis in original); id. at 57 (“These requirements underscore that an agency cannot ignore new and better data.”) (emphasis in original). The Circuit reviewed the data used and explanations given in each rulemaking because “[w]hether an agency has arbitrarily used deficient data depends on the specific facts of a particular case.” Id. For each year—2004, 2005, and 2006—plaintiffs in Dist. Hosp. Partners argued that CMS had “acted arbitrarily and capriciously by setting the outlier thresholds too high.” Id. The Circuit reviewed each year individually because of the varying considerations addressed in each rulemaking. The challenge to the FY 2004 rulemaking focused on CMS’s failure to exclude data from the 123 turbocharging hospitals that were identified in the NPRM. Id. at 58. The Dist. Hosp. Partners plaintiffs focused their argument on the variations between a draft rule, which was never published for notice and comment, and the final rule. In the draft rule, CMS had excluded data from the turbochargers, but in the final rule the data was included. The plaintiffs argued that CMS was arbitrary and capricious because it did not explain the differences Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 22 of 464 1220 C Document 92-1 2 9 7 3 9 23 between the internal draft and final rule. Id. The Circuit determined that federal courts are empowered to review final action of an agency; since the FY 2004 draft was never part of the final rule, it was not reviewable. “[T]he published regulations did not ‘repeal or modify’ anything because the draft ‘never became a binding rule requiring repeal or modification.’” Id. at 58 (quoting Kennecott Utah Copper Corp. v. DOI, 88 F.3d 1191, 1208 (D.C. Cir. 1996)). The Circuit found that CMS was not required to address an internal draft, as part of notice and comment, because it was not part of formulating the proposed new rule. Id. Although the Circuit found CMS was not arbitrary or capricious by failing to comment on the FY 2004 draft rule, it found the 2004 rulemaking otherwise deficient because CMS had failed to address all of the 123 turbocharging hospitals and had only accounted for 50 turbocharging hospitals. Id. at 58-59. The Circuit found this omission to be significant because accounting for only 50 turbocharging hospitals decreased the FY 2004 outlier threshold significantly, which presumably meant that factoring in all 123 hospitals would have further decreased the threshold and resulted in more outlier payments to the plaintiffs. Id. at 59. Thus, the Circuit held that CMS failed to “examine the relevant data and articulate a satisfactory explanation for its action,” because the inconsistency between the 123 turbochargers identified in the NPRM and 50 turbochargers identified in the outlier threshold rulemaking “went unresolved in the 2004 rulemaking.” Id. The Circuit remanded to the Secretary to “explain why [it] corrected for only 50 turbo-charging hospitals in the 2004 rulemaking rather than for the 123 [it] had identified in the NPRM.” Id. at 60. The Circuit rejected plaintiffs’ arguments that the Secretary also acted arbitrarily and capriciously in the 2005 and 2006 rulemakings by “setting the outlier thresholds too high” due to the effect of the turbo-charging hospitals. Id. at 57. The Circuit found that, in the FY Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 23 of 464 1220 C Document 92-1 2 9 7 4 9 24 2005 and 2006 rulemakings, CMS used a new methodology for calculating the charge inflation factor, which obviated the need to factor in any turbocharging hospitals, and avoided the issues present in the 2004 rulemaking. Id. at 61. The Circuit held that CMS adequately explained its new methodology and “used the most recent data that accounted for the outlier correction rule’s effects.” Id. at 62. 2. District Hospital Partners, L.P. v. Sebelius District Hospital Partners II was a partial appeal from the district court’s decision in District Hospital Partners, L.P. v. Sebelius, 973 F. Supp. 2d 1 (D.D.C. 2014) (Dist. Hosp. Partners I). The remaining holdings of the district court are instructive to the current case. The Court considered a challenge to CMS’s cost-to-charge ratio in 3 ways: (1) its failure to account for a continued trend of declining cost-to-charge ratios; (2) its removal of the “floor” with its default to statewide average cost-to-charge ratios; and (3) its failure to account for the effects of reconciliation on an individual hospital’s Fixed Loss Threshold. The district court found that CMS had not been arbitrary or capricious by relying on actual historical data and not projecting continuing declines in cost-to-charge ratios. Id. at 15-16. The district court also found that CMS had adequately considered the effect of terminating its practice of defaulting to statewide averages when a hospital’s cost-to-charge ratio was lower than a predetermined threshold. Id. at 16. Plaintiffs argued that CMS “never addressed . . . how [it] accounted for the change in policy regarding default to statewide averages.” Id. The Court found, however, that despite CMS’s lack of a direct response, the rulemaking “clearly accounted for the change in policy” and the Court would not substitute its judgment for CMS’s decision “not to undertak[e] the task of modeling the undoubtedly complex and attenuated effects of the [change in] policy on hospital behavior.” Id. at 16-17. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 24 of 464 1220 C Document 92-1 2 9 7 5 9 25 Finally, Plaintiffs argued that CMS “acted arbitrarily and capriciously by not accounting for the effect of reconciliation on the fixed loss threshold calculation.” Id. at 17. The Court again considered CMS’s findings and explanations and found that CMS did not ignore the issue. CMS “explained that it was impossible to predict the full effects of reconciliation” and attempted to project reconciled cost-to-charge ratios for those hospitals CMS anticipated would face reconciliation. Id. at 17-18. In light of the new nature of the reconciliation procedure, the Court found CMS’s action “reasonable and adequately responsive to plaintiffs’ [] concerns.” Id. at 18. 3. Banner Health v. Burwell In addition to the two District Hospital Partners cases, Banner Health v. Burwell, 126 F. Supp. 3d 28 (D.D.C. 2015) is relevant to this case. In Banner Health, 29 organizations that owned or operated hospitals challenged the Fixed Loss Thresholds in FYs 1997 through 2007 and challenged the outlier payment regulations of 1988, 1994, and 2004. The Court summarizes only the potentially relevant holdings. First, Banner Health found it was reasonable for CMS to “adjust[ ] charges to cost to determine whether those cost-adjusted charges were above the applicable [fixed loss] threshold, and then ma[ke] a payment based on the amount by which the cost-adjusted charges exceeded that threshold.” Id. at 75. Banner Health also found CMS did not violate the APA by “failing to conduct reconciliation or to account for reconciliation in setting the fixed loss thresholds for FY 2004 through FY 2007,” because “nowhere does the statute require the agency to undertake reconciliation.” Id. at 78-79. The challenged regulations also did not require reconciliation, but instead indicated that some payments could be “subject to adjustment.” Id. at 79. “Because reconciliation became simply an option rather than a requirement, it would be Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 25 of 464 1220 C Document 92-1 2 9 7 6 9 26 irrational to conclude that the statute actually required the agency to account for reconciliation explicitly in calculating the fixed loss threshold.” Id. CMS’s outlier payment determinations were found to be reasonable in that CMS “use[d] the actual cost-to-charge ratios in order to set the FY 2004 through FY 2006 fixed loss threshold, rather than adjusting those ratios to account for possible continued declines” in the cost-to-charge ratios. Id. The statute only required CMS to set the threshold as “tested against historical data,” not considering current trends. Id. The Banner Health plaintiffs had lodged separate challenges to the Fixed Loss Threshold rulemakings in FYs 1998 through 2003 and FYs 2004 through 2007. For the earlier years, they argued that CMS acted arbitrarily and capriciously by not reacting to its own continued failure to meet the targeted amount of outlier payments. The district court concluded that “[j]ust because the agency was aware that actual outlier payments exceeded the predicted levels for these years [ ] does not mean that it was arbitrary or capricious to continue implementing this model.” Id. at 90 (internal citation omitted). Additionally, for FYs 2001 through 2003, the Banner Health plaintiffs challenged what they called “fudge factors” used to set the Fixed Loss Threshold. The district court rejected the argument, finding that the challenged factors were uncertain inflation factors used to project outlier charges. “The agency explained why it used this factor, and it need not explain in any further detail exactly how its analysis of the underlying data generated the [ ] figure.” Id. at 91 (citing Tex. Mun. Power v. EPA, 89 F.3d 858, 869-70 (D.C. Cir. 1996) (“[T]he failure of an agency to identify every detail of a process before it is used does not automatically require judicial interference in matters that must be thought to lie within the agency’s expertise.”)). The district court also found that it was not arbitrary and capricious for CMS to move from a cost Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 26 of 464 1220 C Document 92-1 2 9 7 7 9 27 inflation to a charge inflation methodology when setting the Fixed Loss Threshold.13 Id. at 93. Although CMS switched to the cost inflation methodology in 1994 and then back to the charge inflation method in 2003, the district court determined that “the agency [had] adequately explained its decision in both circumstances” so that it was not arbitrary and capricious. Id. Finally, the Banner Health plaintiffs argued that the FYs 2005-200714 Fixed Loss Threshold rulemakings were arbitrary and capricious because: (1) “the agency failed to adjust the cost-to-charge ratios to account for continuing declines” and (2) “the agency failed to account for reconciliation.” Id. at 96-97. The district court found that those plaintiffs impermissibly relied on the Draft to challenge the cost-to-charge ratios; it ultimately held that CMS’s decision to use historical data and not projection adjustments to calculate the cost-to-charge ratios was reasonable. Id. at 98. The district court rejected the arguments concerning reconciliation because CMS had adequately explained its reasons. Id. at 101. 13 The difference between the two methodologies was explained as follows: Under the charge inflation methodology, which the agency introduced for FY 2003, the agency calculated a measure of past charge inflation based on historical data and used this measure to inflate past charges in order to generate a dataset of projected charges for the fiscal year in question; the agency then adjusted these charges to projected future costs using cost-to-charge ratios. By contrast, under the cost inflation methodology, which was used for FY 1994 through FY 2002, the agency adjusted past charges by cost- to-charge ratios to estimate past costs, and then used a cost inflation factor derived from historical data to inflate the estimated costs and generate projected future costs. Banner Health, 126 F. Supp. 3d at 92. 14 Consistent with the Circuit’s holding in District Hospital Partners, the Banner Health court remanded the 2004 rulemaking to CMS for more explanation regarding the effect of turbocharging, but rejected each of the plaintiffs’ other arguments. 126 F. Supp. 3d at 98. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 27 of 464 1220 C Document 92-1 2 9 7 8 9 28 B. This Case: Challenges to the FY 2008 through 2011 Fixed Loss Threshold Rulemakings The Plaintiff Hospitals here cite “five flaws” in the FY 2008 through 2011 threshold regulations described above. Hosp. Mot. at 27. The Court will address them categorically instead of taking each year in turn. Before addressing the specific “flaws” raised, the Court considers the jurisdictional argument advanced by CMS. CMS argues that some of Plaintiffs’ claims should be dismissed for lack of subject matter jurisdiction because the issues were not approved by the PRRB for judicial review and were not initially made during the relevant comment period. The Court finds it has subject matter jurisdiction over all of the claims presented. The question presented by Plaintiffs for judicial review was very broad: Whether the specific regulations governing Outlier Case Payments as set forth in the two regulatory sources—the Outlier Payment Regulations and the fixed loss threshold (“FLT”) Regulations (collectively, the “Medicare Outlier Regulations”)—as promulgated by the Secretary of Health and Human Services (“HHS” or the “Secretary”) and the Centers for Medicare and Medicaid Services (“CMS”), and in effect for the appealed years are contrary to the Outlier Statute and/or are otherwise substantively or procedurally invalid? PRRB R 87 (Case No. 13-0593GC). The PRRB certified this entire question. In addition, Plaintiffs bring an as-applied challenge to the Medicare regulations, questioning their validity. CMS argues Plaintiffs have waived their right to challenge the consistency between inflation and the Fixed Loss Thresholds because they did not submit relevant comments to each FYs rulemaking. CMS describes Plaintiffs’ challenges to the validity of its rulemakings as “facial,” requiring explicit exhaustion during the administrative proceeding. However, the Court finds that Plaintiffs properly challenged each rulemaking through challenges to the application of the earlier rules. See Banner Health, 126 F. Supp. 3d at 68 (“The Secretary Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 28 of 464 1220 C Document 92-1 2 9 7 9 9 29 has not pointed to any authority suggesting that, just because a plaintiff argues that a regulation is invalid, such plaintiff has waived any arguments not raised in prior rulemaking proceeding. To the contrary, a series of cases from the D.C. Circuit Court of Appeals indicate that a party may challenge the very validity of a regulation when that regulation is applied without waiving arguments that were not raised before the agency in the underlying rulemaking proceedings.”); see also Weaver v. Fed. Motor Carrier Safety Admin., 744 F.3d 142, 145 (D.C. Cir. 2014); National Res. Def. Council. v. EPA, 513 F.3d 257, 260 (D.C. Cir. 2008). Therefore, Plaintiffs’ claims are properly before this Court. 1. CCR adjustment factor Plaintiffs argue CMS’s use of a “token” CCR adjustment factor was arbitrary and capricious because CMS: (1) failed to use the best available data to calculate the adjustment factor, that is, the historic rate of change of CCR; (2) elected to use a complex proxy to calculate the year-over-year change in CCR, which was contrary to CMS’s earlier preference for using historical data; and (3) failed to respond to comments regarding its method for calculating the adjustment factor. Plaintiffs argue CMS failed to use the best available data to calculate the yearly CCR adjustment factor because it relied on a projection, rather than historical data. Defendant responds that CMS “reasonably exercised [its] discretion in deciding on the data to use” and agencies “have no generic obligation to use the best available data.” Gov’t Opp’n at 18-19. Dist. Hosp. Partners II rejected the theory “that the Secretary was obligated to use the best available data.” 786 F.3d at 56. Instead, the D.C. Circuit reviewed the data that was actually used and CMS’s explanation to determine whether the agency “arbitrarily used deficient data.” Id. at 57. This Court, therefore, rejects Plaintiffs’ argument that the regulation was arbitrary and Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 29 of 464 1220 C Document 92-1 2 9 7 30 9 30 capricious for failing to use the best available data and will review the reasonableness of the data used in this particular instance. Plaintiffs also argue that the “token” adjustment factor was arbitrary and capricious because CMS “concocted [it] from projected cost inflation.” Hosp. Mot. at 33. Plaintiffs criticize the use of a projected factor in lieu of historical trends in CCRs. CMS established its methodology to calculate the CCR adjustment factor during the FY 2007 rulemaking, working with the Office of the Actuary. 72 Fed. Reg. at 47,417 (FY 2008 FLT Reg.). The method used in FYs 2008 through 2011 is the same as that established FY 2007. CMS calculated the CCR using estimated cost and charge inflation for the upcoming year. Id. Potential cost inflation was measured using two sets of data: (1) the market basket rate-of- increase and (2) the increase in the average cost per discharge from hospital cost reports. Id. The charge inflation factor is simply the average change in charges. Id. In response to comments urging CMS “to adopt a methodology that uses recent historical industry wide average rate of change,” CMS explained the decision to use two alternative data sets to project cost inflation: [W]e believe this calculation of an adjustment to the CCRs is more accurate and stable than the commenter’s methodology because it takes into account the costs per discharge and the market basket percentage increase when determining a cost adjustment factor. There are times where the market basket and the cost per discharge will be constant, while other times these values will differ from each other, depending on the fiscal year. Therefore . . . , using the market basket in conjunction with the cost per discharge uses two sources that measure potential cost inflation and ensures a more accurate and stable cost adjustment factor. Id. at 47,418. CMS considered the option of using the historical average rate of change, but determined that the projected calculation using the market basket and cost per discharge method was superior. CMS is not required to use the best data, but “cannot ignore new or better data.” Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 30 of 464 1220 C Document 92-1 2 9 7 1 9 31 Dist. Hosp. Partners, 786 F.3d at 57 (emphasis omitted). Here, CMS considered all available data and explained its reasons for not using the historical average rate of change data.15 CMS “articulate[d] a satisfactory explanation for its action including ‘a rational connection between the facts and the choice made.’” Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43 (quoting Burlington Truck Lines v. United States, 371 U.S. 156, 168 (1962)). Finally, Plaintiffs argue CMS failed to respond adequately to comments regarding the CCR adjustment factor. As CMS notes, an “agency’s response to public comments need only ‘enable [the court] to see what major issues of policy were ventilated . . . and why the agency reacted to them as it did.” Public Citizen, Inc. v. FAA, 988 F.2d 186, 197 (D.C. Cir. 1993) (quoting Auto. Parts & Accessories Ass’n v. Boyd, 407 F.2d 330, 335 (D.C. Cir. 1968)). “The agency need only state the main reasons for its decision and indicate that it has considered the most important objections.” Simpson v. Young, 854 F.2d 1429, 1435 (D.C. Cir. 1988). Each year CMS received comments regarding the CCR adjustment factor and each year CMS responded by indicating its reasons for not altering the adjustment factor methodology. See 72 Fed. Reg. at 47, 418 (FY 2008 FLT Reg.); 73 Fed. Reg. at 48,764 (FY 2009 FLT Reg.); 74 Fed. Reg. at 44,010 (FY 2010 FLT Reg.); 75 Fed. Reg. at 50,429 (FY 2011 FLT Reg.). This Court finds CMS’s acknowledgement and consideration of the comments reasonable. CMS’s responses identified the major issues raised by the commenters and stated the main reasons for its decisions. Consequently, use of the CCR adjustment factor was not arbitrary and capricious. 15 CMS also acted reasonably in continuing to use the 2007 methodology until multiple years of data were available to assess its value. See Gov’t Opp’n at 17. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 31 of 464 1220 C Document 92-1 2 9 7 2 9 32 2. Inconsistent relationship between rising inflation factor and deflated Fixed Loss Threshold Plaintiffs argue the FY 2008, 2009, and 2011 Fixed Loss Threshold rulemakings are arbitrary and capricious because of the inconsistencies between the CMS deflation of the Fixed Loss Threshold and the increased inflation factor. Specifically, they argue that if CMS were assuming a positive (upward) trend in hospital costs, it was inconsistent for the Fixed Loss Threshold to be experiencing consistent deflation. Id. at 45. As discussed above, the Court finds Plaintiffs’ argument is properly presented without comment during the rulemaking process. Although Plaintiffs’ argument is proper, CMS adequately explained its calculation of the Fixed Loss Threshold and the factors that it considers when setting the Threshold. Admittedly, CMS failed to address specifically the inconsistency between the positive inflation in hospital charges and costs and the deflation in Fixed Loss Threshold. However, CMS met its burden of “examin[ing] the relevant data and articulat[ing] a satisfactory explanation for its action including a rational connection between the facts found and the choices made.” Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43. Despite Plaintiffs’ arguments, there are no unexplained inconsistencies in the Fixed Loss Threshold rulemakings. See also Dist. Hosp. Partners, 786 F.3d at 59 (“We have often declined to affirm an agency decision if there are unexplained inconsistencies in the final rule.”). CMS sets the Fixed Loss Threshold “in advance of each fiscal year” by projecting what “aggregate outlier payments [will] total[] 5.1% of projected total DRG payments” and setting the Fixed Loss Threshold at the level required to achieve those projected outlier payments. Gov’t Opp’n at 6-7. The Fixed Loss Threshold is based on a projection of future payments, not a previous year’s outlier payments. Plaintiffs argue that CMS fails to consider the year-to-year inflation of hospital charges and costs. However, the inflation factor is simply one Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 32 of 464 1220 C Document 92-1 2 9 7 3 9 33 of many factors evaluated and incorporated into simulations used to determine the aggregate outlier payments that will total 5.1% of aggregate DRG payments in the forthcoming fiscal year. Id. at 31. The simulated outlier payment calculations used to project the Fixed Loss Threshold also incorporate additional inputs, including: cost-to-charge ratios, an adjustment factor to project changes in cost-to-charge ratios, the mix of DRGs and national standardized amounts of labor and nonlabor set forth in tables published in the Federal Register notices, and other hospital-specific information for the upcoming fiscal year that is set forth in the annual impact file, e.g., wage index, medical education, disproportionate share hospital status. Gov’t Opp’n at 31 (citing 68 Fed. Reg. at 34,495). Contrary to Plaintiffs’ arguments, CMS did explain the inconsistency between the decreasing Fixed Loss Threshold and increasing inflation rate: the Fixed Loss Threshold is a product of more than just the inflation of hospital costs and charges. Plaintiffs also critique the failure of CMS to provide the formulas it used to calculate the Fixed Loss Threshold after this Court granted their motion to compel and supplement the administrative record. Plaintiffs mischaracterize this Court’s holding, which only required CMS to produce formulas “if such formulas exist.” Lee Mem’l Hosp., 109 F. Supp. 3d at 51. CMS responded that no additional formulas existed, but that the process for determining the Fixed Loss Threshold was incorporated in the original administrative record, see Gov’t Opp’n at 32, and each year commenters were able to use that explanation to confirm the accuracy of CMS’s calculations. See, e.g., 72 Fed. Reg. at 47,417-18 (FY 2008 FLT Reg.); 73 Fed. Reg. at 48,766 (FY 2009 FLT Reg.); 75 Fed. Reg. at 50,431 (FY 2011 FLT Reg.). This Court finds that CMS has provided a “satisfactory explanation” of its process and the factors considered when it projected the aggregate outlier payments and set the Fixed Loss Threshold in each year. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 33 of 464 1220 C Document 92-1 2 9 7 4 9 34 3. Failure to consider past outlier payments Plaintiffs also argue CMS acted arbitrarily and capriciously by not considering past outlier payments, which “demonstrated the historical failure of [the CMS] model,” when calculating the Fixed Loss Threshold for each year. Hosp. Mot. at 48. Specifically, because the CMS estimate of outlier payments was consistently higher than the actual amount in these years, CMS continually missed the statutory 5.1% target of outlier payments. Nevertheless, it continued to employ the same methodology to set the Fixed Loss Threshold. Id. at 49. Plaintiffs inaccurately interpret the CMS response to their motion to compel, claiming that CMS, through a declarant, admits that it failed to consider past outlier payments during the rulemaking for each following year. Actually, the Acting Director of CMS, Donald Thompson, explained that in each FY’s rulemaking CMS included “an estimate of total outlier payments as a percentage of total IPPS (or diagnosis related group (“DRG”)) payments made during each of the prior two years.” Declaration of Donald Thompson [Dkt. 68-1] ¶ 13. The declaration (and the rulemakings themselves) indicate that CMS reviewed estimates of the past two years’ outlier payments during each year’s rulemaking process. See 72 Fed. Reg. at 47,420 (FY 2008 FLT Reg.) (“Our current estimate, using available FY 2006 bills, is that actual outlier payments for FY 2006 were approximately 4.65 percent of actual total DRG payments. Thus, the data indicate that, for FY 2006, the percentage of actual outlier payments relative to actual total payments is lower than we projected before FY 2006.”); 73 Fed. Reg. at 48,766 (FY 2009 FLT Reg.) (“Our current estimate [ ] is that actual outlier payments for FY 2007 were approximately 4.64 percent of actual total DRG payments.”); 74 Fed. Reg. at 44,012 (FY 2010 FLT Reg.) (“Our current estimate [ ] is that actual outlier payments for FY 2008 were approximately 4.8 percent of actual total DRG payments.”); 75 Fed. Reg. at 50,431 (FY 2011 Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 34 of 464 1220 C Document 92-1 2 9 7 5 9 35 FLT Reg.) (“Our current estimate [ ] is that actual outlier payments for FY 2009 were approximately 5.3 percent of actual total DRG payments.”). Plaintiffs are, therefore, incorrect that CMS did not identify past outlier payments. Plaintiffs’ argument that it is arbitrary and capricious for CMS to fail to adjust the Fixed Loss Threshold based on the multi-year trend of it falling below the 5.1% mandated by statute is also without merit. As CMS explains, it considers past outlier payments during each year’s rulemaking, responds to comments regarding past payments, and, as it thinks appropriate, adjusts the model to set the next Fixed Loss Threshold. See 71 Fed. Reg. at 48,150. During the FY 2007 rulemaking, CMS proposed a change to the Fixed Loss Threshold model to account for the trend in “payments below the 5.1 percent target.” Id. CMS stated: As the commenters noted, the outlier thresholds we have projected in the last several years have resulted in payments below the 5.1 percent target. However, we have been hesitant to change our model because, in the early years of this decade, outlier payments were significantly higher than the 5.1 percent target we projected because the charging practices of some hospitals resulted in overestimation of hospitals’ cost-per-case. However, now that data for later years in which charging practices were stabilized are available, after careful consideration, we agree that a refinement to the proposed methodology to account for the rate of change in the relationship between costs and charges would likely increase the precision of our model and we believe this would be an appropriate refinement to adopt in determining the FY 2007 outlier threshold. Id. Based on CMS’s decision to adjust the model in the FY 2007 rulemaking and inclusion of the estimates of prior payments in each year’s rulemaking, it is evident CMS has not disregarded accurate and reliable information or adopted an estimate it knew at the time to be inaccurate. See Guindon v. Pritzker, 31 F. Supp. 3d 169, 195-96 (D.D.C. 2014). CMS “was not required to ‘meet’ those targets.” Banner Health, 126 F. Supp. 3d at 90 (citing Cnty. of L.A., 192 F.3d at 1013). “Just because the agency was aware that actual outlier payments [did not meet] the Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 35 of 464 1220 C Document 92-1 2 9 7 6 9 36 predicted levels for these years . . . does not mean that it was arbitrary or capricious to continue implementing this model.” Id. CMS has not, as Plaintiffs claim, turned a blind eye to a system that does not work. Hosp. Mot. at 52-53. Instead, it adjusted the model in the FY 2007 rulemaking and has since been monitoring the payouts and “consider[ing] and evaluat[ing] commenters comments on modifying the outlier threshold methodology.” 73 Fed. Reg. at 48,766. It is not arbitrary and capricious to continue with the newly revised model for FYs 2008 through 2011 to determine its efficacy. Due to the complexity of the Medicare payment system and the data collection at issue, it is not unreasonable for CMS to continue to use the model revised in 2007 during FYs 2008 through 2011, especially considering CMS reported that outlier payments in FY 2009 fell within the 5-6% threshold. See 75 Fed. Reg. at 50,431 (FY 2009 outlier threshold calculated as 5.3%). CMS’s continued identification of the outlier payments and consideration of possible revisions and suggestions raised by commenters is reasonable. For the foregoing reasons, the Court finds CMS acted reasonably and complied with the requirements of the APA in considering past outlier payments. 4. Past outlier payment estimates Plaintiffs also lodge three challenges to CMS’s estimate of total outlier payments in each year: CMS (1) failed to provide sufficient notice about how prior outlier payments were determined; (2) failed to respond adequately to comments in FYs 2008 through 2011 regarding the estimated past outlier payments; and (3) failed to respond to a commenter’s recommendation for an estimated adjustment factor in FY 2011. Plaintiffs compare this case to Shands Jacksonville Med. Ctr. v. Burwell, 139 F. Supp. 3d 240 (D.D.C. 2015), in which this Court found that CMS had failed to provide sufficient Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 36 of 464 1220 C Document 92-1 2 9 7 7 9 37 notice of “actuarial assumptions and methodology,” due to CMS’s failure to provide its methods for estimating total outlier payments made in prior years in violation of the APA. Id. at 261. CMS argues that its rulemakings adequately described its methodology, announcing each year that CMS used the same methodology to simulate outlier payments for upcoming fiscal years as it used to estimate past outlier payments. The difference is in the data used. When determining the upcoming Fixed Loss Threshold, CMS used projected payments, while it used the latest available claims information, or bills, to estimate past payments. See, e.g., 72 Fed. Reg. at 47,420 (FY 2008 FLT Reg.) (indicating CMS used “the FY 2005 MedPAR file” to estimate the 2006 past outlier payments during the FY 2007 rulemaking and used the 2006 file to estimate the same 2006 past outlier payments during the FY 2008 rulemaking). In Shands, the Court considered CMS’s creation of an “across-the-board reduction in payments to hospitals for inpatient services.” 139 F. Supp. 3d at 247. Shands found that CMS “did not provide sufficient notice of the actuarial assumptions and methodology [it] employed and that disclosure of this information was essential to communicate the basis for the proposed adjustments and to permit meaningful public comment.” Id. at 261. “[A]n agency cannot rest a rule on data that, [in] critical degree, is known only to the agency.” Time Warner Entm’t Co., L.P. v. FCC, 240 F.3d 1126, 1140 (D.C. Cir. 2001) (internal quotation and citation omitted). CMS only disclosed some of the necessary information in the final rule at issue in Shands. See 139 F. Supp. 3d at 262. Disclosing the data sets used alone was insufficient; CMS needed to “disclose what the actuaries did with that data.” Id. at 263. Hospital Plaintiffs in this case similarly argue that CMS pointed to the data sets used to calculate prior years’ outlier payments, but failed to identify how the estimates were ultimately calculated. Despite Plaintiffs’ insistence, the CMS explanation of its outlier payment Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 37 of 464 1220 C Document 92-1 2 9 7 8 9 38 methodology is available. Prior FY outlier payment estimates are calculated using the same method as CMS uses to predict future payments. The only difference between past and future estimates is the data sets used. See 68 Fed. Reg. at 34,495. Unlike Shands, CMS has provided the data set and the formula used in each year. See id. The only information not provided was the specific set of hospitals CMS used to do its simulations, but that alone does not render its explanations or data inadequate. Plaintiffs had the “critical factual material” necessary to review the agency’s method, Owner-Operator Indep. Drivers Ass’n Inc. v. Fed. Motor Carrier Safety Admin., 494 F.3d 188, 199 (D.C. Cir. 2007), as evidenced by the ability of commenters to replicate CMS’s calculations. See, e.g., 75 Fed. Reg. at 50,431 (FY 2011 FLT Reg.). The rulemakings adequately explained the method used to estimate past outlier payments. Second, Plaintiffs argue that CMS failed to respond to “relevant and significant comments” from the Federation. Hosp. Mot. at 55. Defendant responds that CMS answered the Federation comments with an explanation about the data used to calculate the outlier payments and indicated that it had not used the data set recommended by the Federation. As explained above, in each year, the estimated past outlier payments for the previous two years were included in the rulemaking analysis. For example, in the FY 2008 rulemaking CMS included an estimate of the 2007 outlier payments, which was calculated using FY 2006 data. 72 Fed. Reg. at 47,420. Then in the FY 2009 rulemaking, CMS updated the estimate of 2007 payments using FY 2007 data. 73 Fed. Reg. at 48,766. Plaintiffs challenge the specific data sets used by CMS, arguing they were not the most recent available data. But, CMS is not required to use the best available data, see Dist. Hosp. Partners, 786 F.3d at 56, and CMS adequately explained why it chose to use the earlier data. See 72 Fed. Reg. at 47,418. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 38 of 464 1220 C Document 92-1 2 9 7 9 9 39 CMS clearly responded to Federation comments, explaining the data sets used. The requirement to respond to comments is “not particularly demanding.” Ass’n of Private Sector Colls. & Univs. v. Duncan, 681 F.3d 427, 441-42 (D.C. Cir. 2012) (internal quotation and citation omitted). CMS’s responses to Federation comments in FYs 2008 through 2011 identified the reasons earlier data was selected, thereby demonstrating that CMS considered the comments. Thus, the responses to the comments satisfied the APA requirements. Third, Plaintiffs raise a second argument with respect to the 2011 Fixed Loss Threshold regulation, asserting that CMS failed to respond to different comment from the Federation that recommended an estimate adjustment factor to the outlier threshold. To the contrary, CMS summarized and responded to the Federation’s comment in the 2011 Final Rulemaking. See 75 Fed. Reg. at 50,428-29. CMS explained that it would not apply an estimate adjustment factor—as requested by the Federation—because it believed the current model used to predict the outlier threshold necessary to meet the target of 5.1% of DRG payments was adequate. The Court finds that CMS adequately considered and responded to the comment, even though it expressed no willingness to change its model. 5. Failure to account for reconciliation Plaintiffs’ final challenge to the Fixed Loss Threshold rulemakings is that CMS acted arbitrarily and capriciously in failing to factor the impact of reconciliation into the Fixed Loss Threshold projections for FYs 2008-2011. Plaintiffs argue that CMS failed to conduct any reconciliations and did not adequately respond to comments submitted during the NPRMs for the Fiscal Years at issue. Defendant argues that CMS adequately explained its reasons for not factoring reconciliation into the projections for each year’s Fixed Loss Threshold. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 39 of 464 1220 C Document 92-1 2 9 7 40 9 40 Banner Health found that neither consideration of reconciliation, nor accounting for reconciliation, was required by the 2003 Payment Regulation when setting the Fixed Loss Threshold each year. See 126 F. Supp. 3d at 78-79. This holding was not appealed. The 2003 amendments to the Payment Regulations created a system for reconciling outlier payments that were made using a “significantly inaccurate cost-to-charge ratio.” 68 Fed. Reg. at 34,502. The 2003 Payment Regulation created the reconciliation procedure by which outlier payments are subject to reconciliation when hospitals’ cost reports are finalized. See id. at 34,501. The Payment Regulation stated that “if [CMS] deem[s] it necessary as a result of a hospital-specific data variance to reconcile outlier payments of an individual hospital, such action . . . would not affect the predictability of the entire system.” Id. at 34,502. Nothing in the 2003 rulemaking indicated that reconciliation was required. Banner Health also found it was not arbitrary and capricious for CMS not to consider the effects of reconciliation on the projections of the Fixed Loss Threshold for FY 2004 through 2006. 126 F. Supp. 3d at 99, 101, 103. Just as in those years, CMS explained in the Fixed Loss Threshold rulemakings for FYs 2008 through 2011, at issue here, why it did not account for reconciliation. Each year CMS has explained: As we did in establishing the [previous year’s] outlier threshold, in our projection of [the current year’s] outlier payments, we are not making any adjustments for the possibility that hospitals’ CCRs and outlier payments may be reconciled upon cost report settlement. We continue to believe that, due to the policy implemented in the outlier final rule, CCRs will no longer fluctuate significantly and, therefore, few hospitals will actually have these ratios reconciled upon cost report settlement. 72 Fed. Reg. at 47,419 (FY 2008 FLT Reg.); see also 73 Fed. Reg. at 48,763 (FY 2009 FLT Reg.); 74 Fed. Reg. at 44,007-08 (FY 2010 FLT Reg.); 75 Fed. Reg. at 50,427 (FY 2011 FLT Reg.). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 40 of 464 1220 C Document 92-1 2 9 7 1 9 41 Plaintiffs argue that the reasons given by CMS were not its real reasons: They posit that CMS did not account for reconciliation in the Fixed Loss Threshold projections because CMS never conducted any reconciliations. However, this Court cannot question the legitimacy of the reasoning provided without evidence that CMS was acting in bad faith. See In re Subpoena Duces Tecum Served on Office of the Comptroller of the Currency, 156 F.3d 1279, 1279-80 (D.C. Cir. 1998) (“[T]he actual subjective motivation of agency decisionmakers is immaterial as a matter of law—unless there is a showing of bad faith or improper behavior.”). Plaintiffs have provided no evidence of bad faith or improper behavior. Therefore, this Court finds CMS has provided adequate reasoning for its decision not to account for reconciliation when setting the outlier threshold. Finally, Plaintiffs argue that in 2010 and 2011 CMS failed to respond to comments requesting it to report the amount of money recovered through reconciliation. An agency is not required to respond to every comment, but instead must “only ‘enable [the court] to see what major issues of policy were ventilated . . . and why the agency reacted to them as it did.’” Public Citizen, 988 F.2d at 197 (quoting Boyd, 407 F.2d at 335). In each rulemaking CMS considered and responded to a host of other comments related to reconciliation, which allows the Court to view the “major issues being ventilated” and the agency’s thinking. See 72 Fed. Reg. at 47,419 (FY 2008 FLT Reg.); 73 Fed. Reg. at 48,763 (FY 2009 FLT Reg.); 74 Fed. Reg. at 44,007-08 (FY 2010 FLT Reg.); 75 Fed. Reg. at 50,427 (FY 2011 FLT Reg.). The lack of response to the specific comment asking how much has been collected through reconciliation does not render the rulemaking arbitrary and capricious. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 41 of 464 1220 C Document 92-1 2 9 7 2 9 42 C. The 2003 Payment Regulations Plaintiffs also argue that the Payment Regulations, as amended in 2003, are invalid because they were promulgated in violation of the APA’s procedural requirements (under 5 U.S.C. § 553) and because, as applied, they are arbitrary, capricious or otherwise not in accordance with law (under 5 U.S.C. § 706). 1. APA procedural requirements Plaintiffs argue that CMS failed to comply with the disclosure requirements of the APA by failing to include the 2003 draft Interim Final Rule (Draft) in the NPRM and notice of final amendments to the 2003 Payment Regulations. Plaintiffs rely on this Court’s holding requiring the Draft to be included as part of the administrative record here, arguing that because the Draft was missing from this record, it was also missing from the notice and comment process. Id. at 67-68. Despite this Court’s inclusion of the Draft in the administrative record for this proceeding, an agency is only required to identify in a NPRM the studies and other materials on which the agency “actually relies.” 5 U.S.C. § 553. While it is “especially important for the agency to identify and make available technical studies and data that it has employed,” see Connecticut Light & Power Co. v. Nuclear Regulatory Comm’n, 673 F.2d 525, 530 (D.C. Cir. 1982), an agency is not required to disclose materials or drafts upon which it did not rely. See Banner Health v. Burwell, 55 F. Supp. 3d 1, 9 (D.D.C. 2014). This Court’s order to include the Draft in the administrative record followed prior cases in this District regarding the same Draft. As in Banner Health, Plaintiffs met their burden of showing the agency considered the Draft and that CMS had no legitimate deliberative process argument for shielding the Draft from inclusion. Lee Mem’l Hosp., 109 F. Supp. 3d at 47-49; see Banner Health v. Burwell, 945 F. Supp. 2d 1, 24-27 (D.D.C. 2013). Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 42 of 464 1220 C Document 92-1 2 9 7 3 9 43 However, the Court in Banner Health later denied a motion to amend the complaint because the claims, identical to the claim here, were against Circuit precedent. See id. at 12. This Court agrees. While the D.C. Circuit has repeatedly found agency NPRM’s lacking for failure to disclose “critical material, on which [the agency] relies,” or redacting studies relied upon by an agency, the Circuit’s rule is centered upon the principle that only those studies and materials relied upon must be disclosed. See id. at 9 (emphasis in original) (citing Allina Health Servs. v. Sebelius, 746 F.3d 1102, 1110 (D.C. Cir. 2014)). Plaintiffs’ attempt to equate this case to Shands and American Radio Relay League, Inc. v. FCC, 524 F.3d 227 (D.C. Cir. 2008), is unpersuasive. In both Shands and American Radio, it was apparent that the agency had relied on the reports and data that were either not included or redacted. See Shands, 139 F. Supp. 3d at 263 (finding that “the Secretary’s failure to disclose the critical assumptions relied upon by the HHS actuaries deprived Plaintiffs and other members of the public of a meaningful opportunity to comment”) (emphasis added); American Radio, 524 F.3d at 239 (“[T]he Commission can point to no authority allowing it to rely on the studies in a rulemaking but hide from the public parts of the studies that may contain contrary evidence, inconvenient qualifications, or relevant explanations of the methodology employed.”). Plaintiffs’ only basis for alleging that CMS relied on the Draft is this Court’s order to include the Draft in the administrative record. That is not enough. With the benefit of a full record and briefing, it is now clear that CMS did not rely on the Draft. Although this Court found CMS initially considered the Draft as an alternative to the later Payment Regulations at issue here, that holding does not require a finding that CMS relied on the Draft in these rulemakings. It is noteworthy that, Plaintiffs’ Fourth Amended Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 43 of 464 1220 C Document 92-1 2 9 7 4 9 44 Complaint agrees. It makes no allegation that CMS relied on the Draft in the 2003 rulemaking, but instead faults CMS for not disclosing the “alternatives” it “considered but rejected.” Fourth Am. Compl. [Dkt. 65] at 27. For the reasons stated above, the Court concludes that the 2003 Payment Regulations were promulgated in a manner that was consistent with the procedural requirements under 5 U.S.C. § 553. 2. APA substantive requirements In addition to its procedural claims, Plaintiffs argue the 2003 rulemaking was arbitrary and capricious because CMS failed to address the known data indicating 123 hospitals were turbocharging. Plaintiffs’ argument relies on the Circuit’s finding in Dist. Hosp. Partners that CMS’s FY 2004 Threshold Rulemaking was arbitrary and capricious for failure to account for the 123 turbochargers. Plaintiffs failed to adequately raise their substantive APA claims concerning the 2003 Outlier Payment Regulation in the Fourth Amended Complaint. Plaintiffs claim that a single allegation stating “[w]hile . . . amending the Outlier Payment Regulations . . . the Secretary had both the obligation and the opportunity to reset her [Fixed Loss Threshold], which she had improperly inflated by more than 246%, but she did not” and the broad statement in the request for relief that the Court find “the Outlier Statute and [CMS’s] application of same were, for the FYs here at issue, . . . (B) arbitrary, capricious, and abuse of discretion, or otherwise not in accordance with law” were sufficient to plead a substantive APA claim. Fourth Am. Compl. ¶ 50, Request for Relief ¶ 1. Neither statement sufficiently articulates a substantive APA claim. Plaintiffs cannot rely on a conclusory and ambiguous allegation that CMS was supposed to act in Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 44 of 464 1220 C Document 92-1 2 9 7 5 9 45 a certain manner “but [ ] did not” alert Defendant that a substantive APA claim was raised.16 Id. at ¶ 50. Plaintiffs’ argument that CMS gave express or implied consent by arguing against these claims in its opposition is unpersuasive. Tellingly, CMS’s own motion to dismiss or for summary judgment omits any discussion of a substantive APA claim regarding the 2003 Payment Regulations, indicating it was unaware of the claim. Even if this Court found Plaintiffs had adequately raised a substantive APA claim regarding the 2003 Payment Regulations, summary judgment would be entered for CMS. First, Plaintiffs cannot rely on the Draft, which was never finalized or relied upon by CMS to impugn subsequent rulemakings. See Dist. Hosp. Partners, 786 F.3d at 58; Banner Health, 126 F. Supp. 3d at 69, 94. Second, CMS clearly considered all 123 turbo-charging hospitals in the 2003 amendments to the Payment Regulations. See 68 Fed. Reg. at 34,496 (“We proposed these changes in the payment methodology . . . in order to correct situations in which rapid increases in charges by certain hospitals have resulted in their cost-to-charge ratios being set too high.”). CMS not only considered all the turbochargers, but they were the basis for altering the Payment Regulations in the first place. To the extent that Plaintiffs are also challenging the decision not to make a mid-year adjustment to the Fixed Loss Threshold in 2003, this Court finds that CMS was not required to make a mid-year adjustment and its explanation for “why it concluded that a mid-year adjustment was not warranted” was adequate.17 Banner Health, 126 F. Supp. 3d at 96. 16 “Judges are not expected to be mindreaders. Consequently, a litigant has an obligation to spell out its arguments squarely and distinctly, or else forever hold its peace.” United States v. Zannino, 895 F.2d 1, 17 (1st Cir. 1990) (quoting Rivera-Gomez v. de Castro, 843 F.2d 631, 635 (1st Cir. 1988) (internal quotations omitted). 17 CMS explained: We believe it is appropriate not to change the FY 2003 outlier threshold at this time. Although our current empirical estimate of the threshold indicates it could be slightly higher, there are other Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 45 of 464 1220 C Document 92-1 2 9 7 6 9 46 IV. CONCLUSION For the foregoing reasons, the Court will grant Defendant’s motion for summary judgment and deny Plaintiffs’ motion for summary judgment. The Court will also enter judgment in favor of the Secretary and the consolidated cases, Abbott Northwestern Hospital, et al. v. Sebelius, Case No. 13-cv-775; Buffalo Hospital, et al. v. Sebelius, Case No. 13-cv-776; and Denver Health Medical Center, et al. v. Sebelius, Case No. 14-cv-553, will be closed. A memorializing Order accompanies this Opinion. Date: September 7, 2016 /s/ ROSEMARY M. COLLYER United States District Judge considerations that lead us to conclude the threshold should remain at $33,560. Increasing the threshold would result in lower outlier payments for all hospitals, not just those that have been aggressively maximizing their outlier payments. Changing the threshold for the remaining few months of the fiscal year could disrupt hospitals’ budgeting plans and would be contrary to the overall prospectivity of the [Prospective Payment System]. We do believe that we have the authority to revise the threshold, given the extraordinary circumstances that have occurred (in particular, the manipulation of the policy by some hospitals). However, in light of the relatively small difference between the current threshold and our revised estimate, and the limited amount of time remaining in the fiscal year, we have concluded it is more appropriate to maintain the threshold at $33,560. 68 Fed. Reg. at 34,506. Case 1:13-cv-00643-RMC Document 82 Filed 09/07/16 Page 46 of 464 1220 C Document 92-1 2 9 7 7 9 1 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA __________________________________ ) LEE MEMORIAL HEALTH SYSTEM ) f/b/o LEE MEMORIAL HOSPITAL, ) et al., ) ) Plaintiffs, ) ) v. ) Civil Action No. 13-cv-643 (RMC) ) SYLVIA M. BURWELL, Secretary of the ) U.S. Department of Health & Human ) Services ) ) Defendant. ) _________________________________ ) ORDER For the reasons stated in the Opinion issued contemporaneously with this Order, it is hereby ORDERED that Defendant’s Motion to Dismiss or, in the alternative, Motion for Summary Judgment [Dkt. 73] is GRANTED; and it is FURTHER ORDERED that Plaintiffs’ Motion for Summary Judgment [Dkt. 74] is DENIED; and it is FURTHER ORDERED that JUDGMENT is entered in favor of the Secretary; and it is FURTHER ORDERED that consolidated cases Abbott Northwestern Hospital, et al. v. Sebelius, Case No. 13-cv-775; Buffalo Hospital, et al. v. Sebelius, Case No. 13-cv-776; and Denver Health Medical Center, et al. v. Sebelius, Case No. 14-cv-553 shall be closed. Case 1:13-cv-00643-RMC Document 83 Filed 09/07/16 Page 1 of 2Case 1:14-cv-01220-RC Document 92-1 Filed 02/09/17 Page 48 49 2 This is a final appealable Order. See Fed. R. App. P. 4. This case is closed. Date: September 7, 2016 /s/ ROSEMARY M. COLLYER United States District Judge Case 1:13-cv-00643-RMC Document 83 Filed 09/07/16 Page 2 of 2Case 1:14-cv-01220-RC Document 92-1 Filed 02/09/17 Page 49 49 EXHIBIT B Case 1:14-cv-01220-RC Document 92-2 Filed 02/09/17 Page 1 of 39 4831-2220-7524. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA LEE MEMORIAL HEALTH SYSTEM f/b/o LEE MEMORIAL HOSPITAL 2776 Cleveland Avenue Fort Myers, FL 33901 and ALLINA HEALTH f/b/o BUFFALO HOSPITAL 303 Catlin Street Buffalo, MN 55313 and ALLINA HEALTH f/b/o CAMBRIDGE MEDICAL CENTER 701 South Dellwood Cambridge, MN 55008 and ALLINA HEALTH f/b/o UNITED HOSPITAL 333 North Smith Avenue St. Paul, MN 55102-2389 and ALLINA HEALTH f/b/o UNITY HOSPITAL 550 Osborne Rd. NE Fridley, MN 55432-2718 and ALLINA HEALTH f/b/o NORTHWESTERN HOSPITAL 800 East 28th Street Minneapolis, MN 55407-3731 ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 1:13-cv-00643-RMC Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 1 of 384 1220 C Document 92-2 2 09 7 2 9 2 4831-2220-7524. and ALLINA HEALTH f/b/o MERCY HOSPITAL 4050 Coon Rapid Blvd NW Coon Rapids, MN 55433-2522 and ALLINA HEALTH f/b/o OWATONNA HOSPITAL 903 South Oak Avenue Owatonna, MN 55060-3234 and ALLINA HEALTH f/b/o ST. FRANCIS REGIONAL MEDICAL CENTER 1455 St. Francis Avenue Shakopee, MN 55379-3380 and BANNER HEALTH f/b/o BANNER GOOD SAMARITAN MEDICAL CENTER 1111 E. McDowell Road Phoenix, AZ 85006 and BANNER HEALTH f/b/o BANNER THUNDERBIRD MEDICAL CENTER 5555 W. Thunderbird Road Glendale, AZ 85306 and BANNER HEALTH f/b/o BANNER DESERT MEDICAL CENTER 1400 S. Dobson Road Mesa, AZ 85202 and BANNER HEALTH f/b/o BANNER BOSWELL MEDICAL CENTER ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 2 of 384 1220 C Document 92-2 2 09 7 3 9 3 4831-2220-7524. 10401 W. Thunderbird Blvd. Sun City, AZ 85351 and BANNER HEALTH f/b/o BANNER DEL E. WEBB MEDICAL CENTER 14502 W. Meeker Blvd. Sun City West, AZ 85375 and BANNER HEALTH f/b/o BANNER BAYWOOD HEART HOSPITAL 6750 East Baywood Avenue Mesa, AZ 85206 and BANNER HEALTH f/b/o BANNER BAYWOOD MEDICAL CENTER 6644 E. Baywood Avenue Mesa, AZ 85206 and BANNER HEALTH f/b/o ESTRELLA MEDICAL CENTER 9201 W. Thomas Road Phoenix, AZ 85037 and BANNER HEALTH f/b/o MCKEE MEDICAL CENTER 2000 Boise Avenue Loveland, CO 80538 and BANNER HEALTH f/b/o NORTH COLORADO MEDICAL CENTER 1801 16th Street Greeley, CO 80631 and ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 3 of 384 1220 C Document 92-2 2 09 7 4 9 4 4831-2220-7524. HALIFAX COMMUNITY HEALTH SYSTEM, a/k/a HALIFAX MEDICAL CENTER 303 N. Clyde Morris Boulevard Daytona Beach, FL 32114 and SARASOTA MEMORIAL HOSPITAL 1700 S. Tamiami Trail Sarasota, FL 34239 and LEE MEMORIAL HEALTH SYSTEM f/b/o CAPE CORAL HOSPITAL 636 Del Prado Blvd. Cape Coral, FL 33990 and LEE MEMORIAL HEALTH SYSTEM f/b/o GULF COAST MEDICAL CENTER 13681 Doctor’s Way Fort Myers, FL 33912 and BANNER HEALTH f/b/o BANNER GATEWAY MEDICAL CENTER 1900 North Higley Road Gilbert, AZ 85234 and BILLINGS CLINIC 801 North 29th Street Billings, MT 59107 and CHARLESTON AREA MEDICAL CENTER 501 Morris Street ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 4 of 384 1220 C Document 92-2 2 09 7 5 9 5 4831-2220-7524. Charleston, WV 25325 and GOOD SAMARITAN HOSPITAL 1225 Wilshire Boulevard Los Angeles, CA 90017-2395 and VALLEY VIEW HOSPITAL 1906 Blake Avenue Glenwood Springs, CO 81601 and WEST VIRGINIA UNIVERSITY HOSPITALS 1 Medical Center Drive Morgantown, WV 26506 and UNIVERSITY OF COLORADO HEALTH AT MEMORIAL HEALTH f/k/a MEMORIAL HOSPITAL OF COLORADO SPRINGS 1400 E. Boulder Street Colorado Springs, CO 80909 and DENVER HEALTH MEDICAL CENTER 777 Bannock Street Denver, CO 80204 and BOULDER COMMUNITY HOSPITAL 1100 Balsam Avenue Boulder, CO 80304 and PARKVIEW MEDICAL CENTER 400 West 16th Street Pueblo, CO 81003 ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 5 of 384 1220 C Document 92-2 2 09 7 6 9 6 4831-2220-7524. ) Plaintiffs, ) ) v. ) ) SYLVIA M. BURWELL, Secretary, U.S. DEPARTMENT OF HEALTH and HUMAN SERVICES 200 Independence Avenue, SW Washington, DC 20201 ) ) ) ) ) Defendant. ) ) ) FOURTH AMENDED COMPLAINT I. SUMMARY 1. Plaintiffs are a group of non-profit organizations that own and operate 33 acute care hospitals (the “Hospital Plaintiffs”) participating in the Medicare program. The Hospital Plaintiffs bring this complaint for judicial review of the final administrative decisions of the Secretary of the United States Department of Health and Human Services (the “Secretary”) as to the amount of Medicare “outlier” payments due Plaintiffs for services provided under the Medicare program during each hospital’s fiscal years ending (“FYEs”) in 2008- 2011. 2. Congress has mandated that hospitals participating in the Medicare program shall receive additional payments for treating extraordinarily expensive cases, known as “outlier” cases (“Outlier Case Payments”), under 42 U.S.C. § 1395ww(d)(3)(b) & (5)(A) (the “Outlier Statute”). These additional Outlier Case Payments are intended both to protect hospitals from large financial losses due to unusually expensive cases and to eliminate any disincentive that hospitals might otherwise have to providing critical care to particularly needy, and costly, patients. The Outlier Statute directs, among other things, that Outlier Case Payments “approximate the marginal cost of care” that is in excess of a threshold established annually by the Secretary. 42 U.S.C. § Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 6 of 384 1220 C Document 92-2 2 09 7 7 9 7 4831-2220-7524. 1395ww(d)(5)(A)(iii). The Secretary claims to set the annual threshold at a level such that total projected Outlier Case Payments will equal 5.1% of the total projected inpatient hospital payments for the upcoming Federal Fiscal Year (“FY”). 3. However, the Secretary’s regulations implementing the Outlier Statute have consistently been contrary both to the intent of Congress and to the agency’s obligations under the Administrative Procedure Act (“APA”). Examples of the Secretary’s mismanagement of the program established by the Outlier Statute include her adoption of initial regulations which systematically underpaid hospitals. The Ninth Circuit invalidated the initial regulations as “arbitrary and capricious” in violation of the APA, Alvarado v. Shalala, 155 F.3d 1115 (9th Cir. 1998), and the D.C. Circuit “remanded to the Secretary to allow her either to recalculate outlier thresholds for fiscal years 1985-1986 or to offer a reasonable explanation for refusing to use the 1984 data [i.e., the best available data] in setting outlier thresholds during those years.” See County of Los Angeles v. Shalala, 192 F.3d 1005, 1020-21, 1023 (D.C. Cir. 1999) (remanding for an explanation for the Secretary’s reliance on outdated data that “could not have predicted how, under PPS, the average length of stay for virtually all DRGs would eventually decline dramatically.”) Examples also include the Secretary’s promulgation of further regulations which resulted in paying out more than $10 billion of overpayments to a small percentage of hospitals that were able to exploit three key “vulnerabilities” in her system while, at the same time, systematically denying most other hospitals the financial protection Congress intended. 4. In March 2003, the Secretary issued a notice of proposed rulemaking which openly acknowledged the shortcomings of her outlier regulations and the financial harm they had caused. 68 Fed. Reg. 10,420 (Proposed, Mar. 5, 2003). She proposed and promulgated new regulations which she touted would fix the problems she had created and which she expected would have a Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 7 of 384 1220 C Document 92-2 2 09 7 8 9 8 4831-2220-7524. dramatic impact on the abusive behavior of certain hospitals. However, the Secretary has continued to implement the Outlier program in a manner that is contrary to the Outlier Statute, the intent of Congress, and the requirements under the APA, and that consistently yields payments to hospitals far below her 5.1% target and the 5.1% of payments for Medicare inpatient services that is withheld from hospitals each FY to fund that target. Her errors include, among others, adopting regulations that necessarily result in annual outlier payment thresholds that are inappropriately high and Outlier Case Payments that are inappropriately low and few in number, knowingly relying on faulty data, failing to address one or more important aspects of the problems that are causing the underpayments and relying on unsound methodologies which, without reasonable justification, are contrary to alternatives suggested by commenters and contrary to the data that is before the Secretary. As a result, the Hospital Plaintiffs have not received the number and amount of supplemental Outlier Case Payments as intended by Congress. 5. The Hospital Plaintiffs seek the following remedies: (1) a ruling that the Secretary’s regulations implementing the Outlier Statute and her application of same, for and otherwise affecting the FYs here at issue were (A) in excess of statutory authority or limitations, or short of statutory right, (B) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, (C) without observance of procedure required by law, and/or (D) unsupported by substantial evidence under the APA, 5 U.S.C. §§ 553 & 706; and (2) an order remanding these appeals to the Secretary to (a) recalibrate and reset the fixed-loss thresholds for Hospital Plaintiffs’ respective FYEs 2008-2011, (b) permit the Hospital Plaintiffs to submit amended claims for Outlier Case Payments for their respective FYEs at issue in accordance with the reset fixed-loss thresholds, and (c) re-determine and pay the number and amount of Outlier Case Payments due the Hospital Plaintiffs under the Outlier Statute. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 8 of 384 1220 C Document 92-2 2 09 7 9 9 9 4831-2220-7524. II. PARTIES 6. The Hospital Plaintiffs are non-profit organizations that, directly or through wholly-owned subsidiaries, own and operate the acute care hospitals identified in the subparagraphs below. Each of the Hospital Plaintiffs has been certified to and has participated in the Medicare program as a “provider of services” during the time relevant to this Complaint, including, with respect to each hospital, during each of the fiscal years identified below. a. Plaintiff, Abbott-Northwestern Hospital (“Abbott-Northwestern”), a part of the Allina Health System, is a non-profit organization located in Minneapolis, Minnesota. Abbott-Northwestern is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. b. Plaintiff, Buffalo Hospital (“Buffalo”), a part of the Allina Health System, is a non-profit organization located in Buffalo, Minnesota. Buffalo is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. c. Plaintiff, Cambridge Medical Center (“Cambridge”), a part of the Allina Health System, is a non-profit organization located in Cambridge, Minnesota. Cambridge is appealing its payment by the Secretary for its FYEs ended December 31, 2009 and 2010. d. Plaintiff, Mercy Hospital (“Mercy”), a part of the Allina Health System, is a non-profit organization located in Coon Rapids, Minnesota. Mercy is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 9 of 38Case 1:14-cv-01220-RC Document 92-2 Filed 02/09/17 Page 10 of 39 10 4831-2220-7524. e. Plaintiff, Owatonna Hospital (“Owatonna”), a part of the Allina Health System, is a non-profit organization located in Owatonna, Minnesota. Owatonna is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. f. Plaintiff, St. Francis Regional Medical Center (“St. Francis”), a part of the Allina Health System, is a non-profit organization located in Shakopee, Minnesota. St. Francis is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. g. Plaintiff, United Hospital (“United”), a part of the Allina Health System, is a non-profit organization located in St. Paul, Minnesota. United is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. h. Plaintiff, Unity Hospital (“Unity”), a part of the Allina Health System, is a non-profit organization located in Fridley, Minnesota. Unity is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. i. Plaintiff, Banner Baywood Heart Hospital (“Banner Baywood Heart”), a part of the Banner Health System, is a non-profit organization located in Mesa, Arizona. Banner Baywood Heart is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. j. Plaintiff, Banner Baywood Medical Center (“Banner Baywood”), a part of the Banner Health System, is a non-profit organization located in Mesa, Arizona. Banner Baywood is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 10 of 384 1220 C Document 92-2 2 09 7 1 9 11 4831-2220-7524. k. Plaintiff, Banner Desert Medical Center (“Banner Desert”), a part of the Banner Health System, is a non-profit organization located in Mesa, Arizona. Banner Desert is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. l. Plaintiff, Banner Del E. Webb (“Del Webb”), a part of the Banner Health System, is a non-profit organization located in Sun City West, Arizona. Del Webb is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. m. Plaintiff, Banner Estrella Medical Center (“Banner Estrella”), a part of the Banner Health System, is a non-profit organization located in Phoenix, Arizona. Banner Estrella is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. n. Plaintiff, Banner Boswell Medical Center (“Banner Boswell”), formerly known as Walter O. Boswell Memorial Hospital or Sun Health Boswell Hospital, a part of the Banner Health System, is a non-profit organization located in Sun City, Arizona. Banner Bowell is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. o. Plaintiff, Banner Good Samaritan Medical Center (“Banner Good Samaritan”), a part of the Banner Health System, is a non-profit organization located in Phoenix, Arizona. Banner Good Samaritan is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 11 of 384 1220 C Document 92-2 2 09 7 2 9 12 4831-2220-7524. p. Plaintiff, Banner Thunderbird Medical Center (“Thunderbird”), a part of the Banner Health System, is a non-profit organization located in Glendale, Arizona. Thunderbird is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. q. Plaintiff, McKee Medical Center (“Banner McKee”), a part of the Banner Health System, is a non-profit organization located in Loveland, Colorado. Banner McKee is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. r. Plaintiff, North Colorado Medical Center (“Banner North Colorado”), a part of the Banner Health System, is a non-profit organization located in Greeley, Colorado. Banner North Colorado is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. s. Plaintiff, Banner Gateway Medical Center (“Banner Gateway”), a part of the Banner Health System, is a non-profit organization located in Gilbert, Arizona. Banner Gateway is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. t. Plaintiff, Halifax Community Health System (“Halifax”), also known as Halifax Medical Center, is a non-profit organization located in Daytona Beach, Florida. Halifax is appealing its payment by the Secretary for its FYEs September 30, 2008, 2009, and 2010. u. Plaintiff, Sarasota Memorial Hospital (“Sarasota”), is a non-profit organization located in Sarasota, Florida. Sarasota is appealing its payment by the Secretary for its FYEs September 30, 2008, 2009, and 2010. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 12 of 384 1220 C Document 92-2 2 09 7 3 9 13 4831-2220-7524. v. Plaintiff, Lee Memorial Hospital (“Lee Memorial”), a part of the Lee Memorial Health System, is a non-profit organization located in Fort Myers, Florida. Lee Memorial is appealing its payment by the Secretary for its FYEs September 31, 2009 and 2010. w. Plaintiff, Cape Coral Hospital (“Cape Coral”), a part of the Lee Memorial Health System, is a non-profit organization located in Cape Coral, Florida. Cape Coral is appealing its payment by the Secretary for its FYEs September 31, 2009 and 2010. x. Plaintiff, Gulf Coast Medical Center (“Gulf Coast”), a part of the Lee Memorial Health System, is a non-profit organization located in Fort Myers, Florida. Gulf Coast is appealing its payment by the Secretary for its FYEs September 31, 2009 and 2010. y. Plaintiff, Billings Clinic, is a non-profit organization located in Billings, Montana. Billings Clinic is appealing its payment by the Secretary for its FYEs June 30, 2009, 2010, and 2011. z. Plaintiff, Charleston Area Medical Center (“CAMC”), is a non-profit organization located in Charleston, West Virginia. CAMC is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. aa. Plaintiff, Good Samaritan Hospital (“Good Samaritan”), is a non-profit organization located in Los Angeles, California. Good Samaritan is appealing its payment by the Secretary for its FYEs August 31, 2009 and 2010. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 13 of 384 1220 C Document 92-2 2 09 7 4 9 14 4831-2220-7524. bb. Plaintiff, Valley View Hospital (“Valley View”), is a non-profit organization located in Glenwood Springs, Colorado. Valley View is appealing its payment by the Secretary for its FYE December 31, 2009. cc. Plaintiff, West Virginia University Hospitals (“WVUH”), is a non-profit organization located in Morgantown, West Virginia. WVUH is appealing its payment by the Secretary for its FYEs December 31, 2009 and 2010. dd. Plaintiff, University of Colorado Health at Memorial Hospital, formerly known as Memorial Health System Colorado Springs (“Memorial”), is a non-profit organization located in Colorado Springs, Colorado. Memorial is appealing its payment by the Secretary for FYEs December 31, 2009 and 2010. ee. Plaintiff, Denver Health Medical Center (“Denver Health”), is a non-profit organization located in Denver, Colorado. Denver Health is appealing its payment by the Secretary for its FYE December 31, 2010. ff. Plaintiff, Boulder Community Hospital (“Boulder Community”), is a non- profit organization located in Boulder, Colorado. Boulder Community is appealing its payment by the Secretary for its FYE December 31, 2010. gg. Plaintiff, Parkview Medical Center (“Parkview”), is a non-profit organization located in Pueblo, Colorado. Parkview is appealing its payment by the Secretary for its FYE June 30, 2010. 7. Defendant Sylvia Burwell (the “Secretary”) is Secretary of HHS and is sued in her official capacity. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 14 of 384 1220 C Document 92-2 2 09 7 5 9 15 4831-2220-7524. III. JURISDICTION AND VENUE 8. This Court has jurisdiction under 42 U.S.C. § 1395oo(f), which incorporates the judicial review provisions of the APA (see 5 U.S.C. § 706). 9. Each of the Hospital Providers’ group appeals meets the jurisdictional minimum amount in controversy of $50,000 per group under 42 U.S.C. § 1395oo, as well as other applicable requirements under 42 U.S.C. § 1395oo(a). 10. In several of the group appeals, the Provider Reimbursement Review Board (the “Board”) found that it has jurisdiction over the matter for the subject years and granted the Hospitals’ requests for expedited judicial review under 42 U.S.C. §1395oo(f)(1), determining that the Board did not have authority to overturn the Secretary’s regulations. For several other group appeals, the Board had denied the Hospital Plaintiffs’ request for expedited judicial review on the basis of jurisdiction. The Court has since reversed the Board’s jurisdictional decision, finding that (1) the Hospital Plaintiffs’ administrative appeals met the requirements of the Medicare statute, 42 U.S.C. § 1395oo(a)(1)(B), for Board jurisdiction over appeals where the Medicare contractor did not issue a timely NPR; and (2) the court has subject matter jurisdiction over the merits of the outlier payment claims. 11. Venue is proper in this Court under 42 U.S.C. § 1395oo(f) and 28 U.S.C. § 1391(c). 12. This action is timely filed under 42 U.S.C. § 1395oo(f), in that it has been brought within 60 days of Hospital Plaintiffs’ date of receipt of the Secretary’s final decisions on their administrative appeals. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 15 of 384 1220 C Document 92-2 2 09 7 6 9 16 4831-2220-7524. IV. STATUTORY AND REGULATORY BACKGROUND CREATING THE HOSPITAL PLAINTIFFS’ ENTITLEMENT TO PAYMENT FOR “OUTLIER” CASES a. Under Medicare’s Inpatient Prospective Payment System (“IPPS”), Hospitals Receive Predetermined Amounts, Not Their Actual Costs, In Payment For Treatment Of Ordinary Patient Cases. 13. The Medicare program, established as title XVIII of the Social Security Act, 42 U.S.C. § 1395 et seq. (referred to throughout the rest of this Complaint as the “Medicare Act”), is the federal entitlement program that provides health care insurance to the nation’s aged and disabled. 14. The Secretary administers the Medicare Act. The Centers for Medicare and Medicaid Services (“CMS”) is a component of HHS. CMS is responsible for the daily operation and administration of the Medicare program. 15. Medicare’s hospital insurance program, known as Part A, provides certain benefits covering inpatient hospital, nursing facility, home health and hospice services. From its beginning until October 1983, Medicare paid participating hospitals the “reasonable costs” that they actually incurred in providing inpatient services. See 42 U.S.C. § 1395f(b). In 1983, in an attempt to stem the Medicare program’s escalating costs, and to correct perceived inefficiencies, Congress repealed reasonable cost reimbursement for inpatient operating costs for virtually all acute care hospitals and replaced it with an inpatient prospective payment system (“IPPS”). 16. Under IPPS, rather than reimbursing hospitals for their actual reasonable costs, CMS pays hospitals a fixed, predetermined (i.e., “prospective”) amount assigned to the applicable diagnosis-related group (“DRG”)1 for their services, subject to special rules for certain 1 HHS adopted and implemented a Medicare Severity DRG (“MS-DRG”) classification system under the IPPS beginning in FY 2008, increasing the number of DRGs from 538 to 745. 72 Fed. Reg. 47130, 47419 (Aug. 22, 2007). Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 16 of 384 1220 C Document 92-2 2 09 7 7 9 17 4831-2220-7524. supplemental payments. Generally speaking, CMS pays a fixed amount for each DRG (i.e., type of inpatient case) regardless of the actual costs incurred by the hospital. 42 U.S.C. § 1395ww(d)(1). Thus, hospitals are generally at financial risk that their costs for treating a particular patient may exceed the predetermined amounts under IPPS. 17. CMS makes payments to providers through payment contractors.2 The payment contractors are private insurance companies that process Medicare claims as the Secretary’s agents. 18. In connection with receiving reimbursement from the Secretary for providing covered services to Medicare beneficiaries, each provider submits a cost report at the end of its fiscal year to its payment contractor. 19. The payment contractor audits the cost report and issues a Notice of Program Reimbursement (“NPR”) specifying the amount of reimbursement due to the provider and explaining any adjustments. b. Congress Mandated That Hospitals Be Protected From Extraordinarily High Cost – i.e., “Outlier” – Cases Through Additional Outlier Case Payments. 20. Medicare’s IPPS assumes that fixed payments based on cases of average complexity will, on average, adequately compensate efficiently run hospitals. 21. During the hearings which preceded adoption of the IPPS, however, Congress recognized and made provision for the fact that extraordinarily costly cases could undermine any averaging under IPPS. 2 Until 2005, the payment contractors were known as “fiscal intermediaries.” In 2005, fiscal intermediaries were replaced by Medicare administrative contractors over a transition period. See 42 U.S.C. § 1395h; 42 C.F.R. §413.24(f). Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 17 of 384 1220 C Document 92-2 2 09 7 8 9 18 4831-2220-7524. 22. Accordingly, for discharges after October 1, 1984, the Medicare Act requires extra payments for extraordinarily costly inpatient treatment cases, referred to as “outliers” (hereinafter, the outlier payment provisions of IPPS will be referred to as the “Outlier Program”). 42 U.S.C. § 1395ww(d)(5)(A). Such Outlier Case Payments are made for both operating costs and capital costs. 23. In enacting the Outlier Program, Congress explained: The committee recognizes that under a prospective payment system, there will be cases within each diagnostic category (DRG) that will be extraordinarily costly to treat, relative to other cases within the DRG, because of severity of illness or complicating conditions, and are not adequately compensated for under the DRG payment methodology. The committee amendment, therefore, requires the Secretary to provide additional payments for cases which are extraordinarily costly to treat, relative to other cases within the DRG. S. Rep. No. 98-23, at 51, reprinted in 1983 U.S.C.C.A.N. 143, 191. 24. The Secretary has likewise described the additional Outlier Case Payments as being designed “to protect [Medicare-participating hospitals] against extreme losses imposed by exceptionally costly cases under the prospective payment system.” 53 Fed. Reg. 38,476, 38,506 (Sept. 30, 1988). 25. Moreover, “[t]he outlier payment policy is designed to alleviate any financial disincentive hospitals may have against providing any medically necessary care their patients may require, even those patients who become very sick and require extraordinary resources.” 68 Fed. Reg. at 10,426. 26. The Outlier Program is set forth in four clauses of the Medicare Act codified at 42 U.S.C. § 1395ww(d)(5)(A) and in one clause codified at 42 U.S.C. § 1395ww(d)(3)(B). That statute states, in part, that: Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 18 of 384 1220 C Document 92-2 2 09 7 9 9 19 4831-2220-7524. (ii) . . . [a] hospital may request additional payments in any case where charges, adjusted to cost, . . . exceed the sum of the applicable DRG prospective payment rate plus any amounts payable under subparagraphs (B) and (F)3 plus a fixed dollar amount determined by the Secretary. (iii) The amount of such additional payments . . . shall approximate the marginal cost of care beyond the cutoff point applicable under clause . . . (ii). 42 U.S.C. § 1395ww(d)(5)(A). 27. Further, the statute states that the total amount of Outlier Case Payments “for discharges in a [FY] may not be less than 5 percent nor more than 6 percent of the total payments projected or estimated to be made based on DRG prospective payment rates for discharges in that year.” 42 U.S.C. § 1395ww(d)(5)(A)(iv). The Secretary interprets this statutory mandate as requiring the “Secretary to ensure that outlier payments are equal to or greater than 5 percent and less than or equal to 6 percent of projected or estimated (not actual) DRG payments.” 68 Fed. Reg. 34,494, 34,502 (June 9, 2003). c. The Secretary’s Outlier Payment Regulations And Annual Fixed Loss Threshold (“FLT”) Regulations Determine Hospitals’ Eligibility For, And The Number And Amount Of, Outlier Case Payments. 28. The Secretary’s regulations that govern Outlier Case Payments are located in 42 C.F.R. Part 412 and are set forth in two regulatory sources. The first source comprises the base regulations that establish the method for calculating a hospital’s imputed costs for a patient case and rules concerning eligibility for Outlier Case Payments, which are set forth at 42 C.F.R. §§ 412.80 through 412.86 (the “Outlier Payment Regulations”). 29. The Secretary first promulgated the Outlier Payment Regulations in final form in 1985 and has amended them several times since then, most notably in 2003 when, by her own 3 The subparagraphs (B) and (F) referenced in this clause of the Outlier Statute contemplate certain add-on payments to offset the costs of graduate medical education and care of low-income patients (see 42 U.S.C. § 1395ww(d)(5)(B), (F)) which are not at issue in this action. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 19 of 384 1220 C Document 92-2 2 09 7 20 9 20 4831-2220-7524. admission, she attempted to correct the critical design and implementation flaws that had made them “uniquely susceptible” to abuse, as discussed in paragraphs 37 through 48.4 30. The second source comprises the Secretary’s annual promulgation of “Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year Rates,” which, among other things, establishes the upcoming FY’s cost “cutoff point,” known as the outlier fixed-loss threshold (“FLT”), beyond which patient cases qualify for Outlier Case Payments (the “FLT Regulations”).5 31. In the FLT Regulations, the Secretary purports to meet her obligation under the Outlier Statute by allegedly projecting total IPPS payments for the upcoming FY, determining an FLT that is allegedly projected to result in Outlier Case Payments totaling 5.1% of total IPPS payments (as projected), and then offsetting (i.e., reducing) the payment rate that hospitals receive for IPPS cases by 5.1% (i.e., the hospitals receive only 94.9% of what would have been received but for the Outlier Case Payments offset). See 42 U.S.C. § 1395ww(d)(3)(B), which provides: (B) Reducing for value of outlier payments.— The Secretary shall reduce each of the average standardized amounts determined under subparagraph (A) by a factor equal to the proportion of payments under this subsection (as estimated by the Secretary) based on DRG prospective payment 4 The Secretary’s Outlier Payment Regulations were published in final form on March 29, 1985 at 50 FR commencing at page 12741, and have been subsequently amended 50 FR 35689; 51 FR 31496; 53 FR 38529; 54 FR 36494; 55 FR 15174; 56 FR 43448; 57 FR 39823; 59 FR 45398; 62 FR 45966, 46028; 68 FR 34494, 34515; 71 FR 47870, 48138. 5 The Outlier Program and the Secretary’s Outlier Payment Regulations originally provided two methods for payment of outlier claims: a method for payment of “day outlier” claims (i.e., where a patient’s stay for an inpatient treatment was particularly lengthy), which method is not at issue in this appeal, and a method for payment of “cost outlier” claims, which method is the subject of this appeal. The Secretary’s day outlier regulations were twice successfully challenged by hospitals, in the D.C. and the Ninth Circuits, respectively, for the Secretary’s failure to use the best available data in setting the length of stay thresholds. Alvarado Community Hosp., 155 F.3d 1115; Cnty. of Los Angeles, 192 F.3d 1005. Day outliers were phased out over a 3-year period from FY 1995 through FY 1997. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 20 of 384 1220 C Document 92-2 2 09 7 1 9 21 4831-2220-7524. amounts which are additional payments described in paragraph (5)(A) (relating to outlier payments). 32. Thus, Outlier Case Payments are hospital-funded from the “offset” by what amounts to a self-insured catastrophic-loss fund for making the additional Outlier Case Payments. The Secretary has previously described this fund as the “outlier pool.” See 71 Fed. Reg. 47870, 48151 (Aug. 18, 2006). 33. A hospital’s eligibility for Outlier Case Payments depends on several variables. Most significantly, the hospital’s imputed costs for the case must exceed the sum of (a) the ordinary IPPS payment (and any add-on payments as identified supra in note 2) and (b) the FLT for the then-current FY applicable at the time of the patient’s discharge from inpatient care. The Secretary interprets the mandate of the Outlier Statute – to pay the “marginal cost of care beyond the cutoff point” – as requiring her to pay only 80% of the cost of care beyond the cutoff point. 34. The Secretary annually sets the FLT for the upcoming FY in connection with her annual IPPS rulemaking. 35. The Secretary begins the IPPS rulemaking in February or earlier each year. 36. Any increase in the FLT reduces the total Outlier Case Payments by reducing (a) the number of cases that qualify for such payments, and (b) the amount of Outlier Case Payments for cases that do qualify. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 21 of 384 1220 C Document 92-2 2 09 7 2 9 22 4831-2220-7524. V. THE SECRETARY’S OUTLIER REGULATIONS VIOLATE THE OUTLIER STATUTE, AND CONGRESSIONAL INTENT, AND ARE ALSO BOTH PROCEDURALLY AND SUBSTANTIVELY INVALID UNDER THE APA a. From FY 1998 Through FY 2003, The Secretary, Through Her Invalid Regulations, Wrongly Redistributed More Than $10 Billion Of Outlier Case Payments To A Few Hospitals That Had Exploited The Vulnerabilities In Her System, While Simultaneously Underpaying the Hospital Plaintiffs. 37. The Secretary designed and implemented a system for Outlier Case Payments that, from October 1998 through approximately mid-2003, she has admitted: “thwarted” the intent of Congress; resulted in the redistribution of approximately $10 billion of Outlier Case Payments to a small percentage of hospitals; and, simultaneously, resulted in many other hospitals, including the Hospital Plaintiffs here, being systematically underpaid, and thus denied the financial protection against extraordinarily costly cases that Congress intended and mandated. 38. In June 2003, the Secretary substantially revised the Outlier Payment Regulations to correct design flaws that had resulted in the critical “vulnerabilities” she then admitted had made them “uniquely susceptible” to abuse. 39. In her previous rulemakings promulgating and amending the Outlier Payment Regulations, the Secretary had variously stated that there were no critical flaws in her Outlier Payment Regulations, that she had always used the best available data, and that she would not make retroactive corrections to Outlier Case Payments. 40. Then, in March 2003, in her rulemaking amending the Outlier Payment Regulations, the Secretary reversed herself on each of these points, admitting that there were critical “vulnerabilities” in the Outlier Payment Regulations; that other data, which had always been available, was better, and should be used; and that retroactive corrections should (indeed must) be made through the process of audit and reconciliation. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 22 of 384 1220 C Document 92-2 2 09 7 3 9 23 4831-2220-7524. 41. At the time, the Secretary stated that “[o]ne vulnerability is the time lag between the current charges on a submitted bill and the cost-to-charge ratio taken from the most recent settled cost report. The second vulnerability, in some cases, is that the hospitals may increase their charges so far above costs that their cost-to-charge ratios fall below 3 standard deviations from the geometric mean of cost-to-charge ratios and a higher statewide average cost-to-charge ratio is applied.” 68 Fed. Reg. at 34,496. The Secretary also stated that “[a] final vulnerability remains. Even though the final payment would reflect a hospital’s true cost experience, there would still be the opportunity for a hospital to manipulate its outlier payments by dramatically increasing charges during the year in which the discharge occurs. In this situation, the hospital would receive excessive outlier payments, which, although the hospital would incur an overpayment and have to refund the money when the cost report is settled, would allow the hospital to obtain excess payments from the Medicare Trust Fund on a short-term basis.” Id.at 34,501. 42. The result of these regulatory design flaws was a seriously flawed and unreliable Outlier Program that was “uniquely susceptible” to manipulation by a small number of hospitals that systematically hyper-inflated their charges. Id. at 34,504. The United States Department of Justice has used the term “Turbo-Charging” to describe this practice. 43. By way of example, one hospital charged $240 for green sterile towels that cost $.74 cents, $455 for antibiotics that cost $4.24, and $2,700 for plasma solution that cost $31.93. 44. The then-CMS Administrator stated the following: We had about 300 hospitals chronically “gaming” the system for $2 billion a year for four years in a row, and we did not catch it. That is right— $2 billion a year for four years, or $8 billion total—and the system did not catch it (nor is it designed to catch it). . . . We pay claims quickly and efficiently, but we have no clue what is actually going on in the system. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 23 of 384 1220 C Document 92-2 2 09 7 4 9 24 4831-2220-7524. Uwe E. Reinhardt, Interview: The Medicare World From Both Sides: A Conversation with Tom Scully, Health Affairs, Vol. 22, No. 16 at 169 (Nov./Dec. 2003). 45. In fact, the amount of the overpayments (redistributed to a relatively few hospitals) was, as set forth below, even higher. 46. In an effort to control an extraordinary and accelerating surge in Outlier Case Payments (from FY 1997 through FY 2003) leading up to the time when she amended the Outlier Payment Regulations (a surge she has since admitted she could not at that time explain), the Secretary responded by raising her FLTs by more than 246%. This when, by her own calculations, there was only modest cost inflation (of between 22% and 26%) for the same period. 47. The CMS Administrator testified to Congress as follows: The impact of this is not just that it helps the hospitals that figured out the way to game the system. The impact is that it hurts other people, and on the charts, I attach just one, Thomas Jefferson Hospital, for instance, in Philadelphia, lost about $2 million last year compared to what their normal outliers would have been. In past years, before we started to raise the bar [the FLT], it received about 18 percent, which is what you would expect a big teaching hospital like Thomas Jefferson would get. But their outlier payments have been dropping, because as we raised the bar to get into the pool, they got less for each true high-cost patient. If [we] had lowered the outlier threshold through this current year to what last year’s was [i.e., from $33,560 to $21,025], they would have gotten, just to be precise, $1.6 million more this year, if last year’s rule was still in effect. But because of these abuses, we kept raising the bar, and it hurts all the community hospitals that have not gotten this. . . . A lot of the hospitals that are taking care of these patients have not been paid appropriately. Medicare Outlier Payments to Hospitals: Hearing Before Subcomm. on Labor, Health & Human Services, and Education, 108th Cong. 108-268, at 5-6 (2003) (testimony of Thomas Scully, CMS Administrator). 48. In addition, the CMS Administrator testified: As outlier claims increased (and the agency had no idea why) the outlier threshold has skyrocketed—from $14,050 in 2000 to $33,560 in 2003—as the agency raised the bar to try (very unsuccessfully) to stay within the 5.1 percent target. As a direct result, more hospitals have been forced to absorb the costs of the complex cases they treat, while a relatively small Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 24 of 384 1220 C Document 92-2 2 09 7 5 9 25 4831-2220-7524. number of hospitals that have been aggressively gaming the current rules benefit by getting a hugely disproportionate share of outlier payments. Id. at 7. b. In FY 2003, The Secretary Signed And Sent To OMB For Approval – But Then Silently Abandoned And Failed to Disclose – An Interim Final Regulation Setting Forth Data, Analysis, Methodology And Conclusions Calling For The Immediate Mid-Year Correction Of The FLT And Continued To Disregard The Same In Her FLT Regulations For FYs 2004 And Beyond. 49. In late 2002, the Secretary disclosed, via CMS Program Memorandum, Transmittal A-02-122 (Dec. 3, 2002) and CMS Program Memorandum, Transmittal A-02-126 (Dec. 20, 2002), that she was aware of Turbo-Charging and that she would be amending the Outlier Payment Regulations to fix the “vulnerabilities.” 50. While in the process of amending the Outlier Payment Regulations to attempt to correct for the “vulnerabilities,” the Secretary had both the obligation and the opportunity to reset her FLT, which she had improperly inflated by more than 246%, but she did not. 51. Instead, in amending the Outlier Payment Regulations, and after reviewing hundreds of public comments, many urging the Secretary to lower the FLT materially, she announced that she would leave the threshold where it was – $33,560. 52. By way of explanation, the Secretary stated in the Federal Register: We do believe that we have the authority to revise the threshold, given the extraordinary circumstances that have occurred. . . . However, in light of the relatively small difference between the current threshold and our revised estimate, and the limited amount of time remaining in the fiscal year, we have concluded it is more appropriate to maintain the threshold at $33,560. See 68 Fed. Reg. at 34,506 (emphasis added). 53. The Secretary, however, did not disclose that, during this same rulemaking, the agency had already considered facts, methodology and other analysis on the basis of which the Secretary had concluded that she was required, mid-year, to lower her FY 2003 FLT to $20,760 Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 25 of 384 1220 C Document 92-2 2 09 7 6 9 26 4831-2220-7524. (from $33,560), i.e., that the 2003 FLT was approximately 62% higher than where it should have been, in order to comply with the Outlier Statute’s mandates and the intent of Congress. 54. The analysis, data, methodology, facts and conclusions the agency considered included, among others, the following: “nearly all of the increase in the FY 2003 threshold from FY 2002 ($21,025 to $33,560) was due to a relatively few hospitals with extraordinary rates of increase in their charges”; “we estimate the existing FY 2003 outlier payments made to these [123] hospitals, which make up about 2 percent of all Medicare-participating hospitals, constitute 21.7 percent of all outlier payments nationally”; “[w]e determined that we could not reliably predict the operating or capital cost-to-charge ratios that these 123 hospitals would have in FY 2003; therefore, we excluded them from the simulations we used to determine the revised fixed- loss outlier threshold in this interim final rule with comment period”; “it is necessary to recalculate the outlier threshold to be effective for discharges on or after [insert date of publication], so that outlier payments based on FY 2003 cost-to-charge ratios are still projected to be not less than 5 percent nor more than 6 percent of total operating DRG payments plus outlier payments”; and “[i]n calculating the fixed-loss threshold for this interim final rule with comment period, we excluded the 123 hospitals mentioned above (because they are excluded from the calculation otherwise) and re-estimated the charge inflation factor.” 55. The sixty pages of analysis, data, methodologies, facts and conclusions supporting these statements were set forth in an Interim Final Regulation (“IFR”), which then-HHS Secretary Thompson and then-CMS Administrator Scully had each signed and cleared for distribution outside of the agency to the Office of Management and Budget (“OMB”), and which CMS had submitted to OMB pursuant to Executive Order 12866, for review and approval on or about February 12, 2003. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 26 of 384 1220 C Document 92-2 2 09 7 7 9 27 4831-2220-7524. 56. Moreover, as required by the APA (specifically, 5 U.S.C. § § 553(b)(3)(B)), the agency had made a “good cause finding” that the time that would ordinarily be provided for notice and comment on a proposed rule would be “contrary to the public interest” and “could adversely affect the provision of services to Medicare beneficiaries,” and thus the use of an IFR was necessary and appropriate. 57. Less than three weeks later, the Secretary published in the Federal Register a proposed regulation (not the IFR submitted to OMB). The IFR and the as-published proposed regulation were both assigned the same regulatory identification number and carried identical signature dates, i.e., each document was signed by Administrator Scully on January 24, 2003, and by Secretary Thompson on February 6, 2003. 58. However, in the Federal Register notices relating to her amendment to the Outlier Payment Regulations, the Secretary did not disclose the existence or much of the relevant content of the IFR. She did not disclose the analysis, data, methodologies, facts and conclusions supporting her considered decision to reduce, immediately, the then FY 2003 FLT (from $33,560 to $20,760) as is set forth in the IFR. The Secretary did not mention the same, by way of material alternatives considered but rejected, in her Regulatory Impact Analysis. 59. The Secretary did not disclose the agency’s prior “good cause” finding necessary to waive notice and comment. In addition, the Secretary did not disclose the IFR (or its analysis, data, methodologies, facts and conclusions) in her notices in the Federal Register relating to her FLT regulations for FYs 2004 and beyond. 60. The Secretary’s failure to disclose the agency’s decision not to apply her IFR analysis, methodologies and conclusions, and not to immediately reset the 2003 FLT, deprived the regulated industry of valuable information, improperly limited their ability to comment, and Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 27 of 384 1220 C Document 92-2 2 09 7 8 9 28 4831-2220-7524. dramatically and adversely influenced the Secretary’s setting of the FLTs in FYs 2004 and beyond, including those here at issue. c. The Secretary Has Made Misstatements In Her Annual FLT Rulemakings Since FY 2004 As To One Of Her Essential Corrections To The Outlier Payment Regulations Relating To Reconciliation Of Outlier Payments. 61. As previously noted, the Secretary implemented asserted corrections to her Outlier Payment Regulations in 2003 which she touted as essential to remedying critical “vulnerabilities.” The corrections included requiring the audit and reconciliation of Outlier Case Payments made to providers upon settlement of cost reports to address, as HHS described, the fact that hospitals could still “manipulate [their] outlier payments by dramatically increasing charges during the year in which the discharge occurs . . . .” See 68 Fed. Reg. at 34,501. 62. In justifying the 2003 amendment to the Outlier Payment Regulations that subjected Outlier Case Payments to reconciliation, HHS relied on the requirement, in 42 U.S.C. § 1886(d)(5)(A)(iii), that the amount of any outlier payment must approximate the marginal cost of care beyond the threshold. “This proposed adjustment was [] intended to account for the unique susceptibility of outlier payments to manipulation. Hospitals set their own level of charges and are able to change their charges, without review by their fiscal intermediaries.” 68 Fed. Reg. at 34,501. Thus, it was “necessary to establish a mechanism whereby an adjustment can be made to ensure payments appropriately reflect the marginal cost of care for outlier cases.” Medicare Outlier Payments to Hospitals: Hearing Before a Subcomm. of the S. Comm. on Appropriations, 108th Cong. 3-17, at 51 (2003) (Questions Submitted by Senator Arlen Spector to the HHS). 63. Notwithstanding this reconciliation requirement, and in the face of consistent criticism in public comments received, in establishing each applicable FLT since FY 2004, CMS stated that it would not be “making any adjustments for the possibility that hospitals’ CCRs and Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 28 of 384 1220 C Document 92-2 2 09 7 9 9 29 4831-2220-7524. outlier payments may be reconciled upon cost report settlement.” See, e.g., 73 Fed. Reg. 23,528, 23,711 (Proposed, April 30, 2008). Each time, the Secretary recited the same general excuses as to why she would not take into account the impact of reconciliation: [D]ue to the policy implemented in the June 9, 2003 outlier final rule, cost- to-charge ratios will no longer fluctuate significantly and, therefore, few hospitals, if any, will actually have these ratios reconciled upon cost report settlement. In addition, it is difficult to predict which specific hospitals will have cost-to-charge ratios and outlier payments reconciled in their cost reports in any given year. We also note that reconciliation occurs because hospitals’ actual cost-to-charge ratios for the cost reporting period are different than the interim cost-to-charge ratio used to calculate outlier payments when a bill is processed. Our simulations assume that cost-to- charge ratios accurately measure hospital costs and, therefore, are more indicative of post-reconciliation than pre-reconciliation outlier payments. As a result, we omitted any assumptions about the effects of reconciliation from the outlier threshold calculation. 70 Fed. Reg. 47,278 47,495 (Aug. 12, 2005); see also 69 Fed. Reg. 48,916, 49,278 (Aug. 11, 2004); 71 Fed. Reg. at 48,149; 72 Fed. Reg. 47,130 at 47,418 (Aug. 22, 2007); 73 Fed. Reg. 48,434, 48,765(Aug. 19, 2008); 74 Fed. Reg. 43,754, 44,008-9 (Aug. 27, 2009); 75 Fed. Reg. 50,042, 50,429 (Aug. 16, 2010); 76 Fed. Reg. 51,476, 51,794 (Aug. 18, 2011). 64. On June 28, 2012, however, the HHS Office of Inspector General (“OIG”) issued a report with results from its audit of the Secretary’s outlier reconciliation process that demonstrates the inaccuracy of (and the key information omitted from) the Secretary’s stated reasons for not considering the impact of reconciliation, in establishing the FLTs for FYs 2004 – 2011. See Dep’t. of Health and Human Serv., Office of Inspector Gen., The Centers for Medicare & Medicaid Services Did Not Reconcile Medicare Outlier Payments in Accordance with Federal Regulations and Guidance (June 28, 2012) (A-07-10-02764) 65. Perhaps most compelling is the OIG’s finding (conceded by the Secretary) that seven years after 2003 (the year in which the Secretary published her regulation introducing reconciliation and the charging of interest as two of the four components necessary to “fix” her previously seriously flawed Outlier Payment Regulations) CMS had not reconciled any of the cost reports screened and reported up by its contractors. According to the OIG, the reason for the Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 29 of 384 1220 C Document 92-2 2 09 7 30 9 30 4831-2220-7524. Secretary’s failure to follow her own regulations was that she had not yet developed a methodology for effecting those reconciliations. The Secretary conceded this fact. 66. This fact – that the Secretary simply had not performed the required reconciliation does not support, and in fact contradicts, the reasons given, year after year, for not taking the effect of reconciliation into account when setting the annual FLTs. 67. Further, Outlier Case Payments remained susceptible to charge manipulation, in significant part because HHS disabled its principal safeguard for ensuring that Outlier Case Payments appropriately approximated the marginal cost of care in excess of the FLT, as the statute requires. Upon information and belief, HHS continued to overestimate costs in setting the FLTs because it failed to account for projected claims based on the continuing manipulation of charges. d. The Secretary’s FLTs For The FYs Here At Issue Were Set In Violation Of The APA. 68. The Hospital Plaintiffs assert the Secretary’s FLTs here at issue (those in effect during FYs 2008 through 2011, and which governed the Hospital Plaintiffs’ payments in their respective FYEs in 2008 through 2011) are substantively invalid because, both as written and as implemented, they violated the Outlier Statute, frustrated the intent of Congress and, as measured against the standards set forth in the APA, represent arbitrary and capricious agency action. 69. The Secretary's FLTs for FYs 2008 through 2011 violated the Outlier Statute in that they did not comply with the Secretary’s acknowledged statutory mandate “to ensure that outlier payments are equal to or greater than 5 percent and less than or equal to 6 percent of projected or estimated (not actual) DRG payments.” This is so for reasons that include the following: Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 30 of 384 1220 C Document 92-2 2 09 7 1 9 31 4831-2220-7524. a. The Secretary continued to calculate her projected Outlier Case Payments, “projected or estimated (not actual) DRG payments,” and her FLTs based in part on her annual forward projection of the rate of “charge inflation.” The Secretary did not, however, apply the same forward projection of the rate of charge inflation to the denominator of the fraction (costs/charges) comprising the so called “cost to charge ratios” that she used in the same calculations. Consequently, her “projected or estimated (not actual) DRG payments” and her projected Outlier Case Payments were, by definition, overstated, thus causing her FLTs to be overinflated. b. The Secretary did not implement her policy of audit and reconciliation (and the charging of interest) for the overpayment of Outlier Case Payments, neither did she attempt to reflect the same in her annual calculations setting her FLTs. c. For any and all the above reasons, the Secretary’s FLTs were consistently set too high and, therefore, she consistently underpaid Outlier Case Payments in FYs 2008 through 2011 – upon information and belief by more than approximately $1.72 billion. 70. An agency action is arbitrary and capricious if the agency, among other things: fails to use the best available data for its action and/or does not adequately explain why it is not using such data; fails to consider one or more important aspects of the problem(s); and/or offers explanation(s) for its decision(s) that run counter to the evidence before the agency. 71. The Secretary’s outlier regulations are arbitrary and capricious in that they violate each of the above standards as follows: Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 31 of 384 1220 C Document 92-2 2 09 7 2 9 32 4831-2220-7524. a. The Secretary failed to use the best available data and, in fact, has knowingly used faulty data in setting the annual FLTs. For example, when establishing the FLTs for FYs 2008 through 2011, and despite admonitions in public comments received from hospitals and their major trade associations, the Secretary ignored data relating to Medicare cost inflation (i.e., the “best available” data), choosing instead to use charge inflation data. The Secretary has previously admitted that cost inflation data is the “best available” data. b. The FLTs established by the Secretary have borne no discernible, much less logical, relationship to the Secretary’s published “inflationary factors.” For example, for the fifteen-year period comprising FYs 1998 through 2012, there has been no apparent relationship between (a) the “inflationary factors” which the Secretary has herself calculated, using a number of complex and highly articulated methodologies, to inform her annual adjustment of the FLT, and (b) her actual adjustment of the FLT. The below table reflects the lack of correlation and, in nine of the fifteen years, “negative correlation” between the selected inflationary factor and the adjustment to the FLT: Fiscal Years HHS's 1 Yr. Inflationary Factor HHS's 2 Yr. Inflationary Factor HHS's % Change in Fixed Loss Threshold 1998 -2.005% -3.970% 13.92% 1999 -1.724% -3.418% 0.45% 2000 0.00% 0.00% 26.58% 2001 1.80% 3.632% 24.91% 2002 2.80% 5.678% 19.80% 2003 8.8199% 17.6398% 59.62% 2004 12.5978% 26.8% -7.63% 2005 8.9772% 18.76% -16.77% 2006 7.21% 14.94% -8.53% 2007 7.90% 16.424% 3.75% 2008 6.20% 12.784% -6.00% 2009 5.750% 11.831% -12.90% 2010 6.857% 14.184% 15.44% 2011 4.8257% 9.884% -0.28% 2012 3.89% 7.94% -2.99% Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 32 of 384 1220 C Document 92-2 2 09 7 3 9 33 4831-2220-7524. c. This point is further illustrated by the fact that, beginning with the FY 2004 FLT, the Secretary has steadily reduced her FLTs (in 7 of 9 years). This steady reduction in the FLT cannot be reconciled with her published calculations that hospital costs have steadily continued to rise each year. In fact, over this same nine-year period, the Secretary has said that costs have increased in the aggregate by more than 60% while lowering the FLT in the aggregate by more than 30%, thus showing the Secretary deliberately started from a greatly inflated FLT in FY 2003, which would need to be reduced regardless of the inflation factors that she published. d. The Secretary computed her “inflationary factors” using formulas and data that have, predictably, resulted in total Outlier Case Payments substantially below the 5.1% target. In other words, the Secretary has repeatedly set the FLT too high, with the necessary consequence that she has consistently paid out less in Outlier Case Payments than the amount of money offset from the DRG payments. e. In each of the FLT Regulations here at issue, the Secretary refused to respond adequately (and in some cases at all) to criticisms of and alternatives to her methodology, as suggested by commenters. f. The Secretary’s repeated failures – which show a marked bias toward underpayment – required the Secretary to adopt a revised methodology for computing the inflationary factors and the FLTs, or at least to provide a reasoned explanation as to why the Secretary was refusing to do so. Persisting Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 33 of 384 1220 C Document 92-2 2 09 7 4 9 34 4831-2220-7524. in a process that consistently produces failed results when information was available that would have resulted in an accurate process being used was, and is, arbitrary and capricious and, thus, invalid. g. During the FYs here at issue, the Secretary repeatedly failed to respond to public comments that her estimates of prior years’ Outlier Case Payments (which informed the process of setting the next year’s FLT) were inaccurately high, due to flawed methodology and/or data. h. With and since the FY 2007 FLT, the Secretary has calculated a “CCR adjustment factor” for purposes of projecting Outlier Case Payments and setting the upcoming FLT. In doing so, the Secretary has used neither the best available data, nor a predictably accurate or stable formula, to develop her CCR adjustment factors. The CCR adjustment factors derived by the Secretary’s methodology have been consistently smaller than the rate of decline in average CCRs nationwide, as reflected in the Secretary’s own data. Commenters on the FLT rulemakings have repeatedly raised these and other flaws and suggested alternatives that would yield more accurate projections, but the Secretary has declined to address, or has inadequately addressed, those suggestions, often stating only that she has already responded to the hospitals’ comments in a prior year’s rulemaking. i. For the FYs here at issue, the Secretary has not used the best available data on hospital CCRs in setting the FLTs. For instance, commenters have repeatedly suggested that the agency use the June update, rather than the March update, of the Provider Specific File as the source for such CCRs. In turn, the Secretary Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 34 of 384 1220 C Document 92-2 2 09 7 5 9 35 4831-2220-7524. has repeatedly rejected these suggestions, asserting (inaccurately) that she does not have time to incorporate the data from the June update into the final FLT Regulations, and providing no supporting analysis as to whether or why the same is not feasible. j. For the FYs here at issue, the Secretary has included in her calculations for setting the FLTs assumed charges that are not paid through IPPS, such as charges for anti-hemophilic blood factor and organ acquisition. These errors have resulted in unnecessarily high FLTs. k. Disregarding the suggestions of commenters, the Secretary has refused to make mid-year corrections (on the basis of more current data) to the FLTs in order to achieve greater accuracy. l. For the FYs here at issue, the Secretary has misstated her reasons for refusing to consider the impact of reconciliation in establishing the FLTs. 72. The Secretary has repeatedly failed (or refused) to disclose or publish data and methodologies used (or at least considered) in her Outlier Regulation rulemakings (including information and data adverse to her published conclusions), sometimes even after commenters specifically requested access to such data, and has done so in violation of the APA notice and comment requirements of 5 U.S.C. § 553(c). 73. Because the Secretary deliberately or negligently withheld the IFR from the 2003 Proposed Rule, subsequent Outlier Payment Regulations, and FLT Regulations, the Secretary failed to disclose much of the analysis, data, methodologies, facts, and conclusions set forth in the IFR. This denied the public of its right to notice of and to comment on: (a) material and “reasonably obvious alternatives,” considered and rejected and (b) data and conclusions contrary Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 35 of 384 1220 C Document 92-2 2 09 7 6 9 36 4831-2220-7524. to the Secretary’s final 2003 Outlier Payment Regulation. Accordingly, the Secretary’s final 2003 Outlier Payment Regulation is procedurally invalid. a. Because the Secretary has utilized and relied on her invalid 2003 Outlier Payment Regulation to make projections and to establish her FLTs for FYs 2008 through 2011, each of said FLTs is itself invalid. 74. In summary, due to her substantive and procedural violations, the Secretary has failed to correct (as she has admitted was required by the Outlier Statute) the uninformed and misdirected inflation (246%) of her FLTs for FYs 1998 through 2003, with the predictable result that, in each FY since 2003, including FYs 2008 through 2011 at issue here, the FLT remained unduly inflated and consequently, and the Secretary has paid out substantially less than she has targeted, and substantially less than the amount by which she has offset the hospitals’ DRG payments (i.e., substantially less than the annual outlier pool).As a result, the Hospital Plaintiffs have been denied the Outlier Case Payments that Congress intended for their protection in each of the FYs here at issue. 75. Also, as a result, during the period comprising FYs 2004 through 2012, the Secretary has, arbitrarily and capriciously, implemented the Outlier Statute so as to reduce the total amount of Part A funds paid to hospitals below 100% of what would have been paid had the Outlier Statute not existed. For example, during FYs 2004 through 2012, the 5.1% reduction in total DRG payments made to hospitals exceeded the total Outlier Case Payments paid out each year. The “safety net” Congress envisioned in enacting the Outlier Statute was not intended persistently to create a payment burden for hospitals. 76. The FLTs must be recalibrated and reset for the benefit of the Hospital Plaintiffs for the FYs here at issue. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 36 of 384 1220 C Document 92-2 2 09 7 7 9 37 4831-2220-7524. 77. The Hospital Plaintiffs contend that the Secretary’s Medicare Outlier Regulations – both her Outlier Payment Regulations used to compute imputed costs per case and her annual FLT Regulations setting the fixed-loss thresholds – were contrary to the Social Security Act and the intent of Congress, and were “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” 5 U.S.C. § 706(2)(A), and in violation of 5 U.S.C. § 553. As a result, the FLTs used to calculate the additional payments to which the Hospital Plaintiffs were and continue to be entitled were inherently faulty, caused the payment of fewer and lower Outlier Case Payments to the Hospital Plaintiffs, and must be recalibrated and reset for the benefit of the Hospital Plaintiffs for the FYs at issue in this case. Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 37 of 384 1220 C Document 92-2 2 09 7 8 9 38 4831-2220-7524. VI. REQUEST FOR RELIEF WHEREFORE, Plaintiffs respectfully request as follows: 1. That this Court rule that the Secretary’s regulations implementing the Outlier Statute and her application of same were, for the FYs here at issue, (A) in excess of statutory authority or limitations, or short of statutory right, (B) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, (C) without observance of procedure required by law, and/or (D) unsupported by substantial evidence under the APA, 5 U.S.C. §§ 553 (c) & 706; and 2. That this Court enter an order (a) vacating the Outlier Regulations; and (b) remanding these appeals to the Secretary to: (i) recalibrate and reset the FLTs for Hospital Plaintiffs’ respective FYEs 2008 through 2011, (ii) permit the Hospital Plaintiffs to submit amended claims for Outlier Case Payments for their respective FYEs at issue in accordance with the recalibrated FLTs, and (iii) re-determine and pay the amount of Outlier Case Payments, together with interest, due the Hospital Plaintiffs under the Outlier Statute. Respectfully submitted this 16th day of June, 2015. By: /s/ Stephen P. Nash Stephen P. Nash (D.C. Bar #PA0037) SQUIRE PATTON BOGGS (US) LLP 1801 California, Suite 4900 Denver, CO 80202 Tel.: (303) 830-1776 Fax: (303) 894-6173 E-mail: Stephen.Nash@squirepb.com Counsel for Plaintiffs Case 1:13-cv-00643-RMC Document 65 Filed 06/17/15 Page 38 of 384 1220 C Document 92-2 2 09 7 9 9