University of Colorado Health at Memorial Hospital v. Burwell
UNIVERSITY OF COLORADO HEALTH AT MEMORIAL HOSPITAL, Et Al., Plaintiffs, v. Sylvia M. BURWELL, Secretary, United States Department of Health and Human Services, Defendant
Attorneys
Stephen P. Nash, Squire Patton Boggs, Denver, CO, for Plaintiffs University of Colorado Health at Memorial Hospital, Banner Heart Hospital, Banner Baywood Medical Center, Banner Estrella Medical Center, Banner Gateway Medical Center, Banner Good Samaritan Medical Center, Banner Thunderbird Medical Center, Banner Desert Medical Center, Banner Mesa Medical Center, Banner Del E. Webb Medical Center, Banner Boswell Medical Center, Cape Coral Hospital, Charleston Area Medical Center, Denver Health Medical Center, Boulder Community Hospital, Halifax Community Health System, Sarasota Memorial Hospital, West .Virginia University Hospitals, Allina Health, Banner Health, Lee Memorial, Lee Memorial Hospital, Allina St. Francis Regional Medical Center, Valley View Hospital, Parkview Medical Center, Billings Clinic Hospital, Good Samaritan Hospital Los Angeles and Cabell Huntington Hospital., . Caroline Lewis Wolverton, U.S. Department of Justice, Washington, DC, for Defendant.
Full Opinion (html_with_citations)
MEMORANDUM OPINION
Granting in Part and Denying in Part Plaintiffsâ Motion to Compel ProDUCTION OF THE COMPLETE ADMINISTRATIVE Record
I. INTRODUCTION
This cĂĄse is one in a series of cases in which various hospitals have challenged regulations promulgated by the Department âof Health and Human Services (âHHS") to implement the Outlier Payment System, which provides for supplemental Medicare payments to hospitals when a particular patientâs hospitalization and care is unusually costly. Plaintiffs here, a group of thirty-five acute care hospitals, seek review of the Medicare reimbursements awarded to them under that system. Before the Court is Plaintiffsâ *7 motionâto compel production of the complete administrative record (EOF No. 29). This issue is well-traveled ground. In several other cases challenging HHSâs outlier payment regulations, courts in this district have similarly considered motions to supplement the' administrative record that sought many of the same materials Plaintiffs seek here. See generally Lee Memâl Hosp. v. Burwell, No. 13-643, 109 F.Supp.3d 40, 2015 WL 3631811 (D.D.C. June 11, 2015); Dist. Hosp, Partners v. Sebelius, 971 F.Supp.2d 15 (D.D.C.2013), aff'd, 786 F.3d 46 (D.C.Cir.2015);, Banner Health v. Sebelius, 945 F.Supp.2d 1 (D.D.C.2013). Upon consideration of the partiesâ filings, and for the reasons stated below, the Court will grant in part and deny in part Plaintiffsâ motion to compel production.
II. FACTUAL BACKGROUND
A. The Outlier Payment System
To comprehend the partiesâ dispute about the administrative recordâs contents, one must have a keen understanding of the complex, and at times technical, Medicare Outlier Payment System. Hospitals were originally reimbursed under Medicare for the âreasonable costsâ that they incurred when treating patients. See Dist. Hosp. Partners, L.P. v. Burwell, 786 F.3d 46, 49 (D.C.Cir.2015). Under that model, â[t]he more [hospitals] spent, the more they were reimbursed.â Id. (first alteration in original) (quoting Cnty. of L.A. v. Shalala, 192 F.3d 1005, 1008 (D.C.Cir.1999)). By 1983, however, Congress had determined that a reasonable cost system failed to provide adequate incentives for hospitals to operate efficiently. Id. To remedy the potential for over-spending and to reward cost-effective hospital practices Congress passed as section 1886(d) of the Social Security Act (âSection 1886(d)â) what is called the Inpatient Prospective Payment System (âIPPSâ), administered by the Centers for Medicaid and Medicare Services (âCMSâ) . See Cape Cod Hosp. v. Sebelius, 630 F.3d 203, 205 (D.C.Cir.2011); see also 42 U.S.C. § 1395ww(d). Instead of reimbursing a hospital simply for its reasonable -costs,' Congress directed CMS to calculate a âstandardized amountâ representing- the average operating cost for inpatient hospital services. Cape Cod Hosp., 630 F.3d at 205. Section 1886(d) then provides that Medicare reimbursements made to hospitals are to be based on that standardized amount, regardless of the particular costs a hospital incurs in an individual case. See id.
- Congress did recognize that different illnesses may necessarily -involve more or less costly care, however. To account for those variations, Congress also directed the Secretary of Health and Human Services (the âSecretaryâ) to modify the standardized amount based on a number of diagnosis-related - groups (âDRGsâ). DRGs are âgroup[s] of related illnesses to which the Secretary assigns a weight representing âthe relationship between the costs of treating patients within that group and the average cost of treating all Medicare patients.â â Dist. Hosp. Partners, 786 F.3d at 49 (quoting Cape Cod Hosp., 630 F.3d at 205-06).
Congress further recognized that, notwithstanding the standardized; reimbursement system, âhealth-care providers would inevitably care for some patients whose hospitalization would be extraordinarily costly or lengthy.â Cnty. of L.A., 192 F.3d at 1009. To account for those situations, Congress created the Outlier Payment Program, which permits a hospital to recoup an additional payment, referred to as an âoutlier payment,â if the costs incurred during the care of a particular patient exceed a certain dollar amount. Id. As relevant here, section 1886(d) provides "that *8 a hospital âmay request additional payments in any case where charges, adjusted to cost, ... exceed the sum of the applicable DRG prospective payment rate ... plus a fixed dollar amount determined by the Secretary.â 42 U.S.C. § 1395ww(d)(5)(A)(ii). That fixed dollar amount â referred to as the âfixed loss thresholdâ â âserves as the cutoff point triggering eligibility for outlier payments.â Banner Health, 945 F.Supp.2d at 8.
Section 1886(d) further mandates that the aggregate amount of outlier payments made in any one fiscal year âmay 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.â 42 U.S.C. § 1395ww(d)(5)(A)(iv). During each fiscal year at issue in this case, the Secretary has endeavored to establish payment rates and policies that will produce outlier payments equaling 5.1% of total projected IPPS payments. 1
Hence, it is somewhat of an un derstatement to say that âcalculating outlier payments is an elaborate process.â Dist. Hosp. Partners, 786 F.3d at 49. For simplicityâs sake âthree particular numbers are important: (1) the cost-to-charge ratio, (2) the fixed loss threshold, and (3) the outlier threshold.â Id. The cost-to-charge ratio, or âCCR,â is calculated on an individual hospital level and represents the average differential between the charges that a. particular hospital lists on .a patientâs invoice and the - actual costs that hospital incurs in- treating a patient. In essence, the figure âą represents the hospitalâs âaverage markupâ on its.services. Id. at 50. To calcĂșlatela hospitalâs CCR, the Secretary considers the hospitalâs âmost recent- settled cost report or the most recent tentative, settled cost report, whichever is from the latest cost reporting period.â See 42 C.F.R. § 412.84(i)(2).
As indicated above, the fixed loss threshold is the âfixed dollar amountâ above the DRG prospective payment rate that the cost of a patientâs care must excĂ©ed before a hospital becomes' eligible for an ' outlier payment. 42 U.S.C. § 1395ww(d)(5)(A)(ii). The ' fixed loss threshold â âacts like an insurance deductible because the hospital is responsible for that portion of the treatmentâs excessive costâ above the applicable DRG rate.â Dist. Hosp. Partners, 786 F.3d at 50 (quoting Boca Baton Cmty. Hosp., Inc. v. Tenet Health Care Corp., 582 F.3d 1227, 1229 (11th Cir.2009)). A hospital is simply expected to absorb the additional costs that fall above the DRG but below the fixed loss threshold. The fixed loss threshold is calculated annually and, a new threshold is set for each fiscal year. Id. at. 50.
The third number, the âoutlier threshold,â is calculated by adding the DRG rate for a particular illness - to the fixed loss threshold. Id. Any costs a hospital incurs above the outlier threshold *9 may be reimbursed through an outliei;. payment, although CMS only reimburses a hospital for a fixed percentage of the hospitalâs costs above that outlier threshold. Since at least 2003, CMS has reimbursed hospitals for 80% of their adjusted» costs above the outlier threshold. Id. (citing Medicare Program; Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2004 Rates, 68 Fed.Reg. 45,346, 45,476 (Aug. 1, 2003); 42 C.F.R. § 412.84(k)).
It is important to note that'outlier payments do not provide hospitals with additional funding that is not already allocated to the Medicare program. Instead, outlier payments simply redistribute a portion of IPPS payments that would normally flow to hospitals as reimbursement for typical DRG patients' to those hospitals' that treat outlier patients. See 42 U.S.C. § 1395ww(d)(3)(B). To compensate for the anticipated percentage of outlier payments to be made during the fiscal year, the reimbursements that hospitalsââ receive for ordinary cases under the IPPS program are therefore subject to a percentage reduction âby a factor equal to the proportion of [outlier] payments.â Id.
B. The Challenged Regulations^
Plaintiffsâ claims implicate two types of regulations that HHS has promulgated to implement the outlier payment system. The first is the 2003 Outlier Payment Regulations (the âPayment Regulationsâ), 2 which establish the general model for calculating whether a hospitalâs treatment of a particular patient qualifies for an outlier payment. See Medicare Program; Change in Methodology for Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment Sys-. terns, 68 Fed.Reg. 34,494 (June 9, 2003) [hereinafter â2003 Payment Regulationsâ].
â As noted above, IPPS payments are based âą on the costs a hospital incurs, in treating a patient, not the charges as actually listed on a patientâs invoice. Dist. Hosp. Partners, 786 F.3d at 49-50. CMS adjusts a hospitalâs charges to reflect actual costs using a hospitalâs cost reports. Id. at 49-50, 51. But there is an inevitable time delay between the charges a hospital incurs today and the point at which those charges, as adjusted to cost, will be reflected in a cost report. See 2003 Payment Regulations, 68 Fed.Reg. at 34,496. By 2003, it became clear that several hospitals had learned how to exploit this time lag. Id. Specifically, -if a hospital âdramatically increased charges between past cost reports and the patient costs for which reimbursement is-sought, [that hospitalâs],cost-to-charge ratio âą would be too high and would overestimate the hospitalâs costs.â Dist. Hosp. Partners, 786 F.3d at 51 (internal quotation marks omitted). Such âąoverestimation âmay 'result in some cases receiving outlier payments when th[ose] cases, in actuality, are not high-cost cases.â 2003 Payment Regulations, 68 Fed.Reg. at 34,497. This practice is referred to as turbo-charging. Dist. Hosp. Partners, 786 F.3d at 51. .
In an effort to remedy this problem and to prevent turbo-charging in the future, HHS modified its payment methodology in 2003 to, among other things, provide for the use of âthe most recent tentative settled cost report,â in lieu of a settled cost report, when calculating a hospitalâs OCR. *10 See 2003 Payment Regulations, 68 Fed. Reg. at 34,497. HHS projected that the use of tentative reports would âreduee[] the time lag for updating cost-to-eharge ratios by a year or more.â Id. The Payment Regulations also provided that âoutlier payments would become subject to reconciliation when hospitalsâ cost reports are settled.â Id. at 34,501. HHS did not propose to retroactively adjust the fixed loss threshold for prior fiscal years in light of the reconciled cost reports, however. Id. Instead, HHS explained-that it continued to believe that the threshold âshould be based on projected payments using the latest available, data without retroactive adjustment.â Id.
Using this updated methodology, HHS calculates a new fixed loss threshold each fiscal year to govern hospitalsâ eligibility for outlier payments during that fiscal year (collectively, the âThreshold Regulationsâ). The Threshold Regulations for certain fiscal years (2007, 2008, 2011, and 2012) are the second type of regulations challenged in this case. Using the fiscal year 2008 as an illustration, HHS typically arrives at the upcoming fiscal yearâs fixed loss threshold -through the following process:. 3
First, â the agency âsimulate^] paymentsâ that will be made under the IPPS program during the upcoming fiscal year. FY 2008 Final Rule, 72 Fed.Reg. at- 47,-267. In 2008, the agency simulated payments -with reference to the actual cases and discharges made two years earlier (during fiscal year 2006); that data is set forth in what is called the âMedPAR file,â which contains âfully coded diagnostic and procedure data for all Medicare inpatient hospital bills.â Id. Before simulating the projected payments â for the fiscal year, however, the agency omits inaccurate data from the file â a process that is referred to as âtrimmingâ the data. 4 Id. The trimmed data forms - the universe of cases upon which the next fiscal yearâs projected payments will be based. The agency then adjusts those charges for anticipated inflation. For 2008, HHS âinflated the charges on the MedPAR claims by 2 years, from FY 2006 to FY 2008.â Id. at 47,417. The agency calculates âthe 1 year average annualized rate-of-change in charges-per-caseâ by comparing the charges oyer the first two quarters of the relevant fiscal .year (e.g., 2006) to charges over first two quarters of the following fiscal year (e.g., 2007). Id. at 47,418. That average annual rate of change is referred to as the âcharge inflation factor,â and that factor is applied to the 2006 cases to determine the anticipated charges in 2008. Id. at 47,417.
Because charges submitted for reimbursement will ultimately be adjusted to costs, however, the agency also projects hospitalsâ OCRs for the upcoming fiscal year. The-agency starts with the âmost recent available data at the time of the [proposed or final] rule,â as contained in a particular update to what is called the âProvider Specific File (PSF).â Id. at 47,-417, 47,418. For the 2008 final rulemaking, the agency used the data contained in the âMarch 2007 update-to the PSF.â Id. at 47,418. That PSF data for all Medicaid *11 providers is compiled into a single, aggregated electronic file referred to as an âImpact File.â The Impact File provides âa static snapshot of the actual variables'-that CMS used in the rate-setting and payment modeling work for the rule with which the impact file is associated.â See, Cheng. Decl. ¶ 10, ECF No. â32-1. Those CCRs are then adjusted for anticipated inflation byâ applying what is called a âCCR adjust-, ment factor.â FY 2008 Final Rule, 72 Fed.Reg. at â47,418.
â In 2008, using . the 2006 MedPAR charges and the March 2007 CCRs, both as adjusted for inflation, HHS simiilated payments for the upcoming fiscal year and determined that a fixed loss threshold of $22,635 would ensure, outlier payments equaling â5.1% of total IPPS paymentsâ during the fiscal year. Id. at 47,419, Of course, the agencyâs projections are- dependent on tentative cost reports from prior fiscal years, which may be subject to reconciliation once a final cost report is finalized. See 2003 Payment Regulations, 6(8 Fed.Reg. at 34,501.. Despite this possibility, HHS has repeatedly elected not to adjust its annual projections to account for the possibility that a hospitalâs CCR and outlier payments might be reconciled,, onc^ the final cost reports are settled. 5
C. Procedural History
In this action, Plaintiffs have challenged both the 2003 Payment Regulations and the Threshold Regulations - for the 2007, 2008, 2011, and 2012 fiscal years. See Fourth Am. Compl. ¶¶ 4-5,-ECF No. 41 6 ; see also Pls.â Mem. Supp. Mot. to Compel Produc. at 15, ECF No. 29 [hereinafter âPls.â Mem. Supp.â]. Plaintiffs claim that the Threshold Regulations violate Section 1886(d) of the Social Security Act because they fail to comply with-the statutory mandate that outlier payments fall between five and six percent of all DRG-related payments, and that the regulations are arbitrary and capricious in violation of the Administrative -Procedure Act (âAPAâ). See Fourth Am.. Compl. ¶¶72-73, 75. Plaintiffs also contend, that the 2003 Payment-Regulations are procedurally invalid and that, because the later fiscal year regulations. are implemented using the 2003 methodology, those regulations are also invalid. â See id. ¶ 77. Plaintiffs seek an order vacating the-Payment. Regulations, .remanding these appeals to the Secretary so that she can ârecalibrate and resetâ the fixed loss threshold for each fiscal year at issue, and allowing the Plaintiffs to submit amended claims for outlier payments under the recalibrated threshold levels. See Fourth Am. Compl. at 38.,
HHS initially produced to the Plaintiffs what HHS purported to be the administrative record for the 2003 -Payment Regulations and the Threshold Regulations for fiscal years 2007, 2008, 2011, and 2012. See Certified List of Contents of the Rule- *12 making Record, EOF No. 25. With respect to the Threshold Regulations, the initial record included: the Impact. Files â and MedPAR data files for each fiscal year âą rulemaking, public comments related to those fiscal yearsâ proposed rules, the proposed and final rulemaking notices,' and, for some fiscal years, certain documents specifically referenced in each rulemaking. Id, For the 2003 Payment Regulations, the administrative record included the â Med-PAR data file, the public: comments related to the proposed rule, and the proposed and final rulemaking notices. .Id.
Plaintiffs claim that these documents do not reflect the complete administrative record that was before the agency when it considered these regulations. â Specifically, Plaintiffs have moved to compel the production of nine documents or categories of documents including: (1) an Interim Final Rule considered at the time HHS promulgated the 2003 Payment Regulations; (2) the Impact File for the 2003 Payment Regulations; (3) the formulas used to calculate the fixed loss threshold for each fiscal year at issue in this'case; (4) the formulas and data used to calculate estimated outlier payments, made during the previous FYs; (5) the actuarial analysis and data upon which HHS relied .to calculate the OCR adjustment factors; (6) purportedly missing data HHS used to calculate the inflation factors; (7) purportedly missing and incomplete Impact Files and related data; (8) materials supporting HHSâs regulatory impact analysis considered when promulgating each Threshold Regulation; and (9) materials supporting HHSâs conclusion that it need not consider reconciliation of outlier payments when 'Setting the fixed loss thresholds. See generally Pis.â Mem. Supp. at 21-44. 7
III. LEGAL STANDARD
When a court reviews an agen-, cyâs action under the APA, it must âreview the whole record or .those parts of it cited by a party.â' 5 U.S.C. § 706; see also Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971) (â[R]eview is to be based on the full administrative record that was before the Secretary at the time he made his decision.â). A reviewing court âshould have.before it neither more nor less information than did the agency when it made its decision.â IMS, P.C. v. Alvarez, 129 F.3d 618, 623 (D.C.Cir.1997). Reviewing âless than the full administrative record,â might âallowâa party to withhold evidence unfavorable to its case,â while reviewing âmore than the information before the agency at the time of its decision,â risks ârequiring administrators to be prescient or allowing them to take advantage of post hoc rationalizations.â Walter O. Boswell Memâl Hosp. v. Heckler, 749 F.2d 788, 792 (D.C.Cir.1984). Agencies bear the responsibility of compiling the administrative record,..which must include all of the information that the agency considered âeithĂ©r directly or indirectly.â Marcum v. Salazar, 751 F.Supp.2d 74, 78 (D.D.C. 2010). The record that an agency pro *13 duces âis entitled to a strong presumption of regularity.â Id.
A party may seek to supplement the record produced by the agency however, in âone of two ways.â ' WildEarth Guardians v. Salazar, 670 F.Supp.2d 1, 5 n. 4 (D.D.C.2009). First, a party may seek to include âevidence that should have been properly a part of the administrative record but was excluded by the agency.â Id. Where a plaintiff follows this first route, as Plaintiffs do here, supplementation's appropriate if the agency âdid not include materials that were part -of .its record, whether by design or accident.â Marcum, 751 F.Supp.2d at 78. But to overcome the presumption of regularity, âa plaintiff must put forth concrete evidence that the documents it seeks to âaddâ to the record were actually before the decisionmakers.â Id. To make that showing, a plaintiff musido more than simply assert âthat material^ were relevant or were before an agency when it made its decision.â Id. ââInstead, the plaintiff âmust identify reasonable, non-speculative grounds for its belief that the documents were considered by the agency and not'included in the record.ââ Id. (emphasis in original) (quoting Pac. Shores Subdivision Cal. Water Dist. v. U.S. Army Corps of Engârs, 448 F.Supp.2d 1, 6 (D.D.C.2006)). The plaintiff must alsĂł âidentify the materials allegedly omitted from the record with sufficient specificity, as opposed to merely proffering broad categories of documents and data that are âlikelyâ to exist as a result of other' documents that are included in the administrative record.â Banner Health, 945 F.Supp.2d at 17.
Alternatively, a party may seek to supplement the -record with âextra-judicial evidence that was not initially .before the agency but [which] the party believes should nonetheless be included in the administrative record.â â WildEarth Guardians, 670 F.Supp.2d at 5 n. 4. In these circumstances, a more stringent standard applies. To âjustify! ] a departure from [the] general ruleâ that .review âis to be based on the full administrative record that was before the-Secretary at the time he made his - decision,â a party must demonstrate one of three âunusual circumstances.â Am. Wildlands v. Kempthorne, 580 F.3d 991, 1002 (D.C.Cir.2008) (internal quotation marks omitted).. Those circumstances include: (1) when âthe, agency âdeliberately or negligently excluded documents that may have been adverse to its decision,â â (2) when âbackground information [is] needed, âto. determine whether the agency considered all the relevant factors,â â and (3) when âthe âagency failed to explain administrative action so as to frustrate judicial review.ââ City of Dania Beach v. F.A.A., 628 F.3d 581, 590 (D.C.Cir.2010) (quoting Am. Wildlands, 530 F.3d at 1002).
The Court agrees with another judge in this âdistrict in noting that the dual use of the term âsupplementâ has caused âsome confusionâ about the proper test to apply when-a party seeks to supplement the administrative record. See The Cape Hatteras Access Pres. Alliance v. U.S. Depât of Interior, 667 F.Supp.2d 111, 113 (D.D.C.2009). âSupplementâ has been used synonymously to refer to both a circumstance in which a party argues that the administrative record does not actually reflect the materials that the agency had before it when it made its decision, and a circumstance :in which a party seeks to add extra-record or. extra-judicial information to the record that was concededly not before the agency. Id. Perhaps because of that dual use, courts.in this district have regularly invoked, the language from Da-nia Beach and American Wildlands âand have asked whether a party has shown the existence of one of -the âunusual circumstancesâ â even when considering claims that an agency had not produced materials that it actually had before it. Both par-
*14 ties similarly invoke the Dama Beach and American Wildlands language in this case. But this Court reads those cases to set forth the test for supplementation only with respect to extra-record information. Accord Cape Hatteras, 667 F.Supp.2d at 114-15. For one thing, both cases â and the D.C. Circuit precedent they rely on involved a partyâs effort to introduce information that had not been before the agency when it considered the challenged rule. See, e.g., Dania Beach, 628 F.3d at 590 (seeking to introduce documents from pri- or environmental impact statement processes); Am. Wildlands, 530 F.3d at 1002 (seeking to introduce letters- that âwere written after the [Fish and Wildlife] Service issued its Reconsidered Findingâ and thus were ânot part of the administrative recordâ); James Madison Ltd. by Hecht v. Ludwig, 82 F.3d 1085, 1095 (D.C.Cir.1996) (seeking to introduce bank files that the party conceded âwere not part of the administrative record compiled by the agency when the Senior Deputy Comptroller declared the banks insolventâ). For.another, the Court presumes that, for judicial review to be effective, materials that were before the agency should be included in the administrative record irrespective of whether those materials are-âadverse to [the agencyâs] decisionâ or otherwise satisfy any of the three unusual circumstances identified in American Wildlands and Danta Beach. Similarly, the testâs references to âbackground informationâ or an agencyâs failure to adequately explain its action both imply that the information a court is considering adding to the administrative record in'those circumstances is. information that was not before the agency in the first instance. If a party provides concrete, non-speculative evidence that material an agency did actually consider âeither directly or indirectlyâ is absent from the record, Marcum, 751 F.Supp.2d at 78, however that should be the end of the matter. In those circumstances a court need not go on to ask whether one of the three âunusual circumstancesâ has been shown.
The Court acknowledges that in District Hospital Partners the D.C. Circuit recently applied the American Wildlands test when considering a partyâs effort to supplement the administrative record with materials similar -to those the Plaintiffs seek to add to the record in this case. See 786 F.3d at 55-56. Yet, in that case the Circuit does not seem to have been confronted with materials that the parties claimed had been before the agency in the first instance. The Circuitâs recitation of the test suggests as much. After -reiterating that APA review must âbe based on the full administrative record that was before the Secretary,â the court explained that, to âensure that [courts] review only those documents that were before the agency,â a party may supplement the record only if âthey can demonstrate unusual circumstances justifying a departure from this general rule,â Id. at 55 (emphasis added). Thus, the Circuit appears to have been dealing with a situation in which the parties sought to add extra-record information to the administrative record. 8 As a .result, the Court does not read the opinion to hold that, had the plaintiffs requested to supplement the record with materials that had been before the agency, the Circuit would nĂ©vertheless have required the *15 plaintiffs to show an ââunusual circumstanceâ warranting supplementation.
Plaintiffs here seek to supplement the administrative record with materials that they claim were in' fact before the agency. See Pis.â Mem. Supp. at 17 (claiming, before listing documents Plaintiffs seek; that âHHS has not produced significant additional documents which were before the agency during the rulemakings here at issueâ). Consequently, the Court need only consider whether the Plaintiffs have provided concrete, non-speculative information that the agency directly or indirectly considered the materials Plaintiffs seek in order to resolve this motion. 9
IV. ANALYSIS
Plaintiffs have moved to supplement .the administrative record with materials they claim are relevant to both the 2003. Payment Regulations and the annual Threshold Regulations. Generally, Plaintiffs contend that âthe administrative records that HHS has produced contain .only some of the data inputs and none of the formulas that the agency actually used to set the thresholds? and that-âHHS had omitted a critical document from the rulemaking record for its 2003 amendments to the outlier payment regulations.â Pis.â Mem. Supp. at 2. Without these materials, Plaintiffs claim that âany explanation by HHS of the path taken in arriving at the challenged agency actions will necessarily be incomplete and will thus hinder the Courtâs review.â Id. For its part, HHS "responds that Plaintiffs are seeking materials âthat are not properly included in the administrative records.â Def.âs Mem. Opp. at 2, EOF No. 32. The Court "considers each identified document or category of documents in turn. 10
A. Documents Relevant to the 2003 Payment Regulations
1. The 2003 Interim Finai Rule
Plaintiffs first seek to supplement the record with the draft of a 2003 âInter *16 im Final Ruleâ that HHS developed at the same time that it proposed the Payment Regulations. The draft Interim Final Rule was signed by then-Secretary" of Health and Human Services Tommy G. Thompson on February 6, 2003, the same day that the Secretary signed the proposed final rule, and submitted to the Office of Management and Budget (âOMBâ) on February 13, 2003 pursuant to Executive Order 12,866. 11 See generally Pls.â Mem. Supp. Ex. A (reproducing the Interim Final Rule). In light of certain hospitalsâ turbo-charging practices, which had artificially inflated outlier payments, the Interim Final Rule would have immediately lowered the fixed loss threshold for the 2003 fiscal year from $33,560 to $20,760. See id. at 34-38. The Interim Final Rule also set forth a detailed analysis of why HHS believed that an immediate reduction in the fixed loss threshold was warranted, When HHS published its notice of proposed rulemaking for the new outlier payment methodology on March 5, 2003, however, the agency did not mention the Interim Final Rule and did not address any of the data or analysis that had been laid out in that interim rule. Instead, the agency proposed to make no change to the 2003 fixed loss threshold. See Medicare Program; Proposed Change in Methodology for Determining Payment for Extraordinarily Highr-Cost Cases (Cost Outliers). Under the Acute Care Hospital Inpatient Prospective Payment System, 68 Fed.Reg. 10,420, 10,427 (Mar. 5, 2003). In its subsequent final rule, and contrary, to the analysis contained in the Interim Final Rule, the agency explained that, âin 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.â 2003 Payment Regulations, 68 Fed.Reg. at 34,506.
The Court agrees with three other courts in this district that this course of events provides concrete and non-speculative evidence that the substance of the Interim Final Rule-and its differing conclusion and analysis about the need to lower the fixed loss , threshold-was considered by the agency when settling on the *17 final 2003 Payment Regulations. 12 See Lee Memâl Hosp., 109 F.Supp.3d at 47, 2015 WL 3631811, at *4; Dist. Hosp. Partners, 971 F.Supp.2d at 30; Banner Health, 945 F.Supp.2d at 26. The Interim Final Rule, itself, makes clear that the agency at least considered lowering the 2003 fixed "loss threshold. Marcum, 751 F.Supp.2d at 78. Moreover, contemporaneous testimony-â!)©fore Congress by then-Administrator of the Center for Medicare and Medicaid Services, Thomas Scully, confirms that the agency contemplated lowering the fixed loss threshold but ultimately receded from that position. See Medicare Outlier Payments to Hospitals: Hearing Before a Subcomm. of the Comm. on Appropriations, 108th Cong. 108-268, at 12-13 (2003) (statement of Thomas Scully) (âI feel strongly that, and I have argued strongly within the administration that we should lower the threshold back to $22,000 or $23,000, but you can understand â from OMBâs point of view ... so I agreed with them in the draft rule to leave it where it was.â). As the court pointed out in Banner Health, both the Interim Final âRule and the rule the agency ultimately âproposed âbear the same Regulatory Identification Numberâ and âthe content of the documents are, in large part, identical (except that the proposed rule omits the recommended reduction of the fixed' loss threshold and supporting analysisâ contained within the Interim - Final RulĂ©):â 945 F.Supp.2d at 26. Therefore, âthere can be little doubt that the'Interim Final Rule reflects views adverse to those finally adopted by the Secretary arid that the Secretary considered â and indeed proposed to OMB â the Iriterim Final Rule as an alternative in its path .to promulgation of the 2003 amended Outlier Payment Regulations now challenged by Plaintiffs.â Id. at 27.'
HHSâs only response is its contention that the Interim Final Rule is a âpredecisional documentâ and that âdrafts of agency decisions considered within the agency are typically not considered part of the administrative record even if they are publicly available and therefore not covered by the deliberative process privilege.â 13 Def.âs Mem. Opp. at 10, 12. But the cases that, the agency cites are not- truly comparable. In each of those cases, a court declined to supplement the administrative record with materials that reproduced the internal deliberation among or reflected the thought process of administrative decisionmakers. See, e.g., PLMRS Narrowband Corp. v. F.C.C., 182 F.3d 995, 1001 (D.C.Cir.1999) (refusing to supplement the record with a videotape of a meeting among the FCC Commissioners because agency opinions âspeak for themselvesâ and â[w]here an agency has issued a formal opinion or a written statement of its reasons for acting, transcripts of agency deliberations ... should not routinely be used to impeach that written opinionâ (internal quotation marks and citations omitted)); Checkosky v. S.E.C., 23 F.3d 452, 489 (D.C.Cir.1994) (noting, that agency opinions âspeak for themselvesâ and that requiring an agency to produce âtranscripts of closed agency meetings or intra-agency memoranda and documents.recording the deliberative process leading to the agencyâs decisionâ is âwarranted only in *18 the rarest of casesâ); San Luis Obispo Mothers for Peace v. U.S. Nuclear Regulatory Commân, 789 F.2d 26, 44 (D.C.Cir. 1986) (en banc) (refusing to supplement the record with transcripts of a closed meeting that ârecord[ed] the frank deliberations of Commission members engaged in the' collective mental processes of the agencyâ); cf. Citizens to Preserve Overton Park, 401 U.S. at 420, 91 S.Ct. 814 (stating that âinquiry into the mental processes of administrative decisionmakers is usually to be avoidedâ).
In this case, Plaintiffs do not seek to supplement the record with an informal discussion among regulators, an intra-agency memorandum, or the mental processes of administrative decisionmakers. Instead, although the interim rule was -in draft form when submitted to the OMB for review, it constitutes a âformal opinion or written statement of [the agencyâs] reasons.â See PLMRS Narrowband Corp., 182 F.3d at 1001, Moreover, that draft rule came to a differing conclusion about the wisdom of decreasing the fixed loss threshold â although it was ostensibly based on the same information as the final outlier correction rule. The Interim Final Rule is therefore highly probative in determining the rationality of the agencyâs chosen path. Cf. Hermes Consol., LLC v. E.P.A., 787 F.3d 568, 576 (D.C.Cir.2015) (explaining that, while â[judicial review of a change in agency policy is no stricter than our review of an initial agency action,â- an agency âmust provide reasoned explanation for its action, which normally requires that -it display awar'eness that it is changing positionâ (internal quotation marks and -citations omitted)). HHS has also not cited any authority to support its blanket assertion that âunlike the views of parties outside the agencyâ the views âdeveloped by HHS but ultimately not adoptedâ are categorically shielded from inclusion in the administrative record. Petâs Mem. Opp. at 14-15. To the extent HHS claims that the draft was properly excluded because it ânever became final,â id. at 13, the Court agrees with other courts in this district that such a âbright-line approach â in addition to lacking legal support â is untenable because it may permit the agency to hide from judicial review information regarding alternatives that the agency considered on the, path to reaching its decision.â Banner Health, 945 F.Supp.2d at 23 (citing cases). Accordingly, the Court grants Plaintiffsâ motion to supplement the. administrative record with the Interim Final Rule. 14
2. The 2003 Impact File
The Court similarly grants Plaintiffsâ motion with respect to the 2003: Impact File. As explained above, and as described by the government, the Impact Files contain âall of the provider-specific sourced data, including CCRs, used -to determine the FLT [the fixed loss threshold] for a given fiscal year,â and are derived from data in the . Provider Specific Files. Cheng Decl. ¶ 12. Elsewhere in its memorandum, HHS contends that Impact Files supply one of âthe bases for HHSâs determination of the fixed loss thresholds.â Def.âs Mem. Opp. at 16. Although HHS has included in the administrative record the Impact Files for the fiscal year 2007, 2008, 2011, and 2012 rulemaking, the agency has not supplied the 2003 Impact File.
HHSâs statements demonstrate that the Impact File is important to the rulemaking process and by themselves provide more *19 than speculative evidence that Impact Files were considered in the 2003 rulemak-ing. HHSâs sole response is that the passage of time has left the agency unable to definitively say whether or not Impact Files were considered during the 2003 rulemaking. Def.âs Mem. Opp. at 15; Cheng Decl. ¶ 15. But both the proposed Interim Final Rule and the promulgated Payment Regulations state that the agency reestimated the 2003 threshold when considering whether to alter it. See Fourth Am. Compl. Ex. A at 34-35 (stating that the agency calculated the revised outlier threshold by simulating payments using âthe same dataâ as the existing 2003 threshold, which âincluded the March; 2002 update of the Provider-Specific Fileâ); 2003 Payment Regulations, 68 Fed.Reg. at 34,505 (stating that the agency âreestimated the fixed-loss threshold reflecting the changes implemented in this final Meâ); And the data necessary to make that estimation â including the data from the. Provider Specific File â is contained in the relevant Impact File. See Cheng Deck ¶ 12. The agency has not explained how it could have simtilated these payments without the crucial data contained in the IiripĂĄct File.' Accordingly, the record should be supplemented to include the 2003 Impact file. 15 Accord Lee Memâl Hosp., 109 F.Supp.3d at 49, 2015 WL 3631811, at *5; Banner Health, 945 F.Supp.2d at 32-33.
B. Documents Relevant to thfe Annual Fiscal Year Threshold Regulations
1. Formulas Used to Calculate ;âą the Fixed Loss Thresholds and, Actual Outlier Payments
With respect to the annual Threshold Regulations, Plaintiffs have moved for supplementation of the record on various grounds; First, Plaintiffs seek formulas that they claim were necessarily used each fiscal year to calculate the fixed loss threshold. A critical part of HHSâs efforts to set outlier payment rates and policies each fiscal year is the estimation of anticipated total IPPS payments that hospitals will incur during the upcoming fiscal year. Only by projecting payments is HHS able to determine a threshold level which, it predicts, will result in outlier payments between five and six percent of total IPPS payments. But Plaintiffs contend that HHS has failed to describe the formulas' that it used to determine those fixed loss thresholds.
As already noted, the rulemaking notices explain in general terms how HHS models anticipated IPPS payments for the upcoming fiscal year. For example, in its fiscal year 2008 rulemaking, HHS explains that it âsimulated payments by applying FY 2008 rates and policies using cases from the FY 2006 MedPAR files.â â FY 2008 Final Rule, 72 Fed.Reg. at 47,417. To account for inflation, the charges from *20 those cases were inflated by two years using an inflation factor. HHS then uses the universe of cases from 2006, as inflated, to serve as a proxy for the cases it expects to reimburse during the upcoming fiscal year. To adjust those charges for cost, HHS also uses âthe most recent available data at the time of theâ proposed or final rule to model anticipated OCRs. Id. Those OCRs are also adjusted to take into account both cost and charge inflation, See id. Together, these general descriptions make clear how HHS arrives at the two crucial variables- necessary to its calculation of anticipated IPPS payments: the agency uses MedPAR files from two years prior, as inflated, to approximate the charges that providers will incur and the agency then uses adjusted OCRs to com vert those charges to anticipated costs.
What is not fully explained, however, is the mechanism by which HHS uses those two variables to simulate payments and produce a particular fixed loss threshold. Presumably, HHS uses the cost-adjusted and inflated charges in some type of calculation to model actual payments. Indeed, HHS seems to describe this step as involving the application of a formula. As HHS states in its opposition, after inflating the claims data and adjusting OCRs, the Secretary âfeeds the inflation-adjusted approximated charges data into the payment calculation mechanism, that will be in effect in the coming year..... and tallies the simulated payments that result when the fixed loss threshold is set .at different levels.â Def.âs Mem. Opp. at 5 (emphasis added). But that payment calculation mechanismâs absence from the administrative record â or any detail about it â presents a patent obstacle , to effective judicial review.
. HHS responds that-Plaintiffs have relied only, on .an assumption that formulas beyond the analysis described in the Federal Register exists. Id. at 18. But the Court shares that assumption; indeed, the rule-making noticesâ vague references to âsimulating] payments,â see, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 47,417, and HHSâs own reference before this Court to a âpayment calculation mechanism,â Defiâs Mem. Opp. at 5, all but confirm it. The Court therefore will grant Plaintiffsâ motion and orders HHS to supplement the record with the formula or algorithm through which the agency simulates payments.
The Court recognizes that other courts in this district have come to differing conclusions about the need for supplementing the administrative record with the formula or algorithm HHS has used. Compare Lee Mem'l Hosp., 109 F.Supp.3d at 49, 2015 WL 3631811, at *6 (ordering supplementation), with Banner Health, 945 F.Supp.2d at 29 (concluding that Plaintiffs failed, to identify specific documents âthat might reveal the various formulas, algorithms, and other analysisâ). Yet, this Court believes that the. information is essential to delineate the path HHS has taken to arrive at the chosen fixed loss thresholds. 16
The Court also acknowledges that HHS recently represented in a motion for clarification in Lee Memorial â where the court had ordered supplementation â that âHHS does not possess materials that are responsiveâ to that order âthat have not already been included in the administrative record.â See Def.âs Mot. for Clarification of June 11, 2015 Order and Mem. in Supp. at 2, Lee Mem'l Hosp., No. 1:13-cv-0643 (D.D.C. July 2, 2015), ECF No. 68. *21 This vague assertion provides little explanation and the Court finds it unsatisfying. At present, and for the reasons stated above, the Court fails to understand how that can be so.
It may be that more specificity is provided in the 2003 Payment Regulations, to which CMSâs Director of the Division of Acute Care, Hospital and Ambulatory âąPolicy Group makes passing reference in her declaration. âą See Cheng Decl. ¶ 22. HHS did point to that regulation in its motion for clarification in Lee Memorial and that regulation does describe an elaborate'formula that âsimulates the IPPS outlier payment for a case at a generic hospital.â 2003 Payment Regulations, 68 Fed.Reg. at 34,495. But HHSâs briefing here does not mention the 2003 regulation in connection with the alleged' formulas- that Plaintiffs seek. Moreover, although it is perhaps conceivable that HHS employs this hospital-specific mechanism on a macro level to simulate anticipated payments across all providers (using the inflated charges and adjusted CCRs), the agencyâs description in the Federal Register does not make any connection immediately clear. The current briefing fails to sufficiently explain how the existing administrative record sets forth all of the formulas necessary to fully delineate the agencyâs path. Accordingly, HHS shall supplement the administratiye record with the formulas it used to calculate the fixed loss threshold. 17
2. Formulas and Data Used to Calculate Estimated Outlier Payments for Prior Fiscal Years
During each of its annual rule-makings, HHS also uses morĂ© recent data to update its estimate of the outlier payments made during the prior two fiscal years. See, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 47,420 (detailing the agencyâs âcurrent estimateâ of 2006 actual outlier payments using available 2006 bills and the agencyâs estimate for actual 2007 payments using 2006 bills applied to 2007 rates and policies). âą Plaintiffs similarly seek the formula used to update' those estimates. The rulemakings yet- again reference âsimulationsâ that HHS used to compute the estimated outlier payments for previous fiscal years, see, e.g., id., and the Court assumes that these calculations are similar, if not identical, to those used to simulate payments prospectively when setting the fixed loss threshold. Therefore, the Court similarly concludes that the administrative' record fails to fully delineate the formula used to conduct those acknowledged 'simulations. Accordingly, the Court grants Plaintiffsâ motion with respect to the formulas used to calculate estimated outlier payments for prior fiscal years.
As for the âdataâ underlying those estimates, supplementation is unnecessary. The rulemaking, notices explicitly list which MedPAR files were used to run the simulations. See, e.g., id. The administrative record already contains the relevant MedPAR files for, each rulemaking. See Def.âs Mem. Opp. at 21.
3. Actuarial Analysis and Data Used to Calculate the CCR Adjustment Factor
Since 2007, HHS has applied what it refers to as an âadjustment factorâ to hospitalsâ most recent CCRs when estimating outlier payments for the upcoming *22 fiscal year. The adjustment factor is intended âto account for cost and charge inflation.â FY 2007 Final Rule, 71 Fed.Reg. at 48,150. As explained in the rulemaking notices, HHS works with âthe Office of Actuary to derive the methodology ... to develop the OCR adjustment factor.â FY 2008 Final Rule, 72 Fed.Reg, at 47,417. Broadly speaking, that methodology involves comparing âtwo different measures of cost inflationâ â the average increase in hospitalsâ costs per discharge and a âmarket basket increaseâ determined by Global Insight, Inc., a government consultantâ over a three year period and then dividing that three year average measure of cost inflation by the one year average change in charges. Id. Plaintiffsâ motion to compel seeks production of the âinput from [HHSâs] âactuarial office,â ââ.the memo from that office that HHS used to develop the adjustment factor formula, and âseveral years of cost report dataâ used to calculate the average increase in cost* per discharge. Pis.â Mem. Supp. at 33; Pis.â Reply at 21.
As HHS rightly points out, however, the. final rulemaking notices already describe the full methodology that HHS employs. The Declaration of CMSâs Director of the Division of Acute Care, Hospital and Ambulatory Policy Group explains that the memo from the Office of the Actuary simply contains the âmarket basket' update factors.â Cheng Deck ¶ 24. Those figures are publicly reproduced in the rulemaking notices. See, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 47,417-18 (noting that the 2006 market basket percentage increase wĂĄs 1.0420 and listing the final market basket increases used in prior fiscal years [1.043 for 2005, 1.04 for 2004, and 1.041 for 2003]). Plaintiffs have not attempted to describe with specificity any other information either purportedly contained in those memos or in fact considered by the agency. 18
The Court comes to a different conclusion respecting the cost report data. The rulemaking notices do set forth the annual âpercentage increase of operating costs per dischargeâ figures that the agency. used to calculate a particular adjustment factor for each relevant fiscal year. See id. at 47,418 (listing a percentage increase of 1.0564 from 2004-2005, 1.0617 from 2003-2004, and 1.0715 for 2002-2003). Yet, to the extent the administrative record does not already include the cost report data used to calculate and arrive at those percentage increases, that data should be' included in the. administrative record.
To be sure, â[t]here is no general requirement that the agency include in the record the data underlying each factor,â and, .in some instances, a court âdoes not need to examine the raw data in order to determine whether orâ'not the [agencyâs] decision was arbitrary and capricious or otherwise" not in accordance with law.â Todd v. Campbell , 446 F.Supp. 149, 152 (D.D.C.1978). But a court must be precise. If the raw or underlying source data th'at the parties seek to add was not actually reviewed by the agency, then that data need not be included in the administrative record) Id, (explaining that because the Civil Service Commissionâs staff recommendations were âdeplete with detail to alert the Commission to the self-evident underlying factual data,â there âwas no need for the Commission to have seen the *23 data itselfâ nor for the court âto examine the raw dataâ). â[A]n agency is not normally obligated to make available the raw data upon whichâ the documents, reports, or analyses âconsidered by the agency were based if the agency itself did not rely on the raw data when it reached its decision.â 19 Common Sense Salmon Recovery v. Evans, 217 F.Supp.2d 17, 22 (D.D.C. 2002) (declining to supplement the record with âthe raw genetic data used in some-of the studiesâ the Department of Commerce relied upon when listing a particular species as threatened).
Where, however, the raw data, itself is at issue and was directly considered, analyzed, or manipulated by the agency in the course of reaching its decision, that raw or underlying data is âproperly considered part of the administrative recordââ Ctr. for Biological Diversity v. U.S. Bureau of Land Mgmt., 2007 WL 3049869, at *4 (N.D.Cal. Oct. 18, 2007) (distinguishing Common Sense Salmon Recovery where certain tables of raw data contained < in Excel Spreadsheets and a series of maps had been directly considered by the agency in the course of designating an off-road vehicle route in the California Desert Conservation Area). This conclusion aligns with the requirement that all materials an agency considered âeither directly or indirectlyâ must be included in the administrative record. Marcum, 751 F.Supp.2d at 78. And, here, the Federal Register'notices themselves make plain that HHS specifically used and analyzed the cost report data that the Plaintiffs seek in Order to calculate the annual âpercentage increase of operating costs per dischargeâ for prior fiscal years. See, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 47,418. Thus, Plaintiffs have provided concrete and non-speculative evidence that the underlying cost report data was directly considered by -the agency. The Court will grant the Plaintiffsâ motion with- respect to the cost report data used to calculate the pertinent annual percentage increases of operating costs listed'in each of the Threshold Regulations challenged in this case. 20
4. Data Used to Calculate Inflation Factors
As explained above, when HHS uses prior yearsâ payments to simulate IPPS payments for the upcoming fiscal year, the agency accounts for inflation by applying an âinflation factor.â The inflation factor is derived from a comparison of the charges submitted during the first two quarters of the fiscal year two years prior (e.g., 2006 for the 2008 rulemaking) with the charges submitted during the first two quarters fiscal year one year prior (e.g., 2007). See FY 2008 Final Rule, 72 Fed.Reg. at 47,418. The administrative record here already contains the MedPAR data for each fiscal year between 2006 and 2011. See Def.âs Mem. Opp. at 24. Yet, the government admits that those MedPAR. files differ in certain respects from the MedPAR data that the agency actually used to calculate the charge inflation factor. See id. The agency explains that the data it used to calculate the charge inflation factor set forth in the rulemaking *24 notices âis from an early update of Med-PAR that is highly sensitive and not publicly available because it contains HIPPA-protected personally-identifiable information.â M; see also Cheng Decl. ¶25. The agency explains that one can pull the applicable quarters of data from the publicly available MedPAR files contained in the final rulemaking records in order to âclosely approximate the inflation factor that CMS calculated.â Id. at 24-25; Cheng Decl. ¶ 25.
Although Plaintiffs seek to compel the agency to supplement the record with the actual MedPAR files used to calculate the inflation factor, the Court agrees with HHS that supplementation with the early update of the MedPAR files is not warranted. Despite Plaintiffsâ claim that the withheld files will leave the record without âthe exact data before the agency,â Pis.â Reply at 20, it is not clear to the Court that the withheld files differ from the produced files in any way other than form. The agency notes that the MedPAR files already produced include all of the âactual data used by the agencyâ and that the pertinent quarterâs data can be culled from those files to approximate the charge inflation factor. Cheng Decl. ¶ 25. Other than the sensitive HIPPA-protected inforrriation,'the Court does not understand the actual charge data' contained in the Med-PAR files to differ. Thus, the record already contains the data that the agency actually considered, and Plaintiffsâ motion is denied with respect to the early update of the MedPAR files.
5. Missing or Incomplete Impact Files
Plaintiffs also seek to supplement the administrative record with the source data underlying the Impact Files for each rulemaking challenged in this action. The administrative record here already includes the relevant Impact Files. See Certified List of Contents of the Rulemak-ing Record, EGF No. 25. But Plaintiffs seek the underlying source data for two reasons. First, they contend that âthe administrative record does, not contain HHSâs underlying assumptions and associated data used to compute the conclusory data contained in the Impact Files.â Pls.â Mem. Supp. at 36. Second, they claim that there âare material differences between the CCRs set forth in the Impact Files and those set forth in the March updates of the Provider Specific Fileâ. (âPSFâ). Id. at 37.
As an initial matter, the Court again notes that where an' agency âitself did not rely on'.,. raw data when it reached its decision,â that agfency is ânot normally obligated to make available the raw dataâ in the administrative record. Common Sense Salmon Recovery, 217 F.Supp.2d at 22. Here, Plaintiffs have not even alleged, never mind demonstrated, that when HHS promulgated each yearâs rule the agency considered any of the underlying PSF data 'other than the CCRs that were specifically reproduced in the Impact Files.
Indeed, as Plaintiffs correctly point out, the Impact Files -contain data that is âderivativeâ â that is, the data has been abstracted from other files and merged to form a single Impact File. See Pis.â Mem. Supp. at 36. HHS has provided a robust explanation of how the Impact Files are created. . Specifically, hospitals submit a Medicare cost report each fiscal period (or more frequently) to a government contractor Referred to as a Medicare Administrative Contractor (âMACâ). See Cheng Decl. at ¶6. The MAC then manually calculatesâ CCRs using that hospitalâs most recent s'Ă©ttled cost report and enters that CCR into the hospitalâs PSF which lists both the current and past CCRs, identified by effective date. Id. at ¶ 9. As HHS explains, because âcost report settlement ... can take several years to finalize, the *25 CCRs in the file may repeat across several records for any given provider.â Iff. Every quarter each MAC combines all of the data for the providers that the MAC services into a single âPSF Quarterly Update Fileâ and transmits that file t.o a second contractor called Enterprise Data Center Group (âEDCâ). Id. at ¶ 10. EDC then sends those Quarterly Update Files., to CMS, and CMS compiles them into a single combined file which lists all of the. PSF data for every Medicare provider. Occasionally, there may be problems with the transmission of the data from ĂDC to CMS or other errors may occur. Id. If CMS and EDC are unable to remedy the error in a timely manner, CMS may simply use that providerâs prior CCR figure in place of the updated figure â a practice CMS refers to as âbackfilling.â Id. For purposes of the annual rulemaking* CMS then creates a smaller file â the Impact File â which lists only the PSF data, including the CCR, from the most recent update the agency has received. Id.
This description persuasively rebuts the Plaintiffsâ contention that the underlying source data should be included in the, act-ministrative record. Instead, the record makes clear that the agency only considered the more recent data that was contained in the Impact File, even if, as the agency readily admits, some of that'data was backfilled or substituted with the statewide average CCR. See Cheng peel. ¶ 12; see also Common Sense Salmon Recovery, 217 F.Supp.2d at 22. As a result, Plaintiffs have failed to satisfy their burden of providing concrete evidence that HHS either had the underlying derivative data before it or considered that data when promulgating its final rules. See Marcum, 751 F.Supp.2d at 78.
Nor do the discrepancies Plaintiffs allege that they have- identified provide grounds for supplementing the record. Plaintiffs claim that âmaterial discrepanciesâ exist between' the CCRs listed in the Impact Files and the CCRs reproduced in the publicly available versions of the March update to the relevant Provider Specific File. They further claim that the March update to the files therefore âcould not have been the source of all the CCRs set forth in the Impact Files.â 21 Pis.â Mem. Supp. at 37. As HHS explains, however, the publicly available version of the Provider Specific File may differ from the static Impact File if a MAC lĂĄter received a more recent cost report and updated the PSF to reflect that information. For that reason, HHS points out that one must consider the effective date listed â in the PSF; only the data with an effective date in the early months of each year would have been available to HHS as part of the March update to the PSF and have been included in the Impact File. Cheng Decl. ¶¶ 16-18. HHS represents that when effective dates are considered, the number of discrepancies falls dramatically. Id. ¶ 19. And HHS further argues that the use of statewide averages or backfilling with earlier data in the place of data that was corrupted during transmission from EDC *26 likely explains the remaining discrepancies. Id.
These explanations accord with HHSâs description of the general process by which the Impact Files are compiled and seem to explain why discrepancies may exist between the public file and the Impact File for each fiscal year. See Lee Memâl Hosp., 109 F.Supp.3d at 54, 2015 WL 3631811, at *10 (noting that âthe Provider Specific File data on the CMS website is updated (and may be retroactively corrected) by fiscal intermediaries and therefore cannot be relied upon to mirror the data that was, used to generate the Impact Filesâ (emphasis omitted) (quoting Memorandum-Order at 19, Banner Health, No. 10-1638, (D.D.C. July 30, 2013), ECF No. 96)). Because the agency considered only the Impact Files that have already been produced when setting the threshold level for each fiscal year, any subsequent updates that were made to the CCRs are immaterial for purposes of assessing the validity of the agencyâs rules. 22 At bottom, Plaintiffsâ contention that the agency considered C'CRs other than those memorialized in the Impact Files is speculative. Accordingly, the Court denies the motion to supplement with respect to the Impact Files.
6. Documents Pertaining to the -Regulatory Impact Analyses
Executive Order 12,866 requires federal agencies to prepare a Regulatory Impact Analysis (âRIAâ) for major rules, and HHS prepared an RIA for the annual Threshold Regulations and the Payment Regulations at issue in this case. The RIAs are set forth in the rulemaking notices. Plaintiffs have moved to âą supplement the record with' the âdata, equations, assumptions, and analyses foundational toâ those analyses. Pis.â Mem. Supp. at 39. Specifically, Plaintiffs point to a single paragraph in each rulemakingâs lengthy RlA that references the agencyâs calculation and consideration of the prior yearâs actual anticipated outlier payments when determining the new regulationâs costs and benefits. See id. at 40; see also, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 48,160.
The Plaintiffs appear to be laboring under the mistaken impression that the RIA, itself, is missing from the administrative record. HHS points out, however, that the analysis is reproduced in its entirety as Appendix A to the pertinent yearâs final rulemaking notice. See Def.âs Mem. Opp. at 28; see also, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 48,157-48,173. The Court does not understandâ Appendix A to pro *27 vide merely a summary of the pertinent RIA. To the extent that Plaintiffs .seek the âdata, equations, assumptions, and analysesâ underlying the RIAs, Plaintiffs have not detailed with specificity any particular document they believe was before the agency but has not been produced. The motion to supplement is denied, with respect to the RIAs and data underlying those analyses.
7. Documents Pertaining to Reconciliation of Outlier Payments
Finally, HHS has explained in each Threshold Regulation rulemaking challenged here that it had chosen not to adjust its projection of anticipated outlier payments during thĂ© upcoming fiscal year for âthe possibility that hospitalsâ OCRs and outlier payments' may be reconciled upon cost report settlementâ because it believed that its 2003 correction rules would prevent OCRs from fluctuating significantly. See, e.g., FY 2008 Final Rule, 72 Fed.Reg. at 47,419. As a result,âHHS explained that it expects that âfew hospitals will actually have these ratios reconciled upon cost report settlement.â See, e.g., id. Contrary to this assertion, Plaintiffs claim that âHHS has failed to file' any of the documents underlying and substantiating its assertion that few hospitalsâ will actually have theseâratios reconciled upon cost report settlement,â and have moved to supplement the record with any such documents that exist. Pis.â Mem. Supp. at 42 (internal quotation marks omitted).
In reality, Plaintiffsâ argument is geared toward disputing the adequacy of -the agencyâs proffered rationale. True, Plaintiffs do contend that two reports issued, by the HHS Office of the Inspector General (âOIGâ) indicate that HHS has consistently failed to reconcile past outlier payments in contravention of the 2003 Payment Regulations. See Pls.â Mem. Supp. at 42-43. They further contend that those OIG reports make âclear that either HHS has failed to produce documents that are adverse to its assertion that few hospitals will actually have these ratios reconciled upon cost report settlement,â or that âHHS has failed to provide the true rationale as to why it refused .to, acqount for the impact of. reconciliation when , setting the fixed loss thresholds.â Id. at 43. But Plaintiffs merely speculate that such alternative rationales â or documents memorializing them â exist. Therefore, they have failed to carry their burden of identifying any such documents with specificity. To the extent that Plaintiffs argue that HHSâs stated rational does not adequately support its chosen path, that claim is better left for this Courtâs merits consideration of whether the challenged rules are arbitrary and capricious. Accord Lee Memâl Hosp., 109 F.Supp.3d at 57, 2015 WL 3631811, at *12 (âWhether HHSâs decision may be deemed unreasonable in light of the OIG report is a question to bĂ© addressĂ©d upon the Courtâs review of the merits.â).
V. ' CONCLUSION"'
For the foregoing reasons, the Court grants in part and denies in part the Plaintiffsâ motion to compel production of the complete administrative record. To summarize, Defendant shall supplement the administrative record with- the following materials: . â
(1) The 2003 draft Interim Final Rule;
(2) â The 2003 rulemaking Impact File;
(3) The formula(s) the agency u.sed to calculate the fixed loss threshold for the Threshold Regulations;
(4) The formula(s) used to calculate estimated outlier payments for prior fiscal years; and
(5) . The cost report data used to calculate each of the annual percentage *28 increases of operating costs per discharge- identified in each of. the Threshold Regulations.
Defendant shall produce these materials to Plaintiffs and filé a certified list of contents with the Court pursuant to the local civil rules. See Local Civil Rule 7(n)(l). The parties are to meet and confer and submit on or before November 23, 2015 a proposed timeframe within which to comply with this directive. An order consistent with this Memorandum Opinion is separately and contemporaneously issued.
. Plaintiffs refer to these regulations- interchangeably as the "Payment Regulationsâ and the "Outlier Payment Regulation.â Compare, Pl s.â Mem. Supp. Mot. to Compel Pro-due. at 5, ECF No. 29, with Fourth Am. Compl.â ¶ 77. The Court will refer to the 2003 regulations as the "Payment Regulations.â
. In their respective memoranda the parties often use the 2008 rulemaking as an illustration. The Court follows suit, reserving additional detail with respect to certain aspects of HHSâs methodology for the analysis, below.
. For example, among other alterations, HHS subtracts âorgan acquisition costsâ from the charges for certain types of organ transplants, deletes claims with total charges or total lengths of stay less than or equal to zero, and removes statistical outliers from the data sets. See FY 2008 Final Rule, 72 Fed Reg. at 47,-268,
. See, e.g., FY 2007 Final Rule, 71 Fed.Reg. at 48,149; FY 2008 Final Rule, 72 Fed.Reg. at 47,419; FY 2011 Final Rule, 75 Fed.Reg. at 50,428-29; FY 2012 Final Rule, 76 Fed.Reg. at 51,793.
. On June 16, 2015, and in the midst -of briefing with respect to this motion- to compel, Plaintiffs were granted leave to .file, a Fourth Amended Complaint. The amended complaint added additional claims by certain hospitals, which were already Plaintiffs ip. this case, based on recent activity of the Provider Reimbursement Review Board. Because the amended complaint did not "implicate any new rulemaking records,â the Plaintiffs represented that the "existing briefs associated with Plaintiffsâ Motion to Compel with respect to the completeness of the administrative record will not be impacted by [the] proposed Fpurth Amended complaint.â Pis.â Unopposed Mot. for Leave - to File Fourth Am. Compl. ¶ 12, ECF No. 40. Throughout this memorandum opinion .the Court will cite to the Fourth Amended Complaint,, as the governing complaint.
. For ease of reference, the Court refers to the specific documents discussed in the argument section of Plaintiffsâ memorandum. Although Plaintiffs provide a bullet point list in their memorandum listing the documents they seek, see Pis.â Mem. Supp. at 17-18, that list differs in some respects from the description in the subsequent analysis section. For example, the Court understands Plaintiffsâ general reference to "supporting data which HHS actually used to determine certain key assumptions for projected outlier payment calculations as set forth in HHSâs Impact 'Files for each FY at issue,â Pis.â Mem. Supp. at' 17, to encompass both Plaintiffsâ request for missing data iised to calculate inflation factors and their request for the data missing ' from the purportedly incomplete impact files, â see id. at 34, 36.
. This was undoubtedly the case with two of the three types of material at issue in District Hospital Partners. First, the plaintiffs there sought to supplement the record with the âcongressional testimony of a former HHS official," Dist. Hosp. Partners, 786 F.3d at 56, which, quite obviously, was not part of the agencyâsâ rulemaking record. Second, plaintiffs also argued that the " âtrimmedâ version of hospital charge dataâ should have been *15 added to the record. Id. at 55. But the Circuit noted that there is no stand-alone-version of the trimmed data that differs from the datg files already in the record. Id. at 55; see also infra (explaining that the Federal Register identifies the trims applied to the existing MedPAR files). As for the third category, of material, the Circuit generally explained that plaintiffs had sought to supplement the record with "source data used to approximate cost-to-charge ratios for 2004.â Id. It is not immediately clear from the Circuitâs description, however, whether the Circuit was referring to data -that it understood the agency to have considered directly. As this Court explains below, although an agency must includeâin. the administrative record all materials it directly or indirectly considered, an "agency is not normally obligated to make available the raw data upon which (reports or documents] considered by the agency were based if the agency itself did not rely on the raw data when it reached its decision.â Common Sense Salmon Recovery v. Evans, 217 F.Supp.2d 17, 22 (D.D.C.2002) (emphasis added). And with respect' to these rulemaking records, some underlying source data was considered, analyzed, and manipulated by the agency, itself, while other data was not. See infra at 28-30 (explaining that cost report data was analyzĂ©d and manipulated by the agency), 32-33 (explaining that, with respect to provider CCRs, the agency relied on the Impact Files provided by Enterprise Data Center Group and did not review the underlying source data itself). Accordingly, given the Circuitâs explanation in District Hospital Partners that it-was considering the plaintiffs' efforts to "justifyd a departure from th(e] general ruleâ that the record should include "only those documents that were before the agency,â this Court assumes that the underlying source data at issue there had not been considered by the agency. 786 F.3d at 55.
. Nonetheless, as explained below, the Court notes, that in each instance in which it will order the.record supplemented in this case, one of the three .unusual circumstances is satisfied. See infra notes 14-16, 20.
. To the extent that Plaintiffsâ at times vague - -references to missing "dataâ or "documentsâ are intended to reference any materials, not *16 explicitly discussed in this memorandum, opinion, Plaintiffs have failed to describe those materials with the necessary specificity to overcome the presumption of regularity. Similarly, Plaintiffs make passing reference to CMSâs Record Schedule which defines an official rulemaking record to include:
the published proposed rule, all public comments received in response to the proposed rule or notice that the agency considered in developing the final policy, the public comment log prepared by the recordkeeping office, any computer runs, internal/external studies, final actuarial determinations, and all data that supported the policy, data that refuted the policy and data that would support alternative options.
See Pis.â Mem. Supp. Ex, B (reproducing the records schedule). Despite Plaintiffsâ assertion that this policy makes clear "that there are many other types (or categories) of documents that have not yet been filed with the Court,â Pis.â Mem. Supp. at 26, the Court interprets this policy to merely detail what records must be retained and submitted to the National Archives and Records Administration. The policy does not indicate that every rulemaking will necessarily lead to the production or creation of each of the listed types of documents nor that every record that falls into one of these categories must necessarily become part.pf the administrative record under the APA.
. Executive Order 12,866 requires agencies to submit "significant regulatory action[s]â to the OMB for review. See generally Exec. Or- âą der No. 12,866 § 6, 58 Fed.Reg. 51,735 (Sept. 30, 1993); Plaintiffs represent that they obtained the draft of the Final Interim Rule through a Freedom of Information Act Request submitted to the OMB. Pis,â Mem. Supp. at 22.-
. The D.C. Circuit recently held .that one. of those courts did not abuse its discretion in so deciding. See Dist. Hosp. Partners, 786 F.3d at 55 n. 3.
. HHS concedes that "the draft is publically available and not covered by the deliberative â process privilege.â Def.âs Mem. Opp. at 13; see also Dist. Hosp. Partners, 971 F.Supp.2d at 30 (explaining why the Interim Final Rule is not protected by the deliberative process privilege).
. And to the extent Plaintiffs must show an "usual circumstance" to justify supplementation of the record, the agencyâs about-face certainly suggests that the agency has âdeliberately or negligently excluded documents that may have been adverse to its decision." Am. Wildlands, 530 F.3d at 1002.
. The Court also takes judiciĂĄl notice' of'the fact that HHS recently confirmed,. following the district court's decision in a similar case, that it had supplemented the record with the Impact File for the 2003 Rulemaking. See Def.âs Mot. for Clarification at 1, Lee Memâl Hosp. v. Burwell, No. 1:13-cv-0643-RMC (D.D.C. July 2, 2015), ECF No. 68; see also Lewis v. Drug Enforcement Admin., 777 F.Supp.2d 151, 159 (D.D.C.2011) ("The court may take judicial notice of public records from other court proceedings,ââ), HHS's filing provides non-speculative evidence that a 2003 Impact File does exist. Because the file exists, the Court finds it difficult to understand how the fixed loss threshold could have been calculated without the use of that file for the reasons stated above, For the same reasons, the 2003 Impact File plainly constitutes "background information ... needed âto determine whether the agency considered all the relevant factors,â "â to the extent an âunusual circumstanceâ is necessary to supplement the record. City of Dania Beach, 628 F.3d at 590 (quoting Am. Wildlands, 530 F.3d at 1002).
. And -therefore also constitutes âbackground information ... needed âto determine whether the agency considered all the relevant factors.' â City of Dania Beach, 628 F.3d at 590 (quoting Am. Wildlands, 530 F.3d at 1002).
. Plaintiffs also moved to compel HHS to disclose the data trims that the agency applied to the MedPAR files before it simulated payments. HHS pointed out in its opposition that all of those data trims are explicitly identified in the notices of final rulemaking, see Def.'s Mem. Opp. at 19, and Plaintiffs no longer seek to supplement the administrative âąrecord with the data trims, see Pis.â Reply at 14 n.7.
. In their initial motion/- Plaintiffs also requested that HHS produce the data that Global Insight, Inc. used to calculate the market basket rate of increase. See Pls.â Mem. Supp. at 33. HHS has clarified that it does not consider any of the underlying data used to â generate the market basket figure, Cheng Decl. ¶ 24, and Plaintiffs no longer seek to have the-record supplemented with that data, see Pls.â Mem. Supp. at 21 n.12.
. At least so long as there are no "unique circumstancesâ suggesting that "the agency had reason to doubt the validity of a study on which it had relied.â Common Sense Salmon Recovery, 217 F.Supp.2d at 22 (citing Endangered Species Comm. v. Babbitt, 852 F.Supp. 32, 36-37 (D.D.C. 1994)).
. In addition,: since the cost report data is necessary for one to understand how the agency calculated those annual percentage increases, this data constitutes "background information .... needed âto determine whether the agency considered all the relevant factors.â â City of Dania Beach, 628 F.3d at 590 (quoting Am. Wildlands, 530 F.3d at 1002).
. Plaintiffs claim that 385 CCRs in the 2008 Impact File do not match the CCRs listed in the publicly-available Provider Specific File, and they argue that similar discrepancies exist for each of the fiscal years they have challenged here. See Pls.â Mem. Supp. at 37 & n.27. Yet, Plaintiffs have not identified the effective dates of the data that they reviewed, nor do they detail exactly how their comparative analysis was conducted. Such generalized, assertions are insufficient to overcome the presumption of regularity. In any event, even assuming that Plaintiffsâ contentions are accurate, as just explained it is clear that the agency only considered the data memorialized in the relevant Impact File when it promulgated each Threshold Regulation,
. Plaintiffs argue that two declarations of CMSâs director-, of the Division of Acute Care, Hospital and Ambulatory Policy Group â one filed in this case and a second in another case in this district â confirm that the agency actually used more recent, data than the March updates to create the Impact Files. See Pls.â, Mem. Supp. at 37-38 (discussing, for March 2007 Impact file, June 2007 effective dates); Pls.â Reply at 18 (referring to effective dĂĄtes extending until September 2007, the dnd of the fiscal year). Plaintiffs appear to take the Directorâs references out of context, however. In both declarations Ms. Cheng consistently maintains that CCRs- were calculated- with reference to, and that the Impact File only contained, the data CMS had as of the March update to the Impact Files. See Cheng Decl. at ¶ 19; Decl. of Ing-Jye Cheng ¶ 15, Lee Memâl Hosp. v. Burwell, No. 1:13-cv-0643-RMC (D.D.C, Jan 23, 2015), ECF No. 53-1. As best the Court can discern, Ms. Chengâs references to "effective dates prior toâ June 2007 and" "effective dates prior toâ October 2007 "seem to refer to the dates by which CMS would have received a new quarterly update from EDC that would have displaced the previous March 2007 update. The Court does not read either declaration to suggest that CCRs were sourced from data received after the March 2007 updates. For this same reason, the Court disagrees with Plaintiffsâ claim that Ms. Cherigâs declaration in this case contradicts her prior declaration in Lee Memorial. See Pls.âReply at 18.