# University of Colorado Health at Memorial Hospital v. Burwell

> District Court, District of Columbia · June 17, 2022

URL: https://www.frixlaw.com/law-library/cases/6350974

## Case

- **Court:** District Court, District of Columbia
- **Decided:** June 17, 2022
- **Precedential status:** Published
- **Opinion:** Opinion
- **Judges:** Judge Rudolph Contreras
- **Nature of suit:** Civil
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/6350974

## How later opinions describe it (automated extraction)

- holding that an agency’s statement that it “plan[ned] to assess” an issue commenters had raised fell “well short of what [was] needed to demonstrate the agency grappled with an important aspect of the problem before it or considered another reasonable path forward”
- holding that “the 2004 outlier threshold . . . [was] inadequately explained and” instructing the district court to “remand the 2004 rule to the Secretary for further proceedings consistent with this opinion”
- noting, in the context of rejecting a challenge to various EPA cost assumptions where the challenger had not explained why the assumptions were arbitrary and capricious, that courts “generally defer[] to the agency’s expertise” on “technical details”

## Opinion text

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

UNIVERSITY OF COLORADO HEALTH :
AT MEMORIAL HOSPITAL, et al., :
:
Plaintiffs, : Civil Action No.: 14-1220 (RC)
:
v. : Re Document Nos.: 184, 185, 188
:
XAVIER BECERRA, Secretary of :
Health and Human Services, :
:
Defendant. :

MEMORANDUM OPINION

GRANTING IN PART AND DENYING IN PART PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT;
GRANTING IN PART AND DENYING IN PART DEFENDANT’S CROSS- MOTION FOR SUMMARY
JUDGMENT; AND GRANTING IN PART AND DENYING IN PART PLAINTIFFS’ MOTION TO
COMPLETE ADMINISTRATIVE RECORDS

I. INTRODUCTION

In advance of each fiscal year (“FY”), the Secretary of the Department of Health and

Human Services (“HHS” or the “Secretary”) engages in a notice-and-comment rulemaking

process to establish a number that will play a significant part in determining the extent to which

hospitals will receive Medicare reimbursement payments for certain extraordinarily costly

services performed during the fiscal year. Plaintiffs, a group of hospitals, ask the Court to vacate

the rules for FYs 2007–2013 because of alleged procedural and/or substantive defects in HHS’s

rulemaking proceedings for these years. The Court holds that the Secretary’s explanations of

certain decisions reached in the FY 2012 and FY 2013 rules were inadequate under the

Administrative Procedure Act; accordingly, it remands these rules to the Secretary for further
explanation. Otherwise, the Court holds that the Secretary acted lawfully in promulgating the

remaining challenged rules.

II. BACKGROUND

A. Regulatory Framework

The Court assumes familiarity with its detailed descriptions of the regulations governing

the Medicare outlier payments program found in prior opinions in this case. See Mem. Op.

Granting in Part and Denying in Part Def.’s Partial Mot. Dismiss and Granting in Part and

Denying in Part Pls.’ Mot. Suppl. Admin. R. (“Mot. Dismiss Op.”), ECF No. 155; Mem. Op.

Granting Def.’s Mot. Leave to Suppl. Answer (“Mem. Op. Suppl.”), ECF No. 89; Mem. Op.

Granting Def.’s Mot. for Clarification (“Clarification Op.”), ECF No. 57; Mem. Op. Granting in

Part and Denying in Part Pls.’ Mot. to Compel Prod. of Complete Admin. R. (“Suppl. Rec.

Op.”), ECF No. 47. And it will provide additional detail as necessary throughout its analysis.

Still, for orientation, the Court directly repeats, with some modifications, part of the background

it provided in its most recent opinion in this case. Mot. Dismiss Op. at 1–9.

Under Medicare, the federal government reimburses hospitals for supplying medical

services to the elderly and disabled. See Social Security Amendments of 1965 (“Medicare Act”),

Pub. L. No. 89–97, tit. XVIII, 79 Stat. 286, 291.1 Providers are not reimbursed for the full costs

that they incur; instead, they are paid at fixed rates for different categories of services and

treatments, known as “diagnosis-related groups” (“DRGs”). See Billings Clinic v. Azar, 901

F.3d 301, 303 (D.C. Cir. 2018) (citation omitted). However, hospitals are also eligible for

certain outlier payments as a form of protection against unusually complicated and costly cases.

Id. at 304 (citing 42 U.S.C. § 1395ww(d)(5)(A)(ii)). These payments become available when the

1
Codified as amended in 42 U.S.C. § 1395 et seq.

2
provider’s (1) “cost-adjusted charges” for a case exceed (2) the sum of (2a) the default

reimbursement payment and (2b) a fixed dollar amount (known as the “outlier threshold” or the

“fixed loss threshold” (FLT) and determined by the Secretary through an annual rulemaking

process). Id. at 304 (citation omitted).

That first figure—the provider’s “cost-adjusted charges”—is intended to estimate the

provider’s real cost of care, without any markups, and is calculated by multiplying a provider’s

actual charges by a historical “cost-to-charge ratio.” Id. at 304–05 (citation omitted). The

second figure—the sum of the base reimbursement plus the fixed loss threshold—is known as

the “fixed-loss cost threshold.” Id. at 304 (citation omitted). Cost-adjusted charges above the

fixed-loss cost threshold are reimbursed at a rate intended to approximate the marginal cost of

care, currently set at 80 percent in most cases. Id. at 305 (citation omitted).

As an example: imagine a hospital charges $100,000 for an unusually complicated

procedure.2 The $100,000 will be multiplied by a cost-to-charge ratio (“CCR”) (imagine it’s

72:100 or 72 percent, which HHS will have calculated based on historical data), leaving $72,000

of cost-adjusted charges. Imagine too that the standard DRG reimbursement rate for this kind of

procedure is $8,000, and the fixed loss threshold set by the Secretary that year is $11,000. The

hospital will automatically receive the base reimbursement of $8,000. And because the cost-

adjusted charges ($72,000) are greater than the fixed-loss cost threshold ($19,000), the hospital is

also eligible for an outlier payment. That payment will be 80 percent of the difference between

the cost-adjusted charges ($72,000) and the fixed-loss cost threshold ($19,000), or $42,400.

2
This is based on example offered in the Secretary’s opening motion-to-dismiss brief, see
Def.’s Mem. Supp. Mot. Dismiss at 6, ECF No. 139-1, which is in turn drawn from an August
29, 1997, Federal Register notice: Changes to the Hospital Inpatient Prospective Payment
Systems and Fiscal Year 1998 Rates, 62 Fed. Reg. 45,966, 46,011 (Aug. 29, 1997).

3
Notice that when the fixed loss threshold is smaller, it is more likely that a hospital will receive

an outlier payment and that any outlier payment received will be greater.

That leaves an important question: how does the Secretary determine each fiscal year’s

fixed loss threshold? Well, Congress has limited the aggregate amount of Medicare outlier

payments to a narrow range: it “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). To satisfy this directive, HHS

conducts an annual rulemaking to set the fixed loss threshold at a level that it estimates will

result in total payments within the statutorily-determined range (more on that later). See Billings

Clinic, 901 F.3d at 306–07 (citation omitted). Specifically, since 1989, HHS has attempted to set

an annual threshold that will result in total outlier payments being 5.1 percent of all Medicare

payments. Id. at 307. Crucial to the Secretary’s projections are the providers’ estimated future

cost-to-charge ratios. Id. For instance, if HHS overestimates a future year’s cost-to-charge

ratios (expecting, say, 90 percent when it turns out to be 72 percent), then reimbursable, cost-

adjusted charges will be lower than expected—meaning that HHS may have set the fixed loss

threshold too high and therefore be at risk of undershooting its 5.1 percent payment target.

This is all the more important because, in order to fund outlier payments, the Secretary

withholds the predicted 5.1 percent from all other standard reimbursements. See 42 U.S.C. §

1395ww(d)(3)(B). And the Secretary need not take corrective action when the actual outlier

payments differ from the 5.1 percent target. See Dist. Hosp. Partners L.P. v. Burwell, 786 F.3d

46, 51 (D.C. Cir. 2015) (citing County of Los Angeles v. Shalala, 192 F.3d 1005, 1020 (D.C. Cir.

1999)). As a result, undershooting the 5.1 percent target results in a net loss of payments to

providers as a whole.

4
Procedurally, healthcare providers are reimbursed on a rolling basis, but at the end of

their fiscal years, they submit annual cost reports to so-called “medicare administrative

contractors” or “fiscal intermediaries.”3 See 42 U.S.C. § 1395h(a); 42 U.S.C. § 1395kk-1(a)(3)–

(a)(4)(B); 42 C.F.R. § 413.20(b). Fiscal intermediaries then issue a total reimbursement

determination for the entire year4 through a Notice of Program Reimbursement (“NPR”). 42

C.F.R. § 405.1803(a). Hospitals are permitted to challenge an NPR by appealing to the Provider

Reimbursement Review Board (“PRRB”), a specialized administrative body. 42 U.S.C. §

1395oo(a). Hospitals can in turn seek judicial review of a PRRB’s final decision. §

1395oo(f)(1). Providers also “have the right to obtain judicial review of any action of the fiscal

intermediary which involves a question of law or regulations relevant to the matters in

controversy whenever the [PRRB] determines . . . that it is without authority to decide the

question”; such determinations for expedited review can be made sua sponte by the PRRB or at

the request of a provider. Id. In either case, a district court reviews the challenged action

“pursuant to the applicable provisions” of the Administrative Procedure Act (“APA”). Id.

One other feature of the process bears mentioning at this stage. In the early 2000s, the

Secretary would determine a hospital’s cost-to-charge ratio using “cost and charge data from the

‘latest available settled cost report’ without any forward projections.” Billings Clinic, 901 F.3d

at 305. But this approach proved problematic, because

cost reports take several years to settle. And that time lag generated opportunities
for abuse. Hospitals could manipulate their outlier payments by inflating current

3
“Medicare administrative contractor” is the current statutory terminology. See 42
U.S.C. § 1395h(a). Fiscal intermediary is an older term, see Palisades Gen. Hosp. Inc. v. Leavitt,
426 F.3d 400, 401 (D.C. Cir. 2005), but it remains in usage, see, e.g., 42 U.S.C. §
1395oo(a)(1)(A)(i). The Court will use both terms interchangeably to refer to the kind of entities
described in 42 U.S.C. § 1395h(a).
4
Note that a hospital’s fiscal year may not align with the federal fiscal year, meaning that
a single NPR may be governed by two different fiscal year thresholds.

5
charges so that the historic cost-to-charge ratio employed to calculate outlier
payments did not reflect the hospital’s true costs. In those situations, the hospital’s
cost-to-charge ratio would overstate actual costs, resulting in an inflated cost
estimate for the current year’s claims.

Id. This trick came to be known as “turbo-charging.” Id. at 306. The Secretary responded to the

turbo-charging problem in 2003 by enacting a series of reforms, including “reserv[ing] the right

to recalculate a hospital’s eligibility [for an outlier payment] using actual cost data at the time of

settlement. Through this process, known as reconciliation, the agency [can] claw-back undue

outlier payments.” Id.(citations omitted).

B. Procedural History

Many of the plaintiff hospitals here were plaintiffs in two other related cases. Banner

Health v. Azar, No. 10-cv-1638 (D.D.C.) was filed in 2010. In addition to advancing some other

claims, the Banner Health plaintiffs challenged the fixed loss threshold determinations for

federal fiscal years 1997 through 2007. Banner Health v. Burwell, 126 F. Supp. 3d 28, 43

(D.D.C. 2015). The district court disposed of the plaintiffs’ claims through various motions to

dismiss and for summary judgment. See Banner Health v. Burwell, 174 F. Supp. 3d 206, 207–08

(D.D.C. 2016). The Circuit largely affirmed, though it reversed the district court’s grant of

summary judgment as to fiscal years 2004 through 2006 on the grounds that HHS inadequately

explained certain aspects of those threshold calculations. See Banner Health v. Price, 867 F.3d

1323, 1337–39 (D.C. Cir. 2017). The parties stipulated to dismissal of that case with prejudice

in June 2020. Order, Banner Health v. Azar, No. 10-cv-1638 (D.D.C. June 18, 2020).

Another group of cases were filed in 2013 and 2014 and were consolidated in Lee

Memorial Hospital v. Burwell, No. 13-cv-643 (D.D.C.). The Lee Memorial plaintiffs challenged

certain rulemaking actions taken in 2003 and the fixed loss threshold determinations for federal

fiscal years 2008 through 2011. The court granted summary judgment for the Secretary on all

6
the plaintiffs’ claims. Lee Mem’l Health Sys. v. Burwell, 206 F. Supp. 3d 307, 336 (D.D.C.

2016). On appeal of those cases (under the caption Billings Clinic v. Azar), the Circuit affirmed,

finding that the calculations were reasonable and that the challenge to the 2003 rulemaking

actions was precluded by Banner Health. See Billings Clinic, 901 F.3d at 302–03.

This case, University of Colorado Health at Memorial Hospital v. Azar, No. 14-cv-1220,

was consolidated for all purposes with seven later-filed cases. See Dec. 19, 2018 Order at 1,

ECF No. 108; Feb. 15, 2019 Order at 1, ECF No. 112; April 1, 2019 Order at 2, ECF No. 131.

The consolidated action comprises eight currently operative complaints from hospitals who

administratively appealed their cost reports from various years on the ground that their payments

on outlier claims were too low. See Pls.’ Mot. Summ. J. & Mem. Supp. at 10 (“Pls.’ Summ. J.

Mem.”), ECF No. 185. Each plaintiff hospital received from the PRRB a grant of expedited

judicial review regarding the validity of the fixed loss threshold regulations governing their cost

reports. See id. This Court dismissed certain claims as voluntarily abandoned and others as

barred by claim preclusion. See id.; Mot. Dismiss Op. at 14, 19.

C. The Instant Motions

The parties have filed cross motions for summary judgment in their favor on all

remaining claims. Pls.’ Summ. J. Mem.; Def.’ Cross Mot. Summ. J., ECF No. 188. In general,

Plaintiffs’ remaining claims assert that HHS failed to follow proper procedures and/or acted

unreasonably when it calculated fixed loss thresholds in rulemakings for fiscal years 2007–2016.

These errors allegedly caused HHS to set the fixed loss threshold too high for these years, which

in turn caused Plaintiffs to receive less in outlier payments than they otherwise would have.

Recall that each year, HHS “must estimate the number of outlier cases for the upcoming

year and set a threshold that it believes will result in outlier payments of 5.1%” of total Medicare

payments for the year. Billings Clinic, 901 F.3d at 307. To accomplish this, HHS “forecast[s]

7
the total outlier payments that it would make under various potential thresholds, compared to

total DRG payments it would make during the upcoming [fiscal year], until it finds a threshold

projected to produce total outlier payments at its 5.1% target.” Pls.’ Summ. J. Mem. at 5.

Generally, during the years at issue, HHS used the following method:

1. Assume patient cases in the coming FY will be the same as those in the MedPAR5
from two FYs before (e.g., for FY 2008, HHS used FY 2006 cases).
2. Simulate DRG-related payments on those cases using payment rates and policies
for the coming FY.
3. Simulate any outlier payments on those cases, using the rules governing outlier
payments and the following process:
a. HHS increased the charges from the MedPAR file by two years’ worth of
charge inflation, assuming charges would increase the same amount
annually as the year-on-year increase reflected in that file.
b. HHS then multiplied these forecasted charges by forecasted CCRs. To
derive forecasted CCRs, HHS took each hospital’s most recently available
CCR in the March [Provider Specific File (“PSF”)]. HHS also applied an
“adjustment factor” to the CCRs, which was necessary because (1) the
CCRs in the PSF would later be updated at least once, and in many cases
twice, before their use to calculate individual outlier claims during the
upcoming FY and (2) HHS had long recognized that CCRs have generally
been decreasing over time. Thus, if CMS did not apply an accurate
adjustment to the CCRs, it would systematically over-project hospital costs
and outlier payments and set excessive thresholds.

Id. at 5–6 (citations and footnotes omitted); see also Billings Clinic, 901 F.3d at 307–08. HHS

continued to apply this method across the FY 2007–2013 threshold-setting rules. See Pls.’

Summ. J. Mem. at 20 n.13 (collecting sources).

Plaintiffs’ claims in this case relate to HHS’s calculation of the adjustment factor applied

to estimate CCRs for the coming year. The FY 2007 rule was the first in which HHS applied an

adjustment factor to forecast CCRs—in previous years, it had simply (at a general level) “take[n]

5
“MedPAR is a database that aggregates the claims submitted by hospitals to HHS.”
Banner Health v. Price, 867 F.3d 1323, 1342 (D.C. Cir. 2017).

8
the historical cost-to-charge ratio from the most recent year available and project[ed] those

figures forward.” Billings Clinic, 901 F.3d at 307. The adjustment factor used in the FY 2007

rule consisted of two parts, one for each component of the cost-to-charge ratio: an estimate of

inflation of charges and an estimate of inflation of costs. The “charge inflation factor” consisted

simply of the average annual rate of change in charges per case over the past two years. Id. at

308; 71 Fed. Reg. 47,870,48,149 (Aug. 18, 2006). The “cost inflation factor” was “more

complex,” and “factored in both hospital-specific cost inflation and general inflation as measured

by the change in a standard market basket of goods and services.” Billings Clinic, 901 F.3d at

308. Thus, “HHS calculated . . . the average increase (over all relevant hospitals) in hospital

operating costs; and it divided that figure by the increase in the ‘market basket’ . . . for the same

time period.” Pls.’ Summ. J. Mem. at 16 (citing 71 Fed. Reg. at 48,150). “HHS then averaged

that number over three prior years.” Id.; see Billings Clinic, 901 F.3d at 308; 71 Fed. Reg. at

48,150.

Plaintiffs claim that this method of projecting cost inflation is both procedurally and

substantively unsound. They say that the Secretary violated the Medicare Act’s procedural

notice and comment requirements, see 42 U.S.C. § 1395hh(b)(1), by failing to announce the new

complex CCR adjustment method in the proposed rule for FY 2007 before implementing it in the

final FY 2007 rule and by failing to publicize certain documents related to the method during the

2007–2013 rulemakings. Pls.’ Summ. J. Mem. at 15–18, 20–21. Plaintiffs also claim that the

FY 2008 rule failed to comply with notice and comment procedures because the final rule

forecasted an increase in CCRs even though the proposed rule estimated a decrease in CCRs. Id.

at 18–19. As for substance, Plaintiffs assert that the Secretary was arbitrary and capricious in

setting the thresholds in various fiscal years because its selection of a three-year averaging period

9
for the cost inflation factor was arbitrary, because it persisted in using the same method even

though its selected outlier thresholds frequently failed to hit the intended 5.1 percent target,

because it did not sufficiently engage with commenters’ alternative suggestion of adjusting its

projected payments to account for its historical rate of underestimation, and because it did not

account in its projections for the possibility that it would recoup outlier payments during the

reconciliation process. Id. at 22, 27, 32–33.

In his cross motion for summary judgment and opposition to Plaintiffs’ motion, the

Secretary contends that each of Plaintiffs’ complaints about the threshold-setting rules is legally

deficient. Mem. Supp. Sec’y’s Cross Mot. Summ. J. & Opp’n Pls.’ Mot. Summ. J. at (“Def.’s

Summ. J. Mem.”), ECF No. 188-1 at 12–30. He also says certain hospitals’ claims are untimely

and/or barred by issue preclusion. Id. at 40–43.

On the same day Plaintiffs moved for summary judgment, they also moved to complete

the administrative records for the FY 2008–2013 rules with two documents purportedly showing

analysis relevant to HHS’s method for calculating CCR adjustment factors. Pls.’ Mot. Complete

Admin. R. at 1, ECF No. 184. Defendant opposes this motion. Sec’y’s Opp’n Pls.’ Mot.

Contesting Admin. R. at 1 (“Def.’s Admin. R. Opp’n”), ECF No. 186.

III. LEGAL STANDARDS

In a typical case, the Court must grant summary judgment to a movant who “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); see also Winston & Strawn, LLP v. McLean, 843 F.3d 503,

505 (D.C. Cir. 2016). But in the context of the APA, the Court’s review of the administrative

record is limited. Sierra Club v. Mainella, 459 F. Supp. 2d 76, 89 (D.D.C. 2006) (citing Nat’l

Wilderness Inst. v. U.S. Army Corps of Eng’rs, 2005 WL 691775, *7 (D.D.C. Mar. 23, 2005)). It

10
is the agency’s role to resolve issues of fact and regulate in accordance with those facts. See

Sierra Club, 459 F. Supp. 2d at 90.The district court’s review is confined to determining

whether, as a matter of law, the evidence in the administrative record supports the agency’s

decision. Citizens for Resp. & Ethics in Washington v. SEC, 916 F. Supp. 2d 141, 145 (D.D.C.

2013). “Summary judgment thus serves as the mechanism for deciding, as a matter of law,

whether the agency action is supported by the administrative record and otherwise consistent

with the APA standard of review.” Id. (citing Richards v. INS, 554 F.2d 1173, 1177 & n.28

(D.C. Cir. 1977)).

As the foregoing standard suggests, in an APA case, a reviewing court normally “should

have before it neither more nor less information than did the agency when it made its decision.”

IMS, P.C. v. Alvarez, 129 F.3d 618, 623 (D.C. Cir. 1997) (quoting Walter O. Boswell Mem’l

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 “either directly or indirectly.” Marcum v. Salazar, 751 F. Supp. 2d 74, 78 (D.D.C.

2010). The record that an agency produces “is entitled to a strong presumption of regularity.”

Id.

A party may seek to supplement the record produced by the agency, however, in “one of

two ways.” WildEarth Guardians v. Salazar, 670 F. Supp. 2d 1, 5 n.4 (D.D.C. 2009). First, a

party may seek to include “evidence that should have been properly a part of the administrative

record but was excluded by the agency.” Id. Where a plaintiff follows this first route,

supplementation is appropriate if the agency “did not include materials that were part of its

record, whether by design or accident . . . .” Marcum, 751 F. Supp. 2d at 78. But to overcome

11
the presumption of regularity, “a plaintiff must put forth concrete evidence that the documents it

seeks to ‘add’ to the record were actually before the decisionmakers.” Id.

Alternatively, a party may seek to supplement the record with “extra-judicial evidence

that was not initially before the agency but [which] the party believes should nonetheless be

included in the administrative record.” WildEarth Guardians, 670 F. Supp. 2d at 5 n.4. In these

circumstances, a more stringent standard applies. To “justify[ ] a departure from [the] general

rule” that review “is to be based on the full administrative record that was before the Secretary at

the time he made his decision,” a party must demonstrate one of three “unusual circumstances.”

Am. Wildlands v. Kempthorne, 530 F.3d 991, 1002 (D.C. Cir. 2008) (internal quotation marks

omitted). Those circumstances include: (1) when “the agency ‘deliberately or negligently

excluded documents that may have been adverse to its decision,’” (2) when “background

information [is] needed ‘to determine whether the agency considered all the relevant factors,’”

and (3) when “the ‘agency failed to explain administrative action so as to frustrate judicial

review.’” 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).

IV. ANALYSIS: PROCEDURAL CHALLENGES

“Pursuant to the Medicare Act, 42 U.S.C. § 1395oo(f)(1), this Court reviews the

Secretary’s action under the familiar provisions of the APA, 5 U.S.C. § 706(2)(A).” Shands

Jacksonville Med. Ctr. v. Burwell, 139 F. Supp. 3d 240, 261 (D.D.C. 2015). Thus, HHS “must []

provide the public with a meaningful opportunity to comment on a proposed rule and must offer

reasoned responses to significant comments.” Id. Additionally, “[a]n agency may promulgate a

rule that differs from a proposed rule only if the final rule is a ‘logical outgrowth’ of the

proposed rule. A final rule is a logical outgrowth if affected parties should have anticipated that

12
the relevant modification was possible.” Allina Health Servs. v. Sebelius, 746 F.3d 1102, 1107

(D.C. Cir. 2014) (citations omitted); see Long Island Care at Home, Ltd. v. Coke, 551 U.S. 158,

174 (2007) (noting that the logical outgrowth doctrine is an interpretation of the APA’s

requirement that a notice of proposed rulemaking contain “either the terms or substance of the

proposed rule or a description of the subjects and issues involved.” (quoting 5 U.S.C.

§ 553(b)(3))).

A. FY 2007 Rule

Plaintiffs raise two distinct yet related notice-and-comment arguments about the FY 2007

rule—they argue that HHS was required to present its CCR adjustment factor method for

comment before adopting that method in the FY 2007 final rule, and that HHS “withheld a

critical analysis that it had conducted to develop the method” in violation of the D.C. Circuit’s

Portland Cement doctrine, also known as the critical material doctrine. Pls.’ Summ. J. Mem. at

13, 16, 18 (citing the D.C. Circuit’s quotation in Am. Radio Relay League, Inc. v. F.C.C., 524

F.3d 227, 237 (D.C. Cir. 2008) of the standard articulated in Portland Cement Ass’n v.

Ruckelshaus, 486 F.2d 375, 393 (D.C. Cir. 1973), that “[i]t is not consonant with the purpose of a

rule-making proceeding to promulgate rules on the basis of . . . data that, [to a] critical degree, is

known only to the agency”). Neither objection persuades the Court.

1. The final FY 2007 rule was a logical outgrowth of the proposed FY 2007 rule.

In order to evaluate Plaintiffs’ logical outgrowth challenge, it is necessary to maintain a

bit of perspective. This Court previously held that the rules Plaintiffs challenge are “the overall

calculation of a given year’s fixed los[s] threshold”; that is, Plaintiffs did not preserve any

challenge “to the cost-to-charge ratio methodologies as . . . standalone” rules requiring their own

notice-and-comment proceedings. Mot. Dismiss Op. at 25. Therefore, the question is whether

the overall calculation of the fixed loss threshold implemented in the final FY 2007 Rule was a

13
logical outgrowth of the overall calculation of the fixed loss threshold proposed in the

Secretary’s notice of proposed rulemaking for FY 2007. The method of projecting CCRs is just

one element of this overall calculation, albeit a “crucial” one. Id.

In the notice of proposed rulemaking, the Secretary proposed using the same recent-

history-based method for projecting CCRs it had used up to that point:

As we have done in the past, we are proposing to establish the proposed FY 2007
outlier threshold using hospital cost-to charge ratios from the December 2005
update to the Provider-Specific File—the most recent available at the time of this
proposed rule. This file includes cost-to-charge ratios that reflect implementation
of the changes to the policy for determining the applicable cost-to charge ratios that
became effective August 8, 2003 (68 FR 34494). Using this methodology, we are
proposing to establish an outlier fixed-loss cost threshold for FY 2007 equal to the
prospective payment rate for the DRG, plus any IME and DSH payments, and any
addon payments for new technology, plus $25,530.

71 Fed. Reg. 23,996, 24,150 (Apr. 25, 2006); Administrative Record (“AR”) (FY 2007) at

012369. During the comment period, commenters expressed concern that the proposed threshold

was too high and would cause HHS to undershoot its 5.1 percent target. They “recommended

[that HHS] further refin[e] the outlier methodology,” including by “us[ing] an adjustment factor

to project CCRs” in addition to inflating charges. 71 Fed. Reg. at 48,149. “The commenters

believed that the use of more than one indicator [would] make the threshold calculation more

reliable and accurate.” Id. Thus, these commenters “calculated a cost inflation factor of 5.69

percent by determining the 2002-2004 aggregate annual rate of increase in cost per discharge.”

Id. Another commenter suggested using a “cost inflation factor using the market basket when

projecting CCRs.” Id. at 48,150.

After taking these comments into consideration, HHS agreed in the final rule 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 [its] model . . . .” Id. Thus, it

implemented the same fixed loss threshold calculation methodology it had proposed in its notice,

14
except that it used more recent data for the charge inflation factor and that, as commenters

suggested, it “appl[ied] an adjustment factor to the CCRs to account for cost and charge

inflation.” Id. Rather than adopting the precise method proposed by any commenter, HHS

“worked with [its] actual office in deriving” the cost adjustment factor methodology the Court

described above—it “calculated . . . the average increase (over all relevant hospitals) in hospital

operating costs; and it divided that figure by the increase in the ‘market basket’ . . . for the same

time period. . . . HHS then averaged that number over three prior years.” Pls.’ Summ. J. Mem. at

16 (citing 71 Fed. Reg. at 48,150). HHS explained that it believed this calculation was “more

accurate and stable than the commenters’ methodology because it takes into account the costs per

discharge and the market basket percentage increase when determining a cost adjustment factor.”

71 Fed. Reg. at 48,151. Using this method, the final FY 2007 rule adopted a fixed loss threshold

of $24,475, “$1,055 lower than the $25,530 threshold from the proposed rule.” Id.

The final rule’s fixed loss threshold of $24,475, calculated using a CCR adjustment

factor, was a logical outgrowth of the proposed rule’s suggestion of a fixed loss threshold of

$25,530, calculated using CCRs from the most recent available previous year’s data. A final rule

is a logical outgrowth of a proposed rule “[i]f interested parties ‘should have anticipated’ that the

change was possible, and thus reasonably should have filed their comments on the subject during

the notice-and-comment period . . . .” Am. Coke & Coal Chems. Inst. v. EPA, 452 F.3d 930,

938–39 (D.C. Cir. 2006) (cleaned up). “It generally is not a violation of notice and comment

requirements to amend a proposed rule in response to a comment.” Solite Corp. v. EPA, 952

F.2d 473, 496 (D.C. Cir. 1991); see Select Specialty Hosp.-Akron, LLC v. Sebelius, 820 F. Supp.

2d 13, 23 (D.D.C. 2011) (“There is no requirement that an agency ‘select a final rule from

among the precise proposals under consideration during the comment period.’” (quoting Sierra

15
Club v. Costle, 657 F.2d 298, 352 (D.C. Cir. 1981))). Thus, the agency need not “assiduously lay

out every detail of a proposed rule for comment.” Horsehead Res. Dev. Co. v. Browner, 16 F.3d

1246, 1268 (D.C. Cir. 1994). Indeed, “[t]he whole rationale of notice and comment rests on the

expectation that the final rules will be somewhat different—and improved—from the rules

originally proposed by the agency.” City of Stoughton v. EPA, 858 F.2d 747, 753 (D.C. Cir.

1988). The D.C. Circuit’s notice-and-comment cases “focus . . . primarily on whether the final

rule changes critically from the proposed rule . . . . The question is typically whether the

agency’s final rule so departs from its proposed rule as to constitute more surprise than notice.”

Air Transp. Ass’n of Am. v. F.A.A., 169 F.3d 1, 7 (D.C. Cir. 1999) (emphasis added); see Long

Island Care at Home, Ltd., 551 U.S. at 174 (noting that the object of the logical outgrowth

doctrine “is one of fair notice”).

In the notice of proposed rulemaking for FY 2007, HHS opened for comment its proposal

to use a fixed loss threshold of $24,475 as a means of hitting its 5.1 percent target; it also

proposed for comment its method of achieving that target, which included calculating the year-

on-year average annualized rate of change for charges and using the cost-to-charge ratios from

the most recent available historical data. 71 Fed. Reg. at 24,149–50. It explained, in part, that

this method sought to account for the trend of declining cost-to-charge ratios. Id. at 24,150 (“We

note that the case-weighted national average cost-to-charge ratio declined by approximately 1

percent from the March 2005 to the December 2005 update of the Provider-Specific File.

Hospital charges continue to increase at a steady rate of growth between 7 and 8 percent over

each of the last 2 years, resulting in a decline to the cost-to-charge ratios that are used to compute

the outlier threshold. Using lower cost-to-charge ratios from the December 2005 Provider-

Specific File, in combination with the FY 2005 MedPAR claims and inflated charges,

16
contributes to a higher proposed outlier threshold for FY 2007 compared to FY 2006.”).

Interested hospitals should have anticipated that HHS’s proposed threshold and its method of

calculating it might change in some way, including via refinement of the CCR-projection

element of the calculation. See Long Island Care at Home, Ltd., 551 U.S. at 175 (“Since the

proposed rule was simply a proposal, its presence meant that the Department was considering the

matter.”). Any hospital that wished to suggest that the threshold was too high to hit the target, or

to suggest any adjustment to the projection methodology, was on notice of its opportunity to do

so. And that is exactly what hospitals did. HHS’s final methodology built upon these

comments. 71 Fed. Reg. at 48,149–50 (noting in the final rule commenters’ concern[s] that the

proposed threshold was too high and their suggestions for “further refining the outlier

methodology” and agreeing that it would “increase the precision of [HHS’s] model” to “account

for the rate of change in the relationship in costs and charges”—i.e. the precise nature of the

trend of declining CCRs—by “applying an adjustment factor to the CCRs”). “Commenters

clearly understood that” how best to project CCRs to account for the trend of decline was “under

consideration, as the agency received comments [on the method] from several sources.” See

Appalachian Power Co. v. EPA, 135 F.3d 791, 816 (D.C. Cir. 1998).

This case is similar to Solite Corp. v. EPA, 952 F.2d at 485 (per curiam), which

concerned an EPA rulemaking geared at determining whether certain types of industrial wastes

were subject to a particular regulatory category. A waste qualified for the category if it was both

“high volume” and “low hazard.” See id. at 480. In the notice of proposed rulemaking, the EPA

relied on a combination of plant-specific and industry wide data to propose that a solid waste

would qualify as “high volume” if its annual output crossed the threshold of 50,000 metric tons

per year and a liquid waste would qualify if its annual output crossed the threshold of 1.5 million

17
metric tons per year. Id. But during the comment period, “more recent and complete” data

became available that included “detailed information about volumes and specific types of wastes

generated” at relevant facilities. Id. at 481 (citation omitted). In response, the EPA “revised” its

analysis, and the final rule proposed an annual volume threshold for qualification of 45,000

metric tons for solid wastes and one million tons for liquid wastes. Id. (citation omitted). EPA’s

analysis had changed between the proposed and final rule, but its methodology “[had] not

change[d] significantly.” Id. at 485. The new data had allowed EPA to employ “a more precise

quantitative measure based on more complete information” and allowed EPA to adjust in

response to comments critical of the data used in the proposed rule. Id. The D.C. Circuit upheld

the EPA’s rule against a notice-and-comment challenge. Id.

Similarly, in the instant case, HHS proposed a figure (the fixed loss threshold for FY

2007) and explained its methodology for projecting it, including its effort to account for the trend

of decreasing CCRs. Then, in response to analysis received during the comment period, it

adjusted one piece of its overall method. HHS undoubtedly changed its methodology—it did not

“remain constant”—but it did so in a discrete way that “confirmed,” and built upon, its

announced plan to account for declining CCRs. Id. at 485. Where, as here, “an agency’s

analytic task begins rather than ends with a set of forecasts, sound practice would seem to dictate

disclosure of those forecasts so that interested parties can comment upon the conclusions

properly to be drawn from them.” Air Transp. Ass’n of Am., 169 F.3d at 8 (quoting Indep. U.S.

Tanker Owners Comm. v. Lewis, 690 F.2d 908, 926 (D.C. Cir. 1982)).6 HHS did so here, and

6
Air Transport Association of America involved an F.A.A.-specific procedure that is
“similar to the notice and comment procedure for informal rulemaking under the Administrative
Procedure Act,” so the D.C. Circuit applied logical outgrowth principles drawn from APA cases.
169 F.3d at 6–7.

18
adjusted its forecast methodology in a discrete way that was in line with, though not identical to,

suggestions it received from commenters. Compare Am. Coke & Coal Chems. Inst., 452 F.3d at

940 (“Given that the commenters ‘had a fair opportunity to present their views on how the

industry ought to be subcategorized’ and that the choice to merge the subcategories was a

foreseeable result of the EPA’s solicitation of comment on rationality of the subcategory scheme,

there was no failure of notice or opportunity to comment even though parties may not have been

able to predict how the EPA would choose to act upon their comments.” (quoting BASF

Wyandotte Corp. v. Costle, 598 F.2d 637, 642–46 (1st Cir. 1979))), with CSX Transp., Inc. v.

Surface Transp. Bd., 584 F.3d 1076, 1081–82 (D.C. Cir. 2009) (holding that a final rule

permitting ratemaking parties to rely on four years of comparison data for a certain benchmark

was not a logical outgrowth of a proposal to allow for one year of comparison data, because even

though the rule was not “a complete turnaround from the NPRM,” there was “no way

commenters . . . could have anticipated” that this “particular aspect[] of [the] . . . proposal [was]

open for consideration (citation omitted)).

It is worth pausing further over this point: Plaintiffs are correct that it may not have been

possible for hospitals to predict precisely how HHS would respond to its solicitation for

comments on the CCR projection piece of its methodology for setting the FY 2007 outlier

threshold. They may not have foreseen, for example that HHS would take the three-year average

of the increase in hospital operating costs compared to the market basket increase, rather than, as

some commenters suggested, simply deriving the cost inflation factor from “the annual rate of

increase in the cost per discharge” in recent years. See 71 Fed. Reg. at 48,150. But case law

suggests a distinction between major shifts in direction or policy between proposal and rule,

which are not logical outgrowths, and mere refinements or adjustments consistent with the

19
direction of a proposed policy, which are. CSX Transp., Inc, 584 F.3d at 1081 (noting that “D.C.

Circuit cases finding that a rule was not a logical outgrowth have often involved situations where

the proposed rule gave no indication that the agency was considering a different approach, and

the final rule revealed that the agency had completely changed its position,” and citing cases in

which the final rule “adopt[ed] a maximum velocity cap where a minimum was proposed” and

adopted a “completely different reading of a set of regulatory standards” from the reading

proposed (emphasis added)); Air Transp. Ass’n of Am. v. C.A.B., 732 F.2d 219, 224 (D.C. Cir.

1984) (final rule was a logical outgrowth because the “critical elements of the proposal did not

change”). Thus, in contrast to the D.C. Circuit’s conclusion in Solite Corp. that the change in the

high volume threshold did not violate notice-and-comment requirements because it was merely

the result of EPA’s use of better data “to check or confirm prior assessments,” 952 F.2d at 485,

the same panel held in a later portion of the opinion that the EPA’s final-rule conclusion that a

particular waste would be excluded from the regulatory category at issue was not a logical

outgrowth of its proposed rule, which had listed that waste as a candidate for inclusion in the

regulatory category. The proposed rule had not listed the waste on a separate list of proposed

wastes to be excluded, and did not explain the methodology EPA eventually used to exclude the

waste. Id. at 498–500; compare Husqvarna AB v. EPA, 254 F.3d 195, 199, 203 (D.C. Cir. 2001)

(final rule’s imposition of a four-year implementation period to meet new emission standards

was a logical outgrowth of proposed rule’s five-year period, where EPA decided during

comment period that “‘rapid technological advances’ . . . warranted a more expeditious

implementation”), and Select Specialty Hosp.-Akron, LLC, 820 F. Supp. 2d at 23–24 (rule

imposing discharge limits on certain hospitals-within-hospitals in the first year of a transition

period for implementing a new policy limiting hospitals-within-hospitals’ admissions from their

20
host hospitals to 25 percent of their discharges was a logical outgrowth of proposals that did not

mention the first-year requirements, because these were “merely an implementing mechanism for

the 25 percent rule,” which had been “the subject of extensive public comment”), with Allina,

746 F.3d at 1109 (final rule was not a logical outgrowth because it represented “a volte-face”

from the proposal with “enormous financial implications”), and Air Transp. Ass'n of Am., 169

F.3d at 7–8 (final order partially approving airport’s application to impose a passenger facility

charge did not comply with notice-and-comment procedures where the approval was based on a

projection of passenger increase not included in the initial proposal that was “an order of

magnitude greater” than the increase the initial proposal relied upon and was “a measure of

something completely different”).

HHS’s adjustment of its method of determining a single component of its overall project

of estimating the outlier threshold that would result in outlier payments equal to 5.1 percent of

total payments for the final year, see Billings Clinic, 901 F.3d at 307–09, which adjustment

contributed in part to the final rule’s downward revision of the proposed outlier threshold by

$1,055, fits more neatly into the refinement/adjustment category. See Air Transp. Ass’n of Am.,

732 F.2d at 225 n.12 (concluding that a final fee schedule was a logical outgrowth of a proposal

in part because the changes in fees reflected on the final schedule could not “be considered

major”). Owner-Operator Indep. Drivers Ass’n v. Fed. Motor Carrier Safety Admin., 494 F.3d

188, 202 (D.C. Cir. 2007) at first glance seems to undercut this conclusion, but upon closer

inspection confirms it. There, the D.C. Circuit held that the Federal Motor Carrier Safety

Administration (“FMCSA”) violated the notice-and-comment requirement when it promulgated

a final rule governing rest requirements for truck drivers. Id. The final rule employed a model to

estimate truck drivers’ fatigue by using “time-on-task multipliers,” which sought to account for

21
the fact that time spent driving is more fatiguing than time spent resting. Id. at 200–01. The

flaw: though the FMCSA’s model was an “update” to a safety model it had used in a previous

rule and disclosed in the proposal, the “nature of the update” was to use an “entirely new”

methodology, namely the use of time-on-task multipliers, which were “an integral part” of the

model. Id. at 201.

Here, HHS similarly updated the methodology of a disclosed model between the

proposed and final rule, but HHS’s comment-prompted refinement of a discrete (though

important) factor in a multi-part calculation renders “the nature of the update,” id., different in

kind than FMCSA’s wholesale methodological replacement in Owner-Operator Independent

Drivers Association. For one thing, this portion of the Owner-Operator Independent Drivers

Association opinion did not analyze whether the final rule was a logical outgrowth of the

proposed rule; it instead engaged in the related, but distinct, inquiry of whether the methodology

was “critical factual material” that the agency had to disclose for comment. Id. at 199. More

fundamentally, the D.C. Circuit’s key conclusion—that “[a]lthough interested parties may have

known that FMCSA would incorporate time-on-task effects into its crash-risk model, they had no

way of knowing that the agency would calculate the impact of time on task in the way that it

did”—turned on the conclusion that there was “no way” for commenters “to foresee” four

specific elements of the agency’s methodology, three of which contradicted the approach taken

in supporting studies in the administrative record. Id. at 202. It was only “in light of these

undisclosed elements” that the court concluded that the model had not been “made public in the

proceeding and exposed to refutation.” Id. “Moreover,” the court reasoned, “the addition of the

time-on-task element to the model was not a minor modification used to check or confirm prior

analyses: it constituted the agency’s response to an important defect in its previous methodology

22
identified” in a previous D.C. Circuit decision. Id. at 201. As discussed, commenters foresaw

the possibility that HHS would apply an adjustment factor to CCRs in the FY 2007 final rule,

and though they did not precisely predict HHS’s exact final method for deriving the adjustment

factor, the final method was in line with commenter proposals. Though it is a close question, the

FY 2007 final rule’s refinement of a single element of its method of projecting the fixed loss

threshold was more like a “minor modification used to check or confirm prior analyses,” than the

introduction of an “entirely new” methodology held impermissible in Owner-Operator

Independent Drivers Association, id.

The bottom line is that the $1,055 difference between the proposed and final fixed loss

thresholds, a result at least in part of HHS’s change to its method of projecting CCRs, was

“reasonably foreseeable,” Long Island Care at Home, Ltd, 551 U.S. at 175 , so it did not require

the opening of a new round of notice and comment. See Weyerhaeuser Co. v. Costle, 590 F.2d

1011, 1031 (D.C. Cir. 1978) (an agency “need not subject every incremental change in its

conclusions after each round of notice and comment to further public scrutiny before final

action”).

2. HHS was not required to disclose Attachment A during the FY 2007 Rulemaking.

The Court’s conclusion that the FY 2007 final rule was a logical outgrowth of the

proposed rule dictates the further conclusion that Plaintiffs’ Portland Cement argument against

the FY 2007 rule must fail as well. The D.C. Circuit’s Portland Cement or “critical-material”

doctrine, Post Acute Med. at Hammond, LLC v. Azar, 311 F. Supp. 3d 176, 184–85 (D.D.C.

2018), provides that “[u]nder APA notice and comment requirements, among the information

that must be revealed for public evaluation are the technical studies and data upon which the

agency relies in its rulemaking.” Banner Health, 867 F.3d at 1336 (citation omitted); but see Am.

Radio Relay League, Inc., 524 F.3d at 245–47 (Kavanaugh, J. concurring in part, concurring in

23
the judgment in part, and dissenting in part) (concluding that the Portland Cement doctrine is

inconsistent with the Supreme Court’s holding in Vt. Yankee Nuclear Power Corp. v. Natural

Res. Def. Council, Inc., 435 U.S. 519, 524 (1978) that courts may not impose upon agencies

procedural requirements beyond those found in the APA’s text). Plaintiffs invoke this doctrine

to argue that HHS should have provided the opportunity to comment on “Attachment A,” a

document HHS eventually certified for inclusion in the administrative record in this action for

the final FY 2007 rule. AR (FY 2007) at 14403. According to Plaintiffs’ description of the

document, Attachment A was important to HHS’s decision in the final FY 2007 rule to average

hospital costs compared to general inflation over three years (rather than some other period),

because it shows that HHS ran calculations using different averaging periods:

Attachment A reveals that HHS carried out similar calculations using those other
alternative models. In the first table in the document, the column labeled “Oper
MB Increase” is evidently the “market basket” (the “MB”) for a given year. AR
14403. The column labeled “Operating Cost per Discharge Increase” is presumably
the average hospital operating cost increase over the same year. “Cost/MB” is the
number produced by dividing them . . . . “Mean Ratio to 2004” is . . . the average
of the “Cost/MB” figures for the number of years specified in the “Num Years in
Mean” column. The final column is the result of multiplying the “Mean Ratio to
2004” by the “Oper MB Increase” figure for 2005.

Pls.’ Summ. J. Mem. at 17.7 Thus, Plaintiffs appear to acknowledge (and the document

admits of no other conclusion) that Attachment A is relevant only to calculation of the

7
The Court reproduces the described portion here, AR (FY 2007) 14403:

24
adjustment factor to be applied to CCRs (specifically the selection of a three-year average)—a

choice the Court has already concluded was a logical outgrowth of the proposed rule, and

therefore a choice on which HHS was not required to allow further comment. If HHS was not

required to submit its adjustment-factor method for comment, it follows that it was not required

to submit documents underlying that method for comment. See Air Transp. Ass’n of Am., 732

F.2d at 224 (rejecting APA challenge to agency reliance on internal staff studies not publicly

available during the comment period because the “critical elements of the proposal did not

change, and the final rule was a ‘logical outgrowth’ of the proposed rule”); cf. Bldg. Indus. Ass’n

of Superior Cal. v. Norton, 247 F.3d 1241, 1246 (D.C. Cir. 2001) (“[A] final rule that is a logical

outgrowth of the proposal does not require an additional round of notice and comment even if the

final rule relies on data submitted during the comment period.”); City of Stoughton, 858 F.2d at

753(agency was not required to solicit comment on a study that came to its attention only after

the publication of a proposed rule where the study grounded a final-rule conclusion that was a

logical outgrowth of the proposal because it confirmed the proposal’s conclusion); Chamber of

Com. of U.S. v. SEC, 443 F.3d 890, 900, 903–04 (D.C. Cir. 2006) (distinguishing between

25
“entirely new information critical to the agency’s determination” and “supplementary

information,” including data that “clarif[ies], expand[s], or amend[s] other data that has been

offered for comment,” and noting that absent “a showing of prejudice by an interested party,” the

agency need not allow “further opportunity for comment[] provided that the agency’s response

constitutes a ‘logical outgrowth’ of the rule proposed” (citations omitted and cleaned up)). This

result makes sense, as the purpose of the critical material doctrine is to facilitate comment on a

proposed rule. See Banner Health, 867 F.3d at 1336 (the doctrine “allows for useful criticism,

including by enabling commenters to point out where information is erroneous or where the

agency may be drawing improper conclusions” (citations omitted and cleaned up)). By hewing

sufficiently closely to the proposal to render its final rule a logical outgrowth, the agency has

already complied with its obligation to allow a sufficient opportunity for comment.

B. FY 2008–2013 Rules

1. The Court may consider Attachment A and the associated memorandum in order to evaluate
Plaintiffs’ critical-material challenge to the FY 2008–2013 rules.

Plaintiffs next expand their critical material argument against the FY 2007 rule to assert

that HHS violated the Portland Cement doctrine when it failed to disclose Attachment A and the

accompanying memorandum for comment during the rulemakings for FYs 2008–2013. Pls.’

Summ. J. Mem. at 20–22. As Plaintiffs acknowledge, Attachment A and the associated

memorandum (entitled “Change to Outlier Methodology”) are not currently part of the

administrative records for these rules, and their argument on this point “depends on the

assumption that Attachment A and the associated memo are in the record for the FY 2008

through 2013 rules.” Id. at 20 n.12. Therefore, before reaching the merits of this argument, the

Court must first consider, in part, Plaintiffs’ motion to complete the administrative records. In

this motion, Plaintiffs argue that Attachment A and the Change to Outlier Methodology

26
memorandum should be part of the FY 2008–2013 administrative records for all purposes

because HHS either actually considered these documents during these rulemakings or

negligently failed to do so. Pls.’ Mot. Complete Admin. R. at 5–12. In the alternative, they

argue that the Court should at least consider these documents for the limited purpose of

determining whether HHS violated Portland Cement by failing to disclose them during the FY

2008–2013 rulemakings. Id. at 13–16. The Court concludes that it may consider the documents

at least in order to evaluate the procedural Portland Cement claim and accordingly grants the

motion to complete in part.8

8
The parties have vigorously briefed whether Plaintiffs’ motion to complete the
administrative record by adding Attachment A and the associated memorandum is timely, but, as
the Court sees it, the issue is relatively straightforward. On March 31, 2020, the Court ordered
the Secretary to produce the memorandum to Plaintiffs. Mot. Dismiss Op. at 33 (“The Court will
direct the Secretary to disclose to Plaintiffs the full document with which “Attachment A” is
associated.”). It further held that “[o]nce such document is disclosed, Plaintiffs may, if
appropriate, renew their argument that this document should be part of the administrative
record.” Id. Thus, the Court contemplated a departure from its previous scheduling order, which
set a deadline for supplementation motions of June 5, 2019. ECF No. 137. To be sure, the Court
said this in the context of evaluating Plaintiffs’ assertion that the memorandum was before the
agency during the FY 2007 rulemaking, and therefore arguably did not refer to a motion to
complete the administrative records for FYs 2008–2013. But the Court said Plaintiffs could
renew their “argument,” a term broader than the 2007-specific motion, and, given that the
opinion dealt with challenges to a range of different years’ rules, the use of the word “record” is
fairly read to refer to the entire record before the Court, even though that record is technically
comprised of individual records for various rulemakings. Due to intervening litigation about the
scope of the required disclosure, the Secretary did not produce the memorandum until April 13,
2021. Though Plaintiffs may have been able to surmise it on their own previously, this
production provided—for the first time— record evidence that Attachment A was produced by
the actuary’s office in order to develop the cost inflation adjustment factor method disclosed in
the final FY 2007 rule. Shortly thereafter, in a joint status report, Plaintiffs informed the Court
that they might “need to file a further motion regarding the content of the administrative
records . . . .” ECF No. 179 at 2. About three months after the production, on July 16, 2021,
Plaintiffs moved to add Attachment A and the memorandum to the FY 2008–2013 administrative
records on the theory that the FY 2007 rule relied on these actuary documents, and the
subsequent rules referenced the FY 2007 rule’s actuarial analysis as the basis for their own
methodologies.
Moreover, even though this motion to complete came the same day as Plaintiffs’ motion
for summary judgment, the Secretary had two months to account for the filing before submitting

27
The “record rule” generally prohibits the consideration of evidence outside the

administrative record in APA actions: “[I]t is black-letter administrative law that in an APA case,

a reviewing court should have before it neither more nor less information than did the agency

when it made its decision.” Hill Dermaceuticals, Inc. v. FDA, 709 F.3d 44, 47 (D.C. Cir. 2013)

(cleaned up). However, a court may make an exception when “the procedural validity of the

agency’s action remains in serious question.” CTS Corp. v. EPA, 759 F.3d 52, 64 (D.C. Cir.

2014) (citation omitted); see United Student Aid Funds, Inc. v. Devos, 237 F. Supp. 3d 1, 4

(D.D.C. 2017) (describing the exception for cases in which “the district court cannot determine

from the administrative record whether the agency complied with its procedural obligations”

(first citing Esch v. Yeutter, 876 F.2d 976, 991 (D.C. Cir. 1989), and then citing CTS Corp, 759

F.3d at 64)). Still, this exception applies “at most” to challenges to “gross procedural

deficiencies” (citation and emphasis omitted). CTS Corp., 759 F.3d at 65.

If Plaintiffs are right that Attachment A and the Change to Outlier Methodology

memorandum were critical material to the FY 2008–2013 rulemakings and HHS withheld them

from commenter scrutiny, then HHS’s notice-and-comment procedures were grossly deficient.

See Portland Cement, 486 F.2d at 392 (describing the failure to disclose critical material as a

his own summary judgment motion in September. Therefore, unlike in Banner Health v.
Burwell, 126 F. Supp. 3d 28, 60 (D.D.C. 2015), aff’d in relevant part, Banner Health, 867 F.3d
at 1336, in which the court considered it “tardy” to file a motion for consideration of extra-record
material on the same day that both plaintiffs’ and defendant’s motions for summary judgment
were due, the Secretary has not been prejudiced. The D.C. Circuit held that this conclusion was
within the scope of the district court’s discretion in part because the “delay denied HHS the
opportunity to treat the comment as part of the administrative record in preparing its motion for
summary judgment.” Banner Health, 867 F.3d at 1336. That is not the case here. “Given the
general judicial preference for resolving motions on their merits rather than dismissing them on
technicalities,” Niedermeier v. Off. of Baucus, 153 F. Supp. 2d 23, 27 (D.D.C. 2001), under these
circumstances, the Court finds that the motion to complete the 2008–2013 rules is timely and
will consider its merit.

28
“critical defect”); Solite Corp., 952 F.3d at 484 (describing such a failure a “serious procedural

error” (citation omitted)); Am. Radio Relay League, Inc., 524 F.3d at 237 (“It would appear to be

a fairly obvious proposition that studies upon which an agency relies in promulgating a rule must

be made available during the rulemaking in order to afford interested persons meaningful notice

and an opportunity for comment. It is not consonant with the purpose of a rule-making

proceeding to promulgate rules on the basis of inadequate data, or on data that, [to a] critical

degree, is known only to the agency.” (cleaned up)); Ctr. for Biological Diversity v. U.S. Army

Corps of Eng’rs., No. 20-CV-103, 2020 WL 5642287, at *14–15 (D.D.C. Sept. 22, 2020)

(granting plaintiffs permission to rely on extra-record evidence in order to argue that an agency

failed to comply with applicable notice-and-comment procedures). The Secretary objects on the

ground that CTS Corp. “held that an alleged violation of the [Portland Cement] doctrine did not

justify consideration of extra-record evidence.” Def.’s Admin. R. Opp’n at 13. But that is a

misstatement of the case’s holding—the plaintiff attempted to introduce record evidence not to

show a procedural notice-and-comment defect, but rather to challenge the substance of the

agency’s decision. CTS Corp., 759 F.3d at 63–65 (characterizing the plaintiff’s attempt in a

footnote to frame its argument as procedural as “conclusory,” noting that plaintiff did not seek a

remedy appropriate for a procedural violation, and observing that the plaintiff “could have

pursued a procedural challenge arguing that the EPA’s failure to include [certain] data in the

record at the promulgation stage required that it be afforded an additional opportunity to

comment on the data” but that it did not do so (emphasis added)). Moreover, unlike in this case,

the CTS Corp. plaintiff asked the Court to rely on “its own expert’s newly created analysis”

responding to data in the final administrative record, not to consider data that was within the

agency’s files during the rulemaking and allegedly should have been disclosed for comment. Id.

29
at 65. The Court will consider Attachment A and the Change to Outlier Methodology

memorandum in evaluating Plaintiffs’ critical material challenge to the FY 2008–2013 rules.

2. HHS was not required to disclose Attachment A and the associated memorandum during the
FY 2008–2013 rulemakings.

Plaintiffs’ critical material challenge is that together, the memorandum and Attachment A

were critical factual material for the FY 2008–2013 rules because they represented HHS’s

“analysis of alternative methodologies”; that is, they showed HHS’s exploration of the effect of

using averaging periods other than three years on the CCR adjustment factor. Pls.’ Summ. J.

Mem. at 20–22. According to Plaintiffs, Attachment A’s revelation that different averaging

periods resulted in widely varying adjustment factors belies HHS’s assertions in the FY 2008–

2013 rules that its adjustment factor method was “accurate and stable.” Id. at 23–24 (citation

omitted).

Once again, under Portland Cement, the agency must “identify and make available

technical studies and data that it has employed in reaching the decisions to propose particular

rules. An agency commits serious procedural error when it fails to reveal portions of the

technical basis for a proposed rule in time to allow for meaningful commentary.” Owner-

Operator Indep. Drivers Ass’n, Inc., 494 F.3d at 199 (cleaned up). This disclosure rule does not

extend to all data in an agency’s files; rather, it applies to “the ‘most critical factual material’

used by the agency.” See Chamber of Com. of U.S., 443 F.3d at 900 (citation omitted). Thus,

when “staff reports” are critical to the agency’s rule, the agency must submit them for comment.

See Am. Radio Relay League, Inc., 524 F.3d at 236 (citation and emphasis omitted). Assuming

without deciding that HHS considered Attachment A and the Change to Outlier Methodology

memorandum during the FY 2008–2013 rulemakings, as opposed to only during the FY 2007

rulemaking—something the Secretary denies, Def.’s Summ. J. Mem. at 21–22—the Court

30
concludes that neither the analysis of alternative averaging periods found in Attachment A nor

the background material found in the Change to Outlier Methodology memorandum were critical

material the agency was required to publish during the FY 2008–2013 rulemakings.

In the rulemakings for FY 2008–13, HHS proposed to use the same fixed loss threshold

projection methodology, including the same CCR adjustment-factor method, that it had used in

the FY 2007 final rule:

As discussed in the FY 2007 final rule (71 FR 48150), we worked with the Actuary
to derive the methodology described below to develop the CCR adjustment factor.
For FY 2008, we are proposing to use the same methodology by using the operating
cost per discharge increase in combination with the final updated market basket
increase determined by Global Insight, Inc., as well as the charge inflation factor
described above to estimate the adjustment to the CCRs. By using the market
basket rate-of-increase and the increase in the average cost per discharge from
hospital cost reports, we are using two different measures of cost inflation. For FY
2008, we determined the adjustment by taking the percentage increase in the
operating costs per discharge from FY 2004 to FY 2005 (1.0529) from the cost
report and dividing it by the final market basket increase from FY 2005 (1.043).
We repeated this calculation for 2 prior years to determine the 3-year average of
the rate of adjusted change in costs between the market basket rate-of increase and
the increase in cost per case from the cost report (FY 2002 to FY 2003 percentage
increase of operating costs per discharge of 1.0721 divided by FY 2003 final market
basket increase of 1.041, FY 2003 to FY 2004 percentage increase of operating
costs per discharge of 1.0624 divided by FY 2004 final market basket increase of
1.04). For FY 2008, we averaged the differentials calculated for FY 2003, FY 2004,
and FY 2005 which resulted in a mean ratio of 1.0203. We multiplied the 3-year
average of 1.0203 by the 2006 market basket percentage increase of 1.0420, which
resulted in an operating cost inflation factor of 6.32 percent or 1.0632. We then
divided the operating cost inflation factor by the 1-year average change in charges
(1.0726) and applied an adjustment factor of 0.9912 to the operating CCRs from
the Provider-Specific File.

See 72 Fed. Reg. 24,680, 24,837 (May 3, 2007), AR at 00159 (FY 2008 Proposed Rule). It then

adopted this methodology in each final rule for FY 2008–13. See 72 Fed. Reg. 47,130, 47,419

(Aug. 22, 2022); Pls.’ Summ. J. Mem. at 20 n.13 (collecting citations for each year’s final rule).

Thus, each proposal referenced the 2007 rulemaking, and, according to Plaintiffs, incorporated

HHS’s analysis of Attachment A and the covering memorandum during the 2007 rulemaking.

31
During the comment period for the FY 2008 rule, one commenter suggested that HHS’s

method of deriving the CCR adjustment factor was “unnecessarily complicated and [did] not

lead to a more accurate” result; the commenter instead suggested “a methodology that uses

recent historical industry wide average rate of change, similar to the methodology used to

develop the charge inflation factor.” 72 Fed. Reg. at 47,418. The commenter does not appear to

have specifically objected to the selection of a three-year averaging period, except insofar as this

choice was one element of the overall adjustment-factor calculation method the commenter

criticized as too complex. See id.; AR at 728. HHS rejected this complaint on the ground that

incorporating two sources of inflation (cost per discharge and market basket increase) would

improve accuracy and stability:

[W]e believe [our] 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 as mentioned above, 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.

72 Fed. Reg. 47,130, 47,418 (Aug. 22, 2007). The records for the FY 2009–2012 rules include

very similar comments and responses. Pls.’ Summ. J. Mem. at 13 (citing 73 Fed. Reg. 48,434

(Aug. 19, 2008) 48,763, AR 4928 (FY 2009 rule); 74 Fed. Reg. 43,754, 44,008 (Aug. 27, 2009),

AR 7080 (FY 2010 rule); 75 Fed. Reg. 50,042, 50,427 (Aug. 16, 2010), AR 7815 (FY 2011

rule); 76 Fed. Reg. 51,476, 51,792 (Aug. 18, 2011), AR 11757 (FY 2012 rule)). In 2013,

commenters suggested a wider range of alternatives for adjusting CCRs (none of which

specifically took issue with the three-year averaging period). But HHS stuck with the method it

had been using since 2007, explaining that it needed to study the proposed alternative methods

further. 87 Fed. Reg. 53,258, 53,694 (Aug. 31, 2012).

32
As these proposals and exchanges make clear, HHS disclosed in detail during every

rulemaking each step of its methodology for projecting the fixed-loss threshold, and in turn each

step of its sub-methodology for deriving the CCR adjustment factor, including the selection of a

3-year averaging period. Commenters understood the methodology and took advantage of the

opportunity to suggest alternatives. HHS’s full disclosure of the methodology (and its results)

was sufficient to its critical-material disclosure obligations. Cf. Air Transp. Ass’n of Am., 732

F.2d at 224 (holding that a final fee schedule that turned in part on agency staff studies not

available during the comment period complied with notice-and-requirements because the

proposal “both outlined the method by which [the agency] proposed to calculate the fees and

listed the types of fees it proposed to charge”); Indep. U. S. Tanker Owners Comm., 690 F.2d at

926 (“[W]here an agency’s analytic task begins rather than ends with a set of forecasts, sound

practice would seem to dictate disclosure of those forecasts so that interested parties can

comment upon the conclusions properly to be drawn from them.”); Chamber of Com. of U.S, 443

F.3d at 900 (observing that a second round of notice and comment is not required when an

agency “merely supplements information in the rulemaking record” by “internally generating

information using a methodology disclosed in the rulemaking record”).

It is not as if the document Plaintiffs contend should have been disclosed, Attachment A,

was central to the methodology. It relates at most to a discrete piece of the methodology—

averaging the increase in operating costs compared to the market basket increase over three years

as opposed to some other time period—and even then arguably consists mostly of evaluation of

the results of alternative averaging periods HHS did not ultimately propose or select, rather than

analysis of the three-year choice itself. AR at 14403; see Pls.’ Summ. J. Mem. at 17 (identifying

“[w]hat HHS did not disclose” as the fact that “it had done comparable calculations using

33
averages over two years, four years, five years, etc.”). HHS was not required to disclose analysis

of methodologies it did not ever propose or adopt as a rule.

As for the Change to Outlier Methodology memorandum itself, in the redacted form in

which it appears in the record before the Court, it contains only an anodyne overview of the

adjustment factor methodology and the reasoning behind it. To a significant extent, this

discussion duplicates the description HHS made public in the proposed rules:

We requested OACT [Office of the Actuary] assistance in developing an
adjustment to the cost-to-charge ratios. OACT developed a cost inflation factor
that could be used in our model. It combines the rate of increase in cost per case
with the rate of increase in the IPPS market basket.

If charges are increasing faster than costs, the cost-to-charge ratios will decline,
estimates of cost per case and the outlier threshold will be lower than it otherwise
would be in the absence of making such an adjustment. The opposite will occur if
costs are increasing faster than charges. For FY 2007, the charge inflation factor is
slightly higher than the cost inflation factor resulting in a small reduction to the
cost-to-charge ratios.

AR (FY 2007) at 14407. These generalities are not the type of analysis the critical-material

doctrine contemplates. In any event, HHS had publicly explained more or less all of the

reasoning reflected in these paragraphs by the time the FY 2008 proposed rule opened for

comment. See 72 Fed. Reg. 24,680, 24,837 (May 3, 2007), AR (FY 2008) at 00159 (explaining

in the FY 2008 proposed rule that “by using the market basket rate-of-increase and the increase

in the average cost per discharge from hospital cost reports, we are using two different measures

of cost inflation”); 71 Fed. Reg. at 48,150 (explaining in the FY 2007 final rule that HHS

decided to use an adjustment factor in order to “account for the rate of change in the relationship

between costs and charges”).

That HHS publicly disclosed a detailed step-by-step methodology, complete with the

figures yielded at each step, distinguishes this case from the key authorities on which Plaintiffs

rely. In Owner-Operator Independent Drivers Association, Inc., for example, the D.C. Circuit

34
vacated parts of a rule regulating truck-driver rest practices because the agency “fail[ed]” to

“disclose the methodology” of a model that was “central to the agency’s justification for the

rule.” 494 F.3d at 199–200. In particular, the agency failed to disclose its use of certain

multipliers that measured driver fatigue based on time spent driving; these were “an integral

part” of the model. Id. at 201. Here, in contrast, HHS disclosed each step of its methodology,

including the three-year averaging period Plaintiffs contest. Indeed, Plaintiffs do not claim that

HHS failed to disclose its methodology, but rather “its analysis of alternative methodologies.”

Pls.’ Summ. J. Mem. at 20 (cleaned up). Yet they do not cite any authority for the proposition

that, in addition to disclosing “portions of the technical basis for a proposed rule,” Owner-

Operator Indep. Drivers Ass’n, Inc., 494 F.3d at 199 (cleaned up and emphasis added), an

agency must also disclose material related to its evaluation of a rule or methodology it ultimately

chose not to pursue and not to propose to the public. Cf. Chamber of Com. of U.S., 443 F.3d at

902 (finding a critical-material violation where undisclosed materials “supplie[d] the basic

assumptions” the agency used to support its cost-benefit analysis); Penobscot Indian Nation v.

U.S. Dep’t of Hous. & Urb. Dev., 539 F. Supp. 2d 40, 49 (D.D.C. 2008) (finding a critical-

material violation where the agency failed to disclose an internal analysis that was the

“centerpiece” for the final rule’s rationale where the proposed rule neither referenced the

analysis nor included “at least a summary of the specific data and methodology on which the

analysis relied”).

Similarly, in Shands Jacksonville Med. Ctr. v. Burwell, 139 F. Supp. 3d 240, 247, 265

(D.D.C. 2015), the court held that HHS failed to meet its procedural obligations when it relied on

an undisclosed actuary analysis to estimate that a change in how patient stays were classified

would increase the number of patients classified as inpatients, and, in turn, to reduce hospital

35
compensation for inpatient services. The court framed “[t]he question” as “whether the public

was aware of the methodology the HHS actuaries used to predict the effects of” the classification

change. Id. at 264. The court rejected the Secretary’s contention that the proposed rule

discussed the methodology, because all the proposed rule said was that “the Secretary analyzed

‘FY 2009 through FY 2011 Medicare claims data for extended hospital outpatient encounters

and shorter stay hospital inpatient encounters.’” Id. at 263 (quoting the proposed rule). This did

not reveal “critical assumptions” reflected in an actuarial memorandum used in reaching the

estimate, including that the actuarial analysis accounted only for claims related to certain types

of procedures. Id. at 262–64. Thus, there was “no reason to believe that commenters had any

idea what the actuaries did” with the underlying data. Id. at 264. Here, HHS told the public

exactly what its actuaries did, right down to the selection of a three-year averaging period. The

selection of a three-year period may have been an assumption, but unlike in Shands, HHS

disclosed the choice and opened it to commenter criticism.

American Radio Relay League, Inc. v. FCC is probably the strongest case for Plaintiffs,

but it, too, is meaningfully distinct. In that case, the D.C. Circuit took issue with the fact that the

agency’s “determination [was] based upon a complex mix of controversial and uncommented

upon data and calculations.” 524 F.3d at 237 (citation omitted and cleaned up). The agency had

disclosed parts of studies that it admitted were “a central source of data for its critical

determinations,” but had redacted other parts of the studies. Id. at 238. These hidden portions

“appear[ed] to contain information in tension with the Commission’s conclusion,” id. (citations

omitted and cleaned up); similarly, Plaintiffs contend that Attachment A’s demonstration that the

adjustment factor “could fluctuate significantly” depending on the averaging period chosen “was

36
contrary to HHS’s assertion that the method was accurate and stable.” Pls.’ Summ. J. Mem. at

22.9

Though the American Radio Relay League panel made some sweeping statements during

the course of its discussion, e.g., 524 F.3d at 238 (“It would appear to be a fairly obvious

proposition that studies upon which an agency relies in promulgating a rule must be made

available during the rulemaking in order to afford interested persons meaningful notice and an

opportunity for comment.”), it went on to emphasize the “narrowness of [its] holding,” which

turned in significant part on the fact that “the Commission ha[d] chosen to rely on” the studies

“and to place them in the rulemaking record” while redacting portions that undermined its

position. Id. at 239. In other words, the FCC could not play “hide and seek” by “cherry-

pick[ing]” only the favorable parts of “a study on which it ha[d] chosen to rely in part.” Id. at

237, 239. This feature was a “critical distinction” in American Radio Relay League, id. at 239,

and nothing like it has occurred here. HHS did not present to the public part of a study in

support of its fixed-loss threshold projection method or its three-year average choice while

carving out Attachment A for exclusion from the study. Indeed, HHS did not support its “more

accurate and stable” assertions by referencing its three-year averaging period at all; read in

context, these turned on the fact that unlike the commenter’s proposed method, HHS’s

adjustment factor took into account “two sources that measure potential cost inflation,” costs per

discharge and the market basket. See, e.g., 72 Fed. Reg. at 47,419 (“[W]e believe [our]

9
As the Court will explain, it is not convinced that Attachment A undercuts HHS’s
“more accurate and stable” assertions, which in context did not reference the three-year
averaging period but rather compared HHS’s method of accounting for both costs per discharge
and the market basket increase to a commenter proposal that would not have taken into account
“two sources that measure potential cost inflation.” 72 Fed. Reg. at 47,418.

37
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 as mentioned above, 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.”). Attachment A,

therefore, is not especially relevant to the primary claim Plaintiffs suggest it undermines. See

Pls.’ Summ. J. Mem. at 22.

In sum, in the 2008–2013 rulemakings, HHS disclosed its overall methodology and each

step thereof. The APA did not require it to disclose an analysis of ultimately unchosen

alternatives to a particular step.

3. The FY 2008 final rule’s use of a positive CCR adjustment factor did not necessitate a further
round of notice and comment.

Plaintiffs attempt one final challenge to the FY 2008 rule in particular. That year, HHS

proposed to use the adjustment-factor method it had developed in the FY 2007 final rule, which,

when applied to available data from the December 2006 update to the provider-specific file,

produced an adjustment factor of 0.9912. 72 Fed. Reg. at 24,837, AR 159. In other words, the

model forecast that CCRs would be “almost 1% lower in FY 2008” than those reflected in the

latest provider-specific file data. Pls.’ Summ. J. Mem. at 18. In the final FY 2008 rule, HHS

used the very same model, but, as was its general practice, fed into the model more recent data

that had become available during the comment period. See 72 Fed. Reg. at 47,418 (describing

use of the March 2007 update to the provider-specific file and noting different figures for various

inputs into the adjustment factor calculation methodology); see generally Pls.’ Summ. J. Mem. at

38
5 n.6. The result was an adjustment factor of 1.0027—a projection, contrary to the projection in

the proposed rule, that CCRs would increase. 72 Fed. Reg. at 47,418. Plaintiffs claim that the

final rule’s application of a positive adjustment factor was an unfair surprise that required further

opportunity for comment, especially given that HHS had in the proposed rule explained that it

sought to reflect the trend of declining CCRs. See Pls.’ Summ. J. Mem. at 18–20 (citing 72 Fed.

Reg. at 24,837, AR 159).

This challenge fails for the same reason Plaintiffs’ critical-material challenges failed:

HHS disclosed each step of the methodology it would use to set the final CCR adjustment factor.

Regulated entities had ample opportunity to comment on and suggest changes to this

methodology That the methodology’s application to the latest data produced a surprising

outcome did not obligate HHS to open a new round of notice-and-comment proceedings. The

very authorities on which Plaintiffs rely for their challenge demonstrate that HHS met APA

procedural requirements here. Plaintiffs stress that “HHS was ‘required to disclose what the

actuaries did with [the] data”—here HHS did so, and the actuaries’ methods did not change

between the proposal and final rule. Pls.’ Summ J. Mem. at 19 (quoting Shands Jacksonville,

139 F. Supp. 3d at 264). Plaintiffs also rely heavily on a case in which an agency expanded,

without warning, from a methodology that used one year of comparison data to one that used

four years of comparison data. CSX Transp., Inc., 584 F.3d at 1081–82. In this case, HHS did

not change its data parameters (e.g., it used a three-year averaging period the entire time); all that

changed was the data the actuaries operated upon, and, accordingly, the model’s numeric output.

Having disclosed its model, HHS was not required to provide specific notice of the model’s

result when applied to updated data. See Am. Coke & Coal Chems. Inst., 452 F.3d at 939 (“It is

perfectly predictable that new data will come in during the comment period, either submitted by

39
the public with comments or collected by the agency in a continuing effort to give the regulations

a more accurate foundation . . . . If data used and disclosed for the interim regulations presented

the issues for comment, then there is no need to seek new comment even though significant

quantitative differences result.” (quoting BASF Wyandotte Corp. v. Costle, 598 F.2d 637, 644–45

(1st Cir.1979)); cf. Post Acute Med. at Hammond, LLC v. Azar, 311 F. Supp. 3d 176, 183

(D.D.C. 2018) (“The Administrative Procedure Act . . . does not require an agency to advise

regulated entities as to the individualized implications of a proposed rule—particularly here,

where the rule merely continued a longstanding policy with updates reflecting new data.”).

Admittedly, HHS did not explain with great clarity in the FY 2008 final rule which

particular data changed and why. Compare, e.g., 72 Fed. Reg. at 47, 418 (noting that the 2006

market basket percentage increase in the final rule was 1.0430), with, e.g., id. at 24, 836 (noting

that the 2006 market basket percentage increase in the proposed rule was 1.0420). But any

failure in explanation would sound as a substantive defect, not a procedural failure to comply

with notice-and-comment requirements. Plaintiffs have not argued that any failure to explain the

data changes reflected in the FY 2008 final rule was arbitrary and capricious. See Pls.’ Summ. J.

Mem. at 26 (“The Hospitals are not here contending . . . that it was arbitrary for the model to

produce a particular CCR adjustment factor (like the increase forecasted for FY 2008.”)).

Accordingly, the FY 2008 rulemaking was procedurally sound.

V. ANALYSIS: SUBSTANTIVE CHALLENGES

In addition to their notice-and-comment challenges, Plaintiffs claim that HHS acted

arbitrarily and capriciously in various ways when it set the fixed loss thresholds for FYs 2007–

2016. See 5 U.S.C. § 706(2)(A). “A rule is arbitrary and capricious if the agency: (1) ‘has relied

on factors which Congress has not intended it to consider,’ (2) ‘entirely failed to consider an

40
important aspect of the problem,’ (3) ‘offered an explanation for its decision that runs counter to

the evidence before the agency,’ or (4) ‘is so implausible that it could not be ascribed to a

difference in view or the product of agency expertise.’” United States Sugar Corp. v. EPA, 830

F.3d 579, 606 (D.C. Cir. 2016) (quoting Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm

Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). “Nor will [the Court] uphold agency action if it

fails to consider significant and viable and obvious alternatives.” Dist. Hosp. Partners, L.P. v.

Burwell, 786 F.3d 46, 59 (D.C. Cir. 2015). “[T]he party challenging an agency’s action as

arbitrary and capricious bears the burden of proof.” City of Olmsted Falls v. F.A.A., 292 F.3d

261, 271 (D.C. Cir. 2002) (quoting Lomak Petroleum, Inc. v. FERC, 206 F.3d 1193, 1198 (D.C.

Cir. 2000)) (alteration in original). Though Plaintiffs fail to meet this burden for many of their

challenges, they have demonstrated that the FY 2012 and FY 2013 rules were arbitrary and

capricious in certain respects.

1. HHS’s use of a three-year averaging period when calculating the CCR adjustment factor for
FYs 2007–2013 was not arbitrary and capricious.

Plaintiffs first argue that HHS’s decision to average the increase in hospital operating

costs compared to the market basket increase over three years, as opposed to over some other

term of years, was arbitrary and capricious. Plaintiffs say that the possibility of using an

alternative averaging period was a “significant and viable and obvious alternative[],” Pls.’

Summ. J. Mem. at 23 (quoting Dist. Hosp. Partners, L.P, 786 F.3d at 59), and that “the

possibility that a different averaging period might produce a significantly different reduction in

CCRs, compared to the method that HHS did use, [was] surely an important aspect of the

decision-making” that HHS was required to consider, id. The Court disagrees and holds that the

decision to use a three-year averaging period was not significant enough in the context of each

year’s rulemaking to require HHS to consider and explain this particular choice.

41
Plaintiffs have not persuasively argued that whether to average the comparison of

operating cost increases to market basket increases over three years rather than, say, over two or

four years, was a significant aspect of the problem HHS confronted during each rulemaking.

The problem HHS confronted was where to set the fixed loss threshold in order to achieve outlier

payments equal to 5.1 percent of total payments for the coming year. As the Court has

explained, taking the three-year average was but one sub-step in the multi-step process of

projecting the fixed-loss threshold for a given year. Significant problems, by contrast, are those

that are central to the overall objective of the rule. See Util. Solid Waste Activities Grp. v. EPA,

901 F.3d 414, 429–30 (D.C. Cir. 2018) (holding that it was arbitrary and capricious for the EPA

not to consider, when crafting a rule regulating the disposal of toxic wastes produced by

electrical plants, neither “the risks to public health and to the environment before leakage is

detected, nor the harms from continued leakage during the years before leakage is ultimately

halted by retrofit or closure”). Here, whether to account both for operating cost increases and

market basket increases may have been a significant aspect of the problem, but the granular sub-

issue of whether to average that comparison over two, three, or four years was not. See

Michigan v. EPA, 213 F.3d 663, 690–91 (D.C. Cir. 2000) (noting, in the context of rejecting a

challenge to various EPA cost assumptions where the challenger had not explained why the

assumptions were arbitrary and capricious, that courts “generally defer[] to the agency’s

expertise” on “technical details”). This is especially so where plaintiffs have not demonstrated

(or attempted to demonstrate), at least without referencing Attachment A, that an alternative

averaging period would obviously have better helped HHS reach its 5.1 percent target. Pls.’

Summ. J. Mem. at 23 (noting that various alternative periods would have resulted in larger

downward adjustments in CCRs for the FY 2007 and FY 2008 rules without explaining why

42
these adjustments would have been more accurate than the one produced by the three-year period

and conceding that “the point here is not that the Court should determine a two-year or any

particular averaging period would have been superior”).

The Court’s conclusion would hold even were it to consider Attachment A, which shows

that, at least in 2007, HHS was aware that the selection of a particular averaging period could

change the adjustment factor. Plaintiffs rely on Attachment A to demonstrate that “a four-year or

a two-year [averaging period] . . . would, if anything, have produced adjustment factors closer to

the historical trends” and that “different averaging periods could have resulted . . . in lower

thresholds.” Pls.’ Summ. J. Mem. at 22. But matching historical trends is not HHS’s end goal in

setting the fixed-loss threshold; rather, attempting to match historical trends in CCRs is a means

of meeting HHS’s statutory mandate to project payments for the coming year. See, e.g., 71 Fed.

Reg. at 48,151 (explaining the decision to apply an adjustment factor “so that the CCRs we are

using in our simulation more closely reflect the CCRs that will be used in” the coming year); cf.

Banner Health, 867 F.3d at 1355 (“There may well be many non-arbitrary reasons for predicting

that costs and charges in a particular industry will not continue on their current trajectories.”). In

any event, “imperfection alone does not amount to arbitrary decision-making . . . [an] agency

may use a model ‘even when faced with data indicating that it is not a perfect fit.’” Dist. Hosp.

Partners, 786 F.3d at 61–62 (citation omitted). In short, “the Hospitals fail to show why [HHS]

should not receive the deference typically accorded in this context,” Banner Health, 867 F.3d at

1356, and the Court defers to the agency on the technical determination of whether three years

was a an appropriate period over which to compare operating cost and market basket increases.10

10
Plaintiffs also assert that it was arbitrary and capricious for HHS to repeatedly assert
that its methodology was “accurate and stable” “when the outcome of the method could be dialed
up or down by nearly a factor of ten by changing an arbitrary parameter (the averaging period).

43
Now, we do not know why HHS selected a three-year averaging period; there is no

disputing that HHS never explained this choice. But HHS “was not required to . . . ‘consider all

policy alternatives in reaching its decision.’” Dep’t of Homeland Sec. v. Regents of the Univ. of

Cal., 140 S. Ct. 1891, 1914–15 (2020) (quoting State Farm, 463 U.S. at 51). It follows that HHS

was not required to explain choices that did not rise to the level of significant aspects of the

problem or to explain why it did not select alternatives (e.g., averaging over periods other than

three years) that were not “significant and viable and obvious,” Dist. Hosp. Partners, L.P., 786

F.3d at 59. Cf. Texas Mun. Power Agency v. EPA, 89 F.3d 858, 869–70 (D.C. Cir. 1996) (“And

though the EPA did not explain its precise method for calculating a rate based on a statewide

average that was used in this case until after the close of general proceedings before the agency,

the 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.”).11

Pls.’ Opp’n Sec’y’s Cross-Mot. and Reply Supp. Mot. Summ. J. at 28 (“Pls.’ Combination
Summ. J. Opp’n & Reply”), ECF No. 193. But as the Court has explained, this takes HHS’s
“accurate and stable” assertions out of context. See supra at 37. These did not relate to the
choice of averaging period or even assert as a general matter that the model was maximally
accurate and stable. Instead, they responded to a particular commenter’s suggestion to rely on
historical trends, and noted that using two inflation measures improved accuracy and stability as
compared to this suggested method. 72 Fed. Reg. at 47,418. Plaintiffs do not explain how the
choice of a three-year averaging period undercuts this specific assertion.
11
Because this claim is the sole remaining one for which consideration of Attachment A
and the Change to Outlier methodology memorandum might make any difference, and because
the Court would reject this claim whether or not Attachment A and the memorandum are in the
administrative records, the Court denies the remaining portion of Plaintiffs’ Motion to Complete
Administrative Records—which seeks to have the documents added to the records for all
purposes, not just for evaluation of Plaintiffs’ procedural claims—as moot. See Pls.’ Mot.
Complete Admin. R. at 5–12; cf. County of Los Angeles, 192 F.3d at 1021–22 (finding it
unnecessary to decide whether an affidavit that had “surfaced for the first time during litigation”
was a “post-hoc rationalization” that should have been stricken from the record because even
were it to consider the affidavit, the Court would still have found against the party offering it).

44
2. HHS’s reasoning for rejecting the use of an “estimate adjustment factor” was sufficient to
support the FY 2011 and FY 2014 rules, but was not sufficient to support the FY 2012 and
FY 2013 rules.

Plaintiffs find some, though not complete, success with their next set of arguments: that

HHS acted arbitrarily in the FY 2011–2014 rulemakings when it refused to adopt a commenter’s

repeated suggestion to apply an “estimate adjustment factor” that the commenter said would

improve the accuracy of the fixed-loss threshold projection. Pls.’ Summ. J. Mem. at 32–34. The

commenter first suggested the application of an estimate adjustment factor—not to be confused

with the adjustment factor applied to CCRs, which the Court has discussed at length—during the

comment period for the FY 2011 rule. The commenter presented data which it said

demonstrated that HHS had fallen short of its 5.1 percent target for outlier payments each year

since 2004. AR (FY 2011) at 09476–77. The commenter suggested that HHS should recognize

this consistent shortfall and quantify it by averaging the percentage shortfall from the 5.1 percent

target over two or three past years. Id. For example, the commenter calculated that the average

shortfall from the 5.1 percent target was .385 percent over 2008 and 2009. Thus, for 2011, the

commenter recommended modelling as usual, but setting a fixed loss threshold that HHS

estimated would result in outlier payments equal to 5.485 percent of total payments (the 5.1

percent target plus the .385 percent estimate adjustment factor). In other words, HHS’s ultimate

goal would remain to achieve 5.1 percent, and it would use the same model it had used in the

past, but it would attempt to adjust for whatever imperfections in the model had caused it to

undershoot by a .385 percent average over the previous period by directing the model to achieve

an artificially high percentage. See id. The commenter further suggested that if HHS ever faced

the problem of its model consistently overshooting its target, it could apply a negative estimate

adjustment factor using the same method. Id. As the Secretary puts it, the commenter suggested

45
that if HHS declined to change specific asserted defects in the model, it should use a “fudge

factor” designed to correct the model’s end result. See Def.’s Summ. J. Mem. at 28.

HHS declined to adopt this proposal for the FY 2011 final rule, suggesting that it may

have been inconsistent with HHS’s statutory mandate:

[U]nder the statute, outlier payments are intended to approximate the marginal cost
of providing care above the outlier fixed-loss cost threshold. Any “estimate
adjustment factor” to the outlier threshold or standardized amount in a given year
to account for “overpayments” or “underpayments” of outliers in other years would
result in us making outlier payments that were not directly related to the cost of
furnishing care in extraordinarily costly cases.

75 Fed. Reg. 50,042, 50,429 (Aug. 16, 2010). Moreover, HHS, perhaps understanding the

commenter’s suggestion to relate to revising past outlier payments in addition to projecting

future ones, reiterated its longstanding policy of not making “retroactive adjustments to outlier

payments to ensure that total outlier payments in a past year are equal to 5.1 percent of total

DRG payments.” Id. HHS further asserted that the commenter’s suggestion did “not lend

greater accuracy to [its] estimate of payments that are 5.1 percent of total DRG payments”

because HHS’s model already “factor[ed] in all payments and policies that would affect actual

payments for the fiscal year at hand . . . .” Id.

The commenter tried again during the FY 2012 rulemaking by repeating its estimate-

adjustment-factor suggestion in similar terms. It also attempted to assuage HHS’s statutory

concerns by “stat[ing] that [the proposed estimate adjustment factor method] would fulfill the

statutory requirement in section 1886 (d)(5)(A) of the Act that requires that CMS establish

thresholds such that outlier payments will be projected to achieve at least 5.1 percent of DRG

payments and would more closely achieve a result that is fully consistent with the statute.” 76

46
Fed. Reg. 51,476, 51,793 (Aug. 18, 2011) (describing the comment).12 HHS “thank[ed] the

commenter for further explaining their position on this adjustment” but declined to adopt the

adjustment in two short sentences:

Further analysis by CMS is necessary to determine if the commenter’s approach to
applying an “estimate adjustment factor” is appropriate. We will consider the
commenter’s suggestion of applying an “estimate adjustment factor” in future
rulemaking if, based on our analysis, we determine that application of an “estimate
adjustment factor” is appropriate and consistent with the statute.

Id. at 51,794.

Undeterred, the commenter presented the same suggestion again during the FY 2013

rulemaking, complete with data it said showed consistent underpayment. AR (FY 2013) at

13100–01, 13157. But HHS was not swayed, and essentially recycled its 2012 explanation to

again reject the estimate-adjustment-factor proposal in the FY 2013 final rule:

With regard to the comment that CMS implement an “estimate adjustment factor”,
as we stated last year, further analysis by CMS is necessary to determine if the
commenter’s approach to applying such a factor is appropriate. We will consider
the commenter's suggestion to apply an “estimate adjustment factor” (in
conjunction with analyzing the alternative methodologies to adjust the CCRs
discussed above), for future rulemaking if, based on our analysis, we determine that
application of an “estimate adjustment factor” is appropriate and consistent with
the statute.

77 Fed. Reg. 53,258, 53,694 (Aug. 31, 2012).

Finally, the commenter tried again in 2014. AR (FY 2014) at 15864–65. The FY 2014

final rule again did not employ an estimate adjustment factor; this time, HHS did not even

12
Both parties say that the FY 2012 comment can be found at pages 11339, 11404–05 of
the FY 2012 administrative record, but the Court has been unable to locate these pages in either
the original or corrected submissions of the FY 2012 administrative record. However, HHS
described the comment in some detail in the FY 2012 final rule, and this description substantially
matches the content of the comment submitted for FY 2013. Moreover, the parties do not
suggest in their briefing that there are any material differences between the FY 2012 and FY
2013 comments.

47
address the comment. However, HHS made other significant changes to its fixed-loss threshold

projection methodology, which the Court will discuss below. Plaintiffs claim that each of HHS’s

explanations (and the 2014 non-explanation) for rejecting the use of an estimate of adjustment

factor was arbitrary and capricious. Pls.’ Summ. J. Mem. at 32–34. The Court agrees that the

2012 and 2013 explanations, but not the 2011 and 2014 explanations, were insufficient.

FY 2011. To begin with, it is not entirely clear that Plaintiffs are challenging HHS’s FY

2011 explanation for declining to adopt the estimate adjustment factor. They note in their

opening brief that HHS indicated in 2011 that it “thought the method was contrary to the

statute,” and say no more about this before shifting to discussion of the FY 2012 rulemaking in

the very next sentences: “But in the FY 2012 rulemaking, the commenter explained that HHS

had misunderstood the method and it was actually consistent with the statute. HHS accepted that

explanation, thus removing its prior ground for rejecting the proposed method. . . . Why, then,

would HHS not adopt it?” Pls.’ Summ. J. Mem. at 33. Plaintiffs then focus on the assertion that

“[b]y the FY 2012 rulemaking” HHS’s model had missed its target for five years, and complain

that in this context HHS’s vague indications that it needed to address the issue further (and its

failure to say anything at all in the FY 2014 rule) were inadequate—all complaints specific to

HHS’s responses in 2012–2014, but not to relevant to its 2011 response. Id. at 33–34 (emphasis

added). In his combination response brief and memorandum in support of his cross-motion for

summary judgment, the Secretary does not expressly defend HHS’s FY 2011 statutory

explanation—though he does describe it—and instead focuses on arguing that the comment “did

not demonstrate, and did not even purport to demonstrate, that the proposed ‘estimate adjustment

factor’ would operate as a reliable predictor of future differences between projected and actual

payments.” Def.’s Summ. J. Mem. at 29. But then, in their combination response to the

48
Secretary’s cross-motion for summary judgment and reply in support of their own motion for

summary Judgment, Plaintiffs say for the first time that part of HHS’s FY 2011 statutory

reasoning—that the estimate adjustment factor method was inconsistent with the statute because

it “would mean basing the coming year’s forecast on something other than ‘all payments and

policies that would affect actual payments’ for the coming year”—“was arbitrary and

capricious.” Pls.’ Combination Summ. J. Opp’n & Reply at 34 (quoting 75 Fed. Reg. at 50,429).

Use of historical data, Plaintiffs point out in that brief, is core to HHS’s mandate to “‘select

outlier thresholds which, when tested against historical data, will likely produce’” outlier

payments in the targeted range. Id. (quoting County of Los Angeles v. Shalala, 192 F.3d at 1013)

(emphasis added in Plaintiffs’ brief).

Assuming Plaintiffs have properly presented an argument against the FY 2011 response,

the Court rejects it. For one thing, Plaintiffs have not extensively engaged with HHS’s 2011

statutory position; for example, they have not addressed whether the position represented a

reasonable interpretation of an ambiguous statute and is subject to Chevron deference. The

Court will not raise these issues in the first instance. More importantly, Plaintiffs have not

presented any argument that HHS’s other, non-statutory reason for rejecting the estimate

adjustment factor for FY 2011—its assertion that the method would not improve the projection’s

accuracy because HHS’s model already took into account all relevant payments and policies—

was insufficient. 75 Fed. Reg. at 50,429. Plaintiffs’ filings have not convinced the Court that

HHS acted in an arbitrary and capricious manner when it declined to employ an estimate

adjustment factor for FY 2011.13

13
At this point, the Court has rejected on the merits all of Plaintiffs’ challenges to the
rules for FYs 2007–2011. Therefore, the Court need not and does not address the Secretary’s
alternative argument that even if the challenges to these rules prevail on the merits, certain

49
FY 2012 and FY 2013. The result is different for FYs 2012 and 2013. “An agency is

required to consider responsible alternatives to its chosen policy and to give a reasoned

explanation for its rejection of such alternatives.” Spirit Airlines, Inc. v. United States Dep’t of

Transp., 997 F.3d 1247, 1255 (D.C. Cir. 2021) (quoting Am. Radio Relay League, Inc., 524 F.3d

at 242). In FY 2012, HHS was no longer laboring under its apparent misimpression that the

estimate adjustment factor proposal involved revising past outlier payments. See 76 Fed. Reg. at

51,793–94. HHS did say that it still needed to determine whether the estimate adjustment factor

method was “consistent with the statute,” but it did not say whether this concern rested on either

of the statutory points HHS had raised in 2011—which it did not repeat—or on some other

interpretative concern. Id. at 51,794. More generally, the only information contained in HHS’s

response was that it would consider the suggestion “in future rulemaking if, based on our

analysis, we determine that application of an ‘estimate adjustment factor’ is appropriate and

consistent with the statute.” Id. This was insufficient. See Spirit Airlines Inc., 997 F.3d at 1255

(holding that an agency’s statement that it “plan[ned] to assess” an issue commenters had raised

fell “well short of what [was] needed to demonstrate the agency grappled with an important

aspect of the problem before it or considered another reasonable path forward”). Given the

nature of the comments, HHS was required to say something about why it needed more time to

study the statute than the comment period had allowed. The estimate adjustment factor method

went to the core of the issue before HHS (the accuracy of its projections), was relatively simple

(it allowed HHS to retain the same model it had been using), and was accompanied by

concerning data purporting to show that HHS had consistently missed its targets. See id. at

plaintiffs’ “claims for fiscal years 2007 to 2011 . . . are barred by issue preclusion based on
earlier litigation in Banner Health or Billings Clinic.” Def.’s Summ. J. Mem. at 40, 43–45.

50
51,793 (“Based on actual payments determined by the commenter using data analysis, the

commenter asserted that the underpayment has exceeded 0.5 percent in all years except one.”);

see also Thompson v. Clark, 741 F.2d 401, 409 (D.C. Cir. 1984) (an agency’s failure to respond

to a comment is problematic to the extent that “it demonstrates that the agency’s decision was

not ‘based on a consideration of the relevant factors’ (citation omitted)). HHS did not refute or

otherwise engage with this data. The FY 2013 response, which more or less repeated the FY

2012 response, 77 Fed. Reg. at 53,694, rests on even shakier ground: by the time it issued this

response, HHS had had an entire year (at least) to analyze the proposal. If HHS still needed

more time to evaluate, it should at least have explained why. The FY 2012 and 2013 responses

“provide[] no basis upon which [the Court can] conclude that” the decision not to adopt an

estimate adjustment factor for those years “was the product of reasoned decisionmaking.” Cf.

Butte County v. Hogen, 613 F.3d 190, 195 (D.C. Cir. 2010) (citation omitted).

The Secretary’s most promising argument in support of its explanations is that the

comments and their supporting data were not significant enough to merit a response more

detailed than the one HHS gave. The Secretary insists that “[t]he comments . . . did not

demonstrate, and did not even purport to demonstrate, that the proposed ‘estimate adjustment

factor’ would operate as a reliable predictor of future differences between projected and actual

payments.” Def.’s Summ. J. Mem. at 29. But read in context, the comments at the very least

rely on a strongly implied premise that deriving the estimate adjustment factor from past years’

shortfalls would create a factor in line with the model’s past trend of failure, and therefore would

reasonably anticipate the level of failure the model would produce when applied to the coming

year. AR (FY 2013) at 13100–01 (comment submitted for FY 2013); 76 Fed. Reg. at 51,793

(“The commenter stated that this would fulfill the statutory requirement in section 1886

51
(d)(5)(A) of the Act that requires that CMS establish thresholds such that outlier payments will

be projected to achieve at least 5.1 percent of DRG payments and would more closely achieve a

result that is fully consistent with the statute.”).

Similarly, the Secretary is simply wrong that the comments were bereft of “evidence or

analysis supporting the use of an ‘estimate adjustment factor.’” Def.’s Summ. J. Mem. at 29.

The comments presented an analysis and table purporting to show that “actual outlier payments

have averaged more than 0.5 percentage points below the 5.1% target of actual total DRG

payments” in most years since 2003 (FY 2013 comment) or 2004 (FY 2012 comment). AR (FY

2013) at 13100–01, 13,157; 76 Fed. Reg. at 51,793.14 They also provided concrete examples to

demonstrate how the proposed estimate adjustment factors for each year matched recent

underpayments. AR (FY 2013) at 13101 (“For example, the average shortfall from FYs 2009

and 2011 was 0.68 percentage points based on the VHDC studies. The threshold should be

modeled to produce a payment level of 5.78 percent for FY 2013.”); 76 Fed. Reg. at 51,793

(“The commenter provided an example and computed this factor for FY 2009 and FY 2010 by

taking the average variance in the actual payment for FY 2008 and FY 2009 which was 0.491

percent. Based on this factor, CMS would model the threshold to a level of 5.591 percent (5.1

plus .491 percent).”).

Thus, the FY 2012 and 2013 comments were considerably more developed in their data

support and plausibility than comments which courts have held not significant enough to require

an in-depth response. See Thompson, 741 F.2d at 409 (“None of the comments singled out by

appellant as raising substantial issues contained any meaningful analysis or data refuting the

14
The Court does not mean to suggest that HHS was required to accept the commenters’
analysis of this data, but the presentation was plausible enough that HHS should at least have
engaged with it.

52
agency’s conclusions.”); Am. Great Lakes Ports Ass’n v. Zukunft, 296 F. Supp. 3d 27, 53–54

(D.D.C. 2017) (holding that the an agency’s failure to respond to a commenter suggestion that it

include a “truing up” mechanism to compensate rate payers who had overpaid due to “disparities

between projections and actual data” did not violate the APA because the suggestion was

presented only obliquely and in one sentence of a forty-page comment) (citation omitted)), aff’d,

962 F.3d 510 (D.C. Cir. 2020). If HHS disagreed with the commenter’s premise and/or the

evidence supporting it, it should have explained why. To the extent that the Secretary now seeks

to raise concerns about the method and data that he did not even hint at in the FY 2012 and 2013

rules—such as his suggestion that the adjustment factor would have “introduc[ed] a new source

of potential distortion,” Def.’s Reply Mem. Supp. Cross Mot. Summ. J. at 19, ECF No. 196—

these are “impermissible post hoc rationalizations and thus are not properly before” the Court,

Dep’t of Homeland Sec., 140 S. Ct .at 1909. “In sum,” the estimate adjustment factor

“alternative was neither frivolous nor out of bounds and the [the agency] therefore had an

obligation to consider it.” Chamber of Com. of U.S. v. SEC, 412 F.3d 133, 145 (D.C. Cir. 2005).

The FY 2012 and 2013 responses do not reflect reasoned consideration of this alternative.

FY 2014. Finally, the Court holds that the FY 2014 rule was not arbitrary and capricious

insofar as it did not adopt or discuss the suggested estimate adjustment factor (which the

commenter renewed during the FY 2014 comment period). At first, HHS’s omission of any

discussion of the estimate-adjustment-factor proposal, which it had for two years promised to

study, seems like a shocking oversight that makes the FY 2014 response even more arbitrary and

capricious than the FY 2012 and FY 2013 responses. But a closer look at the comment in

context reveals that HHS did in effect respond to it.

53
As presented during the FY 2014 rulemaking, the estimate-adjustment-factor suggestion

was just one part of a lengthy comment that suggested several alternative methods for improving

the accuracy of HHS’s fixed loss threshold projections. AR (FY 2014) at 015852–65. The

commenter proposed adoption of an estimate adjustment factor only as a fallback alternative to

several preferred methods. The commenter wrote that it “would prefer that CMS implement the

other improvements included in our comments. However, if the other improvements are not

implemented we believe application of this adjustment would be necessary to accurately project

and pay outlier payments at the 5.1 percent target.” Id. at 015865. The “other improvements”

the commenter suggested included a proposal for calculating “actual outlier payment percentages

based on actual historical payment data,” id. at 015853 (cleaned up), and employing a projection

method a consultant had developed, id. at 015859. The consultant’s principal method involved

changing the projection period for CCRs from the one-year period HHS had been using and

estimating the fixed loss threshold using the most recent CCRs from provider specific files. Id.

at 015859–015863. The consultant also presented “two alternate methods” that “yield[ed] results

very close” to those of the consultant’s principal method: projecting CCRs quarter-by-quarter or

“estimating the rate of change in CCRs” by using “a recent historical industry-wide average as

the projection factor,” the “exact[] approach [HHS] uses to project charge inflation.” Id. at

015863–64.

In the FY 2014 final rule, HHS finally abandoned its complicated method of determining

the CCR adjustment factor by comparing the operating cost and market basket changes (the

method discussed at length in the Court’s preceding procedural analysis) in favor of the simpler

method of “us[ing] historical data to adjust the CCRs.” 78 Fed. Reg. at 50,978. Specifically,

HHS projected CCRs by “compar[ing] the percentage change in the national average case-

54
weighted operating CCR and capital CCR from the December 2011 update of the PSF to the

national average case-weighted operating CCR and capital CCR from the December 2012 update

of the PSF”—a method “consistent with [its] estimation of charge inflation.” Id. at 50,978–79.

In other words, HHS adopted the last of the commenter’s proposals for improving the fixed loss

threshold projection, an alternative method that “result[ed] in a close approximation” to the

commenter’s consultant’s principal method. AR (FY 2014) at 015864. HHS’s adoption of one

of the commenter’s suggested accuracy-improvement options sufficed to respond to the

commenter’s estimate-adjustment method, which it proposed only as a fallback in the event HHS

rejected its other preferred options. See id. at 015865 (“[I]f the other improvements are not

implemented we believe application of [an estimate adjustment factor] would be necessary to

accurately project and pay outlier payments at the 5.1 percent target.” (emphasis added)).

To be sure, in an earlier sentence, the commenter said that HHS should employ an

estimate adjustment factor if it did “not adopt all the suggestions mentioned in our comments to

improve the outlier projections.” Id. (emphasis added). HHS did not adopt all of the

commenter’s myriad suggestions. But this commenter statement was somewhat confusing,

because some of its suggestions were presented as alternatives—it would not necessarily have

made sense for HHS to adopt them all. And the change in the CCR adjustment-factor derivation

was enough of a shift in the way HHS projected fixed loss thresholds that it was reasonable for

HHS to rest upon this change as its response to the commenter’s multi-pronged comment

directed toward improving projection accuracy. Plaintiffs have not engaged with the conditional,

fallback nature of the commenter’s estimate-adjustment-factor suggestion. See Pls.’ Summ. J.

Mem. at 34. Under these circumstances, the Court declines to hold that the FY 2014 rule was

arbitrary and capricious insofar as it did not discuss the estimate adjustment factor.

55
3. HHS’s explanation for refusing to account for reconciliation in the FY 2013 rule was arbitrary
and capricious, but HHS sufficiently explained this decision in the FY 2014–2016 rules.

Plaintiffs next claim that the FY 2013–2016 rules were arbitrary and capricious because

HHS refused to account for the effects of its payment reconciliation process on its projections of

the fixed loss threshold. Pls.’ Summ. J. Mem. at 36. A bit of background is necessary to

understand this set of challenges, for the Court does not write on a clean slate with respect to

these claims. First, a refresher on HHS’s reconciliation process, which HHS has used since 2003

to fight the practice of turbo-charging: HHS can “recalculate a hospital’s eligibility [for an

outlier payment] using actual cost data at the time of settlement,” as opposed to the older cost

data used to determine the hospital’s initial CCR, and, accordingly, its eligibility for a particular

outlier payment. Billings Clinic, 901 F.3d at 306. If it turns out that the hospital was not in fact

eligible for the outlier payment it received, HHS can “claw-back” the undue amount via the

reconciliation process. Id. Thus, by recovering sums through reconciliation, HHS might end up

ultimately paying less in outlier payments for a given year than initial projections suggested.

Over the years, “commenters [have] repeatedly argued” that HHS should incorporate an

expectation

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/6350974. Public record. Not legal advice.
