Court Opinion

ID: 4028753
Source: CourtListenerOpinion
Date Created: 2016-08-26 18:02:03.861872+00
Date Added: 2024-06-11T14:22:55.933626
License: Public Domain

UNITED STATES DISTRICT COURT
                         FOR THE DISTRICT OF COLUMBIA

                                         )
CLARIAN HEALTH WEST, LLC,                )
                                         )
            Plaintiff,                   )
                                         )
      v.                                 )      Civil Action No. 14-cv-0339 (KBJ)
                                         )
SYLVIA MATHEWS BURWELL,                  )
                                         )
            Defendant.                   )
                                         )

                             MEMORANDUM OPINION

      The Centers for Medicare and Medicaid Services (“CMS”) is the sub-agency

within the Department of Health and Human Services (“HHS”) that administers the

federal health insurance program known as Medicare. In 2012, an agent of CMS

informed Plaintiff Clarian Health West, LLC (“Clarian”), an Indiana hospital, that it

needed to repay more than $2 million in Medicare reimbursement funds that the hospital

had received under the Medicare program, due to a reconciliation process that CMS had

performed with respect to certain Medicare payments. Clarian objected to CMS’s

repayment demand, and filed the instant action against Sylvia Mathews Burwell, the

Secretary of HHS, to contest the agency’s contentions. Clarian’s one-count complaint

cites the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 701–706, and the

Medicare statute’s review provisions, 42 U.S.C. § 1395oo(f)(1), and asserts that the

agency lacks the statutory and regulatory authority to make Clarian repay the money

because the regulation that authorizes the reconciliation process (“the 2003 Rule”) and

the guidelines that implement that rule (“the 2010 guidelines” or “the 2010 manual”)
were improperly promulgated and are contrary to the terms of the Medicare statute.

        Before this Court at present are the parties’ cross-motions for summary

judgment. (Pl.’s Mot. for Summ. J. (“Pl.’s Mot.”), ECF No. 13; Def.’s Mot. for Summ.

J. (“Def.’s Mot.”), ECF No. 14.) In its motion, Clarian contends, among other things,

that CMS’s decision to recoup the $2 million was procedurally defective because the

agency failed to employ required notice-and-comment procedures prior to adopting the

guidelines that establish the criteria for identifying which hospitals should be subjected

to the reconciliation process. (See Pl.’s Mem. in Supp. of Pl.’s Mot. (“Pl.’s Mem.”),

ECF No. 13-1, at 29–36.) 1 The Secretary’s cross-motion argues that there is nothing

procedurally or substantively improper about the rule that relates to the reconciliation

process or its implementation. (See Def.’s Mem. in Supp. of Def.’s Mot. (“Def.’s

Mem.”), ECF No. 14-1, at 24–49.)

        Upon consideration of the parties’ arguments, this Court agrees with Clarian that

the qualifying criteria contained in the implementing manual were the sort of

substantive rule that must go through notice-and-comment rulemaking, and on that

ground alone, Clarian’s motion for summary judgment will be GRANTED, and the

Secretary’s motion for summary judgment will be DENIED. A separate order

consistent with this opinion will follow.

I.      BACKGROUND

        A. The Applicable Statutory And Regulatory Framework

        The Medicare program “was established in 1965 and provides health care

1
 Page numbers herein refer to those that the Court’s electronic case filing system automatically
assigns.

                                                   2
coverage for persons age 65 and older, disabled persons, and persons with end stage

renal disease who meet certain eligibility requirements.” Allina Health Servs. v.

Burwell, No. 14-cv-1415, 2016 WL 4409181, at *1 (D.D.C. Aug. 17, 2016) (citing 42

U.S.C. §§ 426, 426a). Medicare reimbursements are governed by federal law, and the

obtuse text of the Medicare statute has produced much inspired grappling among

judges, many of whom have described the legal provisions that govern the Medicare

system as a “maze[,]” Hall v. Sebelius, 667 F.3d 1293, 1301 n.9 (D.C. Cir. 2012)

(Henderson, J., dissenting), a “legislative and regulatory thicket[,]” Adirondack Med.

Ctr. v. Sebelius, 29 F. Supp. 3d 25, 28 (D.D.C. 2014), aff’d sub nom. Adirondack Med.

Ctr. v. Burwell, 782 F.3d 707 (D.C. Cir. 2015), and a “labyrinth[,]” Biloxi Reg’l Med.

Ctr. v. Bowen, 835 F.2d 345, 349 (D.C. Cir. 1987), among other things. 2 The instant

lawsuit centers on the government’s reimbursement of inpatient hospital care under

Medicare Part A, pursuant to which the federal government provides direct

reimbursements to healthcare providers to cover the bulk of the expenses that a patient

with Medicare insurance (called a “beneficiary”) incurs for inpatient hospital care. See

42 U.S.C. § 1395d; see also Ctrs. for Medicare & Medicaid Servs., Pub. No. 100-01,

Medicare General Information, Eligibility, and Entitlement Manual, Ch. 3 §§ 10.2–10.3.

               1.      Medicare’s Prospective Payment System

       The complexity of the Medicare scheme is partly due to the intricacies of the

prospective payment system that Congress has adopted with respect to Part A

2
  See also Rehab. Ass’n of Va. v. Kozlowski, 42 F.3d 1444, 1450 (4th Cir. 1994) (calling the Medicare
statute “among the most completely impenetrable texts within human experience”); Catholic Health
Initiatives-Iowa, Corp. v. Sebelius, 841 F. Supp. 2d 270, 271 (D.D.C. 2012) (inviting the reader to
“[p]icture a law written by James Joyce and edited by E.E. Cummings[,]” and remarking that “[s]uch is
the Medicare statute”), rev’d, 718 F.3d 914 (D.C. Cir. 2013).

                                                  3
reimbursements—a payment system that Congress developed in reaction to the failures

of the cost-based payment system that was used when Medicare was first enacted. See

Dist. Hosp. Partners, L.P. v. Burwell, 786 F.3d 46, 49 (D.C. Cir. 2015). Under the

prior regime, hospitals and other health care providers were reimbursed for all

“reasonable costs” that the provider incurred in treating beneficiaries, Good Samaritan

Hosp. v. Shalala, 508 U.S. 402, 405 (1993), but that cost-based system “deteriorated

over time . . . because it provided little incentive for hospitals to keep costs down, as

the more they spent, the more they were reimbursed[,]” Dist. Hosp. Partners, 786 F.3d

at 49 (internal quotation marks and citation omitted); see also H.R. Rep. No. 98-25, at

132 (1983), reprinted in 1983 U.S.C.C.A.N. 219, 351 (asserting that the cost-based

payment system “lack[ed] incentives for efficiency” because the federal government

would “simply respond[] to hospital cost increases by providing increased

reimbursement”). In 1983, Congress replaced Medicare’s cost-based payment system

with the prospective payment scheme that has given rise to many legal disputes and that

is at the heart of the present action. See Social Security Amendments of 1983, Pub. L.

No. 98-21, § 601, 97 Stat. 65, 149-63.

       Under the prospective payment system, in contrast to the cost-based system, the

federal government pays the hospital a set reimbursement amount that is established in

advance of the hospital’s expenditures and that is generally based upon the

government’s ex ante assessment of what it costs to care for an individual with the

Medicare beneficiary’s specific diagnosis, regardless of how much the hospital actually

spends to care for a beneficiary. See Cape Cod Hosp. v. Sebelius, 630 F.3d 203, 205

(D.C. Cir. 2011); see also Dist. Hosp. Partners, 786 F.3d at 49 (explaining that

                                             4
prospective payments incentivize hospitals to reduce the cost of inpatient care because

any reduction in cost directly profits the hospitals, while increases in the cost of care

beyond the predetermined amount are borne by the hospitals rather than the federal

government). The prospective payments that hospitals receive for treating Medicare

patients are calculated by private health care insurers known as Medicare

Administrative Contractors (“MACs”) pursuant to a multifactor formula that begins

with a “standardized amount,” which generally “reflects the average cost incurred by

hospitals nationwide for each patient they treat and then discharge.” Cape Cod Hosp.,
630 F.3d at 205. 3

        In order to ensure that the prospective payment system fairly approximates the

actual cost of the care provided, the MACs adjust the standardized amount to account

for various factors, including the relative cost of the care associated with different

patient diagnoses. See Dist. Hosp. Partners, 786 F.3d at 49; Cape Cod Hosp., 630 F.3d

at 205. Per the Medicare statute, HHS has classified the care that can be afforded to

every type of hospital patient into Diagnosis Related Groups (“DRGs”), see 42 U.S.C.

§ 1395ww(d)(4)(A), and each DRG is weighted in accordance with “the estimated

relative cost of hospital resources used with respect to discharges classified within that

group compared to discharges classified within other groups[,]” 42 C.F.R. § 412.60(b). 4

This means, for example, that the DRG classification that includes a heart transplant

3
  The standardized amount was initially determined as of 1984, after the prospective payment system
came into being; this baseline has been adjusted for inflation each year subsequently. See Cape Cod
Hosp., 630 F.3d at 205.
4
 There are other factors that contribute to the calculation of the DRG weight, see, e.g., Adirondack
Med. Ctr. v. Sebelius, 935 F. Supp. 2d 121, 123–24 (D.D.C. 2013) (describing the need for a budget
neutrality adjustment), but these details are not relevant to this case.

                                                   5
will be weighted more heavily than one for a non-invasive procedure—i.e., the “DRG

weight” will be greater—because heart surgery uses more resources and imposes higher

costs on the hospital. Cty. of Los Angeles v. Shalala, 192 F.3d 1005, 1008 (D.C. Cir.

1999). And the greater the DRG weight, the higher the rate of reimbursement; indeed,

the DRG weight adjustment is such an important factor in determining the rate of

reimbursement under the prospective payment system that the Medicare statute itself

refers to reimbursements as the “DRG prospective payment rate.” See, e.g., 42 U.S.C.

§ 1395ww(d)(5)(A)(ii).

       Significantly for present purposes, Medicare’s prospective payment system not

only seems to provide incentives for hospitals to control costs while accounting for the

variable care costs that are associated with different patient diagnoses, it also

recognizes that the costs of healthcare can sometimes be unpredictable, and that a

purely prospective system would unfairly omit reimbursements for the high costs a

hospital can incur when a particular beneficiary’s care ends up being unduly expensive

through no fault of the hospital, as sometimes happens. See Cty. of Los Angeles, 192
F.3d at 1009 (“Despite the anticipated virtues of [the prospective payment system],

Congress recognized that health-care providers would inevitably care for some patients

whose hospitalization would be extraordinarily costly or lengthy.”). To prevent

hospitals from facing significant losses for providing care to patients in such “outlier”

cases—i.e., situations in which the cost of the care provided to a Medicare beneficiary

far exceeds the prospective reimbursement rate for a particular diagnosis—Congress

authorized HHS to reimburse hospitals for these costs through a system of “outlier

payments.” See 42 U.S.C. § 1395ww(d)(5)(A); H.R. Rep. No. 98-25, at 154, reprinted

                                             6
in 1983 U.S.C.C.A.N. 219, 373. It is the manner in which CMS calculates, assesses,

and retroactively reconciles such outlier payments that is at issue in this case.

              2.     Outlier-Payment Calculations

       Section 1395ww(d)(5)(A)(ii) of Title 42 of the U.S. Code permits a hospital to

“request additional payments” (above and beyond the standardized payments that are

provided pursuant to the prospective payment system) in certain instances, and the

statute identifies the particular circumstances under which such a request is warranted.

Specifically, per the statute, “[a] hospital is eligible for an outlier payment ‘in any case

where charges, adjusted to cost, exceed . . . the sum of the applicable DRG prospective

payment rate . . . plus a fixed dollar amount determined by the Secretary.’” Dist. Hosp.

Partners, 786 F.3d at 49 (alterations in original) (quoting 42 U.S.C.

§ 1395ww(d)(5)(A)(ii)); see also 42 U.S.C. § 1395ww(d)(5)(A)(iii) (stating that the

amount of the outlier payment “shall be determined by the Secretary and shall . . .

approximate the marginal cost of care beyond” the otherwise applicable “cutoff point”).

In practice, this statutory command has spawned an “elaborate process” for calculating

outlier payments, which involves the intersection of three distinct concepts: (1) charges,

adjusted to cost, (2) the outlier threshold, and (3) the marginal cost factor. Dist. Hosp.

Partners, 786 F.3d at 49.

       The “charges, adjusted to cost” figure ensures that the outlier payment reflects

the actual cost of the care provided to a beneficiary, and that the government “does not

simply reimburse a hospital for the charges reflected on a patient’s invoice[.]” Dist.

Hosp. Partners, 786 F.3d at 50. It is calculated by multiplying two different numbers:

the first is the amount that the hospital charged for the service provided to the

beneficiary, and the second is the “cost-to-charge ratio,” which is “a fraction that

                                             7
represents the estimated amount that [a hospital] incurs in costs for every dollar that it

bills in charges.” (Def.’s Mem. at 13.) In other words, the cost-to-charge ratio is “a

number representing a hospital’s average markup[.]” Appalachian Reg’l Healthcare,

Inc. v. Shalala, 131 F.3d 1050, 1052 (D.C. Cir. 1997).

        The outlier threshold is also a combination of numbers, but the numbers are

added rather than multiplied. 5 The first figure is “the applicable DRG prospective

payment rate[,]” 42 U.S.C. § 1395ww(d)(5)(A)(ii), which is the payment that the

hospital would ordinarily receive under Medicare’s reimbursement process for a non-

outlier case. The second number is the “fixed loss threshold,” which is a fixed amount

that the Secretary sets anew each year. Dist. Hosp. Partners, 786 F.3d at 50. 6 The

fixed loss threshold essentially “acts like an insurance deductible[,]” id. (quoting Boca

Raton Cmty. Hosp., Inc. v. Tenet Health Care Corp., 582 F.3d 1227, 1229 (11th Cir.

2009)) (internal quotation mark omitted), in that it reflects an amount that the hospital

simply has to bear in order to receive any outlier payments.

        The final component that factors into the calculation of an outlier payment is the

marginal cost factor. This factor represents the “marginal cost” of offering extra care to

outlier patients, 42 U.S.C. § 1395ww(d)(5)(A)(iii), and by regulation, this factor is set

at 80%, see 42 C.F.R. § 412.84(k).

5
 The outlier threshold can include a number of other factors beyond the two discussed here, such as
when a hospital has a disproportionate share of low-income patients, see 42 U.S.C. § 1395ww(d)(5)(F),
or is a teaching hospital, see id. § 1395ww(d)(5)(B). Because none of these additional factors are
implicated by the present case, discussion of them has been omitted.
6
 The fixed loss threshold is calculated such that outlier payments for the following year will amount to
between 5% and 6% of the Medicare system’s total aggregate reimbursement. See 42 U.S.C.
§ 1395ww(d)(5)(iv).

                                                   8
          Putting these all together, the amount of an outlier payment is determined by

taking the cost-adjusted charges (which are determined by multiplying the charge for

the outlier treatment by the hospital’s cost-to-charge ratio), subtracting the outlier

threshold (which is determined by adding the standard reimbursement payment for the

services provided and the fixed loss threshold), and multiplying that number by the

marginal cost factor (which is always 80%). 7 In a recent opinion, the D.C. Circuit

provided a helpful example that explains how this formula works in practice, and also

illustrates the fact that outlier payments cover some, but not all, of the costs associated

with treating outlier cases :

          Assume that the Secretary sets the fixed loss threshold at $10,000. Assume
          also that a hospital treats a Medicare patient for a broken bone and that the
          DRG rate for the treatment is $3,000. The Medicare patient required
          unusually extensive treatment which caused the hospital to impose $23,000
          in cost-adjusted charges. If no other statutory factor is triggered, . . . the
          hospital is eligible for an outlier payment of $8,000, which is 80% of the
          difference between its cost-adjusted charges ($23,000) and the outlier
          threshold ($13,000).

Dist. Hosp. Partners, 786 F.3d at 50–51.

          B.      The 2003 Rule And The 2010 Implementation

                  1. The Road To Reconciliation Of Past Outlier Payments

          In the early 2000s, many hospitals were attempting to game the outlier-payment

process through a sophisticated form of overbilling known as “turbocharging.” See

Banner Health v. Burwell, 126 F. Supp. 3d 28, 48 (D.D.C. 2015). Through the practice

of turbocharging, which exploits a tension that arises when the cost-adjusted charges

7
    The following formula generally captures the interaction between these various concepts:

          Outlier Payment = (Cost-Adjusted Charges – Outlier Threshold) x Marginal Cost
                             Factor

                                                    9
are calculated, a hospital can generate outlier payments that are significantly greater

than would otherwise be expected under the formula discussed above. This can happen

because, as explained, the cost-adjusted charges are determined by multiplying the

amount the hospital actually charged for a particular type of care by the hospital’s cost-

to-charge ratio. However, there can be a temporal disconnect between these two

numbers, given that the amount charged for a type of care is determined as of the time

that the care is provided, while the cost-to-charge ratio is based on the most recently

settled cost report, and cost reports can take several years to settle. See Dist. Hosp.

Partners, L.P. v. Sebelius, 973 F. Supp. 2d 1, 14 (D.D.C. 2014), aff’d in part, rev’d in

part sub nom. Dist. Hosp. Partners, 786 F.3d 46. Thus, the cost-to-charge ratio that is

used for purposes of calculating outlier payments in any given year is based on data that

lags behind the hospital’s actual cost-to-charge ratio for that year, see id., and a

hospital can manipulate the cost-adjusted charge factor in the outlier-payment

calculation by drastically increasing the amount that it charges for inpatient care, out of

all proportion to the actual increase in costs associated with that care. In other words,

when current (heavily inflated) charges are multiplied by an out-of-date (relatively

deflated) cost-to-charge ratio, the hospital’s cost-adjusted charges figure increases, and

the hospital ends up being reimbursed for outlier payments at ever higher rates despite

no obvious increase in the quality or cost of care. (See Pl.’s Mem. at 15–17.) See also

Elizabeth A. Weeks, Gauging the Cost of Loopholes: Health Care Pricing and

Medicare Regulation in the Post-Enron Era, 40 Wake Forest L. Rev. 1215, 1248–50

(2005) (describing this process). 8

8
 Notably, the outlier-payment system is uniquely susceptible to this kind of manipulation because, as
explained above, outlier payments are partially cost-based—i.e., outlier payments reference the amount

                                                  10
        By 2003, HHS had discovered that turbocharging practices were widespread

among hospitals, and issued a proposed rule regarding a change in the methodology for

determining outlier payments partly to address the turbocharging problem. See

Medicare Program; Proposed Change in Methodology for Determining Payment for

Extraordinarily High-Cost Cases (Cost Outlier) Under the Acute Care Hospital Inpatient

Prospective Payment System, 68 Fed. Reg. 10,420 (March 5, 2003). The agency

received notice and comment, and promulgated the final rule—referred to herein as the

“2003 Rule”—on June 9, 2003. See Medicare Program; Change in Methodology for

Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the

Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment

Systems, 68 Fed. Reg. 34,494 (June 9, 2003).

        The 2003 Rule revised “the methodology for determining payments for

extraordinarily high-cost cases (cost outliers) . . . under the . . . prospective payment

system[.]” Id. at 34,494. Notably, the 2003 Rule did not alter the underlying formula

for calculating outlier payments, but it did include a host of measures designed to

combat turbocharging. For example, instead of relying on the most recent settled cost

report, the rule provided that a MAC can consider “the most recent tentative settled cost

report” when determining the applicable cost-to-charge ratio for the following year.

See id. at 34,499 (emphasis added); see also 42 C.F.R. § 412.84. 9 Furthermore, and

that a hospital actually charges for patient care rather than by a predetermined, standardized amount—
and cost-based repayment systems tend to incentivize providers to increase the cost of care, unmoored
from any improvements in the quality of care being offered. Cf. Alice G. Gosfield, Medicare and
Medicaid Fraud and Abuse § 1:7 (2014) (describing various types of Medicare fraud and abuse in the
context of physician reimbursement, which is governed by a cost-based reimbursement system).

9
 Using the most recent tentative report results in less of a lag time between the cost-to-charge ratio
applied to a provider and that provider’s actual cost-to-charge ratio.

                                                   11
most relevant to the present case, the 2003 Rule provided for the “reconciliation” of

outlier payments after the cost report for the relevant period has been finalized. See

Change in Methodology, 68 Fed. Reg. at 34,501 (“[W]e proposed to add a provision to

our regulations to provide that outlier payments would become subject to reconciliation

when hospitals’ cost reports are settled.”); 42 C.F.R. § 412.84(i)(4) (“[A]ny

reconciliation of outlier payments will be based on operating and capital cost-to-charge

ratios calculated based on a ratio of costs to charges computed from the relevant cost

report and charge data determined at the time the cost report coinciding with the

discharge is settled.”). Pursuant to this new reconciliation process, MACs were

authorized to revisit outlier payments once a hospital’s actual cost-to-charge ratio for a

particular year had been determined—despite the fact that the necessary data for making

that determination is ordinarily not available until years after the pertinent outlier

payments have been disbursed—and to revise outlier payments retroactively.

              2. The 2010 CMS Manual And The Qualifying Criteria For Being
                 Subjected To The Outlier Payment Reconciliation Process

       The core of Clarian’s complaint revolves around the fact that the 2003 Rule only

generally authorized the reconciliation process and specified that any reconciliation

would be based on the cost and charge data contained in the hospital’s final settled cost

report, and did not proceed to detail how the reconciliation process would operate in

practice. See 42 C.F.R. § 412.84(i)(4). In fact, in response to a number of comments

that asked the agency to set certain “parameters” in order to guide the implementation

of the newly authorized reconciliation process, the Secretary expressly acknowledged

that the agency would not be addressing the specific circumstances under which

reconciliation would be appropriate at the time the rule was promulgated. See Change

                                             12
in Methodology, 68 Fed. Reg. at 34,503. The Secretary made crystal clear that the

agency’s plan was to issue implementation guidelines at some later point in time, id.

(stating that HHS “intend[s] to issue a program instruction in the near future . . .

[containing] thresholds for fiscal intermediates to reconcile outlier payments for other

hospitals during FY 2003”) and, in the context of the 2003 Rule, the Secretary’s

preamble merely mentioned that the agency was “considering” certain thresholds for

“cost reporting periods beginning during FY 2004[,]” id.

       In December of 2010—more than seven years after the 2003 Rule took effect—

the HHS finally provided specific standards for MACs to use when administering the

reconciliation process: it published instructions for reconciliation in a CMS manual

governing Medicare claims processing. See Ctrs. for Medicare & Medicaid Servs., Pub.

No. 100-04, Medicare Claims Processing Manual, Ch. 3 § 20.1.2.5. Importantly,

according to this 2010 manual, a hospital’s outlier payments are potentially subject to

reconciliation if two criteria are met:

       (1) the provider’s “actual operating [cost-to-charge ratio] is found to be plus
       or minus 10 percentage points from the [cost-to-charge ratio] used [to
       calculate a provider’s] outlier payments,” and

       (2) the provider’s “[t]otal outlier payments in that cost reporting period
       exceed $500,000.”

Id. § 20.1.2.5(A). The manual instructs that a MAC must follow a step-by-step

procedure for initiating reconciliation if these two criteria are satisfied. See id. (“If the

criteria for reconciliation are met, Medicare contractors shall follow the instructions

below in § 20.1.2.7.”); see also id. § 20.1.2.7 (detailing the 14-step reconciliation

process). And as part of that process, the MAC must alert the CMS Central Office that

the offending hospital has met the reconciliation criteria and provide a bevy of

                                             13
information about the hospital. See id. § 20.1.2.7. If CMS gives the go-ahead, the

MAC must then calculate the difference between the original and revised outlier

payments, finalize the hospital’s cost report, issue a Notice of Program Reimbursement,

and “make the necessary adjustment from or to the provider.” Id. The manual is less

clear about what happens if a hospital does not meet the reconciliation criteria after the

cost report for a given year settles: on the one hand, it suggests that no reconciliation

will occur because “the cost report shall be finalized[;]” on the other hand, it notes that

“[e]ven if a hospital does not meet the criteria for reconciliation . . . the Medicare

contractor has the discretion to request that a hospital’s outlier payments . . . be

reconciled if the hospital’s most recent cost and charge data indicate that the outlier

payments to the hospital were significantly inaccurate.” Id. § 20.1.2.5(A).

       Notably, as mentioned, the Secretary’s statement in the preamble to the 2003

Rule hinted at the possibility that the agency might eventually adopt these two

qualifying criteria for initiating reconciliation, see Change in Methodology, 68 Fed.

Reg. at 34,503, but these reconciliation standards did not become official agency policy

until the 2010 claims processing manual was published. It is undisputed that the 2010

manual was produced without notice or an opportunity for the public to comment on the

selected standards, and the manual contains no statement from the agency that sets forth

any justification for these particular criteria. The only record evidence regarding the

agency’s reasoning appears in the preamble to the 2003 Rule, which notes the agency’s

general view that these thresholds “would appropriately capture those hospitals whose

outlier payments will be substantially inaccurate when using the ratio from the

contemporaneous cost reporting period.” Change in Methodology, 68 Fed. Reg. at

                                             14
34,503.

        C.      Instant Facts And Procedural History 10

        Clarian West Medical Center is a 127-bed hospital that is located in Avon,

Indiana. (See Compl., ECF No. 1, ¶ 8.) Clarian began operating in December of 2004

(see id. ¶ 48), and according to the complaint, in its relatively brief existence, Clarian

has already been subjected to the whims of the outlier-payment reconciliation process

twice. The first instance (which Clarian is not challenging in the instant lawsuit)

purportedly occurred in 2005; Clarian maintains that its outlier payments for that year

should have been—but were not—reconciled, and as a result, the hospital lost out on $1

million in outlier payments. (See Compl. ¶¶ 48–49; Pl.’s Mem. at 23–24.) 11 It is the

second instance of alleged unfairness with respect to the outlier-payment reconciliation

process that is the subject of the instant dispute; specifically, Clarian insists that the

agency has improperly identified it as a turbocharger under the criteria laid out in the

2010 manual, and then subjected its outlier payments for the year 2007 to

reconciliation, which has wrongly resulted in a recoupment demand of more than $2

million. (See id. at 24–25.)

        The problem, according to Clarian, was the agency’s alleged failure to recognize

that the cost-to-charge ratio for new hospitals starts high and inevitably decreases in the

10
   The Secretary has not disputed any of the factual allegations contained in Clarian’s complaint and
this Court therefore accepts these facts as true for purposes of analyzing the cross-motions for summary
judgment. See Lee v. United States, 570 F. Supp. 2d 142, 152 (D.D.C. 2008).
11
  Under the 2003 Rule, outlier payments for new hospitals (like Clarian) are calculated according to
the statewide average cost-to-charge ratio, rather than the hospital’s actual cost-to-charge ratio,
because, by its very nature, a brand new hospital has not submitted any cost reports from which a
genuine cost-to-charge ratio can be predicted. See 42 C.F.R. § 412.84(i)(3). Clarian asserts that if its
actual cost-to-charge ratio in 2005 had been considered, then the reconciliation criteria would have
been met, and it would have netted an extra $1 million worth of outlier payments for that year as a
result of the reconciliation process. (See Compl. ¶ 49.)

                                                   15
first few years of operation, not because of turbocharging but because initial hospital

operations are inherently costly when evaluated on a per-patient basis. (See Compl.

¶ 50.) 12 Per standard practice, the cost-to-charge ratio that was used to calculate

Clarian’s outlier payments for 2007 was based on Clarian’s cost reports from 2005 and

2006; those cost reports necessarily generated a higher cost-to-charge ratio than

Clarian’s actual (decreased) cost-to-charge ratio for 2007. (See Pl.’s Mem. at 24.)

Consequently, the MAC that undertook the retrospective evaluation of Clarian’s 2007

outlier payment once the cost reports for that year had settled determined that the two

qualifying criteria for reconciliation were met, and on March 30, 2012, the MAC

informed Clarian that its outlier payments from 2007 were being revised downward to

reflect updated information regarding Clarian’s actual cost-to-charge ratio for that year.

(See Compl. ¶ 52.) The upshot of Clarian’s claim is that, due to the reconciliation

process, the agency demanded that Clarian pay back more than $2.4 million worth of

outlier payments that it had received during the period at issue, when, according to

Clarian, reconciliation should not have been undertaken in the first place. (See id.

¶ 53.)

         To challenge the agency’s recoupment demand, Clarian appealed the repayment

decision to the Provider Reimbursement Review Board (“PRRB”), which is the

administrative tribunal that Congress has authorized to review cost-report disputes

between MACs and service providers. See 42 U.S.C. § 1395oo; 42 C.F.R.

12
   This is apparently because new hospitals see a sharp increase in the “patient utilization rate” in the
first few years, which decreases their “per-unit costs[.]” (Compl. ¶ 50; see Pl.’s Mem. at 24, 38.) Put
another way, all other things being equal, a new hospital with few patients has higher costs per patient
than a more established hospital with more patients, and as a hospital gains patients, its average costs
decrease even as the amount it charges stays constant, which results in a decrease in its cost-to-charge
ratio. (See Compl. ¶ 50.)

                                                   16
§§ 405.1835–77. Clarian requested expedited judicial review of the dispute pursuant to

42 U.S.C. § 1395oo(f)(1) (see Pl.’s Mem. at 25), and on January 3, 2014, the PRRB

permitted expedited judicial review of some of Clarian’s arguments, paving the way for

the instant action (see id.). 13

        Clarian’s one-count complaint, which was filed in this Court on March 3, 2014,

asserts that “the Secretary’s 2012 [reconciliation] determination, and the agency rules

governing that determination, are invalid and should be set aside” because they violate

the Administrative Procedure Act and the Medicare statute. (Compl. ¶ 58; see id. ¶ 60.)

Thus, Clarian challenges not only the $2.4 million recoupment demand but also the

administrative acts that form the backbone of that repayment determination: the 2003

Rule that authorizes reconciliation and the 2010 guidelines that implement that rule.

And Clarian’s memorandum of law in support of its motion for summary judgment,

which was filed October 10, 2014, clarifies that it seeks to attack these regulatory

enactments on three fronts.

        First, Clarian argues that the Secretary failed to adhere to the Medicare statute’s

notice-and-comment rulemaking requirements when the agency adopted the standards

13
  Expedited judicial review permits the PRRB to grant an appellant access to federal court when the
PRRB has jurisdiction over an appeal but lacks the authority to decide the controlling question of law.
See 42 U.S.C. § 1395oo(f)(1); Three Lower Ctys. Cmty. Health Servs., Inc. v. U.S. Dep’t of Health &
Human Servs., 517 F. Supp. 2d 431, 435 n.4 (D.D.C. 2007), aff’d, 317 F. App’x 1 (D.C. Cir. 2009). In
this instance, the PRRB decided that it lacked jurisdiction over three of Clarian’s claims; as to the other
three, including the key claim that the governing reconciliation standards “were not adopted in
accordance with the notice and comment rulemaking requirements mandated by the [APA] and
Medicare Act” (Administrative Record (“AR”), ECF No. 19, at 10), the PRRB concluded that it
possessed jurisdiction but lacked the authority to decide the question of law, and granted Plaintiff’s
request for expedited judicial review. (See id. at 11–12.) When a party challenges the PRRB’s
determination that it lacks jurisdiction over an issue, the Court “must limit its review to the PRRB’s
jurisdiction determination” and not reach the merits of the claim. Eagle Healthcare, Inc. v. Sebelius,
969 F. Supp. 2d 38, 45 (D.D.C. 2013). However, in this case, the Court addresses only the merits of
the claims over which the PRRB granted expedited judicial review, and addressing these claims is
sufficient to resolve the case. Therefore, there is no need for this Court to assess whether the PRRB
was correct in its determination that it lacked jurisdiction over some of Clarian’s claims.

                                                    17
for reconciliation that appear in the 2010 manual. (Pl.’s Mem. at 29–30, 32–33.) 14

Second, Clarian argues that the Secretary’s decision to authorize reconciliation for

outlier payments in the 2003 Rule was not the product of reasoned decision making,

because the Secretary improperly failed to consider a host of factors, including the

effect of reconciliation on new hospitals (id. at 37–40); the procedures for

implementing the reconciliation rules (id. at 40–43); and whether the retrospective

reconciliation process was justified, given the broader prospective payment scheme (id.

at 43–45). (See also id. at 47–49 (arguing that the Secretary did not have sufficient

evidence from which to conclude that retroactively correcting cost-to-charge ratios

through reconciliation would actually lead to more accurate outlier payments).) Third,

and finally, Clarian argues that, to the extent that the 2003 Rule and the 2010

implementing guidelines permit MACs to recover interest on payments owed as a result

of the reconciliation process (see id. at 50–53) and transgress certain statute of

limitations and beneficiary notification requirements (see id. at 33–36), these agency

pronouncements are inconsistent with the Medicare statute.

        The Secretary filed a cross-motion for summary judgment on October 10, 2014.

In that motion, the Secretary argues that the agency fully complied with the procedural

requirements of the Medicare statute’s notice-and-comment rulemaking provision when

it promulgated the 2003 Rule and undertook the 2010 implementation. (See Def.’s

14
  Clarian specifically objects to the two qualifying criteria for initiating the reconciliation process that
the agency adopted in the 2010 manual (see Pl.’s Mem. at 29–35), and it also challenges the Secretary’s
decision “to use an ‘offline’ process ‘to reprice outlier claims’ [and thereby] make[] hospitals subject
to retroactive outlier adjustments to prior outlier-payment determinations even after expiration of the
four-year reopening period for those determinations” (id. at 33). Clarian’s attack is procedural in
nature, because it maintains that these guidelines for the implementation of the authorized
reconciliation process are substantive rules and thus the agency should only have adopted them after
undertaking adequate notice-and-comment procedures. (See id. at 29–30.)

                                                    18
Mem. at 26–34.) The Secretary further argues that the substance of the 2003 Rule is

entirely consistent with the terms of the Medicare statute. In particular, the Secretary

contends that there is nothing improper about using an “offline” process for reconciling

outlier payments (id. at 35–37), or in requiring that interest be paid on all reconciled

outlier payments (id. at 46–49). Finally, the Secretary defends the 2003 Rule’s

emphasis on revising bloated cost-to-charge ratios without altering other elements of

the outlier-payment formula, and also the fact that it does not exempt new hospitals

from the outlier-payment reconciliation process. (Id. at 37–42, 44–46.)

       This Court held oral argument on the parties’ cross-motions for summary

judgment on February 10, 2015, and it took the motions under advisement at that time.

On March 9, 2015, the Court ordered the parties to submit supplemental briefs on

significant questions of law regarding the Medicare statute and the agency conduct at

issue here. (See Order, ECF No. 20.) Those supplemental briefs became ripe on May 1,

2015. (See Pl.’s Supplemental Brief (“Pl.’s Suppl. Br.”), ECF No. 21; Def.’s

Supplemental Brief (“Def.’s Suppl. Br.”), ECF No. 22.)

II.    LEGAL STANDARDS

       A. Motions For Summary Judgment In APA Cases

       “Summary judgment is the proper mechanism for deciding, as a matter of law,

whether an agency action is supported by the administrative record and consistent with

the APA standard of review.” Hill Dermaceuticals, Inc. v. FDA, No. 11-cv-1950, 2012
WL 5914516, at *7 (D.D.C. May 18, 2012) (citing Richard v. INS, 554 F.2d 1173, 1177

& n.28 (D.C. Cir. 1977)); see also Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077,

1083–84 (D.C. Cir. 2001) (collecting cases). Although, in general, a court will grant

                                            19
summary judgment “if the movant shows that there is no genuine dispute as to any

material fact and the movant is entitled to judgment as a matter of law[,]” Fed. R. Civ.

P. 56(a), due to the limited role a court plays in reviewing the administrative record, the

typical summary judgment standards set forth in Rule 56(c) are not applicable in APA

cases, see Stuttering Found. of Am. v. Springer, 498 F. Supp. 2d 203, 207 (D.D.C.

2007). Rather, “[u]nder the APA, it is the role of the agency to resolve factual issues to

arrive at a decision that is supported by the administrative record, whereas ‘the function

of the district court is to determine whether or not as a matter of law the evidence in the

administrative record permitted the agency to make the decision it did.’” Id. (quoting

Occidental Eng’g Co. v. INS, 753 F.2d 766, 769 (9th Cir. 1985)). In other words,

“when a party seeks review of agency action under the APA, the district judge sits as an

appellate tribunal[,]” and “[t]he ‘entire case’ on review is a question of law.” Am.

Bioscience, 269 F.3d at 1083 (footnote and citations omitted); see also Motor Vehicle

Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (explaining that a

reviewing court cannot “substitute its judgment for that of the agency”).

       This Court’s review of the Secretary’s interpretation of the Medicare Act is

governed by the familiar two-step test that the Supreme Court adopted in Chevron,

U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843–44 (1984).

Under that test, a court first determines “whether Congress has directly spoken to the

precise question at issue[,]” id. at 842; and if not, the court defers to the agency’s

interpretation so long as it is permissible and reasonable, see id. at 843–44. However,

when the question posed is whether or not a particular agency enactment should have

been subjected to notice-and-comment rulemaking or is exempted from that

                                             20
requirement, no deference is owed to an agency’s characterization of its own rule. See

Am. Hosp. Ass’n v. Bowen, 834 F.2d 1037, 1056 (D.C. Cir. 1987) (“[W]e are not

compelled to defer to agency characterizations of rules as [being exempt from notice

and comment.]”); Citizens to Save Spencer Cty. v. U.S. Envtl. Prot. Agency, 600 F.2d
844, 879 n.171 (D.C. Cir. 1979) (“The . . . characterizations of these rules as

interpretive by EPA counsel are of no avail. . . . The label that the particular agency

puts upon its given exercise of administrative power is not, for our purposes,

conclusive; rather it is what the agency does in fact.” (internal quotation marks and

citation omitted)).

       B. Medicare’s Notice-and-Comment Requirements

       In the APA, Congress requires that agency policymaking be subjected to notice-

and-comment procedures (unless an exemption applies) in order “to reintroduce public

participation” and “assure[] that the agency will have before it the facts and information

relevant to a particular administrative problem, as well as suggestions for alternative

solutions.” Am. Hosp. Ass’n, 834 F.2d at 1044 (internal quotation marks and citations

omitted); see also id. (explaining that notice-and-comment requirements instantiate

“policy goals of maximum participation and full information”). In the Medicare

context, the HHS generally must proceed by notice-and-comment rulemaking, but the

notice-and-comment mandate emerges from the Medicare statute itself rather than the

APA. 15 Section 1395hh(a)(1) of the Medicare statute authorizes the Secretary to

“prescribe such regulations as may be necessary to carry out the administration” of the

15
   Medicare is, in fact, statutorily exempt from the APA’s notice-and-comment requirements because
those requirements do not apply to “matter[s] relating to . . . benefits[.]” 5 U.S.C. § 553.

                                                 21
Medicare statute, 42 U.S.C. § 1395hh(a)(1), and Section 1395hh(b)(1) states that,

“[e]xcept as [otherwise] provided . . . , before issuing in final form any regulation under

subsection (a) of this section, the Secretary shall provide for notice of the proposed

regulation in the Federal Register and a period of not less than 60 days for public

comment therein[,]” id. § 1395hh(b)(1). The Secretary’s rulemaking power

encompasses any “rule, requirement, or other statement of policy . . . that establishes or

changes a substantive legal standard governing the scope of benefits, the payment for

services, or the eligibility of individuals, entities, or organizations to furnish or receive

services or benefits[,]” id. § 1395hh(a)(2)—a Medicare-related policy pronouncement

that falls within this definition and that is not subject to an exemption in the Medicare

statute is considered to be a “substantive” rule with respect to which the HHS must

provide notice and an opportunity for comment prior to its adoption. See Allina Health,

2016 WL 4409181, at *8.

       As a general matter, courts use the APA’s standards for determining whether or

not a particular Medicare rule is a “substantive” one for notice-and-comment purposes.

See Monmouth Med. Ctr. v. Thompson, 257 F.3d 807, 814 (D.C. Cir. 2001); Adirondack

Med. Ctr. v. Sebelius, 935 F. Supp. 2d 121, 130 (D.D.C. 2013). This is because the

Medicare statute’s notice-and-comment rulemaking requirements are substantially

similar to those of the APA; however, the two statutes’ notice-and-comment provisions

do differ in certain respects, most notably with respect to the recognized exemptions.

The APA provides four exemptions to notice-and-comment rulemaking: three under

Section 553(b)(A) of Title 5 of the U.S. Code and one under Section 553(b)(B). See 5

U.S.C. § 553(b). The three exemptions under Section 553(b)(A) are for interpretive

                                             22
rules, policy statements, and procedural rules. See id. § 553(b)(A). 16 And the APA

exemption in Section 553(b)(B) is for situations in which a federal agency finds that

notice-and-comment rulemaking would be “impracticable, unnecessary, or contrary to

the public interest.” Id. § 553(b)(B). The D.C. Circuit has cautioned that “Congress

intended the exceptions to § 553’s notice and comment requirements to be narrow

ones[,]” Am. Hosp. Ass’n, 834 F.2d at 1044; therefore, rules that do not fit into any one

of these four categories are typically deemed “substantive” rules and, as such, must be

subjected to notice-and-comment procedures, see U.S. Telecom Ass’n v. FCC, 400 F.3d
29, 34 (D.C. Cir. 2005).

        The Medicare statute expressly exempts the HHS from notice-and-comment

rulemaking in three circumstances: (1) when a statutory provision permits an interim

regulation to be issued, see 42 U.S.C. § 1395hh(b)(2)(A); (2) when a statutory provision

requires that a rule be promulgated within 150 days of the passage of that provision, see

id. § 1395hh(b)(2)(B); and (3) when the rule at issue would be exempt under the APA’s

Section 553(b)(B) exemption, see id. § 1395hh(b)(2)(C). The Medicare statute thus

expressly incorporates only the APA’s exemption for situations where notice and

comment would be impracticable, unnecessary, or contrary to the public interest, but it

does not contain any provision that expressly contains or references the APA’s

exemptions for interpretive rules, policy statements, and procedural rules.

Nevertheless, courts have interpreted the Medicare statute to import the APA’s

16
   Although courts sometimes use the term “interpretive rules” as a catchall term to encompass all three
exceptions contained in 5 U.S.C. § 553(b)(A), see, e.g., Cent. Tex. Tel. Co-op., Inc. v. FCC, 402 F.3d
205, 210 (D.C. Cir. 2005), the instant Memorandum Opinion differentiates between these three
different exemptions; the opinion’s references to “interpretive rules” are intended to address that
exemption alone.

                                                   23
exemption for interpretive rules because one of the Medicare statute’s provisions

requires that the Secretary publish certain material in the Federal Register and indicates

that “manual instructions, interpretative rules, statements of policy, and guidelines of

general applicability,” 42 U.S.C. § 1395hh(c)(1) (emphasis added), may not fit the

definition of a “regulation” under Section 1395hh(a)(1). See Monmouth Med. Ctr., 257
F.3d at 814 n.2 (“Although no explicit exception to those requirements is made for

‘interpretive rules,’ an exception is implicit in the provision for periodic publication for

such rules, see 42 U.S.C. § 1395hh(c), and courts generally have assumed the

exception.”). Thus, while the Medicare Act has been interpreted to incorporate the

APA’s distinction between substantive and interpretive rules, this Court is not aware of

any case that squarely holds that the Medicare statute should be read to incorporate the

other exemptions contained in APA Section 553(b)(A)—i.e., policy statements and

procedural rules.

III.   ANALYSIS

       By pressing a bevy of legal arguments about the agency’s reconciliation process

and the rules that undergird it, Clarian seeks to challenge the Secretary’s decision to

recoup from Clarian the $2.4 million that the agency previously provided to the hospital

for outlier payments under Medicare’s prospective payment system. As explained

above, Clarian’s opening salvo is its contention that the agency guidelines that establish

the criteria for eligibility for reconciliation and other specifics regarding the mechanics

of the reconciliation process constitute a substantive rule, and as such, can only be valid

if promulgated through notice-and-comment rulemaking, which indisputably did not

occur when the Secretary adopted those guidelines in 2010. (See Pl.’s Mem. at 29–32.)

                                             24
If Clarian is right about this threshold issue, then there is no need for this Court to

proceed to consider the merits of Clarian’s myriad contentions regarding the unlawful

and/or improper substance of the guidelines; it can vacate the agency’s recoupment

decision and remand this matter to the agency simply and solely because of the

agency’s failure to comply with required notice-and-comment procedures. See, e.g.,

Catholic Health Initiatives v. Sebelius, 617 F.3d 490, 497 (D.C. Cir. 2010); United

Steel, Paper & Forestry, Rubber, Mfg., Energy, Allied Indus. & Serv. Workers Int’l

Union v. Fed. Highway Admin., 151 F. Supp. 3d 76, 89, 91–92, 94 (D.D.C. 2015).

Consequently, the parties have devoted a considerable amount of time and effort to the

notice-and-comment inquiry—and have even engaged in a round of supplemental

briefing—in an attempt to persuade this Court that the qualifying criteria and other

standards regarding the reconciliation process that the Secretary adopted long after

promulgating the reconciliation rule are substantive provisions that required notice-and-

comment procedures (Clarian’s argument), or, alternatively, are the types of enactments

that the Medicare statute exempts from notice-and-comment rulemaking (the

Secretary’s position). 17

        This Court has evaluated the legal standards for characterizing agency guidelines

such as those at issue here, and, in particular, the requirement that notice-and-comment

17
   Prior to oral argument on the cross-motions for summary judgment, the Secretary had argued only
that the 2010 guidelines qualify as an interpretive rule, and as a result, that it was proper for the agency
to adopt them without notice and comment. (See Def.’s Mem. at 30–34.) Following oral argument, it
became clear that it might also be feasible to consider the 2010 guidelines exempt from notice-and-
comment rulemaking as a so-called procedural rule, but only if the Medicare statute, like the APA,
contains an exemption for procedural rules. On March 9, 2015, this Court ordered the parties to submit
supplemental briefing on two questions related to the applicability of the procedural-rule exemption:
first, whether the guidelines for reconciliation established in the 2010 manual fall within the
procedural-rule exemption as contained in the APA, and if so, second, whether the procedural-rule
exemption is available under the Medicare statute’s notice-and-comment provision.

                                                    25
procedures be afforded unless the agency’s pronouncement is interpretive, procedural,

or otherwise fits into one of the statutory exemptions from notice-and-comment

rulemaking. For the reasons explained below, the Court concludes that the qualifying

criteria for being subjected to the outlier-payment reconciliation process that the agency

adopted in the 2010 manual and applied to Clarian do not qualify as an interpretive rule

or a procedural rule (even assuming that there is a procedural-rule exemption in the

Medicare statute), and thus, must be deemed a substantive rule that should have been

promulgated through notice-and-comment rulemaking. Accordingly, and without

characterizing the other reconciliation standards that Clarian challenges or reaching the

merits of Clarian’s arguments regarding the propriety of the policies that the guidelines

embody, this Court will grant Clarian’s motion for summary judgment and remand this

matter to the agency for proceedings consistent with the findings in this opinion. 18

        A. The Qualifying Criteria For Reconciliation That CMS Established In The
           2010 Guidelines Are Not Interpretive Rules

                1. Interpretive Rules Must Relate To Specific Text In A Statute Or A
                   Regulation

        As noted, this Court’s determination regarding whether or not the qualifying

criteria in the 2010 manual are “substantive” rules involves eliminating the possibility

18
  To be clear, Clarian’s notice and comment–based challenge is broader than the Court’s holding in
this case: Clarian challenges not only the two criteria governing the determination of which hospitals
undergo reconciliation but also the rules governing retroactive adjustments to payments following
reconciliation (including the use of a so-called “offline” re-pricing process), on the ground that the
guidelines did not undergo notice and comment. (See Pl.’s Mem. at 32–36.) The Court addresses only
the validity of the qualifying criteria, which alone is sufficient to merit judgment for the Plaintiff. See
Catholic Health Initiatives, 617 F.3d at 494 (declining to reach a plaintiff’s various other challenges to
an agency’s policy where the court determined, as an “antecedent” matter, that the rule was substantive
yet did not undergo notice and comment); cf. PDK Labs. Inc. v. DEA, 362 F.3d 786, 799 (D.C. Cir.
2004) (Roberts, J., concurring) (stating where there “is a sufficient ground for deciding th[e] case,” the
“cardinal principle of judicial restraint—if it is not necessary to decide more, it is necessary not to
decide more—counsels [the Court] to go no further”).

                                                    26
that these guidelines are the type of pronouncement that is exempted from notice-and-

comment procedures by statute, because a substantive rule is defined in opposition to

the various exemptions. Cf. Mendoza v. Perez, 754 F.3d 1002, 1021 (D.C. Cir. 2014)

(defining substantive rules as “the category of rules to which the notice and comment

requirements do apply”); U.S. Telecom Ass’n, 400 F.3d at 34 (same). Put another way,

a substantive rule is any rule that is not interpretive, procedural, or otherwise subject to

an exemption, and because the statutory exemptions represent a departure from the

default notice-and-comment requirement, the D.C. Circuit has instructed that “the

various exceptions . . . will be narrowly construed and only reluctantly countenanced.”

N.J., Dep’t of Envtl. Prot. v. U.S. Envtl. Prot. Agency, 626 F.2d 1038, 1045 (D.C. Cir.

1980).

         Beginning with the Court’s consideration of whether the qualifying criteria are

interpretive in nature, the Court notes that agency rules are deemed interpretive when

the particular promulgation “clarif[ies] a statutory or regulatory term, remind[s] parties

of existing statutory or regulatory duties, or merely track[s] preexisting requirements

and explain[s] something the statute or regulation already required.” Mendoza, 754
F.3d at 1021 (internal quotation marks and citation omitted). “To fall within the

category of interpretive, the rule must derive a proposition from an existing document

whose meaning compels or logically justifies the proposition[,]” and “[t]he substance of

the derived proposition must flow fairly from the substance of the existing document.”

Catholic Health Initiatives, 617 F.3d at 494 (internal quotation marks and citation

omitted). Courts have warned that “the spectrum between a clearly interpretive rule and

a clearly substantive one is a hazy continuum,” Am. Hosp. Ass’n, 834 F.2d at 1045;

                                             27
consequently, any analysis that seeks to categorize agency action as interpretive or

substantive is necessarily “an extraordinarily case-specific endeavor[,]” id. There are

some guideposts, however; for example, an interpretive rule must be grounded in the

specific text of a statute or a regulation. See Catholic Health Initiatives, 617 F.3d at

494 (“If the rule cannot fairly be seen as interpreting a statute or a regulation, and if (as

here) it is enforced, the rule is not an interpretive rule exempt from notice-and-comment

rulemaking.” (internal quotation marks and citation omitted)); Cent. Tex. Tel. Co-op.,

Inc. v. FCC, 402 F.3d 205, 212 (D.C. Cir. 2005) (“If, despite an agency’s claim, a rule

cannot fairly be viewed as interpreting—even incorrectly—a statute or a regulation, the

rule is not an interpretive rule exempt from notice-and-comment rulemaking.”). Failure

to meet this requirement is fatal to the contention that the 2010 guidelines constitute an

interpretive rule.

              2. The Purported Textual Basis For The Qualifying Criteria Is Too Broad
                 And Attenuated To Render These Guidelines Merely Interpretive

       The Secretary’s cross-motion for summary judgment suggests only one textual

reference point that potentially could support the agency’s contention that the

qualifying criteria for reconciliation that were adopted in the 2010 manual are

interpretive rules: the statement in Section 1395ww(d)(5)(A)(iii) that outlier payments

must “‘approximate the marginal cost of care beyond’ the fixed-loss threshold.” (Def.’s

Mem. at 30 (quoting 42 U.S.C. § 1395ww(d)(5)(A)(iii)). But under binding precedent,

this statutory language is too broad to support the invocation of the interpretive-rule

exemption to Medicare’s notice-and-comment requirements, and the link between it and

the technical details of a reconciliation program is too attenuated. See Catholic Health

                                             28
Initiatives, 617 F.3d at 496; United Steel, Paper & Forestry, Rubber, Mfg., Energy,

Allied Indus. & Serv. Workers Int’l Union, 151 F. Supp. 3d at 89.

       The D.C. Circuit’s opinion in Catholic Health Initiatives v. Sebelius, 617 F.3d
490 (D.C. Cir. 2010), requires this conclusion. That case involved an agency manual

that provided for the reimbursement of a hospital’s insurance costs, see id. at 491–92,

but the relevant statutory and regulatory language said only that the government would

reimburse a hospital’s “reasonable costs” and left the determination of what costs are

“reasonable” to the Secretary, id. at 491. The Secretary subsequently determined that

insurance costs were in the realm of reasonable costs, and also permitted reimbursement

of insurance costs even where those costs were paid to so-called “captive” insurers—

i.e., insurers that were actually a wholly owned subsidiary of the hospital—but the

agency expressly differentiated between “domestic” captives and “offshore” captives,

with insurance costs paid to offshore captives being reimbursable only if those captives

satisfied a series of requirements not imposed on domestic captives. See id. at 492

(noting that, unlike domestic captives, a covered offshore captive could not invest more

than ten percent of its assets in equity securities). Significantly for present purposes,

when setting out the additional coverage requirements for offshore captives, the

Secretary did not use notice-and-comment rulemaking, see id. at 493, and the D.C.

Circuit held that the requirements that the agency imposed on offshore captives had to

be promulgated through notice-and-comment rulemaking because the requirements were

substantive and not interpretive, see id. at 497.

       Two principles undergirded the Circuit’s conclusion in Catholic Health

Initiatives and are instructive here. First, the panel reasoned that, if the statutory or

                                             29
regulatory language that is purportedly being interpreted is sufficiently broad, then any

attempt by the agency to implement that language would necessarily involve making

substantive policy judgments that require notice-and-comment rulemaking. See id. at

494–95. In the context of the Catholic Health Initiatives case, the Circuit concluded

that the statutory term “reasonable cost” was so broad that “the sort of detailed—and

rigid—investment code” that the agency imposed when it determined which offshore

captives would be covered could not have been derived from an act of interpretation.

Id. at 496. Second, the Catholic Health Initiatives Court noted that, if an interpretive

rule imposes “arbitrary” numeric criteria, then it likely reflects a substantive, rather

than interpretive, policy judgment. See id. at 495-96. By “arbitrary,” the Circuit meant

numeric criteria that represented just one “choice among [many] methods of

implementation[,]” id. at 495 (quoting Hoctor v. U.S. Dep’t of Agric., 82 F.3d 165, 170

(7th Cir. 1996)) (internal quotation marks omitted), and the panel viewed the manual’s

requirement that equity securities not exceed ten percent of an offshore captive’s assets

as precisely the sort of numeric requirement that reflects an agency’s substantive policy

determination rather than mere interpretation of statutory provisions, see id. at 496.

       Applying these two principles to the circumstances at issue in the instant case,

this Court concludes that the qualifying criteria for the outlier-payment reconciliation

process that the agency adopted in the 2010 manual are not merely interpretive of

Congress’s command that outlier payments must “approximate the marginal cost of care

beyond” the fixed-loss threshold. 42 U.S.C. § 1395ww(d)(5)(A)(iii). This is so

because the statutory phrase “marginal cost of care”—much like “reasonable cost”—is

quite broad and does not, on its own, suggest any particular application. Furthermore,

                                             30
as the complicated nature of the outlier-payment formula demonstrates, giving effect to

that term requires a series of interlocking policy and technical considerations, see Dist.

Hosp. Partners, 786 F.3d at 49–51, which means that the Secretary’s identification and

adoption of the two qualifying criteria inherently involved the sort of “reasonable but

arbitrary . . . choice among methods” that the D.C. Circuit found to be substantive in

Catholic Health Initiatives. 617 F.3d at 495 (quoting Hoctor, 82 F.3d at 170). The

numeric thresholds that the agency has selected also plainly reflect an arbitrary policy

determination, because nothing in the language of “marginal cost of care” suggests that

a ten percent change in cost-to-charge ratios should trigger the reconciliation process,

as opposed to a five percent or fifteen percent change. And however solid the

Secretary’s reasons for adopting those specific numeric requirements might have been,

the fact that the agency’s policy choice is supported and justified does not make its

decision merely interpretive (i.e., less substantive).

       The Secretary objects to this conclusion on a number of grounds, none of which

succeeds. Starting with the most sweeping contention, the agency argues that the

qualifying criteria must be deemed interpretive rules simply and solely because they are

set forth in CMS instruction manuals. (See Def.’s Reply, ECF No. 18, at 12–13

(“Courts construing [Medicare Provider Reimbursement Manual] provisions have

concluded that they are interpretive rules and do not require notice and comment

rulemaking.” (internal quotation marks and citation omitted).) The D.C. Circuit’s

Catholic Health Initiatives case belies this contention; the provisions under review in

that case were contained in a CMS manual and were nevertheless found to be

substantive, not interpretive. See Catholic Health Initiatives, 617 F.3d at 497.

                                             31
       Undaunted, the Secretary further insists that the qualifying criteria and other,

similar manual instructions provide “technical details of issues such as calculation

methodologies” in order “to help intermediaries and providers better understand the

regulations” and are exempt from Medicare’s notice-and-comment requirements on that

basis as well. (Def.’s Mem. at 31 (internal quotation marks and citations omitted)).

Even if this is an accurate statement regarding the agency’s intentions, it does not help

the Secretary, because the particular criteria that Clarian challenges are much more than

mere “technical details”—they reflect substantive policy decisions, as explained further

below. See infra Part III.C. Moreover, as discussed above, the two qualifying criteria

are not sufficiently grounded in the statutory phrase “marginal cost of care” for them to

amount to an implementation of that language, and their seeming consistency with

Medicare’s outlier-payment provisions and/or the text of the 2003 Rule (see Def.’s

Mem. at 32–33) is beside the point; it is well established that an agency’s well-

intentioned efforts to adopt provisions that are consistent with the text of a statute or

regulation is not a reason to sidestep Medicare’s notice-and-comment requirements if

the rule that emerges “is simply too attenuated to represent an interpretation of those

terms[,]” Catholic Health Initiatives, 617 F.3d at 496.

       Finally, the Secretary argues that the qualifying criteria are distinguishable from

the reimbursement instructions at issue in Catholic Health Initiatives because the

investment instructions in Catholic Health Initiatives were mandatory whereas the

qualifying criteria for the outlier-payment reconciliation process do not necessarily

result in reconciliation—in this regard, the agency emphasizes that the CMS manual

builds in an extra layer of discretion whereby CMS must approve reconciliation once a

                                             32
hospital has been shortlisted. (See Def.’s Mem. at 33–34.) See also Ctrs. for Medicare

& Medicaid Servs., Pub. No. 100-04, Medicare Claims Processing Manual, Ch. 3

§ 20.1.2.5 (providing that reconciliation of any hospitals that satisfy the qualifying

criteria will be “[s]ubject to the approval of the CMS Central Office”). However, the

mandatory-versus-discretionary distinction between the investment instructions in

Catholic Health Initiatives and the qualifying criteria for outlier-payment reconciliation

does not bear on the fundamental question of whether the challenged provisions are tied

to any reasonably specific statutory or regulatory language, or whether those provisions

reflect a substantive policy judgment. In other words, when a rule is plainly not

interpretive in light of the ordinary criteria for making this designation, its mandatory

or voluntary nature is of no moment. Cf. Catholic Health Initiatives, 617 F.3d at 494–

97 (holding that the agency instruction is a substantive rule without reference to its

mandatory nature). Thus, in this Court’s view, the difference between the qualifying

criteria and the agency instructions in Catholic Health Initiatives that the Secretary has

identified is not a meaningful one for the purpose of determining whether the former are

interpretive rules, and the D.C. Circuit’s analysis compels the conclusion that the

qualifying criteria cannot be labeled as such.

       B. The Medicare Statute Does Not Provide For A Procedural-Rule
          Exemption And, In Any Event, The Qualifying Criteria Are Not A
          Procedural Rule

              1. There Is No Express Exemption For Procedural Rules In The Medicare
                 Statute And One Cannot Reasonably Be Inferred

       Procedural rules are agency provisions that are “primarily directed toward

improving the efficient and effective operations of an agency, not toward a

determination of the rights [or] interests of affected parties.” Mendoza, 754 F.3d at

                                            33
1023 (quoting Batterton v. Marshall, 648 F.2d 694, 702 n.34 (D.C. Cir. 1980))

(alteration in original, internal quotation marks omitted). According to the D.C.

Circuit, a “prototypical procedural rule” is an agency’s determination that it will not

search for documents produced after the date of a requester’s letter when responding to

a FOIA request, Pub. Citizen v. Dep’t of State, 276 F.3d 634, 641 (D.C. Cir. 2002); but

“the distinction between substantive and procedural rules” is not always that clear,

Elec. Privacy Info. Ctr. v. U.S. Dep’t of Homeland Sec., 653 F.3d 1, 5 (D.C. Cir. 2011),

and the difference can be “one of degree depending upon whether the substantive effect

is sufficiently grave so that notice and comment are needed to safeguard the policies

underlying the APA[,]” id. at 5–6 (internal quotation marks and citation omitted).

Generally speaking, to determine whether or not a rule qualifies as procedural, courts

often inquire into “whether the agency action . . . encodes a substantive value judgment

or puts a stamp of approval or disapproval on a given type of behavior.” Am. Hosp.

Ass’n, 834 F.2d at 1047.

       As mentioned, the Medicare statute does not contain any express exemption from

notice-and-comment rulemaking for procedural rules, unlike the APA. See 42 U.S.C.

§ 1395hh(b)(2). That fact would ordinarily be sufficient to dispose of the issue of the

applicability of the procedural-rule exemption to the qualifying criteria for the outlier-

payment reconciliation process, but it is at least theoretically possible that an exemption

for procedural rules could be read into the Medicare statute just as the exemption for

interpretive rules has been. Cf. Monmouth Med. Ctr., 257 F.3d at 814 n.2 (holding that

the interpretive-rule exemption exists in the Medicare Act despite its absence from the

Act’s express exemptions). This Court has reviewed the parties’ submissions regarding

                                            34
this possibility (see Order, ECF No. 20; see also Pl.’s Suppl. Br., ECF No. 21; Def.’s

Suppl. Br., ECF No. 22), and concludes that the language and structure of Medicare’s

notice-and-comment requirements foreclose any such reading, for several reasons.

       First of all, given that the Medicare statute expressly provides for some of the

exemptions contained in the APA but not the exemption for procedural rules, see 42

U.S.C. § 1395hh(b)(2)(C), the canon expressio unius est exclusio alterius—“the

expression of one is the exclusion of others[,]” Adirondack Med. Ctr. v. Sebelius, 740
F.3d 692, 696 (D.C. Cir. 2014)—strongly suggests this Court should treat the exclusion

of procedural rules from the list of exemptions to Medicare’s notice-and-comment

requirement as an intentional policy choice, see United States v. Vonn, 535 U.S. 55, 65

(2002) (explaining that, under this canon of interpretation, the legislature’s

“expressi[ion of] one item of a commonly associated group or series” is considered the

intentional “exclu[sion of] another left unmentioned”). Of course, this canon applies

only where “it is fair to suppose that Congress considered the unnamed possibility and

meant to say no to it[.]” Marx v. Gen. Revenue Corp., 133 S. Ct. 1166, 1175 (2013)

(internal quotation marks and citation omitted). And so it is here, because Congress has

expressly incorporated into the Medicare statute one of the four express APA

exemptions, see 42 U.S.C. § 1395hh(b)(2)(C), which makes it entirely plausible that

Congress actually considered—and rejected—the possibility of incorporating the APA’s

other exemptions, including the one for procedural rules. Cf. Council for Urological

Interests v. Burwell, 790 F.3d 212, 221 (D.C. Cir. 2015) (“Congress knew how to

permit per-click payments explicitly, suggesting that the omission in this particular

context was deliberate.”). In addition, the exemptions that Congress expressly included

                                            35
in Section 1395hh(b)(2) of the Medicare statute are all of a common type—that is,

exemptions to notice-and-comment rulemaking—and the procedural-rules exemption is

also of that type, which makes application of the expressio unius canon even more

reasonable. See Barnhart v. Peabody Coal Co., 537 U.S. 149, 168 (2003) (asserting

that the expressio unius canon “has force only when the items expressed are members of

an ‘associated group or series,’ justifying the inference that items not mentioned were

excluded by deliberate choice, not inadvertence”).

       To be sure, the D.C. Circuit has indicated that the expressio unius canon has

limited utility in the administrative law context. See Adirondack Med. Ctr., 740 F.3d at

697. But it can still be relevant where there are no other reasonable explanations for

the exclusion, see Indep. Ins. Agents of Am., Inc. v. Hawke, 211 F.3d 638, 644 (D.C.

Cir. 2000), and, here, the Secretary has offered none (see Def.’s Suppl. Br. at 20–22

(arguing that the procedural-rule exemption should be read into the Medicare statute

without providing any rationale for importing this exemption)). Thus, the expressio

unius canon provides a clear and compelling reason to find that the Medicare statute

does not incorporate the APA’s procedural-rule exemption.

       The text and structure of the Medicare statute also supports the conclusion that

there is no procedural-rule exemption in the Medicare context. First, and foremost,

Medicare’s notice-and-comment provisions are plainly distinguishable from those that

appear in the APA, which means that exemption conformity cannot be assumed. See

Allina Health Servs. v. Sebelius, 746 F.3d 1102, 1109 (D.C. Cir. 2014) (noting that the

fact “that the Medicare statute is similar to the APA hardly means it is identical”).

Moreover, Section 1395hh(b) proceeds in definitive terms, and those terms provide no

                                            36
indication that any exemptions beyond the three specified in that section are applicable.

See 42 U.S.C. § 1395hh(b)(1) (stating that notice-and-comment rulemaking shall apply

“[e]xcept as provided” by the three enumerated exemptions). And Congress’s silence

regarding procedural rules is especially telling in light of the fact that the Medicare

statute expressly cross-references one of the APA’s exemptions, see 42 U.S.C.

§ 1395hh(b)(2)(C); that is, Congress has specified in the clearest possible terms that the

APA exemption contained in 5 U.S.C. § 553(b)(B) applies, but says nothing of the

exemptions contained in 5 U.S.C. § 553(b)(A). Couple this with the fact that the

Medicare statute expressly recognizes that “statements of policy” may not constitute

regulations subject to Medicare’s notice-and-comment procedures, see 42 U.S.C.

§ 1395hh(c)(1), but makes no such references to the types of non-policy procedural

pronouncements that are sometimes needed in order to effectuate the agency’s policy

statements, and one is left with the distinct impression that the exemptions in

Medicare’s notice-and-comment procedures were not intended to incorporate procedural

rules.

         The Secretary is certainly correct to point out that courts have found that certain

APA exemptions have been implicitly incorporated into the Medicare statute under

similar circumstances (see Def.’s Suppl. Br. at 21), as this Court acknowledges above.

See, e.g., Vencor Nursing Centers, L.P. v. Shalala, 63 F. Supp. 2d 1, 11 (D.D.C. 1999)

(“The court treats the Medicare Act’s exemption for interpretive rules as identical to the

APA’s.”). However, courts have made this finding based on a separate subsection of

the Medicare statute that expressly references “interpretative rules[.]” 42 U.S.C. §

1395hh(c)(1) (emphasis added); see Monmouth Med. Ctr., 257 F.3d at 814 (“[I]t seems

                                              37
fair to infer that, as the Medicare Act was drafted after the APA, § 1385hh(c)’s

reference to ‘interpretive rules’ without any further definition adopted an exemption at

least similar in scope to that of the APA.”); see also id. at 814 n.2 (“Although no

explicit exception to those requirements is made for ‘interpretive rules,’ an exception is

implicit in the provision for periodic publication for such rules . . . .”). The Secretary

has not demonstrated that procedural rules are likewise specifically referenced in

another provision of the Medicare statute; therefore, this Court doubts that the

reasoning that has compelled several courts to infer an exemption for interpretive rules

actually supports the conclusion that the Medicare statute has, sub silentio, adopted an

additional exemption for procedural rules.

       The Secretary’s suggestion that this Court should infer that a procedural-rule

exemption exists in the Medicare context nevertheless, because the D.C. Circuit appears

to have done so in American Hospital Association v. Bowen, 834 F.2d 1037 (D.C. Cir.

1987), is also unavailing, and it fails for one simple reason: the challenged agency

action in the American Hospital Association case occurred before the passage of the

Medicare statute’s notice-and-comment provision—at a time when the Secretary had

voluntarily adopted the APA’s notice-and-comment requirements, including the APA’s

exemptions. See 36 Fed. Reg. 2532 (Feb. 5, 1971) (directing agencies “to utilize the

public participation procedures of the APA, 5 U.S.C. 553”); see also Timothy Stoltzfus

Jost, Governing Medicare, 51 Admin. L. Rev. 39, 88 & n.272 (1999). Thus, while it

was entirely appropriate for the D.C. Circuit to apply a procedural-rule exemption in

the American Hospital Association case, that case says nothing about the applicability

of a procedural-rule exemption to Medicare’s current notice-and-comment provisions.

                                             38
       Nor is this Court persuaded by fact that more recent decisions from this district

have relied upon a procedural-rule exemption in the Medicare context. (See Def.’s

Suppl. Br. at 22 (citing Sierra-Nevada Mem’l-Miners Hosp., Inc. v. Shalala, No. 91-cv-

2198, 1994 WL 675720, at *4–6 (D.D.C. Nov. 21, 1994); Beverly Health & Rehab.

Servs. v. Thompson, 223 F. Supp. 2d 73, 99–101 (D.D.C. 2002); and Gentiva

Healthcare Corp. v. Sebelius, 857 F. Supp. 2d 1, 13 (D.D.C. 2012)).) “[A] decision

from another Judge in this District is not controlling authority on this [Court.]” Carik

v. U.S. Dep’t of Health & Human Servs., 4 F. Supp. 3d 41, 54 n.8 (D.D.C. 2013)

(internal quotation marks and citation omitted); see also Cmty. Health Sys., Inc. v.

Burwell, No. 14-cv-1432, 2015 WL 4104644, at *20 n.22 (D.D.C. July 7, 2015) (noting

that, “[w]hile potentially persuasive,” other District Court “decisions are not binding”).

And it appears that the opinions on which the Secretary relies merely assumed the

applicability of a procedural-rule exemption to Medicare’s notice-and-comment

requirement, without specifically analyzing the issue. See Sierra-Nevada Mem’l-Miners

Hosp., 1994 WL 675720 at *4; Beverly Health & Rehab. Servs., 223 F. Supp. 2d at 99;

Gentiva Healthcare Corp., 857 F. Supp. 2d at 13.

       Finally, this Court rejects the Secretary’s suggestion that a procedural-rule

exemption must necessarily be implied because an agency’s ability to develop

procedural rules is a “basic tenet of administrative law[.]” (Def.’s Suppl. Br. at 20

(quoting Perez v. Mortg. Bankers Ass’n, 135 S. Ct. 1199, 1207 (2015)) (internal

quotation marks omitted).) It is no doubt true that an agency must have the capacity to

provide for the implementation of the policies it adopts, especially in the APA context,

see 5 U.S.C. § 553(b)(A), but that is beside the point; what matters for present purposes

                                            39
is whether Congress intended to excuse the agency from its duty to provide the public

with notice of any such procedural command, and an opportunity to comment on it,

prior to its adoption. And the fact that a rule is procedural in nature (and thus important

to the agency’s function) does not, in itself, establish that Congress implicitly desired to

permit the agency to forgo the public vetting that it has otherwise prescribed.

              2. Even If The Medicare Statute Could Be Read To Contain A
                 Procedural-Rule Exemption, The Qualifying Criteria For
                 Reconciliation Are Not Procedural Rules

       The two qualifying criteria for the initiation of the reconciliation process that the

Secretary adopted in the 2010 manual—(1) that a hospital’s actual cost-to-charge ratio

for a given year is “plus or minus 10 percentage points” from the cost-to-charge ratio

that was used to calculate the hospital’s outlier payments for that year, and (2) that the

hospital’s “[t]otal outlier payments in that cost reporting period exceed[ed]

$500,000[,]” Ctrs. for Medicare & Medicaid Servs., Pub. No. 100-04, Medicare Claims

Processing Manual, Ch. 3 § 20.1.2.5(A)—unquestionably “encode[] a substantive value

judgment” about the hospital’s charges and cost reporting for Medicare reimbursements

and “put[] a stamp of . . . disapproval” on the hospitals that are singled out by the rule.

Am. Hosp. Ass’n, 834 F.2d at 1047. Indeed, according to the Secretary, the entire

purpose of the reconciliation process was to prevent the manipulation of outlier

payments by nefarious turbochargers, see 68 Fed. Reg. at 34,5001 (claiming that

reconciliation process was needed to “completely eliminate” the ability of “hospitals to

manipulate the system to maximize outlier payments”), and the selected criteria

purportedly reflect the agency’s substantive judgment regarding how best to

“appropriately capture those hospitals whose outlier payments will be substantially

inaccurate when using the ratio from the contemporaneous cost reporting period.” Id. at

                                             40
34,503. In other words, because the qualifying criteria are the mechanism by which the

agency identifies those hospitals that it has deemed potentially worthy of this

metaphorical “stamp of . . . disapproval[,]” Am. Hosp. Ass’n, 834 F.2d at 1047, the

Secretary is hard-pressed to make a convincing argument that the qualifying criteria fall

within the category of agency actions that properly can be deemed mere “procedural”

rules.

         In its supplemental briefing, the agency makes a valiant effort, nevertheless. The

Secretary contends, in essence, that the qualifying criteria are procedural for two

reasons: first, because they are a “type[] of agency guidance” that merely “ provide[s]

details as to the operational aspects of reconciliation” (Def.’s Suppl. Br. at 17), and second,

because the qualifying criteria are not the final say in determining whether a hospital’s

outlier payments are reconciled because reconciliation is still subject to the approval of

CMS (see id. at 16–17). The first argument is belied by the analysis above, and in

particular, by this Court’s finding that the qualifying criteria initiate the process pursuant

to which the agency disgorges prior Medicare payments and thereby visits opprobrium

upon a hospital, and insofar as the criteria speak to which hospitals may be subjected to

this treatment, they represent substantive policy choices on the part of the agency. The

Secretary’s second contention fails because it is the flip-side of the (misguided) argument

that the mandatory nature of a rule makes it less non-substantive, which is an assertion that

this Court has already rejected. See supra Part III.A.2.

         What is more, the D.C. Circuit has already held that agency discretion does not,

alone, transform an otherwise substantive rule into a procedural one. In Electronic Privacy

Information Center v. U.S. Dep’t of Homeland Sec. , 653 F.3d 1 (D.C. Cir. 2011), the

government sought to defend the introduction of a new type of security-screening machine

                                              41
at airports without going through notice-and-comment rulemaking, on the ground that

“there are no [machines] at some airports and the agency retains the discretion to stop

using the scanners where they are in place.” Id. at 7. 19 The D.C. Circuit rejected this

argument, noting that, although the government retained discretion to use the machines or

not, “[m]ore clearly significant is that a passenger is bound to comply with whatever

screening procedure the TSA is using on the date he is to fly at the airport from which his

flight departs.” Id. In other words, the D.C. Circuit has made clear that the existence of

agency discretion to adopt a rule that mandates certain procedures (or not) does not

ameliorate the fact that the rule has consequences for those subject to its terms, and this

Court finds that principle fully applicable here. That is, although CMS may, in its

discretion, decide not to reconcile a hospital’s outlier payments despite the fact that the

qualifying criteria are satisfied, those criteria have a very real effect on those hospitals that

do not receive the benefit of the agency’s discretionary determination that reconciliation is

not warranted, and thus, the discretionary nature of the challenged criteria is of no moment

with respect to the characterization of those agency pronouncements as of the type that

requires notice-and-comment rulemaking.

        C. The Qualifying Criteria Have The Typical Characteristics Of A
           Substantive Rule Because They Govern The Scope Of Benefits

        Having determined that the qualifying criteria for reconciliation of outlier payments

that the Secretary adopted in the 2010 manual are neither interpretive nor procedural as the

Secretary claims, and seeing no other exemption in the Medicare statute under which these

19
  The discretion argument that was addressed in the EPIC case arose in the context of a dispute about
whether the introduction of the screening machine fell within the APA’s policy statement exemption,
but the circuit panel also addressed the government’s attempt to rely on the procedural-rule exemption.
See Elec. Privacy Info. Ctr., 653 F.3d at 5–6. Thus, the fact that the rule contemplated agency
discretion did not transform it into a procedural rule.

                                                  42
guidelines might fit, this Court has already effectively deemed those criteria substantive.

See Mendoza, 754 F.3d at 1021; U.S. Telecom Ass’n, 400 F.3d at 34. Because courts

have also articulated a number of positive characteristics that tend to indicate that a rule

is substantive rather than interpretive or procedural, see, e.g., Mendoza, 754 F.3d at

1021 (explaining that a rule is likely substantive if it “supplements a statute, adopts a

new position inconsistent with existing regulations, or otherwise effects a substantive

change in existing law or policy”); Syncor Int’l Corp. v. Shalala, 127 F.3d 90, 95 (D.C.

Cir. 1997) (noting that a substantive rule “modifies or adds to a legal norm based on the

agency’s own authority”), this Court observes additionally that the qualifying criteria in

the instant case have at least two quintessential “substantive rule” characteristics.

       First, the qualifying criteria for reconciliation of outlier payments clearly effect a

change in agency policy. In the Secretary’s notice of proposed rulemaking for the 2003

Rule, the Secretary stated that reconciliation was adopted for a singular purpose: “to

correct those situations in which hospitals would otherwise receive overpayments for

outlier cases due to excessive charge increases.” Proposed Change in Methodology, 68

Fed. Reg. at 10,421. The Secretary emphasized the agency’s findings regarding the

substantial number of hospitals that it deemed guilty of engaging in the practice of

drastically increasing charges for care provided to beneficiaries in order to decrease the

cost-to-charge ratio, and explained the agency’s view that combatting such

turbocharging justified the new reconciliation process. See id. at 10,428 (“[W]e have

identified 123 hospitals that appear to have been most aggressively gaming the current

policy.”). But the qualifying criteria that the agency subsequently adopted do not

plainly distinguish between turbocharging hospitals and those hospitals that experience

a significant change in their cost-to-charge ratio for different reasons, as Clarian

                                             43
asserts. Indeed, the qualifying criteria are such that hospitals whose cost-to-charge

ratio increases (i.e., the opposite of turbocharging) by 10 percentage points or more, as

well as hospitals whose cost-to-charge ratio decreases by that much because of a

decrease in costs rather than an increase in charges, are also implicated. The qualifying

criteria thus broaden the applicability of the outlier-payment reconciliation process

beyond the specific problem of turbocharging, and while that approach may well be

justified for reasons of policy and practicality, it clearly represents a substantive

departure from the purposes of the reconciliation process that were identified when the

2003 Rule was proposed.

       The qualifying criteria also plainly “implicate the policy interests animating

notice-and-comment rulemaking.” Elec. Privacy Info. Ctr., 653 F.3d at 6. The purpose

of notice-and-comment rulemaking is “(1) to reintroduce public participation and

fairness to affected parties after governmental authority has been delegated to

unrepresentative agencies; and (2) to assure that the agency will have before it the facts

and information relevant to a particular administrative problem.” MCI Telecomm.

Corp. v. FCC, 57 F.3d 1136, 1141 (D.C. Cir. 1995) (internal quotation marks and

citation omitted); accord Am. Hosp. Ass’n, 834 F.2d at 1044. There were a number of

public comments that addressed how the reconciliation process would be applied during

the 2003 Rule’s notice-and-comment period, despite the fact that the notice of proposed

rulemaking did not discuss how the reconciliation process would be implemented. See

Change in Methodology, 68 Fed. Reg. at 34,503 (“Some commenters suggested that we

clarify how reconciliation will be implemented and only reconcile outlier payments to

those providers whose cost-to-charge ratios increased or decreased outside of certain

                                             44
parameters.”). And not only was there a desire among members of the public to

comment on the specific criteria that would subject a hospital to reconciliation, there is

also reason to think that subjecting those criteria to notice and comment may have led

the agency to a different result. For example, and as noted above, the current

qualifying criteria do not take into account fluctuations in the cost-to-charge ratio that

are caused by decreasing costs rather than increases in the amount that a hospital

charges beneficiaries. According to Clarian, this scenario is common among new

hospitals in particular (see Pl.’s Mem. at 37–40), and notice-and-comment rulemaking

would have allowed the Secretary to respond to these concerns and/or develop a rule

that accounted for this circumstance.

       Thus, in addition to the fact that the qualifying criteria are neither interpretive

nor procedural—which is sufficient to trigger the requirement of notice-and-comment

rulemaking standing alone—this Court finds that the criteria also share at least two of

the characteristics that courts have established as being indicative of a substantive rule.

IV.    CONCLUSION

       Clarian has sustained its contention that the qualifying criteria CMS issued to

MACs in the 2010 manual, which were used to identify Clarian as a candidate for the

outlier-payment reconciliation process, needed to be subjected to notice-and-comment

rulemaking prior to their adoption. This is because, for the reasons explained above,

the criteria are not sufficiently grounded in any statutory or regulatory text to fall

within the interpretive-rule exemption, and the qualifying criteria cannot be construed

as a procedural rule, even assuming that the procedural-rule exemption applies in the

Medicare context. (The Court concludes herein that it does not.) The inapplicability of

                                             45
these exemptions means that the qualifying criteria count as a substantive rule, and the

fact that the criteria also exhibit the characteristics of substantive rules further

reinforces that conclusion.

       Accordingly, and as set forth in the accompanying order, Clarian’s motion for

summary judgment will be GRANTED, the Secretary’s motion for summary judgment

will be DENIED, the matter will be REMANDED to the Secretary for further

proceedings consistent with this opinion.

DATE: August 26, 2016                      Ketanji Brown Jackson
                                           KETANJI BROWN JACKSON
                                           United States District Judge

                                              46