UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA __________________________________ ) AMERICAN HOSPITAL ) ASSOCIATION, et al., ) ) Plaintiffs, ) ) v. ) Civil Action No. 18-2841 (RMC) ) ALEX M. AZAR II, ) Secretary of the Department of Health ) and Human Services, ) ) Defendant. ) __________________________________ )
MEMORANDUM OPINION
Under Medicare Part B, the Centers for Medicare & Medicaid Services (CMS)
pays hospital outpatient departments at predetermined rates for patient services, and Congress
has established the Outpatient Prospective Payment System by which CMS is to set and pay
those rates. CMS came to believe that the rate for certain clinic-visit services at a specific subset
of these outpatient departments—familiarly, off-campus provider-based departments—was too
high and that patients could receive similar services from free-standing physician offices at lower
cost to the government and to taxpayers. Accordingly, CMS promulgated a rule in 2018
lowering the payment rate for clinic-visit services at off-campus provider-based departments to
match the rate for similar services at physician offices, in order to shift patients towards the
latter.
Plaintiffs are hospital organizations which have seen their payment rates cut.
They argue that the method by which CMS has cut their rates has no place in the statutory
scheme established by Congress, and further that Congress has already decided as a matter of
policy and practicality that off-campus provider-based departments should be paid at higher rates 1 than physician offices for similar services. In short, Plaintiffs argue that CMS’ 2018 rule is ultra
vires. CMS opposes. Both parties move for summary judgment.
The Court has given close attention to the parties’ arguments and the statutory
scheme, which, as relevant, is both simple and detailed. For the reasons below, the Court finds
that CMS exceeded its statutory authority when it cut the payment rate for clinic services at off-
campus provider-based clinics. The Court will grant Plaintiffs’ motion, deny CMS’ cross-
motion, vacate the rule, and remand.
I. BACKGROUND
The Medicare program, established by Title XVIII of the Social Security Act, 42
U.S.C. § 1395 et seq., provides federally funded medical insurance to the elderly and disabled.
Medicare Part A addresses insurance coverage for inpatient hospital care, home health care, and
hospice services. Id. § 1395c. Medicare Part B addresses supplemental coverage for other types
of care, including outpatient hospital care. Id. §§ 1395j, 1395k.
A. The Outpatient Prospective Payment System
Under Medicare Part B, CMS directly reimburses hospital outpatient departments
for providing outpatient department (OPD) services to Medicare beneficiaries, which payments
are made through the elaborate Outpatient Prospective Payment System (occasionally, OPPS).
See generally 42 U.S.C. § 1395l(t). Implemented as part of the Balanced Budget Act of 1997,
Pub. L. No. 105-33, 111 Stat. 251, the Outpatient Prospective Payment System does not
reimburse hospitals for their actual costs of providing OPD services. Rather, as with Medicare
generally and in an effort to control costs, the Outpatient Prospective Payment System pays for
OPD services at pre-determined rates. See Amgen, Inc. v. Smith, 357 F.3d 103, 106 (D.C. Cir.
2004). Those payment rates are determined as follows: OPD services which are clinically
comparable or which require similar resource usage are grouped together and assigned an
2 Ambulatory Payment Classification (occasionally, APC). 42 U.S.C. § 1395l(t)(2)(B). A formula
is used to calculate the relative payment weight of each Ambulatory Payment Classification
against other APCs, based on the average cost of providing OPD services in previous years. See
id. § 1395l(t)(2)(C). Each Ambulatory Payment Classification’s relative payment weight is then
multiplied by an Outpatient Prospective Payment System “conversion factor”—which is the
same for, and applies uniformly to, all APCs—to reach the fee schedule amount for each APC.
Id. § 1395l(t)(3)(D). Ultimately, the actual amount paid to the hospital is the calculated fee
schedule amount adjusted for regional wages, transitional pass-through payments, outlier costs,
“and other adjustments as determined to be necessary to ensure equitable payments, such as
adjustments for certain classes of hospitals,” id. § 1395l(t)(2)(D)-(E), less an applicable
deductible and modified by a “payment proportion.” See id. § 1395l(t)(4).
Every year, CMS must review the groups, relative payment weights, and wage
and other adjustments for each Ambulatory Payment Classification to account for changes in
medical practice or technology, new services, new cost data, and other relevant information and
factors. Id. § 1395l(t)(9)(A). This annual review is conducted with an important caveat: any
adjustment to the groups, relative payment weights, or adjustments must be budget neutral,
meaning that it cannot cause a change in CMS’ estimated expenditures for OPD services for the
year. See id. § 1395l(t)(9)(B); cf. id. § 1395l(t)(9)(D)-(E) (requiring initial wage, outlier, and
other adjustments also be budget neutral). Thus, decreases or increases in spending caused by
one adjustment must be offset with increases or decreases in spending by another.
CMS must also update annually the Outpatient Prospective Payment System
conversion factor, generally to account for the inflation rate for the cost of medical services, see
id. § 1395l(t)(3)(C)(iv), but sometimes for other reasons, as discussed below. Unlike
3 adjustments to Ambulatory Payment Classifications under paragraph (t)(9)(A), adjustments to
the conversion factor do not need to be budget neutral. See generally id. § 1395l(t)(3)(C)
(describing conversion factor inputs). However, because the same conversion factor applies
equally to all Ambulatory Payment Classifications, adjustments to the conversion factor cannot
be used to change the fee schedule for specific APCs. In other words, changes to the conversion
factor affect total spending and not spending on specific services.
The Outpatient Prospective Payment System controls overall costs by
incentivizing hospital outpatient departments to provide OPD services at or below the average
cost for such services. That said, while the Outpatient Prospective Payment System limits the
amount Medicare will pay for each service, it does not limit the volume or mix of services
provided to a patient. Concerned that fee schedule limits would not adequately limit increases in
overall expenditures, Congress included as part of the Outpatient Prospective Payment System
two provisions at issue here. Under paragraph (t)(2)(F), “the Secretary shall develop a method
for controlling unnecessary increases in the volume of covered OPD services.” Id.
§ 1395l(t)(2)(F). Further, under paragraph (t)(9)(C), “[i]f the Secretary determines under
methodologies described in paragraph (2)(F) that the volume of services paid for under this
subsection increased beyond amounts established through those methodologies, the Secretary
may appropriately adjust the update to the conversion factor otherwise applicable in a subsequent
year.” Id. § 1395l(t)(9)(C).
B. Off-Campus Provider-Based Departments, Physician Offices, and the Bipartisan Budget Act of 2015
Many medical services that were once only offered in an inpatient hospital setting
can now be provided by hospital outpatient departments whereby the patient does not spend the
night. Medicare traditionally welcomed these cheaper alternatives to inpatient care and, to meet
4 the growing demand for these services, some hospitals have established off-campus provider-
based departments (occasionally, PBDs), which are outpatient departments at facilities separated
by a specific distance (or more) from the physical campus of the hospital with which they are
affiliated. See 42 C.F.R. § 413.65(e). Although not physically proximate to their affiliated
hospital’s main campus, 1 off-campus provider-based departments are so closely integrated into
the same system that they are considered part of the hospital itself. This allows off-campus
provider-based departments to offer more comprehensive services to their patients but also
subjects off-campus provider-based departments to the same regulatory requirements as the main
hospital. See 42 C.F.R. § 413.65 (describing regulatory requirements for off-campus provider-
based departments). Because they are part of the same system and face the same regulatory
requirements and regulatory costs as hospitals, off-campus provider-based departments have
generally been paid at the same rates hospitals are paid for OPD services. 2
That said, some comparable outpatient medical services can also be provided by
free-standing physician offices, which are medical practices not integrated with, or part of, a
hospital. See 42 C.F.R. § 413.65(a)(2). While physician offices do not provide the same array of
services as off-campus provider-based departments, they also do not bear the same regulatory
requirements and costs as hospitals. Accordingly, CMS pays physician offices for outpatient
medical services according to the lower-paying Medicare Physician Fee Schedule instead of the
Outpatient Prospective Payment System. As relevant to this case, in 2017 the Outpatient
Prospective Payment System rate for the most voluminous OPD service provided by off-campus
1 For example, an off-campus provider-based department may be located away from the main hospital because of space constraints at the main campus, or because the hospital wants to have an affiliated facility in a different (oftentimes underserved) neighborhood. 2 Not all are paid the same amounts, for reasons described below.
5 provider-based departments, “evaluation and management of a patient” (E&M), 3 was $184.44
for new patients and $109.46 for established patients while the Physician Fee Schedule rate for
the comparable service at a physician office was $109.46 for a new patient and $73.93 for an
established patient. See 83 Fed. Reg. 37,046, 37,142 (July 31, 2018) (Proposed Rule).
Until 2015, all off-campus provider-based departments were paid according to the
Outpatient Prospective Payment System. At that time, the volume of OPD services had
increased by 47 percent over the decade ending in calendar year 2015 and, in the five years from
2011 to 2016, combined program spending and beneficiary cost-sharing (i.e., co-payments) rose
by 51 percent, from $39.8 billion to $60.0 billion. See Proposed Rule at 37,140. There are many
possible explanations for this increase. For one, the Medicare-eligible population grew
substantially during the same time period. See Medicare Board of Trustees, 2018 Annual Report
of the Board of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical
Insurance Trust Funds 181 (2018), available at https://go.cms.gov/2m5ZCok. For another,
advances in medical technology shifted services from inpatient settings to outpatient settings.
See Ken Abrams, Andreea Balan-Cohen & Priyanshi Durbha, Growth in Outpatient Care,
Deloitte (Aug. 15, 2018), available at https://bit.ly/2nOkG05.
However, the Medicare Payment Advisory Commission (MedPAC), an
independent congressional agency which advises Congress on issues related to Medicare, long
believed that another major reason for this increase was the financial incentive created by the
Outpatient Prospective Payment System compared to the Physician Fee Schedule. See MedPAC,
Report to the Congress: Medicare Payment Policy 69-70 (Mar. 2017). That is, because off-
3 Technically, E&M services fall under Healthcare Common Procedure Coding System (HCPCS) code G0463, billed under APC 5012 (Clinic Visits and Related Services).
6 campus provider-based departments are paid at higher rates than physician offices, MedPAC
advised that hospitals were buying existing physician offices and converting them into off-
campus provider-based departments, sometimes without a change of location or patients,
unnecessarily causing CMS to incur higher costs. See id. To combat this trend, MedPAC
repeatedly recommended that Congress authorize CMS to equalize payment rates under both the
Outpatient Prospective Payment System and Physician Fee Schedule for certain services,
including E&M services, at all off-campus provider-based departments. See id. at 70-71; see
also id. at 69 (“One-third of the growth in outpatient volume from 2014 to 2015 was due to an
increase in the number of evaluation and management (E&M) visits billed as outpatient
services.”). Hospitals responded by advising Congress that MedPAC’s recommendation ignored
the higher costs required to operate a hospital and would force some existing off-campus
provider-based departments, which relied on the rates set by the Outpatient Prospective Payment
System, to reduce their services or close completely. See, e.g., Letter from Atul Grover, Chief
Pub. Policy Officer, Ass’n of Am. Med. Colls., to The Hon. John Barrasso, et al. (Jan. 13, 2012),
available at http://bit.ly/2LVEXOT.
Congress ended the debate, at least momentarily, when it adopted Section 603 of
the Bipartisan Budget Act of 2015, Pub. L. No. 114-74, § 603, 129 Stat. 584, 597 (2015). That
2015 statute neither equalized payment rates for physicians offices and off-campus provider-
based departments, as MedPAC had recommended, nor left the Outpatient Prospective Payment
System untouched, as the hospitals requested. Instead, Congress chose a middle path: Off-
campus provider-based departments that were billing under the Outpatient Prospective Payment
System as of November 2, 2015 (now “excepted off-campus PBDs”) were permitted to continue
that practice. See 42 U.S.C. § 1395l(t)(21)(B)(ii). However, off-campus provider-based
7 departments which were not billing under the Outpatient Prospective Payment System as of
November 2, 2015, i.e., new off-campus provider-based departments (or “nonexcepted off-
campus PBDs”), would be paid according to a different rate system to be selected by CMS. See
id. § 1395l(t)(21)(C). In practice, CMS continues to pay nonexcepted off-campus PBDs under
the Outpatient Prospective Payment System but applies a “[Physician Fee Schedule] Relativity
Adjustor” which approximates the rate the operative Physician Fee Schedule would have paid.
See 81 Fed. Reg. 79,562, 79,726 (Nov. 14, 2016).
C. The Final Rule and Plaintiffs’ Challenge
Despite these changes, the volume of OPD services provided by excepted off-
campus provider-based departments grew. When Congress passed the Bipartisan Budget Act of
2015, expenditures by the Outpatient Prospective Payment System were approximately $56
billion and increasing at an annual rate of about 7.3 percent, with the volume and intensity of
outpatient services increasing by 3.5 percent. See Proposed Rule at 37,139. In 2018, CMS
estimated that, without intervention, expenditures in 2019 would rise to $75 billion (an increase
of 8.1 percent over 2018), with the volume and intensity increasing by 5.3 percent. See id. at
37,139.
CMS thus proposed to implement a “method for controlling unnecessary increases
in the volume of covered OPD services.” See generally id. at 37,138-143; cf. 42 U.S.C.
§ 1395l(t)(2)(F). Specifically, CMS determined that many of the E&M services provided by off-
campus provider-based departments were “unnecessary increases in the volume of outpatient
department services.” Such services were not deemed medically “unnecessary” but financially
“unnecessary” because “these services could likely be safely provided in a lower cost setting,”
8 i.e., at physician offices. 4 Proposed Rule at 37,142. More specifically, CMS determined that the
growth of E&M services provided by off-campus provider-based departments was due to the
higher payment rate available to excepted off-campus provider-based departments under the
Outpatient Prospective Payment System. Id. CMS proposed to solve its financial problem by
applying the corresponding Physician Fee Schedule rate for E&M services to excepted off-
campus PBDs, thereby equalizing the payment rate for E&M services provided by excepted off-
campus PBDs, nonexcepted off-campus PBDs, and physician offices alike. Id. at 37,142.
CMS also determined that it could not control the volume of financially
“unnecessary” OPD services in a budget-neutral fashion, since this would “simply shift the
movement of the volume within the OPPS system in the aggregate.” Id. at 37,143. Therefore,
CMS proposed to implement its new approach in a non-budget-neutral manner, asserting that the
budget neutrality requirements of paragraphs (t)(2)(D)-(E) and (t)(9)(B) do not apply to
“methods” developed under paragraph (t)(2)(F) and that its new approach constituted such a
method. Id. CMS estimated that this approach would save approximately $610 million in 2019
alone. Id.
CMS received almost 3,000 comments on the Proposed Rule, many of which
argued that CMS lacked statutory authority to implement the proposed method. Nonetheless, on
November 21, 2018, CMS issued a Final Rule implementing the proposed method effective
4 As a general matter, CMS uses expenditures over targeted levels to measure “unnecessary” increases in the volume of OPD services, albeit not without criticism. See, e.g., 63 Fed. Reg. 47,552, 47,586 (Sept. 8, 1998) (“[W]e are examining a number of mechanisms to control unnecessary increases, as reflected by expenditure levels, in the volume of covered outpatient department services.”); 65 Fed. Reg. 18,434, 18,503 (Apr. 7, 2000) (“Others argued that an expenditure target is not a reliable way to distinguish the growth of necessary versus unnecessary services.”); 66 Fed. Reg. 44,672, 44,707 (Aug. 24, 2001) (noting MedPAC’s recommendation that CMS “not use an expenditure target to update the conversion factor”).
9 January 1, 2019. See generally Medicare Program: Changes to Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs, 83 Fed. Reg. 58,818, 59,004-15 (Nov. 21, 2018) (Final Rule). The only substantive
change between the Proposed Rule and the Final Rule was that implementation of the full E&M
rate cut was staggered over two years, saving an estimated $300 million in 2019, with additional
savings subsequent. Id. at 59,004.
Plaintiffs are hospital organizations and related trade groups that have provided
services with payment rates affected by the Final Rule, have submitted claims for payment by
Medicare, and have appealed determinations on those claims to CMS. The Defendant is Alex M.
Azar, in his official capacity as the Secretary of the Department of Health and Human Services.
Plaintiffs argue that the Final Rule is contrary to both the Medicare statutory scheme and the
policy decision reached by Congress under Section 603 of the Bipartisan Budget Act of 2015 and
is therefore ultra vires. Both parties have moved for summary judgment; the matter is now ripe. 5
II. LEGAL STANDARD
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment shall
be granted “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); accord Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). “In a case involving review of a final agency
action under the Administrative Procedure Act, however, the standard set forth in Rule 56[] does
5 On August 26, 2019, the Court consolidated two cases challenging the same Final Rule: Am. Hosp. Ass’n v. Azar, No. 18-2841 (RMC), and Univ. of Kansas Hosp. Auth. v. Azar, No. 19-132 (RMC). See 8/26/2019 Minute Order. Although each set of plaintiffs asserts a different legal vehicle to bring their claim—non-statutory review and APA review, respectively—both challenge the same Final Rule on purely legal grounds with largely overlapping, and not inconsistent, legal arguments. Both legal theories are addressed herein.
10 not apply because of the limited role of a court in reviewing the administrative record.” Sierra
Club v. Mainella, 459 F. Supp. 2d 76, 89 (D.D.C. 2006) (internal citation omitted); see also
Charter Operators of Alaska v. Blank, 844 F. Supp. 2d 122, 126-27 (D.D.C. 2012). Under the
APA, the agency’s role is to resolve factual issues to reach a decision supported by the
administrative record, while “‘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.’” Sierra Club, 459 F. Supp. 2d at 90 (quoting Occidental Eng’g Co. v. INS, 753
F.2d 766, 769-70 (9th Cir. 1985)). “Summary judgment thus serves as the mechanism for
deciding, as a matter of law, whether the agency action is supported by the administrative record
and otherwise consistent with the APA standard of review.” Id. (citing Richards v. INS, 554
F.2d 1173, 1177 & n.28 (D.C. Cir. 1977)).
Plaintiffs’ argument that the Secretary acted ultra vires is premised on three basic
tenets of administrative law. First, “an agency’s power is no greater than that delegated to it by
Congress.” Lyng v. Payne, 476 U.S. 926, 937 (1986); see also Transohio Sav. Bank v. Dir.,
Office of Thrift Supervision, 967 F.2d 598, 621 (D.C. Cir. 1992). Second, agency actions beyond
delegated authority are ultra vires and should be invalidated. Transohio, 967 F.2d at 621. Third,
courts look to an agency’s enabling statute and subsequent legislation to determine whether the
agency has acted within the bounds of its authority. Univ. of D.C. Faculty Ass’n/NEA v. D.C.
Fin. Responsibility & Mgmt. Assistance Auth., 163 F.3d 616, 620-21 (D.C. Cir. 1998)
(explaining that ultra vires claims require courts to review the relevant statutory materials to
determine whether “Congress intended the [agency] to have the power that it exercised when it
[acted]”).
11 When reviewing an agency’s interpretation of its enabling statute and the laws it
administers, courts are guided by “the principles of Chevron, U.S.A., Inc. v. Natural Resources
Defense Council, Inc., 467 U.S. 837 (1984).” Mount Royal Joint Venture v. Kempthorne, 477
F.3d 745, 754 (D.C. Cir. 2007) (internal citations omitted). Chevron sets forth a two-step
inquiry. The initial question is whether “Congress has directly spoken to the precise question at
issue.” Chevron, 467 U.S. at 843. If so, then “that is the end of the matter” because both courts
and agencies “must give effect to the unambiguously expressed intent of Congress.” Id. at 842-
43. To decide whether Congress has addressed the precise question at issue, a reviewing court
applies “‘the traditional tools of statutory construction.’” Fin. Planning Ass’n v. SEC, 482 F.3d
481, 487 (D.C. Cir. 2007) (quoting Chevron, 467 U.S. at 843 n.9). It analyzes “the text,
structure, and the overall statutory scheme, as well as the problem Congress sought to solve.” Id.
(citing PDK Labs. Inc. v. DEA, 362 F.3d 786, 796 (D.C. Cir. 2004); Sierra Club v. EPA, 294
F.3d 155, 161 (D.C. Cir. 2002)). When the statute is clear, the text controls and no deference is
extended to an agency’s interpretation in conflict with the text. Chase Bank USA, N.A. v.
McCoy, 562 U.S. 195 (2011).
If the statute is ambiguous or silent on an issue, a court proceeds to the second
step of the Chevron analysis and determines whether the agency’s interpretation is based on a
permissible construction of the statute. Chevron, 467 U.S. at 843; Sherley v. Sebelius, 644 F.3d
388, 393-94 (D.C. Cir. 2011). Under Chevron Step Two, a court determines the level of
deference due to the agency’s interpretation of the law it administers. See Mount Royal Joint
Venture, 477 F.3d at 754. Where, as here, “an agency enunciates its interpretation through
notice-and-comment rule-making or formal adjudication, [courts] give the agency’s
interpretation Chevron deference.” Id. at 754 (citing United States v. Mead Corp., 533 U.S. 218,
12 230-31 (2001)). That is, an agency’s interpretation that is permissible and reasonable receives
controlling weight, 6 id., “even if the agency’s reading differs from what the court believes is the
best statutory interpretation,” see Nat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs.,
545 U.S. 967, 980 (2005). Such broad deference is particularly warranted when the regulations
at issue “concern[] a complex and highly technical regulatory program.” Thomas Jefferson Univ.
v. Shalala, 512 U.S. 504, 512 (1994) (internal quotation marks and citation omitted).
III. ANALYSIS
A. Reviewability
The government contends that this Court lacks jurisdiction to review the Final
Rule under the APA because Congress has precluded judicial review of the development of the
Outpatient Prospective Payment System, including its methods and adjustments, and because
Plaintiffs have failed to exhaust their administrative remedies under the Medicare statute.
1. Preclusion of Judicial Review
Agency action is subject to judicial review under the APA unless the statute
precludes review, or the agency action is committed to agency discretion by law. See COMSAT
Crop. v. FCC, 114 F.3d 223, 226 (D.C. Cir. 1997) (citing 5 U.S.C. § 701(a)). The statute
specifies one such limitation:
There shall be no administrative or judicial review under section 1395ff of this title, 1395oo of this title, or otherwise of—
(A) the development of the classification system under paragraph (2), including the establishment of groups and relative payment weights for covered OPD services, of wage adjustment factors, other adjustments, and methods described in paragraph (2)(F).
6 An interpretation is permissible and reasonable if it is not arbitrary, capricious, or manifestly contrary to the statute. Mount Royal Joint Venture, 477 F.3d at 754.
13 42 U.S.C. § 1395l(t)(12)(A) (emphasis added). The government argues here that the Final Rule
imposed a rate cut as a “method” developed under paragraph (t)(2)(F) and so court review is
barred. Cf. id. § 1395l(t)(2)(F) (“[T]he Secretary shall develop a method for controlling
unnecessary increases in the volume of covered OPD services.”).
Despite the bar against Medicare review in some contexts, “[t]here is a strong
presumption that Congress intends judicial review of administrative action, and it can only be
overcome by a clear and convincing evidence that Congress intended to preclude the suit.”
Amgen, 357 F.3d at 111 (internal citations and quotations omitted). “The presumption is
particularly strong that Congress intends judicial review of agency action taken in excess of
delegated authority.” Id. “Such review is favored . . . ‘if the wording of a preclusion clause is
less than absolute.’” Id. (quoting Dart v. United States, 848 F.2d 217, 221 (D.C. Cir. 1988)).
“Whether and to what extent a particular statute precludes judicial review is determined not only
from its express language, but also from the structure of the statutory scheme, its objectives, its
legislative history, and the nature of the administrative action involved.” Block v. Cmty.
Nutrition Inst., 467 U.S. 340, 346 (1984).
Applied to this case, paragraph (t)(12)(A) plainly shields a “method” to control
volume in outpatient departments from judicial review. To determine whether that shield
applies, though, the Court must ascertain, consistent with Plaintiffs’ ultra vires claims, whether
what CMS calls a “method” satisfies the statute. That is, CMS cannot shield any action from
judicial review merely by calling it a “method,” even if it is not that. Accordingly, “the
determination of whether the court has jurisdiction is intertwined with the question of whether
the agency has authority for the challenged action, and the court must address the merits to the
extent necessary to determine whether the challenged agency action falls within the scope of the
14 preclusion on judicial review.” Id. at 113; see also COMSAT, 114 F.3d at 227 (“The no-review
provision . . . merges consideration of the legality of the [agency’s] action with consideration of
this court’s jurisdiction in cases in which the challenge to the [agency’s] action raises the
question of the [agency’s] authority to enact a particular amendment.”). Because, as explained
below, the Court finds that CMS’ action here does not constitute a “method” within the meaning
of the statute, the Court also finds that paragraph (t)(12)(A) does not preclude judicial review of
Plaintiffs’ claims. 7
2. Exhaustion
As argued by the government, Section 405(g) of the Medicare statute requires a
plaintiff to obtain administrative review of its claims before filing suit in court. See 42 U.S.C.
§ 405(g); see also Am. Hosp. Ass’n v. Azar, 895 F.3d 822, 825 (D.C. Cir. 2018) (describing the
Medicare statute channeling provisions). Specifically, Section 405(g) has two requirements: (1)
“presentment” of the claim; and (2) exhaustion of administrative remedies. See Am. Hosp. Ass’n,
895 F.3d at 825-26. The government does not substantially argue that Plaintiffs have failed to
present their claim. But the government does argue that Plaintiffs have not fully availed
themselves of the administrative review process. Plaintiffs concede that they have not exhausted
their administrative remedies fully but argue that the requirement of exhaustion should be
waived because further administrative review would be futile.
7 Certain plaintiffs argue that they may bring a non-statutory ultra vires claim, even if review under the APA is precluded. See Reply in Supp. of Pls.’ Mot. for Summ. J. [Dkt. 25] at 11-14. True, “the case law in this circuit is clear that judicial review is available when an agency acts ultra vires.” Aid Ass’n for Luterans v. U.S. Postal Serv., 321 F.3d 1166, 1173 (D.C. Cir 2003). But non-statutory claims may also be precluded and the standard for determining whether non- statutory review is limited is the same as under the APA. See Dart, 848 F.2d at 221 (“If the wording of a preclusion clause is less than absolute, the presumption of judicial review . . . is favored when an agency is charged with acting beyond its authority.”). Thus, the analysis and outcome are the same.
15 “Futility may serve as a ground for excusing exhaustion, either on its own or in
conjunction with other factors.” Nat’l Ass’n for Home Care & Hospice, Inc. v. Burwell, 77 F.
Supp. 3d 103, 110 (D.D.C. 2015) (citing Tataranowicz v. Sullivan, 959 F.2d 268, 274 (D.C. Cir.
1992)). Futility applies where exhaustion would be “clearly useless,” such as where the agency
“has indicated that it does not have jurisdiction over the dispute, or because it has evidenced a
strong stand on the issue in question and an unwillingness to reconsider the issue.” Randolph-
Sheppard Vendors v. Weinberger, 795 F.2d 90, 106 (D.C. Cir. 1986). That said, the ordinary
standard for futility in administrative law cases is inapplicable in Medicare cases. See
Weinberger v. Salfi, 422 U.S. 749, 766 (1975) (stating that § 405(g) is “more than simply a
codification of the judicially developed doctrine of exhaustion, and may not be dispensed with
merely by a judicial conclusion of futility”). In the context of Medicare, courts also look to
whether “judicial resolution of the issue will interfere with the agency’s efficient functioning,
deny the agency the ability to self-correct, or deprive the Court of the benefits of the agency’s
expertise and an adequate factual record.” Nat’l Ass’n for Home Care & Hospice, 77 F. Supp.
3d at 111 (citing Tataranowicz, 959 F.2d at 275); see also Am. Hosp. Ass’n v. Azar, 348 F. Supp.
3d 72, 75 (D.D.C. 2018), appeal docketed, No. 19-5048 (D.C. Cir. Feb. 28 2019).
Consideration of these factors makes clear that requiring Plaintiffs to exhaust their
administrative remedies here would be a “wholly formalistic” exercise in futility. Tataranowicz,
959 F.2d at 274. The government does not argue that further administrative review is necessary
for the agency’s efficient functioning. Nor does the government argue that administrative review
will give the agency the opportunity to self-correct. To the contrary, CMS’ interpretation here is
“even more embedded” since it was promulgated through notice-and-comment rulemaking
whereby CMS has already considered and rejected Plaintiffs’ specific arguments. Nat’l Ass’n for
16 Home Care & Hospice, 77 F. Supp. 3d at 112; Final Rule at 59,011-13. Finally, additional
administrative review would do nothing to develop the factual record or provide the Court with
further benefits of agency expertise, since this case concerns a purely legal challenge to the scope
of the Secretary’s statutory authority. See Hall v. Sebelius, 689 F. Supp. 2d 10, 23-24 (D.D.C.
2009) (“[E]xhaustion may be excused where an agency has adopted a policy or pursued a
practice of general applicability that is contrary to the law.” (internal quotations omitted)).
Indeed, it does not appear that further expertise can be brought to bear since no administrative
review body has the authority to override CMS’ binding regulations. See 42 C.F.R.
§ 405.1063(a) (“All laws and regulations pertaining to the Medicare and Medicaid programs . . .
are binding on ALJs and attorney adjudicators, and the [Medicare Appeals] Council.”); see, e.g.,
Noridian Healthcare Solutions, G0463 Has No Appeal Rights (Mar. 22, 2019), available at
http://bit.ly/2K2Yw4W (“CMS has provided direction to the Medicare Administrative
Contractors (MACs) to dismiss requests appealing the reimbursement of HCPCS G0463. No
further appeal rights will be granted at subsequent levels due to the statutory guidance supporting
the pricing of this HCPCS code.”). In short, the government “gives no reason to believe that the
agency machinery might accede to plaintiffs’ claims,” even as it recites the formal steps involved
in administrative review. Tataranowicz, 959 F.2d at 274.
B. The Outpatient Prospective Payment System Statutory Scheme
Plaintiffs argue that if CMS wants to reduce the payment rate for a particular OPD
service, it must change the relative payment weights and adjustments through the annual review
process, see 42 U.S.C. § 1395l(t)(9)(A), in a budget neutral manner, see id. § 1395l(t)(9)(B).
Alternatively, if CMS wants to reduce Medicare costs by addressing “unnecessary increases in
the volume of services,” it must first develop a method to do so, id. § 1395l(t)(2)(F), which it
may then implement across-the-board by adjusting the conversion factor, see id. 17 § 1395l(t)(9)(C). This statutory scheme, Plaintiffs argue, is intended to prevent exactly what
happened here: a selective cut to Medicare funding which targets only certain services and
providers.
The government responds that CMS has authority to “develop a method for
controlling unnecessary increases” in volume under paragraph (t)(2)(F) and that this authority is
independent of its authority under paragraph (t)(9)(C) to adjust the conversion factor. It argues
that these two actions are different and independent cost-control tools in its regulatory belt.
Further, the government argues that CMS may develop a “method” to set payment rates for a
particular service which is causing an “unnecessary” increase in cost (and volume) without
regard to budget neutrality, because there is no logical reason Congress would want CMS to
penalize all outpatient departments—by reducing rates for all OPD services—for the spike in
volume (as measured by total expenditures) if only one such service caused the spike.
The government emphasizes that “method” is not explicitly defined in the statute
and argues that its approach satisfies generic definitions of the term. See, e.g., Method, Black’s
Law Dictionary (11th ed. 2019) (“A mode of organizing, operating, or performing something,
esp. to achieve a goal.”). But “reasonable statutory interpretation must account for both ‘the
specific context in which . . . language is used’ and ‘the broader context of the statute as a
whole.’” Util. Air Regulatory Grp., 573 U.S. at 321 (quoting Robinson v. Shell Oil Co., 519 U.S.
337, 341 (1997)). “A statutory ‘provision that may seem ambiguous in isolation is often clarified
by the remainder of the statutory scheme . . . because only one of the permissible meanings
produces a substantive effect that is compatible with the rest of the law.’” Id. (quoting United
Sav. Ass’n of Tex. v. Timbers of Inwood Forest Assocs., Ltd., 484 U.S. 365, 371 (1988)); see also
King v. Burwell, 135 S. Ct. 2480, 2483 (2015) (“[O]ftentimes the meaning—or ambiguity—of
18 certain words or phrases may only become evident when placed in context.”). As such, the
Court must “read the words ‘in their context and with a view to their place in the overall
statutory scheme.’” King, 135 S. Ct. at 2483 (quoting FDA v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 133 (2000)); see also Util. Air Regulatory Grp., 573 U.S. at 320. That
context does not make clear what a “method” is, but it does make clear what a “method” is not:
it is not a price-setting tool, and the government’s effort to wield it in such a manner is
manifestly inconsistent with the statutory scheme. There are two reasons.
First, Congress established an elaborate statutory scheme which spelled out each
step for determining the amount of payment for OPD services under the Outpatient Prospective
Payment System. As detailed in 42 U.S.C. § 1395l(t)(4), titled “Medicare payment amount,” the
amount paid “is determined” by: the fee schedule amount “computed under paragraph (3)(D)”
for the OPD service’s Ambulatory Payment Classification, adjusted for wages and other factors
“as computed under paragraphs (2)(D) and (2)(E),” see 42 U.S.C. § 1395l(t)(4)(A); less
applicable deductibles under § 1395l(b), see id. § 1395l(t)(4)(B); and modified by a “payment
proportion,” see id. § 1395l(t)(4)(C). The applicable deductible and “payment proportion” are
fixed by statute and are not relevant to this case, but the Ambulatory Payment Classification fee
schedule amount is. That amount is the product of the conversion factor “computed under
subparagraph [(3)(C)]” and the relative payment weight for the Ambulatory Payment
Classification “determined under paragraph (2)(C).” See id. § 1395l(t)(3)(D). The base
ingredients of an Outpatient Prospective Payment System payment over which CMS has
discretion are, therefore, the Ambulatory Payment Classification groups and relative payment
weights; the conversion factor; and the wage adjustment and other adjustments.
19 The Court recounts these cross-referencing provisions—even the irrelevant
ones—to make one thing clear: nowhere is a “method” developed under paragraph (t)(2)(F)
referenced. CMS cannot shoehorn a “method” into the multi-faceted congressional payment
scheme when Congress’s clear directions lack any such reference. See Util. Air Regulatory Grp.,
573 U.S. at 328. (“We reaffirm the core administrative-law principle that an agency may not
rewrite clear statutory terms to suit its own sense of how the statute should operate.”). As such,
if CMS wishes to reduce Outpatient Prospective Payment System payments for E&M services, it
must make budget-neutral adjustments to either that service’s relative payment weight or to other
adjustments under paragraph (t)(9)(A). Alternatively, CMS may update the conversion factor to
apply across-the-board cuts under paragraph (t)(9)(C). But nothing in the adjustment or payment
scheme permits service-specific, non-budget-neutral cuts.
CMS apparently understood this limitation when it considered other “methods” in
the past. For example, when the Outpatient Prospective Payment System was first being
developed in 1998, CMS evaluated three possible methods of volume control, all based on the
Sustainable Growth Rate formula which was enacted by Congress to control the growth of
“physician services” under, ironically, the Physician Fee Schedule, which is itself also a
prospective payment system. See 63 Fed. Reg. at 47,586. Much like payment rates for OPD
services under the Outpatient Prospective Payment System, payment rates for physician services
are prospectively set through a combination of relative resource use, regional adjustments, and
an across-the-board Physician Fee Schedule conversion factor. The Sustainable Growth Rate
formula set overall target expenditure levels for physician services based on changes in
enrollment, changes in physician fees, changes in the legal and regulatory landscape, and total
economic growth, and then manipulated the Physician Fee Schedule conversion factor to achieve
20 that targeted level. Two of CMS’ proposals in 1998 would have modified the Sustainable
Growth Rate formula to also account for a measure of OPD service efficiency as well, while the
third proposal would have developed a similar, independent formula for the Outpatient
Prospective Payment System. All three proposals would have operated through updates to the
relevant conversion factors under paragraph (t)(9)(C). 8 Id. at 47,586-87. None of these
methods, based upon a conversion factor calculated using a Sustainable Growth Rate formula,
was implemented. See Final Rule at 59,005.
Instead, CMS considered and implemented a different method of volume control
known as “packaging,” whereby “ancillary services associated with a significant procedure” are
“packaged into a single payment for the procedure.” 72 Fed. Reg. 66,580, 66,610 (Nov. 27,
2007); see also Final Rule at 58,854 (“Because packaging encourages efficiency and is an
essential component of a prospective payment system, packaging . . . has been a fundamental
part of OPPS since its implementation in August 2000.”). Packaging incentivizes providers “to
furnish services in the most efficient way by enabling hospitals to manage their resources with
maximum flexibility, thereby encouraging long-term cost containment.” 72 Fed. Reg. at 66,611;
see also 63 Fed. Reg. at 47,586 (“We believe that greater packaging of these services might
provide volume control.”); 79 Fed. Reg. 66,770, 66,798-99 (Nov. 10, 2014) (introducing
conceptually similar “comprehensive APCs”). Unlike the proposed methods based on a
Sustainable Growth Rate formula that were considered in 1998, packaging does not control
8 Plaintiffs argue that here CMS acknowledged “possible legislative modification” would be necessary to implement any method other than adjustment to the conversion factor. See Mem. of P. & A. in Supp. of Pls.’ Mot. for Summ. J. [Dkt. 14-1] at 15; see also 63 Fed. Reg. at 47,586. As noted in the text, all three “methods” proposed in 1998 would have adjusted the conversion factor. Possible legislative modification was discussed because, for two of the proposed methods, CMS did not itself have the authority to modify the Sustainable Growth Rate, which Congress implemented by statute. See 42 U.S.C. 1395w-4(f) (1999)).
21 volume by changing the conversion factor and thereby obviates the need to rely on paragraph
(t)(9)(C), and packaging is implemented in a budget neutral manner. See, e.g., 72 Fed. Reg. at
66,615 (“Because the OPPS is a budget neutral payment system[,] . . . the effects of the
packaging changes we proposed resulted in changes to scaled weights and . . . to the proposed
payments rates for all separately paid procedures.”); cf. 42 U.S.C. § 1395l(t)(9)(A)-(B).
This history makes it clear that CMS can adopt volume-control methods under
paragraph (t)(2)(F) which affect payment rates indirectly, even if those methods cannot affect
them directly. Moreover, it demonstrates that the Court’s interpretation does not render
paragraph (t)(2)(F) mere surplusage, since some methods do not depend on manipulation of the
conversion factor.
Second, Congress provided great detail in directing how CMS should develop and
adjust relative payment weights. For example, Congress required that the initial relative
payment weights for OPD services be rooted in verifiable data and cost reports. Id.
§ 1395l(t)(2)(C). Congress also required CMS to develop a wage adjustment attributable to
geographic labor and labor-related costs, id. § 1395l(t)(2)(D); an outlier adjustment to reimburse
hospitals for particularly expensive patients, id. § 1395l(t)(2)(E) and (t)(5) (detailing further the
outlier adjustment); a transitional pass-through payment scheme for innovative medical devices,
drugs, and biologicals, id. § 1395l(t)(2)(E) and (t)(6) (detailing further the pass-through
adjustment); and catch-all “other adjustments as determined to be necessary to ensure equitable
payments,” id. § 1395l(t)(2)(E). This extraordinarily detailed scheme results in a relative
payment system which ensures that payments for one service are rationally connected to the
payments for another and satisfies specific policies considered by Congress. And so that this
system retains its integrity, CMS is required to review annually the relative payment weights of
22 OPD services and their adjustments based on changes in cost data, medical practices and
technology, and other relevant information. See id. § 1395l(t)(9)(A). Further, CMS is required
to consult with “an expert outside advisory panel” to ensure the “clinical integrity of the groups
and weights.” Id.
Congress also required that adjustments to the Outpatient Prospective Payment
System be made in a budget-neutral fashion (with specified exceptions). Congress itself set the
first conversion factor so that the estimated expenditures for the first year of payments under the
Outpatient Prospective Payment System would match estimated expenditures for the same year
under the previous system. Id. § 1395l(t)(3)(C)(i). Congress further specified that the wage
adjustment, outlier adjustment, pass-through adjustment, and the “other adjustments” all be
budget neutral. Id. § 1395l(t)(2)(D)-(E). And Congress directed CMS to make any changes to
the groups, their relative payment weights, or the adjustments resulting from its mandatory
annual review in a budget-neutral fashion. Id. § 1395l(t)(9)(B).
Notwithstanding this granularity in the statute, CMS posits that in a single
sentence Congress granted it parallel authority to set payment rates in its discretion that are
neither relative nor budget neutral. Cf. id. § 1395l(t)(2)(F). But “Congress . . . does not alter the
fundamental details of a regulatory scheme in vague terms or ancillary provisions—it does not,
one might say, hide elephants in mouseholes.” Whitman v. Am. Trucking Ass’ns, 531 U.S. 457,
468 (2001); cf. Air Alliance Houston v. EPA, 906 F.3d 1049, 1061 (D.C. Cir. 2018) (“[I]t is well
established that an agency may not circumvent specific statutory limits on its actions by relying
on separate, general rulemaking authority.”). If CMS reads the statute correctly, its new-found
authority would supersede Congress’ carefully crafted relative payment system by severing the
connection between a service’s payment rate and its relative resource use. In the context of the
23 similarly-designed Physician Fee Schedule system, Congress expressly denounced this
disconnect. See H.R. Rep. No. 105-149, at 1347-48 (1997) (“As a result, relative value units
have become seriously distorted. This distortion violates the basic principle underlying the
resource-based relative value scale (RBRVS), namely that each services [sic] should be paid the
same amount regardless of the patient or service to which it is attached.”). Further, the structure
of the Outpatient Prospective Payment System makes clear that Congress intended to preserve
“the clinical integrity of the groups and weights.” 42 U.S.C. § 1395l(t)(9)(A). There is no
reason to think that Congress with one hand granted CMS the authority to upend such a “basic
principle” of the Outpatient Prospective Payment System while working with the other to
preserve it. 9
The government also argues that Congress knew how to require budget neutrality
when it wanted to, and that its silence in the context of paragraph (t)(2)(F) is telling. Not only
does this argument fail to address damage to the integrity of the relative payment system, but in
the context of the Outpatient Prospective Payment System, the reverse is also true: for decisions
within CMS’ discretion that might affect overall expenditures, Congress made clear when budget
neutrality was not required. See id. § 1395l(t)(7)(I) (exempting transitional payments from
budget neutrality); id. § 1395l(t)(16)(D)(iii) (exempting special payments from budget
neutrality); id. § 1395l(t)(20) (exempting the effects of certain incentives from budget
neutrality); cf. id. § 1395l(t)(3)(C) (permitting negative conversion factors); id. § 1395l(t)(14)(H)
(exempting specific expenditure increases from consideration under paragraph (t)(9)). As CMS
9 CMS’ interpretation would also swallow paragraph (t)(9)(C) in its entirety: why would the agency go through the annual hassle of updating the conversion factor if it could use paragraph (t)(2)(F) to decrease or increase payment rates for disfavored or favored services whenever desired?
24 has said, “the OPPS is a budget neutral payment system.” 72 Fed. Reg. at 66,615. Given how
pervasively the statute requires budget neutrality in the Outpatient Prospective Payment System,
Congress clearly considered effects on total expenditures critical to that system. Yet Congress
did not mention the budgetary impact of paragraph (t)(2)(F) at all. The Court concludes that no
such reference was made because Congress did not intend CMS to use an untethered “method”
to directly alter expenditures independent of other processes. To the contrary, Congress directed
that any “methods” developed under paragraph (t)(2)(F) be implemented through other
provisions of the statute. 10
Finally, the government argues that there is no reason Congress would have
wanted CMS to penalize all outpatient departments in order to control unnecessary increases in
the volume of a single type of service. Of course, that is exactly what Congress did when it
applied the Sustainable Growth Rate formula to the Physician Fee Schedule under the Balanced
Budget Act of 1997—the same Act which created the Outpatient Prospective Payment System—
to disastrous results. See Jim Hahn & Janemarie Mulvey, Congressional Research Service,
Medicare Physician Payment Updates and the Sustainable Growth Rate (SGR) System 8 (2012)
(“There is a growing consensus among observers that the SGR system is fundamentally flawed
and is creating instability in the Medicare program for providers and beneficiaries.”); id. (“One
commonly asserted criticism is that the SGR system treats all services and physicians equally . . .
to the detriment of physicians who are ‘unduly’ penalized.”). Congress recognized its error and
10 Paragraph (t)(9)(C) explicitly provides that methods developed under paragraph (t)(2)(F) may result in adjustments to the conversion factor because subsection (t)(3), governing the conversion factor, does not already provide CMS such authority. Cf. 42 U.S.C. § 1395l(t)(9)(A) (requiring CMS to review and adjust groups and relative payments weights and adjustments for OPD services). Put another way, the provision is permissive, not mandatory, because CMS may choose to implement its methods through other means.
25 repealed the Sustainable Growth Rate formula, see Medicare Access and CHIP Reauthorization
Act of 2015, Pub. L. No. 114-10, 129 Stat. 87, and it has demonstrated that it retains for itself the
authority to make these and similarly selective funding decisions in this highly complicated
intersection of patient needs, medical care, and government funding through the relative payment
weight system. See, e.g., Bipartisan Budget Act § 603 (establishing different payment schemes
for excepted and non-excepted PBDs). Here, Congress has developed a multi-factored,
complicated annual process whereby CMS is to pre-set relative payments for OPD services.
This annual process would be totally ignored and circumvented if CMS could unilaterally set
OPD service-specific rates without regard to their relative position or budget neutrality.
For these reasons, the Court finds that the “method” developed by CMS to cut
costs is impermissible and violates its obligations under the statute. While the intention of CMS
is clear, it would acquire unilateral authority to pick and choose what to pay for OPD services,
which clearly was not Congress’ intention. The Court find that the Final Rule is ultra vires. 11
C. Remedies
A brief note on remedies. Plaintiffs not only ask for vacatur of the Final Rule, but
also for a court order requiring CMS to issue payments improperly withheld due to the Final
Rule. Plaintiffs’ request will be denied. “‘Under settled principles of administrative law, when a
court reviewing agency action determines that an agency made an error of law, the court’s
inquiry is at an end: the case must be remanded to the agency for further action consistent with
the correct legal standards.’” Palisades Gen. Hosp. Inc. v. Leavitt, 426 F.3d 400 (D.C. Cir.
2005) (quoting Cnty. of L.A. v. Shalala, 192 F.3d 1005, 1011 (D.C. Cir. 1999)). That said,
11 Because the Court concludes that service-specific unilateral price setting by CMS is not a “method” within the meaning of the statute, the Court does not reach Plaintiffs’ other arguments.
26 Outpatient Prospective Payment System reimbursements are complex and a third set of plaintiffs
in another case challenging the same rule has raised the spectre of complications resulting from
an order to vacate. See Opposition to Defendant’s Motion to Stay Proceedings, Sisters of
Charity Hospital of Buffalo, New York v. Azar, No. 19-1446 (RMC) (July 25, 2019) Dkt. 13.
Other courts in this district have wrestled with the ripple effects of vacatur caused by Medicare
budget neutrality provisions and interest payments. See Am. Hosp. Ass’n, 348 F. Supp. 3d at 85-
86 (requiring further briefing on remedies related to OPPS adjustments); Shands Jacksonville
Med. Ctr., Inc. v. Azar, 2019 WL 1228061, at *2 (D.D.C. Mar. 15, 2019) (addressing plaintiff-
specific interest payments on improper reimbursement determinations); see also Amgen, 357
F.3d at 112 (“Other circuits have noted the havoc piecemeal review of OPPS payments could
bring about.”). The Final Rule is less than one year old and did not apply budget neutrality
principles. These factors should lessen the burden on reconsideration. Nonetheless, the Court
will require a joint status report to determine if additional briefing is appropriate.
IV. CONCLUSION
CMS believes it is paying millions of taxpayer dollars for patient services in
hospital outpatient departments that could be provided at less expense in physician offices. CMS
may be correct. But CMS was not authorized to ignore the statutory process for setting payment
rates in the Outpatient Prospective Payment System and to lower payments only for certain
services performed by certain providers. Plaintiffs’ Motion for Summary Judgment, Dkt. 14,
will be granted. The government’s Cross-Motion for Summary Judgment, Dkt. 20, will be
denied. The Court will vacate the applicable portions of the Final Rule and remand the matter
for further proceedings consistent with this Memorandum Opinion. The parties will be required
to submit a joint status report by October 1, 2019, to determine if additional briefing on remedies
27 is required, along with the CMS estimate as to the duration of further proceedings. A
memorializing Order accompanies this Memorandum Opinion.
Date: September 17, 2019 ROSEMARY M. COLLYER United States District Judge