UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ____________________________________ ) AMERICAN CLINICAL ) LABORATORY ASSOCIATION, ) ) Plaintiff, ) ) v. ) Civil Action No. 17-2645 (ABJ) ) XAVIER BECERRA, ) Secretary, United States ) Department of Health and ) Human Services, ) ) Defendant. ) ____________________________________)

MEMORANDUM OPINION

In this case, plaintiff American Clinical Laboratory Association challenged a regulation

issued by the Secretary of the U.S. Department of Health and Human Services 1 governing the

reporting of the pricing information used to set Medicare reimbursement rates for clinical

diagnostic laboratory services. Plaintiff is a trade association that represents clinical and anatomic

pathology laboratories, Compl. [Dkt. # 1] ¶ 18, and the challenged regulation implements

section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which established a new

scheme for setting Medicare reimbursement rates for these laboratory tests.

The parties have filed cross-motions for summary judgement and for the reasons set forth

below, the Court will dismiss this case as moot.

1 The newly appointed Secretary, Xavier Becerra, has been substituted as defendant pursuant to Federal Rule of Civil Procedure 25(d). BACKGROUND

Clinical diagnostic laboratory tests are tests performed on specimens of bodily fluids or

tissue that are used to monitor, diagnose, and treat patients, and they range from routine blood

tests to sophisticated genetic and molecular tests. Compl. ¶ 1. The federal Medicare program,

which is administered by the Department of Health and Human Services (“HHS” or “the

Department”) and pays for healthcare for elderly and disabled individuals, is the nation’s largest

purchaser of clinical laboratory services. See

et seq.; Am. Clinical Lab’y Ass’n.

v. Azar,

(2019).

How Medicare reimburses laboratories for clinical diagnostic laboratory tests depends on

the setting in which they are provided. These services may be provided in hospitals on an inpatient

or outpatient basis, in nursing facilities, or at a doctor’s office. Compl. ¶ 22. If a Medicare

beneficiary receives these laboratory tests at a hospital, Medicare pays for all of the services the

hospital provides to the beneficiary – medications, room and board, laboratory, and all other

services – in one bundled payment pursuant to either the Inpatient Prospective Payment System

(“IPPS”) or the Outpatient Prospective Payment System (“OPPS”). See 42 U.S.C. §§ 1395ww(d),

1395l(t); Appalachian Reg’l Healthcare, Inc. v. Shalala,

(D.C. Cir.

1997) (explaining that the IPPS provides a single payment “in full satisfaction of the bundle of

covered items and services provided during a single inpatient hospital stay” based on the diagnosis

related group (“DRG”) of the patient’s stay, rather than on the separate services a patient received

from the hospital). In contrast, if a beneficiary receives laboratory tests outside of a hospital

setting, such as at a doctor’s office or from an independent laboratory, Medicare pays the

laboratory for each test performed based on the Clinical Laboratory Fee Schedule (“CLFS”) or the

2 Physician Fee Schedule (“PFS”). 2 See

, 41,038 (June 23, 2016); J.A.

[Dkt. # 38].3

Some hospital laboratories provide services not only to hospital patients, but also

externally, to individuals who are not patients of the hospital. For example, the blood sample taken

at a doctor’s office may be sent to a hospital laboratory for analysis. Such hospital laboratory

services provided to non-hospital patients are referred to as “outreach services,” and Medicare

pays for them as it would for an independent laboratory: on a fee-for-service basis based on the

CLFS or the PFS.

citing

, 1833(a), (b), (h), 1861.

I. Protecting Access to Medicare Act of 2014

In 2014, Congress passed the Protecting Access to Medicare Act of 2014,

Stat. 1040, to overhaul Medicare payments for laboratory services. Before

PAMA, Medicare’s fee schedule for clinical laboratory services was set by the Secretary based on

a “regional, statewide, or carrier service area basis,” with adjustments for differences in wages.

42 U.S.C. § 1395l(h)(1)(B)–(C), (h)(4)(A). In 2013, the Department’s Office of Inspector General

found that Medicare was paying eighteen to thirty percent more for laboratory tests than private

insurers were paying. Am. Clinical Lab’y Ass’n,

. Congress passed PAMA in an

effort to make Medicare’s reimbursement rates comparable to those paid by private insurers for

the same laboratory tests. Id.; see also 160 Cong. Rec. S2860 (May 8, 2014) (stating Congress

sought to “ensure that Medicare rates reflect true market rates for laboratory services”).

2 Generally speaking, tests that require both a professional and technical component to provide the test results are paid under the PFS, and those that require no interpretation by a physician or professional are paid under the CLFS. See

(b)(2).

3 Citations to the Joint Appendix refer to the Bates numbers appearing at the bottom right of each page of the appendix.

3 PAMA established a market-based approach for setting payment rates based on the

amounts private payors pay for these tests. See 42 U.S.C. § 1395m-1. Section 216 of PAMA

requires “applicable laborator[ies]” to report to the Department every three years the amounts and

volume of payments they receive from private insurers, 42 U.S.C. § 1395m-1(a), 4 exempting

certain “low volume or low expenditure” laboratories from the requirement. Id. § 1395m-1(a)(2).

It requires the Secretary to compile the reported data to calculate Medicare’s reimbursement rates

for laboratory tests. Id. § 1395m-1(b) (requiring the Secretary to calculate a weighted median for

each laboratory test “by arraying the distribution of all payment rates reported for the period for

each test weighted by volume for each payor and each laboratory”).

PAMA defines “applicable laboratory” to mean “a laboratory that, with respect to its

revenues under this subchapter, a majority of such revenues are from this section, section 1395l(h)

of this title, or section 1395w–4 of this title.” Id. § 1395m-1(a)(2). In other words, a laboratory

must receive the majority of its Medicare revenues from the CLFS or the PFS – the payment

mechanisms covering non-hospital settings – rather than the inpatient or outpatient payment

mechanisms, to be obligated to report its private payor data to the Secretary. Id.

II. Rulemaking and Litigation History

As required by the statute, the Secretary promulgated a rule in June of 2016 to implement

PAMA’s provisions, including its data collection requirements. See 42 U.S.C. § 1395m-1(a)(12);

(June 23, 2016); J.A. at 0001, 0004–17 (“2016 Rule”). The 2016 Rule

included its own definition for “applicable laboratory”: a laboratory that “bills Medicare Part B

under its own NPI.” 81 Fed. Reg. at 41,047. The NPI, or National Provider Number, is a unique

4 In the case of advanced diagnostic laboratory tests, laboratories must report this information annually. 42 U.S.C. § 1395m-1(a).

4 billing number assigned by the Department to health care providers to use when submitting claims

for Medicare reimbursement. 81 Fed. Reg. at 41,042, citing

(2004);

, 59,392 (Oct. 1, 2015); J.A. at 00075.

Plaintiff filed this lawsuit on December 11, 2017, challenging the Secretary’s regulatory

definition of “applicable laboratory.” Compl. [Dkt. #1] ¶¶ 3–4. According to plaintiff, defining

the term to mean only laboratories that bill Medicare under their own NPIs excluded significant

numbers of hospital laboratories that provide outreach services from the Secretary’s data

collection; this is because most hospital laboratories bill under their hospitals’ NPIs, rather than

their own. See

(alleging the Secretary improperly “treated the entire hospital as a

laboratory for purposes of evaluating whether the statutory revenue requirements are satisfied” and

“effectively carved out hospital laboratories from the statutory requirements,” ensuring the

reporting obligations would be imposed primarily on only independent and physician-office

laboratories). At the end of the day, less than one percent “of the total number of laboratories that

currently serve Medicare beneficiaries” reported data to the Secretary in 2016.

.

The Court did not reach the merits of plaintiff’s claim that this narrowing of the definition

was arbitrary and capricious. A motion to dismiss was filed, and in light of a provision Congress

included in PAMA, the Court concluded that judicial review was precluded, and it dismissed the

case for lack of subject matter jurisdiction. Order (Sept. 21, 2018) [Dkt. # 46]; Mem. Op.

[Dkt. # 47]. Plaintiff appealed the ruling. Notice of Appeal [Dkt. # 48].

Two months later, on November 23, 2018, the Secretary promulgated another rule that

amended the definition of “applicable laboratory” to address the problem plaintiff had identified.

(Nov. 23, 2018) (“2018 Rule”). The 2018 Rule revised the definition to add

“hospital outreach laboratories” that “bill[ ] Medicare Part B on the CMS 1450 under bill type

14x,” a claim form used by hospitals for non-patient laboratory services.

; see also 5 Am. Clinical Lab. Ass’n,

(explaining that “the CMS-1450 14x TOB” is “a billing

form used only by hospital outreach laboratories”).

On July 30, 2019, the D.C. Circuit overturned the dismissal of the case, remanding the

matter to the Court “to address in the first instance the merits of petitioner’s arbitrary-and-

capricious challenge.” Am. Clinical Lab’y Ass’n,

.

After remand, plaintiff filed a motion for summary judgement on October 14, 2019. Pl.’s

Mot. for Summ. J. [Dkt. # 53] (“Pl.’s Mot.”). Defendant filed a cross-motion for summary

judgment and opposition on November 22, 2019. Def.’s Cross-Mot. and Opp. to Pl.’s Mot. for

Summ. J. [Dkt. # 54]; Def.’s Mem. in Supp. [Dkt. # 54-1] (“Def.’s Mem.”). Plaintiff filed its

cross-opposition and reply brief on December 13, 2019, Pl.’s Reply in Supp. of Pl.’s Mot. and

Opp. to Def.’s Cross-Mot. [Dkt. # 56] (“Pl.’s Opp. & Reply”), and defendant filed his reply brief

on January 24, 2020. Def.’s Reply in Supp. of Cross-Mot. for Summ. J. [Dkt. # 59].

STANDARD OF REVIEW

I. Subject Matter Jurisdiction

Federal courts are courts of limited jurisdiction and the law presumes that “a cause lies

outside this limited jurisdiction.” Kokkonen v. Guardian Life Ins. Co. of Am.,

(1994); see also Gen. Motors Corp. v. EPA,

(D.C. Cir. 2004) (“As a court of

limited jurisdiction, we begin, and end, with an examination of our jurisdiction.”). “[B]ecause

subject-matter jurisdiction is ‘an Art[icle] III as well as a statutory requirement . . . no action of

the parties can confer subject-matter jurisdiction upon a federal court.’” Akinseye v. District of

Columbia,

(D.C. Cir. 2003), quoting Ins. Corp. of Ir., Ltd. v. Compagnie des

Bauxites de Guinee,

(1982). “Federal courts cannot address the merits of a case

until jurisdiction – the power to decide – is established.” Hancock v. Urban Outfitters, Inc.,

(D.C. Cir. 2016).

6 II. Summary Judgment

Summary judgment is appropriate “if the movant shows that there is no genuine dispute as

to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.

56(a). The party seeking summary judgment “bears the initial responsibility of informing the

district court of the basis for its motion, and identifying those portions of the pleadings,

depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,

which it believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v.

Catrett,

(1986) (internal quotation marks omitted). To defeat summary

judgment, the non-moving party must “designate specific facts showing that there is a genuine

issue for trial.”

(internal quotation marks omitted).

The mere existence of a factual dispute is insufficient to preclude summary judgment.

Anderson v. Liberty Lobby, Inc.,

, 247–48 (1986). A dispute is “genuine” only if a

reasonable fact-finder could find for the non-moving party; a fact is “material” only if it is capable

of affecting the outcome of the litigation.

; see also Laningham v. U.S. Navy,

(D.C. Cir. 1987). In assessing a party’s motion, the court must “view the facts and

draw reasonable inferences ‘in the light most favorable to the party opposing the summary

judgment motion.’” Scott v. Harris,

(2007) (alterations omitted), quoting United

States v. Diebold, Inc.,

(1962) (per curiam).

“The rule governing cross-motions for summary judgment . . . is that neither party waives

the right to a full trial on the merits by filing its own motion; each side concedes that no material

facts are at issue only for the purposes of its own motion.” Sherwood v. Wash. Post,

, 1147 n.4 (D.C. Cir. 1989) (alteration in original), quoting McKenzie v. Sawyer,

,

68 n.3 (D.C. Cir. 1982). In assessing each party’s motion, “[a]ll underlying facts and inferences

7 are analyzed in the light most favorable to the non-moving party.” N.S. ex rel. Stein v. District of

Columbia,

(D.D.C. 2010), citing Anderson,

.

ANALYSIS

Plaintiff challenged the definition of “applicable laboratory” in the 2016 Rule, asserting

that it was detrimental to plaintiff’s members because it excluded many hospital laboratories from

reporting their pricing data to the Department, and that therefore, its promulgation violated the

Administrative Procedure Act (“APA”) and PAMA. See Compl.; Pl.’s Mot. In addition to

defending the 2016 Rule on the merits, defendant raises several jurisdictional and procedural

challenges to the complaint, arguing that plaintiff lacks standing, that plaintiff failed to present its

claims and exhaust its remedies with the agency, and that the matter is moot because of the 2018

Rule. See Def.’s Mem. Because the absence of a live controversy divests this Court of jurisdiction

to decide the lawsuit even if plaintiff’s APA claim has force, the Court must stop here.

A case becomes moot “when the issues presented are no longer live or the parties lack a

legally cognizable interest in the outcome.” Larsen v. U.S. Navy,

, 3–4 (D.C. Cir. 2008),

quoting County of Los Angeles v. Davis,

(1979); see also Honig v. Doe,

(1988) (explaining that Article III, Section 2 of the Constitution permits federal

courts to adjudicate only “actual, ongoing controversies”). If events outrun the controversy such

that the Court can grant no meaningful relief, the case must be dismissed as moot. See,

e.g., Church of Scientology of Cal. v. United States,

(1992); McBryde v. Comm. to

Review,

(D.C. Cir. 2001). “Even where litigation poses a live controversy when

filed, the [mootness] doctrine requires a federal court to refrain from deciding it if ‘events have so

transpired that [a judicial] decision will neither presently affect the parties’ rights nor have a more-

than-speculative chance of affecting them in the future.’” Clarke v. United States,

(D.C. Cir. 1990), quoting Transwestern Pipeline Co. v. FERC,

, 575 (D.C. Cir.

8 1990); see also Spencer v. Kemna,

(1998) (noting that a case is moot when “there

is nothing for [the court] to remedy, even if [it] were disposed to do so”).

“A plaintiff always bears the ultimate burden of showing . . . that a court has jurisdiction

over his claims.” Han Jeong Seon v. Lynch,

(D.D.C. 2016), citing Delta

Air Lines v. Exp.-Imp. Bank of United States,

(D.D.C. 2015); see also

Muhammad v. FDIC,

(D.D.C. 2010) (“Plaintiff [must establish] by a

preponderance of the evidence that the Court possesses jurisdiction.”). But where mootness is at

issue, “[t]he initial ‘heavy burden’ of establishing mootness lies with the party asserting a case

is moot, [and] the opposing party bears the burden of showing an exception applies.” Han,

(second alteration added), quoting Honeywell Int’l, Inc. v. Nuclear

Regul. Comm’n,

(D.C. Cir. 2010). “[M]ootness, however it may have come

about, simply deprives [the court] of [its] power to act.”

quoting Spencer,

(first

alteration added).

Defendant argues that plaintiff’s claims concerning the 2016 Rule are moot because the

Secretary revised the definition of “applicable laboratory” in the 2018 Rule, and the challenged

definition is no longer applicable. Def.’s Mem. at 22–24. This lawsuit does not challenge the new

rule, so the only remedy that would be available to plaintiff here would be retrospective relief for

any past payments that were calculated using the only 2016 Rule – that is, payments calculated for

2018–20 based on data collected data in early 2017 using the challenged definition.

. At

first blush, that would appear to create a live controversy. But defendant argues that the Court

cannot provide plaintiff or its members any relief as to the payment calculations for 2018–20

because the statute bars judicial review of “the establishment of payment amounts” under PAMA.

at 23–24, citing 42 U.S.C. § 1395m-1(h).

9 Plaintiff, on the other hand, emphasizes that its complaint does not directly challenge the

determination of the 2018–20 payment amounts. Pl.’s Opp. & Reply at 17–18. It challenges the

“unlawful reporting rule” used to determine which laboratories would report data to the Secretary.

Id. at 17. Plaintiff emphasizes that the D.C. Circuit recognized the “bifurcated structure” of

PAMA, which divided the statute into the data collection process and the establishment of payment

amounts. Am. Clinical Lab’y Ass’n,

. Although the results of the data collection

process are used to establish Medicare payment amounts, the data collection provision is distinct

from its rate-estimation provisions.

Plaintiff contends that its inability to challenge the

reimbursement rates themselves does not prevent the Court from requiring the Secretary to comply

with the data collection provision, even if this “necessarily result[s] in a change to the rates.” Pl.’s

Opp. & Reply at 17.

Plaintiff asserts if the Court were to rule in its favor, nothing in the statute would prevent

the Court from ordering the Secretary to collect 2017 data using a regulation that complies with

PAMA and then recalculate payment rates for 2018–20. Pl.’s Opp. & Reply at 17 (arguing “those

rates can change without any challenge to their ‘establishment’”) (emphasis in original). New data

could be collected. But PAMA provides that “payment amounts under this section shall not be

subject to any adjustment (including any geographic adjustment, budget neutrality adjustment,

annual update, or other adjustment).” 42 U.S.C. § 1395m-1(b)(4)(B) (emphasis added). So even

if the Court were to rule in plaintiff’s favor on the merits, it could not order the agency to revise

any payment amounts in the fee schedules used to determine 2018–20 payments or any particular

payments to plaintiff’s members. See Keli v. Rice,

(D.D.C. 2008) (ruling

that case was moot where “the language of the statute unequivocally bars the Court from granting

the relief sought”).

10 Further, the Court could not vacate the challenged definition and order the Secretary to

bring his regulations into compliance with the Medicare statute since the definition is no longer in

effect. In other words, any decision “will neither presently affect the parties’ rights nor have a

more-than-speculative chance of affecting them in the future.” Clarke,

(internal

quotation marks omitted). For these reasons, the Court finds that this dispute is moot.

CONCLUSION

For the reasons set for above, the Court will dismiss the case for lack of subject matter

jurisdiction.

AMY BERMAN JACKSON United States District Judge

DATE: March 30, 2021

11