Court Opinion

ID: 6347699
Source: CourtListenerOpinion
Date Created: 2022-06-07 19:00:43.626587+00
Date Added: 2024-06-11T14:21:54.005937
License: Public Domain

UNITED STATES DISTRICT COURT
                        FOR THE DISTRICT OF COLUMBIA

    MICHAEL GREENWALD

                    Plaintiff,
                                         Civ. Action No. 17-797(EGS/RMM)
    v.

    XAVIER BECERRA, Secretary of
    the United States Department
    of Health and Human Services
    et al.,
                    Defendants. 1

                        MEMORANDUM OPINION AND ORDER

         Plaintiff Michael Greenwald (“Mr. Greenwald”), a Medicare

beneficiary, brings this suit to challenge the validity of a

Local Coverage Determination (“LCD”) cited when he was denied

Medicare coverage for a pneumatic compression device prescribed

by his physician. See generally First Am. Compl. (“Compl.”), ECF

No. 26. He names as defendants the Secretary of the United

States Department of Health and Human Services (“HHS”)1 and the

Administrator of the Centers for Medicare and Medicaid Services

(“CMS”), both in their official capacities (collectively

“Defendants”). Defendants move to dismiss Mr. Greenwald’s claims

for lack of subject matter jurisdiction and failure to state a

1 Pursuant to Federal Rule of Civil Procedure 25(d), the Court
substitutes as defendant Mr. Xavier Becerra, in place of former
Secretary Alex Azar.

                                     1
claim. See Defs.’ Mem. of P. & A. Supp. Mot. Dismiss (“Mot. to

Dismiss”), ECF No. 27-1. On March 30, 2018, the Court referred

the case to a Magistrate Judge for full case management,

including a Report and Recommendation (“R. & R.”) on the pending

Motion to Dismiss, and the case was randomly referred to

Magistrate Judge Robin M. Meriweather. See generally, Docket for

Civ. Act. No. 17-797. Pending before the Court is Defendants’

Motion to Dismiss, see ECF No. 17. Magistrate Judge Meriweather

issued a R. & R. recommending that this Court grant Defendants’

motion since this Court lacks subject matter jurisdiction over

Mr. Greenwald’s claims. See R. & R., ECF No. 47 at 1-2.

Plaintiff objects to Magistrate Judge Meriweather’s R. & R. See

generally Plaintiff Michael Greenwald’s Objections to the

November 8, 2021 Report and Recommendations Regarding

Defendants’ Motion to Dismiss the Complaint (“Pl.’s Objs.”), ECF

No. 49.

      Upon careful consideration of the R. & R., the objections

of both parties and opposition thereto, the applicable law, and

the entire record herein, the Court hereby ADOPTS IN PART and

REJECTS IN PART the R. & R., see ECF No. 49; and GRANTS IN PART

and DENIES IN PART Defendants’ Motion to Dismiss, see ECF No.

27.

                                 2
    I.        Background 2

         A.     Factual Background

         Accepting the factual allegations in the complaint as true,

as is required at this stage of proceedings, see Jerome Stevens

Pharms., Inc. v. Food & Drug Admin., 402 F.3d 1249, 1253–54

(D.C. Cir. 2005); this case stems from Mr. Greenwald’s

lymphedema—a chronic medical condition that results in the

accumulation of fluid in the subcutaneous tissues of his legs.

See Compl., ECF No. 26 ¶¶ 1, 13, 48. Mr. Greenwald was first

diagnosed with lymphedema in 2014. See id. ¶¶ 13–14, 48. His

physician attempted to treat the condition with compression

stockings, exercise, and limb elevation. See id. ¶¶ 14, 48–49.

In 2016, the physician determined these treatments had been

ineffective in alleviating Mr. Greenwald’s symptoms and

prescribed him a pneumatic compression device (“PCD”). See id.

¶¶ 14, 52. PCDs are items of durable medical equipment designed

to treat patients suffering from a range of circulatory

conditions, including lymphedema. See id. at ¶ 30. They do so by

intermittently inflating a garment with compressed air to

2 In the interest of judicial efficiency, the Background section
is adopted from Magistrate Judge Meriweather’s R. & R. See ECF
No. 49.

                                     3
stimulate fluid circulation in affected parts of the body. See

id. ¶ 31.

     Mr. Greenwald is eligible for Medicare benefits and

expected his PCD prescription to be covered under Medicare Part

B. See id. ¶¶ 13, 18, 24, 54. Mr. Greenwald’s coverage claim was

denied, however. See id. ¶ 55. His appeal for a redetermination

was also unsuccessful. See id. ¶ 56. As a result, Mr. Greenwald

has paid the full cost of his prescribed PCD out-of-pocket. See

id. ¶¶ 47, 63. The following description of the Medicare system

provides necessary context for understanding why Mr. Greenwald’s

coverage claim was denied and the nature of his suit against the

Defendants.

     B.     The Medicare Program

     Congress established the Medicare program in 1965 to

provide health benefits to persons aged sixty-five and older who

are eligible for Social Security benefits or retirement benefits

under the railroad retirement system. Cal. Clinical Lab’y Ass’n

v. Sec’y Health & Hum. Servs., 104 F. Supp. 3d 66, 70 (D.D.C.

2015) (citing Pub. L. No. 89-97, 79 Stat. 291 (July 30, 1965)

(codified at 42 U.S.C. §§ 1395 et seq.)). Part A of the program

covers institutional healthcare services. See 42 U.S.C. § 1395d.

Part B of the program is voluntary, providing enrollees with

coverage for medical professional services, outpatient and

                                   4
homecare services, and durable medical equipment that is not

furnished in an inpatient setting or otherwise covered by Part

A. See id. § 1395k. Part C of the program, also enrollment

based, provides benefits to individuals who elect to receive

coverage through private health insurance companies. See id. §§

1395w-21 to 1395w-28. Both Parts B and C of the Medicare program

cover durable medical equipment, including PCDs, in appropriate

circumstances. See Compl., ECF No. 26 ¶ 46; see also 42 C.F.R.

§§ 410.38, 414.202.

     Those appropriate circumstances are defined in part by the

Medicare Act. Relevant here, Medicare does not cover “expenses

incurred for items or services which . . . are not reasonable

and necessary for the diagnosis or treatment of illness or

injury or to improve the functioning of a malformed body

member[.]” 42 U.S.C. § 1395y(a)(1)(A). The HHS Secretary

implements this rule through CMS—the agency that administers

Medicare more generally. See id. § 1395b-9. CMS in turn

delegates some of its responsibilities to private Medicare

Administrative Contractors (“MACs”). See id. §§ 1395(u), 1395kk-

1. Under this scheme, a healthcare provider who seeks payment

for an item or service provided to a Medicare beneficiary

submits a claim for reimbursement to the MAC authorized in the

provider’s region. See id. § 1395kk-1(a). The MAC then assesses

                                5
whether the item or service is covered by Medicare, including

whether the item or service is “reasonable and necessary” under

§ 1395y.

     The Secretary has significant control over these MAC

coverage determinations. He may promulgate binding regulations

regarding which items or services are covered by Medicare. See

id. §§ 1395hh, 1395ff(a)(1). He may also issue binding national

coverage determinations, or “NCDs,” that reflect his

determination that an item or service is covered under

designated medical circumstances on a nationwide basis. See id.

§ 1395ff(f)(1)(B); 42 C.F.R. § 405.1060(a)(4). Additionally, if

coverage is initially denied by a MAC, a Medicare beneficiary

may appeal the MAC determination to an administrative law judge

(“ALJ”) housed within the Secretary’s Office of Medicare

Hearings and Appeals. See id. § 1395ff(b)(1)(E), (d)(1)(A); see

also Am. Hosp. Ass’n v. Burwell, 76 F. Supp. 3d 43, 46 (D.D.C.

2014), rev’d on other grounds, 812 F.3d 183 (D.C. Cir. 2016)

(describing this process).

     The MACs may also develop their own guidelines for coverage

determinations, known as local coverage determinations (“LCDs”).

See 42 U.S.C. § 1395ff(f)(2)(B). LCDs are limited in scope,

applying only on an “intermediary- or carrier-wide basis.” Id.

They are meant to guide MAC administrators in determining

                                6
whether an item or service is “covered . . . in accordance with

§ 1395y(a)(1)(A)”—in other words, that an item or service is

“reasonable and necessary” as required for Medicare coverage—

within the MAC’s designated service area. Id.

§§ 1395y(a)(1)(A); 1395ff(f)(2)(B). Individuals who believe

their claim was wrongly denied pursuant to an LCD can appeal

their individual coverage determination to an ALJ, and if that

appeal is unsuccessful, to the HHS Departmental Appeals Board

(“DAB”). Id. at § 1395ff(b)– (e); 42 C.F.R. §§ 405.900 et seq.

Neither the ALJ nor the DAB is bound by the LCD, but they cannot

invalidate or set aside the LCD in its entirety. See 42 C.F.R.

§§ 405.1062(a), (c); see also Cal. Clinical Lab’y, 104 F. Supp.

3d at 72. To challenge the validity of the LCD itself, a

Medicare beneficiary must utilize a different complaint process,

appealing to an ALJ and the DAB via 42 U.S.C. § 1395ff(f)(2). If

there are “no material issues of fact in dispute” and the “only

issue of law” is the validity of the LCD, the Medicare recipient

may also side-step the usual administrative review process and

file a complaint directly with “a court of competent

jurisdiction.” Id. § 1395ff(f)(3).

                                7
     C.   Local and National Coverage Determinations for
          Pneumatic Compression Devices, and Their Application to
          Mr. Greenwald’s Claim

     The PCD prescribed by Mr. Greenwald’s physician is subject

to both a NCD and a LCD. The relevant NCD is published in CMS’s

Medicare Coverage Database. See Compl., ECF No. 26 ¶ 31; see

also CMS, Nat’l Coverage Determination for Pneumatic Compression

Devices, Pub. No. 100-3 § 280.6 (eff. Jan. 14, 2002) (“NCD

280.6”). The relevant LCD is also available on CMS’ website, and

is used by MACs serving most of the United States and its

territories. See Compl. ECF No. 26 ¶¶ 33–34, 40–45; Ex. A, ECF

No. 26-1 at 1 (“LCD L33829”) (listing the names and

jurisdictions of MACs using the LCD); see also Compl., ECF No.

26 ¶ 46 (asserting that the LCD is also used by private health

insurers under Medicare Part C, “even though these LCDs are not

binding on Medicare Advantage plans”). Both NCD 280.6 and LCD

L33829 purport to interpret the “reasonable and necessary”

requirement for Medicare coverage for PCDs. See 42 U.S.C. §§

1395ff(f)(1)(B), (f)(2)(B); LCD L33829 at 1 (“The purpose of

[this LCD] is to provide information regarding ‘reasonable and

necessary’ criteria[.]”). The problem, according to Mr.

Greenwald, is that NCD 280.6 and LCD L33829 conflict. See

Compl., ECF No. 26 ¶¶ 5, 6; Mem. of P. & A. in Supp. of Mot. for

Summ. J. and in Opp’n to Defs.’ Mot. to Dismiss (“Pl.’s Opp’n”),

                                8
ECF No. 29 at 29. Mr. Greenwald alleges the LCD “introduced new

legal standards for determining Medicare coverage that were not

included or mentioned in [the] NCD.” Id. at 24. These standards

are substantive, he says, because they add additional

requirements for coverage for a PCD instead of merely

interpreting the guidance in the NCD. See id. at 36; Surreply,

ECF No. 48 at 6. For this reason, when a MAC applied LCD L33829

to Mr. Greenwald’s claim for coverage for his PCD, the claim was

denied even though Mr. Greenwald insists it might have been

approved under the less restrictive NCD 280.6. See Compl., ECF

No. 26 ¶¶ 54–55, 57; Pl.’s Opp’n, ECF No. 29 at 26. That initial

determination was upheld at the redetermination stage, also

based on LCD L33829. See Compl., ECF No. 26 ¶ 56; see also

Compl. Ex. C, ECF No. 26-3 at 3.

     D.   Procedural Background

     Mr. Greenwald did not request reconsideration of his

coverage redetermination. See Compl., ECF No. 26 ¶¶ 55–57; Mot.

to Dismiss, ECF No. 27-1 at 8–9. He instead brought this civil

action to challenge the overarching validity of LCD L33829. See

generally Compl., ECF No. 26. The suit is not an appeal of Mr.

Greenwald’s individual coverage determination, but a claim that

LCD L33829 is invalid as a general matter, whether applied to

Mr. Greenwald or to another. See id. at Prayer for Relief. Mr.

                                   9
Greenwald’s theory is that, because LCD L33829 imposed new

substantive requirements for Medicare coverage for PCDs, the

Defendants were required to follow rulemaking procedures in the

Administrative Procedure Act and Social Security statutes. See

Pl.’s Opp’n, ECF No. 29 at 29; Surreply, ECF No. 48 at 6. Mr.

Greenwald asks this Court to conclude that LCD L33829 is invalid

as a matter of law because these procedures were not followed.

See id. Mr. Greenwald’s complaint was filed in April 2017. See

Compl., ECF No. 1. After several extensions of their time to

respond, Defendants filed a Rule 12 motion to dismiss Mr.

Greenwald’s complaint. See Mot. to Dismiss, ECF No. 20. Mr.

Greenwald amended his complaint soon thereafter. 3 See Compl., ECF

No. 26. This Court then dismissed the Defendants’ motion to

dismiss as moot, see Min. Order (Mar. 12, 2018); and Defendants

filed a renewed motion to dismiss Mr. Greenwald’s amended

complaint for lack of subject matter jurisdiction and failure to

state a claim. See Mot. to Dismiss, ECF No. 27-1. Mr. Greenwald

responded to the Defendants’ motion and moved for entry of

summary judgment. See Pl.’s Opp’n, ECF No. 29. The Court stayed

Mr. Greenwald’s summary judgment motion pending resolution of

3 Additional defendants named in Mr. Greenwald’s first complaint
were dismissed by stipulation in August 2017. See ECF No. 16.

                                10
the Defendants’ renewed motion to dismiss and directed

Defendants to file their reply specifically for the motion to

dismiss. See Min. Order (Feb. 12, 2018). After Defendants filed

their reply, see Defs.’ Reply, ECF No.33; Mr. Greenwald

requested leave to file a sur-reply in further opposition to

Defendants’ motion to dismiss, see Mot. for Leave to File a Sur-

reply, ECF No. 34; which Defendants opposed, see Defs.’ Response

to Pl.’s Mot. for Leave to File Sur-Reply, ECF No. 35. This case

was referred to a Magistrate Judge for full case management, up

to but excluding trial, pursuant to Local Civil Rule 72.2. See

Min. Order (Mar. 30, 2018). Following the assignment of the case

to Magistrate Judge Meriweather, see Min. Entry (Mar. 30, 2018),

the parties filed two notices of supplemental authority and a

response thereto. See ECF Nos. 37, 38, 40. After reviewing these

initial briefs, Magistrate Judge Meriweather requested

supplemental briefing on an issue raised by the parties’

memoranda. See ECF No. 42. The parties’ responsive briefs were

filed in December 2020. See ECF Nos. 43, 44. On November 8,

2021, Magistrate Judge Meriweather entered an order granting Mr.

Greenwald’s motion for leave to fire a sur-reply. See Min. Order

(Nov. 8, 2021). Magistrate Judge Meriweather also issued a R. &

R. recommending that this Court grant Defendants’ motion to

dismiss for lack of subject matter jurisdiction. See ECF No. 49.

                               11
Mr. Greenwald objected to this conclusion, see Pl.’s Objs. ECF

No. 49; and Defendants filed a response thereto, see Defs.’

Resp. to Pl.’s Objs. to the Nov. 8, 2021 R. & R. (“Defs.’

Resp.”), ECF No. 51. The motion is ripe and ready for

adjudication.

  II.     Legal Standard

     A.     Objections to a Magistrate Judge's Report and
            Recommendation

     Pursuant to Federal Rule of Civil Procedure 72(b), a party

may file specific written objections once a magistrate judge has

entered a recommended disposition. Fed. R. Civ. P. 72(b)(1)-(2).

A district court “may accept, reject or modify the recommended

disposition.” Fed. R. Civ. P. 72(b)(3); see also 28 U.S.C. §

636(b)(1) (“A judge of the court may accept, reject, or modify,

in whole or in part, the findings or recommendations made by the

magistrate judge.”). A district court “must determine de novo

any part of the magistrate judge's disposition that has been

properly objected to.” Fed. R. Civ. P. 72(b)(3). “If, however,

the party makes only conclusory or general objections, or simply

reiterates his original arguments, the Court reviews the [R. &

R.] only for clear error.” Houlahan v. Brown, 979 F. Supp. 2d

86, 88 (D.D.C. 2013) (citation omitted). “Under the clearly

erroneous standard, the magistrate judge's decision is entitled

to great deference” and “is clearly erroneous only if on the

                                 12
entire evidence the court is left with the definite and firm

conviction that a mistake has been committed.” Buie v. D.C., No.

CV 16-1920 (CKK), 2019 WL 4345712, at *3 (D.D.C. Sept. 12, 2019)

(citing Graham v. Mukasey, 608 F. Supp. 2d 50, 52 (D.D.C. 2009))

(internal quotation marks omitted).

     Objections must “specifically identify the portions of the

proposed findings and recommendations to which objection is made

and the basis for objection.” LCvR 72.3(b). “[O]bjections which

merely rehash an argument presented to and considered by the

magistrate judge are not ‘properly objected to’ and are

therefore not entitled to de novo review.” Shurtleff v. EPA, 991

F. Supp. 2d 1, 8 (D.D.C. 2013) (quoting Morgan v. Astrue, No.

08-2133, 2009 WL 3541001, at *3 (E.D. Pa. Oct. 30, 2009)).

     B.   Subject Matter Jurisdiction

     Federal district courts are courts of limited jurisdiction

and “possess only that power conferred by [Article III of the]

Constitution and [by] statute.” Logan v. Dep’t of Veterans

Affairs, 357 F. Supp. 2d 149, 152 (D.D.C. 2004)

(quoting Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S.

375, 377, 114 S. Ct. 1673, 128 L. Ed. 2d 391 (1994)). “There is

a presumption against federal court jurisdiction and the burden

is on the party asserting the jurisdiction, the plaintiff in

this case, to establish that the Court has subject matter

                               13
jurisdiction over the action.” Id. at 153 (citing McNutt v. Gen.

Motors Acceptance Corp. of Ind., 298 U.S. 178, 182–83, 56 S. Ct.

780, 80 L. Ed. 1135 (1936)).

     The requirement of “standing is an essential and unchanging

part of the case-or-controversy requirement of Article III.”

Lujan v. Defs. of Wildlife, 504 U.S. 555, 560, 112 S. Ct. 2130

(1992). “[T]he defect of standing is a defect in subject matter

jurisdiction.” Haase v. Sessions, 835 F.2d 902, 906 (D.C. Cir.

1987). There are three requirements for standing:

          First, the plaintiff must have suffered an
          “injury in fact”—an invasion of a legally
          protected interest which is (a) concrete and
          particularized, and (b) “actual or imminent,
          not ‘conjectural’ or ‘hypothetical.’” Second,
          there must be a causal connection between the
          injury and the conduct complained of—the
          injury has to be “fairly . . . trace[able] to
          the challenged action of the defendant, and
          not . . . th[e] result [of] the independent
          action of some third party not before the
          court.” Third, it must be “likely,” as opposed
          to merely “speculative,” that the injury will
          be “redressed by a favorable decision.”

Lujan, 504 U.S. at 560–61 (citation omitted).

     In assessing whether a complaint sufficiently alleges

subject matter jurisdiction, the Court accepts as true the

allegations of the complaint, see Ashcroft v. Iqbal, 556 U.S.

662, 678, 129 S. Ct. 1937 (2009); and liberally construes the

pleadings such that the plaintiff benefits from all inferences

                               14
derived from the facts alleged, Barr. v. Clinton, 370 F. 3d

1196, 1199 (D.C. Cir. 2004).

     However, “[a] pleading that offers labels and conclusions

or a formulaic recitation of the elements of a cause of action

will not do. Nor does a complaint suffice if it tenders naked

assertions devoid of further factual enhancement.” Iqbal, 556

U.S. at 678 (citations, quotation marks and brackets omitted).

Consequently, “[a] claim invoking federal-question jurisdiction

under 28 U.S.C. § 1331 ... may be dismissed for want of subject

matter jurisdiction if it is not colorable, i.e., if it

is immaterial and made solely for the purpose of obtaining

jurisdiction or it is wholly insubstantial and

frivolous.” Arbaugh, 546 U.S. 500, 513 n.10, 126 S. Ct. 1235

(2006) (citation omitted); accord Tooley v. Napolitano, 586 F.3d

1006, 1009 (D.C. Cir. 2009) (citation omitted).

     C.   Rule 12(b)(6) Motion to Dismiss

     A motion to dismiss pursuant to Federal Rule of Civil

Procedure 12(b)(6) tests the legal sufficiency of a complaint.

Browning v. Clinton, 292 F.3d 235, 242 (D.C. Cir. 2002). A

complaint must contain “a short and plain statement of the claim

showing that the pleader is entitled to relief, in order to give

the defendant fair notice of what the ... claim is and the

grounds upon which it rests.” Bell At. Corp. v. Twombly, 550

                               15
U.S. 544, 555, 127 S. Ct. 1955 (2007). While detailed factual

allegations are not required, a complaint must contain

“sufficient factual matter ... to state a claim to relief that

is plausible on its face.” Iqbal, 556 U.S. at 678 (quoting

Twombly, 550 U.S. at 570). When ruling on a Rule 12(b)(6)

motion, the Court “may consider only the facts alleged in the

complaint, any documents either attached to or incorporated in

the complaint and matters of which we may take judicial notice.”

EEOC v. St. Francis Xavier Parochial Sch., 117 F. 3d 621, 624

(D.C. Cir. 1997). In so doing, the court must give the plaintiff

the “benefit of all inferences that can be derived from the

facts alleged.” Kowal v. MCI Commc’ns Corp., 16 F.3d 1271, 1276

(D.C. Cir. 1994). “Threadbare recitals of the elements of a

cause of action, supported by mere conclusory statements” are

not sufficient to state a claim. Iqbal, 556 U.S. at 678. The

plaintiff must “give the defendant fair notice of what the . . .

claim is and the grounds upon which it rests.” Erickson v.

Pardus, 551 U.S. 89, 93 (2007) (quoting Twombly, 550 U.S. at

555).

  III. Analysis

     Mr. Greenwald argues that this Court has subject matter

jurisdiction over this matter under 28 U.S.C. § 1331 (federal

question jurisdiction) and 28 U.S.C. § 1346 (United States as

                               16
defendant), because it involves an agency of the United States

as a defendant, and because it involves the interpretation and

application of the laws of the United States, including the

Administrative Procedure Act and Title XVIII of the Social

Security Act, 42 U.S.C. §§ 1395 et seq. See Compl., ECF No. 26

¶ 10. He also asserts jurisdiction pursuant to 42 U.S.C.

§ 1395ff(f)(3), which authorizes judicial review of an LCD

without prior exhaustion of administrative remedies where there

are no material issues of fact in dispute. Id. ¶ 11. Defendants

respond that Mr. Greenwald is no longer seeking the relief that

his denied claim be reversed and covered under Medicare Part B,

and therefore has no stake in the outcome of this matter,

rendering federal question jurisdiction absent. See Defs.’ MTD,

ECF No. 27-1 at 13. Defendants also assert that this Court lacks

jurisdiction because Mr. Greenwald has not exhausted his

administrative remedies. Id. at 15.

     Magistrate Judge Meriweather finds that Mr. Greenwald

cannot rely on 28 U.S.C. §§ 1331 and 1346, because Section

405(h) of the Social Security Act (as incorporated into the

Medicare Act through 42 U.S.C. § 1395ii) channels “most, if not

all, Medicare claims through agency review provisions,” unless

doing so would result in “complete preclusion of judicial

review,” which is not the case here, where the Medicare statutes

                               17
provide explicitly for judicial review of the agency’s final

determinations on both the issue of Mr. Greenwald’s individual

claim determination and the overarching validity of LCD L33829.

R. & R., ECF No. 47 at 10 (citation and quotation marks

omitted). As to jurisdiction under 42 U.S.C. § 1395ff(f)(3),

Magistrate Judge Meriweather finds that Mr. Greenwald has not

carried his burden of demonstrating that this case falls within

the limited jurisdictional grant of the statute, because the

“undisputed facts are insufficient to demonstrate whether NCD

280.6 and LCD L33829 conflict as a matter of law,” a conflict

which would render LCD L33829 invalid. Id. at 11. Mr. Greenwald

raises objections only as to Magistrate Judge Meriweather’s

findings on jurisdiction under 42 U.S.C. § 1395ff(f)(3).

     A.   Magistrate Judge Meriweather Erred In Concluding That
          This Court Lacks Jurisdiction Under 42 U.S.C.
          § 1395ff(f)(3)

     Section 1395ff(f) provides for facial review of NCDs and

LCDs. See id. § 1395ff(f)(1), (2). Challenges brought under

§ 1395ff(f) are ordinarily reviewed by an ALJ, whose decision is

appealable to the DAB. Id. § 1395ff(2)(A)(i)–(ii). The DAB’s

decision constitutes final agency action subject to judicial

review. Id. § 1395ff(2)(A)(iv). But an aggrieved individual may

avoid the ordinary administrative review process and proceed

directly to a “court of competent jurisdiction” if “the moving

                               18
party alleges that (A) there are no material issues of fact in

dispute, and (B) the only issue of law is . . . that a

regulation, determination, or ruling by the Secretary is

invalid.” Id. § 1395ff(f)(3); see also Bailey v. Mut. of Omaha

Ins. Co., 534 F. Supp. 2d 43, 51 (D.D.C. 2008).

     Here, the parties agree that the LCD at issue would be

invalid if it conflicts with the Medicare NCD for pneumatic

compression devices. R. & R., ECF No. 47 at 11. The relevant NCD

excludes coverage for a pneumatic compression device if

conservative treatment is shown to be effective, and states in

relevant part:

          Pneumatic compression devices are covered in
          the home setting for the treatment of
          lymphedema if the patient has undergone a
          four-week trial of conservative therapy and
          the treating physician determines that there
          has been no significant improvement or if
          significant symptoms remain after the trial.
          The trial of conservative therapy must include
          use of an appropriate compression bandage
          system or compression garment, exercise, and
          elevation of the limb.

NCD 280.6, ECF No. 27-4. As Defendants acknowledge, “if a trial

of a compression bandage or garment leads to significant

improvement and relief of significant symptoms, there is no

Medicare coverage for pneumatic compression devices.” Defs.’

Resp., ECF No. 51 at 4.

                               19
     The relevant LCD states as follows:

          At the end of the four-week trial, if there
          has been improvement, then reimbursement for
          a [pneumatic compression device] is not
          justified. Where improvement has occurred, the
          trial   of  conservative   therapy    must   be
          continued with subsequent reassessment at
          intervals at least a week apart. Only when no
          significant improvement has occurred in the
          most recent four weeks and the coverage
          criteria above are still met, may the
          lymphedema be considered unresponsive to
          conservative therapy, and coverage for a
          [pneumatic compression device] considered.
          CMS’ NCD for [pneumatic compression device]
          (280.6) instructs: “The determination by the
          physician of the medical necessity of a
          pneumatic     compression      device      must
          include...symptoms and objective findings,
          including measurements which establish the
          severity of the condition.”

          At a minimum, re-assessments conducted for a
          trial must include detailed measurements,
          obtained in the same manner and with reference
          to the same anatomic landmarks, prior to and
          at the conclusion of the various trials and
          therapy, with bilateral comparisons where
          appropriate.

LCD L33829, ECF No. 27-5. Explaining the LCD, Defendants state

that “if there has been improvement, but a patient is still

symptomatic, then the patient must continue the trial of

conservative therapy.” Defs.’ Resp., ECF No. 51 at 5. Magistrate

Judge Meriweather observes that “[t]he parties appear to agree

that LCD L33829 would be invalid if it is inconsistent with or

narrows NCD 280.6.” R. & R., ECF No. 47 at 11. However, “[t]hey

disagree on whether this Court can determine if the LCD and NCD

                                20
conflict without considering additional facts or expert

opinions.” Id. at 12. Magistrate Judge Meriweather concludes

that the Court requires additional facts to determine whether

NCD 280.6 and LCD L33829 conflict. Id.   Specifically, Magistrate

Judge Meriweather states that:

          [T]he Court is not equipped to assess the
          merits   of   [Plaintiff’s]   theory   without
          additional facts or expert opinions. The
          record in this case is too sparse to determine
          whether the coverage pathway required by the
          LCD conflicts with, or merely restates and
          interprets,    the   pre-coverage    treatment
          requirements of the NCD. The parties have not
          provided the Court with adequate information
          about   which    symptoms   associated    with
          lymphedema and similar circulatory conditions
          are ‘significant,’ how their significance is
          measured, how improvement is documented and
          weighted, or whether any individuals would
          meet the conservative trial requirements of
          NCD 280.6 but not LCD L33829. Without that
          information, the undersigned cannot determine
          whether LCD conflicts with or is a substantive
          interpretation of NCD 280.6, and so recommends
          this Court dismiss Mr. Greenwald’s case, as it
          cannot exercise subject-matter jurisdiction
          under § 1395ff(f)(3).

R. & R., ECF No. 47 at 15-16. In response, Mr. Greenwald objects

that the question of whether the MACs lacked the legal authority

to impose new legal obligations or conditions for Medicare

coverage and payment through the LCD is purely a question of law

within the authority of this Court. Pl.’s Objs., ECF No. 49 at

3. The Court reviews the R. & R. only for clear error since Mr.

                                 21
Greenwald’s argument is repeated from his filing in opposition

to the Motion to Dismiss. See Pl.’s Opp’n, ECF No. 29 at 28; see

also Houlahan, 979 F. Supp. 2d at 88 (“If, however, the party

makes only conclusory or general objections, or simply

reiterates his original arguments, the Court reviews the [R. &

R.] only for clear error.”) (Internal citation omitted). The

Court finds clear error here.

     The critical question for the Court for the purposes of

subject matter jurisdiction is whether additional facts are

needed to determine if the LCD and NCD at issue conflict. The

potential conflict arises when a conservative therapy trial

leads to improvement, but significant symptoms remain. See Pl.’s

Objs., ECF No. 49 at 5; Defs.’ Resp., ECF No. 51 at 4. The

Medicare NCD clearly states two pathways to coverage: pneumatic

compression devices are covered if the treating physician

determines there has been no significant improvement or if

significant symptoms remain after the trial. NCD 280.6, ECF No.

27-4. As Mr. Greenwald points out, the LCD however, eliminates

the second phrase, by instead requiring that “[o]nly when no

significant improvement has occurred in the most recent four

weeks and the coverage criteria above are still met, may the

lymphedema be considered unresponsive to conservative therapy,

and coverage for a [pneumatic compression device] considered.”

                                22
LCD L33829. Thus, while the NCD ensures coverage for people who

continue to have significant symptoms after the trial,

regardless of improvement, the LCD restricts that coverage only

to people who have seen no significant improvement in the most

recent four weeks. This conflict is evident in the plain

language of the text, and additional facts or expert opinions

would not eliminate the conflict. As the R. & R. acknowledges,

“[t]he national rule requires on its face only one four-week

trial; the local rule might require several, potentially

prolonging a patient’s discomfort and health complications

considerably before the patient can obtain a PCD covered by

Medicare.” R. & R., ECF No. 47 at 15. The Court disagrees with

Magistrate Judge Meriweather that it needs to know “which

symptoms associated with lymphedema and similar circulatory

conditions are ‘significant,’ how their significance is

measured, how improvement is documented and weighted.” Id. at

15-16. The text makes amply clear that individuals who would

meet the conservative trial requirements of NCD 280.6 may not

satisfy LCD L33829 if they have had improvements in their

condition within the past four weeks. Any other conclusion would

make the plain language of NCD 280.6 surplusage and fail to give

it meaning, violating the fundamental tools of interpretation.

See, e.g., Bailey v. United States, 516 U.S. 137, 146 (1995)

                               23
(“We assume that Congress used two terms because it intended

each term to have a particular, nonsuperfluous meaning.”); see

also Colautti v. Franklin, 439 U.S. 379, 392 (1979)

(“Appellants’ argument . . . would make either the first or the

second condition redundant or largely superfluous, in violation

of the elementary canon of construction that a statute should be

interpreted so as not to render one part inoperative.”); Yates

v. United States, 135 S. Ct. 1074, 1085 (2015) (declining to

read statute so as to “significantly overlap” with a distinct

statute, resisting a reading that would “render superfluous an

entire provision passed in proximity as part of the same Act”).

The Court concludes that the LCD and NCD impermissibly conflict,

rendering LCD L33829 invalid and providing this Court with

jurisdiction under § 1395ff(f). The Court need not reach any

additional argument as to jurisdiction.

     B.   Mr. Greenwald Has Standing to Bring This Case

     Because Magistrate Judge Meriweather determines that this

Court does not have subject matter jurisdiction, she does not

reach the issue of standing raised by Defendants in their Motion

to Dismiss. The Court therefore addresses it de novo. Defendants

argue that Mr. Greenwald lacks standing to bring this case

because he has failed to satisfy the redressability requirement

of standing. Defs.’ Reply, ECF No. 33 at 2. Specifically,

                               24
Defendants assert that even if the LCD were invalidated as Mr.

Greenwald requests, his sole injury, paying out of pocket for

the PCD, would not be redressed. Id. at 3. Defendants argue that

Mr. Greenwald’s ability to file future claims based on the NCD

rather than the LCD is too conjectural to be the basis of

redressability and add that even if the LCD and NCD conflict,

Mr. Greenwald “does not qualify for the pneumatic compression

device under the terms of the NCD,” and therefore has no

concrete stake in this lawsuit. Id. at 4-5. Mr. Greenwald

responds that he meets the statutory standing requirements in 42

U.S.C. § 1395ff(f)(5), which are only that he (1) be a Medicare

beneficiary who is (2) in need of the items or services that are

the subject of the coverage determination. Surreply, ECF No. 48

at 2. He further argues that he meets the Lujan standing

requirements since he suffered a concrete injury – the denial of

coverage for a pneumatic compression device through a LCD that

created new rules without the requisite process – and his injury

was caused solely and directly by the Secretary, who authorized

the publication of the LCD. Id. at 3. Mr. Greenwald adds that he

has a procedural right to challenge the LCD which comes with a

relaxed redressability standard. Id. Defendants reply that Mr.

Greenwald’s procedural right to file under section 1395ff(f)(5)

does not suffice for Article III standing, which requires a

                               25
concrete injury even in the context of a statutory violation.

Defs.’ Suppl. Brief, ECF No. 44 at 6-7. The Court concludes that

Mr. Greenwald has standing.

     To demonstrate standing, a litigant must show that they

have suffered a concrete and particularized injury that is

either actual or imminent, that the injury is fairly traceable

to the defendant, and that it is likely that a favorable

decision will redress that injury. Massachusetts v. E.P.A., 549

U.S. 497, 127 S. Ct. 1438 (2007). However, when a litigant is

vested with a procedural right – here the right of Medicare

beneficiaries to directly challenge LCDs in a District Court

under 42 U.S.C. § 1395ff(f)(3) – that litigant has standing if

there is some possibility that the requested relief will prompt

the injury-causing party to reconsider the decision that

allegedly harmed the litigant. Id. Article III standing requires

a concrete injury even in the context of a statutory violation.

Thole v. U. S. Bank N.A, 140 S. Ct. 1615, 1619-20 (2020).

     Defendants do not dispute that Mr. Greenwald has a

procedural right to challenge the LCD; they argue instead that

“Plaintiff’s procedural right to file under section 1395ff(f)(5)

does not suffice for Article III standing.” Defs.’ Suppl. Brief,

ECF No. 44 at 7. Defendants suggest that the reason Plaintiff’s

procedural right is insufficient is the lack of a concrete

                               26
injury, see id.; but it is indisputable that Plaintiff was

injured by having to pay for the PCD out of pocket. This case is

therefore distinct from Spokeo v. Robins, 136 S. Ct. 1540, 1549

(2016), where the Supreme Court held that plaintiff “could not,

for example, allege a bare procedural violation, divorced from

any concrete harm, and satisfy the injury-in-fact requirement of

Article III.”

     It is also not the case, contrary to Defendants’

suggestions, that Mr. Greenwald lacks a concrete interest in the

case because he will not be compensated for his PCD if he

prevails. First, a favorable decision by the Court will redress

Mr. Greenwald’s past injury of having to pay out of pocket by

ensuring he is not in the future denied a PCD for his ongoing

chronic lymphedema because of an invalid LCD. Second, “[a

litigant] who alleges a deprivation of a procedural protection

to which he is entitled never has to prove that if he had

received the procedure the substantive result would have been

altered. All that is necessary is to show that the procedural

step was connected to the substantive result.” Sugar Cane

Growers Cooperative of Fla. v. Veneman, 289 F.3d 89, 94-95 (D.C.

Cir. 2002). Accordingly, Mr. Greenwald does not have to show

that he would receive Medicare coverage without an invalid LCD,

and “the Secretary’s contention that under the Medicare National

                               27
Coverage Determination for pneumatic compression devices Mr.

Greenwald would not qualify for Medicare coverage is pure

speculation and irrelevant to this case.” Surreply, ECF No. 48

at 5. This is especially true given that the record does not

reflect that any MAC relied on the NCD for any determination

affecting Mr. Greenwald. Additionally, the Court is cognizant

Defendants cannot “defeat standing merely by asserting that []

[they] will come to the same conclusion once the procedures are

satisfied on remand.” ADX Communications of Pensacola v. FCC,

794 F.3d 74, 82 (D.C. Cir. 2015) (citations omitted). Finally,

standing is supported by the fact that Mr. Greenwald continues

to suffer from lymphedema, such that the LCD represents an

ongoing harm. See, e.g., Friends of the Earth, Inc. v. Laidlaw

Envtl. Servs. (TOC), Inc., 528 U.S. 167, 184-86 (2000).   The

Court concludes that Mr. Greenwald has standing to bring this

case.

     Mr. Greenwald does not, however, have standing to bring

Count IV of his complaint, which alleges that the Secretary

violated the non-discretionary duty imposed by

42 U.S.C. § 1395ff(1). See Compl., ECF No. 26 at 21. Defendants

raise several arguments as to why Mr. Greenwald lacks standing

for this Count, none of which are addressed by Mr. Greenwald.

See generally Pl.’s Opp’n, ECF No. 29. The Court therefore

                               28
treats these arguments as conceded. See Bancoult v. McNamara,

227 F. Supp. 2d 144, 149 (D.D.C. 2002) (“[I]f the opposing party

files a responsive memorandum, but fails to address certain

arguments made by the moving party, the court may treat those

arguments as conceded, even when the result is dismissal of the

entire case.”).

  IV.     Conclusion and Order

     For the foregoing reasons, the Court

     ADOPTS IN PART and REJECTS IN PART Magistrate Judge

Meriweather’s R. & R., see ECF No. 49. The portion of the

R. &. R that is rejected is Magistrate Judge Meriweather’s

finding that there is no jurisdiction under 42 U.S.C. §

1395ff(f)(3); and further

     GRANTS IN PART and DENIES IN PART Defendants’ Motion to

Dismiss, see ECF No. 27. The Motion is granted only as to Count

IV of the Complaint.

     SO ORDERED.

Signed:     Emmet G. Sullivan
            United States District Judge
            June 7, 2021

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