1 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF COLUMBIA 

MICHAEL GREENWALD 

 

Plaintiff, 

v. 

XAVIER BECERRA, Secretary of 

the United States Department 

of Health and Human Services 

et al., 

Defendants.1

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

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. 
2 

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. 
3 

I. Background2

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. 
4 

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 
5 

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), 1395kk1. 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 
6 

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 
7 

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). 
8 

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”), 
9 

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. 
10 

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. 
11 

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 Surreply, 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. 
12 

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 
13 

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 
14 

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 
15 

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 
16 

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 
17 

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 
18 

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 
19 

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. 
20 

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 
21 

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. 
22 

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.” 
23 

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) 
24 

(“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, 
25 

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 
26 

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 
27 

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 
28 

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 
29 

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