GREENWALD v. PRICE et al

Filing 61

MEMORANDUM OPINION AND ORDER. Signed by Judge Emmet G. Sullivan on 05/24/2023. (lcegs2)

Case 1:17-cv-00797-EGS-RMM Document 61 Filed 05/24/23 Page 1 of 17

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
MICHAEL GREENWALD,
v.

Plaintiff,
Civ. Action No. 17-0797
(EGS/RMM)

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

MEMORANDUM OPINION AND ORDER
I.

Introduction
Mr. Michael Greenwald (“Mr. Greenwald” or “Plaintiff”)

brings this action against the Secretary of the United States
Department of Health and Human Services (“HHS” or the “agency”)
and the Administrator of the Centers for Medicare and Medicaid
Services (“CMS”), both in their official capacities
(collectively, “Defendants”). See First Am. Compl. (“Compl.”),
ECF No. 26. 1 He challenges the validity of Local Coverage
Determination (“LCD”) L33829—the application of which resulted
in the denial of his claim for Medicare coverage for a pneumatic

When citing electronic filings throughout this Opinion, the
Court refers to the ECF page numbers, not the page numbers of
the filed documents.
1

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compression device (“PCD”) that his physician prescribed to
treat his lymphedema. See id. ¶¶ 55, 58-80.
Defendants moved to dismiss the Complaint for lack of
subject matter jurisdiction and failure to state a claim. See
Defs.’ Mem. of P. & A. Supp. Mot. Dismiss (“Defs.’ Mot.
Dismiss”), ECF No. 27-1. Following referral of the case, see
Minute Order (July 11, 2018); Magistrate Judge Robin M.
Meriweather issued a Report and Recommendation (“R. & R.”)
recommending that the Court grant Defendants’ Motion to Dismiss,
see R. & R., ECF No. 47 at 17; and Mr. Greenwald objected, see
Pl. Michael Greenwald’s Objs. Nov. 8, 2021 R. & R. Regarding
Defs.’ Mot. Dismiss Compl. (“Pl.’s Objs.”), ECF No. 49. The
Court thereafter issued a Memorandum Opinion and Order denying
Defendants’ Motion to Dismiss the Complaint. See Greenwald v.
Becerra, No. CV 17-797(EGS/RMM), 2022 WL 2046108, at *9 (D.D.C.
June 7, 2022).
Pending before the Court is Mr. Greenwald’s Motion for
Clarification of that Memorandum Opinion and Order. See Pl.’s
Mot. Clarification Ct.’s June 7, 2022 Mem. Op. & Order (“Pl.’s
Mot.”), ECF No. 56. Upon careful consideration of the motion,
opposition, and reply thereto; the applicable law; and the
entire record herein, the Court hereby the Court hereby DENIES
Mr. Greenwald’s motion.

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II.

Background
A.

Factual

The Court assumes the parties’ familiarity with the facts
of the case as set forth in its June 7, 2022 Memorandum Opinion
and Order. See Greenwald, 2022 WL 2046108, at *1-3. As before,
for the purposes of the Motion to Dismiss, the Court assumes the
following facts alleged in the Amended Complaint to be true and
construes them in Mr. Greenwald’s favor. See Baird v. Gotbaum,
792 F.3d 166, 169 n.2 (D.C. Cir. 2015) (citation omitted).
In short, this case concerns the treatment of Mr.
Greenwald’s lymphedema. See Compl., ECF No. 26 ¶¶ 1, 13, 48.
Following his 2014 diagnosis, his physician attempted to treat
the condition with compression stockings, exercise, and limb
elevation. See id. ¶¶ 13–14, 48-49. These treatments were
ineffective, so in 2016, his physician prescribed him a
pneumatic compression device (“PCD”). See id. ¶¶ 14, 52.
Because Mr. Greenwald is eligible for Medicare benefits, he
expected his PCD prescription to be covered under Medicare Part
B. See id. ¶¶ 13, 18, 24, 54. His coverage claim was denied,
though, as was his appeal for a redetermination. See id. ¶¶ 5556. He therefore has paid the full cost of his prescribed PCD
out of pocket. See id. ¶¶ 47, 63.
Mr. Greenwald’s PCD is subject to a National Coverage
Determination (“NCD”) and Local Coverage Determination (“LCD”).
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Id. ¶¶ 31, 33–34, 40–45; see also CMS, Nat’l Coverage
Determination for Pneumatic Compression Devices, Pub. No. 100-3
§ 280.6 (eff. Jan. 14, 2002) (“NCD 280.6”); Ex. A, ECF No. 26-1
at 1 (“LCD L33829”). 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.”). Mr. Greenwald argues that NCD 280.6 and LCD L33829
conflict, see Compl., ECF No. 26 ¶¶ 5, 6; such that his claim—
denied under application of LCD L33829—might have been approved
under NCD 280.6, see id. ¶¶ 54–55, 57.
B.

Procedural

Mr. Greenwald filed this Motion for Clarification on
September 23, 2022. See Pl.’s Mot., ECF No. 56. Defendants
submitted their brief in opposition on October 7, 2022, see
Defs.’ Resp. Pl.’s Mot. Clarification of Ct.’s June 7, 2022 Mem.
Op. & Order (“Defs.’ Opp’n”), ECF No. 57; and Mr. Greenwald
replied on October 14, 2022, see Pl.’s Reply Mem. Law Supp. Mot.
Clarification of Ct.’s June 7, 2022 Mem. Op. & Order (“Pl.’s
Reply”), ECF No. 58. The motion is now ripe and ready for
adjudication.

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III. Legal Standard
No Federal Rule of Civil Procedure specifically governs
“motions for clarification.” United States v. Philip Morris USA
Inc., 793 F. Supp. 2d 164, 168 (D.D.C. 2011). Nevertheless,
federal courts generally recognize and allow these motions.
Barnes v. Dist. of Columbia, 289 F.R.D. 1, 13 n.6 (D.D.C. 2012).
“The general purpose of a classic motion for clarification is to
explain or clarify something ambiguous or vague.” Id. (internal
quotation marks omitted) (quoting Resol. Tr. Corp. v. KPMG Peat
Marwick, et al., No. 92-1373, 1993 WL 211555, *2 (E.D. Pa. June
8, 1993)). Parties may file motions for clarification “when they
are uncertain about the scope of a ruling.” United States v. All
Assets Held at Bank Julius, Baer & Co., Ltd., 315 F. Supp. 3d
90, 99 (D.D.C. 2018) (citing United States v. Volvo Powertrain
Corp., 758 F.3d 330, 344 (D.C. Cir. 2014); Barnes v. Dist. of
Columbia, 289 F.R.D. 1, 12–13 (D.D.C. 2012)). However, these
motions “cannot open the door to ‘re-litigat[ing] a matter that
the court has considered and decided.’” Id. (quoting SAI v.
Transp. Sec. Admin., No. 14-403, 2015 U.S. Dist. LEXIS 192323
(D.D.C. Aug. 19, 2015)).
III. Analysis
Mr. Greenwald moves the Court to clarify that its June 7,
2022 Memorandum Opinion and Order invalidated LCD L33829 “in its
entirety” such that the Secretary cannot apply the LCD “in any
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way.” Pl.’s Mot., ECF No. 56 at 9. He presents three arguments
to reach this conclusion. First, he argues that the language the
Court used in its Memorandum Opinion and Order plainly means
that LCD L33829 “is invalid in its entirety.” Id. at 6. Second,
he contends that the Court invalidated LCD L33829 completely
because he had previously argued that each provision of the LCD
is invalid in the Complaint and his Motion for Summary Judgment.
See id. at 6-7. Third, he asserts that LCDs are not severable,
so the Court cannot invalidate only one part of LCD L33829. See
id. at 7-8. The Court addresses each argument in turn and, for
the reasons that follow, DENIES Mr. Greenwald’s Motion for
Clarification.
A.

The Plain Meaning of “Invalid” Does Not Resolve Mr.
Greenwald’s Motion

Mr. Greenwald first argues that the Court must have
invalidated LCD L33829 in its entirety based on the language in
the June 7, 2022 Memorandum Opinion and Order. See Pl.’s Mot.,
ECF No. 56 at 6. There, “[t]he Court conclude[d] that the LCD
and NCD impermissibly conflict, rendering LCD L33829 invalid and
providing this Court with jurisdiction under § 1395ff(f).”
Greenwald, 2022 WL 2046108, at *7. He reasons that because
“[t]he plain meaning of the word ‘invalid’ is something that is
‘not legally binding’ or ‘without basis in fact,’” LCD L33829

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“is void in its entirety.” Pl.’s Mot., ECF No. 56 at 6 (quoting
Black’s Law Dictionary 900 (9th ed. 2009)).
Defendants do not respond to this argument. See generally
Defs.’ Opp’n, ECF No. 57. In his reply brief, though, Mr.
Greenwald again emphasizes that “the plain meaning of the word
‘invalid’ should control.” Pl.’s Reply, ECF No. 58 at 2-3
(collecting cases). He also points out that Section 1395ff(f)
does not define “invalid” or otherwise indicate that the term
“ha[s] any meaning other than its ordinary meaning.” Id. at 3
(citing H. Conf. Rep. 106-1033 at 896 (2000)).
The Court is not persuaded by Mr. Greenwald’s argument.
Despite his statements to the contrary, the parties agree that
the Court held that at least part of LCD L33829 is invalid—that
is, “not legally binding”—in its June 7, 2022 Memorandum Opinion
and Order. See generally Pl.’s Mot., ECF No. 56; Defs.’ Opp’n,
ECF No. 57. Stated differently, they agree that the word
“invalid” should be given its plain meaning in this context.
They dispute, however, whether the Court held LCD L33829 invalid
in part or in whole. See generally Pl.’s Mot., ECF No. 56;
Defs.’ Opp’n, ECF No. 57. The meaning of the word “invalid”
therefore does not help explain precisely what is now “void.”

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B.

The Court Previously Considered and Decided Only One
Ground for Subject Matter Jurisdiction

Mr. Greenwald next argues that the Court’s June 7, 2022
Memorandum Opinion and Order must have invalidated LCD L33829 in
its entirety because his “pleadings . . . make it clear that the
LCD [i]s completely invalid.” Pl.’s Mot., ECF No. 56 at 6. He
states that, in the Complaint and in his Motion for Summary
Judgment, he set forth the following points where the LCD
conflicts with the NCD:
(i) The LCDs include a definition of the
severity of lymphedema symptoms that
qualify for Medicare coverage;
(ii) When a trial period of conservative
therapy is a prerequisite for PCD
coverage, the LCDs impose a lengthier
trial period than that stated in the NCD
even
when
the
patient’s
treating
physician determines that significant
symptoms remain after the trial;
(iii)The
LCDs
contain
additional
prerequisites
for
coverage
for
lymphedema treatment;
(iv)The LCDs add new prerequisites for
coverage
for
chronic
venous
insufficiency with venous stasis ulcers;
(v) The LCDs add new prerequisites for
coverage requiring that the lymphedema
extend into the chest, trunk, or abdomen;
and
(vi)The LCDs add a new exclusion from
Medicare coverage for PCDs when used
for peripheral artery disease or for deep
venous thrombosis prophylaxis.
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Id. (quoting Compl., ECF No. 1 ¶ 43; see Pl.’s Mot. Summ. J.,
ECF No. 29 at 15-16, 32). He concedes that the Court’s
Memorandum Opinion and Order discussed only the second point.
Id. Nevertheless, he argues that “the additional five points
demonstrate that the LCD is invalid for exactly the same
reason.” Id.
Defendants oppose this characterization of the proceedings.
See Defs.’ Opp’n, ECF No. 57 at 2-5. They argue instead that the
Court resolved the only issue before it: whether the LCD’s
conservative therapy trial requirements conflict with the NCD
such that the Court has subject matter jurisdiction under
Section 1395ff(f)(3). See id. They recount that Mr. Greenwald
raised several potential conflicts between the LCD and the NCD
as grounds for subject matter jurisdiction in his consolidated
Motion for Summary Judgment and Opposition to Defendants’ Motion
to Dismiss. Id. at 3 (citing Mem. P. & A. Supp. Pl.’s Mot. Summ.
J. & Opp’n Def.’s Mot. Dismiss, ECF No. 30 at 22-23, 39-40).
Defendants concede that Magistrate Judge Meriweather considered
each potential conflict Mr. Greenwald raised as a possible basis
for subject matter jurisdiction. See id. at 4 (citing R. & R.,
ECF No. 47 at 12-17). They explain, however, that in objecting
to the R. & R., Mr. Greenwald “addresse[d] only the conservative
therapy trial requirements” to establish subject matter
jurisdiction under Section 1395ff(f)(3). Id. (quoting Pl.’s
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Objs., ECF No. 49 at 4-5). Further, they argue that the Court’s
Memorandum Opinion and Order “only discusses the conservative
therapy trial requirements”; “does not identify any other
conflict between the [NCD and LCD]”; and rejects the R. & R.’s
conclusion that the Court lacks subject matter jurisdiction
under Section 1395ff(f)(3). Id. (quoting Mem. Op. & Order, ECF
No. 52 at 22-24, 29).
The Court agrees with Defendants that it decided only that
it has subject matter jurisdiction because the LCD’s
conservative therapy trial requirements conflict with the NCD.
In its Memorandum Opinion and Order, the Court stated: “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.” Greenwald, 2022
WL 2046108, at *7. The Court discussed only this potential
conflict for the purpose of determining jurisdiction. See id.
Moreover, upon concluding that “[t]his conflict is evident in
the plain language of the text,” the Court stated that it “need
not reach any additional argument as to jurisdiction.” Id.
Because of this clear language, the Court does not need to
review documents preceding the June 7, 2022 Memorandum Opinion
and Order. Mr. Greenwald’s earlier arguments that other
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conflicts support jurisdiction—and Defendants’ arguments against
those other conflicts—cannot change the scope of the Court’s
ruling. Likewise, the R. & R. cannot alter the Court’s decision—
particularly since the Court held that it rejected “[t]he
portion of the R. &. R . . . finding that there is no
jurisdiction under 42 U.S.C. § 1395ff(f)(3).” Greenwald, 2022 WL
2046108, at *9.
In reply, Mr. Greenwald contends that Defendants have
“misconstru[ed]” the Memorandum Opinion and Order. Pl.’s Reply,
ECF No. 58 at 4. Specifically, he contends that “this action did
not dismiss [his] allegations that the LCD is inconsistent with
the NCD or render them abandoned.” Id. Defendants do not suggest
this outcome in their briefing. See Defs.’ Opp’n, ECF No. 57 at
2-5. Rather, they admit—as they must—that Mr. Greenwald’s Motion
for Summary Judgment raises multiple conflicts between the NCD
and LCD and that the Motion has not yet been decided. See id. at
3. Nevertheless, the Court clarifies that it held only that it
has subject matter jurisdiction because of the conflict
regarding the conservative therapy trial requirements in its
June 7, 2022 Memorandum Opinion and Order. See Greenwald, 2022
WL 2046108, at *6-7, 9. The Court did not decide whether there
are other conflicts. See id.

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C.

LCD L33829 is Severable

Finally, Mr. Greenwald asserts that the entire LCD must be
invalid because one portion is invalid. See Pl.’s Mot., ECF No.
56 at 7-8. He contends that courts may not invalidate “selected
portions of LCDs” for two reasons: (1) courts may not amend
Section 1395ff(f) by inference, id. (citing Hollingsworth v.
Duff, 444 F. Supp. 2d 61, 65 (D.D.C. 2006)); and (2) LCDs are
not severable, id. at 8 (citing United States v. Mead Corp., 533
U.S. 218 (2001); Scenic America, Inc. v. U.S. Dep’t of Transp.,
49 F. Supp. 3d 53, 60 (D.D.C. 2014); 42 C.F.R. § 405.1062). He
suggests instead that the Court adopt “the procedure when a
court finds that a regulation violates the Administrative
Procedure Act and is vacated by a court.” Id. (citing Nat'l
Mining Ass’n v. U.S. Army Corps of Eng’rs, 145 F.3d 1399, 1409
(D.C. Cir. 1998)).
As to Mr. Greenwald’s argument against amendment by
inference, Defendants respond that the caselaw is “irrelevant”
because those cases concern situations where one statute repeals
another statute by implication. Defs.’ Opp’n, ECF No. 57 at 9
(citing Hollingsworth, 444 F. Supp. 2d at 65). The Court agrees
with Defendants on this point. In Hollingsworth, the district
court considered whether the AOUSC Personnel Act repealed and
modified the Rehabilitation Act by implication. See
Hollingsworth, 444 F. Supp. 2d at 65. By contrast, the instant
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case concerns the severability of a single LCD, not a conflict
between two statutes.
As to Mr. Greenwald’s argument against severability,
Defendants insist that the severability doctrine applies to
LCDs. See Defs.’ Opp’n, ECF No. 57 at 5-9. They suggest that the
Court treat LCDs like other agency determinations and apply
binding precedent governing the severability of those
determinations. See id. at 6. Mr. Greenwald contests this
proposal, stating that “[t]he LCD is not a statute, but a policy
published by a private contractor” such that “[i]t does not
qualify for deference and may be disregarded by Administrative
Law Judges.” Pl.’s Reply, ECF No. 58 at 5. This argument
understates the significance of LCDs. As Defendants explain,
LCDs “are only issued after [MACs] follow detailed procedures,
including engaging in a comment-and-notice period, soliciting
feedback and recommendations from the medical community, and
presenting the policy in meetings of stakeholders.” Defs.’
Opp’n, ECF No. 57 at 6 (citation omitted). Further, the agency
has promulgated regulations for administrative challenges to
LCDs that closely track regulations for administrative
challenges to NCDs, which are agency rules. See 42 C.F.R. Part
426 (implementing 42 U.S.C. §§ 1395ff(f)(1),(2)); Defs.’ Opp’n,
ECF No. 57 at 7. Because the agency treats LCDs like
administrative rules, the Court is persuaded that it should
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treat LCDs like other agency determinations to decide the
severability question.
This question is governed by binding precedent from the
Court of Appeals for the District of Columbia Circuit (“D.C.
Circuit”). Accordingly, “[w]hether the offending portion of [the
LCD] is severable depends upon the intent of the agency and upon
whether the remainder of the [LCD] could function sensibly
without the stricken provision.” MD/DC/DE Broadcasters Ass’n v.
F.C.C., 236 F.3d 13, 22 (D.C. Cir. 2001) (citing K Mart Corp. v.
Cartier, Inc., 486 U.S. 281, 294 (1988)). To aid its inquiry,
the Court must consider whether the provisions of the LCD are
“intertwined” or instead “operate entirely independently of one
another.” Davis Cnty. Solid Waste Mgmt. v. EPA, 108 F.3d 1454,
1459 (D.C. Cir. 1997) (per curiam).
The parties agree that the agency has not stated whether
LCDs are severable. See Defs.’ Opp’n, ECF No. 57 at 7; Pl.’s
Reply, ECF No. 58 at 5. Even so, Defendants argue that the
agency must have intended LCDs to be severable because: (1)
requiring the issuance of a new LCD in every instance “would
create an unnecessary burden”; and (2) regulations permit
Administrative Law Judges to sever provisions of LCDs when
parties challenge those provisions in administrative
proceedings. Defs.’ Opp’n, ECF No. 57 at 6-8. Mr. Greenwald
challenges both of these arguments. See Pl.’s Reply, ECF No. 58
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at 5-7. He contends that invalidation of LCD L33829 as a whole
would not be burdensome because: the Secretary compensates MACs
for developing LCDs; the MAC here need only make the LCD conform
with the relevant NCD; and the MAC could reinstate the previous
LCD regarding pneumatic compression devices. See id. at 6. The
Court is not persuaded, as this argument ignores the
comprehensive process MACs must follow to set new LCDs. See
Medicare Program Integrity Manual § 13.7.4.
Mr. Greenwald also challenges Defendants’ reliance on
regulations set pursuant to Section 1395ff(f)(2), which
discusses the administrative appeals process for challenges to
LCDs. See Pl.’s Reply, ECF No. 38 at 5-6. Citing Supreme Court
authority, he argues that Section 1395ff(f)(3) must not be
severable because “Section 1395ff(f)(2) may allow for
severability under the Secretary’s regulations,” but “Congress
did not include any provision for severability in Section
1395ff(f)(3).” Id. at 6 (citing Keene Corp. v. United States,
508 U.S. 200, 208 (1993) (“[W]here Congress includes particular
language in one section of a statute but omits it in another . .
. , it is generally presumed that Congress acts intentionally
and purposely in the disparate inclusion or exclusion.” (quoting
Russello v. United States, 464 U.S. 16, 23 (1983)))). This
argument is unpersuasive. Congress did not specify that LCDs are
severable in Section 1395ff(f)(2); rather, the Secretary
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promulgated regulations setting forth procedures for
administrative procedures and making it clear that LCDs are
severable in these proceedings, see 42 C.F.R. § 426.400. Mr.
Greenwald does not explain why LCDs may be severable in
administrative proceedings but not in federal court, and the
Court declines to formulate a reason now. The Court therefore
agrees with Defendants that the regulatory scheme suggests that
the agency intended for federal courts to treat LCDs as
severable.
This conclusion is further supported by the text of LCD
L33829. In addition to the conservative therapy trial
requirements, the LCD addresses the following topics under
separate headings:
• Requirements for prescriptions for pneumatic
compression devices;
• Definitions of edema, primary lymphedema,
secondary
lymphedema,
chronic
venous
insufficiency, and peripheral artery disease;
• Coding for pneumatic compression devices;
• Requirements for coverage of pneumatic
compression devices for lymphedema;
• Coverage for chronic venous insufficiency
with venous stasis ulcers;
• Various requirements for coverage where
lymphedema extends onto the chest, trunk,
and/or abdomen;
• Coverage for peripheral artery disease;
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•
Coverage
for
deep
venous
thrombosis
prevention;
• Coverage for pneumatic compression device
related accessories;
•
Pneumatic
selection;

compression

device

coding

• Requirements for physician orders; and
• Various documentation requirements.
See LCD L33829. The Court therefore concludes that the
conservative therapy trial requirements are not intertwined with
the other provisions of the LCD and concludes that those
requirements may be severed from the remainder of the LCD. 2
IV.

Conclusion and Order
For the reasons explained above, it is HEREBY ORDERED that

Mr. Greenwald’s Motion for Clarification of the Court’s June 7,
2022 Memorandum Opinion and Order, see ECF No. 56, is DENIED.
SO ORDERED.
Signed:

Emmet G. Sullivan
United States District Judge
May 24, 2023

The Court will not address Defendants’ argument that compliance
with the June 7, 2022 Memorandum Opinion and Order would fully
resolve this action. See Defs.’ Opp’n, ECF No. 57 at 9-11. This
argument ignores the fact that the Court has not reached the
merits of Mr. Greenwald’s claims or decided his summary judgment
motion. See Greenwald, 2022 WL 2046108, at *9; Docket for Civ.
Action No. 17-797.
2

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