IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF OREGON 

MELINDA BROOME, 

Plaintiff, 

V. 

SILVIA MATHEWS BURWELL, 

Secretary, United States Department of 

Health and Human Services, 

Defendant. 

MCSHANE, Judge: 

Case No. 6:14-cv-01248-MC 

OPINION AND ORDER 

Plaintiff Melinda Broome brings this action for judicial review of a decision by the 

Medicare Appeals Council (MAC) denying her continued Medicare Part D coverage for fentanyl , 

citrate lozenges for breakthrough pain (pain that "breaks through" the pain medication she 

regularly takes) associated with her chronic, severe back pain. This Court has jurisdiction under 

42 U:S.C. § 405(g). See 42 U.S.C. § 1395ff(b)(l)(A). 

This Court is asked to consider whether the clause "and such term includes" in the third 

paragraph of 42 U.S.C. § 1395w-102(e)(l) is illustrative (it introduces several examples of 

coverage) or definitional (it imposes additional conditions on coverage). If this clause is 

interpreted as illustrative, then the broad language of42 U.S.C. § 1395w-102(e)(l)(A) endorses 

coverage for Broome's lozenges under Medicare Part D. In contrast, if this clause is interpreted 

as definitional, then Broome's lozenges are not covered because she does not use them for their 

1 -OPINION AND ORDER 

Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 1 of 8
"medically accepted indication" as defined in 42 U.S.C. § 1395w-102(e)(4). Because the use of 

the conjunctive "and" in the third paragraph of 42 U.S.C. § 1395w-102(e)(l) is definitional, this 

Court finds that Broome's use of fentanyl citrate lozenges for breakthrough back pain is not 

covered under Medicare Part D. Thus, defendant's motion for summary judgment, ECF No.6, is 

GRANTED. · 

PROCEDURALANDFACTUALBACKGROUND 

Broome qualified for Social Security Disability benefits on June 27, 2008, based on 

chronic back pain stemming from multiple back surgeries. In order to control this back pain, 

Broome currently receives fentanyl injections through a spinal pump, which she supplemented 

with oral fentanyl citrate lozenges to control her breakthrough pain. In 2013, following an audit 

performed by the Centers for Medicare & Medicaid Services, Broome received notification that 

coverage for her fentanyl citrate lozenges prescription would be discontinued, but the Medicare 

Part D plan would still cover the use of fentanyl in her spinal pump. Broome exhausted her 

administrative appeals up to the MAC, which determined on June 2, 2014, that Broome's 

fentanyl citrate lozenges use did not match the definition of a "medically accepted indication" as 

defined in 42 U.S.C. § 1395w-102(e)(4). Broome now seeks judicial review. 

STANDARD OF REVIEW 

Under the Administrative Procedure Act, a district court may set aside an agency decision 

that is '"arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with 

law."' Palomar Med. Ctr. v. Sebelius, 693 F.3d 1151, 1159 (9th Cir. 2012) (quoting 5 U.S.C. § 

706(2)(A)). A district court must affirm the decision if it is "supported by 'substantial evidence' 

and if the proper legal standards were applied." Mayes v. Masanari, 276 F.3d 453, 458-59 (9th 

Cir. 2001). "Substantial evidence" is "more than a mere scintilla but less than a preponderance; it 

2 - OPINION AND ORDER 

Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 2 of 8
is such relevant evidence as a reasonable mind might accept as adequate to support a 

conclusion." Sandgathe v. Chater, 108 F.3d 978, 980 (9th Cir. 1997) (citation and internal 

quotations marks omitted). 

DISCUSSION 

The Medicare Act, established under Title XVIII of the Social Security Act, 42 U.S.C. §§ 

1395-1395lll, is a federally funded health insurance program for the elderly and disabled. See 

Maximum Comfort Inc. v. Sec. of Health & Human Servs., 512 F.3d 1081, 1083 (9th Cir. 2007). 

At issue here is Part D, a voluntary prescription drug benefit program established by the 

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. No. 

108-173, 117 Stat. 2066 (2012). The MMA identifies three types of drugs covered by Part D, 

including: (1) certain prescription drugs; (2) certain biological products; and (3) certain insulin 

and supplies used to inject insulin. See 42 U.S.C. § 1395w-102(e)(l). 

The MMA further specifies, in the third paragraph of 42 U.S.C. § 1395w-102(e)(l), that 

the definition of !i covered Part D drug includes "a vaccine licensed under section 262 of this title 

... and any use of a covered Part D drug for a medically accepted indication (as defined in 

paragraph ( 4) ). " Because Broome's lozenges are not licensed vaccines, the issue before this 

Court is whether Broome's fentanyl citrate lozenges must be used solely for their "medically 

accepted indication," as defined in 42 U.S.C. § 1395w-102(e)(4), in order to qualify for 

coverage. The disputed provision of the MMA reads as follows: 

(e) Covered part D drug defined 

(1) In general 

Except as provided in this subsection, for purposes of this part, the 

term "covered part D drug" means3 - OPINION AND ORDER 

Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 3 of 8
(A) a drug that may be dispensed only upon a prescription and that is 

described in subparagraph (A)(i), (A)(ii), or (A)(iii) of section 1396r8(k)(2) ofthis title; or 

(B) a biological product described in clauses (i) through (iii) of 

subparagraph (B) of such section or insulin described in subparagraph 

(C) of such section and medical supplies associated with the injection 

of insulin (as defined in regulations of the Secretary), 

and such term includes a vaccine licensed under section 262 of this 

title (and, for vaccines administered on or after January 1, 2008, its 

administration) and any use of a covered part D drug for a medically 

accepted indication (as defined in paragraph (4)). 

( 4) Medically accepted indication defined 

(A) In general 

For purposes of paragraph (1 ), the term "medically accepted 

indication" has the meaning given that term-

(i) in the case of a covered part D drug used in an anticancer 

chemotherapeutic regimen, in section 1395x(t)(2)(B) of this title, 

except that in applying such section-

(I) "prescription drug plan or MA-PD plan" shall be substituted for 

"carrier" each place it appears; and 

(II) subject to subparagraph (B), the compendia described in section 

1396r-8(g)(l )(B)(i)(III) of this title shall be included in the list of 

compendia described in clause (ii)(I) section 1395x(t)(2)(B) qf this 

title; and 

(ii) in the case of any other covered part D drug, in section 1396r8(k)(6) ofthis title. 

42 U.S.C. § 1395w-102(e) (emphasis added). 

Because Broome does not use fentanyl citrate lozenges as part of an anticancer 

chemotherapeutic regimen, see 42 U.S.C. § 1395w-102(e)(4)(A)(i), her use must satisfy the 

"medically accepted indication" criteria listed in 42 U.S.C. § 1396r-8(k)(6), see 42 U.S.C. § 

4- OPINION AND ORDER 

Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 4 of 8
1395w-102(e)(4)(A)(ii). Under§ 1396r-8(k)(6), the "medically accepted indication" is defined 

as (1) a use approved by the Food and Drug Administration (FDA), or (2) "the use of which is 

supported by one or more citations included or approved for inclusion in any of the compendia 

described in section (g)(l)(B)(i) ofthis section." 42 U.S.C. § 1396r-8(k)(6). The compendia 

include: 

(I) the American Hospital Formulary Service Drug Information; 

(II) the United States Pharmacopeia-Drug Information (or its successor 

publications); and 

(III) the DRUGDEX Information Systems. 

42 U.S.C. § 1396r-8(g)(l)(B)(i). 

Broome does not argue that treatment for back pain is an FDA-approved use for fentanyl 

citrate lozenges, or that she satisfies the compendia requirement. Instead, she argues that the 

phrase "any use of a covered Part D drug for a medically accepted indication" is merely 

illustrative, not definitional. 

The United States District Court for the Northern District of California properly rejected 

the same argument inNievodv. Sebellius, No. C11-4134 SBA, 2013 WL 503089, at *7 (N.D. 

Cal. Feb. 8, 2013). In Nievod, the court relied on four findings. 

First, the Nievod court examined the structure of 42 U.S.C. § 1395w-102(e)(l), 

comparing the disjunctive term "or" between subparagraphs (e)(l)(A) and (e)(l)(B), and the 

conjunctive term "and" at the beginning of the third paragraph to (e)(l). Id. at *6-7. The Nievod 

court concluded that "taken together, the provisions of the third paragraph logically convey that 

the medically accepted indication requirement applies generally and in addition to the provisions 

of subsections (A) and (B)." !d. at *7 (emphasis in original). 

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Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 5 of 8
Second, the Nievod court considered the context in which "and such term includes" was 

used in the statute. Id. at *7-8. The court noted that subparagraphs (e)(l)(A) and (e)(l)(B)both 

cross-reference 42 U.S.C. § 1396r-8(k)(2), which "identifies each of the aforementioned items as 

defining what constitutes a 'covered outpatient drug."' Id. at *7. Specifically excluded from the 

definition of a "covered outpatient drug" is any drug "used for a medical indication which is not 

a medically accepted indication." 42 U.S.C. § 1396r-8(k)(3). Put differently, "all of the drugs 

identified in the definition of a covered Part D drug must ... satisfy the medically accepted 

indication requirement." Nievod, 2013 WL 503089, at *7. As a result, the court concluded "it 

would be incongruous to construe section 1395w-1 02(e)'s reference to 'any use of a covered 

Part D drug for a medically accepted indication' as anything other than a specific circumscription 

on the definition of a covered Part D drug." Id. 

Third, the Nievod court determined that its interpretation of "and such term includes" was 

further supported "by the interplay between the reference to 'biological product' and 'vaccines' 

in the second and third paragraphs of section 1395w-102(e), respectively." Id. at *8. The second 

paragraph of section 1395w-1 02( e) defines "biological product." That definition crossreferences 42 U.S.C. 1396r -8(k)(2)(B), which "specifically excludes vaccines." Id. (emphasis in 

original). In contrast, the third paragraph of section 1395w-1 02( e) provides: "and such term 

includes a vaccine licensed under section 262 of this title (and, for vaccines administered on or 

after January 1, 2008, its administration)." 42 U.S.C. § 1395w-1 02( e )(1) (emphasis added). The 

court explained that "[g]iven that the definition of a 'biological product' does not include a 

vaccine, it would be illogical to construe the reference to vaccines as [illustrative], when, in the 

preceding paragraphs, vaccines are expressly excluded." Nievod, 2013 WL 503089, at *8. 

6- OPINION AND ORDER 

Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 6 of 8
Fourth, the Nievod court emphasized that an illustrative interpretation of"includes" under 

the third paragraph of (e)( 1) "cannot be reconciled with the ... l~ngthy and detailed definition of 

'medically accepted indication' within the statutory definition of 'covered Part D drug." !d. The 

definition of"medically accepted indication" under. section 1395w-102(e) is divided into two 

parts. See 42 U.S.C. § 1395w-102(e)(4)(A). The first part, which applies to Part D drugs "used 

in an anticancer chemotherapeutic regimen," incorporates the definition of "medically accepted 

indication" in Medicare Part B, codified at 42 U.S.C. § 1395x(t)(2)(B). See 42 U.S.C. § 1395w1 02( e)( 4 )(A)(i). The second part, which applies to any other covered Part D drug, incorporates a 

narrower definition of"medically accepted indication" codified at 42 U.S.C. § 1396r-8(k)(6). 

See 42 U.S.C. § 1395w-102(e)(4)(A)(ii); Nievod, 2013 WL 503089, at *9 n.3 ("Unlike section 

1396r-8(k)(6), the definition for medically accepted indication set forth in Medicare Part B is 

broader in that it permits the use of certain 'peer reviewed medical literature."' (citation 

omitted)). The court found that this detailed definitional framework "belie[ d) Plaintiffs assertion 

that the reference to the medically accepted indication requirem~nt [in the third paragraph of 

(e)(1)] is merely 'illustrative' and not restrictive." Nievod, 2013 WL 503089, at *9. 

Because of these findings, the Nievod court held that, "[i]n the case of an off label use of 

a Part D drug, coverage under Part D is dependent upon whether the Medicare enrollee is able to 

satisfy the compendia requirement."'Nievod, 2013 WL 503089, at *9. This Court is persuaded by 

the reasoning in Nievod. See also Rickoff v. United States Sec y for the Dep 't of Health & Human 

Servs., No. CV-11-2189-PHX-DGC, 2012 WL 6177411, at *2 (D. Ariz. Dec. 11, 2012) 

(''Fentanyl in lozenge form is not a 'medically accepted indication' for non-cancer patients and 

7 - OPINION AND ORDER 

Case 6:14-cv-01248-MC Document 16 Filed 04/01/15 Page 7 of 8
this is not a covered Part D drug."); Kilmer v. Leavitt, 609 F. Supp. 2d 750, 753 (S.D. Ohio 

2009) (concluding that "the medically accepted indication clause must be read as a limitation"). 1 

CONCLUSION 

For these reasons, defendant's motion for summary judgment, ECF No.6, is GRANTED. 

IT IS SO ORDERED. 

DATED this 1st day of April, 2015. 

!----

.\______ 

Michael J. McShane 

United States District Judge 

1 But see Layzer v. Leavitt, 770 F. Supp. 2d 579, 587 (S.D. N.Y. 2011) (holding that "Congress did not intend to 

impose the Compendia Requirement"). 

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