Broome v. Secretary of Health and Human Services

Filing 16

Opinion and Order: Defendant's Motion for Summary Judgment 6 is Granted. Signed on 4/1/2015 by Judge Michael W. Mosman. (cp)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON

MELINDA BROOME,

Plaintiff,

Case No. 6:14-cv-01248-MC
OPINION AND ORDER

V.

SILVIA MATHEWS BURWELL,
Secretary, United States Department of
Health and Human Services,

Defendant.

MCSHANE, Judge:

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

"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

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

(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

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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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

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. § 1395w102(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

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").

8 - OPINION AND ORDER