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Broome v. Burwell

United States District Court, D. Oregon

April 1, 2015

MELINDA BROOME, Plaintiff,
v.
SILVIA MATHEWS BURWELL, Secretary, United States Department of Health and Human Services, Defendant.

OPINION AND ORDER

MICHAEL J. McSHANE, District 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)(1) 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)(1)(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 "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)(1) 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.

PROCEDURAL AND FACTUAL BACKGROUND

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 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. §§ 1395-1395111, 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)(1).

The MMA further specifies, in the third paragraph of 42 U.S.C. § 1395w-102(e)(1), that the definition of a 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" means-
(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 ...

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