Kilmer v. Leavitt, Case No. 2:07-cv-1094.

• Decision Date: 10 March 2009
• Docket Number: Case No. 2:07-cv-1094.
• Parties: Patricia KILMER, Plaintiff, v. Michael O. LEAVITT, Secretary of Health and Human Services, Defendant.
• Court: U.S. District Court — Southern District of Ohio

609 F.Supp.2d 750

Patricia KILMER, Plaintiff, v. Michael O. LEAVITT, Secretary of Health and Human Services, Defendant.

Case No. 2:07-cv-1094.

United States District Court, S.D. Ohio, Eastern Division.

March 10, 2009.

As Modified March 26, 2009 Nunc Pro Tunc.

Elizabeth Ilgen Cooke, Columbus, OH, for Plaintiff.

John J. Stark, U.S. Attorney Office, Columbus, OH, for Defendant.

OPINION AND ORDER

GREGORY L. FROST, District Judge.

This case is an appeal from the denial of Medicare part D benefits. For the reasons that follow, the Court affirms.

I. Background

Title XVIII of the Social Security Act, 42 U.S.C. § 1395 et seq., provides for the Medicare program, which is a health insurance program for qualifying individuals that is funded and administered by the federal government. The Secretary of Health and Human Services ("the Secretary") administers the Medicare program, one component of which is a voluntary prescription drug benefits program constituting Medicare Part D. See 42 U.S.C. § 1395w-101 et seq. In 2006, Part D began to cover a range of outpatient prescription drugs, which previously had been covered only in select instances. These Part D benefits are provided by a plan sponsor, which, broadly described, is required to provide qualified prescription drug coverage, 42 U.S.C. § 1395w-102(a)(1), and can provide supplemental prescription drug coverage, 42 U.S.C. § 1395w-102(a)(2). A Part D plan sponsor need not provide coverage for a Part D drug that is not reasonable and necessary for circumstances specified in the statutory framework or that is not prescribed in accordance with the plan or the Medicare Act. See 42 U.S.C. §§ 1395w-102(e)(3) and 1395y(a). To qualify for coverage, an outpatient prescription drug must be used for a medically accepted indication, see 42 U.S.C. 1395w-102(e)(1), which at the time the events involved in this case occurred meant that it must be used as approved under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., or used as supported by at least one citation included or approved for inclusion in the American Hospital Formulary Service Drug Information, the United States Pharmacopeia-Drug Information (or its successor publications), or the DRUGDEX Information System, see 42 U.S.C. § 1396r-8(k)(6).¹

Patricia Kilmer is an adult female and plan participant who suffers from systemic lupus erythematosus. As one of her numerous complications related to this condition, Kilmer is also afflicted with a disorder known as heterotopic bone ossification, which means that bone has developed in what would otherwise be soft tissue in multiple locations in her body, such as her joints. Kilmer is therefore unable to walk, stand, or move without assistance, and is confined to a wheelchair.

As part of her treatment regimen, Kilmer undergoes physical therapy in which her calcified joints are moved, which often causes breakthrough pain, or pain that "breaks through" the pain medicine she regularly takes. To treat this breakthrough pain, her treating physician prescribed a painkiller known as oral transmucosal fentanyl citrate, which is also known as Actiq.² Kilmer regularly took Actiq until 2006, when Cephalon, Inc., the drug's manufacturer, discontinued the "compassionate use" program under which she received Actiq. The Cigna Medicare Part D plan in which Kilmer is enrolled then denied her coverage for the drug.³ Kilmer pursued the administrative appeals process, which eventually led to a May 8, 2007 decision in which an administrative law judge denied her coverage for Actiq. (Admin. R. at 12-23.) Her subsequent appeal of that unfavorable decision to the Medicare Appeals Council resulted in an August 21, 2007 decision that adopted the findings and conclusions of the administrative law judge. (Admin. R. at 3-4.)

Kilmer then timely filed this appeal under 42 U.S.C. § 1395w-104(h)(1), which incorporates applicable provisions of 42 U.S.C. § 1395w-22(g)(5) and 42 U.S.C. § 405(g). (Doc. # 5.) The parties have completed briefing on the issues involved, including supplemental filings permitted by leave of court, and the appeal is now ripe for disposition. (Doc. # 16, 19, 24, 27, 30, 33.)

II. Analysis

A. Standard involved

In reviewing a decision to deny coverage, this Court does not consider the case de novo and does not resolve conflicts in the evidence or questions of credibility. See Brainard v. Secretary of Health & Human Servs., 889 F.2d 679, 681 (6th Cir.1989); Garner v. Heckler, 745 F.2d 383, 387 (6th Cir.1984). Rather, the Court's review is limited to determining whether the findings of the administrative law judge are supported by substantial evidence and employed the proper legal standards. Richardson v. Perales, 402 U.S. 389, 401, 91 S.Ct. 1420, 28 L.Ed.2d 842 (1971). Substantial evidence is more than a scintilla of evidence but less than a preponderance; it is "`such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.'" Id. (quoting Consolidated Edison Company v. NLRB, 305 U.S. 197, 229, 59 S.Ct. 206, 83 L.Ed. 126 (1938)); see also Kirk v. Secretary of Health & Human Servs., 667 F.2d 524, 535 (6th Cir.1981), cert. denied, 461 U.S. 957, 103 S.Ct. 2428, 77 L.Ed.2d 1315 (1983). In determining the existence of substantial evidence, this Court must examine the administrative record as a whole. Harris v. Heckler, 756 F.2d 431, 435 (6th Cir.1985); Fraley v. Secretary, 733 F.2d 437, 439-40 (6th Cir.1984); Kirk, 667 F.2d at 536. If the denial of coverage is supported by substantial evidence, the Court must affirm even if the Court would decide the matter differently, see Kinsella v. Schweiker, 708 F.2d 1058, 1059 (6th Cir.1983), and even if substantial evidence also supports the opposite conclusion, see Mullen v. Bowen, 800 F.2d 535, 545 (6th Cir.1986) (en banc).

B. Discussion

1. Actiq as a Covered Part D Drug

The threshold question in this appeal is whether Medicare covers a drug under part D when that drug is not used for a "medically accepted indication." Kilmer's first argument on appeal posits that the administrative law judge erred in concluding that Actiq fails to qualify as a covered part D drug. Although conceding that the off-label use involved here—use not approved by the FDA—is not a medically accepted indication, Kilmer argues that there is no requirement that covered drugs be used only for medically accepted indications. Thus, she reasons, coverage should exist because her use is "medically necessary," a requirement for qualifying off-label prescriptions that neither party disputes.

The Court begins with the definition of a covered Part D drug. The statutory scheme provides that

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 section 1396r-8(k)(2) of this 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)).

42 U.S.C.A. § 1395w-102(e)(1). It is this statutory definition that presents the first point at which the parties' analyses diverge.

Kilmer argues that the last paragraph of § 1395w-102(e)(1) cannot be read as a limitation on the preceding (A) and (B) paragraphs, which would mean that there is no requirement that all covered part D drugs be used only for a medically accepted indication. To support this proposition, Kilmer asserts that the reference to a medically accepted indication "is most naturally read as expressing an addition to, or illustration of, part D coverage." (Doc. # 24, at 4.) If the clause at issue is a limitation on (A), then Actiq is not a covered part D drug here, but if the clause is merely illustrative, then the broad language of (A) would endorse coverage.

This Court is constrained by the plain language of the statutory scheme to conclude that the medically accepted indication clause must be read as a limitation. The Court agrees with Kilmer that the clause's use of "any use of a covered part D drug" points to an understanding on the part of Congress that the meaning of "`covered part D drug' has already been substantially given." (Doc. # 24, at 5-6 (emphasis deleted).) But the key word in Kilmer's proposition is "substantially"; absent that word, this Court could not agree with Kilmer's isolated statement. This is because the statute provides in (A) two initial conditions that define a covered part D drug under that subparagraph: one, that the drug that may be dispensed only upon a prescription, and two, that the drug is also described in select provisions of 42 U.S.C. § 1396r-8(k)(2). This provides a substantial portion of the definition of— but not the complete definition of—a covered part D drug. The last paragraph of § 1395w-102(e)(1) then adds a third condition, specifically that any use of a drug (a drug that satisfies the first two requirements for a covered part D drug) be for a medically accepted indication.

To read the statute otherwise would be to ignore the statute's use of the language "such term" in the clause "and such term includes ... any use of a covered part D drug for a medically accepted indication...." 42 U.S.C.A. § 1395w-102(e)(1). "Such term" refers back to "the term `covered part D drug.'" Id. The specific reference is to covered part D drug, which means that the statutory scheme provides that the term means condition one (prescribed drug) and condition two (described-in-another-statute drug) and includes condition three (use is for medically accepted indication). Kilmer's...