Kilmer v. Leavitt

609 F. Supp. 2d 750, 2009 WL 921434
CourtDistrict Court, S.D. Ohio
DecidedMarch 26, 2009
Docket2:07-cv-01094
StatusPublished
Cited by6 cases

This text of 609 F. Supp. 2d 750 (Kilmer v. Leavitt) is published on Counsel Stack Legal Research, covering District Court, S.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Kilmer v. Leavitt, 609 F. Supp. 2d 750, 2009 WL 921434 (S.D. Ohio 2009).

Opinion

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)(l), 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)(l), 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-soo©. 1

*752 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)(l), 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.

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Cite This Page — Counsel Stack

Bluebook (online)
609 F. Supp. 2d 750, 2009 WL 921434, Counsel Stack Legal Research, https://law.counselstack.com/opinion/kilmer-v-leavitt-ohsd-2009.