Rickhoff v. U.S. Sec'y for the Dep't of Health & Human Servs.
| Decision Date | 11 December 2012 |
| Docket Number | No. CV-11-2189-PHX-DGC,CV-11-2189-PHX-DGC |
| Parties | Penny Rickhoff, Plaintiff, v. United States Secretary for the Department of Health and Human Services, Defendant. |
| Court | U.S. District Court — District of Arizona |
Plaintiff Penny Rickhoff has commenced this action under 42 U.S.C. § 1395w-104(h)(1) for review of a final decision of the Secretary of Health and Human Services ("Defendant") that denied Plaintiff's claim for coverage of a particular prescription drug. Doc. 1. The dispute centers on whether the drug at issue is covered by Medicare Part D. Plaintiff filed her opening brief on August 8, 2012 (Doc. 18), and Defendant filed a response on September 13, 2012 (Doc. 19). No reply brief was filed. For reasons that follow, the Court will affirm Defendant's decision. 1
Title XVIII of the Social Security Act, 42 U.S.C. § 1395 et seq., provides for the Medicare program, a federally funded and administered health insurance program for qualifying individuals. Defendant administers the Medicare program through the Centersfor Medicare and Medicaid Services ("CMS"), a federal agency within the Department of Health and Human Services. Since 2006, Medicare has included Medicare Part D, a voluntary prescription drug benefits program for Medicare enrollees. 42 U.S.C. § 1395w-101 et seq. The CMS provides drug coverage to Part D enrollees through private Part D Plans ("PDP") offered and administered by private PDP sponsors. Id. PDP sponsors are required to provide qualified prescription drug coverage. 42 U.S.C. §§ 1395w-102-1395w-104.
To qualify as a covered Part D drug, a drug must be used for a "medically accepted indication." 42 U.S.C. § 1395w-102(e)(1); see also 42 C.F.R. § 423.100 (defining "Part D drug"); Kilmer v. Leavitt, 609 F. Supp. 2d 750, 753-54 (S.D. Ohio 2009) (); U.S. ex. rel. Fox Rx., Inc. v. Omnicare Inc., No. 1:11-cv-00962-WSD, 2012 U.S. Dist. LEXIS 145036, at *23-25 (N.D. Ga. 2012) (same); but see Layzer v. Leavitt, 770 F. Supp. 2d 579, 584-85 (S.D.N.Y. 2011) (). A "medically accepted indication" means "any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.], or 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)(1)(B)(i) of this section." 42 U.S.C. § 1396r-8(k)(6). The compendia are (1) the American Hospital Formulary Service Drug; (2) the United States Pharmacopeia-Drug Information; and (3) the DRUGDEX Information Systems (herein collectively referred to as "Compendia"). 42 U.S.C. § 1396r-8(g)(1)(B)(i).
Effective January 1, 2009, Congress expanded the definition of "medically accepted indication" to include off-label usage of Food and Drug Administration ("FDA") approved drugs when used in an anticancer chemotherapeutic regimen as supported by peer-reviewed medical literature. See 42 U.S.C. § 1395w-102(e)(4)(A)(i). Congress did not, however, change the Compendia requirement for non-cancer related,off-label drug therapies.
In accordance with the Medicare Act, Defendant has created an administrative review process that allows enrollees to appeal a PDP's coverage determination. 42 U.S.C. § 1395w-104(g), (h) (incorporating requirements of § 1395w-22(g)); 42 C.F.R. § 423.560 et seq. A coverage determination includes a decision not to provide or pay for a Part D drug, the failure to provide a timely coverage determination when delay would adversely affect the enrollee's health, or a decision concerning an exceptions request. 42 C.F.R. § 423.566(b).
Plaintiff is a Medicare beneficiary who suffers from chronic non-cancer pain stemming from "failed back syndrome" and other diagnoses and injuries. A.R. 338-39, 567-68. On September 21, 2010, Plaintiff's physician, Dr. Anita Mayer, submitted a request for prior authorization to MedicareRX Rewards Plus, Plaintiff's PDP ("the Plan"), for a prescription of transmucosal fentanyl lozenge (Actiq 800 mcg). A.R. 64, 323. The Plan denied the prior authorization request on September 23, 2010 (A.R. 343), and reaffirmed that denial on October 19, 2010 (A.R. 415-16).
Plaintiff pursued an administrative appeal, which eventually led to a May 5, 2011, decision of an administrative law judge ("ALJ") affirming the Plan's denial of coverage. A.R. 40-58. The ALJ found that the FDA had approved fentanyl lozenges such as Actiq "only for breakthrough pain for cancer patients who have become habituated to other pain killing drugs." A.R. 56. The ALJ further found that Plaintiff had not been prescribed Actiq for cancer breakthrough pain but rather for other diagnoses "which have not been deemed 'medically accepted indications' by the FDA." A.R. 56. The ALJ determined that the Compendia "are not inconsistent with the FDA's position that cancer breakthrough pain is the only medically accepted indication for the fentanyl lozenge." A.R. 56. The ALJ also found that the record failed to support the medical necessity of fentanyl in lozenge form, as opposed to fentanyl in skin patch or injection form. A.R. 57.
Plaintiff's appeal of that decision to the Medicare Appeals Council ("MAC")resulted in a September 8, 2011, decision that adopted the findings and conclusions of the ALJ. A.R. 8. The MAC agreed with the ALJ that Plaintiff presented a "sympathetic and compelling case," but concluded nonetheless that "the adjudicator is bound to follow Medicare law and regulations, which do not provide an exception when the drug, as used, does not meet the legal definition of a Part D drug." A.R. 8.
Under 42 U.S.C. § 1395w-104(h)(1), which incorporates the requirements of 42 U.S.C. § 1395w-22(g)(5), judicial review of Defendant's decision in this case is governed by 42 U.S.C. § 405(g).2 See 42 U.S.C. § 1395w-22(g)(5); see also Kilmer, 609 F. Supp. 2d at 752-53 (). Section 405(g) also governs judicial review of claims for benefits under the Social Security Act. Thus, Defendant's denial of a Part D coverage claim will be vacated "only if it is not supported by substantial evidence or is based on legal error." Robbins v. Soc. Sec. Admin., 466 F.3d 880, 882 (9th Cir. 2006); Flaten v. Sec. of Health & Human Servs., 44 F.3d 1453, 1457 (9th Cir. 1995) (). "'Substantial evidence' means more than a mere scintilla, but less than a preponderance, i.e., such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Id. In determining whether the decision is supported by substantial evidence, the Court must consider the record as a whole, weighing both the evidence that supports the decision and the evidence that detracts from it. Reddick v. Charter, 157 F.3d 715, 720 (9th Cir. 1998).
Plaintiff argues that Defendant's decision results in unfair discrimination because it limits coverage of fentanyl lozenges to cancer-patients when the injection and skinpatch form of fentanyl is covered regardless of diagnosis. Plaintiff also contends that fentanyl in lozenge form is medically necessary to treat Plaintiff's breakthrough pain. Doc. 18 at 13. Plaintiff does not argue that fentanyl in lozenge form was prescribed to her for a "medically accepted indication" or that it otherwise is a covered Part D drug. Doc. 18 at 9.
In adopting the ALJ's decision, the MAC noted that Plaintiff had argued that the decision to deny her coverage resulted in discrimination based on diagnosis type because she would not have been denied coverage if she had been diagnosed with cancer. A.R. 6. The MAC pointed to the ALJ's response "that the law covering Medicare Part D prescription drug benefit requires that drugs eligible for coverage must be used for a medically accepted indication," and that since "fentanyl lozenge is only approved by the FDA for breakthrough cancer pain, payment cannot be made." A.R. 6.
Plaintiff makes the same argument here, contending that Defendant's decision is discriminatory because fentanyl in lozenge form is a covered Part D drug for cancer patients suffering from breakthrough pain, but is not covered for non-cancer patients suffering from similar breakthrough pain. Doc. 18 at 9. Plaintiff argues that a "distinction based on labeling creates an unjust result." Id.
Plaintiff appears to be making an equal protection challenge, but she does not assert that this case involves a suspect class or fundamental right. As a result, any equal protection challenge is governed by the rational basis test. See F.C.C. v. Beach Comms., Inc., 508 U.S. 307, 313 (1993) (). The Court agrees with the conclusion in Kilmer that the statutory scheme as applied to fentanyl in lozenge form survives rational-basis review:
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