Edmonds v. Levine

• Decision Date: 14 February 2006
• Docket Number: No. 05-21215-CIV.,05-21215-CIV.
• Citation: 417 F.Supp.2d 1323
• Parties: Jack EDMONDS, et al., on behalf of themselves and all others similarly situated, Plaintiffs, v. Alan LEVINE, in his official capacity as secretary, Agency for Health Care Administration of the State of Florida, Defendant.
• Court: U.S. District Court — Southern District of Florida

417 F.Supp.2d 1323

Jack EDMONDS, et al., on behalf of themselves and all others similarly situated, Plaintiffs, v. Alan LEVINE, in his official capacity as secretary, Agency for Health Care Administration of the State of Florida, Defendant.

No. 05-21215-CIV.

United States District Court, S.D. Florida.

February 14, 2006.

Miriam Harmatz, Florida Legal Services, Inc., Miami.

C. Shawn Bochringer, Legal Aid Service of Broward County, Inc., Plantation.

Neil Kodsi, Carlton Fields, P.A., Miami.

Jennifer Wimberly, Legal Aid Society of Orange County Bar, Orlando.

Jane Perkins, National Health Law Program, Chapel Hill, N.C.

ORDER GRANTING PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT, ENTERING PERMANENT INJUNCTION, AND DENYING AS MOOT PLAINTIFFS' AMENDED MOTION FOR PRELIMINARY INJUNCTION

THEODORE KLEIN, United States Magistrate Judge.

THIS MATTER came before the Court on Plaintiffs' Motion for Summary Judgment (D.E. No. 92) filed on September 16, 2005, and related filings. Before the summary judgment motion had been fully briefed by the parties, the Court held a hearing on September 21-23, 2005, on Plaintiffs' Amended Motion for Preliminary Injunction (D.E. No. 11) and related filings, at which time the Court heard live testimony from several witnesses and oral argument from counsel on the preliminary injunction issue. After careful consideration of all materials submitted in connection with both the preliminary injunction and summary judgment motions, the Court concludes that this case turns on an issue of statutory construction and that there are no material facts in dispute. Accordingly, the Court is able to rule directly on Plaintiffs' summary judgment motion which, for the reasons discussed below, is GRANTED. The Court enters a PEMANENT INJUNCTION directing Defendant to stop applying the Neurontin policy announced in "Medicaid Changes Effective July 1, 2004, Neurontin Label Indications and Dosing," provide coverage for off-label uses of Neurontin which are cited in one of the congressionally-approved compendia listed in 42 U.S.C. § 1396r-8(g)(1)(B)(i), as discussed herein; and take other steps necessary to ensure that notice of this change in policy is communicated to affected individuals. The Court DENIES AS MOOT Plaintiffs' amended motion for preliminary injunction.¹

BACKGROUND

Present Dispute

Plaintiffs Jack Edmonds, Susan Weschke, and Gaylord Payne (collectively referred to herein as "Plaintiffs") are Medicaid recipients who are challenging a policy of the Florida Agency for Health Care Administration ("AHCA")² to deny reimbursement under the federal Medicaid program for prescriptions for the drug Neurontin and/or its generic equivalent, Gabapentin (collectively referred to herein as "Neurontin"), except when prescribed for four indications or uses: adjunctive therapy for partial seizures (including partial seizure refractory); postherpetic neuralgia; diabetic neuropathy; and amyotrophic lateral sclerosis ("ALS"). AHCA's policy on Neurontin, which was announced in "Medicaid Changes Effective July 1st, 2004, Neurontin Label Indications and Dosing," took effect on July 1, 2004 (the "Neurontin policy"). See Plfs.' Not. of Filing Exs. ("Plfs.' Not.") (D.E. No. 9), Ex. 5-4.

Plaintiffs suffer from neuropathic pain resulting from conditions other than the four identified above. Plaintiffs and their treating physicians or psychiatrists claim that Neurontin is one of the first-line medications for neuropathic pain, is a relatively safe and inexpensive drug widely used to treat nerve-related pain and some psychiatric disorders, and is medically necessary for the treatment of their conditions. Prior to July 1, 2004, Plaintiffs' prescriptions for Neurontin were covered under Medicaid by AHCA. Since July 1, 2004, however, their requests for Neurontin coverage have been, and will continue to be, denied as a result of AHCA's new policy, if the drug is not being prescribed for one of the four approved uses cited above. Plaintiffs claim that AHCA's Neurontin policy violates the federal Medicaid Act because it fails to provide them with coverage of prescriptions for Neurontin for medically accepted indications as required by the Medicaid Act.

Plaintiffs seek a permanent injunction directing Defendant Alan Levine, in his official capacity as Secretary of AHCA ("Defendant"), to: (1) refrain from continuing to implement the policy announced in "Medicaid Changes Effective July 1st, 2004, Neurontin Label Indications and Dosing;" (2) adopt a written policy that ensures that a prescription for the covered outpatient drug Neurontin/Gabapentin will be reimbursed by Defendant if the drug use is cited in either the drug labeling or in at least one of the drug compendia cited at 42 U.S.C. § 1396r-8(g)(1)(B)(i); (3) publish notice to all physicians and pharmacists that their patients can resubmit a prescription for Neurontin/Gabapentin, along with an amended prior authorization form; and (4) provide written notice to members of the class whose prescriptions were denied since July 2004 that they can submit new prescriptions and prior authorization requests.

Statutory Framework

The Medicaid program is a cooperative federal-state program designed to assist states with the cost of providing health care to the poor. See 42 U.S.C. §§ 1396-1396v; see also Wilder v. Va. Hosp. Ass'n, 496 U.S. 498, 110 S.Ct. 2510, 2513, 110 L.Ed.2d 455 (1990); Pharm. Research & Mfrs. of Am. v. Meadows, 304 F.3d 1197, 1199-1200 (11th Cir.2002). States are not required to participate in the program; however, if a state chooses to do so, it must comply with federal statutory and regulatory requirements. Fla. Ass'n of Rehab. Facilities, Inc. v. Fla. Dept. of Health & Rehab. Servs., 225 F.3d 1208, 1211 (11th Cir.2000). Actual Medicaid relief is administered through state agencies pursuant to a Medicaid plan that has been approved by the U.S. Department of Health and Human Services ("HHS"). Meadows, 304 F.3d at 1199-1200. AHCA is the state agency that administers the Medicaid program in Florida. Fla. Stat. §§ 409.901(14), 409.902 (2004).

The Medicaid Act requires participating states to make certain mandatory services available to all individuals who are covered by the state's Medicaid plan. See 42 U.S.C. § 1396a(a)(10). States may also provide other, optional medical services such as coverage for outpatient prescription drugs. Id.; see also 42 U.S.C. § 1396d(a)(12). Once "a state elects to provide an optional service, that service becomes part of the state Medicaid plan and is subject to the requirements of federal law." Doe v. Chiles, 136 F.3d 709, 714 (11th Cir.1998).

Coverage of Outpatient Prescription Drugs

The Medicaid Act's provisions for coverage of outpatient prescription drugs (also referred to herein as "Medicaid-eligible drugs") are set forth in 42 U.S.C. § 1396r-8. The Act provides coverage for the "medically accepted indication" of "any covered outpatient drug."³ The term "medically accepted indication" is defined as

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 subsection (g)(1)(B)(i) of this section.

§ 1396r-8(k)(6). There are three compendia listed in subsection (g)(1)(B)(i): United States Pharmacopeia—Drug Information ("USP"), American Hospital Formulary Service Drug Information ("AHFS"), and DRUGDEX Information System ("DRUDEX"). Thus, the Medicaid Act directs states to reimburse any use for a covered outpatient drug which is either (1) approved by the Federal Drug and Food Administration ("FDA") or (2) supported by one or more citations in any congressionally-recognized compendia.⁴

The FDA has approved Neurontin, a covered outpatient prescription drug, for two uses: adjunctive therapy for partial seizures and postherpetic neuralgia. There are many off-label uses for Neurontin, all of which thus call into play the question of whether such uses are "supported by one or more citations included . . . in any of the compendia." Florida covers the two FDA-approved uses, and two other off-label uses of Neurontin, adopting its own criteria for deciding that those are the only two such uses which are properly supported by citation in the compendia. It is the meaning of the phrase "supported by one or more citations included ... in any of the compendia" upon which this case turns.

States' Ability to Restrict or Exclude Coverage

While the Medicaid Act requires a state paying for outpatient prescription drugs to reimburse for "medically accepted indications," the Act does permit states to limit coverage under certain circumstances. See § 1396r-8(d). Under § 1396r-8(d)(1)(B), a state may exclude a drug from coverage, that is, deny reimbursement, under four circumstances: if the prescribed use is not for a medically accepted indication (i.e., either FDA approved or supported by citation in a compendium); if the drug is listed in § 1396r-8(d)(2) or is subsequently determined by the Secretary of HHS by regulation to be subject to clinical abuse or inappropriate use; if the drug is subject to restriction pursuant to an agreement between the state and drug manufacturer; or if the drug has been excluded by a state-established formulary.

The only one of the four circumstances listed above which is at issue here is whether the disputed uses are for medically accepted indications. The parties agree that the other three of these circumstances do not exist here. Neurontin is not on the list of restricted drugs delineated in § 1396r-8(d)(2) nor has it been restricted by HHS regulation; there is no agreement between Neurontin's manufacturer and the State of Florida to restrict coverage; and Florida has not established a drug formulary. Two of the circumstances above, i.e., appearance on a restricted drug list or drugs subject to a coverage...