## Facts

- Florida Medicaid recipients were prescribed Neurontin (gabapentin) for off-label uses their physicians considered medically necessary.
- The off-label uses at issue were supported by citations in at least one drug compendium listed in 42 U.S.C. § 1396r-8(g)(1)(B)(i).
- Florida’s Medicaid agency adopted a July 1, 2004 policy limiting reimbursement for Neurontin to four specified indications and denying reimbursement for other uses unless the agency found them “safe and effective.”
- In practice, the agency tied “safe and effective” to evidence criteria such as randomized, double-blind, placebo-controlled clinical trials.
- Plaintiffs sought prospective, class-wide injunctive relief against the Medicaid administrator under 42 U.S.C. § 1983, alleging the state policy conflicted with federal Medicaid drug-coverage requirements.

## Issues

1. Whether federal Medicaid law (42 U.S.C. § 1396r-8) requires coverage of Neurontin for off-label uses supported by citations in congressionally identified drug compendia.
2. Whether a state Medicaid agency may impose an additional state “effectiveness” requirement that narrows coverage for compendia-supported off-label uses.
3. Whether the asserted federal Medicaid drug-coverage rights were enforceable through prospective relief under 42 U.S.C. § 1983.

## Decision

- The court found the dispute turned on statutory construction and that no material facts were in genuine dispute.
- The court granted plaintiffs’ motion for summary judgment.
- The court permanently enjoined the Medicaid agency from applying the Neurontin policy.
- The injunction required coverage of off-label Neurontin uses supported by citations in the specified federal compendia and required steps to communicate the policy change to affected individuals.
- The court denied the amended motion for a preliminary injunction as moot after entering final relief.
- Class certification was granted by separate order.

## Legal Principles

- Under 42 U.S.C. § 1396r-8, a “medically accepted indication” includes FDA-approved uses and certain off-label uses supported by citations in congressionally recognized drug compendia.
- A state Medicaid program may not restrict outpatient drug coverage in a manner that conflicts with the federal definition of “medically accepted indication.”
- When Congress designates compendia as the benchmark for medical acceptance of off-label uses for Medicaid coverage purposes, a state may not override that standard by requiring additional proof of effectiveness beyond compendia support.
- Prospective injunctive relief may be available under 42 U.S.C. § 1983 to stop enforcement of state Medicaid policies that contravene federally defined coverage requirements.

## Conclusion

The court held that Florida’s Neurontin reimbursement policy unlawfully narrowed federally required Medicaid coverage by adding a state effectiveness screen for compendia-supported off-label uses, and it entered a permanent injunction requiring coverage consistent with federal law.


Edmonds v. Levine, 417 F. Supp. 2d 1323 (S.D. Fla. 2006)