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Legal Corner

Off-Label Prescription Drug Coverage under Medicare Part D

References

  • Steven R. Salbu, Off-Label Use, Prescription, and Marketing of FDA-Approved Drugs: An Assessment of Legislative and Regulatory Policy, 51 Fla. L. Rev. 181, 189 (1999) (defining “off-label use”).
  • 42 C.F.R. § 423.100 (2007) (defining “Covered Part D drug”).
  • Medicare Rights Center. Off-Base: The Exclusion of Off-label Prescriptions from Medicare Part D Coverage. August 2007; Available at www.medicarerights.org/Off-label_PartD_Coverage.pdf.

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