Medically Unnecessary: How the Laws in Medicare Part D’s Coverage of Off-Label Medicines With Demonstrable Medical Necessity Prevents Better Healthcare Outcomes, Including for Beneficiaries With Psychiatric Disorders

Alexander W. Wang

Volume 19

Issue 1

PUBLISHED

Fall 2012

Abstract

This article examines the hardships faced by Medicare Part D patients—particularly mental health patients—in obtaining coverage for necessary but off-label drug prescriptions. It argues that the current Medicare Part D system is failing not only in its mission to provide quality care but also in its goal of cost-effectiveness. The paper advocates a comprehensive reform approach that would address both deficiencies by allowing case-by-case exceptions to the FDA-approved use requirement when such exceptions are supported by scientific evidence. This type of exception process would enable deserving beneficiaries to obtain the prescriptions they need while also avoiding the heightened costs associated with an abundance of undertreated or mistreated patients.