Medicare Self-Injectable Coverage Standard Is “Weighted Average” Of Uses
Executive Summary
Medicare contractors should use a "weighted average" of indications in determining whether an injectable drug is "usually" self-administered and therefore excluded from coverage, CMS says
You may also be interested in...
CMS Medicare Self-Injectable Guidelines Maintain Split Within Drug Classes
The Centers for Medicare & Medicaid Services' self-injectables guidelines would still divide Medicare coverage within a therapeutic drug class based on route of administration
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials