Category Archives: Legal

Medicare Payment Data Raises Questions About Drug Costs

Even though the just-released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, it opens the door to sharp scrutiny of Medicare reimbursement for medicines delivered in physician offices. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 health care providers who collectively […]
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After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come. Project DataSphere, the newest data transparency and […]
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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
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UK Drug Pricing: An ICER of Zero?

by Leela Barham The incremental cost effectiveness ratio (ICER) – or the threshold for determining whether the costs of a new medicine are worth it – has been controversial since it’s inception. There are those who deny that anyone can put a price-tag on life; those that accept the concept but are happy to let […]
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Obama Administration Halts Attack on Medicare Drug Plans

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year. CMS had issued a proposed rule January 10 to drop “protected” class status for antidepressants and immunosuppressants in […]
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