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News

New CMS Policy Eliminates Personalized Medicine Adoption Challenge


A new policy adopted by the Centers for Medicare and Medicaid Services (CMS) in response to comment letters submitted by the Personalized Medicine Coalition and other organizations eliminates an administrative burden that hindered the adoption of personalized medicine in the clinic. In keeping with PMC's mission to ease the regulatory burden on implementation of personalized medicine, PMC's comment letter recognized the need for a change to CMS' "laboratory date of service policy," which inadvertently discouraged the timely ordering of many personalized medicine tests by requiring hospitals to manage the complex billing processes for tests performed within 14 days after a patient's discharge from the hospital — even if the test is performed at an outside laboratory. CMS has now eliminated the so-called "14-day" rule for most personalized medicine tests.
» PMC comment letter (PDF)


FDA Voice

FDA Touts 'Encouraging' Future for Personalized Medicine at Agency


In a blog titled "Two Recent Scientific Advances Underscore an Encouraging Future for Precision Medicine at FDA," the agency's Center for Drug Evaluation and Research Director Janet Woodcock, M.D., welcomes new developments in personalized medicine, which she notes is a powerful tool for developing drugs that benefit patients with particular biological characteristics. The agency, she said, believes it is important to make personalized medicines available to patients, and is "actively pursuing more advances" in the field.
» FDA Voice: Two Recent Scientific Advances Underscore an Encouraging Future for Precision Medicine at FDA