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CMS Decides to Put Treatment Decisions in the Hands of Insurers

Tuesday, August 14, 2018

On August 7, the Centers for Medicare and Medicaid Services (CMS) issued guidance giving Medicare Advantage (MA) plans (private insurance plans approved by Medicare that cover hospital and medical expenses) the option of applying prior authorization and step therapy for physician-administered and other Medicare Part B drugs (effective January 1, 2019) stating that this policy change will lower costs, improve quality of life, and ensure that patients receive the most preferred treatment.

Patient Focused Drug Development

Thursday, May 24, 2018

Starting in 2012 the Food and Drug Administration (FDA) began to integrate the patient perspective into the drug development process through their Patient-Focused Drug Development (PFDD) initiative. The patient advocacy community can and should partner with the FDA to ensure that they are measuring the full patient experience in clinical trials to include the physical, social, and emotional impacts of a therapy, and CSC has been working closely with the FDA, and other researchers, to explore ways to do so in a more meaningful way.

FDA Reauthorization Bill a Win for Psychosocial Care

Tuesday, August 29, 2017

On August 17, 2017, the Food and Drug Administration Reauthorization Act of 2017 (FDARA) became law. FDARA is primarily responsible for funding the Food and Drug Administration (FDA) so that the agency can review and approve drugs and devices in a timely manner. It also contains provisions that provide guidance for manufacturers on how they conduct research on the drugs and devices they are developing.

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