Tag Archives: CMS

What Parallel Review Means for Manufacturers

Drug Manufacturing

By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >

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Current Challenges in Payment Reform

By Alyson Pusey, BIO. The Affordable Care Act created several demonstration projects to test innovative care delivery systems that increase quality of care while decreasing costs.  Speaking as a panelist was Jonathan Blum, Deputy Administrator and Director of the Center for Medicare at CMS, who discussed how the agency is thinking about payment reform.  Evidenced by the recent proposed rule on accountable care organizations (ACOs), the agency is looking to providers and the health care Read More >

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