Tag: guidance

FDA Issues Two CLIA-Related Final Guidance Documents

The FDA issued the following two final guidance documents:

  • Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: This guidance describes study designs for generating data that may support both 510(k) clearance and ...

    CY 2020 MA VBID Marketing and Communications Guidelines Posted

    The Center for Medicare and Medicaid Innovation (Innovation Center) posted CY 2020 marketing and communications guidelines for the Medicare Advantage (MA) Value-Based Insurance Design (VBID) model. This document provides communications and marketing ...

    Updated eCQM Specifications and Materials for 2020 Reporting Now Available

    The Centers for Medicare and Medicaid Services (CMS) has posted the electronic clinical quality measure (eCQM) specifications for the 2020 reporting period for Eligible Hospitals and Critical Access Hospitals, and the 2020 performance period for Elig...

    CMS Posts Applications for the MA VBID Model

    On February 1, 2019, the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) posted Request for Applications (RFA) and actuarial guidance documents for the recently announced Medicare Advan...