In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more
CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data.
The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more
The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more
CMS’s August 2013 notice establishes a new internal review process, signalling increased agency-initiated activity -
The Centers for Medicare & Medicaid Services (CMS or the Agency) has initiated an automatic,...more