The U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) recently released its Regulatory Science Priorities (FY 2016), which will “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products, and …
The U.S. District Court for the Southern District of Ohio has granted a Cincinnati, Ohio Planned Parenthood ambulatory surgical facility (ASF) a preliminary injunction in an enforcement action that would have shut the facility down (Planned Parenthood Sw. Ohio Region …
Ohio Planned Parenthood Facility Wins Preliminary Injunction Read more »
The U.S. Food and Drug Administration recently announced (80 Fed. Reg. 57007, 9/21/15) the creation of the Patient Engagement Advisory Committee (PEAC) to advise the agency “on complex issues relating to medical devices, regulation of devices, and their use by …
The U.S. Centers for Medicare & Medicaid Services (CMS) recently released a proposed rule (80 Fed. Reg. 59386, 10/1/15) on how Medicare determines reimbursement payment within the Clinical Laboratory Fee Schedule (CLFS). This action was based upon Section 216 of …
CMS Proposed Rule on Clinical Laboratory Test Reimbursement Read more »
The U.S. Centers for Medicare & Medicaid Services (CMS) has just issued a “Request for Information (RFI) Regarding Implementation of the Merit-Based Incentive Payment System (MIPS), Promotion of Alternative Payment Models (APMs), and Incentive Payments for Participation in Eligible Alternative …
RFI on Medicare Merit-Based Incentive Payment System & Alternative Payment Models Read more »
