certification Archives - Page 11 of 11

Medicare to expand ‘prior authorization’ for device coverage | TheHill

May 23, 2014

“In a shift from the current system, Medicare is proposing to rule on seniors’ coverage for home medical devices before the supplies are delivered or claims for payment are submitted. The Centers for Medicare and Medicaid Services CMS is planning to expand the use of “prior authorization” for power scooters and wheelchairs, and introduce the […]

The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace

May 21, 2014

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How To Approach, Read, and Interpret the DSCSA Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article. “So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on […]

FDA DSCSA Workshop – Meeting Materials

May 17, 2014

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Follow the link below to the FDA webpage of all related meeting materials and notices: “[This FDA public workshop, May 8-9, 2014, was] intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of […]

Apply for a Designated Representative License – CA Board of Pharmacy

May 16, 2014

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Follow the link below to find and download the application form that you need, including Designated Representative, and Wholesaler applications: “Apply for a License – Please select the license type you wish to apply for to download the application and instructions.” – via CA Board of Pharmacy – Apply for a License. Go to DREprof.com: The […]

FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop

May 15, 2014

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Follow the link below for a sobering report of the FDA’s first DSCSA public workshop, and the short implementation timeline that faces the supply chain: “Without an issued guidance, however, what are supply chain members to do in the meantime? Perhaps the most important thing to do is to try to understand the DSCSA, and how different […]

About The HMDR Licensing Program

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Follow the link below to learn more about the California HMDR Licensing Program: “Welcome to the home page for the Home Medical Device Retailer (HMDR) licensing program. The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities […]