“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 […]
Read MoreHow 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 […]
Read MoreFollow 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 […]
Read MoreFollow 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 […]
Read MoreFollow 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 […]
Read MoreFollow 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 […]
Read More