The Official Medicare Set Aside Blog And Information Resource

FDA Grants OTC Status to Voltaren® 1% Gel

FDA, Medicare Set-Aside Blog, Medicare Set-Asides, Rx/Pharmacy on February 21, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last Friday, while many of us may have been focused on Valentine’s Day activities, the Food and Drug Administration (FDA) was busy granting over-the-counter status to three products which were previously available only by prescription. One of those products was Voltaren (diclofenac) 1% gel, which is manufactured by GSK. When the product makes its OTC […] Continue

UPDATED WCMSA REFERENCE GUIDE EXPANDS AMENDED REVIEW TIMEFRAME TO 6 YEARS AFTER A CMS APPROVAL HAS BEEN ISSUED

CMS, Medicare Set-Aside Blog, Medicare Set-Asides, WCRC on November 6, 2019
Posted by Jean S. Goldstein, JD, CMSP

Last week, in a pre-Halloween treat mode, CMS released a revised Workers’ Compensation Medicare Set-Aside (WCMSA) Reference Guide.  The updated guide is version 3.0, dated October 10, 2019, and can be found here.  As with other versions of the guide, updates are found in Section 1.1.  Of the updates, there are two of great significance […] Continue

CMS Issues Revised Self-Administration Toolkit for WCMSAs, Version 1.3

CMS, Medicare Set-Aside Blog, Medicare Set-Asides, Professional Administration on October 18, 2019
Posted by Jean S. Goldstein, JD, CMSP

The Centers for Medicare & Medicaid Services (CMS) issued a revised Self-Administration Toolkit for Workers’ Compensation Medicare Set-Aside (WCMSA) Arrangements, version 1.3 yesterday. The purpose of this toolkit is to describe the WCMSA self-administration process and provide guidelines for claimants who are administering their own WCMSA.  Specifically, the toolkit: Describes the self-administration process, from when […] Continue

Behind the Counter Availability of Naloxone

Medicare Set-Aside Blog, Medicare Set-Asides, Opioids, Rx/Pharmacy on October 2, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

One component of the FDA’s drug approval process is a designation of the drug as prescription only or over-the-counter (OTC). If a drug is initially approved as a prescription only medication, this doesn’t mean that the drug cannot later be approved for over-the-counter status. In order to facilitate this change, the drug manufacturer files a […] Continue

CMS to Begin Utilizing 2016 Life Table

CMS, Medicare Set-Asides, WCRC on September 13, 2019
Posted by Jean S. Goldstein, JD, CMSP

Starting October 12, the Centers for Medicare and Medicaid Services (CMS) will begin using the CDC’s “Table 1: Life Table for the total population: United States, 2016” for Workers’ Compensation Medicare Set Aside (WCMSA) life expectancy calculations.  This means that for any WCMSA proposal received by CMS through the voluntary review program, or where any […] Continue