The Official Medicare Set Aside Blog And Information Resource

CMS UPDATES NOTICE REGARDING PROPOSED RULEMAKING: WILL LMSAS/NFMSAS BE DELAYED AGAIN?

Liability, MSAs, MSP News on August 6, 2019
Posted by Jean S. Goldstein, JD

In the end of 2018, we reported that the Centers for Medicare & Medicaid Services (CMS) added an item to the Unified Agenda, which is semiannual compilation of information about regulations under development by federal agencies.  The Unified Agenda is published in both the spring and fall.  The item added was a notice regarding an […] Continue

Gabapentin Abuse on the Rise

FDA, MSAs, Rx/Pharmacy on April 25, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

All of the focus on the opioid crisis may have overshadowed a growing trend of abuse and misuse for another drug that’s well known to those of us in the workers’ compensation industry . . . gabapentin. Ironically, the growing trend of gabapentin abuse is related to the opioid crisis. In an effort to adhere […] Continue

FDA Takes Interest in Compounding Medications; Does this Mean Compounded Medications Will be Included in WCMSAs in the Future?

FDA, MSAs, Rx/Pharmacy on April 10, 2019
Posted by Jean S. Goldstein, JD

Last week the Food and Drug Administration’s (FDA) Commissioner, Scott Gottlieb, M.D. and Deputy Commissioner, Anna Abram issued a statement on new 2019 efforts to improve the quality of compounded drugs.  The statement can be found here.  Interestingly in 2018, the FDA also announced a new and expanded compounded research project, for which the FDA announced […] Continue

FDA Approves Esketamine Nasal Spray (Spravato™) for Treatment-Resistant Depression

FDA, MSAs, Rx/Pharmacy on March 13, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Earlier this month, the Food and Drug Administration (FDA) approved esketamine nasal spray, which will be marketed by Johnson & Johnson (J&J) under the trade name of Spravato™. Spravato is approved for use in conjunction with an oral antidepressant for treatment-resistant depression. The term “treatment-resistant” refers to those patients who have failed to achieve relief […] Continue

Osteoarthritis Drug Receives Fast Track Designation from FDA

FDA, MSAs, Rx/Pharmacy on February 21, 2019
Posted by Leah King, PharmD, JD and Marilyn J. Larrimer, RN, BSN, JD

In late November 2018, the FDA announced that it was granting Fast Track designation to an investigational drug for the treatment of osteoarthritis (OA). The drug, developed by Galapagos, is known by its identifier GLPG1972/S201086.  This drug is one to watch, since it has a novel mechanism of action for this therapeutic category. GLPG1972/S201086 is […] Continue