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

The Opioid Crisis . . . Is It Still a Crisis?

Medicare Set-Aside Blog, Opioids, Rx/Pharmacy on February 4, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

During the past year and a half, we’ve detailed the efforts of the federal government and many state governments to combat the opioid crisis. We devoted a blog series to the Department of Health and Human Services’ five-part strategy to curb the epidemic. We’ve discussed educational efforts for prescribers and revisions to prescribing guidelines which […] Continue

State-Imposed Restrictions on Gabapentin

Medicare Set-Aside Blog, MSAs, Rx/Pharmacy on January 8, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

In recent years, we have seen a growing number of instances where federal law and state law are not in perfect alignment with regard to certain medications. As one example, we’ve seen a number of states pass laws allowing for the medical and/or recreational use of marijuana compounds even though marijuana is classified as a […] Continue

Department of Health and Human Services Issues New Opioid Guidelines

Medicare Set-Aside Blog, Opioids, Rx/Pharmacy on December 18, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

This past July, CMS issued an educational piece that warned of the dangers associated with the concurrent use of opioids and benzodiazepines. You may have seen our blog on the CMS publication. If you missed that blog, you can read it here. In October, the Department of Health and Human Services (HHS) issued guidelines on […] Continue

Does Orphan Drug Status for Rofecoxib Open the Door for Increased Use?

Medicare Set-Aside Blog, Rx/Pharmacy on December 13, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Just over two years ago, the FDA granted orphan drug status to rofecoxib for the treatment of hemophilic arthropathy. Rofecoxib was previously marketed by Merck under the trade name of Vioxx and depending on your age, you may recall hearing about Vioxx in the news. Vioxx was initially approved by the FDA in 1999 for […] Continue