The Official Medicare Set Aside Blog And Information Resource

FDA Requests Endo Pharmaceuticals Withdraw Opana ER From the Market

FDA, Medicare Set-Aside Blog, Opioid, Opioids on June 9, 2017 | Posted by Erin O'Neill, PA-C, JD

On June 8, 2017, the Food and Drug Administration (FDA) requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of ongoing misuse and abuse of the drug. As you will recall from our prior blog post, in March 2017, an FDA advisory committee found that the risks associated with use of Opana ER […] Continue

FDA Advisory Committee Finds Opana ER Risks Outweigh Benefits

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on March 21, 2017 | Posted by Erin O'Neill, PA-C, JD

On March 14, 2017, a Food and Drug Administration (FDA) advisory committee found that the risks associated with use of Opana ER (oxymorphone hydrochloride) outweighed the potential benefits. Opana ER is an opioid pain medication, which was first introduced in 2006 and then reintroduced in a new abuse deterrent formulation in 2012. The new formulation was designed […] Continue

Arymo ER – Latest Addition to the Abuse Deterrent Opioids Market

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on January 19, 2017 | Posted by Abidemi Oyebode, R.Ph., MBA - Clinical Pharmacist

Last week, the FDA approved Arymo ER, an abuse-deterrent formulation of morphine sulfate extended release tablets, marketed by Egalet Corporation. Arymo ER comes in three dosage strengths: 15mg, 30mg, and 60mg and slated to hit the market first quarter 2017.  Arymo ER is the latest addition to the growing list of abuse-deterrent opiates like Troxyca […] Continue

Inclusion of CT Scans Instead of MRI Scans in WCMSAs for Claimants with Intrathecal Pumps

FDA, Medicare Set-Aside Blog, Medicare Set-Asides on January 12, 2017 | Posted by Erin O'Neill, PA-C, JD

It is commonplace for CT scans to be included in WCMSAs, in lieu of MRI scans, for Claimants with implanted intrathecal pumps; however, little thought is given to the reason for this substitution. Intrathecal pumps are small implanted programmable battery powered devices that dispense medication which is carried directly to the spinal cord by a […] Continue