The Official Medicare Set Aside Blog And Information Resource

Endo Pharmaceuticals Voluntarily Withdraws Opana ER From the Market: What Does This Mean For Your Cases?

CMS, Medicare Set-Aside Blog, MSP News, Opioids, Re-Review Process on July 11, 2017 | Posted by Erin O'Neill, PA-C, JD

On July 6, 2017, Endo Pharmaceuticals issued a statement indicating it would voluntarily withdraw the opioid pain medication, Opana ER, from the market, in response to the Food and Drug Administration’s request one month earlier. As noted in our prior blog post, the FDA requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of […] Continue

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

California Proposition 64, and Other Marijuana Legislation: Are These Legislative Actions the Gateway to Marijuana Inclusion in Medicare-Set Asides?…Not Likely.

Medical Marijuana, Medicare Set-Aside Blog on February 6, 2017 | Posted by Jean S. Goldstein, JD

In 1996, California became the first state to allow for medical use of marijuana.  Marijuana is and remains classified as a Schedule I drug, which is defined by the United States Drug Enforcement Agency as, “substances with no currently accepted medical use and a high potential for abuse.”  Schedule I drugs also include drugs, such […] Continue