The Official Medicare Set Aside Blog And Information Resource

The Opioid Crisis: What is the Government Doing About It? Part 4 – Increasing the Availability of Overdose-Reversing Drugs

FDA, Opioids, Rx/Pharmacy on December 17, 2018
Posted by Complex Claims Division

This blog series is devoted to better understanding the efforts our Federal government is undertaking to combat the opioid epidemic in America. Earlier this year, the Department of Health and Human Services (HHS) announced a five-part strategy that will be utilized to combat the opioid epidemic. In previous posts, we have focused on the first […] Continue

FDA Awards Six-Month Patent Extension for Lyrica

FDA, MSP News, Rx/Pharmacy on November 30, 2018
Posted by Complex Claims Division

You may recall our earlier blog this week about Lyrica in the News.  Once again, the spotlight is on Lyrica.  First, after Pfizer was awarded a six-month patent extension based on a new pediatric indication for the drug.  Earlier this month, the Supreme Court in the United Kingdom ruled against Pfizer in a longstanding patent […] Continue

FDA Issues Safety Communication Regarding Medications Utilized in Intrathecal Pumps

FDA, MSP News, Rx/Pharmacy on November 20, 2018
Posted by Erin O'Neill, PA-C, JD

On November 14, 2018, the Food and Drug Administration (FDA) issued a safety communication to all patients with implanted intrathecal pumps, their caregivers and health care providers, and medication compounding companies warning of the dangers of utilizing medications in intrathecal pumps that have not specifically been approved for intrathecal pump use. Intrathecal pumps are programmable devices that […] Continue

FDA Approves Consensi™: A Novel Combination but a Conundrum for the Medicare Set-Aside

FDA, Medicare Set-Asides, Rx/Pharmacy on September 11, 2018
Posted by Complex Claims Division

On May 31st, the FDA approved Kitov Pharma’s application for Consensi™. Consensi is a unique combination product containing amlodipine, a calcium channel blocker used for the treatment of hypertension, and celecoxib, a non-steroidal anti-inflammatory used for the treatment of osteoarthritis. The product’s labeling will include a single indication for patients for whom treatment with amlodipine […] Continue

FDA Approval of the First Plant-Derived Cannabinoid Prescription Medication

FDA, Medical Marijuana, MSP News, Rx/Pharmacy on July 30, 2018
Posted by Complex Claims Division

In a landmark approval on June 25th, the Food and Drug Administration (FDA) approved Epidiolex® (oral cannabidiol solution) for the treatment of seizures associated with Lennox-Gestaut Syndrome or Dravet Syndrome, in children two years of age and older.  Epidiolex is the first marijuana-based drug approved for use in the United States. Two other drugs previously […] Continue

Sublocade – A New Once-Monthly Injection for the Treatment of Opioid Use Disorder

CMS, FDA, Medicare, Medicare Set-Aside Blog, Medicare Set-Asides, MSP News, Opioids on February 5, 2018
Posted by Katherine Bales, RN, JD

The opioid crisis continues to be one of the most talked about issues facing the health care community, and the nation as a whole, having been declared a national public health emergency. In response, pharmaceutical companies have been actively working on ways to treat the crisis with the development of alternative treatment methods. The FDA […] 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

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