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

Lyrica In the News

CMS, MSP News, Rx/Pharmacy on November 26, 2018
Posted by Complex Claims Division

Lyrica and its manufacturer Pfizer have been in the news quite frequently this month, and the publicity has not been positive.  Most recently, on November 14th, the Supreme Court of the United Kingdom (U.K.) ruled against Pfizer in a patent infringement lawsuit that has spanned the past several years. It’s no secret that pharmaceutical manufacturers […] 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

The Opioid Crisis: What is the Government Doing About It? Part 3 – The Promotion of Healthy, Evidence-Based Methods of Pain Management

Medicare Set-Aside Blog, MSP News, Rx/Pharmacy on November 2, 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 parts one […] Continue

Inclusion of Lyrica in Workers’ Compensation Medicare Set-Aside Arrangements

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

Lyrica (pregabalin) is an analog of the neurotransmitter gamma-aminobutryic acid, or GABA. Within the brain and nervous system, GABA plays an important role in behavior, cognition and the body’s response to stressful situations. A deficiency in naturally-occurring levels of GABA has been linked to conditions such as schizophrenia, depression, anxiety and various sleep disorders.  While […] 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

The Opioid Crisis: What is the Government Doing About It?

Opioids, Rx/Pharmacy on August 29, 2018
Posted by Complex Claims Division

There can be little doubt that the opioid crisis has reached staggering levels. The Centers for Disease Control and Prevention (CDC) statistics from 2016 reveal that on average, opioids killed about 115 Americans every day.[1] Drug overdoses have become the leading cause of death in Americans under the age of 50, with opioids accounting for […] 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

Change is Needed: CWCI Study Provides Concrete Evidence of Over Inclusion of Opioids in WCMSAs

CMS, Medicare Set-Aside Blog, Medicare Set-Asides, Opioids, Rx/Pharmacy on November 3, 2017
Posted by Jean S. Goldstein, JD

This week, the California Workers’ Compensation Institute (CWCI) released a study documenting opioid use in Workers’ Compensation Medical Set-Asides (WCMSAs).  The study (for which MEDVAL contributed both data and advice concerning MSAs) focused on a specific dataset of CMS approved California WCMSAs from 2015 and 2016, against a control group of claims from 2006 through […] Continue