Welcome to this month's edition of Comp Medical News. Opioids in MSAs, fentanyl bribes, and “liquid gold” drug screens and related genetic tests are your headlines for November 2017.
Drug Pricing Watchdog Gets New Funding
The Boston-based Institute for Clinical and Economic Review (ICER) announced a three-year, $13.9 million grant from the Laura and John Arnold Foundation to evaluate the clinical and cost effectiveness of new medicines. This new funding follows the organization's initial two-year $5.2 million award from the foundation in 2015. The steep costs and price increases of prescription drugs in the United States has been under social and Congressional scrutiny over the last several years.
FDA Announces New Strategies for Disposal and Labeling of Opioids
A recent statement from FDA Commissioner Scott Gottlieb explains a new agency initiative to curb opioid addiction by limiting diversion of prescription painkillers. The announcement includes several new steps under consideration including, blister packs that have a defined duration of use and “other packaging innovations that could make it easier to track the number of doses that have been taken.” In the same statement, Gottlieb also announced a two-day public workshop, which will take place on December 11th and 12th, 2017. The workshop will focus on three key areas: define the specific problems that these types of packaging and disposal solutions can help address; define the guiding principles that the scientific community should consider in designing product features that achieve these possible solutions; and define the types of data needed in order to evaluate how these solutions are working.
A new Kaiser Health News (KHN) report entitled “Liquid Gold: Pain Doctors Soak Up Profits by Screening Urine for Drugs” investigates the business model of urine drug screen referral. The authors (from both KHN and the Mayo Clinic) used billing data, which revealed several striking findings, including the work of a single nurse practitioner who generated $1.1 million in Medicare billing for urine drug screens in a year. Further, available billing data from Medicare and private insurance nationwide showed that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year – more than the entire budget of the Environmental Protection Agency. The federal government paid providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.
Leaders of a 30-fund group that includes state pension officials and religious and labor organizations plan to revealed recently that they have begun filing shareholder resolutions regarding opioid controls at 10 companies, including distributors AmerisourceBergen Corp and Cardinal Health Inc and manufacturers Johnson & Johnson and Insys Therapeutics. According to Reuters, in resolutions aimed at annual shareholder meetings to be held in 2018 and in letters to the companies, activists are urging independent directors to review and report on how the boards are managing the legal, financial and reputational risks their enterprises face from their involvement with opioids.
Study Finds Basic NSAIDs as Effective as Opioids in ER
A recent study of 400 people in the Bronx found that a combination of over-the-counter medicines ibuprofen and acetaminophen is an effective pain management therapy in emergency departments. Patients who participated in the study came with a variety of problems such as leg fractures, leg and arm strains, and sprains. They received either a combination of Motrin and Tylenol or one of three different opioid-based pain relievers. The patients then rated their pain on an 11-point scale after two hours of medication. Upon comparison of the results, researchers noted that the pain ratings did not differ much between two groups suggesting that simple painkillers have an effect similar to opioids but without the addictive potential.
Insys Founder Arrested on Fraud, Bribery Charges Related to Opioids
The billionaire founder of Insys Therapeutics Inc. was arrested late last month on charges alleging that he participated in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug, marking another step in the crackdown on opioid prescribing and marketing. The 74-year-old was charged with engaging in conspiracies to commit racketeering, mail fraud and wire fraud in an indictment filed in federal court in Boston. He was added as a defendant in a case against six former Insys executives and managers.
MEDVAL: New Evidence Showing Overinclusion of Opioids in WCMSAs
Jean Goldstein, JD, of MEDVAL, wrote a new editorial in which she breaks down a recent California Workers' Compensation Institute (CWCI) study about opioids in WCMSAs. She notes the stark differences between the dataset of CMS-approved California WCMSAs from 2015 and 2016 against a control group of claims from 2006 through 2009 that involved similar injuries, for cases without a WCMSA. The study found that nearly 70 percent of CMS-approved WCMSAs contained a lifetime allocation for opioids. Goldstein explains, “Unfortunately, CMS has historically allocated prescription medications as taken, at the time of the CMS review, over an individual's entire life expectancy; whether or not the medications are appropriate or safe – completely disregarding any possible regimen changes. Essentially, the end result: the liable party pays for any and all over inclusion of medications, including opioids, whether or not they are safe, appropriate or contribute to the current opioid crisis.”
Read the piece here. Purchase a copy of the study here.
ABOUT THE AUTHOR
Nina Luckman is the writer and editor of New Orleans-based Louisiana Comp Blog, which launched in 2014 and is sponsored by LCI Workers' Comp. She is originally from Pennsylvania but lived most of her life in Florida. Her credentials include a Bachelor's and a Master of Arts degree from Tulane University, both in the study of English Literature.
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