First-Time Generics Approved for Two Pain Medications

The FDA recently approved the first generic versions of two different pain medications that have previously only been available as brand drugs. As pain medications, these drugs could appear in workers’ comp claims, and the availability of generic versions could provide significant cost savings without any alterations to clinical impact.

Ultram (tramadol hydrochloride) tablets are for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. An abbreviated new drug application (ANDA) was approved for tramadol hydrochloride tablets in late June.

This generic approval is for both 50 mg and 100 mg tablets. The FDA noted that while Ultram 100 mg tablets were discontinued, the reasons for discontinuation were not for reasons of safety or effectiveness.

Dyloject (diclofenace sodium) injections are for the management of mild to moderate pain, or for the management of moderate to severe pain alone or in combination with opioid analgesics. An ANDA for diclofenac sodium injections was approved in mid-June.

This generic approval is for 37.5 mg/mL singe-dose vials. The FDA noted that while Dyloject 37.5 mg/mL singe-dose vials were discontinued, the reasons for discontinuation were not for reasons of safety or effectiveness.

Tags: FDA, product approval, generic, Ultram, tramadol hydrochloride, Dyloject, diclofenac sodium, opioid

NCCI Examines Impact of the ODG Formulary in Arizona and Tennessee

The National Council on Compensation Insurance (NCCI) released Formulary Implementations and Initial Impacts on Workers’ Compensation, a new report that investigates the impact of the Official Disability Guidelines (ODG) formulary in Arizona and Tennessee.

This report utilized the NCCI Medical Data Call, a database of paid medical transactions reported by all workers’ comp carriers, focusing on calendar years 2014-2017, excluding Texas and Oklahoma.

Key findings within the report included:

  • Prescription drug utilization decreased across all drug categories, regardless of if they did or did not require prior authorization. Furthermore, this occurred in other states without closed formularies
  • The utilization of topical and compound drugs in Tennessee decreased dramatically after formulary implementation
  • Opioid utilization fell 16% in Tennessee and 22% in Arizona
  • 80% of opioid prescriptions prior to formulary implementation were for drugs which the formularies ended up categorizing as pre-approved
  • Though drug utilization decreased, there’s little evidence that the ODG formulary led to physician services, such as physical medicine, substituting prescription drugs
  • The formulary had limited impact on opioid utilization

News publications such as WorkCompCentral reported on the story, speaking with industry experts about the report, including Healthesystems’ Chief Medical Officer, Robert Goldberg, MD, FACOEM.

Dr. Goldberg listed several factors that could explain the ODG’s lack of impact on opioid utilization, primarily the fact that the formulary includes many commonly prescribed opioids as Y drugs. The NCCI study reports that 80% of opioid prescriptions prior to formulary implementation were for drugs that were later categorized as pre-approved by the formulary. Because of this, it would stand to reason that most opioid prescriptions could still be dispensed in accordance with these formulary guidelines.

Furthermore, Dr. Goldberg noted that while the formulary labels certain drugs as N for pre-authorization, that doesn’t guarantee the drug will be denied, as this depends on the practice of claims organizations and individual adjusters.

“That happens no matter what state or what formulary is being implemented,” said Dr. Goldberg, who went on to state, “You’ve got some megatrends that are also pushing down opioid prescribing,” which does align with the overall decrease in opioid utilization seen even in states without formularies.

Formularies are still a useful tool in curbing problematic prescription drug use when their structure is designed in way to effectively reduce opioid use.

For example, a recent study published by the Journal of Occupational and Environmental Medicine (JOEM) examined the impact that adhering to the American College of Occupational and Environmental Medicine’s (ACOEM) evidence-based medicine guidelines had on low-back pain claims in workers’ comp.

This study collected data from the Workers’ Compensation Fund Insurance of Utah, covering 50% of the workers’ comp market of Utah. The data included medical records, treatment instructions, claim duration and cost, and more. One hundred random cases of acute low-back pain were analyzed, with treatment at first appointments abstracted and two scoring tools used to asses each patient’s treatment plan.

The study found a significant trend between increased compliance to ACOEM guidelines and decreasing costs. Medical and total costs trended lower by an average $352.90 and $586.20 per unit of compliance score respectively.

The ACOEM guidelines are used to direct various workers’ compensation programs, including the California workers’ comp formulary, and so far, clinical reports have found that the formulary has made significant impacts on workers’ comp claims.

As the reports for different formulary types differ, it is critical that payers understand the effectiveness of diverse guidelines and formularies in order to provide optimal patient care.

Tags: NCCI, ODG, formulary, opioid, Tennessee, Arizona, ACOEM, JOEM, Utah

Healthesystems Product Owner Receives IAIABC NextGen Award

The International Association of Industrial Accident Boards and Commissions (IAIABC) launched the NextGen awards in 2017 to recognize talented young professionals who are having a positive impact on workers' compensation, making a difference within their organizations and leading the industry into the future.

The IAIABC announced the 2019 recipients of the NextGen Awards, and Healthesystems is proud to announce that among them is Stephanie Arkelian, a Product Manager who has spent eight years in the workers’ comp industry.

Having spent two years as a claims adjuster, Stephanie has put her frontline claims experience to use at Healthesystems for six years and has been instrumental in launching multiple programs, including the Healthesystems’ RideShare and Physical Medicine programs, ensuring that such programs were developed with efficiency in mind for claims staff, helping adjusters to maximize patient benefit.

According to Stephanie’s nomination:

Stephanie is a big-picture visionary, one who can connect the dots and gain the consensus and buy-in necessary to orchestrate a large-scale project according to plan. Stephanie's dedication to quality, to customers, and patients sets her apart; and through her stewardship our organization ensures that user validation is a part of our day-to-day process, whether by interviewing adjusters and managed care program liaisons, or through objective metrics, such as examining vendor utilization data to understand claims staff behavior.

Stephanie and the other NextGen Award recipients will be participating in a special session during the IAIABC 105th Convention in Pittsburgh in October.

Learn more about the IAIABC NextGen Awards and about the other recipients.

Tags: IAIABC, NextGen, Award, Stephanie Arkelian

New York City and Nevada Prohibit Hiring Discrimination for Positive Marijuana Tests

Marijuana continues to gain public acceptance, as evidenced by the growing legalization movement across the country. Illinois recently became the 11th state to legalize recreational marijuana, and the first to do so legislatively as opposed to via referendum.

But perhaps an even greater sign of the public’s growing acceptance of marijuana is the arrival of new laws to protect prospective employee’s right to use marijuana.

Nevada Assembly Bill No. 132 was signed into law earlier this June, prohibiting the denial of employment over the presence of marijuana in a drug screening test taken by a prospective employee. While a large majority of prospective employees can effectively test positive for marijuana under this new law and not be denied employment, certain exceptions are noted in the bill, including:

  • Firefighters and EMTs
  • An employee required to operate a motor vehicle for which federal or state law requires the employee to submit to drug tests
  • Jobs that, in the determination of the employer, could adversely affect the safety of others
  • Positions funded by federal grants, or with federally mandated requirements surrounding abstinence from drug use

Also in June, the New York City Council prohibited employers from requiring a prospective employee to submit to testing for the presence of any tetrahydrocannabinols (THC), the active ingredient in marijuana, in such prospective employee’s system as a condition of employment.

This rule will go into effect May 10, 2020, but exceptions are provided for safety and security sensitive jobs, and those tied to a federal or state contract or grant. This includes:

  • Police officers or peace officers
  • Any position requiring a commercial driver’s license or the supervision of care of children, medical patients, or vulnerable persons
  • Any position with the potential to significantly impact the health or safety of employees or members of the public, as determined by key city council figures
  • Jobs requiring security clearance
  • Emergency responders

While so far these are the only two examples passed, the fact that they were passed so close to one another could indicate that other localities might have similar plans in motion. Not only does this have the potential to impact workers’ comp from an employee safety position, but if further down the line patients are free to use recreational marijuana, that could impact recovery efforts and drug therapy when a patient is injured on the job.

Tags: Marijuana, legal, recreational, drug testing, drug screening, employment

Marijuana Laws No Longer Thought to Reduce Opioid Overdose Deaths

In 2014, the Journal of the American Medical Association (JAMA) published a study that conducted a time-series analysis examining medical cannabis laws and state-level death certificated data in the U.S. from 1999-2010, covering all 50 states with the goal of analyzing age-adjusted opioid analgesic overdose death rates per 100,000 population in each state.

The study found a link between states that had implemented medical cannabis laws and slower increases in opioid overdose deaths, creating further support for the legalization of marijuana. In fact, to date this study has been cited by over 350 scientific articles.

However, a new study from the National Academy of Sciences of the United States of America was recently published, finding that this is no longer the case. This study was conducted using the same methods as the original JAMA study, but with extra data extending through 2017, a total of seven years of additional information to pull from. In that time, 32 states enacted medical cannabis laws, and eight states enacted recreational cannabis laws.

The original JAMA study’s findings no longer held up across the longer period. Using the full 1999-2017 dataset, the new study found that states that enacted a medical cannabis law experienced a 22.7% increase in opioid overdose deaths. However, the study does not conclude that marijuana laws increase opioid overdose deaths, claiming that if a relationship exists between the two, it cannot be rigorously discerned with aggregate data and that more research should continue.

Currently, the clinical research is still inconsistent. A study from the Public Library of Science (PLOS) found a strong correlation between enrollment in medical marijuana programs and reduced opioid use for patients with chronic pain, while another study from the Journal of Bone and Joint Surgery found self-reported marijuana use during injury recovery was associated with an increased amount and duration of opioid use.

Furthermore, JAMA also published a new study on the association of medical marijuana laws with nonmedical prescription opioid use and prescription opioid use disorder. Looking at data from 627,000 individuals from the 2004-2014 National Survey on Drug Use and Health, little evidence was found for an association between medical marijuana law enactment and nonmedical prescription opioid use or prescription opioid use disorder among prescription opioid users.

As clinical research goes on, Healthesystems will continue to monitor ongoing developments.

Tags: marijuana, cannabis, JAMA, National Academy of Sciences, opioid overdose, PLOS, Journal of Bone and Joint Surgery

Healthesystems at WCI Orlando 2019

Healthesystems will exhibit at the 2019 Workers’ Compensation Institute’s (WCI) Conference in Orlando, Florida from August 12-14.

WCI is a nonprofit educational organization for workers’ comp professionals, and their annual conference is one of the biggest events in the country, bringing stakeholders from all over together for networking, information sharing, and educational sessions.

This year’s conference exhibitor theme is “Coast to Coast” and Healthesystems invites conference attendees to visit booth #909 to learn how Healthesystems is making waves in workers’ comp.

Interruptions in care can cause a ripple effect across claims, which is why we treat every step of a claim as an opportunity to improve care, because we know that when we do our part, even the smallest of actions can turn the tides in the long run.

Not only is Healthesystems dedicated to making a difference in the lives of injured workers, but we are also dedicated to making a difference for our environment:

In honor of WCI’s Coast to Coast theme, for every badge we scan, we’ll donate $1.00 to coastal cleanups. Every donation counts, so visit us at booth #909 at WCI.

Discover how deep Healthesystems dives into pharmacy and ancillary benefits management – and help clean up our coasts in the process. Pick up a reusable metal straw to keep plastic out of our coasts!

Tags: WCI, Healthesystems, conference