Government Struggles to Hold Opioid Manufacturers Accountable

Government Struggles to Hold Opioid Manufacturers Accountable

For the first time ever, the U.S. DEA targeted a prescription drug manufacturer for their role in black market opioids and damages incurred. Mallinckrodt Pharmaceuticals, one of the largest national manufacturers of the highly addictive generic painkiller oxycodone, one of the leading drugs responsible for the more than 15,000 overdose deaths in 2015, was accused of shirking its responsibility to report suspicious drug orders.

Who’s to Blame For The Opioid Epidemic?

Created at Mallinckrodt’s Hobart, NY facility, oxycodone shipped via its distributor network, including KeySource, Sunrise Wholesale and Cardinal Health, who later supplied the pills to retailers, including pharmacies and hospitals accused of illegally diverting the drugs. Discovered in a 2009 Tennessee Drug Task Force sting and linked back to Mallinckrodt’s distributors Florida retailers, 2010-2011 DEA investigations uncovered large amounts of Mallinckrodt oxycodone – such as the 41 million KeySource Medical oxycodone tablets delivered to Florida retailers in 2010 – about 2.5 pills for every man, woman and child in the state. Accused of splitting orders to conceal shipment amounts, KeySource was ordered by the DEA to halt, later relinquishing its distribution license. Distributors Sunrise Wholesale and Cardinal Health likewise delivered vast quantities of Mallinckrodt’s oxycodone to pharmacies in Florida. 500 million Mallinckrodt pills ended up in Florida from 2008-2012 — 66% of state oxycodone sales. A 2011 subpoena following this the discovery further revealed, 6 weeks after the Tennessee task force alerted Mallinckrodt to the drugs found in the 2009 sting, Mallinckrodt shipped another 2.1 million tablets their Sunrise distributor, 92,400 tablets of which were sold to Dr. Barry Schultz, the Delray Beach doctor whose oxycodone was found in Tennessee. Schultz was later convicted of drug trafficking and manslaughter (for a related overdose death). In one day, he prescribed 1,000 tablets to a single patient. Ultimately, the DEA and federal prosecutors alleged Mallinckrodt ignored its responsibility to report suspicious orders, in violation of the Controlled Substances Act.

Shirking Responsibilities?
Under federal law and DEA policy, pharmaceutical companies are required to “know their customers,” monitoring amounts, frequencies, and patterns of drug orders, immediately notifying the DEA of suspicious activity – or risk losing their license to manufacture and sell controlled substances, as well as civil and criminal penalties. Though Mallinckrodt maintained publicly the company has worked hard to fight drug diversion, internal case summaries prepared by federal prosecutors indicated Mallinckrodt’s response was that ­‘everyone knew what was going on in Florida but they had no duty to report it.’ Sources familiar with settlement talks indicated Mallinckrodt acknowledged its responsibility to report suspiciously large orders, but contended the DEA did not require manufacturers to know about (or be responsible for) ‘their customers’ customers,’ further pointing to conflicting DEA advice as to legal responsibilities. Prosecutors considered a whopping 43,991 unreported orders from distributors and retailers suspicious.

Uncharted Waters
Appalled by the rising opioid death toll, the DEA’s push to hold drug manufacturers accountable was hoped to be a wake-up call, putting the industry on notice for its responsibilities in the diversion of drugs to the black market. Instead, after years of industry investigations spanning five states to build the massive case, the results mirrored the DEAs previous attempt to hold wholesale distributors accountable. The case stalled. Fierce company resistance and intense lobbying efforts may have played a role in the lack of legal action pursued. The case settled for $35 million in fines and no admission of wrongdoing.

Small Potatoes
The proposed settlement, a mere fraction of the 44,000 federal violations pointed to in the investigation which could have cost the company $2.3 billion in fines, amounts to small potatoes for a company that posted $3.4 billion in revenue and $489 million in profit in 2016. In a later February 2017 SEC filing, Mallinckrodt even noted the investigation “will not have a material adverse effect on its financial condition” because it had set aside the funds.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit


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Medical Marijuana and the Workers Compensation Conundrum – Part 1

Medical Marijuana and the Workers Compensation Conundrum – Part 1

Because the U.S. Federal Government has dug-in its feet, leaving marijuana as an illegal, Schedule I drug under the Controlled Substances Act, state governments have been left to individually pave their own legalization paths, leaving a frustrated public in the wake. Employers, employees, doctors, workers comp case managers, and more feel frustratingly in-the-dark as ever-diversified, continually evolving legislation continues to change the landscape. This is the first post of our two part series of spotlighting medical marijuana in the marketplace.

What We Do Know About Medical Marijuana

Though state laws vary widely on the amount of legal possession and personal cultivation for medical use, to-date 29 states and D.C. have legalized marijuana for medical use, including 8 states who’ve legalized its use recreationally. For medicinal purposes, marijuana has been scientifically confirmed effective for pain relief, appetite stimulation, nausea control, and reducing ocular pressure. It is arguably cheaper and less addictive than opioids, however both research and quality control are lacking. For injured workers and those in the workers’ comp industry, its most-likely application is pain relief, however it’s typically not be the first drug in the treatment lineup for prescribing physicians.

What’s Murky About Medical Marijuana and Workers’ Compensation

Marijuana dispensing differs from run-of-the-mill pharmaceuticals, with product obtained from dispensaries or home growth, not pharmacies, leading to a gap in patient information on potentially dangerous drug interactions. Patient protections also remain muddy. Still illegal under federal law, stateside court rulings are chaotic. Fifteen states offer little to no employee protection, while 11 states explicitly provide protections from retaliatory actions to limits on drug testing from employers. Furthermore, all states with medical marijuana have pending legislation and litigation that could have a broad impact on the workplace, creating a landscape reminiscent of the Wild West.

Who’s Paying For Medical Marijuana Prescriptions?

Who knows? Medical marijuana’s Schedule I status prohibits its inclusion in the National Drug Code, leaving Medicaid and Medicare patients on the sidelines. This lack of regulation also equates to a dearth of coding, complicating processing for pharmacy benefits managers. And state-by-state case law for prescription coverage from employer-sponsored coverage to workers’ comp, like employee protection legislation, also varies widely.

Who’s Got a Headache?

Employers. Though there is federal protection backing drug-free workplace policies, including “zero-tolerance” for specific jobs such as heavy equipment operators, pilots, and surgeons, ever-changing legislation makes it difficult for employers to figure out which end is up. In the meantime, knowledge of state-specific legislation remains key to compliance, with an attitude of managing medical marijuana like any other powerful legal prescription drug that could impair mental capacity a logical choice: Accommodate the needs of injured workers – but uphold a safe work environment, as always. ANS Solutions Medical Cost Containment Programs are the only end to end pharmaceutical cost containment programs in the industry that genuinely put the patient first, while minimizing the cost of settlement in large loss workers’ comp claims.


ASansAbout the Author:  Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit

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How Technology Is Shaping The Workers’ Compensation Industry

The technology now used within today’s workers’ comp industry is remarkable compared to what was available just a few decades prior. A dominant component of advocacy, claims, and treatment, technology is helping employers and insurers work the bugs out of the process, producing amazing results and the promise of even more unbelievable advancements on the horizon…

How is Technology Reshaping the Workers Compensation Industry?

  • Paper Falls by the Wayside
    • NOW: Endless forms and lost paperwork are no longer, replaced by automated forms, electronic signatures and correspondence that is both faster and easily trackable.
    • LATER: Lengthy, written legalese explanations will be replaced by clearer video demonstrations. Avatars, virtual assistants, and chat will become more commonplace.
  • “Smart” Tech Takes Over
    • NOW: Smartphones and mobile devices empower injured workers, offering personal claims reporting, teledoctor consultations and referrals, status and payment checks, virtual correspondence examiners/case managers, and easy access to information via chat/messaging. This faster reporting and assessment speeds treatment, lowering pain severity and costs, and boosting network penetration.
    • LATER: Wearable Tech will become increasingly common in the workplace, from high-tech safety vests and helmets to watches that identify fatigue, repetitive motions, and even alert employees of dangerous situations. For the injured, mobile self-service tools will encourage a more active role in recovery and return-to-work, and the introduction of digital wallets will offer more convenient access to prescriptions.
  • Automation Moves Things Along
    • NOW: Triggered by specific claims events, automated correspondence speeds the process with real-time text/email notifications, boosting productivity and claimant satisfaction.
    • LATER: Tech driven by “empathetic” artificial intelligence will aid claimants, further reducing workloads.
  • Video Trumps Phone Communication
    • NOW: Employers, claims professionals, nurses, and attorneys can more easily communicate remotely and interactively.
    • LATER: The transition to a more personal video telepresence will boost efficiency and improve interactions, making them more personable.
  • Analytics Provide Greater Insight
    • NOW: Predictive analysis through text mining is granting ever-faster access to previously unknown variables, identifying cost triggers (opioid use, comorbidities), and unearthing previously unidentified information.
    • LATER: Prescriptive analytics will come into play, implementing new tech that prescribes successful and actionable intervention techniques.

Exciting Times, Amazing Opportunities
The industry and employers are capitalizing on this wave of technological change. When was the last time you initiated change in your workers’ compensation medical cost containment strategy? ANS Solutions’ streamlined Pharmacotherapy Review program has a proven track record for improving efficiency, reducing costs by over 25% with a success ratio of 94%, yielding a guaranteed return-on-investment of 20-to-1 through our Guarantee Program. Centered around maximizing treatment outcomes for injured workers, our unique, multi-faceted approach delivers cost-effective, proven treatment solutions that make a lasting, positive impact on the overall employee workers’ comp experience. Blaze a new trail in this innovative era. Contact today.

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New FDA Warning: Avoid Prescribing Opioids & Benzos Together

In a recent announcement by the FDA, boxed warning labels will now be required to advise against the utilization of prescription opioid pain medicines alongside benzodiazepines unless no other adequate alternative treatment method exists. Warnings about the risks of combining these two classes of drugs are nothing new. Already required on drug warning labels, additional black box warnings are an effort by the FDA to reach out to those who may have “missed the message.”

Classified as Central Nervous System (CNS) depressants, each drug alone can trigger side effects such as respiratory depression (slowed/labored breathing), coma, and death, the effects of which are enhanced in combination. For clinicians living in the dark, these risks will now be spelled out in the black boxes of 389 different pharmaceuticals. Additionally, opioid painkillers such as oxycodone and benzos like alprazolam (i.e. Xanax®) – even the combination of opioid cough medicines with benzos and other CNS depressants (like alcohol) should be avoided. If the drugs must be used together, clinicians have been advised to warn patients of these risks.

The FDA’s latest measure in battling the nationwide epidemic of prescription opioid abuse, essentially classifies this drug combination in the “last resort” genre. Rates of emergency room visits resulting from the nonmedical use of this combination of drugs has tripled from 2004-2011, with the rates of drug-related deaths following suit. According to the FDA, these rates coincide with a 41% increase in patients prescribed both an opioid and benzo between years 2002-2014. The measure is a win for public health officials from 17 states and territories and 13 cities who petitioned the agency in February to require the boxed warning in an effort to fight the routine but unproven treatment method.

Bridging the gap is possible, however, with the help of clinically proven injury and disability treatments from ANS Solutions. Our expert medical legal nurse consultation services and Pharmacotherapy Review Program get the result patients need – without side effects – protecting and enhancing the quality of life for injured workers, and guarding against the medical and financial risks of unproven treatment methods with scientifically-backed protocols. Are you ready to set out on a new path in worker’s comp injury management? Contact today!

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Patient Engagement Encouraged through Prescription Drug Label Enhancements

Upcoming improvements to prescription drug labeling are hoped to positively affect patient care across the board. Intentionally kept in the dark on the ingredients and indications of prescription drugs for well-over 100 years, the healthcare industry is shifting from the past’s blind trust to finally realizing today’s modern paradigm: Engaging patients as active participants in their own healthcare endeavors.

Small Label, Big Impact
Improving the synchronization between in-office care and home care, the FDA’s latest labeling procedures will not only help patients under a physician’s care better understand why each medication is being prescribed, clearly listing indications on each prescription drug product’s label, but offer a vast array of opportunities for the betterment of treatment regimes, helping…
In the understanding of prescription regimens and scheduling.

  • Verify each prescription is effective/providing benefits for its intended purpose.
  • Reduce confusion following brief or rushed clinic encounters.
  • Make the identification of drugs easier to allow for proper use/best practices.
  • Reduce the incidence of over-prescription, duplicate or unnecessary medications.
  • Keep not only patients, but caregivers, pharmacists, and other treating physicians in-the-know on conditions being treated and desired outcomes.
  • Improve safety by reducing prescription or dispensing errors.

The Missing Link
This added information, “knowledge” (dubbed the “sixth” patient right in a recent publication of The New England Journal of Medicine), is bringing to light details which have previously fallen through the cracks in today’s modern world of typically rushed, commonly overcomplicated healthcare regimens. Information critical to the patient’s understanding of why a medication has been prescribed and for what conditions or purposes, allowing for a clearer assessment of efficacy for all involved parties.

Are You Living In The Dark?
At ANS Solutions, we also understand the benefits of synchronicity in patient care. The role this plays in in treatment progression, effectiveness, and quality of life from the treatment of routine health issues to return-to-work programs for injured workers is second-to-none. That’s why our industry standard pharmacotherapy review program focuses on face-to-face collaborative care, built upon the integrative collaboration of all effected parties, from the injured worker to our skilled nurse experts and treating physicians, allowing us to produce the very best outcomes in the business with the latest in clinically-proven treatment regimens.
Healthcare costs and injured workers ailing? Uncover a new era in workers’ comp treatment. Contact today.


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No Proven Benefit for the Use of Opioids in Chronic Pain

Millions are addicted to or dependent on prescription opioids. Worse than the dependency, over 200,000 deaths are attributable to prescription opioids, as well as hundreds of thousands of overdoses. What’s the biggest contributor to the epidemic, you ask? Most commonly, it’s the inappropriate prescription of opioids for the treatment of issues like musculoskeletal disorders, chronic low back pain, headaches, and other issues.

Insights from a Leading Pain Expert

A recent study conducted by leading pain expert Gary Franklin, MD, MPH, V.P. of Physicians for Responsible Opioid Prescribing, provides substantial evidence that prescribing opioids for chronic pain offers no real benefit. Franklin has been striving to shed light on this issue which is believed to be contributing in large part to the prescription opioid abuse epidemic sweeping the nation. Opioids such as hydrocodone and oxycodone have increased in prescription from around 76 million in 1991 to nearly 207 million in 2013, making the U.S. the biggest global consumer for these products at nearly 100% of word consumption for hydrocodone, 81% for oxy. Most notably, Dr. Franklin’s research found clear evidence of dose-dependent risk for serious harm:

  • A dramatic increase in death with opioids administered at a dose of 100mg MED (morphine equivalent dose).
  • A risk of overdose 2-5 times higher when the above MED runs between 50-99mg.
  • Doses lower than 100mg MED still result in overdose – even without long-term therapy.
  • Opioids administered in combination with benzodiazepines, sedative-hypnotics, or muscle relaxants dramatically increase the risk for harm.
  • Double the risk of remaining on disability 1 year for those treated with opioids for at least 7 days (cumulative dose: 150mg MED).

Reversing the Trend

Believed to be the direct result of poor research and outdated teaching practices, the most important step toward reversing the opioid epidemic is simple- putting a stop to improperly prescribed opioids particularly for chronic pain. To aid this effort, t­he American Academy of Neurology and a number of states have produced product guidelines advising against the use of opioids for the treatment of musculoskeletal conditions, headache, or fibromyalgia, and additionally advising physicians to proceed with caution when initiating opioid therapy for pain or long-term use. (Since released, the guidelines created as a result of the drug utilization review have effected a 30% sustained decline in overdose deaths and a substantial decline in injured workers on chronic opioids in Washington State.)

Evidence-based Alternatives

Opioid therapy is not necessarily the only answer to treating chronic pain. Drug utilization review programs such as ANS Pharmacotherapy Review can provide alternative therapy recommendations. ANS deploys an exceptionally credentialed network of nurse experts to deliver recommendations in face-to-face meetings with treating physicians. These recommended treatment options are equally, if not more effective than opioids. Better still, they offer improved quality of care and quality of life for the injured worker.

If the pitfalls of opioid therapies are taking over your workers’ comp claim settlements, the proven drug utilization review protocols at ANS Solutions can show you a better path. Optimized outcomes for the injured worker are possible. Contact ANS today or visit


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Ineffective Intervention Results in Less Than Optimal Outcomes

Workers’ compensation payers industry-wide have relied on pharmaceutical cost containment measures in one form or another as a means to manage escalating costs. But as everyone has learned, not all strategies are created equal. In fact, most are limited in scope and effectiveness.Holistic Drug Utilization Review

A Holistic Approach to Medical Cost Management

At ANS, we take a holistic, collaborative approach to managing medical costs. When a comprehensive drug utilization review is conducted on a pharmaceutical regimen, it reveals the bigger picture, thus uncovering points of concern that may impact the pharmacy plan. Quite often we uncover opportunities for modifications that improves patient efficacy while decreasing costs. Conducting an extensive review of a patient’s medical history can avoid missing crucial factors that are all too often overlooked by other programs.

Nurse Experts Apply Advanced Pharmaceutical and Jurisdictional Knowledge

ANS’ advanced program includes a national network of highly credentialed legal nurse consultants. Utilizing experts to employ a collaborative environment with the physician and integrating a holistic approach to medical cost containment results in successful, optimal outcomes for both the injured worker and the carrier:

ANS Solutions

We offer an industry-leading suite of Workers’ Compensation Medical Cost Containment Services designed to lower costs, improve loss ratios, and enhance the claimant’s quality of care. For more information contact us today or visit

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