Opioid Rescue Therapy, Not Just A Quick Fix…

Opioid Rescue Therapy, Not Just A Quick Fix…

91 Americans lose their lives every day to opioid overdose, according to the Centers for Disease Control and Prevention (CDC).  That is over 33,000 Americans each year, and the rate is only rising, actually having quadrupled since 1999.  It is now accurately categorized as an Epidemic and, appropriately, stringent private and public institutional changes are being implemented to minimize the likelihood of future abuse.  This includes limited pill counts, prescription drug monitoring platforms, closed formularies, etc.  These improvements reduce the likelihood of future dependency, but what about those already dependent, the most at risk for potential overdoses.  What can we do about them?

The first answer: Keep them alive.  Enter the growing availability of Opioid Rescue Therapies.  Two of the most commonly prescribed are Narcan® and Evzio®.  Both medications utilize naloxone, an opioid antagonist, which can be a life-saving treatment in the case of an opioid overdose.  Rescue Therapies have become standard issue to police, emergency medical personnel, and recently have become available over-the-counter without a prescription at participating CVS Pharmacy® locations in 41 states. The reason: they work.

However, we cannot have Rescue Therapy serve as just a ‘Band-Aid’. Furthermore, the issues of cost need to be addressed. There are currently multiple formulations of naloxone available, the cost of which varies dramatically. Evzio® ($4,500.00) is a brand-name naloxone auto-injector that uses a pre-filled device with a voice-prompt providing direction for use. Conversely, Narcan® ($150.00) is a fast-action nasal spray that also provides two doses, but at a fraction of the cost.

Prescribing naloxone should be viewed as one step in a comprehensive opioid risk assessment strategy. Patients, prescribers, and loved ones should periodically question the opioid doses/regimen employed. Is it effectively reducing pain and improving function with minimal side-effects?  Could a lower dose provide similar efficacy with a reduced overdose risk?  Has weaning been tried recently?  Has an opioid rotation to a lower dose alternative or non-opioid pain reliever been trialed?

When further examining treatment, it is also important to consider additional risk factors, such as other medications employed and co-morbidities. For example, patients with COPD or sleep apnea or who are prescribed opioids in conjunction with central nervous system (CNS) depressants such as diazepam or clonazepam are at a significantly increased risk for overdose.

While the decision to prescribe naloxone can be a necessary emergency step, it is important it be viewed as a window of opportunity for patients and prescribers alike to address the current medication regimen, while ensuring the most cost-effective naloxone formulation is easily accessible for the patients who need it most.

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 http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/opioid-rescue-therapy-not-just-quick-fix/

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Exorbitant Price Increases in Workers’ Compensation

Exorbitant Price Increases in Workers’ Compensation

Sudden and exorbitant drug price increases in recent years have brought the annual cost of treatment for some patients to hundreds of thousands of dollars, and have forced others to go without, sparking outrage throughout the United States.

Price increases involving critical, life-saving drugs like EpiPen® and Daraprim® have been labeled “outrageous”, “predatory”, and “price gouging” events that solely drive drug company profits. The example of Daraprim®, a medication that had been available for 63 years yet had a 5,000% price increase in a single day, was so shocking it sparked a U.S. Senate special investigation and report. While drug price spikes involving prescriptions used in the group health setting have been widely covered in the press, unfortunately, the same pricing trend has occurred with several drugs used in the pain management setting for Workers’ Compensation injuries. The following chart contains three such examples:

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Vimovo®: This brand-name combination NSAID/PPI was historically manufactured by AstraZeneca for approximately $2/capsule. However, in January 2014 the rights to manufacture Vimovo® were sold to Horizon Pharma, which increased the cost, overnight, to $16/capsule (a 700% price increase). Horizon has since increased the cost of Vimovo® on a regular basis with a current, exorbitant price of $2,710.90 ($45.18/capsule).

Pennsaid®: The price of this is topically applied NSAID was increased by 480% in one day in January 2015 by Horizon Pharma. Since that time the cost has risen even further to an excessive $2,716.02 per prescription.

Levorphanol: This “generic” opioid has only one manufacturer, Sentynl Therapeutics. Given they are the sole generic manufacturer of levorphanol, they have increased the cost by an astronomical 2,959% since 2011, currently charging nearly $50 per tablet.

If, in this financially turbulent pharmaceutical environment, you find patients on inordinately high-priced mediations such as Vimovo®, Pennsaid®, or levorphanol, often the prescriber is not aware of the exorbitant cost of these products and/or the safe, effective treatment options available. While primary consideration should always be clinical efficacy, having an open, transparent discussion with the prescribing provider about these unfortunate realities can only be of benefit to all parties with a vested interest in the outcome of care.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of  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 http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/exorbitant-price-increases-workers-compensation/

Saving Billions with Collaboration

Saving Billions with Collaboration

Medical misdiagnoses happen. However, a recently released report shows a staggeringly-high incidence: As much as one-fifth of claims involve diagnosis errors that are extending the treatment of injured workers and costing the workers’ comp system billions.

Stunning Numbers

The 10-year study, conducted by Boston medical consultation service, Best Doctors, uncovered in an estimated 250,000 workers’ comp injuries 21% involved misdiagnosis and/or inappropriate medical treatment. In the most expensive top 5% of claims, error rates were estimated to jump as high as 50%. Cumulatively, these errors can add up to as much as $15 billion of the estimated $65 billion in workers’ comp claims expenditures annually nationwide.

Added Complications

Language barriers and misunderstandings may increase complications. Treatments take a wrong turn, sometimes resulting in the prescription of dangerous opioids and unnecessary treatment plans, increasing subsequent costs. Managing Director of Best Doctor Occupational Health Institute, Michael Shor, indicated that such findings remain consistent among all areas of the medical profession.

Blame?

It is irresponsible and simply wrong to place the blame on any one entity or component. It is critical to remember that medical professionals make every effort to ensure treatment is appropriate and that their patients receive the highest level of care available. But they are human, just like the injured workers, case managers, and insurance employees.

How to Improve

The first step in preventing the physical, emotional, and financial tolls of diagnoses errors that result in prolonged disability and jeopardized careers is simple: Collaboration. Essential to quality of care, particularly in complex cases, the collaborative effort of medical personal with employers, patients, carriers and workers’ comp case managers can provide improved quality assurance and help prevent these issues. Peer review of diagnoses and second opinions can likewise reduce issues at the pass, putting injured workers on a better path, circumnavigating unnecessary costs and extended recoveries.

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 http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/savings-billions-collaboration/

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 http://ans-solutions.com/.

SOURCES:
https://www.washingtonpost.com/graphics/investigations/dea-mallinckrodt/?_hsenc=p2ANqtz-9DxkF3wbuslmavvDf3o8CSw_0KLDObRAx7Ah4JgQ2Vi7_84yvAVhoUcmcpQyMQ-LDuL7935zGFyhc7J8njQ-cALSVCEg&_hsmi=51277531&utm_campaign=Rx%20Summit&utm_content=51277531&utm_medium=&utm_source=hs_email&utm_term=.ebaec91ff136
http://www.reuters.com/article/us-mallinckrodt-settlement-idUSKBN1751JM
https://www.opensecrets.org/lobby/clientsum.php?id=D000022900

Original content posted on http://ans-solutions.com/government-struggles-to-hold-opioid-manufacturers-accountable/ 

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 http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/medical-marijuana-and-the-workers-compensation-conundrum-part-1/

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 http://www.ans-solutions.com today.

Original content posted on http://ans-solutions.com/how-technology-is-shaping-the-workers-compensation-industry/

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 http://www.ans-solutions.com today!

Original content posted on http://ans-solutions.com/new-fda-warning-avoid-prescribing-opioids-benzos-together/