MSP Compliance Blog

Expert summary, analysis and recommendations on issues impacting Medicare Secondary Payer compliance.

High-Risk Opioid Abuse Is Just As High In Prescribed Users

Posted on March 27, 2014 by Rita Wilson

In this JAMA research letter findings show that doctor prescribed opioids cause over-doses just as much, if not more, as non-medical use of prescription pain medicine. People who are at the greatest risk for abuse are those being prescribed pain medication. CDC’s new analysis shows that while non-medical users abuse opioids, prescribed users are even more likely to purchase opioids illegally.
Precautions need to be in place to prevent this type of abuse. Educating physicians and the general public about the dangers of opioid abuse is a crucial step in prevention. Some states are taking steps to prevent opioid abuse by implementing electronic databases that track patient history. This prevents a patient from filling multiple prescriptions at different pharmacies, which is one of the most common occurrences in opioid abuse.

“Many abusers of opioid pain relievers are going directly to doctors for their drugs,” said CDC Director Tom Frieden, M.D., M.P.H. “Health care providers need to screen for abuse risk and prescribe judiciously by checking past records in state prescription drug monitoring programs. It’s time we stop the source and treat the troubled.”

FDA Approves Long-Lasting Narcotic – Oxycodone / Acetaminophen

Posted on March 19, 2014 by Rita Wilson

The first FDA approved long-acting combination of narcotic analgesic oxycodone with acetaminophen is now available for pain management. It will be manufactured by Mallinckrodt and is a single strength tablet to be dosed twice daily. This new form of pain medicine is sold under the name Xartemis XR, and will treat patients with severe pain who don’t respond to alternate therapies.   Xartemis XR should not be used with other medicines that contain acetaminophen, nor should it be used in place of other oxycodone/acetaminophen products. Mallinckrodt is looking to provide more abuse-deterrent features for the FDA, as Xartemis does not currently have them.

“The FDA approval of Xartemis XR exemplifies Mallinckrodt’s dedication to developing and providing new treatment options for people with pain,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. “Mallinckrodt remains committed to continuing its work to develop innovative formulations for our product lines to help ensure access to appropriate pain treatment for the millions of patients suffering from acute pain, and we will continue to work closely with the FDA as we engage in further development programs for Xartemis XR and other products utilizing this technology platform.”

Warnings and Precautions
For those who manage workers’ compensation claims, the following warnings and precautions should be reviewed with claimants and their treating physicians before approval of this long acting opioid medication.
  • XARTEMIS XR contains oxycodone, a Schedule II controlled substance. As an opioid, XARTEMIS XR exposes users to the risks of addiction, abuse, and misuse. Abuse or misuse of XARTEMIS XR by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxycodone and can result in overdose and death. With intravenous abuse, the inactive ingredients in XARTEMIS XR can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
  • Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of XARTEMIS XR, the risk is greatest during the initiation of therapy or following a dose increase. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. In patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, XARTEMIS XR may decrease respiratory drive to the point of apnea.
  • Hypotension, profound sedation, coma, respiratory depression, and death may result if XARTEMIS XR is used concomitantly with alcohol or other central nervous system (CNS) depressants.
  • Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines.
  • Due to the potential for acetaminophen hepatotoxicity at doses higher than 4000 milligrams/day, XARTEMIS XR should not be used concomitantly with other acetaminophen-containing products.

Impact on Settlement and MSA Projections

As a long acting opioid, XARTEMIS XR represents yet another medication to be added to the list of potentially addictive drugs approved by the FDA in 2014 (Zohydro, a new formulation of pure hydrocodone is scheduled for release in late March, 2014).  When the US represents only 5% of the world’s population, yet consumes more than 75% of the world’s prescription drugs, one should question the need for another opioid drug; especially when this formulation of oxycodone / acetaminophen is not available in a tamper proof formulation.  With overdose deaths involving opioid analgesics increasing from 4,030 deaths in 1999 to 16,651 in 2010, how can the benefits of this drug possibly outweigh the danger?

As a trigger for potential intervention, use of XARTEMIS XR to treat chronic pain for periods of more than 30 days, will be escalated to our medical team for review.  With availability as a single source drug only, XARTEMIS XR is extremely expensive.  If included in the drug regimen for an MSA beneficiary at the time of settlement, this would result in a high dollar.  When identified in the treatment regimen of an injured worker during the pre-MSA review our medical team with will dialogue with the treating physician in an effort to discontinue or replace XARTEMIS XR with a therapeutic equivalent medication to mitigate exposure with the MSA and achieve an optimal settlement.

CMS Proposes Expansion of WCMSA Re-Review Process – The Good, The Bad & The Ugly

Posted on March 16, 2014 by Rita Wilson

On February 11, 2014, the Centers for Medicare and Medicaid (CMS) announced its proposed changes to the current Medicare Set-Aside Arrangement re-review process, seeking comments and feedback by March 31, 2014.

The current CMS process for WCMSA re-review requests is limited to situations where CMS is notified that the submitter omitted documentation from the original proposal, or when submitter believed there to be a mathematical error made by Medicare’s review contractor.  The re-review process in these situations will remain unchanged.     

Re-review requests may be submitted to the WCRC at any time for the following reasons:

  • A mathematical error was identified in the approved set-aside amount.
  • Original submission included case records for another beneficiary

 In its proposed expanded process, however, WCMSA re-reviews will be available for a broader array of categories and reasons.

 Re-review requests may be submitted to the WCRC ONLY when ALL of the following are met:

  • The original WCMSA was approved within the last 180 days,
  • The case has not settled,
  • No prior re-review request has been submitted for this WCMSA
  • The re- review requests a change to the approved amount of 10% or $10,000 (whichever is more).

Re-review requests may be submitted for ANY of the following when ALL qualifying criteria are met:  

  • Submitter disagrees with how the medical records were interpreted.
  • Medical records dated prior to the submission date were mistakenly omitted.
  • Items or services priced in the approved set-aside amount are no longer needed or there is a change in the beneficiary’s treatment plan.
  • A recommended drug should not be used because it may be harmful to the beneficiary.
  • Dispute of items priced for an unrelated body part.  
  • Dispute of the rated age used to calculate life expectancy

 In its explanation, CMS goes on to say that a re-review may be escalated by the WCRC to a CMS Regional Office “in certain situations”.  My assumption is that the decision would be at the discretion of the WCRC rather than by submitter request.  Examples identified included failure to adhere to court findings, CMS policy disputes, situations where the carrier maintains ‘Ongoing Responsibility for Medicals’ for treatment that has been included in approved WCMSA, etc. 

 The Good, the Bad and the Ugly

The ‘Good’….  On a positive note, I see any expansion to the re-review process as a good thing for the MSA industry.   I have seen countless times when I disagreed with the WCRC’s interpretation of the medical records, or I wanted to dispute prescription drugs or medical procedures that were being prescribed for unrelated body parts or were dangerous to the claimant. 

An opportunity to ‘challenge’ in these situations gives me new hope that the countless studies documenting the dangers of long term opioid use may now be introduced as rationale to exclude these drugs from the WCMSA.  This may also mark the beginning of the inclusion of state and national evidence based treatment guidelines to establish or dispute the appropriateness of treatment.

The ‘Bad’….  Am I being too optimistic?  The bad, as I see it, is that CMS provided us with nothing to explain how the information submitted in the re-review will be analyzed, nor does it list the criteria it would deem as acceptable evidence to justify a change.  Therefore, while positive on paper, it remains to be seen whether the expansion provides a real venue to evaluate appropriate care over life expectancy.

And the ‘Ugly’….  Unfortunately, I’ve seen multiple scenarios where re-reviews were submitted in follow up to what we believed to be complete omission of findings and recommendations in the medical records submitted to WCRC.  Upon re-review, the reviewer actually increased the allocation.  With the expanded re-review process, therefore, does the WCRC have total autonomy to modify/increase any portion of  the WCMSA, or will their response be limited to that portion of the WCMSA being challenged?     

Tower MSA Partners is currently preparing its response to CMS for submission on or before the March 31, 2014 deadline.   In doing so, one of the key points we will advocate to CMS is our strong belief that evidence based national and state medical and pharmacy guidelines should be included an any re-review process as a primary resource to establish appropriate treatment for long term pain management. As such, these should sit at the forefront of any assessment process. 

We solicit and welcome your feedback.

 

 

Zohydro – Promised Relief or One More Opioid in the Spiral of Addiction?

Posted on March 5, 2014 by Rita Wilson

When Zogenix announced on October 25, 2013 that the U.S. Food and Drug Administration (FDA) had approved ZohydroTM ER (hydrocodone bitartrate) extended-release capsules,  an extended-release oral formulation of hydrocodone without acetaminophen, the announcement came with the promise of continuous relief in the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate”. 

In fact, according to  Dr. Srinivas Nalamachu, M.D., a pain specialist at the International Clinical Research Institute, Overland Park, Kansas and investigator in the clinical trials of Zohydro ER, “Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids. It is the first extended-release hydrocodone medicine that is acetaminophen-free. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients.”

Just Say ‘No’ to Zohydro

If Zohydro ER truly is “an important option for patients with chronic pain”, why, then, would 40 experts, in a recent letter entitled  “Just Say No to Zohydro”,  urge the Food and Drug Administration (FDA) to reconsider its approval?   And why did a coalition of Congressional representatives and state Attorney Generals also urge the FDA to listen to is own advisory panel, which voted 11 to 2 against the approval of Zohydro? The major question being posed by the experts who are challenging Zohydro is whether we can justify another potentially addictive opioid when the U.S. has seen deaths from opiate painkillers jump by 415 percent in women and 265 percent in men since 1999.  According to the CDC, nearly 60 percent of all drug overdoses occurred from FDA-approved prescription medications (not illegal drugs) with 3 in 4 drug overdose deaths due to an opioid painkiller such as oxycodone, hydrocodone or methadone.

What We Learned From Oxycontin

Looking back, it would seem that our experience with crushed Oxycontin might have taught us that no Class II opioid narcotic should be approved for general release without the existence of an ‘abuse deterrent formulation’.  Yet according to Andrew Kolodny, President of the advocacy group, Physicians for Responsible Opioid Prescribing (www.supportprop.org ), “It’s a whopping dose of hydrocodone five times more potent than what we’re dealing with now packed neatly in an easy-to-crush capsule.  It will kill people as soon as it’s released.”

Yet the FDA continues to move forward.  Zohydro is expected to enter the market later this month  already classified as a Schedule II narcotic — one reason both the FDA and the drug’s maker are confident it will not contribute to the broader overdose problem.  However, even the less potent formulation of hydrocodone (combined with Tylenol) is of such concern to the DEA that it is recommending it be re-classified from a Schedule III narcotic to Schedule II http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0227.htm.  Also, Zohydro’s labeling will feature warnings about abuse, addiction and misuse, and according to a Zogenix spokesperson, the company is now working on an abuse-deterrent version of Zohydro that should become available in three years.

Unfortunately, none of those precautions has assuaged concerns.   Those who seek to block Zohydro’s release said that while a small subset of patients may benefit from Zohydro, unleashing such a potent drug in the current environment is unsafe.

Zohydro’s Impact on Claims, Settlement and the MSA

It goes without saying that the release of a new, single source opioid into the current mix of medications prescribed for pain management in a workers’ compensation claim is of significant concern to employers, carriers and TPA’s.  So what can be done to prepare for Zohydro’s release?

  1. Request that your PBM block Zohydro so that prior authorization is required before it can be filled.  When requested, verify that other courses of pain management have been tried without success, and if available, send the request through UR.
  2. If Zohydro is approved, limit the authorization to a maximum of 60 days so that prior authorization will be required for future fills.
  3. Consider engaging a nurse or practicing physician to dialogue with the treating physician to discuss the long term viability of Zohydro and potential substitutions.
  4. Implement random UDT’s to insure that the medication is being used as prescribed.
  5. Monitor for changes in dosage, for the addition of short acting opioids and for increases in MED (morphine equivalent dosage) of > 50mg

To achieve optimum outcomes in care, cost and compliance when settling a workers’ compensation claim, replacement of  Zohydro in the drug treatment regimen must be pursued in a proactive and aggressive manner.  For more information about strategies to mitigate exposure with Zohydro and other opioids that drive MSA costs to a level that can prohibit settlement, email us at info@towermsa.com.

Why Workers’ Comp Claims Drag On and On

Posted on February 26, 2014 by Rita Wilson

Any employer who has dealt with legacy claims understands the financial strain it can cause.  Does the term ‘creeping catastrophic claims’ resonate?  When you look below the surface, there are a multitude of reasons for a  workers’ compensation claim to stay open for an extended period of time. Inadequate training, inappropriate handling at the beginning of the claim,  too many claims assigned to a single adjuster and claim handling by a TPA that no longer values your business are just a few of the reasons behind the increased financial burden of the ‘old dog’ claims.   This article highlights and explains many of the reasons legacy claims drag on, and offers strategies that can intercept the downward spiral.

If you ask the third party administrator (TPA) adjuster why any particular claim is still open, the adjuster will recite the employee’s medical condition and possibly the industrial commission ruling on the particular claim.


Click here to read more

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