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.
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?
- 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.
- If Zohydro is approved, limit the authorization to a maximum of 60 days so that prior authorization will be required for future fills.
- Consider engaging a nurse or practicing physician to dialogue with the treating physician to discuss the long term viability of Zohydro and potential substitutions.
- Implement random UDT’s to insure that the medication is being used as prescribed.
- 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 email@example.com.
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.
Posted on February 24, 2014 by Rita Wilson
Signs that opioid therapy is being abused in a workers’ compensation claim can be difficult to pinpoint. The behavior may not seem consistent due to the nature of the injury, so sometimes it can go undetected. This article provides 5 basic criteria to assist in recognizing potential abuse in opioid therapy…
“Early warning signs of potential abuse or misuse frequently go unnoticed because some characteristics seem insignificant when considered in isolation. However, when multiple attributes are combined, they can reveal serious risks for inappropriate drug utilization. In order to identify characteristics that should raise red flags, the prescription data must be monitored from multiple perspectives.”
With a Pre-MSA review model that evaluates medical records from all prescribers with the Rx filling history from all sources to identify potential intervention triggers, Tower MSA Partners seeks to identify and address issues before MSA and settlement, and to remain involved until resolution is achieved. The 5 triggers included in this article are among the behaviors / triggers we seek to identify with each claim, and are a great starting point to build you own criteria to stage claims for early intervention.
Posted on February 24, 2014 by Rita Wilson
In an environment where we cringe each time we see one more article on opioid use, it’s easy to forget the primary reason these medications were developed …. pain management in terminal illness and at end of life. David DePaolo’s recent post was both powerful and informative. He contrasts the peace that opioids can bring for those who are at the end of their fight with disease and pain against the abuse of these medications by those who put financial gain above appropriate care. Please take a moment to read this great post, and if you are angered by what physician dispensing is doing in workers’ compensation, go to www.supportprop.org (Physicians for Responsible Opioid Prescribing) and become a subscriber.
I believe that most physicians in our industry strive daily to do what is in the best interest of their patients. When we see studies such as this, I hope we will be motivated to take action, while reminding ourselves that these are the outliers.
The Sun is Shining — By David DePaolo
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