Blog Archives

DEA Proposes Reclassification of Hydrocodone Products

April 6, 2014

On March 5, 2014, the DEA issued an NPRM (Notice of Proposed Rule Making) to move hydrocodone combination products (HCPs) from their current classification as Schedule III narcotics to Schedule II, a classification reserved for the most harmful and potentially addictive medications. http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0227.htm.

As one of the most frequently prescribed drugs in workers compensation, this is a most interesting development and its impact will be felt across our industry. Also, in light of the announcement last week that Zohydro, a new formulation of 100% pure hydrocodone being manufactured by Zogenix, is scheduled for release later this month, I find it to be more than coincidence that this more benign version of hydrocodone is now being recommended for movement to the Schedule II classification.

All substances placed under the control of the CSA since it was passed by Congress in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its implementing regulations, found in Title 21 of the Code of Federal Regulations. Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health, or on the petition of any interested party. (Detailed information on the scheduling and rescheduling process can be found in the first chapter of Drugs of Abuse on the DEA’s website.)

For those who manage claims in workers’ compensation, the rescheduling of HCPs to Schedule II will create more changes than just a reclassification. Procedural requirements include the following:

Every Class II Rx requires a written prescription from a practicing physician.
While most states limit Class II Rx’s to 30 days, there are no federal limits to days supply.
A physician may write multiple paper Rx’s for up to a 90-day supply, but the Rx’s must be written separately.
Refills for a Class II narcotic are prohibited

While the logistics may present a challenge in our day to day management of claims, I believe this to be a very positive move in our fight against opioid addiction in the US, particularly in workers’ compensation. I strongly believe that the DEA, in its proposed movement of HCPs to the same classification as drugs like Oxycontin, Opana, ACTIQ, etc., is making a clear statement of its concern over the overuse, over prescribing and abuse potential of HCPs.

I trust that all those in the medical community who respond to the NPRM will affirm support of the reclassification and that the result will be less frequent use of HCPs as long term therapy in workers’ compensation.

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

March 27, 2014

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.”

— Press Release

FDA Approves Long-Lasting Narcotic – Oxycodone / Acetaminophen

March 19, 2014

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.”

— Drugs.com

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

March 16, 2014

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?

March 5, 2014

When Zogenix announced on October 25, 2013 that the U.S. Food and Drug Administration (FDA) had approved Zohydro^TM 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 info@towermsa.com.

Why Workers’ Comp Claims Drag On and On

February 26, 2014

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

Opioid Therapy: Red Flags That Warrant Intervention

February 24, 2014

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.

Click here for the full article

Opioids As They Were Intended…. Comfort At End of Life

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

Specialty Pharmacy Invades Workers’ Compensation

February 22, 2014

According to a recent issue of Workcompwire, “specialty medications”, drugs that may require special handling, distribution, administration and patient management, are beginning to have a significant impact on workers compensation. With specialty conditions such as hepatitis C, rheumatoid arthritis, and multiple sclerosis occurring through direct or indirect contact by healthcare or emergency workers, specialty medications, at costs that can exceed $1,000 per day, may become standard protocol.

Currently there are more than 5,000 new medications in the drug pipeline globally, and 70 percent of those are potential first-in-class medicines – those that use a different mechanism of action from any other already approved medicine. Many of these first-in-class medicines will be considered specialty medications once they complete phase III approval by the FDA. For several years, the pipeline for specialty medications has been far more robust than that for non-specialty medications.

CMS / WCRC Development Letters…. Essential Information or Delay Tactic?

January 17, 2014

In the most recent version of the WCMSA Reference Guide, released on November 6, 2013 (COBR-M11-2013-v2.0), CMS announced a series of changes that submitters should expect to see in the WCMSA review process. Of the changes announced, none appeared to have significant impact on submitter workflow as most were clarifications rather than actual changes in process.

At first glance, I found the updated guide info to be both relevant and helpful. Having a detailed explanation of the rationale and resources used to evaluate the WCMSA should be invaluable in creating an accurate cost projection. And having a clear understanding of when and why development letters might be requested should lead to a more comprehensive submission. It only follows that setting clear expectations up front should lead to better outcomes in both CMS acceptance and WCMSA turnaround time….. Right?

Unintended Consequences…. or Not?
Unfortunately, the outcome of the changes announced on November 6, 2013 has been nothing short of disastrous for WCMSA submitters, and for the carriers, employers and TPA’s they represent. Over the past 75 days, statistics across multiple companies show that 98% of the WCMSA’s submitted to CMS for review have not received final acceptance, all as a result of development requests that fall into one of the following 3 categories:

1. Requests for treatment records for co-morbid conditions unrelated to the workers’ compensation injury from primary care and other physicians (information that can only be obtained via written HIPAA patient consent);
2. Requests for ‘current’ treatment records, whether paid by the carrier or not, when there is clear evidence that the claimant hasn’t treated in months or even years (i.e. the information doesn’t exist);
3. Requests for ‘current’ medical records, pharmacy history, and an updated carrier payout that becomes a circuitous cycle in cases where the patient continues to treat;
In every situation, the submitter is told that the case will be closed within the allotted time period (usually 10 days) if the information is not received.

Early Responses and Explanations
When development requests initially surfaced in early November, 2013, our response was to contact CMS immediately and explain the issue. In every situation, however, our explanations were discarded. Whether we were asked to pierce the HIPAA veil to obtain unrelated information, or to provide medical records that didn’t exist, ‘No’ was not an acceptable response. As a result, less than 2% of all WCMSA’s submitted to CMS since November 1, 2013 have completed the WCRC review process and achieved CMS acceptance.

As we’ve watched cases being closed and re-opened multiple times, we’ve seen the 45-60 day turnaround times from last summer disappear completely. For the WCRC, however, a closure due to missing information places the burden back on the submitter and the case is technically complete. The WCRC’s statistics look great, yet they’ve accomplished nothing.

How are Payers Responding to the ‘Stalemate’?
So what does this mean to our clients? The business result of this dramatic increase in development requests is that many claims aren’t being settled. If settlement is pursued, either new language is generated to make final closure contingent on CMS acceptance, or the settlement is finalized for indemnity only, leaving medical open. What’s even more interesting, however, is the trend we’ve seen recently where certain payers are making the decision to move forward with settlement without CMS acceptance.

CMS Submission – What is Required vs. Recommended?
While it is our legal responsibility to protect Medicare’s interest, CMS has made it clear that WCMSA submission is recommended, not required. It remains to be seen how this will play out in the coming months, but the business question that is being pondered today is whether payers can fulfill their legal obligation under the MSP statute and move forward with settlement without CMS acceptance. By doing what is reasonable and putting forth our best efforts to allocate for future medical expenses, can we lay a foundation that will mitigate future exposure once the WCMSA amount is exhausted?

The information and experiences relayed here are not those of a single company or submitter. They are being felt across the industry and are being reviewed within NAMSAP (National Association of MSA Professionals), both at committee and board of director levels. Hopefully, this will lead to both discussion and direction from CMS.

Stay tuned…..