Blog Archives

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…..

The WSJ Picks Up NAMSAP Press Release

April 22, 2013

Recently, one of the many but ongoing successes for Tower MSA has occurred. The Wall Street Journal and others covered CEO Rita Ayers’ discussion on pharmacy trends during NAMSAP’s Annual Meeting and Educational Conference on April 25. The Wall Street Journal was just one of many that put out a press release on the discussion. For More information check out the link below.

Tower MSA Partners CEO Rita Ayers Discusses Pharmacy Trends in MSAs at NAMSAP

Effective June 1, 2013 WCMSA Proposals Will Include Benzodiazepines and Barbituates

April 17, 2013

April 8, 2013

On October 2, 2012, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum to Part D Sponsors concerning the transition to Part D Coverage of Benzodiazepines and Barbiturates beginning in 2013.

Effective June 1, 2013, all Workers’ Compensation Medicare Set-Aside (WCMSA) proposals submitted to CMS for a review of the adequacy of the proposal amount are to include the pricing of benzodiazepines and barbiturates, where appropriate.

Please note that WCMSA cases submitted to CMS before June 1, 2013, closed due to missing, incomplete and/or inadequate supporting documentation (or any other reason), and subsequently re-opened after June 1, 2013, will also be subject to a review that includes the pricing of benzodiazepines and barbiturates.

To read the memo from CMS to all plans that explains the transition guidance with regards to benzodiazepines and certain barbiturates starting in 2013.

Download

CMS Releases Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide

On March, 29, CMS announced the release of a new Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide. The new guide has been posted and is available in the Downloads section of the CMS Workers’ Compensation Agency Services site at http://www.cms.gov/Medicare/Coordination-of-Benefits/WorkersCompAgencyServices/Downloads/March-29-2013-WCMSA-Reference-Guide-Version-13.pdf.

The WCMSA Reference Guide was created to consolidate information currently found within the Workers’ Compensation Agency Services webpages and CMS Regional Office Program Memorandums, while providing WCMSA information to attorneys, Medicare beneficiaries, claimants, insurance carriers, representative payees, and WCMSA vendors. After reviewing the new guide, I would agree that it is exactly as advertised. There is little new to report for those of us who have researched the CMS website at length and studied each CMS memo released over the past 12 years. For those new to the process, however, the reference guide is an excellent summarization of all requirements, recommendations memos, etc. that have guided us over the years to appropriately protect Medicare’s interests.

While much of the reference guide is technical in nature, providing specific directives for submission, appeals, use of the portal, review expectations, etc., I found three very specific points made to address an area that has historically created confusion. ” If I settle below the CMS threshold amount, does this mitigate the need to prepare an MSA? ” The short answer is, “No”. The reasons, specifically explained in the reference guide, are included below:

Protecting Medicare’s Interests is ‘The Law’
Any claimant who receives a WC settlement, judgment, or award that includes an amount for future medical expenses must take Medicare’s interest with respect to future medicals into account. If Medicare’s interests are not considered, CMS has a priority right of recovery against any entity that received a portion of a third party payment either directly or indirectly. Medicare may also refuse to pay for future medical expenses related to the WC injury until the entire settlement is exhausted.
CMS Submission is Recommended, not Required
There are no statutory or regulatory provisions requiring that you submit a WCMSA amount proposal to CMS for review. If you choose to use CMS’ WCMSA review process, however, the Agency requests that you comply with CMS’ established policies and procedures.”
CMS Submission Thresholds Are For Workload Management Only
The thresholds for WCMSA submission to CMS for approval are created based on CMS’ workload, and are not intended to indicate that claimants may settle below the threshold with impunity. Claimants must still consider Medicare’s interests in all WC cases and ensure that Medicare pays secondary to WC in such cases.Also note that both the beneficiary and non-beneficiary workload review thresholds are subject to adjustment. CMS reserves the right to change or remove these thresholds based on Medicare’s interests. Claimants, employers, carriers, and their representatives should regularly monitor the CMS website at http://www.cms.gov/Medicare/Coordination-of-Benefits/Workers-Compensation-Medicare-Set-Aside-Arrangements/Whats-New/Whats-New.html for changes to these thresholds and for other changes in policies and procedures.

I hope the three points above adequately clarify when an MSA is needed as compared to when CMS submission is appropriate. If questions remain, however, or should you other questions about the guide and its legal implications in settlement, please contact Kristine Wilson, Esq. @ 888-331-4941.

CMS encourages us to continue to visit its website for future updates to the reference guide, including additional details regarding the Workers’ Compensation Review Contractor’s review process

The FDA Focuses New Attention on Compounding Pharmacies

According to an article released by NBC News on April 11, 2013, the FDA posted reports on its web site for 28 of 31 compounding pharmacies it inspected between February and April listing a raft of violations ranging from inappropriate clothing for sterile drug processing to insufficient testing for contaminants.

The release of the inspection reports comes five days before a congressional hearing into the meningitis outbreak traced to the Framingham, Massachusetts-based New England Compounding Center (NECC) that killed more than 50 people and sickened hundreds. The hearing, by the House Committee on Energy and Commerce, will be the second held on the matter.

In November, the FDA’s commissioner, Dr. Margaret Hamburg, testified before the same committee that ambiguities in the law had inhibited its ability to take aggressive enforcement action against compounding pharmacies, which are mostly regulated by the states. Republican lawmakers argued that the agency has plenty of authority but failed to use it in a way that could have prevented the meningitis outbreak.

In my post on December 13, 2012, I summarized the first hearing held by the House Committee on Energy and Commerce noting that in follow up the committee sent letters to the board of pharmacy for all 50 states making specific points regarding their responsibility to regulate compounding pharmacies and asking for a response from each by December 7, 2012. If responses were submitted, they were neither published nor acknowledged by the committee. Now, it appears that the FDA is back in the hot seat, being challenged on its lack of action.

On Thursday a group of Democratic lawmakers urged the Committee in a letter to invite the head of the International Academy of Compounding Pharmacists (IACP), an industry association, to testify at Tuesday’s hearing. The letter specifically noted Internal IACP documents provided to the Committee reveal that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies, even when top IACP leaders were aware of significant public health risks from compounding.”

Last month the IACP wrote to members of the Senate Committee on Health, Education, Labor and Pensions in a bid to head off any attempt to allow the FDA to determine whether a firm should be classed as a compounding pharmacy and which pharmaceuticals company. That authority, the letter said, “should and must remain exclusively” with the states.

Both the FDA and the state boards of pharmacy have done a great job of dodging the bullet thus far. Unfortunately, however, it is the patient who suffers. And in the case of a workers’ compensation case, the payer as well. Compounds represent one of the most dangerous and fraudulent forms of medication dispensing. That being said, compounds can also be extremely beneficial when medically necessary, and in the right environment of audits and controls.

Compounds are difficult to analyze value and benefit. As such, they are never indicated for pain management in Evidence Based Medical (EBM) guidelines such as the Official Disabilities Guidelines (ODG).

While there are exceptions, as a general rule compounds should never be authorized and/or covered without consideration of the following intervention strategies:

If Utilization Review (UR) is a part of the state regulatory landscape, compounds should be sent through UR before being authorized for fill the first time.
If the UR reviewer deems the compound to be unnecessary, immediately direct your PBM to exclude it from the patient’s formulary.
If UR isn’t an alternative, escalate the authorization request to a nurse, clinician or physician to request a determination of necessity and appropriateness based on the state’s designated treatment guidelines.
As an example, for states that follow ODG, compounds would be indicated as necessary and appropriate ONLY in the following situations:
1. An indicated first line therapy was tried and failed,
2. The patient has an allergy to an inactive ingredient of a more traditional form of a medication.

At the claim level, we cannot protect our patients against every danger, clinical oversight and scam artist seeking to benefit financially from the workers’ compensation system. By consistently following the guidelines available, however, and encouraging more states to implement treatment guidelines like ODG, we can better position our companies and our patients to achieve the best in care, cost and compliance.