Chronic Pain Can Be Managed With Alternative Therapies

July 10, 2014

Traumatic injuries and opioid therapy can alter the pain pathways in the central nervous system, and this process is called neuroremodeling. This can cause unwanted or undesirable reactions to pain and negatively impact the recovery process. There are several approaches to reversing the neuroremodeling, some of these alternative treatments include cognitive behavior therapy and opioid tapering.
A patient cannot overcome chronic pain when their mind is at odds with their body, and so psychological therapy can be an effective way to reverse the body’s perception of pain. Cognitive behavior therapy uses teaching strategies to enable patients to control their perception of pain, and to overcome the feeling of defeat about an injury.   Through CBT, patients learn to cope with existing pain using relaxation, distraction, imagery and self-hypnosis.

Chronic pain affects the whole person… mind, body and spirit.  As such, pain management alternatives must consider more than just the physical.

“In some patients, opioid therapy administered to reduce pain has the opposite effect and the patient experiences an increased feeling of pain. This effect is called opioid-induced hyperalgesia (OIH). OIH is an example of neuroremodeling that occurs to the specialized receptors in the body that respond to opioids. The cause is unknown, but sometimes a normal perception of pain can be restored by discontinuing opioid therapy through a medically supervised program. The assistance of a comprehensive pain management center experienced in opioid tapering may be necessary.”

Many are resistant to standard detoxification programs, noting that most are cost-prohibitive, and many times the patient returns to old habits.  While this may occur in some cases,  greater attention is being given in treatment guidelines, especially when opioids are involved, to recommend alternative pain management strategies like CBT in an effort to heal the whole person.  Leveraging the patient’s individual strengths while building compensatory strategies to offset weaknesses, long term success can be achieved. 
                     
What’s the old saying…..

 “Give a man fish and he will have food today.  Teach a man to fish and he will have food for a lifetime.”

Are we, as an industry,  willing to spend the time, money and effort to teach?

Managing Costs Of The Aging Workforce In Workers’ Comp Claims

Problems arise in the workplace with aging employees, especially when the work involved requires physical stamina. The same can be said for those employees with pre-existing medical conditions, like diabetes or asthma. One way to manage the occurrence of workers’ compensation claims is to provide a number of alternatives for employees, measures that will act as preventative care.

Some companies determine the definition of aging by setting a certain age limit, depending on the type of work it can be as early as 35. While it has been shown that there are no greater instances of workers’ compensation claims in older workers, the cost of claims from aging workers is significant to companies. Implementing wellness programs that provide incentives for healthy behavior is one way to counter the aging or ailing of your workforce. Marsh has released a Risk Management Research Briefing that shows ways in which employers can counter the workers’ compensation costs for an aging workforce.

The cost to employers when older workers are injured can be much higher than when younger employees are injured. Obesity and other comorbidities common to older employees could also extend recovery times. But you can take action to reduce the frequency of injuries and help your employees remain fit and better able to recover following an injury.

In light of  our current challenges with MSAs, and the struggle we see with CMS acceptance in cases where co-morbidities and obesity complicate treatment and settlement, this article brings to light some interesting points.  Accidents in the elderly may be inevitable, but proactive steps taken now to create a healthier workforce at any age may result in significantly less severe accidents.  For Medicare beneficiaries, the financial ramifications could be significant.

Is The Tidal Wave of CMS Development Letters Behind Us?

May 14, 2014

In case you didn’t hear us shouting from the rooftop, Tower MSA Partners (as well as other companies across the MSA industry) was notified Tuesday, May 13, 2014 that full MSA approval had been given for approximately 100 cases, more than 50 of which were in various stages of development request processing.  While this was certainly a welcomed announcement, I believe strongly that it was not an arbitrary decision by CMS, nor was it achieved by a few large companies.  I see this accomplishment as the result of the combined and focused efforts of many in the MSP compliance industry.  

Where Do I Begin?

As many of our clients have become painfully aware, development requests have been a major issue for Tower, as well as every carrier, employer and MSA provider in our industry, since late 2013.  In early January, I discussed this new trend via a blog article (http://www.mspcomplianceblog.com/cms-wcrc-development-letters-essential-information-or-delay-tactic/ ) to explain what we were seeing as a company.  In follow up to the article, I took this information to my industry peers, encouraging their participation to track the trend through my involvement with the Data and Development Committee of NAMSAP (National Alliance of MSA Professionals).   

An Industry Moved to Action

Data capture of development requests began in January with analytics by the DDC for the next 90 days.  At the same time, the NAMSAP Board of Directors asked that I prepare an article to be published in NAMSAP’s national newsletter, and also to help author a letter to be submitted to CMS on behalf of the NAMSAP BOD.  The article’s intent was to communicate the source and impact of development letters among our membership, and to encourage readers to share their experiences in the form of actual data.  The letter to CMS presented aggregated, experiential data to demonstrate the effects of the WCRC’s actions, and to communicate the settlement obstacles being created by this process (not the least of which was the request for HIPAA protected primary care physician medical records). 

Communication Through Data Analytics

Through the efforts of the DDC to summarize the data obtained from multiple companies across our industry, the letter submitted by NAMSAP’s BOD to CMS provided clear evidence of the impact of the actions of the WCRC on settlement initiatives.  We then requested that CMS work with our industry to reestablish a strategy that included only ‘injury related’ medical and pharmacy history, and followed the published standards defined in the March 2013, November 2013 and February 2014 editions of CMS’s own WCMSA Reference Guide as their only criteria to ensure that Medicare’s interests are adequately protected.   

While we cannot confirm that CMS’s recent actions were in response to the initiatives pursued by NAMSAP, or through the efforts of a single company, we certainly believe industry involvement for the benefit of all stakeholders was the right course of action and are thrilled with the outcome.  We are pleased to have been an active participant in this process.

Lessons Learned?

As the MSP compliance partner for employers, TPAs and carriers, our primary responsibility is to prepare and submit Medicare Set Asides that to the best of our knowledge, ability and expertise ensure that Medicare’s interests are adequately protected when settling future medical claims.  From a professional ethics perspective, this means doing what is reasonable on behalf of the claimant.  For Tower, we describe this as, “helping clients balance care, cost and compliance when settling claims that involve Medicare beneficiaries”.       

One of our client’s website taglines reads as follows, “We strive to ensure that injured workers get the right care at the right time—and we focus on getting it done the right way. It’s our commitment.”  I’ve read this quote many times and strongly believe this is the goal of most in our industry….. do what is reasonable.  And in the end, regardless of CMS submission and approval, I believe this will provide adequate evidence of our efforts to protect Medicare.

Looking ahead, we must now prepare our team and our clients for the next wave of CMS submissions.  How do the experiences of the past 6 months impact our internal processes going forward?  Was the development letter barrage truly a ‘ghost hunt’, or is there something to be learned from the WCRC’s actions?   This will be the focus of our attention in the coming weeks.

 

 

 

 

Can A Medicare Beneficiary Obtain Coverage Under ACA Compliant Major Medical Plan?

April 21, 2014

This was a question raised recently within the NAMSAP (National Association of MSA Professionals) listserv.   While it seemed simple and straightforward, it generated so much interest from so many within our organization, I thought it worthy of a blog post to communicate both dialogue and  dilemma .

Setting the Stage

n 2011, a medical liability claim was filed when a first time mom lost her child 19 weeks into pregnancy due to a missed diagnosis of sepsis.  Not only did she lose her child, she also lost both legs below the knees, nine of her ten fingertips and now has only 25% kidney function.  In spite of the horrific outcome resulting from the misdiagnosis, the woman has a marvelous attitude about life.  Having received SSDI benefits for almost 24 months, she will become Medicare eligible in the next six months.

As a result of her pending Medicare beneficiary status, plaintiff attorney requested an MSA allocation.   The MSA was finalized with total future medical and pharmacy costs projected at approximately $1,000,000.  Settlement negotiations remain ongoing.  At this point, however, defense counsel believes that an MSA is not necessary noting that claimant could easily obtain an ACA compliant, standalone major medical policy during an open enrollment period.

If an ACA compliant policy is an appropriate alternative to an MSA to address future medical treatment, then what’s to stop all injured claimants that are Medicare beneficiaries, whether involved in a workers’ compensation liability claim, from doing the same, effectively ignoring the MSP statute’s legal obligation to consider and protect Medicare’s future interests?  The question at hand….

If an injured claimant can obtain ACA coverage at any time, before or after Medicare eligibility, why bother with a MSA? 

Can A Medicare Beneficiary Obtain ACA Coverage?

The short answer, per 45 CFR 148.103, is that ACA policies can only be provided to “eligible individuals”, and a person  who is eligible for Medicare is not eligible for coverage under the ACA.

From the ACA FAQ link, we find the following (http://obamacarefacts.com/obamacare-medicare.php)

Does Medicare Meet ObamaCare’s requirement that all Americans have health insurance?
If you have Medicare Part A (Hospital Insurance) or Medicare Part C (Medicare Advantage, you’re considered covered and won’t need a Marketplace plan. Having Medicare Part B (Medical Insurance) alone doesn’t meet this requirement.

Can I get a Marketplace Plan in Addition to Medicare?
No. It’s against the law for someone who knows that you have Medicare to sell you a Marketplace plan. This is true even if you have only Part A or only Part B.

If you want the technical version, go to  http://www.socialsecurity.gov/OP_Home/ssact/title18/1882.htm for specific guidance.  And in Medicare’s own words, the relationship between ACA and Medicare is explained http://www.medicare.gov/about-us/affordable-care-act/affordable-care-act.html.

MSP Compliance Within An ACA Environment… Back to the Beginning 

While the answer appears to be simple in this case,  the fact that such a recommendation was made by an attorney should raise a flag to all who live daily in the MSP compliance arena.  With so many unknowns surrounding the ACA, “Will a healthier workforce yield fewer claims and a faster return to work?  Will the ACA create cost shifting from workers’ compensation to group health?   Will the scarcity of primary care physicians impede carriers’ ability to deny questionable claims as quickly as possible?”, miscommunication and confusion are inevitable.  If for no other reason than clarity for ourselves and our clients, this is worthy of our attention.

How do we overlay what we’ve learned in recent months about the ACA with our understanding of the mandates imposed by the MSP statute so that we can educate, advocate and set expectations for our clients?  The first step, I believe, is to go back to the the beginning, and to remind ourselves of the intent of the MSP statute… to protect Medicare from making payments it shouldn’t make, regardless of whether payment represents past, present or future exposure.

The MSP statute mandates that:

  • Payments made ‘conditionally’ by Medicare for treatment for a workers’ compensation, liability, no-fault claim that was reasonably be expected to be paid by an entity other than Medicare be recovered;
  • Medicare’s interests be considered and protected when settling a claim when any portion of the settlement dollars is intended to cover future medical treatment for a current or pending (within 30 months) Medicare beneficiary;
  • All Responsible Reporting Entities (payers) report, through MMSEA Section 111 Mandatory Insurer Reporting, the total settlement amount when a TPOC event (Total Payment Obligation to Claimant) occurs.

These are the pillars of MSP compliance, and represent the filters we should use each time we contemplate settlement  in a case that involves a Medicare beneficiary.  Does the action being proposed adequately protect Medicare’s past, present and future interests?

In this situation, we find ourselves at a disadvantage as we know little from the ACA as to its prospective relationship to the non-group health environment.  What we do know, however, and the looming danger, is that the ACA guarantees no exclusions for pre-existing conditions and no lifetime limit for medical care.  Its boundaries, therefore, are non-existent.

How Will the Government Respond?

With limitless dollars for medical treatment under an ACA plan, a reasonable expectation is that the US government will attempt to recover each and every penny when treatment of an ICD9 code can be linked to a workers’ compensation, liability or no-fault claim.  As such, it seems logical that an MSA is the only way to ensure that Medicare’s past, present and future interests are appropriately protected.

To shift the burden to a health exchange supports neither the recovery of past payments nor the means to provide future protection for those government payments made on behalf of the Medicare beneficiary (Medicare Part  A & B).  To complicate the equation even further, if there is a third party Advantage C plan in the picture, those commercial dollars that partially fund the care are also at risk.  As such, the commercial carriers will seek every available dollar on a case such as this where lifetime exposure exists.

Today’s Conclusion

The introduction of ACA within the framework of MSP compliance is certainly an issue that requires further research, and one I’m pleased to see NAMSAP follow.  At this point, unless something comes to light to dispute the information included above, it would appear that ACA plans and Medicare will exist mutually exclusive of each other.  As such, to comply with the intent of the MSP statute, any settlement pursued for a Medicare beneficiary, regardless of total settlement dollars or the availability of ACA plans, should include an MSA.

ACA policies can only be provided to “eligible individuals”. 45 CFR 148.103 provides that someone who is eligible for Medicare is not eligible for coverage under the ACA.

 

Is Opioid Use Under Control in Workers’ Compensation?

April 15, 2014

With the recent publication of the ACOEM Guidelines for Opioid Use and new guidelines from the American Chronic Pain Association (ACPA) that include very specific recommendations to monitor opioid use, the question was raised generically as to whether opioid use is under control in workers’ compensation.  Certainly, with greater specificity in Morphine Equivalent Dosage (MED) directives, reducing the maximum threshold for potential concern for dependency to 50MED, our experiences and research have intensified our understanding of where and how the problem begins.  Does this, then, mean that opioid use is under control?

According to the CDC, the US makes up only 4.5% of the world’s population, yet consumes more than 80% of all opioids.  My short answer, then, is “No, opioid use is not under control in any industry in the US.”

 The title of the cover article in this month’s (April 2014) issue of ‘The American Legion Magazine’ is “Pain’s Addiction: Opioids and the Military Veteran.’  Quoting from the first line of the article,  

By the time Justin Minyard discovered the video of himself stoned, drooling and unable to help his daughter unwrap her Christmas presents, he was taking enough OxyContin, oxycodone and Valium every day to deaden the pain of several terminally ill cancer patients.

And later, from a veteran’s widow,

Just before Ricky’s overdose and death, his medication list included oxycodone (short-acting opioid, pain), hydrocodone (short-acting opioid, pain), Valium (anti-anxiety), Ambien (insomnia), Zoloft (anti-depressant), Gabapentin (Neurontin, neuropathic pain) and Tramadol (Ultram, ‘narcotic like’ medication for moderate to severe pain).

The shocking realization for me…  I can’t tell you the number of times I’ve seen this exact drug regimen in a legacy workers’ compensation claim referred to Tower for an MSA. 

Other Recent Opioid Related Announcements:

  • March, 2014, Attorneys General from 29 states sent letters to the FDA to request the withdrawal of FDA approval for ZOHYDRO, a pure version of the opioid, hydrocodone.
  • 6 days ago, Business Insurance released its latest white paper, “Opioid Abuse, How to Tackle a Growing Problem.”   
  • March, 2014, the Reed Group announced that it dedicated an entire chapter to its Disability Guidelines to provide opioid guidance, documented and independently researched by ACOEM (the American College of Occupational and Environmental Medicine.)
  • February, 2014, the ACPA (American Chronic Pain Association) released its 2014 Resource Guide to Chronic Pain Management.  The guide specifically noted that 30% of hospital admissions among the elderly can be linked to an adverse drug event or toxic effect of opioids and sedatives.

While it remains the exception, I believe this 16-20% segment of the workers’ compensation population consumes more than its reciprocal 85% of the system’s money, time and expertise.  I believe opioid use, combined with its side effects, interactions and impact on quality of life, to be the key driver of cost and appropriate care with the MSA and associated settlement. I support and follow PROP (Physicians for Responsible Opioid Prescribing  http://www.supportprop.org).  I will also continue use our blog, http://www.mspcomplianceblog.com to communicate issues, strategies, treatment guidelines, etc. 

The more we understand about chronic pain, as compared to acute pain, and the effects of long term opioid use, the more aggressive we will be in our efforts to identify and address its potential for misuse early in the claim. 

 

Managing Chronic Pain in Older Adults

April 8, 2014

According to the ACPA (American Chronic Pain Association) Resource Guide to Chronic Pain Management, “persistent or chronic pain is prevalent in older adults.”

“Nearly one third of all prescribed medications are for patients over the age of 65 years.   More than thirty percent of hospital admissions among the elderly may be linked to an adverse drug related event or toxic effect from opioids and sedatives.  Unfortunately, many adverse drug effects in older adults are overlooked as age-related changes (general weakness, dizziness, and upset stomach) when in fact the patient is experiencing a medication-related problem.  In addition, some older individuals may be more sensitive to medications, more likely to experience side effects, and more likely to be using multiple drugs with the associated risk of interactions between the drugs.”

Workers’ Comp Implications

For those who manage workers’ compensation claims, these statistics should highlight the importance of a consistently executed decision making paradigm when authorizing prescription medications for older patients. 

  • Before approving a new pain medication for an elderly injured worker, confirm that the initial dose is being prescribed at the lowest possible strength and frequency. 

  • When increases are requested, approve only those changes to strength and frequency that are adjusted slowly to optimize pain relief. 

  • When possible, confirm that the patient is monitoring and managing his / her own side effects.

When dealing with less dangerous treatment options for injuries in the elderly population, potential treatment options include:

  • Use of multiple drugs together – Careful  use of multiple drugs is potentially advantageous as the combination of smaller doses of more than one medication may minimize the dose-limiting adverse effects of using a particular single drug.

  • Alternatives to pharmacologic treatment – As an alternative to prescription drugs, physical rehabilitation and other interventional therapies, including targeted injections and acupuncture, can be helpful to minimize side-effects and maximize physical function with pain relief

Triggers For Potential Concern

Pain management in the elderly is a unique challenge.  Beyond the normal concerns of addiction and overuse, those who authorize treatment in a workers’ compensation claim for an older worker must also compare the potential dangers associated with the side effects of the medication against its promised value.  Triggers that may warrant intervention for an older injured worker include:

  • Opioid treatment that continues for more than 90 days post injury / surgery

  • An increase in the strength or frequency of an opioid prescribed more than 90 days post injury / surgery

  • A request to change from an orthopedic or other specialist to a pain management specialist more than 90 days post injury/surgery

  • A decrease in opioid drug use followed by a request for a new treating physician

  • The appearance of a long acting opioid medication following continued use and/or an increase in dosage of a short acting opioid more than 60 months post injury

Identify, Intervene and Remain Involved

By peeling back the onion one layer at a time, questions can be raised, physicians can be challenged and evidence based treatment guidelines can be used to confront the status quo.   The first step is to ask your workers’ comp PBM to identify claims that meet your triggers.   Once identified, intervene with the treating physician either directly, or through a formal peer review.  Once intervention is complete, remain involved until changes are complete.  

When preparing for settlement, it’s critical to work with an MSA partner who will serve as gatekeeper to identify the same triggers and  intercept problem claims before the MSA is prepared.  Working hand in hand, positive outcomes can be achieved for the elderly.   The process is simple.  Consistent execution is the key.

For more information on medical and pharmacological issues related to pain management in the elderly population, I encourage you to review the publications made available by the American Geriatrics Society  (http://www.americangeritrics.org).  For questions related to pain management issues related to Medicare Set Asides, email us at info@towermsa.com.

 

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.

Read More At WorkCompWire

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.”

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.”

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

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.