Tag: Opioids

What Do Medicare Part D, Medicare Set-Asides and Parenting Have in Common?

March 2, 2018

parenting - father hugging two young children

For those who have raised children, or are in the process of doing so, one of our biggest challenges is to instill in our children some sort of positive decision-making paradigm in our children.  You can call it religious values, moral absolutes, grounding, or just plain common sense, but as parents, we set boundaries (rules) from the earliest age, and try to be consistent in our enforcement.  Our children may think we’re just mean, but this is a price we’re willing to pay if it helps establish an internal barometer to use when approached by people, thoughts and ideas that challenge them.

In raising my three children, one of the techniques I used was a simple, banded bracelet with the acronym, “WWJD” that is, What Would Jesus Do? This was a popular phrase in the Bible Belt where we lived.  I asked that they look at the bracelet each time they were faced with an obstacle or asked to do something that didn’t quite feel right.  One afternoon, my son was telling a story about something that happened at his elementary school that caused him to look at his bracelet. I was so pleased when he said he actually looked at it!  He then responded, “Mom, I tried to decide what Jesus would do, but had a little bit of a tough time, so I switched it in my head to “WWMD”, and I knew exactly what Mom would do!”  I couldn’t help laughing, but based on his response to the situation, my simple reinforcement worked.  At the same time, this also reminded me that our actions speak much louder than our words….children will “do as we do” long before they will ”do as we say.”

How does this relate to Medicare Part D and Medicare Set Asides?

Each day, one of my first activities is to review my Google Alerts to look for news about NGHPs, Medicare Secondary Payer issues and opioids.  This morning, the article that drew my attention was from MedPageToday.com entitled “CMS Proposes Opioid Prescribing Limits for Medicare Enrollees.”  My first thought in reading the article was that this was great news.

“We are proposing important new actions to reduce seniors’ risk of being addicted to or overdoing it on opioids while still having access to important treatment options,” said Demetrios Kouzoukas, CMS deputy administrator and director of the Center for Medicare.

“We believe these actions will reduce the oversupply of opioids in our communities.”

Key components of the proposal include:

  • Hard formulary levels at pharmacies that would restrict the amount of opioids beneficiaries could receive
  • Establishment of a safety level of 90 morphine mg equivalent (MME)
  • Limiting the # of pills and days supply in an initial prescription for acute pain

According to Kouzoukas, “these are triggers … [that] can prompt conversations between physicians, patients, and plans about appropriate opioid use and prescribing.”

I then realized what CMS was doing.  CMS was setting boundaries to help physicians, patients and plans make better decisions about opioid use…. the same type of boundaries I set for my children so they would make better decisions as adults.  What a great idea!  If physicians, patients and plans (both Medicare and workers’ compensation) can dialogue before Rxs are filled, better decisions about opioids are inevitable and the frequency of opioid addiction will diminish.

So what’s the problem?

Unfortunately, there remains a problem in the world of workers’ compensation and the WCMSA review process.  While I applaud CMS’s effort, there remains a strong disconnect between CMS’s proactive stance on opioid limitations with Medicare Part D and its opioid-friendly review process for WCMSAs.  At the same time, I must also admit to a similar disconnect between what happens with prescription opioids during the life of a workers’ compensation claim and what we are asking CMS to do when reviewing the MSA at settlement time.  Are we asking  CMS to “do as I say,” instead of providing the example of   “do as I do?”

Can we ‘connect the dots’?

After reading the article, I realized that as an MSP compliance company that has integrated opioid triggers into its Pre-MSA Triage and review process since Day #1, Tower now has a new weapon in its arsenal to assist clients to identify pharmacy obstacles as early possible, and to address issues of inappropriate drug use.  By advising clients to establish and enforce “CMS-like” boundaries at Rx fill time, we have the potential to reduce opioid use in workers’ compensation just as CMS seeks to accomplish with Medicare Part D.  Through such efforts, we can reinforce dialogue between physicians, claimants and workers’ compensation plans before the Rx is filled, and hopefully facilitate better decisions about the first opioid Rx.

And as for the disconnect between Medicare Part D and the WCMSA review process, we cannot force CMS to change its WCMSA prescription drug review process.  We can, however, leverage CMS’s expertise to support better outcomes with Medicare beneficiaries, MSAs and settlements by mirroring their Medicare Part D policies and processes within the workers’ compensation PBM model.  In doing so, we provide CMS with a positive example of their own recommendations implemented successfully, and can hopefully encourage them to “do as we do.”

Conclusion

So how do we affect change in opioid prescribing habits in workers’ compensation?  It’s as simple as the bracelet I gave my children.  From Day #1 of a claim involving an active or soon to be active Medicare beneficiary, we continually ask the question, “What Would Medicare Do?” and we execute.

CMS Statement on Opioids and WCMSAs Provides Little Clarity as to Future Review Practices

December 27, 2017

In a recent post on its website, the Centers for Medicare and Medicaid Services (CMS) acknowledged the opioid crisis in this country, but provided little clarity as to how it intends to address this crisis in its review and approval of Workers’ Compensation Medicare Set-Asides (WCMSAs).

The 12/14/2017 statement provides as follows:

CMS understands the concerns regarding the opioid crisis occurring in the United States. We are committed to ensuring the determination of Workers’ Compensation Medicare Set Aside Arrangement (WCMSA) amounts are an adequate projection of claimant’s needs for future medical services and prescription drugs. CMS continually evaluates all policies and procedures related to WCMSA amounts. Any changes that Medicare pursues related to this issue will be reflected in our WCMSA amount review process.

More information on the WCMSA process can be found in the WCMSA Reference Guide.

We assume the above statement may be, in part, related to the California Workers Compensation Institute (CWCI) study finding nearly 70% of CMS approved MSAs require funding of opioids over an injured worker’s life expectancy (See our article, Opioids in the MSA . . . Challenges and Strategies, where this study is discussed). While we credit CMS’s Office of Financial Management (the CMS department which oversees the WCMSA review program and contractor) with recognizing the opioid crisis, what is left uncertain is what specific actions CMS is to take to address this problem in WCMSAs. Instead, CMS provides a vague statement indicating any changes related to the opioid issue will be reflected in its WCMSA review process and then cites its WCMSA Reference Guide.

CMS does not cite to a particular section of the guide, but we assume the following would be the most pertinent:

Drug Weaning/Tapering

Drug weaning commonly occurs with pain medications, such as opioids, especially when claimants’ work injuries improve. The WCRC takes all evidence of drug weaning into account, although in most circumstances the WCRC cannot assume that the weaning process will be successful. Usually, the latest weaned dosage is extrapolated for the life expectancy, but again, they assess all records when making these types of determinations. Where a treating physician believes tapering is possible and in the best interests of the claimant, CMS will consider all evidence in making a WCMSA determination, including medical evidence of current actual tapering.

Based upon the Tower MSA CMS Reconciliation Module, which reviews all MSA determinations for the purpose of identifying trends in CMS WCMSA allocation practices, CMS consistently disregards any active weaning or tapering process or scheduled reduction to future medication use and instead takes the latest dosage found in the medical records and/or prescription history and extrapolates it over the claimant’s life expectancy.

The question then is whether this December 2017 statement signals a departure by CMS from these past practices to a policy which will now give more weight to a weaning or tapering schedule from the treating physician which translates into limitations on the allocation of opioids in the WCMSA. We will take a wait and see approach in this regard.

It should be understood though that even were CMS to limit the allocation of opioids in the WCMSA, this in no way prevents the claimant from using the WCMSA funds for filling opioid prescriptions in excess of what is allocated. The reason being is CMS rules for administering a WCMSA allow for the funds in the account to be used for any Medicare-covered injury-related treatment or medication. As such, with a valid prescription, there is nothing to stop a claimant from converting funds allocated to a surgery to pay for medications, including opioids. It will remain then in the hands of the claimant’s medical provider to wean the claimant off opioids and other medications not intended for long-term use.

Practical Implications

As always, we will monitor CMS WCMSA determinations for signs of any changes to their allocating practices for prescription medications, especially in regard to opioids. However, we have to assume that until we see any changes, CMS will continue to follow its policy of taking the most recent medication dosage and frequency and pricing it out over the claimant’s life expectancy.

What this means then is opioid misuse must be addressed prior to submission of a WCMSA to CMS with any actual elimination of opioids documented in the medical records prior to submission of the MSA. Tower MSA is committed to working with our clients on reduction and elimination of opioids prior to CMS submission. Our Pre-MSA triage service is uniquely designed to identify such MSA cost-drivers and recommend intervention strategies, including escalating the matter to our Internal Pharm. D. for direct contact with the treating physician. Resulting reductions in opioid use limit MSA costs to the employer and provide for a healthier injured worker over his or her lifetime.

Please contact Dan Anders at Daniel.anders@towermsa.com or (888) 331-4941 with any questions regarding CMS practices in allocation of prescription medications in the WCMSA.

Opioids in the MSA… Challenges and Strategies

November 3, 2017

If seeing the word opioids one more time doesn’t trigger some sort of reaction, whether sadness, anger, desperation, or possibly hope at what appears to be traction to ‘Turn the Tide’ of addiction, then I can only surmise that you must live under a rock! That certainly isn’t the case here, as in our world of MSP compliance, the word opioids is either read, spoken or written every single day. It permeates our industry and our lives.

The most recent example of the profound impact opioids continue to have on workers’ compensation, the MSP industry, and specifically on the Medicare Set Aside (MSA), came from a study released earlier this week by the California Workers’ Compensation Institute (http://www.cwci.org). Those who saw the study became painfully aware that in the state of California,

“Nearly 70% of federally mandated and approved Medicare settlements for injured workers require funding for decades of opioid use, often at dangerously high levels and in conjunction with other high-risk drugs.”

CWCI study and key findings

The CWCI examined data from 7,926 California WCMSA plans completed, submitted and approved by the Centers for Medicare and Medicaid Services (CMS) in 2015 and 2016. To achieve a representative cross section of the state’s MSA cases, the authors compiled its dataset of 7,926 WCMSAs from four national vendors whose work product represented more than 50% of the state’s MSA market.

Overall findings were as follows:

  • $103,393 Average CMS approved WCMSA
  • $48,986 Average RX$ (47.6% of MSA)
  • 69.4% % WCMSAs with opioids (twice the rate of any other drug class)
  • Norco / Vicodin were included in 44% of the opioid inclusive WCMSAs

Also significant were CWCI’s findings when the authors compared opioids found in WCMSAs to a case-matched control group of closed workers’ comp permanent disability claims for similar injuries. This comparison demonstrated that the WCMSA allocations included much stronger opioids, with average morphine milligram equivalents (MMEs) at 45 times the level used in the control group during the life of the claim. In addition, the WCMSAs with opioids required funding for an average daily dose of 54.7 morphine equivalents (MEDs) for a period of 20.9 years.

An industry’s call to action

The realization that opioids represent a major problem with the WCMSA did not come as a surprise to Tower, or to the National Alliance of MSA Professionals (NAMSAP). For the past 2 years, NAMSAP, through its Evidence Based Medicine and Data and Development committees, has been working tirelessly to educate the MSP community as to what happens in the MSA when opioids are prescribed over the life of the claim and remain as standard treatment when the MSA is prepared and submitted to CMS. NAMSAP has hosted multiple webinars to bring industry, regulatory and legislative experts together to discuss the opioid impact, and sent representatives to Washington to discuss our concerns with CMS. At our most recent annual conference, NAMSAP hosted Assistant Surgeon General, RADM Pamela Schweitzer, Pharm.D., BCACP, who shared both her concern for our situation, and her enthusiasm for our passion and our efforts.

With a singular focus among our members, I am hopeful that NAMSAP can successfully modify prescribing behavior and ultimately impact WCMSA outcomes. Unfortunately, this doesn’t benefit carriers, employers, third party administrators and injured workers today.

What are we doing now?

At Tower, the issue of opioid misuse and the importance of pre-MSA intervention has been in the forefront of our business model, our technology platform and our workflow from day 1. Our Pre-MSA Triage service identifies issues long before the MSA and provides practical recommendations to address obstacles. Our integrated technology platform tracks pharmacy triggers and interventions, escalates to our Internal Pharm. D. to contact the treating physician and diaries to track progress until treatment has been optimized. We then finalize the MSA and submit to CMS for approval.

The result of our workflow, our technology and the internal team of clinical, legal and medical experts we’ve built is a streamlined, end-to-end process that identifies issues, tracks progress and drives results for our clients.

Results achieved across all clients:

  • $59,070 Average CMS approved (Non-Zero) WCMSA$
  • 58.7% CMS approved WCMSAs with $0 Pharmacy
  • 22.6% CMS approved WCMSAs that include opioids
  • 61.4% MSA savings through integrated Rx interventions

These are numbers we track monthly through our CMS Reconciliation Module to confirm that CMS performance continues to improve. Our belief is that until prescribing habits change and best practices in opioid treatment can be implemented and enforced, our responsibility is to drive better outcomes through both formal intervention services and consultative oversight. Our clear focus is to limit pharmacy to those medications that are appropriate for long term use, to discontinue opioids where possible and to reduce MED to the lowest level possible when opioids must be included in the WCMSA.

Conclusion

In the words of HHS Secretary, Tom Price, M.D. and Kellyanne Conway, counselor to President Trump,

“Ending the opioid epidemic will require an all hands on deck effort”.

Stay tuned.

FDA Mandates New Warnings for Opioid and Benzodiazepines

September 20, 2016

Hydrocodone Rescheduled

In a statement released on September 1, 2016 (FDA Black Box Warning), the Food and Drug Administration (FDA) announced that “after an extensive review of the latest scientific evidence, it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.”

Background

Benzodiazepine medications are most commonly prescribed to treat anxiety and mood disorders, such as depression and insomnia. The drugs also are used to treat seizures.  According to the FDA, the number of individuals who were prescribed both opioids and benzodiazepines grew by 41 percent, or 2.5 million, between 2002 and 2014.

States submitted a petition to FDA calling for the agency to add black-box warnings about the potentially fatal combination of opioid painkillers and benzodiazepines to the drugs. The officials said prescription opioids and benzodiazepines often are used together, and data show that almost one in three unintentional overdose deaths from prescription opioids also involved benzodiazepines.

What drugs are impacted?

The agency is requiring that black box warnings, the strongest available, be added to nearly 400 products (of which more than 200 are opioid painkillers) alerting doctors and patients that combining opioids and benzodiazepines can cause extreme sleepiness, slowed breathing, coma, and death.

The FDA is warning patients and their caregivers about the serious risks of taking opioids along with benzodiazepines or other central nervous system (CNS) depressant medicines, including alcohol. Serious risks include unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, coma, and death. These risks result because both opioids and benzodiazepines impact the CNS, which controls most of the functions of the brain and body.

The bigger picture

The agency said the move is one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.  For those who may not know what’s in play or want more information about the national effort, go to TurnTheTideRx.Org to access the U.S. Surgeon General’s plans to curb the epidemic.

In responding to the announcement, FDA commissioner Robert Califf noted, “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” He further added, “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines … together outweigh these serious risks.”

What does this mean to you?

In dealing with workers’ compensation claims for Class I and Class II Medicare beneficiaries, the combination of opioid pain killers and benzodiazepines is a common occurrence.  When we see it, we immediately notify the claims handler that this is a dangerous combination and certainly not intended for long term use.  For the elderly, drug combinations such as this are even more dangerous as their effects are exacerbated due to the rate at which they metabolize in an elderly person.  For those who may not be familiar, there is an excellent resource (2015 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults) that focuses on commonly used drugs and the risks and potential dangers when prescribed to the elderly.  According to the guide,

“Older adults have increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents; in general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle crashes in older adults and should be avoided”.

One of many pieces of the opioid puzzle

As stated within the “TurnTheTideRx” campaign literature, it is truly “All hands on deck” if we hope to change the course of the opioid epidemic.  It will take patient, family members, friends, and in the case of workers’ compensation claims, claims handlers, nurse case managers, employers,  carriers and even MSP compliance providers to help change prescribing habits.  While legislative, regulatory and compliance entities can assist by setting policy, it is the physician who writes the first script.  When I see that one of the largest emergency rooms in the country (One of Nation’s Largest ERs Kicks the Opioid Habit) can function without writing opioids as first line pain management for acute pain, I am convinced that a change is possible if we can engage our physicians.

We are but one piece of this very complicated puzzle, and “Big Pharma” has deep pockets.  Through education of all stakeholders, advocacy to those in positions of power and influence, and our respective collaborative efforts to optimize claims and treatment, we can make a difference in the lives of our patients.

 

Opioids in the Life of the MSA… Coming Soon

June 10, 2016

In a statement released on June 7, 2016, the National Alliance of Medicare Set-Aside Professionals (NAMSAP) announced the 2nd in a series of webinars focused on opioid drugs in the Medicare Set Aside.  The release can be found at NAMSAP Presents “Opioids in the Life of the MSA” Webinar on June 21

 Background

Since the creation of NAMSAP’s Evidence Based Medicine Committee in 2014, opioid use has been in the forefront of attention within NAMSAP.  As a member of NAMSAP’s Board of Directors, I have participated in our organization’s efforts to collaborate with experts on this critical issue, to educate our members as to what is happening when opioid involved MSAs are reviewed by CMS, and now to advocate to entities outside of workers’ compensation.

Our goal is to publicize the conflict between the WCMSA review process and  CMS’s own criteria for opioid addiction triggers, prior authorization requirements and mandatory weaning.   This release explains the rationale and basis for our request: NAMSAP has called for CMS to limit opioids in the MSA review;

The easy answer

Many say the answer to the inconsistencies in the WCMSA review process as it relates to opioids is to stop submitting the MSA to CMS.  “Why feed into a broken system?” is the question I’ve heard.  If opioids aren’t appropriate for life expectancy, if addiction is imminent, if weaning is appropriate, then include this in the MSA and just don’t submit.

I absolutely endorse CMS non-submission as an option.  Where I may differ from others is that I believe it should be decided based on the facts of the case as compared to the objective and subjective nature of CMS’s review and approval process.  Unfortunately, I fear a corporate non-submit strategy is a slippery slope down the path of massaging the MSA to ‘fit’ the needs of the moment.  That is not its intent of the MSA, nor will it be left unchallenged in the long term.

What if?

I believe the prevalence of opioids in workers’ compensation indicates something is broken, but the break is much further up the food chain.  Can and should CMS ‘fix’ a problem that we have allowed and enabled over the life of the claim?  Can an excise tax on opioids fix the problem?

What if we looked at things differently?

  • What if we identify the physicians who don’t write for opioids as first line treatment for pain?
  •  What if we know and use the physicians with a proven track record of getting patients back to work
  •  What if we implement triggers to identify initial onset and changes in opioid dosage and frequency?
  • What if an increase in Morphine Equivalent Dosage was measured and addressed immediately with the physician?
  •  What if we leverage PBM reports and tools to block opioids based  on corporate designated criteria, and then execute an action plan?
  •  What if we use jurisdictional options like UR, IMR, challenging treatment to force dispute resolution and state options to allow the carrier to control physician choice where these options exist?

What if?

Working both sides

Every company has its own strategies to address the opioid issue.  Our policy at Tower is to ask every ‘what if‘ question possible as we work with clients throughout the claim and settlement process.  Whatever the answer, whether it’s physician follow up to track weaning, a formal physician peer review to challenge inappropriate treatment, or negotiating a Conditional Payment Notice to dissociate unrelated treatment, our MSP Automation Suite drives and tracks every step in the process.  We push the claim to optimize outcomes and acknowledge when the MSA is ‘ready‘ to submit.

The result of the combined efforts of all stakeholders in workers’ compensation, according the WCRI report on opioids released on June 9, 2016 is that the industry has made positive strides to address opioid issues.  Now NAMSAP is challenging CMS to modify the WCMSA review criteria so that it more closely mirrors its own Part D approvals process.

I hope you will join the webinar as we look at the policy side of the opioid issue within the MSA and that you join our advocacy efforts.

 

The VA’s Proactive Move on Opioids

October 3, 2014

I don’t need to reiterate how big a problem prescription drugs continue to be not only in the work comp industry as well as society, but I just did anyway. Recently I wrote here about the rescheduling of hydrocodone combination products and how it was a long overdue move for the DEA to make. As a reminder, the reclassification goes into effect on October 6, and this was no doubt the reason that the Veterans Health Administration sent a letter to my dad yesterday.

As well deserved as the scrutiny against the V.A. has been in recent months, the letter that they sent my father was an absolutely needed step and one that hopefully represents the direction in which the disgraced organization is heading.

It was a simple letter and you can see it by clicking on the link below, but the VA decided to take decisive action and inform what appears to be all patients who have been prescribed hydrocodone combination products in the past about the DEA’s decision to reclassify. Furthermore, they took the time to explain to our veterans the changes to the typical process that they will experience.

There are two aspects of the letter that really stick out. First, it explains the reasoning behind the DEA’s decision in a simple, yet alarming way – one I which my dad really took notice to. The letter states:

The DEA did this because these medications were found to be highly abused, habit forming, and potentially deadly in overdoses and need stricter regulations to improve their safe use.

Simple yet effective. It reads a lot like a surgeon general warning on a pack of cigarettes. The second impressive aspect of the letter is the fact that my dad hasn’t had a prescription for any drug that fits this category since his neck surgery 4 years ago. And so who knows how far back the VA went in considering which vets to send this letter to, and perhaps it was everyone who has ever received a hydrocodone combination product. Whatever they did, from my perspective it was above and beyond and so kudos to the Department of Veteran Affairs for stepping up and being proactive.

VA Letter on HC Products

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

February 24, 2014

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