MSP Compliance Blog

Expert summary, analysis and recommendations on issues impacting Medicare Secondary Payer compliance.

FDA Approves Generic Release of Abilify

Posted on May 1, 2015 by Rita Wilson

The U.S. Food and Drug Administration (FDA) approved the first AB-rated generics to Bristol-Myers Squibb and Otsuka’s Abilify® (aripiprazole) tablets, an atypical antipsychotic drug commonly used for treating schizophrenia and bipolar disorder. The agency approved generics from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. At least one manufacturer, Teva, announced the launch of its generic in the currently marketed strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg tablets.

Specifics of Release

  • Brand Name: Abilify® (aripiprazole – Bristol-Myer’s Squibb/Otsuka)
  • Indication: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, treatment of irritability associated with autistic disorder and treatment of Tourette’s disorder.
  • Generic Manufacturer(s): Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals
  • Launch Date: April 28, 2015

Potential Obstacles and Alternatives

  • Teva’s launch is considered “at risk” due to ongoing litigation over three later listed patents in FDA’s Orange Book covering Abilify. The other manufacturers have not yet announced the launch of their generics.
  • Other atypical antipsychotic medications include Clozaril® (clozapine – Novartis, generics), Fanapt™ (iloperidone – Vanda), Geodon® (ziprasidone – Pfizer, generics), Invega™ (paliperidone – Janssen), Latuda® (lurasidone– Sunovion), Risperdal® (risperidone – Janssen, generics), Saphris® (asenapine – Merck / Actavis), Seroquel® (quetiapine – AstraZeneca, generics) and Zyprexa® (olanzapine – Lilly, generics).

The Good, the Bad and the Ugly

  • The good….As an expensive brand medication commonly prescribed in workers’ comp for off label use for depression and sleep related issues, the release of generic Abilify® (aripiprazole) tablets is certainly a welcomed event for our MSA submissions.  
  • The bad….We know from past history that price concessions during the initial generic release period are normally no more than 10-12% off the original brand AWP (average wholesale price).
  • The ugly…  We also know from past history that as one brand moves to generic, soon to follow are new and even more expensive alternatives.  Two new atypical antipsychotic drugs are currently under FDA review. Actavis’ cariprazine could be approved during the second quarter of 2015. Brexpiprazole, Otsuka’s follow-on to Abilify, has an FDA action date of July 11, 2015.

Impact on CMS Review of WCMSAs:

Abilify is an expensive medication used off label by many physicians in workers’ comp.  As such, it is consistently identified as a medication trigger in our pre-MSA review and triage process.  When possible our team of physicians attempt collegial dialogue with the treating physician to discuss the nature of the injury and causal relationship with psych conditionals, and to specifically discuss the rationale behind off label use of Abilify. 

According to ODG (Official Disabilities Guideline), Abilify is a ‘N’ drug (as are all atypical anti-psychotic medications), meaning it is not appropriate for first-line therapy.  This is how Medicare views Abilify, and why it’s critical to address Abilify’s use before it shows up as treatment on an MSA.  As an ‘N’ drug, Ability should go thru a pre-authorization process where the prescriber justifies its use before being dispensed through the PBM. 

For questions about Abilify, its generic release, its use in WCMSAs, both FDA approved and off label uses, please contact us @ info@towermsa.com or 888-331-4941. 

CMS Releases Updated WCMSA Reference Guide v2.3

Posted on January 12, 2015 by Rita Wilson

On January 6, 2015, CMS released an updated version of the WCMSA Reference Guide (COBR-Q1-2015-v2.3).  A complete list of the changes can be found in Section 1.1 (p. 7) of the Guide and include language changes and clarifications as follows:

  • Corrected reference from 42 CFR 411.46 to Section 1862(b)(2) of the Social Security Act.
  • Clarified reference to costs related to the workers’ compensation claim, rather than the compensable injury.
  • Clarified reference to future medical items and services as “Medicare covered and otherwise reimbursable.”
  • Clarified that CMS approves the WCMSA amount, not the WCMSA, upon submission of a request.
  • Correspondingly, clarified language referring to submission of a proposed WCMSA amount, rather than a WCMSA proposal.
  • Restated the comparison of fee-schedule vs. full-and-actual-costs pricing as the basis of pricing the proposed amount, rather than the basis of payment from an approved WCMSA account.
  • Clarified attestation vs. accounting wording.
  • Clarified procedural results when Medicare is not provided with information in response to a development request.
  • Removed the word “form” from references to documents that are not forms.
  • Added language to address schedule change for hydrocodone compounds from schedule III schedule II. See Section 9.4.6.2.
  • Changed deadline for responding to development requests for submission through the WCMSA Portal to 20 from the previous 10 days. See Sections 9.4.1 and 9.5.

What’s the Significance?

Of the updates noted above, the only items of significance to those who interact with CMS on a daily basis, are the last two changes listed – language changes as a result of the reclassification of hydrocodone to Schedule II,  and the extension of the deadline for responding to development requests.

Reclassification of Hydrocodone

As documented in Section 9.4.6.2,  Hydrocodone products now require new prescriptions at intervals of no greater than 30 days, however, a practitioner may issue up to three consecutive prescriptions in one visit, authorizing the patient to receive a total of up to a 90-day supply of a C-II prescription.  For all new cases submitted after January 1, 2015, the WCMSA guidelines require allocation of a minimum of 4 healthcare provider visits per year when schedule II controlled substances (including hydrocodone combination products) are used continuously, unless healthcare provider visits are more frequent per medical documentation.

The allocation of 4 physician visits per year for ongoing monitoring has been a standard CMS response trend for more than a year, and is commonly seen for long term pain management.  What is different here, and of potential concern, is the final statement “unless healthcare provider visits are more frequent per medical documentation.”  We have seen a recent CMS response trend in which 12 physician visits per year were allocated when medical records indicated that the patient was seeing  a healthcare provider monthly, even if only to obtain prescriptions.  With the number of patients taking hydrocodone, and the April 5, 2015 cutoff for hydrocodone refills  (6 months after the October 5, 2014 reclassification), is it possible that adjusters may see an increase in the number of office visits?

When long term use of hydrocodone products exists and patients are seeing healthcare providers at more than a 90 day frequency, with office visits only to obtain new prescriptions, adjusters should be aware that this practice may have a negative impact on the number of physicians allocated on the  MSA.  As part of the Tower MSA Partners pre-MSA review process, the issue of office visit frequency is identified as a potential cost driver and efforts are made to leverage the 90-day prescription authorization and reduce the number of  office visits documented in the medical records before finalizing the MSA.  This will ensure that CMS will respond with no more than the published 4 visits per year.

20 Day Deadline for Development Requests

According to the WCRC, the five most frequent reasons for development requests include the following:

  1. Insufficient or out-of-date medical records (CMS requests current payout and will expect all associated medical records).
  2. Insufficient payment histories, usually because the records do not provide breakdown for medical, indemnity, or expenses categories;
  3. Failure to address draft or final settlement agreements and court rulings in the cover letter or elsewhere in the submission;
  4. Documents referred to in the file are not provided—this usually occurs with court rulings or settlement documents;
  5. Submissions refer to state statutes or regulations without providing sufficient documentation, i.e., a copy of the statute or regulation, or notice of which statutes or regulations apply to which payments.

Regardless of the date of the completion of the MSA, Tower’s pre-CMS submission process will include a review of all recent treatment records to ensure that the allocation accurately reflects current treatment and up to date prices.  We also look for gaps in treatment that could result in CMS requests for primary care physician records.  When identified, we attempt to address this before CMS submission, providing the necessary documentation in the MSA to mitigate development requests and slower CMS turnaround times.

Conclusion

Tower will continue to benchmark CMS response trends externally, as well as measure internal submission / response accuracy and inclusion by evaluating  each procedure, service and medication against CMS’s response frequency and price, acknowledging that we do not seek 100% CMS acceptance.  Our goal is to proactively identify and address cost drivers before CMS submission, to provide clear documentation of optimized treatment, and to prepare an MSA that appropriately protects Medicare’s interest.

The VA’s Proactive Move on Opioids

Posted on October 3, 2014 by Tower MSA Partners

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

The DEA Finally Decides To Reschedule Hydrocodone

Posted on August 27, 2014 by Tower MSA Partners

Last week the DEA released a final rule on the rescheduling of hydrocodone removing it from the schedule III controlled substances list in favor of a schedule II designation. To be clear, this decision specifically addresses hydrocodone combination products (i.e., hydrocodone-acetaminophen formulations such as Vicodin) as hydrocodone by itself has always been a schedule II drug.

The new parameters surrounding the prescribing of hydrocodone under the more restrictive schedule II classification will go into effect on October 6, but the decision by the DEA in conjunction with the Assistant Secretary for Health of the U.S. Department of Health and Human Services has been a long time coming. Hydrocodone combination products (HCP’s) have been schedule III since the Controlled Substances Act was passed in 1970 despite, as mentioned, the fact that hydrocodone itself has always been a schedule II drug. The thought initially was that by combining hydrocodone with another substance such as acetaminophen would diminish the abuse potential, but in the DEA’s final order they actually point to several different statistics that definitively portray just the opposite. Perhaps the most eye opening of these statistics tells us that high school aged children have actually abused Vicodin at twice the rate of Oxycontin, a more tightly controlled schedule II drug that has in the past, grabbed a lot more of the headlines.

Not surprisingly, there was a lot of pushback from the pharmaceutical community as well as some from the medical community throughout this process which has taken 15 years to come to fruition (the original petition was submitted by a physician in 1999). This dissent however, is misplaced and perhaps even irresponsible considering hydrocodone is the most prescribed drug in the United States. Last I checked, heart disease was the biggest killer in this country, not pain, yet hydrocodone is prescribed more than even ACE inhibitors (for hypertension) or statin drugs (to lower cholesterol).  And if that is surprising to you try to wrap your head around this: the United States is comprised of about 4% of the world’s population yet we use 99% of the world’s hydrocodone.

The affect this will have on the workers compensation industry could prove to be significant. In terms of PBM’s who commonly push for mail order distribution, schedule II drugs have restrictive policies not conducive to this type of service. It would therefore be a good idea to check with your PBM to ensure that they are actively transitioning all applicable injured workers.

A second implication could be in regards to the widely utilized Official Disability Guidelines (ODG) which have long classified several HCP’s as Y drugs (recommended for first line treatment) within their workers compensation formulary. If changed to N drugs, those HCP’s would be subject to immediate utilization review in states such as Texas and Oklahoma that have instituted a closed formulary.

In my world of Medicare Secondary Payer compliance, it’s tough to say exactly where the effect of this rescheduling will be felt, but there are some trends that I hope we begin to see starting with less hydrocodone on MSA’s. It is easy to get caught up in cost drivers and how to mitigate unnecessary medical treatment in my line of work, and rightfully so when a prescription that was never meant to be maintained long term must be allocated for because it is part of the current treatment plan. But oftentimes, payers tend to overlook or not focus on HCP’s due to their relative low cost in comparison to some of their counterparts such as Oxycontin, Opana or Actiq. The result of that is we are consistently including long term use of hydrocodone-acetaminophen (for example) within MSA allocations in spite of the fact that no opioid has ever been recommended for long term use. This sort of tradeoff is unavoidable at times, but I will still hold out hope that the DEA’s most recent stance to reschedule hydrocodone combination products will prove to have a significant impact on the misuse and abuse of prescription painkillers, not just in our little world of work comp, but far reaching into our society as a whole.

New Additions to Tower Executive Team

Posted on August 13, 2014 by Rita Wilson

In our continued commitment  to build a unique MSP compliance model focused on  identification, intervention and involvement to stage claims prior to MSA and settlement, I am pleased to announce the addition of two key individuals to the Tower MSA Partners executive team.

Scott E. Yasko, MBA

Scott joined tower in July to serve as EVP, Business Development.  In his new role Scott is responsible for management of sales and marketing activities for all products and service offered by Tower.  Prior to joining Tower, Scott served in a sales and marketing capacity at PRIUM, a medial cost management firm with focus on prescription drug misuse and above within the workers’ compensation industry.

As an expert in the arena of pharmaceutical knowledge and the impact of drug misuse on workers’ compensation claims,  Scott plays a strategic rol in Tower’s pre-MSA intervention model, a key differentiator for the company in the MSP compliance arena.

Holly Neary, RPh

As Director of Clinical Services, Holly will oversee all aspects of the company’s Pre-MSA review and intervention services, as well as serving as client and physician liaison for issues related to inappropriate medication use, particularly as it relates to the long term use of opioids to manage chronic pain. 

 Prior to coming to Tower, Holly spent the previous 14 years serving in various capacities of pharmacy management within retail and compounding pharmacies. In her role as manager, Holly’s strength throughout her career has been work flow optimization and streamlined processes, balancing expertise with personal attention in an effort to deliver appropriate prescription solutions through drug utilization review.   Holly also served as clinical specialty pharmacist with United Health writing guidelines for Medicare and Private Insurance plans. 

Tower is fortunate to have two such talented individuals to help guide our future. 

 

 

 

 

For Media Inquires, Contact:

Helen King Patterson
813.690.4787
helen@kingknight.com

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