On Thursday, April 25, 2013 Panelists John P Albert – Acting Director, Division of Medicare Secondary Payer Policy and Operations; Cynthia Gross – Health Insurance Specialist, Division of Medicare Secondary Payer Policy and Operations; Elizabeth V. Poole – Health Insurance Specialist, Division of Medicare Secondary Payer Policy and Operations; and Barbara Jean Wright – Senior Technical Advisor, MSP were welcomed by almost 200 members of the National Alliance of Medicare Set Aside Professionals at its annual conference in Baltimore, Maryland.   During the one hour  presentation, CMS Panelists discussed various changes to the CMS website, the Statement of Work (SOW) for the new WCRC Contractor for completing and returning determinations in a timely manner for newly submitted WCMSAs, the new web-portal for submissions/re-considerations and the recent CMS Town Hall Teleconference. They also responded to attendee’s questions.

Changes to CMS Website

CMS reiterated that over the past several years they have been working diligently to make the CMS website more “user-friendly”  more efficient and easier for the user to find information.  The Coordination of Benefits and Medicare Secondary Payer tabs of the CMS.gov website are undergoing updates.  The first completed phase is the WC Agency Services Section which has been replaced by the WCMSA section.   One of the most significant improvements is a tab for “new information.” All newly released information will be housed and maintained for one year, after which it will be archived but remain accessible.  The URL for direct access is: http://www.cms.gov/Medicare/Coordination-of-Benefits/Workers-Compensation-Medicare-Set-Aside-Arrangements/WCMSA-Overview.html

Established Turnaround Time for WCRC

CMS made it clear that when the new contract was awarded to Provider Resources, Inc. (PRI) it implemented a Statement of Work (SOW) to ensure timely responses to allocations submitted in the established WCMSA process.   For new allocations, the WCRC now has twenty two (22) business days to review a proposal that is “clean.”  In other words, if the WCRC does not need to “develop” or request for additional information, Allocators should receive the CMS determination within twenty two (22) working days after receipt by WCRC.  If the WCRC is required to develop for additional information, there will be an additional 17 days from the date of receipt of the information.  If the correct information is not received, then an additional 17 days will be added.   It is therefore important to submit all information at the time of initial submission and, where additional development requests are made, to provide the requested information in a timely manner in order to shorten the response time.

New Web-Portal

The new web-portal is up and running and CMS expressed extreme satisfaction with the fact that the utilization of the web-portal as compared to paper submissions is greater than what was originally anticipated.  More than 90% of all allocations are submitted through the web-portal which is designed to be the most efficient means for the WCMSA process. Electronic submissions are encouraged over paper submissions.

CMS Townhall Teleconference April 9, 2013

The CMS Panelists reiterated that one of the focuses of the WCRC contract with new Contractor PRI is outreach and education.   To that end, CMS held its first of what it hopes to be many such Town Halls in the coming years.  They expect to have similar Town Hall conferences  twice per year.   The recent teleconference Town Hall was viewed as a great success with Pharmacists, Clinical, and Legal representation from PRI answering very detailed questions and providing key operational information.  CMS expects to publish a transcript of the April 9, 2013 call as soon as it obtains approval to do so.  It is anticipated that there will be about 37 pages of single-spaced typewritten information in the  transcript.   Due to the ongoing confirmation process for the CMS Administrator, the dissemination of the transcript to the public is on hold until the confirmation process is completed and authorization is provided to release the information.   The transcript is expected to be a good resource for individuals who were not able to attend the teleconference.   Ms. Gross did, however, point out that while every attempt was made to clarify and provide accurate information during the call, the written memoranda and policies of the agency always prevail over information provided in an oral forum such as the teleconference.   CMS is also looking to social media to facilitate its reach through the use of Twitter, Facebook and U-Channel.

Denied Claims for Medicare Beneficiaries with Open Workers Compensation Claims

The CMS panel addressed the issue of denied claims for Medicare beneficiaries and stated that the fact that there is an open MSP occurrence or common working file should not result in denial of benefits for Medicare beneficiaries.   The panel believed that the situation is improving and that there is, unfortunately, nothing that vendors can do with this issue.   They reiterated that physicians are required to bill correctly and that the agency has been completing additional edits and are looking at eliminating certain codes to minimize the incidence of denied claims.  However, CMS maintained that most cases were appropriately denied mostly due to the fact that the affected beneficiaries did, in fact, have other insurance that was primary to Medicare.

A few FAQ’s

CMS had a few pre-approved questions that were submitted in advance of the visit.  The  responses were no surprise to the industry and were as follows:

Q:        Since pricing an MSA is not an exact science, why doesn’t CMS accept the allocation as submitted?

A:         The CMS response (which garnered a huge laugh from attendees) essentially indicated that Allocators have their own assessment of future Medicare related expenses and CMS has its own.

Q:        Will CMS ever provide a new determination when the claim does not settle and things have changed?

A:         No.  CMS reiterated that they do not have enough resources to re review submissions and that WCMSA’s should not be requested prior to the point of MMI so that the claimant’s condition is stable and future care can be reasonably evaluated.

As CMS usually anticipates settlement within four months of an approved WCMSA, if the parties are not reasonably expected to the settle, the WCMSA should not be submitted until there is reasonable certainty that a settlement will occur. Once an approval is offered,  absent a mistake or because CMS has misconstrued the evidence, the parties will be unable to obtain a revised allocation.

Q:        What sources does CMS use for Usual and Customary Charges and why are  State Laws not followed in pricing decisions?

A:         There is no direct system that is used for pricing.  The panel reiterated that the WCRC utilizes evidence based treatment guidelines and multiple sources are used.   It is not the Agency’s intent to include services that are not covered by the WC state law.   However, it is up to the parties to address anything that is not covered by the state law and provide the specific information directly in the MSA.  The specific arguments must be outlined.   Ms. Gross further stated that if the state law does not cover unauthorized case, it is not the CMS intent to price care related to unauthorized treatment. All arguments as to authorization must be made specifically within the MSA.

All in all, the visit from CMS was viewed as an overwhelming success by both the CMS panelists and NAMSAP conference attendees.

Gary Patereau, of the Louisiana Association of Self Insured Employers, certainly deserves the thanks of the Alliance and all attendees as does the NAMSAP Board of Directors for orchestrating the very informative CMS visit. Gould & Lamb will continue to keep you advised of any important developments regarding WCRC processes, procedures and news as it is received

The June 28, 2012 decision by the United States Supreme Court on the Affordable Care Act may go down as one of those “Where were you when the ruling was announced?” type of moments. As both a self-proclaimed C-SPAN and political junkie, I followed the debate from the beginning, when President Obama signed into law the Patient Protection and Affordability Care Act of 2010 (PPACA) and the Healthcare and Education Reconciliation Act of 2010 (HCERA), including reading the transcripts of the oral arguments made to the U.S. Supreme Court a few months back.

The reason for my interest was a key provision pertaining to prescription drug plans which, if enacted, will have an affect on Medicare Part-D and, therefore, on Workers’ Compensation Medicare Set-Asides (WCMSA). PPACA § 2502 pertains to the elimination of the exclusion of coverage of certain drugs that traditionally have not been compensable under Medicare Part-D.

Now that the healthcare law has been upheld, beginning in 2013 Medicare Part-D will begin to cover Benzodiazepines and barbiturates used for certain conditions such as epilepsy, cancer, or a chronic mental disorder. Currently, these medications are excluded from Medicare Part-D prescription drug plans.

Benzodiazepines are those medications such as Diazepam (Valium), Clonazepam (Klonopin), Alprazolam (Xanax), and barbiturates and include the commonly used medication Phenobarbital. Although we do not see use of Phenobarbital often in the WC arena, Benzodiazepines are utilized for many conditions in WC, such as anxiety, sleep, and muscle relaxation.

Normally, these medications would not generate any concern as they are typically dispensed as generic and are relatively inexpensive. However, the expansion of Medicare to cover them will have a direct impact on WCMSAs in two ways.

First, individuals may request the brand name Benzodiazepines in lieu of a generic at the time of fill. Average Wholesale Price (AWP) of brand name Valium costs about $3 per tablet and averages 15 times higher than the price of the generic equivalent Diazepam.

Second, although Benzodiazepines are abused less than opioids, there is now the potential for an increase in prescriptions for these medications. Benzodiazepines abuse is commonly seen when there is an established pattern of opioid abuse or with an illicit substance. Therefore, the potential for increased rates of abuse may rise. The WC community is already struggling with overuse of opioid medications and, conceivably, the new coverage could compound the problems the workers’ compensation community is seeing with the abuse of opioids.

These changes are certainly something to keep any eye on. They provide a strong argument for both early intervention strategies and prescription management and requires further close scrutiny on how it may affect the bottom line.

Further information on these and other changes can be found at:

http://www.medicareadvocacy.org/InfoByTopic/Reform/10_04.08.MAandPDChanges.htm

About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation. He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims. Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.

Two strategies are routinely sought after in healthcare: positive clinical outcomes for the patient and controlling the costs.  The proper use of generic medications is one way to manage costs. Another way costs can be controlled, while simultaneously achieving positive clinical outcomes, is through the use of Over-the-Counter (OTC) medications.

Controlling Costs with OTC Medications

Because OTC medications do not require visiting a physician or a physician’s prescription, the cost of going to a doctor’s office is eliminated and there is greater and easier access to the medications. Over the last two decades, the notion of “self-care”, a program where the patient can treat conditions they normally would not due to perceived barriers, such as socio-economic factors or the inability to see a physician, has increased. The greater access to OTC medications to treat conditions prevents unnecessary ER or hospital visits, thereby allowing physicians to focus their time and energy on more serious conditions.

A recent study released by the Consumers Healthcare Products Association (CHPA) concluded that for every $1 spent on an OTC medication, a $7 in savings to the overall healthcare system is realized.

Potential Savings Recognized in Workers’ Compensation Cases

In the Workers’ Compensation insurance sector, use of OTC medications is an under utilized standard of care and makes good sense. Factors such as the lack of formulary management allow for the prescription version of OTC medications to continue to be prescribed with the payer ultimately absorbing the costs. As an example, the chart below illustrates the AWP for two common GI medications and the potential savings as measured against the OTC version. We see these medications commonly prescribed in the Workers’ Compensation industry secondary to NSAID usage (Meloxicam, Ibuprofen) or with opioids (Hydrocodone/APAP) to alleviate upset stomach or other GI effects.

*AWP based on 30 day supply. BC/BS Michigan Pharmacy Sheet.

Although this may not seem significant or substantial, use of an OTC medication to take the place of a prescription can yield substantial savings to a Workers’ Compensation Medicare Set-Aside and could make the difference between settling the file or having to keep it open.  Keep in mind, both Omeprazole and Lansoprazole are not indicated to be utilized for chronic periods. Thus, it makes sense to utilize OTC versions of these products once or twice yearly as opposed to funding a Workers’ Compensation Medicare Set-Aside monthly for the prescription versions.

In today’s Workers’ Compensation claims handling setting, each and every dollar must be managed appropriately. OTC medication utilization is one way that Part-D allocations can be significantly reduced and properly funded in a Workers’ Compensation Medicare Set-Aside, providing both positive outcomes while being cost effective as well.

About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC.  His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.

Carriers face enormous challenges when attempting to settle cases with Workers’ Compensation Medicare Set-Aside (WCMSA) arrangements.  Currently, one of these challenges is the appropriate use of prescription medications and their proper allocation. The Center for Medicare and Medicaid Services’ (CMS) operating memo of April 2009 changed the entire landscape as we know it, especially with regard to the management and allocation of prescription medications.

CMS Decisions Regarding Prescriptions Drug Therapy

I travel across the country educating carriers, attorneys, physicians, Workers’ Compensation judges, and even a state senator about these changes and how to best handle the ever-rising prescription drug costs and utilization in a WCMSA in the hope of a favorable decision by CMS.

A recent audit by Gould & Lamb has found that in a six month period, CMS has agreed to an alteration of prescription drug therapy that resulted in approval for nearly 51% of the submitted files. Considering how the April 2009 memo changed everything with Part-D allocations, this is very encouraging. Could it be the realization by CMS of inappropriate drug therapy, contraindications, or other factors which account for these approvals? Or, could it once again show the value of Pharmacists as a member of the multi-disciplinary approach to WCMSA?

Value-Added with Pharmacists Involvement

Some may say that use of a Pharmacist in WCMSA reviews is both useless and senseless. As the Senior Clinical Pharmacist for Gould & Lamb, I differ with this notion.  Pharmacists bring a unique perspective and training that is a valuable asset to both carrier and organization alike. Who can best explain whether a medication can be identified as off-label, compensable, or contraindicated as part of a claimant’s long-term drug regimen? Who can best engage the prescribing physician in dialogue concerning the long-term impact of a claimant’s pharmacotherapy regimen?

For many Pharmacists, daily responsibilities center on both off-label review and Part-D allocations, while they spend hours reading medical journals, and presenting relevant pharmacy information to keep those involved with WCMSA educated and informed on the ever-changing Part-D rules.

As prescription utilization continues to escalate in the Workers’ Compensation industry, carriers will continue to rely on Pharmacists for guidance and recommendations on how to best handle rising costs and cost-containment strategies in order to settle claims.

Handling WCMSA Through Multi-Disciplinary Approach – Best Solution

As the favorable decisions from CMS continue, it is prudent for carriers to use a vendor with the proper professions on staff, including Pharmacists.  WCMSA are best handled through a multi-disciplinary approach that involves input and skill from many different professions, not just pharmacy. Although Part-D represents a huge slice of the total MSA allocation, other disciplines are needed as well to ensure both the appropriateness and accuracy of them.

Don’t listen to the nay-sayers!  Pharmacists will continue to play an important part in WCMSA reviews. As a licensed pharmacist for close to twenty years, I cannot give you legal advice, but I can give you pharmacy advice. You wouldn’t go to an accountant to fill a prescription, would you??

About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Off Label Drugs – Part One

As we know, off-label prescribing is both commonplace and legal in the United States; it is off-label marketing that is suspect. Off Label drugs can be defined as the use of a medication outside of its specific Federal Drug Administration (FDA) indication. An examination of 160 of the most commonly prescribed medications showed that off-label use accounted for 21% of these medications, while 74% of these prescriptions written for conditions not medically supported by the literature (Stafford, 2008). A well-known medication in the Workers’ Compensation (WC) world, Gabapentin (Neurontin) has close to 10 off-label drug indications in addition to its FDA indications of both seizure management and post-herpetic neuralgia.

As part of the changes outlined in its guidance for submitters memo (June 1, 2009), the Centers for Medicare Medicaid Services (CMS) memo determined that prescription medications used for any condition or indication, whether FDA approved or not, were to be included when calculating the final costs associated with Part-D of a Workers’ Compensation Medicare Set Aside  WCMSA. This meant that medications, such as Actiq and Lidoderm, must be allocated for in a WCMSA, even though they are used for conditions not routinely seen in Workers’ Compensation cases. Through their professional and medical judgment, physicians are free to write for prescriptions regardless of the condition it is intended to treat.

Possibly due to pressure or in keeping with the Medicare Part-D statute, CMS reversed its previous position on the inclusion of off-label medications in a WCMSA. Essentially, CMS will now exclude those prescription medications, which are not FDA, approved for a particular indication and are not supported by one or more citations in the compendia. The compendia includes the American Hospital Formulary Service Drug Information (AHFSDI), United States Pharmacopeia- Drug Information (USPDI), and the DRUGDEX Information System. Now, Actiq and Lidoderm can be excluded from the final Part-D costs in a WCMSA as their off label uses are not supported by the compendia.

How Complex Is the Off Label Drug Issue?

The above examples show just how complex the off-label drug issue really is.

First – we need to understand the specific FDA indications of medications utilized.
Second – we need a thorough understanding of what exactly the compendia is and how the literature can be interpreted and validated for accuracy, free from bias.
Third – we need to put both together and come up with a sound clinical judgment to in deciding which medications should be included and excluded from a WCMSA, thereby providing a safe and effective medication regimen for long-term use.

As a licensed pharmacist for close to twenty years, I fully understand both the pros and cons with off-label use of medications.

The Pros

A wider access to medications for those with rare conditions resulting in lower medical expenditures and hospitalization costs.

The Cons

Unsupported, undocumented research and safety profiles with use of medications for conditions that they had not been originally tested for.

However, since a majority of workers’ compensation claimants use medications for chronic and not rare conditions, (such as pain management), off-label exclusion of medications is one way to contain both the costs in an WCMSA as well as allocated for safe and effective medications while not adding to unnecessary costs and secondary conditions.

Be sure to watch for my post on Off Label Drugs – Part 2 which will focus on the compendia and the complexity of these findings as well.

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