Tag: WCMSA

Practical Implications of the Revised CMS WCMSA Reference Guide

August 18, 2017

Earlier this month the Centers for Medicare and Medicaid Services (CMS) released a revised Workers’ Compensation MSA Reference Guide (WCMSA) (find Version 2.6 here) with several notable changes and additions impacting its review of MSAs in workers’ compensation cases. The Tower MSA compliance team has taken some time to review and consider not only the substantive impact these changes have on our processes, but the implications for our clients. Please find below a summary of the notable changes to the Reference Guide along with practical implications.

Recognition of a Hearing on the Merits of the Case (Section 4.1.4)

The relevant change to this section is as follows:

Because the CMS prices based upon what is claimed, released, or released in effect, the CMS must have documentation as to why disputed cases settle future medical costs for less than the recommended pricing. As a result, when a state WC judge or other binding party approves a WC settlement after a hearing on the merits, Medicare generally will accept the terms of the settlement, unless the settlement does not adequately address Medicare’s interests. This shall include all denied liability cases, whether in part or in full . . .

Practical Implications

Over the years CMS has had several definitions of under what circumstances it will recognize a hearing on the merits, but the takeaway has consistently been that CMS gives itself complete discretion as to whether or not it will recognize a particular judicial decision, order or finding as limiting the MSA. Some commentary in response to the Reference Guide revisions has indicated the changes found in this section will result in Zero MSAs based upon a complete claim denial no longer being approved without a hearing on the merits confirming the basis for the denial. We are not certain this is the correct inference to draw from this change. This section addresses the effect of a hearing on the merits of a case to the projection of future medical care. If there is no hearing on the merits of the case, which is the situation in most MSA submission, Zero MSA or otherwise, then this section should have no applicability to CMS’s review of a Zero MSA.

Tower MSA’s plan is to stay the course on the long-used criteria for a Zero MSA based upon a claim denial unless and until we identify any changes through the MSA submission process which requires modification to these criteria.

Recognition of State-Specific Statutes (Section 9.4.5)

The relevant change to this section as follows:

Submitters requesting alteration to pricing based upon state-legislated time limits must be able to show by finding from a court of competent jurisdiction, or appropriate state entity as assigned by law, that the specific WCMSA proposal does not meet the state’s list of exemptions to the legislative mandate. For those states where treatment is varied by some type of state-authorized utilization review board, the submitter shall include the alternative treatment plan showing what treatment has replaced the treatment in question from the beneficiary’s treating physician for those items deemed unnecessary by the utilization review board. Failure to include these items initially will result in pricing at the full life expectancy of the beneficiary or the original value of treatment without regard to the state utilization review board recommendation.

Practical Implications – State-Legislated Time Limits: Similar towards its policy on recognizing decisions stemming from hearings on the merits, CMS has consistently given itself complete discretion as to when it will recognize any state statute as providing a limitation on the medical care allocated in the MSA. Experience has shown CMS to be unwilling, under most circumstances, to recognize a state statute as having the affect of limiting medical care in the MSA. A notable example is the Georgia statutory provision limiting an employer’s responsibility for medical care to 400 weeks post the date of injury in non-catastrophic claims (applicable to cases with DOIs of 7/1/2013 and later). We have yet to see an instance where CMS has agreed to limit the MSA amount based upon this statute.

The changes to this section of the Reference Guide provide hope that CMS may be more open to recognizing state statutes, like Georgia’s, as a basis for limiting medical treatment and medications in the MSA. Unfortunately, the requirement “to show by a finding from a court of competent jurisdiction . . . that the specific WCMSA proposal does not meet the state’s list of exemptions to the legislative mandate” presents a challenge in attempting to use a statutory provision to limit the MSA. For example, in Georgia a workers’ compensation case is by default considered non-catastrophic unless accepted by the employer or carrier as catastrophic or the claimant’s attorney submits to the Georgia Workers’ Compensation Board a request for the claimant to be designated as catastrophic. It is unclear at this point whether confirming the non-catastrophic nature of the claim in board approved settlement documents or a separate finding by the board that the claim is non-catastrophic will be sufficient for CMS to recognize the limitation. Based upon our experience with similar types of issues, we expect CMS to require a specific finding separate and apart from the settlement documents. Accordingly, this will require settling parties, whether in Georgia or in other states, to work with their WC board, commission or other judicial authority to provide the necessary finding confirming the claim does not meet any of the exemptions to the statute.

Practical Implications – Utilization Reviews: Revisions to this section of the Reference Guide also address the use of URs to limit care in the MSA. According to the requirements delineated by CMS the following must be presented with the MSA submission:

UR denial pursuant “some type of state-authorized utilization review board.”
“Alternative treatment plan” from the treating physician showing what treatment has replaced the UR denied treatment or medications.

The addition of the language regarding URs raises more questions than it answers. What does CMS define as a UR Board? For example, the California Independent Medical Review (IMR) process, while statutorily created, does not include a UR review board (Although we believe it can be argued that the IMR process is equivalent to such a board). Further, CMS fails to define what would be considered an “alternative treatment plan.” It would seem that an intransigent treating physician could refuse to provide alternative treatment, thus resulting in inclusion of treatment or medications in the MSA denied through the UR process. It is unfortunate CMS added this “alternative treatment plan” requirement as it undermines the very reason a UR process is in place, namely to limit medical care based upon evidence-based treatment guidelines. As Tower MSA submits MSAs to CMS with UR denials we will provide further recommendations as to how CMS is defining a “UR board” and “alternative treatment plan.”

Addition of “Amended Review” to Re-Review Policy (Section 16.0)

As fully explained in the Tower MSA article of 7/12/2017, “Second Chance with MSA Approval!: New CMS Policy Allows for Review of a New MSA Post a Prior Approval,” CMS has introduced what is called an Amended Review process for cases meeting the following criteria:

    CMS has issued a conditional approval/approved amount at least 12 but no more than 48 months prior,
    The case has not yet settled as of the date of the request for re-review, and
    Projected care has changed so much that the submitter’s new proposed amount would result in a 10% or $10,000 change (whichever is greater) in CMS’ previously approved amount.

Practical Implications: The Amended Review criteria presents an opportunity to have a second bite at the CMS MSA review apple when it comes to claims which despite having a previously approved MSA, failed to settle medical. It is important to note that the Amended Review process applies not only to MSA determinations resulting in counter-highers, but any MSA determination, approved as submitted or counter-lower, that meets the above-defined criteria. Please contact Tower MSA to discuss eligible claims.

Added Section on Required Resubmission (Section 16.1)

The addition to this section is as follows:

Where a proposed WCMSA amount has been closed due to inactivity for one year or more from the original date of submission, a full-file resubmission will be required.

Practical Implications: Previously a case closed for inactivity for one year or more would be reopened if the submitter provided the documentation in response to a Development Letter (The most common reason for case closure). CMS is now indicating solely providing the documentation in response to the Development Letter will be insufficient for them to reopen, instead a completely new MSA proposal and supporting documentation will be required. Tower MSA will advise when a case meets the criteria for filing a resubmission.

Additional MSA Administration Guidelines (Section 17.1)

The addition to this section is as follows:

Although beneficiaries may act as their own administrators, it is highly recommended that settlement recipients consider the use of a professional administrator for their funds.

Practical Implications: While not requiring professional administration, this is an acknowledgement by CMS of the difficulties a claimant may face on their own in administering an MSA. Tower MSA agrees with CMS on the benefits of professional administration and when requested by our client will provide MSA professional administration through our partner, Ametros.

Other less notable changes found in the Reference Guide apply to clarifying the order of jurisdictional precedence for MSA pricing, updating requirements for spinal cord stimulator pricing, updating off-label medication requirements, clarifying total settlement calculation guidelines and clarification of change of submitter requirements.

Final Comments: While we are pleased CMS is addressing the concerns expressed by Tower MSA and others in the MSP compliance field concerning a second chance at CMS review of an MSA and recognition of state statutory limitations on injury-related medical care, the real test will be in the coming weeks and months the affect these revisions have on the review of MSAs submitted to CMS for approval. Tower MSA continuously monitors these responses and will provide our clients appropriate guidance on the impact, or lack thereof, of these revisions and additions to the WCMSA Reference Guide.

Second Chance with MSA Approval!: New CMS Policy Allows for Review of a New MSA Post a Prior Approval

July 12, 2017

While there may be no second chances in life, there is now a second chance for CMS review and approval of an MSA. On July 10, 2017, the Centers for Medicare and Medicaid Services (CMS) quietly rolled out a new policy allowing for a re-review of a previously approved Medicare Set-Aside which is between one and four years post-submission and for which there is a certain dollar amount change in projected future medical care since that time. The policy, which CMS calls an Amended Review, requires the previously approved MSA meet the following criteria:

  • Must have been originally submitted between one and four years from the current date.
  • Cannot have a previous request for an Amended Review.
  • Must result in a 10% or $10,000 change (whichever is greater) in CMS’ previously approved amount (The amount can be greater or less than the previously approved MSA amount).

    • CMS also notes that while you may change from brand-name to generic drug types, this change cannot be the sole reason for the Amended Review request. You must include additional changes such as changes in dosage and/or frequency, additional drugs or drugs no longer taken to qualify for the Amended Review.

    A copy of the policy can be found in Section 12.4.3 of the revised Workers’ Compensation Medicare Set-Aside Portal (WCMSAP) User Guide found here.

    Practical Implications of Amended Review Policy

    Prior to this new policy, CMS, in almost all cases, would not review a new MSA proposal based upon post-submission medical records and pharmacy history once an MSA was approved. Consequently, if parties were unable to settle a case because of a high CMS MSA approval, but came back to the settlement table a couple years later when the claimant’s medical care had subsided, they were unable to obtain a revised MSA approval from CMS which would accurately reflect the claimant’s current and future course of medical care. Under this new policy, these cases which are within 1-4 years post the original MSA submission and meet the 10% or $10,000 (whichever is greater) criteria will have a second chance at CMS review and approval of an MSA.

    Unanswered Questions Regarding Policy

    As with many a new policy CMS left some unanswered questions.

    It is unclear why CMS limited the Amended Review policy to submissions made within four years. We assume this is to limit the number of MSAs submitted for an Amended Review, but there remain cases older than four years which would benefit from this policy.

    While we do not like to look a gift horse in the mouth, it seems unreasonable of CMS to preclude from its Amended Review policy requests which are based solely upon a brand name medication going generic or a claimant otherwise switching to a generic medication. This type of change often results in a significant reduction to the MSA.

    The 10% or $10,000 change (whichever is greater) policy effectively means that there must be a $10,000 change to a previously approved MSA of $100,000 or less before it meets the criteria for an Amended Review. However, the example CMS provides in the User Guide inaccurately reflects a change on an $80,000 MSA of $8,000 as meeting the Amended Review criteria. We believe either the policy or the example is in error. We await CMS correcting this example or clarifying its policy.

    Does My Case Fit the CMS Amended Review Criteria?

    The Amended Review criteria opens the door to the settlement of some older cases where prior CMS approved MSA amounts no longer accurately reflect the claimant’s current and future course of medical care. Please feel free to reach out to Tower MSA Partners for an evaluation as to whether your previous CMS approved MSA may meet the Amended Review criteria. Tower MSA may be contacted at info@towermsa.com or (888) 331-4941.

    Additional Changes in Updated WCMSAP User Guide

    Besides the introduction of the Amended Review policy, CMS also made the following notable changes to the WCMSAP:

  • Claimants who are Medicare beneficiaries now have access to the WCMSAP through MyMedicare.gov. Accordingly, claimants are able to view MSA submissions and supporting documentation although will not be able to modify the documentation or otherwise take any actions on the submission which remain solely with the submitter of the MSA, i.e. Tower MSA.
  • For MSA submissions that have been closed for more than 12 months (Usually as a result of a non-response to a Development Letter), an entirely new MSA submission must be made with all documents generally required of a new MSA submission, i.e. two years of medical records. The new MSA submission will be assigned a new Case Control Number.

    • Denied Claim Zero MSAs: Still Available, but Put Through the Wringer by CMS

    April 28, 2017

    In October 2016, CMS made an unannounced policy change which effectively eliminated the ability to obtain a Zero MSA approval from CMS based upon a complete denial of the claim, without a supporting judicial decision. After only a couple weeks, CMS withdrew this policy change and again allowed for approval of Zero MSAs based solely upon a complete claim denial. Nonetheless, these Zero MSAs reviews are placed through the proverbial wringer by CMS such that it is important to understand when a case meets the criteria for a Denied Claim Zero MSA and the documentation required to obtain CMS approval.

    Denied Claim Zero MSA Approval Criteria: A Denied Claim Zero MSA (or Legal Zero MSA) approval from CMS is available when the claim has been completely denied with no medical or indemnity payments having been made with the exception of medical payments made for non-treatment purposes such as IMEs, case management and medical records copies (Note, in certain limited situations a Zero MSA may be approved with medical treatment payments having been made. Please consult with Tower MSA).

    Importantly, CMS will not approve a Denied Claim Zero MSA if settlement is made final and/or a settlement payment or any medical or indemnity payment is made prior to CMS approval of the Zero MSA. A tentative or agreed to settlement is allowable, but please do not make the settlement final or make indemnity or medical payments prior to CMS approval of the Zero MSA.

    If the case meets this criteria, then CMS has strict documentation requirements which must be adhered to or the Zero MSA will be rejected. Notably, since the policy change and rollback occurred in October 2016, CMS has added a requirement to provide claim reserve documentation. The requirement for claim reserve documentation, as well as all other supporting documentation, is detailed below.

    Denied Claim Zero MSA documentation requirements: The following documents are required by CMS to obtain approval of a Zero MSA based upon a complete claim denial:

    1. Claim Payment History

  • A claim payment history printout, even if blank, representing payments since the inception of the claim. All payments must be itemized.
  • Printout must be divided into categories for medical, indemnity and expenses with subtotals for each category and a grand total listed. Print or run date listed on the printout.
  • Date range for listed payments – Must be since inception of claim.
  • If the Claim Payment History does not meet the above requirements, then the following rules apply:

    • Provide a copy of the available Claim Payment History with the following statement inserted, signed and dated in the document:
    This document provides a complete representation of all payments made on the life of the claim (including medical of $0* and indemnity of $0)

    Signed:
    Date:
    *If medical payments were made, provide the invoices or reports, i.e. IME report, associated with those payments and see below Financial Detail and Denial Letter requirement.

  • Letter providing an explanation why a Claim Payment History meeting CMS’s requirements is not available (See below Financial Detail and Denial Letter)

    • 2. Claim Reserves

  • A Claim Reserves printout divided into categories for medical, indemnity and expenses with subtotals for each category and a grand total.
  • Print or run date listed on the printout.
  • If there is a legal argument for claiming the reserve information is privileged then the legal argument, including citations to statute or case law must be provided along with a copy of a redacted (reserve information blacked out) version of the Claim Reserves printout.
  • If no reserves were placed on the claim, then a statement regarding the same.

    • 3. Draft or final settlement documents and court orders or rulings or a statement that no such documents exist
    (See below Financial Detail and Denial Letter).

    4. First Report of Injury or a statement that no such document exists (See below Financial Detail and Denial Letter).

    5. Financial Detail and Denial Letter – Tower MSA will provide draft letter upon request for submission of the Zero MSA to CMS

  • A statement indicating the claim was completely or fully denied with no medical or indemnity payments having been made.
  • If medical payments have been made for non-treatment purposes, i.e. IME, case management, medical records requests, then if the Claim Payment History does not properly explain the purpose of these payments, then provide an explanation for the payments.
  • If the available Claim Payment History does not meet the requirements under #1, then state that the carrier’s claim system does not have the ability to provide a Claim Payment History printout with the information requested by CMS, i.e. print date, subtotals for medical, indemnity and expenses.
  • If Claim Payment History did not meet the requirements under #1, then insert the requested information into the letter, i.e.list categories for medical, indemnity and expenses with subtotals for each category and a grand total.
  • If there are no draft or final settlement documents and no court orders or rulings, then a statement regarding the same.
  • If there is no First Report of Injury, then a statement regarding the same.
  • Letter must be placed on letterhead and hand signed.


    • 6. Consent to Release form executed by claimant

    While CMS places Zero MSA submissions based upon a complete denial through the wringer, these approvals remain available for workers’ compensation cases meeting the applicable criteria. Please contact Tower MSA Partners at referrals@towermsa.com or (888) 331-4941 to refer a claim meeting these requirements or for further consultation.

    WorkersCompensation.com: Tower MSA Partners’ Rita Wilson Predicts CMS Re-Review Changes Will Help Payers

    January 27, 2017

    Tower MSA Partners CEO, Rita Wilson, was recently interviewed by WorkersCompensation.com following her participation in a January 24, 2017 “State of MSP” webinar presented by the National Alliance of Medicare Set-Aside Professionals (NAMSAP).

    Workerscompensation.com asked Rita to comment on CMS’s December 21, 2016 announcement regarding its plans to update its WCMSA re-review process in 2017. This includes expansion of the process to previously approved MSAs where there has been a substantial change in the claimant’s medical condition and the case has not settled (For details see Tower MSA blog on the announcement: CMS Announces Plans for 2017 Expansion of MSA Re-Review Process & New Policy Regarding URs in MSAs)

    Rita’s comments to WorkersCompensation.com follow:

    “CMS will need to establish the parameters for re-review and define ‘substantial changes.’ We expect costly procedures such as surgeries and spinal cord stimulators to be included,” Wilson said. “A WCMSA involving patients who have weaned off expensive polypharmacy regimens could also qualify.”

    “Tower’s workflow and decision-tree software application identifies recommended, not-yet-performed procedures and intervenes to address inappropriate treatment prior to submitting an MSA,” Wilson said, “But this could be a game-changer for payers with CMS-approved MSAs that they were unable to settle.”

    The full article may be found here.

    CMS MSA Review Expansion to Liability Planned for 2018

    January 4, 2017

    We are not even a week into 2017, but already have news to share regarding Medicare’s planned expansion of its Workers’ Compensation MSA review process to liability in 2018. In its recently released Request for Proposal for the Workers Compensation Review Contractor (WCRC), the Centers for Medicare and Medicaid Services (CMS) includes an option allowing CMS to expand the responsibilities of the WCRC to review of Liability Medicare Set-Asides (LMSAs) and No-Fault Medicare Set-Asides (NFMSAs) effective July 1, 2018.

    The CMS WCRC RFP Solicitation may be viewed here.

    Background on CMS Review of MSAs

    Since 2001 CMS has had in place an official voluntary review process for Worker’ Compensation Medicare Set-Asides (WCMSAs). A WCMSA, as CMS states, is a “financial agreement that allocates a portion of a workers’ compensation settlement to pay for future medical services related to the workers’ compensation injury.” The purpose of the review then is “to independently price the future Medicare-covered medical services costs related to the WC injury, illness, and/or disease and to price the future Medicare covered prescription drug expenses related to the WC injury, illness and/or disease thereby taking Medicare’s payment interests appropriately into account.”

    These WCMSA reviews were initially handled by the CMS Regional Offices spread throughout the country, but eventually transitioned to a centralized WCRC in 2005 (The CMS Regional Offices must still approve the review recommendation of the WCRC before it is released to the WCMSA submitter). CMS’s RFP solicitation for the new WCRC contract indicates the contract is to be awarded by June 30, 2017 with a contract term running for five years from July 1, 2017 to June 30, 2022.

    Expectations for Liability MSA Reviews

    Presently, CMS allows its 10 Regional Offices to accept voluntary requests for review of LMSAs at each office’s discretion. Some Regional Offices have consistently refused to review any LMSAs while other offices agree to review based upon criteria that seemingly changes over time and bears no indication that it is indeed the official policy of CMS. It appears then that just as it did in 2005 when CMS took the responsibility away from the Regional Offices for reviewing WCMSAs, CMS is now considering centralizing the process of reviewing LMSAs with a contractor, leaving the Regional Offices to only approve of the contractor’s recommendations.

    Some may recall CMS launched a prior initiative to establish a formal policy for consideration of future medicals in liability settlements when it issued an Advanced Notice of Proposed Rulemaking in 2012. This initial effort was ultimately withdrawn by CMS in 2014. CMS’s new initiative began with this June 9, 2016 notice on the CMS website:

    The Centers for Medicare and Medicaid Services (CMS) is considering expanding its voluntary Medicare Set-Aside Arrangements (MSA) amount review process to include the review of proposed liability insurance (including self-insurance) and no-fault insurance MSA amounts. CMS plans to work closely with the stakeholder community to identify how best to implement this potential expansion. CMS will provide future announcements of the proposal and expects to schedule town hall meetings later this year. Please continue to monitor CMS.gov for additional updates.

    No town hall meetings were scheduled in 2016, however, based upon this RFP indicating LMSA reviews will not begin until at least July 1, 2018, CMS has given itself 18 months to develop and implement a formal LMSA review policy. In terms of how many liability settlements such a review process would impact, CMS seems uncertain. A Statement of Work attached to the RFP indicates “reviews could represent as much as 11,000 additional cases (based on all FY2015 NGHP demands), or as little as 800 additional cases annually, depending upon industry response.”

    Tower MSA Takeaways

    Over the past 15 years, starting with the formalized review of WCMSAs, continuing with the implementation of Section 111 Mandatory Insurer Reporting and recent stepped up efforts at denying injury-related medical care and recovery of conditional payments for medical care related to workers’ compensation, liability and no-fault claims, CMS has expanded its enforcement under the Medicare Secondary Payer Act. It is not surprising then that CMS’s next objective is formalizing a voluntary review process for LMSAs.

    It has been our experience that when CMS does implement new policy and procedures it does take a deliberative approach evidenced by the at least 18-month timeframe signaled with this RFP to expand the MSA review process to liability and no-fault. Our expectation then is over the next 18 months or longer, CMS will provide additional announcements concerning the rules and procedures around expansion of the review process.

    Tower MSA will be involved in these discussions and will keep you abreast of relevant developments. In the interim, there remain important obligations of parties to liability settlements and no-fault claims under the Medicare Secondary Payer Act. Rest assured that you can rely upon Tower MSA’s team of MSP compliance experts for consultation and expert guidance in liability and no-fault matters.

    If you have any questions, please contact Tower MSA Partners, Chief Compliance Officer, Dan Anders, at (847) 946-2880 or daniel.anders@towermsa.com

    CMS Hits ‘Reset’ Button With Workers’ Compensation Review Contractor Procedures and Request for Approval of Zero-Dollar Medicare Set-Aside Amounts

    November 2, 2016

    In an announcement distributed on November 1, 2016, CMS acknowledged the receipt of many inquiries from the MSP industry regarding procedural changes in the way CMS’s  Workers’ Compensation Review Contractor (WCRC) reviews proposed zero-dollar Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) amounts.  CMS further acknowledged that as a result of these inquiries, it has determined that changes had transpired without prior notification, and that effective immediately, the WCRC will utilize (the) procedures that were previously in effect, further noting that CMS continually evaluates all policy and procedures related to WCMSA reviews and will publish any pending changes when or before they go into effect.

    Background

    Prior to October, 2016, the Workers’ Compensation Review Contractor’s procedure with Zero Dollar WCMSAs in cases where evidence of a complete denial of the claim was handled as follows:

    1. The carrier’s complete denial would be evidenced by
      • a claim payment history documenting no payments for medical treatment and indemnity and
      • a letter from the adjuster or defense attorney confirming such full denial.
    2. The MSA must be submitted to CMS for approval PRIOR to obtaining a court-approved settlement.

    When these conditions were met, the settlement would be recognized as a strict compromise and CMS would issue a determination letter staying no MSA is needed.

    While CMS never published this procedure as an official policy in the WCMSA Reference Guide, the policy was exercised regularly and consistently.   As such, Tower, as well as many other MSP companies, incorporated this “policy” into its standard CMS submission procedure for Zero WCMSAs for denied claims.

    The October ‘Surprise’

    Beginning in October, 2016, with no notice, CMS responses for denied claims took a complete 180 degree turn in terms of the WCRC’s review process.  No longer was the carrier’s evidence of complete denial of the claim sufficient to obtain CMS’s approval of a Zero WCMSA.

    When questioned regarding its rationale for this drastic change, CMS noted only that there was a ‘NEW‘ procedure being followed by the WCRC, and in order to obtain approval of a Zero WCMSA one of the following would be required:

    1. A court ruling regarding the compensability of the claim; or,
    2. Treatment records (i.e. a letter from the treating physician) which demonstrate/indicate that no further treatment for the alleged industrial condition(s) will be required.

    Unfortunately for the industry, there was no advanced notice of the change in procedure, no documentation of the change and no explanation of CMS’s rationale for making such a drastic change.  We, along with everyone else in our industry, basically learned about this through development letters and undesirable dialogue with WCRC & CMS representatives.

    Industry Reaction and CMS’s ‘Reset’

    As expected, companies reacted immediately, contacting CMS to request answers, and seeking to determine how WCMSAs currently being reviewed would be handled.  Tower clients with cases pending with CMS were advised to wait to see if the case would be developed or if CMS would follow its original policies.  If developed, the case could be withdrawn.

    In an effort to further clarify, NAMSAP (National Alliance of MSA Professionals) also intervened on behalf of its constituent members to confirm why the change was made, to ‘demand’ the courtesy of notice, and to offer its expertise to assist CMS in setting future policy to simplify the process rather than creating confusion and chaos.

    As a result of the avalanche of questions, concerns and complaints, CMS has now taken a very positive step back, announcing that it will revert to its original, established procedure for reviewing Zero WCMSA for denied claims until such time as it can analyze, define policy, establish review procedures, communicate to the MSP industry and provide ample notice.

    What’s Next?

    With today’s announcement that the WCRC will revert to its original procedure for reviewing Zero WCMSAs for denied claims, the industry can return to its internal policies for setting settlement strategy with a clear understanding of the review process that will be executed by CMS’s review contractor when evaluating Zero WCMSAs.

    As a reasonable next step, NAMSAP has offered to serve as a resource to CMS to provide industry experiences, to identify the perceived impact of the WCRC’s shift in policy, and to open dialogue regarding both our goals and the unintended consequences of CMS’s shift in review practices.  I trust CMS will consider this offer, and will engage in conversations that will lead to a seamless

    Stay tuned….

    Related:

    Denied Claim Zero MSAs: Still Available, but Put Through the Wringer by CMS

    CMS: Workers’ Compensation Medicare Set Aside Arrangements

    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.

     

    FDA Approves Generic Release of Abilify

    May 1, 2015

    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

    January 12, 2015

    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.

    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.