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CLASSIC LIST

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15/Nov/2022

The Centers for Medicare & Medicaid Services (CMS) released a revised Workers’ Compensation Medicare Set-Aside Arrangement (WCMSAReference Guide (“Reference Guide”) Version 3.8 on November 14, 2022. This Reference Guide replaces Version 3.7 which was released on June 6, 2022. There are a few notable changes when comparing the two Reference Guides.
 

CMS’s Version 3.8 Reference Guide, Section 1.1 includes the following changes:

Changes in This Version of the Guide Version 3.8 of this guide includes the following changes: Clarification has been provided regarding re-review requests when errors exist in the submission documentation, as well as re-review limitations (Sections 16.1 and 16.2). Note: These re-review changes are only available for approvals from September 1, 2022 forward.

To download the new WCMSA Reference Guide v3.8 Click Here.

For your convenience, we have included the entirety of Section 16.1 and 16.2, so you will have the most up to date information regarding the process of re-review:

16.1 Re-Review

When CMS does not believe that a proposed set-aside adequately protects Medicare’s interests, and thus makes a determination of a different amount than originally proposed, there is no formal appeals process. However, there are several other options available. First, the claimant may provide the WCRC with additional documentation in order to justify the original proposal amount. If the additional information does not convince the WCRC to change the originally submitted WCMSA amount and the parties proceed to settle the case despite the lack of change, then Medicare will not recognize the settlement. Medicare will exclude its payments for the medical expenses related to the injury or illness until WC settlement funds expended for services otherwise reimbursable by Medicare use up the entire settlement. Thereafter, when Medicare denies a particular beneficiary’s claim, the beneficiary may appeal that particular claim denial through Medicare’s regular administrative appeals process. Information on applicable appeal rights is provided at the time of each claim denial as part of the explanation of benefits.

 

A request for re-review may be submitted based one of the following:
  1. Mathematical Error: Where the appropriately authorized submitter or claimant disagrees with CMS’ decision because CMS’ determination contains obvious mistakes (e.g., a mathematical error or failure to recognize medical records already submitted showing a surgery, priced by CMS, that has already occurred), or
  1. Missing Documentation: Where the submitter or claimant disagrees with CMS’ decision because the submitter has additional evidence, not previously considered by CMS, which was dated prior to the submission date of the original proposal and which warrants a change in CMS’ determination.
    • Disagreement surrounding the inclusion or exclusion of specific treatments or medications does not meet the definition of a mathematical error.
    • Re-Review requests based upon failure to properly review already submitted records must include only the specific documentation referenced as a basis for the request.
    • Should no change be made upon response to a re-review request (i.e., no error was identified), additional requests to re-review the same error will not be entertained.
  1. Submission Error: Where an error exists in the documentation provided for a submission that leads to a change in pricing of no less than $2500.00, a re-review request may be made by submitting updated documents free of errors that caused the original review outcome. Amended documents must come from the originators with appropriate notation to identify that the error was corrected, along with the date of correction and no less than hand-written “wet” signature of the correcting individual. Note: This submission option is only available for approvals from September 1, 2022 forward.
    • Examples include, but may not be limited to; medical records with incorrect patient identifying information or rated ages where the rated-age assessor provided incorrect information in the rated-age document.

 

16.2 Re-Review Limitations

Note: The following re-review limitations are only available for approvals from September 1, 2022 forward.
Re-review shall be limited to no more than one request by type.
Disagreement surrounding the inclusion or exclusion of specific treatments or medications does not meet the definition of a mathematical error.
Re-Review requests based upon failure to properly review already submitted records must include only the specific documentation referenced as a basis for the request.

 

Medivest will continue to monitor changes occurring at CMS and will keep its readers up to date when such changes are announced. For questions, feel free to reach out to the Medivest representative in your area by clicking here or call us direct at 877.725.2467.

 


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15/Aug/2022

Consider this scenario: you are a personal injury attorney, and you get a call from a new client who is 63 years old and is interested in settling her automobile accident case.  Per the Medicare Secondary Payer statute and as part of the case workup, you need to make sure you are not shifting the burden to Medicare.

What is the Medicare Secondary Payer Statute?

The MSP statute was passed by Congress in 1980 in order to protect the financial integrity of the Medicare Trust Fund. Per this statute/law, Medicare is a secondary payer for workers’ compensation, no-fault insurance, liability insurance, self-insured plans, and employer group health plan insurance. According to the MSP regulations, these other sources of health care coverage are to be the primary payer, with Medicare being the secondary form of payment.

What is a Medicare Set-Aside (MSA) Proposal?

A MSA proposal is a detailed report indicating the anticipated Medicare allowable, Injury-related expenses for the remainder of the injured individual’s life expectancy.  It is a calculation that determines a dollar amount that should be “set aside”  as part of the settlement process to satisfy the Medicare Secondary Payer Statute (MSP) and to avoid shifting the burden to Medicare.

Guidance from Medicare for Liability Cases

The Centers for Medicare and Medicaid Services (CMS) published the WCMSA Reference Guide to help attorneys understand the process CMS uses for approving proposed Workers’ Compensation MSA (WCMSA) arrangements. The purpose of the WCMSA Reference Guide was to consolidate and supplant all the historical CMS memos into a single point of reference.
However, Workers’ Compensation and Liability settlements have several different nuances.  CMS has yet to release the long-awaited LMSA Reference Guide for liability settlements, despite announcing its intention to do so in 2018. Given the current lack of guidance concerning Liability MSAs from CMS, attorneys should look to the WCMSA Reference Guide for guidance when settling their liability cases.

Litmus Test –  Is a MSA Proposal Recommended?

In order to determine if a MSA allocation is recommended to cover Medicare’s interest in your settlement, there are several key items to review. Attorneys can do a quick MSA litmus test to determine whether or not a MSA is recommended.
  • Your client is currently Medicare-eligible
  • Your client is 62.5 years old and within 30 months of becoming eligible for Medicare benefits
  • Your client has either applied for Social Security Disability Insurance (SSDI) or has an open or pending application Will there be any money after medical liens have been resolved to fund a Medicare Set-Aside (MSA) account?

Medicare Eligibility

What is Medicare’s criteria for an individual to become Medicare eligible? Medicare is available for people aged 65 or older, younger people with disabilities, and people with End Stage Renal Disease (permanent kidney failure requiring dialysis or transplant).

Social Security Disability Insurance (SSDI)

An individual who has either applied or has reapplied for Social Security Disability Insurance can become Medicare eligible. Social Security Disability Insurance (SSDI) is a federal program that helps those who have become disabled from work.  An individual can apply for SSDI when:
  • A person is unable to engage in any “substantial gainful activity” due to an illness or disability and;
  • When a person is not able to return to work for 12 months or more and;
  • When a person has accumulated enough work credits in the last 10 years to qualify.

30 Months to Become Medicare Eligible

The reason why it takes 30 months to become Medicare eligible after the individual has either applied or reapplied for SSDI is that:
  • The individual needs to wait one month after the date of injury to apply for SSDI.
  • After the SSDI applicate date, there is a waiting period of 5 months to receive SSDI entitlement.
  • From the date of SSDI entitlement, Medicare has 24 months waiting period to become Medicare eligible.

Medicare Set-Aside (MSA) – Not Required by Law

Did you know that a Medicare Set-Aside is not required by law? You should know the risks if you choose not to have a MSA prepared, by understanding CMS’ interpretation regarding MSP compliance. In the event there was a failure to address Medicare’s interest in the settlement, Medicare may refuse to pay future medical expenses that are injury-related until the entire settlement is exhausted.

Best Practices

Our highly trained Medicare Expert Case Advisors can help you figure out if Medicare may have an interest in your settlement. We assist all settling parties to navigate the MSP complexities and provide you with cost-saving strategies for your settlement.
To receive our complimentary MSA Decision Tree, “When Is a MSA Allocation Recommended?”  click here.

 


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24/Mar/2022

The Centers for Medicare & Medicaid Services (CMS) released a revised Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide (“Reference Guide”) Version 3.6 on March 15, 2022. This Reference Guide replaces Version 3.5 on January 10, 2022. There are a few notable changes when comparing the two Reference Guides.  The blue highlights below indicate the updated changes provided in Reference Guide Version 3.6.
To download the new WCMSA Reference Guide v3.6 click here.
Version 3.6 of this guide includes the following changes:
Clarification has been provided regarding the use of non-CMS-approved products to address future medical care (Section 4.3), as well as documentation and re-review tips (Sections 9.4.1.1, 10.2, and 16.1).

 

4.3 The Use of Non-CMS-Approved Products to Address Future Medical Care – Additions and Replacements

A number of industry products exist for the purpose of complying with the Medicare Secondary Payer regulations without participation in the voluntary WCMSA review process set forth in this reference guide. Although not inclusive of all products covered under this section, these products are most commonly termed “evidence-based” or “non-submit.”
42 C.F.R. 411.46 specifically allows CMS to deny payment for treatment of work-related conditions if a settlement does not adequately protect the Medicare program’s interest. Unless a proposed amount is submitted, reviewed, and approved using the process described in this reference guide prior to settlement, CMS cannot be certain that the Medicare program’s interests are adequately protected. As such, CMS treats the use of non-CMS-approved products as a potential attempt to shift financial burden by improperly giving reasonable recognition to both medical expenses and income replacement.
As a matter of policy and practice, CMS may at its sole discretion deny payment for medical services related to the WC injuries or illness, requiring attestation of appropriate exhaustion equal to the total settlement as defined in Section 10.5.3 of this reference guide, less procurement costs and paid conditional payments, before CMS will resume primary payment obligation for settled injuries or illnesses, unless it is shown, at the time of exhaustion of the MSA funds, that both the initial funding of the MSA was sufficient, and utilization of MSA funds was appropriate. This will result in the claimant needing to demonstrate complete exhaustion of the net settlement amount, rather than a CMS-approved WCMSA amount.
Notes: This official policy shall apply to all notifications of settlement that include the use of a non-CMS-approved product received on, or after, January 11, 2022; however, flags in the Common Working File for notifications received prior to that date will be set to ensure Medicare does not make payment during the spend-down period.
CMS does not intend for this policy to affect any settlement that would not otherwise meet review thresholds. This comment does not relieve the settling parties of an obligation to consider Medicare’s interests as part of the settlement; however, CMS does not expect notification or submission where thresholds are not met. 

 

9.4.1.1 Most Frequent Reasons for Development Requests – Expanded Explanations

The five most frequent reasons for development requests by the WCRC:
    1. Insufficient or out-of-date medical records. Medical records are required documents for all submissions, including situations where the parties are in dispute.
    2. Insufficient payment histories, usually because the records do not provide a breakdown for medical, indemnity or expenses categories. Payment histories are required documents for all submissions, including situations where the parties are in dispute, and must include breakdowns for payment categories along with identification of any category codes.
    3. Failure to address draft or final settlement agreements and court rulings in the cover letter or elsewhere in the submission. Draft or final settlement agreements and court rulings are required documents for all submissions, if they exist. For settlements where conditional payments are made as an element of the agreement, the WCRC will not accept a letter indicating that draft or final settlements do not exist.
    4. Documents that are referenced in the file are not provided—this usually occurs with court rulings or settlement documents.
    5. References to state statutes or regulations without providing sufficient documentation (i.e., to which payments the statutes/regulations apply or a copy of the statute or regulation, or notice of which statutes or regulations apply to which payments).

 

10.2 Section 10 – Consent to Release Note – Additions

The Consent to Release note is the claimant’s signed authorization for CMS, its agents and/or contractors to discuss his or her case/medical condition with the parties identified on the authorization in regard to the WC settlement that includes a WCMSA. When you submit your WCMSA, you are required to include the signed consent, plus any applicable court papers if the consent is signed by someone other than the claimant (for example, a guardian, power of attorney, etc.). Do not include unsigned consents or consents to obtain medical records from a provider.
All consent-to-release notes must include language indicating that the beneficiary reviewed the submission package and understands the WCMSA intent, submission process, and associated administration. This section of the consent form must include at least the beneficiary’s initials to indicate their validation.
Consent to Release documents must be signed (by hand or electronically) with the full name of either the claimant, matching the claimant’s legal name, or by the claimant’s authorized representative, if documentation establishing the relationship is also provided. It must be a full signature, not just initials. For electronic standards, only the use of an E-SIGN Act-compliant e-signature or initials are considered valid.
If there is a change in submitter, please see Section 19.4 for more information.

 

16.1 Re-Review – Additions

A request for re-review may be submitted based one of the following:
    1. Mathematical Error: Where the appropriately authorized submitter or claimant disagrees with CMS’ decision because CMS’ determination contains obvious mistakes (e.g., a mathematical error or failure to recognize medical records already submitted showing a surgery, priced by CMS, that has already occurred), or
    2. Missing Documentation: Where the submitter or claimant disagrees with CMS’ decision because the submitter has additional evidence, not previously considered by CMS, which was dated prior to the submission date of the original proposal and which warrants a change in CMS’ determination.
      • Disagreement surrounding the inclusion or exclusion of specific treatments or medications does not meet the definition of a mathematical error.
      • Re-Review requests based upon failure to properly review already submitted records must include only the specific documentation referenced as a basis for the request.
      • Should no change be made upon response to a re-review request (i.e. no error was identified), additional requests to re-review the same error will not be entertained.”

 

Analysis

The removal of the reference to indemnification in the first part of Section 4.3 seems to have been CMS’s way of expressing its realization that the intent of settling parties in using non-submit WCMSAs is to protect Medicare’s interests as opposed to being designed merely to protect against MSP exposure via a shift of risk from one company’s errors and omissions coverage to another’s.
[Old Section 4.3 phrase]: “with the intent of indemnifying insurance carriers and CMS beneficiaries against future recovery for conditional payments made by CMS for settled injuries.” [New Section 4.3 phrase]: “for the purpose of complying with the Medicare Secondary Payer regulations without participation in the voluntary WCMSA review process set forth in this reference guide.”
Does the additional language about expectations for WC settlements that do not meet workload review threshold in Section 4.3 now really clarify what the plan for future care should be when the two examples in Section 8.1, titled Review Thresholds still describe recoveries by CMS for payments and care related to the injury up to the total value of the settlement if the settling parties fail to consider Medicare’s future interests/fail to establish “some plan for future care” ?  The referenced examples are listed below for ease of access:
Example 1: A recent retiree aged 67 and eligible for Medicare benefits under Parts A, B, and D files a WC claim against their former employer for the back injury sustained shortly before retirement that requires future medical care. The claim is offered settlement for a total of $17,000.00. However, this retiree will require the use of an anti-inflammatory drug for the balance of their life. The settling parties must consider CMS’ future interests even though the case would not be eligible for review. Failure to do so could leave settling parties subject to future recoveries for payments related to the injury up to the total value of the settlement ($17,000.00).
Example 2: A 47 year old steelworker breaks their ankle in such a manner that leaves the individual permanently disabled. As a result, the worker should become eligible for Medicare benefits in the next 30 months based upon eligibility for Social Security Disability benefits. The  steelworker is offered a total settlement of $225,000.00, inclusive of future care. Again, there is a likely need for no less than pain management for this future beneficiary. The case would be ineligible for review under the non-CMS-beneficiary standard requiring a case total settlement to be greater than $250,000.00 for review. Not establishing some plan for future care places settling parties at risk for recovery from care related to the WC injury up to the full value of the settlement.

 

Stay Up To Date

Count on Medivest to help you navigate your risk tolerance in light of the new CMS WCMSA Reference Guide language to see if we can’t find the right balance to reasonably protect Medicare’s interests in your settlement. Medivest will continue to monitor changes in the guidance and regulations published by CMS and will keep its readers up to date when such changes are announced/made. For questions regarding these updates, please reach out to a Medivest representative in your area by clicking here or by calling us direct at 877.725.2467.


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On February 17, Centers for Medicare & Medicaid Services (CMS) held a webinar concerning Workers’ Compensation Medicare Set-Aside (WCMSA) and updates from Section 4.3 of the New WCMSA Reference Guide. John Jenkins, Health Insurance Specialist for CMS, and Contracting Officer’s Representative (COR) hosted the presentation and addressed a variety of questions on the topics.

Note: CMS opened the call with a disclaimer indicating that if there are any discrepancies between what is said on the call and what is written in the Workers’ Compensation Medicare Set-Aside Arrangement Reference Guide (WCMSA Reference Guide or Reference Guide), what is written in the Reference Guide will control.

Treatments

When the Injured Worker (IW), due to comorbidities, is not medically cleared to have a recommended surgery CMS still wants the surgery to be included in the Medicare Set-Aside (MSA). It cannot assume the IW will not be able to meet the medical clearance requirement in the future.

 

No Treatment Necessary

  • According to Jenkins, if there is a reasonable expectation that there is or will be future treatment for an ongoing medical condition, the Workers’ Compensation Review Contractor  (WCRC) has a reasonable expectation that future care should be projected. If a specialist opines that care has concluded, the WCRC feels that it is extremely rare that an individual has only one provider, and there may be other providers including a primary treating physician that would recommend future care. If the individual truly does not need future care beyond a settlement and this is documented, the file should not rise to the level that requires submission. *
Medivest commentary: While not specifically mentioned on the call, Section 4.2 of the Reference Guide lists three requirements that should be met for this no future treatment necessary to take effect as an indication that Medicare’s future interests in a settlement are protected: 
“4.2     Indications That Medicare’s Interests are Protected
Submitting a WCMSA proposed amount for review is never required. But WC claimants must always protect Medicare’s interests. A WCMSA is not necessary under the following conditions because when all three are true, they indicate that Medicare’s interests are already protected:
        1. The facts of the case demonstrate that the injured individual is only being compensated for past medical expenses (i.e., for services furnished prior to the settlement);
        2. There is no evidence that the individual is attempting to maximize the other aspects of the settlement (e.g., the lost wages and disability portions of the settlement) to Medicare’s detriment; and
        3. The individual’s treating physicians conclude (in writing) that to a reasonable degree of medical certainty the individual will no longer require any Medicare-covered treatments related to the WC injury.”

 

Denial / State Specific / Hearings on the Merit

  • CMS recognizes there is such a thing as a legal denial. Jenkins emphasized that CMS standards say there must be some written response from a court of competent jurisdiction or associated board with authority under the law, pursuant to a disputed hearing on the merits. CMS will not decide whether a specific medical condition is or is not causally related to the compensated claim or whether it is or is not catastrophic if a statute limits WC benefits after a set time for catastrophic injuries. If you submit an unfunded “Zero MSA” for approval, CMS and its WCRC expects that such legal support will be included as documentation for the same. Any documentation must be signed by the legal authority.

 

Regarding a Medical Item, Service, or Expense Recommended by the Treating Physician but Denied by an Independent Medical Review (IMR)

  • It depends on whether an alternative treatment plan is provided. In California, the initial IMR denial is only good for a period of one year and does mean that the denial won’t be overturned on appeal. CMS’s position is if a submitter is going to send in a package and has an item, service, or a prescription drug that the IMR states does not meet the requirements of appropriate treatment, then the item, service, or expense will not be considered unwarranted by the WCRC unless an alternative treatment is provided. If there is no alternative item, service, or expense provided by the treating physician after any such denial, CMS will default to what the treating physician originally recommended.
Medivest commentary: This discussion addressed several areas discussed in the Reference Guide under Section 9.4.5 Medical Review Guidelines specifically listed in its subsection titled State-Specific Statutes, with the main points being listed below for additional clarification:
“A submitter requesting that CMS review the applicability of a state WC statute must include a copy of the statute with the submission and indicate to which section the topic in the submission the statute applies.
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.
Note: Failure to include the required documentation at the time of original submission will not constitute a reason for the request of a re-review.”

 

Regarding RX Drugs

  • CMS is open to input from the MSP compliance community regarding improvements that might be made in the future regarding dispensing fees and the lowest-priced accepted national drug code at below average market rate.

 

Amended Review Process

  • CMS did not answer the question posed regarding approved cases that are over 72 months old and did not settle and whether the original MSA approval should be funded for approved cases.

 

Regarding Annual Attestation

  • Jenkins says CMS places a flag in their system related to body parts and treatment as a result of the CMS submission. That flag will not be removed from the system until the individual provides the attestation as per CMS guidelines.

 

Regarding Data Sharing with Part D Prescription Drug Plans (PDPs)

  • CMS is not currently sharing all data with Part D plans because those part D plans have not specifically requested it.

 

Regarding Non-CMS Approved MSAs

  • CMS indicated it had received a lot of questions regarding non-submit MSAs, so that was the driving force behind the inclusion of Section 4.3 in the recently updated WCMSA Reference Guide.
  • Jenkins indicated that CMS’s position with under-threshold WC settlements is that they never would have seen them. He indicated that CMS will issue additional clarification on how to handle those cases in the future.
Medivest commentary: Presumably to add clarification to Section 8.1 entitled Review Thresholds that already provides the two specific examples listed below to illustrate CMS expectations when a WC settlement does not meet Workload Review Threshold: 
“Example 1: A recent retiree aged 67 and eligible for Medicare benefits under Parts A, B, and D files a WC claim against their former employer for the back injury sustained shortly before retirement that requires future medical care. The claim is offered settlement for a total of $17,000.00. However, this retiree will require the use of an anti-inflammatory drug for the balance of their life. The settling parties must consider CMS’ future interests even though the case would not be eligible for review. Failure to do so could leave settling parties subject to future recoveries for payments related to the injury up to the total value of the settlement ($17,000.00).
Example 2: A 47-year-old steelworker breaks their ankle in such a manner that leaves the individual permanently disabled. As a result, the worker should become eligible for Medicare benefits in the next 30 months based upon eligibility for Social Security Disability benefits. The steelworker is offered a total settlement of $225,000.00, inclusive of future care. Again, there is a likely need for no less than pain management for this future beneficiary. The case would be ineligible for review under the non-CMS-beneficiary standard requiring a case total settlement to be greater than $250,000.00 for review. Not establishing some plan for future care places settling parties at risk for recovery from care related to the WC injury up to the full value of the Settlement.”
  • With respect to non-approved products, CMS is still putting a marker in their system indicating there is a MSA. The marker allows CMS to avoid making payment.
Medivest commentary:  What was not discussed was how WC settlements compensating for future medicals but not submitted for approval to CMS (such as Evidence-Based Medicine MSAs or other non-submit WCMSAs) that are reported by Responsible Reporting Entities (RREs) for self-insured employers or WC carriers under Section 111 Mandatory Insurance Reporting will also be flagged for medical denials. RREs report the ICD diagnosis codes being compensated in a settlement at the time of their electronic Section 111 submission of data including the total settlement amount. Because an approved WCMSA amount is not listed for non-submitted WCMSAs, the default in the Common Working File (CWF) for the WCMSA amount is the settlement amount. Therefore, it seems highly likely that CMS will become more and more efficient in setting the system flags to deny future payments of medicals that correspond to compensated ICD codes deemed by RREs to be associated with a WC settlement. While the remedy of a denied medical is an appeal, if the goal is to not have an injured worker experience a future Medicare medical denial, CMS seems to suggest that the best way to address this issue would be to submit those WC settlements that meet workload review thresholds.
  • The non-CMS approved products do not allow CMS to put a marker in the system and block payment. Until recently, no one provided CMS with that documentation.
Medivest commentary:  This statement seemed to contradict the prior statement. The theory initially described was that only submitted WCMSAs are flagged for medical denials to help ensure that CMS complies with the MSP by not paying for medicals when the items, services, or expenses for those specific ICD codes were compensated by the WC settlement.  There was no discussion during this webinar on the interplay between Section 111 data and the data obtained via the WCMSA submission process.  We hope that CMS will clarify this issue moving forward.
  • There is the possibility the beneficiary will have to expend some of their funds outside of the MSA in a non-approved product situation – it was stated CMS was allowed to deny medicals up to the entire net settlement (allowing for a deduction for procurement costs to be consistent with existing MSP regulations).
  • CMS does not recognize the use of structured settlements for non-submitted MSA products. The individual must demonstrate they have exhausted the full value. CMS will only consider them as a lump sum settlement. CMS will not make payment until the full MSA amount has been exhausted even if they are notified the funding of the MSA was via structure.
  • The WCMSA does not demonstrate post-settlement compliance. The WCMSA is strictly an agreement between CMS and the CMS beneficiary about what dollar value/time, CMS will return as a primary payor if they can show the funds were used correctly. This is an agreement between CMS and the beneficiary only.
  • CMS will stick to the release date of Jan 11th, 2022, regarding how it handles the use of non-CMS approved products.
  • “If a non-approved product is priced correctly, Medicare is never going to see a bill.”
Medivest commentary: This was possibly the most important statement made by Jenkins.  He is admitting the reality that there certainly can be reasonably priced non-submit MSAs that do exactly what they were intended to do.  If the non-submit MSA accurately reflects the Medicare beneficiary’s injury related Medicare covered medicals and is exhausted exclusively for those purposes, then clearly Medicare’s interests have been protected because Medicare will not be prematurely (or ever) billed for those medicals.

 

Medivest will continue to monitor changes occurring at CMS and will keep its readers up to date when such changes are announced. For questions, feel free to reach out to the Medivest representative in your area by clicking here or call us direct at 877.725.2467. For any specific questions regarding MSAs of any type, click here.


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23/Feb/2022

On November 16, 2021, the State of California’s Medicaid Agency, the Department of Health Care Services (DHCS or Medi-Cal), issued an All County Welfare Directors Letter (ACWDL or Letter) number 21-26 as a memo to all counties and people who administer various state based benefits, including all Medi-Cal Program Specialists/Liaisons.
The Letter provides clarification on Medicare Set-Aside (MSA) funds, as defined by CMS in the Workers’ Compensation realm. The primary message is that “MSAs, also called Workers’ Compensation Medicare Set-Aside Arrangement Accounts (WCMSA), are not countable as income and property on the basis of their unavailability when determining an individual’s eligibility for Medi-Cal.”
This can be significant for several reasons outlined in the Takeaways section.  Traditionally, an injured party that was otherwise eligible for need based benefits would be advised by their attorney to have a 1st Party Special Needs Trust of some type (individual or Pooled Trust – together referred to here as an SNT) established to help assure the eligibility of those benefits at that time or in the future.  However, there may be times when the cost of establishing such an SNT might be cost prohibitive compared to the value of the benefits to be protected.

Summary

The Letter describes that because the funds in the MSA account are to be used for their intended purpose, covering the costs of future medical needs [that are injury related and Medicare covered], they should be considered unavailable income and not countable when determining an individual’s eligibility for Non-Modified Adjusted Gross Income (MAGI) programs. However, the Letter indicates that it is important to note that interest or dividends generated by the interest-bearing account should be considered available income for MAGI eligibility determination.
The Letter explains that MSAs had previously been determined to not be countable as property pursuant to a previous All County Welfare Directors letter numbered 90-01 from 1990.  “MSA funds are considered unavailable property under ACWDL 90-01 (January 5, 1990), Section 50402 of that letter.”
The Letter also provides guidance to California counties on MSAs regarding:
    • MAGI eligibility
    • Non-MAGI eligibility concerning:
      • Property
      • Income
    • Tasks that are County responsibilities
    • Tasks that are NOT County responsibilities
The full ACWDL 21-26 Letter with additional details and information is available here.

Takeaways

  • This Letter does not discuss settlements that exceed the WCMSA amount. Settlements that exceed the WCMSA amount meaning they exceed the injury related Medicare covered medical items, services, and expenses reasonably expected for the injured party and that are paid outside the WCMSA, might disqualify the injured party from Medi-Cal benefits.
  • The Letter also does not discuss that the injured party’s need based benefits may be jeopardized if the injured party moves to another state without taking steps to address the eligibility of the new state’s Medicaid benefits via the use of an SNT within the required time frame to afford such protection.
  • The information in this Letter may come in handy for certain cases where the cost of a SNT is a prohibitive factor that would affect whether a smaller Workers’ Compensation settlement could proceed.
  • The letter does not make it clear how Medi-Cal would view a liability MSA (LMSA), i.e., an MSA allocation report and arrangement for administration pursuant to the settlement of a liability case.
  • As always, you should consult with an attorney licensed in the state where the settlement occurs (as well as disclose to the injured party to consult with an attorney specializing in the protection of need based benefits for the state where the settlement occurs and in any state they plan to move to ahead of their move) to confirm their rights, their entitlement to any specific benefits, and so that they understand that state need based benefit eligibility varies and other states’ laws likely do not afford this same protection.
Count on Medivest to help guide you through some of the complexities associated with Workers’ Compensation and liability settlements that involve some evaluation of Medicare Secondary Payer Act (MSP) compliance, when you are not sure whether a Medicare Set-Aside arrangement should be utilized, or when need based benefits are in the picture or may be in the injured party’s future.

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08/Feb/2022

On Thursday, February 17 at 1 pm EST, Centers for Medicare & Medicaid Services (CMS) will host a webinar regarding Workers’ Compensation Medicare Set-Aside (WCMSA). The full notice can be read below:


 

CMS will be hosting a webinar to discuss a variety of WCMSA topics, including a summary of what’s new in Medicare set-asides, and addressing questions related to the inclusion of treatments, application of state rules, re-reviews/amended reviews and more. The webinar format will be opening remarks and a presentation by CMS followed by a live question and answer session with representatives from CMS.

Date: Thursday, February 17, 2022
Time: 1:00 PM ET

Webinar URL: https://www.mymeetings.com/nc/join.php?i=PWXW2628369&p=6930242&t=c

and

Conference Dial-In: 800-779-1251
Conference Passcode: 6930242

Please note that for this webinar you will need to access the webinar link and dial in using the information above to access the visual and audio portion of the presentation. Due to the number of participants please dial in at least 15 minutes prior to the start of the presentation.


 

Additional information about recent updates from CMS about WCMSAs can be found here. If you have questions on how topics discussed in this webinar may affect your clients, please contact Medivest here or call us at 877.725.2467.

 


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03/Feb/2022

1. Section 4.3 of the new WCMSA Reference Guide does not constitute new policy at CMS or new risk for settlement stakeholders. The WCMSA Reference Guide has for a long time maintained the same position on and response to submission and non-submission of MSAs that meet the submission threshold. It is, however, the first time CMS has specifically referenced MSA products branded as “evidence-based” or “non-submit” and given an opinion on those products.

2. CMS is communicating its concern that MSAs specifically designed to forego the submission/approval process may inadequately consider Medicare’s interest. While it is reasonable for CMS to maintain such a concern, the assumption that any MSA not approved by CMS is inadequate is problematic and contradictory to their position on MSAs that do not meet review thresholds. And submission/approval for MSAs that do meet review thresholds is still voluntary.

3. The party with the most to lose is the beneficiary. The primary consequence referenced in 4.3 is denial of payment for the beneficiary’s injury-related care in the event of MSA exhaustion. CMS says it will continue to deny payment until the entire net settlement has been fully spent down (not the total MSA amount). This could occur in events of permanent exhaustion or during temporary exhaustion periods when the beneficiary’s MSA is exhausted until the next funding payment is received. Keep in mind that this doesn’t apply to MSAs that do not meet the review threshold. Also, there is an appeal process for denial of payment. But the greatest risk-bearer is the applicant.

4. Since MSA exhaustion represents the greatest risk to the applicant, a program of proper funds administration is preferable. A burden shift to Medicare can only occur once Medicare becomes the primary payer. A MSA that remains solvent will maintain Medicare’s payment position as secondary indefinitely. While it is impossible to foresee every expense that a MSA may incur over an applicant’s lifetime, a properly funded MSA in the hands of a competent administrator is the best protection of the interests of both Medicare and the applicant.

5. Thoughtful consideration should be given to the adequacy of an evidence-based or non-submit program. It is entirely possible to produce a fully adequate and reasonable MSA without CMS’s review and approval. However, not all products are created equally. It’s important to be confident that the methodology in use produces MSAs that consider Medicare’s interests sufficiently.

6. The best indemnification is a reasonable MSA properly administered. CMS mentions indemnification in their 4.3 language. Many MSA vendors pair specific indemnification language with their non-submit products. The purpose of the indemnification language is to provide stakeholders with a layer of protection for bypassing CMS approval. Those stakeholders will want to pay special attention to any loopholes that condition any protection on the behavior of the beneficiary. Thoughtfully consider indemnification language before going the non-submit route. And as mentioned in #4 above, much of the risk produced by not submitting MSAs to CMS is mitigated by properly written MSAs administered by a competent professional.

Recommendation

Section 4.3 of the latest WCMSA Reference Guide does not produce anything particularly new. Still, it’s important to cover all the bases. For maximum avoidance of risk, submit MSAs to CMS for review that meets the review threshold. If submission is not palatable, it is still possible to write fully adequate MSAs that reasonably consider Medicare’s interests. The important questions to ask are: 1) Does the writing methodology stand on its own apart from CMS submission, rather than taking advantage of the lack of oversight to unreasonably shave costs? 2) If there is indemnification language provided with the non-submit MSA, is it heavily contingent on exceptions that weaken the protection it purports to provide? 3) Understanding that the risk mainly falls in the lap of the beneficiary and is triggered at exhaustion, is a competent administrator with the ability to contain medical costs in the picture to make sure the MSA has the best chance of remaining solvent throughout the applicant’s life?

For a downloadable copy of this piece please click here.

 


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18/Jan/2022

The Centers for Medicare & Medicaid Services (CMS) released a revised Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide (“Reference Guide”) Version 3.5 on January 10, 2022. This Reference Guide replaces Version 3.4 which was released on October 4, 2021.  When comparing the two Reference Guidesnew section 4.3 and new language has been added. Below indicates the new section and language added in the (WCMSA) Reference Guide Version 3.5.

To download the new WCMSA Reference Guide v3.5Click Here. 

CMS’s Version 3.5 Reference Guide, Section 1.1 includes the following changes:

Clarification has been provided regarding the use of non-CMS-approved products to address future medical care (Section 4.3).   

 

Section 4.3   The Use of Non-CMS-Approved Products to Address Future Medical Care

A number of industry products exist with the intent of indemnifying insurance carriers and CMS beneficiaries against future recovery for conditional payments made by CMS for settled injuries. Although not inclusive of all products covered under this section, these products are most commonly termed “evidence-based” or “non-submit.” 42 C.F.R. 411.46 specifically allows CMS to deny payment for treatment of work-related conditions if a settlement does not adequately protect the Medicare program’s interest.  Unless a proposed amount is submitted, reviewed, and approved using the process described in this reference guide prior to settlement, CMS cannot be certain that the Medicare program’s interests are adequately protected. As such, CMS treats the use of non-CMS-approved products as a potential attempt to shift financial burden by improperly giving reasonable recognition to both medical expenses and income replacement.   

 

As a matter of policy and practice, CMS will deny payment for medical services related to the WC injuries or illness requiring attestation of appropriate exhaustion equal to the total settlement less procurement costs before CMS will resume primary payment obligation for settled injuries or illnesses. This will result in the claimant needing to demonstrate complete exhaustion of the net settlement amount, rather than a CMS-approved WCMSA amount.   

   

Keep in mind the WCMSA Reference Guide states:   

There are no statutory or regulatory provisions requiring that you submit a WCMSA amount proposal to CMS for review. If you choose to use CMS’ WCMSA review process, the Agency requests that you comply with CMS’ established policies and procedures. 

 

Take Aways

  • While CMS added Section 4.3, this language is not entirely new or at least not entirely unexpected.  Similar currently existing Reference Guide language has for years included warnings about what could happen if parties failed to adequately consider Medicare’s future interests in WC settlements.  For example, language from previous Reference Guide versions indicated in Section 8.0 that even for examples where a settlement did not meet CMS workload review thresholds “The settling parties must consider CMS’ future interests even though the case would not be eligible for review.  Failure to do so could leave settling parties subject to future recoveries for payments related to the injury up to the total value of the settlement” (Example 1) and “Not establishing some plan for future care places the settling parties at risk for recovery from care related to the WC injury up to the full value of the settlement”  (Example 2).

 

  • Also in prior versions of the Reference Guide in Section 4.1.4, CMS has warned of its ability and intention to deny injury-related medical services when it said that “If Medicare’s interests were not reasonably considered, Medicare will refuse to pay for services related to the WC injury (and otherwise reimbursable by Medicare) until such expenses have exhausted the entire dollar amount of the entire WC settlement.  Medicare may also assert a recovery claim, if appropriate.”

 

  • On a positive note, CMS has now clarified in the new language in Section 4.3 that it will allow for a procurement cost reduction when there is a denial of service when there was no approved WCMSA submission.  The new language clearly explains that the denial of service amount will not exceed the gross settlement minus procurement costs.  This is more reasonable than denying services up to the entire amount of the settlement as it had previously listed or perhaps denying services up to double the amount of services.  The double damages concept has been sometimes misstated in industry circles.  (In court cases, even double damages claims have first determined the recovery damages by determining the conditional payment amount after applying a procurement cost reduction and then doubling that amount).   The new language actually helps with this issue.

 

  • However, perhaps even more troubling is whether funds earmarked to help protect Medicare’s future interests as WCMSA funds are actually used for the intended purpose.  According to the National Council on Compensation Insurance, Inc. (NCCI) 2018 research brief updating its 2014 survey on WCMSAs, approximately ninety-eight percent (98%) of the Workers’ Compensation cases settled with the injured worker choosing to self-administer their MSA funds.  This 2018 NCCI update published research brief included a sample of over 11,500 WC settlements between 2010 and 2015.

 

  • Perhaps to address this gap between what is said will be done (i.e. WCMSA allocation reports) and what actually is done (the administration of settlement dollars to pay for injury-related medical items, services, and expenses including prescription drug expenses, CMS already has the following language recommending professional administration in its Reference Guide in Section 17:

 “CMS highly recommends professional administration where a claimant is taking controlled substances that CMS determines are “frequently abused drugs” according to CMS’ Part D Drug Utilization Review (DUR) policy. That policy and supporting information are available on the web at https://cms.gov/Medicare/Prescription-Drug- Coverage/PrescriptionDrugCovContra/RxUtilization.html.

Claimants may also administer their own WCMSAs, if State law allows. Claimants should submit annual self-attestations, just as a professional administrator would. This arrangement is subject to the same rules and reporting requirements as any other WCMSA. See Section 17.5 for more on this annual attestation. 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.”

 

  • Perhaps CMS felt that its existing high recommendation language for professional administration was sufficient to encourage settling parties to avoid pitfalls of incompetent administration of WCMSAs.  But has CMS or any other entity ever done research to see what percentage of self-administered MSA funds were properly and fully exhausted before any injury-related medical bills were submitted to Medicare? If a non-submit WCMSA comes in at 80% of the CMS methodology submitted and approved WCMSA (80% because it follows an evidence-based drug tapering program guideline often seen in a state-based Workers’ Compensation medical protocol like the MTUS in California for example) but the WCMSA funds are professionally administered, wouldn’t that seem to protect Medicare’s real-world interests rather than a CMS submitted and approved WCMSA allocation report but self-administered by an injured claimant?

 

Stay Up To Date

Count on Medivest to help you navigate your risk tolerance in light of the new CMS WCMSA Reference Guide language and see if we can’t find the right balance to reasonably protect Medicare’s interests in your settlement. Medivest will continue to monitor changes occurring at CMS and will keep its readers up to date when such changes are announced. For questions regarding these updates, please reach out to a Medivest representative in your area byclicking here or call us direct at 877.725.2467. 


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12/Oct/2021

 

The Centers for Medicare & Medicaid Services (CMS) released a revised Workers’ Compensation Medicare Set-Aside Arrangement (WCMSAReference Guide (“Reference Guide”) Version 3.4 on October 4, 2021. This Reference Guide replaces Version 3.3 which was released on April 19, 2021. There are a few notable changes when comparing the two Reference Guides.  The yellow highlights below indicate the updated changes provided in Reference Guide Version 3.4.

 

CMS’s Version 3.4 Reference Guide, Section 1.1 includes the following changes:

To help ensure that funding information is provided for the WCMSA amount as part of a settlement agreement, clarification language has been added to several conditional letters (see Section 10.5 and the Approval and Development sample letters in Appendix 5).

To download the new WCMSA Reference Guide v3.4 Click Here.

 

☑ Section 10.5 wording change is as follows in yellow highlight:

“The parties can proceed with the settlement of the medical expenses portion of a WC claim before CMS actually reviews the proposed WCMSA and determines an amount that adequately protects Medicare’s interests. However, approval of the WCMSA is not effective until a copy of the final executed WC settlement agreement, which must include the funding information for the WCMSA amount, is received by CMS.”

 

☑ A similar word change was included in the Approval and Development sample letters in Appendix 5 of the Reference Guide to remind submitters that the method of funding is now required to be listed in the WCMSA submission.

 

☑ The approval letter to be included with the WCMSA submission to CMS should now include the language listed in the version appearing in Appendix 5 with the following statement in bold below:

Approval of this WCMSA amount is not effective until the Centers for Medicare & Medicaid Services (CMS) receive a copy of the final executed workers’ compensation settlement agreement, which must include the funding information for this WCMSA amount.”

 

☑  Lastly, in Section 17.7 the WCMSA Reference guide updated references from MyMedicare.gov to Medicare.gov.

 

Medivest will continue to monitor changes occurring at CMS and will keep its readers up to date when such changes are announced. For questions, feel free to reach out to the Medivest representative in your area by clicking here or call us direct at 877.725.2467. For any specific questions regarding MSAs of any type, click here.

 


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CMS published the latest version of the WCMSA Reference Guide as Version 2.9 (Reference Guide or Guide) on January 4, 2019. In addition to changes announced in Section 1.1 of the Reference Guide titled Changes in This Version of the Guide, there are several other changes made that were not announced. The announced changes were as follows:

Version 2.9 of the guide includes the following changes:

• To eliminate issues around Development Letter and Alert templates auto populating with individual Regional Office (RO) reviewer names and direct phone numbers, these will now display the generic “Workers’ Compensation Review Contractor (WCRC)” and the WCRC customer service number “(833) 295-3773” (Appendix 5).
• Per CMS’ request, certain references to memoranda on cms.gov have been removed.
• The CDC Life Table has been updated for 2015 (Section 10.3).
• Updates have been provided for spinal cord stimulators and Lyrica (Sections 9.4.5 and 9.4.6.2)

Below, in numerical order, please find some of the main changes made by CMS, many of which were not announced in Section 1.1 quoted above. Sections, titles and additions have been bolded for emphasis and ease of reading.

A change in Section 4.1.1, titled Commutation and Compromise, on page 4, was one of the announced changes, and omits the previous Reference Guide’s reference to the July 2001 WC Regional Office (RO) Memorandum known in the industry as the Patel Memo. This is consistent with the statement in Section 1.0 that the Reference Guide “. . . reflects information compiled from all WCMSA Regional Office (RO) Memoranda issued by CMS, from information provided on the CMS website, from information provided by the Workers Compensation Review Contractor (WCRC), and from the CMS WCMSA Operating Rules. The intent of this reference guide is to consolidate and supplant all historical memoranda in a single point of reference. Please discontinue the reference of prior documents.” The concept is that the Reference Guide is the policy of CMS and prior documents or Memos it has issued should not be referred to or otherwise used to support a party’s position regarding matters addressed in the Reference Guide unless it continues to be referenced in the Reference Guide.

Section 4.2, titled Indications That Medicare’s Interests are Protected, has a new unannounced on page 5 bullet stating:

• CMS’ voluntary, yet recommended, WCMSA amount review process is the only process that offers both Medicare beneficiaries and Workers’ Compensation entities finality, with respect to obligations for medical care required after a settlement, judgment, award, or other payment occurs. When CMS reviews and approves a proposed WCMSA amount, CMS stands behind that amount. Without CMS’ approval, Medicare may deny related medical claims, or pursue recovery for related medical claims that Medicare paid up to the full amount of the settlement, judgment, award, or other payment.

Medivest’s take on the subject: CMS makes it sound enticing for Workers’ Compensation entities by using the word “finality.” Many parties have used the voluntary process to obtain approvals but have felt there has been a lack of consistency in review standards, especially from one contractor to another. Blogs and websites of many other companies that prepare Medicare Set-Aside (MSA) allocations indicate that they have experienced an increase in surprise counter highers over expenses like off-label prescription drug use as well as some other medical services when submitting WCMSAs to CMS for approval. As a result of what may have been perceived as a lack of consistency or perhaps a lack of confidence that the counter highers reflect real-world evidence-based needs of injured parties, many settling parties have seemed less inclined to choose submission as a regular practice, even when WC settlements fall within the CMS workload review thresholds, opting instead to follow the Medicare Secondary Payer Act, 42 U.S.C. § 1395y(b) et. seq. (MSP), and its corresponding regulations, instead of the voluntary policies of CMS.

On pages 8-9, under Section 8.1, titled Review Thresholds, two new unannounced examples have been included as follows:

Example 1: A recent retiree aged 67 and eligible for Medicare benefits under Parts A, B, and D files a WC claim against their former employer for the back injury sustained shortly before retirement that requires future medical care. The claim is offered settlement for a total of $17,000.00. However, this retiree will require the use of an anti-inflammatory drug for the balance of their life. The settling parties must consider CMS’ future interests even though the case would not be eligible for review. Failure to do so could leave settling parties subject to future recoveries for payments related to the injury up to the total value of the settlement
($17,000.00).

 

Example 2: A 47 year old steelworker breaks their ankle in such a manner that leaves the individual permanently disabled. As a result, the worker should become eligible for Medicare benefits in the next 30 months based upon eligibility for Social Security Disability benefits. The steelworker is offered a total settlement of $225,000.00, inclusive of future care. Again, the steelworker [typo fixed] is offered a total settlement of $225,000.00, inclusive of future care. Again, there is a likely need for no less than pain management for this future beneficiary. The case would be ineligible for review under the non-CMS-beneficiary standard requiring a case total settlement to be greater than $250,000.00 for review. Not establishing some plan for future care places settling parties at risk for recovery from care related to the WC injury up to the full value of the
settlement.

Medivest’s take on the subject: These examples illustrate CMS’s position that Medicare’s future interests need to be considered even if the dollar amount of the judgment, settlement, award or other payment does not meet the CMS workload review thresholds. The examples emphasize that CMS considers the establishment of a plan for future care to be a priority and that CMS is serious about protecting Medicare’s future interests. These examples further spell out that CMS reserves the right to request an injured party to fully exhaust the amount of money equal to the entire settlement (not mentioning anything about allowing for a reduction of procurement costs such as attorney’s fees and costs expended to obtain the settlement typically allowed to be deducted under MSP regulations when parties timely request to resolve conditional payment/Medicare liens) when an injured party who is compensated for future medicals, fails to establish a plan for future care.

On page 9 under Section 9.0, titled WCMSA Submission Process Overview, CMS allows for a WCMSA proposal to be submitted either by paper or CD to the Benefits Coordination & Recovery Center or online via the WCMSA Portal (WCMSAP) and clarifies that these are the only acceptable submission delivery methods to be used.

In Section 9.4.5, titled Medical Review Guidelines, under the subsection heading Spinal Cord Stimulators on page 22, the following language was added to change the former policy of not including lead implantation in revision surgeries to the newly adopted policy whereby “Routine replacement of the neurostimulator pulse generator includes the lead implantation up to the number of leads related to the associated code. Revision surgeries should only be used where a historical pattern of a need to relocate leads exists.”

In Section 9.4.5, titled Medical Review Guidelines, under the subsection Pricing for Spinal Cord Stimulator (SCS) Surgery on page 22, the following text was inserted “SCS pricing is based on identification of: 1.) Rechargeable vs. Non-rechargeable and 2.) Single vs. Multiple Arrays (leads). If unknown, CMS will default to non-rechargeable single array.”

In Section 9.4.5, titled Medical Review Guidelines, under the subsection Pricing for Spinal Cord Stimulator (SCS) Surgery on page 22, the following language was deleted: “Preadmission Testing will be included where appropriate.”

In Section 9.4.5, titled Medical Review Guidelines, under the subsection Pricing for Spinal Cord Stimulator (SCS) Surgery, a table titled Table 9-3: Spinal Cord Stimulator Surgery CPT Codes on page 24, was expanded from three procedure (CPT) codes previously listed for Post Placement System Testing to a total of 12 including the same Post Placement System Testing as well as a series of CPT codes for Pre-Placement Psychological Testing, Anesthesia, and various other codes for the implantation procedures, etc. along with detailed descriptions of each.

In Section 9.4.6.2, titled Pharmacy Guidelines and Conditions, under the subsection Medically Accepted Indications and Off-Label Use, on page 28, there are now two detailed examples of off-label use instead of only one off-label use example in the prior version. The additional language appears in bold as follows:

Example 1: Lyrica (Pregabalin) is cited in MicroMedEx for an off-label medication use related to neuropathic pain from spinal cord injury, and a number of scientific studies indicate that Pregabalin shows statistically significant positive results for the treatment of radicular pain (a type of neuropathic pain). Spinal cord neuropathy includes injuries directly to the spinal cord or its supporting structures causing nerve impingement that results in neuropathic pain. Lyrica is considered acceptable for pricing as a treatment for WCMSAs that include diagnoses related to radiculopathy because radiculopathy is a type of neuropathy related to peripheral nerve impingement caused by injury to the supporting structures of the spinal cord.

 

Example 2: Trazodone” – which was previously described as – “Trazodone is approved by the FDA for the treatment of major depressive disorder,
but is commonly given off-label to treat insomnia. So the WCRC would include trazodone in a WCMSA if used to treat insomnia, if it is related to the workers’ compensation injury.”

Medivest’s take on the subject: This seems to be a situation where the new WCRC has been including more off-label drugs in its counter highers than the prior contractor, with the expensive drug Lyrica, gaining the most industry attention. Entities submitting WCMSAs for approval should be aware of the language referred to on page 28 of the Reference Guide that cites the Medicare IOM (Internet Only Manual) rules concerning Medicare covered off-label usage. The standard is as follows, “FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the carrier determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.” Because this standard is so broad and the CMS and its WCRC seems to be taking an expansive approach to what types of off-label use is determined to be includable, parties seeking to control costs but still interested in CMS submission should consider professional consultations with treating physicians as to whether there are less costly medications and/or alternate treatment/prescription doses that can be utilized, implemented, and confirmed as equally effective, prior to submission.

Under Section 10.4 Section 20 – Life Care / Future Treatment Plan, page 43, a new statement “A Future Treatment Plan is required in the absence of a Life-Care Plan” makes it clear that there is a minimum requirement for future treatment to be listed in a submitted allocation in absence of a Life-Care Plan.

Medivest’s take on the subject: This is not really news because the term Future Treatment Plan existed in the prior Reference Guide’s title for this section. This seems to be a way to bring some consistency to the idea and to tie the term Future Treatment Plan together with the terms Future Treatment and Future Treatment Summary that also appear (and previously appeared) in the section.

In Section 10.5.2, titled Use of WC Fee Schedule vs. Actual Charges for WCMSA, on page 43, the state of Virginia was removed from the list of states that do not have a state Workers’ Compensation (WC) Fee Schedule. The states that do not have a WC fee schedule currently are Indiana, Iowa, Missouri, New Hampshire, New Jersey, and Wisconsin. The Reference Guide instructs, “Do not use a fee schedule in a state that does not have a fee schedule.”

Under Section 16, titled Re-Review, there are three subheadings describing circumstances under which a party may request a Re-Review. Under the subheadings of Mathematical Error and Missing Documentation on page 55, the following unannounced Note was inserted:

Notes:
• Disagreement surrounding the inclusion or exclusion of specific
treatments or medications does not meet the definition of a mathematical error.

• Re-Review requests based upon failure to properly review already submitted records must include only the specific documentation referenced as a basis for the request.

Under the third subheading titled Amended Review, the criteria and information remained the same, but the information was reformatted as follows with a phrase added to last note bullet in bold:

• 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.

• 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.

• Where a re-review request is reviewed and approved by CMS, the new approved amount will take effect on the date of settlement, regardless of whether the amount increased or decreased.

• This new submission may be delivered in both paper and portal formats. Please see the WCMSAP User Guide for more information.

In order to justify that the projected care would result in a 10% or $10,000 change (whichever is greater), the submitter must return CMS’ Recommendation Sheet that was included in CMS’ conditional approval letter and identify the following:

• Line items that were included in the approved amount, but are for care that has already been provided to the beneficiary. Please identify where references to records indicating that the care has already been provided can be found in the updated proposal.

• Line items for care that is no longer required. Please identify where references to replacement treatment can be found in the updated proposal.

• If additional care is required that was not otherwise included in CMS’ conditional approved amount, please add line items.

Notes:
• In the event that treatment has changed due to a state-specific requirement, a life-care plan showing replacement treatment for denied treatments will be required if medical records do not indicate a change.

• The approval of a new generic version of a medication by the Food and Drug Administration does not constitute a reason to request an amended review for supposed changes in projected pricing.

• CMS will deny the request for re-review if submitters fail to provide the above-referenced justifications with the request for re-review.

• Submitters will not be permitted to supplement the request for re-review, nor will they be developed.

Under Section 17.3 Use of the Account on Page 57, the bolded language replaced prior language on the subject:

“Please note: If payments from the WCMSA account are used to pay for services other than Medicare-allowable medical expenses related to medically necessary services and prescription drug expenses for the WC settled injury or illness, Medicare will deny all WC-injury-related claims until the WCMSA administrator can demonstrate appropriate use equal to the full amount of the WCMSA.”

Medivest’s take on the subject: CMS is indicating that Administrators have the burden to show appropriate use of MSA funds and therefore, must keep accurate records to prevent mistaken denial of injury related Medicare covered claims by Medicare after MSA funds are exhausted.

Under Chapter 18 titled CMS Submission, after the sentence, “Additionally, the contractor must ensure that Medicare makes no payments related to the WC injury until the WCMSA has been used up”, the following language was added on page 60:

This is accomplished by placing an electronic marker in CMS’ systems used to pay or deny claims. That marker is removed once the beneficiary can demonstrate the appropriate exhaustion of an amount equal to the WCMSA plus any accrued interest from the account. For those with structured settlements, the marker is removed in any period where the beneficiary exhausts their available funds; however, it is replaced once the anniversary fund deposit occurs until the entire value of the WCMSA is demonstrated as entirely exhausted.

Medivest’s take on the subject: This is the first indication of an “electronic marker” and gives an idea of how the CMS computer system will be flagging those injury related medicals submitted for payment by Medicare, but that Medicare may deny.

In Appendix 4, WCRC Proposal Review Reference Tools on page 69, the link to CMS Memos and written references to CMS Memos going back to 2001 were removed.

All references in Appendix 5. Sample Letters to Sherri McQueen, as Acting Director, were changed to Sherri McQueen, Director, Financial Services Group Office of Financial Management.

In the Development Letter Sample, the CMS Regional Office Contact reference and contact phone numbers were removed and replaced with “the Workers’ Compensation Review Contractor (WCRC) at (833) 295-3773” on pages 81 and 85.

Medivest’s take on the subject:  The WCRC now has the responsibility to field calls regarding submission of WCMSAs instead of the CMS Regional Offices.

Medivest will continue to follow changes in policy at CMS and in the actions of its Workers’ Compensation Review Contractor, Capitol Bridge, LLC, and will keep our readers up to date on developing trends.

 


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