CMS recently released Version 3.0 of its WCMSA Reference Guide, what we informally call the “MSA bible.”  The reference guide provides most CMS policy and procedures relating to its review of Workers’ Compensation Medicare Set-Asides.

The updated guide can be found here.

Notable additions or changes to this version are detailed below with takeaways and comments.

Amended Review Criteria Expanded to Six Years

CMS has expanded the Amended Review MSA lookback from one to four years to one to six years post the prior MSA approval.  As a refresher, the Amended Review process in Section 16.2 allows a new MSA to be submitted following a prior approval if all of the following criteria are met:

• CMS has issued a conditional approval/approved amount at least 12 but no more than 72 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.

Tower appreciates CMS expanding the lookback to six years as this should allow for more cases to be submitted through this process and potentially settle with an MSA that better reflects the claimant’s current and future course of treatment.  If your case may meet this criteria, please contact Tower to review and determine the feasibility of submitting an Amended Review MSA.

Claimant Authorization to Submit Added to Consent to Release Form

Longstanding policy requires any MSA submitted to CMS must include a Consent to Release form signed by the claimant.  The primary purpose of the document is to provide Medicare beneficiary authorization for CMS to communicate with the MSA submitter concerning the workers’ compensation claim. 

Per the updated reference guide, effective 4/1/2020 a consent must include the following language:

Further, I have had the Workers’ Compensation Medicare Set-Aside Arrangement need and process explained to me, and I approve of the contents of the submission.

Beneficiary Initials: ____

As a result of the addition of this statement, CMS is effectively asking the claimant to approve the MSA along with supporting documents in the submission.  We anticipate two consequences as a result of this addition:

• Claimants will sign the consent but forget to initial this section.
• Claimants will not sign the consent until such time as they review the MSA and perhaps the supporting documentation, i.e. medical records, which are submitted with the MSA.

While we understand CMS wanting to ensure the claimant understands the purpose of the MSA, we would assert this is already effectively done, in most cases, as part of the settlement process. 

At this time, Tower will continue to use the Consent to Release without the requirement that the claimant approve the MSA submission.  However, we will need to begin using the revised consent as we get closer to 4/1/2020.

Submission of Annual Attestations through the WCMSAP

As we previously discussed in CMS Adds Electronic Submission Option for MSA Attestations, CMS is now allowing MSA self and professional administrators to submit annual attestations through the Workers’ Compensation Medicare Set-Aside Portal (WCMSAP).  Section 11.1.1. of the guide was updated to reflect the addition of this feature and a new Section 17.6 “Electronic Attestations” was added which directs both MSA self and professional administrators to the WCMSAP User Guide for further information on submitting annual attestations electronically.

Policies Added to Address Opioid Epidemic

CMS has been very active in the past two years at addressing the opioid epidemic among its Medicare beneficiaries.  The exception to this has largely been the MSA program.

In an effort to address opioids in MSA CMS added the following statement to section 17.1 on MSA administrators:

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.

CMS takes this further in Section 17.3 by stating:

CMS expects that WCMSA funds be competently administered in accordance with all Medicare coverage guidelines, including but not limited to CMS’ Part D Drug Utilization Review (DUR) policy. As a result, all WCMSA administration programs should institute Drug Management Programs (DMPs) (as described at https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf) for claimants at risk for abuse or misuse of “frequently abused drugs.”

While MSA professional administration is recommended for most MSAs, CMS is correct in asserting it is of special value for a claimant utilizing opioid medications.  MSA professional administrators like our partner, Ametros, can readily provide the type of drug management program expected by CMS.  We applaud CMS for implementing these guidelines addressing opioid use in MSAs.

If you have any questions regarding theses MSA updates, please contact Tower’s Chief Compliance Officer, Dan Anders, at (888) 331-4941 or daniel.anders@towermsa.com.

In an October 10, 2019 decision from the U.S. Court of Appeals for the Ninth Circuit, the California Insurance Guarantee Association (CIGA) was found not to be a primary plan under the Medicare Secondary Payer (MSP) Act.  The result of this decision, if not reversed on further appeal, is that CIGA would have no responsibility to reimburse Medicare for conditional payments or to allocate funds in a Medicare Set-Aside (MSA) for future medical.  Whether this decision applies to other state guaranty associations or funds depends on whether that state is located within the Ninth Circuit and on the statutory language that established the fund.

Background on CIGA Case

CIGA is a statutorily created association that requires its insurer members to pay premiums, which are then used to discharge an insolvent insurer’s covered claims.  The statute specifically indicates CIGA is a payor of last resort and cannot reimburse state and federal government agencies, including Medicare.

Tower previously reported on CIGA’s suit against Medicare, Federal Court Holds Against Medicare Practice of Over-Inclusive Reimbursement Demands and U.S. District Court Declares CMS Practice of Over-Inclusive Reimbursement Demands to be Unlawful, but Withholds Injunction.  In the lower court, the judge had quickly dismissed CIGA’s argument that it was not a primary plan, subject to the provisions of the MSP Act, by focusing on CIGA’s obligation to pay for workers’ compensation medical benefits for the insolvent insurer.  The judge went on to address the CMS practice of claiming reimbursement for a charge that includes both injury-related and non-injury-related services.  While the District Court for the Central District of California found CMS’s practice unlawful as the state law requires only payment for injury-related charges, the court did not issue an injunction stopping this CMS practice.  

Appeals Court Holds CIGA is Not a Primary Plan

On appeal, the focus shifted back to whether CIGA was a primary plan and thus subject to the MSP Act.  The appellate court indicated the question is not whether CIGA made workers’ compensation payments on a claim from an insolvent insurer, but whether CIGA is a workers’ compensation plan.  The MSP Act, 42 U.S.C. § 1395y(b)(2)(A)(ii), defines entities that are primary plans to Medicare as follows:

payment has been made or can reasonably be expected to be made under a workmen’s compensation law or plan of the United States or a State or under an automobile or liability insurance policy or plan (including a self-insured plan) or under no fault insurance.

The court found CIGA does not fall into any of these categories and instead falls into the category or class of “insolvency insurance” as it is “an insurer of last resort.”  Based upon a review of the MSP Act and its history, the court found that the primary plan provisions do not preempt state law. (Federal preemption means that when federal and state law are in conflict, the federal law is followed rather than the state law).

To argue its position that the state law is preempted, the federal government cited the 1996 decision from the U.S. Court of Appeals, First Circuit, in U.S. v. Rhode Island Insurer’ Insolvency Fund, 80 F.3d 616 (1^st Cir. 1996), in which the court found this guaranty fund’s statutory provision requiring claimants to seek recovery from any governmental insurance, e.g., Medicare, before seeking reimbursement from the fund, to be preempted by the MSP Act.

The Ninth Circuit distinguishes its decision by noting the Rhode Island statutory scheme deems the fund to be the new insurer upon insolvency of the old insurer.  In other words, the Rhode Island fund steps into the shoes of the insolvent carrier.  In contrast, the court holds that based on the state statute, CIGA does not become the insurer. Instead, CIGA is only authorized to disburse funds for “covered claims” from the insolvent insurer.  A key distinction for the court.

Practical Implications

This decision is only binding upon the federal courts within the Ninth Circuit, namely Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington. To determine whether this decision may apply to guaranty funds in those states, each fund would need to review its statutory language against the California statutory language that was determinative in this case.  For funds located outside the Ninth Circuit, this decision may be persuasive to federal district and circuit courts if asked to rule on the issue.  

CMS has the option to first appeal the decision to the full circuit (called en banc), meaning all judges sitting in the Ninth Circuit would hear the case.  If this is turned down, which is likely, then an appeal can be filed with the U.S. Supreme Court, which may or may not choose to hear the case.

Finally, compliments to CIGA for maintaining this litigation, which has resulted in decisions addressing the extent of Medicare conditional payment recovery and defining whether a guaranty fund is a primary plan under the MSP Act.

If you have any questions, please contact Tower’s Chief Compliance Officer, Dan Anders, at daniel.anders@towermsa.com or (888) 331-4941.

On October 7, 2019, the Centers for Medicare and Medicaid Services (CMS) released an updated Workers’ Compensation Medicare Set-Aside Portal (WCMSAP) User Guide (Version 5.9) which adds the capability for both MSA self and professional administrators to electronically submit annual attestations for CMS-approved MSAs.  Previously, the sole option for an MSA administrator was to complete the attestation form and submit to Medicare’s Benefits Coordination & Recovery Center (BCRC) via mail.

Pursuant to CMS rules, once the approved MSA is funded through settlement:

Every year, beginning no later than 30 days after the 1-year anniversary of settlement, the administrator must sign and send a statement that payments from the WCMSA account were made for Medicare-covered medical expenses and Medicare-covered prescription drug expenses related to the work-related injury, illness, or disease.

CMS provides blank attestation letters with the appropriate identification numbers in each CMS WCMSA approval letter for this very use.

Through this new electronic option, MSA self-administrators or those representing MSA self-administrators may login through MyMedicare.gov and by clicking the WCMSA Attestation Information button, may submit a new attestation and view past attestations. 

For professional administrators, they may set up an account in the WCMSAP and manage their authorized cases within the portal.  Per CMS, professional administrators’ access will allow them to “submit account transactions via input file submissions and download response files online, allowing them to administer and keep detailed records for a WCMSA account without the need for submitting an attestation.”

Importantly, final settlement documents must be submitted to CMS, including a professional administration agreement if the MSA is to be professionally administered, before the electronic attestation submission option may be used. 

CMS Webinars to Highlight Enhancements

CMS has scheduled two webinars to highlight the new WCMSA Electronic Attestation Enhancements.  The first webinar, to be held on October 30, 2019 at 1:00 PM ET, will be for Medicare beneficiaries and their representatives.  The second webinar, to be held on November 6, 2019 at 1:00 PM ET, will be for Professional Administrators. 

Practical Implications

Providing for electronic submission of annual attestations will benefit both CMS and MSA administrators as it will allow for better and faster coordination of benefits.  This coordination of benefits ensures that when MSA funds exhaust, either temporarily or permanently,  Medicare payment for the Medicare beneficiary’s injury-related bills will be triggered. 

Tower offers MSA professional administration services through our partner, Ametros.  If you have any questions regarding MSA administration or this enhancement, please contact Dan Anders at daniel.anders@towermsa.com or (888) 331-4941.

On July 19, 2019, the Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin). This follows the expiration of Pfizer’s patent on Lyrica at the end of June. The generic is expected to be available at pharmacies in the coming weeks.

 

Lyrica remains FDA approved for the following indications:

• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain associated with spinal cord injury
• Adjunct therapy for the treatment of partial-onset seizures
• Postherpetic neuralgia

If a claimant is being prescribed Lyrica for any of the above indications and such indication is related to the workers’ compensation injury, then it will be included in the MSA. In workers’ compensation injuries, Lyrica is most frequently prescribed for neck or back pain. For years, CMS considered Lyrica non-Medicare-covered for neck or back pain unless such treatment stemmed from a traumatic spinal cord injury. However, CMS recently expanded its interpretation of what is considered a spinal cord injury, explaining in the updated WCMSA Reference Guide released this past January:

 

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.

 

As a result, MSAs have included Lyrica more frequently.

 

Red Book currently prices brand-name Lyrica in the range of at $9.36 to $10.30 per pill depending upon the dosage. The MSA for a person taking Lyrica 50mg three times a day over a 20-year life expectancy would allocate $222,580 for the medication. Red Book shows a generic price range of $7.58 to $8.43 per pill depending on the dosage. While not a significant per-pill decrease, the generic switch over the 20-year life expectancy produces an allocation of $163,728 – a $58,752 reduction. The good news is with multiple manufacturers approved to sell the generic; we expect the per-pill price to drop even further.

 

Practical Questions

 

Will CMS automatically allocate the Lyrica in the MSA at the generic price?

 

As with any medication, including Lyrica, it is important to keep in mind that CMS will not automatically use the generic price when the treatment records and/or prescription history document brand name use. Instead, it must be proven to CMS typically, through prescription payment history, that the claimant has been switched to the generic. One fill documenting the switch to generic should be sufficient.

 

What is Tower doing for MSA referrals which include brand-name Lyrica?

 

If the claim prescription history documents brand Lyrica, we will advise you that a generic version of Lyrica has been approved and is or will soon be available.  Tower will show you the price difference between brand and generic and recommend working with the treating physician and your pharmacy benefit manager to make the switch.  If a statement from the treating physician is required to authorize the switch, Tower can obtain it from the physician (although we will still need prescription history documenting at least one fill of the generic).

 

If the MSA was previously approved by CMS with brand-name Lyrica can it be re-priced to generic?

 

CMS will not consider an MSA Re-Review or Amended Review based solely upon a prescription medication pricing change. An Amended Review MSA would need to document not only the switch to generic Lyrica but other changes as well, such as a previously allocated medication having been discontinued.

 

If you have any questions, please contact Tower’s Chief Compliance Officer, Dan Anders, at (888) 331-4941 or daniel.anders@towermsa.com.