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.

 

 

 

 

 

Two years ago, CMS rolled out a policy that enabled submission of a new MSA even if an MSA had previously been approved for the same date of injury. The purpose of this “Amended Review” is to provide parties who have not settled the case an opportunity to update the MSA to better reflect the current and future course of medical care. Since its implementation, this policy has allowed many parties in workers’ compensation cases to move forward with a settlement and closure of medicals.

Does your MSA qualify?

CMS provides the following base criteria for an Amended Review:

Where the following criteria are met, CMS will permit a one-time request for re-review in the form of a submission of a new cover letter, all medical documentation related to the settling injury(s)/body part(s) since the previous submission date, the most recent six months of pharmacy records, a consent to release information, and a summary of expected future care.

• 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.

If you think your case may qualify, contact Tower to determine whether current medical records support a change in the MSA. Proper medical documentation is critical to ensuring CMS will agree to the Amended MSA. CMS requires an affirmative statement from a treating physician or physicians confirming the originally allocated treatment or medication has changed or is no longer necessary. The following case study illustrates how it works.

Amended Review Case Study

CMS approved an MSA on 5/7/2015 for $147,483. The parties were unable to settle the workers’ compensation case at that time. Nearly four years later, the parties were again ready to consider settlement, but the 2015 MSA no longer reflected the injured worker’s course of medical care.

A review of recent medical records caused Tower to suspect that a supplemental oxygen delivery system was no longer used and that the injured worker could switch from brand-name Crestor to generic. Tower’s Physician Follow-Up service obtained the treating physician’s signed statement regarding the discontinuation of the oxygen system and the injured worker’s current use of the generic, which enabled us to revise the MSA down to $46,171. It was submitted shortly before the Amended Review deadline and approved by CMS on 5/13/2019 for a $101,312 reduction from the previously approved MSA.

Key Takeaways

CMS will agree to a change in the previously approved MSA amount when the medical documentation supports the change. Since the Amended Review is a one-time opportunity, it is vital to conduct the review well before the deadline and to obtain proper medical documentation to support MSA modifications.

Finally, keep in mind that while the CMS Amended Review policy allows for an MSA that better reflects the current and future course of care, CMS does not require the settling parties to submit a new MSA, even when the criteria are met. Per our understanding of CMS WCMSA rules, the original approved MSA does not expire or otherwise become invalid.

This is another way Tower delivers on its promise of Compliance by the book, closure by the numbers.

WCI comes a little earlier this year (August 11-14), so make plans to attend now. Tower will present in two back-to-back sessions on August 14. Starting at 9 a.m., “Optimizing Settlement Outcomes by Measuring and Managing MSA Costs” stresses the importance of determining which metrics to use and how to use them to evaluate and improve your MSA program. Moderated by Michael Stack, CEO of AMAXX, the session features American Airline’s Kris Sallee and Tower’s Chief Compliance Officer Dan Anders who will also describe how clinical interventions produce MSAs that balance care, cost, and compliance.

Then, at 10 a.m., “Allaying the MSA Fear at Time of Settlement” examines reasons employers and injured workers avoid settling claims. Employers anticipate the MSA cost will be too high; injured workers worry that the funds will be too low, or they won’t be able to properly administer the MSA. Marques Torbert, CEO of the professional administration firm Ametros, and Joe Bornstein, a structured settlement consultant with Arcadia Settlements Group, join Kris, Dan, and Michael in a lively discussion of these challenges and their solutions and share case studies that resulted in a win-win for the employer and the injured worker.

For more information and to register for the conference, see https://www.wci360.com/conference/

Just like all of us, CMS makes occasional errors. Believe it or not, the government is not infallible! To protect our clients from unnecessary allocation costs, Tower takes a “lead, not follow” approach to deliver Medicare-compliant MSAs that are not overfunded. This means that we don’t just follow CMS’s rules to prepare and submit MSAs, we take the initiative to make sure CMS follows its own rules.

 

Tower challenges a CMS MSA counter-higher when our clinical and legal review produces a basis for a re-review request (a form of post-determination appeal). We typically submit re-review requests within 48 hours of receipt of the counter-higher and CMS responds in less than 14 days. Our challenges have yielded a 71% success rate and saved our clients hundreds of thousands of dollars.

 

As the following examples from the past six months demonstrate–whether its $2,000 or $200,000–Tower will dispute CMS’s calculations when we believe they are in error:

 

Miscalculated surgical pricing

CMS increased the cost of a knee replacement by $8,769. Tower submitted a re-review and stated CMS had incorrectly used the state fee schedule in calculating the surgical cost. After two re-reviews, CMS corrected the pricing to the proposed amount.

 

Addition of discontinued medication

CMS added a medication, Etodolac, that, per the medical records, had been replaced with another medication, Ibuprofen. Tower referenced the submitted medical records and Rx history on re-review and CMS agreed to remove the medication from the MSA for a $16,704 reduction.

 

Medication allocated at the wrong frequency

CMS increased the refill schedule of Tylenol #4 from every three months to monthly, increasing the MSA by $8,650. Tower submitted a re-review and cited the prescription payment history as confirming “as needed” use of the medication. CMS agreed and returned the MSA to the originally proposed amount.

 

Non-Medicare covered medication added

CMS added the medication Lyrica to the MSA resulting in a $205,658 increase in the allocation. Tower argued that Medicare coverage guidelines did not provide a basis for inclusion of Lyrica for treatment of a foot crush injury. After a re-review and escalating to CMS senior management, CMS agreed and removed the Lyrica from the MSA.

 

Treatment unrelated to the WC injury

CMS added left hip x-rays and MRIs even though the hip was not accepted on the WC claim. Tower disputed the tests’ inclusion and CMS agreed to remove, thus lowering the MSA by $2,657.

 

Miscalculated Rx pricing

CMS modified the pricing of Morphine Sulfate resulting in a $12,376 increase to the MSA. Tower advised CMS that it had used the incorrect NDC code to price the medication at $1.50 per unit versus the correct $0.73. CMS acknowledged the error and corrected.

 

Key Takeaways

The good news is that the above errors occur in the minority of MSA submissions. Most of the time CMS gets it right. However, when errors occur, Tower quickly identifies and submits a re-review request to CMS. And, in most cases, our re-review requests yield a cost-savings MSA that is Medicare-compliant. This is another way Tower delivers on its promise of Compliance by the book, closure by the numbers.