Category Archives: Medicare Set-Asides (MSAs)

Recently Released and Soon to be Released Generics Expected to Reduce Claims Costs

Over the past several years, prescription drug costs related to workers’ compensation claims have risen dramatically, making it increasingly important for claims professionals to carefully evaluate this exposure and mitigate costs when possible. Optum Settlement Solutions understands that keeping up to date on new generic formulations is part of an overall strategic approach to reduce the cost of claims and ultimately the prescription allocation of a Medicare Set-Aside (MSA).

Every brand medication has a patent life that will ultimately expire. Once the patent expires, generic formulations become available on the market, typically at a lower cost. Although there is no set brand-versus-generic price differential upon generic entry, clinical analysis shows, on average, the generic has a 10% lower price at time of launch over its brand counterpart.

There were several brand name medications during 2016 and already in 2017, commonly prescribed in workers’ compensation claims, whose patents expired with their Food and Drug Administration (FDA) approved generic formulations released to the market.

Generics released in 2016 and first quarter of 2017:

Intermezzo (Zolpidem sublingual tablet): Sedative/hypnotic which is FDA approved for the treatment of insomnia. This is the only indication The Centers for Medicare and Medicaid Services (CMS) currently accepts for inclusion of Intermezzo (Zolpidem) in an MSA. Brand: $13.60/tab* Generic: $10.03/tab* (all strengths)

Frova (Frovatriptan 2.5mg): Central serotonin-receptor 1B and 1D agonist which is FDA approved for the treatment of acute migraine attacks with or without aura. This is the only indication CMS currently accepts for inclusion of Frova (Frovatriptan) in an MSA. Brand: $88.35/tab* Generic: $72.27/tab*

Nasonex (Mometasone Furoate 50mcg/actuation nasal spray): Medium –potency synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties which is FDA approved for the treatment of allergic rhinitis and allergic rhinitis prophylaxis. These are the only indications CMS currently accepts for inclusion of Nasonex (Mometasone Furoate) in an MSA. Brand: $16.74/gm* Generic: $15.07/gm*

Voltaren Gel 1% (Diclofenac Gel): Topical non-steroidal anti-inflammatory which is FDA approved for the treatment of osteoarthritis of the feet, ankles, knees, wrists, hands, and elbows. It is utilized most often in workers’ compensation claims for the treatment of inflammation and mild to moderate pain. While not FDA approved indications, CMS recognizes these as “medically accepted” indications for use on the body parts listed above and will include Voltaren Gel (Diclofenac Gel) in an MSA. It is considered to be utilized off-label when applied to other body parts such as the neck, shoulder or back and CMS will exclude this medication from the MSA. Brand: $0.49/gm* Generic: $0.54/gm* (Note: currently the generic formulation is more expensive, but as more manufacturers release their generic products the cost should become more competitive and decrease).

Nuvigil (Armodafinil): A psychostimulant which is FDA approved for the treatment of circadian rhythm disruption, narcolepsy, and sleep apnea. It is utilized most often in workers’ compensation claims off-label for daytime somnolence or fatigue due to the utilization of narcotic pain medications which is not recognized by CMS as an accepted indication (FDA or “medically accepted”); therefore, it would be excluded from the MSA for this diagnosis. Brand: 50mg, $8.86/tab, 150,200, & 250mg, $26.60/tab* Generic: 50mg, $7.26/tab, 150,200,250mg $21.86/tab*.

Seroquel XR (Quetiapine Fumarate Extended Release): Atypical antipsychotic which is FDA approved for the treatment of bipolar disorder, schizophrenia, and depression. These are the only indications CMS currently accepts for inclusion of Seroquel XR (Quetiapine Fumarate Extended Release) in an MSA. It is most often utilized in workers’ compensation claims for the treatment of depression. Brand: e.g., 200mg strength, $19.47/tab* Generic: 200mg, $15.52/tab* (Note: All strengths are available in generic formulation).

Pristiq (Desvenlafaxine Succinate): Serotonin-norepinephrine reuptake inhibitor which is FDA approved for the treatment of depression. This is the only indication CMS currently accepts for inclusion of Pristiq (Desvenlafaxine Succinate) in an MSA. Recently released in March 2017, no generic price available for comparison at this time.

*Current pricing based on lowest Redbook AWP

Generics to be released later in 2017:

Relpax (Eletriptan): Serotonin agonist which is FDA approved for the treatment of acute migraine attacks with or without aura. This is the only indication CMS currently accepts for inclusion of Relpax (Eletriptan) in an MSA.

Proair HFA (Albuterol Sulfate inhaler): Moderately selective short-acting beta -2 receptor agonist which is FDA approved for the treatment of acute bronchospasm and exercise-induced bronchospasm prophylaxis. These are the only indications CMS currently accepts for the inclusion of Proair HFA (Albuterol Sulfate) in an MSA.

Viagra (Sildenafil): Phosphodiesterase type 5 inhibitor which is FDA approved for the treatment of erectile dysfunction (ED) and pulmonary hypertension. CMS accepts the indication of pulmonary hypertension for inclusion of Viagra (Sildenafil) in an MSA; however, Viagra (Sildenafil) is Part D excluded for treatment of erectile dysfunction and would not be included by CMS in the MSA for this diagnosis.

Generics can help to lower the cost of the claim:

As healthcare expenditures continue to climb, the effect has been felt in the workers’ compensation industry. Generic medications play a key role in helping to lower costs. It is important, as an industry, we keep up to date on generic availability and intercede when necessary if generics are not being utilized by the treating physician. Optum, being a leader in the industry, has products and programs which can assist clients with managing and mitigating prescription drug costs. These include identification of claims where generic options are available (based on availability of data) and, when applicable, reaching out to the treating physician to discuss conversion to lower cost prescription drug alternatives.

For questions, please contact our Settlement Solutions Division at 888-672-7674 or contactus@helioscomp.com

CMS to Apply New Life Tables to WCMSAs as of 4/1/2017

The Centers for Disease Control and Prevention (CDC) recently released United States Life Tables, 2012 reflecting population estimates for 2012 of life populations. Beginning April 1, 2017, the Centers for Medicare and Medicaid Services (CMS) will be utilizing Table 1: Life table for the total population: United States, 2012 for Workers’ Compensation Medicare Set-Aside Agreements (WCMSAs) in regards to life expectancy.

The increases in life expectancy are minor. However, we suggest any previously prepared MSAs be reviewed prior to submission to CMS to verify if there is a change in life expectancy. At Optum, our knowledgeable staff can re-evaluate your MSA, if needed, to verify if there is any impact due to this change.

For questions, please contact our Settlement Solutions Division at 888-672-7674 or contactus@helioscomp.com

CMS Release
https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Workers-Compensation-Medicare-Set-Aside-Arrangements/Whats-New/Whats-New.html

New Life Tables
http://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_08.pdf

MSA Optimism for the New Year

The Centers for Medicare & Medicaid Services (CMS) announced the organization will be reconsidering a new policy in 2017 regarding re-reviews of otherwise approved Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) amounts. According to the CMS announcement, this new policy would only apply to claims “where settlement has not occurred.” As such, if settlement has been agreed upon CMS will not consider a re-review. The timing of any such change, however is yet unknown.

The Centers for Medicare & Medicaid Services recently revisited the task of reviewing its process for addressing requests for CMS to “re-review” otherwise approved Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) amounts. In Calendar year 2017, CMS expects to update its existing re-review process to address situations where CMS has provided an approved amount, but settlement has not occurred and the medical care that supported the approved amount has changed substantially. CMS also expects its updated process to address situations where certain states rely on Utilization Review Processes to justify proposed WCMSA amounts.

At present, CMS provides no formal appeal process. Rather, a one shot re-review process allowing submitters to provide new and different information not previously considered so long as the new and different information predates submission of the case to CMS. Employers, insurers and claimants are also unable to obtain revised MSA approval following a significant change in the claimant’s pre-settlement medical condition.

In addition, CMS will be issuing a policy regarding use of utilization review in MSA submissions in certain states where there is reliance on Utilization Review Processes (UR) to justify proposed WCMSA amounts. Currently, CMS generally recognizes California UR determinations as a limitation on medical care in the MSA if upheld through the statutory Independent Medical Review (IMR) process. Other state UR processes, however, have not been recognized as they are not considered by CMS to be final determinations.

While many states do not rely on UR processes to allocate MSAs, many stakeholders do rely on state law to justify a suggested MSA amount. Unfortunately, CMS policies do not always take into account the statutes used to adjudicate the underlying claim.

A revised MSA re-review process along with an accurate interpretation of state law will allow stakeholders to question the reasonableness of CMS’ counter-higher demands. Such changes will also give stakeholders the opportunity to provide the documentary support needed to explain their proposal and give MSP stakeholders a valid and meaningful appeals process with which to challenge proposed WCMSAs. Whether this announcement will eventually allow for a hearing or a neutral decision maker to review, or other administrative and judicial appellate rights, remains to be seen. Nevertheless, we are optimistic about the potential expansion of the CMS MSA Re-Review process where there has been a substantial change in medical care as this gives insurers, employers and claimants another opportunity to more appropriately settle workers’ compensation claims with open medical benefits. The ability to rely on applicable state statutes during the WCMSA process is similarly encouraging.

Will CMS raise the bar for Zero MSA Allocations?

For many years, the Centers for Medicare and Medicaid Services (CMS) would approve a zero MSA allocation if the submission met the following criteria, along with supporting documentation, was provided as proof thereof:

  1. The claim had been denied
  2. There had not been any
    1. indemnity payments
    2. paid medical expenses
    3. prior indemnity settlement

CMS announced today (11/1/2016), that effective immediately, the Workers’ Compensation Review Contractor (WCRC) will utilize procedures that were previously in effect in reviewing zero MSAs. Additionally, despite not specifically announcing plans to do so, there are indications that CMS may be re-evaluating an internal rule associated with denied and zero MSA allocations that is being misinterpreted. If pursued, the revisions stand to raise the bar for approval even higher. If implemented, CMS plans to use the following three-pronged test in order for a Medicare Set-Aside (MSA) to qualify for a zero allocation:

  1. The claim itself or the injury alleged had been initially denied in its entirety
  2. There has been no medical or indemnity payments for the claim or alleged injury, and no acceptance of ongoing responsibility for medicals (ORM) reported
  3. There has been either a final judicial determination after an evidentiary hearing on the merits eliminating the employer of responsibility, OR there exists medical records or documentation from the Medicare beneficiary’s treating physician indicating that no future treatment is anticipated.

Said another way, CMS may only approve a zero allocation if it can be determined that no compensable workers’ compensation claim exists, or no future medical expenses are anticipated, and no payments to the contrary have been made. You may ask, if I have one of the items listed above in number three, would I really need to have an MSA allocation at all?

There is no indication that zero MSA allocation changes will be a topic of discussion at the recently announced CMS Town Hall Teleconference scheduled from 1:00 to 2:30 p.m. EST on Nov. 17, 2016. The subject of the teleconference was listed as pertaining to: Ongoing Responsibility for Medicals (ORM) recovery, Final Conditional Payment (CP) process reminders, and Medicare Secondary Payer Recovery Portal (MSPRP) improvements. However, inquiry about zero MSA allocations may occur. To participate, you may call (800) 603-1774 and enter the pass-code: 987659 between 5-10 minutes before the event begins. For now, you may proceed as usual as CMS states it will publish any pending changes when or before they go into effect. Additionally, denied or zero MSAs are still being reviewed without a court order. However, if you have a zero MSA in the future, you may wish to:

  1. Submit treatment records from the treating physician demonstrating no further treatment for the claimed injuries/illnesses will be required
  2. Obtain, and provide CMS, a judiciary ruling after a hearing on the merits regarding the compensability of the claim
  3. Review and if applicable, proceed to finalize as a strict compromise settlement as defined by CMS guidelines rather than submit.

If you have questions, please contact Lavonya Chapman, Esq., RN, CMSP; Optum, Medicare Secondary Payer Compliance Counsel, Settlement Solutions, 813-612-5525, lavonya.chapman@optum.com.

*Note: CMS approval of zero MSAs is intended for commutation claims. You may wish to refer to the WMCSA Reference Guide to determine whether your claim is considered a “compromise” versus “commutation” type settlement. See § 4.1.1 of the Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide, version 2.5, revised 4/4/2016.