Success in the CMS Re-Review Process

Pursuant to Section 16.0 of the Workers’ Compensation Medicare Set Aside (WCMSA) Reference Guide, Version 2.8, October 1, 2018, COBR-Q4-2018-v2.8, CMS will conduct a Re-Review of a prior WCMSA determination in certain circumstances.  Specifically, CMS will complete this process in cases involving a mistake in the allocation; mathematical error; or when there is missing documentation that pre-dated the WCMSA submission date that could change its value.  CMS will also perform an Amended Review when there are changes to the WCMSA that post-date CMS approval and the case meets certain criteria.  Knowing when and how to use the appropriate Re-Review process is imperative in helping to prevent inaccurate or over-inflated WCMSAs.

One recent example of NuQuest successfully utilizing the appropriate Re-Review option involved an appellate court order that was issued after the date of the WCMSA submission.  The case involved whether claimant required ongoing treatment for a work-related lumbar spine injury.  The appellate court determined that the description of injury was an aggravation of a lumbar sprain and claimant’s intervening injuries as well as a gap in treatment evidenced that claimant’s work injury had resolved.  Highlighting the timeline of the appellate process; the court’s rationale; medical evidence; and the nature of injury, NuQuest was able to successfully advocate for a zero dollar WCMSA.  This resulted in over an $18,000 savings to the client.

Critical review of a WCMSA to determine if a Re-Review is warranted is a necessary part of the Medicare compliance process.  However, identifying these issues is only one part of the equation.  Knowing the appropriate arguments to include in a Re-Review as well as the appropriate mechanism to make this request is equally important to obtain a successful result.

For further information regarding WCMSAs or any Medicare compliance needs, please contact the NuQuest Legal Team.

THE WHITTLING AWAY OF CMS OFF-LABEL USAGE ARGUMENTS IN THE WCMSA

With the transition to the new Workers’ Compensation Review Contractor (WCRC), the industry is seeing many changes in the Workers’ Compensation Medicare Set-Aside (WCMSA) review process. One of the biggest changes has been the shift from excluding Lyrica from the WCMSA when it is being prescribed for an off-label use to the inclusion of this medication regardless of usage guidelines.

Pursuant to the Food and Drug Administration, Lyrica is clinically indicated for diabetic peripheral neuropathy, post-herpetic neuralgia, partial onset of seizures, fibromyalgia and neuropathic pain associated with spinal cord injuries. However, Lyrica is highly prescribed in the Workers’ Compensation arena to treat pain complaints associated with industrial injuries.

Effective June 1, 2009, CMS began including Part D covered drugs in WCMSAs even if they were being prescribed for an off-label use.   As a result, many claims were not able to resolve due to the exorbitant price of medications.  However, on May 14, 2010, CMS issued a memorandum stating in pertinent part as follows:

“[C}overed Part D drug” is “a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) . . .” of 42 U.S.C. section 1396r-8(k)(2). 42 U.S.C. Section 1395w-102(e)(1)(A). For a Part D drug to be covered by Medicare, and thus included properly in a WCMSA, the drug should be prescribed for an outpatient use that is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.], or supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(I) of 42 U.S.C. Section 1396r-8.”

This off-label exclusion became effective on June 1, 2010, allowing drugs such as Lyrica to be removed from the WCMSA when they were not prescribed for clinical usage as outlined by the Food and Drug Administration and medical drug compendia.  For over 7 years, the Medicare compliance industry, insurers, employers, claimants and counsel have relied on the exclusion of off-label drugs when settling claims and submitting WCMSAs to CMS for review.

However, without notice or warning, CMS has now started including Lyrica in some WCMSAs raising the cost of these allocations by hundreds of thousands of dollars.  As support for this inclusion, CMS has relied on Section 9.4.6.2 of the WCMSA Reference Guide which states in pertinent part 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.

CMS is now including Lyrica in the WCMSA when it has been paid for as part of the claim.  This is contrary to its post-2010 submission review policy.  Since 2010, CMS has not considered payment of Lyrica as a basis for inclusion of the medication in the WCMSA.  Even when payment screens evidenced multiple years of payments, CMS would allow the parties to exclude this medication if it was being prescribed for an off-label use.  CMS is now not only scrutinizing prior payments of Lyrica, but is also whittling away at off-label usage arguments for other prescription medications as well.

As a result of this shift, primary payers are once again being faced with the unknown when it comes to CMS submissions and medication costs.  Because CMS allocates medications for the beneficiary’s entire life expectancy without taking into account usage guidelines, inclusion of these medications could once again preclude settlement.

Understanding CMS trends, reducing drug exposure prior to submission of a WCMSA, or utilizing an evidence based non-submission process are some ways to mitigate prescription drug costs.

For questions regarding this article or for further information on NuQuest services, please contact Bridget Smith, JD at  bsmith@mynuquest.com

What’s New in the New WCMSA Reference Guide 2.8

On October 1, 2018, the Centers for Medicare and Medicaid Services (CMS) issued the latest version of the WCMSA Reference Guide, COBR-Q4-2018-v2.8.  The Guide includes updates regarding the discontinuation of Social Security numbers as  a Medicare identifier; a link to the applicable CDC Life Table; and further illustrations for determining the jurisdiction and pricing methods for a WCMSA.

As required by Section 501 of the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act (MACRA) of 2015, CMS is required to discontinue utilizing Social Security Numbers (SSNs) as Medicare identifiers and must distribute new 11-byte Medicare Beneficiary Identifier (MBI) cards to each Medicare beneficiary.  Distribution of these MBI cards began in April 2018.  As noted in the new Reference Guide and prior CMS publications, the distribution must be completed by April 2019. In addition, fields that were formerly labeled as “HICN” have now been relabeled as “Medicare ID. ” CMS noted that it can now can accept either HICN numbers or the new MBI numbers for beneficiary identification.

In prior versions of WCMSA Reference Guide, CMS delineates how to determine the correct jurisdiction for the WCMSA.  The new Reference Guide does not change this analysis and, instead, includes additional illustrations to further clarify this process.  This illustration can be found in Table 9-1 of the Guide.  In addition, in Table 9-2, CMS delineates the appropriate pricing methodology to utilize once the jurisdiction has been determined.  Specifically, CMS notes that for cases filed with the U.S. Department of Labor Office of Workers’ Compensation Programs (OWCP), pricing is based upon the OWCP Fee Schedule; for Longshore Harbor Workers’ Compensation Act settlements, pricing is based upon the Office of Workers’ Compensation Programs fee schedule for the zip code of claimant’s residence, unless actual charges are specified; for jurisdictions with a workers’ compensation fee schedule, the most current version of the fee schedule will be used; and for jurisdictions that do not have fee schedules, pricing is based upon actual charges.

The new WCMSA Reference Guide can be found here at https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Workers-Compensation-Medicare-Set-Aside-Arrangements/Downloads/WCMSA-Reference-Guide-Version-2_8.pdf

Gucwa v. Lawley: Injured worker and attendant care provider did not demonstrate standing in their complaint to sue under Medicare Secondary Payer Act (“MSP”).

On 4/16/2018, the United States District Court of Appeals for the Sixth Circuit ruled that a workers’ compensation carrier did not have to reimburse an injured worker or attendant care provider for double the amount of payments of medical expenses made by Medicare under the MSP. Gucwa v. Lawley, 2018 U.S. App. Lexis 9428 (4/16/2018, 6th Cir.). The Court ruled the injured worker, and attendant care provider did not demonstrate standing in their complaint to seek reimbursement for from the workers’ compensation carrier under the MSP.

Standing is one among other requirements that must be demonstrated by a plaintiff in Federal Court in order for the Court to have authority over the parties and case. The plaintiff must show that they were in fact injured by the other party. There are a few federal laws that allow a person to sue on behalf of the government where the person suffered no injury at all, called whistleblower laws or qui tam statutes. The MSP is not, however, one of those statutes.

In the circumstances of this claim, Nancy Gucwa provided attendant care treatment to an injured worker, Mark Marusza, related to a workers’ compensation claim and sought payment from the workers’ compensation carrier. The workers’ compensation carrier disputed payments after obtaining favorable independent medical examinations. Medicare paid allegedly $15,665.00 in charges for Mr. Marusza’s treatment costs. The workers’ compensation claim went to trial, and a workers’ compensation judge ruled that claimant’s medical expenses should have been paid for by the workers’ compensation carrier.

After the workers’ compensation decision, Marusza and Gucwa filed an amended complaint in District Court alleging violations under various state and federal laws but also alleged double damages under the MSP for the expenses paid by Medicare. The District Court dismissed the complaint because Marusza or Gucwa did not demonstrate a concrete injury as a result of the carrier’s non-payment.

Marusza and Gucwa appealed the dismissal and provided the District Court with a demonstration of financial injury by stating that Marusza made for co-payments made to Medicare for Gucwa’s treatment in a request for reconsideration. However, because the copayment information was not a part of the original or amended complaint, the District Court continued to uphold its dismissal. Marusza and Gucwa appealed this decision to the Sixth Circuit Court of Appeals.

Although a party may bring a suit on behalf of the federal government under the MSP, the Sixth Circuit Court of Appeals stated in Gucwa that the federal law is not a qui tam statute and the plaintiff must also demonstrate injury. This means that where payments are made by Medicare that may require reimbursement under the MSP, the Sixth Circuit Court held a person suing on behalf of the government must also demonstrate an injury due to Medicare making payments.

The Court of Appeals agreed that the plaintiff did not demonstrate in their complaint that there was a financial or concrete injury suffered by Marusza or Gucwa as a result of Medicare making payments for the attendant care services. Although the plaintiff’s tried to bring in additional allegations of co-payments after dismissal, the Sixth Circuit noted no supporting documentation was provided with the allegation copayments. The Sixth Circuit Court of Appeals was not persuaded the additional allegations warranted an exception to the general law that arguments raised the first time in a motion for reconsideration are untimely and forfeited on appeal.

This case does not speak to the requirements or legal aspects of the MSP. Instead, this case demonstrates a plaintiff’s failure to allege financial injury in a suit under the MSP can lead to a dismissal, which is a universal legal principle.