Office of Management and Budget Issues Proposed Rulemaking Regarding MSP Compliance Options

Under the title “ Miscellaneous Medicare Secondary Payer Clarifications and Updates,” the Office of Management and Budget issued proposed rulemaking to address Medicare Secondary Payer obligations in the context of automobile and liability insurance, no-fault insurance and workers’ compensation recovery.  The abstract of the proposed rule states as follows:

“This proposed rule would ensure that beneficiaries are making the best health care choices possible by providing them and their representatives with the opportunity to select an option for meeting future medical obligations that fits their individual circumstances, while also protecting the Medicare Trust Fund. Currently, Medicare does not provide its beneficiaries with guidance to help them make choices regarding their future medical care expenses when they receive automobile and liability insurance (including self-insurance), no fault insurance, and workers’ compensation settlements, judgments, awards, or payments, and need to satisfy their Medicare Secondary Payer (MSP) obligations.”

Although there is no legal deadline listed as part of the posting, the timetable for the Notice of Proposed Rule Making is September 2019.   NuQuest will continue to monitor the proposed rulemaking process and will provide updates as they become available.  Should you have any questions regarding the above or need any Medicare compliance assistance, please contact the NuQuest Legal Team.

For more information, go to: https://bit.ly/2QCe6d

 

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.

NuQuest’s Diligent Monitoring of CMS Determinations Results in a Successful Re-Review and MSA Reduction

Pursuant to Section 9.4.6.1 of the WCMSA Reference Guide, version 2.8, prescription medication pricing is based upon the Average Wholesale Price (AWP) of the drug with generic drugs being priced at the lowest non-repacked AWP rate.  In accordance with WCMSA pricing guidelines, NuQuest submitted a WCMSA utilizing the lowest AWP price for a prescribed generic medication.  CMS thereafter issued an approval letter increasing the price of the medication by approximately $17,000.  After a critical review of the CMS determination by the NuQuest medical team, it was found that CMS did not follow the protocol outlined in Section 9.4.6.1 of the Guide and, instead, priced the generic medication at a much higher rate.  NuQuest thereafter filed a Re-Review outlining the mistake in pricing. CMS agreed with the Re-Review and issued a new approval letter including our original pricing for the medication.

This case not only illustrates the importance of understanding WCMSA guidelines, but also the need to critically review CMS determinations to make sure these guidelines are followed.  Failure to do so can result in increased WCMSA costs and missed opportunities for WCMSA reductions.  NuQuest will continue to advocate for clients throughout the WCMSA process to help ensure CMS protocols are followed.  Should you have any questions or need further information on our MSA services, please contact NuQuest at (866) 858-7161.

Medicare Open Enrollment and its Potential Impact on Conditional Lien Recovery

The Medicare Open Enrollment Period or Annual Election Period runs each year from October 15 to December 7. During this period, Medicare enrollees can make changes to their current Medicare plan to best suit their needs for the upcoming year.  Medicare beneficiaries can: elect to enroll in a new Medicare Advantage Plan (MAP); switch to or from a MAP and original Medicare; change or enroll in Part D prescription drug coverage; or opt out of Part D coverage altogether.

Changes made during this open enrollment period can have a significant impact on primary payers and their conditional lien recovery efforts.  Because a beneficiaries’ Medicare plan coverage can change from year to year, primary payers may have multiple lienholders asserting recovery rights on one claim. Failure to identify these lienholders can lead to potential exposure down the road.

It is important to have a formal policy and procedure in place for MAP lien recovery in addition to traditional Medicare Part A and B lien resolution. Decide when and how MAP liens will be addressed in the claims process and who will be responsible for obtaining lien information. Once this step has been taken, it is important to create clear policies and procedures that reflect these internal decisions.

Because MAP lien enrollment can change from year to year, identifying potential lienholders can be a challenge. Unlike traditional Medicare, there is no central lien recovery portal to identify MAPs and lien amounts.  As such, it is important to consider other ways to obtain this information.  Utilizing the discovery process through well-crafted interrogatories to address MAP enrollments and production of documents requests to obtain copies of Medicare card(s) is one way. If the case is not in litigation, claims questionnaires can be crafted to request this information and documentation.  A review of medical bills can also identify various lienholders.

Further, drafting appropriate settlement language identifying all lienholders and how liens will be satisfied is also an important part of managing potential lien recovery risks. Although Medicare is not bound by the parties’ settlement language, the settlement does bind the parties.  Clear language in the settlement over this issue also can avoid confusion between the parties as to who is negotiating or reimbursing the payments.

In sum, Medicare Open Enrollment time is a good time to review internal policies on lien resolution. It is also a reminder to update claims files with any changes to Medicare/MAP enrollment that may be taking place as of January 1.

For further questions regarding the above or for help in your lien recovery 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