CMS Issues a Revised WCMSA Reference Guide and Section 111 User Guide

The Centers for Medicare and Medicaid Services issued a revised WCMSA Reference Guide (Reference Guide), Version 2.9, which can be found here: WCMSA Reference Guide.  In addition to changes to development and alert templates; references to removal of certain memorandum from cms.gov; and reference to the updated CDC Life Table, the Reference Guide also includes updates to Spinal Cord Stimulators (SCS), and the inclusion of Lyrica, Trazodone and other off-label drugs in an MSA.

Section 1.1 of the Reference Guide state as follows:

  • To eliminate issues around Development Letter and Alert templates auto-populating with individual Regional Office (RO) reviewer names and direct phone numbers, these will now display the generic “Workers’ Compensation Review Contractor    (WCRC)” and the WCRC customer service number “(833) 295-3773” (Appendix 5).
  • Per CMS’ request, certain references to memoranda on cms.gov have been removed.
  • The CDC Life Table has been updated for 2015 (Section 10.3).
  • Updates have been provided for spinal cord stimulators and Lyrica (Sections 9.4.5 and 9.4.6.2).

With respect to SCS, Section 9.4.5 now includes the following language:

Routine replacement of the neurostimulator pulse generator includes the lead implantation up to the number of leads related to the associated code. Revision surgeries should only be used where a historical pattern of a need to relocate leads exists…

Surgery pricing may include physician, facility, and anesthesia fees. SCS pricing is based on identification of: 1.) Rechargeable vs. Non-rechargeable and 2.) Single vs. Multiple Arrays (leads). If unknown, CMS will default to non-rechargeable single array.

This pricing methodology outlined by CMS is consistent with recent CMS approval trends.

In addition, traditionally excluded from MSAs based upon off-label usage arguments, CMS has recently included Lyrica in certain allocations.  The new Reference Guide specifically addresses off-label usage arguments with respect to Lyrica as follows:

Example 1: Lyrica (Pregabalin) is cited in MicroMedEx for an off-label medication use related to neuropathic pain from spinal cord injury, and a number of scientific studies indicate that Pregabalin shows statistically significant positive results for the treatment of radicular pain (a type of neuropathic pain). Spinal cord neuropathy includes injuries directly to the spinal cord or its supporting structures causing nerve impingement that results in neuropathic pain. 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.

The language above utilized by CMS for the inclusion of Lyrica in the MSA may be an indication of things to come not only with respect to more and more allocations including this medication, but inclusion of additional off-label medications that were previously excluded from the MSA. A second example in the Reference Guide describes circumstances in which Trazodone will be included in MSAs.

In addition to the new WCMSA Reference Guide, CMS has also issued a new Section 111 NGHP User Guide (Guide).  The updated Guide includes the confirmation that the review threshold for reporting in 2019 will remain $750 for liability insurance settlements, judgments awards or other payments and $750 for no-fault and workers’ compensation claims where there is no ongoing responsibility for medicals (ORM) that was previously posted by CMS.  The Guide can be found here – Full Guide for further review and reference.

NuQuest will continue to keep you apprised of further Medicare compliance developments as they become available.

 

CMS and Medicaid to Convert to CDC 2015 Life Table

The Centers for Medicare and Medicaid Services has announced that it will convert to the CDC’s “Table 1: Life Table for the total population: United States, 2015“ for Workers’ Compensation Medicare Set-Aside life expectancy calculations.  The change to the updated life table will become effective as of January 5, 2019.  There is a slight increase in life expectancy reflected in the new table and in some circumstances this may decrease WCMSA calculations.  All WCMSAs should reflect the updated life table changes from January 5, 2019 and ongoing.

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

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

 

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