Nancy Heidrich, BSN, RN, CDMS, MSCC
With the release of the WCMSA Reference Guide, Version 2.6 dated July 10, 2017; how is the WCRC actually applying these guidelines when reviewing a WCMSA? CMS noted 13 changes to Version 2.6 of the Guide. Three of these changes are addressed below.
The expanded state specific statute guidelines (Section 9.4.5) have changed the way CMS is reviewing the Independent Medical Review (IMR) in California. Since the Guide was released, we have seen CMS including provision for treatment that the IMR found not medically necessary and appropriate. In one case, the IMR Final Determination found gabapentin 800mg #90 per month not medically necessary and appropriate. WCRC included this medication in the Part D drug costs which over a 33-year life expectancy, added $102,287 to the MSA amount. In another case, the IMR final determination found lumbar transforaminal epidural steroid injections (ESI) not medically necessary and appropriate. WCRC included provision for three lumbar transforaminal ESIs noting these were included “per the treatment recommendations” in the medical records. Unless alternative treatment is provided specifically to the IMR reviewed treatment and would be acceptable through the IMR process, CMS is not considering the IMR and is including provision for the recommended treatment.
Based on another change to the Guide; the updated defined requirements for Spinal Cord Stimulator (SCS) pricing (Section 9.4.5); WCRC is now pricing the SCS per the state fee schedule or usual and customary charges depending on the state of jurisdiction. Previous versions of the Guide did not specifically address SCS pricing and the WCRC priced all SCS trials, replacements and reprogramming at a set amount. Regardless of the jurisdiction, an SCS trial was priced at $9,328, the SCS placement/replacement was priced at $30,274, and SCS reprogramming was priced at $222. A CMS determination letter provided in August 2017 priced the SCS replacement at $28,397 and the reprogramming at $76 which resulted in a counterlower. Another CMS determination letter provided in the same time period priced the SCS replacement at $59,368 and the SCS reprogramming at $86 which resulted in a counter-higher. It is apparent that WCRC has implemented this update and continues to do so
The updated off-label medication requirement (Section 188.8.131.52) introduces “Unlabeled Use of Drug” according to Medicare IOM (Internet-Only Manuals) 100- 02 Chapter 15 section 50.4.2 in addressing the off-label use of drugs. This version of the Guide states “Off-label use is when a drug is prescribed in a manner that is different from the FDA-approved product labeling… There are many off-label indications that are listed in recognized compendia and peer- reviewed sources; thus, they would be covered under the Part D Benefit, and should also be included in a WCMSA.” The previous version of the Guide stated “Off-label use is when a drug is prescribed in a manner that is different from the FDA-approved product labeling. There are many off-label indications that are listed in recognized compendia, and thus would be covered under the Part D Benefit, and so should be included in a WCMSA.” Now, CMS is taking peer- reviewed sources as well as an unlabeled use of a drug into consideration. “An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the carrier (emphasis added) determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.” We have yet to see a change in CMS determination letters specific to this update; however, this is something to watch. Will CMS include provision for a drug prescribed for an off-label use that previously was considered an off-label use not supported by compendia but was paid for by the workers’ compensation carrier? This will be interesting to see.