Appeal type: Lab
Decision: Favorable

We have decided to dismiss the Plan's request to reopen the case because it does not meet Medicare rules for a reopening. The Plan submitted their own physician review of this case in which they disagree with our decision. At issue is coverage for Myeloproliferative Neoplasm External Reflex Panel testing. The Maximus Physician Reviewer determined that the documentation supported that the requested testing was medically reasonable and necessary. Our physician reviewer found the enrollee had persistent thrombocytosis since 2018, and there was concern for a possible underlying primary bone marrow disorder, including Essential (hemorrhagic) thrombocythemia. The enrollee's hematologist wrote that step-wise testing (first JAK2 V617F with reflex exon 12 testing, followed by CALR and MPL testing if the first testing was negative) would be okay. LCD L36180 states that coverage for the genetic testing at issue is provided the genetic testing would impact medical management. The Myeloproliferative Neoplasm External Reflex Panel includes qualitative detection of JAK2 V617F, JAK2 Exon 12-14, CALR exon 9, and MPL exon 10. Testing proceeds by reflex through the four-step panel until a mutation is identified, when the result is considered informative and no further testing is performed.

Our Medical director says that the Plan requested a reopen stating the documentation did not support that the enrollee had a negative BCR-ABL test result, and that the enrollee would not meet WHO criteria for essential thrombocytopenia if JAK2 V617F were identified. Our Medical Director reviewed the case file, the reopening request, and the medical review. In this case, the requested service is the preapproval of the Myeloproliferative Neoplasm External Reflex Panel. For laboratories performing single gene technologies, a sequential genetic testing approach is expected. Once a positive result is obtained and the appropriate diagnosis is established, further testing should stop. Reflex testing to the next gene will be considered reasonable and necessary if the following sequence of genetic tests produce a negative result: BCR-ABL negative test results, progress to #2, JAK 2, cv negative test results, progress to #3 or #4, JAK, exon 12 (JAK2 exon 12 is only done when PV is suspected), CALR/MPL (CALR/MPL is only done when either ET or PMF is suspected; testing for CALR/MPL does NOT require a negative JAK2 exon 12, just a negative JAK2 V617F result)Step one of the panel requires a negative test result for the BCR-ABL mutation. The requested service that the plan denied was the performance of the reflex panel. Therefore, the BCL-ABL test has not been done completed because it is part of the panel. The Myeloproliferative Neoplasm External Reflex Panel is recommended. The Plan also argued that the enrollee would not meet the WHO criteria for essential thrombocytopenia if JAK2 V617F were identified and that the enrollee did not have a bone marrow biopsy. While the enrollee did not have a bone marrow documented in the record, a biopsy is not required for the Reflex Panel. Our Medical Director says that in conclusion, we find no evidence of error in this case and we are therefore dismissing the request to reopen. Our decision remains that the Plan has to provide coverage for Myeloproliferative Neoplasm External Reflex Panel for the enrollee.