This article appeared in the June 2018 issue of ASBMT eNews. Download the full issue in PDF format here.
By Stephanie Farnia
We all have mental associations with summer — school being out, trips “up north” (as we like to say here in Wisconsin), ice cream, the sound of the lawn mower and so much more. My summer days center around early morning rows on Lake Mendota in Madison, Wisconsin, evening neighborhood chats after a long winter of not seeing each other and, unusually, hours crafting responses to the CMS proposed rules. Summer is rule season in the regulatory world — IPPS, OPPS, PFS, QPP (if you ever find yourself in a bizarre game of Federal Agency Wheel of Fortune, always choose a “P” for your free letter).
As noted in the last column, we are preparing comments to submit to CMS before the June 25 deadline. We plan to continue our requests to CMS to reimburse for the costs of donor acquisition for HCT cases, and we are closer to choosing our preferred option among those proposed by CMS for CAR-T reimbursement. We will distribute key information the week of June 11 for your use in finalizing your own program or individual letters.
To add to the summer regulatory flurry, CMS recently issued a National Coverage Analysis for CAR-T. There are several potential concerns with this, and we plan to discuss them in a comment letter before the initial comment period ends on June 15. Please see our ASBMT communication on the issue for more details and look for more information to come. We encourage providers and centers to send in comments as well; CMS specifically noted they were undertaking the NCA process because, “To date, few Medicare patients have been studied and follow up has been limited.” Comments and clinical references on these points would be helpful.
Finally, there were two very important coding meetings that happened in May. First, the CMS HCPCS meeting was held on May 16 and included discussion of two Q codes (outpatient drug codes) for axicabtagene ciloleucel and tisagenlecleucel, respectively. ASBMT attended the meeting and presented comments encouraging CMS to separate the apheresis/cell harvest procedure, which is currently included in the coding definition, from the drug itself. ASH, the College of American Pathologists and several other commenters also attended and expressed their concerns. We are optimistic about changes being made, but we will not know the official CMS position until later this year. In the interim, we have encouraged CMS to issue guidance on the concerns we have shared with them. We will continue to track this and share more information as it becomes available. Second, Dr. EJ Shpall, a past-ASBMT president from MD Anderson Cancer Center, represented the society during our request for new CPT codes for CAR-T. We are unable to share information about the meeting until it is officially posted on the American Medical Association website, but Dr. Shpall should be commended for her great efforts in presenting this new set of therapies to the CPT Editorial Panel for review and discussion (and for sitting in the committee meetings for 15 hours before our topic was called).
This will be an intense few months of activity, and I will likely be sequestering myself for the month of June to get the NCA and IPPS comment letters completed before the next round hits in early July. Please be patient with my reply time during this period. I think Frozen’s Olaf said it best (or rather, sang it best), “When life gets rough, I like to hold on to my dream of relaxing in the summer sun just lettin’ off steam! In summer!”