By Stephanie Farnia, ASBMT Director of Health Policy and Strategic Relations
Eclipses & Ellipses…
It has been a much busier summer in the health policy world than usual – multiple comment periods for CMS proposed annual policy rules, uncertainty around the Affordable Care Act repeal efforts and a couple of ‘out of left field’ issues I’m blaming on eclipse-driven zaniness. In large part, summer in the policy area is always reactionary – anticipating proposed rules and responding as needed when they are released – but this year felt particularly so. As we move into Autumn, efforts traditionally shift to implementation of policy changes clarified in the final rules, as well as strategic planning efforts around new or continued areas of concern. I welcome that shift this year in particular and hope that the eclipse marked the beginning of a new cosmic alignment that bodes well for collaboration and partnership in health care. (At this point, I’ll grasp at any straws I can dream up!) There are numerous updates to share this month; I will divide them up between HCT and CAR T for easy future reference.
Medicare and HCT
Thanks to your outreach efforts, the HCT community was able to prevent a proposed change to the logic that CMS uses to assign claims to MS-DRGs for the Inpatient Prospective Payment System. The change was of a technical nature – correctly recategorizing HCT as a “Non Operating Room” procedure – but would have greatly impacted the payment rates for autologous and allogeneic HCT. CMS issued the following response in the Final Rule issued in August: “We acknowledge the concerns of the commenters. We agree that it is important to maintain the current Pre-MDC logic for these procedures while also appropriately designating them as non-O.R. procedures. After consideration of the public comments we received, we are finalizing our proposal to change the designation for the 20 ICD 10–PCS procedure codes listed in Table 6P.4o. associated with the proposed rule and this final rule from O.R. procedures to non-O.R. procedures, effective October 1, 2017, and maintaining their assignment to the Pre-MDC MS–DRGs 014, 016, and 017 for FY 2018” (p. 92 of the FY2018 Final Rule). This will sound like gibberish to many of you, but please feel good in knowing that it translates to no negative change in reimbursement.
While avoiding a loss on the MS-DRG payment was a successful demonstration of our defensive skills, there is much more to do in terms of seeking improved reimbursement for transplant. The National Marrow Donor Program/Be The Match has been working on that issue for several years now and is advancing legislation through Congress that asks for parity between solid organ and HCT in terms of Medicare payment policies. In an era where almost no issues have bipartisan support, this does. Please read the newsletter item on this issue and and share this page HCT and Government Affairs teams.
The Quality Payment Program (aka MIPS, MACRA) recently held its open comment period for the second year of the program. While most HCT clinician teams will not feel great impact from QPP in the next few years, quality-based payment programs will not be disappearing any time soon. ASBMT submitted a brief comment letter in regard to key aspects of the proposed rule and welcomes your individual thoughts on areas for improvement as you become more involved with the program.
Finally, as we highlighted in a column a few months ago, HCT physicians will now be able to formally identify as Hematopoietic Cell Transplant and Cellular Therapy (HCTCT) physicians within the CMS system for purposes of billing. This status essentially affords you additional options for billing specialty care and will be helpful in allowing CMS to compare a true peer group when it begins evaluating cost and quality. We will issue more detail on the specific benefits of using this designation in your billing practices in a future newsletter. In the meantime, start work on signing yourself up as a HCTCT physician prior to October 1. A CMS reference document can be found here and some specific advice from a CMS representative is as follows:
“The new specialty codes will be effective October 1, 2017 and can be utilized as valid primary specialty codes or a secondary specialty code. The Provider Enrollment Chain and Ownership System (PECOS) shall make the necessary changes to recognize and use the new physician specialty codes. You can submit the CMS-855I and CMS-855O applications using the ‘Undefined Physician Type’ option and write in the specific specialty until the forms can be updated with the new specialty. For any “new” submissions for the C9, complete the application via PECOS or paper application. For existing providers who are currently practicing Hematopoietic Cell Transplantation and Cellular Therapy, you can submit a change of information for those providers. If a provider has more than one specialty, it can be listed as a secondary specialty. For anything related to the application submittal process, please contact your local Medicare Administrative Contractor.”
(I put this in a separate paragraph to give you enough room to print it, cut it out and tape it to the monitor of your program administrator’s computer – advisably alongside a coffee gift card or candy bar of choice. This is where the first ellipses come in, as the implementation of this change sounds relatively straightforward, but only time will tell…)
CAR T Reimbursement Policy Updates
As I mentioned earlier, a significant amount of my time and focus over the last few months has been shifting to CAR T – trying to understand the reimbursement models and predicted impact on centers, working on applications for new codes your teams will need in the near future and providing input into discussions being had by payers and other national organizations. While busy, it has been a tremendously exciting time and a chance to put many of our HCT lessons to good use.
Approval Timing and Reimbursement Concerns: As most of you know, FDA approval for Novartis’s CTL019 is expected sometime in September and approval for Kite’s AxiCel could come anytime before December. The treatment populations are very different between the products and have accordingly dissimilar payer implications; Kite’s product will face Medicare hurdles and Novartis will need to navigate Medicaid on a state-by-state basis. We will be sending a letter into CMS in a few weeks outlining our concerns with the expected reimbursement structure and asking them to consider payment policy alternatives where possible. The other major ellipses in this area is pricing of the products – estimates run from $250,000 to upwards of $650,000, all of which will have substantial repercussions for the health care system…
As some of you already know, the Institute for Clinical and Economic Review (ICER) has announced that it will be conducting an analysis of the “comparative clinical effectiveness and value” of the first two CAR T products. The process is clearly outlined on the ICER website and there are several opportunities for public comment. ASBMT has submitted a public comment letter, which can be read here.
Finally, the new ICD-10-PCS code for CAR T will go into effect on October 1, 2017. We will remind you when the time comes, but please feel free to share this code with your billing teams now . Kite requested the development of these codes from CMS last Winter, but new ICD-10 codes are payer- and product-agnostic, meaning the new CAR T codes can be used with all payers and for all CAR T products. Caveat: check with your commercial payers in terms of their use and acceptance of this code, as always.
XW033C3: New Technology, Introduction via Peripheral Vein; Engineered Autologous Chimeric Antigen Receptor T-cell Immunotherapy
XW043C3: New Technology, Introduction via Central Vein; Engineered Autologous Chimeric Antigen Receptor T-cell Immunotherapy
And with that, a hectic summer of policy initiatives comes to a close. Next month, look for updates on ASBMT’s submitted comment letters to CMS regarding the proposed Physician Fee Schedule and Outpatient Payment System rules, as well as a recap of our planned September 7 ASBMT/NMDP Legislative Day.
CAR T approval and Tocilizumab approval for CRS treatment
Many of you will have already seen the approval notice for Novartis’s CAR T product; FDA approval letter can be found here: http://ow.ly/JFrp30eN9DS. It includes post-market surveillance requirements and states that labeling needs to be specified on the website within 10 days. Pricing is set at $475,000 and tied to one month response (more info needed). http://ow.ly/3y0230eN9z3
One item that is easy to miss is that Actemra/Tociluzimab has also been approved for on-label use for treatment of CRS. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf.
Read the entire September 2017 ASBMT eNews here.