Policy Perspectives, December 2017
By Stephanie Farnia, ASBMT Director of Health Policy and Strategic Relations
“Winter is coming…” I have never seen Game of Thrones, but am told this phrase is an ominous bit of foreshadowing. In the slightly less bloody realm of healthcare policy, winter is instead a brief and welcome respite from the Medicare rule-making cycles that dominate the calendar between April and November. It also affords a bit of time to reflect on accomplishments of the year to date, prioritize issues left undone and start to develop plans to tackle those concerns.
My primary regret in the close of this year is having had to tell many of you that certain issues - of real importance to your programs - need to wait in queue behind other matters; as someone that has long asked members of the transplant community to consider problems of access and reimbursement, it is painful to know that not all can be addressed simultaneously. 2017 was the year of CAR-T from the reimbursement perspective and my hope is that 2018 allows me to re-integrate HCT concerns into the working agenda.
There are a number of significant updates since late October. Each of the following items and issues deserves its own long form discussion, but due to the constraints of the space time continuum, brevity will have to suffice.
- HR 4215: The NMDP/Be The Match has successfully introduced legislation in the House of Representatives that would require CMS to pay for HCT donor acquisition costs in the same way they utilize for solid organ transplant. The simple version of this is essentially pass-through payment of donor costs, calculated on a center-specific ‘reasonable cost’ basis each year. Now that legislation has been introduced, it is crucial to contact offices and ask them to move this forward. Please see the NMDP/Be The Match page on this issue for more information.
- Medicare Coverage of HCT for Lymphoma: As many of you know, there is no clear national Medicare coverage policy for lymphoma, leaving each center to attempt to try to gain coverage for individual patients when needed. The ASBMT and NMDP have been working on this jointly for the past several years. In July, Dr. Komanduri was asked to present to a group of Medicare Administrative Contractor (MAC) medical directors and shared information on the need for HCT as an option to treat lymphoma. In October, one regional contractor – National Government Services (NGS) - issued a Local Coverage Article supporting the use of HCT for certain lymphoma diagnoses. Please share with your financial teams, as the information is new and may not have been highlighted in contractor communications. For those of you outside of the NGS area, this is a great resource to utilize when requesting approval of patient cases through your own MAC. Resources: NGS Article A52879 and detail on the codes included on this NMDP/Be The Match reference sheet.
- Medicare Coverage of Leukemia Codes: The current National Coverage Determination (NCD) for HCT provides coverage for “…leukemia, leukemia in remission…” – phrasing that implies coverage for individuals with leukemia regardless of disease state - i.e. leukemia [without having achieved remission] and leukemia in remission. However, all coverage language is translated into billing codes for the purposes of claims processing, and the intent of the language may not always be retained in this process. In this case, when the diagnosis code set for the covered indications were converted from ICD-9 to ICD-10, an overly limited list of codes was created and programmed into the Medicare Code Editor. These edits resulted in denials when a patient claim was submitted with a code that read “leukemia, not in remission/without having achieved remission,” despite the broader allowance that the NCD language allows. The ASBMT and NMDP approached CMS about this issue in 2016, at which time the Coverage and Analysis Group said they would take it into consideration for future updates. In early November, CMS published a summary of changes to coverage coding tables that went into effect at the beginning of the FY 2018 year (October 1, 2017) and included updates to the coding table for the Stem Cell Transplantation NCD (110.23). The updates clarified that codes for leukemia subtypes not having achieved remission are covered and also added codes for polycythemia vera and CLL BCR/ABL-positive. As with all things on the CMS website, It is a bit complicated to get to the reference documents for these issues. Start with the MLN Matters article (MLN10086), click on the link to the NCD spreadsheets at the end of the bulleted list of changes, open the zip file and look for the spreadsheet corresponding to NCD 110.23. There are several tabs that allow you to then look more closely at CMS’s interpretation of the codes which should be allowed to pass through the code editor.
- The ASBMT Recommended Coding Guidance document can be found on the website. Thank you to the 300+ of you that joined us on our recent webinar to explain this effort.
- The Novartis product, Kymriah, was granted a Q code by CMS that can be used in the outpatient setting for provision of the product. Note that the code includes payment for leukapheresis.
- Two additional letters were submitted to CMS and CMMI requesting new solutions to the reimbursement issues associated with the provision of CAR-T to Medicare beneficiaries in the inpatient setting. Copies can be found on the Advocacy Archive page and are considered to be public documents. ASBMT representatives met with CMMI staff on November 27 to discuss the potential for a model that would allow for site-neutral separate payment for CAR-T products. More discussion will be forthcoming.
- While we are not at liberty to discuss details, the ASBMT has submitted requests to the American Medical Association for new CPT codes to describe the procedural aspects of CAR-T. Presentation of the applications will take place in early February. The codes would not be effective until 2020 due the coding approval and update cycle.
CMS Rule Making: As it is the holiday season, I will give you the gift of not discussing the finalized CMS rules for the Quality Payment Program, the Physician Fee Schedule and the Outpatient Prospective Payment System until January.
For those of you that will be attending ASH, I’ll keep an eye out for you. I will never be as twitter-prolific (twitterific?) as @BldCancerDoc or @DrMiguelPerales, but will share key reimbursement and policy information as I can. @HCT_Policy
I have greatly enjoyed my first full year with the ASBMT and I am thankful for the first-hand view into the passion and commitment you bring to your work. I wish all of you a peaceful holiday season and will look forward to more partnership on these issues in 2018.