News

This article appeared in the May 2018 issue of ASBMT eNews. View the full issue in PDF format here.

When I am crunched for time, I make lists. As the Centers for Medicare and Medicaid Services (CMS) Inpatient Prospective Payment System (IPPS) FY2019 Proposed Rule came out on April 24 and is chock-full of issues that impact our field, I am most definitely crunched for time — meaning that this month, we have a “listicle” update for you from the policy team at ASBMT.

Here are the primary items to know about the proposed rule and what sections and specifics relate to HCT and CAR-T therapies.

Logistics of the Medicare FY2019 IPPS Proposed Rule

1. Where you can read the rule:
   • The main file is “CMS-1694-P” and is approximately 1,800 pages long. Use the “Find” feature and search for keywords of interest. (Only the really fun-loving of us read the whole thing.)
   • FY2019 Data Files – There are several files of interest in this set that I review each year. Table 5 reports the weighting proposed for the DRG and the mean length of stay (LOS), and Table 7A_7B provides the number of discharges and percentiles for LOS.
   • FY2019 Proposed Rule Data Tables – Most of the data tables are very technical, but the data enthusiasts among you will enjoy the AOR/BOR file, which contains detailed information on the claims used for rate-setting. See if you can find the arithmetic mean for MS-DRG 014 (and $2.5 million maximum charge case) based on the rate-setting file.
2. Any proposals discussed in this rule are not considered final.
   • CMS will review comments after the close of the comment period.
   • A final rule will be issued sometime in late July/early August.
   • Provisions in the final rule go into effect on October 1, 2018.
   • Changes made to reimbursement practices will not be retroactive.
3. Comments are due by June 25 and can be submitted at regulations.gov (search for CMS-1694-P or go directly to this link). The staff at CMS read all submitted comments (yes, they really read every single one).
   • Your opinion matters (again, really). Share your concerns and ask for clarification if you have questions. Tell CMS about your work, your patients and your thoughts on the rule.
   • Talk to the government affairs or relations team at your center and ask for an opportunity to share your thoughts as they prepare your institutional letter.
   • File an individual comment letter even if your institution will be incorporating your comments into their formal document. You can reference talking points that will be distributed by ASBMT later in May or simply share the discussions happening at your program about Medicare reimbursement. If there is something in the proposal that you see as positive, please thank them for incorporating it. The staff at CMS are asked to make very difficult decisions, often with extremely limited time, resources and data.
   • Bonus activity: Print out your submitted comment, hang it on the fridge and bore your children or significant other by lauding your civic participation. It’s the IPPS equivalent of wearing an “I Voted” sticker.

What you need to know about the proposed rule:

HCT Provisions within the Medicare FY2019 IPPS Proposed Rule

1. CMS did not make any changes to the reimbursement structure for Allogeneic HCT, despite ongoing requests for separate payment for donor acquisition charges. It is important to let CMS know in your comments that the reimbursement for AlloHCT is still inadequate and that it is disappointing that the rule did not contain proposed changes. The NMDP/Be the Match continues to advance HR 4215, legislation that would require reimbursement for donor acquisition costs in addition to the MS-DRG payment. HR 4215 has many sponsors in the House, but very much needs a Senate champion. Contact me (sfarnia@asbmt.org) if your program has a relationship with a congressional office that would like to help with this cause.
2. Approximate proposed base payments for HCT for FY2019 can be calculated from the rule. The approximate dollars per unit is $5,498, and the approximate base weights and estimated reimbursements are below. Center-specific payment varies based on a number of factors including location and academic teaching hospital status. Talk with your financial team if you want a more personalized number. These payment rates apply only to hospitals paid by the PPS system; DRG-exempt centers are reimbursed via the methodology outlined in the applicable legislation, per usual.

CAR-T Provisions within the Medicare FY2019 IPPS Proposed Rule

1. CMS proposed a significant number of changes to CAR-T coding and reimbursement. These proposals reflect the requests made by ASBMT on behalf of our members. The types of changes CMS proposes are extremely rare and should (somewhat cautiously) be considered a very positive reflection of the collective advocacy by ASBMT members on this issue.
2. CMS issued clarification that the ICD-10-PCS codes (XW033C3, XW043C3) can be used with both approved products when administered in the Inpatient setting. See page 106 of the CMS-1694-P PDF file for detail.
3. CMS responded to the applications for participation in the New Technology Add-on Payment program made by Novartis and Kile/Gilead for their CAR-T products. The comments by CMS can generally be viewed as supportive. CMS is supposed to act as a gatekeeper of the NTAP funds by being stringent about qualification criteria, so they will always note ways in which technologies may fall short. The questions CMS has noted will be reviewed by the ASBMT Committee on Cellular Therapy and incorporated into the final comment letter. The NTAP payment, if awarded in the Final Rule, provides an additional and separate payment equivalent of up to 50 percent of the product cost in addition to the MS-DRG payment received for the episode of care. NTAP status has to be reestablished each Fiscal Year for each product and can only be awarded for a maximum of three Fiscal Years after approval. Discussion of this issue starts on page 400 of the CMS-1694-P main file.
4. CMS is considering placing CAR-T in a specified MS-DRG so that providers know approximate reimbursement in advance. This is a positive change from the current status of MS-DRG assignment based on whatever mix of codes is on the claim. Only claims that are correctly coded with the ICD-10-PCS code will drive to the specified MS-DRG. CMS is proposing assignment to MS-DRG 016 (AutoHCT w/ CC/MCC) OR to a new MS-DRG that has not yet been created. The ASBMT is vetting the potential options based on financial modeling and financial risk. More information will be issued in the next few weeks.
5. CMS proposed assigning a Cost-to-Charge Ratio of 1.0 to be used when billing the cost of the product on your inpatient claims. This could be a very good thing, and we are vetting the particulars. Anything further I tell you on this matter will push out some very important piece of clinical knowledge that your patients need more than this, so just know we will get back to you with language for your comment letter. See page 1628 in the file for details.
6. Many stakeholders are paying very close attention to the proposed changes tied to CAR-T reimbursement. ASBMT is engaged with patient advocacy groups, our fellow professional societies, the manufacturers and other trade and specialty provider associations. Where it makes strategic sense to do so, we may sign on to joint/multi-stakeholder letters about specific proposals. The ASBMT will separately author a comprehensive letter reflecting the unique voice and concerns of the membership.

Finally, thanks to those who joined our first Coding and Reimbursement Town Hall. There will be more sessions to come as we aim to communicate key issues to you in a non-list format.

As always, find me at SFarnia@asbmt.org or @HCT_Policy on Twitter.