Board member insights: The excitement with CAR-T

by Jugna Shah, MPH

Chimeric Antigen Receptor Therapy (CAR-T) is the latest breakthrough in oncology care. Simply put, it involves taking a patient’s cells, sending them to the drug manufacturer where they are re-engineered, and then infusing them back into the patient to attack the patient’s cancer. CAR-T will impact many core aspects of revenue integrity, including reimbursement.

Revenue integrity folks will need to care about coding, billing, and the setup of their internal charges. There are no perfect CPT® codes for facilities to report the collection of the patient’s cells nor for the physician to report the infusion of the cells, so providers will have to determine how best to report these services until specific codes or coding guidance is released. For now, I recommend using the unlisted CPT code 38999 (under other procedures of the hemic or lymphatic system). While use of this code means providing additional information to the carrier for physician reimbursement, it’s appropriate for CPT coding instructions, which clearly state not to report a code that simply approximates or is similar to another code/service. The good news is that there is an inpatient CAR-T infusion code for the facility to report when CAR-T is infused in the inpatient setting. This is where the majority of this care will be delivered, at least for now.

In late August, Novartis received unanimous Federal Drug Administration (FDA) approval for its ground-breaking CAR-T. In its approval announcement, the FDA said that the medical community is entering a new frontier with the ability to program a patient’s own cells to attack cancer. Many believe CAR-T is the most revolutionary discovery in oncology in more than 50 years and is expected to replace conventional therapies. Since then, there are two companies with FDA approval for CAR-T; Novartis for a pediatric indication that’s been approved and, most recently, Kite/Gilead with an adult, Lymphoma indication approved. Novartis is hoping to see its adult indication approved any day now.

What does this mean for providers? Well, a few things:

• Find out if your facility is one of the approved sites
• Be aware that there is an ICD-10-PCS code to report the inpatient infusion of CAR-T and it’s in the new technology ICD-10-PCS code section
• There are no perfect CPT codes for outpatient or physician reporting when it comes to reporting the collection of the patient’s cells or the infusion of the cells, so providers will have to determine how best to report these services until specific codes or coding guidance is released
• With a hefty price tag of $475,000 for the Novartis pediatric product or $373,000 for the Kite product for Lymphoma, many chief financial officers are asking whether it’s even feasible to provide this service given existing Medicare reimbursement rates, and are uncertain about what their commercial contracts will look like

While CAR-T may not impact every institution this year or next, healthcare organizations must stay abreast of the changes this therapy may bring, if for no other reason than the fact that Novartis appears to have struck an outcomes-based pricing/reimbursement deal with CMS. This means the response of the patient at one month will drive whether the provider or payer bears the cost of the CAR-T therapy since the manufacture will issue a credit.

This is an exciting and novel approach but is leaving providers with many questions. If providers must pay the manufacturer $475,000 upfront for the personalized cell engineering, but the patient has a poor outcome, meaning there is no complete response within 30 days, then what does this really mean in terms of the manufacturer not charging the provider for the product? At this point, the provider will already have paid and now will likely be receiving a credit for their next patient. There are very few if no scenarios under which hospital providers will fare well today with Medicare reimbursement given that the MS-DRG payment is still low and the outlier is not a panacea, and there is no new technology add-on payment for fiscal year 2018.

For the first time that I can recall, finance departments are asking tough questions about the cost of the new breakthrough therapy vs. the benefit. Hands down, most clinicians want to be able to offer this care option to their patients. In fact, some clinicians have indicated that they have waited a long time to provide this therapy, and now they feel like their hands are tied because of the significant financial constraints. The bottom line is that Medicare inpatient reimbursement is inadequate, and the fact that Medicare will provide separate ASP +6% reimbursement for the drug in the outpatient setting, but essentially provide nothing separate in the inpatient setting, is naturally concerning to providers.

Perhaps something will change in the coming months as CMS examines its inpatient and outpatient payment policies. Hopefully, CMS will find a new way to address higher cost cell and gene therapies that are typically, and at least initially, provided in the inpatient setting in low volume and by few providers. This is the perfect storm where reimbursement is terrible. It appears that payers and the industry are waiting to see what providers do, but at the end of the day, it’s patients who may suffer from this perfect storm if they are unable to get the treatment due to reimbursement issues and politics.

Editor’s Note: Shah is president and founder of Nimitt Consulting, Inc., in Spicer, Minnesota, and serves as a NAHRI advisory board member.