Nine months after the first PET/MR hybrid scanner was approved by the FDA, what inroads has the technology made, and should you be adding one to your practice?
Nine months after the first PET/MR hybrid scanner was approved by the FDA, what inroads has the technology made, and should you be adding one to your practice? The answers are interesting.
But first an explanation. A hybrid PET/MR scanner simultaneously delivers functional information plus anatomy and tissue characterization (soft tissue contrast and blood vessel physiology), from a state-of-the-art MR scanner. At the same time, it provides metabolic imaging from PET technology. Fusing these images gives the best of both worlds, providing greatly superior information to what you’d get from either machine individually, according to Kirk Reinitz, president and CEO of Advocate Radiology Billing and Reimbursement Specialists.
“While PET/CT is faster and cheaper, MR provides better soft-tissue contrast, plus functional information, and what is particularly important, it works without radiation exposure to the patient,” he said. Reinitz added that PET/MR produces up to 70 percent less ionizing radiation than PET/CT.
The two hybrid PET/MR machines currently available are the Siemens Healthcare Biograph mMR (FDA approved in June 2011) and the Philips Ingenuity TF System (FDA cleared in November 2011).
Last summer Diagnostic Imaging polled readers on whether (and when) they planned to get the hybrid machines. In the nonscientific poll, 21 percent said they planned to purchase it in the next six to 12 months, and 24 percent said that purchasing would depend on reimbursement. Another 16 percent planned to wait and see, while 38 percent had no purchase plans.
While radiologists are excited about the technology, the only U.S. customers so far are large-scale research hospitals and institutions, according to Satrajit Misra, director of marketing for nuclear medicine at Philips. “As of today we are looking at a market of roughly 15 to 20 units per year over the past couple of years. It’s evenly split between us and Siemens at this point,” he said. Misra noted that they currently have seven units installed worldwide, and a “fairly large backlog” that they’re shipping.
U.S. adopters are facilities like Washington University School of Medicine, interested in translational research as well as clinical work. Translational work mainly involves new development with tracers and discovering other clinical uses. “When you’re doing this kind of translational work, you want students and postdocs working on this. Access to a teaching institution is a big benefit,” Misra said, especially since leveraging off grants helps pay for equipment acquisition.
These customers are using the technology for stand-alone clinical work as well, and billing it as such. “I’ve seen usage patterns that vary from 80 percent standard clinical MR use and 20 to 30 percent for research work. You get a lot of billing done through using it as a normal clinical MR or PET,” Misra said.
Billing for PET/MR
Using the machines as stand-alone devices is a smart option, because there are currently no CPT codes for hybrid use. “Just because the FDA approved it, doesn’t mean payment for doing the procedure,” said Jennifer Bash, senior coding specialist at Advocate Radiology Billing and Reimbursement Specialists. “There’s no CPT code for PET/MR, so reimbursement likely won’t come,” she said.
If using the technology in its hybrid modality, Bash recommends billing the regular PET code and an unlisted code on top of that for a fusion procedure. However, there is no guarantee that would be accepted by payers, and the biller might need to go through an appeal process, providing a report copy and a letter of medical necessity from the medical director. Even with this additional documentation, Bash doubts that many payers would reimburse the procedure. Outpatient clinical billing offices don’t have experience doing this, since the machines are only at hospital and academic institutions.
Once CPT codes are approved, Misra said he believes that the customers will come. “I believe reimbursement is going to be primary enabler to mass scale adoption,” he said. “Once you have specific PET/MR reimbursement codes, that’s when you’ll start seeing lots and lots of customers.” Misra noted that the ability to use lower dose, yet see more soft tissue at better resolution, is very appealing.
To Buy Or Not To Buy
Deciding whether to buy a PET/MR machine, a practice would go through the same evaluation process as with any other capital investment, according to John Buckhalter, Vice President of the AGI Healthcare Group.
“Once you’ve determined the cost of the equipment, will there be sufficient demand (referrals) in the market and will Medicare and commercial payers reimburse sufficiently to make the investment financially viable? Currently we don’t see evidence of either happening anytime soon,” he said.
While there’s been a lot of buzz and discussion about it, Buckhalter’s outpatient imaging clients haven’t shown much interest. “If no one is going to pay for it, it’s irrelevant in the commercial world,” he said.
With PET technology, it took many yearsbefore it was approved for payment other than special circumstances, Buckhalter said. Once Medicare started approving particular codes, it was reimbursed at a high rate on a limited basis. As volumes grew, reimbursements dropped at the same rate. “It’s still an expensive technology and you have to have a certain volume to make it viable at all,” he said.
He said it’s uncertain who the referral sources for PET/MR scans would be for outpatient imaging centers, so it’s not currently viable to them. “I’m not speaking for academic institutions. They have an entirely different set of needs which determine the direction they go,” he said.
Misra said that the only private practices buying the machine currently are internationally based. These clients want additional and better referrals, as well as bragging rights for being first, he said. Misra has not seen much private practice interest in the U.S. market yet. “I believe that’s going to change, but we need a few years for that to happen,” he said.
A few other prohibiting factors, including cost, will hold back imaging centers and hospitals, according to Reinitz. Others are space and training. “The size of the required room will also prevent some locations from moving forward. Finally, the specialized technology will require a technologist with very specific training,” he said.
Misra said he thinks that the first CPT codes will be for pediatric applications. “They’re small, the most dose-susceptible, and because of their anatomy, you need higher tissue specificity,” he said, adding that there’s an emotional component to pediatrics as well.
As for adult use, Misra said he’s seeing the hybrid technology used for dose-sensitive organs needing a lot of repeat scans, like the breast and neuro imaging, with cardiac uses as well.
Reinitz said it’s also good for imaging the pelvis, neck and head, as well as lymphomas and for Alzheimer’s disease.
In addition to known uses, Misra said he anticipates finding new applications for the technology, which will be another driving factor for sales: “the big killer applications that you can do on a PET/MR that you can’t do on stand-alone machines.” Those uses will emerge in the next few years, when the current users publish their findings, he said, adding they’ve done over 500 patient scans so far, and “it’s amazing what we’re beginning to see.”