Reimbursements for I-123 ioflupane (DaTscan), a radiopharmaceutical used in dopamine transporter imaging to differentiate Parkinson’s disease from essential tremor or normalcy, decreased significantly in the years after gaining FDA approval, according to a study published by the Journal of the American College of Radiology.

Should practices expect this to be the pattern for other radiopharmaceuticals in the future?

Lead author Phillip H. Kuo, MD, PhD, University of Arizona College of Medicine in Tucson, Arizona, and colleagues compared a facility’s I-123 ioflupane reimbursement data from two different time periods: from July 2011 to October 2012 and January 2014 to December 2014.

Kuo et al. studied more than 340 studies overall. The average reimbursement per study for all payors was $2,469 in 2011 and 2012. In 2014, however, that number dropped to $1,657 per study.

The authors noted that this is largely because I-123 ioflupane lost CMS pass-through status, a transitional payment designed to help practices recover the costs of new products, for the hospital-based outpatient setting on Jan. 1, 2014. Private insurers reimbursed an average of $595 more than CMS in 2011-2012. In 2014, after I-123 ioflupane lost its pass-through status, private insurers reimbursed an average of $2,369 more than CMS.

“This reduced the total reimbursement for I-123 ioflupane imaging for hospital-based imaging by $1,148, a nearly 50 percent reduction compared to the year prior,” the authors wrote. “This reduction drastically altered the price point to break even on the cost of the radiopharmaceutical alone, much less to cover costs of scanners and personnel.”

The authors added that this made more complicated due to specific rules built into the CMS Hospital Outpatient Prospective Payment System (HOPPS).

“HOPPS reimbursement policy with bundling from the loss of pass-through status does not apply to imaging performed at free-standing facilities,” the authors wrote. “Dopamine transporter imaging performed at free-standing facilities will consequently receive higher CMS reimbursement ($1,148 higher in 2014) compared to hospital-based outpatient imaging. Our institution only has hospital-based gamma cameras. Thus, a limitation is that our data may not represent reimbursement from practices with free-standing facilities.”

Such policy that “favors imaging at free-standing facilities,” Kuo and colleagues said, could “create a financial bias that distorts optimal workflow, staffing and patient access to imaging.”

The new normal?  

The authors concluded that when other radiopharmaceuticals are approved by the FDA, providers may want to keep the recent history of I-123 ioflupane fresh in their minds.  

“Historical data for I-123 Ioflupane imaging suggest that practices should expect wide reimbursement disparity when future radiopharmaceuticals enter the market,” the authors wrote. “Practices with a high proportion of CMS patients should expect less reimbursement variability but greater difficulty covering radiopharmaceutical costs given overall lower reimbursement levels.”