Two steps forward, one step back

Progress, in any realm, is seldom steady. Instead, the path forward tends to marked by barriers; traversing one often leads to another, perhaps unexpected, obstacle. So goes the ups and downs of PET reimbursement and Alzheimer’s research.

On March 7, the Centers for Medicare & Medicaid Services removed the national non-coverage decision for PET for FDA-approved oncologic applications. The decision prompted a mixed reaction from molecular imaging stakeholders. That’s because the agency skirted the issue of neurologic and cardiac studies.

The Medical Imaging & Technology Alliance (MITA), for one, has made its position loud and clear. “We are disappointed that these applications were not included in the decision memorandum and believe that the consideration of coverage for PET tracers should be no different than for other items and services,” MITA wrote. The alliance urged CMS to continue to evaluate the evidence and “avoid lengthy, bureaucratic reviews.”

Other regulatory news is a bit more promising.

FDA leaders indicated in a perspective published in New England Journal of Medicine that the agency may soon clear a path for promising drug treatments for patients showing signs of Alzheimer’s disease in order to foster development and commercial availability and fill the void in treatments.

Meanwhile, clinical research continues at a healthy clip. Though the monumental challenges of Alzheimer’s disease are by no means solved, nearly every day brings new hope.

Researchers at the University of California, Los Angeles paired high-field diffusion MRI with genomic screening to pinpoint an Alzheimer’s disease risk gene, a leap forward that might inform development of new therapies.

Finally, Victor L. Villemagne, MD, of the Australian Imaging Biomarkers and Lifestyle Research Group, and colleagues published a study in The Lancet suggesting the Alzheimer’s disease may take more than two decades to develop.

What progress has your practice seen in the molecular imaging realm? Please let us know.

Lisa Fratt, editor