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Radiopharmaceuticals: Should reimbursement rule treatment options?

by Gus Iversen, Editor in Chief | June 18, 2015
Molecular Imaging
From the June 2015 issue of HealthCare Business News magazine


Other countries followed the U.S. example. NICE and NHS in the U.K. also decided not to reimburse PET amyloid imaging on grounds of insufficient evidence. France and some Nordic countries are reimbursing in a limited way, but most want more clinical data showing the impact of the diagnosis on outcomes.

The Amyloid Imaging Taskforce, alongside SNMMI and the Alzheimer’s Association, set out to illustrate the value those tracers can have in the diagnosis and treatment of certain patients struggling with symptoms of dementia. According to the appropriate use criteria, candidates for amyloid imaging include patients who complain of progressive unexplained memory problems and demonstrate impairments using standard tests of memory. Amyloid imaging of people who were diagnosed with Alzheimer’s but was unusual in their presentation, as well as those with early onset of dementia, were also found to be appropriate.

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Their criteria does not find patients 65 or older who meet standard Alzheimer’s definitions, or asymptomatic patients with no clinical confirmation of impairment, to be appropriate for amyloid testing. In the U.S., a four-year research study has just gotten underway with an 18,000-patient study and an estimated budget of $100 million, called Imaging Dementia - Evidence for Amyloid Scanning (IDEAS), which will seek to illustrate the perceived value in amyloid imaging.

IDEAS will enroll patients age 65 and older who meet the appropriate use criteria over 24 months at roughly 200 facilities across the U.S. Participants will be placed into either a subgroup for progressive and unexplained mild cognitive impairment, or a subgroup for dementia of uncertain cause. The research will be neutral with respect to which of the three FDA-approved amyloid agents are used, and aim to demonstrate that amyloid imaging can lead to better outcomes.

The expectation is that amyloid imaging can allow physicians to make more informed judgments as to what the patient has; be it Alzheimer’s, vascular dementia, frontal lobe dementia, or even no dementia.

Revising the APC model for today’s radiopharmaceuticals
Nuclear medicine studies are billed differently through Medicare depending on whether they are conducted in a freestanding imaging center or in a HOPPS. In freestanding centers the radiologist can bill the procedure and the radiopharmaceuticals separately, but in a hospital setting the treatment is assigned an APC.

Complexity of the study and body part being looked at are two factors contributing to the designated category. They were set up to bundle payments and make an average charge which could cover everything in the procedure – including the radiopharmaceuticals. And for most radiopharmaceuticals it has been a reasonably successful system. With newer radiopharmaceuticals however, the drugs themselves can sometimes cost more than the entire study. In those cases the hospital loses money the minute the study begins. Consequently some hospitals will simply stop doing them.

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