Is Molecular Imaging Due for a Fallow Period?

During the past five years, I have spent a considerable amount of time on the issue of supply of Tc-99m and its parent, Mo-99. That effort has been quite complicated, requiring me to learn about the intricacies of reactor operating schedules, regulatory issues for nuclear operations, transportation of radioactive materials, nuclear security treaties, clinical trial protocols, New Drug Approval and adherence to USP guidelines. All of these issues relate to an isotope that has been in use clinically for more than 40 years.

Yet, nothing in all of this morass of bureaucratic procedure prepared me for the mind-blowing issues related to the interactions with the Center for Medicare and Medicaid Services, including why the acronym is CMS rather than CMMS as its name would suggest. Trying to make sense out of what CMS does, how they do it, and when is a baffling experience. I thank my lucky stars that Denise Merlino has been available to guide me through the labyrinth of CMS.

The critical issue for molecular imaging is how one can bring a compound into routine clinical use, which of course entails both regulatory approval and adequate reimbursement. The fact that the Food and Drug Administration (FDA) and CMS are part of the same agency, the U.S. Dept. of Health and Human Services, confounds me even more. FDA treats radiopharmaceuticals as drugs, and requires testing as though they had physiologic action, which of course nearly all do not. Their mandate is to demonstrate that the compound is safe and effective, no more.

CMS, on the other hand, treats radiopharmaceuticals as supplies, which is their justification for bundling many of those that we use into the technical fee for the procedure. Thus, they are treated as though they were disposables—syringes, sponges or bandages.

Compounding all of what I have described is the fact that the updates to the CMS fee schedule is often two to three years behind. And as we have seen in the past several years as Mo-99 prices spiked, as did the Tc-99m generator price, these changes take time to work into the reimbursement that CMS will provide. And realize, too, that third-party private insurers often follow CMS’ lead on reimbursement, so its impact is much greater than patients covered by Medicare or Medicaid.

This time lag is created by the annual process that CMS uses to survey the market, analyze the data collected on price, and then implement the changes. There is no pressure to do this in a timely fashion, so some increases are not incorporated in the year following, but lag an additional year.

This is the economic and regulatory minefield we navigate in 2014. We must negotiate in the practice of molecular imaging. I believe we are due for a fallow period as these hurdles become even more severe with increasing emphasis on safety and cost containment in medical imaging.

Editor’s Note: It was previously reported that the AECL plans to shut down the NRU reactor in 2016.  However, they have applied for a five-year license extension. AECL officials have made it clear that they do intend to cease medical isotope production in Oct. 2016. There is some question about whether the AECL will continue to produce Cobalt-60, which is used in sterilization systems and in gamma knife radiation therapy technology.