MITA Comments to CMS Healthcare Common Procedural Coding System Workgroup Item #3

Dear Ms. Hake:

As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) preliminary HCPCS decisions for 2018.  As the leading trade association representing medical imaging and radiopharmaceutical manufacturers, we have in-depth knowledge of the significant benefits that medical imaging provide to the health of Medicare beneficiaries.  MITA is pleased to work with CMS to ensure that assigned coding adequately describes products and services provided to Medicare beneficiaries.

MITA respectfully disagrees with the HCPCS Workgroup preliminary decisions on Item #3:

Existing descriptor of A9587, which reads, “Gallium ga-68, dotatate, diagnostic, 0.1 millicurie”, adequately describes the product that is the subject of this request

MITA believes the descriptor would be improved by changing to “per study dose.”

  1. Unique logistical challenges

MITA believes the current 0.1 milliCurie descriptor for diagnostic Gallium 68 dotatate does not appropriately describe NETSPOT®.  MITA supports the applicant’s request to instead have it read Gallium Ga-68, dotatate, diagnostic, per study dose.  The NETSPOT® Kit approved by the FDA allows for only one dose to be reconstituted.  The half-life of NETSPOT® is 68 minutes.  Logistical challenges such as delivery delays or patient scheduling changes, can lead to decay resulting in a different administered dose than the prescribed does.  This can lead to confusion.

  1. Inconsistent with CMS position on coding for PET radiopharmaceuticals


MITA believes that NETSPOT® should be coded the same as all other PET radiopharmaceuticals and the preliminary coding decision should be changed to a “per study dose.” To be consistent, NETSPOT® should be treated like all other PET radiopharmaceuticals, such as Amyvid, Vizamyl, Neuraceq, C-11 Choline, FDG, NaF, Cardiogen, and N-13 Ammonia.

In consideration of these reasons and other data presented by the imaging community, we respectfully request that you reconsider your preliminary decision for Item #3 and instead accept the manufacturer’s request for a “per study dose.”

MITA appreciates this opportunity to comment on the preliminary decisions.  We would be pleased to answer any questions you might have about these comments.  Please contact me at (703) 841-3258 if MITA can be of any assistance.



Sue Bunning

Director, Molecular Imaging & PET