President, Nuclear Pharmacy Services
Cardinal Health is pleased to respond to the Centers for Medicaid and Medicare Services (CMS) request for comments on the reconsideration request of Section 220.6 of the National Coverage Determinations (NCD) Manual, dealing with Positron Emission Tomography or PET imaging. Cardinal Health’s Nuclear Pharmacy Services provides over 12 million nuclear medicine and PET radiopharmaceutical doses annually in the United States. We also provide support for more than 20 early phase clinical trials in nuclear medicine and PET.
We take this opportunity to share with CMS the significant investment we have made into PET imaging since we began providing clinical PET doses in the late 1990s. To date we have invested nearly a quarter of a billion dollars to build the network and quality systems it takes to manufacture, dispense and deliver the highest quality, clinically relevant radiopharmaceuticals across the United States. Over the last decade and a half, the PET industry has been working with the Food and Drug Administration (FDA) on current Good Manufacturing Practices (cGMP) for PET manufacturing, which recently culminated in the FDA’s promulgation of 21 C.F.R. Part 212. The manufacture of PET radiopharmaceuticals is now subject to rigorous requirements regarding safety, identity, strength, quality and purity. Cardinal Health applauds the development of these regulations.
In addition to this fundamental change in manufacturing requirements for providing clinical PET doses, Cardinal Health created the Center for the Advancement of Molecular Imaging (The Center) in Phoenix, Arizona. The Center was developed to allow innovators access to both molecular imaging agent manufacturing expertise and the costly equipment needed to facilitate their early phase clinical trials. Clinical trials performed for new radiopharmaceuticals must meet significantly higher regulatory standards for approval than ones in the past, particularly the PET radiopharmaceuticals which were addressed in the March 1, 2000, Federal Register Notice of Safety and Efficacy. These three radiopharmceuticals (18F FDG, 18F NaF and 13N ammonia) were essentially given this Notice of Safety and Efficacy based upon a 505(2)(b) review of literature and had no single sponsor company to handle standardization of practice and education. These types of FDA reviews will not be the mode of approval for future PET radiopharmaceuticals. The sponsor of any new PET radiopharmaceutical must now file a new drug application with the FDA and receive approval before marketing that drug for clinical use. The FDA will review those applications to ensure that the drug can be produced in a manner that ensures its safety, identity, strength, quality and purity and that the drug is safe and effective for its intended use.
CMS also requested comment on the breadth of the reconsideration request. We feel the breadth of the request is appropriate given the current evidentiary requirements for FDA approval as noted above. Future PET radiopharmaceuticals which are approved by the FDA, should be treated in the same manner as all other diagnostic radiopharmaceuticals. Specifically, without a change to section 220.6, a newly FDA-approved PET radiopharmaceutical is automatically treated as not reasonable and necessary for its FDA labeled indication. Removing the “exclusionary language” would allow the new radiopharmaceutical to be covered by the local Medicare Administrative Contractors (MACs) upon FDA approval, but would not exclude the possibility of a full National Coverage Analysis. This flexibility is entirely appropriate given the success of this method for all other diagnostic radiopharmaceuticals and the many other items and services which are covered by Medicare. Removing the unnecessary delay in access to new radiopharmaceuticals for Medicare beneficiaries will benefit the Medicare population when they are used for the right patient at the right time as they can vastly improve the diagnosis of disease which can have a positive impact on patient management. Rest assured, we are not advocates of “screening” or unfettered use of new radiopharmaceuticals which are not medically necessary and may provide little to no benefit to the referring physician in making care management decisions. More importantly, we do advocate for appropriate use resulting in a positive impact on patients and on healthcare in general.
In closing, Cardinal Health would like to thank CMS for the opportunity to comment on this reconsideration request and we urge you to approve the requested change to section 220.6 of the NCD manual. We also acknowledge and support opening of a second or parallel reconsideration request to section 220.6 relative to Amyvid™, which was recently approved by the FDA.
For any questions regarding our comments, please contact Terri Wilson at (407) 790-8287 or email@example.com.