News that the American Medical Isotope Production Act of 2011 was signed early this year by President Obama — coupled with CMS’ announcement that additional payments were available for a radiopharmaceutical diagnostic dose produced from non-highly enriched uranium — is thought to be a push in the right direction.
But some in the industry are confused. What does all this mean for diagnostic imaging?
The bill, signed by the president on January 2, supports the domestic production of Technetium-99 diagnostic doses produced from non-highly enriched uranium (HEU) sourced molybdenum -99 (Mo-99), and phasing out HEU export from the U.S. It’s part of a multinational effort to reduce the use of weapons-grade HEU.
Mo-99 is the parent isotope that decays to Tc-99, used in 16.7 million U.S. procedures annually, according to the Society of Nuclear Medicine. The most widely used radioisotope in the world can help diagnose heart disease, detect and stage cancer, detect thyroid disease, study kidney function and the brain, and image some bone fractures.
The FDA allows eight foreign producers of HEU-derived Mo-99 to import the product to the U.S.; the U.S. has no domestic facilities to produce Mo-99 for medical use. Two foreign reactors can supply the low enriched uranium (LEU)-derived raw product to the U.S., those being the Safari reactor in South Africa, and the Opal reactor in Australia, which accounts for its the limited availability, said Colleen M. Glynn, senior marketing director for the Nuclear Pharmacy Services Business of Cardinal Health, which operates the largest network of radiopharmacies in the U.S. . A full conversion to LEU is expected in 2015 or 2016.
“Some in the industry may think that the use of LEU generators is new. But in reality, generators have been made with a blend of LEU and HEU Mo-99 for quite some time,” said Glynn. “At this point, depending on what pharmacies have, they could be receiving all HEU, or a blended dose.”
Glynn explained that the new CMS initiative provides an additional payment only for product made with 95 percent or more from LEU.
Lantheus Medical Imaging shipped the first TechneLite Generator in the U.S. on January 7, the first company offering a Tc-99 generator produced using at least 95 percent LEU. The other company cited with this capability is Covidien.
Lynn Phillips from Covidien’s pharmaceutical branch Mallinckrodt said, “Mallinckrodt can offer LEU-derived Tc-99m generators meeting CMS criteria. Our customers have not requested them, and thus we have produced none to date.”
Glynn said that due to limited availability of non-HEU Mo-99, generators are only available on Mondays and Tuesdays. Within the hospital, staff must know which patients are eligible to participate as part of the CMS initiative, and to schedule them earlier in the week. The only eligible patients are Medicare hospital outpatients. There’s no additional CMS reimbursement if used in a clinic or inpatient setting.
Given the product’s half-life, “the logistics of delivering radiopharmaceuticals is similar to delivering melting ice cubes. If we have a block of material Monday and Tuesday, by Friday we won’t have that much,” Glynn said.
She stressed that there is not a scarcity of the radiopharmaceutical. “There is not a shortage, just a limited supply of this specific LEU product, because of the CMS requirement that the dose be 95 percent LEU-derived instead of blends using less LEU. Because it’s a fairly limited supply and we’re only getting that generator one to two days a week, we need to know which patients are eligible,” said Glynn.
Phillips says that currently, the global supply of non-HEU derived Mo-99 constitutes less than 15 percent of total global need. Mallinckrodt is the only U.S. generator manufacturer that processes its own Mo-99, and it expects to fully convert their processing facility by 2015, said Phillips.
Cardinal Health held several forums to educate its customers, sales force and pharmacy managers and on eligibility, reimbursement, computer, billing, ordering and tracking systems. Other companies supplying these doses, like Triad Isotopes, are also educating customers.
Glynn said that while Cardinal Health is ready to handle orders, customers are still looking at the internal changes needed to get their systems in place.
To get the additional reimbursement, “the code that’s used is Q9969 and that’s per study dose. CMS has assigned that code to a specific APC, 1442, and it has a calendar year 2013 payment rate of $10,” Glynn said.
Some have expressed concern that the additional $10 payment would not cover the actual expenses involved. “When you look at the $10 and figure that the non-HEU generators cost more and we have duplication in the system with dual generators as well as compounded vials, certification of doses, and additional work on the customer side, there’s a good chance that the cost could be at or more than $10. But that’s something we have to look at relative to efficiency, availability, and how many customers want it,” Glynn said.
According to Glynn, the non-HEU derived product is no different in dose, effectiveness, adverse effects or radiation level than the HEU-derived product.