Isotope Availability

Background

Molybdenum-99 (Mo-99), the parent isotope of Technetium-99m (Tc-99m), is used in approximately 40,000 diagnostic medical procedures every day in the United States.  Mo-99 is one of the most ideal radioisotopes for certain medical imaging tests because it results in the least amount of radioactive exposure for patients. It has a very short half-life and therefore must be produced on a continuous basis to meet the needs of the medical community. Any interruptions in production can place patients at great risk of not getting much-needed “standard of care” diagnostic tests.

The U.S. consumes approximately one-half of the world’s supply of Mo-99, but has no domestic source of supply. The two primary sources of Mo-99 used in the U.S. are located in Canada and the Netherlands, which provide more than half of the world’s supply. These reactors are each nearly 50 years old and will be phased out of commercial isotope production beginning in 2016. Future sources of Mo-99 are not yet readily apparent.

U.S. patients and the U.S. health care system are in need of a reliable supply of Mo-99. The best way to ensure a reliable supply of Mo-99 is to encourage the development of new technology and domestic production facilities.

The Obstacles:

1. Inadequate reimbursement system for diagnostic radiopharmaceuticals in the hospital outpatient setting - Radiopharmaceuticals used in nuclear medicine imaging are often the best and most affordable diagnostic tools available to doctors and patients. Without the development of new Mo-99 technology and domestic production facilities, doctors will be forced to use more expensive and less effective products. Patients will also be at risk due to the use of higher doses of radiation and less accurate treatments, and more invasive procedures associated with higher morbidity and mortality. These inferior alternatives will result in increased medical costs.  Congress has continually cut imaging over the past few years to curb costs and utilization, which adds to an already precarious reimbursement environment. Diagnostic radiopharmaceuticals are paid as a packaged payment, which are set utilizing two year old claims data. Therefore, increases in costs are not recognized early enough for updated bundled payments for at least two years and sometimes three or more with the current system. Without adequate reimbursement for nuclear medicine procedures, advances will never be incorporated into medical practice and the patient will never benefit.
   
   
2. Increased costs associated with developing new technology that employs LEU - New domestic sources of Mo-99 will require substantial investment and will result in a significant impact to industry.  Prices are expected to increase as all producers of Mo-99 convert from HEU to LEU.

Immediate action is needed to remove the obstacles to the development of new technologies and production facilities, and to create a reliable domestic supply of Mo-99.  This will ensure that patients will continue to receive the most appropriate cost-effective treatments and diagnostic services available.  In the absence of adequate Mo-99 and therefore, Tc-99m supply, patients will be imaged using procedures that are less accurate, have a higher cost, a higher radiation dose, and could possibly lead to increased morbidity and mortality.

One way to make sure that new production facilities will be available to create a reliable domestic supply of Mo-99 is to ensure that the costs associated with the new technology and the new facilities are adequately reimbursed.  This requires that Centers for Medicare and Medicaid Services (CMS) utilize its authority to reform the Hospital Outpatient Prospective Payment System (HOPPS).  Recognizing the current crisis, CMS authorized an additional $10 reimbursement per dose for Tc-99m produced by non-HEU methods in a diagnostic procedure.  There are challenges to implementing this new policy, which include lack of supply, hospital administrative challenges, etc, but the real challenge is cost.  In the end, we still have no idea what the true cost of conversion will be and whether or not it can be absorbed into the bundled HOPPS payment.  CMS should consider new and unique options for bundled payments for these unique drugs, using more current data than their two year old data for setting current rates. We are not suggesting unbundling, rather a consideration of alternate new models for bundled radiopharmaceutical which would include external data and CMS claims data.

Current Status

In December 2012, Congress enacted S. 99, the American Medical Isotopes Production Act of 2011, as part of the Defense Authorization bill.  S. 99 addressed some of the technology and waste disposal issues that were obstacles to the development of new Mo-99 production facilities.  Also, industry must now convert its technology from highly enriched uranium (HEU) to lowly enriched uranium (LEU).  We are grateful that Congress took that first step in solving this crisis -- but there is more that needs to be done. While SNMMI agrees that removing HEU from medical isotope production is important, we are concerned that this nonproliferation program is placing the cost of a national security policy on the patients and their providers.

SNMMI continues to meet with members of Congress concerning the future of isotope availability.  We have requested that Congress take the following action:

• Understand the problem of unstable supply and pledge to work with the members of the OSTP Work Group trying to avert the crisis.  Agencies involved include CMS, FDA, NNSA/DOE, NIH, NRC, and others.
• Monitor the progress of the Administration to implement the American Medical Isotopes Production Act of 2011.  Utilizing committee oversight authority over DOE and NRC efforts to bring about a domestic source of Tc-99 before the US supplies are shut down due to the aging foreign reactors.
• Let NNSA and CMS know we need adequate funding to develop domestic capability by 2016, and a sound reimbursement structure that will allow for appropriate reimbursement.