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Obama HEU Reduction Proposal Insufficient, Health Care Providers Say

By Douglas P. Guarino

Global Security Newswire

The Chalk River medical isotope production facility in Ontario, Canada. U.S. health care industry officials have voiced doubt over an Obama administration plan to promote the use of medical radioisotopes manufactured without weapon-usable uranium (Atomic Energy of Canada photo). The Chalk River medical isotope production facility in Ontario, Canada. U.S. health care industry officials have voiced doubt over an Obama administration plan to promote the use of medical radioisotopes manufactured without weapon-usable uranium (Atomic Energy of Canada photo).

WASHINGTON – An Obama administration plan to change to the Medicare payment system for radiological isotopes used in diagnostic procedures would not give health care providers enough incentive to end their reliance on bomb-grade uranium, industry officials say.

The Health and Human Services Department in July proposed to pay providers more if they conduct diagnostic procedures on their Medicare patients using isotopes derived from low-enriched uranium. The plan – part of a wide-ranging proposed rule that would make numerous adjustments to the Medicare system -- is the latest attempt by Washington to wean the United States off medical isotopes produced with highly enriched uranium.

Proponents of the effort argue that terrorists could use HEU material to construct nuclear weapons, and that minimizing use of the substance reduces the possibility that it could fall into the wrong hands.

Under the HHS proposal, the government would pay health care providers an extra $10 every time they conducted a diagnostic procedure using radiopharmaceuticals that were “produced by non-HEU methods.” Currently most providers use technetium 99– a product of the decay of molybdenum 99 – derived from highly enriched uranium, but the Obama administration is looking to encourage production by other means.

Health care industry officials, however, argue the administration is underestimating how much it would cost to switch to more expensive isotopes derived from lowly enriched uranium. The extra $10 per procedure will likely not be enough to persuade relevant entities to use isotopes produced with the more proliferation-resistant material, they claim.

“We believe that [the] proposed payment adjustment policy for non-HEU sources, as conceived, will not promote the conversion to non-HEU sources in hospitals,” the American Hospital Association said in recent comments on the plan.

The group, which represents more than 5,000 hospitals and other medical facilities, submitted the remarks to the HHS Centers for Medicare and Medicaid Services shortly before Tuesday’s deadline for public comments on the proposal.

“A payment of $10 per dose is inadequate to incentivize hospitals to change their current practices and transition purchases to non-HEU sources,” the hospital group added. It argued that “the $10 is insufficient to cover the costs passed on to hospitals from the various levels of the supply chain, including the producer, the generator, manufacturer and the nuclear pharmacy.”

The American Society of Nuclear Cardiology, which represents more than 4,500 specialists, aired similar concerns.

“Indeed, our clinical conclusion is that $10 will be wholly inadequate across the supply chain to facilitate non-HEU production and we fear patients and their clinical providers will suffer the most loss,” the cardiology group said in its own comments on the proposal.

The industry officials said they in principle support the HHS effort to encourage hospitals to switch to using medical isotopes produced without highly enriched uranium, but argued the department has not provided enough information about how its cost estimates were calculated. The HHS proposal says the increased payment in its planned rule is based “on the best available estimations of the marginal costs associated with non-HEU radioisotope production,” but provides no further detail.

“We encourage CMS to explain in more detail how it arrived at the conclusion that a $10 adjustment would be adequate to incent hospital behavior,” the American Hospital Association said in its comments.

The American Society of Nuclear Cardiology said it cannot “provide sufficient comment on the proposed payment level without having the opportunity to evaluate the sources and data CMS used to make its determination that an additional $10 is the appropriate amount to cover the costs of isotopes from non-HEU sources.”

Health and Human Services officials declined to provide such information, saying they could not comment on a pending rulemaking.

Nonproliferation experts have described the CMS proposal as a positive step toward addressing concerns that Russia – which is expected to expand medical isotope production using highly enriched uranium when a Canadian reactor goes offline in 2016 – could undercut U.S. companies developing the likely more expensive technology needed to create a steady supply of isotopes derived from LEU material.

One issue specialist warned, however, that the plan might not on its own be enough to ensure a switch to LEU material. He said the dispute over how much Medicare should pay for non-HEU isotopes underscores this concern.

The disagreement over proper compensation “underlines the need to pass appropriate legislation that would provide additional incentives for LEU-based production,” Miles Pomper, a senior research associate with the James Martin Center for Nonproliferation Studies, told Global Security Newswire on Thursday.

Another concern for the industry groups is an aspect of the proposal that, in the event of an audit, would require hospitals to prove that a medical isotope for which it received the additional $10 credit was derived entirely from non-highly enriched uranium sources. They say this requirement would be difficult to meet, particularly because the LEU isotope manufacturing industry is still developing.

Until a steady supply of non-HEU isotopes are available, the government “should, at a minimum, allow a payment adjustment for lower percentages of non-HEU sources and institute a multiyear phase-in period,” according to the American Hospital Association.

The American Society of Nuclear Cardiology also encouraged a phase-in period and raised concerns about liability. It said “hospitals may understandably be uncomfortable in attesting that the supplies are from non-HEU sources when there is no reliable guarantee that the products are indeed from non-HEU sources.”

The final rule should “clarify the adequate documentation necessary to confirm that the provider obtained a dose for a particularly patient is 100 percent non-HEU,” the group said. “Hospitals and nuclear medicine laboratories should not bear the significant administrative burden to achieve this goal.”

Centers for Medicare and Medicaid Services officials are expected to make a final decision on the proposal after reviewing the public comments.

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