Medical Device Daily Washington Editor
The Centers for Medicare & Medicaid Services has announced that it will not offer blanket coverage of the use of PET with an isotope of sodium fluoride (NaF-18) to stage treatments of metastatic bone cancer, declaring that the evidence "is not sufficient to determine that the results of NaF-18 PET imaging to identify bone metastases improve health outcomes." However, CMS is proposing to cover the technology as part of clinical trials, and at least one organization that commented on the idea saw the shortage of technetium-99 (Tc-99) as part of the rationale for covering NaF-18 PET.
According to the Nov. 30 announcement, any sponsors who would draw coverage for their trials will have to forge a trial that answers one or more of three questions. These are whether the diagnostic effort would prompt "a change in the likelihood of appropriate referrals for palliative care," would lead to an improved quality of life, or would improve survival. CMS proposes that the procedure would be covered for both initial staging and subsequent staging of tumor treatment in such trials, and the agency expects to finalize the memo by Feb. 28, 2010.
The memo states that while the literature is fairly supportive of the use of the technology in this application, these scans are somewhat subject to false positives. CMS also makes specific mention of outside concerns regarding the Tc-99 crunch, noting that several of those who commented upon the opening of the decision memo in July were of the view that this application of PET technology might become more essential given the recent scarcity of TC-99.
The announcement is fairly well supported by private insurers if a comment from America's Health Insurance Plans (AHIP; Washington) is any indication. Carmella Bocchino, AHIP's executive VP for clinical affairs said in a July 2 letter to CMS that the association's members "would support" a CED determination, although AHIP has questions regarding "diagnostic accuracy." Bocchino's letter also makes reference to the technetium crunch as an underlying rationale.
Robert Atcher, MD, past president of the Society for Nuclear Medicine (SNM; Reston, Virginia) and the chairman of SNM's domestic radioisotope task force, told Medical Device Daily that CMS handled the decision with a lot of input from medical societies. "The major reason [for the CED decision] was that they said they could make the decision much more quickly than if they had to do a standard reimbursement process." He added, "this is what we had agreed to with CMS."
Atcher noted that the CED route is "the same mechanism used to fund the National Oncology PET Registry (NOPR) study." He noted that as a result of the data garnered from this effort, "in about 40% of the cases, we either upstaged or downstaged" treatment due to data derived from the NOPR.
Atcher said the decision "is terrific because it gives us an alternative" to Tc-99, a commodity likely to be in short supply again when the reactor at Petten, the Netherlands, goes offline again in spring. With this decision, "if we ever get into a situation again where we're in a really short supply," doctors and patients have alternatives.
Atcher acknowledged that this decision was largely driven by the Tc-99 problem. He said that CMS "had been approached once and decided not to pursue it," but he also pointed out that European nations and Canada have already decided to pay for sodium fluoride PET imaging. "From that standpoint, the U.S. was really lagging," he observed.
Atcher also noted that medical societies are not averse to pitching in on studies of NaF-18 PET. "We're interested," he said, particularly because industry might not have a strong profit motive to conduct such trials due to lack of patent protection for NaF-18. He said SNM is particularly interested "in compounds like sodium fluoride, which don't have intellectual property interests" attached to them.
GAO: CMS contract controls deficient
The Government Accountability Office issued a report recently addressing CMS's contract controls, and while the report doesn't issue CMS a failing grade, the target of the report did not fare particularly well, either.
According to the Oct. 23 report, CMS administered roughly $3.6 billion in contracts in fiscal 2008 for various programs, but only about $2.5 billion of that amount was subject to the kind of scrutiny that was the subject of the GAO analysis. The report offers an analysis of 102 contracts, including those for work on programs such as the Part D prescription drug benefit, Medicaid and the State Children's Health Insurance Program. GAO asserts in the summary that more than 84% of the contracts lacked "a key control," and that "at least 37.2% ... had three or more instances in which a key control was not adequately implemented."
According to GAO, CMS "used cost reimbursement contracts without first ensuring that the contractor had an adequate accounting system," and the report blames much of the problem on "a weak overall control environment" and a failure to implement a series of recommendations made by GAO in 2007. Among those recommendations was that CMS clarify "the roles and responsibilities for implementing certain contractor oversight responsibilities," and the report alleges that CMS "had a backlog of contracts that were due for closeout" as of July.
CMS had a somewhat different take on the situation as expressed in an Oct. 2 letter from acting CMS administrator Charlene Frizzera to Andrea Palm, the acting assistant secretary for legislation at HHS. Frizzera notes that the report on CMS's work from 2007 "was issued in fiscal 2008" and that as a consequence, many of the contract actions reviewed in the latest report by GAO took place outside a time frame when "it was reasonably possible" for CMS to make some of the fixes recommended by GAO in the 2007 report.
Frizzera also flatly disagreed with many of the findings, arguing for instance that contractor accounting systems are now checked by an online system for contract applicants. Frizzera also argues that many contracts are mandated by Congress to go out on extremely short timelines, hence necessitating a work-around of the usual rules of contract acquisition.
Mark McCarty, 703-268-5690