Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services this week reported that it has opted to stand pat on its national coverage determination for clinical trial policy rather than impose further conditions for coverage.

According to an Oct. 17 statement, the agency decision “is based on a thorough review and consideration of comments from the public, and the enactment of the Food and Drug Administration Amendments Act of 2007.” Comments provided by various other stakeholders influenced the outcome as well.

CMS had come to the conclusion that Medicare contractors had been paying for beneficiary participation in clinical trials that were outside the terms of the previous iteration of clinical trial policy, issued in 2000. But that version apparently did not mandate that CMS pay for beneficiary participation in clinical trials for off-label device use or in trials that sought to enhance surgical procedures.

The preliminary version of the new policy, published in April, did nothing to clarify the matter and, despite the fact that there was little indication that CMS had previously been stingy about coverage, hospitals and device makers saw the new policy as an opening for coverage denial.

The agency floated a series of additional standards in July in an attempt to clarify the issue, but, according to the agency’s statement, it had “received numerous comments from the public with regard to the authority of CMS to establish standards and provide limitations to coverage within research studies.” Some of those comments indicated that “the proposed policy was confusing, and that CMS should use notice and comment rulemaking to provide a longer transition period for clinical trials to prepare for these changes.”

Among the comments received by CMS was one from the American Medical Association (AMA; Washington), which said that the policy of non-coverage of services, that would be covered had the beneficiary not been enrolled in the trial, would be “punitive to beneficiaries and is not consistent with the statutory language” that requires coverage of services deemed reasonable and necessary.

AMA urged CMS to “revise this policy in the final decision memorandum.”

Alexandra Clyde, VP for health policy and payment at Medtronic (Minneapolis, Minnesota), wrote that “without the requested clarifications to the NCD, it is likely that Medicare beneficiaries will have to be informed that their coverage may be withdrawn if they participate in certified clinical studies.”

Clyde said that such a scenario “would have a chilling effect on Medicare beneficiaries’ participation in clinical studies, particularly when they can receive the same covered items and services outside of the study without risk of non-coverage.”

CMS said that after “careful consideration of the public comments and this new legislation, the agency has decided that a change to the July 9, 2007, NCD would be inappropriate at this time.”

CMS indicated that it h two priorities in the case of such coverage. The first is that trials provide appropriate protections for patients and the second is to ensure beneficiary access to studies, and this latter priority forces CMS “to ensure providers are confident of payment for services provided to Medicare beneficiaries.”

Kerry Weems, acting CMS administrator, said in the statement that the decision to make no change “enables Medicare beneficiaries to continue, as before, participation in clinical research studies with the support of Medicare.” He said that the agency “will continue to work to further refine the policy, as appropriate, in order to ensure the quality and appropriateness of trials that enroll Medicare beneficiaries.”

AHRQ says hospital CV mortality down

The Agency for Healthcare Research and Quality (AHRQ; Washington) recently published a statistical brief on hospital mortality for a series of diagnoses as part of its Healthcare Cost and Utilization Project (HCUP), the numbers indicating that hospitals have made substantial inroads on mortality associated with cardiovascular disease.

According to the HCUP statistical brief, covering data from community hospitals between 1994 and 2004, hospital mortality for acute myocardial infarction (AMI) “had the largest [absolute] reduction in hospital deaths per 1,000 admissions” for all the procedures tracked in the survey, “with 43 fewer in-hospital deaths per 1,000 admission” in 2004 compared to 1994. The drop was from 125 deaths per 1,000 to 82 for AMI.

Hospital mortality rates for abdominal aortic aneurysm also demonstrated substantial reductions in mortality, dropping from 103 to 74 deaths per 1,000 admissions for a net reduction of 29. Congestive heart failure deaths per 1,000 admissions fell from 67 to 38 deaths per 1,000, whereas mortality from stroke fell 138 to 105 deaths per 1,000. Pneumonia mortality also fell by more than 30 per 1,000, from 106 to 70.

Some other conditions — not quite so deadly to begin with — offered less opportunity for improvement.

Neurosurgical procedures requiring craniotomy (removal and replacement of skull) declined by 15, from 83 to 68 deaths per 1,000, and carotid endartectomy, the removal of stenotic tissue from the carotid artery, dropped by only five per 1,000. But the mortality rate in 1994 for this procedure was only 12 per 1,000, a reduction of nearly 40%, a figure much higher than for the other procedures.