Medicare's Proposed Decision on CT Colonography: Why Not Coverage with Evidence Development?
In its work on health care reform, the Congressional Budget Office has noted that “[m]any analysts attribute the bulk of the growth in health care spending to the development and diffusion of new medical technology.” However, it’s one thing to identify the issue; quite another to deal with it. When one looks at actual reform options, it becomes apparent that wringing budget savings out of technology is no easy task, for, to do so, reformers must plumb complex issues that shape the content of care for many Americans. These complex issues are on display already in Medicare, and they suggest that the road to health reform will be littered with medical nuance and controversy.
For example, earlier this week, CMS released a draft coverage decision on CT colonography as a screening test for colorectal cancer based on an evaluation of clinical factors as well as cost effectiveness. The AHRQ tech assessment on CT colonography, which calculated the cost effectiveness ratios for several types of screening tests and scenarios, appears to be the very type of information that will be supported by the $1.1 billion investment in the stimulus bill.
The preliminary coverage decision states that “CMS does not believe that the evidence is sufficient to conclude that screening CT colonography improves net health benefits for asymptomatic, average risk Medicare beneficiaries”. The Agency has raised several questions where it wants additional information about the use of the procedure in the Medicare population. CMS could answer these questions by applying its own policy of Coverage with Evidence Development (CED) to CT colonography, thereby contributing to the substantial evidence base that was developed already as part of a significant investment on the part of health care professionals, researchers and health care manufacturers.
The application of CED for some clinical uses of Positron Emission Tomography (PET) is proof that, though cumbersome, CED data collection is possible, even before we have the clinical data repositories which will become part of the national health information technology infrastructure outlined in the health IT provisions of the stimulus bill.
The Agency for Healthcare Research and Quality (AHRQ) is set to receive $300 million for comparative effectiveness research; a 20 fold budget increase for similar activities authorized by the Medicare Modernization Act (MMA) of 2003. While some fear that the substantial amount of funding for comparative effectiveness, coupled with the investment in health IT will lead to a rationing of health care, others see the research as an important investment in providing useful information to decide between two or more tests or treatments.
The stimulus bill’s conference report tries to balance the two perspectives and notes that comparative effectiveness research is not intended to be used to “mandate coverage, reimbursement, or other policies for any public or private payer”. Nonetheless, several CMS national coverage decisions make it obvious that the research can “inform” coverage policy.
The lesson of the draft coverage decision on CT colonography is that our binary approach to coverage decision-making is flawed. CMS was wise to develop the CED policy. In the short-term, CMS should apply the CED policy to answer important questions which the Agency raised about the use of CT colonography to increase the woefully inadequate rate of colorectal cancer screening among Medicare beneficiaries. Longer-term, CMS should contribute to the discussions of how beneficiary access to valuable, innovative health care services can be assured by the appropriate application of the CED policy, facilitated in the long term by a functional national health IT infrastructure.
