Medicare's National Coverage Determinations in Diagnostic Radiology: Examining Evidence and Setting Limits

doi:10.1016/j.acra.2012.05.005

Academic Radiology

Volume 19, Issue 9, September 2012, Pages 1060-1065

https://doi.org/10.1016/j.acra.2012.05.005 Get rights and content

Objective

To systematically review and summarize the Center for Medicare and Medicaid Services (CMS) national coverage determination (NCDs) pertaining diagnostic imaging technologies from 1999 through 2010.

Methods

All NCDs pertaining to diagnostic imaging were identified from the Tufts Medical Center NCD database. The variables under study included the quality of the clinical evidence and the final coverage determination. The types of restrictions were categorized. We also categorized the final decisions as “positive coverage” or “no positive/no change in coverage” and assessed the correlation between positive coverage and other variables using Fisher exact test.

Results

Twenty-two of 152 (15%) NCDs pertained to diagnostic imaging technologies. The supporting evidence was judge to be good, fair, and poor in 5, 6, and 11 cases, respectively. Eleven technologies (50%) were covered with conditions, four (18%) deferred the coverage decision to local level, and two (9%) were completely not covered. In five instances there was no change to the prior coverage status. Of the 11 decisions resulting in positive coverage, 8 (73%) restricted use to specific population subgroups, 5 (46%) applied restrictions related to treatment, 4 were covered with evidence development, and 2 were restricted to care in specific settings. A significantly higher rate of positive coverage decisions was achieved if the available evidence was good (100% 5/5) or fair (83% 5/6) compared to technologies with poor evidence (10% 1/10) (P < .01).

Conclusion

CMS has demonstrated a propensity to limit the use of advanced diagnostic imaging to scenarios in which appropriateness is supported by adequate evidence of clinical utility and improved outcomes with the quality of evidence being a significant factor on final decisions. Understanding the need for high-quality evidence and the types of limitations placed on coverage allows for appropriate planning for the incorporation of diagnostic imaging technologies into clinical practice.

Section snippets

Materials and methods

We used the Tufts Medical Center NCD database maintained by the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center for this research (12). We identified all the NCDs pertaining to diagnostic imaging on the database, which includes information for all NCDs made since 1999 (Fig 1). To construct the database, each NCD was reviewed independently by two trained readers using a standardized nonvalidated data extraction form and data collected for more than 30 attributes.

Results

Thirty-six of 152 (24%) NCDs between 1999 and 2010 pertained to imaging technologies, 22 evaluated diagnostic imaging (14.5% of all NCDs and 61% of all imaging-related NCDs), and 12 evaluated image-guided therapy, nuclear medicine therapy, or interventional imaging procedures.

The imaging modalities most commonly reviewed were: positron emission tomography (PET) (n = 15) and MRI (n = 4). PET technologies included the following radiopharmaceutical tracers: ¹⁸F-fleurodeoxy-glucose (18F-FDG; n

Discussion

We found that diagnostic imaging and other imaging technologies had substantial representation in Medicare NCDs, accounting for approximately 15% and 24%, of total NCDs between 1999 and 2010, respectively. These percentages are higher than the proportion of Medicare expenditures consumed by diagnostic imaging. For example, in the most common types of cancer, the percentage of estimated total cost represented by imaging in Medicare patients in 2006 was between 2.7% and 5.8% (14). Overall,

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Radiological alliance for health services researchMedicare's National Coverage Determinations in Diagnostic Radiology: Examining Evidence and Setting Limits

Objective

Methods

Results

Conclusion

Section snippets

Materials and methods

Results

Discussion

J Am Coll Radiol

Medicare program; revised process for making Medicare National Coverage Determinations

Federal Register

Does Medicare have an implicit cost-effectiveness threshold?

Med Decis Making

Radiological alliance for health services research
Medicare's National Coverage Determinations in Diagnostic Radiology: Examining Evidence and Setting Limits