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.
Developments in medical imaging technology represent a surpassing diagnostic advancement in modern medicine. These advancements have been accompanied by increased utilization and substantial associated costs (eg, the estimated number of magnetic resonance imaging [MRI] and computed tomography [CT] studies tripling over the past 10 years). This “imaging boom” raises myriad questions for patients, providers, and payers with respect to the appropriateness of the use of diagnostic imaging technology . Between 2000 and 2006, Medicare spending for imaging services more than doubled to an estimated $14 billion . Some evidence suggests that a portion of this spending was neither necessary nor appropriate . Based on that premise, the US Government Accountability Office recommended that the Centers for Medicare and Medicaid Services (CMS) implement additional management practices such as prior authorization and modifications to its payment methods in order to limit the growth . More recently, CMS established an imaging demonstration project to evaluate whether the implementation of clinical decision support systems increases the appropriateness of use of advanced imaging services for specific indications .
Medicare coverage decisions are guided by the legislation that created Medicare, which states that “Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury” . Fifteen regional Medicare administrative contractors make the majority of coverage decisions for medical interventions. However, for interventions deemed to have a significant impact on the Medicare program, CMS performs a national coverage determination (NCD) . CMS makes approximately 10–15 NCDs each year. In an NCD, CMS reviews the available evidence to determine if the intervention is reasonable and necessary for the diagnosis of illness or injury for Medicare beneficiaries. As part of the NCD, CMS may commission a technology assessment or consult the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), an external advisory panel established to provide independent guidance and expert advice to CMS on specific clinical topics. The NCD process is transparent and includes opportunity for public participation. NCDs are publicly available via decision memoranda on the CMS website. Although on occasion CMS has cited cost-effectiveness evidence in decision memoranda, its stated position is that cost and cost-effectiveness evidence is not relevant to coverage . CMS rarely issues an absolute coverage decision; rather, coverage is typically restricted to patient subgroups or to particular clinical circumstances .
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Materials and methods
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Results
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Table 1
Basic Characteristics of Diagnostic Imaging Pertaining National Coverage Determinations-NCD between 1999 and 2010
Imaging modality under study Number (%) PET 15 (68) Magnetic resonance imaging 4 (18) Computed tomography 2 (9) Ultrasound 1 (5) Total 22 (100) NCD requestor Number (%) Professional/medical societies 12 (55) Internally generated 8 (36) Private party 1 (5) Manufacturer 1 (5) Total 22 (100) FDA status Number (%) Approved for indication 18 (82) Off-label use 3 (14) Under FDA review 1 (5) Total 22 (100) Reason for NCD Number (%) New evidence 9 (41) Requested by professional society/medical group 8 (36) Recent FDA approval 7 (32) Clinical controversy 4 (18) As part of broader PET coverage petition 2 (9) At manufacturer’s request 1 (5) Technology newly commercially available 1 (5) Reason not stated in decision memorandum 1 (5) Formal technology assessment Number (%) Yes 14 (64) No 8 (36) Reviewed by MedCAC Number (%) Yes 9 No 13
FDA, Food and Drug Administration; MedCAC, Medicare Evidence Development & Coverage Advisory Committee; NCD, national coverage determination; PET, positron emission tomography.
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Table 2
List of All Center for Medicare and Medicaid Services Diagnostic Imaging Related National Coverage Determinations between 1999 and 2010
Year Technology Technology Assessment Formal MedCAC Review Quality of Evidence Final Decision Restrictions Decision ID 2000 FDG PET Yes Yes Fair Covered with conditions Treatment restrictions applied CAG-00065N 2001 FDG PET scanner technology (differences between full-ring PET and gamma cameras) No No Poor No change in coverage CAG-00090N 2002 FDG PET for breast cancer Yes Yes Poor No change in coverage CAG-00094N 2002 FDG PET for myocardial viability Yes No Good Covered with conditions Restricted to certain population subgroups CAG-00098N 2003 FDG PET scan for the standard work-up of AD Yes Yes Poor No change in coverage CAG-00088N 2003 FDG PET for soft-tissue sarcoma Yes Yes Poor No change in coverage CAG-00099N 2003 MR angiography of the abdomen and pelvis No No Good Covered with conditions Restricted to certain population subgroups CAG-00142N 2003 N-13 ammonia PET for myocardial perfusion No No Good Covered with conditions Restricted to certain population subgroups CAG-00165N 2003 FDG PET for thyroid cancer Yes Yes Fair Covered with conditions Only approved within data collection process
Treatment restrictions applied
Restricted to certain population subgroups CAG-00095N 2004 MR spectroscopy for brain tumors Yes No Poor Completely not covered CAG-00141N 2004 FDG PET and other neuroimaging devices for mild cognitive impairment (MCI) and early dementia in elderly patients Yes No Fair Covered with conditions Only approved within data collection process
Restricted to patients receiving care in specific care settings
Restricted to certain population subgroups CAG-00088R 2005 FDG PET for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers Yes No Poor Covered with conditions Restricted to certain population subgroups
Treatment restrictions applied CAG-00181N 2007 Esophageal ultrasound doppler monitoring of cardiac output Yes No Good Covered with conditions Restricted to certain population subgroups
Restricted to patients receiving care in specific care settings CAG-00309R 2008 Cardiac computed tomography angiography for coronary artery disease Yes Yes Poor Coverage decision to be made at local level CAG-00385N 2008 FDG PET for chronic osteomyelitis, infection of hip arthroplasty, and fever of unknown origin No No Poor Completely not covered CAG-00382N 2009 MR imaging: remove noncoverage of blood flow measurement and noncoverage for patients with cardioverter-defibrillators/pacemakers No No Fair Coverage decision to be made at local level CAG-00399R 2009 Screening CT colonography for colorectal cancer Yes Yes Poor No change in coverage CAG-00396N 2009 FDG PET for cervical cancer Yes Yes Good Covered with conditions Treatment restrictions applied CAG-00181R2 2009 FDG PET for most solid tumor oncologic indications and for myeloma Yes Yes Fair Covered with conditions Only approved within data collection process
Restricted to certain population subgroups
Treatment restrictions applied CAG-00181R 2010 MR angiography No No Poor Coverage decision to be made at local level (merge to MRI section: see CAG-00399R) CAG-00142R 2010 Positron emission tomography for initial treatment strategy in solid tumors and myeloma No No Poor Coverage decision to be made at local level CAG-00181R3 2010 NaF-18 PET to identify bone metastasis of cancer No No Fair Covered with conditions Only approved within data collection process CAG-00065R
AD, alzheimer dementia; CT, computed tomography; decision ID, decision memoranda identification number; FDG, 18-fludeoxyglucose; MedCAC, Medicare Evidence Development & Coverage Advisory Committee; MR, magnetic resonance; PET, positron emission tomography.
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Discussion
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