Radiology continues to benefit from constant innovation and technological advances.
However, for promising new imaging technologies to reach widespread clinical practice,
several milestones must be met. These include regulatory approval, early clinical
evaluation, payer reimbursement, and broader marketplace adoption. Successful implementation
of new imaging tests into clinical practice requires active stakeholder engagement
and a focus on demonstrating clinical value during each phase of translation.
Key Words
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References
- Optimizing technology development and adoption in medical imaging using the principles of innovation diffusion, part II: practical applications.J Digit Imaging. 2012; 25: 7-10
- “Off label” use of FDA-approved devices and digital breast tomosynthesis.AJR Am J Roentgenol. 2015; 205: 1149-1151
- Overview of device regulation.(Available at)http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/Date: 2017Date accessed: January 2, 2017
- Regulation of medical devices in radiology: current standards and future opportunities.Radiology. 2001; 218: 329-335
- The adoption of innovation.Radiology. 2008; 246: 659-661
- Diffusion of innovations.5th ed. Free Press, New York, NY2003
- Assessing radiologist performance using combined digital mammography and breast tomosynthesis compared with digital mammography alone: results of a multicenter, multireader trial.Radiology. 2013; 266: 104-113
- Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice.AJR Am J Roentgenol. 2014; 203: 687-693
- Digital breast tomosynthesis and the challenges of implementing an emerging breast cancer screening technology into clinical practice.J Am Coll Radiol. 2013; 10: 913-917
- Current procedural terminology: history, structure, and relationship to valuation for the neuroradiologist.AJNR Am J Neuroradiol. 2016; https://doi.org/10.3174/ajnr.A4863
- CPT: an open system that describes all that you do.J Am Coll Radiol. 2008; 5: 555-560
- From concept to CPT code to compensation: how the payment system works.J Am Coll Radiol. 2004; 1: 48-53
- Current procedural terminology; a primer.J Neurointerv Surg. 2015; 7: 309-312
- Reassessing Medicare trends in diagnostic CT colonography after achieving CPT code category I status.Abdom Radiol (NY). 2016; 41: 1357-1362
- Cardiac CT and coronary CTA: early Medicare claims analysis of national and regional utilization and coverage.J Am Coll Radiol. 2011; 8: 549-555
- Expanding utilization and regional coverage of diagnostic CT colonography: early Medicare claims experience.J Am Coll Radiol. 2011; 8: 235-241
- An overview of the development and refinement of the Resource-Based Relative Value Scale. The foundation for reform of U.S. physician payment.Med Care. 1992; 30: NS1-12
- Resource-based relative values. An overview.JAMA. 1988; 260: 2347-2353
- RVU & RBRVS basics.(Available at)http://medgroup.ucsf.edu/data-warehouse/rvu-rbrvs-basicsDate accessed: July 30, 2016
- RBRVS overview.(Available at)https://www.ama-assn.org/rbrvs-overviewDate accessed: July 30, 2016
- Medicare's national coverage determinations in diagnostic radiology: examining evidence and setting limits.Acad Radiol. 2012; 19: 1060-1065
- Compilation of the social security laws.(Available at)http://www.ssa.gov/OP_Home/ssact/title18/1862.htmDate accessed: September 26, 2016
- Revised process for making Medicare national coverage determinations.2003
- Medicare coverage policy—MCAC charter.(Available at)http://www.cms.gov/mcac/default.aspDate accessed: September 28, 2016
- Guidance for the public, industry and CMS staff. Factors CMS considers in opening a national coverage determination 2006.(Available at)https://www.cms.gov/medicarecoverage-database/details/medicare-coverage-document-details.aspxDate accessed: September 26, 2016
- Reduced lung-cancer mortality with low-dose computed tomographic screening.N Engl J Med. 2011; 365: 395-409
- Issues to consider before implementing digital breast tomosynthesis into a breast imaging practice.AJR Am J Roentgenol. 2015; 204: 681-684
- Overview of the evidence on digital breast tomosynthesis in breast cancer detection.Breast. 2013; 22: 101-108
- Breast density legislation and opportunities for patient-centered outcomes research.Radiology. 2012; 264: 632-636
- Patient-centered outcomes research in radiology: trends in funding and methodology.Acad Radiol. 2014; 21: 1156-1161
- Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program.Radiology. 2013; 267: 47-56
- Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study.Lancet Oncol. 2013; 14: 583-589
- Breast cancer screening using tomosynthesis in combination with digital mammography.JAMA. 2014; 311: 2499-2507
- Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society.JAMA. 2015; 314: 1599-1614
- Screening for breast cancer: U.S. preventive services task force recommendation statement.Ann Intern Med. 2016; 164: 279-296
- Comparative effectiveness research: what it means for radiology.Radiology. 2009; 253: 600-605
- Comparative effectiveness of combined digital mammography and tomosynthesis screening for women with dense breasts.Radiology. 2015; 274: 772-780
- ACR advocates for breast tomosynthesis coverage.(Available at)https://www.acr.org/Advocacy/eNews/20160812-Issue/20160812-ACR-Advocates-for-Breast-Tomosynthesis-CoverageDate accessed: March 14, 2017
Article info
Publication history
Published online: August 23, 2017
Accepted:
March 30,
2017
Received:
March 26,
2017
Footnotes
Dr. C.I. Lee receives research support from the American Cancer Society (126947-MRSG-14-160-01-CPHPS). Dr. Chokshi receives research support from the AUR GE Radiology Research Academic Fellowship and the ASNR Comparative Effectiveness Research Award. Dr. Duszak receives research support from the Harvey L. Neiman Health Policy Institute.
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Copyright
© 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.