What GAO Found
The Centers for Medicare & Medicaid Services (CMS) did not establish minimum national standards for the accreditation of suppliers of advanced diagnostic imaging (ADI) services, which cover the production of images for computed tomography, magnetic resonance imaging, and nuclear medicine services. While CMS adopted the broad criteria from the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) for ADI accreditation, it relied on the three accrediting organizations it selected to establish their own standards for quality and safety. To establish a framework for assessing the ADI standards currently in use, GAO developed a list of nine standards based on recommendations from 11 organizations with imaging expertise from which GAO obtained information. Two of the three accrediting organizations that CMS selected use all nine standards, while the third organization uses six of the nine standards. For example, while two of the organizations evaluate suppliers' patient images, the third said that it instead assesses suppliers' compliance with other standards necessary to maintain image quality, such as those related to inspection and testing of imaging equipment. As a result of these significant differences among the accrediting organizations, which arise from the lack of minimum national standards, important aspects of imaging, such as qualifications of technologists and medical directors and the quality of clinical images, are difficult for CMS to monitor and assess. Nine of the 11 organizations with imaging expertise and representatives from all three accrediting organizations recommended that CMS adopt minimum national standards. CMS drafted standards in 2010, but did not publish them because the agency was focused on other priorities.
CMS's current oversight for the accreditation requirement is limited, as the agency focused its initial oversight efforts on ensuring that claims were paid only to accredited suppliers. Although CMS is responsible for evaluating the performance of accrediting organizations, the agency has not developed an oversight framework that would enable it to monitor and measure performance. CMS has not established specific performance expectations or developed plans for the validation audits of accredited suppliers as described in its regulations. Our previous work has shown that such independent evaluations are one of the most effective techniques CMS has to collect information about whether serious deficiencies are being identified. In addition, CMS's guidance to accrediting organizations on mid-cycle audits and serious care problems is limited. For example, CMS requires accrediting organizations to conduct mid-cycle audits to help ensure accredited suppliers maintain compliance for the 3-year accreditation cycle, but did not specify minimum expectations for this task, such as the minimum number or percentage of audits required or the types of supplier activities that should be assessed. In addition, two of the three accrediting organizations reported that CMS's guidance on identifying and reporting deficiencies that pose immediate jeopardy to Medicare beneficiaries or suppliers' staff was unclear. A CMS official stated that the accreditation requirement had been in operation for less than 1 year at the time of GAO's review, and reported that responsibility for oversight of the accreditation requirement was in the process of being transferred to another group within the agency.
Why GAO Did This Study
MIPPA required that beginning January 1, 2012, suppliers that produce the images for ADI services, such as physician offices and independent diagnostic testing facilities, be accredited by an organization approved by CMS. MIPPA directed GAO to conduct a preliminary report on the accreditation requirement in 2013 and a final report in 2014.
In this report, GAO assessed (1) CMSs standards for accreditation of ADI suppliers, and (2) CMSs oversight of the accreditation requirement. To assess CMSs standards and oversight, GAO reviewed CMS regulations related to MIPPA, interviewed and reviewed information from CMS and CMS-approved accrediting organizations, and reviewed information on recommended standards for ADI accreditation from 11 organizations with imaging expertise.
To help ensure that ADI suppliers provide safe and high-quality imaging to Medicare beneficiaries, GAO recommends that the Administrator of CMS determine the content of and publish minimum national standards for the accreditation of ADI suppliers; develop an oversight framework for evaluating accrediting organization performance; and develop more specific requirements for accrediting organization audits and clarify guidance on immediate-jeopardy deficiencies. The Department of Health and Human Services, which oversees CMS, concurred with GAOs recommendations.
Recommendations for Executive Action
|Centers for Medicare & Medicaid Services||To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should determine the content of and publish minimum national standards for the accreditation of ADI suppliers, which could include specific qualifications for supplier personnel and requiring accrediting organization review of clinical images.|
|Centers for Medicare & Medicaid Services||To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop an oversight framework for evaluating accrediting organization performance, which could include collecting and analyzing information on accreditation results and conducting validation audits.|
|Centers for Medicare & Medicaid Services||To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop more specific requirements for accrediting organization mid-cycle audit procedures and clarify guidance on immediate-jeopardy deficiencies to ensure consistent identification and timely correction of serious care problems for the duration of accreditation.|