CMS Currently Relies on Each Accrediting Organization to Establish Its Own Standards

CMS did not establish minimum national standards for ADI accreditation,  and instead required each accrediting organization to establish its own  specific standards for quality and safety of ADI services. CMS drafted more specific standards for the accreditation of ADI  suppliers in 2010, but did not publish these standards or propose  adopting them. Representatives from the three approved accrediting  organizations—as well as 9 of the 11 organizations with imaging  expertise from which we obtained information—recommended that CMS  adopt minimum national standards, which would help to ensure that all  accredited ADI suppliers meet a minimum level of quality and safety. In addition, prior to granting accreditation, both ACR and IAC evaluate  suppliers’ patient images (called “clinical images”) to ensure that images  meet specific criteria, as recommended by 8 of the 11 organizations with  imaging expertise. CMS’s Current Oversight Is Limited

CMS’s oversight efforts have focused primarily on ensuring that only  accredited suppliers’ claims are paid; the agency does not have a  systematic oversight process for other aspects of the ADI accreditation  requirement. CMS Has Not Developed an Oversight Framework for Evaluating Accrediting Organization Performance

Although CMS is responsible for evaluating the performance of  accrediting organizations, and CMS officials have indicated that its goal is  to improve the quality of ADI services, it has not developed an oversight  framework that would enable it to monitor and measure performance. A  CMS official knowledgeable about the accreditation requirement stated  that the requirement had been in effect for less than 1 year at the time of  our review, and acknowledged that the agency’s oversight process was  not as robust as it could be. This official reported that primary  responsibility for oversight of the accreditation requirement was in the  process of being transferred from CMS’s Center for Program Integrity to  the Center for Clinical Standards and Quality. We found that as of January 2013, CMS had not yet established specific  performance expectations or developed plans for conducting validation  audits of accredited suppliers, which are one of the most effective  techniques CMS has for collecting information about accrediting  organization performance. CMS Guidance on Mid- Cycle Audits and Identification of Serious Care Problems Is Limited

Although CMS requires accrediting organizations to conduct mid-cycle  audits of accredited suppliers—including unannounced site visits—to help  ensure they maintain compliance for the duration of the accreditation  cycle, CMS does 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 during such audits. In addition, CMS guidance is not sufficient to ensure that accrediting  organizations consistently identify and report serious care problems that  pose immediate jeopardy to Medicare beneficiaries or suppliers’ staff. However, there are  significant differences among the accrediting organizations, which arise  from CMS’s lack of minimum national standards. As a result, 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. Recommendations for Executive Action

To help ensure that ADI suppliers provide consistent, safe, and high- quality imaging to Medicare beneficiaries, we recommend that the  Administrator of CMS take the following three actions: 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; develop an oversight framework for evaluating accrediting  organization performance, which could include collecting and  analyzing information on accreditation results and conducting  validation audits; and 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. The three accrediting organizations also reviewed and provided  comments on a draft of this report. ACR and IAC concurred with the  report’s findings and recommendations. Rather, because our study is focused on imaging in particular, we  determined whether the three CMS-selected accrediting organizations  use standards specific to imaging that were recommended by  organizations with expertise in this area. We indicate in the report that the standards the 11  organizations identified do not represent the full range of possible  standards for the accreditation of ADI suppliers, but rather provide a  framework for comparing the standards used by the accrediting  organizations selected by CMS. While our report assessed the standards currently in use for ADI  accreditation, it is ultimately CMS’s responsibility to determine the content  of minimum national standards for ADI accreditation.
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.

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.

What GAO Recommends

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.