Medicare Imaging Accreditation: Establishing Minimum National Standards and an Oversight Framework Would Help Ensure Quality and Safety of Advanced Diagnostic Imaging Services
Highlights
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) CMS’s standards for accreditation of ADI suppliers, and (2) CMS’s oversight of the accreditation requirement. To assess CMS’s 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.
Recommendations
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
| Agency Affected | Recommendation | Status |
|---|---|---|
| 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. |
CMS concurred with the recommendation in 2013, stating they would take steps to develop standards. The agency stated that when it concurred with our recommendation, it was agreeing to gather feedback on standards, which it did, as well as changing its oversight of the ADI program within CMS. The agency subsequently stated that, in the 10 years since our report was published, CMS has taken steps to ensure the health and safety of ADI services. For example, CMS developed a process for overseeing accrediting organizations which, according to CMS, its process includes monitoring AO data, complaints, and immediate jeopardy deficiencies. According to 2013-2022 data, the agency received few complaints. The agency also reported that there were no reported deficiencies and that it has not identified problems through its oversight of the four AOs. CMS believes these findings suggest that the health and safety of imaging services provides to Medicare beneficiaries is sufficient. CMS told us and provided documentary evidence that the agency would continue to monitor AO data and will revisit the issue of national standards if they are warranted in the future. Considering the actions CMS has taken since our report was issued, we believe it is no longer clear that implementing our recommendation is necessary to help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries. As such, we are closing this recommendation as no longer valid.
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| 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. |
CMS concurred with this recommendation and stated in September 2022 that the agency had taken several actions-including reviewing ADI accrediting organization standards-to oversee ADI accrediting organizations. In addition, CMS monitors accrediting organization-submitted data, including information on the number of accredited ADI organizations, beneficiary complaints, and immediate jeopardy deficiencies. CMS stated that the agency reviews this along with previously submitted data to identify trends or changes in ADI accrediting organizations over time.
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| 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. |
CMS concurred with the recommendation in 2013, noting it would develop more specific requirements for AO review procedures and would provide guidance and education on immediate jeopardy deficiencies. Since our report was issued in 2013, CMS has reviewed AOs' mid-cycle audit policies and the agency's guidance on immediate jeopardy deficiencies. CMS determined, based on its review of AOs' mid-cycle audit procedures and discussions with principal AO staff, that each AO has sufficient policies for regular performance of unannounced mid-cycle audits and that each AO regularly performs these audits in accordance with these policies. In addition, in 2016, CMS obtained AO feedback on an immediate-jeopardy policy and a standard reporting form that AOs are required to complete upon learning of an immediate-jeopardy deficiency. In 2021, the agency determined, based on feedback from the AOs, that adding specificity on the types of situations that constitute immediate-jeopardy deficiencies would not be helpful in identifying such situations. CMS therefore requires AOs to establish and implement their own procedures for identifying immediate-jeopardy deficiencies and investigating them in a timely manner, which includes notifying CMS immediately of such situations and initiating an investigation within two business days. CMS provided quarterly meeting minutes documenting discussions the agency had with AOs on immediate jeopardy deficiencies between April 2016 and July 2022. These discussions involved CMS providing examples of what it considered immediate jeopardy deficiencies and describing the requirements for reporting deficiencies. The AOs also had opportunities during these meetings to ask questions and report deficiencies. The documentation we reviewed did not indicate any reported deficiencies. Given the steps CMS has taken since 2013 to review AOs' mid-cycle audit procedures and clarify its guidance on immediate-jeopardy deficiencies, we believe it is unclear whether fully implementing our recommendation by developing more specific requirements regarding such deficiencies is necessary to ensure the health and safety of ADI imaging. As such, we are closing this recommendation as no longer valid.
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