Medicare Imaging Accreditation: Establishing Minimum National Standards and an Oversight Framework Would Help Ensure Quality and Safety of Advanced Diagnostic Imaging Services
Published: 2013-05-31T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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 GAOs recommendations.

section_title: Letter
paragraphs: Advanced diagnostic imaging (ADI) services, such as computed  tomography (CT), magnetic resonance imaging (MRI), and nuclear  medicine (NM), allow physicians to diagnose life-threatening diseases like  cancer and heart disease with greater speed and precision. However,  quality problems such as inadequately trained technologists or poorly  functioning equipment can lead to duplicative or inaccurate imaging tests,  unnecessary exposure to radiation, missed or inaccurate diagnoses, and  inappropriate treatment. To address concerns regarding the quality of  imaging services provided to Medicare beneficiaries, the Medicare  Payment Advisory Commission (MedPAC) recommended that the  Centers for Medicare & Medicaid Services (CMS), which administers the  Medicare program, establish standards for imaging suppliers and select  accrediting organizations to verify compliance with those standards. The  Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)  required that beginning January 1, 2012, suppliers of the technical  component of ADI services be accredited by a designated accrediting  organization in order to receive Medicare payment for these services.  This requirement applies to ADI suppliers paid under the physician fee  schedule, such as physician offices and independent diagnostic testing  facilities. MIPPA outlined broad criteria that accrediting organizations  should use to evaluate ADI suppliers, such as standards for qualifications  of personnel and standards to ensure the safety of beneficiaries and staff.
CMS administers the MIPPA accreditation requirement on behalf of the  Secretary of Health and Human Services and has selected three  organizations to serve as designated accrediting organizations—the  American College of Radiology (ACR), the Intersocietal Accreditation  Commission (IAC), and The Joint Commission (TJC). CMS is also  responsible for overseeing accreditation organizations’ compliance with  MIPPA regulations. CMS officials indicated that the overall goal of the  program is to improve the quality of ADI services.
MIPPA directed us to report on the effect of the accreditation requirement  administered by CMS. We are required to issue a preliminary report in  2013 and a final report in 2014. In this preliminary report, we assessed   (1) CMS’s standards for accreditation of ADI suppliers, and (2) CMS’s  oversight of the accreditation requirement.
To assess CMS’s standards for accreditation of ADI suppliers, we  reviewed federal regulations related to the MIPPA accreditation  requirement, reviewed applications from accreditation organizations, and  interviewed CMS officials. In addition, we interviewed representatives  from each of the three accrediting organizations and collected information on the standards and processes they used to assess ADI  suppliers’ compliance with those standards. To establish a framework for  assessing the standards currently in use, we also obtained information on  recommended standards for ADI suppliers from 11 organizations with  imaging expertise. These included either organizations that represent  individuals that order, perform, or interpret images such as national  medical specialty societies or other organizations that focus on the quality  or safety of ADI services. We identified these 11 organizations through a  review of relevant industry and scholarly articles, government reports, and  congressional hearings. To identify recommended standards, we used a  structured questionnaire to ask these 11 organizations about the specific  types of standards they would expect for the accreditation of ADI  suppliers. On the basis of our review of their responses, we derived a list  of specific standards or practices supported by at least 5 of the 11  organizations—which we refer to as recommended standards—that could  be used by accrediting organizations to evaluate ADI suppliers. We then  determined whether each of the three CMS-designated accrediting  organizations used the recommended standards in its accreditation  process. Because we used a sample of organizations with imaging  expertise, the standards they 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.
To assess the effectiveness of CMS’s oversight of the accreditation  requirement, we analyzed the laws and regulations that define CMS’s role  and authority. On the basis of our review of CMS’s oversight authority and  the agency’s goal for accreditation to improve the quality of ADI services,  we reviewed three components of CMS oversight: (1) mechanisms for  ensuring payment is made only to accredited suppliers; (2) processes for  evaluating accrediting organizations’ performance; and (3) policies for  ensuring that ADI suppliers maintain compliance with standards for the  duration of the accreditation cycle and that serious care problems are  identified and corrected. To supplement our review of CMS oversight, we  also collected information on accreditation results from each of the three  accrediting organizations, including the percentage of suppliers that were  not granted accreditation after the first attempt, as well as the types of  deficiencies most frequently identified.
To provide context for our findings, we also compared CMS’s standards  and oversight mechanisms for the ADI accreditation requirement to those  used by the Food and Drug Administration (FDA) to ensure the quality of  another type of imaging—mammography. We previously reported that  FDA’s implementation of the Mammography Quality Standards Act of  1992 (MQSA) had a positive effect on the quality of mammography  without negatively affecting access to these services.reviewing our prior work on mammography, we reviewed the laws and  regulations that define FDA’s responsibilities for oversight of  mammography and its standards for selected accrediting bodies.
We conducted this performance audit from May 2012 to May 2013 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Imaging Modalities
paragraphs: MIPPA defines ADI services to include diagnostic CT, MRI, and NM,  including positron emission tomography (PET). CT is an imaging  modality that uses ionizing radiation and computers to produce cross- sectional images of internal organs and body structures. MRI is an  imaging modality that uses powerful magnets, radio waves, and  computers to create cross-sectional images of internal body tissues. NM  is the use of radioactive materials in conjunction with an imaging modality  to produce images that show both structure and function within the body.  During an NM service, such as a PET scan, a patient is administered a  small amount of radioactive substance, called a radiopharmaceutical or  radiotracer, which is subsequently tracked by a radiation detector outside  the body to render time-lapse images of the radioactive material as it  moves through the body.
Imaging equipment that uses ionizing radiation—such as CT and NM— poses greater potential short- and long-term health risks to patients than  other imaging modalities, such as ultrasound. This is because ionizing  radiation has enough energy to potentially damage DNA and thus  increase a person’s lifetime risk of developing cancer. In addition,  exposure to very high doses of this radiation can cause short-term  injuries, such as burns or hair loss. Each of the modalities using ionizing  radiation uses different amounts of such radiation. For example,  conventional X-ray imaging, in which X-rays are projected through a  patient’s body to produce two-dimensional pictures of organs and tissue,  uses relatively low amounts of radiation in order to render a diagnostic- quality radiographic image. Because CT and NM services can involve  repeated or extended exposure to ionizing radiation, they are associated  with the administration of higher radiation doses than conventional X-ray  imaging systems. In its 2010 initiative to reduce unnecessary radiation,  FDA reported that the effective dose from a CT is roughly equivalent to  100 to 800 chest X-rays, whereas a NM service is equivalent to 10 to  2,050 chest X-rays.higher-resolution images, FDA advises that an optimal radiation dose is  one that is as low as reasonably achievable while maintaining sufficient  image quality to meet the clinical need. Although MRIs do not use ionizing  radiation, they pose other potential dangers; for example, magnetic fields  from the MRI unit can result in a “projectile effect,” in which magnetic  material, such as the metal in oxygen cylinders or wheelchairs, can be  pulled suddenly and—often violently—toward the imaging equipment at  times while a patient lies in the center of the magnet and while medical  personnel are attending to the patient.
section_title: MIPPA Requirements
paragraphs: MIPPA requires the establishment of procedures to ensure that  accrediting organizations include standards specific to each imaging  modality for ADI suppliers in the following five areas: (1) qualifications of  medical personnel who are not physicians and who furnish the technical  component of ADI services; (2) qualifications and responsibilities of  medical directors and supervising physicians; (3) procedures to ensure  that equipment used in furnishing the technical component of ADI  services meets performance specifications; (4) procedures to ensure the  safety of beneficiaries and staff; and (5) establishment and maintenance  of a quality-assurance and quality-control program that ensures the  reliability, clarity, and accuracy of the technical quality of diagnostic  images produced by suppliers.
MIPPA accreditation applies only to suppliers paid under the Medicare  physician fee schedule that provide the technical component of ADI  services. Suppliers paid under the physician fee schedule include  physician offices and independent diagnostic testing facilities, which are  independent of a hospital or physician office and provide only diagnostic  outpatient services. MIPPA accreditation does not apply to the technical  component of ADI services provided in Medicare settings not paid under  the physician fee schedule, such as hospital inpatient or outpatient  departments.of the three CMS-designated organizations and pay the organization an  accreditation fee. Among other things, CMS requires accrediting  organizations to evaluate ADI suppliers during the initial application  regarding compliance with MIPPA requirements—such as qualifications  of personnel—as well as during mid-cycle audit procedures to ensure  suppliers maintain compliance for the duration of the accreditation cycle,  which is a 3-year period. ACR and IAC primarily grant initial accreditation  through an online application and review of suppliers’ documents, while  TJC uses an online application but also conducts an on-site visit for each  supplier prior to granting accreditation.
To become accredited, ADI suppliers must first select one  Information about the three accrediting organizations that CMS has  designated for ADI suppliers—ACR, IAC, and TJC—follows in table 1.
CMS has several responsibilities to ensure the quality of ADI services  paid under Medicare’s physician fee schedule. In addition to selecting  accrediting organizations, CMS is responsible for ensuring that Medicare  payment is made only to ADI suppliers accredited by a CMS-approved  accrediting organization. MIPPA requires CMS to oversee the accrediting  organizations and authorizes CMS to modify the list of selected  accrediting organizations, if necessary. Federal regulations specify that  CMS may conduct “validation audits” of accredited ADI suppliers and  provide for the withdrawal of CMS approval of an accrediting organization  at any time if CMS determines that the accrediting organization no longer  adequately ensures that ADI suppliers meet or exceed Medicare  requirements. In addition, accrediting organizations are required to  report serious care problems that pose immediate jeopardy to a  beneficiary or to the general public to CMS within 2 business days of  identifying such problems. CMS also has ongoing requirements for  accrediting organizations; among other things, accrediting organizations  are responsible for using mid-cycle audit procedures, such as  unannounced site visits, to ensure that accredited suppliers maintain  compliance with MIPPA’s requirements for the duration of the  accreditation cycle.
section_title: FDA Oversight of Mammography
paragraphs: MQSA, as amended by the Mammography Quality Standards  Reauthorization Acts of 1998 and 2004, established national quality  standards for mammography to help ensure the high quality of images  and image interpretation that mammography facilities produce. Under  MQSA, FDA—acting on behalf of the Department of Health and Human  Services (HHS)—has several responsibilities to ensure the quality of  mammography: establishing quality standards for mammography equipment,  personnel, and practices; ensuring that all mammography facilities are accredited by an FDA- approved accrediting body and have obtained a certificate permitting  them to provide mammography services from FDA or an FDA- approved certification agency; ensuring that all mammography equipment is evaluated at least  annually by a qualified medical physicist and that all mammography  facilities receive an annual compliance inspection from an FDA- approved inspector; and performing annual evaluations of the accreditation bodies and  certification agencies.
section_title: CMS Currently Relies on Each Accrediting Organization to Establish Its Own Standards
paragraphs: 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. In 2009, CMS  solicited applications from accrediting organizations and outlined the  information that needed to be furnished by each organization to be  considered for approval. As part of its application requirements, CMS  adopted the broad MIPPA criteria for ADI accreditation and required each  accrediting organization to provide a detailed description of how its  standards satisfy these requirements. For example, CMS required each  accrediting organization to have standards regarding qualifications for  suppliers’ technologists and medical directors, but allowed the accrediting  organizations to establish their own minimum certification, experience,  and continuing education requirements. In addition, CMS required  accrediting organizations to provide documentation of other requirements,  such as detailed information about the individuals who perform  evaluations for accrediting organizations and a description of the  organization’s data management and analysis capabilities in support of its  surveys and accreditation decisions. CMS received three applications  from its solicitation and in January 2010, the agency reported that an  internal professional panel had reviewed the applications and determined  that all three organizations provided sufficient evidence of their ability to  accredit ADI suppliers on the basis of CMS’s requirements.
CMS drafted more specific standards for the accreditation of ADI  suppliers in 2010, but did not publish these standards or propose  adopting them. A CMS official told us that the agency developed the draft  standards in conjunction with FDA and incorporated comments from  each of the accrediting organizations. This official also told us that the  draft standards were not put through the rulemaking process because the  agency was focused on developing regulations for the Patient Protection  and Affordable Care Act, which was enacted 2010. As of January 2013,  these CMS standards remained in draft form, and officials told us that the  agency did not have a specific timeline for publishing the standards in a  proposed rule. 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, we have reported that the quality of mammography services  improved under MQSA primarily as a result of setting national quality- assurance standards—such as those related to personnel qualifications  and clinical image quality—and establishing enforcement mechanisms to  ensure that the standards are met by all mammography providers.
The list of recommended standards was derived from recommendations obtained from  at least 5 of 11 organizations with imaging expertise about the specific types of standards  that they would expect accrediting organizations to use. variation in state requirements for training and certification of  technologists, and lack of training is widely recognized as a cause of  significant errors in the provision of ADI services. Another of the 11  organizations, the American Society of Radiologic Technologists,  reported that imaging services performed by individuals who are not  experienced, educated, or certified in a specific imaging modality could  compromise the quality of images or jeopardize the health or safety of  supplier staff or Medicare beneficiaries.
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. One of the 8, the American College of Cardiology,  called the review of clinical images an essential component for assessing  the capability of imaging equipment and the proficiency of staff in  acquiring images. ACR and IAC also evaluate suppliers’ phantom images  prior to granting accreditation, which are images of a solid object  designed to mimic critical imaging characteristics of patients that are used  for the assessment of certain performance parameters of imaging  equipment, as recommended by 5 of the 11 organizations. One of the 5,  the American Association of Physicists in Medicine, reported that  phantom images permit more objective evaluations of ADI equipment  performance and a standardized format against which the imaging  performance of various facilities can be evaluated. Further, FDA- approved accrediting bodies are also required to review mammography  suppliers’ clinical and phantom images, and we have reported with regard  to mammography that evaluating phantom images is one of the most  important processes for testing equipment.
TJC does not systematically evaluate suppliers’ clinical or phantom  images to ensure that images meet specific criteria, although TJC  representatives reported assessing compliance with standards that  require suppliers to identify and implement activities necessary to  maintain the reliability, clarity, and accuracy of the technical quality of  images. According to TJC representatives, health care services are  provided in an environment that must be comprehensively assessed, and  no single checklist can fulfill this. For example, they reported that  evaluating an image does not reveal anything about the systems that  support imaging safety such as the adequacy of safety checks,  equipment maintenance, expertise of staff, and whether there is a  primacy on patient and staff safety that permeates the facility’s culture  and process. However, ADI suppliers have been delayed accreditation by  ACR and IAC on the basis of problems with the quality of their clinical  images, such as inadequate anatomic coverage or excessive artifacts.  We and others have reported that quality problems with medical images  can have serious consequences, such as missed or inaccurate diagnoses  or inappropriate treatment.that can result from poor-quality images, there are currently no image  review requirements or other national standards for ADI accreditation.
section_title: CMS’s Current Oversight Is Limited
paragraphs: 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 a framework for evaluating  accrediting organization performance, and its current guidance is  insufficient to ensure that suppliers maintain compliance with standards  for the duration of the accreditation cycle and to ensure that serious care  problems are consistently identified and reported.
subsections: section_title: CMS’s Oversight Efforts Have Focused on Ensuring That Only Accredited Suppliers Are Paid
paragraphs: CMS’s oversight efforts have primarily focused on ensuring that only  accredited suppliers’ claims are paid. To ensure payment is made only to  accredited suppliers, CMS officials told us that they require accrediting  organizations to submit updated information about accredited suppliers  on a weekly basis, including their national provider identifier (NPI),  enrollment number, address, name, and dates of accreditation for each  modality. They explained that these data are uploaded into the Medicare  Provider Enrollment, Chain and Ownership System (PECOS)—CMS’s  centralized database for Medicare provider enrollment information—and  are matched against all claims submitted by ADI suppliers. If the NPI on a  supplier’s claim does not match an accredited supplier listed in PECOS,  the claim is denied. CMS officials told us that there were problems with  accredited suppliers’ claims being denied when the accreditation  requirement first went into effect because suppliers used an incorrect  NPI; however, CMS officials and representatives from two of the  accrediting organizations reported that these issues generally have been  resolved.
section_title: CMS Has Not Developed an Oversight Framework for Evaluating Accrediting Organization Performance
paragraphs: 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. Although the accreditation  requirement became effective January 1, 2012, it has been enacted into  law since 2008 and CMS had selected accrediting organizations in  January 2010, providing the agency with nearly 2 years to develop a plan  for evaluating their performance before the effective date of the  requirement.
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. Federal regulations provide for audits of a  representative sample of accredited suppliers, which enable CMS to  validate the processes used by approved accrediting organizations.  These regulations also note that CMS may notify an accrediting  organization of its intent to withdraw approval for an accrediting  organization on the basis of the disparity between its findings and those  of the respective accrediting organization. Further, in the absence of  minimum national standards, it is unclear what measures CMS would use  in its audits to validate the accreditation process and determine whether  services provided by accredited ADI suppliers meet a sufficient level of  quality and safety.
In addition, CMS does not systematically collect or analyze readily  available data to monitor accrediting organization performance. Collecting  and analyzing information from accrediting organizations on accreditation  results, such as the proportion of suppliers delayed accreditation and the  types of care problems identified, could provide useful information about  accrediting organization performance and help CMS ensure that  accreditation is improving the quality and safety of ADI services. CMS  does not systematically collect or analyze data on the proportion of  suppliers that were not granted accreditation after the first attempt, and  we found significant variation among accrediting organizations on the  rates of these “delayed” accreditations. For calendar year 2012, IAC and  ACR representatives reported that the proportion of CT suppliers delayed  accreditation was 81 percent with IAC and 25 percent with ACR; likewise,  the proportion of NM suppliers delayed accreditation was 60 percent with  IAC and 4 percent with ACR.were due to actual variations in the quality of services provided by  suppliers or to differences in approaches used by accrediting  organizations to enforce compliance with their standards. Similarly, CMS  does not define the care problems, or “deficiencies,” that may be  identified by accrediting organizations that can result in delayed or denied  accreditations, nor does it systematically collect information about or  analyze the deficiencies identified. We found wide variation in the types of  deficiencies most frequently identified by each accrediting organization  during the accreditation process, which raises questions about whether  organizations are consistently identifying care problems. For example,  ACR most frequently identified problems with suppliers failing to submit  required information, including clinical images of diagnostic quality; IAC  most frequently identified problems with the interpretive reports written by  physicians; and TJC most frequently identified problems on a wider range  of issues, including problems with clinical privileges, equipment  maintenance, medication management, infection control, and leadership.
section_title: CMS Guidance on Mid- Cycle Audits and Identification of Serious Care Problems Is Limited
paragraphs: 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. We found  that the mid-cycle audits conducted by accrediting organizations varied in  number and type. ACR conducted unannounced site visits for  approximately 1 percent of its accredited suppliers in 2012, but ACR  intends to increase this amount to approximately 15 percent in 2013. IAC  representatives stated that they ensure that all accredited suppliers  undergo at least one unannounced site visit or a performance audit— which requires accredited suppliers to submit specified documentation  including clinical images, interpretive reports, and quality-improvement  documentation—to ensure continued compliance with IAC standards over  the 3-year accreditation period. TJC representatives stated that they  conduct unannounced site visits for 2 percent of its accredited suppliers  and also require all accredited suppliers to demonstrate ongoing  compliance with TJC standards on an annual basis by having TJC  conduct an on-site assessment or by means of electronic submission of  an annual self-assessment. In contrast, federal regulations governing  mammography accreditation specify the minimum number or percentage  of on-site visits that should be conducted annually of accredited facilities  to monitor ongoing compliance with standards and outline the activities  that should be conducted during these visits.
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.  CMS developed a definition of immediate jeopardy, but did not provide  specific examples of the types of problems that pose an immediate health  risk for ADI services. We found a difference of opinion among the  accrediting organizations about the sufficiency of CMS’s guidance.  Representatives from TJC stated that CMS’s guidance was clear, while  ACR and IAC stated that the definition was too broad and stated that  additional guidance is needed on the types of activities that constitute  immediate jeopardy to either Medicare beneficiaries or suppliers’ staff.  We also found a difference of opinion about the types of activities that  could constitute immediate jeopardy. For example, ACR reported that  identifying metallic objects in the MRI suite would definitely constitute  immediate jeopardy, whereas TJC told us that this could constitute  immediate jeopardy if it was related to other pervasive lapses in safety.
ACR representatives stated that without more specific guidance, CMS  relies on accrediting organizations to determine what constitutes  immediate jeopardy, and noted that FDA’s guidance on this topic for  mammography accreditation is more helpful. Although federal regulations  require the accrediting organizations to report immediate-jeopardy  deficiencies of accredited suppliers to CMS within 2 business days, CMS  officials reported that none had been reported since the accreditation  requirement went into effect. It is unclear whether CMS’s lack of guidance  has contributed to the fact that no immediate-jeopardy deficiencies have  been reported. For example, representatives from one accrediting  organization reported that there were circumstances in which they may  not report potential immediate jeopardy deficiencies to CMS because they  were not certain of exactly what constituted immediate jeopardy.
section_title: Conclusions
paragraphs: The MIPPA accreditation requirement is an important step in helping to  ensure the safety and quality of imaging services. To meet the January 1,  2012, implementation date for MIPPA’s accreditation requirement, CMS  focused its initial efforts on selecting accrediting organizations and  ensuring that only accredited suppliers were paid. 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. CMS lacks an oversight framework for evaluating the  performance of selected accrediting organizations, and lacks specific  guidance to help ensure that a sufficient number or percentage of mid- cycle audits occurs and that the types of serious care problems that could  constitute immediate jeopardy are clear to all accrediting organizations.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency and Third Party Comments and Our Evaluation
paragraphs: We provided a draft of this report to HHS and to the three CMS-approved  accrediting organizations for comment. In its written response,  reproduced in appendix I, HHS concurred with all of our  recommendations and identified actions that the department and CMS  officials plan to take to implement them. Specifically, HHS stated these  actions would include  facilitating discussions with stakeholders and national experts to  gather feedback on national standards for accreditation of ADI  suppliers; developing an oversight framework for evaluating accrediting developing more specific requirements for accrediting  organizations’ review procedures and providing guidance and  education on immediate-jeopardy deficiencies.
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. IAC representatives also said  that minimum standards for ADI accreditation should include a review of  suppliers’ interpretive reports of patient images, in addition to the other  standards identified in the report. In contrast, TJC disagreed with the  report’s findings and methodology. A summary of TJC’s specific  comments and our response follows. The three accrediting organizations  also provided technical comments, which we incorporated as appropriate.
TJC stated that the report’s methodology was flawed and that it provided  an incomplete portrayal of the necessary components of an ADI  accreditation program. TJC indicated that the 11 organizations from which  we obtained information on standards focused only on imaging and did  not include organizations that focus more broadly on quality and safety.  As a result, TJC stated that the report excluded other factors that affect  quality oversight and improvement, and indicated that we lacked data to  analyze the effectiveness of the different approaches used by each of the  three organizations. Our purpose was not to compare the effectiveness of  the three ADI accreditation programs, but rather to assess the ADI  standards currently in use and determine whether CMS has adequate  assurance that all accredited suppliers meet a minimum level of quality  and safety. Further, we did not intend to conduct a comprehensive  evaluation of TJC’s overall accreditation program, which considers  aspects of quality and safety that go beyond criteria outlined in MIPPA for  imaging accreditation, such as examining whether a supplier creates and  maintains a culture of safety and quality throughout the organization.  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.
TJC also questioned our threshold for presenting standards that were  recommended by 5 of 11 of the organizations, indicating that this  represented agreement from less than 50 percent of the organizations.  Because the 11 organizations have expertise in different areas of  imaging, not all organizations commented on all sections of the  questionnaire we sent to them. For example, the American Board of  Orthopaedic Surgery recommended standards related to the  qualifications of medical directors, but not procedures to ensure that  equipment meets performance specifications. As a result, it would not be  reasonable or appropriate to expect consensus for all recommended  standards, as some standards were outside of an organization’s area of  expertise. 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. HHS has indicated that it plans to  facilitate discussions with stakeholders and national experts to gather  feedback on national standards for accreditation of ADI suppliers.
Finally, TJC stated that the report places inordinate value on image  accuracy and professional credentials. We discuss those aspects of  imaging in the report because they were among the nine standards that  were identified by at least 5 of the 11 organizations with imaging  expertise. For example, 8 of the 11 organizations believe that examining  clinical images is an important aspect of accreditation for ADI services,  and it is unclear how problems with image quality can be detected without  reviewing images. Similarly, TJC stated that we provided no data to show  that phantom testing results in better image quality in practice. Phantom  image testing was recommended by 5 of the 11 organizations with  imaging expertise, and has been required by FDA for over a decade to  test imaging conducted by mammogram facilities under MQSA. Further,  phantom images provide a standardized format against which imaging  performance of various suppliers can be evaluated; this is important given  that factors outside of a supplier’s control, such as a patient’s weight or  particular health conditions, can affect a supplier’s ability to produce high- quality images.
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. This could include,  for example, determining whether clinical image review and phantom  testing should be required for ADI accreditation, a decision that could be  informed by its planned discussions with stakeholders and national  experts. We stand by our report and findings, and believe that by  adopting our recommendations for minimum national standards, as HHS  has stated it intends to do, CMS will significantly enhance its ability to  ensure both imaging quality and patient safety.
We are sending copies of this report to the Secretary of Health and  Human Services and relevant congressional committees. The report will  also be available at no charge on the GAO website at http://www.gao.gov.
If you or your staff has any questions about this report, please contact me  at (202) 512-7114 or cosgrovej@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made major contributions to this report  are listed in appendix II.
section_title: Appendix I: Comments for the Department of Health and Human Services
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Phyllis Thorburn, Assistant  Director; William Black; Kye Briesath; William A. Crafton; Beth Morrison;  Jennifer Whitworth; and Rachael Wojnowicz made key contributions to  this report.