MEDICARE IMAGING 

ACCREDITATION

Establishing Minimum 

National Standards 

and an Oversight 

Framework Would 

Help Ensure Quality 

and Safety of 

Advanced Diagnostic 

Imaging Services

Report to Congressional Committees

May 2013

GAO-13-246

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-13-246, a report to 

congressional committees

May 2013

MEDICARE IMAGING ACCREDITATION

Establishing Minimum National Standards and an 

Oversight Framework Would Help Ensure Quality 

and Safety of Advanced Diagnostic Imaging Services

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 CMSapproved accrediting organizations, 

and reviewed information on 

recommended standards for ADI 

accreditation from 11 organizations 

with imaging expertise.

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 GAO’s 

recommendations.

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 

View GAO-13-246. For more information, process of being transferred to another group within the agency.

contact James Cosgrove at (202) 512-7114 or 

cosgrovej@gao.gov.
Page i GAO-13-246 Medicare Imaging Accreditation

Letter 1 

Background 5

CMS Currently Relies on Each Accrediting Organization to 

Establish Its Own Standards 10

CMS’s Current Oversight Is Limited 15

Conclusions 20

Recommendations for Executive Action 20

Agency and Third Party Comments and Our Evaluation 21

Appendix I Comments for the Department of Health and Human 

Services 25

Appendix II GAO Contact and Staff Acknowledgments 27

Tables

Table 1: Information about CMS-Designated Accrediting 

Organizations 8

Table 2: Accrediting Organizations’ Use of Advanced Diagnostic 

Imaging Standards Recommended by Organizations with 

Imaging Expertise 14

Contents 
Page ii GAO-13-246 Medicare Imaging Accreditation

Abbreviations

ACR American College of Radiology

ADI advanced diagnostic imaging

CMS Centers for Medicare & Medicaid Services

CT computed tomography

FDA Food and Drug Administration

HHS Department of Health and Human Services

IAC Intersocietal Accreditation Commission

MedPAC Medicare Payment Advisory Commission

MIPPA Medicare Improvements for Patients and Providers Act 

 of 2008

MQSA Mammography Quality Standards Act of 1992

MRI magnetic resonance imaging

NM nuclear medicine

NPI national provider identifier

PECOS Provider Enrollment, Chain and Ownership System

PET positron emission tomography

TJC The Joint Commission

This is a work of the U.S. government and is not subject to copyright protection in the 

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Page 1 GAO-13-246 Medicare Imaging Accreditation

441 G St. N.W.

Washington, DC 20548

May 31, 2013

Congressional Committees

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.1 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)2 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.3

This requirement applies to ADI suppliers paid under the physician fee 

schedule, such as physician offices and independent diagnostic testing 

facilities.4

 

1

There are six types of medical imaging capabilities, referred to as modalities: CT, MRI, 

NM, ultrasound, X-ray and other standard imaging, and procedures that use imaging, such 

as using ultrasound to localize a needle when performing a biopsy.

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. 

2

MedPAC is an independent federal body that advises Congress on issues affecting the 

Medicare program. See MedPAC, Report to the Congress: Medicare Payment Policy 

(Washington, D.C.: March 2005). 

3

Pub. L. No. 110-275, § 135(a), 122 Stat. 2494, 2532 (codified at 42 U.S.C.§ 1395m(e)).

Medicare divides payment for ADI services into two components: the technical 

component, which is the production of the image, and the professional component, which 

is a physician’s interpretation of the image and report on the findings.

4

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.

 
 

Page 2 GAO-13-246 Medicare Imaging Accreditation

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.5

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.

CMS officials indicated that the overall goal of the 

program is to improve the quality of ADI services. 

6

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 organizations7

 

5

Federal agencies in addition to CMS have regulatory responsibility for imaging devices 

and services, including FDA and the Nuclear Regulatory Commission. FDA is responsible 

for establishing quality standards for mammography equipment and ensuring that 

manufacturers of radiation-emitting imaging equipment are in compliance with applicable 

performance standards. The Nuclear Regulatory Commission oversees the medical uses 

of nuclear materials used by physicians, hospitals, and others through licensing, 

inspection, and enforcement programs.

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 

6

In the final report, we plan to examine the effect of the accreditation requirement on ADI 

services on the basis of data available in 2013. This could include the effect of 

accreditation on utilization, quality, and beneficiary access to ADI services.

7

At the time of our review, CMS was in the process of reviewing an application for another 

accrediting organization.
 

Page 3 GAO-13-246 Medicare Imaging Accreditation

or safety of ADI services.8 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.9

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 

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.

 

8

We obtained information from the following organizations: The American Academy of 

Neurology, the American Academy of Orthopaedic Surgeons, the American Board of 

Orthopaedic Surgery, the American Association of Physicists in Medicine, the American 

College of Cardiology, the American Society of Nuclear Cardiology, the American Society 

of Radiologic Technologists, the Conference on Radiation Control Program Directors, the 

Medical Imaging & Technology Alliance, the Radiology Outcomes Research Laboratory at 

the University of California, San Francisco, and the Society for Nuclear Medicine and 

Molecular Imaging. 

9

The 11 organizations have expertise in different areas of ADI services; as a result, not all 

organizations commented on all sections of the questionnaire or on all three modalities. 

For example, the American Board of Orthopaedic Surgery recommended standards 

related to the qualifications of medical directors or supervising physicians, but not 

procedures to ensure that equipment meets performance specifications.
 

Page 4 GAO-13-246 Medicare Imaging Accreditation

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.10 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.11

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.

In addition to 

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.

 

10In response to concerns about the safety, accuracy, and quality of mammography—an 

imaging service that uses X-rays to detect small tumors and breast abnormalities—the 

Mammography Quality Standards Act of 1992 (MQSA) and the Mammography Quality 

Standards Reauthorization Acts of 1998 and 2004 were enacted. Pub. L. No. 102-539, 

106 Stat. 3547; Pub. L. No. 105-248, 112 Stat. 1864; Pub. L. No. 108-365, 118 Stat. 1738 

(pertinent provisions of all three laws codified at 42 U.S.C. § 263b). FDA administers the 

requirements of MQSA on behalf of the Department of Health and Human Services 

(HHS). 

11See GAO, Mammography Services: Impact of Federal Legislation on Quality, Access, 

and Health Outcomes, GAO/HEHS-98-11 (Washington, D.C.: Oct. 21, 1997).
 

Page 5 GAO-13-246 Medicare Imaging Accreditation

MIPPA defines ADI services to include diagnostic CT, MRI, and NM, 

including positron emission tomography (PET).12

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 diagnosticquality 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 

CT is an imaging 

modality that uses ionizing radiation and computers to produce crosssectional 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.

 

12MIPPA also provided for the inclusion of certain other diagnostic imaging services as 

specified by CMS in consultation with physician specialty organizations and other 

stakeholders.

Background 

Imaging Modalities
 

Page 6 GAO-13-246 Medicare Imaging Accreditation

2,050 chest X-rays.13 Because using a higher radiation dose can produce 

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.

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.14

 

13The radiation doses vary based on the type of imaging exam conducted. For example, a 

CT scan of the head uses less radiation than a CT scan of the abdomen. See FDA, 

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging (Silver 

Spring, Md.: February 2010), accessed January 6, 2013, http://www.fda.gov/RadiationEmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm.

14MIPPA also provided for the inclusion of any additional standards CMS determines 

appropriate. Throughout this report, we use the term technologists to refer to nonphysician 

medical personnel who furnish the technical component of ADI services. We use the term 

medical directors to refer to medical directors and supervising physicians because, under 

applicable federal regulations, these may be the same person. 42 C.F.R. § 414.68 

(c)(1)(ii) (2012). 

MIPPA Requirements
 

Page 7 GAO-13-246 Medicare Imaging Accreditation

MIPPA accreditation applies only to suppliers paid under the Medicare 

physician fee schedule that provide the technical component of ADI 

services.15 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.16

Information about the three accrediting organizations that CMS has 

designated for ADI suppliers—ACR, IAC, and TJC—follows in table 1.

To become accredited, ADI suppliers must first select one

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.

 

15The technical component of the Medicare payment is designed to cover the cost of 

performing an imaging test, including the costs for equipment, supplies, and nonphysician 

staff, whereas the professional component is designed to cover the provider’s time in 

interpreting the image and writing a report on the findings. The technical and professional 

components of imaging can be billed separately if the performing and interpreting 

providers are different, and can be billed together on what is called a global claim if the 

same provider performs and interprets the imaging service.

16Hospitals must comply with Medicare’s “conditions of participation” rules, which include 

general standards for imaging equipment and facilities, staff qualifications, patient safety, 

record keeping, and proper handling of radioactive materials.
 

Page 8 GAO-13-246 Medicare Imaging Accreditation

Table 1: Information about CMS-Designated Accrediting Organizations

American College of Radiology 

(ACR)

Intersocietal Accreditation 

Commission (IAC)

The Joint Commission 

(TJC)

Suppliers accredited, by modalitya

CT suppliers 3,636 1,361 64

MRI suppliers 4,035 1,052 68

NM suppliers 2,488 6,554 23

PET suppliers 1,009 635 7 

Total unique suppliers 6,855 8,491 98

Accreditation fee (dollars) 1,800 to 2,400

(per unit of imaging equipment; 

varies by modality)b

2,600 to 3,800

(per application; varies 

by modality)c

8,740 to 14,890

(per facility; varies by 

patient volume and 

includes an on-site visit 

for all applicants)d

Source: GAO analysis of information from CMS and CMS-designated accrediting organizations.

a

The number of accredited suppliers was provided by CMS on January 3, 2013. Each supplier may 

have multiple locations. The sum of the number of accredited suppliers by modality does not equal 

the total number of unique suppliers because some suppliers provide more than one imaging 

modality.

b

Discounted fees are available for facilities with more than one imaging unit and multiple modalities. 

Additional fees of $780 to $3,315 apply for a phantom, a solid object designed to mimic critical 

imaging characteristics of patients, such as bone and tissue, that is imaged using suppliers’ 

equipment to help assess performance parameters such as resolution and image uniformity. The 

price varies depending on the specific phantom and modality.

c

Application fee varies by modality and covers the first unit of imaging equipment for MRI and CT; the 

fee for NM and PET covers all of the equipment. For MRI and CT, discounted fees are available for 

each additional unit for facilities with more than one imaging unit. For all modalities, there is a 

discount for facilities with more than one site.

d

Additional fees apply for suppliers with more than one location or that require additional specialists. 

TJC accreditation for ADI is part of the accreditation program for ambulatory care facilities; its costs 

are based on the number of patient visits rather than on each imaging unit or modality. TJC 

accreditation fees include an on-site visit fee for all applicants and an annual fee billed each year 

during the 3-year accreditation cycle.

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 

CMS Oversight
 

Page 9 GAO-13-246 Medicare Imaging Accreditation

requirements.17 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.18 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.

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 FDAapproved accrediting body and have obtained a certificate permitting 

them to provide mammography services from FDA or an FDAapproved certification agency;

19

• 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 FDAapproved inspector; and

• performing annual evaluations of the accreditation bodies and 

certification agencies.

 

1742 C.F.R. § 414.68(g), (h) (2012).

1842 C.F.R. § 414.68(g), (2012).

19Mammography facilities operated by the Department of Veterans Affairs are excluded 

from FDA review.

FDA Oversight of 

Mammography
 

Page 10 GAO-13-246 Medicare Imaging Accreditation

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.20

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

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.

21

 

20Medicare Program: Payment Policies Under the Physician Fee Schedule and Other 

Revisions to Part B for CY 2010. 74 Fed. Reg. 61,738 (Nov. 25, 2009) (codified at 

42 C.F.R. § 414.68(c)(1)(2012)).

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 

21FDA collaborated with CMS to incorporate key quality-assurance practices into 

accreditation and participation criteria for imaging facilities as part of its ongoing efforts to 

reduce radiation exposure from imaging services. See FDA, Initiative to Reduce 

Unnecessary Radiation Exposure from Medical Imaging. 

CMS Currently Relies 

on Each Accrediting 

Organization to 

Establish Its Own 

Standards 
 

Page 11 GAO-13-246 Medicare Imaging Accreditation

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 qualityassurance 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.22

CMS’s lack of similar minimum national standards may prevent it from 

ensuring that all accredited ADI suppliers meet a minimum level of quality 

and safety. We found that two of the three accrediting organizations used 

all nine recommended standards we assessed, while the third 

organization used six of the nine standards (see table 2).23 For example, 

ACR and IAC standards require technologists and medical directors to 

meet minimum qualifications based on specific certification, experience, 

or continuing-education requirements, as recommended by organizations 

with expertise in imaging.24

 

22See 

In contrast, TJC standards do not require 

technologists and medical directors to meet specified minimum 

qualifications, but rather require these personnel to meet applicable laws 

as well as to meet qualifications defined by the supplier to perform 

assigned responsibilities. However, TJC’s guide for evaluating ADI 

services indicates that not all states require technologists to be certified 

and have ongoing education. Further, 1 of the 11 organizations with 

imaging expertise—the Radiology Outcomes Research Laboratory at the 

University of California, San Francisco—reported that there is wide 

GAO/HEHS-98-11 and Mammography Services: Initial Impact of New Federal Law 

Has Been Positive, GAO/HEHS-96-17 (Washington, D.C.: Oct. 27, 1995).

23The 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.

24Nine of the 11 organizations with imaging expertise recommended specific minimum 

qualifications for technologists or medical directors, and 5 of the 11 organizations 

recommended minimum qualifications for both. As an example of such qualifications, ACR 

requires medical directors for MRI services to have certain specified qualifications, such 

as board certification from the American Board of Radiology and specified experience 

requirements, such as reading 300 exams over a 36-month period; in addition, medical 

directors must earn at least 15 hours of continuing medical education requirements over a 

36-month period.
 

Page 12 GAO-13-246 Medicare Imaging Accreditation

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, FDAapproved 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.25

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 

 

25See GAO, FDA’s Mammography Inspections: While Some Problems Need Attention, 

Facility Compliance is Growing, GAO/HEHS-97-25 (Washington, D.C.: Jan. 27, 1997).

FDA also requires each accrediting body to annually conduct random clinical image 

reviews of at least 3 percent of the facilities the body accredits.
 

Page 13 GAO-13-246 Medicare Imaging Accreditation

images.26 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.27

We and others have reported that quality problems with medical images 

can have serious consequences, such as missed or inaccurate diagnoses 

or inappropriate treatment.28 Despite the potential health consequences 

that can result from poor-quality images, there are currently no image 

review requirements or other national standards for ADI accreditation.

 

26Such standards include, for example, requiring suppliers to inspect, test, and maintain 

imaging equipment. In addition, TJC representatives told us that a radiologist on the team 

may review supplier clinical images, but a systematic evaluation of clinical images is not 

part of the organization’s accreditation standards.

27Artifacts refer to any feature that appears in an image that is not present in the original 

imaged object. Artifacts may be caused by a variety of factors, such as improper operation 

by the technologist or patient movement. Image artifacts can obscure, and be mistaken 

for, pathology.

28See GAO/HEHS-98-11; MedPAC: Report to the Congress: Medicare Payment Policy; 

and Examining the Appropriateness of Standards for Medical Imaging and Radiation 

Therapy Technologists: Testimony in Support of the Consistency, Accuracy, 

Responsibility and Excellence in Medical Imaging and Radiation Therapy Bill (H.R. 2104),

Before the House Energy and Commerce Committee, Subcommittee on Health, 112th 

Cong. (2012) (statement of Sal Martino, Chief Executive Officer, American Society of 

Radiologic Technologists).
 

Page 14 GAO-13-246 Medicare Imaging Accreditation

Table 2: Accrediting Organizations’ Use of Advanced Diagnostic Imaging Standards Recommended by Organizations with 

Imaging Expertise

Recommended standardsa American College of Radiology (ACR)

Intersocietal 

Accreditation 

Commission (IAC)

The Joint 

Commission (TJC)

Personnel qualifications

Ensures that supplier technologists and medical directors 

meet minimum qualifications based on specified 

certification, experience or continuing education 

requirementsb

  c

Equipment performance

Ensures that supplier conducts equipment maintenance 

and quality control tests as specified by the manufacturer

  

Ensures that supplier medical physicist (or similarly 

qualified expert) evaluates equipment performance at least 

annually

  

Evaluates supplier phantom imagesd  

Quality assurance

Ensures that supplier has established a quality assurance 

program that evaluates specific components of 

performance such as image quality and peer review of 

image interpretation

  

Evaluates supplier patient (clinical) images  

Ensures that supplier reviews whether patient images are 

clinically appropriate

  

Safety

Ensures that supplier maintains policies and procedures for 

patient and personnel safety as appropriate for the modality

  

Ensures that supplier keeps radiation exposure as low as 

reasonably achievable for a quality image

  

Source: GAO analysis of information from accrediting organizations and organizations with imaging expertise.

a

The list of recommended standards above 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.

b

We use the term medical directors to refer to medical directors and supervising physicians because 

these may be the same person.

c

TJC standards require technologists and medical directors to meet applicable laws as well as to 

meet qualifications defined by the supplier to perform assigned responsibilities. Its standards also 

require that licensed independent practitioners, such as radiologists and nonradiologist physicians, be 

licensed by the state or the Nuclear Regulatory Commission; however, documentation does not 

indicate whether these requirements apply specifically to technologists or medical directors and may 

not apply to all modalities.

d

A phantom is a solid object designed to mimic critical imaging characteristics of patients, such as 

bone and tissue, that is imaged using suppliers’ equipment to help assess performance parameters 

such as resolution and image uniformity.
 

Page 15 GAO-13-246 Medicare Imaging Accreditation

A CMS official told us that each accrediting organization has unique 

strengths, and representatives from the three accrediting organizations 

cited examples of their organization’s strengths. For example, an ACR 

representative told us that ACR systematically evaluates phantom

images,29 whereas IAC representatives told us that IAC evaluates 

suppliers’ interpretive reports of images and the associated clinical 

findings. Representatives from TJC indicated that TJC’s approach is 

holistic, using a tracer methodology to follow the care, treatment, or 

services received by patients.30 According to TJC representatives, a 

checklist approach can be problematic because the processes used by 

suppliers to achieve their goals may differ, and innovations with respect to 

quality may occur faster than standards can be developed. In addition, 

TJC representatives pointed out that TJC is the only organization that 

conducts an on-site visit of each ADI supplier prior to accreditation, 

providing onsite education and offering suggestions for approaches and 

strategies that may help the supplier better meet the intent of the 

standards and, more importantly, improve performance.

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.

 

29ACR representatives told us that its physicists evaluate and score phantom images on 

the basis of performance criteria that the organization has specified for each modality. In 

contrast, representatives from IAC told us that its organization evaluates phantom images 

on the basis of criteria established by each supplier’s quality improvement committee or 

the equipment manufacturer, or both.

30The tracer methodology is used during TJC’s on-site survey to identify performance 

issues in one or more steps of the health care delivery process. TJC uses three types of 

tracers: (1) program-specific tracers, which identify safety concerns within different levels 

and types of care, treatment, or services; (2) individual tracers, which “trace” the care, 

treatment, or services received by individual patients; and (3) system tracers, which 

explore one specific system or process across the organization.

CMS’s Current 

Oversight Is Limited
 

Page 16 GAO-13-246 Medicare Imaging Accreditation

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.

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.31 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.

 

31In its comments on our draft report, the Department of Health and Human Services 

indicated that the transition to the Center for Clinical Standards and Quality would become 

effective April 1, 2013. 

CMS’s Oversight Efforts 

Have Focused on Ensuring 

That Only Accredited 

Suppliers Are Paid

CMS Has Not Developed 

an Oversight Framework 

for Evaluating Accrediting 

Organization Performance
 

Page 17 GAO-13-246 Medicare Imaging Accreditation

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.32

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 

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.

 

32We have previously reported that a similar type of independent survey used by CMS is 

the most effective technique the agency has for assessing the ability of state agencies to 

identify serious deficiencies in nursing homes. See GAO, Nursing Homes, Prevalence of 

Serious Quality Problems Remains Unacceptably High, Despite Some Decline. 

GAO-03-1016T (Washington, D.C.: July 17, 2003) and Nursing Home Care, Enhanced 

HCFA Oversight of State Programs Would Better Ensure Quality, GAO/HEHS-00-6

(Washington, D.C.: Nov. 4, 1999).
 

Page 18 GAO-13-246 Medicare Imaging Accreditation

IAC and 4 percent with ACR.33 It is unclear whether these differences 

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.

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 

 

33We did not include TJC because of its small number of suppliers accredited. However, 

TJC representatives reported that they also delay accreditation when deficiencies are 

identified and do not grant accreditation until suppliers are in compliance with their 

standards.

CMS Guidance on MidCycle Audits and 

Identification of Serious 

Care Problems Is Limited
 

Page 19 GAO-13-246 Medicare Imaging Accreditation

the 3-year accreditation period.34 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.35

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.36

 

34IAC representatives reported that they prefer not to publish the percent of unannounced 

site visits as the percentages are routinely evaluated internally and may fluctuate.

35FDA requires each accrediting body to annually visit at least 5 percent of the facilities it 

accredits. However, a minimum of 5 facilities shall be visited, and visits to no more than 

50 facilities are required unless identified problems indicate a need to visit more than 

50 facilities. FDA requires accrediting bodies to conduct onsite visits according to a visit 

plan that includes assessment of quality-assurance activities, review of mammography 

reporting procedures, review of medical audit systems, verification of consumer complaint 

mechanisms, selection of a sample of clinical images for clinical image review, equipment 

verification, and verification that personnel specified by the facility are the ones actually 

performing designated personnel functions. 21 C.F.R. § 900.4(f) (2012).

36TJC representatives told us that while identifying metallic objects in the MRI suite may or 

may not constitute an immediate-jeopardy deficiency that is reported to CMS, this is 

always considered a serious problem that, if identified, must be corrected immediately.
 

Page 20 GAO-13-246 Medicare Imaging Accreditation

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.

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 midcycle audits occurs and that the types of serious care problems that could 

constitute immediate jeopardy are clear to all accrediting organizations.

To help ensure that ADI suppliers provide consistent, safe, and highquality 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 

Conclusions 

Recommendations for 

Executive Action
 

Page 21 GAO-13-246 Medicare Imaging Accreditation

analyzing information on accreditation results and conducting 

validation audits; and

• develop more specific requirements for accrediting organization midcycle 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.

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 

organization performance; and 

• 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 

Agency and Third 

Party Comments and 

Our Evaluation
 

Page 22 GAO-13-246 Medicare Imaging Accreditation

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 
 

Page 23 GAO-13-246 Medicare Imaging Accreditation

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 highquality 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.

James Cosgrove

Director, Health Care
Page 24 GAO-13-246 Medicare Imaging Accreditation

List of Committees

The Honorable Max Baucus

Chairman

The Honorable Orrin G. Hatch

Ranking Member

Committee on Finance

United States Senate

The Honorable Fred Upton

Chairman

The Honorable Henry A. Waxman

Ranking Member

Committee on Energy and Commerce

House of Representatives

The Honorable Dave Camp

Chairman

The Honorable Sander M. Levin

Ranking Member

Committee on Ways and Means

House of Representatives
Appendix I: Comments for the Department of 

Health and Human Services

Page 25 GAO-13-246 Medicare Imaging Accreditation

Appendix I: Comments for the Department of 

Health and Human Services
Appendix I: Comments for the Department of 

Health and Human Services

Page 26 GAO-13-246 Medicare Imaging Accreditation
Appendix II: GAO Contact and Staff 

Acknowledgments

Page 27 GAO-13-246 Medicare Imaging Accreditation

James Cosgrove, (202) 512-7114 or cosgrovej@gao.gov

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.

Appendix II: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(291044)
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