Medicare Imaging Accreditation: Effect on Access to Advanced Diagnostic Imaging Is Unclear amid Other Policy Changes
Published: 2014-04-18T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) required that beginning January 1, 2012, suppliers that produce the images for Medicare-covered ADI services in office settings, such as physician offices, be accredited by an organization approved by CMS. MIPPA mandated that GAO issue two reports on the effect of the accreditation requirement. The first report, issued in 2013, assessed CMS's standards for the accreditation of ADI suppliers and its oversight of the accreditation requirement.
In this report, GAO examined the effect the accreditation requirement may have had on beneficiary access to ADI services provided in the office setting. To do this, GAO examined trends in the use of the three ADI modalities—CT; MRI; and NM, including PET—provided to Medicare beneficiaries from 2009 through 2012 that were subject to the ADI accreditation requirement. GAO also interviewed CMS officials, representatives of the Intersocietal Accreditation Commission and the American College of Radiology—the two CMS-approved accrediting organizations that accounted for about 99 percent of all accredited suppliers as of January 2013; and 19 accredited ADI suppliers that reflected a range of geographic areas, imaging services provided, and accrediting organizations used. In addition, GAO reviewed relevant literature to understand the context of any observed changes in ADI services throughout the period studied.
section_title: What GAO Found
paragraphs: GAO found that the number of advanced diagnostic imaging (ADI) services provided to Medicare beneficiaries in the office setting—an indicator of access to those services—began declining before and continued declining after the accreditation requirement went into effect on January 1, 2012. In particular, the rate of decline from 2009 to 2010 was similar to the rate from 2011 to 2012 for magnetic resonance imaging (MRI); computed tomography (CT); and nuclear medicine (NM), including positron emission tomography (PET) services. These results suggest that the overall decline was driven, at least in part, by factors other than accreditation. The percentage decline in the number of ADI services provided in the office setting was generally similar in both urban and rural areas during the period GAO studied.
The effect of accreditation on access is unclear in the context of recent policy and payment changes implemented by Medicare and private payers. For example, the Centers for Medicare & Medicaid Services (CMS) reduced Medicare payment for certain CT and MRI services, which could have contributed to the decline in the number of these services. Officials from CMS, representatives from the accrediting organizations, and accredited ADI suppliers GAO interviewed suggested that any effect of the accreditation requirement on access was likely limited.
The Department of Health and Human Services stated that it had no comments on a draft of this report.

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,  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. 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—specifically CT,  MRI, and NM, including positron emission tomography (PET)—be  accredited by a designated accrediting organization in order to receive  Medicare payment for these services. The requirement applies to ADI  services provided in office settings, including physician offices and  independent diagnostic testing facilities (IDTF), which are paid under the  physician fee schedule. MIPPA accreditation does not apply to ADI  services provided in institutional settings, including hospital inpatient or  outpatient departments, which are not paid under the physician fee  schedule.should use to evaluate ADI suppliers, such as standards for qualifications   MIPPA outlined broad criteria that accrediting organizations  of personnel and standards to ensure the safety of beneficiaries and staff.  The Centers for Medicare & Medicaid Services (CMS) administers and  oversees the MIPPA accreditation requirement on behalf of the Secretary  of Health and Human Services and has selected four organizations to  serve as designated accrediting organizations—the American College of  Radiology (ACR), the Intersocietal Accreditation Commission (IAC), The  Joint Commission, and RadSite. In order to become accredited, ADI  suppliers must select one of the accrediting organizations and undergo an  accreditation review process to demonstrate that they meet the  organization’s standards. Although the accreditation requirement has the  potential to improve the quality and safety of ADI services, it could  potentially disrupt Medicare beneficiaries’ access to ADI services if some  suppliers are unwilling or unable to become accredited and, as a result,  stop furnishing ADI services to Medicare beneficiaries.
MIPPA mandated that we issue a preliminary report in 2013 and a final  report in 2014 on the effect of the accreditation requirement administered  by CMS. Our first report, issued in May 2013, assessed CMS’s standards  for the accreditation of ADI suppliers as well as its oversight of the  accreditation requirement. We found that CMS did not establish  minimum national standards for the accreditation of suppliers of ADI  services, but rather relied on its selected accrediting organizations to  establish their own standards for quality and safety. We also found that  CMS’s oversight of the accreditation requirement was limited, as the  agency focused its initial oversight efforts on ensuring that claims were  paid only to accredited suppliers. We recommended, among other things,  that the Administrator of CMS determine the content of and publish  minimum national standards for the accreditation of ADI suppliers and  develop an oversight framework for evaluating accrediting organization  performance. The Department of Health and Human Services, which  oversees CMS, concurred with our recommendations. This final report  examines the effect, if any, of the accreditation requirement on  beneficiary access to ADI services provided in the office setting.
To examine the effect the accreditation requirement may have had on  beneficiary access to ADI services in the office setting, we identified  trends in the number of these services provided to Medicare  beneficiaries—an indicator of access—before and after the accreditation  requirement went into effect. We examined these trends for each of the  three ADI modalities—CT; MRI; and NM, including PET—using Medicare  Part B Carrier claims from 2009 through 2012, which were the most  recent data available at the time of our analysis. We limited our analysis  to the technical component of those services that were provided in the  office setting, as the professional component is not subject to the  accreditation requirement. We further limited the ADI services in our study  to those Current Procedural Terminology (CPT) codes that are subject to  ADI accreditation, according to CMS. We excluded certain codes to  ensure that our results reflected trends in the number of ADI services  rather than changes in billing practices. Specifically, because CPT codes  can change over time, we excluded any codes from CMS’s list that were  not billed at least once each year from 2009 to 2012. We also excluded  CPT codes for any services that were combined, or “bundled,” with  another service at any time during our study period. After these  exclusions, the codes we analyzed represented 171 of the 219 CPT  codes (78 percent) subject to the ADI accreditation requirement and   75 percent of Medicare-covered ADI services in 2012 that were subject to  the requirement. Using claims data for these CPT codes, we analyzed  trends in the number of ADI services provided to Medicare beneficiaries,  both at the national level and separately for urban and rural areas  nationwide, before and after January 1, 2012, the date the accreditation  requirement went into effect. Specifically, we examined the total number  of CT, MRI, and NM/PET services in the office setting per 1,000 Medicare  fee-for-service (FFS) beneficiaries each year from 2009 to 2012. In  2012, approximately 21 percent of ADI services included in our study  were provided in the office setting, while the remaining 79 percent were  provided in the institutional setting. Although our analyses provide insight  into the extent to which the accreditation requirement may have affected  access to ADI services in the office setting, we did not determine whether  a given level of utilization indicated sufficient access or whether changes  in ADI service use were medically appropriate. We assessed the reliability  of the data from CMS that we analyzed by reviewing relevant  documentation and examining the data for obvious errors. We determined  that the data were sufficiently reliable for the purposes of our study.
We also interviewed CMS officials, representatives of IAC and ACR—the  two CMS-approved accrediting organizations that accounted for about   99 percent of all accredited suppliers as of January 2013, accredited ADI suppliers to obtain their perspectives on the effect of  accreditation on beneficiary access to ADI services. In addition, we  reviewed relevant literature on trends in imaging to better understand the  context of any observed changes in ADI services throughout the time  period we studied.
We did not interview suppliers accredited by The Joint Commission because of the small  number of suppliers accredited by the organization as of January 2013. In addition, we did  not include suppliers accredited by RadSite as it had not been designated as a CMS- approved accrediting organization when we interviewed suppliers. 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: CT uses ionizing radiation and computers to produce cross-sectional  images of internal organs and body structures. MRI uses powerful  magnets, radio waves, and computers to create cross-sectional images of  internal body tissues. NM uses 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.
section_title: ADI Accreditation Process and CMS Oversight
paragraphs: To become accredited, ADI suppliers must select a CMS-designated  accrediting organization, pay the organization an accreditation fee, and  demonstrate that they meet the organization’s standards. As we noted in  our May 2013 report, the accrediting organization fees vary. For  example, as of January 2013, ACR’s accreditation fees ranged from  $1,800 to $2,400 per unit of imaging equipment, while IAC’s fees ranged  from $2,600 to $3,800 per application. While the specific standards  used by accrediting organizations vary, MIPPA requires all accrediting  organizations to have standards in 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. To demonstrate that  they meet their chosen accrediting organization’s standards, ADI  suppliers must submit an online application as well as required  documents, which could include information on qualifications of personnel  or a sample of patient images.
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 organization no longer adequately ensures that ADI suppliers  meet or exceed Medicare requirements. CMS also has requirements for accrediting organizations. For example, 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 3-year accreditation cycle.  According to CMS officials, five full-time staff are budgeted to oversee  and develop standards for the ADI accreditation requirement.report was issued in May 2013, CMS has begun to gather input from  stakeholders on the development of national standards for the  accreditation of ADI suppliers, which it intends to develop by the end of  2014.
section_title: Medicare Payment and Billing Policies for ADI Services
paragraphs: Medicare payment for the technical component of ADI services is  intended to cover the cost of the equipment, supplies, and nonphysician  staff and is generally significantly higher than the payment for the  professional component. The payment for the professional component is  intended to cover the physician’s time in interpreting the image and  writing a report on the findings. Medicare reimburses providers through  different payment systems depending on where an ADI service is  performed. When an ADI service is performed in an office setting such as  a physician’s office or IDTF, both the professional and technical  component are billed under the Medicare physician fee schedule.  Alternatively, when the ADI service is performed in an institutional setting,  the physician can only bill the Medicare physician fee schedule for the  professional component, while the payment for the technical component  is covered under a different Medicare payment system, according to the  setting in which the service is provided. For example, the technical  component of an ADI service provided in a hospital outpatient department  is paid under the hospital outpatient prospective payment system  (OPPS).
section_title: Laws and Policies Designed to Control Imaging Utilization and Expenditures
paragraphs: The use of imaging services grew rapidly during the decade starting in  2000—MedPAC reported that cumulative growth between 2000 and 2009  totaled 85 percent—although the rate of growth has declined in recent   Growth in imaging utilization and expenditures—including those  years.for ADI services—prompted action from Congress, CMS, and private  payers. Congress has enacted legislation to help ensure appropriate  Medicare payment for ADI services; in some cases, this legislation has  had the effect of reducing Medicare payment for the technical component  of certain imaging services, such as the following:
The Deficit Reduction Act of 2005 required that, beginning January 1,  2007, Medicare payment for certain imaging services under the  physician fee schedule not exceed the amount Medicare pays under  the OPPS.
The Patient Protection and Affordable Care Act (PPACA), as  amended by the Health Care and Education Reconciliation Act of  2010 (HCERA) and the American Tax Relief Act of 2012 (ATRA),  reduced payment for the technical component of ADI services by  adjusting assumptions, known as utilization rates, related to the rate  at which certain imaging equipment is used. These changes had the effect of reducing payments for the technical component of ADI  services beginning in January 2011, with additional reductions  scheduled to take effect in 2014.
CMS implemented additional changes to Medicare payment policy to help  ensure appropriate payment for ADI services, which had the effect of  reducing Medicare payment for certain imaging services. In January 2006  CMS began applying a multiple procedure payment reduction (MPPR)  policy to the technical component of certain CT and MRI services, which  reduces payments for these services when they are furnished together by   Beginning in  the same physician, to the same patient, on the same day.January 2012, CMS expanded the MPPR by reducing payments for the  lower-priced professional component of certain CT and MRI services by  25 percent when two or more services are furnished by the same  physician to the same patient, in the same session, on the same day.
Private payers have also implemented policies designed to help control  imaging utilization and expenditures. One such policy is the use of prior  authorization, which can involve requirements that physician orders of  imaging services meet certain guidelines in order to qualify for payment.   Further, best practice guidelines, such as ACR’s Appropriateness Criteria,  as well as efforts to educate physicians and patients about radiation  exposure associated with imaging, have been used to promote the  appropriate use of imaging services.
section_title: Effect of Accreditation Requirement on Access to Advanced Diagnostic Imaging in Office Settings Is Unclear in Context of Other Policy Changes
paragraphs: We found that the number of ADI services provided to Medicare  beneficiaries in the office setting—an indicator of access to those  services—began declining before and continued declining after the  accreditation requirement went into effect on January 1, 2012 (see fig. 1).  In particular, the rate of decline from 2009 to 2010 was similar to the rate  from 2011 to 2012 for the CT; MRI; and NM, including PET, services in  our analysis. These results suggest that the overall decline was driven, at  least in part, by factors other than accreditation. For example, the number  of CT services per 1,000 FFS beneficiaries declined by 9 percent  between 2009 and 2010, 4 percent between 2010 and 2011, and   9 percent between 2011 and 2012.
The percentage decline in the number of ADI services provided in the  office setting was generally similar in both urban and rural areas during  the period we studied, although we found that substantially more services  were provided in urban areas than in rural areas (see fig. 2). The number  of ADI services per 1,000 FFS beneficiaries provided in urban areas  declined by 7 percent between 2011 and 2012, while the number of  services provided in rural areas declined by 8 percent. In addition, 148  services were provided per 1,000 FFS beneficiaries in urban areas in  2012, as compared to 81 services per 1,000 beneficiaries in rural areas.  One reason the use of ADI services in the office setting was relatively low  in rural areas was that a smaller percentage of ADI services in these  areas were provided in the office setting. Specifically, in 2012, about   14 percent of ADI services in rural areas were provided in the office  setting, compared to 23 percent of ADI services in urban areas. See  appendix I for trends in the number of urban and rural ADI services by  modality.
The effect of accreditation on access—as illustrated by our analysis of the  trends in ADI services in the office setting—is unclear in the context of  recent policy and payment changes as well as other factors affecting the  use of imaging services. In particular, the decline in ADI services  occurred amid the implementation in recent years of public and private  policies to slow rapid increases in imaging utilization and spending.  Factors, including public and private policies, that may have played a role  in the decline in ADI service utilization include the following:
Medicare payment reductions. Reductions in Medicare payment  may have contributed to the decline in ADI services between 2009  and 2012 as reduced fees may affect physicians’ willingness to   For example,  provide imaging services for Medicare beneficiaries.PPACA and ATRA reduced payment for the technical component of  ADI services by adjusting assumptions related to the rate at which  certain imaging equipment is used. In addition, CMS implemented a  25 percent payment reduction for the professional component of  certain CT and MRI services under the MPPR, effective January 1,  2012—the same date the accreditation requirement went into effect.
Prior authorization. Studies have suggested that increased use of  prior authorization policies among private payers in recent years has  contributed to a decrease in ADI services provided to privately insured  individuals. These policies may have had a spillover effect on Medicare, thus contributing to the decline in ADI services provided to  Medicare beneficiaries from 2009 to 2012.
Radiation awareness. Studies have suggested that increased  physician and patient awareness of the risks associated with radiation  exposure may have led to a decline in CT and NM services provided  to Medicare beneficiaries.
Of the remaining two suppliers, one indicated that it was unsure whether accreditation  has affected the number of services it provides, while the other indicated that accreditation  may have led to a slight increase in the number of services it provides. accreditation process. According to the representatives, IAC and ACR  requested that CMS provide a provisional accreditation period for new  suppliers that would allow them to obtain reimbursement for applicable  ADI services while they undergo the accreditation process. According to  CMS, it does not have the authority under MIPPA to provide provisional  accreditation, as the statute only allows accredited suppliers to be paid for  the technical component of ADI services beginning on January 1, 2012.
section_title: Agency Comments
paragraphs: We provided a draft of this report for review to the Department of Health  and Human Services, and the agency stated that it had no comments.
We are sending copies of this report to the Secretary of Health and  Human Services and appropriate 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 have 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: Advanced Diagnostic Imaging Services in Office Settings per 1,000 Medicare FFS Beneficiaries, 2010-2012
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, Assistant Director; Priyanka Sethi Bansal;   William A. Crafton; Richard Lipinski; Beth Morrison; Jennifer Whitworth;  and Rachael Wojnowicz made key contributions to this report.