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. 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. 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). 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. 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. 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. 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.

Summary: 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. 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.