Medicare Ultrasound Procedures: Consideration of Payment Reforms and Technician Qualification Requirements
Released: 2007-06-28T00:00:00

Letter

Background

Ultrasound is a noninvasive form of imaging that, unlike X-ray and certain other diagnostic modalities, does not expose patients to the risks associated with the emission of ionizing radiation. To perform a diagnostic ultrasound exam, a sonographer applies a hand-held medical device called a transducer to the skin through which the ultrasound machine emits and receives sound waves. As the sonographer moves the transducer around the patient’s body, an image of the various organs or blood flow under study appears on a monitor. The sonographer electronically stores what he or she considers as the most diagnostically useful images.

The ultrasound systems that sonographers use differ along multiple dimensions, including their types of transducers, documentation capabilities, and cost. The type and number of transducers on a given ultrasound system depend on the parts of the body to be examined and the conditions intended to be diagnosed. In addition, some ultrasound systems have additional documentation capability, which allows sonographers and other health care personnel to electronically transmit and display ultrasound images. According to the ultrasound device manufacturers with whom we spoke, an ultrasound machine can range in price from $20,000 to $200,000 or more. Prices are partially based on the system’s features, such as the number and type of different transducers it has and its capacity to store and transmit data.

Sonographer Credentialing and Training and Facility Accreditation

Sonographers can demonstrate that they have the appropriate level of training and experience by becoming credentialed by a nationally recognized organization. The American Registry for Diagnostic Medical Sonography (ARDMS) and Cardiovascular Credentialing International (CCI) are two main sonographer credentialing organizations. Each organization has multiple pathways to becoming credentialed that are designed to account for differences in sonographers’ training and experience. CCI allows sonographers without formal education, but with experience in the field, to take its credentialing exam, but ARDMS requires that all sonographers have a combination of education and experience to take its exam.

Sonographers can obtain formal training through numerous education programs. For example, the Commission on Accreditation of Allied Health Education Programs lists 151 programs for diagnostic medical sonographers, including associate’s degree programs from community colleges as well as bachelor’s degree programs. Individuals we spoke with from ultrasound-related professional organizations noted that, although sonographers are more likely than in the past to undergo formal training, there are still practicing sonographers who do not have it.

Several organizations offer accreditation for facilities that conduct ultrasound procedures as a way to demonstrate that they meet the standards necessary to perform quality exams. To work in an accredited facility, sonographers may be required to have certain credentials or have received a minimum number of training hours. For example, sonographers working in facilities that are accredited by the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL) must either be credentialed or have a specified level of training and experience in sonography. Similarly, for a facility to become accredited by the American Institute of Ultrasound in Medicine (AIUM), the sonographers who work there must either be credentialed by ARDMS or become credentialed before re-accreditation, which occurs every 3 years. This allows new sonographers to obtain experience conducting exams, which they need to be eligible to take a credentialing exam, such as from ARDMS and CCI. In addition to requirements for sonographers, accreditation can address broader aspects of ultrasound procedures, including qualification requirements for physicians, the condition of the ultrasound equipment, patient safety, images produced, and documentation.

Medicare and Its Coverage Processes

Medicare is the federally financed health insurance program for persons age 65 and older and certain individuals with disabilities. The program serves over 42 million beneficiaries. Eligible individuals are automatically covered by Part A, which helps pay for inpatient hospital, skilled nursing facility, and hospice care, as well as some home health care. Most eligible individuals elect to pay a monthly premium to obtain Medicare Part B coverage, which covers physician services, hospital outpatient services, and certain other services, such as physical therapy. In addition to the premium, beneficiaries are required to pay an annual Part B deductible as well as coinsurance of 20 percent for most Part B services.

Medicare covers items or services that are provided for by statute and that meet the applicable criteria for coverage when furnished to a particular beneficiary. Decisions on the extent to which, and under what circumstances, Medicare will cover specific services, procedures, or technologies may be made by CMS or its contractors in a number of ways. At the national level, CMS can make National Coverage Determinations (NCD) that apply across the country. More typically, most coverage issues are decided on the local level through Local Coverage Determinations (LCD) or other decisions made by the contractors that pay Medicare claims. For Part B claims for physician services, the contractors that pay claims and create LCDs are generally called carriers. If an NCD or other authority does not provide specific guidance about the conditions for covering a service, procedure, or technology, the carrier has the discretion to adopt an LCD to address the issue. LCDs only apply to a carrier’s service area or to the providers it serves.

Medicare Payment for Ultrasound Procedures and Associated Ambulance and Equipment Transportation

Medicare covers physicians’ interpretations of ultrasound and other imaging exams under Part B for all beneficiaries. For beneficiaries, except for those in a Part A-covered hospital or SNF stay, Medicare also provides Part B coverage of ultrasound and other imaging exams as well as medically necessary ambulance transportation. How Medicare pays for ultrasound exams and associated ambulance transportation for beneficiaries in a SNF depends on whether Medicare covers the stay under Part A. For beneficiaries in Part A-covered SNF stays, Medicare bundles payment for one part of the ultrasound procedure—the exam—as well as associated ambulance transportation into the daily Part A PPS payment. When beneficiaries remain in a SNF after exhausting their Part A SNF benefits or if the SNF stay is not covered for some other reason, they are in a “noncovered” SNF stay during which Medicare covers ultrasound exams and medically necessary ambulance transportation under Part B.

Although nearly all Medicare services provided to beneficiaries in Part A- covered SNF stays are paid through the Part A PPS payment, certain services are paid for separately under Part B. The Balanced Budget Act of 1997 (BBA) excluded from the Part A PPS payment all physician services for beneficiaries in Part A-covered SNF stays, which include interpretations of ultrasound and other imaging exams, and provides for separate payments for these services under Part B. In addition, certain categories of services—for example, the exam for computed tomography (CT) scans, magnetic resonance imaging (MRI), and angiography—are excluded from the Part A PPS payment and are paid for separately under Part B when provided in a hospital outpatient setting. CMS identified these services as ones that “lie well beyond the scope of care that SNFs would ordinarily furnish.” (See table 1.) One of our previous reports noted that CMS considered the possibility of paying separately for certain ultrasound exams and associated ambulance transportation but decided not to do so because they did not meet the criteria used to identify such services.

Legend: ● = bundled into SNF PPS payment; ○ = paid separately under Part B Medically necessary ambulance transportation is paid for separately from the PPS payment under Part B when associated with dialysis and with the following services if provided in a hospital outpatient department: cardiac catheterization, MRI, CT scan, certain ambulatory surgery procedures, emergency services, radiation therapy, angiography, and lymphatic and venous procedures. See CMS, Skilled Nursing Facility Consolidated Billing as it Relates to Ambulance Services, MLN Matters No. SE0433 (2005).

Medicare does not make separate Part B payments to transport ultrasound equipment to a home or SNF for an exam. The transportation of the ultrasound equipment and sonographer is considered to be bundled into the ultrasound exam payment. However, Medicare does make separate Part B payments for the transportation and set-up of equipment used to conduct diagnostic X-ray exams.

Policy concerning payment for the transportation of ultrasound equipment has changed over time. Prior to 1996, CMS did not have a national policy concerning the transportation of ultrasound equipment, but some of its carriers developed their own policies to cover it. In 1995, carriers for 14 states and the northern part of California had a policy to reimburse providers for additional transportation costs associated with providing mobile ultrasound exams, as they did for mobile X-ray exams, which is another type of imaging service. However, beginning January 1, 1996, CMS determined that the statutory provision that provided coverage for the transportation of portable X-ray equipment did not provide this coverage for diagnostic ultrasounds and, therefore, carriers could no longer make separate Part B payments for the transportation of ultrasound equipment.

The Most Common Medicare Ultrasound Procedures in 2005 Were Echocardiograms and Noninvasive Vascular Studies

Echocardiograms and noninvasive vascular procedures accounted for about three-fourths of the approximately 41 million ultrasound procedures provided to Medicare beneficiaries in 2005 in any setting. Nearly all of the ultrasound exams paid under Part B were performed in physician offices and hospital outpatient departments. The remaining 1 percent were conducted in various sites of service, including SNFs and beneficiaries’ homes. Among the exams provided in SNFs to beneficiaries in noncovered SNF stays, noninvasive vascular studies were the most prevalent, followed by echocardiograms.

About Three-Quarters of Ultrasound Procedures Provided to All Beneficiaries in 2005 Were Echocardiograms and Noninvasive Vascular Studies

Echocardiograms, used to diagnose heart conditions, and noninvasive vascular studies, often used to diagnose blood clots, were the most common diagnostic ultrasound procedures provided to Medicare beneficiaries in 2005. (See fig. 1.)

Specifically, of the 41 million total procedures provided to nearly 12.4 million beneficiaries in 2005 in any site of service, the following apply.

Echocardiograms were the most frequently performed type of ultrasound, accounting for about 53 percent of the total number of procedures and 49 percent of Medicare Part B payments. Echocardiograms are commonly used to diagnose medical conditions such as heart failure, problems with the innermost layer of the heart or the respiratory system, and disorders of the heart rate.

Noninvasive vascular studies represented about 20 percent of ultrasound procedures provided to beneficiaries and 30 percent of Medicare Part B payments for ultrasounds. Among other conditions, noninvasive vascular ultrasounds are used to monitor the blood flow through veins and arteries and to detect blockage, or blood clots. They are frequently used to diagnose deep vein thrombosis (DVT).

Ultrasounds of the abdomen and pelvis accounted for about 12 percent of the ultrasound procedures and 10 percent of Medicare Part B payments for ultrasounds. Abdominal ultrasounds are commonly used to identify disorders of the kidney and ureter, tumors, and disorders of the urinary tract.

Ultrasounds of the head, neck, chest, and other ultrasound procedures, accounted for about 11 percent of the total number of Medicare ultrasound procedures and 7 percent of Part B Medicare payments. Cataracts and disorders of the breast were among the top medical conditions diagnosed with these procedures.

Ultrasound guidance procedures accounted for the remaining share— about 3 percent of the number of procedures and Part B Medicare payments. Ultrasound guidance is used, for example, to direct the placement of a needle to withdraw fluid from the membrane surrounding the heart or lungs or to guide the performance of breast, liver, and prostate biopsies. Some of these ultrasound procedures require the attendance of a physician in the room during the performance of the procedure. (In appendix II, see table 4 for details on the level of physician supervision required for different types of procedures and table 5 for the top five medical conditions diagnosed by type of procedure.)

Our analysis of the available site-of-service data showed that nearly all (99 percent) of the 28 million ultrasound exams provided to beneficiaries under Part B in 2005 were performed in physician offices and hospital outpatient departments—68 percent and 31 percent, respectively. The remaining 1 percent (about 387,000 exams) were conducted in various sites of service, including SNFs and beneficiaries’ homes. Of the 28 million ultrasound exams provided to Medicare beneficiaries under Part B, about 129,000 were conducted in SNFs for beneficiaries in noncovered SNF stays and about 101,000 were conducted in beneficiaries’ homes.

Noninvasive Vascular Studies Were the Most Prevalent Ultrasound Exams Provided in SNFs to Beneficiaries in Noncovered SNF Stays

Of the 129,000 ultrasound exams conducted in SNFs for beneficiaries in noncovered SNF stays, noninvasive vascular procedures were the most common, accounting for 53 percent of the exams and 68 percent of the Medicare Part B payments. The noninvasive vascular procedures were used to diagnose conditions such as disorders of the soft tissues, skin conditions, and deep vein thrombosis. Echocardiograms were the second most frequently performed ultrasound exam in SNFs for beneficiaries in noncovered SNF stays, representing 22 percent of the procedures and 20 percent of Part B Medicare payments. Ultrasounds of the abdomen or pelvis were also common among this population, accounting for about 17 percent of the ultrasound procedures and 10 percent of Medicare Part B payments. The remaining 8 percent of the procedures and 2 percent of Part B Medicare payments were for various other categories, including head, neck, and chest. Only 5 ultrasound guidance procedures were conducted in SNFs for this population in 2005. (See fig. 2 and table 6 in app. II, which shows the top 5 medical conditions diagnosed by type of procedure provided to beneficiaries in noncovered SNF stays.) Data limitations did not allow us to examine the site of service for approximately 262,000 ultrasound procedures provided to beneficiaries in Part A-covered SNF stays, but our analysis of the types of procedures these beneficiaries received shows similar results to those provided in SNFs during noncovered stays.

Because of congressional interest in the quality of ultrasound services, and particularly those conducted in SNFs, we examined clinical considerations associated with the site where exams were performed. Our literature search produced no pertinent studies on clinical issues associated with transporting elderly patients to obtain ultrasound exams as opposed to providing mobile services in SNFs or beneficiaries’ homes. Our analysis of CMS’s 2005 data on the level of physician supervision required to perform ultrasound procedures indicates that about 90 percent of them did not require a physician to be present. Thus, having a sonographer provide these procedures could be appropriate for mobile services provided in a SNF or home even if a physician was not present.

Representatives from nationally recognized professional organizations, including professionals in the fields of geriatrics and sonography, as well as ultrasound providers and long-term care provider organizations, provided their views on clinical considerations associated with transporting elderly patients to obtain an ultrasound or providing an ultrasound in a SNF. In general, they said that the risks and benefits depend on the patient’s condition—such as whether the beneficiary requires emergency care, the most appropriate setting for follow-up care, and the type of ultrasound services provided. For example, there are risks in transporting elderly patients, particularly those with certain medical conditions including dementia, who can become disoriented in new surroundings. Some geriatricians, medical directors of SNFs, and long- term care providers said that moving patients could increase their risk of falls or fractures. A gerontologist and a geriatrician further noted that pain is a major issue to consider in caring for frail, bedridden patients. Transporting patients with deep vein thrombosis and pressure sores may expose them to skin tears and pain. On the other hand, certain ultrasound exams may be best performed in hospitals or physician offices, according to organization representatives that we contacted. For example, some beneficiaries may require emergency care, and therefore require hospitalization. Others who need ultrasound exams may have conditions that involve risks of serious complications that could require surgical or other interventions more readily provided in a hospital. In addition, a hospital or physician’s office may be the best setting for certain types of procedures, such as ultrasound guidance for needle placement during biopsies, which requires the presence of a physician during the performance of the procedure.

Changing Ultrasound Payment Methods Would Likely Increase Expenditures and Beneficiary Cost Sharing

We addressed two potential changes to Medicare payment methods related to ultrasound procedures, both of which are likely to increase Medicare expenditures and beneficiary cost sharing. The first potential change we addressed, which would involve paying to transport equipment to SNFs during noncovered SNF stays for ultrasound exams, could have increased Medicare expenditures by an estimated $9.8 million and beneficiary cost sharing by an estimated $2.6 million in 2005, assuming that this policy change would not affect the number and location of exams provided. The second potential change in Medicare payment methods involves paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation during Part A- covered SNF stays, as opposed to bundling payments for these services as is done now. We found that paying separately under Part B for these services could have increased Part B Medicare payments by an estimated $22.0 million and beneficiary cost sharing by an estimated $13.4 million in 2005, assuming no change in the number of services provided as a result of this policy. However, because these revised payment policies could affect the use of these services, the actual financial impacts could differ from our estimates. For instance, paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation during Part A-covered SNF stays could cause the use of these services to grow because the PPS incentive to provide services efficiently would be absent, so the actual impact of this policy could exceed our estimates. Further, unless these separate Part B payments were offset by a reduction in the Part A PPS payment, they would increase overall Medicare expenditures.

Part B Equipment Transportation Payments Would Likely Increase Expenditures and Beneficiary Cost Sharing

Paying to transport ultrasound equipment for the 129,000 exams done in SNFs during noncovered SNF stays in 2005 could have increased Medicare expenditures by an estimated $9.8 million and beneficiary cost sharing by an estimated $2.6 million, assuming the number and location of exams would not have changed in response to this policy. If this policy also applied to mobile exams conducted in other sites of service, the financial impact could be greater. For example, if Medicare made separate Part B payments to transport ultrasound equipment to beneficiaries’ homes, as is the case for the transportation of portable X-ray equipment, the financial impact could be higher by about $4.4 million for Medicare expenditures and $1.2 million higher for beneficiary cost sharing. Similarly, paying to transport ultrasound equipment to custodial care and assisted living facilities could have increased the financial impact of this policy further (see table 2).

The actual financial impact of paying to transport ultrasound equipment to SNFs would differ from our estimates if this policy caused the number of mobile exams provided to increase or decrease, but this would not affect our determination that this policy would likely lead to higher Medicare expenditures and beneficiary cost sharing. The mobile providers we spoke with noted that Medicare payments to transport ultrasound equipment would allow them to expand their service area and thus could increase the number of exams they provide. For example, one provider noted that transportation payments might allow it to serve beneficiaries in rural areas where doing so would have proved cost prohibitive before. Thus, payments to transport ultrasound equipment could potentially increase the number of mobile exams and provide more beneficiaries with access to these services.

Increasing access to mobile ultrasound exams could possibly lessen the need for ambulance services to transport beneficiaries from a SNF to another location for an ultrasound exam, which could in turn reduce the financial impact of this policy. Mobile providers stressed that Medicare and its beneficiaries save money when beneficiaries in SNF stays receive mobile exams in a SNF as opposed to being transported to another location, in part because payments and beneficiary cost sharing to transport ultrasound equipment are less than for an ambulance round trip. We identified about 13,900 exams that potentially could have been conducted in a SNF during a noncovered SNF stay rather than using ambulance transportation to travel to another location for the exam. If the increased availability of mobile exams allowed all of these 13,900 exams to be conducted in a SNF rather than in the locations (such as a hospital outpatient facility) where they actually took place, the financial impact of this policy would have been about $3.0 million lower for Medicare expenditures and about $1.2 million lower for beneficiary cost sharing.

However, if mobile providers increased the number of ultrasound exams conducted in SNFs and other locations, it is also possible that this increase could lead to larger than estimated increases in Medicare expenditures and beneficiary cost sharing. Some of the exams conducted for beneficiaries in noncovered SNF stays likely were conducted in other sites of service (for example, physicians’ offices or hospital outpatient departments) but did not involve Medicare-covered ambulance services to transport the beneficiary there. If mobile providers furnished more ultrasound exams in SNFs by expanding their service area, some of these beneficiaries might have received exams in this site of service rather than in other locations. As a result of this change in the site of service for these exams, our estimated impacts on Medicare expenditures and beneficiary cost sharing could (1) increase because Medicare would be paying for the additional ultrasound equipment transportation cost that would otherwise not have been necessary and (2) change due to the different cost of the exams themselves in the new locations. However, data constraints do not allow us to estimate the extent to which this would occur.

Based on what mobile providers told us, one might expect the number of mobile exams to increase in response to the provision of payments to transport ultrasound equipment. However, our analysis of the effect of ceasing to pay for ultrasound equipment transportation in 1996 indicates that the opposite might occur. In 1995, Medicare carriers in 14 states and Northern California paid to transport ultrasound equipment, but these payments ceased in all localities as of January of 1996. We compared the growth rate in the number of exams conducted in SNFs in the 14 states where Medicare paid to transport ultrasound equipment in 1995 and stopped doing so thereafter to the rate across all other states where this change did not occur. The number of exams conducted in SNFs grew by about 237 percent from 1995 to 1997 in states where Medicare paid to transport ultrasound equipment in 1995 and ceased doing so thereafter, which was substantially greater than the 62 percent growth rate in other states where Medicare had not paid to transport ultrasound equipment. This suggests that the elimination of Medicare payments to transport ultrasound equipment may have led to an increase in the number of mobile exams as the amount paid per exam decreased.

These results raise the possibility that mobile providers might maintain or decrease the number of exams they provide if Medicare began paying to transport ultrasound equipment. A decrease in the number of exams conducted in SNFs, if it occurred, could require that more beneficiaries use ambulance services to be transported to other locations for the exams. We estimated that a reduction in the number of exams conducted in SNFs could cause the estimated increases in Medicare expenditures and beneficiary cost sharing to be greater.

Paying Separately for Ultrasound Services during Part A-Covered SNF Stays Would Likely Increase Part B Expenditures, Beneficiary Cost Sharing, and Service Use

Paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation during Part A-covered SNF stays, as opposed to bundling these services into the Part A PPS payment as is done now, could have increased Medicare Part B payments in 2005 by an estimated $22.0 million and caused beneficiary cost sharing to rise by about $13.4 million, assuming that this policy would not affect service use. (See table 3 and app. I for details on how these estimates were calculated.)

The actual financial impact of paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation could differ from the estimates in table 3 because this policy could cause their use to grow by undermining the incentive inherent in the PPS to efficiently provide these services. Although we did not find published studies specific to ultrasound or certain other imaging modalities predicting that this would occur, one of our previous reports found that bundling SNF services into a single PPS payment caused the use of therapy services to decrease. This suggests that paying separately under Part B for these services could possibly have the opposite effect and cause use to grow, which could also cause the actual financial impact of this policy to exceed our estimates. Similarly, MedPAC has reported that there are efficiency gains from bundling payments. In addition, both we and MedPAC have previously noted that bundling Medicare payments for certain end-stage renal disease drugs together with other items for this condition could improve efficiency by eliminating the financial incentive to overuse separately billable drugs. Furthermore, we have reported that the home health PPS, which involves paying home health agencies a single bundled payment per 60-day episode of care, provides strong financial incentives to reduce the cost of providing home health care.

Paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation also would increase overall Medicare payments for these services unless the additional Part B expenditures were offset by payment reductions for other services. Congress chose to do this on a previous occasion. Thus, if Congress instituted separate Part B payments for ultrasound exams and associated equipment and ambulance transportation during Part A-covered SNF stays, these payments could possibly be made budget neutral by a reduction in the Part A PPS payment. However, making this policy budget neutral would require that the Part A PPS payment reduction account for the potential of increased service use associated with unbundling services.

Evidence and Variation in Federal Requirements Are Among Factors to Consider in Determining Whether to Establish Credentialing or Other Qualification Requirements for Sonographers

Factors for CMS to consider in determining whether to establish credentialing or other qualification requirements for sonographers include findings about the value of credentialing from peer-reviewed studies, MedPAC, and ultrasound-related organizations, coupled with variation in federal requirements and lack of state requirements for sonographers. Options available to CMS for promoting the quality of ultrasound services include specifying sonographers’ qualifications via a National Coverage Determination (NCD), promulgating a regulation, and offering a financial incentive for quality improvements through “pay for performance” mechanisms.

Studies and Professional Organizations Suggest that Setting Requirements for Sonographers’ Qualifications Could Promote Quality

Sonographer qualifications play an important role in the quality and diagnostic usefulness of ultrasound procedures. Representatives from ultrasound-related professional organizations described ultrasound procedures as highly operator dependent. In addition, they noted that the accuracy and diagnostic usefulness of the images captured depends on the sonographer’s skills and abilities. When conducting diagnostic ultrasound procedures, the sonographer is responsible for obtaining quality images of internal body parts to enable the physician to make correct diagnoses of patients’ diseases and medical conditions. Two studies have shown that poor quality images can lead to misdiagnosis or unnecessarily repeated exams. Representatives of some ultrasound-related professional organizations that we interviewed noted that the increased use of ultrasound procedures in clinical practice and sophistication of the equipment have heightened the need for sonographers to undergo formal training. Currently, about 50 to 60 percent of the sonographers have the appropriate credentials, according to ARDMS estimates.

While studies that demonstrate the need for credentialing and accreditation have been limited in number and scope, those that exist seem to suggest that imposing credentialing or other qualifications on sonographers can improve the accuracy of ultrasound procedures. For example, two of the four relevant peer-reviewed studies from our literature review found that the results of noninvasive vascular ultrasound exams done by accredited facilities were more accurate than those exams by nonaccredited facilities. The authors of these studies emphasized the importance of accurate ultrasound exams for clinical decisions that vascular surgeons make about patient treatment.

Medicare experience with another type of imaging—mammography—also suggests that establishing federal standards that include requirements for personnel qualifications and facility accreditation could improve quality. In contrast to diagnostic ultrasound procedures, the Food and Drug Administration (FDA) established and enforces national quality standards for mammography services, which appear to have improved the quality of these procedures. Among other provisions in these standards, FDA established qualifications and continuing training requirements for mammography personnel, such as radiological technologists who perform the examinations, and also required facility accreditation. We previously reported that these quality standards, in conjunction with state inspection programs, have increased mammography facilities’ adherence to accepted quality assurance standards and improved the quality of X-ray images.

Furthermore, MedPAC and various ultrasound-related professional organizations with which we spoke support the implementation of a Medicare policy establishing requirements for the qualifications of sonographers. MedPAC recommended in 2005 that CMS “strongly consider” establishing standards for providers that perform and bill for imaging exams, which include diagnostic ultrasound procedures. MedPAC noted that these standards should address the qualifications of the performing technicians in addition to other aspects of imaging procedures. In addition, representatives from 11 ultrasound-related professional organizations support establishing requirements concerning sonographers’ qualifications through sonographer credentialing and facility accreditation. (See app. V for a list of these organizations.) Of these 11 organizations, 4 are ultrasound-related medical societies that do not credential sonographers or accredit facilities that conduct ultrasound procedures and the remaining 7 do.

Representatives from these organizations said that to conduct diagnostic ultrasounds, sonographers need to be trained and have broad knowledge, good judgment, and discretion. Representatives from the Society for Vascular Surgery stated that, because some procedures were done by inadequately trained technical staff or by facilities with little or no quality control, there are a “disturbing number” of patients who have (1) missed or delayed treatment of major health issues or (2) undergone unnecessary treatment due to abnormal results being classified normal or normal results being classified as abnormal. An article in a peer-reviewed journal reported that 91 percent of members of the Society for Vascular Ultrasound and the Society of Diagnostic Medical Sonography agreed that adding requirements for sonographer credentialing and facility accreditation would improve the quality of vascular ultrasound procedures.

Some representatives of ultrasound equipment manufacturers and mobile ultrasound providers we interviewed also generally support sonographer credentialing. However, two of the manufacturer-related organizations we contacted and one provider were concerned that requirements for credentialing or accreditation could result in significant shortages of sonographers. Representatives from these manufacturer-related organizations noted that a phase-in period for establishing new requirements for sonographers would help prevent any potential access problems. Similarly, representatives of ultrasound-related professional organizations that we interviewed emphasized the importance of a phase- in period to allow time for sonographers to become credentialed.

Federal Requirements for Sonographers’ Qualifications Vary and State Requirements Are Absent

Federal requirements relating to the qualifications of sonographers are inconsistent. This variation calls into question whether all sonographers paid by Medicare have appropriate and sufficient skills, knowledge, and experience to serve beneficiaries. Variation in federal requirements is also more of a concern because none of the states require that sonographers register or obtain a license from the state prior to providing ultrasound services, according to ultrasound-related professional organizations. At the federal level, CMS has not developed a national policy, such as an NCD, regarding the qualifications needed by sonographers as a condition for payment of ultrasound services. In the absence of an NCD for sonographers’ qualifications, carriers have established Local Coverage Determinations (LCD) for different types of diagnostic ultrasound procedures.

Allowing carriers to develop their own LCDs has resulted in varying Medicare requirements in different states for sonographers who perform particular types of diagnostic ultrasound procedures. For example, as of April 2007, carriers in 24 states and the District of Columbia have established one or more LCDs that require that noninvasive vascular diagnostic ultrasound procedures be performed by a credentialed sonographer (one that has undergone a certification process) or in an accredited facility that may require sonographers to meet certain qualification requirements. Carriers’ rationale was that the quality of these ultrasound procedures depends on the knowledge, skill, and experience of the sonographer. Carriers in 17 states have LCDs that recommend that noninvasive vascular diagnostic ultrasound procedures be performed by a credentialed sonographer or in an accredited facility. However, in the remaining 9 states, Medicare carriers have not established requirements through an LCD specifying the qualifications for sonographers who conduct noninvasive vascular ultrasound procedures. (See fig. 3.) Regarding mandatory requirements, a 2003 study that discussed reasons influencing a provider’s decision to obtain facility accreditation in vascular ultrasound cited a 1998 study that found that providers are more likely to seek facility accreditation when it is required for Medicare payment. The 2003 study noted that “alternatives that consider voluntary compliance to ultrasound standards may be unsuccessful.”

There is also variation in LCDs concerning diagnostic ultrasound procedures used to diagnose heart and other conditions. While carriers in 12 states had developed LCDs as of April 2007 that require that these procedures be performed by a credentialed sonographer or in an accredited laboratory and carriers in 4 states had LCDs that recommended these types of qualifications for sonographers, the remaining states and the District of Columbia have no such LCDs. Finally, as of September 2006, carriers in 4 states had LCDs that established qualification requirements for sonographers that perform certain other diagnostic ultrasound procedures, such as abdominal and pelvic ultrasound. However, there are no similar LCDs in the remaining states and the District of Columbia.

Variations in Medicare requirements regarding sonographers’ qualifications also relate to the sites of service where diagnostic ultrasound procedures are performed. For example, CMS has developed standards for nonphysician personnel that could be applicable to sonographers who perform diagnostic ultrasound procedures in independent diagnostic testing facilities (IDTF), but has not done so for physicians’ offices. For IDTFs, CMS requirements specify that nonphysician personnel, including sonographers, who perform diagnostic ultrasound procedures, must demonstrate the basic qualifications to perform those procedures and have appropriate training and proficiency. To meet this requirement, in the absence of a state licensing board, sonographers must be credentialed by an appropriate national credentialing body. Furthermore, the IDTF must maintain documentation available for review that Medicare credentialing requirements are being met.

Although there are no Medicare standards specifically related to the qualifications of sonographers working in hospitals, Medicare providers need to abide by the relevant Medicare Conditions of Participation (CoP), some of which appear to be applicable to the performance of ultrasound procedures. There are CoP provisions that include specific standards for medical staff and for radiology, nuclear medicine, and outpatient services. According to the Medicare CoP for medical staff, hospitals are responsible for the quality of medical care provided to patients and must examine the qualifications and credentials of applicants for medical staff positions. If the hospital provides outpatient services, the CoP also requires that services must meet the needs of the patients in “accordance with acceptable standards of practice.” Further, hospital outpatient departments are required to have appropriate professional and nonprofessional personnel available. In 2003, over 80 percent of hospitals met the applicable conditions of participation through accreditation from the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission)—a nonprofit organization created to provide voluntary health care accreditation for hospitals.

In contrast to IDTFs and hospitals, there are no Medicare standards that apply specifically to diagnostic ultrasound procedures conducted in physicians’ offices aside from those relating to the level of physician supervision required. The absence of qualification standards for sonographers working in physicians’ offices is of particular interest given MedPAC and the Lewin Group’s findings that there has been an increasing movement of imaging services, including ultrasound, from hospitals to physicians’ offices.

CMS Has Several Implementation Options

Several options are available to CMS for promoting the quality of diagnostic ultrasound procedures. Maintaining the status quo certainly imposes the least administrative burden and additional costs. However, this approach will not address the inconsistencies in requirements for sonographers’ qualifications. We present three options for promoting the quality of ultrasound procedures, with associated potential benefits and challenges.

One option would be to develop an NCD requiring that sonographers either be credentialed or work in an accredited facility. Because NCDs apply to all Medicare beneficiaries regardless of their treatment locations, an NCD would provide a more consistent level of assurance as to the qualifications of sonographers performing diagnostic ultrasound procedures. However, under the NCD option, CMS indicated it would have to implement the sonographer qualification requirements immediately rather than gradually over a period of time, according to a CMS official. This time constraint could be problematic given that representatives of various ultrasound-related societies and organizations we interviewed generally suggested a phase-in period of 2 or more years to allow noncredentialed sonographers time to comply with the newly imposed requirements. Finally, establishing an NCD could be difficult, according to the CMS official, if it limited access to services for some beneficiaries, such as for those that lived in locations where no credentialed sonographer was readily available.

A second option would be to issue a regulation that establishes a requirement that sonographers either be credentialed or work in an accredited facility as a condition for Medicare payment. Such a regulation could be phased in over 2 or more years, which as noted by representatives of ultrasound-related professional organizations we interviewed, would allow noncredentialed sonographers time to comply with this requirement. A CMS official noted that the regulatory process would allow CMS to use a phase-in period for establishing such a requirement but that developing regulations can be burdensome and time consuming for CMS.

A third option would be for CMS to explore the possibility of “paying for performance” to encourage quality in the provision of diagnostic ultrasound procedures. CMS has recognized that the current Medicare reimbursement structure does not target resources to support specific efforts to provide the highest quality care. To address this shortcoming, CMS has initiated a number of demonstration and pilot projects, several required by Congress under statute, aimed at encouraging quality care and designed to lay the groundwork for pay-for-performance systems in the future. However, these pay-for-performance efforts are in the early stages of development, and none of them is focused on imaging services or diagnostic ultrasound procedures. A CMS official and representatives of various ultrasound-related professional organizations told us that it is difficult to develop clear and valid quality measures that could be applied to the performance of sonographers that conduct diagnostic ultrasound procedures.

Conclusions

We did not find compelling clinical or financial evidence in favor of providing Part B payments for ultrasound equipment transportation in addition to those for the exams themselves, for beneficiaries in noncovered SNF stays. While testimonial evidence suggests that there may be benefits of performing ultrasound exams in SNFs for some beneficiaries as opposed to transporting them to other locations, we could not locate any studies documenting this. Furthermore, our analysis suggests that Part B payments for ultrasound equipment transportation could increase Medicare expenditures and beneficiary cost sharing. In addition, paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation during Part A- covered SNF stays would undermine the financial incentive of the PPS for SNFs to deliver these services efficiently. Paying separately under Part B for these services would also increase overall Medicare expenditures unless Congress made these additional Part B payments budget-neutral by reducing the Part A PPS payment.

As a national program affecting over 42 million beneficiaries, Medicare has a responsibility to ensure that the services it covers are of consistently high quality. Our findings from peer-reviewed studies and MedPAC and ultrasound-related professional organizations, coupled with our analysis of the variation in current requirements for sonographers, suggest that establishing requirements for sonographers’ qualifications could improve the quality of ultrasound procedures. Maintaining the status quo of allowing Medicare carriers to have different requirements for sonographer qualifications in different states undermines the assurance that beneficiaries are receiving consistently high-quality services. CMS has several available implementation options including developing a National Coverage Determination and promulgating regulations.

Recommendation for Executive Action

We recommend that the Administrator of CMS require that sonographers paid by Medicare either be credentialed or work in an accredited facility. The Administrator should weigh the advantages and disadvantages of implementing a National Coverage Determination compared with promulgating regulations that this requirement be a condition for Medicare payment.

Agency Comments and Our Evaluation

In written comments on a draft of this report, CMS stated that while it would consider our recommendation to require that sonographers furnishing services to Medicare beneficiaries either be credentialed or work in an accredited facility, it would rather have states engage their own licensing bodies in implementing sonographer licensure programs that address competency and qualification issues. We reprinted CMS’s written comments in appendix VI.

CMS characterized our recommendation as providing two options— issuing an NCD or promulgating a regulation establishing sonographer qualifications as a Condition of Participation—and stated that these options do not provide the most effective mechanism for addressing sonographer quality. We noted in our report that issuing a regulation was an option for CMS. However, we did not specify that this regulation apply only to ultrasound services furnished in or by providers that are subject to Conditions of Participation (generally, institutional providers, such as hospitals) because we believe it is important that sonographer qualification requirements apply to all sonographers, regardless of the setting in which they provide the service, including physicians’ offices. CMS agreed with our finding that sonographer qualification requirements vary but stated that a national policy would not take into account regional variation in factors such as access to care and state licensing requirements. We agree that access is an important issue when considering whether to implement an NCD or a regulation, and we pointed out that such a regulation could include a phase-in period to provide noncredentialed sonographers with time to comply with the newly imposed requirements. Furthermore, although CMS asserted that states should engage their own licensure bodies to implement sonographer licensure programs, we reported that state licensing requirements for sonographers do not exist. Consequently, we continue to believe that CMS should implement our recommendation and develop a national policy establishing sonographer qualification requirements. Such requirements, that sonographers paid by Medicare either be credentialed or work in an accredited facility, would help to promote the quality of ultrasound procedures across states and sites of service where consistent policy is currently lacking.

CMS agreed with our conclusion that paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation would undermine the financial incentive for SNFs to deliver these services efficiently. CMS further noted that paying separately for ultrasound exams could potentially lead to doing so for other services and lead to the “unraveling” of the SNF PPS bundle.

We are sending copies of this report to the Administrator of CMS, appropriate congressional committees, and other interested parties. We will also provide copies to others on request. In addition, this report is available at no charge on the GAO Web site at http://www.gao.gov.

If you or your staff have questions about this report, please contact me at (202) 512-7114 or steinwalda@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 members who made contributions to this report are listed in appendix VII.

Appendix I: Scope and Methodology

This appendix explains the methodology that we used to address our reporting objectives on (1) the types of ultrasound procedures commonly used to diagnose medical conditions of Medicare beneficiaries, particularly those in skilled nursing facilities (SNF); (2) the financial impact of changing how Medicare pays for ultrasound exams and associated equipment and ambulance transportation for beneficiaries receiving care in a SNF; and (3) the factors to consider in determining whether the Centers for Medicare & Medicaid Services (CMS) should establish credentialing or other qualification requirements for sonographers that provide diagnostic ultrasound procedures.

Types of Ultrasound Procedures Provided to Beneficiaries

To examine the types of diagnostic ultrasound procedures provided to Medicare beneficiaries, medical conditions that were diagnosed, and sites of service where these procedures were performed, we analyzed Medicare claims for ultrasound procedures paid under Part B in 2005. These data came from the National Claims History (NCH) carrier file and the Standard Analytical File (SAF) outpatient claims files. We based our analysis of the types of procedures on claims for physicians’ interpretations of ultrasound exams, which account for procedures provided to all beneficiaries because all physicians’ interpretations of ultrasound exams are paid under Part B, regardless of whether the exam itself was paid under Part A or Part B. We based our analysis of the site of service of ultrasound procedures on claims for ultrasound exams that were paid under Part B. Therefore, our site of service analysis does not cover exams for beneficiaries in Part A-covered SNF and hospital inpatient stays because Part A payment for these exams is bundled with other services and thus not separately reported in claims data.

To identify the specific diagnostic ultrasound procedures to analyze, we performed several steps. We began by developing a list of all the relevant diagnostic ultrasound procedures using information from the 2005 American Medical Association (AMA) Current Procedural Terminology (CPT) guide, and interviews with a credentialed sonographer with particular expertise in ultrasound coding and billing issues, and CMS officials, as well as documents provided during these interviews. We also reviewed the CMS Berenson-Eggers Type of Service (BETOS) codes, which categorize Healthcare Common Procedure Coding System (HCPCS) codes into clinically relevant categories. For this report, we selected 94 HCPCS codes in the BETOS categories for echography, which is a synonym for ultrasound. We then supplemented these 94 codes with 10 additional ones that we identified based on our review of codes in the AMA CPT Guide for 2005. The 104 total HCPCS codes we selected accounted for approximately 99 percent of all Medicare Part B payments for diagnostic ultrasound procedures in 2005.

To analyze sites of service where ultrasound procedures were performed, we used Medicare data from the 2005 NCH carrier and SAF outpatient claims files. In addition, we used data and reviewed regulations from CMS on the appropriate level of physician supervision for each ultrasound procedure to examine how supervision levels varied across sites of service.

To examine clinical considerations associated with site of service and to supplement our data analysis on the medical conditions, we conducted a literature search and structured interviews with representatives of gerontological, radiological, and ultrasound-related professional organizations. Key search terms included transition of care, which involves moving the beneficiary from the SNF to another facility for the purpose of performing an ultrasound procedure; transfer trauma; patient transfers; and risks and morbidity associated with the movement of elderly persons to different settings. For the structured interviews, we contacted representatives from the American Geriatrics Society, the American Medical Directors Association, the American College of Radiology, the American Society of Echocardiography, the Society for Vascular Surgery, and the Society for Vascular Ultrasound. In addition, we interviewed four mobile ultrasound providers that provide services to SNFs or nursing homes and representatives from the National Association for the Support of Long-Term Care and the American Association of Homes and Services for the Aging. We also conducted structured interviews with SNF directors of nursing in states selected based on criteria including their ultrasound use level per beneficiary.

Financial Impact of Changing Payment Methods

We estimated the financial impact of two changes in Medicare payment methodology for ultrasound exams and associated equipment and ambulance transportation for beneficiaries receiving care in a SNF. The first change we addressed was to make payments to transport and set up ultrasound equipment for exams conducted in SNFs during noncovered SNF stays, which is not currently done. The second change involved paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation during Part A-covered SNF stays.

Paying to Transport and Set Up Ultrasound Equipment

To estimate the financial impact of this potential change, we used Medicare Part B claims data for 2005 for ultrasound exams and ambulance services from the NCH carrier and SAF outpatient files. Based on these data, we (1) identified the number of exams conducted in SNFs during noncovered SNF stays, in beneficiaries’ homes, or in custodial care or assisted living facilities, (2) determined the number of beneficiary days on which these exams were conducted, and (3) multiplied the number of beneficiary days by our estimate of the average Medicare payment and beneficiary cost sharing for ultrasound equipment transportation, both including and excluding the equipment set-up fee, in the Medicare locality where the claim was processed. Through these steps, we estimated how the expenditures of Medicare and its beneficiaries would have differed if Medicare had paid to transport and set up ultrasound equipment in 2005, assuming that the number and location of exams would not have changed in response to this policy. (See app. III, table 7.)

To gain insight into how Medicare payments to transport and set up ultrasound equipment would affect the number of ultrasound exams in SNFs during noncovered SNF stays, we used information from interviews and two types of analyses. First, we interviewed representatives of four mobile ultrasound providers. Second, we analyzed Part B claims data from the Part B Extract Summary System for 1995, when Medicare contractors in some states paid to transport and set up ultrasound equipment, and 1997, when these payments were no longer provided. We compared the change between 1995 and 1997 in the number of ultrasound exams conducted in SNFs in 14 states that provided these payments in 1995 to the same measure in the remaining states that did not provide such payments. (See app. III, table 8.) Third, we analyzed Part B claims data for ambulance services that appear to have been used in conjunction with ultrasound exams.

If there was a decline in the number of ultrasound exams in SNFs during noncovered SNF stays in response to Medicare payments to transport and set up ultrasound equipment, it could cause the site of service of some exams to shift from these locations to other sites of service (such as a hospital outpatient facility). To determine whether this change in site of service would increase or decrease our impact estimates for paying to transport and set up ultrasound equipment, we accounted for how this change would affect Medicare expenditures and beneficiary cost sharing for (1) ambulance transportation, (2) the transportation and set up of ultrasound equipment, and (3) the ultrasound exam.

Some ultrasound exams conducted during noncovered SNF stays may require ambulance services to transport the beneficiary to another location, such as a hospital outpatient facility, for the exam. To estimate how Medicare payments and beneficiary cost sharing would have differed in 2005 if these exams had instead been conducted in SNFs during noncovered SNF stays, we first identified ambulance trips used to transport these beneficiaries from SNFs to another location for an ultrasound procedure. We then calculated how Medicare payments and beneficiary cost sharing for the ultrasound exam and associated transportation would have differed if, rather than transporting the beneficiary via ambulance to another location, ultrasound equipment had been transported to the SNF for the exam. To estimate how conducting the exam in a SNF during a noncovered SNF stay rather than in another location would have affected Medicare payments and beneficiary cost sharing for transportation, we (1) calculated the number of beneficiary days on which these exams occurred, (2) determined the savings to Medicare and its beneficiaries per beneficiary day if, instead of transporting a beneficiary via ambulance to another location, ultrasound equipment were transported to the beneficiary for the exam, by subtracting our estimate of the ultrasound equipment transportation payment and cost-sharing amounts for each beneficiary day from the actual payment for ambulance services, and (3) multiplied this difference by the number of beneficiary days. To estimate the savings to Medicare and its beneficiaries for the exam itself, we subtracted the cost of conducting all of these exams in a SNF during noncovered SNF stays from the actual cost of these exams.

The key limitation of our analysis of the financial impact of paying to transport and set up ultrasound equipment involves the accuracy of our assumption that this policy would not affect the number and location of ultrasound exams in SNFs during noncovered SNF stays. Therefore, to address the possibility that this policy change could affect ultrasound service use, we analyzed how such a change could affect our impact estimates.

Paying Separately under Part B for Ultrasound Exams and Related Transportation during Part A-Covered SNF Stays

To estimate the financial impact of paying separately under Part B for ultrasound exams and associated equipment and ambulance transportation during Part A-covered SNF stays, we analyzed claims for ultrasound exams and physicians’ interpretations of them for beneficiaries in Part A-covered SNF stays from Medicare Part B claims data for 2005 from the NCH carrier file and the SAF outpatient claims files. We first counted the number of physicians’ interpretations of ultrasound exams that were conducted during Part A-covered SNF stays in 2005. We merged Part B claims for physicians’ interpretations of ultrasound exams in 2005 with SNF claims for the same year to determine which interpretations occurred during Part A-covered SNF stays. We then multiplied the number of physician interpretations of each exam by the average Medicare payment and beneficiary cost-sharing amounts for the corresponding exam.

Ultrasound exams and other services are bundled into the SNF prospective payment system (PPS) rate for beneficiaries in Part A-covered SNF stays, so Medicare should not pay separately under Part B for these exams. However, we identified claims for up to 33,000 ultrasound exams conducted during Part A-covered SNF stays as having been improperly billed. Medicare paid approximately $2.6 million for these exams, and beneficiaries paid about $1.5 million. If Medicare contractors did not recoup all of these improper payments as they are required to, then our estimate of the financial impact of paying separately under Part B for ultrasound exams would be overstated because Medicare would have already been paying separately under Part B for some of these exams in the absence of this policy. However, because data for improperly paid claims do not indicate whether the payments were recouped, we were unable to accurately estimate the extent to which these improper payments affect our estimates.

To estimate the financial impact of paying separately under Part B for ultrasound equipment transportation for beneficiaries in Part A-covered SNF stays, we first estimated the number of ultrasound exams conducted in SNFs, as opposed to other sites of service, for these beneficiaries in 2005. To do so, we multiplied the number of physician interpretations of exams for these beneficiaries in that year by the proportion of all ultrasound exams for the same population in 1997 that were conducted in SNFs. We converted this estimate of the number of exams done in SNFs for these beneficiaries into the number of beneficiary days to indicate how many equipment transportation and set-up fees Medicare would have paid. To calculate the financial impact on Medicare payments, we added the product of (1) the number of beneficiary days and the average estimated equipment transportation fee and (2) the number of exams and estimated average of the equipment set-up fee. To calculate the financial impact on beneficiary cost sharing, we added the product of (1) the number of beneficiary days and the average estimated cost sharing for equipment transportation and (2) the number of exams and average estimated equipment transportation fee.

We used a similar process to estimate the financial impact of separate Part B payments for ambulance services used during Part A-covered SNF stays to transport beneficiaries from a SNF to another location for an ultrasound exam and back. We (1) estimated the number of ultrasound exams for beneficiaries in Part A-covered SNF stays in 2005 that involved ambulance transportation, by multiplying the number of physician interpretations of exams for these beneficiaries in that year by the proportion of exams for the same population in 1997 that involved ambulance transportation; (2) converted this estimate of the number of exams involving ambulance transportation into the number of beneficiary days to indicate how many ambulance round trips Medicare would have paid; and (3) multiplied the number of beneficiary days by the average cost to Medicare and a beneficiary of an ambulance round trip. We also did a literature search to locate studies addressing the effect of the SNF PPS on the use of ultrasound and certain other imaging services. Key search terms included Medicare, skilled nursing facility, prospective payment system, ultrasound, imaging, X-ray, computed tomography, magnetic resonance imaging, and angiography.

Our analysis of the financial impact of paying separately under Part B for ultrasound exams and related transportation has two key limitations. First, because more recent information was unavailable, we used 1997 data to estimate the number of ultrasound exams conducted in SNFs or that involved ambulance transportation. Therefore, the precision of estimates of the financial impact of paying separately under Part B for these services is limited by the accuracy with which the results based on the 1997 data we used would have been similar if 2005 data had been available. In addition, the financial impact estimates we present are based on the assumption that service use would not change in response to this policy. To address the possibility that a policy of paying separately for services, as opposed to bundling payment for them, would affect the use of services, we (1) summarized studies we found that addressed how bundling payment for services can affect their use and (2) conducted a literature search to identify studies addressing how the use of certain imaging, and specifically ultrasound, services changed in response to the SNF PPS.

Factors to Consider Concerning Sonographer Qualification Requirements

To identify factors to consider in determining whether CMS should establish credentialing or other qualification requirements for sonographers, we reviewed applicable Medicare regulations and CMS documents on Medicare coverage policies, including Medicare National Coverage Determinations. In addition, we reviewed Medicare carriers’ Local Coverage Determinations (LCD) related to the qualification requirements for sonographers that perform echocardiograms, noninvasive vascular ultrasounds, and other diagnostic ultrasounds, such as abdominal and pelvic ultrasounds. To identify these coverage policies, we conducted searches in CMS’s Medicare Coverage Database for draft and final LCDs related to echocardiograms and noninvasive vascular ultrasounds as of April 2007 for each Medicare carrier. We also conducted a search in CMS’s Medicare Coverage Database for LCDs related to other diagnostic ultrasounds as of September 2006.

In addition, we interviewed CMS and Medicare Payment Advisory Commission officials and representatives from national organizations that award credentials in sonography or accredit facilities that perform ultrasound procedures, and reviewed documents that they provided to us. These organizations included the American Registry for Diagnostic Medical Sonography, the Intersocietal Accreditation Commission, the American Institute of Ultrasound in Medicine, Cardiovascular Credentialing International, and the American College of Radiology. Finally, we conducted a literature search and reviewed relevant studies in peer-reviewed journals.

Data Reliability

Medicare claims data, which are used by the Medicare program as a record of payments made to health care providers, are monitored by CMS. The data are subject to various checks and edits. Although we did not review these checks and edits, we assessed the reliability of the NCH data, which include all claims data analyzed for this report. We found the data sufficiently reliable for purposes of this report.

We performed our work from July 2006 through May 2007 in accordance with generally accepted government auditing standards.

Appendix II: Ultrasound Procedures and Medicare Part B Payments in 2005

This appendix contains information on the number of ultrasound procedures provided to Medicare beneficiaries in 2005 by site of service and the level of physician supervision required to administer the procedures. (See table 4.) This appendix also includes data on the five top medical conditions diagnosed by type of ultrasound procedures provided to Medicare beneficiaries overall and to those in SNF stays in 2005 that were not covered by Medicare. (See tables 5 and 6.)

Appendix III: Detailed Estimates of the Financial Impact of Changing Medicare Ultrasound Payment Methods

This appendix contains information on the financial impact of paying for ultrasound equipment transportation. (See table 7.) In addition, this appendix presents information on changes in the number of ultrasound exams conducted in skilled nursing facilities (SNF) between 1995 and 1997 (see table 8).

Appendix IV: Studies on Accreditation of Facilities and the Credentialing of Sonographers

To determine the accuracy of noninvasive vascular ultrasound procedures conducted by accredited and nonaccredited facilities.

The study compared the results of noninvasive vascular ultrasound procedures performed by an accredited facility to the results of studies that were initially performed by both accredited and nonaccredited facilities. The study reviewed a total of 437 ultrasound carotid duplex exams.

The study found an 83 percent correlation rate for ultrasound procedures that were initially performed at accredited facilities.

However, when the initial study was performed by a nonaccredited facility, the correlation rate for reviewed studies was 45 percent.

To determine the effectiveness of the American Institute of Ultrasound in Medicine (AIUM) accreditation program in improving compliance with standards and guidelines for the performance of obstetric and gynecologic ultrasound examinations.

The scores of case studies in 82 AIUM accreditation applications were compared with their respective scores at the time of reaccreditation 3 years later. To account for the element of time, scores of applications that recently completed first-time accreditation were also compared as a control group.

The study found that practices that applied for, and were granted, ultrasound accreditation were able to improve the scores of case studies and to achieve compliance with AIUM minimum standards and guidelines for the performance of gynecologic and obstetric ultrasound examinations. The study concluded that the improvement in scores should translate into an enhancement of the quality of the ultrasound practice.

To evaluate the reliability of carotid duplex ultrasound scanning procedures performed by nonaccredited vascular laboratories and to assess the clinical effect on patient management.

The study compared the quality and reliability of carotid duplex ultrasound scanning procedures performed by a nonaccredited vascular laboratory with repeat examinations performed in the Beaumont laboratory, which is accredited by the Intersocietal Commission for Accreditation of Vascular Laboratories.

The study found that of the 174 patients referred for surgical evaluation for carotid endarterectomy, 88 of these patients did not have the severe or critical carotid stenosis (narrowing) that had been diagnosed initially. Since these patients had all been referred for carotid endarterectomy, unnecessary and potentially dangerous operations were avoided when the accredited laboratory disproved the false positive results from the nonaccredited facilities. For an additional 19 patients, the disease severity had been significantly underestimated by the nonaccredited laboratories.

Objective(s) of study To evaluate the opinions of vascular technologists and sonographers who routinely perform vascular procedures about the value of credentialing and accreditation and to assess their current practice patterns for the performance of carotid duplex ultrasound procedures.

Researchers surveyed 100 members of the Society of Diagnostic Medical Sonography and the Society for Vascular Ultrasound in Kentucky and Indiana. There was a 30 percent response rate.

The study found that 12 percent of (4,782) carotid duplex procedures considered in the study were repeated annually.

Among the reasons cited by respondents for repeat tests was that the sonographers conducting the exams were not sufficiently competent.

Respondents noted that the original procedures often showed a lack of basic sonography knowledge, resulting in poor quality images.

A duplex ultrasound scan is a noninvasive diagnostic ultrasound procedure that uses color Doppler technology to provide information about blood flow and the condition of the arteries and veins. This test is typically used to diagnose suspected artery disease and other vascular problems, including blockage in the carotid artery in the neck.

Appendix V: Information about Groups That Support Ultrasound Credentialing and Accreditation Requirements

Appendix V: Information about Groups That Support Ultrasound Credentialing and Accreditation Requirements The American College of Radiology is a nonprofit, professional association that represents 30,000 diagnostic radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists. The organization’s ultrasound accreditation program was established in 1995, and it includes general ultrasound, obstetrics, gynecological, and vascular ultrasound. This accreditation program requires that all sonographers be certified.

The American Society of Echocardiography is a professional organization of physicians, cardiac sonographers, nurses, and scientists involved in echocardiography, which is the use of ultrasound to image the heart and cardiovascular system. The organization was founded in 1975 and has more than 10,000 members nationally and internationally.

The American Institute of Ultrasound in Medicine is a multidisciplinary organization that was officially established in 1952. The organization supports professional and public education, research, development of guidelines, and accreditation. The organization’s ultrasound practice accreditation council has developed standards for the accreditation of ultrasound practices.

The American Registry for Diagnostic Medical Sonography is an independent nonprofit organization that, for 29 years, has awarded credentials to ultrasound professionals through examinations. The organization offers certification in three ultrasound clinical specialties: Registered Diagnostic Medical Sonographer, Registered Diagnostic Cardiac Sonographer, and Registered Vascular Technologist. The organization has over 44,000 actively certified ultrasound professionals.

Cardiovascular Credentialing International Cardiovascular Credentialing International is an independent nonprofit organization that awards credentials to vascular technology professionals through credentialing examinations. The organization administers credentials in four cardiovascular technology specialties: Certified Cardiographic Technician, Registered Cardiovascular Invasive Specialist, Registered Cardiac Sonographer, and Registered Vascular Specialist.

The Intersocietal Commission for the Accreditation of Echocardiography Laboratories has been in operation since 1996 and currently has accredited over 900 echocardiography laboratories in the United States and Canada. The commission provides a laboratory peer-review evaluation program for echocardiography procedures.

The Intersocietal Commission for the Accreditation of Vascular Laboratories has been in operation since 1991 and currently has over 1,400 accredited laboratories in the United States and Canada. The organization provides a peer-review process of laboratory accreditation for noninvasive vascular diagnostic testing.

Founded in 1979, the Joint Review Committee on Education in Diagnostic Medical Sonography is the only nationally recognized organization that accredits diagnostic medical sonography programs. The primary purpose of the organization is to establish, maintain, and promote appropriate standards of quality for educational programs in diagnostic medical sonography and to provide recognition for educational programs that meet or exceed these standards.

Society of Diagnostic Medical Sonography The Society of Diagnostic Medical Sonography is a professional membership organization founded in 1970 to promote, advance, and educate its members and the medical community in the science of diagnostic medical sonography. The organization has over 17,000 members and is the largest association of sonographers and sonography students in the world.

The Society for Vascular Surgery is the oldest and largest national association of vascular surgeons in the United States. It was founded in 1947 and merged with the American Association for Vascular Surgery in 2003. The Society has a membership of more than 2,200 vascular surgeons. Society members serve on the boards of major vascular sonographer associations as well as the major ultrasound credentialing and accrediting organizations.

The Society for Vascular Ultrasound is the only national professional organization dedicated exclusively to the advancement of noninvasive vascular technology used for diagnostic purposes. The organization’s membership is comprised of more than 4,100 registered vascular technologists, sonographers, nurses, and physicians.

Appendix VI: Comments from the Centers for Medicare & Medicaid Services

Appendix VII: GAO Contact and Staff Acknowledgments

GAO Contact

Acknowledgments

In addition to the contact named above, Sheila K. Avruch, Assistant Director; Jennie Apter; William Black; Kevin Dietz; Sandra Gove; and Carmen Rivera-Lowitt made key contributions to this report.