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

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Medicare spending on imaging services, among which are ultrasound procedures that use sound waves to facilitate diagnosis, nearly doubled from 1999 to 2004. The Congress required GAO to examine Medicare's payment methods for ultrasound procedures and whether the technicians that conduct them--called sonographers--should be subject to qualification standards, such as having to undergo a certification process called credentialing. This report addresses (1) the ultrasound procedures commonly used to diagnose medical conditions of Medicare beneficiaries, particularly for beneficiaries in a skilled nursing facility (SNF), (2) the financial impact of changing how Medicare pays for ultrasound exams and associated equipment and ambulance transportation for beneficiaries in a SNF, and (3) the factors for the Centers for Medicare & Medicaid Services (CMS) to consider in determining whether to establish credentialing or other requirements for sonographers. For this review, GAO analyzed Medicare claims data and conducted interviews and literature reviews.
section_title: What GAO Found
paragraphs: Three-fourths of the approximately 41 million ultrasound procedures provided to Medicare beneficiaries in 2005 in any setting were one of two types: (1) echocardiograms to diagnose heart conditions or (2) noninvasive vascular procedures used to monitor blood flow and detect blockage or injury in veins and arteries. Ultrasound procedures consist of the ultrasound exam itself and the physician's interpretation of the exam. Nearly all of the ultrasound exams provided under Medicare Part B, which covers physician, hospital outpatient, diagnostic testing, and certain other services, were performed in physicians' offices and hospital outpatient departments. Of these exams, less than 1 percent were conducted in SNFs or homes, generally using ultrasound equipment that was transported to these settings by a mobile provider. Among beneficiaries in SNF stays not covered by Medicare who received ultrasound exams in SNFs, noninvasive vascular exams were the most prevalent type performed. Two ultrasound procedure payment changes affecting SNF beneficiaries that GAO examined would likely increase expenditures and beneficiary cost sharing. If CMS had paid to transport ultrasound equipment to beneficiaries in SNF stays not covered by Medicare, which is not currently done, Medicare expenditures could have increased by an estimated $9.8 million and beneficiary cost sharing could have been about $2.6 million higher in 2005, assuming the number and location of services would not change in response to this policy. Moreover, paying separately for ultrasound exams and related transportation during beneficiaries' Medicare-covered SNF stays, as opposed to bundling these and other services into a single daily payment as CMS currently does, could have increased Medicare payments by about $22.0 million and beneficiary cost sharing by about $13.4 million in 2005, assuming no change in service use due to the revised policy. The actual financial impact for Medicare could differ from these estimates if, for example, providers increased their service provision due to these policy changes. Factors for CMS to consider in determining whether to establish credentialing or other qualification requirements for sonographers include the evidence of the value of setting such requirements and variation in federal requirements for sonographers. The skill of the sonographer conducting an ultrasound is critical for its use to support a physician's correct diagnosis; poorly captured images can lead to misdiagnoses or unnecessarily repeated exams. Findings from several peer-reviewed studies, the Medicare Payment Advisory Commission, and ultrasound-related professional organizations support requiring that sonographers either have credentials or operate in facilities that are accredited, where specific quality standards apply. In some localities and practice settings, CMS or its contractors have required that sonographers either be credentialed or work in an accredited facility. Medicare's inconsistent requirements undermine assurance that beneficiaries are receiving high-quality services across the country.

section_title: Letter
paragraphs: Medicare spending on imaging services nearly doubled from $5.7 billion in  1999 to $10.9 billion in 2004, in part due to growth in the number of  procedures. Diagnostic ultrasound procedures, an imaging service which  uses high-frequency sound waves to create images of internal body organs  and blood flow, accounted for about one-fourth of this spending in 2004.  Growth in the use of diagnostic ultrasound procedures has been due in  part to technological advances, which have improved the quality of  ultrasound images and physicians’ ability to employ them to diagnose  medical conditions. Technological advances also have led to the  development of ultrasound devices that are smaller and more portable.  The enhanced portability of ultrasound equipment has made it easier for  beneficiaries to receive ultrasound exams in skilled nursing facilities  (SNF) or beneficiaries’ homes to which ultrasound equipment generally  must be transported by a mobile provider.
Ultrasound procedures consist of two parts—the ultrasound exam itself  and the physician’s interpretation of the exam. The first part of the  procedure—the ultrasound exam—generally involves an ultrasound  technician called a sonographer taking the image. The second part of the  procedure is the physician’s interpretation of images from the ultrasound  exam. Medicare, administered by the Centers for Medicare & Medicaid  Services (CMS), pays for the ultrasound exam and the physician’s  interpretation of it separately or together.
Medicare covers ultrasound and other imaging procedures and certain  related transportation under Part A and Part B of the program, and  beneficiaries are responsible for part of the cost of these services through  cost sharing. For all beneficiaries, Medicare covers the physician’s  interpretation of ultrasound exams under Part B. For beneficiaries in a  Part A-covered SNF or hospital inpatient stay, Medicare covers most  services under Part A and pays for them through a prospective payment  system (PPS), which involves bundling payment for multiple services.  Specifically, for beneficiaries in Part A-covered SNF stays, payment for  ultrasound exams and medically necessary ambulance transportation is  bundled with other services into a single daily rate. A PPS gives providers  the incentive to furnish services efficiently because if the actual cost of  services is less than the bundled payment, the provider keeps the  difference. For beneficiaries who are not in a Part A-covered SNF or  hospital inpatient stay, which includes those in a noncovered SNF stay,  Medicare covers ultrasound exams and medically necessary ambulance  transportation under Part B.
The rapid growth in spending for imaging has contributed to interest in the  Congress and the Medicare Payment Advisory Commission (MedPAC)  about whether Medicare’s payment methodology for these services creates  the proper incentives for appropriate use. Further, MedPAC has expressed  concern that not all imaging providers have the ability to conduct quality  exams, and several ultrasound-related professional organizations have  raised this issue with regard to sonographers. Becoming credentialed by a  nationally recognized organization, which can require obtaining a  combination of training and experience and passing an examination, is one  way for sonographers to demonstrate that they have the necessary skill  level to perform quality exams. In addition, accreditation is a mechanism  for facilities that conduct ultrasound procedures to demonstrate that their  affiliated sonographers meet the standards necessary to perform quality  exams. For example, to work in an accredited facility, sonographers may  be required to have certain credentials or be working toward obtaining  them.
The Medicare Prescription Drug, Improvement, and Modernization Act of  2003 required that we assess issues associated with providing ultrasound  procedures to Medicare beneficiaries. As discussed with the committees  of jurisdiction, we address the following issues in this report: (1) the types  of ultrasound procedures commonly used to diagnose medical conditions  of Medicare beneficiaries, particularly those in SNFs, (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 CMS should establish credentialing or other qualification  requirements for sonographers.
To examine the types of diagnostic ultrasound procedures provided to  Medicare beneficiaries and the sites of service where the exams were  performed, we analyzed Medicare claims data for 2005. Our analysis of the  types of procedures provided to all Medicare beneficiaries was based on  claims for physicians’ interpretations of ultrasound exams, which are paid  under Part B regardless of whether the exam itself was covered under   Part A or Part B. Our analysis of the site of service of ultrasound  procedures was based on claims for ultrasound exams that were paid  under Part B because Part A payments for these exams are bundled with  other services and not separately reported in the Medicare claims data. To  understand clinical issues associated with the site of service, we  performed a literature search; conducted structured interviews with  representatives of gerontological, radiological, and other ultrasound- related professional organizations; and reviewed CMS documents. To  estimate the financial impact to Medicare and its beneficiaries of providing  payments for ultrasound equipment transportation and of paying  separately for ultrasound exams and associated equipment and ambulance  transportation for beneficiaries in Part A-covered SNF stays, we analyzed  Medicare claims data for ultrasound exams and ambulance services in  2005 and for exams in 1995 through 1997. We found the Medicare claims  data we analyzed to be sufficiently reliable for the purposes of this  report. To identify factors to consider in determining whether CMS  should establish credentialing or other requirements for sonographers, we  reviewed Medicare regulations, CMS documents, Medicare carriers’  credentialing requirements for sonographers, and relevant literature and  also interviewed officials from agencies and organizations such as CMS,  MedPAC, and those that credential sonographers. Appendix I provides  more detail on our scope and methodology. We performed our work from  July 2006 through May 2007 in accordance with generally accepted  government auditing standards.
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: Sonographer Credentialing and Training and Facility Accreditation
paragraphs: 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.
section_title: Medicare and Its Coverage Processes
paragraphs: 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.
section_title: Medicare Payment for Ultrasound Procedures and Associated Ambulance and Equipment Transportation
paragraphs: 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.
section_title: The Most Common Medicare Ultrasound Procedures in 2005 Were Echocardiograms and Noninvasive Vascular Studies
paragraphs: 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.
subsections: section_title: About Three-Quarters of Ultrasound Procedures Provided to All Beneficiaries in 2005 Were Echocardiograms and Noninvasive Vascular Studies
paragraphs: 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.
section_title: Noninvasive Vascular Studies Were the Most Prevalent Ultrasound Exams Provided in SNFs to Beneficiaries in Noncovered SNF Stays
paragraphs: 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.
section_title: Changing Ultrasound Payment Methods Would Likely Increase Expenditures and Beneficiary Cost Sharing
paragraphs: 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.
subsections: section_title: Part B Equipment Transportation Payments Would Likely Increase Expenditures and Beneficiary Cost Sharing
paragraphs: 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.
section_title: Paying Separately for Ultrasound Services during Part A-Covered SNF Stays Would Likely Increase Part B Expenditures, Beneficiary Cost Sharing, and Service Use
paragraphs: 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.
section_title: Evidence and Variation in Federal Requirements Are Among Factors to Consider in Determining Whether to Establish Credentialing or Other Qualification Requirements for Sonographers
paragraphs: 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.
subsections: section_title: Studies and Professional Organizations Suggest that Setting Requirements for Sonographers’ Qualifications Could Promote Quality
paragraphs: 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.
section_title: Federal Requirements for Sonographers’ Qualifications Vary and State Requirements Are Absent
paragraphs: 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.
section_title: CMS Has Several Implementation Options
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
subsections: section_title: Types of Ultrasound Procedures Provided to Beneficiaries
paragraphs: 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.
section_title: Financial Impact of Changing Payment Methods
paragraphs: 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.
subsections: section_title: Paying to Transport and Set Up Ultrasound Equipment
paragraphs: 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.
section_title: Paying Separately under Part B for Ultrasound Exams and Related Transportation during Part A-Covered SNF Stays
paragraphs: 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.
section_title: Factors to Consider Concerning Sonographer Qualification Requirements
paragraphs: 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.
section_title: Data Reliability
paragraphs: 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.
section_title: Appendix II: Ultrasound Procedures and Medicare Part B Payments in 2005
paragraphs: 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.)
section_title: Appendix III: Detailed Estimates of the Financial Impact of Changing Medicare Ultrasound Payment Methods
paragraphs: 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).
section_title: Appendix IV: Studies on Accreditation of Facilities and the Credentialing of Sonographers
subsections: section_title: To determine the accuracy of noninvasive vascular ultrasound procedures conducted by accredited and nonaccredited facilities.
paragraphs: 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.
section_title: Appendix V: Information about Groups That Support Ultrasound Credentialing and Accreditation Requirements
paragraphs: 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.
section_title: Appendix VI: Comments from the Centers for Medicare & Medicaid Services
section_title: Appendix VII: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: 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.