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Report to Congressional Committees: 

United States Government Accountability Office: 

GAO: 

June 2007: 

Medicare Ultrasound Procedures: 

Consideration of Payment Reforms and Technician Qualification 
Requirements: 

GAO-07-734: 

GAO Highlights: 

Highlights of GAO-07-734, a report to congressional committees 

Why GAO Did This Study: 

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. 

What GAO Found: 

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. 

What GAO Recommends: 

CMS should require sonographers providing Medicare-covered ultrasound 
exams to either be credentialed or work in an accredited facility. CMS 
stated that it would consider this recommendation. 

[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-734]. 

To view the full product, including the scope and methodology, click on 
the link above. For more information, contact A. Bruce Steinwald at 
(202) 512-7114 or steinwalda@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

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

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

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

Conclusions: 

Recommendation for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

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

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

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

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

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

Appendix VII: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Medicare Payment Methodology for Selected Imaging Procedures 
and Associated Transportation for Beneficiaries in SNF Stays: 

Table 2: Financial Impact of Part B Ultrasound Equipment Transportation 
Payments, 2005: 

Table 3: Increase in Part B Expenditures and Beneficiary Cost Sharing 
Due to Separate Payments for Ultrasound Services during Part A-Covered 
SNF Stays, 2005: 

Table 4: Number of Ultrasound Procedures Provided to Medicare 
Beneficiaries by Site of Service and Level of Physician Supervision 
Required, 2005: 

Table 5: Top Five Medical Conditions Diagnosed by Type of Ultrasound 
Procedure Provided to Medicare Beneficiaries under Medicare Part B, 
2005: 

Table 6: Top Five Medical Conditions Diagnosed by Type of Ultrasound 
Procedure Provided in SNFs to Medicare Beneficiaries in Noncovered SNF 
stays and Paid Under Medicare Part B, 2005: 

Table 7: Financial Impact of Ultrasound Equipment Transportation 
Payments, 2005: 

Table 8: Percentage Change in Number of Ultrasound Exams in SNFs, 1995 
to 1997: 

Figures: 

Figure 1: Percentages of Total Procedures and Total Part B Medicare 
Payments for Ultrasound Procedures Provided to Beneficiaries, 2005: 

Figure 2: Percentages of Total Procedures and Total Part B Medicare 
Payments for Ultrasound Procedures Conducted in SNFs for Beneficiaries 
in Noncovered SNF Stays, 2005: 

Figure 3: Medicare Carriers' Part B LCDs on Noninvasive Vascular 
Diagnostic Ultrasound Procedures, as of April 2007: 

Abbreviations: 

AIUM: American Institute of Ultrasound in Medicine: 
ARDMS: American Registry for Diagnostic Medical Sonography: 
BBA: Balanced Budget Act of 1997: 
BETOS: Berenson-Eggers Type of Service: 
CCI: Cardiovascular Credentialing International: 
CMS: Centers for Medicare & Medicaid Services: 
CoP: Medicare Conditions of Participation: 
CPT: Current Procedural Terminology: 
FDA: Food and Drug Administration: 
HCPCS: Healthcare Common Procedure Coding System: 
HHS: Department of Health and Human Services: 
ICAVL: Intersocietal Commission for the Accreditation of Vascular 
Laboratories: 
IDTF: independent diagnostic testing facility: 
LCD: Local Coverage Determination: 
MedPAC: Medicare Payment Advisory Commission: 
NCD: National Coverage Determination: 
NCH: National Claims History: 
OIG: Office of Inspector General: 
PPS: prospective payment system: 
SAF: Standard Analytical File: 
SNF: skilled nursing facility: 

United States Government Accountability Office: 
Washington, DC 20548: 

June 28, 2007: 

The Honorable Max Baucus: 
Chairman: 
The Honorable Charles Grassley: 
Ranking Minority Member: 
Committee on Finance: 
United States Senate: 

The Honorable John D. Dingell: 
Chairman: 
The Honorable Joe Barton: 
Ranking Minority Member:
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Charles B. Rangel: 
Chairman: 
The Honorable Jim McCrery: 
Ranking Minority Member: 
Committee on Ways and Means: 
House of Representatives: 

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.[Footnote 1] 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.[Footnote 2] 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.[Footnote 3] 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.[Footnote 
4] 

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.[Footnote 5] 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,[Footnote 
6] 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.[Footnote 7] 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.[Footnote 8] 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.[Footnote 9] 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.[Footnote 10] We found the Medicare claims 
data we analyzed to be sufficiently reliable for the purposes of this 
report.[Footnote 11] 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.[Footnote 12] 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. 

Results in Brief: 

The most common diagnostic ultrasound procedures provided to all 
Medicare beneficiaries and to those in noncovered SNF stays were used 
to diagnose heart and circulatory (vascular) problems. Echocardiograms, 
used to diagnose conditions such as heart failure and problems with the 
innermost layer of the heart, were the most frequently performed type 
of ultrasound procedure in 2005. They accounted for about 53 percent of 
the 41 million procedures provided to nearly 12.4 million Medicare 
beneficiaries in any setting and 49 percent of the $3.2 billion in 
Medicare Part B payments for ultrasound procedures. Noninvasive 
vascular studies--used to examine the blood flow through veins and 
arteries and to detect blockage, injury, or blood clots--represented 
about 20 percent of the ultrasound procedures and 30 percent of the 
Medicare Part B payments. Nearly all (99 percent) of the ultrasound 
exams provided to beneficiaries under Medicare Part B in 2005 were 
performed in physician offices and hospital outpatient departments. The 
remaining 1 percent were conducted in various sites of service, 
including about 129,000 exams conducted in SNFs and 101,000 exams 
conducted in beneficiaries' homes. Among the ultrasound exams provided 
in SNFs to beneficiaries in noncovered SNF stays, noninvasive vascular 
studies were the most prevalent, followed by echocardiograms. 

We examined two potential changes to Medicare payment methods related 
to ultrasound procedures for beneficiaries in SNFs and found that both 
are likely to increase Medicare expenditures and beneficiary cost 
sharing based on 2005 data and assuming that the provision of exams 
would not change in response to this policy. First, we found that 
providing Part B payments to transport equipment to SNFs during 
noncovered SNF stays for ultrasound exams could have increased Medicare 
expenditures by about $9.8 million and beneficiary cost sharing by 
about $2.6 million in 2005. Second, we estimated the impact of paying 
separately under Part B for ultrasound exams and associated equipment 
and ambulance transportation for beneficiaries in Part A-covered SNF 
stays, as opposed to bundling these services into the Part A PPS 
payment as is currently done. We found that this policy could have 
increased Part B Medicare expenditures by about $22.0 million and 
beneficiary cost sharing by about $13.4 million in 2005. However, these 
types of changes in payment policies could affect service use and thus 
could cause the actual financial impact to differ from our estimates. 
For example, paying separately under Part B for ultrasound exams and 
associated equipment and ambulance transportation for beneficiaries in 
Part A-covered SNF stays could cause the use of these services to grow 
because the PPS incentive to provide them efficiently would be absent, 
and this could cause the actual financial impacts to be greater than 
our estimates. In addition, unless these separate Part B payments were 
offset by a reduction in the Part A PPS payment, they would increase 
overall Medicare expenditures. 

Factors for CMS to consider in determining whether to establish 
credentialing or other requirements for sonographers include the 
evidence of the value of establishing such requirements and the 
variation in federal requirements for sonographers. Having qualified 
sonographers is important because their skill in performing an 
ultrasound exam is critical to capturing quality images that physicians 
can use in making appropriate clinical decisions and avoiding 
misdiagnoses or unnecessarily repeated exams. Findings from peer- 
reviewed studies, MedPAC, and ultrasound-related professional 
organizations support the establishment of qualification requirements 
for sonographers. In some locations and practice settings, Medicare 
mandates that certain sonographers either be credentialed or work in an 
accredited facility that requires sonographers to demonstrate that they 
meet certain quality standards. The inconsistency of Medicare's 
requirements across the country, coupled with the absence of state 
licensure requirements for sonographers, undermines the assurance that 
beneficiaries are receiving similarly high-quality services in 
different locations and settings. 

To help ensure consistency in the quality of ultrasound services 
provided to Medicare beneficiaries nationwide, we recommend that the 
Administrator of CMS require that sonographers serving Medicare 
beneficiaries either be credentialed or work in an accredited facility. 

In its written comments on a draft of this report, CMS stated that it 
would consider our recommendation but would prefer that states engage 
their own licensing bodies in implementing sonographer licensure 
programs. (See app. VI.) CMS 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 a national policy, and our 
report states that 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. 

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.[Footnote 13] 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.[Footnote 14] 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.[Footnote 
15] 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.[Footnote 16] 

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.[Footnote 17] 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.[Footnote 18] 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.[Footnote 19] 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.[Footnote 20] 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.[Footnote 21] 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."[Footnote 22] (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.[Footnote 23] 

Table 1: Medicare Payment Methodology for Selected Imaging Procedures 
and Associated Transportation for Beneficiaries in SNF Stays: 

Imaging procedures. 

Type of procedure or transportation: Exam; 
Part A-covered SNF stays: Ultrasound: [Empty]; 
Part A-covered SNF stays: X-ray[A]: [Empty]; 
Part A-covered SNF stays: CT scan, MRI, Angiography[B]: [C]; 
Noncovered SNF stays: Ultrasound: [Empty]; 
Noncovered SNF stays: X- ray[A]: [Empty]; 
Noncovered SNF stays: CT scan, MRI, Angiography[B]: [Empty]. 

Type of procedure or transportation: Interpretation of exam; 
Part A- covered SNF stays: Ultrasound: [Empty]; 
Part A-covered SNF stays: X- ray[A]: [Empty]; 
Part A-covered SNF stays: CT scan, MRI, Angiography[B]: [Empty]; 
Noncovered SNF stays: Ultrasound: [Empty]; 
Noncovered SNF stays: X-ray[A]: [Empty]; 
Noncovered SNF stays: CT scan, MRI, Angiography[B]: [Empty]. 

Type of procedure or transportation: Ambulance transportation 
associated with imaging exam[D]; 
Part A-covered SNF stays: Ultrasound: [Empty]; 
Part A-covered SNF stays: X-ray[A]: [Empty]; 
Part A-covered SNF stays: CT scan, MRI, Angiography[B]: [C]; 
Noncovered SNF stays: Ultrasound: [Empty]; 
Noncovered SNF stays: X-ray[A]: [Empty]; 
Noncovered SNF stays: CT scan, MRI, Angiography[B]: [Empty]. 

Source: GAO analysis of CMS guidance on Medicare payment methodology 
for SNF services. 

Legend: = bundled into SNF PPS payment; = paid separately under Part B: 

[A] Does not include angiography. 

[B] Angiography is a type of imaging procedure that involves the use of 
X-rays to develop images of arteries after dye is injected into the 
bloodstream. 

[C] Exams and associated ambulance transportation are only paid for 
separately under Part B if the exam is conducted in a hospital 
outpatient facility. 

[D] 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). 

[End of table] 

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.[Footnote 24] 

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.[Footnote 
25] 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.[Footnote 26] 

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.[Footnote 27] 
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.) 

Figure 1: Percentages of Total Procedures and Total Part B Medicare 
Payments for Ultrasound Procedures Provided to Beneficiaries, 2005: 

[See PDF for image] 

Source: GAO analysis of Medicare Part B claims data for 2005. 

Notes: Percentages may not sum to 100 due to rounding. The number of 
procedures is based on claims for physicians' interpretations of 
ultrasound exams and claims for ultrasound procedures classified solely 
as physician services that did not have a separately billed exam and 
physician's interpretation of the exam. Medicare payments do not 
include beneficiary cost-sharing amounts. Our calculation of Medicare 
payments does not include payment for ultrasound exams that were 
provided to beneficiaries in Part A-covered SNF or inpatient hospital 
stays because Part A payments for these exams are bundled with other 
services and not separately reported in Medicare claims data. 

[End of figure] 

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).[Footnote 
28] 

* 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.[Footnote 29] 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.[Footnote 30] 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.[Footnote 31] 

Figure 2: Percentages of Total Procedures and Total Part B Medicare 
Payments for Ultrasound Procedures Conducted in SNFs for Beneficiaries 
in Noncovered SNF Stays, 2005: 

[See PDF for image] 

Source: GAO analysis of Medicare Part B claims for 2005. 

Notes: We based this analysis on claims for ultrasound exams and claims 
for ultrasound procedures classified solely as physician services that 
do not include a separately billed exam and physician's interpretation 
of the exam. Medicare payments in this figure do not include 
beneficiary cost-sharing amounts. Our calculation of Medicare payments 
does not include those for ultrasound exams that were provided to 
beneficiaries in Part A-covered SNF or inpatient hospital stays because 
Part A payments for these exams are bundled with other services and not 
separately reported in Medicare claims data. 

[End of figure] 

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.[Footnote 32] 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.[Footnote 33] 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.[Footnote 34] 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). 

Table 2: Financial Impact of Part B Ultrasound Equipment Transportation 
Payments, 2005: 

Site of service: Skilled nursing facilities[A]; 
Financial impact: Ultrasound exams (number): 129,119; 
Financial impact: Medicare payments (dollars): $9.8 million; 
Financial impact: Beneficiary cost sharing (dollars): $2.6 million. 

Site of service: Home; 
Financial impact: Ultrasound exams (number): 101,285; 
Financial impact: Medicare payments (dollars): $4.4 million; 
Financial impact: Beneficiary cost sharing (dollars): $1.2 million. 

Site of service: Custodial care and assisted living facilities; 
Financial impact: Ultrasound exams (number): 22,787; 
Financial impact: Medicare payments (dollars): $1.3 million; 
Financial impact: Beneficiary cost sharing (dollars): $0.3 million. 

Site of service: Total; 
Financial impact: Ultrasound exams (number): 253,191; 
Financial impact: Medicare payments (dollars): $15.5 million; 
Financial impact: Beneficiary cost sharing (dollars): $4.1 million. 

Source: GAO analysis of Medicare Part B claims data for 2005. 

Notes: Dollar amounts may not sum to totals due to rounding. To 
calculate the number of ultrasound exams, we counted the exams 
themselves that were paid under Part B, as well as ultrasound 
procedures classified solely as physician services that do not include 
a separately billed exam. Ultrasound exams were defined as Healthcare 
Common Procedure Coding System codes in the Berenson-Eggers Type of 
Service categories for echography in addition to 10 diagnostic 
ultrasound codes that were not in these categories. Calculations are 
based on the assumption that mobile ultrasound providers would receive 
a fee for transporting and setting up the equipment. See appendix I for 
more information on how we defined ultrasound exams and appendix III 
for detailed results. 

[A] Based on exams conducted in either a SNF or nursing facility during 
a noncovered SNF stay. 

[End of table] 

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.[Footnote 35] 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.[Footnote 36] 

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.[Footnote 37] 

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.[Footnote 38] 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.[Footnote 39] 

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.[Footnote 40] 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.[Footnote 41] (See table 3 and app. I for details on how these 
estimates were calculated.) 

Table 3: Increase in Part B Expenditures and Beneficiary Cost Sharing 
Due to Separate Payments for Ultrasound Services during Part A-Covered 
SNF Stays, 2005: 

Type of service: Ultrasound exams[A]; 
Increase in Part B expenditures (dollars): $19.5 million; 
Increase in beneficiary cost sharing (dollars): $12.7 million. 

Type of service: Ultrasound equipment transportation[B]; 
Increase in Part B expenditures (dollars): $2.3 million; 
Increase in beneficiary cost sharing (dollars): $0.6 million. 

Type of service: Ambulance transportation for ultrasound exam[C]; 
Increase in Part B expenditures (dollars): $0.2 million; 
Increase in beneficiary cost sharing (dollars): $0.1 million. 

Type of service: Total; 
Increase in Part B expenditures (dollars): $22.0 million; 
Increase in beneficiary cost sharing (dollars): $13.4 million. 

Source: GAO analysis of Medicare claims for 2005 and 1997 (see app. I 
for more detail). 

Notes: Dollar amounts may not sum to totals due to rounding. Ultrasound 
exams were defined as Healthcare Common Procedure Coding System codes 
in the Berenson-Eggers Type of Service categories for echography in 
addition to 10 diagnostic ultrasound codes that were not in these 
categories. See appendix I for more detail. 

[A] Estimates based on physicians' interpretations of ultrasound exams 
conducted during Part A-covered SNF stays and estimates of the Medicare 
payment and beneficiary cost sharing for the exam that corresponds to 
these interpretations. See appendix I for more detail. 

[B] Estimates based on the assumption that Medicare would pay for both 
the transportation and set-up of the ultrasound equipment. If Medicare 
only paid for the transportation of ultrasound equipment, Part B 
expenditures due to separate Part B payments during Part A-covered SNF 
stays for this service would increase by about $2.0 million, and 
beneficiary cost sharing would increase by approximately $0.5 million. 

[C] Defined as ambulance services used to transport a beneficiary from 
a SNF to another facility and back for an ultrasound exam. 

[End of table] 

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.[Footnote 42] 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.[Footnote 43] 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.[Footnote 44] 
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.[Footnote 45] 

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.[Footnote 46] 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.[Footnote 47] 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.[Footnote 48] 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.[Footnote 49] 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.[Footnote 50] 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.[Footnote 51] 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.[Footnote 52] 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.[Footnote 53] 

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.[Footnote 54] 
MedPAC noted that these standards should address the qualifications of 
the performing technicians in addition to other aspects of imaging 
procedures.[Footnote 55] 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[Footnote 56] 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.[Footnote 57] 

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.[Footnote 58] 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.[Footnote 59] 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.[Footnote 60] 
The 2003 study noted that "alternatives that consider voluntary 
compliance to ultrasound standards may be unsuccessful."[Footnote 61] 

Figure 3: Medicare Carriers' Part B LCDs on Noninvasive Vascular 
Diagnostic Ultrasound Procedures, as of April 2007: 

[See PDF for image] 

Source: GAO analysis of of carriers' Part B local coverage 
determinations concerning noninvasive vascular diagnostic ultrasound 
procedures and echocardiography. 

[A] The Medicare carrier in Queens, N.Y., does not have an LCD that 
includes a recommendation or requirement that noninvasive vascular 
diagnostic ultrasound procedures be performed by a credentialed 
sonographer or in an accredited laboratory. 

[End of figure] 

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.[Footnote 62] 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.[Footnote 63] There are CoP provisions that 
include specific standards for medical staff and for 
radiology,[Footnote 64] 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.[Footnote 65] 

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.[Footnote 66] 

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.[Footnote 67] 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.[Footnote 68] 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. 

Signed by: 

A. Bruce Steinwald: 
Director, Health Care: 

[End of section] 

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.[Footnote 69] We based our 
analysis of the site of service of ultrasound procedures on claims for 
ultrasound exams that were paid under Part B.[Footnote 70] 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.[Footnote 71] For this 
report, we selected 94 HCPCS codes in the BETOS categories for 
echography, which is a synonym for ultrasound.[Footnote 72] 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.[Footnote 73] 

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.[Footnote 74] 

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.[Footnote 75] 

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,[Footnote 76] (2) determined the number of 
beneficiary days on which these exams were conducted,[Footnote 77] 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.[Footnote 78] 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.[Footnote 79] 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.[Footnote 80] (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,[Footnote 81] (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,[Footnote 82] we first identified ambulance trips 
used to transport these beneficiaries from SNFs to another location for 
an ultrasound procedure.[Footnote 83] 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.[Footnote 84] 

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.[Footnote 85] 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.[Footnote 86] 

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.[Footnote 87] 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.[Footnote 88] 

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;[Footnote 89] 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.[Footnote 90] 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,[Footnote 91] 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. 

[End of section] 

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.) 

Table 4: Number of Ultrasound Procedures Provided to Medicare 
Beneficiaries by Site of Service and Level of Physician Supervision 
Required, 2005: 

Type of ultrasound procedure: Noninvasive vascular; 
Level of physician supervision required: Subtotal: General;
 Number of procedures[A]: Subtotal: 6,347,815; 
Site of service: Physician's office: Subtotal: 3,821,749; 
Site of service: Hospital outpatient department: Subtotal: 2,376,169; 
Site of service: Skilled nursing facility[B]: Subtotal: 69,704; 
Site of service: Other[C]: Subtotal: 80,193. 

Type of ultrasound procedure: Subtotal; 
Level of physician supervision required: [Empty]; 
Number of procedures[A]: 6,347,815; 
Site of service: Physician's office: 3,821,749; 
Site of service: Hospital outpatient department: 2,376,169; 
Site of service: Skilled nursing facility[B]: 69,704; 
Site of service: Other[C]: 80,193. 

Type of ultrasound procedure: Echocardiograms; 
Level of physician supervision required: General; 
Number of procedures[A]: 12,698,357; 
Site of service: Physician's office: 9,517,262; 
Site of service: Hospital outpatient department: 3,065,385; 
Site of service: Skilled nursing facility[B]: 28,655; 
Site of service: Other[C]: 87,055. 

Type of ultrasound procedure: Echocardiograms; 
Level of physician supervision required: Direct; 
Number of procedures[A]: 421,801; 
Site of service: Physician's office: 276,498; 
Site of service: Hospital outpatient department: 145,051; 
Site of service: Skilled nursing facility[B]: 6; 
Site of service: Other[C]: 246. 

Type of ultrasound procedure: Echocardiograms; 
Level of physician supervision required: Personal; 
Number of procedures[A]: 77,040; 
Site of service: Physician's office: 3,507; 
Site of service: Hospital outpatient department: 51,842; 
Site of service: Skilled nursing facility[B]: 30; 
Site of service: Other[C]: 21,661. 

Type of ultrasound procedure: Echocardiograms; 
Level of physician supervision required: Subtotal: N/A[D]; 
Number of procedures[A]: Subtotal: 1,008; 
Site of service: Physician's office: Subtotal: 5; 
Site of service: Hospital outpatient department: Subtotal: 1,003; 
Site of service: Skilled nursing facility[B]: Subtotal: 0; 
Site of service: Other[C]: Subtotal: 0. 

Type of ultrasound procedure: Echocardiograms; 
Subtotal; 
Level of physician supervision required: [Empty];
 Number of procedures[A]: 13,198,206; 
Site of service: Physician's office: 9,797,272; 
Site of service: Hospital outpatient department: 3,263,281; 
Site of service: Skilled nursing facility[B]: 28,691; 
Site of service: Other[C]: 108,962. 

Type of ultrasound procedure: Abdomen and pelvis; 
Level of physician supervision required: General; 
Number of procedures[A]: 3,579,463; 
Site of service: Physician's office: 1,848,590; 
Site of service: Hospital outpatient department: 1,685,573; 
Site of service: Skilled nursing facility[B]: 21,882; 
Site of service: Other[C]: 23,418. 

Type of ultrasound procedure: Abdomen and pelvis; 
Level of physician supervision required: Subtotal: Personal; 
Number of procedures[A]: Subtotal: 24,523; 
Site of service: Physician's office: Subtotal: 13,489; 
Site of service: Hospital outpatient department: Subtotal: 10,924; 
Site of service: Skilled nursing facility[B]: Subtotal: 0; 
Site of service: Other[C]: Subtotal: 110. 

Type of ultrasound procedure: Abdomen and pelvis; 
Subtotal; 
Level of physician supervision required: [Empty]; 
Number of procedures[A]: 3,603,986; 
Site of service: Physician's office: 1,862,079; 
Site of service: Hospital outpatient department: 1,696,497; 
Site of service: Skilled nursing facility[B]: 21,882; 
Site of service: Other[C]: 23,528. 

Type of ultrasound procedure: Head, neck, and chest; 
Level of physician supervision required: General; 
Number of procedures[A]: 1,907,810; 
Site of service: Physician's office: 1,295,574; 
Site of service: Hospital outpatient department: 603,117; 
Site of service: Skilled nursing facility[B]: 1,853; 
Site of service: Other[C]: 7,266. 

Type of ultrasound procedure: Head, neck, and chest; 
Level of physician supervision required: Subtotal: Direct; 
Number of procedures[A]: Subtotal: 148,023; 
Site of service: Physician's office: Subtotal: 135,164; 
Site of service: Hospital outpatient department: Subtotal: 11,784; 
Site of service: Skilled nursing facility[B]: Subtotal: 729; 
Site of service: Other[C]: Subtotal: 346. 

Type of ultrasound procedure: Head, neck, and chest; 
Subtotal; 
Level of physician supervision required: [Empty]; 
Number of procedures[A]: 2,055,833; 
Site of service: Physician's office: 1,430,738; 
Site of service: Hospital outpatient department: 614,901; 
Site of service: Skilled nursing facility[B]: 2,582; 
Site of service: Other[C]: 7,612. 

Type of ultrasound procedure: Ultrasonic guidance; 
Level of physician supervision required: General; 
Number of procedures[A]: 454,230; 
Site of service: Physician's office: 248,076; 
Site of service: Hospital outpatient department: 199,252; 
Site of service: Skilled nursing facility[B]: 0; 
Site of service: Other[C]: 6,902. 

Type of ultrasound procedure: Ultrasonic guidance; 
Level of physician supervision required: Personal; 
Number of procedures[A]: 530,948; 
Site of service: Physician's office: 273,706; 
Site of service: Hospital outpatient department: 249,159; 
Site of service: Skilled nursing facility[B]: 7; 
Site of service: Other[C]: 8,076. 

Level of physician supervision required: N/A[D]; 
Number of procedures[A]: Subtotal: 18,042; 
Site of service: Physician's office: Subtotal: 34; 
Site of service: Hospital outpatient department: Subtotal: 16,704; 
Site of service: Skilled nursing facility[B]: Subtotal: 0; 
Site of service: Other[C]: Subtotal: 1,304. 

Type of ultrasound procedure: Subtotal; 
Level of physician supervision required: [Empty]; 
Number of procedures[A]: 1,003,220; 
Site of service: Physician's office: 521,816; 
Site of service: Hospital outpatient department: 465,115; 
Site of service: Skilled nursing facility[B]: 7; 
Site of service: Other[C]: 16,282. 

Type of ultrasound procedure: Other diagnostic ultrasound; 
Level of physician supervision required: General; 
Number of procedures[A]: 538,598; 
Site of service: Physician's office: 414,036; 
Site of service: Hospital outpatient department: 115,241; 
Site of service: Skilled nursing facility[B]: 1,300; 
Site of service: Other[C]: 8,021. 

Type of ultrasound procedure: Other diagnostic ultrasound; 
Level of physician supervision required: Direct; 
Number of procedures[A]: 21,220; 
Site of service: Physician's office: 10,857; 
Site of service: Hospital outpatient department: 10,051; 
Site of service: Skilled nursing facility[B]: 0; 
Site of service: Other[C]: 312. 

Type of ultrasound procedure: Other diagnostic ultrasound; 
Level of physician supervision required: Personal; 
Number of procedures[A]: 18,959; 
Site of service: Physician's office: 2,661; 
Site of service: Hospital outpatient department: 16,113; 
Site of service: Skilled nursing facility[B]: 0; 
Site of service: Other[C]: 185. 

Type of ultrasound procedure: Other diagnostic ultrasound; 
Level of physician supervision required: N/A[D]; 
Number of procedures[A]: 1,440,976; 
Site of service: Physician's office: 1,319,944; 
Site of service: Hospital outpatient department: 102,963; 
Site of service: Skilled nursing facility[B]: 7,230; 
Site of service: Other[C]: Subtotal: 10,839. 

Type of ultrasound procedure: Other diagnostic ultrasound; 
Subtotal; 
Level of physician supervision required: [Empty]; 
Number of procedures[A]: 2,019,753; 
Site of service: Physician's office: 1,747,498; 
Site of service: Hospital outpatient department: 244,368; 
Site of service: Skilled nursing facility[B]: 8,530; 
Site of service: Other[C]: 19,357. 

Total number of all procedures provided to beneficiaries; 
Level of physician supervision required: [Empty]; 
Number of procedures[A]: 28,228,813; 
Site of service: Physician's office: 19,181,152; 
Site of service: Hospital outpatient department: 8,660,331; 
Site of service: Skilled nursing facility[B]: 131,396; 
Site of service: Other[C]: 255,934. 

Source: GAO analysis of Medicare claims data for 2005 and Medicare 
regulations and policy guidance on the level of physician supervision 
required for diagnostic tests. 

Notes: General supervision level means that the procedure is furnished 
under the physician's overall direction and control, but physician 
presence is not required during the performance of the procedure. This 
is the minimal level required for all diagnostic tests payable under 
the physician fee schedule, unless there are specific exceptions by 
regulation. Direct supervision means that the physician does not have 
to be present in the room when the procedure is performed, but the 
physician must be in the suite and be immediately available to furnish 
assistance throughout the procedure. Personal supervision means that 
the physician must be in attendance in the room during the performance 
of the procedure. 

[A] The number of procedures is based on claims for ultrasound exams 
paid and claims for ultrasound procedures classified solely as 
physician services that do not include a separately billed exam and 
physician's interpretation of it. 

[B] We counted the number of exams in skilled nursing facilities and 
nursing facilities. 

[C] Other includes (but is not limited to) home, independent 
laboratory, inpatient hospital, ambulatory surgical center, and 
emergency room. 

[D] N/A means not applicable. 

[End of table] 

Table 5: Top Five Medical Conditions Diagnosed by Type of Ultrasound 
Procedure Provided to Medicare Beneficiaries under Medicare Part B, 
2005: 

Type of ultrasound procedure: Noninvasive vascular. 

Top five medical conditions diagnosed: Occlusion and stenosis of 
precerebral arteries; 
Number of procedures: 1,661,280; 
Percentage within procedure type: 20. 

Top five medical conditions diagnosed: Other disorders of soft tissue; 
Number of procedures: 1,603,593; 
Percentage within procedure type: 19. 

Top five medical conditions diagnosed: Atherosclerosis; 
Number of procedures: 737,405; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Other peripheral vascular 
diseases; 
Number of procedures: 728,566; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Cardiovascular system problems; 
Number of procedures: 541,018; 
Percentage within procedure type: 6. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 5,271,862; 
Percentage within procedure type: 63. 

Top five medical conditions diagnosed: Other noninvasive vascular; 
Number of procedures: 3,086,800; 
Percentage within procedure type: 37. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 8,358,662; 
Percentage within procedure type: 100. 

Type of ultrasound procedure: Echocardiogram. 

Top five medical conditions diagnosed: Other diseases of endocardium; 
Number of procedures: 5,740,723; 
Percentage within procedure type: 26. 

Top five medical conditions diagnosed: Symptoms involving respiratory 
system and other chest symptoms; 
Number of procedures: 2,655,795; 
Percentage within procedure type: 12. 

Top five medical conditions diagnosed: Other forms of chronic ischemic 
heart disease; 
Number of procedures: 2,058,896; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Heart failure; 
Number of procedures: 2,054,101; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Cardiac dysrhythmias; 
Number of procedures: 1,375,924; 
Percentage within procedure type: 6. 

Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 13,885,439; 
Percentage within procedure type: 64. 

Top five medical conditions diagnosed: Other echocardiograms;
Number of procedures: 7,947,756; 
Percentage within procedure type: 36. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 21,833,195; 
Percentage within procedure type: 100. 

Type of ultrasound procedure: Abdomen and pelvis. 

Top five medical conditions diagnosed: Other symptoms involving abdomen 
and pelvis; 
Number of procedures: 1,340,438; 
Percentage within procedure type: 27. 

Top five medical conditions diagnosed: Other disorders of kidney and 
ureter; 
Number of procedures: 462,420; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Other disorders of urethra and 
urinary tract; 
Number of procedures: 263,473; 
Percentage within procedure type: 5. 

Top five medical conditions diagnosed: Cholelithiasis; 
Number of procedures: 242,872; 
Percentage within procedure type: 5. 

Top five medical conditions diagnosed: Symptoms involving urinary 
system; 
Number of procedures: 194,177; 
Percentage within procedure type: 4. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 2,503,380; 
Percentage within procedure type: 51. 

Top five medical conditions diagnosed: Other abdomen and pelvis; 
Number of procedures: 2,425,031; 
Percentage within procedure type: 49. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 4,928,411; 
Percentage within procedure type: 100. 

Type of ultrasound procedure: Head, neck, and, chest. 

Top five medical conditions diagnosed: Cataract; 
Number of procedures: 1,176,137; 
Percentage within procedure type: 49. 

Top five medical conditions diagnosed: Other disorders of breast; 
Number of procedures: 386,908; 
Percentage within procedure type: 16. 

Top five medical conditions diagnosed: Nontoxic nodular goiter; 
Number of procedures: 162,762; 
Percentage within procedure type: 7. 

Top five medical conditions diagnosed: Nonspecific abnormal findings on 
radiological and other examinations of body structure; 
Number of procedures: 146,047; 
Percentage within procedure type: 6. 

Top five medical conditions diagnosed: Benign mammary dysplasias; 
Number of procedures: 103,954; 
Percentage within procedure type: 4. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 1,975,808; 
Percentage within procedure type: 82. 

Top five medical conditions diagnosed: Other head, neck, chest; 
Number of procedures: 438,042; 
Percentage within procedure type: 18. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 2,413,850; 
Percentage within procedure type: 100. 

Type of ultrasound procedure: Ultrasonic guidance. 

Top five medical conditions diagnosed: Malignant neoplasm of prostate; 
Number of procedures: 229,242; 
Percentage within procedure type: 18. 

Top five medical conditions diagnosed: Nonspecific findings on 
examination of blood; 
Number of procedures: 150,046; 
Percentage within procedure type: 12. 

Top five medical conditions diagnosed: Other and unspecified aftercare; 
Number of procedures: 120,019; 
Percentage within procedure type: 10. 

Top five medical conditions diagnosed: Pleurisy; 
Number of procedures: 104,175; 
Percentage within procedure type: 8. 

Top five medical conditions diagnosed: Other symptoms involving abdomen 
and pelvis; 
Number of procedures: 84,506; 
Percentage within procedure type: 7. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 687,988; 
Percentage within procedure type: 55. 

Top five medical conditions diagnosed: Other ultrasonic guidance; 
Number of procedures: 552,716; 
Percentage within procedure type: 45. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 1,240,704; 
Percentage within procedure type: 100. 

Type of ultrasound procedure: Other diagnostic ultrasounds. 

Top five medical conditions diagnosed: Symptoms involving urinary 
system; 
Number of procedures: 836,940; 
Percentage within procedure type: 40. 

Top five medical conditions diagnosed: Hyperplasia; 
Number of procedures: 310,658; 
Percentage within procedure type: 15. 

Top five medical conditions diagnosed: Nonspecific findings on 
examination of blood; 
Number of procedures: 168,274; 
Percentage within procedure type: 8. 

Top five medical conditions diagnosed: Malignant neoplasm of prostate; 
Number of procedures: 93,512; 
Percentage within procedure type: 4. 

Top five medical conditions diagnosed: Other disorders of bladder; 
Number of procedures: 83120; 
Percentage within procedure type: 4. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 1,492,504; 
Percentage within procedure type: 70. 

Top five medical conditions diagnosed: All other; 
Number of procedures: 626,456; 
Percentage within procedure type: 30. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 2,118,960; 
Percentage within procedure type: 100. 

Type of ultrasound procedure: Total number of procedures provided to 
Medicare beneficiaries; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 40,893,782; 
Percentage within procedure type: [Empty]. 

Source: GAO analysis of Medicare claims data for 2005. 

Note: Percentages may not sum to 100 due to rounding. Our analysis is 
based on claims for physicians' interpretation of the exams and claims 
for ultrasound procedures classified solely as physician services that 
do not include a separately billed exam and physician's interpretation 
of it. 

[End of table] 

Table 6: Top Five Medical Conditions Diagnosed by Type of Ultrasound 
Procedure Provided in SNFs to Medicare Beneficiaries in Noncovered SNF 
stays and Paid Under Medicare Part B, 2005: 

Type of ultrasound procedure: Noninvasive vascular. 

Top five medical conditions diagnosed: Other disorders of soft tissues; 
Number of procedures: 19,019; 
Percentage within procedure type: 28. 

Top five medical conditions diagnosed: Symptoms involving skin and 
other integumentary tissue; 
Number of procedures: 12,444; 
Percentage within procedure type: 18. 

Top five medical conditions diagnosed: Other peripheral vascular 
disease; 
Number of procedures: 10,876; 
Percentage within procedure type: 16. 

Top five medical conditions diagnosed: Phlebitis and thrombophlebitis; 
Number of procedures: 5,606; 
Percentage within procedure type: 8. 

Top five medical conditions diagnosed: Atherosclerosis; 
Number of procedures: 5,239; 
Percentage within procedure type: 8. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 53,184; 
Percentage within procedure type: 78. 

Top five medical conditions diagnosed: Other noninvasive vascular; 
Number of procedures: 15,227; 
Percentage within procedure type: 22. 

Type of ultrasound procedure: Total; Top five medical conditions 
diagnosed: [Empty]; Number of procedures: 68,411; Percentage within 
procedure type: 100.00. 

Type of ultrasound procedure: Echocardiogram. 

Top five medical conditions diagnosed: Heart failure; 
Number of procedures: 7,943; 
Percentage within procedure type: 28. 

Top five medical conditions diagnosed: Other diseases of endocardium; 
Number of procedures: 3,763; 
Percentage within procedure type: 13. 

Top five medical conditions diagnosed: Cardiac dysrhythmias; 
Number of procedures: 2,884; 
Percentage within procedure type: 10. 

Top five medical conditions diagnosed: Symptoms involving Respiratory 
systems and other chest symptoms; 
Number of procedures: 2,669; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Diseases of mitral and aortic 
valves; 
Number of procedures: 1,623; 
Percentage within procedure type: 6. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 18,882; 
Percentage within procedure type: 66. 

Top five medical conditions diagnosed: Other echocardiograms; 
Number of procedures: 9,571; 
Percentage within procedure type: 34. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 28,453; 
Percentage within procedure type: 100.00. 

Type of ultrasound procedure: Abdomen and pelvis. 

Top five medical conditions diagnosed: Other symptoms involving abdomen 
and pelvis; 
Number of procedures: 10,450; 
Percentage within procedure type: 48. 

Top five medical conditions diagnosed: Other disorders of kidney and 
ureter; 
Number of procedures: 1,408; 
Percentage within procedure type: 7. 

Top five medical conditions diagnosed: Nonspecific abnormal results of 
function studies; 
Number of procedures: 1,314; 
Percentage within procedure type: 6. 

Top five medical conditions diagnosed: Other disorders of urethra and 
urinary tract; 
Number of procedures: 1,239; 
Percentage within procedure type: 6. 

Top five medical conditions diagnosed: Symptoms involving urinary 
system; 
Number of procedures: 1,081; 
Percentage within procedure type: 5. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 15,492; 
Percentage within procedure type: 72. 

Top five medical conditions diagnosed: Other abdomen and pelvis; 
Number of procedures: 6,145; 
Percentage within procedure type: 28. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 21,637; 
Percentage within procedure type: 100.00. 

Type of ultrasound procedure: Head, neck, and chest. 

Top five medical conditions diagnosed: Cataract; 
Number of procedures: 889; 
Percentage within procedure type: 35. 

Top five medical conditions diagnosed: Other disorders of breast; 
Number of procedures: 244; 
Percentage within procedure type: 10. 

Top five medical conditions diagnosed: Other retinal disorders; 
Number of procedures: 218; 
Percentage within procedure type: 9. 

Top five medical conditions diagnosed: Simple and unspecified goiter; 
Number of procedures: 174; 
Percentage within procedure type: 7. 

Top five medical conditions diagnosed: Visual disturbances; 
Number of procedures: 120; 
Percentage within procedure type: 5. 

Type of ultrasound procedure: Subtotal five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 1,645; 
Percentage within procedure type: 65. 

Top five medical conditions diagnosed: Other; 
Number of procedures: 905; 
Percentage within procedure type: 35. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 2,550; 
Percentage within procedure type: 100.00. 

Type of ultrasound procedure: Ultrasonic guidance; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: [Empty]; 
Percentage within procedure type: [Empty]. 

Top five medical conditions diagnosed: Nonspecific findings on 
examination of the blood; 
Number of procedures: 2; 
Percentage within procedure type: 40. 

Top five medical conditions diagnosed: Chronic renal failure; 
Number of procedures: 1; 
Percentage within procedure type: 20. 

Top five medical conditions diagnosed: Other disorders of soft tissue; 
Number of procedures: 1; 
Percentage within procedure type: 20. 

Top five medical conditions diagnosed: Organ or tissue replaced by 
transplant; 
Number of procedures: 1; 
Percentage within procedure type: 20. 

Type of ultrasound procedure: Subtotal top four[A]; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 5; 
Percentage within procedure type: 100.00. 

Top five medical conditions diagnosed: Other; 
Number of procedures: 0; 
Percentage within procedure type: 0. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 5; 
Percentage within procedure type: 100.00. 

Type of ultrasound procedure: Other diagnostic ultrasound. 

Top five medical conditions diagnosed: Symptoms involving urinary 
system; 
Number of procedures: 5,700; 
Percentage within procedure type: 71. 

Top five medical conditions diagnosed: Other disorders of bladder; 
Number of procedures: 676; 
Percentage within procedure type: 8. 

Top five medical conditions diagnosed: Other disorders of bone and 
cartilage; 
Number of procedures: 560; 
Percentage within procedure type: 7. 

Top five medical conditions diagnosed: Other disorders of male genital 
organs; 
Number of procedures: 188; 
Percentage within procedure type: 2. 

Top five medical conditions diagnosed: Symptoms involving skin and 
integumentary tissue; 
Number of procedures: 130; 
Percentage within procedure type: 2. 

Type of ultrasound procedure: Subtotal top five; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 7,254; 
Percentage within procedure type: 90. 

Top five medical conditions diagnosed: Other; 
Number of procedures: 809; 
Percentage within procedure type: 10. 

Type of ultrasound procedure: Total; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 8,063; 
Percentage within procedure type: 100.00. 

Type of ultrasound procedure: Total number of procedures provided in 
SNFs to Medicare beneficiaries in noncovered SNF stays; 
Top five medical conditions diagnosed: [Empty]; 
Number of procedures: 129,119; 
Percentage within procedure type: 100.00. 

Source: GAO analysis of Medicare claims data for 2005. 

Note: Percentages may not sum to 100 due to rounding. Our analysis is 
based on claims for ultrasound exams and claims for ultrasound 
procedures classified solely as physician services that do not include 
a separately billed exam and physician's interpretation of it. 

[A] There were only four medical conditions diagnosed by these five 
ultrasound guidance procedures. 

[End of table] 

[End of section] 

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). 

Table 7: Financial Impact of Ultrasound Equipment Transportation 
Payments, 2005: 

Site of service: Skilled nursing facilities[B]; 
Ultrasound exams (number): 129,119; 
Beneficiary days[A] (number): 83,591; 
Equipment transportation payment only: Increase in Medicare payments 
(dollars): 8,477,240; 
Equipment transportation payment only: Increase in beneficiary cost 
sharing (dollars): 2,262,706; 
Equipment transportation and set-up payments: Increase in Medicare 
payments (dollars): 9,786,084; 
Equipment transportation and set-up payments: Increase in beneficiary 
cost sharing (dollars): 2,636,868. 

Site of service: Home; 
Ultrasound exams (number): 101,285; 
Beneficiary days[A] (number): 36,880; 
Equipment transportation payment only: Increase in Medicare payments 
(dollars): 3,362,665; 
Equipment transportation payment only: Increase in beneficiary cost 
sharing (dollars): 883,980; 
Equipment transportation and set-up payments: Increase in Medicare 
payments (dollars): 4,408,509; 
Equipment transportation and set-up payments: Increase in beneficiary 
cost sharing (dollars): 1,164,498. 

Site of service: Custodial care facilities; 
Ultrasound exams (number): 17,490; 
Beneficiary days[A] (number): 7,900; 
Equipment transportation payment only: Increase in Medicare payments 
(dollars): 837,061; 
Equipment transportation payment only: Increase in beneficiary cost 
sharing (dollars): 218,101; 
Equipment transportation and set- up payments: Increase in Medicare 
payments (dollars): 1,007,215; 
Equipment transportation and set-up payments: Increase in beneficiary 
cost sharing (dollars): 264,314. 

Site of service: Assisted living facilities; 
Ultrasound exams (number): 5,297; 
Beneficiary days[A] (number): 2,724; 
Equipment transportation payment only: Increase in Medicare payments 
(dollars): 253,723; 
Equipment transportation payment only: Increase in beneficiary cost 
sharing (dollars): 68,711; 
Equipment transportation and set-up payments: Increase in Medicare 
payments (dollars): 304,903; 
Equipment transportation and set-up payments: Increase in beneficiary 
cost sharing (dollars): 83,795. 

Site of service: Total; 
Ultrasound exams (number): 253,191; 
Beneficiary days[A] (number): 131,095; 
Equipment transportation payment only: Increase in Medicare payments 
(dollars): 12,930,690; 
Equipment transportation payment only: Increase in beneficiary cost 
sharing (dollars): 3,433,498; 
Equipment transportation and set-up payments: Increase in Medicare 
payments (dollars): 15,506,711; 
Equipment transportation and set-up payments: Increase in beneficiary 
cost sharing (dollars): 4,149,475. 

Source: GAO analysis of Medicare Part B claims data for 2005. 

Notes: Dollar amounts may not sum to totals due to rounding. To 
calculate the number of ultrasound exams, we counted the exams 
themselves that were paid under Part B, as well as ultrasound 
procedures classified solely as physician services that do not include 
a separately billed exam. Ultrasound exams were defined as HCPCS codes 
in the BETOS categories for echography in addition to 10 diagnostic 
ultrasound codes that were not in these categories. Calculations are 
based on the assumption that mobile ultrasound providers would receive 
a single transportation fee per beneficiary day. When indicated, mobile 
ultrasound providers also receive a single equipment set-up payment for 
each ultrasound exam. Transportation and set-up payment amounts are 
estimated based on the amount Medicare carriers paid for portable X-ray 
equipment transportation in the locality where the exam was conducted. 
See appendix I for more information on how we defined ultrasound exams. 

[A] Indicates the number of days on which ultrasound exams occurred. 
For example, if a given beneficiary received at least one ultrasound 
exam on 2 days, this would count as 2 beneficiary days. 

[B] Based on exams conducted in either a SNF or nursing facility during 
a noncovered SNF stay. 

[End of table] 

Table 8: Percentage Change in Number of Ultrasound Exams in SNFs, 1995 
to 1997: 

States where Medicare provided separate payments for ultrasound 
equipment transportation in 1995[A]; 
Number of ultrasound exams: 1995: 8,365; 
Number of ultrasound exams: 1997: 28,170; 
Percentage change: 237. 

States where Medicare did not provide separate payments for ultrasound 
equipment transportation in 1995[A]; 
Number of ultrasound exams: 1995: 23,281; 
Number of ultrasound exams: 1997: 37,708; 
Percentage change: 62. 

Source: GAO analysis of Medicare Part B claims data for 1995 and 1997 
from the Part B Extract Summary System. 

Note: Ultrasound exams that were conducted in a SNF or nursing facility 
were defined as HCPCS codes in the BETOS categories for echography. 

[A] Beginning in 1996, there were not any states with carriers that 
provided separate payments for ultrasound equipment transportation, but 
carriers in the following states did so in 1995: Arizona, California 
(Northern), Connecticut, Delaware, Georgia, Iowa, Maine, Maryland, 
Massachusetts, Missouri, Nevada, New Hampshire, New Jersey, 
Pennsylvania, and Vermont. We excluded California from our analysis 
because the policy on payments for ultrasound equipment transportation 
and set up was not consistent throughout the state. 

[End of table] 

[End of section] 

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

Author/title: David G. Stanley, "The Importance of Intersocietal 
Commission for the Accreditation of Vascular Laboratories (ICAVL) 
Certification for Noninvasive Peripheral Vascular Tests: The Tennessee 
Experience," The Journal for Vascular Ultrasound, vol. 28, no. 2 
(2004); 
Objective(s) of study: To determine the accuracy of noninvasive 
vascular ultrasound procedures conducted by accredited and 
nonaccredited facilities; 
Study methods: 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.[A]; 
Study results: 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. 

Author/title: Alfred Z. Abuhamad et al., "The Accreditation of 
Ultrasound Practices Impact on Compliance with Minimum Performance 
Guidelines," Journal of Ultrasound in Medicine, vol. 23, no. 8 (2004); 
Objective(s) of study: 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.[B]; 
Study methods: 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; 
Study results: 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. 

Author/title: O. William Brown, et al., "Reliability of Extracranial 
Carotid Artery Duplex Ultrasound Scanning: Value of Vascular Laboratory 
Accreditation," Journal of Vascular Surgery, vol. 39, no. 2 (2004); 
Objective(s) of study: To evaluate the reliability of carotid duplex 
ultrasound scanning procedures performed by nonaccredited vascular 
laboratories and to assess the clinical effect on patient 
management.[A]; 
Study methods: 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; 
Study results: The study found that of the 174 patients referred for 
surgical evaluation for carotid endarterectomy,[C] 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. 

Author/title: S. Boswell et al., "Practice Patterns and Membership 
Opinion About the Value of Credentialing and Accreditation: Results of 
a Membership Survey," Journal of Diagnostic Medical Sonography, vol. 
19, no. 6 (2003); 
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; 
Study methods: 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; 
Study results: 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. 

Source: GAO based on sources cited above. 

[A] 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. 

[B] The AIUM provides accreditation for practices rather than 
individuals. As one step in the process, practices applying for 
accreditation must submit four case studies for each specified area of 
accreditation (obstetrics, gynecology, breast, and abdomen). These case 
studies are scored by independent reviewers according to established 
criteria that conform to the minimum standards and guidelines for 
ultrasound practices as developed by the AIUM. 

[C] Endarterectomy is the general term for the surgical removal of 
plaque from an artery that has become narrowed or blocked. To perform 
an endarterectomy, the physician makes an incision in the affected 
artery and removes the plaque contained in the artery's inner lining. 
This procedure opens the artery and restores blood flow. Physicians use 
endarterectomy to treat many arteries; however, the most common use is 
for carotid arteries, which are in the neck and deliver blood to the 
brain. 

[End of table] 

[End of section] 

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

Group: The American College of Radiology; 
Information on group: 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. 

Group: The American Society of Echocardiography; 
Information on group: 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. 

Group: American Institute of Ultrasound in Medicine; 
Information on group: 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. 

Group: American Registry for Diagnostic Medical Sonography; 
Information on group: 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. 

Group: Cardiovascular Credentialing International; 
Information on group: 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. 

Group: Intersocietal Commission for the Accreditation of 
Echocardiography Laboratories; 
Information on group: 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. 

Group: Intersocietal Commission for the Accreditation of Vascular 
Laboratories; 
Information on group: 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. 

Group: Joint Review Committee on Education in Diagnostic Medical 
Sonography; 
Information on group: 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. 

Group: Society of Diagnostic Medical Sonography; 
Information on group: 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. 

Group: Society for Vascular Surgery; 
Information on group: 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. 

Group: Society for Vascular Ultrasound); 
Information on group: 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. 

Sources: GAO interviews and analysis of information presented in the 
letter from the Coalition for Quality in Ultrasound to MedPAC, 
September 3, 2004, and groups' Web sites concerning their history, 
mission, and membership, including Who's Who in Sonography, Membership 
Associations, http://www.sdms.org/about/who.asp, downloaded October 23, 
2006. 

[End of table] 

[End of section] 

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

Department Of Health & Human Services: 
Centers for Medicare & Medicaid services: 
200 Independence Avenue SW: 
Washington, DC 20201: 

Date: June 15, 2007: 

To: A, Bruce Steinwald:
Director, Health Care Government Accountability Office: 

From: Leslie V. Norwalk, Esq: 
Acting Administrator: 

Subject: GAO Draft Report: "Medicare Ultrasound Procedures: 
Consideration of Payment Reforms and Technician Qualification 
Requirements" (GAO-07-734): 

Thank you for the opportunity to review and comment on the General 
Accounting Office's (GAO) draft report "Medicare Ultrasound Procedures: 
Consideration of Payment Reforms and Technical Qualification 
Requirements" (GAO-07-734). We appreciate the GAO's efforts to ensure 
that the Centers for Medicare & Medicaid Services' (CMS) coverage, 
quality, and payment services encourage providers to deliver the best 
possible care to Medicare beneficiaries, particularly those receiving 
ultrasound diagnostic services from sonographers. 

The CMS is committed to ensuring that its beneficiaries receive high 
quality care and maintains several clinical quality programs to carry 
out this commitment. The GAO's report particularly speaks to the 
national coverage program, under which CMS develops national coverage 
determinations (NCDs) under section 1862(a)(1) of the Social Security 
Act (the Act), and the Conditions of Participation (CoP) process, under 
which CMS promulgates regulations under the Act for institutional and 
non-institutional providers to meet as a condition of participating in 
the Medicare program. CMS also encourages States to use their own 
authorities to ensure that highly trained, capable professionals 
deliver services throughout their own jurisdictions. It is for this 
reason that CMS offers an alternative to GAO's recommended approach for 
ensuring sonographer quality (see "CMS Response" below). 

GAO Recommendation: 

The GAO recommends that CMS require Medicare-participating sonographers 
to be credentialed and/or work in an accredited facility. Furthermore, 
the GAO advises CMS to weigh the advantages and disadvantages of 
implementing an NCD compared with promulgating regulations that this 
requirement be a condition for Medicare payment. 

CMS Response: 

Provider Quality Issues: 

The CMS supports the GAO's interest in the quality of ultrasound 
services; however, the Agency asserts that CMS' authorities under the 
Act are not the most effective mechanism for addressing sonographer 
quality, Rather, we recommend that States engage their own licensing 
bodies in implementing sonographer licensure programs that address the 
competency/qualification issues GAO addresses in the report. 

In the report, the GAO offers two potential avenues for CMS to use its 
administrative authorities under the Social Security Act-(1) by issuing 
an NCD; or (2) by promulgating a CoP regulation. While both authorities 
are integral cornerstones of CMS' clinical quality assurance program, 
neither of these administrative approaches are appropriate mechanisms 
for CMS to promulgate sonographer credentialing requirements in order 
to deliver ultrasound procedures. 

We note the regional variation in carrier coverage policies regarding 
the provision of ultrasound services; however, we believe that a 
national policy would not take into account regional variations in 
access to care, state licensing requirements, etc. To remain sensitive 
to the needs of local communities in providing ultrasound services, CMS 
recommends that States and local carriers continue to review 
sonographer qualification requirements on a state-by-state level. 

We note that the report indicates that in 2005, of the 28 million 
ultrasound exams furnished to beneficiaries under Part B, 68 percent 
were furnished in physicians' offices, and 31 percent in hospital 
outpatient departments. The statute does not provide for conditions of 
participation for physicians. 

Conditions of participation do apply to hospitals. The current Medicare 
hospital CoPs address indirectly the specific competencies or 
qualifications standards for technicians providing ultrasound services. 
For example, if a hospital provides ultrasound services the hospital is 
responsible for ensuring the quality and the safety of the care 
provided as per the existing requirements. 

In the hospital setting, most ultrasound services are provided in or 
supervised by the imaging or radiological department. Specifically, the 
requirements at 42 CFR 482.26, "Radiologic Services" state, "The 
hospital must maintain, or have available, diagnostic radiological 
services. If therapeutic services are also provided, they as well as 
the diagnostic services, must meet professionally approved standards 
for safety and personnel qualifications." 

Additionally, as required at 42 CFR 482.11, "Compliance with Federal, 
State and Local Laws," those personnel must meet the specific State 
licensure requirements relative to their areas of expertise. When a 
hospital is surveyed for compliance with the Medicare requirements and 
ultrasound is offered at that facility, it is likely that technician 
personnel files would be reviewed to ensure they have the necessary 
training and certifications as appropriate for that particular State. 

The requirements at 42 CFR 482.21, "Quality Assessment and Performance 
Improvement" (QAPI) states, "The hospital must develop, implement and 
maintain an effective, ongoing, hospital-wide, data-driven quality 
assessment and performance improvement program." Involvement of all 
hospital departments and the quality indicators they are tracking are 
determined when surveying for compliance with the Medicare 
requirements. A hospital radiological department has the opportunity to 
include indicators related to ultrasound services, such as the quality 
of the results in the hospital's overall QAPI program. 

Approximately 80 percent of the Medicare-participating hospitals are 
accredited by the Joint Commission. As a Medicare accrediting body, 
they are required by statute to have standards that meet or exceed the 
Medicare requirements. The Joint Commission Standard HR. 1.20 requires 
that staff qualifications are consistent with his or her job 
responsibilities. Additionally, the Joint Commission standards require 
ongoing maintenance of licensure, certification, or registration as 
required by law or regulation. 

Payment Reform Issues: 

The CMS concurs with GAO's conclusion (on page 36 of the draft) that ". 
. . 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." Further, we believe that such an action 
would be contrary to the overall purpose of the skilled nursing 
facility (SNF) consolidated billing (or "bundling") provision, as 
discussed in the SNF prospective payment system (PPS) final rule for FY 
2001 (65 FR 46791, July 31, 2000): 

We do not view the identification of new service categories for 
exclusion from this provision in terms of a process of continual 
expansion to encompass an ever-broadening array of excluded services. 

As we noted in the May 12, 1998 interim final rule (63 FR 26297), the 
fundamental purpose of the consolidated billing provision is ".to: 

make the SNF itself responsible for billing Medicare for essentially 
all of its residents' services, other than those identified in a small 
number of narrow and specifically delimited exclusions." 

Historically, the number of exclusions from the SNF PPS has been 
relatively small, and has tended to focus on those types of 
exceptionally intensive, "high cost, low probability" services that 
clearly lie beyond the normal scope of SNF care. By contrast, an 
ultrasound exam is a type of routine diagnostic procedure that would 
fall well within the normal scope of SNF care. Accordingly, we believe 
that if such a procedure were to be unbundled, it would set a dangerous 
precedent that would prompt suppliers of many other routine, bundled 
services to clamor for a similar exception-which ultimately could lead 
to the unraveling of the SNF PPS bundle itself. 

Conclusion: 

The CMS appreciates the GAO's efforts to study payment reform and 
provider quality issues related to ultrasound services and will 
consider the GAO's recommendations in addressing these issues as the 
Medicare clinical quality and payment programs evolve. 

[End of section] 

Appendix VII: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

A. Bruce Steinwald (202) 512-7114 or steinwalda@gao.gov: 

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. 

FOOTNOTES 

[1] See Medicare Payment Advisory Commission (MedPAC), A Data Book: 
Healthcare Spending and the Medicare Program, June 2006. MedPAC is an 
independent federal body established by law to advise the Congress on 
issues affecting the Medicare program, including its payment methods. 
MedPAC's data cited here are based on Medicare Part B payments under 
the physician fee schedule and include beneficiary cost sharing. 
Medicare Part B covers physician services, hospital outpatient 
services, diagnostic tests, and ambulance services as well as certain 
other services such as physical therapy. 

[2] See MedPAC 2006. 

[3] CMS refers to ultrasound exams as "technical components" and 
physicians' interpretations of images from these exams as "professional 
components." 

[4] CMS is an agency within the Department of Health and Human Services 
(HHS), to which HHS has delegated responsibility for administering the 
Medicare program. 

[5] Medicare Part A covers inpatient hospital, skilled nursing 
facility, hospice care, and some home health care. 

[6] The American Registry for Diagnostic Medical Sonography (ARDMS) is 
one example of a nationally recognized organization that credentials 
sonographers. 

[7] See Pub. L. No. 108-173, § 513, 117 Stat. 2066, 2300. 

[8] The claims data that we used came from the National Claims History 
(NCH) carrier file, and the Standard Analytical File (SAF) outpatient 
claims files. 

[9] The organizations interviewed included 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; 
four mobile ultrasound providers that provide services to SNFs and 
nursing homes in various states; and representatives from the National 
Association for the Support of Long-Term Care and the American 
Association of Homes and Services for the Aging. 

[10] Medicare only covers ambulance transportation that is medically 
necessary. See CMS, Medicare Benefit Policy Manual, Chapter 10, §10.2, 
10.2.1, May 28, 2004. 

[11] The Medicare claims data are used by the Medicare program as a 
record of payments to health care providers and are monitored by CMS. 

[12] The credentialing organizations included the American Registry for 
Diagnostic Medical Sonography (ARDMS), the Intersocietal Commission for 
the Accreditation of Vascular Laboratories (ICAVL), and the American 
Institute of Ultrasound in Medicine (AIUM). 

[13] These organizations include the American College of Radiology, the 
American Institute of Ultrasound in Medicine, the Intersocietal 
Commission for the Accreditation of Vascular Laboratories, and the 
Intersocietal Commission for the Accreditation of Echocardiography 
Laboratories. 

[14] Certification by the American Registry of Radiologic Technologists 
is also acceptable if the facility is applying for accreditation in 
breast ultrasound. 

[15] Medicare also covers individuals with end-stage renal disease. 

[16] Beneficiaries' coinsurance can be higher than 20 percent for Part 
B-covered services provided in a hospital outpatient facility. 

[17] CMS has begun a process of using competition to choose its 
Medicare claims processing contractors and is awarding new contracts to 
entities called Medicare Administrative Contractors. When this process 
is complete, these contractors will review and pay all Part B claims. 

[18] Medicare covers skilled nursing and rehabilitative therapy for 
beneficiaries being treated in SNFs for conditions related to a 
hospital stay lasting at least 3 days and occurring within 30 days 
before admission to the SNF. For beneficiaries who qualify, Medicare 
pays under Part A for most necessary services, including room and 
board, nursing care, and ancillary services such as drugs, laboratory 
tests, and physical therapy, for up to 100 days per benefit period. A 
benefit period begins when a Medicare beneficiary is admitted to a 
hospital or a SNF and ends when he or she has not been an inpatient of 
these facilities for 60 consecutive days. Beneficiaries are responsible 
for a daily copayment after the 20th day of SNF care, regardless of the 
cost of services received. 

[19] Under the SNF PPS, the SNF receives a single daily payment for 
almost all Part A-and Part B-covered services provided to a SNF 
resident. Certain items and services are excluded from the PPS by 
statute and thus are paid for separately under Part B. In conjunction 
with the PPS, each SNF is responsible for billing Medicare for almost 
all services provided during a Part A-covered SNF stay, including 
services rendered by an outside supplier. 

[20] For a discussion of the services paid for separately for 
beneficiaries in Part A-covered SNF stays, see GAO, Skilled Nursing 
Facilities: Services Excluded from Medicare's Daily Rate Need to be 
Reevaluated, GAO-01-816 (Washington, D.C.: Aug. 22, 2001). 

[21] See Pub. L. No. 105-33, § 4432, 111 Stat. 251, 414-22. 

[22] See Health Care Financing Administration Program Memorandum A-00- 
01 (January 2000). 

[23] See GAO-01-816. CMS used three criteria to identify services to be 
paid for separately under Part B during Part A-covered SNF stays--these 
services were required to be (1) high cost, (2) infrequently needed by 
SNF beneficiaries, and (3) unlikely to be overprovided. CMS decided 
that doppler flow studies, a type of ultrasound procedure, did not meet 
the first or second of these criteria and thus should not be paid for 
separately under Part B. Similarly, CMS decided that ambulance 
transportation not already paid for separately under Part B--for 
example, ambulance service to transport a beneficiary from a SNF to 
another location for an ultrasound exam--should not be paid for 
separately because this service did not meet the first of these 
criteria. 

[24] Section 1861(s)(3) of the Social Security Act provides coverage of 
diagnostic x-rays furnished in a Medicare beneficiary's place of 
residence. CMS determined that because of the increased costs 
associated with transporting x-ray equipment to the beneficiary, 
Congress intended to provide an additional payment amount for the 
transportation of equipment for services furnished by an approved 
portable x-ray supplier. See 60 Fed Reg. 63124, 63149 (1995). Thus, CMS 
established specific procedure codes to pay for the transportation of 
portable x-ray equipment. 

[25] In California, while the carrier for the northern part of the 
state paid for ultrasound equipment transportation, the carrier for the 
southern part of the state did not. 

[26] CMS had also allowed carriers to develop their own policies 
concerning separate Part B payments for the transportation of 
electrocardiogram equipment. However, beginning January 1, 1997, 
carriers were no longer able to do so. Section 4559 of the BBA 
temporarily restored separate payments for the transportation of 
equipment for EKG tests performed during 1998 but not thereafter. This 
section did not address payments for the transportation of ultrasound 
equipment. See Pub. L. No. 105-33, § 4559, 111 Stat. 251, 464. 

[27] The total number of procedures (41 million) is based on analysis 
of Medicare claims data for physician interpretations of ultrasound 
exams. These data account for procedures provided to all Medicare 
beneficiaries regardless of setting and whether the exams were paid 
under Part A or Part B. 

[28] Deep vein thrombosis is a condition where a blood clot forms in a 
vein, usually in the lower leg. This condition can cause pain and 
swelling. If a clot breaks free and moves through the vascular system 
to the heart and lungs it can be fatal. 

[29] This number of exams is smaller than the total number of 
procedures discussed above (41 million total procedures) because it is 
based on the number of technical components (exams) associated with the 
image production, whereas the 41 million procedures are based on counts 
of the physician interpretations of the exam and the procedures 
classified solely as physician services. The 28 million exams excludes 
exams provided to beneficiaries in Part A-covered SNF or hospital 
inpatient stays that are bundled with other services under Medicare 
Part A and not reported separately in the Part B data. 

[30] These were exams that cost about $14 million and were paid for 
separately under part B for beneficiaries whose SNF stay was not 
covered by Part A. Our site-of-service analysis of exams performed in 
SNFs focuses on beneficiaries that were not in Part A SNF stays because 
the data did not allow us to identify site of service for beneficiaries 
in Part A SNF stays. As noted earlier, payment for procedures provided 
in SNFs for Part A beneficiaries are not reported separately in the 
Part B data. 

[31] For example, vascular procedures were the most prevalent (44 
percent of the procedures) for this population, followed by 
echocardiograms (33 percent). Ultrasounds of the abdomen and pelvis 
accounted for 12 percent of the ultrasound procedures provided to those 
in Part A SNF stays. The remaining 11 percent of the procedures were 
for various other categories, including ultrasound guidance. 

[32] We conducted interviews with geriatricians and a gerontologist 
from the American Geriatrics Society and structured interviews with SNF 
medical directors who are members of the American Medical Directors 
Association. We also interviewed professionals from ultrasound-related 
organizations (the Society for Vascular Surgery, the Society for 
Vascular Ultrasound, and Society of Diagnostic Medical Sonography); 
four mobile ultrasound companies that provide services to the elderly 
in SNFs or nursing homes; and representatives of the National 
Association for the Support of Long-Term Care and the American 
Association of Homes and Services for the Aging. 

[33] In addition, patients may miss medication doses or meals, which 
can be serious for people with certain diseases, such as diabetes. 

[34] The financial impact estimates in this section are based primarily 
on Medicare claims data for 2005. Since 2005, there have been changes 
that could affect the use of ultrasound exams and associated equipment 
and ambulance transportation and thus also affect our estimates. These 
changes include those related to Medicare payment methodology as well 
as other changes, such as technological advances, that could affect 
service use. However, accounting for changes that occurred since 2005 
and those that could occur in the near future is beyond the scope of 
this report. 

[35] See appendix I for how we identified these exams. 

[36] These estimates take into account that (1) ultrasound equipment 
transportation (if it were covered) likely would, on average, be less 
expensive than ambulance transportation for Medicare and its 
beneficiaries--the average amount paid by Medicare and its 
beneficiaries for ultrasound equipment transportation (including the 
equipment set-up fee) for each of these 13,900 exams in 2005 was $138, 
compared to $514 for an ambulance round trip--and (2) Medicare 
expenditures and beneficiary cost sharing for an ultrasound exam can be 
different in a SNF compared to other locations such as a hospital 
outpatient facility. 

[37] We were only able to identify exams conducted during noncovered 
SNF stays if they were conducted in a SNF or nursing facility because 
we did not have accurate data on which beneficiaries were in noncovered 
SNF stays. Therefore, we could not estimate the financial impact of a 
change in the site of service for exams conducted during noncovered SNF 
stays that were not conducted in a SNF or nursing facility. 

[38] See appendix III, table 8, for detailed results of this analysis. 
We excluded California from this analysis because the two Medicare 
carriers in this state did not have the same policy regarding payments 
to transport ultrasound equipment. 

[39] An increase in the number of exams conducted in SNFs following the 
elimination of transportation payments does not necessarily imply that 
the opposite would occur if these payments were reinstated. 

[40] We have reported that about 40 percent of beneficiaries who 
received an ultrasound exam in a nursing home would require ambulance 
services to be transported to another site of service for the exam if 
mobile ultrasound services were unavailable. See GAO, Medicare: Impact 
of Changing Transportation Policy for Portable Equipment is Uncertain, 
GAO/HEHS-98-82 (Washington, D.C.: May 18, 1998). 

[41] These estimates include up to $2.6 million in Medicare payments 
and $1.5 million in beneficiary cost sharing for up to 33,000 
ultrasound exams for which Medicare appears to have improperly paid for 
separately under Part B. HHS's Office of Inspector General (OIG) is 
currently reviewing improper billing of services under Part B provided 
to beneficiaries in Part A-covered SNF stays that should have been 
covered under the PPS payment. OIG officials noted that Medicare 
contractors likely recouped these improper payments. However, if these 
contractors failed to recoup all of these improper payments, then we 
would have overestimated the financial impact of paying separately 
under Part B for these exams because Medicare would have already been 
paying separately under Part B for some of them in the absence of this 
policy. Because data for improperly paid claims do not indicate whether 
the payment was recouped, we are unable to accurately estimate the 
extent to which these improper payments affect our impact estimates. 
See appendix I for more detail. 

[42] GAO, Skilled Nursing Facilities: Providers Have Responded to 
Medicare Payment System By Changing Practices, GAO-02-841 (Washington, 
D.C.: Aug. 23, 2002). 

[43] Medicare Payment Advisory Commission, Report to the Congress: 
Medicare Payment Policy (Washington, D.C.: March 1999). 

[44] See GAO, End-Stage Renal Disease: Bundling Medicare's Payment for 
Drugs with Payment for All ESRD Services Would Promote Efficiency and 
Clinical Flexibility, GAO-07-77 (Washington, D.C.: Nov. 13, 2006) and 
Medicare Payment Advisory Commission, Report to the Congress, Medicare 
Payment Policy (Washington, D.C.: Mar. 2001). 

[45] GAO, Medicare Home Health Care: Payments to Home Health Agencies 
Are Considerably Higher than Costs, GAO-02-663 (Washington, D.C.: May 
6, 2002). 

[46] On the basis of recommendations from CMS, Congress mandated in the 
Balanced Budget Refinement Act of 1999 that Medicare pay separately 
under Part B for certain services (for example, chemotherapy and 
customized prosthetic devices) during Part A-covered SNF stays. See 
Pub. L. No. 106-113, div. B, § 1000(a)(6) [H.R. 3426, title I, sec. 
103(a)], 113 Stat. 1501, 1536 and 1501A-325-326 (codified at 42 U.S.C. 
§ 1395yy(e)(2)(A)(iii)). In doing so, Congress required that CMS reduce 
the Part A PPS payment to offset the increase in Part B expenditures 
resulting from paying separately for these services. 

[47] See D. G. Stanley, "The Importance of Intersocietal Commission for 
the Accreditation of Vascular Laboratories (ICAVL) Certification for 
Noninvasive Peripheral Vascular Tests: The Tennessee Experience," The 
Journal for Vascular Ultrasound, vol. 28, no. 2 (2004) and O. William 
Brown, et al., "Reliability of Extracranial Cartoid Artery Duplex 
Ultrasound Scanning: Value of Vascular Laboratory Accreditation," 
Journal of Vascular Surgery, vol. 39, no. 2 (2004). 

[48] See appendix IV for summaries of the studies discussed in this 
section. 

[49] See D. G. Stanley, "The Importance of Intersocietal Commission for 
the Accreditation of Vascular Laboratories (ICAVL) Certification for 
Noninvasive Peripheral Vascular Tests: The Tennessee Experience," p. 1, 
and O. William Brown, et al., "Reliability of Extracranial Cartoid 
artery duplex Ultrasound scanning: Value of vascular laboratory 
accreditation," p. 369. 

[50] Mammography is an X-ray imaging procedure that can detect small 
tumors and breast abnormalities. 

[51] The Mammography Quality Standards Act of 1992, Pub. L. No. 102- 
539, § 2, 106 Stat. 3547, 3547-61 amended by the Mammography Quality 
Standards Reauthorization Acts of 1998 and 2004, Pub. L. No. 105-248, 
§§ 2-13, 112 Stat. 1864, 1864-67, Pub. L. No. 108-365, §§ 2-4, 118 
Stat. 1738, 1738-40, respectively, required that the HHS establish 
these standards. 

[52] FDA regulations also specify detailed requirements for 
qualifications and continuing training for physicians who interpret the 
images and for mammography equipment and recordkeeping practices. See 
21 C.F.R. § 900.12 (2006). 

[53] See GAO, Mammography Services: Impact of Federal Legislation on 
Quality, Access, and Health Outcomes, GAO/HEHS-98-11 (Washington, D.C.: 
Oct. 21, 1997); Mammography Quality Standards Act: X-ray Quality 
Improved, Access Unaffected, but Impact on Health Outcomes Unknown, 
GAO/HEHS-98-164 (Washington, D.C.: May 8, 1998; Mammography Services: 
Initial Impact of New Federal Law Has Been Positive, GAO/HEHS-96-17 
(Washington, D.C.: Oct. 27, 1995); and Mammography: Current Nationwide 
Capacity Is Adequate, but Access Problems May Exist in Certain 
Locations, GAO-06-724 (Washington, D.C.: July 25, 2006). 

[54] MedPAC also recommended that the Secretary of HHS select private 
organizations to administer these standards, and noted that CMS has 
similar "deeming" arrangements with private accreditation groups for 
several types of providers, such as hospitals and ambulatory surgical 
centers." See Medicare Payment Advisory Commission, Report to the 
Congress: Medicare Payment Policy (Washington, D.C.: Mar. 2005). 

[55] MedPAC (2005) noted the following with regard to imaging services, 
which include ultrasound procedures: "CMS should strongly consider 
setting standards for at least the following areas: the imaging 
equipment, qualifications of technicians, qualifications and 
responsibilities of the supervising physician, technical quality of the 
images produced, and procedures for ensuring patient safety (for 
example, monitoring radiation exposure)." 

[56] These four organizations were the American Society of 
Echocardiography, the Society of Diagnostic Medical Sonography, the 
Society for Vascular Surgery, and the Society for Vascular Ultrasound. 
See appendix V for descriptions of these organizations. 

[57] See S. Boswell et al., "Practice Patterns and Membership Opinion 
About the Value of Credentialing and Accreditation: Results of a 
Membership Survey," Journal of Diagnostic Medical Sonography, vol. 19, 
no. 6 (2003), p. 390. 

[58] In 2003, we reported that giving Medicare contractors broad 
discretion to make local coverage policies had led to inequitable 
variations in coverage for beneficiaries depending on where they were 
treated. We recommended that CMS develop and implement a plan to 
evaluate the merits of existing coverage policies with the intent of 
incorporating appropriate aspects of local policies into national 
coverage policies and eliminating the remainder. See GAO Medicare: 
Divided Authority for Policies on Coverage of Procedures and Devices 
Results in Inequities, GAO-03-175 (Washington, D.C.: Apr. 11, 2003). 
CMS has implemented a policy to consider and address policy variations, 
but the agency has not considered developing an NCD concerning 
sonographers' qualifications. 

[59] Accredited facilities may require that sonographers have certain 
credentials or a combination of formal training and experience. 

[60] Among the other reasons that providers gave for obtaining facility 
accreditation was the expectation that CMS would develop such a 
requirement and providers' own interest in meeting medical practice 
standards. In contrast, some providers cited difficulty in meeting 
technical requirements, lack of staff or time resources, and expensive 
application fees as a reason not to seek facility accreditation. The 
information about these reasons is based on a pilot study that the 
author conducted in 1998. See Kathleen M. Wilson, The Emergence and 
Fall of the Ultrasound Quality Standards Act (H.R. 4217): Exploring the 
Interaction of Policy and Politics. Unpublished doctoral dissertation, 
University of Maryland, Baltimore County, Baltimore, Md. (2003), p. 18. 

[61] See Kathleen M. Wilson, The Emergence and Fall of the Ultrasound 
Quality Standards Act, p. 21. 

[62] See 42 C.F.R. § 410.33(c) (2006). 

[63] CMS's Conditions of Participation are requirements that health 
care organizations must meet in order to begin, and continue, 
participating in the Medicare program. 

[64] A CMS official told us that diagnostic ultrasound procedures are 
typically provided in hospitals' radiology departments. 

[65] Hospitals may also apply to CMS for a review of their compliance 
with CoP, or through accreditation from the American Osteopathic 
Association, as an alternative to accreditation by the Joint 
Commission. CMS's review is typically conducted by a state agency under 
contract with CMS. 

[66] See Medicare Payment Advisory Commission (MedPAC), Report to the 
Congress, Medicare Payment Policy (March 2005), p. 154 and Lane Koenig 
et al, Lewin Group, An Analysis of the Use of Ultrasound Imaging 
Services in the Medicare Program, pp. 19-20 (Washington, D.C.: 2005). 

[67] The CMS official explained that because Medicare pays for services 
that are reasonable and necessary, if clinical evidence supported the 
need for an NCD relating to qualification requirements for 
sonographers, CMS would not be in a position to allow a phase-in 
period. 

[68] For example, CMS has recently begun to implement the Medicare 
health quality demonstration, which is a 5-year program designed to 
achieve a number of goals, including enhancing quality, improving 
patient safety, and increasing efficiency. In addition, CMS is 
coordinating with a number of stakeholders, including physicians, to 
develop and implement uniform, standardized sets of performance 
measures for various health care settings. 

[69] In this analysis of the types of ultrasound procedures, we also 
included claims for ultrasound procedures classified solely as 
physician services that do not include a separately billed exam and 
physician's interpretation of it. 

[70] The Medicare Part B claims for ultrasound exam allowed us to 
identify the site of service where the sonographers produced the actual 
image. In this analysis of the site of service of ultrasound exams, we 
also included claims for ultrasound procedures classified solely as 
physician services that do not include a separately billed exam and 
physician's interpretation of it. 

[71] HCPCS is a standardized classification method used by CMS to 
identify medical, including ultrasound, services and procedures. It is 
used in the submission to Medicare and other insurers of claims for 
payment of services rendered by physicians and other providers. 

[72] The six BETOS echography categories used to group HCPCS codes are 
as follows: (1) eye (category I3A), (2) abdomen/pelvis (category I3B), 
(3) heart (category I3C), (4) carotid arteries (category I3D), (5) 
prostate, transrectal (category I3E), and (6) other (category I3F). 

[73] We supplemented the HCPCS codes in the BETOS categories for 
echography rather than using all HCPCS codes for diagnostic ultrasound 
procedures for two reasons. First, we wanted to promote comparability 
with other studies that use the BETOS categories. Second, supplementing 
the HCPCS codes in the BETOS echography categories accounted for 
virtually all (99 percent) of Medicare Part B spending on diagnostic 
ultrasound procedures. 

[74] CMS has established three levels of physician supervision for the 
technician who conducts the exam component of ultrasound procedures and 
other diagnostic tests. The first level involves general supervision, 
which means that the procedure must be provided under the physician's 
overall direction and control, but the physician's presence is not 
required while the technician performs the exam. The second level 
involves direct supervision in the office setting, which means that the 
physician must be present in the office suite and immediately available 
to furnish assistance and direction while the technician performs the 
exam. The third level involves personal supervision, which requires a 
physician to be in attendance in the room during the performance of the 
procedure. See appendix II for more detail. 

[75] We obtained information from four directors of nursing in four 
states: Connecticut, Florida, New York and Pennsylvania. 

[76] The number of exams includes ultrasound procedures classified 
solely as physician services that do not include a separately billed 
exam. To identify exams conducted in SNFs during noncovered SNF stays, 
we first selected all Part B claims for ultrasound exams that were 
conducted in a SNF or nursing facility and then, based on claims for 
Part A-covered SNF stays, we omitted those that were billed during Part 
A-covered SNF stays. 

[77] The number of beneficiary days is defined as the sum across all 
beneficiaries in a given site of service of the number of days on which 
ultrasound exams occurred for each beneficiary. For example, if a 
beneficiary received at least one ultrasound exam on 2 separate days, 
this beneficiary would contribute 2 beneficiary days to the total. 

[78] We based our estimate of the average Medicare payment and 
beneficiary cost sharing for ultrasound equipment transportation on the 
same measures for a similar service--the transportation and set-up fees 
for portable x-ray equipment transportation in 2005. 

[79] Carriers in the following 14 states provided these payments in 
1995: Arizona, Connecticut, Delaware, Georgia, Iowa, Maine, Maryland, 
Massachusetts, Missouri, Nevada, New Hampshire, New Jersey, 
Pennsylvania, and Vermont. Transportation payments were also made in 
Northern California, but not in the southern part of that state. 

[80] We excluded California from our analysis because the policy 
regarding payments for ultrasound equipment transportation and set up 
was not consistent throughout the state. For this analysis, we defined 
ultrasound exams as HCPCS codes in the BETOS categories for echography 
and included exams in both SNFs and nursing facilities. 

[81] On the basis of our earlier work, we estimated that 40 percent of 
beneficiaries who received an ultrasound exam in a nursing home would 
need to be transported via ambulance if the exam were conducted at 
another site of service, such as a hospital outpatient facility. See 
GAO/HEHS-98-82. 

[82] To identify beneficiaries in noncovered SNF stays, we first used 
the origin and destination of the ambulance trips to determine whether 
a beneficiary was in a SNF stay and then omitted any beneficiary whose 
ultrasound exam, based on the SNF claims, occurred during a Part A- 
covered SNF stay. 

[83] Ambulance trips for these beneficiaries (1) were on the same day 
as their ultrasound exam, which was not conducted in a SNF during a 
noncovered SNF stay and (2) transported a beneficiary from a SNF to a 
physician's office, hospital, or diagnostic or therapeutic site (for 
example, an independent diagnostic testing facility) and back. 

[84] The average Medicare payment and beneficiary cost-sharing amounts 
for each HCPCS code were calculated based on Part B claims for 
ultrasound exams for all Medicare beneficiaries in 2005. Estimates for 
this analysis may slightly overstate the actual financial impact of 
separate Part B payments for ultrasound exams and associated equipment 
and ambulance transportation because up to 5 percent of ultrasound 
exams conducted during Part A-covered SNF stays were on beneficiaries 
in critical access hospitals that may have been certified as swing bed 
hospitals, which were not subject to the PPS. 

[85] The actual number of improperly paid exams and associated Medicare 
payments and beneficiary cost sharing may be slightly lower than these 
estimates because up to 3 percent of these exams may have been 
conducted on beneficiaries in Part A-covered SNF stays who were in 
critical access hospitals that were certified as swing bed hospitals, 
which were not subject to the PPS. 

[86] The Office of Inspector General (OIG) of HHS is currently 
addressing the issue of improper billing for beneficiaries in Part A- 
covered SNF stays. For previous OIG reports on this issue, see HHS OIG, 
Review of Improper Payments Made by Medicare Part B for Services 
Covered Under the Part A Skilled Nursing Facility Prospective Payment 
System in Calendar Years 1999 and 2000, A-01-02-00513 (Washington, 
D.C.: May 2004); Review of Potential Improper Payments Made by Medicare 
Part B for Services Covered Under the Part A Skilled Nursing Facility 
Prospective Payment System, A-01-00-00538 (Washington, D.C.: June 
2001); and Review of Compliance with the Consolidated Billing Provision 
Under the Prospective Payment System for Skilled Nursing Facilities, A- 
01-99-00531 (Washington, D.C.: March 2000). 

[87] Based on current payment policy for portable x-ray equipment 
transportation, when multiple exams occur on a single beneficiary day 
(that is, during a single session for a given beneficiary), only one 
equipment transportation payment is required, although a set-up fee is 
paid for each exam. To convert the number of ultrasound exams conducted 
in SNFs to beneficiary days, we divided the number by the average 
number of these exams per beneficiary day based on Part B claims for 
exams conducted for beneficiaries in Part A-covered SNF stays in 1997-
-the most recent year for which these data were reported separately for 
these beneficiaries. 

[88] As with the first component of our financial impact analysis, we 
based our estimate of the average Medicare payment and beneficiary cost 
sharing for ultrasound equipment transportation on the same measures 
for a similar service--the transportation and set-up fees for portable 
x-ray equipment in 2005. 

[89] To convert the number of ultrasound exams involving ambulance 
transportation to beneficiary days, we divided the number by the 
average number of these exams per beneficiary day based on Part B 
claims for exams conducted for beneficiaries in Part A-covered SNF 
stays in 1997. 

[90] Data from 1997 are the most recent available for which the exams' 
site of service was available for beneficiaries in Part A-covered SNF 
stays because, in 1998, CMS began phasing in the SNF PPS, which bundled 
payment for these and other services provided to beneficiaries in Part 
A-covered SNF stays. 

[91] The Intersocietal Accreditation Commission has five subgroups: the 
Intersocietal Commission for the Accreditation of Vascular 
Laboratories, the Intersocietal Commission for the Accreditation of 
Echocardiography Laboratories, the Intersocietal Commission for the 
Accreditation of Nuclear Medicine Laboratories, and the Intersocietal 
Commission for the Accreditation of Magnetic Resonance Laboratories. 

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