Medicare Ultrasound Procedures: Consideration of Payment Reforms 
and Technician Qualification Requirements (28-JUN-07,		 
GAO-07-734).							 
                                                                 
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.		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-734 					        
    ACCNO:   A71628						        
  TITLE:     Medicare Ultrasound Procedures: Consideration of Payment 
Reforms and Technician Qualification Requirements		 
     DATE:   06/28/2007 
  SUBJECT:   Beneficiaries					 
	     Cost sharing (finance)				 
	     Disease detection or diagnosis			 
	     Financial analysis 				 
	     Health care facilities				 
	     Medical equipment					 
	     Medical examinations				 
	     Medical procedures 				 
	     Medical technology 				 
	     Medicare						 
	     Physicians 					 
	     Policy evaluation					 
	     Skilled labor					 
	     Skilled nursing facilities 			 
	     Cost estimates					 
	     Policies and procedures				 

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GAO-07-734

   

     * [1]Results in Brief
     * [2]Background

          * [3]Sonographer Credentialing and Training and Facility Accredit
          * [4]Medicare and Its Coverage Processes
          * [5]Medicare Payment for Ultrasound Procedures and Associated Am

     * [6]The Most Common Medicare Ultrasound Procedures in 2005 Were

          * [7]About Three-Quarters of Ultrasound Procedures Provided to Al
          * [8]Noninvasive Vascular Studies Were the Most Prevalent Ultraso

     * [9]Changing Ultrasound Payment Methods Would Likely Increase Ex

          * [10]Part B Equipment Transportation Payments Would Likely Increa
          * [11]Paying Separately for Ultrasound Services during Part A-Cove

     * [12]Evidence and Variation in Federal Requirements Are Among Fac

          * [13]Studies and Professional Organizations Suggest that Setting
          * [14]Federal Requirements for Sonographers' Qualifications Vary a
          * [15]CMS Has Several Implementation Options

     * [16]Conclusions
     * [17]Recommendation for Executive Action
     * [18]Agency Comments and Our Evaluation
     * [19]Appendix I: Scope and Methodology

          * [20]Types of Ultrasound Procedures Provided to Beneficiaries
          * [21]Financial Impact of Changing Payment Methods

               * [22]Paying to Transport and Set Up Ultrasound Equipment
               * [23]Paying Separately under Part B for Ultrasound Exams and
                 Rela

          * [24]Factors to Consider Concerning Sonographer Qualification Req
          * [25]Data Reliability

     * [26]Appendix II: Ultrasound Procedures and Medicare Part B Payme
     * [27]Appendix III: Detailed Estimates of the Financial Impact of
     * [28]Appendix IV: Studies on Accreditation of Facilities and the
     * [29]Appendix V: Information about Groups That Support Ultrasound
     * [30]Appendix VI: Comments from the Centers for Medicare & Medica
     * [31]Appendix VII: GAO Contact and Staff Acknowledgments

          * [32]GAO Contact
          * [33]Acknowledgments

               * [34]Order by Mail or Phone

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

Contents

Letter 1

Results in Brief 5
Background 7
The Most Common Medicare Ultrasound Procedures in 2005 Were
Echocardiograms and Noninvasive Vascular Studies 13
Changing Ultrasound Payment Methods Would Likely Increase Expenditures and
Beneficiary Cost Sharing 19
Evidence and Variation in Federal Requirements Are Among Factors to
Consider in Determining Whether to Establish Credentialing or Other
Qualification Requirements for Sonographers 26
Conclusions 36
Recommendation for Executive Action 37
Agency Comments and Our Evaluation 37
Appendix I Scope and Methodology 39
Appendix II Ultrasound Procedures and Medicare Part B Payments in 2005 49
Appendix III Detailed Estimates of the Financial Impact of Changing
Medicare Ultrasound Payment Methods 55
Appendix IV Studies on Accreditation of Facilities and the Credentialing
of Sonographers 57
Appendix V Information about Groups That Support Ultrasound Credentialing
and Accreditation Requirements 59
Appendix VI Comments from the Centers for Medicare & Medicaid Services 61
Appendix VII GAO Contact and Staff Acknowledgments 65

Tables

Table 1: Medicare Payment Methodology for Selected Imaging Procedures and
Associated Transportation for Beneficiaries in SNF Stays 11
Table 2: Financial Impact of Part B Ultrasound Equipment Transportation
Payments, 2005 20
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 24
Table 4: Number of Ultrasound Procedures Provided to Medicare
Beneficiaries by Site of Service and Level of Physician Supervision
Required, 2005 49
Table 5: Top Five Medical Conditions Diagnosed by Type of Ultrasound
Procedure Provided to Medicare Beneficiaries under Medicare Part B, 2005
51
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 53
Table 7: Financial Impact of Ultrasound Equipment Transportation Payments,
2005 55
Table 8: Percentage Change in Number of Ultrasound Exams in SNFs, 1995 to
1997 56

Figures

Figure 1: Percentages of Total Procedures and Total Part B Medicare
Payments for Ultrasound Procedures Provided to Beneficiaries, 2005 14
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 17
Figure 3: Medicare Carriers' Part B LCDs on Noninvasive Vascular
Diagnostic Ultrasound Procedures, as of April 2007 32

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

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separately.

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.^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.^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.

^1See 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.

^2See MedPAC 2006.

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.^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.^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.^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.

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

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

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

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,^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.^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.^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.^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.^10 We found the Medicare claims data we analyzed to be sufficiently
reliable for the purposes of this report.^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.^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.

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

^7See Pub. L. No. 108-173, S 513, 117 Stat. 2066, 2300.

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

^9The 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.

^10Medicare only covers ambulance transportation that is medically
necessary. See CMS, Medicare Benefit Policy Manual, Chapter 10, S10.2,
10.2.1, May 28, 2004.

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

^12The 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).

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.^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.^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.^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.^16

13These 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.

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

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

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.^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.^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.^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.

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

^17CMS 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.

^18Medicare 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.

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.^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.^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."^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.^23

^19Under 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.

^20For 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, [35]GAO-01-816
(Washington, D.C.: Aug. 22, 2001).

^21See Pub. L. No. 105-33, S 4432, 111 Stat. 251, 414-22.

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

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

                   Part A-covered SNF stays            Noncovered SNF stays
Type of                                                                           
procedure or                      CT scan, MRI,                     CT scan, MRI, 
transportation Ultrasound X-ray^a Angiography^b  Ultrasound X-ray^a Angiography^b 
Imaging                                                                           
procedures                                                                        
Exam               0M       0M        0m^c           0m       0m         0m       
Interpretation     0m       0m         0m            0m       0m         0m       
of exam                                                                           
Ambulance          0M       0M        0m^c           0m       0m         0m       
transportation                                                                    
associated                                                                        
with imaging                                                                      
exam^d                                                                            

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

Legend: 0M = bundled into SNF PPS payment; 0m = paid separately under Part
B

aDoes not include angiography.

bAngiography 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.

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

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

Medicare does not make separate Part B payments to transport ultrasound
equipment to a home or SNF for an exam. The transportation of the
ultrasound equipment and sonographer is considered to be bundled into the
ultrasound exam payment. However, Medicare does make separate Part B
payments for the transportation and set-up of equipment used to conduct
diagnostic X-ray exams.^24

23See [36]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.

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.^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.^26

^24Section 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.

^25In 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.

^26CMS 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, S
4559, 111 Stat. 251, 464.

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.^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.)

^27The 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.

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

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

           o 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.

           o 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).^28

           o 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.

           o 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.

           o 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.^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.

^28Deep 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.

           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.^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.^31
			  
^29This 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.

^30These 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.

^31For 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.

           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

           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.

           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.^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.^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.

^32We 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.

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

           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.^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.
			  
^34The 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.		

           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

                                             Financial impact
                                                   Medicare                   
                             Ultrasound exams      payments  Beneficiary cost 
Site of service                   (number)     (dollars) sharing (dollars) 
Skilled nursing                                                            
facilities^a                       129,119  $9.8 million      $2.6 million 
Home                               101,285  $4.4 million      $1.2 million 
Custodial care and                                                         
assisted living                                                            
facilities                          22,787  $1.3 million      $0.3 million 
Total                              253,191 $15.5 million      $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.

           aBased on exams conducted in either a SNF or nursing facility
           during a noncovered SNF stay.

           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.^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.^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.^37

^35See appendix I for how we identified these exams.

^36These 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.

           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.^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.^39
			  
^37We 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.

^38See 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.

^39An 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.			  

           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.^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.^41 (See table 3 and
           app. I for details on how these estimates were calculated.)
			  
^40We 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,
[37]GAO/HEHS-98-82 (Washington, D.C.: May 18, 1998).

^41These 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.

           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

                                                                  Increase in 
                                         Increase in Part B  beneficiary cost 
Type of service                   expenditures (dollars) sharing (dollars) 
Ultrasound exams^a                         $19.5 million     $12.7 million 
Ultrasound equipment                                                       
transportation^b                            $2.3 million      $0.6 million 
Ambulance transportation for                                               
ultrasound exam^c                           $0.2 million      $0.1 million 
Total                                      $22.0 million     $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.

           aEstimates 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.

           bEstimates 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.

           cDefined as ambulance services used to transport a beneficiary
           from a SNF to another facility and back for an ultrasound exam.

           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.^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.^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.^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.^45
			  
^42GAO, Skilled Nursing Facilities: Providers Have Responded to Medicare
Payment System By Changing Practices, [38]GAO-02-841 (Washington, D.C.:
Aug. 23, 2002).

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

^44See GAO, End-Stage Renal Disease: Bundling Medicare's Payment for Drugs
with Payment for All ESRD Services Would Promote Efficiency and Clinical
Flexibility, [39]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).

^45GAO, Medicare Home Health Care: Payments to Home Health Agencies Are
Considerably Higher than Costs, [40]GAO-02-663 (Washington, D.C.: May 6,
2002).

           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.^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.
			  
^46On 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, S 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. S
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.

           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.^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.
			  
^47See 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).

           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.^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.^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.^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.^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.^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.^53
			  
^48See appendix IV for summaries of the studies discussed in this section.

^49See 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.

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

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

^52FDA 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. S 900.12
(2006).

^53See GAO, Mammography Services: Impact of Federal Legislation on
Quality, Access, and Health Outcomes, [41]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,
[42]GAO/HEHS-98-164 (Washington, D.C.: May 8, 1998; Mammography Services:
Initial Impact of New Federal Law Has Been Positive, [43]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,
[44]GAO-06-724 (Washington, D.C.: July 25, 2006).

           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.^54 MedPAC noted that these standards should address
           the qualifications of the performing technicians in addition to
           other aspects of imaging procedures.^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^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.^57
			  
^54MedPAC 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).

^55MedPAC (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)."

^56These 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.

^57See 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.			  

           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.^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.^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.^60 The 2003 study noted that
           "alternatives that consider voluntary compliance to ultrasound
           standards may be unsuccessful."^61
			  
^58In 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, [45]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.

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

^60Among 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.

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

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

aThe 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.

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.^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.^63 There are CoP provisions that include specific standards
for medical staff and for radiology,^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.^65

^62See 42 C.F.R. S 410.33(c) (2006).

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

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

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.^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.^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.

^65Hospitals 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.

^66See 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).

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.^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.

^67The 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.

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.

^68For 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.

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 [email protected]. 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.

A. Bruce Steinwald
Director, Health Care

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.^1 We based our analysis of the site of service of
ultrasound procedures on claims for ultrasound exams that were paid under
Part B.^2 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.^3 For this report, we selected 94 HCPCS codes in the BETOS
categories for echography, which is a synonym for ultrasound.^4 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.^5

^1In 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.

^2The 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.

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.^6

^3HCPCS 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.

^4The 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).

^5We 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.

^6CMS 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.

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.^7

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,^8 (2) determined the number of beneficiary
days on which these exams were conducted,^9 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.^10 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.)

^7We obtained information from four directors of nursing in four states:
Connecticut, Florida, New York and Pennsylvania.

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.^11 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.^12 (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.

^8The 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.

^9The 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.

^10We 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.

^11Carriers 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.

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,^13 (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,^14
we first identified ambulance trips used to transport these beneficiaries
from SNFs to another location for an ultrasound procedure.^15 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.

^12We 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.

^13On 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 [46]GAO/HEHS-98-82
.

^14To 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.

^15Ambulance 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.

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.^16

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.^17
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.^18

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.^19
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.^20

^16The 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.

^17The 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.

^18The 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).

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;^21 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.

^19Based 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.

^20As 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.

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.^22 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.

^21To 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.

^22Data 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.

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,^23 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.

^23The 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.

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

                                                               Site of service
Type of         Level of                                        Hospital    Skilled         
ultrasound      physiciansupervision    Number of Physician's outpatient    nursing         
procedure       required             procedures^a      office department facility^b Other^c 
Noninvasive                                                                                 
vascular                                                                                    
                General                 6,347,815   3,821,749  2,376,169     69,704  80,193 
Subtotal                                6,347,815   3,821,749  2,376,169     69,704  80,193 
Echocardiograms                                                                             
                General                12,698,357   9,517,262  3,065,385     28,655  87,055 
                Direct                    421,801     276,498    145,051          6     246 
                Personal                   77,040       3,507     51,842         30  21,661 
                N/A^d                       1,008           5      1,003          0       0 
Subtotal                               13,198,206   9,797,272  3,263,281     28,691 108,962 
Abdomen and                                                                                 
pelvis                                                                                      
                General                 3,579,463   1,848,590  1,685,573     21,882  23,418 
                Personal                   24,523      13,489     10,924          0     110 
Subtotal                                3,603,986   1,862,079  1,696,497     21,882  23,528 
Head, neck, and                                                                             
chest                                                                                       
                General                 1,907,810   1,295,574    603,117      1,853   7,266 
                Direct                    148,023     135,164     11,784        729     346 
Subtotal                                2,055,833   1,430,738    614,901      2,582   7,612 
Ultrasonic                                                                                  
guidance                                                                                    
                General                   454,230     248,076    199,252          0   6,902 
                Personal                  530,948     273,706    249,159          7   8,076 
                N/A^d                      18,042          34     16,704          0   1,304 
Subtotal                                1,003,220     521,816    465,115          7  16,282 
Other           General                   538,598     414,036    115,241      1,300   8,021 
diagnostic                                                                                  
ultrasound      Direct               21,220      10,857    10,051      0        312 
                Personal                   18,959       2,661     16,113          0     185 
                N/A^d                   1,440,976   1,319,944    102,963      7,230  10,839 
Subtotal                                2,019,753   1,747,498    244,368      8,530  19,357 
Total number of                                                                             
all procedures                                                                              
provided to                                                                                 
beneficiaries                          28,228,813  19,181,152  8,660,331    131,396 255,934 

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.

aThe 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.

bWe counted the number of exams in skilled nursing facilities and nursing
facilities.

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

dN/A means not applicable.

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

                                                                   Percentage 
Type of ultrasound   Top five medical conditions  Number of         within 
procedure            diagnosed                   procedures procedure type 
Noninvasive vascular                                                       
                        Occlusion and stenosis of    1,661,280             20 
                        precerebral arteries                                  
                        Other disorders of soft      1,603,593             19 
                        tissue                                                
                        Atherosclerosis                737,405              9 
                        Other peripheral vascular      728,566              9 
                        diseases                                              
                        Cardiovascular system          541,018              6 
                        problems                                              
Subtotal top five                                 5,271,862             63 
                        Other noninvasive vascular   3,086,800             37 
Total                                             8,358,662            100 
Echocardiogram                                                             
                        Other diseases of            5,740,723             26 
                        endocardium                                           
                        Symptoms involving                                    
                        respiratory system and                                
                        other chest symptoms         2,655,795             12 
                        Other forms of chronic       2,058,896              9 
                        ischemic heart disease                                
                        Heart failure                2,054,101              9 
                        Cardiac dysrhythmias         1,375,924              6 
Subtotal top five                                13,885,439             64 
                        Other echocardiograms        7,947,756             36 
Total                                            21,833,195            100 
Abdomen and pelvis                                                         
                        Other symptoms involving     1,340,438             27 
                        abdomen and pelvis                                    
                        Other disorders of kidney      462,420              9 
                        and ureter                                            
                        Other disorders of urethra     263,473              5 
                        and urinary tract                                     
                        Cholelithiasis                 242,872              5 
                        Symptoms involving urinary     194,177              4 
                        system                                                
Subtotal top five                                 2,503,380             51 
                        Other abdomen and pelvis     2,425,031             49 
Total                                             4,928,411            100 
Head, neck, and,                                                           
chest                                                                      
                        Cataract                     1,176,137             49 
                        Other disorders of breast      386,908             16 
                        Nontoxic nodular goiter        162,762              7 
                        Nonspecific abnormal                                  
                        findings on radiological                              
                        and other examinations of                             
                        body structure                 146,047              6 
                        Benign mammary dysplasias      103,954              4 
Subtotal top five                                 1,975,808             82 
                        Other head, neck, chest        438,042             18 
Total                                             2,413,850            100 
Ultrasonic guidance                                                        
                        Malignant neoplasm of          229,242             18 
                        prostate                                              
                        Nonspecific findings on        150,046             12 
                        examination of blood                                  
                        Other and unspecified          120,019             10 
                        aftercare                                             
                        Pleurisy                       104,175              8 
                        Other symptoms involving        84,506              7 
                        abdomen and pelvis                                    
Subtotal top five                                   687,988             55 
                        Other ultrasonic guidance      552,716             45 
Total                                             1,240,704            100 
Other diagnostic                                                           
ultrasounds                                                                
                        Symptoms involving urinary     836,940             40 
                        system                                                
                        Hyperplasia                    310,658             15 
                        Nonspecific findings on        168,274              8 
                        examination of blood                                  
                        Malignant neoplasm of           93,512              4 
                        prostate                                              
                        Other disorders of bladder       83120              4 
Subtotal top five                                 1,492,504             70 
                        All other                      626,456             30 
Total                                             2,118,960            100 
Total number of                                                            
procedures provided                                                        
to Medicare                                                                
beneficiaries                                    40,893,782                

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.

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

                                                                   Percentage 
Type of ultrasound        Top five medical        Number of         within 
procedure                 conditions diagnosed   procedures procedure type 
Noninvasive vascular                                                       
                             Other disorders of         19,019             28 
                             soft tissues                                     
                             Symptoms involving         12,444             18 
                             skin and other                                   
                             integumentary tissue                             
                             Other peripheral           10,876             16 
                             vascular disease                                 
                             Phlebitis and               5,606              8 
                             thrombophlebitis                                 
                             Atherosclerosis             5,239              8 
Subtotal top five                                    53,184             78 
                             Other noninvasive          15,227             22 
                             vascular                                         
Total                                                68,411         100.00 
Echocardiogram                                                             
                             Heart failure               7,943             28 
                             Other diseases of           3,763             13 
                             endocardium                                      
                             Cardiac dysrhythmias        2,884             10 
                             Symptoms involving          2,669              9 
                             Respiratory systems                              
                             and other chest                                  
                             symptoms                                         
                             Diseases of mitral and      1,623              6 
                             aortic valves                                    
Subtotal top five                                    18,882             66 
                             Other echocardiograms       9,571             34 
Total                                                28,453         100.00 
Abdomen and pelvis                                                         
                             Other symptoms             10,450             48 
                             involving abdomen and                            
                             pelvis                                           
                             Other disorders of          1,408              7 
                             kidney and ureter                                
                             Nonspecific abnormal        1,314              6 
                             results of function                              
                             studies                                          
                             Other disorders of          1,239              6 
                             urethra and urinary                              
                             tract                                            
                             Symptoms involving          1,081              5 
                             urinary system                                   
Subtotal top five                                    15,492             72 
                             Other abdomen and           6,145             28 
                             pelvis                                           
Total                                                21,637         100.00 
Head, neck, and chest                                                      
                             Cataract                      889             35 
                             Other disorders of            244             10 
                             breast                                           
                             Other retinal                 218              9 
                             disorders                                        
                             Simple and unspecified        174              7 
                             goiter                                           
                             Visual disturbances           120              5 
Subtotal five                                         1,645             65 
                             Other                         905             35 
Total                                                 2,550         100.00 
Ultrasonic guidance       
                             Nonspecific findings            2             40 
                             on examination of the                            
                             blood                                            
                             Chronic renal failure           1             20 
                             Other disorders of              1             20 
                             soft tissue                                      
                             Organ or tissue                 1             20 
                             replaced by transplant                           
Subtotal top four^a                                       5         100.00 
                             Other                           0              0 
Total                                                     5         100.00 
Other diagnostic                                                           
ultrasound                                                                 
                             Symptoms involving          5,700             71 
                             urinary system                                   
                             Other disorders of            676              8 
                             bladder                                          
                             Other disorders of            560              7 
                             bone and cartilage                               
                             Other disorders of            188              2 
                             male genital organs                              
                             Symptoms involving            130              2 
                             skin and integumentary                           
                             tissue                                           
Subtotal top five                                     7,254             90 
                             Other                         809             10 
Total                                                 8,063         100.00 
Total number of                                                            
procedures provided in                                                     
SNFs to Medicare                                                           
beneficiaries in                                                           
noncovered SNF stays                                129,119         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.

aThere were only four medical conditions diagnosed by these five
ultrasound guidance procedures.

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

                                                                        Equipment   
                                          Equipment                   transportation
                                    transportation payment              and set-up  
                                             only                        payments   
                                      Increase Increase in   Increase                
                                            in beneficiary         in   Increase in  
             Ultrasound Beneficiary   Medicare        cost   Medicare   beneficiary  
Site of           exams      days^a   payments     sharing   payments  cost sharing  
service        (number)    (number)  (dollars)   (dollars)  (dollars)     (dollars)  
Skilled         129,119      83,591  8,477,240   2,262,706  9,786,084     2,636,868  
nursing                                                                              
facilities^b                                                                         
Home            101,285      36,880  3,362,665     883,980  4,408,509     1,164,498  
Custodial        17,490       7,900    837,061     218,101  1,007,215       264,314  
care                                                                                 
facilities                                                                           
Assisted          5,297       2,724    253,723      68,711    304,903        83,795  
living                                                                               
facilities                                                                           
Total           253,191     131,095 12,930,690   3,433,498 15,506,711     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.

aIndicates 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.

bBased on exams conducted in either a SNF or nursing facility during a
noncovered SNF stay.

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

                                        Number of ultrasound exams            
                                                                   Percentage 
                                                 1995         1997     change 
States where Medicare provided                                             
separate payments for ultrasound                                           
equipment transportation in 1995^a           8,365       28,170        237 
States where Medicare did not                                              
provide separate payments for                                              
ultrasound equipment transportation                                        
in 1995^a                                   23,281       37,708         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.

aBeginning 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.

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

                     Objective(s) of                                          
Author/title      study             Study methods     Study results        
David G. Stanley, To determine the  The study         The study found an   
"The Importance   accuracy of       compared the      83 percent           
of Intersocietal  noninvasive       results of        correlation rate for 
Commission for    vascular          noninvasive       ultrasound           
the Accreditation ultrasound        vascular          procedures that were 
of Vascular       procedures        ultrasound        initially performed  
Laboratories      conducted by      procedures        at accredited        
(ICAVL)           accredited and    performed by an   facilities.          
Certification for nonaccredited     accredited                             
Noninvasive       facilities.       facility to the   However, when the    
Peripheral                          results of        initial study was    
Vascular Tests:                     studies that were performed by a       
The Tennessee                       initially         nonaccredited        
Experience," The                    performed by both facility, the        
Journal for                         accredited and    correlation rate for 
Vascular                            nonaccredited     reviewed studies was 
Ultrasound, vol.                    facilities. The   45 percent.          
28, no. 2 (2004).                   study reviewed a                       
                                       total of 437                           
                                       ultrasound                             
                                       carotid duplex                         
                                       exams.^a                               
Alfred Z.         To determine the  The scores of     The study found that 
Abuhamad et al.,  effectiveness of  case studies in   practices that       
"The              the American      82 AIUM           applied for, and     
Accreditation of  Institute of      accreditation     were granted,        
Ultrasound        Ultrasound in     applications were ultrasound           
Practices Impact  Medicine (AIUM)   compared with     accreditation were   
on Compliance     accreditation     their respective  able to improve the  
with Minimum      program in        scores at the     scores of case       
Performance       improving         time of           studies and to       
Guidelines,"      compliance with   reaccreditation 3 achieve compliance   
Journal of        standards and     years later. To   with AIUM minimum    
Ultrasound in     guidelines for    account for the   standards and        
Medicine, vol.    the performance   element of time,  guidelines for the   
23, no. 8 (2004). of obstetric and  scores of         performance of       
                     gynecologic       applications that gynecologic and      
                     ultrasound        recently          obstetric ultrasound 
                     examinations.^b   completed         examinations. The    
                                       first-time        study concluded that 
                                       accreditation     the improvement in   
                                       were also         scores should        
                                       compared as a     translate into an    
                                       control group.    enhancement of the   
                                                         quality of the       
                                                         ultrasound practice. 
O. William Brown, To evaluate the   The study         The study found that 
et al.,           reliability of    compared the      of the 174 patients  
"Reliability of   carotid duplex    quality and       referred for         
Extracranial      ultrasound        reliability of    surgical evaluation  
Carotid Artery    scanning          carotid duplex    for carotid          
Duplex Ultrasound procedures        ultrasound        endarterectomy,^c 88 
Scanning: Value   performed by      scanning          of these patients    
of Vascular       nonaccredited     procedures        did not have the     
Laboratory        vascular          performed by a    severe or critical   
Accreditation,"   laboratories and  nonaccredited     carotid stenosis     
Journal of        to assess the     vascular          (narrowing) that had 
Vascular Surgery, clinical effect   laboratory with   been diagnosed       
vol. 39, no. 2    on patient        repeat            initially. Since     
(2004).           management.^a     examinations      these patients had   
                                       performed in the  all been referred    
                                       Beaumont          for carotid          
                                       laboratory, which endarterectomy,      
                                       is accredited by  unnecessary and      
                                       the Intersocietal potentially          
                                       Commission for    dangerous operations 
                                       Accreditation of  were avoided when    
                                       Vascular          the accredited       
                                       Laboratories.     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.        
S. Boswell et     To evaluate the   Researchers       The study found that 
al., "Practice    opinions of       surveyed 100      12 percent of        
Patterns and      vascular          members of the    (4,782) carotid      
Membership        technologists and Society of        duplex procedures    
Opinion About the sonographers who  Diagnostic        considered in the    
Value of          routinely perform Medical           study were repeated  
Credentialing and vascular          Sonography and    annually.            
Accreditation:    procedures about  the Society for                        
Results of a      the value of      Vascular          Among the reasons    
Membership        credentialing and Ultrasound in     cited by respondents 
Survey," Journal  accreditation and Kentucky and      for repeat tests was 
of Diagnostic     to assess their   Indiana. There    that the             
Medical           current practice  was a 30 percent  sonographers         
Sonography, vol.  patterns for the  response rate.    conducting the exams 
19, no. 6 (2003). performance of                      were not             
                     carotid duplex                      sufficiently         
                     ultrasound                          competent.           
                     procedures.                                              
                                                         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.

aA 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.

bThe 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.

cEndarterectomy 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.

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

Group                        Information on group                          
The American College of      The American College of Radiology is a        
Radiology                    nonprofit, professional association that      
                                represents 30,000 diagnostic radiologists,    
                                radiation oncologists, interventional         
                                radiologists, nuclear medicine physicians,    
                                and medical physicists. The organization's    
                                ultrasound accreditation program was          
                                established in 1995, and it includes general  
                                ultrasound, obstetrics, gynecological, and    
                                vascular ultrasound. This accreditation       
                                program requires that all sonographers be     
                                certified.                                    
The American Society of      The American Society of Echocardiography is a 
Echocardiography             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.       
American Institute of        The American Institute of Ultrasound in       
Ultrasound in Medicine       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.                                    
American Registry for        The American Registry for Diagnostic Medical  
Diagnostic Medical           Sonography is an independent nonprofit        
Sonography                   organization that, for 29 years, has awarded  
                                credentials to ultrasound professionals       
                                through examinations. The organization offers 
                                certification in three ultrasound clinical    
                                specialties: Registered Diagnostic Medical    
                                Sonographer, Registered Diagnostic Cardiac    
                                Sonographer, and Registered Vascular          
                                Technologist. The organization has over       
                                44,000 actively certified ultrasound          
                                professionals.                                
Cardiovascular Credentialing Cardiovascular Credentialing International is 
International                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.                                   
Intersocietal Commission for The Intersocietal Commission for the          
the Accreditation of         Accreditation of Echocardiography             
Echocardiography             Laboratories has been in operation since 1996 
Laboratories                 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.                  
Intersocietal Commission for The Intersocietal Commission for the          
the Accreditation of         Accreditation of Vascular Laboratories has    
Vascular Laboratories        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.                           
Joint Review Committee on    Founded in 1979, the Joint Review Committee   
Education in Diagnostic      on Education in Diagnostic Medical Sonography 
Medical Sonography           is the only nationally recognized             
                                organization that accredits diagnostic        
                                medical sonography programs. The primary      
                                purpose of the organization is to establish,  
                                maintain, and promote appropriate standards   
                                of quality for educational programs in        
                                diagnostic medical sonography and to provide  
                                recognition for educational programs that     
                                meet or exceed these standards.               
Society of Diagnostic        The Society of Diagnostic Medical Sonography  
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.                                        
Society for Vascular Surgery 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.                                
Society for Vascular         The Society for Vascular Ultrasound is the    
Ultrasound)                  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,
[47]http://www.sdms.org/about/who.asp , downloaded October 23, 2006.

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

Appendix VII: GAO Contact and Staff Acknowledgments

GAO Contact

A. Bruce Steinwald (202) 512-7114 or [email protected]

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.

(290557)

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[54]www.gao.gov/cgi-bin/getrpt?GAO-07-734 .

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Highlights of [55]GAO-07-734 , a report to congressional committees

June 2007

MEDICARE ULTRASOUND PROCEDURES

Consideration of Payment Reforms and Technician Qualification Requirements

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.

[56]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.

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.

References

Visible links

  35. http://www.gao.gov/cgi-bin/getrpt?GAO-01-816
  36. http://www.gao.gov/cgi-bin/getrpt?GAO-01-816
  37. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-98-82
  38. http://www.gao.gov/cgi-bin/getrpt?GAO-02-841
  39. http://www.gao.gov/cgi-bin/getrpt?GAO-07-77
  40. http://www.gao.gov/cgi-bin/getrpt?GAO-02-663
  41. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-98-11
  42. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-98-164
  43. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-96-17
  44. http://www.gao.gov/cgi-bin/getrpt?GAO-06-724
  45. http://www.gao.gov/cgi-bin/getrpt?GAO-03-175
  46. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-98-82
  47. http://www.sdms.org/about/who.asp
  48. http://www.gao.gov/
  49. http://www.gao.gov/
  50. http://www.gao.gov/fraudnet/fraudnet.htm
  51. mailto:[email protected]
  52. mailto:[email protected]
  53. mailto:[email protected]
  54. http://www.gao.gov/cgi-bin/getrpt?GAO-07-734
  55. http://www.gao.gov/cgi-bin/getrpt?GAO-07-734
*** End of document. ***