Medicare Ultrasound Procedures
Consideration of Payment Reforms and Technician Qualification Requirements Gao ID: GAO-07-734 June 28, 2007Medicare 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.
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.
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Report to Congressional Committees:
United States Government Accountability Office:
GAO:
June 2007:
Medicare Ultrasound Procedures:
Consideration of Payment Reforms and Technician Qualification
Requirements:
GAO-07-734:
GAO Highlights:
Highlights of GAO-07-734, a report to congressional committees
Why GAO Did This Study:
Medicare spending on imaging services, among which are ultrasound
procedures that use sound waves to facilitate diagnosis, nearly doubled
from 1999 to 2004. The Congress required GAO to examine Medicare‘s
payment methods for ultrasound procedures and whether the technicians
that conduct them”called sonographers”should be subject to
qualification standards, such as having to undergo a certification
process called credentialing. This report addresses (1) the ultrasound
procedures commonly used to diagnose medical conditions of Medicare
beneficiaries, particularly for beneficiaries in a skilled nursing
facility (SNF), (2) the financial impact of changing how Medicare pays
for ultrasound exams and associated equipment and ambulance
transportation for beneficiaries in a SNF, and (3) the factors for the
Centers for Medicare & Medicaid Services (CMS) to consider in
determining whether to establish credentialing or other requirements
for sonographers. For this review, GAO analyzed Medicare claims data
and conducted interviews and literature reviews.
What GAO Found:
Three-fourths of the approximately 41 million ultrasound procedures
provided to Medicare beneficiaries in 2005 in any setting were one of
two types: (1) echocardiograms to diagnose heart conditions or (2)
noninvasive vascular procedures used to monitor blood flow and detect
blockage or injury in veins and arteries. Ultrasound procedures consist
of the ultrasound exam itself and the physician‘s interpretation of the
exam. Nearly all of the ultrasound exams provided under Medicare Part
B, which covers physician, hospital outpatient, diagnostic testing, and
certain other services, were performed in physicians‘ offices and
hospital outpatient departments. Of these exams, less than 1 percent
were conducted in SNFs or homes, generally using ultrasound equipment
that was transported to these settings by a mobile provider. Among
beneficiaries in SNF stays not covered by Medicare who received
ultrasound exams in SNFs, noninvasive vascular exams were the most
prevalent type performed.
Two ultrasound procedure payment changes affecting SNF beneficiaries
that GAO examined would likely increase expenditures and beneficiary
cost sharing. If CMS had paid to transport ultrasound equipment to
beneficiaries in SNF stays not covered by Medicare, which is not
currently done, Medicare expenditures could have increased by an
estimated $9.8 million and beneficiary cost sharing could have been
about $2.6 million higher in 2005, assuming the number and location of
services would not change in response to this policy. Moreover, paying
separately for ultrasound exams and related transportation during
beneficiaries‘ Medicare-covered SNF stays, as opposed to bundling these
and other services into a single daily payment as CMS currently does,
could have increased Medicare payments by about $22.0 million and
beneficiary cost sharing by about $13.4 million in 2005, assuming no
change in service use due to the revised policy. The actual financial
impact for Medicare could differ from these estimates if, for example,
providers increased their service provision due to these policy
changes.
Factors for CMS to consider in determining whether to establish
credentialing or other qualification requirements for sonographers
include the evidence of the value of setting such requirements and
variation in federal requirements for sonographers. The skill of the
sonographer conducting an ultrasound is critical for its use to support
a physician‘s correct diagnosis; poorly captured images can lead to
misdiagnoses or unnecessarily repeated exams. Findings from several
peer-reviewed studies, the Medicare Payment Advisory Commission, and
ultrasound-related professional organizations support requiring that
sonographers either have credentials or operate in facilities that are
accredited, where specific quality standards apply. In some localities
and practice settings, CMS or its contractors have required that
sonographers either be credentialed or work in an accredited facility.
Medicare‘s inconsistent requirements undermine assurance that
beneficiaries are receiving high-quality services across the country.
What GAO Recommends:
CMS should require sonographers providing Medicare-covered ultrasound
exams to either be credentialed or work in an accredited facility. CMS
stated that it would consider this recommendation.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-734].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact A. Bruce Steinwald at
(202) 512-7114 or steinwalda@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
The Most Common Medicare Ultrasound Procedures in 2005 Were
Echocardiograms and Noninvasive Vascular Studies:
Changing Ultrasound Payment Methods Would Likely Increase Expenditures
and Beneficiary Cost Sharing:
Evidence and Variation in Federal Requirements Are Among Factors to
Consider in Determining Whether to Establish Credentialing or Other
Qualification Requirements for Sonographers:
Conclusions:
Recommendation for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Ultrasound Procedures and Medicare Part B Payments in
2005:
Appendix III: Detailed Estimates of the Financial Impact of Changing
Medicare Ultrasound Payment Methods:
Appendix IV: Studies on Accreditation of Facilities and the
Credentialing of Sonographers:
Appendix V: Information about Groups That Support Ultrasound
Credentialing and Accreditation Requirements:
Appendix VI: Comments from the Centers for Medicare & Medicaid
Services:
Appendix VII: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Medicare Payment Methodology for Selected Imaging Procedures
and Associated Transportation for Beneficiaries in SNF Stays:
Table 2: Financial Impact of Part B Ultrasound Equipment Transportation
Payments, 2005:
Table 3: Increase in Part B Expenditures and Beneficiary Cost Sharing
Due to Separate Payments for Ultrasound Services during Part A-Covered
SNF Stays, 2005:
Table 4: Number of Ultrasound Procedures Provided to Medicare
Beneficiaries by Site of Service and Level of Physician Supervision
Required, 2005:
Table 5: Top Five Medical Conditions Diagnosed by Type of Ultrasound
Procedure Provided to Medicare Beneficiaries under Medicare Part B,
2005:
Table 6: Top Five Medical Conditions Diagnosed by Type of Ultrasound
Procedure Provided in SNFs to Medicare Beneficiaries in Noncovered SNF
stays and Paid Under Medicare Part B, 2005:
Table 7: Financial Impact of Ultrasound Equipment Transportation
Payments, 2005:
Table 8: Percentage Change in Number of Ultrasound Exams in SNFs, 1995
to 1997:
Figures:
Figure 1: Percentages of Total Procedures and Total Part B Medicare
Payments for Ultrasound Procedures Provided to Beneficiaries, 2005:
Figure 2: Percentages of Total Procedures and Total Part B Medicare
Payments for Ultrasound Procedures Conducted in SNFs for Beneficiaries
in Noncovered SNF Stays, 2005:
Figure 3: Medicare Carriers' Part B LCDs on Noninvasive Vascular
Diagnostic Ultrasound Procedures, as of April 2007:
Abbreviations:
AIUM: American Institute of Ultrasound in Medicine:
ARDMS: American Registry for Diagnostic Medical Sonography:
BBA: Balanced Budget Act of 1997:
BETOS: Berenson-Eggers Type of Service:
CCI: Cardiovascular Credentialing International:
CMS: Centers for Medicare & Medicaid Services:
CoP: Medicare Conditions of Participation:
CPT: Current Procedural Terminology:
FDA: Food and Drug Administration:
HCPCS: Healthcare Common Procedure Coding System:
HHS: Department of Health and Human Services:
ICAVL: Intersocietal Commission for the Accreditation of Vascular
Laboratories:
IDTF: independent diagnostic testing facility:
LCD: Local Coverage Determination:
MedPAC: Medicare Payment Advisory Commission:
NCD: National Coverage Determination:
NCH: National Claims History:
OIG: Office of Inspector General:
PPS: prospective payment system:
SAF: Standard Analytical File:
SNF: skilled nursing facility:
United States Government Accountability Office:
Washington, DC 20548:
June 28, 2007:
The Honorable Max Baucus:
Chairman:
The Honorable Charles Grassley:
Ranking Minority Member:
Committee on Finance:
United States Senate:
The Honorable John D. Dingell:
Chairman:
The Honorable Joe Barton:
Ranking Minority Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Charles B. Rangel:
Chairman:
The Honorable Jim McCrery:
Ranking Minority Member:
Committee on Ways and Means:
House of Representatives:
Medicare spending on imaging services nearly doubled from $5.7 billion
in 1999 to $10.9 billion in 2004, in part due to growth in the number
of procedures.[Footnote 1] Diagnostic ultrasound procedures, an imaging
service which uses high-frequency sound waves to create images of
internal body organs and blood flow, accounted for about one-fourth of
this spending in 2004.[Footnote 2] Growth in the use of diagnostic
ultrasound procedures has been due in part to technological advances,
which have improved the quality of ultrasound images and physicians'
ability to employ them to diagnose medical conditions. Technological
advances also have led to the development of ultrasound devices that
are smaller and more portable. The enhanced portability of ultrasound
equipment has made it easier for beneficiaries to receive ultrasound
exams in skilled nursing facilities (SNF) or beneficiaries' homes to
which ultrasound equipment generally must be transported by a mobile
provider.
Ultrasound procedures consist of two parts--the ultrasound exam itself
and the physician's interpretation of the exam. The first part of the
procedure--the ultrasound exam--generally involves an ultrasound
technician called a sonographer taking the image. The second part of
the procedure is the physician's interpretation of images from the
ultrasound exam.[Footnote 3] Medicare, administered by the Centers for
Medicare & Medicaid Services (CMS), pays for the ultrasound exam and
the physician's interpretation of it separately or together.[Footnote
4]
Medicare covers ultrasound and other imaging procedures and certain
related transportation under Part A and Part B of the program, and
beneficiaries are responsible for part of the cost of these services
through cost sharing.[Footnote 5] For all beneficiaries, Medicare
covers the physician's interpretation of ultrasound exams under Part B.
For beneficiaries in a Part A-covered SNF or hospital inpatient stay,
Medicare covers most services under Part A and pays for them through a
prospective payment system (PPS), which involves bundling payment for
multiple services. Specifically, for beneficiaries in Part A-covered
SNF stays, payment for ultrasound exams and medically necessary
ambulance transportation is bundled with other services into a single
daily rate. A PPS gives providers the incentive to furnish services
efficiently because if the actual cost of services is less than the
bundled payment, the provider keeps the difference. For beneficiaries
who are not in a Part A-covered SNF or hospital inpatient stay, which
includes those in a noncovered SNF stay, Medicare covers ultrasound
exams and medically necessary ambulance transportation under Part B.
The rapid growth in spending for imaging has contributed to interest in
the Congress and the Medicare Payment Advisory Commission (MedPAC)
about whether Medicare's payment methodology for these services creates
the proper incentives for appropriate use. Further, MedPAC has
expressed concern that not all imaging providers have the ability to
conduct quality exams, and several ultrasound-related professional
organizations have raised this issue with regard to sonographers.
Becoming credentialed by a nationally recognized organization,[Footnote
6] which can require obtaining a combination of training and experience
and passing an examination, is one way for sonographers to demonstrate
that they have the necessary skill level to perform quality exams. In
addition, accreditation is a mechanism for facilities that conduct
ultrasound procedures to demonstrate that their affiliated sonographers
meet the standards necessary to perform quality exams. For example, to
work in an accredited facility, sonographers may be required to have
certain credentials or be working toward obtaining them.
The Medicare Prescription Drug, Improvement, and Modernization Act of
2003 required that we assess issues associated with providing
ultrasound procedures to Medicare beneficiaries.[Footnote 7] As
discussed with the committees of jurisdiction, we address the following
issues in this report: (1) the types of ultrasound procedures commonly
used to diagnose medical conditions of Medicare beneficiaries,
particularly those in SNFs, (2) the financial impact of changing how
Medicare pays for ultrasound exams and associated equipment and
ambulance transportation for beneficiaries receiving care in a SNF, and
(3) the factors to consider in determining whether CMS should establish
credentialing or other qualification requirements for sonographers.
To examine the types of diagnostic ultrasound procedures provided to
Medicare beneficiaries and the sites of service where the exams were
performed, we analyzed Medicare claims data for 2005.[Footnote 8] Our
analysis of the types of procedures provided to all Medicare
beneficiaries was based on claims for physicians' interpretations of
ultrasound exams, which are paid under Part B regardless of whether the
exam itself was covered under Part A or Part B. Our analysis of the
site of service of ultrasound procedures was based on claims for
ultrasound exams that were paid under Part B because Part A payments
for these exams are bundled with other services and not separately
reported in the Medicare claims data. To understand clinical issues
associated with the site of service, we performed a literature search;
conducted structured interviews with representatives of gerontological,
radiological, and other ultrasound-related professional organizations;
and reviewed CMS documents.[Footnote 9] To estimate the financial
impact to Medicare and its beneficiaries of providing payments for
ultrasound equipment transportation and of paying separately for
ultrasound exams and associated equipment and ambulance transportation
for beneficiaries in Part A-covered SNF stays, we analyzed Medicare
claims data for ultrasound exams and ambulance services in 2005 and for
exams in 1995 through 1997.[Footnote 10] We found the Medicare claims
data we analyzed to be sufficiently reliable for the purposes of this
report.[Footnote 11] To identify factors to consider in determining
whether CMS should establish credentialing or other requirements for
sonographers, we reviewed Medicare regulations, CMS documents, Medicare
carriers' credentialing requirements for sonographers, and relevant
literature and also interviewed officials from agencies and
organizations such as CMS, MedPAC, and those that credential
sonographers.[Footnote 12] Appendix I provides more detail on our scope
and methodology. We performed our work from July 2006 through May 2007
in accordance with generally accepted government auditing standards.
Results in Brief:
The most common diagnostic ultrasound procedures provided to all
Medicare beneficiaries and to those in noncovered SNF stays were used
to diagnose heart and circulatory (vascular) problems. Echocardiograms,
used to diagnose conditions such as heart failure and problems with the
innermost layer of the heart, were the most frequently performed type
of ultrasound procedure in 2005. They accounted for about 53 percent of
the 41 million procedures provided to nearly 12.4 million Medicare
beneficiaries in any setting and 49 percent of the $3.2 billion in
Medicare Part B payments for ultrasound procedures. Noninvasive
vascular studies--used to examine the blood flow through veins and
arteries and to detect blockage, injury, or blood clots--represented
about 20 percent of the ultrasound procedures and 30 percent of the
Medicare Part B payments. Nearly all (99 percent) of the ultrasound
exams provided to beneficiaries under Medicare Part B in 2005 were
performed in physician offices and hospital outpatient departments. The
remaining 1 percent were conducted in various sites of service,
including about 129,000 exams conducted in SNFs and 101,000 exams
conducted in beneficiaries' homes. Among the ultrasound exams provided
in SNFs to beneficiaries in noncovered SNF stays, noninvasive vascular
studies were the most prevalent, followed by echocardiograms.
We examined two potential changes to Medicare payment methods related
to ultrasound procedures for beneficiaries in SNFs and found that both
are likely to increase Medicare expenditures and beneficiary cost
sharing based on 2005 data and assuming that the provision of exams
would not change in response to this policy. First, we found that
providing Part B payments to transport equipment to SNFs during
noncovered SNF stays for ultrasound exams could have increased Medicare
expenditures by about $9.8 million and beneficiary cost sharing by
about $2.6 million in 2005. Second, we estimated the impact of paying
separately under Part B for ultrasound exams and associated equipment
and ambulance transportation for beneficiaries in Part A-covered SNF
stays, as opposed to bundling these services into the Part A PPS
payment as is currently done. We found that this policy could have
increased Part B Medicare expenditures by about $22.0 million and
beneficiary cost sharing by about $13.4 million in 2005. However, these
types of changes in payment policies could affect service use and thus
could cause the actual financial impact to differ from our estimates.
For example, paying separately under Part B for ultrasound exams and
associated equipment and ambulance transportation for beneficiaries in
Part A-covered SNF stays could cause the use of these services to grow
because the PPS incentive to provide them efficiently would be absent,
and this could cause the actual financial impacts to be greater than
our estimates. In addition, unless these separate Part B payments were
offset by a reduction in the Part A PPS payment, they would increase
overall Medicare expenditures.
Factors for CMS to consider in determining whether to establish
credentialing or other requirements for sonographers include the
evidence of the value of establishing such requirements and the
variation in federal requirements for sonographers. Having qualified
sonographers is important because their skill in performing an
ultrasound exam is critical to capturing quality images that physicians
can use in making appropriate clinical decisions and avoiding
misdiagnoses or unnecessarily repeated exams. Findings from peer-
reviewed studies, MedPAC, and ultrasound-related professional
organizations support the establishment of qualification requirements
for sonographers. In some locations and practice settings, Medicare
mandates that certain sonographers either be credentialed or work in an
accredited facility that requires sonographers to demonstrate that they
meet certain quality standards. The inconsistency of Medicare's
requirements across the country, coupled with the absence of state
licensure requirements for sonographers, undermines the assurance that
beneficiaries are receiving similarly high-quality services in
different locations and settings.
To help ensure consistency in the quality of ultrasound services
provided to Medicare beneficiaries nationwide, we recommend that the
Administrator of CMS require that sonographers serving Medicare
beneficiaries either be credentialed or work in an accredited facility.
In its written comments on a draft of this report, CMS stated that it
would consider our recommendation but would prefer that states engage
their own licensing bodies in implementing sonographer licensure
programs. (See app. VI.) CMS stated that a national policy would not
take into account regional variation in factors such as access to care
and state licensing requirements. We agree that access is an important
issue when considering whether to implement a national policy, and our
report states that a regulation could include a phase-in period to
provide noncredentialed sonographers with time to comply with the newly
imposed requirements. Furthermore, although CMS asserted that states
should engage their own licensure bodies to implement sonographer
licensure programs, we reported that state licensing requirements for
sonographers do not exist. Consequently, we continue to believe that
CMS should implement our recommendation and develop a national policy
establishing sonographer qualification requirements.
Background:
Ultrasound is a noninvasive form of imaging that, unlike X-ray and
certain other diagnostic modalities, does not expose patients to the
risks associated with the emission of ionizing radiation. To perform a
diagnostic ultrasound exam, a sonographer applies a hand-held medical
device called a transducer to the skin through which the ultrasound
machine emits and receives sound waves. As the sonographer moves the
transducer around the patient's body, an image of the various organs or
blood flow under study appears on a monitor. The sonographer
electronically stores what he or she considers as the most
diagnostically useful images.
The ultrasound systems that sonographers use differ along multiple
dimensions, including their types of transducers, documentation
capabilities, and cost. The type and number of transducers on a given
ultrasound system depend on the parts of the body to be examined and
the conditions intended to be diagnosed. In addition, some ultrasound
systems have additional documentation capability, which allows
sonographers and other health care personnel to electronically transmit
and display ultrasound images. According to the ultrasound device
manufacturers with whom we spoke, an ultrasound machine can range in
price from $20,000 to $200,000 or more. Prices are partially based on
the system's features, such as the number and type of different
transducers it has and its capacity to store and transmit data.
Sonographer Credentialing and Training and Facility Accreditation:
Sonographers can demonstrate that they have the appropriate level of
training and experience by becoming credentialed by a nationally
recognized organization. The American Registry for Diagnostic Medical
Sonography (ARDMS) and Cardiovascular Credentialing International (CCI)
are two main sonographer credentialing organizations. Each organization
has multiple pathways to becoming credentialed that are designed to
account for differences in sonographers' training and experience. CCI
allows sonographers without formal education, but with experience in
the field, to take its credentialing exam, but ARDMS requires that all
sonographers have a combination of education and experience to take its
exam.
Sonographers can obtain formal training through numerous education
programs. For example, the Commission on Accreditation of Allied Health
Education Programs lists 151 programs for diagnostic medical
sonographers, including associate's degree programs from community
colleges as well as bachelor's degree programs. Individuals we spoke
with from ultrasound-related professional organizations noted that,
although sonographers are more likely than in the past to undergo
formal training, there are still practicing sonographers who do not
have it.
Several organizations offer accreditation for facilities that conduct
ultrasound procedures as a way to demonstrate that they meet the
standards necessary to perform quality exams.[Footnote 13] To work in
an accredited facility, sonographers may be required to have certain
credentials or have received a minimum number of training hours. For
example, sonographers working in facilities that are accredited by the
Intersocietal Commission for the Accreditation of Vascular Laboratories
(ICAVL) must either be credentialed or have a specified level of
training and experience in sonography. Similarly, for a facility to
become accredited by the American Institute of Ultrasound in Medicine
(AIUM), the sonographers who work there must either be credentialed by
ARDMS or become credentialed before re-accreditation, which occurs
every 3 years.[Footnote 14] This allows new sonographers to obtain
experience conducting exams, which they need to be eligible to take a
credentialing exam, such as from ARDMS and CCI. In addition to
requirements for sonographers, accreditation can address broader
aspects of ultrasound procedures, including qualification requirements
for physicians, the condition of the ultrasound equipment, patient
safety, images produced, and documentation.
Medicare and Its Coverage Processes:
Medicare is the federally financed health insurance program for persons
age 65 and older and certain individuals with disabilities.[Footnote
15] The program serves over 42 million beneficiaries. Eligible
individuals are automatically covered by Part A, which helps pay for
inpatient hospital, skilled nursing facility, and hospice care, as well
as some home health care. Most eligible individuals elect to pay a
monthly premium to obtain Medicare Part B coverage, which covers
physician services, hospital outpatient services, and certain other
services, such as physical therapy. In addition to the premium,
beneficiaries are required to pay an annual Part B deductible as well
as coinsurance of 20 percent for most Part B services.[Footnote 16]
Medicare covers items or services that are provided for by statute and
that meet the applicable criteria for coverage when furnished to a
particular beneficiary. Decisions on the extent to which, and under
what circumstances, Medicare will cover specific services, procedures,
or technologies may be made by CMS or its contractors in a number of
ways. At the national level, CMS can make National Coverage
Determinations (NCD) that apply across the country. More typically,
most coverage issues are decided on the local level through Local
Coverage Determinations (LCD) or other decisions made by the
contractors that pay Medicare claims. For Part B claims for physician
services, the contractors that pay claims and create LCDs are generally
called carriers.[Footnote 17] If an NCD or other authority does not
provide specific guidance about the conditions for covering a service,
procedure, or technology, the carrier has the discretion to adopt an
LCD to address the issue. LCDs only apply to a carrier's service area
or to the providers it serves.
Medicare Payment for Ultrasound Procedures and Associated Ambulance and
Equipment Transportation:
Medicare covers physicians' interpretations of ultrasound and other
imaging exams under Part B for all beneficiaries. For beneficiaries,
except for those in a Part A-covered hospital or SNF stay, Medicare
also provides Part B coverage of ultrasound and other imaging exams as
well as medically necessary ambulance transportation. How Medicare pays
for ultrasound exams and associated ambulance transportation for
beneficiaries in a SNF depends on whether Medicare covers the stay
under Part A.[Footnote 18] For beneficiaries in Part A-covered SNF
stays, Medicare bundles payment for one part of the ultrasound
procedure--the exam--as well as associated ambulance transportation
into the daily Part A PPS payment.[Footnote 19] When beneficiaries
remain in a SNF after exhausting their Part A SNF benefits or if the
SNF stay is not covered for some other reason, they are in a
"noncovered" SNF stay during which Medicare covers ultrasound exams and
medically necessary ambulance transportation under Part B.
Although nearly all Medicare services provided to beneficiaries in Part
A-covered SNF stays are paid through the Part A PPS payment, certain
services are paid for separately under Part B.[Footnote 20] The
Balanced Budget Act of 1997 (BBA) excluded from the Part A PPS payment
all physician services for beneficiaries in Part A-covered SNF stays,
which include interpretations of ultrasound and other imaging exams,
and provides for separate payments for these services under Part
B.[Footnote 21] In addition, certain categories of services--for
example, the exam for computed tomography (CT) scans, magnetic
resonance imaging (MRI), and angiography--are excluded from the Part A
PPS payment and are paid for separately under Part B when provided in a
hospital outpatient setting. CMS identified these services as ones that
"lie well beyond the scope of care that SNFs would ordinarily
furnish."[Footnote 22] (See table 1.) One of our previous reports noted
that CMS considered the possibility of paying separately for certain
ultrasound exams and associated ambulance transportation but decided
not to do so because they did not meet the criteria used to identify
such services.[Footnote 23]
Table 1: Medicare Payment Methodology for Selected Imaging Procedures
and Associated Transportation for Beneficiaries in SNF Stays:
Imaging procedures.
Type of procedure or transportation: Exam;
Part A-covered SNF stays: Ultrasound: [Empty];
Part A-covered SNF stays: X-ray[A]: [Empty];
Part A-covered SNF stays: CT scan, MRI, Angiography[B]: [C];
Noncovered SNF stays: Ultrasound: [Empty];
Noncovered SNF stays: X- ray[A]: [Empty];
Noncovered SNF stays: CT scan, MRI, Angiography[B]: [Empty].
Type of procedure or transportation: Interpretation of exam;
Part A- covered SNF stays: Ultrasound: [Empty];
Part A-covered SNF stays: X- ray[A]: [Empty];
Part A-covered SNF stays: CT scan, MRI, Angiography[B]: [Empty];
Noncovered SNF stays: Ultrasound: [Empty];
Noncovered SNF stays: X-ray[A]: [Empty];
Noncovered SNF stays: CT scan, MRI, Angiography[B]: [Empty].
Type of procedure or transportation: Ambulance transportation
associated with imaging exam[D];
Part A-covered SNF stays: Ultrasound: [Empty];
Part A-covered SNF stays: X-ray[A]: [Empty];
Part A-covered SNF stays: CT scan, MRI, Angiography[B]: [C];
Noncovered SNF stays: Ultrasound: [Empty];
Noncovered SNF stays: X-ray[A]: [Empty];
Noncovered SNF stays: CT scan, MRI, Angiography[B]: [Empty].
Source: GAO analysis of CMS guidance on Medicare payment methodology
for SNF services.
Legend: = bundled into SNF PPS payment; = paid separately under Part B:
[A] Does not include angiography.
[B] Angiography is a type of imaging procedure that involves the use of
X-rays to develop images of arteries after dye is injected into the
bloodstream.
[C] Exams and associated ambulance transportation are only paid for
separately under Part B if the exam is conducted in a hospital
outpatient facility.
[D] Medically necessary ambulance transportation is paid for separately
from the PPS payment under Part B when associated with dialysis and
with the following services if provided in a hospital outpatient
department: cardiac catheterization, MRI, CT scan, certain ambulatory
surgery procedures, emergency services, radiation therapy, angiography,
and lymphatic and venous procedures. See CMS, Skilled Nursing Facility
Consolidated Billing as it Relates to Ambulance Services, MLN Matters
No. SE0433 (2005).
[End of table]
Medicare does not make separate Part B payments to transport ultrasound
equipment to a home or SNF for an exam. The transportation of the
ultrasound equipment and sonographer is considered to be bundled into
the ultrasound exam payment. However, Medicare does make separate Part
B payments for the transportation and set-up of equipment used to
conduct diagnostic X-ray exams.[Footnote 24]
Policy concerning payment for the transportation of ultrasound
equipment has changed over time. Prior to 1996, CMS did not have a
national policy concerning the transportation of ultrasound equipment,
but some of its carriers developed their own policies to cover it. In
1995, carriers for 14 states and the northern part of California had a
policy to reimburse providers for additional transportation costs
associated with providing mobile ultrasound exams, as they did for
mobile X-ray exams, which is another type of imaging service.[Footnote
25] However, beginning January 1, 1996, CMS determined that the
statutory provision that provided coverage for the transportation of
portable X-ray equipment did not provide this coverage for diagnostic
ultrasounds and, therefore, carriers could no longer make separate Part
B payments for the transportation of ultrasound equipment.[Footnote 26]
The Most Common Medicare Ultrasound Procedures in 2005 Were
Echocardiograms and Noninvasive Vascular Studies:
Echocardiograms and noninvasive vascular procedures accounted for about
three-fourths of the approximately 41 million ultrasound procedures
provided to Medicare beneficiaries in 2005 in any setting.[Footnote 27]
Nearly all of the ultrasound exams paid under Part B were performed in
physician offices and hospital outpatient departments. The remaining 1
percent were conducted in various sites of service, including SNFs and
beneficiaries' homes. Among the exams provided in SNFs to beneficiaries
in noncovered SNF stays, noninvasive vascular studies were the most
prevalent, followed by echocardiograms.
About Three-Quarters of Ultrasound Procedures Provided to All
Beneficiaries in 2005 Were Echocardiograms and Noninvasive Vascular
Studies:
Echocardiograms, used to diagnose heart conditions, and noninvasive
vascular studies, often used to diagnose blood clots, were the most
common diagnostic ultrasound procedures provided to Medicare
beneficiaries in 2005. (See fig. 1.)
Figure 1: Percentages of Total Procedures and Total Part B Medicare
Payments for Ultrasound Procedures Provided to Beneficiaries, 2005:
[See PDF for image]
Source: GAO analysis of Medicare Part B claims data for 2005.
Notes: Percentages may not sum to 100 due to rounding. The number of
procedures is based on claims for physicians' interpretations of
ultrasound exams and claims for ultrasound procedures classified solely
as physician services that did not have a separately billed exam and
physician's interpretation of the exam. Medicare payments do not
include beneficiary cost-sharing amounts. Our calculation of Medicare
payments does not include payment for ultrasound exams that were
provided to beneficiaries in Part A-covered SNF or inpatient hospital
stays because Part A payments for these exams are bundled with other
services and not separately reported in Medicare claims data.
[End of figure]
Specifically, of the 41 million total procedures provided to nearly
12.4 million beneficiaries in 2005 in any site of service, the
following apply.
* Echocardiograms were the most frequently performed type of
ultrasound, accounting for about 53 percent of the total number of
procedures and 49 percent of Medicare Part B payments. Echocardiograms
are commonly used to diagnose medical conditions such as heart failure,
problems with the innermost layer of the heart or the respiratory
system, and disorders of the heart rate.
* Noninvasive vascular studies represented about 20 percent of
ultrasound procedures provided to beneficiaries and 30 percent of
Medicare Part B payments for ultrasounds. Among other conditions,
noninvasive vascular ultrasounds are used to monitor the blood flow
through veins and arteries and to detect blockage, or blood clots. They
are frequently used to diagnose deep vein thrombosis (DVT).[Footnote
28]
* Ultrasounds of the abdomen and pelvis accounted for about 12 percent
of the ultrasound procedures and 10 percent of Medicare Part B payments
for ultrasounds. Abdominal ultrasounds are commonly used to identify
disorders of the kidney and ureter, tumors, and disorders of the
urinary tract.
* Ultrasounds of the head, neck, chest, and other ultrasound
procedures, accounted for about 11 percent of the total number of
Medicare ultrasound procedures and 7 percent of Part B Medicare
payments. Cataracts and disorders of the breast were among the top
medical conditions diagnosed with these procedures.
* Ultrasound guidance procedures accounted for the remaining share--
about 3 percent of the number of procedures and Part B Medicare
payments. Ultrasound guidance is used, for example, to direct the
placement of a needle to withdraw fluid from the membrane surrounding
the heart or lungs or to guide the performance of breast, liver, and
prostate biopsies. Some of these ultrasound procedures require the
attendance of a physician in the room during the performance of the
procedure. (In appendix II, see table 4 for details on the level of
physician supervision required for different types of procedures and
table 5 for the top five medical conditions diagnosed by type of
procedure.)
Our analysis of the available site-of-service data showed that nearly
all (99 percent) of the 28 million ultrasound exams provided to
beneficiaries under Part B in 2005 were performed in physician offices
and hospital outpatient departments--68 percent and 31 percent,
respectively.[Footnote 29] The remaining 1 percent (about 387,000
exams) were conducted in various sites of service, including SNFs and
beneficiaries' homes. Of the 28 million ultrasound exams provided to
Medicare beneficiaries under Part B, about 129,000 were conducted in
SNFs for beneficiaries in noncovered SNF stays and about 101,000 were
conducted in beneficiaries' homes.
Noninvasive Vascular Studies Were the Most Prevalent Ultrasound Exams
Provided in SNFs to Beneficiaries in Noncovered SNF Stays:
Of the 129,000 ultrasound exams conducted in SNFs for beneficiaries in
noncovered SNF stays, noninvasive vascular procedures were the most
common, accounting for 53 percent of the exams and 68 percent of the
Medicare Part B payments.[Footnote 30] The noninvasive vascular
procedures were used to diagnose conditions such as disorders of the
soft tissues, skin conditions, and deep vein thrombosis.
Echocardiograms were the second most frequently performed ultrasound
exam in SNFs for beneficiaries in noncovered SNF stays, representing 22
percent of the procedures and 20 percent of Part B Medicare payments.
Ultrasounds of the abdomen or pelvis were also common among this
population, accounting for about 17 percent of the ultrasound
procedures and 10 percent of Medicare Part B payments. The remaining 8
percent of the procedures and 2 percent of Part B Medicare payments
were for various other categories, including head, neck, and chest.
Only 5 ultrasound guidance procedures were conducted in SNFs for this
population in 2005. (See fig. 2 and table 6 in app. II, which shows the
top 5 medical conditions diagnosed by type of procedure provided to
beneficiaries in noncovered SNF stays.) Data limitations did not allow
us to examine the site of service for approximately 262,000 ultrasound
procedures provided to beneficiaries in Part A-covered SNF stays, but
our analysis of the types of procedures these beneficiaries received
shows similar results to those provided in SNFs during noncovered
stays.[Footnote 31]
Figure 2: Percentages of Total Procedures and Total Part B Medicare
Payments for Ultrasound Procedures Conducted in SNFs for Beneficiaries
in Noncovered SNF Stays, 2005:
[See PDF for image]
Source: GAO analysis of Medicare Part B claims for 2005.
Notes: We based this analysis on claims for ultrasound exams and claims
for ultrasound procedures classified solely as physician services that
do not include a separately billed exam and physician's interpretation
of the exam. Medicare payments in this figure do not include
beneficiary cost-sharing amounts. Our calculation of Medicare payments
does not include those for ultrasound exams that were provided to
beneficiaries in Part A-covered SNF or inpatient hospital stays because
Part A payments for these exams are bundled with other services and not
separately reported in Medicare claims data.
[End of figure]
Because of congressional interest in the quality of ultrasound
services, and particularly those conducted in SNFs, we examined
clinical considerations associated with the site where exams were
performed. Our literature search produced no pertinent studies on
clinical issues associated with transporting elderly patients to obtain
ultrasound exams as opposed to providing mobile services in SNFs or
beneficiaries' homes. Our analysis of CMS's 2005 data on the level of
physician supervision required to perform ultrasound procedures
indicates that about 90 percent of them did not require a physician to
be present. Thus, having a sonographer provide these procedures could
be appropriate for mobile services provided in a SNF or home even if a
physician was not present.
Representatives from nationally recognized professional organizations,
including professionals in the fields of geriatrics and sonography, as
well as ultrasound providers and long-term care provider organizations,
provided their views on clinical considerations associated with
transporting elderly patients to obtain an ultrasound or providing an
ultrasound in a SNF.[Footnote 32] In general, they said that the risks
and benefits depend on the patient's condition--such as whether the
beneficiary requires emergency care, the most appropriate setting for
follow-up care, and the type of ultrasound services provided. For
example, there are risks in transporting elderly patients, particularly
those with certain medical conditions including dementia, who can
become disoriented in new surroundings.[Footnote 33] Some
geriatricians, medical directors of SNFs, and long-term care providers
said that moving patients could increase their risk of falls or
fractures. A gerontologist and a geriatrician further noted that pain
is a major issue to consider in caring for frail, bedridden patients.
Transporting patients with deep vein thrombosis and pressure sores may
expose them to skin tears and pain. On the other hand, certain
ultrasound exams may be best performed in hospitals or physician
offices, according to organization representatives that we contacted.
For example, some beneficiaries may require emergency care, and
therefore require hospitalization. Others who need ultrasound exams may
have conditions that involve risks of serious complications that could
require surgical or other interventions more readily provided in a
hospital. In addition, a hospital or physician's office may be the best
setting for certain types of procedures, such as ultrasound guidance
for needle placement during biopsies, which requires the presence of a
physician during the performance of the procedure.
Changing Ultrasound Payment Methods Would Likely Increase Expenditures
and Beneficiary Cost Sharing:
We addressed two potential changes to Medicare payment methods related
to ultrasound procedures, both of which are likely to increase Medicare
expenditures and beneficiary cost sharing.[Footnote 34] The first
potential change we addressed, which would involve paying to transport
equipment to SNFs during noncovered SNF stays for ultrasound exams,
could have increased Medicare expenditures by an estimated $9.8 million
and beneficiary cost sharing by an estimated $2.6 million in 2005,
assuming that this policy change would not affect the number and
location of exams provided. The second potential change in Medicare
payment methods involves paying separately under Part B for ultrasound
exams and associated equipment and ambulance transportation during Part
A-covered SNF stays, as opposed to bundling payments for these services
as is done now. We found that paying separately under Part B for these
services could have increased Part B Medicare payments by an estimated
$22.0 million and beneficiary cost sharing by an estimated $13.4
million in 2005, assuming no change in the number of services provided
as a result of this policy. However, because these revised payment
policies could affect the use of these services, the actual financial
impacts could differ from our estimates. For instance, paying
separately under Part B for ultrasound exams and associated equipment
and ambulance transportation during Part A-covered SNF stays could
cause the use of these services to grow because the PPS incentive to
provide services efficiently would be absent, so the actual impact of
this policy could exceed our estimates. Further, unless these separate
Part B payments were offset by a reduction in the Part A PPS payment,
they would increase overall Medicare expenditures.
Part B Equipment Transportation Payments Would Likely Increase
Expenditures and Beneficiary Cost Sharing:
Paying to transport ultrasound equipment for the 129,000 exams done in
SNFs during noncovered SNF stays in 2005 could have increased Medicare
expenditures by an estimated $9.8 million and beneficiary cost sharing
by an estimated $2.6 million, assuming the number and location of exams
would not have changed in response to this policy. If this policy also
applied to mobile exams conducted in other sites of service, the
financial impact could be greater. For example, if Medicare made
separate Part B payments to transport ultrasound equipment to
beneficiaries' homes, as is the case for the transportation of portable
X-ray equipment, the financial impact could be higher by about $4.4
million for Medicare expenditures and $1.2 million higher for
beneficiary cost sharing. Similarly, paying to transport ultrasound
equipment to custodial care and assisted living facilities could have
increased the financial impact of this policy further (see table 2).
Table 2: Financial Impact of Part B Ultrasound Equipment Transportation
Payments, 2005:
Site of service: Skilled nursing facilities[A];
Financial impact: Ultrasound exams (number): 129,119;
Financial impact: Medicare payments (dollars): $9.8 million;
Financial impact: Beneficiary cost sharing (dollars): $2.6 million.
Site of service: Home;
Financial impact: Ultrasound exams (number): 101,285;
Financial impact: Medicare payments (dollars): $4.4 million;
Financial impact: Beneficiary cost sharing (dollars): $1.2 million.
Site of service: Custodial care and assisted living facilities;
Financial impact: Ultrasound exams (number): 22,787;
Financial impact: Medicare payments (dollars): $1.3 million;
Financial impact: Beneficiary cost sharing (dollars): $0.3 million.
Site of service: Total;
Financial impact: Ultrasound exams (number): 253,191;
Financial impact: Medicare payments (dollars): $15.5 million;
Financial impact: Beneficiary cost sharing (dollars): $4.1 million.
Source: GAO analysis of Medicare Part B claims data for 2005.
Notes: Dollar amounts may not sum to totals due to rounding. To
calculate the number of ultrasound exams, we counted the exams
themselves that were paid under Part B, as well as ultrasound
procedures classified solely as physician services that do not include
a separately billed exam. Ultrasound exams were defined as Healthcare
Common Procedure Coding System codes in the Berenson-Eggers Type of
Service categories for echography in addition to 10 diagnostic
ultrasound codes that were not in these categories. Calculations are
based on the assumption that mobile ultrasound providers would receive
a fee for transporting and setting up the equipment. See appendix I for
more information on how we defined ultrasound exams and appendix III
for detailed results.
[A] Based on exams conducted in either a SNF or nursing facility during
a noncovered SNF stay.
[End of table]
The actual financial impact of paying to transport ultrasound equipment
to SNFs would differ from our estimates if this policy caused the
number of mobile exams provided to increase or decrease, but this would
not affect our determination that this policy would likely lead to
higher Medicare expenditures and beneficiary cost sharing. The mobile
providers we spoke with noted that Medicare payments to transport
ultrasound equipment would allow them to expand their service area and
thus could increase the number of exams they provide. For example, one
provider noted that transportation payments might allow it to serve
beneficiaries in rural areas where doing so would have proved cost
prohibitive before. Thus, payments to transport ultrasound equipment
could potentially increase the number of mobile exams and provide more
beneficiaries with access to these services.
Increasing access to mobile ultrasound exams could possibly lessen the
need for ambulance services to transport beneficiaries from a SNF to
another location for an ultrasound exam, which could in turn reduce the
financial impact of this policy. Mobile providers stressed that
Medicare and its beneficiaries save money when beneficiaries in SNF
stays receive mobile exams in a SNF as opposed to being transported to
another location, in part because payments and beneficiary cost sharing
to transport ultrasound equipment are less than for an ambulance round
trip. We identified about 13,900 exams that potentially could have been
conducted in a SNF during a noncovered SNF stay rather than using
ambulance transportation to travel to another location for the
exam.[Footnote 35] If the increased availability of mobile exams
allowed all of these 13,900 exams to be conducted in a SNF rather than
in the locations (such as a hospital outpatient facility) where they
actually took place, the financial impact of this policy would have
been about $3.0 million lower for Medicare expenditures and about $1.2
million lower for beneficiary cost sharing.[Footnote 36]
However, if mobile providers increased the number of ultrasound exams
conducted in SNFs and other locations, it is also possible that this
increase could lead to larger than estimated increases in Medicare
expenditures and beneficiary cost sharing. Some of the exams conducted
for beneficiaries in noncovered SNF stays likely were conducted in
other sites of service (for example, physicians' offices or hospital
outpatient departments) but did not involve Medicare-covered ambulance
services to transport the beneficiary there. If mobile providers
furnished more ultrasound exams in SNFs by expanding their service
area, some of these beneficiaries might have received exams in this
site of service rather than in other locations. As a result of this
change in the site of service for these exams, our estimated impacts on
Medicare expenditures and beneficiary cost sharing could (1) increase
because Medicare would be paying for the additional ultrasound
equipment transportation cost that would otherwise not have been
necessary and (2) change due to the different cost of the exams
themselves in the new locations. However, data constraints do not allow
us to estimate the extent to which this would occur.[Footnote 37]
Based on what mobile providers told us, one might expect the number of
mobile exams to increase in response to the provision of payments to
transport ultrasound equipment. However, our analysis of the effect of
ceasing to pay for ultrasound equipment transportation in 1996
indicates that the opposite might occur. In 1995, Medicare carriers in
14 states and Northern California paid to transport ultrasound
equipment, but these payments ceased in all localities as of January of
1996. We compared the growth rate in the number of exams conducted in
SNFs in the 14 states where Medicare paid to transport ultrasound
equipment in 1995 and stopped doing so thereafter to the rate across
all other states where this change did not occur.[Footnote 38] The
number of exams conducted in SNFs grew by about 237 percent from 1995
to 1997 in states where Medicare paid to transport ultrasound equipment
in 1995 and ceased doing so thereafter, which was substantially greater
than the 62 percent growth rate in other states where Medicare had not
paid to transport ultrasound equipment. This suggests that the
elimination of Medicare payments to transport ultrasound equipment may
have led to an increase in the number of mobile exams as the amount
paid per exam decreased.[Footnote 39]
These results raise the possibility that mobile providers might
maintain or decrease the number of exams they provide if Medicare began
paying to transport ultrasound equipment. A decrease in the number of
exams conducted in SNFs, if it occurred, could require that more
beneficiaries use ambulance services to be transported to other
locations for the exams.[Footnote 40] We estimated that a reduction in
the number of exams conducted in SNFs could cause the estimated
increases in Medicare expenditures and beneficiary cost sharing to be
greater.
Paying Separately for Ultrasound Services during Part A-Covered SNF
Stays Would Likely Increase Part B Expenditures, Beneficiary Cost
Sharing, and Service Use:
Paying separately under Part B for ultrasound exams and associated
equipment and ambulance transportation during Part A-covered SNF stays,
as opposed to bundling these services into the Part A PPS payment as is
done now, could have increased Medicare Part B payments in 2005 by an
estimated $22.0 million and caused beneficiary cost sharing to rise by
about $13.4 million, assuming that this policy would not affect service
use.[Footnote 41] (See table 3 and app. I for details on how these
estimates were calculated.)
Table 3: Increase in Part B Expenditures and Beneficiary Cost Sharing
Due to Separate Payments for Ultrasound Services during Part A-Covered
SNF Stays, 2005:
Type of service: Ultrasound exams[A];
Increase in Part B expenditures (dollars): $19.5 million;
Increase in beneficiary cost sharing (dollars): $12.7 million.
Type of service: Ultrasound equipment transportation[B];
Increase in Part B expenditures (dollars): $2.3 million;
Increase in beneficiary cost sharing (dollars): $0.6 million.
Type of service: Ambulance transportation for ultrasound exam[C];
Increase in Part B expenditures (dollars): $0.2 million;
Increase in beneficiary cost sharing (dollars): $0.1 million.
Type of service: Total;
Increase in Part B expenditures (dollars): $22.0 million;
Increase in beneficiary cost sharing (dollars): $13.4 million.
Source: GAO analysis of Medicare claims for 2005 and 1997 (see app. I
for more detail).
Notes: Dollar amounts may not sum to totals due to rounding. Ultrasound
exams were defined as Healthcare Common Procedure Coding System codes
in the Berenson-Eggers Type of Service categories for echography in
addition to 10 diagnostic ultrasound codes that were not in these
categories. See appendix I for more detail.
[A] Estimates based on physicians' interpretations of ultrasound exams
conducted during Part A-covered SNF stays and estimates of the Medicare
payment and beneficiary cost sharing for the exam that corresponds to
these interpretations. See appendix I for more detail.
[B] Estimates based on the assumption that Medicare would pay for both
the transportation and set-up of the ultrasound equipment. If Medicare
only paid for the transportation of ultrasound equipment, Part B
expenditures due to separate Part B payments during Part A-covered SNF
stays for this service would increase by about $2.0 million, and
beneficiary cost sharing would increase by approximately $0.5 million.
[C] Defined as ambulance services used to transport a beneficiary from
a SNF to another facility and back for an ultrasound exam.
[End of table]
The actual financial impact of paying separately under Part B for
ultrasound exams and associated equipment and ambulance transportation
could differ from the estimates in table 3 because this policy could
cause their use to grow by undermining the incentive inherent in the
PPS to efficiently provide these services. Although we did not find
published studies specific to ultrasound or certain other imaging
modalities predicting that this would occur, one of our previous
reports found that bundling SNF services into a single PPS payment
caused the use of therapy services to decrease.[Footnote 42] This
suggests that paying separately under Part B for these services could
possibly have the opposite effect and cause use to grow, which could
also cause the actual financial impact of this policy to exceed our
estimates. Similarly, MedPAC has reported that there are efficiency
gains from bundling payments.[Footnote 43] In addition, both we and
MedPAC have previously noted that bundling Medicare payments for
certain end-stage renal disease drugs together with other items for
this condition could improve efficiency by eliminating the financial
incentive to overuse separately billable drugs.[Footnote 44]
Furthermore, we have reported that the home health PPS, which involves
paying home health agencies a single bundled payment per 60-day episode
of care, provides strong financial incentives to reduce the cost of
providing home health care.[Footnote 45]
Paying separately under Part B for ultrasound exams and associated
equipment and ambulance transportation also would increase overall
Medicare payments for these services unless the additional Part B
expenditures were offset by payment reductions for other services.
Congress chose to do this on a previous occasion.[Footnote 46] Thus, if
Congress instituted separate Part B payments for ultrasound exams and
associated equipment and ambulance transportation during Part A-covered
SNF stays, these payments could possibly be made budget neutral by a
reduction in the Part A PPS payment. However, making this policy budget
neutral would require that the Part A PPS payment reduction account for
the potential of increased service use associated with unbundling
services.
Evidence and Variation in Federal Requirements Are Among Factors to
Consider in Determining Whether to Establish Credentialing or Other
Qualification Requirements for Sonographers:
Factors for CMS to consider in determining whether to establish
credentialing or other qualification requirements for sonographers
include findings about the value of credentialing from peer-reviewed
studies, MedPAC, and ultrasound-related organizations, coupled with
variation in federal requirements and lack of state requirements for
sonographers. Options available to CMS for promoting the quality of
ultrasound services include specifying sonographers' qualifications via
a National Coverage Determination (NCD), promulgating a regulation, and
offering a financial incentive for quality improvements through "pay
for performance" mechanisms.
Studies and Professional Organizations Suggest that Setting
Requirements for Sonographers' Qualifications Could Promote Quality:
Sonographer qualifications play an important role in the quality and
diagnostic usefulness of ultrasound procedures. Representatives from
ultrasound-related professional organizations described ultrasound
procedures as highly operator dependent. In addition, they noted that
the accuracy and diagnostic usefulness of the images captured depends
on the sonographer's skills and abilities. When conducting diagnostic
ultrasound procedures, the sonographer is responsible for obtaining
quality images of internal body parts to enable the physician to make
correct diagnoses of patients' diseases and medical conditions. Two
studies have shown that poor quality images can lead to misdiagnosis or
unnecessarily repeated exams.[Footnote 47] Representatives of some
ultrasound-related professional organizations that we interviewed noted
that the increased use of ultrasound procedures in clinical practice
and sophistication of the equipment have heightened the need for
sonographers to undergo formal training. Currently, about 50 to 60
percent of the sonographers have the appropriate credentials, according
to ARDMS estimates.
While studies that demonstrate the need for credentialing and
accreditation have been limited in number and scope, those that exist
seem to suggest that imposing credentialing or other qualifications on
sonographers can improve the accuracy of ultrasound
procedures.[Footnote 48] For example, two of the four relevant peer-
reviewed studies from our literature review found that the results of
noninvasive vascular ultrasound exams done by accredited facilities
were more accurate than those exams by nonaccredited
facilities.[Footnote 49] The authors of these studies emphasized the
importance of accurate ultrasound exams for clinical decisions that
vascular surgeons make about patient treatment.
Medicare experience with another type of imaging--mammography--also
suggests that establishing federal standards that include requirements
for personnel qualifications and facility accreditation could improve
quality.[Footnote 50] In contrast to diagnostic ultrasound procedures,
the Food and Drug Administration (FDA) established and enforces
national quality standards for mammography services, which appear to
have improved the quality of these procedures.[Footnote 51] Among other
provisions in these standards, FDA established qualifications and
continuing training requirements for mammography personnel, such as
radiological technologists who perform the examinations, and also
required facility accreditation.[Footnote 52] We previously reported
that these quality standards, in conjunction with state inspection
programs, have increased mammography facilities' adherence to accepted
quality assurance standards and improved the quality of X-ray
images.[Footnote 53]
Furthermore, MedPAC and various ultrasound-related professional
organizations with which we spoke support the implementation of a
Medicare policy establishing requirements for the qualifications of
sonographers. MedPAC recommended in 2005 that CMS "strongly consider"
establishing standards for providers that perform and bill for imaging
exams, which include diagnostic ultrasound procedures.[Footnote 54]
MedPAC noted that these standards should address the qualifications of
the performing technicians in addition to other aspects of imaging
procedures.[Footnote 55] In addition, representatives from 11
ultrasound-related professional organizations support establishing
requirements concerning sonographers' qualifications through
sonographer credentialing and facility accreditation. (See app. V for a
list of these organizations.) Of these 11 organizations, 4 are
ultrasound-related medical societies that do not credential
sonographers or accredit facilities that conduct ultrasound
procedures[Footnote 56] and the remaining 7 do.
Representatives from these organizations said that to conduct
diagnostic ultrasounds, sonographers need to be trained and have broad
knowledge, good judgment, and discretion. Representatives from the
Society for Vascular Surgery stated that, because some procedures were
done by inadequately trained technical staff or by facilities with
little or no quality control, there are a "disturbing number" of
patients who have (1) missed or delayed treatment of major health
issues or (2) undergone unnecessary treatment due to abnormal results
being classified normal or normal results being classified as abnormal.
An article in a peer-reviewed journal reported that 91 percent of
members of the Society for Vascular Ultrasound and the Society of
Diagnostic Medical Sonography agreed that adding requirements for
sonographer credentialing and facility accreditation would improve the
quality of vascular ultrasound procedures.[Footnote 57]
Some representatives of ultrasound equipment manufacturers and mobile
ultrasound providers we interviewed also generally support sonographer
credentialing. However, two of the manufacturer-related organizations
we contacted and one provider were concerned that requirements for
credentialing or accreditation could result in significant shortages of
sonographers. Representatives from these manufacturer-related
organizations noted that a phase-in period for establishing new
requirements for sonographers would help prevent any potential access
problems. Similarly, representatives of ultrasound-related professional
organizations that we interviewed emphasized the importance of a phase-
in period to allow time for sonographers to become credentialed.
Federal Requirements for Sonographers' Qualifications Vary and State
Requirements Are Absent:
Federal requirements relating to the qualifications of sonographers are
inconsistent. This variation calls into question whether all
sonographers paid by Medicare have appropriate and sufficient skills,
knowledge, and experience to serve beneficiaries. Variation in federal
requirements is also more of a concern because none of the states
require that sonographers register or obtain a license from the state
prior to providing ultrasound services, according to ultrasound-related
professional organizations. At the federal level, CMS has not developed
a national policy, such as an NCD, regarding the qualifications needed
by sonographers as a condition for payment of ultrasound services. In
the absence of an NCD for sonographers' qualifications, carriers have
established Local Coverage Determinations (LCD) for different types of
diagnostic ultrasound procedures.
Allowing carriers to develop their own LCDs has resulted in varying
Medicare requirements in different states for sonographers who perform
particular types of diagnostic ultrasound procedures.[Footnote 58] For
example, as of April 2007, carriers in 24 states and the District of
Columbia have established one or more LCDs that require that
noninvasive vascular diagnostic ultrasound procedures be performed by a
credentialed sonographer (one that has undergone a certification
process) or in an accredited facility that may require sonographers to
meet certain qualification requirements.[Footnote 59] Carriers'
rationale was that the quality of these ultrasound procedures depends
on the knowledge, skill, and experience of the sonographer. Carriers in
17 states have LCDs that recommend that noninvasive vascular diagnostic
ultrasound procedures be performed by a credentialed sonographer or in
an accredited facility. However, in the remaining 9 states, Medicare
carriers have not established requirements through an LCD specifying
the qualifications for sonographers who conduct noninvasive vascular
ultrasound procedures. (See fig. 3.) Regarding mandatory requirements,
a 2003 study that discussed reasons influencing a provider's decision
to obtain facility accreditation in vascular ultrasound cited a 1998
study that found that providers are more likely to seek facility
accreditation when it is required for Medicare payment.[Footnote 60]
The 2003 study noted that "alternatives that consider voluntary
compliance to ultrasound standards may be unsuccessful."[Footnote 61]
Figure 3: Medicare Carriers' Part B LCDs on Noninvasive Vascular
Diagnostic Ultrasound Procedures, as of April 2007:
[See PDF for image]
Source: GAO analysis of of carriers' Part B local coverage
determinations concerning noninvasive vascular diagnostic ultrasound
procedures and echocardiography.
[A] The Medicare carrier in Queens, N.Y., does not have an LCD that
includes a recommendation or requirement that noninvasive vascular
diagnostic ultrasound procedures be performed by a credentialed
sonographer or in an accredited laboratory.
[End of figure]
There is also variation in LCDs concerning diagnostic ultrasound
procedures used to diagnose heart and other conditions. While carriers
in 12 states had developed LCDs as of April 2007 that require that
these procedures be performed by a credentialed sonographer or in an
accredited laboratory and carriers in 4 states had LCDs that
recommended these types of qualifications for sonographers, the
remaining states and the District of Columbia have no such LCDs.
Finally, as of September 2006, carriers in 4 states had LCDs that
established qualification requirements for sonographers that perform
certain other diagnostic ultrasound procedures, such as abdominal and
pelvic ultrasound. However, there are no similar LCDs in the remaining
states and the District of Columbia.
Variations in Medicare requirements regarding sonographers'
qualifications also relate to the sites of service where diagnostic
ultrasound procedures are performed. For example, CMS has developed
standards for nonphysician personnel that could be applicable to
sonographers who perform diagnostic ultrasound procedures in
independent diagnostic testing facilities (IDTF), but has not done so
for physicians' offices. For IDTFs, CMS requirements specify that
nonphysician personnel, including sonographers, who perform diagnostic
ultrasound procedures, must demonstrate the basic qualifications to
perform those procedures and have appropriate training and proficiency.
To meet this requirement, in the absence of a state licensing board,
sonographers must be credentialed by an appropriate national
credentialing body.[Footnote 62] Furthermore, the IDTF must maintain
documentation available for review that Medicare credentialing
requirements are being met.
Although there are no Medicare standards specifically related to the
qualifications of sonographers working in hospitals, Medicare providers
need to abide by the relevant Medicare Conditions of Participation
(CoP), some of which appear to be applicable to the performance of
ultrasound procedures.[Footnote 63] There are CoP provisions that
include specific standards for medical staff and for
radiology,[Footnote 64] nuclear medicine, and outpatient services.
According to the Medicare CoP for medical staff, hospitals are
responsible for the quality of medical care provided to patients and
must examine the qualifications and credentials of applicants for
medical staff positions. If the hospital provides outpatient services,
the CoP also requires that services must meet the needs of the patients
in "accordance with acceptable standards of practice." Further,
hospital outpatient departments are required to have appropriate
professional and nonprofessional personnel available. In 2003, over 80
percent of hospitals met the applicable conditions of participation
through accreditation from the Joint Commission on Accreditation of
Healthcare Organizations (Joint Commission)--a nonprofit organization
created to provide voluntary health care accreditation for
hospitals.[Footnote 65]
In contrast to IDTFs and hospitals, there are no Medicare standards
that apply specifically to diagnostic ultrasound procedures conducted
in physicians' offices aside from those relating to the level of
physician supervision required. The absence of qualification standards
for sonographers working in physicians' offices is of particular
interest given MedPAC and the Lewin Group's findings that there has
been an increasing movement of imaging services, including ultrasound,
from hospitals to physicians' offices.[Footnote 66]
CMS Has Several Implementation Options:
Several options are available to CMS for promoting the quality of
diagnostic ultrasound procedures. Maintaining the status quo certainly
imposes the least administrative burden and additional costs. However,
this approach will not address the inconsistencies in requirements for
sonographers' qualifications. We present three options for promoting
the quality of ultrasound procedures, with associated potential
benefits and challenges.
One option would be to develop an NCD requiring that sonographers
either be credentialed or work in an accredited facility. Because NCDs
apply to all Medicare beneficiaries regardless of their treatment
locations, an NCD would provide a more consistent level of assurance as
to the qualifications of sonographers performing diagnostic ultrasound
procedures. However, under the NCD option, CMS indicated it would have
to implement the sonographer qualification requirements immediately
rather than gradually over a period of time, according to a CMS
official.[Footnote 67] This time constraint could be problematic given
that representatives of various ultrasound-related societies and
organizations we interviewed generally suggested a phase-in period of 2
or more years to allow noncredentialed sonographers time to comply with
the newly imposed requirements. Finally, establishing an NCD could be
difficult, according to the CMS official, if it limited access to
services for some beneficiaries, such as for those that lived in
locations where no credentialed sonographer was readily available.
A second option would be to issue a regulation that establishes a
requirement that sonographers either be credentialed or work in an
accredited facility as a condition for Medicare payment. Such a
regulation could be phased in over 2 or more years, which as noted by
representatives of ultrasound-related professional organizations we
interviewed, would allow noncredentialed sonographers time to comply
with this requirement. A CMS official noted that the regulatory process
would allow CMS to use a phase-in period for establishing such a
requirement but that developing regulations can be burdensome and time
consuming for CMS.
A third option would be for CMS to explore the possibility of "paying
for performance" to encourage quality in the provision of diagnostic
ultrasound procedures. CMS has recognized that the current Medicare
reimbursement structure does not target resources to support specific
efforts to provide the highest quality care. To address this
shortcoming, CMS has initiated a number of demonstration and pilot
projects, several required by Congress under statute, aimed at
encouraging quality care and designed to lay the groundwork for pay-
for-performance systems in the future.[Footnote 68] However, these pay-
for-performance efforts are in the early stages of development, and
none of them is focused on imaging services or diagnostic ultrasound
procedures. A CMS official and representatives of various ultrasound-
related professional organizations told us that it is difficult to
develop clear and valid quality measures that could be applied to the
performance of sonographers that conduct diagnostic ultrasound
procedures.
Conclusions:
We did not find compelling clinical or financial evidence in favor of
providing Part B payments for ultrasound equipment transportation in
addition to those for the exams themselves, for beneficiaries in
noncovered SNF stays. While testimonial evidence suggests that there
may be benefits of performing ultrasound exams in SNFs for some
beneficiaries as opposed to transporting them to other locations, we
could not locate any studies documenting this. Furthermore, our
analysis suggests that Part B payments for ultrasound equipment
transportation could increase Medicare expenditures and beneficiary
cost sharing. In addition, paying separately under Part B for
ultrasound exams and associated equipment and ambulance transportation
during Part A-covered SNF stays would undermine the financial incentive
of the PPS for SNFs to deliver these services efficiently. Paying
separately under Part B for these services would also increase overall
Medicare expenditures unless Congress made these additional Part B
payments budget-neutral by reducing the Part A PPS payment.
As a national program affecting over 42 million beneficiaries, Medicare
has a responsibility to ensure that the services it covers are of
consistently high quality. Our findings from peer-reviewed studies and
MedPAC and ultrasound-related professional organizations, coupled with
our analysis of the variation in current requirements for sonographers,
suggest that establishing requirements for sonographers' qualifications
could improve the quality of ultrasound procedures. Maintaining the
status quo of allowing Medicare carriers to have different requirements
for sonographer qualifications in different states undermines the
assurance that beneficiaries are receiving consistently high-quality
services. CMS has several available implementation options including
developing a National Coverage Determination and promulgating
regulations.
Recommendation for Executive Action:
We recommend that the Administrator of CMS require that sonographers
paid by Medicare either be credentialed or work in an accredited
facility. The Administrator should weigh the advantages and
disadvantages of implementing a National Coverage Determination
compared with promulgating regulations that this requirement be a
condition for Medicare payment.
Agency Comments and Our Evaluation:
In written comments on a draft of this report, CMS stated that while it
would consider our recommendation to require that sonographers
furnishing services to Medicare beneficiaries either be credentialed or
work in an accredited facility, it would rather have states engage
their own licensing bodies in implementing sonographer licensure
programs that address competency and qualification issues. We reprinted
CMS's written comments in appendix VI.
CMS characterized our recommendation as providing two options--issuing
an NCD or promulgating a regulation establishing sonographer
qualifications as a Condition of Participation--and stated that these
options do not provide the most effective mechanism for addressing
sonographer quality. We noted in our report that issuing a regulation
was an option for CMS. However, we did not specify that this regulation
apply only to ultrasound services furnished in or by providers that are
subject to Conditions of Participation (generally, institutional
providers, such as hospitals) because we believe it is important that
sonographer qualification requirements apply to all sonographers,
regardless of the setting in which they provide the service, including
physicians' offices. CMS agreed with our finding that sonographer
qualification requirements vary but stated that a national policy would
not take into account regional variation in factors such as access to
care and state licensing requirements. We agree that access is an
important issue when considering whether to implement an NCD or a
regulation, and we pointed out that such a regulation could include a
phase-in period to provide noncredentialed sonographers with time to
comply with the newly imposed requirements. Furthermore, although CMS
asserted that states should engage their own licensure bodies to
implement sonographer licensure programs, we reported that state
licensing requirements for sonographers do not exist. Consequently, we
continue to believe that CMS should implement our recommendation and
develop a national policy establishing sonographer qualification
requirements. Such requirements, that sonographers paid by Medicare
either be credentialed or work in an accredited facility, would help to
promote the quality of ultrasound procedures across states and sites of
service where consistent policy is currently lacking.
CMS agreed with our conclusion that paying separately under Part B for
ultrasound exams and associated equipment and ambulance transportation
would undermine the financial incentive for SNFs to deliver these
services efficiently. CMS further noted that paying separately for
ultrasound exams could potentially lead to doing so for other services
and lead to the "unraveling" of the SNF PPS bundle.
We are sending copies of this report to the Administrator of CMS,
appropriate congressional committees, and other interested parties. We
will also provide copies to others on request. In addition, this report
is available at no charge on the GAO Web site at http://www.gao.gov.
If you or your staff have questions about this report, please contact
me at (202) 512-7114 or steinwalda@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff members who made contributions
to this report are listed in appendix VII.
Signed by:
A. Bruce Steinwald:
Director, Health Care:
[End of section]
Appendix I: Scope and Methodology:
This appendix explains the methodology that we used to address our
reporting objectives on (1) the types of ultrasound procedures commonly
used to diagnose medical conditions of Medicare beneficiaries,
particularly those in skilled nursing facilities (SNF); (2) the
financial impact of changing how Medicare pays for ultrasound exams and
associated equipment and ambulance transportation for beneficiaries
receiving care in a SNF; and (3) the factors to consider in determining
whether the Centers for Medicare & Medicaid Services (CMS) should
establish credentialing or other qualification requirements for
sonographers that provide diagnostic ultrasound procedures.
Types of Ultrasound Procedures Provided to Beneficiaries:
To examine the types of diagnostic ultrasound procedures provided to
Medicare beneficiaries, medical conditions that were diagnosed, and
sites of service where these procedures were performed, we analyzed
Medicare claims for ultrasound procedures paid under Part B in 2005.
These data came from the National Claims History (NCH) carrier file and
the Standard Analytical File (SAF) outpatient claims files. We based
our analysis of the types of procedures on claims for physicians'
interpretations of ultrasound exams, which account for procedures
provided to all beneficiaries because all physicians' interpretations
of ultrasound exams are paid under Part B, regardless of whether the
exam itself was paid under Part A or Part B.[Footnote 69] We based our
analysis of the site of service of ultrasound procedures on claims for
ultrasound exams that were paid under Part B.[Footnote 70] Therefore,
our site of service analysis does not cover exams for beneficiaries in
Part A-covered SNF and hospital inpatient stays because Part A payment
for these exams is bundled with other services and thus not separately
reported in claims data.
To identify the specific diagnostic ultrasound procedures to analyze,
we performed several steps. We began by developing a list of all the
relevant diagnostic ultrasound procedures using information from the
2005 American Medical Association (AMA) Current Procedural Terminology
(CPT) guide, and interviews with a credentialed sonographer with
particular expertise in ultrasound coding and billing issues, and CMS
officials, as well as documents provided during these interviews. We
also reviewed the CMS Berenson-Eggers Type of Service (BETOS) codes,
which categorize Healthcare Common Procedure Coding System (HCPCS)
codes into clinically relevant categories.[Footnote 71] For this
report, we selected 94 HCPCS codes in the BETOS categories for
echography, which is a synonym for ultrasound.[Footnote 72] We then
supplemented these 94 codes with 10 additional ones that we identified
based on our review of codes in the AMA CPT Guide for 2005. The 104
total HCPCS codes we selected accounted for approximately 99 percent of
all Medicare Part B payments for diagnostic ultrasound procedures in
2005.[Footnote 73]
To analyze sites of service where ultrasound procedures were performed,
we used Medicare data from the 2005 NCH carrier and SAF outpatient
claims files. In addition, we used data and reviewed regulations from
CMS on the appropriate level of physician supervision for each
ultrasound procedure to examine how supervision levels varied across
sites of service.[Footnote 74]
To examine clinical considerations associated with site of service and
to supplement our data analysis on the medical conditions, we conducted
a literature search and structured interviews with representatives of
gerontological, radiological, and ultrasound-related professional
organizations. Key search terms included transition of care, which
involves moving the beneficiary from the SNF to another facility for
the purpose of performing an ultrasound procedure; transfer trauma;
patient transfers; and risks and morbidity associated with the movement
of elderly persons to different settings. For the structured
interviews, we contacted representatives from the American Geriatrics
Society, the American Medical Directors Association, the American
College of Radiology, the American Society of Echocardiography, the
Society for Vascular Surgery, and the Society for Vascular Ultrasound.
In addition, we interviewed four mobile ultrasound providers that
provide services to SNFs or nursing homes and representatives from the
National Association for the Support of Long-Term Care and the American
Association of Homes and Services for the Aging. We also conducted
structured interviews with SNF directors of nursing in states selected
based on criteria including their ultrasound use level per
beneficiary.[Footnote 75]
Financial Impact of Changing Payment Methods:
We estimated the financial impact of two changes in Medicare payment
methodology for ultrasound exams and associated equipment and ambulance
transportation for beneficiaries receiving care in a SNF. The first
change we addressed was to make payments to transport and set up
ultrasound equipment for exams conducted in SNFs during noncovered SNF
stays, which is not currently done. The second change involved paying
separately under Part B for ultrasound exams and associated equipment
and ambulance transportation during Part A-covered SNF stays.
Paying to Transport and Set Up Ultrasound Equipment:
To estimate the financial impact of this potential change, we used
Medicare Part B claims data for 2005 for ultrasound exams and ambulance
services from the NCH carrier and SAF outpatient files. Based on these
data, we (1) identified the number of exams conducted in SNFs during
noncovered SNF stays, in beneficiaries' homes, or in custodial care or
assisted living facilities,[Footnote 76] (2) determined the number of
beneficiary days on which these exams were conducted,[Footnote 77] and
(3) multiplied the number of beneficiary days by our estimate of the
average Medicare payment and beneficiary cost sharing for ultrasound
equipment transportation, both including and excluding the equipment
set-up fee, in the Medicare locality where the claim was
processed.[Footnote 78] Through these steps, we estimated how the
expenditures of Medicare and its beneficiaries would have differed if
Medicare had paid to transport and set up ultrasound equipment in 2005,
assuming that the number and location of exams would not have changed
in response to this policy. (See app. III, table 7.)
To gain insight into how Medicare payments to transport and set up
ultrasound equipment would affect the number of ultrasound exams in
SNFs during noncovered SNF stays, we used information from interviews
and two types of analyses. First, we interviewed representatives of
four mobile ultrasound providers. Second, we analyzed Part B claims
data from the Part B Extract Summary System for 1995, when Medicare
contractors in some states paid to transport and set up ultrasound
equipment, and 1997, when these payments were no longer
provided.[Footnote 79] We compared the change between 1995 and 1997 in
the number of ultrasound exams conducted in SNFs in 14 states that
provided these payments in 1995 to the same measure in the remaining
states that did not provide such payments.[Footnote 80] (See app. III,
table 8.) Third, we analyzed Part B claims data for ambulance services
that appear to have been used in conjunction with ultrasound exams.
If there was a decline in the number of ultrasound exams in SNFs during
noncovered SNF stays in response to Medicare payments to transport and
set up ultrasound equipment, it could cause the site of service of some
exams to shift from these locations to other sites of service (such as
a hospital outpatient facility). To determine whether this change in
site of service would increase or decrease our impact estimates for
paying to transport and set up ultrasound equipment, we accounted for
how this change would affect Medicare expenditures and beneficiary cost
sharing for (1) ambulance transportation,[Footnote 81] (2) the
transportation and set up of ultrasound equipment, and (3) the
ultrasound exam.
Some ultrasound exams conducted during noncovered SNF stays may require
ambulance services to transport the beneficiary to another location,
such as a hospital outpatient facility, for the exam. To estimate how
Medicare payments and beneficiary cost sharing would have differed in
2005 if these exams had instead been conducted in SNFs during
noncovered SNF stays,[Footnote 82] we first identified ambulance trips
used to transport these beneficiaries from SNFs to another location for
an ultrasound procedure.[Footnote 83] We then calculated how Medicare
payments and beneficiary cost sharing for the ultrasound exam and
associated transportation would have differed if, rather than
transporting the beneficiary via ambulance to another location,
ultrasound equipment had been transported to the SNF for the exam. To
estimate how conducting the exam in a SNF during a noncovered SNF stay
rather than in another location would have affected Medicare payments
and beneficiary cost sharing for transportation, we (1) calculated the
number of beneficiary days on which these exams occurred, (2)
determined the savings to Medicare and its beneficiaries per
beneficiary day if, instead of transporting a beneficiary via ambulance
to another location, ultrasound equipment were transported to the
beneficiary for the exam, by subtracting our estimate of the ultrasound
equipment transportation payment and cost-sharing amounts for each
beneficiary day from the actual payment for ambulance services, and (3)
multiplied this difference by the number of beneficiary days. To
estimate the savings to Medicare and its beneficiaries for the exam
itself, we subtracted the cost of conducting all of these exams in a
SNF during noncovered SNF stays from the actual cost of these exams.
The key limitation of our analysis of the financial impact of paying to
transport and set up ultrasound equipment involves the accuracy of our
assumption that this policy would not affect the number and location of
ultrasound exams in SNFs during noncovered SNF stays. Therefore, to
address the possibility that this policy change could affect ultrasound
service use, we analyzed how such a change could affect our impact
estimates.
Paying Separately under Part B for Ultrasound Exams and Related
Transportation during Part A-Covered SNF Stays:
To estimate the financial impact of paying separately under Part B for
ultrasound exams and associated equipment and ambulance transportation
during Part A-covered SNF stays, we analyzed claims for ultrasound
exams and physicians' interpretations of them for beneficiaries in Part
A-covered SNF stays from Medicare Part B claims data for 2005 from the
NCH carrier file and the SAF outpatient claims files. We first counted
the number of physicians' interpretations of ultrasound exams that were
conducted during Part A-covered SNF stays in 2005. We merged Part B
claims for physicians' interpretations of ultrasound exams in 2005 with
SNF claims for the same year to determine which interpretations
occurred during Part A-covered SNF stays. We then multiplied the number
of physician interpretations of each exam by the average Medicare
payment and beneficiary cost-sharing amounts for the corresponding
exam.[Footnote 84]
Ultrasound exams and other services are bundled into the SNF
prospective payment system (PPS) rate for beneficiaries in Part A-
covered SNF stays, so Medicare should not pay separately under Part B
for these exams. However, we identified claims for up to 33,000
ultrasound exams conducted during Part A-covered SNF stays as having
been improperly billed.[Footnote 85] Medicare paid approximately $2.6
million for these exams, and beneficiaries paid about $1.5 million. If
Medicare contractors did not recoup all of these improper payments as
they are required to, then our estimate of the financial impact of
paying separately under Part B for ultrasound exams would be overstated
because Medicare would have already been paying separately under Part B
for some of these exams in the absence of this policy. However, because
data for improperly paid claims do not indicate whether the payments
were recouped, we were unable to accurately estimate the extent to
which these improper payments affect our estimates.[Footnote 86]
To estimate the financial impact of paying separately under Part B for
ultrasound equipment transportation for beneficiaries in Part A-covered
SNF stays, we first estimated the number of ultrasound exams conducted
in SNFs, as opposed to other sites of service, for these beneficiaries
in 2005. To do so, we multiplied the number of physician
interpretations of exams for these beneficiaries in that year by the
proportion of all ultrasound exams for the same population in 1997 that
were conducted in SNFs. We converted this estimate of the number of
exams done in SNFs for these beneficiaries into the number of
beneficiary days to indicate how many equipment transportation and set-
up fees Medicare would have paid.[Footnote 87] To calculate the
financial impact on Medicare payments, we added the product of (1) the
number of beneficiary days and the average estimated equipment
transportation fee and (2) the number of exams and estimated average of
the equipment set-up fee. To calculate the financial impact on
beneficiary cost sharing, we added the product of (1) the number of
beneficiary days and the average estimated cost sharing for equipment
transportation and (2) the number of exams and average estimated
equipment transportation fee.[Footnote 88]
We used a similar process to estimate the financial impact of separate
Part B payments for ambulance services used during Part A-covered SNF
stays to transport beneficiaries from a SNF to another location for an
ultrasound exam and back. We (1) estimated the number of ultrasound
exams for beneficiaries in Part A-covered SNF stays in 2005 that
involved ambulance transportation, by multiplying the number of
physician interpretations of exams for these beneficiaries in that year
by the proportion of exams for the same population in 1997 that
involved ambulance transportation; (2) converted this estimate of the
number of exams involving ambulance transportation into the number of
beneficiary days to indicate how many ambulance round trips Medicare
would have paid;[Footnote 89] and (3) multiplied the number of
beneficiary days by the average cost to Medicare and a beneficiary of
an ambulance round trip. We also did a literature search to locate
studies addressing the effect of the SNF PPS on the use of ultrasound
and certain other imaging services. Key search terms included Medicare,
skilled nursing facility, prospective payment system, ultrasound,
imaging, X-ray, computed tomography, magnetic resonance imaging, and
angiography.
Our analysis of the financial impact of paying separately under Part B
for ultrasound exams and related transportation has two key
limitations. First, because more recent information was unavailable, we
used 1997 data to estimate the number of ultrasound exams conducted in
SNFs or that involved ambulance transportation.[Footnote 90] Therefore,
the precision of estimates of the financial impact of paying separately
under Part B for these services is limited by the accuracy with which
the results based on the 1997 data we used would have been similar if
2005 data had been available. In addition, the financial impact
estimates we present are based on the assumption that service use would
not change in response to this policy. To address the possibility that
a policy of paying separately for services, as opposed to bundling
payment for them, would affect the use of services, we (1) summarized
studies we found that addressed how bundling payment for services can
affect their use and (2) conducted a literature search to identify
studies addressing how the use of certain imaging, and specifically
ultrasound, services changed in response to the SNF PPS.
Factors to Consider Concerning Sonographer Qualification Requirements:
To identify factors to consider in determining whether CMS should
establish credentialing or other qualification requirements for
sonographers, we reviewed applicable Medicare regulations and CMS
documents on Medicare coverage policies, including Medicare National
Coverage Determinations. In addition, we reviewed Medicare carriers'
Local Coverage Determinations (LCD) related to the qualification
requirements for sonographers that perform echocardiograms, noninvasive
vascular ultrasounds, and other diagnostic ultrasounds, such as
abdominal and pelvic ultrasounds. To identify these coverage policies,
we conducted searches in CMS's Medicare Coverage Database for draft and
final LCDs related to echocardiograms and noninvasive vascular
ultrasounds as of April 2007 for each Medicare carrier. We also
conducted a search in CMS's Medicare Coverage Database for LCDs related
to other diagnostic ultrasounds as of September 2006.
In addition, we interviewed CMS and Medicare Payment Advisory
Commission officials and representatives from national organizations
that award credentials in sonography or accredit facilities that
perform ultrasound procedures, and reviewed documents that they
provided to us. These organizations included the American Registry for
Diagnostic Medical Sonography, the Intersocietal Accreditation
Commission,[Footnote 91] the American Institute of Ultrasound in
Medicine, Cardiovascular Credentialing International, and the American
College of Radiology. Finally, we conducted a literature search and
reviewed relevant studies in peer-reviewed journals.
Data Reliability:
Medicare claims data, which are used by the Medicare program as a
record of payments made to health care providers, are monitored by CMS.
The data are subject to various checks and edits. Although we did not
review these checks and edits, we assessed the reliability of the NCH
data, which include all claims data analyzed for this report. We found
the data sufficiently reliable for purposes of this report.
We performed our work from July 2006 through May 2007 in accordance
with generally accepted government auditing standards.
[End of section]
Appendix II: Ultrasound Procedures and Medicare Part B Payments in
2005:
This appendix contains information on the number of ultrasound
procedures provided to Medicare beneficiaries in 2005 by site of
service and the level of physician supervision required to administer
the procedures. (See table 4.) This appendix also includes data on the
five top medical conditions diagnosed by type of ultrasound procedures
provided to Medicare beneficiaries overall and to those in SNF stays in
2005 that were not covered by Medicare. (See tables 5 and 6.)
Table 4: Number of Ultrasound Procedures Provided to Medicare
Beneficiaries by Site of Service and Level of Physician Supervision
Required, 2005:
Type of ultrasound procedure: Noninvasive vascular;
Level of physician supervision required: Subtotal: General;
Number of procedures[A]: Subtotal: 6,347,815;
Site of service: Physician's office: Subtotal: 3,821,749;
Site of service: Hospital outpatient department: Subtotal: 2,376,169;
Site of service: Skilled nursing facility[B]: Subtotal: 69,704;
Site of service: Other[C]: Subtotal: 80,193.
Type of ultrasound procedure: Subtotal;
Level of physician supervision required: [Empty];
Number of procedures[A]: 6,347,815;
Site of service: Physician's office: 3,821,749;
Site of service: Hospital outpatient department: 2,376,169;
Site of service: Skilled nursing facility[B]: 69,704;
Site of service: Other[C]: 80,193.
Type of ultrasound procedure: Echocardiograms;
Level of physician supervision required: General;
Number of procedures[A]: 12,698,357;
Site of service: Physician's office: 9,517,262;
Site of service: Hospital outpatient department: 3,065,385;
Site of service: Skilled nursing facility[B]: 28,655;
Site of service: Other[C]: 87,055.
Type of ultrasound procedure: Echocardiograms;
Level of physician supervision required: Direct;
Number of procedures[A]: 421,801;
Site of service: Physician's office: 276,498;
Site of service: Hospital outpatient department: 145,051;
Site of service: Skilled nursing facility[B]: 6;
Site of service: Other[C]: 246.
Type of ultrasound procedure: Echocardiograms;
Level of physician supervision required: Personal;
Number of procedures[A]: 77,040;
Site of service: Physician's office: 3,507;
Site of service: Hospital outpatient department: 51,842;
Site of service: Skilled nursing facility[B]: 30;
Site of service: Other[C]: 21,661.
Type of ultrasound procedure: Echocardiograms;
Level of physician supervision required: Subtotal: N/A[D];
Number of procedures[A]: Subtotal: 1,008;
Site of service: Physician's office: Subtotal: 5;
Site of service: Hospital outpatient department: Subtotal: 1,003;
Site of service: Skilled nursing facility[B]: Subtotal: 0;
Site of service: Other[C]: Subtotal: 0.
Type of ultrasound procedure: Echocardiograms;
Subtotal;
Level of physician supervision required: [Empty];
Number of procedures[A]: 13,198,206;
Site of service: Physician's office: 9,797,272;
Site of service: Hospital outpatient department: 3,263,281;
Site of service: Skilled nursing facility[B]: 28,691;
Site of service: Other[C]: 108,962.
Type of ultrasound procedure: Abdomen and pelvis;
Level of physician supervision required: General;
Number of procedures[A]: 3,579,463;
Site of service: Physician's office: 1,848,590;
Site of service: Hospital outpatient department: 1,685,573;
Site of service: Skilled nursing facility[B]: 21,882;
Site of service: Other[C]: 23,418.
Type of ultrasound procedure: Abdomen and pelvis;
Level of physician supervision required: Subtotal: Personal;
Number of procedures[A]: Subtotal: 24,523;
Site of service: Physician's office: Subtotal: 13,489;
Site of service: Hospital outpatient department: Subtotal: 10,924;
Site of service: Skilled nursing facility[B]: Subtotal: 0;
Site of service: Other[C]: Subtotal: 110.
Type of ultrasound procedure: Abdomen and pelvis;
Subtotal;
Level of physician supervision required: [Empty];
Number of procedures[A]: 3,603,986;
Site of service: Physician's office: 1,862,079;
Site of service: Hospital outpatient department: 1,696,497;
Site of service: Skilled nursing facility[B]: 21,882;
Site of service: Other[C]: 23,528.
Type of ultrasound procedure: Head, neck, and chest;
Level of physician supervision required: General;
Number of procedures[A]: 1,907,810;
Site of service: Physician's office: 1,295,574;
Site of service: Hospital outpatient department: 603,117;
Site of service: Skilled nursing facility[B]: 1,853;
Site of service: Other[C]: 7,266.
Type of ultrasound procedure: Head, neck, and chest;
Level of physician supervision required: Subtotal: Direct;
Number of procedures[A]: Subtotal: 148,023;
Site of service: Physician's office: Subtotal: 135,164;
Site of service: Hospital outpatient department: Subtotal: 11,784;
Site of service: Skilled nursing facility[B]: Subtotal: 729;
Site of service: Other[C]: Subtotal: 346.
Type of ultrasound procedure: Head, neck, and chest;
Subtotal;
Level of physician supervision required: [Empty];
Number of procedures[A]: 2,055,833;
Site of service: Physician's office: 1,430,738;
Site of service: Hospital outpatient department: 614,901;
Site of service: Skilled nursing facility[B]: 2,582;
Site of service: Other[C]: 7,612.
Type of ultrasound procedure: Ultrasonic guidance;
Level of physician supervision required: General;
Number of procedures[A]: 454,230;
Site of service: Physician's office: 248,076;
Site of service: Hospital outpatient department: 199,252;
Site of service: Skilled nursing facility[B]: 0;
Site of service: Other[C]: 6,902.
Type of ultrasound procedure: Ultrasonic guidance;
Level of physician supervision required: Personal;
Number of procedures[A]: 530,948;
Site of service: Physician's office: 273,706;
Site of service: Hospital outpatient department: 249,159;
Site of service: Skilled nursing facility[B]: 7;
Site of service: Other[C]: 8,076.
Level of physician supervision required: N/A[D];
Number of procedures[A]: Subtotal: 18,042;
Site of service: Physician's office: Subtotal: 34;
Site of service: Hospital outpatient department: Subtotal: 16,704;
Site of service: Skilled nursing facility[B]: Subtotal: 0;
Site of service: Other[C]: Subtotal: 1,304.
Type of ultrasound procedure: Subtotal;
Level of physician supervision required: [Empty];
Number of procedures[A]: 1,003,220;
Site of service: Physician's office: 521,816;
Site of service: Hospital outpatient department: 465,115;
Site of service: Skilled nursing facility[B]: 7;
Site of service: Other[C]: 16,282.
Type of ultrasound procedure: Other diagnostic ultrasound;
Level of physician supervision required: General;
Number of procedures[A]: 538,598;
Site of service: Physician's office: 414,036;
Site of service: Hospital outpatient department: 115,241;
Site of service: Skilled nursing facility[B]: 1,300;
Site of service: Other[C]: 8,021.
Type of ultrasound procedure: Other diagnostic ultrasound;
Level of physician supervision required: Direct;
Number of procedures[A]: 21,220;
Site of service: Physician's office: 10,857;
Site of service: Hospital outpatient department: 10,051;
Site of service: Skilled nursing facility[B]: 0;
Site of service: Other[C]: 312.
Type of ultrasound procedure: Other diagnostic ultrasound;
Level of physician supervision required: Personal;
Number of procedures[A]: 18,959;
Site of service: Physician's office: 2,661;
Site of service: Hospital outpatient department: 16,113;
Site of service: Skilled nursing facility[B]: 0;
Site of service: Other[C]: 185.
Type of ultrasound procedure: Other diagnostic ultrasound;
Level of physician supervision required: N/A[D];
Number of procedures[A]: 1,440,976;
Site of service: Physician's office: 1,319,944;
Site of service: Hospital outpatient department: 102,963;
Site of service: Skilled nursing facility[B]: 7,230;
Site of service: Other[C]: Subtotal: 10,839.
Type of ultrasound procedure: Other diagnostic ultrasound;
Subtotal;
Level of physician supervision required: [Empty];
Number of procedures[A]: 2,019,753;
Site of service: Physician's office: 1,747,498;
Site of service: Hospital outpatient department: 244,368;
Site of service: Skilled nursing facility[B]: 8,530;
Site of service: Other[C]: 19,357.
Total number of all procedures provided to beneficiaries;
Level of physician supervision required: [Empty];
Number of procedures[A]: 28,228,813;
Site of service: Physician's office: 19,181,152;
Site of service: Hospital outpatient department: 8,660,331;
Site of service: Skilled nursing facility[B]: 131,396;
Site of service: Other[C]: 255,934.
Source: GAO analysis of Medicare claims data for 2005 and Medicare
regulations and policy guidance on the level of physician supervision
required for diagnostic tests.
Notes: General supervision level means that the procedure is furnished
under the physician's overall direction and control, but physician
presence is not required during the performance of the procedure. This
is the minimal level required for all diagnostic tests payable under
the physician fee schedule, unless there are specific exceptions by
regulation. Direct supervision means that the physician does not have
to be present in the room when the procedure is performed, but the
physician must be in the suite and be immediately available to furnish
assistance throughout the procedure. Personal supervision means that
the physician must be in attendance in the room during the performance
of the procedure.
[A] The number of procedures is based on claims for ultrasound exams
paid and claims for ultrasound procedures classified solely as
physician services that do not include a separately billed exam and
physician's interpretation of it.
[B] We counted the number of exams in skilled nursing facilities and
nursing facilities.
[C] Other includes (but is not limited to) home, independent
laboratory, inpatient hospital, ambulatory surgical center, and
emergency room.
[D] N/A means not applicable.
[End of table]
Table 5: Top Five Medical Conditions Diagnosed by Type of Ultrasound
Procedure Provided to Medicare Beneficiaries under Medicare Part B,
2005:
Type of ultrasound procedure: Noninvasive vascular.
Top five medical conditions diagnosed: Occlusion and stenosis of
precerebral arteries;
Number of procedures: 1,661,280;
Percentage within procedure type: 20.
Top five medical conditions diagnosed: Other disorders of soft tissue;
Number of procedures: 1,603,593;
Percentage within procedure type: 19.
Top five medical conditions diagnosed: Atherosclerosis;
Number of procedures: 737,405;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Other peripheral vascular
diseases;
Number of procedures: 728,566;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Cardiovascular system problems;
Number of procedures: 541,018;
Percentage within procedure type: 6.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 5,271,862;
Percentage within procedure type: 63.
Top five medical conditions diagnosed: Other noninvasive vascular;
Number of procedures: 3,086,800;
Percentage within procedure type: 37.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 8,358,662;
Percentage within procedure type: 100.
Type of ultrasound procedure: Echocardiogram.
Top five medical conditions diagnosed: Other diseases of endocardium;
Number of procedures: 5,740,723;
Percentage within procedure type: 26.
Top five medical conditions diagnosed: Symptoms involving respiratory
system and other chest symptoms;
Number of procedures: 2,655,795;
Percentage within procedure type: 12.
Top five medical conditions diagnosed: Other forms of chronic ischemic
heart disease;
Number of procedures: 2,058,896;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Heart failure;
Number of procedures: 2,054,101;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Cardiac dysrhythmias;
Number of procedures: 1,375,924;
Percentage within procedure type: 6.
Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 13,885,439;
Percentage within procedure type: 64.
Top five medical conditions diagnosed: Other echocardiograms;
Number of procedures: 7,947,756;
Percentage within procedure type: 36.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 21,833,195;
Percentage within procedure type: 100.
Type of ultrasound procedure: Abdomen and pelvis.
Top five medical conditions diagnosed: Other symptoms involving abdomen
and pelvis;
Number of procedures: 1,340,438;
Percentage within procedure type: 27.
Top five medical conditions diagnosed: Other disorders of kidney and
ureter;
Number of procedures: 462,420;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Other disorders of urethra and
urinary tract;
Number of procedures: 263,473;
Percentage within procedure type: 5.
Top five medical conditions diagnosed: Cholelithiasis;
Number of procedures: 242,872;
Percentage within procedure type: 5.
Top five medical conditions diagnosed: Symptoms involving urinary
system;
Number of procedures: 194,177;
Percentage within procedure type: 4.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 2,503,380;
Percentage within procedure type: 51.
Top five medical conditions diagnosed: Other abdomen and pelvis;
Number of procedures: 2,425,031;
Percentage within procedure type: 49.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 4,928,411;
Percentage within procedure type: 100.
Type of ultrasound procedure: Head, neck, and, chest.
Top five medical conditions diagnosed: Cataract;
Number of procedures: 1,176,137;
Percentage within procedure type: 49.
Top five medical conditions diagnosed: Other disorders of breast;
Number of procedures: 386,908;
Percentage within procedure type: 16.
Top five medical conditions diagnosed: Nontoxic nodular goiter;
Number of procedures: 162,762;
Percentage within procedure type: 7.
Top five medical conditions diagnosed: Nonspecific abnormal findings on
radiological and other examinations of body structure;
Number of procedures: 146,047;
Percentage within procedure type: 6.
Top five medical conditions diagnosed: Benign mammary dysplasias;
Number of procedures: 103,954;
Percentage within procedure type: 4.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 1,975,808;
Percentage within procedure type: 82.
Top five medical conditions diagnosed: Other head, neck, chest;
Number of procedures: 438,042;
Percentage within procedure type: 18.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 2,413,850;
Percentage within procedure type: 100.
Type of ultrasound procedure: Ultrasonic guidance.
Top five medical conditions diagnosed: Malignant neoplasm of prostate;
Number of procedures: 229,242;
Percentage within procedure type: 18.
Top five medical conditions diagnosed: Nonspecific findings on
examination of blood;
Number of procedures: 150,046;
Percentage within procedure type: 12.
Top five medical conditions diagnosed: Other and unspecified aftercare;
Number of procedures: 120,019;
Percentage within procedure type: 10.
Top five medical conditions diagnosed: Pleurisy;
Number of procedures: 104,175;
Percentage within procedure type: 8.
Top five medical conditions diagnosed: Other symptoms involving abdomen
and pelvis;
Number of procedures: 84,506;
Percentage within procedure type: 7.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 687,988;
Percentage within procedure type: 55.
Top five medical conditions diagnosed: Other ultrasonic guidance;
Number of procedures: 552,716;
Percentage within procedure type: 45.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 1,240,704;
Percentage within procedure type: 100.
Type of ultrasound procedure: Other diagnostic ultrasounds.
Top five medical conditions diagnosed: Symptoms involving urinary
system;
Number of procedures: 836,940;
Percentage within procedure type: 40.
Top five medical conditions diagnosed: Hyperplasia;
Number of procedures: 310,658;
Percentage within procedure type: 15.
Top five medical conditions diagnosed: Nonspecific findings on
examination of blood;
Number of procedures: 168,274;
Percentage within procedure type: 8.
Top five medical conditions diagnosed: Malignant neoplasm of prostate;
Number of procedures: 93,512;
Percentage within procedure type: 4.
Top five medical conditions diagnosed: Other disorders of bladder;
Number of procedures: 83120;
Percentage within procedure type: 4.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 1,492,504;
Percentage within procedure type: 70.
Top five medical conditions diagnosed: All other;
Number of procedures: 626,456;
Percentage within procedure type: 30.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 2,118,960;
Percentage within procedure type: 100.
Type of ultrasound procedure: Total number of procedures provided to
Medicare beneficiaries;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 40,893,782;
Percentage within procedure type: [Empty].
Source: GAO analysis of Medicare claims data for 2005.
Note: Percentages may not sum to 100 due to rounding. Our analysis is
based on claims for physicians' interpretation of the exams and claims
for ultrasound procedures classified solely as physician services that
do not include a separately billed exam and physician's interpretation
of it.
[End of table]
Table 6: Top Five Medical Conditions Diagnosed by Type of Ultrasound
Procedure Provided in SNFs to Medicare Beneficiaries in Noncovered SNF
stays and Paid Under Medicare Part B, 2005:
Type of ultrasound procedure: Noninvasive vascular.
Top five medical conditions diagnosed: Other disorders of soft tissues;
Number of procedures: 19,019;
Percentage within procedure type: 28.
Top five medical conditions diagnosed: Symptoms involving skin and
other integumentary tissue;
Number of procedures: 12,444;
Percentage within procedure type: 18.
Top five medical conditions diagnosed: Other peripheral vascular
disease;
Number of procedures: 10,876;
Percentage within procedure type: 16.
Top five medical conditions diagnosed: Phlebitis and thrombophlebitis;
Number of procedures: 5,606;
Percentage within procedure type: 8.
Top five medical conditions diagnosed: Atherosclerosis;
Number of procedures: 5,239;
Percentage within procedure type: 8.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 53,184;
Percentage within procedure type: 78.
Top five medical conditions diagnosed: Other noninvasive vascular;
Number of procedures: 15,227;
Percentage within procedure type: 22.
Type of ultrasound procedure: Total; Top five medical conditions
diagnosed: [Empty]; Number of procedures: 68,411; Percentage within
procedure type: 100.00.
Type of ultrasound procedure: Echocardiogram.
Top five medical conditions diagnosed: Heart failure;
Number of procedures: 7,943;
Percentage within procedure type: 28.
Top five medical conditions diagnosed: Other diseases of endocardium;
Number of procedures: 3,763;
Percentage within procedure type: 13.
Top five medical conditions diagnosed: Cardiac dysrhythmias;
Number of procedures: 2,884;
Percentage within procedure type: 10.
Top five medical conditions diagnosed: Symptoms involving Respiratory
systems and other chest symptoms;
Number of procedures: 2,669;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Diseases of mitral and aortic
valves;
Number of procedures: 1,623;
Percentage within procedure type: 6.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 18,882;
Percentage within procedure type: 66.
Top five medical conditions diagnosed: Other echocardiograms;
Number of procedures: 9,571;
Percentage within procedure type: 34.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 28,453;
Percentage within procedure type: 100.00.
Type of ultrasound procedure: Abdomen and pelvis.
Top five medical conditions diagnosed: Other symptoms involving abdomen
and pelvis;
Number of procedures: 10,450;
Percentage within procedure type: 48.
Top five medical conditions diagnosed: Other disorders of kidney and
ureter;
Number of procedures: 1,408;
Percentage within procedure type: 7.
Top five medical conditions diagnosed: Nonspecific abnormal results of
function studies;
Number of procedures: 1,314;
Percentage within procedure type: 6.
Top five medical conditions diagnosed: Other disorders of urethra and
urinary tract;
Number of procedures: 1,239;
Percentage within procedure type: 6.
Top five medical conditions diagnosed: Symptoms involving urinary
system;
Number of procedures: 1,081;
Percentage within procedure type: 5.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 15,492;
Percentage within procedure type: 72.
Top five medical conditions diagnosed: Other abdomen and pelvis;
Number of procedures: 6,145;
Percentage within procedure type: 28.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 21,637;
Percentage within procedure type: 100.00.
Type of ultrasound procedure: Head, neck, and chest.
Top five medical conditions diagnosed: Cataract;
Number of procedures: 889;
Percentage within procedure type: 35.
Top five medical conditions diagnosed: Other disorders of breast;
Number of procedures: 244;
Percentage within procedure type: 10.
Top five medical conditions diagnosed: Other retinal disorders;
Number of procedures: 218;
Percentage within procedure type: 9.
Top five medical conditions diagnosed: Simple and unspecified goiter;
Number of procedures: 174;
Percentage within procedure type: 7.
Top five medical conditions diagnosed: Visual disturbances;
Number of procedures: 120;
Percentage within procedure type: 5.
Type of ultrasound procedure: Subtotal five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 1,645;
Percentage within procedure type: 65.
Top five medical conditions diagnosed: Other;
Number of procedures: 905;
Percentage within procedure type: 35.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 2,550;
Percentage within procedure type: 100.00.
Type of ultrasound procedure: Ultrasonic guidance;
Top five medical conditions diagnosed: [Empty];
Number of procedures: [Empty];
Percentage within procedure type: [Empty].
Top five medical conditions diagnosed: Nonspecific findings on
examination of the blood;
Number of procedures: 2;
Percentage within procedure type: 40.
Top five medical conditions diagnosed: Chronic renal failure;
Number of procedures: 1;
Percentage within procedure type: 20.
Top five medical conditions diagnosed: Other disorders of soft tissue;
Number of procedures: 1;
Percentage within procedure type: 20.
Top five medical conditions diagnosed: Organ or tissue replaced by
transplant;
Number of procedures: 1;
Percentage within procedure type: 20.
Type of ultrasound procedure: Subtotal top four[A];
Top five medical conditions diagnosed: [Empty];
Number of procedures: 5;
Percentage within procedure type: 100.00.
Top five medical conditions diagnosed: Other;
Number of procedures: 0;
Percentage within procedure type: 0.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 5;
Percentage within procedure type: 100.00.
Type of ultrasound procedure: Other diagnostic ultrasound.
Top five medical conditions diagnosed: Symptoms involving urinary
system;
Number of procedures: 5,700;
Percentage within procedure type: 71.
Top five medical conditions diagnosed: Other disorders of bladder;
Number of procedures: 676;
Percentage within procedure type: 8.
Top five medical conditions diagnosed: Other disorders of bone and
cartilage;
Number of procedures: 560;
Percentage within procedure type: 7.
Top five medical conditions diagnosed: Other disorders of male genital
organs;
Number of procedures: 188;
Percentage within procedure type: 2.
Top five medical conditions diagnosed: Symptoms involving skin and
integumentary tissue;
Number of procedures: 130;
Percentage within procedure type: 2.
Type of ultrasound procedure: Subtotal top five;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 7,254;
Percentage within procedure type: 90.
Top five medical conditions diagnosed: Other;
Number of procedures: 809;
Percentage within procedure type: 10.
Type of ultrasound procedure: Total;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 8,063;
Percentage within procedure type: 100.00.
Type of ultrasound procedure: Total number of procedures provided in
SNFs to Medicare beneficiaries in noncovered SNF stays;
Top five medical conditions diagnosed: [Empty];
Number of procedures: 129,119;
Percentage within procedure type: 100.00.
Source: GAO analysis of Medicare claims data for 2005.
Note: Percentages may not sum to 100 due to rounding. Our analysis is
based on claims for ultrasound exams and claims for ultrasound
procedures classified solely as physician services that do not include
a separately billed exam and physician's interpretation of it.
[A] There were only four medical conditions diagnosed by these five
ultrasound guidance procedures.
[End of table]
[End of section]
Appendix III: Detailed Estimates of the Financial Impact of Changing
Medicare Ultrasound Payment Methods:
This appendix contains information on the financial impact of paying
for ultrasound equipment transportation. (See table 7.) In addition,
this appendix presents information on changes in the number of
ultrasound exams conducted in skilled nursing facilities (SNF) between
1995 and 1997 (see table 8).
Table 7: Financial Impact of Ultrasound Equipment Transportation
Payments, 2005:
Site of service: Skilled nursing facilities[B];
Ultrasound exams (number): 129,119;
Beneficiary days[A] (number): 83,591;
Equipment transportation payment only: Increase in Medicare payments
(dollars): 8,477,240;
Equipment transportation payment only: Increase in beneficiary cost
sharing (dollars): 2,262,706;
Equipment transportation and set-up payments: Increase in Medicare
payments (dollars): 9,786,084;
Equipment transportation and set-up payments: Increase in beneficiary
cost sharing (dollars): 2,636,868.
Site of service: Home;
Ultrasound exams (number): 101,285;
Beneficiary days[A] (number): 36,880;
Equipment transportation payment only: Increase in Medicare payments
(dollars): 3,362,665;
Equipment transportation payment only: Increase in beneficiary cost
sharing (dollars): 883,980;
Equipment transportation and set-up payments: Increase in Medicare
payments (dollars): 4,408,509;
Equipment transportation and set-up payments: Increase in beneficiary
cost sharing (dollars): 1,164,498.
Site of service: Custodial care facilities;
Ultrasound exams (number): 17,490;
Beneficiary days[A] (number): 7,900;
Equipment transportation payment only: Increase in Medicare payments
(dollars): 837,061;
Equipment transportation payment only: Increase in beneficiary cost
sharing (dollars): 218,101;
Equipment transportation and set- up payments: Increase in Medicare
payments (dollars): 1,007,215;
Equipment transportation and set-up payments: Increase in beneficiary
cost sharing (dollars): 264,314.
Site of service: Assisted living facilities;
Ultrasound exams (number): 5,297;
Beneficiary days[A] (number): 2,724;
Equipment transportation payment only: Increase in Medicare payments
(dollars): 253,723;
Equipment transportation payment only: Increase in beneficiary cost
sharing (dollars): 68,711;
Equipment transportation and set-up payments: Increase in Medicare
payments (dollars): 304,903;
Equipment transportation and set-up payments: Increase in beneficiary
cost sharing (dollars): 83,795.
Site of service: Total;
Ultrasound exams (number): 253,191;
Beneficiary days[A] (number): 131,095;
Equipment transportation payment only: Increase in Medicare payments
(dollars): 12,930,690;
Equipment transportation payment only: Increase in beneficiary cost
sharing (dollars): 3,433,498;
Equipment transportation and set-up payments: Increase in Medicare
payments (dollars): 15,506,711;
Equipment transportation and set-up payments: Increase in beneficiary
cost sharing (dollars): 4,149,475.
Source: GAO analysis of Medicare Part B claims data for 2005.
Notes: Dollar amounts may not sum to totals due to rounding. To
calculate the number of ultrasound exams, we counted the exams
themselves that were paid under Part B, as well as ultrasound
procedures classified solely as physician services that do not include
a separately billed exam. Ultrasound exams were defined as HCPCS codes
in the BETOS categories for echography in addition to 10 diagnostic
ultrasound codes that were not in these categories. Calculations are
based on the assumption that mobile ultrasound providers would receive
a single transportation fee per beneficiary day. When indicated, mobile
ultrasound providers also receive a single equipment set-up payment for
each ultrasound exam. Transportation and set-up payment amounts are
estimated based on the amount Medicare carriers paid for portable X-ray
equipment transportation in the locality where the exam was conducted.
See appendix I for more information on how we defined ultrasound exams.
[A] Indicates the number of days on which ultrasound exams occurred.
For example, if a given beneficiary received at least one ultrasound
exam on 2 days, this would count as 2 beneficiary days.
[B] Based on exams conducted in either a SNF or nursing facility during
a noncovered SNF stay.
[End of table]
Table 8: Percentage Change in Number of Ultrasound Exams in SNFs, 1995
to 1997:
States where Medicare provided separate payments for ultrasound
equipment transportation in 1995[A];
Number of ultrasound exams: 1995: 8,365;
Number of ultrasound exams: 1997: 28,170;
Percentage change: 237.
States where Medicare did not provide separate payments for ultrasound
equipment transportation in 1995[A];
Number of ultrasound exams: 1995: 23,281;
Number of ultrasound exams: 1997: 37,708;
Percentage change: 62.
Source: GAO analysis of Medicare Part B claims data for 1995 and 1997
from the Part B Extract Summary System.
Note: Ultrasound exams that were conducted in a SNF or nursing facility
were defined as HCPCS codes in the BETOS categories for echography.
[A] Beginning in 1996, there were not any states with carriers that
provided separate payments for ultrasound equipment transportation, but
carriers in the following states did so in 1995: Arizona, California
(Northern), Connecticut, Delaware, Georgia, Iowa, Maine, Maryland,
Massachusetts, Missouri, Nevada, New Hampshire, New Jersey,
Pennsylvania, and Vermont. We excluded California from our analysis
because the policy on payments for ultrasound equipment transportation
and set up was not consistent throughout the state.
[End of table]
[End of section]
Appendix IV: Studies on Accreditation of Facilities and the
Credentialing of Sonographers:
Author/title: David G. Stanley, "The Importance of Intersocietal
Commission for the Accreditation of Vascular Laboratories (ICAVL)
Certification for Noninvasive Peripheral Vascular Tests: The Tennessee
Experience," The Journal for Vascular Ultrasound, vol. 28, no. 2
(2004);
Objective(s) of study: To determine the accuracy of noninvasive
vascular ultrasound procedures conducted by accredited and
nonaccredited facilities;
Study methods: The study compared the results of noninvasive vascular
ultrasound procedures performed by an accredited facility to the
results of studies that were initially performed by both accredited and
nonaccredited facilities. The study reviewed a total of 437 ultrasound
carotid duplex exams.[A];
Study results: The study found an 83 percent correlation rate for
ultrasound procedures that were initially performed at accredited
facilities; However, when the initial study was performed by a
nonaccredited facility, the correlation rate for reviewed studies was
45 percent.
Author/title: Alfred Z. Abuhamad et al., "The Accreditation of
Ultrasound Practices Impact on Compliance with Minimum Performance
Guidelines," Journal of Ultrasound in Medicine, vol. 23, no. 8 (2004);
Objective(s) of study: To determine the effectiveness of the American
Institute of Ultrasound in Medicine (AIUM) accreditation program in
improving compliance with standards and guidelines for the performance
of obstetric and gynecologic ultrasound examinations.[B];
Study methods: The scores of case studies in 82 AIUM accreditation
applications were compared with their respective scores at the time of
reaccreditation 3 years later. To account for the element of time,
scores of applications that recently completed first-time accreditation
were also compared as a control group;
Study results: The study found that practices that applied for, and
were granted, ultrasound accreditation were able to improve the scores
of case studies and to achieve compliance with AIUM minimum standards
and guidelines for the performance of gynecologic and obstetric
ultrasound examinations. The study concluded that the improvement in
scores should translate into an enhancement of the quality of the
ultrasound practice.
Author/title: O. William Brown, et al., "Reliability of Extracranial
Carotid Artery Duplex Ultrasound Scanning: Value of Vascular Laboratory
Accreditation," Journal of Vascular Surgery, vol. 39, no. 2 (2004);
Objective(s) of study: To evaluate the reliability of carotid duplex
ultrasound scanning procedures performed by nonaccredited vascular
laboratories and to assess the clinical effect on patient
management.[A];
Study methods: The study compared the quality and reliability of
carotid duplex ultrasound scanning procedures performed by a
nonaccredited vascular laboratory with repeat examinations performed in
the Beaumont laboratory, which is accredited by the Intersocietal
Commission for Accreditation of Vascular Laboratories;
Study results: The study found that of the 174 patients referred for
surgical evaluation for carotid endarterectomy,[C] 88 of these patients
did not have the severe or critical carotid stenosis (narrowing) that
had been diagnosed initially. Since these patients had all been
referred for carotid endarterectomy, unnecessary and potentially
dangerous operations were avoided when the accredited laboratory
disproved the false positive results from the nonaccredited facilities.
For an additional 19 patients, the disease severity had been
significantly underestimated by the nonaccredited laboratories.
Author/title: S. Boswell et al., "Practice Patterns and Membership
Opinion About the Value of Credentialing and Accreditation: Results of
a Membership Survey," Journal of Diagnostic Medical Sonography, vol.
19, no. 6 (2003);
Objective(s) of study: To evaluate the opinions of vascular
technologists and sonographers who routinely perform vascular
procedures about the value of credentialing and accreditation and to
assess their current practice patterns for the performance of carotid
duplex ultrasound procedures;
Study methods: Researchers surveyed 100 members of the Society of
Diagnostic Medical Sonography and the Society for Vascular Ultrasound
in Kentucky and Indiana. There was a 30 percent response rate;
Study results: The study found that 12 percent of (4,782) carotid
duplex procedures considered in the study were repeated annually; Among
the reasons cited by respondents for repeat tests was that the
sonographers conducting the exams were not sufficiently competent;
Respondents noted that the original procedures often showed a lack of
basic sonography knowledge, resulting in poor quality images.
Source: GAO based on sources cited above.
[A] A duplex ultrasound scan is a noninvasive diagnostic ultrasound
procedure that uses color Doppler technology to provide information
about blood flow and the condition of the arteries and veins. This test
is typically used to diagnose suspected artery disease and other
vascular problems, including blockage in the carotid artery in the
neck.
[B] The AIUM provides accreditation for practices rather than
individuals. As one step in the process, practices applying for
accreditation must submit four case studies for each specified area of
accreditation (obstetrics, gynecology, breast, and abdomen). These case
studies are scored by independent reviewers according to established
criteria that conform to the minimum standards and guidelines for
ultrasound practices as developed by the AIUM.
[C] Endarterectomy is the general term for the surgical removal of
plaque from an artery that has become narrowed or blocked. To perform
an endarterectomy, the physician makes an incision in the affected
artery and removes the plaque contained in the artery's inner lining.
This procedure opens the artery and restores blood flow. Physicians use
endarterectomy to treat many arteries; however, the most common use is
for carotid arteries, which are in the neck and deliver blood to the
brain.
[End of table]
[End of section]
Appendix V: Information about Groups That Support Ultrasound
Credentialing and Accreditation Requirements:
Group: The American College of Radiology;
Information on group: The American College of Radiology is a nonprofit,
professional association that represents 30,000 diagnostic
radiologists, radiation oncologists, interventional radiologists,
nuclear medicine physicians, and medical physicists. The organization's
ultrasound accreditation program was established in 1995, and it
includes general ultrasound, obstetrics, gynecological, and vascular
ultrasound. This accreditation program requires that all sonographers
be certified.
Group: The American Society of Echocardiography;
Information on group: The American Society of Echocardiography is a
professional organization of physicians, cardiac sonographers, nurses,
and scientists involved in echocardiography, which is the use of
ultrasound to image the heart and cardiovascular system. The
organization was founded in 1975 and has more than 10,000 members
nationally and internationally.
Group: American Institute of Ultrasound in Medicine;
Information on group: The American Institute of Ultrasound in Medicine
is a multidisciplinary organization that was officially established in
1952. The organization supports professional and public education,
research, development of guidelines, and accreditation. The
organization's ultrasound practice accreditation council has developed
standards for the accreditation of ultrasound practices.
Group: American Registry for Diagnostic Medical Sonography;
Information on group: The American Registry for Diagnostic Medical
Sonography is an independent nonprofit organization that, for 29 years,
has awarded credentials to ultrasound professionals through
examinations. The organization offers certification in three ultrasound
clinical specialties: Registered Diagnostic Medical Sonographer,
Registered Diagnostic Cardiac Sonographer, and Registered Vascular
Technologist. The organization has over 44,000 actively certified
ultrasound professionals.
Group: Cardiovascular Credentialing International;
Information on group: Cardiovascular Credentialing International is an
independent nonprofit organization that awards credentials to vascular
technology professionals through credentialing examinations. The
organization administers credentials in four cardiovascular technology
specialties: Certified Cardiographic Technician, Registered
Cardiovascular Invasive Specialist, Registered Cardiac Sonographer, and
Registered Vascular Specialist.
Group: Intersocietal Commission for the Accreditation of
Echocardiography Laboratories;
Information on group: The Intersocietal Commission for the
Accreditation of Echocardiography Laboratories has been in operation
since 1996 and currently has accredited over 900 echocardiography
laboratories in the United States and Canada. The commission provides a
laboratory peer-review evaluation program for echocardiography
procedures.
Group: Intersocietal Commission for the Accreditation of Vascular
Laboratories;
Information on group: The Intersocietal Commission for the
Accreditation of Vascular Laboratories has been in operation since 1991
and currently has over 1,400 accredited laboratories in the United
States and Canada. The organization provides a peer-review process of
laboratory accreditation for noninvasive vascular diagnostic testing.
Group: Joint Review Committee on Education in Diagnostic Medical
Sonography;
Information on group: Founded in 1979, the Joint Review Committee on
Education in Diagnostic Medical Sonography is the only nationally
recognized organization that accredits diagnostic medical sonography
programs. The primary purpose of the organization is to establish,
maintain, and promote appropriate standards of quality for educational
programs in diagnostic medical sonography and to provide recognition
for educational programs that meet or exceed these standards.
Group: Society of Diagnostic Medical Sonography;
Information on group: The Society of Diagnostic Medical Sonography is a
professional membership organization founded in 1970 to promote,
advance, and educate its members and the medical community in the
science of diagnostic medical sonography. The organization has over
17,000 members and is the largest association of sonographers and
sonography students in the world.
Group: Society for Vascular Surgery;
Information on group: The Society for Vascular Surgery is the oldest
and largest national association of vascular surgeons in the United
States. It was founded in 1947 and merged with the American Association
for Vascular Surgery in 2003. The Society has a membership of more than
2,200 vascular surgeons. Society members serve on the boards of major
vascular sonographer associations as well as the major ultrasound
credentialing and accrediting organizations.
Group: Society for Vascular Ultrasound);
Information on group: The Society for Vascular Ultrasound is the only
national professional organization dedicated exclusively to the
advancement of noninvasive vascular technology used for diagnostic
purposes. The organization's membership is comprised of more than 4,100
registered vascular technologists, sonographers, nurses, and
physicians.
Sources: GAO interviews and analysis of information presented in the
letter from the Coalition for Quality in Ultrasound to MedPAC,
September 3, 2004, and groups' Web sites concerning their history,
mission, and membership, including Who's Who in Sonography, Membership
Associations, http://www.sdms.org/about/who.asp, downloaded October 23,
2006.
[End of table]
[End of section]
Appendix VI: Comments from the Centers for Medicare & Medicaid
Services:
Department Of Health & Human Services:
Centers for Medicare & Medicaid services:
200 Independence Avenue SW:
Washington, DC 20201:
Date: June 15, 2007:
To: A, Bruce Steinwald:
Director, Health Care Government Accountability Office:
From: Leslie V. Norwalk, Esq:
Acting Administrator:
Subject: GAO Draft Report: "Medicare Ultrasound Procedures:
Consideration of Payment Reforms and Technician Qualification
Requirements" (GAO-07-734):
Thank you for the opportunity to review and comment on the General
Accounting Office's (GAO) draft report "Medicare Ultrasound Procedures:
Consideration of Payment Reforms and Technical Qualification
Requirements" (GAO-07-734). We appreciate the GAO's efforts to ensure
that the Centers for Medicare & Medicaid Services' (CMS) coverage,
quality, and payment services encourage providers to deliver the best
possible care to Medicare beneficiaries, particularly those receiving
ultrasound diagnostic services from sonographers.
The CMS is committed to ensuring that its beneficiaries receive high
quality care and maintains several clinical quality programs to carry
out this commitment. The GAO's report particularly speaks to the
national coverage program, under which CMS develops national coverage
determinations (NCDs) under section 1862(a)(1) of the Social Security
Act (the Act), and the Conditions of Participation (CoP) process, under
which CMS promulgates regulations under the Act for institutional and
non-institutional providers to meet as a condition of participating in
the Medicare program. CMS also encourages States to use their own
authorities to ensure that highly trained, capable professionals
deliver services throughout their own jurisdictions. It is for this
reason that CMS offers an alternative to GAO's recommended approach for
ensuring sonographer quality (see "CMS Response" below).
GAO Recommendation:
The GAO recommends that CMS require Medicare-participating sonographers
to be credentialed and/or work in an accredited facility. Furthermore,
the GAO advises CMS to weigh the advantages and disadvantages of
implementing an NCD compared with promulgating regulations that this
requirement be a condition for Medicare payment.
CMS Response:
Provider Quality Issues:
The CMS supports the GAO's interest in the quality of ultrasound
services; however, the Agency asserts that CMS' authorities under the
Act are not the most effective mechanism for addressing sonographer
quality, Rather, we recommend that States engage their own licensing
bodies in implementing sonographer licensure programs that address the
competency/qualification issues GAO addresses in the report.
In the report, the GAO offers two potential avenues for CMS to use its
administrative authorities under the Social Security Act-(1) by issuing
an NCD; or (2) by promulgating a CoP regulation. While both authorities
are integral cornerstones of CMS' clinical quality assurance program,
neither of these administrative approaches are appropriate mechanisms
for CMS to promulgate sonographer credentialing requirements in order
to deliver ultrasound procedures.
We note the regional variation in carrier coverage policies regarding
the provision of ultrasound services; however, we believe that a
national policy would not take into account regional variations in
access to care, state licensing requirements, etc. To remain sensitive
to the needs of local communities in providing ultrasound services, CMS
recommends that States and local carriers continue to review
sonographer qualification requirements on a state-by-state level.
We note that the report indicates that in 2005, of the 28 million
ultrasound exams furnished to beneficiaries under Part B, 68 percent
were furnished in physicians' offices, and 31 percent in hospital
outpatient departments. The statute does not provide for conditions of
participation for physicians.
Conditions of participation do apply to hospitals. The current Medicare
hospital CoPs address indirectly the specific competencies or
qualifications standards for technicians providing ultrasound services.
For example, if a hospital provides ultrasound services the hospital is
responsible for ensuring the quality and the safety of the care
provided as per the existing requirements.
In the hospital setting, most ultrasound services are provided in or
supervised by the imaging or radiological department. Specifically, the
requirements at 42 CFR 482.26, "Radiologic Services" state, "The
hospital must maintain, or have available, diagnostic radiological
services. If therapeutic services are also provided, they as well as
the diagnostic services, must meet professionally approved standards
for safety and personnel qualifications."
Additionally, as required at 42 CFR 482.11, "Compliance with Federal,
State and Local Laws," those personnel must meet the specific State
licensure requirements relative to their areas of expertise. When a
hospital is surveyed for compliance with the Medicare requirements and
ultrasound is offered at that facility, it is likely that technician
personnel files would be reviewed to ensure they have the necessary
training and certifications as appropriate for that particular State.
The requirements at 42 CFR 482.21, "Quality Assessment and Performance
Improvement" (QAPI) states, "The hospital must develop, implement and
maintain an effective, ongoing, hospital-wide, data-driven quality
assessment and performance improvement program." Involvement of all
hospital departments and the quality indicators they are tracking are
determined when surveying for compliance with the Medicare
requirements. A hospital radiological department has the opportunity to
include indicators related to ultrasound services, such as the quality
of the results in the hospital's overall QAPI program.
Approximately 80 percent of the Medicare-participating hospitals are
accredited by the Joint Commission. As a Medicare accrediting body,
they are required by statute to have standards that meet or exceed the
Medicare requirements. The Joint Commission Standard HR. 1.20 requires
that staff qualifications are consistent with his or her job
responsibilities. Additionally, the Joint Commission standards require
ongoing maintenance of licensure, certification, or registration as
required by law or regulation.
Payment Reform Issues:
The CMS concurs with GAO's conclusion (on page 36 of the draft) that ".
. . paying separately under Part B for ultrasound exams and associated
equipment and ambulance transportation during Part A-covered SNF stays
would undermine the financial incentive of the PPS for SNFs to deliver
these services efficiently." Further, we believe that such an action
would be contrary to the overall purpose of the skilled nursing
facility (SNF) consolidated billing (or "bundling") provision, as
discussed in the SNF prospective payment system (PPS) final rule for FY
2001 (65 FR 46791, July 31, 2000):
We do not view the identification of new service categories for
exclusion from this provision in terms of a process of continual
expansion to encompass an ever-broadening array of excluded services.
As we noted in the May 12, 1998 interim final rule (63 FR 26297), the
fundamental purpose of the consolidated billing provision is ".to:
make the SNF itself responsible for billing Medicare for essentially
all of its residents' services, other than those identified in a small
number of narrow and specifically delimited exclusions."
Historically, the number of exclusions from the SNF PPS has been
relatively small, and has tended to focus on those types of
exceptionally intensive, "high cost, low probability" services that
clearly lie beyond the normal scope of SNF care. By contrast, an
ultrasound exam is a type of routine diagnostic procedure that would
fall well within the normal scope of SNF care. Accordingly, we believe
that if such a procedure were to be unbundled, it would set a dangerous
precedent that would prompt suppliers of many other routine, bundled
services to clamor for a similar exception-which ultimately could lead
to the unraveling of the SNF PPS bundle itself.
Conclusion:
The CMS appreciates the GAO's efforts to study payment reform and
provider quality issues related to ultrasound services and will
consider the GAO's recommendations in addressing these issues as the
Medicare clinical quality and payment programs evolve.
[End of section]
Appendix VII: GAO Contact and Staff Acknowledgments:
GAO Contact:
A. Bruce Steinwald (202) 512-7114 or steinwalda@gao.gov:
Acknowledgments:
In addition to the contact named above, Sheila K. Avruch, Assistant
Director; Jennie Apter; William Black; Kevin Dietz; Sandra Gove; and
Carmen Rivera-Lowitt made key contributions to this report.
FOOTNOTES
[1] See Medicare Payment Advisory Commission (MedPAC), A Data Book:
Healthcare Spending and the Medicare Program, June 2006. MedPAC is an
independent federal body established by law to advise the Congress on
issues affecting the Medicare program, including its payment methods.
MedPAC's data cited here are based on Medicare Part B payments under
the physician fee schedule and include beneficiary cost sharing.
Medicare Part B covers physician services, hospital outpatient
services, diagnostic tests, and ambulance services as well as certain
other services such as physical therapy.
[2] See MedPAC 2006.
[3] CMS refers to ultrasound exams as "technical components" and
physicians' interpretations of images from these exams as "professional
components."
[4] CMS is an agency within the Department of Health and Human Services
(HHS), to which HHS has delegated responsibility for administering the
Medicare program.
[5] Medicare Part A covers inpatient hospital, skilled nursing
facility, hospice care, and some home health care.
[6] The American Registry for Diagnostic Medical Sonography (ARDMS) is
one example of a nationally recognized organization that credentials
sonographers.
[7] See Pub. L. No. 108-173, § 513, 117 Stat. 2066, 2300.
[8] The claims data that we used came from the National Claims History
(NCH) carrier file, and the Standard Analytical File (SAF) outpatient
claims files.
[9] The organizations interviewed included the American Geriatrics
Society, the American Medical Directors Association, the American
College of Radiology, the American Society of Echocardiography, the
Society for Vascular Surgery, and the Society for Vascular Ultrasound;
four mobile ultrasound providers that provide services to SNFs and
nursing homes in various states; and representatives from the National
Association for the Support of Long-Term Care and the American
Association of Homes and Services for the Aging.
[10] Medicare only covers ambulance transportation that is medically
necessary. See CMS, Medicare Benefit Policy Manual, Chapter 10, §10.2,
10.2.1, May 28, 2004.
[11] The Medicare claims data are used by the Medicare program as a
record of payments to health care providers and are monitored by CMS.
[12] The credentialing organizations included the American Registry for
Diagnostic Medical Sonography (ARDMS), the Intersocietal Commission for
the Accreditation of Vascular Laboratories (ICAVL), and the American
Institute of Ultrasound in Medicine (AIUM).
[13] These organizations include the American College of Radiology, the
American Institute of Ultrasound in Medicine, the Intersocietal
Commission for the Accreditation of Vascular Laboratories, and the
Intersocietal Commission for the Accreditation of Echocardiography
Laboratories.
[14] Certification by the American Registry of Radiologic Technologists
is also acceptable if the facility is applying for accreditation in
breast ultrasound.
[15] Medicare also covers individuals with end-stage renal disease.
[16] Beneficiaries' coinsurance can be higher than 20 percent for Part
B-covered services provided in a hospital outpatient facility.
[17] CMS has begun a process of using competition to choose its
Medicare claims processing contractors and is awarding new contracts to
entities called Medicare Administrative Contractors. When this process
is complete, these contractors will review and pay all Part B claims.
[18] Medicare covers skilled nursing and rehabilitative therapy for
beneficiaries being treated in SNFs for conditions related to a
hospital stay lasting at least 3 days and occurring within 30 days
before admission to the SNF. For beneficiaries who qualify, Medicare
pays under Part A for most necessary services, including room and
board, nursing care, and ancillary services such as drugs, laboratory
tests, and physical therapy, for up to 100 days per benefit period. A
benefit period begins when a Medicare beneficiary is admitted to a
hospital or a SNF and ends when he or she has not been an inpatient of
these facilities for 60 consecutive days. Beneficiaries are responsible
for a daily copayment after the 20th day of SNF care, regardless of the
cost of services received.
[19] Under the SNF PPS, the SNF receives a single daily payment for
almost all Part A-and Part B-covered services provided to a SNF
resident. Certain items and services are excluded from the PPS by
statute and thus are paid for separately under Part B. In conjunction
with the PPS, each SNF is responsible for billing Medicare for almost
all services provided during a Part A-covered SNF stay, including
services rendered by an outside supplier.
[20] For a discussion of the services paid for separately for
beneficiaries in Part A-covered SNF stays, see GAO, Skilled Nursing
Facilities: Services Excluded from Medicare's Daily Rate Need to be
Reevaluated, GAO-01-816 (Washington, D.C.: Aug. 22, 2001).
[21] See Pub. L. No. 105-33, § 4432, 111 Stat. 251, 414-22.
[22] See Health Care Financing Administration Program Memorandum A-00-
01 (January 2000).
[23] See GAO-01-816. CMS used three criteria to identify services to be
paid for separately under Part B during Part A-covered SNF stays--these
services were required to be (1) high cost, (2) infrequently needed by
SNF beneficiaries, and (3) unlikely to be overprovided. CMS decided
that doppler flow studies, a type of ultrasound procedure, did not meet
the first or second of these criteria and thus should not be paid for
separately under Part B. Similarly, CMS decided that ambulance
transportation not already paid for separately under Part B--for
example, ambulance service to transport a beneficiary from a SNF to
another location for an ultrasound exam--should not be paid for
separately because this service did not meet the first of these
criteria.
[24] Section 1861(s)(3) of the Social Security Act provides coverage of
diagnostic x-rays furnished in a Medicare beneficiary's place of
residence. CMS determined that because of the increased costs
associated with transporting x-ray equipment to the beneficiary,
Congress intended to provide an additional payment amount for the
transportation of equipment for services furnished by an approved
portable x-ray supplier. See 60 Fed Reg. 63124, 63149 (1995). Thus, CMS
established specific procedure codes to pay for the transportation of
portable x-ray equipment.
[25] In California, while the carrier for the northern part of the
state paid for ultrasound equipment transportation, the carrier for the
southern part of the state did not.
[26] CMS had also allowed carriers to develop their own policies
concerning separate Part B payments for the transportation of
electrocardiogram equipment. However, beginning January 1, 1997,
carriers were no longer able to do so. Section 4559 of the BBA
temporarily restored separate payments for the transportation of
equipment for EKG tests performed during 1998 but not thereafter. This
section did not address payments for the transportation of ultrasound
equipment. See Pub. L. No. 105-33, § 4559, 111 Stat. 251, 464.
[27] The total number of procedures (41 million) is based on analysis
of Medicare claims data for physician interpretations of ultrasound
exams. These data account for procedures provided to all Medicare
beneficiaries regardless of setting and whether the exams were paid
under Part A or Part B.
[28] Deep vein thrombosis is a condition where a blood clot forms in a
vein, usually in the lower leg. This condition can cause pain and
swelling. If a clot breaks free and moves through the vascular system
to the heart and lungs it can be fatal.
[29] This number of exams is smaller than the total number of
procedures discussed above (41 million total procedures) because it is
based on the number of technical components (exams) associated with the
image production, whereas the 41 million procedures are based on counts
of the physician interpretations of the exam and the procedures
classified solely as physician services. The 28 million exams excludes
exams provided to beneficiaries in Part A-covered SNF or hospital
inpatient stays that are bundled with other services under Medicare
Part A and not reported separately in the Part B data.
[30] These were exams that cost about $14 million and were paid for
separately under part B for beneficiaries whose SNF stay was not
covered by Part A. Our site-of-service analysis of exams performed in
SNFs focuses on beneficiaries that were not in Part A SNF stays because
the data did not allow us to identify site of service for beneficiaries
in Part A SNF stays. As noted earlier, payment for procedures provided
in SNFs for Part A beneficiaries are not reported separately in the
Part B data.
[31] For example, vascular procedures were the most prevalent (44
percent of the procedures) for this population, followed by
echocardiograms (33 percent). Ultrasounds of the abdomen and pelvis
accounted for 12 percent of the ultrasound procedures provided to those
in Part A SNF stays. The remaining 11 percent of the procedures were
for various other categories, including ultrasound guidance.
[32] We conducted interviews with geriatricians and a gerontologist
from the American Geriatrics Society and structured interviews with SNF
medical directors who are members of the American Medical Directors
Association. We also interviewed professionals from ultrasound-related
organizations (the Society for Vascular Surgery, the Society for
Vascular Ultrasound, and Society of Diagnostic Medical Sonography);
four mobile ultrasound companies that provide services to the elderly
in SNFs or nursing homes; and representatives of the National
Association for the Support of Long-Term Care and the American
Association of Homes and Services for the Aging.
[33] In addition, patients may miss medication doses or meals, which
can be serious for people with certain diseases, such as diabetes.
[34] The financial impact estimates in this section are based primarily
on Medicare claims data for 2005. Since 2005, there have been changes
that could affect the use of ultrasound exams and associated equipment
and ambulance transportation and thus also affect our estimates. These
changes include those related to Medicare payment methodology as well
as other changes, such as technological advances, that could affect
service use. However, accounting for changes that occurred since 2005
and those that could occur in the near future is beyond the scope of
this report.
[35] See appendix I for how we identified these exams.
[36] These estimates take into account that (1) ultrasound equipment
transportation (if it were covered) likely would, on average, be less
expensive than ambulance transportation for Medicare and its
beneficiaries--the average amount paid by Medicare and its
beneficiaries for ultrasound equipment transportation (including the
equipment set-up fee) for each of these 13,900 exams in 2005 was $138,
compared to $514 for an ambulance round trip--and (2) Medicare
expenditures and beneficiary cost sharing for an ultrasound exam can be
different in a SNF compared to other locations such as a hospital
outpatient facility.
[37] We were only able to identify exams conducted during noncovered
SNF stays if they were conducted in a SNF or nursing facility because
we did not have accurate data on which beneficiaries were in noncovered
SNF stays. Therefore, we could not estimate the financial impact of a
change in the site of service for exams conducted during noncovered SNF
stays that were not conducted in a SNF or nursing facility.
[38] See appendix III, table 8, for detailed results of this analysis.
We excluded California from this analysis because the two Medicare
carriers in this state did not have the same policy regarding payments
to transport ultrasound equipment.
[39] An increase in the number of exams conducted in SNFs following the
elimination of transportation payments does not necessarily imply that
the opposite would occur if these payments were reinstated.
[40] We have reported that about 40 percent of beneficiaries who
received an ultrasound exam in a nursing home would require ambulance
services to be transported to another site of service for the exam if
mobile ultrasound services were unavailable. See GAO, Medicare: Impact
of Changing Transportation Policy for Portable Equipment is Uncertain,
GAO/HEHS-98-82 (Washington, D.C.: May 18, 1998).
[41] These estimates include up to $2.6 million in Medicare payments
and $1.5 million in beneficiary cost sharing for up to 33,000
ultrasound exams for which Medicare appears to have improperly paid for
separately under Part B. HHS's Office of Inspector General (OIG) is
currently reviewing improper billing of services under Part B provided
to beneficiaries in Part A-covered SNF stays that should have been
covered under the PPS payment. OIG officials noted that Medicare
contractors likely recouped these improper payments. However, if these
contractors failed to recoup all of these improper payments, then we
would have overestimated the financial impact of paying separately
under Part B for these exams because Medicare would have already been
paying separately under Part B for some of them in the absence of this
policy. Because data for improperly paid claims do not indicate whether
the payment was recouped, we are unable to accurately estimate the
extent to which these improper payments affect our impact estimates.
See appendix I for more detail.
[42] GAO, Skilled Nursing Facilities: Providers Have Responded to
Medicare Payment System By Changing Practices, GAO-02-841 (Washington,
D.C.: Aug. 23, 2002).
[43] Medicare Payment Advisory Commission, Report to the Congress:
Medicare Payment Policy (Washington, D.C.: March 1999).
[44] See GAO, End-Stage Renal Disease: Bundling Medicare's Payment for
Drugs with Payment for All ESRD Services Would Promote Efficiency and
Clinical Flexibility, GAO-07-77 (Washington, D.C.: Nov. 13, 2006) and
Medicare Payment Advisory Commission, Report to the Congress, Medicare
Payment Policy (Washington, D.C.: Mar. 2001).
[45] GAO, Medicare Home Health Care: Payments to Home Health Agencies
Are Considerably Higher than Costs, GAO-02-663 (Washington, D.C.: May
6, 2002).
[46] On the basis of recommendations from CMS, Congress mandated in the
Balanced Budget Refinement Act of 1999 that Medicare pay separately
under Part B for certain services (for example, chemotherapy and
customized prosthetic devices) during Part A-covered SNF stays. See
Pub. L. No. 106-113, div. B, § 1000(a)(6) [H.R. 3426, title I, sec.
103(a)], 113 Stat. 1501, 1536 and 1501A-325-326 (codified at 42 U.S.C.
§ 1395yy(e)(2)(A)(iii)). In doing so, Congress required that CMS reduce
the Part A PPS payment to offset the increase in Part B expenditures
resulting from paying separately for these services.
[47] See D. G. Stanley, "The Importance of Intersocietal Commission for
the Accreditation of Vascular Laboratories (ICAVL) Certification for
Noninvasive Peripheral Vascular Tests: The Tennessee Experience," The
Journal for Vascular Ultrasound, vol. 28, no. 2 (2004) and O. William
Brown, et al., "Reliability of Extracranial Cartoid Artery Duplex
Ultrasound Scanning: Value of Vascular Laboratory Accreditation,"
Journal of Vascular Surgery, vol. 39, no. 2 (2004).
[48] See appendix IV for summaries of the studies discussed in this
section.
[49] See D. G. Stanley, "The Importance of Intersocietal Commission for
the Accreditation of Vascular Laboratories (ICAVL) Certification for
Noninvasive Peripheral Vascular Tests: The Tennessee Experience," p. 1,
and O. William Brown, et al., "Reliability of Extracranial Cartoid
artery duplex Ultrasound scanning: Value of vascular laboratory
accreditation," p. 369.
[50] Mammography is an X-ray imaging procedure that can detect small
tumors and breast abnormalities.
[51] The Mammography Quality Standards Act of 1992, Pub. L. No. 102-
539, § 2, 106 Stat. 3547, 3547-61 amended by the Mammography Quality
Standards Reauthorization Acts of 1998 and 2004, Pub. L. No. 105-248,
§§ 2-13, 112 Stat. 1864, 1864-67, Pub. L. No. 108-365, §§ 2-4, 118
Stat. 1738, 1738-40, respectively, required that the HHS establish
these standards.
[52] FDA regulations also specify detailed requirements for
qualifications and continuing training for physicians who interpret the
images and for mammography equipment and recordkeeping practices. See
21 C.F.R. § 900.12 (2006).
[53] See GAO, Mammography Services: Impact of Federal Legislation on
Quality, Access, and Health Outcomes, GAO/HEHS-98-11 (Washington, D.C.:
Oct. 21, 1997); Mammography Quality Standards Act: X-ray Quality
Improved, Access Unaffected, but Impact on Health Outcomes Unknown,
GAO/HEHS-98-164 (Washington, D.C.: May 8, 1998; Mammography Services:
Initial Impact of New Federal Law Has Been Positive, GAO/HEHS-96-17
(Washington, D.C.: Oct. 27, 1995); and Mammography: Current Nationwide
Capacity Is Adequate, but Access Problems May Exist in Certain
Locations, GAO-06-724 (Washington, D.C.: July 25, 2006).
[54] MedPAC also recommended that the Secretary of HHS select private
organizations to administer these standards, and noted that CMS has
similar "deeming" arrangements with private accreditation groups for
several types of providers, such as hospitals and ambulatory surgical
centers." See Medicare Payment Advisory Commission, Report to the
Congress: Medicare Payment Policy (Washington, D.C.: Mar. 2005).
[55] MedPAC (2005) noted the following with regard to imaging services,
which include ultrasound procedures: "CMS should strongly consider
setting standards for at least the following areas: the imaging
equipment, qualifications of technicians, qualifications and
responsibilities of the supervising physician, technical quality of the
images produced, and procedures for ensuring patient safety (for
example, monitoring radiation exposure)."
[56] These four organizations were the American Society of
Echocardiography, the Society of Diagnostic Medical Sonography, the
Society for Vascular Surgery, and the Society for Vascular Ultrasound.
See appendix V for descriptions of these organizations.
[57] See S. Boswell et al., "Practice Patterns and Membership Opinion
About the Value of Credentialing and Accreditation: Results of a
Membership Survey," Journal of Diagnostic Medical Sonography, vol. 19,
no. 6 (2003), p. 390.
[58] In 2003, we reported that giving Medicare contractors broad
discretion to make local coverage policies had led to inequitable
variations in coverage for beneficiaries depending on where they were
treated. We recommended that CMS develop and implement a plan to
evaluate the merits of existing coverage policies with the intent of
incorporating appropriate aspects of local policies into national
coverage policies and eliminating the remainder. See GAO Medicare:
Divided Authority for Policies on Coverage of Procedures and Devices
Results in Inequities, GAO-03-175 (Washington, D.C.: Apr. 11, 2003).
CMS has implemented a policy to consider and address policy variations,
but the agency has not considered developing an NCD concerning
sonographers' qualifications.
[59] Accredited facilities may require that sonographers have certain
credentials or a combination of formal training and experience.
[60] Among the other reasons that providers gave for obtaining facility
accreditation was the expectation that CMS would develop such a
requirement and providers' own interest in meeting medical practice
standards. In contrast, some providers cited difficulty in meeting
technical requirements, lack of staff or time resources, and expensive
application fees as a reason not to seek facility accreditation. The
information about these reasons is based on a pilot study that the
author conducted in 1998. See Kathleen M. Wilson, The Emergence and
Fall of the Ultrasound Quality Standards Act (H.R. 4217): Exploring the
Interaction of Policy and Politics. Unpublished doctoral dissertation,
University of Maryland, Baltimore County, Baltimore, Md. (2003), p. 18.
[61] See Kathleen M. Wilson, The Emergence and Fall of the Ultrasound
Quality Standards Act, p. 21.
[62] See 42 C.F.R. § 410.33(c) (2006).
[63] CMS's Conditions of Participation are requirements that health
care organizations must meet in order to begin, and continue,
participating in the Medicare program.
[64] A CMS official told us that diagnostic ultrasound procedures are
typically provided in hospitals' radiology departments.
[65] Hospitals may also apply to CMS for a review of their compliance
with CoP, or through accreditation from the American Osteopathic
Association, as an alternative to accreditation by the Joint
Commission. CMS's review is typically conducted by a state agency under
contract with CMS.
[66] See Medicare Payment Advisory Commission (MedPAC), Report to the
Congress, Medicare Payment Policy (March 2005), p. 154 and Lane Koenig
et al, Lewin Group, An Analysis of the Use of Ultrasound Imaging
Services in the Medicare Program, pp. 19-20 (Washington, D.C.: 2005).
[67] The CMS official explained that because Medicare pays for services
that are reasonable and necessary, if clinical evidence supported the
need for an NCD relating to qualification requirements for
sonographers, CMS would not be in a position to allow a phase-in
period.
[68] For example, CMS has recently begun to implement the Medicare
health quality demonstration, which is a 5-year program designed to
achieve a number of goals, including enhancing quality, improving
patient safety, and increasing efficiency. In addition, CMS is
coordinating with a number of stakeholders, including physicians, to
develop and implement uniform, standardized sets of performance
measures for various health care settings.
[69] In this analysis of the types of ultrasound procedures, we also
included claims for ultrasound procedures classified solely as
physician services that do not include a separately billed exam and
physician's interpretation of it.
[70] The Medicare Part B claims for ultrasound exam allowed us to
identify the site of service where the sonographers produced the actual
image. In this analysis of the site of service of ultrasound exams, we
also included claims for ultrasound procedures classified solely as
physician services that do not include a separately billed exam and
physician's interpretation of it.
[71] HCPCS is a standardized classification method used by CMS to
identify medical, including ultrasound, services and procedures. It is
used in the submission to Medicare and other insurers of claims for
payment of services rendered by physicians and other providers.
[72] The six BETOS echography categories used to group HCPCS codes are
as follows: (1) eye (category I3A), (2) abdomen/pelvis (category I3B),
(3) heart (category I3C), (4) carotid arteries (category I3D), (5)
prostate, transrectal (category I3E), and (6) other (category I3F).
[73] We supplemented the HCPCS codes in the BETOS categories for
echography rather than using all HCPCS codes for diagnostic ultrasound
procedures for two reasons. First, we wanted to promote comparability
with other studies that use the BETOS categories. Second, supplementing
the HCPCS codes in the BETOS echography categories accounted for
virtually all (99 percent) of Medicare Part B spending on diagnostic
ultrasound procedures.
[74] CMS has established three levels of physician supervision for the
technician who conducts the exam component of ultrasound procedures and
other diagnostic tests. The first level involves general supervision,
which means that the procedure must be provided under the physician's
overall direction and control, but the physician's presence is not
required while the technician performs the exam. The second level
involves direct supervision in the office setting, which means that the
physician must be present in the office suite and immediately available
to furnish assistance and direction while the technician performs the
exam. The third level involves personal supervision, which requires a
physician to be in attendance in the room during the performance of the
procedure. See appendix II for more detail.
[75] We obtained information from four directors of nursing in four
states: Connecticut, Florida, New York and Pennsylvania.
[76] The number of exams includes ultrasound procedures classified
solely as physician services that do not include a separately billed
exam. To identify exams conducted in SNFs during noncovered SNF stays,
we first selected all Part B claims for ultrasound exams that were
conducted in a SNF or nursing facility and then, based on claims for
Part A-covered SNF stays, we omitted those that were billed during Part
A-covered SNF stays.
[77] The number of beneficiary days is defined as the sum across all
beneficiaries in a given site of service of the number of days on which
ultrasound exams occurred for each beneficiary. For example, if a
beneficiary received at least one ultrasound exam on 2 separate days,
this beneficiary would contribute 2 beneficiary days to the total.
[78] We based our estimate of the average Medicare payment and
beneficiary cost sharing for ultrasound equipment transportation on the
same measures for a similar service--the transportation and set-up fees
for portable x-ray equipment transportation in 2005.
[79] Carriers in the following 14 states provided these payments in
1995: Arizona, Connecticut, Delaware, Georgia, Iowa, Maine, Maryland,
Massachusetts, Missouri, Nevada, New Hampshire, New Jersey,
Pennsylvania, and Vermont. Transportation payments were also made in
Northern California, but not in the southern part of that state.
[80] We excluded California from our analysis because the policy
regarding payments for ultrasound equipment transportation and set up
was not consistent throughout the state. For this analysis, we defined
ultrasound exams as HCPCS codes in the BETOS categories for echography
and included exams in both SNFs and nursing facilities.
[81] On the basis of our earlier work, we estimated that 40 percent of
beneficiaries who received an ultrasound exam in a nursing home would
need to be transported via ambulance if the exam were conducted at
another site of service, such as a hospital outpatient facility. See
GAO/HEHS-98-82.
[82] To identify beneficiaries in noncovered SNF stays, we first used
the origin and destination of the ambulance trips to determine whether
a beneficiary was in a SNF stay and then omitted any beneficiary whose
ultrasound exam, based on the SNF claims, occurred during a Part A-
covered SNF stay.
[83] Ambulance trips for these beneficiaries (1) were on the same day
as their ultrasound exam, which was not conducted in a SNF during a
noncovered SNF stay and (2) transported a beneficiary from a SNF to a
physician's office, hospital, or diagnostic or therapeutic site (for
example, an independent diagnostic testing facility) and back.
[84] The average Medicare payment and beneficiary cost-sharing amounts
for each HCPCS code were calculated based on Part B claims for
ultrasound exams for all Medicare beneficiaries in 2005. Estimates for
this analysis may slightly overstate the actual financial impact of
separate Part B payments for ultrasound exams and associated equipment
and ambulance transportation because up to 5 percent of ultrasound
exams conducted during Part A-covered SNF stays were on beneficiaries
in critical access hospitals that may have been certified as swing bed
hospitals, which were not subject to the PPS.
[85] The actual number of improperly paid exams and associated Medicare
payments and beneficiary cost sharing may be slightly lower than these
estimates because up to 3 percent of these exams may have been
conducted on beneficiaries in Part A-covered SNF stays who were in
critical access hospitals that were certified as swing bed hospitals,
which were not subject to the PPS.
[86] The Office of Inspector General (OIG) of HHS is currently
addressing the issue of improper billing for beneficiaries in Part A-
covered SNF stays. For previous OIG reports on this issue, see HHS OIG,
Review of Improper Payments Made by Medicare Part B for Services
Covered Under the Part A Skilled Nursing Facility Prospective Payment
System in Calendar Years 1999 and 2000, A-01-02-00513 (Washington,
D.C.: May 2004); Review of Potential Improper Payments Made by Medicare
Part B for Services Covered Under the Part A Skilled Nursing Facility
Prospective Payment System, A-01-00-00538 (Washington, D.C.: June
2001); and Review of Compliance with the Consolidated Billing Provision
Under the Prospective Payment System for Skilled Nursing Facilities, A-
01-99-00531 (Washington, D.C.: March 2000).
[87] Based on current payment policy for portable x-ray equipment
transportation, when multiple exams occur on a single beneficiary day
(that is, during a single session for a given beneficiary), only one
equipment transportation payment is required, although a set-up fee is
paid for each exam. To convert the number of ultrasound exams conducted
in SNFs to beneficiary days, we divided the number by the average
number of these exams per beneficiary day based on Part B claims for
exams conducted for beneficiaries in Part A-covered SNF stays in 1997-
-the most recent year for which these data were reported separately for
these beneficiaries.
[88] As with the first component of our financial impact analysis, we
based our estimate of the average Medicare payment and beneficiary cost
sharing for ultrasound equipment transportation on the same measures
for a similar service--the transportation and set-up fees for portable
x-ray equipment in 2005.
[89] To convert the number of ultrasound exams involving ambulance
transportation to beneficiary days, we divided the number by the
average number of these exams per beneficiary day based on Part B
claims for exams conducted for beneficiaries in Part A-covered SNF
stays in 1997.
[90] Data from 1997 are the most recent available for which the exams'
site of service was available for beneficiaries in Part A-covered SNF
stays because, in 1998, CMS began phasing in the SNF PPS, which bundled
payment for these and other services provided to beneficiaries in Part
A-covered SNF stays.
[91] The Intersocietal Accreditation Commission has five subgroups: the
Intersocietal Commission for the Accreditation of Vascular
Laboratories, the Intersocietal Commission for the Accreditation of
Echocardiography Laboratories, the Intersocietal Commission for the
Accreditation of Nuclear Medicine Laboratories, and the Intersocietal
Commission for the Accreditation of Magnetic Resonance Laboratories.
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