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The National Quality Forum
Comments on Draft Report: National Voluntary Consensus Standards for Outpatient Imaging Efficiency
Note: Items with proposed actions or questions are bolded & blue.
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1 Public Vincent Polkus, GE General GE Healthcare (GEHC) recognizes the broad objectives of industry and professional societies to implement appropriateness Comment appreciated.
Healthcare criteria and accreditation guidelines whose purpose is to improve the quality and efficiency of non-invasive diagnostic imaging
and reduce healthcare costs. For purposes of assessing conformance of actual practice to established standards of care, GEHC
recognizes the role for and importance of performance benchmarks such as those proposed by NQF as part of the National
Voluntary Consensus Standards for Outpatient Imaging Efficiency. In accordance with your July 31st 2008 request to NQF
Members, GEHC is grateful to offer the following comments for your consideration following an internal review:
2 M, Health Rita Munley General NQFs efforts to identify and endorse measures for public accountability and quality improvement related to the appropriateness Comment appreciated.
Professional Gallagher, PhD, and efficiency of outpatient imaging at the practitioner and facility levels are laudable. ANA concurs that it is incumbent on NQF
RN, American to assist stakeholders to measure what makes a difference, and address what is important to achieving the best outcomes for
Nurses Association patients and populations. Given that the cost of imaging studies is approximately $100 billion annually for health plans with as
much as $30 billion being due to inappropriate utilization of imaging or duplication of studies measurement of imaging certainly
meets those criteria. The outpatient imaging efficiency measures rely on an extensive literature review and address the issue of
health disparities and the realities of providing follow-up care to patients.
3 M, Purchaser Gaye Fortner, General Today, most providers are paid for the number of services and procedures they provide, regardless of the quality or Comment appreciated.
HealthCare 21 appropriateness of that care. Not surprisingly, the number of procedures, diagnostic tests and use of new technologies is sky-
Business Coalition rocketing as is their cost. According to recent Medicare Payment Advisory Commission (MedPAC) analyses, the volume of doctor
services per beneficiary grew by 3.6 percent in 2006, and the highest growth rates were attributable to tests (6.9 percent) and
medical imaging (6.2 percent). We wholeheartedly support NQF working in this important area. We view these measures as an
initial step, and look forward to more measures in the future that truly address the overuse of imaging.
4 M, Purchaser Gaye Fortner, General Communication of findings, both with other providers and the patient, is important to care coordination and we agree with the Comment appreciated.
HealthCare 21 Committees recommendation that there should be an overarching measure that addresses the issues rather than individual
Business Coalition condition or procedure specific measures that are not harmonized.
5 M, Purchaser Barbara Rudolph, General Dear Dr. Corrigan: We want to thank the National Quality Forum for this opportunity to comment on the Outpatient Imaging Comment appreciated.
Ph.D., The Leapfrog Efficiency Measures. The Leapfrog Group and its members have supported the efforts of the National Quality Forum to endorse
Group measures for public reporting that both increase transparency and improve the quality of care. Through the consensus
development process the Leapfrog Group has supported a significant number of measures for public reporting, most in the area of
access to care, quality of care, and more recently a limited number of efficiency of care measures. We are very pleased that the
National Priorities Partnership now also has a priority area of eliminating waste while ensuring the delivery of appropriate care.
The proposed goal is to reduce wasteful and inappropriate care for the top ten targeted areas by 50% by 2012. This priority area
appears to be highly aligned with the objectives of CMSs outpatient imaging efficiency measures. Today, most providers are paid
for the number of services and procedures they provide, regardless of the quality or appropriateness of that care. Not surprisingly,
the number of procedures,
diagnostic tests and use of new technologies is sky-rocketing as is their cost. According to
recent MedPAC analyses, the volume of doctor services per beneficiary grew by 3.6 percent in
2006, and the highest growth rates were attributable to tests (6.9 percent) and medical imaging
(6.2%).
6 M, Purchaser Barbara Rudolph, General However, costs are not the only concern; these measures also benefit the consumer who is being subject to increasing radiation Comment appreciated.
Ph.D., The Leapfrog from excess use of CT and MRIs. Exposure to radiation is an issue in which more care can actually lead to greater risks for the
Group patient. Patients, along with their providers, need to understand the risks and benefits so they can make informed decisions. We
wholeheartedly support NQF working in this important area. We view these measures as an initial step, and look forward to
more measures in the future that truly address the overuse of imaging.
7 M, Purchaser Barbara Rudolph, General We would also like to recommend that the National Quality Forum pursue a cross-cutting measure for the communication of Text has been added to Research
Ph.D., The Leapfrog findings to patients and other care providers, rather than creating a new measure on communication of findings for each condition Recommendations.
Group or procedure. Thank you for this opportunity to comment.
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8 M, Provider Brian Clement, General non-concur with the time-limited endorsement of OIE-008-08: Reminder system for mammograms.The measurement of a patient's Comment appreciated. The Steering Committee
Organization OASD, HA/TMA info being entered into a reminder system is an ineffective proxy for actually reminding the patient months to years later (which is feels this measure will maximize the use of
the true USE of patient reminders associated with an increase in screening mammography). mammography in appropriate patients
populations. The Steering Committee also noted
the importance of examining the periodicity of
notification which will ensure that screening
9 M, Health Nancy Nielsen, General The American Medical Association (AMA) is pleased to have the opportunity to comment on the National Quality Forum (NQF) continues appropriately over time.
Comment appreciated.
Professional AMA draft report, National Voluntary Consensus Standards for Outpatient Imaging Efficiency. In this letter, we outline a request for
clarification on the intent and desired goal for Measure OIE-19-08 and our concern with Measure OIE-020-08.
10 M, Health Joseph Drozda, General The American College of Cardiology supports NQF's Outpatient Efficiency draft report and the general effort to address imaging Comment appreciated.
Professional American College efficiency. Although we agree that there are a significant number of imaging procedures which are unnecessary we don't estimate
of Cardiology the proportion of such procedures to be as high as the 30% number cited in the report and don't believe that the references listed in
the document substantiate such a high number. Whatever the actual number is we concur that it is too high and needs to be
addressed.
11 M, Purchaser Tanya Alteras, General Today, most providers are paid for the number of services and procedures they provide, regardless of the quality or Comment appreciated.
Consumer- appropriateness of that care. Not surprisingly, the number of procedures, diagnostic tests and use of new technologies is sky-
Purchaser rocketing as is their cost. According to recent Medicare Payment Advisory Commission (MedPAC) analyses, the volume of doctor
Disclosure Project services per beneficiary grew by 3.6 percent in 2006, and the highest growth rates were attributable to tests (6.9 percent) and
medical imaging (6.2 percent). We wholeheartedly support NQF working in this important area. We view these measures as an
initial step, and look forward to more measures in the future that truly address the overuse of imaging.
12 M, Purchaser Tanya Alteras, General Communication of findings, both with other providers and the patient, is important to care coordination and agree with the Comment appreciated.
Consumer- Committees recommendation that there should be an overarching measures that addresses the issues rather than individual
Purchaser condition or procedure specific measures that are not harmonized.
Disclosure Project
13 M, Health Robert Pyatt, General The measures developed through the AMA PCPI Radiology workgroup are based on the best available evidence and the most Comment appreciated.
Professional American College authoritative guidelines and standards in the specialty. They address documented gaps in care, are not unduly burdensome and
of Radiology are attributable to the radiologist directly. The mammography measures take steps to achieve the best possible results beyond
compliance with existing Mammography Quality Standards Act (MQSA) regulations. The radiation safety measures [CT dose
management and fluoroscopy documentation] reflect growing awareness of non threshold dose effect models of carcinogenesis
and recognize an obligation to consider the cumulative impacts of medical radiation.
14 M, Madeleine Smith, General AdvaMed welcomes the opportunity to comment on this draft report and recommendations on measures. AdvaMed commends Text has been modified to provided a more
Supplier/Ind AdvaMed the project Steering Committee members and NQF staff on their efforts. AdvaMed is concerned that the opening paragraph in the balanced tone.
ustry Executive Summary lacks balance. A more neutral opening would change the second sentence by replacing is with may be. The
sentence would then read: A significant portionas much as $30 billion- may be due to inappropriate utilization In addition, the
last sentence in the opening paragraph states that MRI studies have increased with radiographs have decreased. Linking the two
statistics in the same sentence could be interpreted to imply that these changes are inappropriate. We believe that the first
paragraph in the Background section is more balanced and urge that the Executive Summary be modified to include some of the
context provided in the Background.
15 M, Madeleine Smith, General Recommendations for further investigation and measure development include several related to accreditation: accreditation of all Comment appreciated.
Supplier/Ind AdvaMed modalities, percentage of physician staff members who are fellowship trained, use of appropriately certified radiologic
ustry technologists, site inspection by qualified radiologic physicist at least every 2 years. Current law now requires providers who bill
Medicare for the technical component of advanced imaging modalities, including MRI, CT and nuclear medicine (including PET)
to become accredited by 2012. Accreditation applies to non-physician personnel, medical directors and supervising physicians,
and equipment. AdvaMed believes that NQF should monitor Medicares accreditation requirements before urging development of
measures focused on accreditation.
16 M, Madeleine Smith, General AdvaMed supports developing a framework to examine appropriateness, utilization, safety and outcomes of diagnostic imaging Text has been added to Research
Supplier/Ind AdvaMed studies. We also support encouraging imaging centers to educate referring physicians on when and how to conduct appropriate Recommendations.
ustry population-specific imaging studies, based on appropriateness criteria developed by physician specialty societies.
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17 M, Health Rebecca General Recent studies continue to demonstrate unsustainable trends in costs of imaging studies. Both AHIP and the GAO have recently Comment appreciated. Links were forwarded to
Plan Zimmermann, released reports that document dramatic surge in the use of high tech imaging, rapid growth in spending, and substantial the Steering Committee.
AHIP variation in the use of services across regions that suggests not all utilization is necessary or appropriate. NQFs work to develop a
framework for Imaging Efficiency measures represents an important step in furthering the appropriate use of imaging services.
The imaging measures recommended represent clinically appropriate indicators for assessing imaging utilization. Measures that
were not recommending by the Steering Committee were also appropriately excluded. We are including links to both papers for
the project Steering Committee and NQF members to review. Link to AHIP white paper on quality in high tech imaging:
http://www.ahip.org/content/default.aspx?docid=24057 Link to GAO report on imaging services in Medicare Part B:
http://www.gao.gov/new.items/d08452.pdf
18 M, Consumer Debra Ness, General The National Partnership for Women and Families enthusiastically supports the National Quality Forum's project on outpatient Comment appreciated.
National imaging efficiency measures. These measures are the first step toward addressing overuse and misuse of services. In addition to
Partnership for our comments on specific measures, we support the steering committee's assessment that communication of findings between
Women & Families providers and patients is vitally important to care coordination. We therefore agree with the Committees view that there should
be an overarching measure that addresses this issue rather than individual condition or procedure specific measures that may not
be harmonized.
19 M, Health Catherine MacLean, General We have reviewed the imaging measures and feel that they are clinically appropriate. We don't have any specific comments on Comment appreciated.
Plan WellPoint, Inc any of the proposed measures. Also, we think that the measures that were proposed but excluded were appropriately exclude.
20 Public Mark Morasch, OIE-003-08 The Society for Vascular Surgery commends the diligent work of the Outpatient Imaging Efficiency Steering Committee. We fully Comment appreciated.
Society for Vascular support the measure: Stenosis measurement in carotid imaging studies (OIE-003-08).
Surgery
21 Public Michael Rothman OIE-003-08 Agreed - previously commented on this. Comment appreciated.
MD, M. I. Rothman,
MD
22 Public Vincent Polkus, GE OIE-003-08 GEHC imaging systems provide the necessary measurement tools that enable physicians to make consistent and accurate Comment appreciated.
Healthcare measurement of lumen stenosis in support of this proposed quality metric. In addition, GEHC supports the NQF industry-
consensus approach to increase the consistency of accurate quantification of carotid artery stenoses in order to further improve the
soundness of subsequent carotid artery intervention decisions that are based on this measurement.
23 M, Health Rachel Groman, OIE-003-08 The Stenosis Measurement in Carotid Imaging Studies attempts to standardize the measurement of carotid stenosis. It states that Steering Committee and Measure Developer agree that
Professional AANS "direct or indirect reference to measurements of distal internal carotid artery diameter as the denominator for stenosis the measure is not instructing how to calculate stenosis in
measurement" should be used to quantify the degree of carotid stenosis. While this is reasonable for catheter angiography and for ultrasound studies – it is recommending that US study
findings (findings based on velocity parameters of
MRA and CTA, many centers use carotid duplex imaging. The measure accounts for this, but incorrectly states that velocity
ICA/CCA) are correlated to anatomic measurements that
measurements that "correlate with anatomic measurements that use the distal internal carotid lumen" should be used. The
are gathered in methods such as NASCET. Reference
definition of how carotid stenosis is measured by carotid duplex ultrasound needs to be clarified since it is currently written standards for US, CTA, MRA, and angiographic
incorrectly. The measure should indicate that carotid duplex imaging calculates the degree of stenosis based upon the velocity in interpretation that coordinate with NASCET
the internal carotid artery over the velocity in the common carotid vessel (not the distal internal carotid). A thorough methodology of angiographic interpretation are available
interpretation of carotid duplex studies entails evaluation of the ultrasound images, the ICA velocities and the velocity ratios. To to permit implementation of the performance measure.
focus on any one of these measures References:
without the others significantly diminishes the value of the study. The published literature 1. Bartlett ES, Walters TD, Symons SP, et al.
validates this approach. Quantification of carotid stenosis on CT angiography.
AJNR Am J Neuroradiol 2006;1:13–19.
2. Nederkoorn PJ, van der Graaf Y, Hunink MGM. Duplex
ultrasound and magnetic resonance angiography
compared with digital subtraction angiography in carotid
artery stenosis: a systematic review. Stroke
2003;34:1324–31.
3. Grant EG, Benson CB, Moneta GL, et al. Carotid artery
stenosis: gray-scale and Doppler US diagnosis—Society of
Radiologists on Ultrasound Consensus Conference.
Radiology 2003;229:340–46.
4. Gaitini D, Soudack M. Diagnosing carotid stenosis by
Doppler sonography: state of the art. J Ultrasound Med
2005;24:1127–36.
5. Sabeti S, Schillinger M, Mlekusch W, et al.
Quantification of internal carotid artery stenosis with
duplex US: comparative analysis of different flow velocity
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24 M, Health Robert Pyatt, OIE-003-08 This measure is expanded from a previously NQF-endorsed measure (Stroke/Stroke Rehab Carotid Imaging Reports) with the Comment appreciated.
Professional American College denominator population expanded to all patients, not just those with stroke. As supported by evidence from randomized trials,
of Radiology stenosis calculation should always be based on a denominator of distal internal carotid diameter or, in the case of duplex
ultrasound, velocity measurements that have been correlated to angiographic stenosis calculation based on distal internal carotid
diameter. Since the degree of stenosis is an important element of the decision for carotid intervention, characterization of the
degree of stenosis needs to be standardized. It is believed that the documented wide variation in the use of methods for stenosis
calculation leads to variation in the appropriateness of carotid intervention, and consequently to over-use, under-use, or misuse of
these procedures.
25 M, Health Robert Pyatt, OIE-003-08 The measure does not privilege one imaging technique over any other, recognizing that many reasons may exist for preferring Comment appreciated.
Professional American College ultrasound (US), CT angiography (CTA), MR angiography (MRA), or conventional angiography in a given situation. It simply
of Radiology requires that the interpreting physician use a standardized method for stenosis quantification validated in clinical intervention
outcome trials. Although different studies use different physical principles to arrive at estimates of narrowing, there is little room
for debate about the need to convert the inferences drawn from these disparate techniques into a common metric applicable across
all of them. The measure expects velocity parameters from duplex ultrasound to be correlated with anatomic measurements
gathered in methods such as NASCET. Reference standards for US, CTA, MRA, and angiographic interpretation that coordinate
with NASCET methodology of angiographic interpretation are available to permit implementation of the performance measure.
26 M, Health Robert Pyatt, OIE-003-08 Physicians need imaging-derived stenosis measurements translatable directly into widely accepted practice guidelines that rely on Comment appreciated.
Professional American College imaging to direct patient management. This measure facilitates coordination of care and communication among members of the
of Radiology patient care team. Because they specify the precise nature of the information in the radiology report to be communicated in order
that other physicians may approach the patient in a manner consistent with the best available evidence, they promote coordinated
care.1. Bartlett ES, Walters TD, Symons SP, et al. Quantification of carotid stenosis on CT angiography. AJNR Am J Neuroradiol
2006;1:13-19;2. Nederkoorn PJ, van der Graaf Y, Hunink MGM. Duplex ultrasound and magnetic resonance angiography
compared with digital subtraction angiography in carotid artery stenosis: a systematic review. Stroke 2003;34:1324-31;3. Grant EG,
Benson CB, Moneta GL, et al. Carotid artery stenosis: gray-scale and Doppler US diagnosis‖Society of Radiologists on Ultrasound
Consensus Conference. Radiology 2003;229:340-46;4. Gaitini D, Soudack M. Diagnosing carotid stenosis by Doppler sonography:
state of the art. J Ultrasound Med 2005;24:1127-36;5. Sabeti S, Schillinger M, Mlekusch W, et al.
Quantification of internal carotid artery stenosis with duplex US: comparative analysis of
different flow velocity criteria. Radiology 2004;232:431-39
27 M, Health Janet Leiker (on OIE-003-08 This measure represents a low hurdle and standard of care; not appropriate for accountability. Steering Committee and Measure Developer agree that
Professional behalf of the the measure addresses documented gaps in care. ―The
Commission on performance of carotid US and the interpretation of US
results vary considerably from laboratory to laboratory.
Quality), American
Interpretive criteria for carotid stenosis are either
Academy of Family
indiscriminately applied or the interpreters are uncertain
Physicians about exactly how to make the diagnosis of carotid
stenosis."(Grant et al., SRU, 2003) More specifically, a
study conducted by Byrd and colleagues evaluated
routine practice in vascular laboratories across 26
countries participating in The Asymptomatic Carotid
Surgery Trial (ACST) in order to determine the areas
which are in need of future standardisation. With greater
than 41 interpretation criteria reported and only 29%
using a standardised Doppler angle, this study highlights
the need for standardization in characterizing the degree
of stenosis. (Byrd, 1998)
28 Public Vincent Polkus, GE OIE-005-08 GEHC supports efforts to improve patient management clarity in order to further improve the overall accuracy of screening Comment appreciated.
Healthcare mammography. Relative to the BIRADS 3 criteria in the NQF proposal, GEHC believes that appropriateness criteria should
originate from recognized medical-specialty organizations such as the American College of Radiology (ACR). GEHC
recommends that NQF consider additional metrics directed at the formation of a CMS reporting group to additionally monitor
cancer detection and screening recall rates to further ensure more consistent and appropriate use of all BIRADS codes to improve
the accuracy of mammography.
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29 M, Purchaser Gaye Fortner, OIE-005-08 While we do believe it is important to have accurate categorizations for screening mammography, we do not support Steering Committee and Measure Developer feel
HealthCare 21 inappropriate use of probably benign assessment category as a measure for accountability. Rather, this measure is more that the measure has a strong clinical evidence
Business Coalition appropriate for internal quality improvement programs. base, addresses known gaps in care and was
developed to ultimately improve the quality of care
for patients undergoing screening mammograms.
This measure is appropriate for accountability as it
focuses on measuring performance of individual
clinicians and is restricted to measuring aspects of
care actionable by the individual clinician.
30 M, Purchaser Barbara Rudolph, OIE-005-08 OIE-005-08** Inappropriate use of probably benign assessment category in mammography screening. We believe this measure is Steering Committee and Measure Developer feel
Ph.D., The Leapfrog more appropriate for quality improvement activities versus accountability. We recommend this measure not go forward for that the measure has a strong clinical evidence
Group endorsement. base, addresses known gaps in care and was
developed to ultimately improve the quality of care
for patients undergoing screening mammograms.
This measure is appropriate for accountability as it
focuses on measuring performance of individual
clinicians and is restricted to measuring aspects of
care actionable by the individual clinician.
31 M, Purchaser Tanya Alteras, OIE-005-08 While we do believe it is important to have accurate categorizations for screening mammography, we do not support Steering Committee and Measure Developer feel
Consumer- inappropriate use of probably benign assessment category as a measure for accountability. Rather, this measure is more that the measure has a strong clinical evidence
Purchaser appropriate for internal quality improvement programs. base, addresses known gaps in care and was
Disclosure Project developed to ultimately improve the quality of care
for patients undergoing screening mammograms.
This measure is appropriate for accountability as it
focuses on measuring performance of individual
clinicians and is restricted to measuring aspects of
care actionable by the individual clinician.
32 M, Health Robert Pyatt, OIE-005-08 This is a useful measure deserving passage. Overuse of the BiRads 3 code is part of the broader issue of over-utilization, and lack Comment appreciated.
Professional American College of feedback concerning radiologist outcomes. Though this measure stands alone as a valid indicator or quality, it would be best if
of Radiology the other codes were monitored as well, simplifying implementation of this measure. The approach for expecting the performance
rate to approach 0% may seem appropriate, but again this would be better implemented with the more complete BiRads data
collection. With complete BiRads data collection, a more precise number could be created, such as < 0.5% because the ambiguities
are alleviated. That code three has the greatest discordance in assessment vs. recommendations attests to the value of the measure
but greater impacts on quality assurance would occur if the entire BiRads audit were facilitated.
33 M, Madeleine Smith, OIE-005-08 AdvaMed supports efforts to improve patient management clarity in order to further improve the overall accuracy of screening Comment appreciated.
Supplier/Ind AdvaMed mammography. AdvaMed recommends that CMS consider additional metrics directed at the formation of a CMS reporting
ustry group to additionally monitor cancer detection and screening recall rates to further ensure more consistent and appropriate use of
all BIRADS codes to improve the accuracy of mammography.
34 M, Consumer Debra Ness, OIE-005-08 We thank NQF for including mammography-related measures in this project. However, we cannot support this measure for Steering Committee and Measure Developer agree
National accountability. Having accurate categorizations for mammography screening is highly necessary; however this measure is more that the measure has a strong clinical evidence
Partnership for appropriate to internal quality measurement goals rather than quality improvement base, addresses known gaps in care and was
Women & Families developed to ultimately improve the quality of care
for patients undergoing screening mammograms.
This measure is appropriate for accountability as it
focuses on measuring performance of individual
clinicians and is restricted to measuring aspects of
care actionable by the individual clinician.
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35 Public Vincent Polkus, GE OIE-008-08 GEHC endorses methods that are directed at increasing regular breast cancer screening compliance as a means of reducing breast Comment appreciated. The measure would
Healthcare cancer mortality. The mammogram reminder system is an appropriate and important step in achieving that goal. The require that the physician, with his/her practice,
requirement that the reminder system automatically generate notifications may present some barriers for many MQSA-accredited has a system in place to allow for reminders if and
practices that provide screening mammography services. NQF should consider the acceptability of a comparable process whereby when they are appropriate. It does not require a
service providers notify patients of follow-on examination dates at the time of their initial index mammogram and subsequently reminder system that generates notification
contact women of the need to return for follow-on examination. Objective evidence of compliance could include but not automatically. The specific attributes of the
necessarily be limited to written procedures of the process and auditable records. reminder system are at the discretion of the
practices who utilize this measure.
36 M, Provider Diane Wilson, OIE-008-08 OIE-008-08 Reminder system for mammogram We agree with this measurement no comments. Comment appreciated.
Organization Butler Memorial
Hospital
37 M, Health Robert Pyatt, OIE-008-08 The ACR is pleased that this measure was recommended for endorsement. Although screening mammograms can reduce breast Comment appreciated.
Professional American College cancer mortality by 20-35% in women aged 40 years and older, recent evidence has suggested a decreasing trend in screening rates
of Radiology and a need for intervention. (CDC, 2005) The use of patient reminders is associated with an increase in screening mammography
and is currently recommended based on the results of a systematic review of studies conducted by the Task Force on Community
Preventive Services. Encouraging the implementation of a reminder system could therefore help to reverse the trend and lead to
an increase in mammography screening at appropriate intervals.Furthermore, the IOM Report (Improving Breast Imaging Quality
Standards) concluded that patient reminder systems are an important and effective tool to encourage women to undergo breast
cancer screening at recommended intervals, and that broader use should be encouraged.Many American women do not receive
mammograms at recommended intervals, as illustrated by a multiyear study of mammography utilization in a large screening
center at Massachusetts General Hospital. It showed that more than half of
women who received a mammogram in 1992 had fewer than five mammograms during the
subsequent 10 years (the expected number if following a 2-year screening interval), and that
only 6 percent received annual mammograms during the entire 10 years. (1)
38 M, Health Robert Pyatt, OIE-008-08 Improving utilization is very important to improving quality. There may be problems with patients who have serious co- Comment appreciated.
Professional American College morbidities receiving letters, but this is outweighed by the patients that are currently underutilizing mammography. The potential
of Radiology for system improvement in this measure would be enhanced by the collection of all of the Birads audit codes as proposed in
Measure OIE-004-08 Mammography assessment category data collection. Thus patients with different screening outcomes would
be best served when the follow-up letter was tailored to their recent screening assessment code. Specifically, patients with early
follow up receive a letter at 6 months, and patients with immediate follow up (BiRads 0,4,5) receive letters earlier.1. Nass S, Ball J,
eds. Improving Breast Imaging Quality Standards. Washington, DC: The National Academies Press; 2005.
39 Public Pam Hayden, OIE-009-08 Do not support with the following comments This measure is interesting but as written does not improve patient care or imaging Steering Committee and Measure Developer agree
North American efficiency. No evidence has been presented that simply recording the duration of fluoroscopy and the radiation expose leads to that increased oversight of fluoroscopy time will
Spine Society improved patient outcomes. The measure does facilitate the collection of data for researchers that may someday result in specific promote acute awareness of radiation exposure
absolute limits on radiation exposure. New measures should first focus on those areas with proven health benefits to patients and levels. The fluoroscopy time for various
to society. Implementation of this measure will increase paperwork and facilitate data collection but will not result in improve procedures can be compared with benchmark
patient care. figures, such as those published by the AAPM
[American Association of Physicists in Medicine.
Managing the use of fluoroscopy in medical
institutions. Madison, Wis: Medical Physics
Publishing; 1998. AAPM Report No. 58.]. If more
complete patient radiation dose data is recorded,
then excessive exposure times and doses can be
further evaluation as part of practices‘ quality
assurance programs and Joint Commission sentinel
event policy. Additionally, including the
exposure/exposure time in the final report will
provide such information to the referring/ordering
physician.
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40 Public Vincent Polkus, GE OIE-009-08 All X-Ray based GEHC imaging systems incorporate advanced imaging technologies and system controls that facilitate consistent Comment appreciated.
Healthcare X-Ray examination outcomes with the least possible radiation dose for adult as well as pediatric applications. GEHC supports
industry-consensus approaches such as the NQF proposal that are directed at measuring fluoroscopic exposure time, actual
radiation dose, or both. This exposure information is important information to assess current performance and to develop future
performance benchmarks that are considerate of inter- and intra-procedural complexity, patient habitus, and other clinical factors.
In addition GEHC is working with ACR to develop strategies for reducing patient dose as summarized in American College of
Radiology White Paper on Radiation Dose in Medicine, 2007; 4: 272-284 including a patient dose index registry to estimate dose as
a function of patient parameters and examination type. GEHC is also engaged with Integrating the Healthcare Enterprise (IHE)
to develop profiles intended to collect and distribute reports detailing patient radiation exposure resulting from all imaging
procedures.
41 M, Health Joyce Bruno, OIE-009-08 Disapprove with comment. On behalf of the American College of Chest Physicians (ACCP) the ACCP Quality Improvement Comment appreciated. The measure developer
Professional American College Committee (QIC) appreciates the opportunity to comment on this measure. While the QIC recognizes the value of the information confirmed that the measure only requires that the
of Chest Physicians attained from this measure and believes this measure to be a basic safety issue, the QIC disapproves this measure. The QIC feels exposure data be included in the procedure final
that collecting and imputing this data into a national registry would be burdensome on the physician and staff. Furthermore, if report, implementation of measures such as this
this information were collected how would it be segmented for the physician and patient to use? Additionally, the QIC recognizes will help drive demand for software vendors to
that there is no evidence, from which a standard for fluoroscopy exposure time can be established. include fields for radiation dose data such as this in
electronic patient records, as well as an impetus for
vendors of digital radiological equipment to
implement standardized exposure indicators on
their equipment. See Line #39.
42 M, Purchaser Gaye Fortner, OIE-009-08 Exposure to radiation is an issue in which more care can actually lead to greater risks for the patient. Patients, along with their Comment appreciated.
HealthCare 21 providers, need to understand the risks and benefits so they can make informed decisions. Exposure time is a good first step and
Business Coalition as it becomes more feasible, dose should also be captured.
43 M, Provider Diane Wilson, OIE-009-08 OIE-009-08 Exposure Time Reported for Procedures Using Fluoroscopy-Documentation of total radiation dose in the patients Comment appreciated. The measure states that if
Organization Butler Memorial record is valuable to determine a patients total lifetime dose of radiation. Some difficulties I see implementing this will be: There automated dose data is not available, fluoro
Hospital is still a significant volume of equipment in use today for standard fluoroscopy procedures that does not calculate the radiation exposure time should be recorded. Secondly,
dose. You can only record the exposure time, a calculation would then have to been completed for each case using the technical although the measure only requires that the
factors, mA, KVP, distance etc..Usually this dose is completed by a Radiation Physicist. Additionally, there is a need to exposure data be included in the procedure final
standardize a place to record the exposure in the patients record. Secondly, what will the data be used for? Who is responsible for report, implementation of measures such as this
reviewing this dose, will the physician ordering the imaging study be responsible for determining the risk verse benefit, what role will help drive demand for software vendors to
will the imaging service provider have in this. include fields for radiation dose data such as this in
electronic patient records, as well as an impetus for
vendors of digital radiological equipment to
implement standardized exposure indicators on
their equipment. See Line #39.
44 M, Purchaser Tanya Alteras, OIE-009-08 Exposure to radiation is an issue in which more care can actually lead to greater risks for the patient. Patients, along with their Comment appreciated.
Consumer- providers, need to understand the risks and benefits so they can make informed decisions. Exposure time is a good first step and
Purchaser as it becomes more feasible, dose should also be captured.
Disclosure Project
45 M, Health Robert Pyatt, OIE-009-08 Radiation induced skin damage is the most common effect occurring as a result of fluoroscopic procedures. It is often difficult to Comment appreciated.
Professional American College diagnose given the two to three week time period from exposure to symptom onset. In order to monitor these short and
of Radiology additional long term effects (i.e., that the lifetime risk for cancer can be increased), the exposure time or radiation dose that a
patient receives as a result of the procedure should be measured and recorded in the patients record. The measure is a first step at
quantitative reporting of radiation exposure for procedures using fluoroscopy. To the point, the Joint Commission recently added
[a] new item to its list of events that are reviewable under its Sentinel Event Policy: Prolonged fluoroscopy with cumulative dose
>1500 rads to a single field or any delivery of radiotherapy to the wrong region or >25% above the planned dose. One of the main
reasons for adding this event to the Joint Commissions list of reviewable sentinel events was to raise awareness of the severity of
the associated outcomes often overlooked or unrecognized because of the delay in their appearance. Although the ACR applauds
the
recommendation to approve this measure, the College is discouraged that a similar measure
was not recommended: OIE-001-08: CT radiation dose reduction, which attempts to address
the well-documented concern over radiation exposure resulting from exponential increases in
the use of CT scans.
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46 M, Consumer Debra Ness, OIE-009-08 We strongly support this measure. Exposure to excess radiation can pose significant risks to patients. It is important for both Comment appreciated.
National patients and providers to understand the risks and benefits of imaging diagnostics so they can make informed decisions. We hope
Partnership for to see a measure developed in the future that builds upon exposure and captures radiation dose.
Women & Families
47 Public Vincent Polkus, GE OIE-010-08 GEHC provides imaging systems that have been deemed by the US FDA to be safe and effective for studies used to evaluate the Comment appreciated.
Healthcare distribution of active bone formation in the body. GEHC supports the process of quality for improved imaging standards and
procedural improvements that relate to NQF efforts to develop industry-consensus standards for bone scintigraphy.
48 Public Pam Hayden, OIE-010-08 Support with no comments. Comment appreciated.
North American
Spine Society
49 M, Purchaser Gaye Fortner, OIE-010-08 We agree with the Committees recommendation that the correlation with existing imaging studies for all patient undergoing bone The measure developer responded, while we agree
HealthCare 21 scintigraphy be applicable at the facility level as well. The rationale for not having it applicable to facilities because it has not been that this measure may be appropriate at the facility-
Business Coalition tested in that arena does not make sense since this is a time-limited measure and has not been tested in the clinician arena as well. level, this measure was developed initially to apply
We also have concerns about the use of not available and strongly recommend this issue be examined during the testing. at the individual clinician level and the scope of the
measure development did not include measures
that would be appropriate at the facility-level. The
reliability/validity of the system reason (e.g., not
available) will be included in the testing of this
measure.
50 M, Purchaser Barbara Rudolph, OIE-010-08 OIE-010-08** Correlation with existing imaging studies for all patients undergoing bone scintigraphy. The Leapfrog Group agrees The measure developer responded, while we agree
Ph.D., The Leapfrog with the Steering Committee that this measure addresses an important area, and that it should encourage providers to conduct that this measure may be appropriate at the facility-
Group appropriate physical examination and imaging prior to bone scintigraphy. We also have concerns about the use of not available level, this measure was developed initially to apply
and strongly recommend this issue be examined during the testing. This measure should also apply at the facility level and at the individual clinician level and the scope of the
recommend that during testing it would be appropriate to test at the facility level as well, to assess the possibility of gaming. measure development did not include measures
that would be appropriate at the facility-level. The
reliability/validity of the system reason (e.g., not
available) will be included in the testing of this
measure.
51 M, Provider Diane Wilson, OIE-010-08 OIE-010-08 Correlation with existing imaging studies for all patients undergoing bone scintigraphy. We agree with the Comment appreciated.
Organization Butler Memorial measurement
Hospital
52 M, Provider Barbara OIE-010-08 Agree with the comments of the work group - difficult to implement. Comment appreciated.
Organization Spreadbury, Child
Health Corporation
of America
53 M, Purchaser Tanya Alteras, OIE-010-08 We agree with the Committees recommend that the correlation with existing imaging studies for all patient undergoing bone The measure developer responded, while we agree
Consumer- scintigraphy be applicable at the facility level as well. The rationale for not having it applicable to facilities because it has not been that this measure may be appropriate at the facility-
Purchaser tested in that arena does not make sense since this is a time-limited measure and has not been tested in the clinician arena as well. level, this measure was developed initially to apply
Disclosure Project We also have concerns about the use of not available and strongly recommend this issue be examined during the testing. at the individual clinician level and the scope of the
measure development did not include measures
that would be appropriate at the facility-level. The
reliability/validity of the system reason (e.g., not
available) will be included in the testing of this
measure.
54 M, Health Robert Pyatt, OIE-010-08 The ACR supports this measure. Correlation with existing radiographs is essential in ensuring that benign conditions are not Comment appreciated.
Professional American College interpreted as tumor. Providing such information in the radiology report ensures proper diagnosis and appropriate patient
of Radiology treatment.
55 M, Madeleine Smith, OIE-010-08 AdvaMed supports the recommendation for limited endorsement because this measure has not gone through a testing phase. Comment appreciated.
Supplier/Ind AdvaMed
ustry
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56 M, Consumer Debra Ness, OIE-010-08 As currently developed, this measure is specified to be used at the clinician level of analysis. We agree with the recommendation Comment appreciated.
National from the steering committee that this measure be applied to the facility level. Given that it is a time-limited measure, we believe it
Partnership for should be tested at the facility level so that it can be applied more broadly.
Women & Families
57 Public Michael Rothman OIE-012-08 Agreed, but given the serious outcomes of even a subtle missed finding, and the limited ability to intercede in an emergent Steering Committee felt that evidence strongly
MD, M. I. Rothman, situation where many other priorities exist, I don't think this is either reasonable or feasible... supports that if the patient does not have these
MD indications that c-spine radiographs should not be
performed.
58 M, QMRI Barbara Corn, OIE-012-08 Comment: Percentage of patients undergoing cervical spine radiographs in trauma who do not have neck pain, distracting pain, Comment appreciated. The medical record is an
NAHQ neurological deficits, reduced level of consciousness. This will not always be coded so the information will have to be pulled from appropriate data source.
the documentation which will require manual review of the documentation for validation.
59 Public Pam Hayden, OIE-012-08 Support with no comments, assuming that the evidence supports this, however, we have not had an opportunity to review the Comment appreciated.
North American evidence due to the time constraints of the review period.
Spine Society
60 M, Purchaser Gaye Fortner, OIE-012-08 We strongly support the measure of percentage of patient undergoing cervical spine radiographs as it addresses appropriateness Comment appreciated.
HealthCare 21 and is supported by good evidence.
Business Coalition
61 M, Provider Barbara OIE-012-08 Our main concern with this indicator is how to actually measure this in actual practice. In particular, how are "trauma" and the Comment appreciated. The measure specifications
Organization Spreadbury, Child other descriptors truly defined and obtained to measure. and supporting text has been modified to offer
Health Corporation clarification.
of America
62 M, Purchaser Tanya Alteras, OIE-012-08 We strongly support the measure of percentage of patient undergoing cervical spine radiographs as it addresses appropriateness Comment appreciated.
Consumer- and is supported by good evidence.
Purchaser
Disclosure Project
63 M, Consumer Debra Ness, OIE-012-08 We support this measure. It is an excellent example of a measure that addresses appropriateness of service use, and is backed up Comment appreciated.
National by strong evidence.
Partnership for
Women & Families
64 M, Purchaser Susan L. Arday, OIE-019-08 Thorax CT Use of Combined Studies (Non-Contrast Thorax CT Study followed by a Contrast Enhanced Thorax CT Study) Comment appreciated.
CMS/OCSQ/QMH Rationale Clinical Basis The proposed measure seeks to promote the use of studies that are considered reasonable for the
AG/DHMM indication while avoiding potentially harmful effects of unnecessary radiation and contrast exposure. The measure assesses
potentially inappropriate utilization of combined thorax CT studies (non-contrast enhanced study performed contemporaneously
with a contrast enhanced study), which carries an element of risk and significantly increases examination cost. Combined CT
studies not only carry an element of risk, but also significantly increase examination costs. The purpose of measuring
inappropriate utilization of combined CT studies is to reduce unnecessary radiation exposure, and to reduce the number of false
positives and negatives. Inappropriate diagnostic imaging services in general may have negative consequences on health
outcomes, including poor test results (false positive, false negative) and the effects of exposure to ionizing radiation and contrast
material. A combined CT study, at a minimum, doubles the
radiation dose to the patient and exposes him/her to the potential harmful side effects of the
contrast material itself.
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65 M, Purchaser Susan L. Arday, OIE-019-08 This measure will be instrumental in identifying practice patterns, and norms for the use of combined studies, as well as Comment appreciated.
CMS/OCSQ/QMH identifying providers that vary substantially from the norms, to document possible inefficient examination protocols. The
AG/DHMM measure allows identification of providers that may employ interdepartmental/facility protocols calling for a combined study for
nearly all cases. While there is inadequate guidance in the literature around appropriate indications for either a contrast or non-
contrast Thorax CT study, there is greater consensus in the lack of indications for use of a combined (non-contrast enhanced
followed by a contrast enhanced study). The measure will identify providers that may employ interdepartmental/facility
protocols that call for a combined study in nearly all cases. In addition to the financial implications, there is a simultaneous
patient safety consideration since a contrast study obtained in conjunction with a non-contrast study increases the radiation dose
to the patient. Financial Basis A June 2008 GAO analysis indicates that Medicare spending on imaging services increased more
than two-fold from 2000 to 2006, with
the proportion of spending on imaging services shifting away from the hospital setting (35%
to 25%) and towards physician offices (58% to 64%) during this time period.
66 M, Purchaser Susan L. Arday, OIE-019-08 Estimates from a 1999 Health Care Financing Administration (now CMS) report suggest that up to 30% of diagnostic imaging is Comment appreciated.
CMS/OCSQ/QMH unnecessary. Abdomen CT examinations are one of the most frequently requested advanced imaging studies, and comprises one
AG/DHMM of the top 10 studies in both volume and cost in the Medicare Fee-for-Service population. Mettler et al. report that over 93% of all
abdominal and pelvic scans in their study were conducted with intravenous contrast. The 7% not using intravenous contrast were
primarily conducted for evaluation of renal or ureteral calculi. This distribution has also likely changed since the year of the study,
as the indications for the performance of non-contrast studies have expanded considerably. Current literature admonishes against
the use of a tailored approach to all CT. Research Basis Application of Evaluation Criteria Framework Throughout the measure
development process, the development team consistently applied the four criteria, as set forth in CMS Measure Manager System
Blueprint for measure development. Specific application of
these criteria to the measure can be summarized as follows:
67 M, Purchaser Susan L. Arday, OIE-019-08 Importance/Relevance: Diagnostic imaging is the fastest growing segment of Medicare spending on physicians services. Between Comment appreciated.
CMS/OCSQ/QMH 1999 and 2003, data from MedPAC indicates that the volume and complexity of services grew by 9.9 percent per year on average,
AG/DHMM nearly twice as fast as all physician services (5.4 percent) during this time period. This measure carries relevance for patient safety
issues related to contrast reactions and excess radiation exposure. Financial relevance is substantial, as the inappropriate use of
combined studies increases the cost of the examination. Scientific Soundness: There is some evidence base available in the
literature related to the appropriate use of contrast agents in the specific indications for the evaluation of solid organs and body
cavities, and there is greater consensus around use of a non-contrast study (stone protocol) for specific urological diagnosis such as
painful hematuria. Analysis of Medicare claims data also indicates that measurement of inefficient practice based on variation has
reliability and face validity. Usability/Actionability: The intended audience (service providers) will easily understand the results
and find them useful
in decision-making. The health care provider can use the results to diminish cost without
compromise of the quality of care. This represents a clear message to the information
recipient and has undeniable day-to-day relevance.
68 M, Purchaser Susan L. Arday, OIE-019-08 Feasibility: Detailed and precise specifications apply to the analysis of a standard claims file for determining utilization ratios as Comment appreciated.
CMS/OCSQ/QMH described herein. The data source, frequency, and provider identification, can all be determined from standard Medicare claims
AG/DHMM files. Because of the ease of acquisition of the data source, the cost of collection is well worth the effort. No distortion of the result
is anticipated. Medicare Claims Evidence CMS limited the testing of the measure to studies performed in the hospital outpatient
and physician office settings the measure was calculated separately for each setting. The calculation for the measure in the
outpatient setting was based on 100 percent of the 2005 Outpatient claims (claims paid under the OPPS/APC methodology). The
measure for the physician office setting was calculated using 100 percent of the 2005 Medicare Physician/Supplier claims (claims
paid under the Medicare physician fee schedule).
69 M, Purchaser Susan L. Arday, OIE-019-08 Table 1 shows the average measure value and coefficient of variation in each setting. The coefficient of variation (CV) is a measure Comment appreciated.
CMS/OCSQ/QMH of how much variability can be observed by calculating the measure for each individual provider (CV values below 100 are
AG/DHMM generally considered to reflect relative stability, and CV values above 100 are generally considered to reflect relative instability or
variability). In both settings, the CV for this measure indicates that there is relative stability among providers with respect to the
proportion of thoracic CT studies they performed with and without contrast material in 2005.
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70 M, Purchaser Susan L. Arday, OIE-019-08 The following table, Exhibit 1, shows the average measure value and coefficient of variation in each setting. The coefficient of Comment appreciated.
CMS/OCSQ/QMH variation (CV) is a measure of how much variability can be observed by calculating the measure for each individual provider (CV
AG/DHMM values below 100 are generally considered to reflect relative stability, and CV values above 100 are generally considered to reflect
relative instability or variability). In both settings, the CV for this measure indicates that there is significant variability among
providers with respect to the proportion of thoracic CT studies they performed with and without contrast material in 2005.
Exhibit 1
Thorax CT – Combined Studies as Proportion of Total Studies
Hospital Outpatient Setting: Average Measure Value = 5.94%; Coefficient of Variation (CV) = 223.64
Physician Office Setting: Average Measure Value = 8.32%; Coefficient of Variation (CV) = 239.13
71 M, Purchaser Susan L. Arday, OIE-019-08 This measure was also analyzed at other summary levels. Key findings include: Of the 65 different specialist types that performed Comment appreciated.
CMS/OCSQ/QMH this study in a physician office setting in 2005, the top three in terms of total studies, diagnostic radiology, independent diagnostic
AG/DHMM testing facility, and hematology/oncology, performed 84.6% of the total studies performed. The average measure values for these
specialties were 7.6%, 13.7%, and 2.9% respectively – the measure for hematologist/oncologist-performed studies was among the
lowest observed for any specialty. This evidence further confirms the significant variability we observed for the measure overall.
Of the studies performed in a hospital outpatient setting, 76% were performed at Hospital-Outpatient (HHA-A also) facilities. The
average measure value for these procedures was 5.7% in 2005, well above average. The second most outpatient studies were
performed at Hospital-Other (Part B) facilities, where the average measure value for these studies was 5.6%.
72 M, Purchaser Susan L. Arday, OIE-019-08 The third most outpatient studies were performed at Special facility or ASC surgery-rural primary care hospital facilities, where Comment appreciated.
CMS/OCSQ/QMH the average measure was considerably higher – 11.6%. The was significant variation in the measure geographically. The highest
AG/DHMM average measure values among individual providers were observed in the California (California, Arizona, Nevada, Hawaii) and
Texas (Texas, Oklahoma, New Mexico, Arkansas, Louisiana) regions at 12.0% and 10.9%, respectively; the lowest average measure
values among individual providers were observed in the Washington (Washington, Oregon, Idaho, Alaska) and Massachusetts
(Massachusetts, Rhode Island, Connecticut, Maine, New Hampshire, Vermont) regions at 3.4% and 4.7%, respectively.
73 M, Purchaser Susan L. Arday, OIE-019-08 Stakeholder Input Informing the Measure Informal Public Comment and Technical Expert Panel As part of the measure Comment appreciated.
CMS/OCSQ/QMH refinement process, all of CMS' proposed imaging efficiency measures were presented to a wide range of potential users,
AG/DHMM stakeholders, organizations and individuals interested in imaging efficiency to solicit feedback. The process generated comment
from a variety of stakeholders including a response from the American College of Radiology (ACR), and was recommended as
written by the NQF steering committee. Many of the public and TEP comments focused on uncertainty in defining via claims
appropriate indications for either a non-contrast only or contrast enhanced only study. As a result, the measure was refined to
look at use of combined studies versus a focus on all contrast-enhanced studies (contrast only and combined). The measure
proposed is a direct reflection of guidance from the measure developers TEP and comments from the ACR. The ACR and TEP
supported the development of measures focusing on the use of contrast material. Specifically the ACR commented that measures
associated with contrast material were reasonable and an
area where evaluation is warranted. The current measure construction reflected in the
measure submission to the NQF varies from the original, in part, based upon the ACR
guidance specifically calling for measurement of combined studies: the focus should be on
routine use of combined, not studies with contrast only.
74 M, Purchaser Susan L. Arday, OIE-019-08 The NQF Steering Committee (SC) recommended this measure as written. The SC's discussion identified that there is clear Comment appreciated.
CMS/OCSQ/QMH indication of when to perform Thorax CTs with or without contrast materials, and that in general, rendering physicians know how
AG/DHMM to make a clinical decisions in these circumstances. Conclusion The indiscriminate use of combined Thorax CT studies defined as
those that are performed without and with contrast agents for the evaluation of solid organs and body cavities represents a serious
inefficiency of practice and a patient safety issue. Extensive claim analysis from the private sector suggests that a significant
pattern of variation exists among high volume providers in their use of combined studies related to Thorax CT. Facilities using
combined contrast enhanced studies in cases where consensus suggests otherwise are likely to be following unproven protocols
and not tailoring the examinations to the needs of the individual patient, while those that seldom or never perform combination
examinations suggest the absence of skilled staffing or emergency equipment to care for the rare but likely adverse reaction. Either
of these
conditions represents a significant measurable and correctable inefficiency of practice that
must be addressed.
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75 M, Purchaser Susan L. Arday, OIE-019-08 REFERENCES: 1. Elicker B, Cypel Y. IV Contrast Administration for CT: A Survey of Practices for the Screening and Prevention Comment appreciated.
CMS/OCSQ/QMH of Contrast Nephropathy. AJR. 006; 186:1651-1658. 2. Government Accountability Office. Medicare Part B Imaging Services:
AG/DHMM Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices.
GAO-08-452 (Washington, DC: June 2008). 3. Health Care Financing Administration. 1999 HCFA statistics. Washington, DC: US
Government Printing Office; April 2000. HCFA publication 03421.4. Based on internal analyses of CMS 2005 5% Sample Hospital
Outpatient and Carrier Standard Analytic Files. 5. Mettler F. CT scanning: patterns of use and dose. J. Radiol. Protection. 20
(2000): 353-359. 6. Chen M, Zagoria R, et al. Trends in the use of unenhanced helical CT for acute urinary colic. American
Journal of Roentgenology. (1999) Vol 173: 1447-1450. 7. Lautin E, Novick M, Jean-Baptiste R. Tailored CT: primum non nocere.
British Journal of Radiology. (2008) Vol 81: 442-443. 8. MedPAC. Continued...
76 M, Purchaser Susan L. Arday, OIE-019-08 Continued... Recommendations on Imaging Services. Statement of Glenn M. Hackbarth, J.D., Chairman of the Medicare Payment Comment appreciated.
CMS/OCSQ/QMH Advisory Commission, before the US House Committee on Energy and Commerce, Subcommittee on Health. July 18, 2006.9.
AG/DHMM Memo from the American College of Radiology to Kerry N. Weems, CMS
Administrator (acting). December 14, 2007.
77 Public Vincent Polkus, GE OIE-019-08 GEHC recognizes the efforts of industry stakeholders to further refine the appropriate use of non-invasive diagnostic imaging thru Comment appreciated. The measure developer
Healthcare industry coalition efforts. GEHC supports initiatives directed at, accreditation programs to ensure qualified and trained personnelsought input to the proposed measure
are operating imaging systems. Relative to cervical spine imaging criteria, GEHC believes that appropriateness criteria should development from a technical expert panel
originate from recognized medical-specialty organizations. consisting of individuals from various medical
specialty societies. In addition to TEP
endorsement, the NQF Steering Committee
recommended this measure for approval. Finally,
the ACR provided comment that they support this
measure.
78 M, Health Joyce Bruno, OIE-019-08 Disapprove with comment. On behalf of the American College of Chest Physicians (ACCP) the ACCP Quality Improvement Comment appreciated. The measure developer
Professional American College Committee (QIC) appreciates the opportunity to comment on this measure. While the QIC agrees with the concept of the measure, concurs there is inadequate guidance in the
of Chest Physicians the QIC does understand what this measure is attempting to measure. Furthermore, the measure does not clearly specify the literature to support routine use of either a non-
indications and contra-indications for when contrast should and should not be used. Overall, the QIC feels this is a reimbursement contrast only or contrast-enhanced only study.
rather than a quality issue. Perhaps, this would be better handled by denying reimbursement for use of contrast when contrast Consensus was expressed by the measure
should not have been ordered for a respective indication. developer's technical expert panel, NQF steering
committee and ACR comments that there are few
indications for the use of combined Thorax CT
studies. This measure seeks to identify practice
variation in the use of combined Thorax CT which
may be considered inefficient. While quality is
inextricably linked to efficiency, the focus of this
measure is to identify inappropriate/wasteful use
of imaging studies. Clarifying text has been added
to the report.
79 M, Purchaser Barbara Rudolph, OIE-019-08 OIE-019-08 Use of contrast: Thorax CT The Leapfrog Group strongly supports this measure it will reduce the amount of exposure Comment appreciated.
Ph.D., The Leapfrog to excess radiation, reduce cost, and will motivate providers to more appropriately assess which of the two forms of contrast
Group should be ordered. Combined studies should not be part of provider protocols.
80 M, Provider Diane Wilson, OIE-019-08 OIE-019-08 Use of contrast : Thorax CT We agree with the measurement no comments Comment appreciated.
Organization Butler Memorial
81 M, Health Hospital
Nancy Nielsen, OIE-019-08 Request for Clarification on Measure OIE-19-08: We agree that combined CT studies should be used only when clinically necessary We (the measure developer) appreciate the support
Professional AMA and exposure times for patients should be minimized. We believe that the goal for this measure is for a clinician or facility to and comments. Consensus was expressed by the
achieve a low rate of performance; however, it is not clearly stated in the measure description or specifications. We recommend measure developer's technical expert panel, NQF
that the intent of the measure be clarified and a note included with the measure indicating that lower performance rates are steering committee and ACR comments that there
desirable. are few indications for the use of combined Thorax
CT studies. As a result, the expectation, confirmed
through an analysis of Medicare claims data, is that
the aggregate measurement result will be low. The
measure seeks to identify practice variation in the
use of combined Thorax CT which may be
considered inefficient. Clarifying text has been
added to the report.
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82 M, Health Robert Pyatt, OIE-019-08 It is unclear whether the measure is evaluating performance of studies with contrast or combined with and without contrast Comment appreciated. The measure developer
Professional American College studies. The focus should be on routine use of combined, not studies with contrast only. During a recent review of the ACR concurs there is inadequate guidance in the
of Radiology Thoracic CT guideline, thoracic experts debated largely whether the basic exam should be with contrast or without. There was no literature to support routine use of either a non-
argument for routine use of combined studies. There are clear indications to use without contrast for parenchyma and contrast only or contrast-enhanced only study.
calcification, with contrast for adenopathy or PE. The measure specifications also are unclear as to the performance rate desired. Consensus was expressed by the measure
The numerator is the number of studies with contrast plus the number of combined studies OVER the denominator of all studies developer's technical expert panel, NQF steering
(including those without contrast). Is a lower rate better? committee and ACR comments that there are few
indications for the use of combined Thorax CT
studies. While preliminary versions of the measure
looked at both contrast only and combined studies,
the current measure submitted to NQF, is
constructed as the number of combined studies
divided by total studies. This measure seeks to
identify practice variation in the use of combined
Thorax CT which may be considered inefficient.
The aggregate measure result is expected and has
been confirmed by an analysis of Medicare claims
data to be low.
83 M, Madeleine Smith, OIE-019-08 AdvaMed would like to know if the measure will answer the question of what medical benefit the administration of contrast Comment appreciated. The measure is neutral on
Supplier/Ind AdvaMed material provided. the medical benefit of contrast material. The
ustry measure developer believes the literature is
inadequate to support routine use of either a non-
contrast or contrast-enhanced study; however,
there is greater consensus that there are few
indications for use of combined Thorax CT studies.
84 M, Provider Margaret Reagan, OIE-019-08 Disapprove with comment. The measures pertaining to the diagnostic imaging studies are unadjusted utilization rates; they are Comment appreciated. As a general concept the
Organization Premier, Inc. not measures of efficiency. Unadjusted utilization rates could potentially be measures of efficiency in a standardized industrial measure developer concurs that patient mix can
process in which all components are uniform from one case to the next. This is simply not the case in health care and for reasons impact utilization rates; however the measure
stated below the optimum rate or the appropriate rate may be very difficult to determine. It is difficult, if not impossible, to know assumes that patient mix is equally distributed by
the optimum (or appropriate) rate of these procedures for each facility population. The optimum rate of each of these is not 100%, provider and that centers of excellence/unusual
nor is it 0. Beyond these extremes, the appropriate rate will be determined based upon the underlying population, including the variation can be easily identified in the claims. We
reason for the procedure, the accompanying comorbid conditions and the underlying rate a particular disease in the population. sought input to the proposed measure from a
Diagnostic facilities associated with acute care centers might be expected to have more diagnostically complex cases, cases with technical expert panel consisting of individuals
high comorbidities, or cases which have been referred to the institution when simpler diagnostic procedures have been from various medical specialty societies. In
uninformative. Without any way of addition to TEP endorsement, the NQF Steering
accounting for the nature of the populations, the utilization rates of these procedures, though Committee recommended this measure for
easily obtained, is not likely to be an informative measure, nor is it likely to provide any approval. Finally, the ACR provided comment
information on the quality of care being provided. that they support this measure.
85 M, Provider Margaret Reagan, OIE-019-08 Secondly, one must be careful not to attend to the effect of local maxima, but rather optimize the entire diagnostic process. It may Comment appreciated. The measure developer
Organization Premier, Inc. be that performing a procedure with contrast could provide a definitive diagnosis, whereas performing a procedure without agrees that the that case mix is important and
contrast, though less expensive, would lead to an inconclusive diagnosis and the need for repeated testing, thus increasing the necessary for defining clinical efficacy. The intent
total cost of the diagnosis. Isolated components of the diagnostic process should be studied only in the context of knowledge of of this measure is to detect system inefficiencies
the effects on the entire process. These tests are not conducted in isolation of other diagnostic and therapeutic modalities, and suggested by either very high or very low use rates
trying to optimize their rate without consideration of the broader economic and clinical outcomes, has the potential to be and not too define new science. With the exception
misleading. of centers of excellence, our assumption is that with
a significant number of examinations, variations
attributable to case mix are neutralized when
making comparisons between various providers.
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86 M, Purchaser Susan L. Arday, OIE-020-08 Lumbar MRI is a common study to evaluate patients with suspected disease of the lumbar spine. The most common indications Comment appreciated.
CMS/OCSQ/QMH for this study include low back pain and neurological deficits in the lower extremities. Many patients without lumbar spine
AG/DHMM symptoms have abnormal Lumbar MRI exams. Even large herniated discs seen on a Lumbar MRI can resolve with conservative
therapy. Hence, there is a poor correlation between MRI findings and clinical course, and the results of a Lumbar MRI may have
little or no influence on the management of most patients with low back pain that do not need invasive therapy. While this
measure is categorized as a negative study evaluation, it is more correctly characterized as a low clinical impact examination
because it rarely affects subsequent treatment whether positive or negative. Lumbar MRI for low back pain is not typically
indicated unless the patient has received a period of conservative therapy and serious symptoms persist. Throughout the measure
development process, the measure development team consistently applied the four criteria, as set forth in CMS Measure Manager
System (MMS) Blueprint for measure development.
87 M, Purchaser Susan L. Arday, OIE-020-08 The MMS is aligned and harmonized with the NQFs Consensus Development Process (CDP), resulting in rigorous measurement Comment appreciated.
CMS/OCSQ/QMH development and maintenance procedures in the MMS. Specific application of MMS criteria to the measure are summarized as
AG/DHMM follows: Importance/ Relevance: This measure carries significant epidemiologic relevance in that it is aimed at reducing the use of
an examination that, when misused, carries significant risk of false positive misinterpretation, possible exacerbation of symptoms
from positive reinforcement and a significant loss of on-the-job productivity. Financial relevance is substantial as lumbar spine
imaging represents the second most commonly utilized advanced imaging study. This measure carries modest policy implications
as it will reinforce already accepted guidelines. Scientific Soundness: An explicit evidence base is available in the peer-reviewed
literature that repeatedly demonstrates the clinical need for conservative therapy prior to diagnostic imaging in common back
pain. The measure is scientifically reliable and demonstrates face-validity, as well as external criteria that have been scientifically
developed and continually
reassessed throughout the past two decades. The results may be compared among population
cohorts and therefore risk adjustment will be necessary based on age and sex.
88 M, Purchaser Susan L. Arday, OIE-020-08 Usability/Actionability: The intended audience (health care providers) will easily understand the premise and the results and find Comment appreciated.
CMS/OCSQ/QMH them useful in decision-making. The health care provider can use the results to improve productivity and diminish the direct cost
AG/DHMM of imaging without compromising quality of care. This represents a clear message to the information recipient and has undeniable
day-to-day relevance in both elective and emergency settings. Feasibility: Detailed and precise specifications easily apply to the
analysis of a standard claims file for determining the frequency that lumbar MRI imaging occurs in the absence of indicators of
conservative therapy. The data source, (claim files), provider identification, and site of service can all be determined from the
Medicare claims files through ResDAC (Research Data Assistance Center). Considering the ease of acquisition of the data source,
the cost of collection is well worth the effort. Finally, we anticipate modest distortion in the results due to a compromised (coding)
ability to exclude acute trauma and tumor diagnosis from the study group.
89 M, Purchaser Susan L. Arday, OIE-020-08 Medicare Claims Evidence Testing of the measure was limited to MRI studies performed in the hospital outpatient and physician Comment appreciated.
CMS/OCSQ/QMH office settings. The measure separately calculated for MRI studies performed in each setting (though the antecedent conservative
AG/DHMM therapy could take place in either setting). The calculations for the measure were based on 100 percent of the 2005 Outpatient
claims (claims paid under the OPPS/APC methodology) and 100 percent of the 2005 Medicare Physician /Supplier claims (claims
paid under the Medicare physician fee schedule). Table 1 shows the average measure value and coefficient of variation in each
setting. The coefficient of variation (CV) is a measure of how much variability can be observed by calculating the measure for each
individual provider (CV values below 100 are generally considered to reflect relative stability, and CV values above 100 are
generally considered to reflect relative instability or variability). While there was significant variability in the measure between
the two settings, the CV for this measure indicates that there was relative stability among providers with respect to the proportion
of patients
receiving antecedent conservative therapy in 2005 within each setting.
90 M, Purchaser Susan L. Arday, OIE-020-08 The following table, Exhibit 1, shows the average measure value and coefficient of variation in each setting. The coefficient of Comment appreciated.
CMS/OCSQ/QMH variation (CV) is a measure of how much variability can be observed by calculating the measure for each individual provider (CV
AG/DHMM values below 100 are generally considered to reflect relative stability, and CV values above 100 are generally considered to reflect
relative instability or variability). While there was significant variability in the measure between the two settings, the CV for this
measure indicates that there was relative stability among providers with respect to the proportion of patients receiving antecedent
conservative therapy in 2005 within each setting.
Exhibit 1
Lumbar MRI – Proportion with Antecedent Conservative Therapy
Hospital Outpatient Setting: Average Measure Value = 22.10%; Coefficient of Variation (CV) = 76.86
Physician Office Setting: Average Measure Value = 59.90%; Coefficient of Variation (CV) = 45.80
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91 M, Purchaser Susan L. Arday, OIE-020-08 We also analyzed this measure at other summary levels. Key findings include: There was relative stability in the measure across Comment appreciated.
CMS/OCSQ/QMH specialties. Of the 57 different specialist types that performed the MRI study in a physician office setting in 2005, the top three in
AG/DHMM terms of total studies, diagnostic radiology, independent diagnostic testing facility, and orthopedic surgery, performed 91.9% of
the total studies performed. The average measure values for these specialties were 60.2%, 60.0%, and 57.6% respectively. Of the
studies performed in a hospital outpatient setting, 94.4% were performed at Hospital-Other (Part B) or Hospital-Outpatient (HHA-
A also) facilities. In these facilities, the average measure values for MRI lumbar studies were 21.6% and 22.3%, respectively, in
2005. The third highest outpatient studies (5.5% of total studies) were performed at special facility or ASC surgery-rural primary
care hospital facilities, where the average measure value was very similar – 22.3%.
92 Susan L. Arday, OIE-020-08 There was some variation in the measure geographically. The highest average measure values among individual providers were Comment appreciated.
CMS/OCSQ/QMH observed in the New York (New York, New Jersey, Puerto Rico, Virgin Islands) and California (California, Arizona, Nevada,
AG/DHMM Hawaii) regions at 62.5% and 61.5%, respectively; the lowest average measure values among individual providers were observed
in the Washington (Washington, Oregon, Idaho, Alaska) and Missouri (Missouri, Kansas, Nebraska, Iowa) regions at 55.1% and
55.6%, respectively.
93 M, Purchaser Susan L. Arday, OIE-020-08 Providers who performed these MRI studies least often (9 or fewer procedures in a physician office setting in 2005) also performed Comment appreciated.
CMS/OCSQ/QMH them for patients who had received antecedent conservative therapies least often – 57.0% of the time on average – and providers
AG/DHMM who performed MRI studies most frequently (more than 500 procedures in a physician office setting in 2005) also performed them
for patients who had received antecedent conservative therapies most often – 61.2% of the time on average.
Stakeholder Comments
As part of the measure refinement process, the measures were presented by the measure developer to a wide range of potential
users, stakeholders, organizations and individuals interested in imaging efficiency to solicit feedback.
94 Susan L. Arday, OIE-020-08 The process generated comment from a variety of stakeholders including response from the American College of Radiology Comment appreciated.
CMS/OCSQ/QMH (ACR). Comments reflected general support for the measure. The process included iterative revisions, reflected in the current NQF
AG/DHMM submission of the measure. Specifically addressed in the process and reflected in the currently proposed measure is the exclusion
of ‗red flag‘ indicators such as cancer, recent trauma, recent IV drug abuse and recent neurologic impairment. In addition to
addressing the clinical concern, the red-flag exclusion serves to better harmonize the measure with the existing NQF endorsed
NCQA/HEDIS measure on "Low Back Pain: Use of Imaging Studies".
95 M, Purchaser Susan L. Arday, OIE-020-08 Conclusion Low back pain affects a reported 5.6 percent of U.S. adults each day. Ironically, the premature performance of a Comment appreciated.
CMS/OCSQ/QMH Lumbar MRI study in an uncomplicated episode of low back pain is not a benign study as it has been proven to often increase
AG/DHMM symptoms in individuals as the result of positive reinforcement. Guidelines issued by the Agency for Healthcare Quality and
Research (AHRQ) in the mid 1990s and subsequently ratified by national orthopedic, osteopathic and chiropractic associations
clearly spell out the time proven method for the treatment of back pain absent red flag findings such as infection, tumor, cauda
equine syndrome, etc. Studies such as those published in the Archives of Family Medicine conclude. The management of patients
with acute low back problems by primary care physicians differs significantly from Agency for Health Care Policy and Research
(now AHRQ) guideline recommendations in several key areas that include awareness of red flags, use of medication, use of
radiographic studies, the need for patient education, and the use of physical modalities. [Continued...]
96 M, Purchaser Susan L. Arday, OIE-020-08 [Continued...]The management of patients with back pain often involves the performance of a Lumbar MRI on the first visit, Comment appreciated.
CMS/OCSQ/QMH which is directly contrary to accepted treatment consensus. This type of inefficient provider behavior is easily determined by a
AG/DHMM simple claims analysis looking for evidence of antecedent conservative treatment.
97 M, Purchaser Susan L. Arday, OIE-020-08 In the absence of codes indicative of red flag conditions the medical claim record should demonstrate an antecedent indication of Comment appreciated.
CMS/OCSQ/QMH physical therapy, anti-inflammatory or pain reduction agents, chiropractic treatment or other elements of supervised conservative
AG/DHMM care. Certainly some affected individuals will self medicate over a period of time and as a result of the lack of claims evidence
may appear as a false positive (no conservative treatment before Lumbar MRI) but they are stated to be less than one percent in
personal communication to the NQF by the SC participating orthopedic surgeon Robert Haralson, MD. This efficiency measure
harmonizes with the NCQA/HEDIS objective of decreasing inappropriate spine imaging in low back pain. Adding a CPT Level II
code, as suggested by the NQF steering committee, would cause this measure to no longer harmonize with the companion
NCQA/HEDIS measure.
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98 M, Purchaser Susan L. Arday, OIE-020-08 REFERENCES: 1. Gilbert FJ, et al. Low Back Pain: Influence of Early MR Imaging or CT on Treatment and Outcome--Multicenter Comment appreciated.
CMS/OCSQ/QMH Randomized Trial. Radiology. 2004 Mar 18. 2. Acute low back problems in adults: assessment and treatment. Rockville, MD:
AG/DHMM AHCPR, 1994. (Quick reference guide for clinicians; no.14). AHCPR Publication No. 95-0643. 3. Gordon Waddell. The Back Pain
Revolution. 2004 Elsevier Health Sciences ISBN 0443072272. pp43 ff. 4. NIA Magellan data of claims in the Medicare Advantage
population. 5. Loney PL, Stratford PW. The prevalence of low back pain in adults: a methodological review of the literature. Phys
Ther. 1999; 79:384-96. 6. Gilbert FJ, et al. Low Back Pain: Influence of Early MR Imaging or CT on Treatment and Outcome--
Multicenter Randomized Trial. Radiology. 2004 Mar 18.7. Di Lorio D, Henley E, Doughty A. A Survey of Primary Care Physician
Practice Patterns and Adherence to Acute Low Back Problem Guidelines. Arch Fam Med. 2000; 9:1015-1021.
99 Public Michael Rothman OIE-020-08 Agreed. Improved clinical history, physical exam findings and response to prior treatments strongly improves report integration Comment appreciated.
MD, M. I. Rothman, into overall patient care pathways.
MD
100 Public Yair Safriel, OIE-020-08 In essence, the lumbar spine MRI measure takes the prerogative out of a physicians hand as to when to order a lumbar MRI. Comment appreciated. The Steering Committee
Radiology Therefore, if a young patient has a sudden attack of acute back pain that is limiting his work or limiting a mothers ability to take acknowledges the difficulty to determining the
Associates of care of her children but does not complete debilitate him/her, the patient will have to wait six weeks or be completely debilitated course of treatment for these types of patients.
Clearwater before he can have a diagnostic MRI. The guidelines also specifically state that during those 6 weeks part of conservative care Lumbar MRI for low back pain (excluding
includes ESI's - how can one do an ESI if one doesn't know which level to aim for? This is a very dangerous item. While all the operative, acute injury or tumor patients) is not
other items in the quality markers seek to improve quality of care (ensuring that actual stenosis is reported for carotid US, etc) or typically indicated unless the patient has received a
force a physician to do something they may have otherwise omitted, this item is designed only to save money for the insurers as period of conservative therapy and significant
there is no possible patient benefit in fewer MRI scans and there may be harm as described above. symptoms persist.
101 Public Yair Safriel, OIE-020-08 If quality measures are allowed to go this way, we go down a slippery slope of having a physician's ability to care for patients Comment appreciated.
Radiology constricted by insurers in the name of 'quality'.
Associates of
Clearwater
102 Public Barry Kraus, OIE-020-08 This item should not be passed. Many patients with low back pain benefit from noninvasive therapy that depends upon MR Comment appreciated. The Steering Committee
Radiology imaging for guidance. Specifically, epidural steroid injections, facet injections, and nerve blocks are often performed within the and the measure developer agreed that ―injectable
Associates of first six weeks after onset of pain. Choosing the appropriate site for injection depends upon guidance from MRI. I am concerned analgesics‖ be removed from the list of appropriate
Clearwater that, if this section is implemented, patients would undergo CT scans more often, with resultant less useful information and an antecedent conservative therapy preceding MRI as
increase in radiation exposure. Or worse, patients would be denied access to potentially minimally invasive therapies that would an epidural injection, a type of injectable analgesic,
alleviate pain and suffering. Thank you. necessitates an MRI prior to the procedure.
103 Public Patrick Turski, OIE-020-08 ASNR Comments: While the objective of educating referring physicians about appropriateness and potentially influencing Commented appreciated. The measure developer
American Society of inappropriate utilization is good, there are some issues with the proposed language. 1) The principal problem with this measure is sought input to the proposed measure
Neuroradiology the attribution of responsibility solely to the radiology practice. In most cases the primary care or ordering physician is in the best development from a technical expert panel
position to access the requisite information to comply with the measure. Once the test has been ordered, or the patient has arrived consisting of individuals from various medical
for imaging, any cancellation of the examination by the imaging facility/radiologist causes a significant negative impact on the specialty societies. In addition to TEP
doctor patient relationship. Furthermore, the radiologist may erroneously cancel an indicated examination because he/she and the endorsement, the NQF Steering Committee
patient may be unaware of the appropriate indication for imaging that led to the referral. This is especially true of elderly, recommended this measure. The developers agree
cognitively impaired, low socioeconomic status, immigrant and other hard to serve populations that are most likely to be affected that the radiologist does not occupy a primary role
adversely by this measure. 2) The measure creates a conflict in management in which a physician considering performing an in the decision as to when to obtain imaging
image studies, however, we believe that an efficient
guided spinal injection procedure is required to do so prior to imaging. Imaging which is radiology (imaging) practice will consult with its
typically done before the procedure may help with decision-making regarding the procedure. referring physicians regarding appropriate use of
The current wording proposes that the injection itself is taken as evidence of an indication for this technology. It is not the role of a radiologist to
imaging by the measure. (continued..) categorically deny an examination but he/she does
have a contingent role in assuring appropriate use
of the technology.
104 Public Patrick Turski, OIE-020-08 ASNR Comments Continued..3) The exclusion of "red flag" diagnoses is inadequate: For example, the patient may present with Comment appreciated. This measure is not
American Society of back pain and carry a diagnosis of malignancy that has not been active for the period of data analysis. 4) The measure endorses intended to establish scientific, clinical indications
Neuroradiology certain modes of therapy that are supported only weakly if at all in practice guidelines, over less expensive and equally effective but rather to identify inappropriate variations from
modes for which no CPT or system cost is present, e.g. self treatment by over the counter non-steroidal anti-inflammatory drugs, accepted consensus. The measure exclusions were
and alteration of activities of daily living for a period of time. As presented, the measure is likely to increase the cost of services by constructed to harmonize with the NQF-endorsed,
endorsing unproven modes of therapy, discouraging inexpensive equally effective approaches and by adversely impacting the NCQA Measure 'Low Back Pain: Use of Imaging'
doctor patient. measure.
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105 Public Patrick Turski, OIE-020-08 Additional comments received by ANSR from the membership: Patients with fever, compromised immune status or diabetes or Comment appreciated. This measure is not
American Society of elevated C reactive protein probably should be excluded from a waiting period as well because MR will pick up infection much intended to establish scientific, clinical indications
Neuroradiology sooner than any other imaging modality. This will be a very difficult study for Radiologists to comply with as we do not have but rather to identify inappropriate variations from
access to the prior management of the patient and associated E/M codes. This will take a substantial investment in administrative accepted consensus. The measure exclusions were
infrastructure in order for sites to be compliant.(...) I did not see anything regarding acute infection in the lumbar spine except for constructed to harmonize with the NQF-endorsed,
history of drug abuse. If a patient presents with acute back pain and fever, one needs to rule out discitis and osteomyelitis and the NCQA Measure 'Low Back Pain: Use of Imaging'
patient should not wait for the completion of 6 weeks of conservative therapy. They should include signs and symptoms of measure.
infection as reasons not to require conservative therapy. (continued..)
106 Public Patrick Turski, OIE-020-08 Additional comments received by ANSR from the membership continued...This constitutes an inappropriate assignment of Comment appreciated. The measure developer
American Society of sought input to the proposed measure
responsibility for appropriateness of spine MRI to the radiologist. This seems to be a stretch of the intent of quality metrics-- the
Neuroradiology physician doing the reporting is not the one whose quality is being evaluated. I understand that one could argue that part of a development from a technical expert panel
consisting of individuals from various medical
radiologists' responsibility is to screen study requests for appropriateness, but it seems much more direct to say that in most cases,
physicians treating routine back pain shouldn't refer patients for imaging without first attempting conservative therapy. The specialty societies. In addition to TEP
referrals should be measured (by the physicians requesting them), not the radiology reports. If one wants to use "pay for endorsement, the NQF Steering Committee
performance" as a tool to reduce inappropriate referrals, the focus (and penalty) should be on the referrer. Medicare already has a recommended this measure. The developers agree
powerful tool in place to reduce the cost of studies without carrier-approved indications/non-coverage.-The data tracking for this that the radiologist does not occupy a primary role
project is significantly problematic for the radiologist and in many ways would result in practice impairment. The proposal will in the decision as to when to obtain imaging
drive the antecedents to lumbar spine studies, however we believe that an efficient
MRI inappropriately -There will be some patients that will be denied lumbar spine MRI radiology (imaging) practice will consult with its
studies to their detriment because they fall outside of the listed exclusions, potentially raising referring physicians regarding appropriate use of
medical legal issues. this technology. While one might conjecture that
these measures may be used as some form of a pay-
for-performance element for a radiology practice,
this was not the developer's imperative or goal.
The improved efficiency of a radiology practice
that maintains a good working relationship with its
referring physicians cannot be disputed and may
serve a useful role in pay-for-performance
differential payment, but is also important in and
of itself.
107 Public Pam Hayden, OIE-020-08 Support with the following comments. This measure as written applies to patients with LBP (axial pain) and also to patients with Comment appreciated. The Steering Committee
North American LBP and sciatica. The measure combines two different pathologies. While the early treatment for these two different and the measure developer agreed that ―injectable
Spine Society presentations is often similar there are differences which complicate addressing them with one measure. For example, in a patient analgesics‖ be removed from the list of appropriate
with axial back pain from a muscle strain, in the absence of red flags, we agree that an MRI should not be ordered without an antecedent conservative therapy preceding MRI as
attempt of medical management. However, in a patient with acute LBP and sciatica and without a neurologic deficit, if an an epidural injection, a type of injectable analgesic,
epidural cortisone injection is recommended within the first 6 weeks, most practitioners require an imaging study to confirm the necessitates an MRI prior to the procedure.
diagnosis and to plan the site of injection.
108 Public Pam Hayden, OIE-020-08 Conservative Care Inclusion of OTC Medications Definition of conservative care should also include oral medication prescribed by Comment appreciated. The measure developer
North American the treating MD. Treatment with NSAIDs and other oral medications is useful in controlling the patients pain in an effort to agrees that OTC is important. The measure intends
Spine Society realize the excellent natural history of patients with acute exacerbations of low back and leg pain. American College of Physicians to capture use of OTC medication with the
(ACP) guidelines published in the Annals of Internal Medicine (147[7], Oct 2007, pp478-491) recommend acetaminophen and inclusion of E&M office visit claims. One may infer
NSAIDs as first line treatment (Recommendation #6, strong recommendation, moderate evidence). Limiting this measure to that there would be the occurrence of an office visit
treatment supervised by a treating physician may obviate some of the obvious difficulties in assessing home treatment with OTC if OTC medications were recommended -- the
meds. treating physician prescribing would have seen the
patient for a history and physical with a recorded
E&M office visit.
109 Public Pam Hayden, OIE-020-08 Conservative Care-Inclusion of OTC Meds. The list of conservative treatments which might be considered before an imaging Comment appreciated. The Steering Committee
North American study, includes injectable analgesic care. Is this an epidural injection? If yes, then again most practitioners require an MRI prior to and the measure developer agreed that ―injectable
Spine Society this treatment. Initial treatment for LBP may be instituted following a phone call or internet communication with a physician. An analgesics‖ be removed from the list of appropriate
E/M visit code for these services is often not submitted due to no, limited or minimal insurance coverage for these procedure antecedent conservative therapy preceding MRI as
codes. The lack of a documented E/M visit may not indicate a lack of supervised medical care. Finally there is little evidence that an epidural injection, a type of injectable analgesic,
supervised medical care for acute LBP is any better than self administered treatment with modified activity and OTC medications. necessitates an MRI prior to the procedure.
The time from the onset of symptoms may be a better yardstick for determining the need for an imaging study.
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110 Public Pam Hayden, OIE-020-08 Exclusions should also include patients with immunosuppression and uncontrolled pain. Patients should also be excluded when Comment appreciated. The measure developer
North American there is a clinical or radiological suspicion of infection or malignancy (fever or weight loss), and in patients with radiological sought input to the proposed measure
Spine Society evidence of infection or malignancy (e.g. osteolytic or destructive lesion, or unexplained fracture on plain radiography). All of development from a technical expert panel
these exclusions, with the exception of uncontrolled pain, are included in the American College of Radiology (ACR) consisting of individuals from various medical
appropriateness Criteria (Bradley, AJNR 28, May 2007, pp990-992). In addition, the severity of a neurologic deficit, if present, may specialty societies. In addition to TEP
mitigate against "conservative management" and render lumbar spine MRI appropriate in the acute setting without "conservative endorsement, the NQF Steering Committee
management" or OTC medications. NQF should consider inclusion of other "red flag" conditions (e.g. long term steroid use, recommended this measure as acceptable. We
history of fever of unknown origin, etc.). Harmonization with NQF#0052.The supporting text currently indicates that "lumbar have considered the other suggested extenuating
MRI is an appropriate study to evaluate patients with low back pain accompanied by a measurable neurological deficit in the circumstances and do not feel that they will
lower extremity(s) unresponsive to materially impact the intent of the measure.
conservative management." NQF should consider clarifying this statement per prior NQF However, we do agree that significant pain in an
#0052 and differentiate between acute and chronic low back pain. The previously endorsed NQF immunosuppressed individual should be included
#0052 applies to acute low back pain only. with the standard "Red Flags".
111 Public Vincent Polkus, GE OIE-020-08 GEHC recognizes the efforts of industry stakeholders to further refine the appropriate use of non-invasive diagnostic imaging thru Comment appreciated. The measure developer
Healthcare industry coalition efforts and believes that appropriateness criteria for the MRI lumbar spine quality metric proposed by NQF sought input to the proposed measure
should originate from recognized medical-specialty organizations. development from a technical expert panel
consisting of individuals from various medical
specialty societies. In addition to TEP
endorsement, the NQF Steering Committee
recommended this measure for approval. Finally,
the ACR provided comment that they support this
measure.
112 Public Pam Hayden, OIE-020-08 Disagree with wording--"For example, in a patient with axial back pain from a muscle strain, in the absence of red flags, we agree Comment appreciated. The Steering Committee
North American that an MRI should not be ordered without an attempt of medical management. "The contention that axial back pain arises form "a and the measure developer agreed that ―injectable
Spine Society muscle strain" is not substantiated by any diagnostic method. Reword: "For example, in a patient with acute axial back pain, in the analgesics‖ be removed from the list of appropriate
absence of red flags, we agree that an MRI should not be ordered without an attempt of medical management.""... However, in a antecedent conservative therapy preceding MRI as
patient with acute LBP and sciatica and without a neurologic deficit, if an epidural cortisone injection is recommended within the an epidural injection, a type of injectable analgesic,
first 6 weeks, most practitioners require an imaging study to confirm the diagnosis and to plan the site of injection. ""sciatica" is an necessitates an MRI prior to the procedure.
obsolete term. "Radicular pain" or "referred somatic pain" is appropriate. "epidural cortisone" is not accurate. "cortisone" refers to
a specific type of water soluble contrast which is rarely, if ever, used for transforaminal epidural steroid injection. Suggest
rewording to: "... However, in a patient with acute LBP and severe suspected
radicular pain, in the absence of a demonstrable motor or sensory radiculopathy, MRI may be
indicated to determine whether a focal source of compressive pathology (e.g. disc herniation,
protrusion) may be present corresponding with the clinical distribution of suspected radicular
symptoms."
113 M, Purchaser Barbara Rudolph, OIE-020-08 OIE-020-08 MRI lumbar spine for low back pain. The Leapfrog Group strongly supports this measure; as documented in the NQF Comment appreciated.
Ph.D., The Leapfrog report, almost 22% of MRIs (for low back pain) are potentially inappropriate. Many of these MRIs are performed on the first visit,
Group prior to any attempt to diagnose or treat the patient through more conservative means. Without evidence of more conservative
therapy being attempted, MRIs may be inappropriate. A systematic review of the evidence* concluded, that during the history,
the clinician can accurately identify sciatica due to disc herniation, as well as serious pathology, and that there is sufficient
evidence regarding the accuracy of specific tests for identifying sciatica or radiculopathy (such as the straight-leg raise) or certain
orthopaedic tests of the neck. Plain spinal radiography in combination with standard laboratory tests is useful for identifying
pathology. After pursuing this type of history and testing, clinicians can rule out all but non-specific low-back pain. Rubenstein,
SM., van Tulder, M. A best-evidence review of diagnostic procedures for neck and low-back pain. Best Practice & Research
Clinical Rheumatology. 2008 Jun;22(3):471-82
114 M, Health Gary Bryant, OIE-020-08 Overall agreement. Comment made whether conservative care may include epidural injection, and fact that most Comment appreciated. The Steering Committee
Professional American College interventionalists would require an MRI prior to consideration of that, in patients with unusually severe pain not responding to and the measure developer agreed that ―injectable
of Rheumatology other conservative care within the early time period. Other comment is what documentation is required regarding conservative analgesics‖ be removed from the list of appropriate
care - eg. for patients who may have had care elsewhere and one is now seeing them as a consultant antecedent conservative therapy preceding MRI as
an epidural injection, a type of injectable analgesic,
necessitates an MRI prior to the procedure.
115 M, Provider Diane Wilson, OIE-020-08 OIE-020-08 MRI Lumbar spine for low back pain Difficult to measure this because the patients full history and treatment regiment Comment appreciated.
Organization Butler Memorial is not always available. Agree a separate CPT II code should be generated to provide data.
Hospital
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116 M, Health Nancy Nielsen, OIE-020-08 Concern with Measure OIE-020-08: While we agree with the concept of this measure, we are concerned that the measure will not Comment appreciated. The measure developer
Professional AMA attribute accountability appropriately. As currently specified, the denominator relies on the CPT procedure codes for MRI, which sought input to the proposed measure
is derived from claims submitted by the imaging provider (eg, radiologist). It is not clear whether the purpose of the measure is to development from a technical expert panel
assess whether the imaging provider adequately determined that conservative therapy was provided prior to referral for an MRI consisting of individuals from various medical
or whether the ordering/referring provider attempted other therapies prior to ordering the test. In addition, this measure is specialty societies. In addition to TEP
duplicative to the NQF-endorsed Appropriate Imaging for Acute Back Pain measure, which appropriately attributes responsibility endorsement, the NQF Steering Committee
to the ordering physician, and we question the need for an additional measure on this aspect of care. recommended this measure. Excluding patients
with red-flag conditions and specific ICD-9 codes
consistent with the NCQA measure and limiting
the data collection to administrative data (claims)
serve to harmonize this measure with the currently
endorsed NCQA measure. The developers agree
that the radiologist does not occupy a primary role
in the decision as to when to obtain imaging
studies however we believe that an efficient
radiology (imaging) practice will consult with its
referring physicians regarding appropriate use of
this technology. It is not the role of a radiologist to
categorically deny an examination but he/she does
have a contingent role in assuring appropriate use
of the technology.
117 M, Provider Barbara OIE-020-08 We question how the facility/radiologist would obtain the information included in this measure. The measure developer sought input to the
Organization Spreadbury, Child proposed measure development from a technical
Health Corporation expert panel consisting of individuals from various
of America medical specialty societies. In addition to TEP
endorsement, the NQF Steering Committee
recommended this measure which limits the data
collection to administrative data (claims). The
developers agree that the radiologist does not
occupy a primary role in the decision as to when to
obtain imaging studies however we believe that an
efficient radiology (imaging) practice will consult
with its referring physicians regarding appropriate
use of this technology. We believe that this measure
is supportive of a stated NQF goal of achieving
care coordination.
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118 M, Health Robert Pyatt, OIE-020-08 The ACR generally supports this measure as the exam is one of the most over utilized imaging exams. However, there are several The measure developer sought input to the proposed
Professional American College substantial issues with the measure as currently constructed. Attributability/determination of previous conservative therapy. It ismeasure development from a technical expert panel
of Radiology suggested that the measure results be segmented and reported by rendering provider. If CMS retrospectively analyzes claims data consisting of individuals from various medical
to search and correlate imaging and conservative therapy, is the measure then attributable to the imaging or rendering provider specialty societies. In addition to TEP endorsement,
rather than the referring provider? Complete details of a patient treatment plan and history are often unavailable to imaging the NQF Steering Committee recommended this
provider, particularly for patients originating from outside of the health system doing imaging. Conservative therapy is often measure. The developers agree that the radiologist
does not occupy a primary role in the decision as to
supervised by generalists who refer patients who do not respond to conservative treatment to specialists. Specialists often order
when to obtain imaging studies however we believe
MRI immediately without more conservative therapy. The MRI referring physician may not appear in administrative data, though
that an efficient radiology (imaging) practice will
the patient may have had extensive exercise, over the counter medications during the period of the acute episode. It will be
consult with its referring physicians regarding
difficult to
appropriate use of this technology. It is not the role
measure conservative therapy such as bed rest or over the counter pain medications utilized. of a radiologist to categorically deny an examination
This is especially important, because the use of self care techniques is advised in order to but he/she does have a contingent role in assuring
avoid over medicalization of episodic lumbar pain and radiculopathy. appropriate use of the technology. The Radiology
profession (specialty) hold themselves to be the
authority on the use of diagnostic imaging and
therefore have an ethical to responsibility to assure its
appropriate use through research, teaching and
consultation when and where necessary. The
measure developer agrees that conservative therapy
such as bed rest and OTC medication is important.
The measure attempts to capture use of OTC
medication and bed rest with the inclusion of E&M
office visit claims. One may infer that there would be
119 M, Health Robert Pyatt, OIE-020-08 Comment appreciated. The measure medication
As stated above, the rationale for the intent of the measure is recognized and supported, but in the manner constructed it may not the occurrence of an office visit if OTC developer
Professional American College provide the most useful data. The following is offered for consideration: Rate when the ordering and interpreting physician are concurs the recommended analyses would provide
of Radiology one and same would be of interest.A large percentage of cases are referred by orthopedic or neuro surgeons, in which case most important information to supplement and enhance
patients would have undergone conservative therapy. Those without conservative therapy often come from the emergency room. the current measure. Self-referral abuse may
More and more frequently insurers deny claims on patients without conservative therapy. Diagnoses codes used for inclusion in represent an inherent inefficiency which would be
measure inaccurate or incomplete. identified and captured through this measure.
120 M, Health Robert Pyatt, OIE-020-08 Using ICD9 codes specific to lumbar conditions from imaging procedure claims may not gather patients into the denominator that Comment appreciated. 'Red-flag' indicators have
Professional American College would be expected since studies without definitive diagnosis for lumbar disease will be coded with specific findings. This is been harmonized with the existing NQF-endorsed
of Radiology problematic because a high proportion of lumbar spine imaging reveals findings not distinguishing normal from abnormal measure. Exclusions include cancer, recent trauma,
subjects. Therefore, normal results may indicate a high quality of radiological performance that certain degenerative findings are recent IV drug abuse and recent neurologic
often seen in normal subjects, such as disk protrusions (722.2).There are other indications for a lumbar MRI other than for impairment. We agree that immunosuppression
suspected neurological deficit such as for spinal therapeutic injections. The MRI determines the level for the injection and which should be considered an exclusion in this measure.
levels have adequate epidural fat to inject. The measure needs to take into account red flag indications for the lumbar MRI.
Clinical indications of a more complicated low back pain condition include:Recent significant trauma, or milder trauma, age >50;
Unexplained weight loss (783.2);Unexplained fever (780.6);Immunosuppression (279.3); History of cancer;IV drug use;Prolonged
use of corticosteroids, osteoporosis Age>70 Focal
neurologic deficit, progressive or disabling symptoms;Important clinical indications for MRI
not addressed.
121 M, Madeleine Smith, OIE-020-08 AdvaMed supports the NQF Steering Committees strong recommendation that CMS collect information about antecedent therapy Comment appreciated.
Supplier/Ind AdvaMed for this measure through development of a CPT-II code. We support harmonizing the exclusions to use same red-flag conditions
ustry and specific ICD-9 codes related to the red-flag conditions as NQF#0052- Appropriate Imaging for Acute Back Pain.
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122 M, Provider Margaret Reagan, OIE-020-08 Disapprove with comment. The measures pertaining to the diagnostic imaging studies are unadjusted utilization rates; they are Steering Committee and Measure Developer input.
Organization Premier, Inc. not measures of efficiency. Unadjusted utilization rates could potentially be measures of efficiency in a standardized industrial As a general concept the measure developer
process in which all components are uniform from one case to the next. This is simply not the case in health care and for reasons concurs that patient mix can impact utilization
stated below the optimum rate or the appropriate rate may be very difficult to determine. It is difficult, if not impossible, to know rates; however, patient mix was not anticipated to
the optimum (or appropriate) rate of these procedures for each facility population. The optimum rate of each of these is not 100%, be a driver of variation by the measure developer's
nor is it 0. Beyond these extremes, the appropriate rate will be determined based upon the underlying population, including the technical expert panel in application of the
reason for the procedure, the accompanying comorbid conditions and the underlying rate a particular disease in the population. measure. We (the measure developer) sought
Diagnostic facilities associated with acute care centers might be expected to have more diagnostically complex cases, cases with input to the proposed measure development from
high comorbidities, or cases which have been referred to the institution when simpler diagnostic procedures have been a technical expert panel consisting of individuals
uninformative. Without any way of from various medical specialty societies. In
accounting for the nature of the populations, the utilization rates of these procedures, though addition to TEP endorsement, the NQF Steering
easily obtained, is not likely to be an informative measure, nor is it likely to provide any Committee recommended this measure for
information on the quality of care being provided. approval. Patients with known 'red-flag' indicators
have been excluded consistent with the existing
NQF- endorsed measure Low Back Pain: Use of
Imaging in an effort to minimize potential impacts
associated with patient mix.
123 M, Provider Margaret Reagan, OIE-020-08 Secondly, one must be careful NOT to attend to the effect of local maxima, but rather optimize the entire diagnostic process. It Comment appreciated. The measure developer
Organization Premier, Inc. may be that performing a MRI could provide a definitive diagnosis, whereas not performing a MRI, though less expensive, would agrees that case mix is important and necessary for
lead to an inconclusive diagnosis and the need for repeated testing, thus increasing the total cost of the diagnosis. Isolated defining clinical efficacy. The intent of this
components of the diagnostic process should be studied only in the context of knowledge of the effects on the entire process. measure is to detect system inefficiencies suggested
These tests are not conducted in isolation of other diagnostic and therapeutic modalities, and trying to optimize their rate without by either very high or very low use rates and not to
consideration of the broader economic and clinical outcomes, has the potential to be misleading. define new science. With the exception of centers
of excellence, our assumption is that with a
significant number of examinations, variations
attributable to case mix are neutralized when
making comparisons between various providers.
124 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates This measure estimates the percentage of patients requiring follow up to a Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend screening mammography study. In addition, the measure estimates the average length of time it takes for the follow up study to maintains its recommendation to not endorse this
AG/DHMM ed occur. Measure Rationale Clinical Basis A high or low percentage of additional or add-on studies performed after a routine measure.
screening mammogram such as diagnostic views and/or breast ultrasound may be an indicator of a unique population or that the
reader is exceeding the accepted limits of false positive or false negative interpretations. Additional study rates following
screening mammography studies (within 0-45 days of the initial study) significantly greater or less than 10% to 14% are generally
felt to be unusual unless explained by the morbidity of the underlying population. When controlling for patient demographics,
performance of post-screening studies at higher rates than those found in the physician community population may be an
indicator of a large number of false-positive interpretations while a low rate of additional studies may indicate a false-negative
outcome or missed pathology. Capturing the
percent of the claims submitted with a breast-related, post screening code compared to all
screening mammogram codes can identify instances of suspect quality and/or coding issues.
125 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Research Basis Application of Evaluation Criteria Framework Throughout the Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend measure development process, the measure development team consistently applied the four criteria, as set forth in CMS Measure maintains its recommendation to not endorse this
AG/DHMM ed Manager System (MMS) Blueprint for measure development. The MMS is aligned and harmonized with the NQF Consensus measure.
Development Process (CDP), resulting in rigorous measurement development and maintenance procedures in the MMS. Specific
application of MMS criteria to the measure are summarized as follows: Importance/Relevance: This measure carries significant
epidemiologic relevance in that it is aimed at optimizing the use of an examination that carries a proven benefit in terms of life
quality and longevity. Breast cancer is the most common non-skin malignancy among women in the United States and second
only to lung cancer as a cause of cancer-related death. In 2001, an estimated 192,200 new cases of breast cancer were diagnosed in
American women, and 40,200 women died of the disease. The risk for developing breast cancer increases with age beginning in
the fourth decade of life.
The probability of developing invasive breast cancer over the next 10 years is 0.4% for women
aged 30-39, 1.5% for women aged 40-49, 2.8% for women aged 50-59, and 3.6% for women
aged 60-69.
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126 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Individual factors other than age that increase the risk for developing breast cancer Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend include family history or a personal history of breast cancer, biopsy-confirmed atypical hyperplasia, and having a first child after maintains its recommendation to not endorse this
AG/DHMM ed age 30. Similar to other cancer screening tests, the large majority (80% to 90%) of abnormal screening mammograms or CBEs are measure.
false-positives. These may require follow-up testing or invasive procedures such as breast biopsy to resolve the diagnosis, and can
result in anxiety, inconvenience, discomfort, and additional medical expenses. In one large community study, 6.5% of screening
mammograms required some additional follow-up and, over a 10-year period, 23% of all women had experienced at least one
abnormal mammogram. The cumulative risk for a false-positive result after 10 mammograms was estimated to be 49%. The
proportion of false-positive results that lead to biopsy varies substantially in different settings. In screening trials, 1% to 6% of all
women screened underwent biopsy, and the proportion of biopsies that revealed cancer ranged from 12% to 78%. In two RCTs,
BSE
education resulted in a nearly two-fold increase in false-positive results, physician visits, and
biopsies for benign disease.
127 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates The consequences of false-positive mammograms are uncertain. Most, but not all, Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend studies report increased anxiety from an abnormal mammogram. At the same time, some studies report that women in the United maintains its recommendation to not endorse this
AG/DHMM ed States may be willing to accept a relatively high number of false-positive results in the population in return for the benefits of measure.
mammography. Studies do not indicate that false-positive results diminish adherence to subsequent screening. False-negatives
also occur with mammograms and CBE. Although false-negative results might provide false reassurance, the USPSTF found no
data indicating these led to further delays in diagnosis. Some experts view the over-diagnosis and treatment of ductal carcinoma
in situ (DCIS) as a potential adverse consequence of mammography. Although the natural history of DCIS is variable, many
women in the United States are treated aggressively with mastectomy or lumpectomy and radiation. Given the dramatic increase
in the incidence of DCIS in the past two decades (750%) and autopsy series suggesting that there is a significant pool of DCIS
among women
who die of other causes, screening may be increasing the number of women undergoing
treatment for lesions that might not pose a threat to their health.
128 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates A final potential concern about mammography is radiation-induced breast cancer, Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend but there are few data to directly assess this risk. A 1997 review, using risk estimates provided by the Biological Effects of Ionizing maintains its recommendation to not endorse this
AG/DHMM ed Radiation report of the National Academy of Sciences, estimated that annual mammography of 100,000 women for 10 consecutive measure.
years beginning at age 40 would result in up to 8 radiation-induced breast cancer deaths. Financial relevance is modest, as a
modification in mammography recalls would only impact a small cohort of an already small percentage of examinations. This
measure carries modest policy implications as it uses established guidelines to evaluate clinical compliance rather than set new
examination policy.
129 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Scientific Soundness: An explicit evidence base is available in the peer reviewed Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend literature, as this represents one of the most debated and evaluated diagnostic imaging examination in day to day practice. The maintains its recommendation to not endorse this
AG/DHMM ed impact on patient safety from under-utilization of follow-up studies is well documented with evidence of increased cancer measure.
occurrence in these patients. Widely published measures for screening and mammography follow-up are scientifically reliable.
There is substantial validity based on day to day experience and a wide range of literature based on scientifically rigorous
research. Provider performance results may be compared among differing population cohorts and therefore some risk adjustment
may be necessary. Usability/Actionability: The intended audience (imaging providers) will easily understand the premise and the
results and may find them useful in decision-making. The health care provider can use the results to measure their performance to
improve the quality of their interpretations. This represents a clear message to the information recipient and has undeniable day-
to-day relevance in the performance and
interpretation of screening mammography.
130 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Feasibility: Detailed and precise specifications easily apply to the analysis of a Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend standard claims file for determining the frequency of the use of follow-up examinations. The data source, (claim files), allows for maintains its recommendation to not endorse this
AG/DHMM ed tabulation and analysis of study performance, provider identification, and site of service. Considering the ease of data acquisition, measure.
the cost of collection is well worth the effort. Finally, CMS does not anticipate distortion in the process of this mathematical
analysis. Medicare Claims Evidence Testing of the measure was limited to studies performed in the hospital outpatient and
physician office settings the measure was calculated separately for initial studies performed in each setting (though the follow-up
study could take place in either setting). The calculations for the measure were based on 100 percent of the 2005 Outpatient claims
(claims paid under the OPPS/APC methodology) and 100 percent of the 2005 Medicare Physician/Supplier claims (claims paid
under the Medicare physician fee schedule).
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131 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Table 1 shows the average measure value and coefficient of variation in each Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend setting. The coefficient of variation (CV) is a measure of how much variability can be observed by calculating the measure for each maintains its recommendation to not endorse this
AG/DHMM ed individual provider (CV values below 100 are generally considered to reflect relative stability, and CV values above 100 are measure.
generally considered to reflect relative instability or variability). In both settings, the CV for this measure indicates that there is
significant variability among providers with respect to the proportion of patients returning for follow-up studies in 2005, more so
for initial studies performed in the physician office setting than for initial studies performed in the hospital outpatient setting.
132 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Table 1. Screening Mammography Follow-Up Rates. Proportion of Initial Studies Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend Matched to a Follow-up Study. Rates Calculated based on 100% Q1 through Q4 2005 Medicare Claims. Physician Outpatient maintains its recommendation to not endorse this
AG/DHMM ed Mean 12.73% 9.13% measure.
Standard Deviation 21.80 10.73; Coefficient of Variation*171.57 117.57; Percentiles: 10th 0.00 2.95; 25th 0.00
4.98;50th(median)6.67 7.54; 75th12.81 10.43; 90th 26.00 14.21; 95th 66.67 17.33; * Coefficient of Variation = (Std.Dev/Mean)*100
133 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Within each setting, these measures were considerably higher when measured at Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend the individual provider level rather than at the service level (9.1% in hospital outpatient settings and 12.7% in physician office maintains its recommendation to not endorse this
AG/DHMM ed settings). This measure was analyzed at other summary levels. Key findings include: Of the 69 different specialist types that measure.
performed this study in a physician office setting in 2005, the top specialty in terms of total studies, diagnostic radiology,
performed 76.5% of the total studies performed. The average measure value for this specialty was 9.16%. Among the top ten
specialties, the measure was highest for the general surgery specialty 27.4% and lowest for the obstetrics/gynecology specialty
7.6%.Of the studies performed in a hospital outpatient setting, 72.3% were performed at Hospital-Outpatient (HHA-A also)
facilities. The average measure value for initial studies performed at these sites was 8.7% in 2005, slightly above average. The
second most outpatient studies were performed at Hospital-Other (HHA-A also) facilities (21.3%), where the average measure
value for these studies was considerably lower
6.8%.
134 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates There was significant geographic variation in the measure. The highest average Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend measure values among individual providers were observed in the New York (New York, New Jersey, Puerto Rico, Virgin Islands) maintains its recommendation to not endorse this
AG/DHMM ed and Pennsylvania (Pennsylvania, Delaware, Maryland, West Virginia, Virginia, District of Columbia) regions at 16.6% and 13.1%, measure.
respectively; the lowest average measure values among individual providers were observed in the Missouri (Missouri, Kansas,
Nebraska, Iowa) and Michigan (Michigan, Illinois, Indiana, Ohio, Wisconsin, Minnesota) regions at 10.2% and 10.7%, respectively.
Volume matters - Providers who performed the initial studies least often (9 or fewer procedures in a physician office setting in
2005) performed follow-up studies more frequently 19.7% of the time on average and providers who performed the initial studies
very frequently (between 100 and 499 procedures in a physician office setting in 2005) performed follow-up studies less frequently
9.4% of the time on average. For those cases where a follow-up study was performed, the amount of time passing between the
initial
study and the follow-up study, on average, was assessed. A distribution of this measure
across both settings is shown in Chart 1 (submitted to NQF via e-mailed document). There are
clear peaks in the measure at 0 days (follow-up study the same day as the initial study), 7 days,
14 days, and 21 days after the initial study.
135 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates NQF Steering Committee (SC) concerns: There is not a specific benchmark for Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend mammography recall. Difficult to determine efficiency without evidence of what the optimal recall rate is. Response: The original maintains its recommendation to not endorse this
AG/DHMM ed measure included a proposed 10% benchmark; however, based upon comment from a variety of stakeholders, the discussion of measure.
the measure was revised to incorporate a more robust set of literature indicating a 10% - 14% follow up rate reflective of current
practice. The purpose of the range is to identify individual variation among interpreting radiologists. Too low a recall rate is
undesirable (risk of undetected cancers), as is too high a recall rate (patient radiation exposure, patient anxiety, cost, etc.). When
results are controlled for special populations, the mitigation of variation is considered desirable from a health policy standpoint.
136 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates NQF SC concern: No correlation between recall rate and patient outcome. Response: Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend A high or low percentage of additional or add-on studies performed after a routine screening mammogram such as diagnostic maintains its recommendation to not endorse this
AG/DHMM ed views and/or breast ultrasound may be an indicator of a unique population or that the reader is exceeding the accepted limits of measure.
false positive or false negative interpretations. Measuring the cancer detection rate associated with all mammograms should be
considered in addition to the screening mammography recall rate. If a higher recall rate for screening mammograms is associated
with a statistically significant higher cancer detection rate, it would provide some support for the variation to the recall rate
community benchmark. However, given the high volume of screening mammography studies, the screening mammogram recall
rate still is a valuable tool in assessing results that are either too high or too low relative to the benchmark range of 10% to 14%.
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137 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates NQF SC concern: No correlation between recall rate and patient outcome Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend (Continuation of response) Additional study rates following screening mammography studies (within 0-45 days of the initial maintains its recommendation to not endorse this
AG/DHMM ed study) significantly greater or less than 10% to 14% are generally felt to be unusual unless explained by the morbidity of the measure.
underlying population. When controlling for patient demographics, performance of post-screening studies at higher rates than
those found in the physician community population may be an indicator of a large number of false-positive interpretations and a
low rate of additional studies may indicate a false-negative outcome or missed pathology. NQF SC concern: Encouraging an
increase in recalls may lead to an increase in false-positive results. Response: This measure is not designed to encourage an
increase in recalls from screening mammograms. This measure estimates the percentage of patients requiring follow up to a
screening mammography study. In addition, the measure estimates the average length of time it takes for the follow up study to
occur.
138 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates NQF SC concern: Many imaging centers are not advanced enough to perform Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend mammography studies which may result in access issues. Response: Recent proposals regarding an increase to the number of maintains its recommendation to not endorse this
AG/DHMM ed films required for physicians to read mammography under the Mammography Quality Standards Act (MQSA) has generated measure.
significant concern regarding the impact on access to mammography services in rural populations in particular. This measure
does not intend to reduce access to or availability of screening mammography.
139 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates NQF SC concern: Extensive NQF SC discussion on whether that measure is Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend generalizable enough to implement measure developer felt adverse effects would result if the measure was not implemented. maintains its recommendation to not endorse this
AG/DHMM ed Response: The intent of this measure is not to imply a specific operational modus for the interpretation of screening measure.
mammograms but rather, to evaluate (under any circumstance) whether a typical reader, after examining a screening study,
requires additional imaging information to arrive at a diagnosis. Wide variance from the well established percentage range of
10% to 14% represents an opportunity to further study the potential drivers of the variance. Capturing the percent of the claims
submitted with a breast-related, post screening code compared to all screening mammogram codes can identify instances of
suspect quality and/or coding issues. Recent studies in the literature show contradictory results concerning the value of CAD
software for mammography screening. One supplemental measure for future consideration would be to monitor the variations in
recall rates for screening mammography studies
performed with CAD versus those done without CAD.
140 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Conclusion The absolute probability of benefits of regular mammography increases Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend along a continuum with age, whereas the likelihood of harms from screening (false-positive results and unnecessary anxiety, maintains its recommendation to not endorse this
AG/DHMM ed biopsies, and cost) diminishes from ages 40-70. The balance of benefits and potential harms, therefore, grows more favorable as measure.
women age. The precise age at which the potential benefits of mammography justify the possible harms is a subjective choice. In
the trials that demonstrated the effectiveness of mammography in lowering breast cancer mortality, screening was performed
every 12-33 months. For women aged 50 and older, there is little evidence to suggest that annual mammography is more effective
than mammography done every other year. The precise age at which to discontinue screening mammography is uncertain. Only
two randomized controlled trials enrolled women older than 69 and no trials enrolled women older than 74. Older women face a
higher probability of developing and dying from breast cancer but also have a greater chance of dying from other causes. Women
with comorbid conditions that limit their life expectancy are unlikely to benefit from
screening.
141 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates Clinicians should refer patients to mammography screening centers with proper Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend accreditation and quality assurance standards to ensure accurate imaging and radiographic interpretation. Clinicians should maintains its recommendation to not endorse this
AG/DHMM ed adopt office systems to ensure timely and adequate follow-up of abnormal results. A listing of accredited facilities is available at measure.
http://www.fda.gov/cdrh/mammography/certified.html. Breast cancer is a potentially curable disease and from a health policy
standpoint should receive a significant expenditure of financial and intellectual resource. The risks and benefits of self-
examination, mammographic screening and follow-up studies are well understood by health care providers but less so by
consumers. Assessment of the rate of mammography follow-up studies to basic screening mammography (adjusted for
demographic variation) is a simple measure upon which the consumer and payer can estimate quality and efficiency. The
promulgation of acceptable norms and provider performance rates represents a long overdue measure of accountability by the
health care system.
142 M, Purchaser Susan L. Arday, Not OIE-021-08: Mammography Follow-Up Rates REFERENCES: 1. Smith RA, Saslow D, et al. American Cancer Society Guidelines Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend for Breast Cancer Screening: Update 2003. CA Cancer J Clin 2003; 53:141-169. 2. American Cancer Society Surveillance Program. maintains its recommendation to not endorse this
AG/DHMM ed Estimated new cancer cases by sex and age. Atlanta: American Cancer Society, 2003. 3. BNL, ALARA Center Radiological measure.
Sciences Division, Building 703M, Brookhaven National Laboratory: Upton, NY 11973. 4. Yankaskas BC, Cleveland RJ, et al.
Association of Recall Rates with Sensitivity and Positive Predictive Values of Screening Mammography. AJR 2001; 177:543-549. 5.
Rosenberg RD, Yankaskas BC, et al. Performance Benchmarks for Screening Mammography. Radiology. October 1, 2006; 241(1):
55 - 66. 6. U.S. Preventive Services Task Force (USPSTF). Guide to Clinical Preventive Services, Breast Cancer (Mammography):
Screening (2002). http://www.ahrq.gov/clinic/uspstf/uspsbrca.htm
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143 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) Measure Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend Rationale Clinical Basis The proposed measure seeks to promote the use of studies that are considered reasonable for the maintains its recommendation to not endorse this
AG/DHMM ed indication, while avoiding potentially harmful effects of unnecessary radiation and contrast exposure. The intent of this measure measure.
is to assess questionable utilization of contrast agents specifically for those with Diagnoses of Hydronephrosis, Calculus of Kidney
and Ureter, Calculus of Lower Urinary Tract and Renal Colic which carry an element of risk and significantly increase
examination cost in circumstances where the consensus is quite clear that a non-contrast study is clinically preferable. Combined
CT studies not only carry an element of risk, but also significantly increase examination costs. The purpose of measuring
inappropriate utilization of combined CT studies is to reduce unnecessary radiation exposure, and to reduce the number of false
positives and negatives. Inappropriate diagnostic imaging services in general may have negative consequences on health
outcomes, including poor test results (false positive, false
negative) and the effects of exposure to ionizing radiation and contrast material. A combined
CT study, at a minimum, doubles the radiation dose to the patient and exposes him/her to the
potential harmful side effects of the contrast material itself.
144 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) This Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend measure will be instrumental in identifying practice patterns, and norms for the use of combined studies, as well as identifying maintains its recommendation to not endorse this
AG/DHMM ed providers that vary substantially from the norms, to document possible inefficient examination protocols. The measure allows measure.
identification of providers that may employ interdepartmental/facility protocols calling for a combined study for nearly all cases.
While Mettler et al. report that over 93% of all abdominal and pelvic scans in their study were performed with intravenous
contrast, the 7% not using intravenous contrast were primarily done for evaluation of renal or ureteral calculi. This has likely
increased since the publication of his article (year 2000) as non-contrast studies have all but completely replaced intravenous
pyelograms for renal evaluations. The universe of Abdomen CT studies were culled for diagnoses typically best suited to a non-
contrast study; these were usually associated with an evaluation of the urinary tract. Significant variation from consensus for this
subset of indications would point to
potential inefficiencies of delivery. Despite a somewhat inadequate evidence base related to
the appropriate use of contrast material in most Abdomen CT studies, there is an accepted
consensus around utilization of a non-contrast study for specific urology related indications.
145 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) The intent Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend of the measure is to isolate particular diagnoses where the use of a non-contrast study approaches a consensus and report maintains its recommendation to not endorse this
AG/DHMM ed significant variation from accepted protocols. It is anticipated that any public reporting of the measure would be limited to measure.
providers with adequate volume to avoid issues associated with small sample size. Research Basis Application of Evaluation
Criteria Framework Throughout the measure development process, the measure development team consistently applied the four
criteria, as set forth in CMS Measure Manager System (MMS) Blueprint for measure development. Specific application of these
criteria to the measure can be summarized as follows: Importance / Relevance: Inappropriate diagnostic imaging services may
have negative consequences on health outcomes, including poor test results (false positive, false negative) and the effects of
exposure to ionizing radiation and contrast material. Diagnostic imaging is the fastest growing segment of Medicare spending on
physicians services. Between 1999 and 2003, data
from MedPAC indicates that the volume and complexity of services grew by 9.9% per year on
average, nearly twice as fast as all physician services (5.4%) during this time period. This
measure carries relevance for patient safety issues related to contrast reactions and excess
radiation exposure.
146 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) This Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend measure carries relevance for patient safety issues related to contrast reactions and excess radiation exposure. Financial relevance maintains its recommendation to not endorse this
AG/DHMM ed is substantial, as the inappropriate use of combined studies increases the cost of the examination. Scientific Soundness: There is measure.
some evidence base available in the literature related to the appropriate use of contrast agents in the specific indications for the
evaluation of solid organs and body cavities, and there is greater consensus around use of a non-contrast study (stone protocol) for
specific urological diagnosis such as painful hematuria. Analysis of Medicare claims data also indicates that measurement of
inefficient practice based on variation has reliability and face validity. Usability / Actionability: The intended audience (service
providers) will easily understand the results and find them useful in decision-making. The health care provider can use the results
to diminish cost without compromise of the quality of care. This represents a
clear message to the information recipient and has undeniable day-to-day relevance.
NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE 25
Member
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147 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) Feasibility : Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend Detailed and precise specifications easily apply to the analysis of a standard claims file for determining utilization ratios as maintains its recommendation to not endorse this
AG/DHMM ed described here. The data source (claim files), frequency and provider identification, can all be determined from standard measure.
(Medicare) claims files. Because of the ease of acquisition of the data source, the cost of collection is well worth the effort. No
distortion of the result is anticipated. Medicare Claims Evidence CMS limited the testing of the measure to studies performed in
the hospital outpatient and physician office settings the measure was calculated separately in each setting. The calculation for the
measure in the outpatient setting was based on 100% of the 2005 Outpatient claims (claims paid under the OPPS/APC
methodology). The measure for the physician office setting was calculated using 100% of the 2005 Medicare Physician /Supplier
claims (claims paid under the Medicare physician fee schedule).
148 M, Purchaser Susan L. Arday, Not Percentage of Abdomen CT Studies with Diagnoses of Hydronephrosis, Calculus of Kidney and Ureter, Calculus of Lower Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend Urinary Tract and Renal Colic performed as non-contrast studies. The ratio is anticipated to be high. The following table, Exhibit 1, maintains its recommendation to not endorse this
AG/DHMM ed shows the average measure value and coefficient of variation in each setting. The coefficient of variation (CV) is a measure of how measure.
much variability can be observed by calculating the measure for each individual provider (CV values below 100 are generally
considered to reflect relative stability, and CV values above 100 are generally considered to reflect relative instability or
variability). In both settings, the CV for this measure indicates that there is relative stability among providers with respect to the
proportion of abdomen CT studies they performed without contrast material in 2005.
149 M, Purchaser Susan L. Arday, Not Exhibit 1 - Abdomen CT –Studies Without Contrast as Proportion of Total Studies (Renal Diagnosis Specific) Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend Hospital Outpatient Setting: Average Measure Value = 72.39%; Coefficient of Variation (CV) = 37.04 maintains its recommendation to not endorse this
AG/DHMM ed Physician Office Setting: Average Measure Value = 61.96%; Coefficient of Variation (CV) = 55.69 measure.
150 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) We also Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend analyzed this measure at other summary levels. Key findings include: Of the 43 different specialist types that performed this maintains its recommendation to not endorse this
AG/DHMM ed study in a physician office setting in 2005, the top three in terms of total studies, diagnostic radiology, independent diagnostic measure.
testing facility, and urology, performed 94.4% of the total studies performed. The average measure values for these specialties
were 59.2%, 58.4%, and 77.5% respectively – the measure for urologist-performed studies was among the highest observed for any
specialty with a significant volume of studies performed. Of the studies performed in a hospital outpatient setting, 80% were
performed at Hospital-Outpatient (HHA-A also) facilities. The average measure value for these studies was 72.4% in 2005. The
second most outpatient studies were performed at Hospital-Other (Part B) facilities, where the average measure value for these
studies was very similar – 72.2%.
151 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) There was Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend significant variation in the measure geographically. The highest average measure values among individual providers were maintains its recommendation to not endorse this
AG/DHMM ed observed in the Washington (Washington, Oregon, Idaho, Alaska) and New York (New York, New Jersey, Puerto Rico, Virgin measure.
Islands) regions at 71.4% and 68.6%, respectively; the lowest average measure values among individual providers were observed
in the Missouri (Missouri, Kansas, Nebraska, Iowa) and Michigan (Michigan, Ohio, Indiana, Illinois, Minnesota, Wisconsin)
regions at 56.1% and 58.0%, respectively. Providers who performed these studies least often (9 or fewer procedures in a physician
office setting in 2005) performed the study without contrast most frequently – 63.7% of the time on average – and providers who
performed abdominal CT studies very frequently (between 100 and 499 procedures in a physician office setting in 2005)
performed the study without contrast most infrequently – 52.4% of the time on average.
152 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend Stakeholder Input Informing the Measure Informal Public Comment and Technical Expert Panel As part of the measure maintains its recommendation to not endorse this
AG/DHMM ed refinement process, the measures were presented to a wide range of potential users, stakeholders, organizations and individuals measure.
interested in imaging efficiency to solicit feedback during an informal public comment period. The process generated comment
from a variety of stakeholder including response from the American College of Radiology (ACR). While ACR comments expressed
support for measures related to the use of contrast materials, ACR, public and TEP comments all expressed concern with the
uncertainty associated in defining, via claims, appropriate indications for either a non-contrast only or contrast enhanced only
study. Feedback focused on patient mix among providers rendering general measures of either non-contrast or with contrast
measurement meaningless. Stakeholders recommended limiting the measure focus to particular indications for non-contrast
studies. As a result, the measure was refined to look
at the use of non-contrast enhanced Abdomen CT studies for specific diagnoses.
153 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) Conclusion Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend The inappropriate use of contrast agents in the presence of specific indications to the contrary represents a serious inefficiency of maintains its recommendation to not endorse this
AG/DHMM ed practice and a patient safety issue. Extensive claim analysis from the private sector validates that the usual examination for measure.
renal/ureteral stone disease (painful hematuria) is a non-contrast study. Facilities using contrast in nearly all cases are likely to be
ignoring proven urological protocols and not tailoring the examinations to the needs of the individual patient. This represents a
significant measurable and correctable inefficiency of practice that must not be left unchecked.
NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE 26
Member
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Public
154 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (Renal Diagnosis Specific) Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend REFERENCES: 1. Elicker B, Cypel Y. IV Contrast Administration for CT: A Survey of Practices for the Screening and Prevention of maintains its recommendation to not endorse this
AG/DHMM ed Contrast Nephropathy. AJR.2006; 186:1651-1658. 2. Mettler F. CT scanning: patterns of use and dose. J. Radiol. Protection. Vol 20 measure.
(2000): 353-359. 3. Chen M, Zagoria R, et al. Trends in the use of unenhanced helical CT for acute urinary colic. American Journal
of Roentgenology. Vol 173 (1999): 1447-1450. 4. MedPAC. Recommendations on Imaging Services. Statement of Glenn M.
Hackbarth, J.D., Chairman of the Medicare Payment Advisory Commission, before the US House Committee on Energy and
Commerce, Subcommittee on Health. July 18, 2006. 5. Memo from the American College of Radiology to Kerry N. Weems, CMS
Administrator (acting). December 14, 2007.
155 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Measure Rationale Clinical Basis The maintains its recommendation to not endorse this
AG/DHMM ed proposed measure seeks to promote the use of studies that are considered reasonable for the indication, while avoiding potentially measure.
harmful effects of unnecessary radiation and contrast exposure. The measure assesses the extent to which combined abdomen CT
studies (non-contrast enhanced study performed contemporaneously with a contrast enhanced study) are performed relative to all
CT studies. Combined CT studies not only carry an element of risk, but also significantly increase examination costs. The purpose
of measuring inappropriate utilization of combined CT studies is to reduce unnecessary radiation exposure, and to reduce the
number of false positives and negatives. Inappropriate diagnostic imaging services in general may have negative consequences on
health outcomes, including poor test results (false-positive, false-negative) and the effects of exposure to ionizing radiation and
contrast
material. A combined CT study, at a minimum, doubles the radiation dose to the patient and
exposes him/her to the potential harmful side effects of the contrast material itself.
156 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) This measure will be instrumental in maintains its recommendation to not endorse this
AG/DHMM ed identifying practice patterns, and norms for the use of combined studies, as well as identifying providers that vary substantially measure.
from the norms, to document possible inefficient examination protocols. The measure allows identification of providers that may
employ interdepartmental/facility protocols calling for a combined study for nearly all cases. This measure is complementary to
measure "OIE-019-08 -- Use of contrast: Thorax CT". Financial Basis A June 2008 GAO analysis indicates that Medicare spending
on imaging services increased more than two-fold from 2000 to 2006, with the proportion of spending on imaging services shifting
away from the hospital setting (35% to 25%) and towards physician offices (58% to 64%) during this time period. Estimates from a
1999 Health Care Financing Administration (now CMS) report suggest that up to 30% of diagnostic imaging is unnecessary.
Abdomen CT examinations are
one of the most frequently requested advanced imaging studies, and comprises one of the top
10 studies in both volume and cost in the Medicare Fee-for-Service population.
157 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Mettler et al. report that over 93% of all maintains its recommendation to not endorse this
AG/DHMM ed abdominal and pelvic scans in their study were conducted with intravenous contrast. The 7% not using intravenous contrast were measure.
primarily conducted for evaluation of renal or ureteral calculi. This distribution has also likely changed since the year of the
study, as the indications for the performance of non-contrast studies have expanded considerably. Current literature admonishes
against the use of a tailored approach to all CT. Research Basis Application of Evaluation Criteria Framework Throughout the
measure development process, the measure development team consistently applied the four criteria, as set forth in CMS Measure
Manager System (MMS) Blueprint for measure development. Specific application of these criteria to the measure can be
summarized as follows:
158 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Importance/Relevance: Diagnostic imaging maintains its recommendation to not endorse this
AG/DHMM ed is the fastest growing segment of Medicare spending on physicians services. Between 1999 and 2003, data from MedPAC indicates measure.
that the volume and complexity of services grew by 9.9% per year on average, nearly twice as fast as all physician services (5.4%)
during this time period. This measure carries relevance for patient safety issues related to contrast reactions and excess radiation
exposure. Financial relevance is substantial, as the inappropriate use of combined studies increases the cost of the examination.
Scientific Soundness: There is an evidence base available in the literature related to the appropriate use of contrast agents in the
specific indications for the evaluation of solid organs and body cavities. Analysis of Medicare claims data also indicates that
measurement of inefficient practice based on variation has reliability and face validity. Usability/Actionability: The intended
audience (service providers) will
easily understand the results and find them useful in decision-making. The health care
provider can use the results to diminish cost without compromise of the quality of care. This
represents a clear message to the information recipient and has undeniable day-to-day
relevance.
NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE 27
Member
Organization
# Council/ Topic Comment Proposed Action
Contact
Public
159 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Feasibility: Detailed and precise maintains its recommendation to not endorse this
AG/DHMM ed specifications apply to the analysis of a standard claims file for determining utilization ratios as described here. The data source measure.
(claim files), frequency and provider identification, can all be determined from standard (Medicare) claims files. Because of the
ease of acquisition of the data source, the cost of collection is well worth the effort. No distortion of the result is anticipated.
Medicare Claims Evidence Testing of this measure was limited to studies performed in the hospital outpatient and physician office
settings the measure was calculated separately in each setting. The calculation for the measure in the outpatient setting was based
on 100% of the 2005 Outpatient claims (claims paid under the OPPS/APC methodology). The measure for the physician office
setting was calculated using 100% of the 2005 Medicare Physician/Supplier claims (claims paid under the Medicare physician fee
schedule).
160 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Table 1 shows the average measure value maintains its recommendation to not endorse this
AG/DHMM ed and coefficient of variation in each setting. The coefficient of variation (CV) is a measure of how much variability can be observed measure.
by calculating the measure for each individual provider (CV values below 100 are generally considered to reflect relative stability,
and CV values above 100 are generally considered to reflect relative instability or variability). In both settings, the CV for this
measure indicates that there is significant variability among providers with respect to the proportion of abdomen CT studies they
performed with and without contrast material in 2005.
161 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Table 1. Use of Contrast Abdomen CT maintains its recommendation to not endorse this
AG/DHMM ed Combined Studies as Proportion of Total Studies (General Population. Non-contrast enhanced Abdomen CT Study followed by a measure.
Contrast Enhanced Abdomen CT Study). Rates Calculated based on 100% Q1 through Q4 2005 Medicare Claims. Physician
Outpatient: Mean 29.98% 21.06%; Standard Deviation 33.69 28.35; Coefficient of Variation*
112.35 134.64; Percentiles: 10th 0.00 0.00; 25th 0.00
0.00; 50th (median) 15.22 6.97; 75th 53.57 33.33; 90th
87.88 70.54; 95th 100.00 82.76; * Coefficient of Variation = (Std.Dev/Mean)*100
162 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) This measure was also analyzed at other maintains its recommendation to not endorse this
AG/DHMM ed summary levels. Key findings include: Of the 68 different specialist types that performed this study in a physician office setting in measure.
2005, the top two in terms of total studies (diagnostic radiology and independent diagnostic testing facility) performed 80.0% of
the total studies performed. The average measure values for these specialties were 31.0% and 38.8%, respectively, which further
confirms the significant variability observed for the measure overall There was considerable geographic variation. The highest
average measure values among individual providers were observed in the Texas (Texas, Oklahoma, Arkansas, Louisiana, New
Mexico), California (California, Arizona, Hawaii, Nevada), and Missouri (Missouri, Kansas, Nebraska, Iowa) regions at 46.0%,
37.2%, and 37.0%, respectively; the lowest average measure values among individual providers were observed in the Washington
(Washington, Oregon, Idaho,
Alaska), Massachusetts (Massachusetts, Rhode Island, Connecticut, Maine, New Hampshire,
Vermont), and Wyoming (Wyoming, Utah, Montana, North Dakota, South Dakota) regions at
18.2%, 18.3%, and 19.5%, respectively.
163 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Providers who performed abdominal CT maintains its recommendation to not endorse this
AG/DHMM ed studies least often (9 or fewer procedures in a physician office setting in 2005) performed the combined study most infrequently measure.
27.6% of the time on average and providers who performed abdominal CT studies very frequently (between 100 and 499
procedures in a physician office setting in 2005) performed the combined study most frequently 34.7% of the time on average.
Stakeholder Input Informing the Measure Informal Public Comment As part of the measure refinement process, the measures
were presented to a wide range of potential users, stakeholders, organizations and individuals interested in imaging efficiency to
solicit feedback. The process generated comment from a variety of stakeholder including a detailed response from the American
College of Radiology (ACR).
NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE 28
Member
Organization
# Council/ Topic Comment Proposed Action
Contact
Public
164 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) The ACR in their informal public comment maintains its recommendation to not endorse this
AG/DHMM ed submission for this measure provided results of an analysis suggesting significant variation in the use of combined exams: measure.
Insurance data has shown 15% to 54% variation in use of combined exams, even after some level of intervention. ACR analysis on
the variability of CT abdomen procedures across states based on 2006 Medicare shows a national average of twice (.50) as many
with contrast only procedures as without and with contrast combined, but a range at state level from .13 to 1.28 (combined/with
contrast only). The ACR also provided guidance on specific indicators, so called red flag indications, for a combined abdomen CT
study. This list included studies for indications related to unspecified disorder of the kidney and ureter, hematuria, pancreatic and
adrenal mass. This measure follows the ACR public comment guidance by focusing on the use of combined studies with
exclusions for the specific red flag
indications noted.
165 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Technical Expert Panel Many of the public maintains its recommendation to not endorse this
AG/DHMM ed and TEP comments focused on uncertainty in defining via claims appropriate indications for either a non-contrast only or contrast measure.
enhanced only study. As a result, the measure was refined to look at use of combined studies versus a focus on all contrast-
enhanced studies (contrast only and combined). The measure proposed is a direct reflection of guidance from the measure
developer TEP and comment from the ACR. In general, the ACR supported the development of measures focusing on the use of
contrast material. Specifically the ACR commented that measures associated with contrast material were reasonable and an area
where evaluation is warranted. The current measure construction varies from the original, in part, based upon the ACR guidance
specifically calling for measurement of combined studies: performance of combined with and without contrast studies as a
percentage of total Abdominal CT scans
should be the main area of evaluation. Comment from the ACR further provided specific
indications for use of a combined abdomen CT study, which are reflected in the measure
exclusions.
166 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) In addition to the exclusions articulated by maintains its recommendation to not endorse this
AG/DHMM ed the ACR, the measure developer TEP recommended further exclusions (neoplasms) also excluded from the measure. NQF Steering measure.
Committee NQF steering committee discussion included a lack of guidelines for appropriate use and uncertainty as to the extent
of overuse as a problem. Discussion also included circumstances under which the use of contrast materials would be warranted,
and the circumstances under which non-emergency cases (which this measure is largely confined to) would be having an imaging
study. Analyses were conducted based on 100% Medicare claims to identify the extent of overuse, and ranges for appropriate use.
These pilot test analyses were made available to the steering committee, and are available as part of the supporting materials
submitted for this measure.
167 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Conclusion The indiscriminate use of maintains its recommendation to not endorse this
AG/DHMM ed combined studies, those that are performed without and with contrast agents, in the presence of specific indications for when and measure.
when not to use combination studies in the evaluation of solid organs and body cavities represents a serious inefficiency of
practice and a patient safety issue. Extensive claim analysis from the private sector suggests that a significant pattern of variation
among high volume providers exists in the use of combination examinations in conjunction with abdomen CT. While norms in
large practices cluster around 25% to 30% of all abdomen CT studies performed in the commercial population will be combination
examinations there are worrisome variations from 0% to well over 80% of all abdomen studies. It can be reasonably assumed that
facilities that use little or no contrast or perform few or no combination examinations in conjunction with their abdomen studies
treats either a very unique
population or has the inability/unwillingness to use intravenous contrast even when
indicated. These could be facilities where there is no contemporaneous film review and/or no
capable physician present to administer the intravenous injection on some or all days.
168 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) Facilities producing combination studies maintains its recommendation to not endorse this
AG/DHMM ed and the use of contrast in nearly all cases are likely to be following unproven protocols and not tailoring the examinations to the measure.
needs of the individual patient. This represents a significant measurable and correctable inefficiency of practice that must not be
left unchecked.
NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE 29
Member
Organization
# Council/ Topic Comment Proposed Action
Contact
Public
169 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) REFERENCES: 1. Elicker B, Cypel Y. IV maintains its recommendation to not endorse this
AG/DHMM ed Contrast Administration for CT: A Survey of Practices for the Screening and Prevention of Contrast Nephropathy. AJR. 2006; measure.
186:1651-1658. 2. Government Accountability Office. Medicare Part B Imaging Services: Rapid Spending Growth and Shift to
Physician Offices Indicate Need for CMS to Consider Additional Management Practices. GAO-08-452 (Washington, DC: June
2008). 3. Health Care Financing Administration. 1999 HCFA statistics. Washington, DC: US Government Printing Office; April
2000. HCFA publication 03421.4. Based on internal analyses of CMS 2005 5% Sample Hospital Outpatient and Carrier Standard
Analytic Files. 5. Mettler F. CT scanning: patterns of use and dose. J. Radiol. Protection. Vol 20 (2000): 353-359.6. Chen M, Zagoria
R, et al. Trends in the use of unenhanced helical CT for acute urinary colic. American Journal of Roentgenology. Vol 173 (1999):
1447-1450. 7. Lautin E, Novick M, Jean-
Baptiste R. Tailored CT: primum non nocere. British Journal of Radiology. (2008) Vol 81:
442-443.
170 M, Purchaser Susan L. Arday, Not OIE-018-08: Use of Contrast Abdomen CT Combined Studies as Proportion of Total Studies (General Population. Non-contrast Comment appreciated. The Steering Committee
CMS/OCSQ/QMH Recommend enhanced Abdomen CT Study followed by a Contrast Enhanced Abdomen CT Study) REFERENCES (continued): 8. MedPAC. maintains its recommendation to not endorse this
AG/DHMM ed Recommendations on Imaging Services. Statement of Glenn M. Hackbarth, J.D., Chairman of the Medicare Payment Advisory measure.
Commission, before the US House Committee on Energy and Commerce, Subcommittee on Health. July 18, 2006. 9. Memo from
the American College of Radiology to Kerry N. Weems, CMS Administrator (acting). December 14, 2007.
171 M, QMRI Naomi Kuznets, Not I'm considering measure OIE-012-08 (recommended--Percentage of patients undergoing cervical spine radiographs in trauma who Comment appreciated. The Steering Committee
AAAHC Institute Recommend do not have neck pain, distracting pain, neurological deficits, reduced level of consciousness or intoxication) and comparing it to maintains its recommendation to not endorse this
for Quality ed the measure we submitted (OIE-002-08-Inappropriate indications for knee arthroscopy--Positive MRI is the only documented measure.
Improvement justification for performing the procedure), that was not recommended. The description of why OIE-012-08 was recommended
includes an American Academy of Family Physicians (AAFP) guideline, a strong evidence base, and agreement with the American
College of Radiology (ACR) Appropriateness Criteria. The description of why OIE-002-08 was not recommended included unclear
measure specifications, and suggested consideration of patient acuity, and time course expected for evaluation (not addressed by
the cervical spine measure). The TEP also indicated that clinical practice guidelines are needed for appropriate indications for
MRI of the knee.
172 M, QMRI Naomi Kuznets, Not Measure specifications: OIE-002-08 specifications were originally derived from an American Academy of Orthopaedic Surgeons Comment appreciated. The Steering Committee
AAAHC Institute Recommend (AAOS) algorithm (1997 used in current Washington State Review Criteria for Knee Surgery clinical practice guideline listed on maintains its recommendation to not endorse this
for Quality ed the National Guideline Clearinghouse website). When the AAAHC Institute repeatedly received an indication of positive MRI measure.
Improvement written in under the other option in the Institute measure of knee arthroscopies being studied, this option was added to the list of
options furnished by the AAOS algorithm. More recent studies about the appropriateness of knee arthroscopy for arthritis led to
the inclusion of that option on the list within the measure. The measure is as follows. Indications for Procedure Mark all that
apply. Arthritis, Delayed swelling, Effusion, Joint line tenderness, Negative x-ray, Painful popping/catching/locking, Positive
McMurray test, Positive MRI, Twisting injury, Other (specify) ____________________________.
173 M, QMRI Naomi Kuznets, Not If Positive MRI is the only indication listed, (i.e., there is no evidence of a physical exam that shows appropriate physical Comment appreciated. The Steering Committee
AAAHC Institute Recommend symptoms/use of an x-ray) this indicates a problem. Not only does this measure mesh with the AAOS algorithm, it also is maintains its recommendation to not endorse this
for Quality ed supported by the ACR Appropriateness Criteria 2005 (clinical practice guideline listed on the National Guideline Clearinghouse measure.
Improvement website and which examine issues of acuity): Non-traumatic knee injury: An MRI is not indicated before physical exam or before
routine conventional radiographs or when there is routine diagnostic conventional radiographic evidence for severe degenerative
joint diseases, inflammatory arthritis, stress fracture, osteonecrosis, or reflex sympathetic dystrophy, for which additional imaging
is not going to alter the treatment plan. Acute trauma to the knee: Without symptoms (focal tenderness, effusion, or inability to
bear weight) or a suspected posterior knee dislocation, the appropriateness of MRI does not exceed a rating of 2 on a scale of 1 to 9,
with 1 = Least appropriate to 9 = Most appropriate.
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174 M, QMRI Naomi Kuznets, Not -An X-ray (rating = 9) should be used before an MRI (rating = 5), when a patient has had an acute injury (fall or twisted knee) Comment appreciated. The Steering Committee
AAAHC Institute Recommend AND has at least one symptom (focal tenderness, effusion, inability to bear weight). ACR also gives X-rays a rating of 9 versus maintains its recommendation to not endorse this
for Quality ed MRI a rating of 5 for an acute injury that occurred 2 days ago, with an unknown mechanism, AND for which there is focal patellar measure.
Improvement tenderness, effusion, and ability to walk.In other words, according to the ACR, with the exception of when suspected posterior
knee dislocation, an MRI is of equally questionable appropriateness (2) to an X-ray or a physical exam of some sort is necessary (to
find focal tenderness, effusion, and/or inability to bear weight/walk) before considering MRI (5) and even then, an X-ray has
precedence (9).Problems associated with use of MRI (especially associated with suspected meniscal damage in those with
osteoarthritis [a population that is growing geometrically with the aging of the baby boomer generation]) are cited on the AAOS
website Overutilization of MRI in the Osteoarthritis Patient (2008 AAOS Annual Meeting Poster Presentation): Patients with
osteoarthritis of the knee were often referred with
a torn meniscus. Patients often expect arthroscopy and are upset if the orthopaedic surgeon
doesnt use MRIs. In a random sample of orthopaedic surgeons patients, 3/5 had an MRI
ordered before consultation with the surgeon and more than half did not have any
radiographs
175 M, QMRI Naomi Kuznets, Not According to the University of Michigan Health System Knee Pain or Swelling clinical practice guideline Comment appreciated. The Steering Committee
AAAHC Institute Recommend (http://cme.med.umich.edu/pdf/guideline/knee.pdf): MRI of the knee has been proven not to be superior to the clinical exam by maintains its recommendation to not endorse this
for Quality ed an experienced examiner in the evaluation of acute knee injuries [A*]. The A indicates that this recommendation is supported by measure.
Improvement randomized clinical trials. This guideline also states that: Plain x-rays and MRI are usually not useful for the evaluation of
atraumatic knee pain unless [emphasis added] indicated by history and physical examination. This guideline is cited by the AAFP
guideline on the best way to evaluate an acute traumatic knee injury
(http://www.jfponline.com/pdf%2F5702%2F5702JFP_ClinicalInq1.pdf). Last, but no least, like to address a couple of additional
arguments that I've heard against measure the AAAHC Institute proposed. These are (1) the MRI wouldn't have been ordered if
there wasn't a physical exam/appropriate symptoms and (2) the facts that the MRI was positive and the procedure being studied
was a knee arthroscopy with meniscectomy show the use of the MRI was appropriate. [continued...]
176 M, QMRI Naomi Kuznets, Not [continued...] Evidence from the Institute studies and those such as the one presented at the AAOS 2008 poster sessions, in Comment appreciated. The Steering Committee
AAAHC Institute Recommend addition to the guideline recommendations, show that, contrary to the deductive reasoning offered in the two arguments above, maintains its recommendation to not endorse this
for Quality ed MRIs are ordered and not necessarily with the appropriate symptoms documented in the physical exam. measure.
Improvement
177 Public Ceela McElveny, Not Regarding OIE-001-08: CT Radiation Dose Reduction The American Society of Radiologic Technologists urges the NQF Steering Comment appreciated. The Steering Committee
ASRT Recommend Committee to reconsider its decision not to endorse CT dose reduction practices. The ASRT represents more than 129,000 medical maintains its recommendation to not endorse this
ed imaging technologists and radiation therapists, including the technologists who perform CT scans. The ASRT also is a founding measure.
member of the Alliance for Radiation Safety in Pediatric Imaging, a coalition of 26 organizations dedicated to minimizing the
radiation dose delivered to children during medical imaging examinations. The Alliance is focusing on the pediatric population
because children are more sensitive to the effects of radiation than adults. In early 2008, the Alliance introduced its Image Gently
campaign to educate health care providers about dose reduction techniques during CT exams. Through the Image Gently Web site
at www.imagegently.org, physicists, radiologic technologists, radiologists and other physicians can download recommendations,
protocol guidance and a worksheet for reducing radiation dose during pediatric CT scans. When properly implemented, these
guidelines will
significantly reduce the risk of harm to pediatric patients. The ASRT believes these guidelines
are in line with the NQFs goals of improving patient safety and improving care. Therefore,
we encourage the NQF to endorse the Image Gently initiative as a safe practice and include it
in the Outpatient Imaging Efficiency Project.
178 Public James Brink, Yale Not Comment on OIE-001-08: CT Radiation Dose Reduction James A. Brink, MD Chancellor for Body Imaging, American College of Comment appreciated. The Steering Committee
University School of Recommend Radiology Professor and Chair, Department of Diagnostic Radiology, Yale University School of Medicine Concern about the dose maintains its recommendation to not endorse this
Medicine ed of radiation administered with Computed Tomography has increased dramatically owing to two important factors. First, the measure.
number of CT scans performed in the U.S. annually has increased exponentially over the past two decades to over 67 million CT
scans performed in 2006. While these CT scans account for only 12% of the imaging procedures that use ionizing radiation, they
account for 46% of the collective dose to the population (1). Second, the radiation exposure from a CT scan is approximately two
orders of magnitude higher than plain radiographic studies that it may replace. The combination of increased utilization and
increased dose per examination has lead to heighten concerns about the radiation exposure experienced by the U.S. population
from CT scanning.
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179 Public James Brink, Yale Not Fortunately, there are many steps that can be taken to reduce the dose to the population from CT scanning. Appropriate Comment appreciated. The Steering Committee
University School of Recommend utilization of CT imaging is paramount, however, physician and patient education about issues related to radiation exposure are maintains its recommendation to not endorse this
Medicine ed critical to control utilization. We previously published a study in which referring physicians, radiologists, and patients who measure.
underwent CT scans for abdominal pain in the Emergency Room were questioned about their radiation dose in terms of chest x-
ray equivalents (2). While the dose is typically equivalent to 150 to 250 x-rays, the majority of referring physicians, radiologists,
and patients thought that the dose from the CT scan was equivalent to only 1 to 10 chest x-rays. This study highlights the need for
education about radiation exposure from CT scanning and the potential benefit that could be realized from a broad-based
educational campaign.
180 Public James Brink, Yale Not The benefits of CT scanning are well known with innumerable diagnoses confirmed and excluded on a minute-by-minute basis Comment appreciated. The Steering Committee
University School of Recommend world-wide. However, these successes have led to injudicious use, particularly in the emergency setting. Medical, legal and maintains its recommendation to not endorse this
Medicine ed financial pressures often lead practitioners to order CT scanning when a sonogram or a plain radiograph might otherwise suffice. measure.
We evaluated the frequency with which CT scans were repeated in patients with renal colic and found that approximately 5,500
CT examinations were performed for this indication in 4,500 patients over a six-year period (3). The mean age of these patients
was 45 years, and 4% of exams were performed in children. Given that renal stone disease is a benign condition and the relatively
high numbers of exams that are performed in younger individuals, the risk from radiation exposure is heightened in this patient
population. We found that 4% of patients evaluated had three or more renal colic CT scans during this six-year period. Some
patients had as many as 10, 15 and 18 flank pain CT scans during this period. While such estimates are crude, the estimated
exposure from the patient who received
18 CT scans is approximately 150 mSv with an estimated risk of fatal cancer of 1 in 133.
181 Public James Brink, Yale Not While it is possible that repetitive CT studies are needed in certain indications, renal stone disease is visible at plain radiography Comment appreciated. The Steering Committee
University School of Recommend and follow-up examinations with a plain radiograph or ultrasound are likely sufficient in patients who have had stone disease maintains its recommendation to not endorse this
Medicine ed documented with CT previously. Renal colic CT is one examination in which dose reduction quality measures could be employed measure.
to encourage the judicious use of repetitive CT imaging in younger patients with benign disease. I understand the Steering
Committees concern about the need to provide a more robust measure of radiation exposure from CT imaging. However, such
efforts should not be a pre-requisite to incentivize practitioners to control or reduce radiation exposure through educational efforts
and utilization management. These efforts should proceed in parallel with research on dose measurements techniques, for the
benefit to the individual patient and to the U.S. population as a whole.
182 Public James Brink, Yale Not References:1.Fred Mettler, MD. Magnitude of Radiation Uses and Doses in the US: NCRP Scientific Committee 6-2 Analysis of Comment appreciated. The Steering Committee
University School of Recommend Medical Exposures. Presented at the Annual Meeting of the National Council for Radiation Protection, Arlington, VA, April, 2007. maintains its recommendation to not endorse this
Medicine ed 2.Lee CI, Haims AH, Monico EP, Brink JA, Forman HP. Diagnostic CT scans: assessment of patient, physician, and radiologist measure.
awareness of radiation dose and possible risks. Radiology 2004; 231: 393-398.3.Katz S, Saluja S, Brink JA, Forman HP. Radiation
dose associated with unenhanced CT for suspected renal colic: impact of repetitive studies. AJR 2006;186:1120-1124.
183 Public Patrick Turski, Not The ASNR also supports the following ACR statement regarding the CT Dose Reduction Measure: The ACR (...) [was] greatly Comment appreciated. The Steering Committee
American Society of Recommend disappointed by the negative decisions of the Steering Committee, particularly regarding the CT Dose Reduction measure. (...) The maintains its recommendation to not endorse this
Neuroradiology ed issue of not doing dose reduction and moving to dose calculation is not a good idea at this point, as it is too complex, and can be measure.
dealt with in future ACR endeavors such as the Dose Index Registry. This measure was also developed to focus on measuring
performance of individual clinicians and was appropriately restricted to measuring aspects of care actionable by the individual
clinician. It also reflects growing awareness of non-threshold dose effect models of carcinogenesis and recognizes an obligation to
consider the cumulative impacts of medical radiation. We are trying to start at a basic level with this measure, to raise awareness,
and to increase the use of dose reduction protocols, even if the slightest, is a move in a much-needed direction as has been the
widely supported Image Gently pledge campaign. Many of the measures currently utilized do not have well quantifiable
measures, like this one, as we are
trying to get a start with measures. This is a significant measure to begin with, and is a "hot"
public health issue that would be very good to link with the Image Gently campaign. The
complexities of calculating dose reduction are quite big. This measure serves as a proxy until
this is accomplished.
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184 M, Health Emily Wilson, Not Measure #OIE-001-08: CT radiation dose reduction The American Society for Therapeutic Radiology and Oncology (ASTRO), Comment appreciated. The Steering Committee
Professional American Society Recommend representing more than 9,000 radiation oncologists, radiation therapists, medical physicists, nurses and other members of the maintains its recommendation to not endorse this
for Therapeutic ed radiation therapy team, appreciates the opportunity to comment on the National Voluntary Consensus Standards for Outpatient measure.
Radiology & Imaging Efficiency. Radiation oncologists are acutely aware of the remarkable benefits and dangers of ionizing radiation to
Oncology patients and the public. Benefits are derived from radiations powerful ability to destroy tumor DNA in the course of treating and
curing cancer. Conversely, severe dangers are posed by the damage radiation can cause to healthy tissue. In this context, we are
disappointed by the steering committees decision not to recommend for NQF endorsement Measure #OIE-001-08: CT Radiation
Dose Reduction. As you well know, numerous studies have documented that radiation exposure is posing an increasing public
health and patient safety threat, with the use of CT in adults and children increasing by about 7-fold in the past 10 years. Studies
have also shown that there is a
significant opportunity for improvement in using dose reduction techniques to reduce
unnecessary exposure.
185 M, Health Emily Wilson, Not Measure #OIE-001-08: CT radiation dose reduction We support the ACR/AMA PCPI/NCQA Radiology Work Group request Comment appreciated. The Steering Committee
Professional American Society Recommend that the steering committee reconsider its decision not to recommend the CT dose reduction measure. We believe that this maintains its recommendation to not endorse this
for Therapeutic ed measure represents an important step in building awareness among individual clinicians of the need to reduce radiation exposure measure.
Radiology & and the means to do it. We concur with the steering committee that the ultimate goal should be capturing and assessing radiation
Oncology dosage, but considering that the state of medical imaging equipment does not yet allow for such an assessment, the committee
should support this measure in the interim. We believe that this measure also would be valuable and easily understandable for
helping consumers choose a high quality imaging center that is both aware of the dangers of radiation exposure and is taking
steps to mitigate the threat. We are also pleased that this measure addresses the needs of children, who are most imperiled by the
increasing, cumulative effect of the use of CT and other medical imaging over the course of their lifetime. Any valid step to reduce
childrens exposure to
radiation is a step in the right direction.
186 M, Health Emily Wilson, Not Measure #OIE-001-08: CT radiation dose reduction ASTRO supports ACRs efforts to develop a database that captures more Comment appreciated. The Steering Committee
Professional American Society Recommend granular data on radiation dose. Such a database would demonstrate changes in dose indices due to technological advances and maintains its recommendation to not endorse this
for Therapeutic ed practice modifications and would be useful in comparing individual practice doses against established benchmarks. This measure measure.
Radiology & serves as an important proxy until this is accomplished. Therefore, we urge the steering committee to revise its decision and
Oncology recommend this measure for time-limited endorsement to allow for measure field testing, which should assess the potential for
measure gaming and validate actual use of dose reduction techniques, as well as allow new technology, evidence, and guidelines
to develop to update the measure in the near future.
187 M, Health Joseph Drozda, Not Although we understand the rationale behind the non-recommendation for Measure OIE-001-08 (CT Radiation Dose Reduction), Comment appreciated.
Professional American College Recommend we look on the issue of radiation dose as a critical one that should be addressed in performance measures as soon as possible. We
of Cardiology ed support NQF's efforts to work with measures developers in filling this need with all due speed.
188 M, Health Robert Pyatt, Not OIE-004-08 Mammography assessment category data collection The intent of the measure is to encourage physicians to collect the Comment appreciated. The Steering Committee
Professional American College Recommend data necessary to track and subsequently analyze recall rate for internal quality improvement. This measure requires that analysis maintains its recommendation to not endorse this
of Radiology ed be performed for internal quality improvement purposes. While the MQSA requires an overall final assessment of findings of each measure.
mammography examination performed, it does not require an analysis of the abnormal interpretation (recall) rate across a
physicians patient population or collection of the assessment category of negative mammograms BiRads codes 0,1,2,3. Recent
studies have shown that the recall rate for almost half of radiologists is higher than recommended (1) and developing a measure
that would encourage this analysis could help to improve patient care. The PCPI Radiology Work Group decided against
developing a measure that would set an appropriate target for the recall rate. Nevertheless, higher recall rates suggest
unnecessary additional imaging or biopsies are being performed. An internal calculation of recall rate is a first step in
encouraging quality improvement activities. Greater impacts on quality
improvement would occur if the entire BiRads audit were facilitated.
189 M, Health Robert Pyatt, Not OIE-004-08 Mammography assessment category data collection It is also important to require that the associated Comment appreciated. The Steering Committee
Professional American College Recommend recommendations to the final assessment categories are concordant. Mammography reports often have this discordance. (2) For maintains its recommendation to not endorse this
of Radiology ed example, The final assessment BiRads 3 - may be avoided, but the usual associated recommendation could be used with other measure.
BiRads codes to the same effect: Impression: Benign appearing left breast mass.BiRads 2 (or 0) Recommend early follow up in 6
months to ensure stability. Thusly, implementation of this measure would also increase the impact of Measure OIE-005-08,
Inappropriate use of BiRads Code 3, offering broader knowledge of all of the assessments of screening mammograms, not just the
BiRads Category 3 in isolation. 1. Rosenberg RD, Yankaskas BC, Abraham LA et al. Performance benchmarks for screening
mammography. Radiology. 2006;241:55-66. 2. Improving the Concordance of Mammography Assessment and Management
Recommendations. Berta M. Geller, EdD, Laura E. Ichikawa,MS, Diana S. M. Buist, PhD, Edward A. Sickles,MD, Patricia A.
Carney, PhD, et al. Radiology: Volume 241:
Number 1October 2006
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190 M, Health Robert Pyatt, Not OIE-006-08 Communication of suspicious findings from the diagnostic mammogram to the practice managing ongoing care AND Comment appreciated. The Steering Committee
Professional American College Recommend OIE-007-08 Communication of suspicious findings from the diagnostic mammogram to the patient. These measures emphasize the maintains its recommendation to not endorse this
of Radiology ed ACR communication standard for non-routine reporting of imaging findings and are important from a patient safety perspective measure.
by encouraging the timely communication of positive findings from a diagnostic mammogram to the patient and practice
managing the patients ongoing care. This would ultimately help to speed up the process of patient biopsy and minimize patients
that are lost to follow-up. The measures address the well documented communication delays that can negatively impact patient
care as characterized by the 28% of breast cancer malpractice claims that resulted from a delay in diagnosis stemming from some
type of communication breakdown. Of those claims, no direct contact was made for urgent or significant unexpected findings
71% of the time and there was a failure to document attempts to communicate 90% of the time. Furthermore, the measure
supports the care coordination
priority area of the Institute of Medicine (IOM) which aims to establish and support a
continuous healing relationship, enabled by an integrated clinical environment and
characterized by the proactive delivery of evidence-based care and follow-up.
191 M, Health Robert Pyatt, Not OIE-006-08 Communication of suspicious findings from the diagnostic mammogram to the practice managing ongoing care AND Comment appreciated. The Steering Committee
Professional American College Recommend OIE-007-08 Communication of suspicious findings from the diagnostic mammogram to the patient. The MQSA currently requires maintains its recommendation to not endorse this
of Radiology ed that communication of all results to the referring health care provider be done within 30 days by a written report. In addition, measure.
when there are Suspicious or Highly suggestive of malignancy results, the facility must also make reasonable attempts to
communicate the results to the referring health care provider or a responsible designee as soon as possible using either a written
report or documented verbal communication. Three days (for communication to the referring physician) is recommended but not
required by MQSA, nor is confirmed receipt of findings as in the measure.
192 M, Health Robert Pyatt, Not OIE-006-08 Communication of suspicious findings from the diagnostic mammogram to the practice managing ongoing care AND Comment appreciated. The Steering Committee
Professional American College Recommend OIE-007-08 Communication of suspicious findings from the diagnostic mammogram to the patient. The Radiology Work Group maintains its recommendation to not endorse this
of Radiology ed recognized the potential value in developing a broader measure that would address the timely communication of critical results. measure.
However, consideration of this broader type of measure is deferred to a later point in time for various reasons. Apart from the
ACR guidelines for the Communication of Diagnostic Imaging Findings which served as a basis for the development of the two
ACR/AMA PCPI/ NCQA Radiology communication measures submitted for NQF endorsement, no additional guidelines are
available from which this type of measure may be derived. Standard 02.03.01 from the 2009 chapter of the Joint Commission
National Patient Safety Goals states that The [organization] measures, assesses, and, if needed, takes action to improve the
timeliness of reporting, and the timeliness of receipt of critical tests and critical results and values by the responsible licensed
caregiver.The Joint Commission does not
provide further guidance and allows each organization to define its own critical tests and
critical results based on the scope of services provided.
193 M, Health Robert Pyatt, Not OIE-006-08 Communication of suspicious findings from the diagnostic mammogram to the practice managing ongoing care AND Comment appreciated. The Steering Committee
Professional American College Recommend OIE-007-08 Communication of suspicious findings from the diagnostic mammogram to the patient. There remain concerns maintains its recommendation to not endorse this
of Radiology ed regarding the feasibility of developing a broader measure as described by the steering committee. In order to specify measures for measure.
data collection purposes for use with administrative/claims data, the denominator population must be identified using codes
recorded on claims or billing forms (ICD-9 diagnoses, CPT E/M service codes, and CPT category II codes, where appropriate).
The denominator population of patients who have received critical results would be difficult to define and would need to be
specified for each of the imaging studies included in the denominator. Furthermore, as noted by the Steering Committee, there is
a lack of guidance regarding the time frames for communicating these critical results for the variety of imaging studies. The ACR
Metrics Committee attempted to develop a similar measure for the communication of non-routine findings which was posted for a
30 day comment period and
considered prior to the development of the measures submitted for the steering committees
consideration. Given the feasibility concerns identified above, it was ultimately decided
against the further development of this type of measure. Focusing the measure on a smaller
group of patients, such as those receiving diagnostic mammograms
194 M, Health Robert Pyatt, Not OIE-006-08 Communication of suspicious findings from the diagnostic mammogram to the practice managing ongoing care AND Comment appreciated. The Steering Committee
Professional American College Recommend OIE-007-08 Communication of suspicious findings from the diagnostic mammogram to the patient with positive findings as maintains its recommendation to not endorse this
of Radiology ed defined with current BI-RADs terminology, eliminates these concerns. It is also important to note that 2 similar communication measure.
measures developed by the AMA PCPI have been previously endorsed by the NQF. They include an osteoporosis measure
addressing the timely communication with the physician managing the patients on-going care post fracture and a diabetic
retinopathy measure that encourages communication with the physician managing the patients ongoing diabetes care.
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195 M, Health Robert Pyatt, Not OIE-001-08: CT radiation dose reduction This measure attempts to address the well-documented concern over radiation exposure Comment appreciated. The Steering Committee
Professional American College Recommend resulting from exponential increases in the use of CT scans. CT examinations in the US have increased by a factor of 20 over the maintains its recommendation to not endorse this
of Radiology ed last 25 years (from 3m in 1980 to 60m in 2005). While only accounting for about 15% of imaging exams using ionizing radiation, measure.
CT exams are estimated to contribute 70% of effective radiation dose from all medical imaging. For perspective, an average
effective estimated radiation dose for a CT of the abdomen is comparable to 3 years of natural background radiation.This measure
was developed to focus on assessing performance of individual clinicians and was appropriately restricted to measuring aspects of
care actionable by the individual clinician. The measure reflects growing awareness of non linear threshold dose effect models of
carcinogenesis and recognizes an obligation to consider the cumulative impacts of medical radiation. As the use of CT and other
imaging modalities that depend on ionizing radiation increases, it is crucial that we optimize radiation exposure to individuals
and the population
as a whole. It remains prudent to assume that the cancer risks associated with radiation
exposure during imaging actually exist and to take measures, even small steps, to reduce
them.
196 M, Health Robert Pyatt, Not OIE-001-08: CT radiation dose reduction Although dose reduction techniques, such as automated exposure controls, have been Comment appreciated. The Steering Committee
Professional American College Recommend shown to reduce radiation dose by 20-40%, broad use of procedures or protocols is not in place to tailor CT examinations to the maintains its recommendation to not endorse this
of Radiology ed patient for dose reduction. (1) Evidence also suggests a lack of provider awareness regarding dose exposure and associated risks, measure.
which would serve as the foundation for the development of strategies to minimize radiation dose, as concluded by 2 recent
investigations. In the first investigation, (2) emergency department patients, physicians, and radiologists were surveyed. The
results indicated that only 7% of patients indicated that there was any discussion outlining the radiation risks and benefits from an
abdominal CT examination, only 9% of emergency department physicians believed that the lifetime risk of cancer was potentially
increased by CT scanning, and 75% of physicians surveyed underestimated the accurate range for the equivalent number of chest
radiographs for a CT examination. In the second investigation only 12.5% physicians surveyed in the United Kingdom were aware
of the potential
association of CT radiation and cancer. Less than 20% correctly identified the relative
radiation dose of CT examinations. These studies support a continued and compelling need for
radiation safety education for health care professionals and the public.
197 M, Health Robert Pyatt, Not OIE-001-08: CT radiation dose reduction. We understand there is issue with the measure not requiring actual dose information to Comment appreciated. The Steering Committee
Professional American College Recommend be recorded, however, to do so is not straightforward. Although dose or dose estimation data is more readily available with maintains its recommendation to not endorse this
of Radiology ed digital x-ray imaging systems that can provide an index related to the amount of radiation used, there is such variability in how measure.
this data is stored across procedure/exam names, sites and vendors that standardized aggregation to make comparisons is
difficult at best. Patient specific information cannot be compared across sites. Thus, any type of re-assessment of the way dose is
described is years away. Similarly, the inclusion of dose estimates in the DICOM header, while nearing completion, will only be
mandated in new scanners. It is not clear what, if any, software pathway will exist for older scanners to be upgraded. A central
database established for dose indices as a function of patient qualities (i.e., gender, age, size, etc.) and exam type (i.e., lateral
lumbar spine, pelvis CT, etc.), would allow the relative range of radiation doses to be analyzed. Such a database would be
valuable in its ability to demonstrate changes in
dose indices due to technological advances and practice modifications and would be useful to
advisory radiation safety bodies as well as to individual practices wishing to compare their
own doses against established benchmarks.
198 M, Health Robert Pyatt, Not OIE-001-08: CT radiation dose reduction-Although work is being done to develop a comparative database like this through the Comment appreciated. The Steering Committee
Professional American College Recommend ACRs dose index registry pilot, the fruit of such efforts will not be widely implementable until beyond 2009.This measure serves maintains its recommendation to not endorse this
of Radiology ed as a proxy until this is accomplished. To raise awareness, and to increase the use of dose reduction protocols, even if the slightest, measure.
is a move in a much needed direction as has been the widely supported Image Gently pledge campaign. Furthermore, all AMA
PCPI measurement sets undergo a periodic review every 3-4 years or sooner if new evidence or guidelines become available that
would warrant a change in the measures. Advances in medical imaging equipment or the development of a comparative database
as described above will be considered in these measure updates.
199 M, Health Robert Pyatt, Not OIE-001-08: CT radiation dose reduction 1. Frush DP. Review of radiation issues for computed tomography. Semin Ultrasound Comment appreciated. The Steering Committee
Professional American College Recommend CT MR. 2004 Feb;25(1):17-24. 2. Lee CI, Haims AH, Monico EP, et al. Diagnostic CT scans: assessment of patient, physician, and maintains its recommendation to not endorse this
of Radiology ed radiologist awareness of radiation dose and possible risks. Radiology 2004; 393-398 3. Jacob K, Vivian G, Steel JR. X-ray dose measure.
training: are we exposed to enough? Clin Radiol. 2004;59:928-934
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200 M, Health Robert Pyatt, Not OIE-011-08 Communication to referring physician of patients potential risk for fracture for all patients undergoing bone Comment appreciated. The Steering Committee
Professional American College Recommend scintigraphy The ACR supports this measure. Similar to the two mammography communication measures in the Radiology maintains its recommendation to not endorse this
of Radiology ed Measure Set, reporting of non-routine imaging findings is important from a patient safety perspective by encouraging timely measure.
communication. Physician communication of serious risk to patients with condition such as bone metastases with lesions in
weight bearing bones, occult fractures, injuries from child abuse or falls is crucial to patient care. Furthermore, the measure
supports the care coordination priority area of the Institute of Medicine (IOM) which aims to establish and support a continuous
healing relationship, enabled by an integrated clinical environment and characterized by the proactive delivery of evidence-based
care and follow-up. Clinical integration is further defined in the IOM report as the extent to which patient care services are
coordinated across people, functions, activities, and sites over time so as to maximize the value of services delivered to patients.
201 M, Health Robert Pyatt, Not OIE-018-08 Use of contrast: Abdomen CT The ACR supports the decision to not recommend this measure. As constructed, the Comment appreciated.
Professional American College Recommend measure could identify potential outliers in terms of underutilization (for example for sites that do not have anyone to start IVs),
of Radiology ed but given the high rate of use of contrast material, it would be difficult to confirm over-utilization just from the perspective of the
percentage of use of contrast material per patient. Performance of combined with and without contrast studies as a percentage of
total abdominal CT scans should be the main area of evaluation.
202 M, Health Robert Pyatt, Not OIE-021-08 Mammography follow up rates - Administrative data sets such as that available to CMS are easily used to calculate The measure developer agrees with this comment
Professional American College Recommend surrogate recall (abnormal interpretation) rates, but that rate must be defined properly and use a valid conceptual construct. that the rate must be defined properly and use a
of Radiology ed Emphasizing recall rates could have unintended consequences on patient care. Too low a call back rate is problematic in terms of valid conceptual construct, and further emphasize
good care if efforts to lower recall result in decreased early detection of cancer. that this measure is intended to focus on a recall
range, not a specific target.
203 M, Health Donald Frush, ACR Not OIE-001-08: CT Radiation Dose Reduction The Pediatric Commission of the American College of Radiology and the Steering Comment appreciated. The Steering Committee
Professional Pediatric Committee for the Alliance for Radiation Safety in Pediatric Imaging strongly urges the NQF Steering Committee to reconsider its
Recommend maintains its recommendation to not endorse this
Commission on ed decision regarding the CT dose reduction measure. The Alliance for Radiation Safety in Pediatric Imaging is an organization of 29 measure.
behalf of the Image medical societies and agencies representing over 500,000 healthcare professionals worldwide. The Alliance includes radiologists,
Gently Campaign physicists and radiology technologists as well as other clinical physicians such as from the American Academy of Pediatrics. The
guiding principle of the Alliance and the Image Gently Campaign is to increase awareness of methods to reduce radiation dose for
children undergoing CT scans through an educational and awareness campaign. One of the principle target audiences is
radiologists, and Campaign guidelines include assessment of current pediatric CT protocols and a template for protocol
modification. Since it will be important to assess the impact of these guidelines, it would be very important to have a clinical
performance measure, such as
submitted through the ACR/AMA NCQA (Measure #7).
204 M, Health Donald Frush, ACR Not OIE-001-08: CT Radiation Dose Reduction While there are considerations other than those proposed in the measure, such as CT Comment appreciated. The Steering Committee
Professional Pediatric Recommend dose index (CTDI), we believe that the methods proposed in the measure (eg automatic tube current modulation, and size-based maintains its recommendation to not endorse this
Commission on ed pediatric protocols) are the most familiar to radiologists and technologists. In addition, the CTDI is a parameter that is already measure.
behalf of the Image assessed through the ACR CT Accreditation program. Implementation of these familiar dose optimization techniques for children
Gently Campaign can serve as a straightforward method for assessing clinical performance, changing practice when at variance with available
indicators of CT dose in children, and equally important, serve as a promoter for understanding CT, radiation dose and children
in daily practice. This is the foundation for the ALARA (as low as reasonably achievable) principle and safe and high quality CT in
children.
205 M, Not AdvaMed supports the Steering Committee's recommendations about the measures that were not recommended. Comment appreciated.
Supplier/Ind Madeleine Smith, Recommend
ustry AdvaMed ed
NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE 36
