Imaging_Member_and_Public_Comments by O0i1oX

VIEWS: 26 PAGES: 36

									                                                                                          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.

     Member
                     Organization
#    Council/                           Topic     Comment                                                                                                                            Proposed Action
                     Contact
     Public
    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.


                                                                               NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                 1
       Member
                      Organization
#      Council/                          Topic     Comment                                                                                                                                Proposed Action
                      Contact
       Public
     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.




                                                                                 NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                  2
       Member
                      Organization
#      Council/                           Topic         Comment                                                                                                                                 Proposed Action
                      Contact
       Public
    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
                                                                                      NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                            3
       Member
                      Organization
#      Council/                          Topic        Comment                                                                                                                             Proposed Action
                      Contact
       Public
    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.

                                                                                   NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                         4
       Member
                      Organization
#      Council/                          Topic        Comment                                                                                                                          Proposed Action
                      Contact
       Public
    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.




                                                                                   NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                5
       Member
                      Organization
#      Council/                          Topic        Comment                                                                                                                             Proposed Action
                      Contact
       Public
    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.




                                                                                    NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                  6
       Member
                      Organization
#      Council/                          Topic         Comment                                                                                                                                 Proposed Action
                      Contact
       Public
    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.
                                                                                        NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                     7
       Member
                      Organization
#      Council/                          Topic        Comment                                                                                                                                      Proposed Action
                      Contact
       Public
    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
                                                                                     NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                           8
      Member
                     Organization
#     Council/                           Topic        Comment                                                                                                                            Proposed Action
                     Contact
      Public
    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.




                                                                                   NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                 9
      Member
                   Organization
#     Council/                      Topic        Comment                                                                                                                                      Proposed Action
                   Contact
      Public
    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.




                                                                                NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                               10
      Member
                   Organization
#     Council/                      Topic        Comment                                                                                                                            Proposed Action
                   Contact
      Public
    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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                      Contact
       Public
    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.


                                                                                    NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                            16
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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
                                                                                      NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                        18
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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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#       Council/                          Topic        Comment                                                                                                                                Proposed Action
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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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#      Council/                          Topic        Comment                                                                                                                                 Proposed Action
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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.



                                                                                    NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                     21
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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).




                                                                                    NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                            22
        Member
                      Organization
#       Council/                          Topic        Comment                                                                                                                       Proposed Action
                      Contact
        Public
    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%.




                                                                                   NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                          23
       Member
                      Organization
#      Council/                           Topic       Comment                                                                                                                      Proposed Action
                      Contact
       Public
    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

                                                                                  NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                         24
        Member
                      Organization
#       Council/                          Topic       Comment                                                                                                                      Proposed Action
                      Contact
        Public
    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
                      Organization
#       Council/                          Topic        Comment                                                                                                                       Proposed Action
                      Contact
        Public
    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
                      Organization
#      Council/                          Topic        Comment                                                                                                                      Proposed Action
                      Contact
       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.




                                                                                    NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                               30
        Member
                   Organization
#       Council/                       Topic         Comment                                                                                                                             Proposed Action
                   Contact
        Public
    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.




                                                                                  NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                               31
        Member
                   Organization
#       Council/                        Topic        Comment                                                                                                                               Proposed Action
                   Contact
        Public
    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.




                                                                                   NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                32
        Member
                       Organization
#       Council/                          Topic        Comment                                                                                                                             Proposed Action
                       Contact
        Public
    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
                                                                                  NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                 33
        Member
                       Organization
#       Council/                          Topic        Comment                                                                                                                             Proposed Action
                       Contact
        Public
    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.




                                                                                    NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                               34
        Member
                       Organization
#       Council/                          Topic        Comment                                                                                                                               Proposed Action
                       Contact
        Public
    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




                                                                                     NQF DRAFT: DO NOT CITE, QUOTE, REPRODUCE, OR CIRCULATE                                                                                                35
        Member
                       Organization
#       Council/                           Topic        Comment                                                                                                                                Proposed Action
                       Contact
        Public
    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

								
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