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September 2, 2008 Kerry Weems Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1404-P Mail Stop C4-26-05 7500 Security Boulevard Baltimore, MD 21244-1850 Re: Medicare Program; Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates; Proposed Rule Dear Mr. Weems: The American College of Radiology (ACR), representing over 32,000 diagnostic radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists, appreciates this opportunity to comment on the proposed notice “Hospital Outpatient Prospective Payment System (HOPPS)” published in the Federal Register on July 18, 2008. The ACR would like to present positions on the following issues: the composite ambulatory payment classification (APCs), packaging issues, contrast studies, pricing of therapeutic radiopharmaceuticals, transitional pass-through payments and new technologies, Research Triangle Institute and cost compression, quality measures and hospital quality data reporting. Imaging Composite Ambulatory Payment Classifications (APCs) The Centers for Medicare and Medicaid Services (CMS) is proposing to establish five imaging composite APCs based on the families of codes used for the multiple imaging procedure payment reduction policy under the Medicare Physician Fee Schedule (MFS). The proposed new imaging composite APCs include: • • • • • Ultrasound Computed tomography (CT) and computed tomographic angiography (CTA) without contrast CT and CTA with contrast Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) without contrast; and MRI and MRA with contrast The ACR understands that Medicare Payment Advisory Commission (MedPAC) has been urging CMS to address how they can ensure that economies can be captured when two CT, MR or US studies that are done on the same patient and in the same session. The ACR believes that composites may be a good way to ensure that CMS is capturing this data and thus, any savings. As the ACR has commented previously, the level of savings vary between CT, MR, and US with respect to time and resources used when two studies are done on a patient in the same session. The use of composite APCs is preferable to the arbitrary reduction for multiple imaging services previously proposed by CMS. Hospitals are supposed to report their actual costs and thus, these differences could be better reflected in actual reporting rather than with specified percentages. 1 The ACR believes important issues need to be addressed before implementing the five composites for CT, MR, and US. However, if CMS chooses to move forward there are a few changes that ACR believes must take place in order for hospitals to avoid creating incentives for hospitals to provide these services on different days and thus, inconveniencing patients. We performed a detailed analysis of CMS claims to assess the impact of the CMS proposal. CMS’ proposed methodology appears to be reasonable when two studies are done in the same session. However, when three or more studies are performed in the same session the extra margin in the payment reduces significantly. The CMS data shows that three or more CT and MR studies are billed in the same session at least 25 percent of the time multiple examinations are billed. The ACR requests that CMS review at these cases and consider the development of a separate composite methodology for those instances where more than two CT, MR, or US exams are performed in the same session. If the payment for three or more studies is not increased, the ACR is concerned that hospitals will break out the studies into separate imaging sessions and inconvenience the patient by scheduling them for more than one visit to provide all the necessary imaging needed to diagnose their condition. Our findings are summarized in the table below. APC 8004 8005 8006 8007 8008 Number of Procedures on Same Date of Service within the Composite APC 2 Procedures 3 Procedures 4 Procedures 5 Procedures >5 Procedures 96.40% 2.57% 0.27% 0.17% 0.04% 81.83% 15.88% 1.65% 0.32% 0.15% 71.39% 25.06% 2.94% 0.42% 0.16% 84.92% 11.82% 2.15% 0.78% 0.30% 73.50% 20.67% 3.92% 1.25% 0.66 The ACR also requests that if CMS moves forward with the proposed composite methodology that the CT and MR studies that are done with and without contrast (and described by a single CPT code) be broken out into separate APCs. These studies grouped in with other “with contrast” studies causes their median payment level to drop significantly. The payment rates to CT and MR with and without contrast studies would be more stable in their separately assigned APCs. The ACR is concerned that hospitals will not be able to adjust to these issues in time before the outpatient prospective payment system (HOPPS) Final Rule. Below is an example of three CT procedures with contrast with CMS’ proposed payment and composite single session payment. Example: Three CT Procedures with Contrast Codes on Same Date of Service 72193 71260 74160 Q9965 Total CMS Proposed 2009 Payment Rate per Separately Paid Procedure $ 310.46 $ 310.46 $ 310.46 $0 $931.38 Composite Single Session APC Rate $ 639.09 In addition to our concerns about the potential re-scheduling of patients for a separate session when the imaging services are performed in a non-emergency situation, we also are concerned that the drop in 2 payment when three or more imaging studies are done in the same session will have a significant and immediate negative impact on hospital trauma centers. Packaging Issues Technical Comments on Increasing the Number of Single Claims for Codes with Q1 or Q2 Status Indicator The ACR commented extensively on the packaging of imaging into other procedures under CMS’ new methodology in 2007. As a result, CMS created the distinction between “STVX-packaged” and “Tpackaged” which significantly increased the number of single claims for these codes. In this proposed rule, the ACR appreciates the fact that the methodology is much more transparent, but we are concerned that the programming logic for capturing the costs of codes with Q1 and Q2 status indicators on single claims is not selecting sufficient number of data to be used in rate setting for the imaging codes that could otherwise be promoted to “majors”. “Q1 and Q2 packaged” are procedures that can be packaged (status indicator of N) based on the presence of other codes on the claim on the same day, otherwise they become procedures in their own right. A procedure with status indicator Q1 is packaged if there are any procedures on the same day with status indicators: S, T, U, or X. A procedure with a status indicator Q2 is packaged if there are any other procedures on the same day with status indicator T. Otherwise, the procedures are “promoted” and become majors. Note that there are special sets of rules if there are multiple procedures with status indicator Q1 or Q2 on the same day. Currently, the determination of whether or not the line is to be packaged is made at the very start of the ratesetting process. The result appears to be that more lines are packaged than are necessary or appropriate. For example, take the case of a claim that on a single day has two bypass codes and a procedure with a Q1 status indicator. The current logic would change the Q1 status indicator to an N, and then apply the ratesetting methodology. The methodology would then extract the two bypass codes creating pseudo-singles from them, leaving a single code with a status indicator N, which would not be used. If instead, the conditional status indicator (Q1) was assessed at each stage of the process, this Q1 status indicator line could be “promoted” to a single major after removal of the bypass codes, allowing this line to be used in the rate setting. In the example just presented, this alternative approach is consistent with current CMS policy to not include packaging with bypass codes, but then also to attempt to use as much of the HOPPS data as possible. Technical Comments on Packaging Imaging “Dependent” Codes into Independent Codes CMS packaged image guidance and supervision and interpretation (S&I) codes into their corresponding “independent” procedural codes last year under the assumption that the S&I codes are always incident to another paid procedure. Under this assumption, a significant proportion of the costs associated with the packaged codes that are included on single claims should be captured through the “independent” paid procedures. However, CMS’ recently released 2007 data show that a number of guidance or S&I 3 “dependent” codes are not on claims with paid procedures as often as 75% or more of the time. In some cases, when bypass codes are removed the packaged procedures are left on a claim with no other paid procedure and are dropped from rate-setting. In the situation where a packaged procedure is only included in rate setting 5 percent or 10 percent or 25 percent of the time, the hospitals using those technologies will, in fact, not be reimbursed for most of the costs associated with those procedures. The ACR urges CMS to carefully check to make sure that packaging and composite APC methodologies are working correctly before expanding their use into more comprehensive groupings. The ACR would like to explore developing composite APCs with CMS in order to be able to capture more multiple claims data to be used in the rate-setting methodology in the future. The ACR requests that CMS make the preliminary packaging and composite data available to the public for review as soon as possible. This would allow for stakeholders to determine if the packaging and composite methodologies are meeting the goals of capturing accurate multiple claims data. It also would allow stakeholders to be able to make more accurate suggestions of future changes within their specialty areas of interest. Packaging of Image Guided Radiation Therapy Our analysis of the packaging of image guided radiation therapy (IGRT) indicates that the CMS methodology includes only a small percentage of the costs of the packaged services in the calculation of the payment rates for the APCS into which they are packaged. We are concerned that inappropriately low payment rates will slow the adoption and continued use of this valuable technology. The ACR recommends that the packaging of IGRT be eliminated in CY 2009. The ACR supports the APC Advisory Panel’s most recent recommendation to unpackage Image Guided Radiation Therapy (IGRT) from treatment delivery and pay separately for two years. The ACR believes CMS must address the underlying problems in the methodology that eliminates a significant percentage of the costs of IGRT from the calculation of the costs of the independent APCs. Packaging of CT Guidance in Placement of Radiation Therapy Fields If CMS is going to continue to package, then CT guidance for the placement of radiation therapy fields should have a Q status indicator for those instances where it is the only service provided at the hospital. Patients are often sent to the hospital for a CT for which the purpose is to send these images over to a separate cancer treatment center or facility to be used to set up the cancer patient’s simulation and treatment plan for radiation therapy. The ACR has been receiving phone calls already asking how to handle this situation. The ACR recommends placing a Q status indicator on the code for CT guidance for the placement of radiation therapy fields to eliminate confusion and allow for this standard of patient care to continue. 4 Contrast Studies The ACR has conducted an analysis to determine if the multiple claims data used to determine the median APC weight for contrast-enhanced studies would improve if CMS required a contrast code to always be present on a claim with a contrast-enhanced study. The findings below indicate that the number of claims used in rate setting would be less but the quality of the data with respect to more accurate payment rates for contrast procedures would be improved if an edit policy were implemented similar to that of radiopharmaceuticals and nuclear medicine studies. Effect of Potential Edit Requiring Presence of Contrast Code with Imaging Procedure Codes for HOPPS Ratesetting Source: 2007 Claims Released with 2009 Proposed HOPPS Rule APC Procedure 0274 0337 Myelography CT with Contrast Ct w/o followed by w/ MRI/MRA w/o followed by w/ 0662 CTA 0283 0333 Single Frequency Under Current Policy Single Frequency With Edit Median Cost Under Current Policy 1,051 203 $384.43 $625.08 43,528 $10,475,050.53 510,345 369,329 $309.92 $315.19 3,061,256 $16,127,785.24 219,658 159,159 $345.02 $346.75 846,682 $1,462,209.17 524,712 375,434 $545.35 $558.02 805,225 $10,201,523.97 125,021 93,198 $357.01 $369.02 389,298 $4,673,904.56 Median Cost With Edit Total Frequency in 2007 Impact The ACR requests that CMS require that at least one contrast code be on a claim for an imaging service that requires contrast in order for it to be used in rate-setting. The ACR believes that this will ensure that the packaged costs of contrast are being captured in the contrast-enhanced APCs for which contrast is packaged. Attachment 1 is a list of CPT codes that ACR has identified as procedures that use contrast. Pricing of Therapeutic Radiopharmaceuticals For CY 2009, CMS proposes to pay for therapeutic radiopharmaceuticals under the standard drug payment method, based on average sales price (ASP) + 4 percent , when reported by the manufacturer through the standard CMS ASP reporting mechanisms. If ASP is not available, CMS would determine payment based on the mean costs of the therapeutic radiopharmaceutical, derived from hospital claims data. Pricing of radiopharmaceuticals has continued to be a challenge and the ACR is concerned that because of the low volume, certain high priced radiopharmaceuticals’ full costs are not being captured in the HOPPS under the conventional hospital charge data. Shortly after publication of the proposed rule, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) continued the mandate that hospital outpatient payments for therapeutic 5 radiopharmaceuticals will be based on the individual hospital’s charges reduced to costs until December 21, 2009. The ACR supports this legislative change and recommends that it be made permanent by CMS in CY 2010 and beyond through regulation. Pricing of Diagnostic Radiopharmaceuticals The ACR believes that CMS should provide preliminary and ongoing data that shows the outcome of CMS’ packaging of diagnostic radiopharmaceuticals into nuclear medicine APCs in order to determine exactly how hospitals are reporting their costs on these very important studies and drugs. The ACR also requests that CMS ensure that nuclear medicine APCs that have packaged diagnostic radiopharmaceuticals do not violate the two-times rule. Correct pricing of radiopharmaceuticals is particularly important as we head into the era of molecular imaging. If the cost of these new radiopharmaceuticals cannot be captured by the hospitals, there will be disincentive to provide these new and potentially life saving treatment options to Medicare beneficiaries. Transitional Pass-through Payments and New Technologies The ACR supports CMS’ acknowledgement that new diagnostic and therapeutic radiopharmaceuticals qualify for transitional pass through payment for up to three years. The ACR urges CMS to keep these new drugs in the transitional pass through status for the full three year time frame in order to ensure that costs are calculated on an adequate amount of data, especially for low volume high cost radiopharmaceuticals, before they are incorporated into regular APCs. The ACR understands that CMS should not double pay for the use of a radiopharmaceutical with a nuclear medicine procedure and supports taking the offset off of the procedure in order to preserve the data for the new drug and its correct establishment into the APC system. The ACR requests that CMS be careful to assure that accurate data are used when calculating the offset and that those data be made available stakeholders to ensure stability and accurate payment for the entire study through the transitional period. The ACR continues to be concerned with how new technologies are being handled under HOPPS. There has not been consistency of: 1) When they are assigned to new technology APCs; 2) How long they remain in new technology APCs; and 3) When they are assigned to regular APCs. The ACR requests that CMS consider consistently placing new technologies in new technology APCs similar to how CMS is suggesting it will handle pass-through payments for radiopharmaceuticals. This would allow for new technologies to be in a neutral category, where cost data can be collected and then the appropriate placement can be made, hopefully with stable cost data, in a regular APC. The ACR requests improvement and consistency in the placement of new technologies and how they are handled under HOPPS. These services are the cutting edge advances in medicine that need to be available for future patient care. 6 Research Triangle Institute (RTI)/Cost Compression The ACR appreciates that CMS is not proposing to adopt any short-term adjustments to the HOPPS payment rate calculations for 2009 and agrees that the changes RTI suggests are complex and that CMS should proceed with caution. The ACR supports CMS’ efforts to work on educational activities for hospitals to improve their cost reporting. We believe that educational efforts to help hospitals to more accurately report their costs for high cost services like CT and MRIs is especially important. The ACR remains very concerned about the effects of charge compression on the pricing of new and highcost technologies in hospital charge masters and how this affects the payment of these technologies under the HOPPS. The recent RTI reports on charge compression (January 2007 and April 2008) show low costto-charge ratios (CCRs) for advanced imaging services such as MR and CT scans. One set of RTI estimates suggests that hospitals on average mark up CT services by more than 1800 percent over cost (CCR of 0.054), compared to an average markup of just over 300 percent for routine radiology costs (CCR of 0.308). This roughly five-fold differential in markup of these high cost imaging studies seems too large to be an accurate reflection of typical hospital charging behavior. Accordingly, we believe the RTI CCRs are implausibly low and would result in substantial distortion of payments if used for calibrating Medicare rates. The use of these CCRs for setting Medicare payment rates would significantly reduce payment for imagingintensive Diagnosis Related Groups (DRGs) such as those for trauma services. But the impact on the HOPPS and technical payments under the physician fee schedule would be more dramatic. Currently, CMS uses a CT- or MR-specific CCR for about a third of hospitals in the HOPPS rate calculation. Expanding that, by using the RTI CCRs through out or by following RTI’s lead in re-assigning cost report line designations, would cause an inappropriate reduction in the HOPPS rates. Furthermore, due to the Deficit Reduction Act (DRA) caps on payments in the MFS, these HOPPS reductions would spill over onto services performed in non-hospital outpatient settings. The ACR hired Christopher Hogan, Ph.D. to examine this issue for us. Dr. Hogan concluded that the measured CCRs for advanced imaging may reflect a mis-allocation of capital costs on the cost report. That is, a significant number of hospitals report little or no capital costs for MR and CT. Therefore, these hospitals may be treating CT and MR machines as hospital fixtures (allocated to hospital overhead) instead of equipment (allocated to radiology cost). If this is so, RTI’s estimate of the costs and CCRs for CT and MR are substantially too low. Regardless of the actual reason for the low CCRs, the use of the RTI CCRs could result in some highly anomalous payments. For example, as shown below, they could result in higher payment for x-ray than for a similar CT scan. They could also result in physician fee schedule rates for technical component costs of CT scans to be less than CMS’ own estimate of cost of the CT scanner alone (let alone all other costs associated with the service), even under the assumption of full-time use of the scanner. This would effectively prohibit physicians from providing these services. This also strongly suggests that hospitals would find it highly unprofitable to provide these services at those rates. To illustrate this we performed a payment rate and cost calculation for x-ray versus CT scan of the head. These services image the same part of the body and take roughly the same amount of time (24 and 26 minutes respectively, based on the 2008 physician practice expense data). Because the treatment of capital cost may be the key issue, we compare projected HOPPS payments using the RTI CCRs to the estimated 7 direct (no overhead) equipment cost per procedure from the physician fee schedule practice expense calculation. Table 1 shows what the use of these CCRs would imply for the Medicare HOPPS. To calculate the projected HOPPS rates, we started from the current OPPS rate. We adjusted that using the ratio of the RTI CCRs to the actual HOPPS CCRs used to create those rates (the average CCR on single-procedure claims using calendar year 2006 HOPPS claims). Table 1 shows that the use of the RTI CCRs would create several anomalies in the rates. First, the RTI regression-based CCRs would result in paying more for x-ray ($99) than for the corresponding CT service ($65). In effect, that set of CCRs says that x-ray is more costly than CT. Second, while the RTI rates always exceed the equipment cost of the x-ray service, they are often substantially below the equipment cost of the CT service. Using CMS’ current assumption of an average 50 percent use rate, neither of the HOPPS rates based on the RTI CCRs would be enough to pay for the cost of the equipment. We emphasize that this is just the cost of amortizing and maintaining the equipment, and does not include the additional personnel, supplies, and overhead costs actually involved in providing that service. Even at an assumed full-time (100 percent) use rate, the RTI-based HOPPS rates would barely cover the CT equipment cost or fall just below the CT equipment cost. The clear implication here is that using the RTI CCRs to calculate the HOPPS rates (and hence the DRA physician fee caps) would make it impossible to offer CT services in stand-alone outpatient settings such as physician offices, and would make those services substantially unprofitable in hospital outpatient settings. Table 1: Projected HOPPS Rates Versus Estimated Equipment Cost per Procedure, Using RTI Costto-Charge Ratios Payment Rate, Actual 2008 Payment Rate Using 2008 RTI CCR, cost report Payment Rate Using 2008 RTI CCR, regression 70450 Ct head/brain w/o dye (26 minutes) Cost-to-Charge Ratio 0.160 0.066 0.054 Actual or Projected HOPPS Rate Phy. Equipment Cost, 50% Use Rate $192 $79 $65 $144 $144 $144 Difference, Payment less Eq. Cost $48 -$65 -$79 Phy. Equipment Cost, 100% Use Rate $72 $72 $72 $120 $7 -$7 0.230 0.191 0.308 $74 $61 $99 Difference, Payment less Eq. Cost 70260 X-ray exam of skull (24 minutes) Cost-to-Charge Ratio Actual or Projected HOPPS Rate 8 Phy. Equipment Cost, 50% Use Rate $14 $14 $14 Difference, Payment less Eq. Cost $60 $47 $85 $7 $7 $7 Difference, Payment less Eq. Cost $67 $54 $92 Memo: Ratio of CT to Xray rate 2.59 1.30 0.66 Phy. Equipment Cost, 100% Use Rate Sources: Physician cost calculated from 2008 physician final rule practice expense data, using CMS methodology, at 50 percent and 100 percent use rate. Current HOPPS CCRs calculated from single procedure claims extracted from the Propose Rule 2008 HOPPS file. RTI CCRs taken from the April 2008 RTI report to CMS on charge compression. Projected rates calculated as current rate time ratio of RTI to current CCR. The ACR requests that CMS not implement the adjustments recommended in the RTI reports and continue to study this further. Implementation of these methodological changes without further review and analysis of the hospital claims data could have severe negative impacts on both the hospital outpatient and non-hospital settings for those sites that offer CT and MR services. Proposed Quality Measures for CY 2010 Hospital Outpatient Payment Determination As required by law, CMS is proposing to reduce the annual HOPPS payment inflation update by 2 percent for hospitals that do not meet quality reporting requirements beginning in CY 2009. The ACR is concerned that hospitals may be inappropriately penalized for not being able to comply with reporting quality measures due to lack of funding and time. New hospital claims systems can cost as much as $50 million. Hospitals will need to upgrade their hospital electronic medical record systems in order to have the data fields available to report the quality measures. Rural hospitals may need to install new electronic medical record systems if they do not have an electronic medical record system. This new requirement also increases the need for staff to collect the measures and report accurately. The ACR requests that CMS not penalize hospitals by cutting their payments by 2 percent if they can demonstrate that they currently are working to comply with the reporting requirements but do not yet have the infrastructure to fully comply. For a hospital to receive the full outpatient update payment factor in 2010, CMS proposes reporting on four new imaging efficiency measures, along with continued reporting on the seven quality measures in place during the initial measurement reporting period of the HOP QRDP in 2008. The ACR commented on these measures in December 2007. Since that time, any revision to measure specifications has not been made publicly available. Included in Attachment 2 are our previous comments. 9 The ACR is concerned that the four new imaging measures proposed for reporting in 2009 are not appropriate to be included in the 2010 payment year because they are still in the developmental phase. These measures have not yet received National Quality Forum (NQF) endorsement nor have they been considered for adoption by the AQA-HQA Collaboration – Quality Alliance Steering Committee (QASC). Adoption of appropriate performance measures and continued progress in constructively improving quality of care requires meaningful public comment on quality measures that have been broadly vetted at the stakeholder level and needs to occur through adoption of measures by the QASC and endorsement by the NQF. In the proposed rule, CMS did not provide critical information about the proposed measures, such as measure specifications, an appropriate rationale for each measure, discussion of the evidence underlying the measures, an explanation of the expected value of putting the measure into place, nor any indication of previous measure testing or results of testing. Rulemaking is intended to provide the opportunity for public comment, but this cannot be achieved when a proposal is so vague and incomplete that it prevents meaningful comment. Accordingly, we urge CMS to not adopt the four imaging measures at this time and to re-evaluate the measures at such time as essential measure specification, NQF endorsement, and QASC consideration can be accomplished. CMS’ current proposal with regard to these imaging measures is unclear both in the detail of the measures and the method of implementation. CMS is proposing to “adopt” the four imaging measures beginning with the CY 2010 payment determination and states that CMS will calculate the measures using CY 2008 Medicare Part B claims data. This is elusive and vague as to how compliance with reporting the measures is determined – since, unlike the existing seven HOP QDRP measures, measure data is not reported but derived from claims. It is unclear whether compliance is based on “reporting” through claims submission, or whether compliance is based on an unknown performance rate. CMS also did not provide hospitals fair notice or due process that 2008 claims would potentially be used for the purpose of measure analysis, for payment update determination or for publicly available comparative data. Services billed on CY 2008 claims are being provided now. Hospitals did not have the opportunity to review and understand the implications of the measures or make changes in their processes or care prior to use of claims for measure analysis. It is also unclear as to how CMS will attribute measure performance or reporting compliance, because imaging measures may require analysis of Medicare beneficiary claims from multiple facilities, as in the case of the MRI Lumbar Spine measure. The ACR requests clarification on the form and manner of reporting the imaging measures and urges CMS to not adopt these measures in any manner until specific information as to implementation is provided through due process. CMS states that it intends to harmonize measures to be used in the HOP QDRP with measures that can be or are already adopted in comparable inpatient and ambulatory care and across settings and providers and to use the same measure specifications. When harmonizing measures across settings, CMS should be specific as to what the particular entity is accountable or responsible. Moreover, measures that relate to physician performance in the hospital outpatient setting should be aligned with physician measures utilized in other CMS quality programs, such as the Physician Quality Reporting Initiative (PQRI). 10 The newly enacted MIPPA calls for the Secretary to contract with a consensus-based organization like the NQF, to develop and report annually, to the Secretary and Congress on goals and priorities and specific measures to help health care providers meet those goals and procedures, and for the Secretary to then set national goals. It seems that the outcome of such a priority setting process could greatly inform and focus future measures to be considered in the outpatient setting. The ACR urges CMS to work with stakeholders, especially the AMA PCPI, NQF, and the QASC, to prioritize any new measures and to work to ensure that newly selected measures align with overall national goals for quality improvement. Conclusion Thank you for the opportunity to comment on this proposed rule. The ACR looks forward to continued dialogues with CMS officials. Should you have any questions on the items addressed in this comment letter, please contact Sneha Soni at (800) 227-5463, ext. 4576 or via email at [email protected]. Respectfully Submitted, Harvey L. Neiman, MD, FACR Executive Director Cc: Carol Bazell, MD, MPH, CMS Edith Hambrick, MD, CMS Tamar Spolter, MHS, CMS Bibb Allen, MD, FACR, Chair, ACR Commission on Economics Richard R. Duszak, Jr., MD, FACR, Vice-Chair, ACR Commission on Economics James V. Rawson, MD, Chair, ACR Economics Committee on HOPPS/APC Pamela J. Kassing, ACR Maurine Spillman-Dennis, ACR Angela J. Kim, ACR Sneha J. Soni, ACR 11 Attachment 1 Procedures that Use Contrast 0145T 0150T 0151T 70460 70470 70481 70482 70487 70488 70491 70492 70496 70498 71260 Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; cardiac structure and morphology Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; cardiac structure and morphology in congenital heart disease Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing, function evaluation (left and right ventricular function, ejection-fraction and segmental wall motion) (List separately in addition to code for primary procedure) Computed tomography, head or brain; with contrast material(s) Computed tomography, head or brain; without contrast material, followed by contrast material(s) and further sections Computed tomography, orbit, sella, or posterior fossa or outer, middle, or inner ear; with contrast material(s) Computed tomography, orbit, sella, or posterior fossa or outer, middle, or inner ear; without contrast material, followed by contrast material(s) and further sections Computed tomography, maxillofacial area; with contrast material(s) Computed tomography, maxillofacial area; without contrast material, followed by contrast material(s) and further sections Computed tomography, soft tissue neck; with contrast material(s) Computed tomography, soft tissue neck; without contrast material followed by contrast material(s) and further sections Computed tomographic angiography, head, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomographic angiography, neck, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomography, thorax; with contrast material(s) cardiovascular system cardiovascular system cardiovascular system Neuro Neuro Head and Neck Head and Neck Head and Neck Head and Neck Head and Neck Head and Neck Head and Neck Head and Neck Chest 12 71270 71275 72126 72127 72129 72130 72132 72133 72191 72193 72194 73201 73202 73206 73701 73702 73706 74160 Computed tomography, thorax; without contrast material, followed by contrast material(s) and further sections Computed tomographic angiography, chest (noncoronary), with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomography, cervical spine; with contrast material Computed tomography, cervical spine; without contrast material, followed by contrast material(s) and further sections Computed tomography, thoracic spine; with contrast material Computed tomography, thoracic spine; without contrast material, followed by contrast material(s) and further sections Computed tomography, lumbar spine; with contrast material Computed tomography, lumbar spine; without contrast material, followed by contrast material(s) and further sections Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomography, pelvis; with contrast material(s) Computed tomography, pelvis; without contrast material, followed by contrast material(s) and further sections Computed tomography, upper extremity; with contrast material(s) Computed tomography, upper extremity; without contrast material, followed by contrast material(s) and further sections Computed tomographic angiography, upper extremity, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomography, lower extremity; with contrast material(s) Computed tomography, lower extremity; without contrast material, followed by contrast material(s) and further sections Computed tomographic angiography, lower extremity, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomography, abdomen; with contrast material(s) Chest Chest Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis Spine and Pelvis Pelvis Spine and Pelvis Upper Extremities Upper Extremities Upper Extremities Lower Extremities Lower Extremities Lower Extremities Abdomen 13 74170 Computed tomography, abdomen; without contrast material, followed by contrast material(s) and further sections Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomographic angiography, abdominal aorta and bilateral iliofemoral lower extremity runoff, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), without quantitative evaluation of coronary calcium Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), with quantitative evaluation of coronary calcium Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; cardiac structure and morphology and computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), with quantitative evaluation of coronary calcium Abdomen 0149T Computed tomography, heart, without contrast material followed by contrast material(s) and further sections, including cardiac gating and 3D image postprocessing; cardiac structure and morphology and computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), with quantitative evaluation of coronary calcium cardiovascular system 70542 Magnetic resonance (eg, proton) imaging, orbit, face, and/or neck; with contrast material(s) Magnetic resonance (eg, proton) imaging, orbit, face, and/or neck; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, head; with contrast material(s) Neuro - Head and Neck Neuro - Head and Neck 74175 75635 0146T 0147T 0148T 70543 70545 Abdomen Aorta and Arteries cardiovascular system cardiovascular system cardiovascular system Neuro - Head and Neck 14 70546 70548 70549 70552 70553 70554 70555 70558 70559 71551 71552 71555 72142 72147 72149 72156 Magnetic resonance angiography, head; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, neck; with contrast material(s) Magnetic resonance angiography, neck; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance (eg, proton) imaging, brain (including brain stem); with contrast material(s) Magnetic resonance (eg, proton) imaging, brain (including brain stem); without contrast material, followed by contrast material(s) and further sequences Magnetic resonance imaging, brain, functional MRI; including test selection and administration of repetitive body part movement and/or visual stimulation, not requiring physician or psychologist administration Magnetic resonance imaging, brain, functional MRI; requiring physician or psychologist administration of entire neurofunctional testing Magnetic resonance (eg, proton) imaging, brain (including brain stem and skull base), during open intracranial procedure (eg, to assess for residual tumor or residual vascular malformation); with contrast material(s) Magnetic resonance (eg, proton) imaging, brain (including brain stem and skull base), during open intracranial procedure (eg, to assess for residual tumor or residual vascular malformation); without contrast material(s), followed by contrast material(s) a Magnetic resonance (eg, proton) imaging, chest (eg, for evaluation of hilar and mediastinal lymphadenopathy); with contrast material(s) Magnetic resonance (eg, proton) imaging, chest (eg, for evaluation of hilar and mediastinal lymphadenopathy); without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, chest (excluding myocardium), with or without contrast material(s) Magnetic resonance (eg, proton) imaging, spinal canal and contents, cervical; with contrast material(s) Magnetic resonance (eg, proton) imaging, spinal canal and contents, thoracic; with contrast material(s) Magnetic resonance (eg, proton) imaging, spinal canal and contents, lumbar; with contrast material(s) Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; cervical Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Neuro - Head and Neck Chest Chest Chest Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis 15 72157 72158 72159 72196 72197 72198 73219 73220 73222 73223 73225 73719 73720 73722 73723 73725 74182 74183 74185 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; thoracic Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; lumbar Magnetic resonance angiography, spinal canal and contents, with or without contrast material(s) Magnetic resonance (eg, proton) imaging, pelvis; with contrast material(s) Magnetic resonance (eg, proton) imaging, pelvis; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, pelvis, with or without contrast material(s) Magnetic resonance (eg, proton) imaging, upper extremity, other than joint; with contrast material(s) Magnetic resonance (eg, proton) imaging, upper extremity, other than joint; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance (eg, proton) imaging, any joint of upper extremity; with contrast material(s) Magnetic resonance (eg, proton) imaging, any joint of upper extremity; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, upper extremity, with or without contrast material(s) Magnetic resonance (eg, proton) imaging, lower extremity other than joint; with contrast material(s) Magnetic resonance (eg, proton) imaging, lower extremity other than joint; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance (eg, proton) imaging, any joint of lower extremity; with contrast material(s) Magnetic resonance (eg, proton) imaging, any joint of lower extremity; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, lower extremity, with or without contrast material(s) Magnetic resonance (eg, proton) imaging, abdomen; with contrast material(s) Magnetic resonance (eg, proton) imaging, abdomen; without contrast material(s), followed by with contrast material(s) and further sequences Magnetic resonance angiography, abdomen, with or without contrast material(s) Neuro - Spine and Pelvis Neuro - Spine and Pelvis Neuro - Spine and Pelvis Spine and Pelvis Spine and Pelvis Spine and Pelvis Upper Extremities Upper Extremities Upper Extremities Upper Extremities Upper Extremities Lower Extremities Lower Extremities Lower Extremities Lower Extremities Lower Extremities Abdomen Abdomen Abdomen 16 75561 75562 75563 75564 77058 77059 Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences; Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences; with flow/velocity quantification Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences; with stress imaging Cardiovascular System Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences; with flow/velocity quantification and stress Magnetic resonance imaging, breast, without and/or with contrast material(s); unilateral Magnetic resonance imaging, breast, without and/or with contrast material(s); bilateral Cardiovascular System Cardiovascular System Cardiovascular System Breast Breast 17 Attachment 2 Measure #1: MRI Lumbar Spine for Low Back Pain There is general support for this measure as the exam is one of the most over utilized imaging exams. However, there are several substantial issues with the measure as currently constructed. 1. Attributability/determination of previous conservative therapy It is suggested that the measure results be segmented and reported by rendering provider. If CMS retrospectively analyzes claims data to search and correlate imaging and conservative therapy, is the measure then attributable to the imaging or rendering provider rather than the referring provider? a. Complete details of a patient treatment plan and history are often unavailable to imaging provider, particularly for patients originating from outside of the health system doing imaging. b. Conservative therapy is often supervised by generalists who refer patients who do not respond to conservative treatment to specialists. Specialists often order MRI immediately without more conservative therapy. The MRI referring physician may not appear in administrative data, though the patient may have had extensive exercise, over the counter medications during the period of the acute episode. c. It will be difficult to measure conservative therapy such as bed rest or over the counter pain medications utilized. This is especially important, because the use of self care techniques is advised in order to avoid “over medicalization” of episodic lumbar pain and radiculopathy. 2. Relevance As stated above, the rationale for the intent of the measure is recognized and supported, but in the manner constructed it may not provide the most useful data. The following is offered for consideration: a. Rate when the ordering and interpreting physician are one and same would be of interest. b. A large percentage of cases are referred by orthopedic or neuro surgeons, in which case most patients would have undergone conservative therapy. Those without conservative therapy often come from the emergency room. c. More and more frequently insurers deny claims on patients without conservative therapy. 3. Diagnoses codes used for inclusion in measure inaccurate or incomplete a. Using ICD9 codes specific to lumbar conditions from imaging procedure claims may not gather patients into the denominator that would be expected since studies without definitive diagnosis for lumbar disease will be coded with specific findings. This is problematic because a high proportion of lumbar spine imaging reveals findings not distinguishing normal from abnormal subjects in the Gaussian sense. Therefore, “normal” results may indicate a high quality of radiological performance – that certain degenerative findings are often seen in normal subjects, such as disk protrusions (722.2). Consider a patient with disk protrusion on right side but pain on left side. Also, there are other indications for a lumbar MRI other than for suspected neurological deficit such as for spinal therapeutic injections. The MRI determines the level for the injection and which levels have adequate epidural fat to inject. b. 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: 18 1) Recent significant trauma, or milder trauma, age >50 2) Unexplained weight loss (783.2) 3) Unexplained fever (780.6) 4) Immunosuppression (279.3) 5) History of cancer 6) IV drug use 7) Prolonged use of corticosteroids, osteoporosis 8) Age>70 9) Focal neurologic deficit, progressive or disabling symptoms c. Important clinical indications for MRI not addressed For patients with acute significant motor or sensory loss or those with a known malignancy and sudden back pain with normal radiographs, an urgent MRI would be standard of care. 4. Other concerns a. A more specific definition of “false positive misinterpretation” referred to in Section I of the measure is needed. Does this allude to incorrect identification of a finding or a problem of correlating the imaging finding with the clinical complaint? b. Malpractice issues – in an environment of capricious malpractice courts, especially in cases alleging a “failure to diagnose” or a “delay in treatment” where is protection for a physician who conscientiously attempts to follow prescribed policies? It must be noted that cauda equina syndrome is among the more frequent causes of litigation. Measure #2: Mammography Follow-Up Rates 1. Lack of understanding of mammography practice operations The discussion states that high recall rates are an indication of absence of real-time review of screening exams, and that the most efficient delivery of diagnostic mammography services is that which is contemporaneous with the initial screening. This seems to indicate a lack of understanding of the operational processes and efficiencies, and conditions required for optimal image interpretation for most sites performing and interpreting screening mammograms. In order to best utilize resources and services of radiologists interpreting mammograms, it is most efficient to conduct “batch reading” of images. In this way the radiologist is not rushed in the interpretation, images are more easily organized and patients are not “collecting” in the waiting area stressing the system. As the number of radiologists willing to review mammograms is declining, in many locales there are few who are immediately available to do real time reading. Real time reading, or on the fly interpretation would require a major change in logistics, radiologist and technologist staffing and likely lead to lower productivity. This in turn could result in longer wait times for patients before their screening mammograms can be scheduled. Additionally, since ultrasound is frequently used for additional imaging after a screening mammogram, ultrasound would also be necessary at a screening mammography site. Because qualified ultrasound technologists are in short supply, it would be counterproductive to encourage a practice style that would result in waste of this scarce resource. 19 It must be noted that any gains in patient convenience that might be derived from avoiding a return visit by 10 percent of women who are recalled for additional study will almost certainly be more than fully offset by the additional time that the 90 percent who require no additional imaging will be detained at the mammography center awaiting preliminary interpretation of the screening mammogram. Some of these patients will require recall in any event if the preliminary impression is revised upon reflection, or ultrasound, for example, is not available at the moment. In addition, this style of practice is not feasible for extended hours, mobile mammography outreach, rural or inner city satellite clinics and other methods to increase screening prevalence. Additional concerns with real-time reading will be discussed below. 2. Unintended consequences Same day diagnostic mammography The measure is seriously flawed in setting “on the fly” interpretation as the ideal method for mammography. This is an inefficient way to perform screening mammography (which normally would increase the cost in most other economic situations), but also is the most distracting way, which does not allow the mammographer to concentrate on screening. Error rate in interpretation may increase in real time reading. There is literature that suggests the superiority of batch film reading where conditions are controlled and decisions are made in an orderly fashion (ES Burnside, et al AJR: 185, September 2005). This study showed that batch reading can significantly reduce screening mammography recall rates without affecting the cancer detection rate or the proportion of cancers diagnosed with favorable prognostic indicators. Also, prior mammograms are typically reviewed prior to assigning a final assessment code or a decision for further work up. Reviewing prior films (which frequently come from outside facilities and can take weeks to arrive) will impact the decision for more imaging or a BIRADS category 1 or 2 assessment. The same day approach may lead to more overall diagnostic studies way above 10 percent recalled (patient already there, not inconvenienced to get additional view). Real-time interpretation of screening mammograms has been shown to be associated with a statistically significant higher recall rate than batch reading (Ghate et al. Radiology 2005;235:31-35). A same day diagnostic will still cause separate charges, additional radiation, and patient anxiety (although less so than a request to return). This seems contrary to the goal of the measure. The costs of imposition of same day diagnostic services on screening programs would negatively impact access and population screening rates, particularly for under- and uninsured populations as well as underserved rural and urban populations. Population based screening attempts to increase access through efficiency and economy. If the radiologist looks at every screening exam before the patient leaves the efficiency of high volume is lost. Furthermore, scarce physician resources would be consumed in this inefficient screening approach that could be better utilized in diagnostic mammography, breast ultrasound, and biopsy. Recall Rate Administrative data sets such as that available to CMS are easily used to calculate surrogate recall (abnormal interpretation) rates, but that rate must be defined properly and use a valid conceptual construct. The measure appears not to take into account the following: 20 • Stating that a recall rate greater than 10 percent is “unusually high” means that 50 percent of the radiologists in the cited study (Rosenberg et al. Radiology 2006; 241:55) have a recall rate that is unusually high. • Emphasizing recall rates could very well be detrimental to patient care. Too low a call back rate is problematic in terms of good care if efforts to lower recall result in decreased early detection of cancer. The Technical Panel (TEP) of imaging experts that was convened to advise L&M, The Lewin Group and the National Imaging Associates (NIA) voiced this very concern. There are no established, proven methods for lowering recall rates without potentially sacrificing cancer detection rates. For this reason the mammography measures developed in the AMA Consortium Workgroup focused on ensuring individual sites/radiologists developed a system for calculating and reviewing their own recall rates. • The statement in the proposed metric that “unusually high” recall rates are due to “the inability of the reader to adequately determine when additional imaging is necessary (high false positive rate)” is not necessarily true. Actually, the inability of a reader to determine when additional imaging is necessary may lead to lower recalls. A high false negative rate has more serious implications for patients than a high false positive rate. • Studies have shown that American women prefer and are willing to tolerate a high false positive rate in order to detect more cancers. • Same day diagnostic services must not be excluded from abnormal interpretation rate. Additional views beyond the normal screening must be included in the abnormal interpretation (recall) rate. After all, additional radiation dose, anxiety, etc. result from the additional views. 3. Relevance While shorter time to call back completion seems obviously better, the total time from initiation of contact to completion is important. You are farther ahead if you get the initial mammogram completed in 40 days and call back 14 days later than wait 100 days for a screening and get called back in three. Most radiologists in the United States interpret a relatively small volume of screening mammograms per year. 54 percent of radiologists in the US do fewer than 2000 mammograms per year (screening and diagnostic), (Institute Of Medicine (IOM) 2005). As a result, recall rates often will show statistical variation from one year to the next, even in the face of consistent performance by the radiologists, strictly on the basis of random chance. This is, particularly true for those radiologists who interpret the minimum number of mammograms required under Mammography Quality Standards Act (MQSA). It is strongly recommended that if the data collection specified in this measure is done, a desired “follow up” level should not be mandated. Doing so would likely result in decreased numbers of qualified breast imagers with a resultant decrease in patient access to mammography. 4. Measure construction, incomplete codes a. The measure should include CPT codes for all procedures that would capture true abnormal interpretation rate within a period of time that is reasonable to allow a patient to return for a 21 diagnostic exam or other downstream service. • Extend the 45 day period following a screening mammography to 7 months to capture those given an (inappropriate) initial screening assessment category of “probably benign” (BIRADS 3) to capture the six month follow up screening exam • Include same day diagnostic exam in recall rate b. No reference or guideline was given for the 5 day recall timeframe. Literature suggests at least 14 days as a median (RYabroff, et al AJR 2007; 188:242-245). Delay also must consider patient availability. Measure #3: Abdomen CT – Use of Contrast Material Overall, both measures focusing on use of contrast material were felt to be reasonable and an area where evaluation is warranted. Measuring referring physician performance may be much more relevant than radiology performance to the frequency of acute imaging. Several recommendations are provided below. 1. Relevance As constructed, the measure may could catch potential outliers in terms of underutilization (for example for sites that do not have anyone to start IVs), 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 rather than “questionable utilization of contrast agents”. Insurance data has shown 15 to 54 percent variation in use of combined exams, even after some level of intervention. The 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). 2. Measure construction, incomplete codes Looking at ratios of contrast, no contrast, with and without is relatively easy from administrative data (e.g., CPT) codes. However the differences between practices may by due to differences in patient mix. The relative frequency of renal, pancreatic or adrenal mass in the practice as compared with other indications such as flank pain or abdominal pain will affect the relative frequency with which contrast, non contrast and with and without contrast examinations are performed. Contrast use is a function of the population of patients with renal dysfunction, which can vary strongly by institution. Another variable is the lack of use of contrast on follow-up in some categories of patients. Also a factor is a high frequency “rule-out stone” requests typically coming from the Emergency Department. Risk adjustment or stratification on the basis of ICD9 codes for relevant clinical syndromes or pathological conditions ought to be performed. Red flag indications for combined studies: Unspecified disorder of kidney and ureter Hematuria Benign, essential, idiopathic 593.9 599.7 22 Schistosoma haematobium Pancreatic Hypoglycemia, unspecified Hypoglycemia with coma In diabetes mellitus Leucine-induced Adrenal mass Unspecified disorder of adrenal glands 120.0 251.2 251.0 250.8 270.3 255.9 Measure #4: Thorax CT – Use of Contrast Material 1. Relevance There is concern that the measure is evaluating performance of studies with contrast. The focus should be on routine use of combined, not studies with contrast only. During a recent review of the ACR Thoracic CT guideline, thoracic experts debated largely whether the basic exam should be with contrast or without. There was no argument for routine use of combined studies. There are clear indications to use without contrast for parenchyma and calcification, with contrast for adenopathy or practice expense. 23