June 25, 2012 Ms. Marilyn Tavenner Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1588-P P.O. Box 8011 Baltimore, MD 21244-8050 RE: CMS-1588-P - Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2013 Rates Dear Acting Administrator Tavenner: The Society for Vascular Surgery (SVS), representing over 3,500 practicing vascular surgeons in the United States, offers the following comments on the Centers for Medicare & Medicaid Services (CMS) Medicare hospital inpatient prospective payment system (IPPS) proposed rule for fiscal year (FY) 2013. SVS supports CMS s intent of working to ensure that Medicare payments for inpatient services are accurate and reflect the cost to the hospital of providing high quality care. Therefore, we would make the following recommendations and comments to CMS on the four issues listed below. Recommendations MDC 5, Diseases and Disorders of the Circulatory System - Endovascular Implantation of Branching or Fenestrated Graft of the Aorta SVS disagrees with CMS proposal to not change the MS-DRG assignment for ICD-9- CM procedure code 39.78 endovascular implantation of branching or fenestrated grafts in the aorta to MS-DRGs 237 and 238. SVS believes that endovascular implantation of branching or fenestrated grafts of the aorta is more clinically similar to other aorta procedures versus other endovascular procedures and that procedure code 39.78 should be reassigned to MS-DRGs 237 and 238 with the other aorta procedure codes. From an analysis of 20 cases of endovascular implantation of the branching or fenestrated grafts of the aorta, SVS found that the average charges of these cases was over $263,000, approximately 3.5 times the standardized charge from the MedPAR data used by CMS to set the proposed rate for MS-DRG 237. SVS believes the resource data history it collected for procedure code 39.78 is representative of patients treated since October 1, 2011 and we believe this data does 1
justify a reassignment of ICD-9-CM procedure code 39.78 to MS-DRGs 237 and 238 as of October 1, 2012. Suggested Changes to MS-DRG Severity Levels for Diagnosis Codes for FY 2013 - Chronic Total Occlusion of Artery of the Extremity SVS supports CMS proposal to change the severity level for diagnosis code 440.4 from a non-cc to a CC. Re-opening chronic total occlusions requires far more time and resource utilization compared to arteries that are not completely occluded. We believe this is an appropriate recommendation. New Technology Add-On Payments - Zenith Fenestrated AAA Endovascular Graft SVS encourages CMS to approve the Zenith Fenestrated AAA Endovascular Graft for new technology add-on payment for FY 2013. It offers an AAA repair option to those patients with short infrarenal necks who, because of severe co-morbidities and high physiologic risk, would not have been considered open surgical repair candidates and therefore would have had no other treatment option. Also, for AAA patients with short infrarenal necks, it offers a less invasive treatment option that, compared to open surgical repair, results in: o Reduced mortality, o Reduced morbidity, o Shorter hospital stays, and o Significantly less operative blood loss. Removal and Suspension of Hospital IQR Program Measures Abdominal Aortic Aneurysm (AAA) Mortality Rate Measure SVS strongly supports CMS in its proposal to remove the measure known as IQI 11 AAA repair mortality rate, with or without volume. SVS recommended this action to CMS in response to both the FY 2011 and FY 2012 Proposed IPPS rules. We believe the measure as currently written has no scientific valid and that it is not an accurate measure. The differences in patient profile and perioperative mortality with regard to patients undergoing elective repair versus those undergoing emergent or urgent repair is so great (as much as a 20-fold mortality difference) that these two groups of patients cannot be risk stratified accurately in a single measure. Furthermore, any quality measures that are created regarding AAA mortality should be stratified by open surgical vs. endovascular repair because the expected mortality of the former is twice that of the latter. Also, the AAA mortality risk adjustment model should be tested prospectively for accuracy. SVS appreciates CMS taking this proposed action and urges CMS to remove the IQI 11 AAA repair mortality rate, with or without volume measure in the FY 2013 Final Rule. SVS has on numerous occasions voiced our concerns about this measure and the process by which it was developed to AHRQ and the National Quality Forum (NQF). 2
Background MDC 5, Diseases and Disorders of the Circulatory System - Endovascular Implantation of Branching or Fenestrated Graft of the Aorta Clinical Coherence It is estimated that over one million Americans have Abdominal Aortic Aneurysms (AAAs) and at least 95% of these can be successfully treated if detected prior to rupture. But because AAAs are almost always asymptomatic, the problem goes largely undetected and untreated resulting in a reasonably high mortality rate as evidenced by the 10581 deaths in the USA from AAA and aortic dissection in 2009. 1 AAAs occur in the body s largest blood vessel, the aorta. The walls of the aorta weaken and the artery begins to bulge. After several years of very slow enlargement, the aorta eventually ruptures, causing potentially fatal internal bleeding. If detected, a physician can monitor small AAAs and begin treating the risk factors such as high blood pressure and smoking. Large or rapidly growing aneurysms can be treated by an open surgical procedure or less invasive procedures such as endovascular stent grafts. Patients with short infrarenal aortic necks who, because of severe co-morbidities and high physiologic risk, would not have been considered open surgical repair candidates can now be treated with endovascular implantation of branching or fenestrated grafts to repair their AAA. SVS disagrees with CMS rationale that endovascular procedures that repair the aorta are more clinical coherent to other endovascular procedures for general blood vessels than they are to the abdominal aortic repair procedures that are assigned to MS-DRGs 237 and 238. The abdominal aorta is known as the great, vessel. It carries all the blood from the lower extremities, through the heart to the brain. Repairing the aorta, regardless of method, is clinically similar. Repairing the aorta versus repairing a vessel in the leg or the arm is not the same. SVS believes that clinical coherence should be based on the anatomy, first, not the method of the procedure. SVS believes that endovascular implantation of branching or fenestrated grafts of the aorta is more clinically similar to other aorta procedures versus other endovascular procedures and that procedure code 39.78 should be reassigned to MS-DRGs 237 and 238. Resource Consumption We understand that ICD-9-CM procedure code 39.78 Endovascular implantation of branching or fenestrated graft(s) in the aorta was created for use effective with discharges on or after October 1, 2011. We also are aware that because of the newness of this code, CMS does not have any claims data with which to judge the resource consumption for those patients where their primary procedure was an endovascular fenestrated graft procedure as identified by ICD-9-CM code 39.78. Therefore, SVS conducted its own data collection efforts from two hospitals for those patients, since October 1, 2011, where the primary procedure was identified by ICD-9-CM code 39.78. 1 Kochanek K, Xu J, Murphy, S, Miniño A, Kung H. Deaths: Preliminary Data for 2009. National Vital Statistics Report. Volume 59, Number 4. March 2011 (the most current figures from the Centre for Disease Control) 3
Given the small numbers of patients that have an AAA that would be appropriate for a fenestrated procedure - i.e., approximately only 4,000 cases treated since the initial clinical use in 1998 we believe that the claims we collected from two hospitals for patients treated since October 1, 2011 is a representative sample for normal resource consumption for this procedure. SVS s results are as follows: Sample: 20 discharges since October 1, 2011 Maximum Actual Total Charges: $485,914 Minimum Actual Total Charges: $ 31,283 Median Actual Total Charges: $154,097 Mean Actual Total Charges: $263,079 As part of this analysis regarding resource consumption and whether ICD-9-CM code 39.78 should be assigned to MS-DRGs 237 and 238, SVS also reviewed the FY 2011 MedPAR, claims used for IPPS rate calibration. We observed the following regarding MS-DRGS 252, 253, and 254 where code 39.78 is currently assigned and MS-DRGs 237 and 238, where SVS believes it should be assigned: DRG drg_label standardized charges 237 MAJOR CARDIOVASC PROCEDURES W MCC $ 118,707 238 MAJOR CARDIOVASC PROCEDURES W/O MCC $ 72,152 252 OTHER VASCULAR PROCEDURES W MCC $ 69,112 253 OTHER VASCULAR PROCEDURES W CC $ 57,767 254 OTHER VASCULAR PROCEDURES W/O CC/MCC $ 40,416 Given whether it is the mean actual total charges or the median actual total charges that SVS collected, both numbers are markedly more than even the standardized charges for MS-DRG 237. In the case of the MS-DRGs where 39.78 is currently assigned, the mean total charge of the 20 cases that we collected is more than 3.5 times the standard charge that CMS is using to assign the payment rate for this DRG. SVS believes this resource data history for procedure code 39.78 is representative of patients treated since October 1, 2011 and we believe this data does justify a reassignment of ICD-9-CM procedure code 39.78 to MS-DRGs 237 and 238 and we would recommend that CMS make this change effective October 1, 2012. Suggested Changes to MS-DRG Severity Levels for Diagnosis Codes for FY 2013 - Chronic Total Occlusion of Artery of the Extremity CMS received a request to change the severity level for diagnosis code 440.4 (Chronic total occlusion of artery of the extremities) from a non-cc to a CC. Based on analysis of data from the FY 2011 Medicare Provider Analysis and Review File and clinical review, CMS is proposing to change the severity level for diagnosis code 440.4 from a non-cc to a CC. SVS supports this recommendation. For endovascular therapy to succeed, a wire and catheter must be maneuvered past the arterial blockage into the true lumen of the distal vessel. When crossing a stenotic occlusive lesion, this typically requires manipulation of the guidewire with a single catheter that remains in the vessel lumen. In contrast, crossing a chronic total occlusion typically requires multiple wires and catheters whereby the wire leaves the vessel lumen, dissects through the subintimal plane around the occlusive lesion, and then must be manipulated back into 4
the true outflow lumen. The additional time, intensity of work, and resources necessary to perform an endovascular revascularization of a chronic total occlusion justify the proposed increase in severity level. In summary, re-opening chronic total occlusions requires far more time and resource utilization compared to arteries that are not completely occluded. We believe this is an appropriate recommendation. New Technology Add-On Payments - Zenith Fenestrated AAA Endovascular Graft Regarding the question of does the Zenith Fenestrated AAA Endovascular Graft meet the substantial clinical improvement criterion to be approved to receive new technology add-on payments, SVS believes that the clinical literature does demonstrate that for patients with abdominal aortic aneurysms with infrarenal aortic necks as short as 4 mm, use of the Zenith Fenestrated AAA Endovascular Graft is a substantial clinical improvement over an open repair procedure. CMS has raised the concern that there was no data submitted comparing a fenestrated AAA endovascular graft repair to having treated that same patient with medical management. SVS does not believe this is an appropriate concern given the patient s that are candidates for a fenestrated AAA endovascular graft procedure. These patients have already been treated with medical management and their AAA has grown to a point that some type of surgical intervention is warranted. Therefore, the data that CMS should be comparing to determine if a Zenith Fenestrated AAA endovascular graft is a substantial clinical improvement is the data comparing fenestrated AAA endovascular graft procedures to open repair procedures. We believe the data summarized in the proposed IPPS Rule and submitted with the new-technology add-on application demonstrates fevar s substantial clinical benefit as compared to open surgical repair for AAA patients with short infrarenal aortic necks. The fenestrated AAA endovascular graft procedure results in reduced peri-operative mortality, reduced morbidity, significantly less blood loss and shorter hospital stays resulting in financial savings. The relative benefits of the procedures are even more impressive when one considers that, todate, fenestrated endovascular AAA graft procedures have been primarily reserved for sicker cohorts of patients deemed to be at high-risk or even unsuitable for open surgical repair. Due to its less invasive nature, these procedures now offer an attractive alternative to open surgical repair, and the only interventional treatment option to Medicare patients, whose AAA need to be repaired, but are not otherwise deemed surgical candidates. CMS has also raised a concern regarding a lack of randomized studies, comparing patients by infrarenal neck length and/or suitability for other endovascular grafts and then an additional concern regarding lack of long-term follow-up data regarding complications and secondary intervention or re-interventions. On the question of randomized studies, SVS does not believe that a randomized study could be conducted given the inability to ever gain informed consent to randomize those patients with short infrarenal aortic necks to any type of intervention besides a fenestrated AAA endovascular graft repair, particularly if they had other co-morbidities. While we understand that randomized controlled trials are the gold-standard, for clinical research, it would be difficult for vascular surgeons to randomize the patients they now treat with fenestrated grafts to other study arms, given the published data on this procedure. 5
Regarding the availability of long-term follow-up data, we would point CMS staff in the direction of the Chisci et al. study published in 2009 in the Journal of Endovascular Therapy. This study published clinical outcomes of endovascular aneurysm repair compared to conventional open repair in patients with challenging proximal necks. Data collected from 187 consecutive patients with abdominal aortic aneurysms and challenging proximal neck morphology were retrospectively analyzed. Fifty-two of these patients underwent fevar procedures. All patients undergoing fenestrated repair received customized Cook fenestrated devices incorporating 149 fenestrations/scallops. In total, 108 stents were placed into target vessels, typically the superior mesenteric artery (SMA) and renal arteries (75%). Regarding the question of long-term follow-up data, in the fenestrated group, the Kaplan-Meier estimate of overall freedom from AAA-related mortality was 94.2% at 36 months. Tambyraja et al. (2011) reported their outcomes on 29 patients with juxtarenal aneurysms who were deemed unfit for open repair. One procedure was abandoned due to preoperative sizing miscalculation and inability to position the stent. The remaining procedures were immediately successful with 100% patency of target vessels at the end of the cases. There were no early postoperative mortalities. One patient required early re-intervention for a renal stent occlusion. Regarding the question of long-term follow-up, patients were followed for a median of 20 months (range 7-62). There were no aneurysm-related deaths. Fourteen patients (48%) developed graftrelated complications, including visceral artery occlusion in 2 patients. A total of 9 patients (32%) required at least one late intervention, and 4 patients (14%) had sac growth >5mm. 2 SVS believes the published data addresses CMS concerns regarding substantial clinical improvement and recommends that CMS approve a new-technology add-on payment for the Zenith Fenestrated Endovascular AAA Graft. Removal and Suspension of Hospital IQR Program Measures Abdominal Aortic Aneurysm (AAA) Mortality Rate Measure SVS strongly supports CMS in its proposal to remove the measure known as IQI 11 AAA repair mortality rate, with or without volume. SVS recommended this action to CMS in response to both the FY 2011 and FY 2012 Proposed IPPS rules. We believe the measure as currently written has no scientific valid and that it is not an accurate measure. The differences in patient profile and perioperative mortality with regard to patients undergoing elective repair versus those undergoing emergent or urgent repair is so great (as much as a 20-fold mortality difference) that these two groups of patients cannot be risk stratified accurately in a single measure. SVS strongly recommends that mortality measures regarding the repair of ruptured AAAs should not be bundled with that of elective AAAs because the disadvantages to overall accuracy of such a measure vastly outweigh any theoretical advantages associated with obtaining a larger sample size. Thus, we commend CMS for redrawing the current AAA mortality measures. Instead, SVS would recommend development of separate measures, one for elective AAA repairs and one for emergent ruptured AAA repairs. Separating these surgical events into two separate measures will provide data that are more accurate and more valuable to consumers and purchasers than a single combined measure. SVS believes the evidence AHRQ used to justify creation of a single combined AAA mortality measure fails on many counts. In our discussions with AHRQ, we were told that their primary 2 Tambyraja, A.L., et al., Fenestrated aortic endografts for juxtarenal aortic aneurysm: medium term outcomes. Eur J Vasc Endovasc Surg, 2011. 42(1): p. 54-8 6
reason for bundling these events into a single measure was that using a broad denominator increases the reliability of the indicator (i.e., the probability that differences in indicator reflect true differences in performance) and that a bundled indicator provides a better decision-making tool for consumers and purchasers since they do not know what type of AAA they will have prior to the event-this is basically a Bayesian decision-making framework. Furthermore, AHRQ conveyed to SVS that it believes that surgeons with clinical experience in treating ruptured aneurysms would likely carry over that skill to elective aneurysm repair. Finally, it was stated that the risk adjustment in the AAA Mortality Indicator adequately accounts for ruptures status. While these issues may seem intuitively correct, when applied to AAA repair SVS believes each point to be inaccurate and CMS is right to delete this measure because these points are each inaccurate. SVS supports the general principle that the denominator of a quality measure should be as broad as reasonably possible. However, in proposing to bundle mortality for elective and ruptured AAA repair, the AHRQ is attempting to force a combination for which there is little natural synergy. First, there exists an overt clinical difference and a major disparity in mortality between these two procedures. The established mortality for elective AAA repair is 1-5%, while that of emergent ruptured AAA repair is greater than 40-50%. Ruptured AAA outcomes depend on different pre-operative clinical variables and on the clinical excellence of various different departments within the hospital. Elective AAA repair outcome depends primarily on the surgical and anesthesia teams, while survival of the ruptured AAA patient is additionally dependent on pre-hospital Emergency Response Teams, the Emergency Department staff and postoperative Critical Care. Ruptured AAA repair is more similar to the triage and care of a major trauma victim than it is to elective AAA repair. Primary risk factors for mortality after elective AAA repair include pre-operative renal insufficiency and a history of congestive heart failure, among others, and the vascular surgeon considers these carefully in deciding whether to recommend surgery. In so doing, the surgeon has a major opportunity to influence the hospital s elective AAA results. In contrast, the major risk factors for mortality after a ruptured AAA include pre-hospital arrest, shock, and anuria. Although the surgeon is well aware of these, the decision to offer surgical repair is not something that is customarily withheld for concern over potentially poor outcomes, and most patients confronting immediate death will request potentially life-saving therapy. In summary, elective and emergent AAA repairs have vastly different mortality profiles, involve different resources within the hospital, and there exists a major difference in the ability of providers to influence outcomes by patient selection. SVS believes these differences are not reconcilable and should not be bundled in a single outcome measure simply to broaden the denominator. CMS is making the right decision by proposing to remove the measure known as IQI 11 AAA repair mortality rate, with or without volume. In the future, SVS recommends development of separate mortality measures for elective and ruptured AAAs, and we are available to work with CMS and AHRQ in the development and field testing of these measures. +++ SVS appreciates the opportunity to submit these comments and looks forward to working with CMS to implement these recommendations. Please feel free to contact Pamela Phillips, Director of the SVS Washington Office at 202-787-1220 or pphillips@vascularsociety.org, if we can provide further information. 7
Sincerely, Peter Gloviczki, MD Peter Gloviczki, MD President Society for Vascular Surgery Robert M. Zwolak, M.D. Robert M. Zwolak, M.D. Past President Society for Vascular Surgery Sean P. Roddy, MD Sean P. Roddy, MD Chair, Health Policy Committee Society for Vascular Surgery 8