THE SOCIETY OF THORACIC SURGEONS

Transcription

1 THE SOCIETY OF THORACIC SURGEONS 20 F STREET NW, SUITE 310 C WASHINGTON, DC Phone: Fax: sts@sts.org Web: Marilyn Tavenner Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building Room 445G 200 Independence Avenue SW Washington, DC Re: CMS-1524-FC; Medicare Program; Payment Policies Under the Physician Fee Schedule, Five- Year Review of Work Relative Value Units, and Other Revisions to Part B for CY 2012, Final Rule with comment period Dear Administrator Tavenner: On behalf of The Society of Thoracic Surgeons (STS), the largest organization representing cardiothoracic surgeons in the United States and the world, I am writing to provide comments on the Centers for Medicare and Medicaid Services CY 2012 Physician Fee Schedule final rule with comment CMS-1524-FC. STS represents more than 6,200 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. We appreciate the opportunity to provide comments on this final rule. STS has carefully reviewed the final rule and offers the following comments, in particular, we are responding to the call for public nomination of misvalued codes and address concerns relative to misvalued work values for certain thoracic surgery codes. PUBLIC NOMINATION PROCESS FOR POTENTIALLY MISVALUED CODES In the calendar year (CY) 2012 Final Rule, the Centers for Medicare and Medicaid Services (CMS) has finalized the proposed process to allow the public to nominate codes during the 60-day comment period following the release of the annual Medicare Physician Fee Schedule (PFS) Final Rule with comment period. Guidelines have been established that require supporting documentation. In response to this new process, STS is nominating several codes as potentially misvalued. Potentially Misvalued Codes Esophagogastric fundoplasty partial or complete; laparotomy Esophagogastric fundoplasty partial or complete; thoracotomy Repair, paraesophageal hiatal hernia (including fundoplication), via laparotomy, except neonatal; without implantation of mesh or other prosthesis Repair, paraesophageal hiatal hernia (including fundoplication), via laparotomy, except neonatal; with implantation of mesh or other prosthesis

2 Page Repair, paraesophageal hiatal hernia (including fundoplication), via thoracotomy, except neonatal; without implantation of mesh or other prosthesis Repair, paraesophageal hiatal hernia (including fundoplication), via thoracotomy, except neonatal; with implantation of mesh or other prosthesis Repair, paraesophageal hiatal hernia, (including fundoplication), via thoracoabdominal incision, except neonatal; without implantation of mesh or other prosthesis Repair, paraesophageal hiatal hernia, (including fundoplication), via thoracoabdominal incision, except neonatal; with implantation of mesh or other prosthesis Esophageal lengthening procedure (e.g., Collis gastroplasty or wedge gastroplasty) (List separately in addition to code for primary procedure) In the CY 2011 Final Rule, CMS states that: [T] he CPT Editorial Panel deleted six existing CPT codes and created ten new codes to remove obsolete and duplicative codes and add new codes to report current surgical techniques for paraesophageal hernia procedures. Since in this case there would be more codes that describe the same physician work with a greater degree of precision, the aggregate increase in work RVUs that would result from our adoption of the CMS recommended RVUs that are largely based on the AMA RUC s work RVU recommendations would not represent a true increase in physician work. Therefore, we believe it would be appropriate to apply work budget neutrality to this set of codes A work budget neutrality factor of was applied to what CMS called clinically related codes. This was finalized in the CY 2012 Final Rule. We believe that the only rational explanation for this CMS action is that these codes were not brought forward by the public nomination process for the year review. Although the codes were considered during this time period, and the RUC actions included the positive determination of compelling evidence that physician work had changed, the 2-year CPT process that had preceded their survey and valuation overlapped the public comment period for that 5-year review. Now that CMS has officially designated an annual nomination process, the STS nominates nine paraesophageal hernia repair codes listed below as misvalued and provides the following compelling evidence to support review of these codes: Laparoscopy, surgical, esophageal lengthening procedure (e.g., Collis gastroplasty or wedge gastroplasty) (List separately in addition to code for primary procedure) [RUC recommended value 4.00 CMS-adjusted work RVU, pre-bn 4.00 Final Work RVU 2.95] Esophagogastric fundoplasty partial or complete; thoracotomy [RUC recommended value CMS-adjusted work RVU, pre-bn Final Work RVU 19.91] Repair, paraesophageal hiatal hernia (including fundoplication), via laparotomy, except neonatal; without implantation of mesh or other prosthesis [RUC recommended value CMS-adjusted work RVU, pre-bn Final Work RVU 19.62] Repair, paraesophageal hiatal hernia (including fundoplication), via laparotomy, except neonatal; with implantation of mesh or other prosthesis [RUC recommended value [RUC recommended

3 Page 3 value CMS-adjusted work RVU, pre-bn Final Work RVU 21.46] Repair, paraesophageal hiatal hernia (including fundoplication), via thoracotomy, except neonatal; 0020 without implantation of mesh or other prosthesis [RUC recommended value [RUC recommended value CMS-adjusted work RVU, pre-bn Final Work RVU 22.12] Repair, paraesophageal hiatal hernia (including fundoplication), via thoracotomy, except neonatal; with implantation of mesh or other prosthesis [RUC recommended value CMSadjusted work RVU, pre-bn Final Work RVU 23.97] Repair, paraesophageal hiatal hernia, (including fundoplication), via thoracoabdominal incision, except neonatal; without implantation of mesh or other prosthesis [RUC recommended value CMS-adjusted work RVU, pre-bn Final Work RVU 25.81] Repair, paraesophageal hiatal hernia, (including fundoplication), via thoracoabdominal incision, except neonatal; with implantation of mesh or other prosthesis [RUC recommended value CMS-adjusted work RVU, pre-bn Final Work RVU 27.65] Esophageal lengthening procedure (e.g., Collis gastroplasty or wedge gastroplasty) (List separately in addition to code for primary procedure) [RUC recommended value 3.00 CMSadjusted work RVU, pre-bn 3.00 Final 2012 CY 2012 Final Work RVU 2.21] 1. Evidence that incorrect assumptions were made in the previous valuation of the service; flawed mechanism or methodology used in the previous valuation. Codes 39502, 39520, 39530, 39531, 43324, and were deleted and replaced by new codes 43327, 43328, 43332, 43334, and [Codes 43333, 43335, 43337, and represent new/different work]. For the deleted codes, Harvard surveyed only general surgeons even though cardiothoracic surgeons perform these procedures.

4 Page 4 CPT 2008 Medicare Utilization GS CTS ,658 85% 7% % 36% % 28% Harvard Study N / Specialty 14 / general surgery 11 / general surgery 10 / general surgery % 31% 9 / general surgery ,401 77% 18% 7 / general surgery % 60% 7 / general surgery Codes and were included in the list of 314 procedures submitted for review by the American College of Surgeons (ACS) during the second 5-year-review (2000). Only general surgeons were included in the RUC survey process. Further, although the ACS used a RUC Research Subcommittee approved survey instrument and methodology to review these 314 codes, the Workgroup review and subsequent RUC valuation for all 314 codes was based on approved increases or decreases to 16 anchor codes. The current RVWs for and are based on a percentage change across a small family of codes, rather than considering each code on its own merit. 2. Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: The change in the work to repair an esophageal hernia over time has resulted in confusion and deficiencies in the coding structure necessitating a revision of the current CPT codes. When the original paraesophageal hernia repair codes were introduced, they were meant to report anatomic defects within the diaphragm. Dr. Allison originated these repairs and emphasized the importance of the diaphragm in the pathophysiology of hiatus hernias (Allison PR, Ann Surg 1973; 178:273-6). Thus for many years (in the now distant past), paraesophageal hernias were repaired by simply reducing the hernia contents below the diaphragm and narrowing the diaphragmatic crura with suture to prevent re-herniation. These repairs were performed in an open fashion by either a transabdominal or transthoracic approach. Sometimes tacking sutures were used to fix the stomach to the abdominal wall or occasionally a gastrostomy tube was placed to fix the stomach in place so it would not re-herniate. Occasionally, strictures were dilated or concomitant ulcer disease was treated by vagotomy and pyloroplasty. Because this was the era prior to modern anti-acid treatment with H2 histamine blockers and PPIs, esophageal strictures requiring treatment were frequent occurrences in paraesophageal hernia patients. In addition, ulcer disease of the stomach and duodenum was also common at that time because H. pylori had not yet been recognized as an etiologic agent. It was therefore frequent to find giant paraesophageal hernias associated with concomitant strictures and/or ulcer disease. For these reasons, the diaphragmatic hernia repair codes were written to include concomitant treatment for strictures (with and without dilation) and ulcer disease (with or without vagotomy and pyloroplasty). However, in 2010, these

5 Page 5 treatments (dilation, V&P) are virtually never performed concomitant with paraesophageal hernia repair, and thus the codes as written do not reflect current therapy. Modern investigation has emphasized the importance of the lower esophageal sphincter s ability to generate pressure to prevent gastroesophageal reflux and the need to augment sphincter pressure with creation of a fundoplication, typically a 360 degree full wrap (Nissen) or a partial wrap (Belsey Mark IV or Toupet). With this further understanding of the pathophysiology, these defects have now been reclassified as variants of hiatal hernia. The current coding schema is in direct opposition to this modern classification. The adjunctive surgical procedures of intraoperative dilatation, vagotomy, and pyloroplasty are now virtually never concomitantly performed with paraesophageal hernia repair; however, fundoplasty is almost always performed. Esophageal dilatation, if needed, is now done by gastroenterologists before any surgical procedure. In summary, the work described by the current (to-be-deleted) codes was intended for patients with reflux/acid (chemical symptoms) or blockage (mechanical symptoms). With the advent of medical management and less invasive treatments, the patients currently undergoing surgery are symptomatic, have more advanced disease, and require more complex repair. We believe that we have conclusively demonstrated that the physician work has changed since these codes were originally valued, and that they were not appropriately valued originally due to flawed methodology. Both the RUC and the CMS refinement panels have agreed that aggregate physician work has increased and agreed that compelling evidence exists on this basis alone. 3. An anomalous relationship between the code being valued and other codes. In the CY 2012 Final Rule, CMS states that: [I]t is important to note that the code-specific resource based relative value framework under the PFS system is one in which services are ranked relative to each other. That is, the work RVUs assigned to a code are based on the physician time and intensity expended on that particular service as compared to the physician time and intensity of the other services paid under the PFS. In applying budget neutrality, CMS has created undervalued codes that are inconsistent with many other code values in the physician fee schedule. The following chart illustrates the disparities thus created:

6 Page 6 Total RVW vs Total RUC Time Esophageal Codes T o t a l R V W Upper 99th Confidence Interval Regression Line 152 CVT Codes since 2005 Lower 99th Confidence Interval RUC Recommendations 2012 Values Total RUC Minutes This chart illustrates the relationship between Intraservice work and Intraservice time for the last 152 Cardiovascular and Thoracic (CVT) surgical procedures valued by CMS, the now current values, and the previous RUC recommendations. The current values are clearly inappropriate, and provide insufficient work RVU per unit time for the procedure performance compared to procedures of similar work intensity. The intra-service work per unit of time (IWPUT) that results from the CMS decisions for the 090 global codes range from for to for 43335, making them some of the lowest intensities in the entire fee schedule and lower than the vast majority of major inpatient surgical procedures. The RUC recommendations place the code values in appropriate alignment with the CVT codes, consistent with the survey results used and the Multispecialty Points of Comparison list codes provided, as well as other crosswalk codes used by the RUC to confirm the appropriateness of the recommended work values. In applying budget neutrality, CMS has created an artificial boundary to determine the total work units currently performed, ignoring the fact that many of the procedures that could be coded with the new codes are currently reported using unlisted codes. We would argue that the coding inconsistencies that have existed and are now corrected make defining the family for budget neutrality determination and employing existing Medicare utilization data impossible and fraught with hazard even if budget neutrality were indicated. For example, the methodology utilized by CMS has resulted in a relative work value of for (Abdominal open approach, Nissen fundoplication) and for (Thoracic open approach, Nissen fundoplication). To the best of our ability to map the deleted code (43324 Nissen fundoplication RVW 22.99), all of the procedures and probably some unlisted

7 Page 7 procedures would now be coded using either or Thus, a code formerly valued at work units is now two codes each with substantially lower values compared to the RUC recommendations that were already budget negative (i.e., less total RVW than current). The value of for represents a 42 percent decrease in value, with an IWPUT of for a 2 hour major invasive surgical procedure with a three-day inpatient length of stay. We also do not agree with the reduction of the RUC recommended code values for and 43335, where CMS artificially established a reduced increment of 2.5 RVW for using mesh in the repair based upon the difference between and (similar paired major procedures with and without mesh). The new values are not supported by the survey results or RUC recommendations, which were not derived by such a building block methodology. The RUC evaluated the differential values as part of its robust consideration of the survey results, and found the magnitude estimation of the survey respondents to be supportive, providing correct rank order and dispersion for these codes. This is an extremely important point, in that magnitude estimation produces a value for all the physician work, which includes work related to inserting mesh as well as other patient factors that in turn make the insertion of mesh necessary. Choosing an abdominal, thoracic, or thoraco-abdominal approach is integrally related to the patient s condition and whether or not mesh will be required, and all should be valued according to the total surveyed work and not trivially adjusted. In summary, we ask that CMS reconsider its prior decisions which are at odds with all external recommendations and which unfairly single out this family of codes for unequal treatment. It is particularly disheartening to have expended many hundreds of hours of extensive and intensive effort to improve the ability of physicians to accurately describe their work and to have that work accurately valued, only to have the work values accepted in theory by CMS and subsequently arbitrarily reduced below those accepted for major therapeutic surgical procedures.

8 Page 8 RECOMMENDED WORK VALUES FOR CERTAIN THORACIC SURGERY CODES Respiratory: Lungs and Pleura CPT Descriptor code RUC Rec RVU CMS Proposed Interim RVU Thoracotomy, with diagnostic biopsy(ies) of lung infiltrate(s) (e.g., wedge, incisional), unilateral Thoracotomy, with diagnostic biopsy(ies) of lung nodule(s) or mass(es) (e.g., wedge, incisional), unilateral Thoracotomy, with biopsy(ies) of pleura Thoracotomy; with exploration Thoracotomy; with therapeutic wedge resection (e.g., mass, nodule), initial Thoracotomy; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure) Thoracoscopy, surgical; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure) STS appreciates the fact that CMS has accepted 15 of the RUC recommended values for the lung resection codes. In reference to the above table from the final rule, for code Thoracotomy; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure) and code Thoracoscopy, surgical; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure) CMS has applied a work value of 3.0 rather than 3.78 and 4.0 respectively. Upon review, we believe that these values are within a reasonable range for these services and are consistent with the survey results, the RUC deliberations and comparable services within the specialty. We urge CMS to reconsider its actions for the remaining 5 codes, where the RUC recommendations are based on 25th percentile physician survey supported by comparisons to other codes in the fee schedule and robust, lengthy deliberation and consideration of alternative value recommendations. The proposed code values will result in rank order anomalies with other codes in the fee schedule, as well as within the specialty of Thoracic Surgery. For example, in Figure 1 below is seen the relationship between physician time and physician work for all Thoracic Surgery codes valued since 2005 (blue diamonds), CMS accepted RUC recommended lung resection codes (red triangles, N=15), CMS published values for Thoracic Surgery codes from the year review (yellow squares N=27) and the 7 new CMS values that replace the RUC recommended values (green triangles).

9 Page 9 It is evident from this display that the RUC recommended values for lung resection fit the calculated regression line very nicely, which indicates appropriate work intensity, while the alternate values proposed by CMS fall clearly below the line for the same physician time, which indicates inappropriately low work intensity. Specifically, the CMS proposed work values are lower for equivalent physician time than virtually all prior CMS decisions for our specialty, and also lower than all its accepted RUC recommended work values in this same family in this rule. Further, the following Figure (1A) demonstrates the CMS work value assignments along with the RUC recommendations for the same codes. This figure has been simplified truncating the axes to better display the code values in question and by showing the regression line for 152 consecutive RUC recommendations that have been accepted by CMS since 2006 for codes that describe procedures performed by thoracic surgeons. The 99th percentile confidence intervals are displayed, and the regression equation has an R2 value of 0.94 indicating that it is highly predictive.

10 Page 10 We would ask CMS to observe that the proposed values for the 5 codes in question (green triangles) are not at all consistent with the proposed values where CMS has accepted the RUC recommendations (yellow triangles). If CMS were to reconsider, as we recommend, the work values shown in the red triangles would then become consistent and supportable within the physician fee schedule. Specifically, for codes (Thoracotomy, with diagnostic biopsy(ies) of lung infiltrate(s) (e.g., wedge, incisional), unilateral ), (Thoracotomy, with diagnostic biopsy(ies) of lung nodule(s) or mass(es) (e.g., wedge, incisional), unilateral), and (Thoracotomy; with exploration) CMS performed a direct crosswalk to CPT code (Placement, enterostomy or cecostomy, tube open (e.g., for feeding or decompression) to obtain a work RVU of rather than In doing so, CMS has simply stated that the placement of a feeding tube is similar in physician work and intensity to major open thoracic procedures. The procedures are in fact not comparable at all in any rational construct of relativity within the fee schedule.

11 Page 11 STS strongly disagrees with the CMS values, which results in IWPUT values of.032,.049 and.043 respectively for these lung resection codes. Rather than similar in intensity, these values are approximately 1/2 of those ordinarily associated with major surgical procedures, including the.086,.089 and.079 that would result from the RUC recommended values. For the first three codes discussed above, this relationship is clarified with the same data truncated to 750 minutes of total RUC time, with these codes encircled: STS finds it difficult to understand why an arbitrary crosswalk was used for 32096, and 32100, which places these work values out of step with values accepted by CMS in this same family and out of step with its last 136 recommendations for this specialty. To correct these anomalies, we urge CMS to assign the work value of 17.0 to all three codes as the RUC has recommended. Similarly, for CPT code (Thoracotomy, with biopsy(ies) of pleura) CMS has performed a direct crosswalk to CPT code (Biopsy of liver, wedge) to propose a work value of rather than which is the RUC recommendation and the 25th percentile of the physician survey. This results in an IWPUT of.074 which as is shown encircled in Figure 3 is of insufficient intensity compared to other similar procedures:

12 Page 12 We would also call your attention to the CMS accepted RUC recommendation for within the same circle, which has 9 minutes less total time, yet 1.59 more work units. We therefore ask CMS to reconsider and to accept the RUC recommended work value of which has ample support from comparable codes and is consistent with prior CMS decisions for this specialty and this family of codes. For CPT code (Thoracotomy; with therapeutic wedge resection (e.g., mass, nodule, initial), CMS has proposed a work RVU of rather than the RUC recommended survey 25th percentile work RVU of CMS has arrived at this work value by an artificial building block of 2.0 work units for 30 minutes of intraservice time added to which CMS determined to be the appropriate value for Notwithstanding the arguments made above for the CMS proposed value for 32096, with which we disagree, we disagree entirely with this extremely artificial methodology which has to our knowledge never been employed to determine a code work value. This recommendation results in an IWPUT of.060 for a major therapeutic cancer procedure rather than the IWPUT of.094 that was the consensus of the RUC in its recommendation. As shown in the next figure:

13 Page 13 Again, the encircled code is not consistent with the relationship of total work and total time for this specialty or for this code in relationship to other codes accepted by CMS in this family in the Final Rule. For example (red arrows), this code with the CMS proposed value has 95 minutes more time but only 1.25 more RVW than Similarly, it has 20 minutes less time than code 32673, but CMS has proposed a value of 5.38 fewer work units. To summarize, STS asks CMS to reconsider its decisions to reject the RUC recommendations for codes 32096, 32097, 32098, 32100, and instead accept the RUC recommended work values. To do otherwise would be indefensible and reflect an arbitrary decision-making process that is without a credible foundation. Further, per the final rule which states, we would like to remind specialty societies seeking reconsideration of proposed or interim final work RVUs, including consideration by a refinement panel, to specifically request refinement panel review in their public comment letters, STS would like to formally request refinement panel review of these codes. CMS has indicated that additional information beyond that available from the RUC presentation and the CMS comments is desired for refinement panel referral in the final rule. STS submits the above mentioned rank order anomalies and abnormal relationship of the CMS values to other codes in the PFS as that additional information. Finally, it should be evident from the information provided above that all of these codes are in line or below the typical relationship between physician work and physician time that CMS states as a concern. The charts presented above should completely resolve the issue of consistent valuations of RVUs and time that CMS specifically states as its objective in this section of the final rule. STS also noted, that CMS requests in the Final Rule that the RUC review laparoscopic vs open and heart surgery analogs to confirm their recommended values. STS does not understand this request because these codes are not directly related to either laparoscopic or cardiac surgical procedures.

14 Page 14 Further, we object to any requirement for further surveys or an abstract deliberation of the relationship of these codes to other codes as an undue burden on our specialty outside of the normal process of code valuation. On behalf of STS, thank you for the opportunity to provide these comments on the CY 2012 Physician Fee Schedule final rule. If you have any questions, please contact Phil Bongiorno, STS Director of Government Relations, at (202) or Sincerely, Michael J. Mack, MD President