Re: CMS-1613-P Medicare Program; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2015 Payment Rates

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1 Marilyn Tavenner, MHA, BSN, RN Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1613-P Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC Re: CMS-1613-P Medicare Program; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2015 Payment Rates Dear Administrator Tavenner: The American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), and the American Society for Gastrointestinal Endoscopy (ASGE) welcome the opportunity to provide comments on CMS proposed rule (CMS-1613-P), published in the Federal Register on July 14, 2014, regarding proposed changes to the hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system for CY Our three societies represent virtually all practicing gastroenterologists in the United States. The ASC is an important part of the practice of gastroenterology (GI), providing a safe, patient friendly and cost-effective environment for the provision of medical services, such as colorectal cancer screening, for patients of all ages. The majority of ASCs in which gastroenterologists practice are single specialty centers. Because of their single specialty structure, gastroenterology ASCs are particularly sensitive to changes in Medicare payments. Our societies offer comments on the following areas of the proposed rule: Ambulatory Payment Classification (APC) Assignment for GI CPT Codes Date of Service for Diagnostic Tests Spanning Several Days ASC Quality Reporting Program Collecting Data on Services Furnished in Off-Campus Hospital Provider-Based Departments ASC Inflation Update

2 Page 2 of 11 AMBULATORY PAYMENT CLASSIFICATION ASSIGNMENT FOR GI CPT CODES Our societies appreciate CMS being responsive to our concerns with several APC assignments in the CY 2014 OPPS/ASC Payment System final rule. Specifically, we thank CMS for accepting our recommendations to move CPT codes and from APC 0151, endoscopic retrograde cholangiopancreatography (ERCP) to APC 0384, GI Procedures with Stents. We note that code 43240, Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed), also involves the placement of a metal stent. We, therefore, request CMS to move this procedure (43240) from APC 0419 to APC 0384 from the standpoint of resource and clinical coherence. Endoscopic Mucosal Resection Our societies thank CMS for responding to our request to move CPT code 43211, Esophagoscopy, flexible, transoral; endoscopic mucosal resection, and code 43254, Esophagogastroduodenoscopy, flexible, transoral; endoscopic mucosal resection (EMR) from APC 0141, Level I Upper GI Procedures, to APC 0419, Level II Upper GI Procedures. As CMS obtains data on the utilization of the newly-established endoscopic EMR codes in the upper and lower gastrointestinal tract, we look forward to reviewing the cost data in future years to assess the appropriateness of the APC assignment for these EMR procedures. APC Assignment of Codes 0355T and Our societies appreciate CMS accepting our recommendations to move CPT Codes 91110, 91111, and into APC 0142, Level I Small Intestine Endoscopy. Our societies request that CMS assign code 0355T, Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report, into APC 0142 as well. As we stated in our comments to the CY 2014 final rule, we believe the clinical coherence of code 0355T is identical to 91110, Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus through ileum, with interpretation and report, and code 91111, Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus with interpretation and report. For these three procedures, the patient swallows a capsule and wears monitoring equipment which tracks the physiologic and/or image findings from the digestive tract. The resources, primarily the cost of the capsules and the monitoring equipment for performing these procedures, are relatively similar. Our societies appreciate that CMS has proposed to add CPT code (Esophagus, gastroesophageal reflux test; with mucosal attached telemetry ph electrode placement, recording, analysis and interpretation) to the list of ASC covered ancillary services and is proposing separate ASC payment as a covered ancillary service for this code beginning in CY 2015 when the test is integral to an ASC-covered surgical procedure. For this procedure, ph data from the gastrointestinal tract is captured over multiple days and transmitted wirelessly to a recorder worn on

3 Page 3 of 11 a shoulder strap or waistband. At the end of the monitoring period, the patient returns the monitoring device to the physician, and the physician downloads, analyzes, and interprets the data. We appreciate CMS proposal to separately reimburse code when performed in the ASC setting; however, we are concerned that the proposed ASC reimbursement rate of $ is not adequate to cover an ASC s costs for performing this service. This rate is based on the proposed OPPS reimbursement rate for APC 0361, Level II Alimentary Tests, of $ Because an ASC s purchase price for the esophageal ph capsule is approximately $225, the proposed rate would cover only 79 percent of the device cost and none of the costs of the service itself or of the other supplies used. In order to reimburse ASCs fairly for their costs and ensure that beneficiaries have access to this important procedure in an ASC, we urge CMS to establish a more appropriate payment rate. Specifically, we request that CMS assign code to a different APC in the OPPS, resulting in an increased payment rate in the ASC setting. A suitable APC is 0142, Level I Small Intestine Endoscopy. This APC includes procedures that are comparable clinically and with respect to the use of resources. In particular, APC 0142 includes other capsule-based procedures that are clinically similar to 91035, such as (gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report). Both and involve the use of a capsule to collect ph and other data from the patient s gastrointestinal tract over a period of several days. The geometric mean costs of the procedures used to calculate the payment rate for APC 0142 range from $ to $ These costs are higher than the geometric mean cost of code 91035, $479.22, but an exception to the 2x (two times) rule for placing in APC 0142 would be justified by the clinical homogeneity of these procedures. DATE OF SERVICE FOR DIAGNOSTIC TESTS SPANNING SEVERAL DAYS Our societies are concerned about the date of service (DOS) for diagnostic tests that span an overnight period to several days. We appreciate that in Chapter 16, Section 40.8 of the Claims Processing Manual, CMS provides guidance on laboratory tests that are collected over a period that spans two calendar days, stating that the DOS must be the date the collection ended. We believe that the same guidance on reporting the DOS should be applicable for diagnostic tests that span a period of two or more calendar days, such as codes 91034, 91035, 91038, 91110, and There are numerous examples of tests where the procedure involves the collection of data over a several-day period, including: Cardiology (e.g. Holter , MOCT cardiac event monitoring 93228, 93229) Neurology (e.g. EEG monitoring, unattended 95953, EEG all night recording 95827, ambulatory EEG monitoring 95950) Pulmonary/Sleep Medicine (e.g. unattended and attended sleep studies, ) Endocrine (e.g. ambulatory continuous glucose monitoring for a minimum of 72 hours, 95250, 95251) Gastroenterology (e.g. esophageal ph 91034, 91035, esophageal impedance 91038, gastrointestinal tract imaging, esophagus through small intestine 91110, gastrointestinal pressure and transit measurement, stomach through colon 91112)

4 Page 4 of 11 The American Medical Association s (AMA) Current Procedural Terminology (CPT ) Assistant advises physicians to report the date of service as the date the data are downloaded, which is consistent with the instructions on laboratory tests that are collected over a period that spans several calendar days. We urge CMS to clarify the reporting of DOS for diagnostic procedures that span two or more calendar days to be consistent with the current instructions regarding the reporting of laboratory tests, namely that the DOS must be the date the collection ended and the data is available for interpretation. Additional issues and confusion have arisen in situations where claims for technical and professional portions of a service spanning several days are submitted on different days with a different DOS. This can result in claims rejections due to an incomplete link between the professional and technical portions and the absence of a common DOS. In these cases, it can be difficult to retroactively match the services together and causes a significant administrative burden for both physicians and payers. We ask for guidance from CMS on situations where the DOS for a diagnostic procedure differs from the DOS for professional services. ASC QUALITY REPORTING PROGRAM 2013 Data Analysis and 2015 Payment Adjustment Our societies support quality reporting by ASCs. We have educated our members about the program and have provided them the necessary tools and information to fulfill program reporting requirements. Additionally, we thank CMS staff for their ongoing support and assistance. Based on CMS 2013 data analysis of ASC Quality Reporting Program, 93.1 percent of single-specialty GI ASCs had quality data code (QDC) submission rates of 50 percent or more. This is a significant improvement over the 81 percent submission rate in the last quarter of We are pleased with the improved successful reporting rate of QDCs, and we hope these rates will continue to increase for the 2014 and 2015 performance years. For the 2013 performance year, CMS added two additional measures to the program, ASC-6: Safe Surgery Checklist, and ASC-7: ASC Facility Volume Data on Selected ASC Surgical Procedures. We were disappointed to see the submission rates for ASC-6 and ASC-7 drop below the QDC submission rates to 82.2 percent and 83.1 percent, respectively. While we are unable to ascertain from available data the breakdown of submission rates by GI facility size (based on claims), the aggregate data across ASCs shows that success rates fell below 50 percent for small ASCs (0-99 claims). For larger ASCs, success rates were better, but still lower than what we would have hoped or expected. ASC claims = 46% success rate claims = 71.8% success rate 300+ claims = 89.8% success rate

5 Page 5 of 11 ASC claims = 47.5% success rate claims = 72.5% success rate 300+ claims = 90.5% success rate We attribute the drop in reporting success rates for ASC-6 and ASC-7 to the reporting method the QualityNet secure portal. We believe there are probably a number of factors that contributed to fewer practices successfully reporting ASC-6 and ASC-7, including lack of familiarity of the QualityNet reporting portal by ASCs, the process for a practice to establish a Security Administrator, and the short reporting window (July 1-August 15) despite the extension to August 23 due to software testing needs. Given the high QDC reporting success rate among GI ASCs and the failure of some of these ASCs, particularly smaller facilities, to successfully submit measures through the QualityNet portal for a variety of reasons, including those noted above, we ask CMS to provide a onetime 2015 penalty exception to those practices that successfully submitted QDCs but failed to successfully report ASC-6 and ASC-7. Furthermore, our societies believe that ASCs would greatly benefit from a period of stability in the ASC Quality Reporting Program during which no significant changes to the program are made. In addition, we ask CMS to publish each year, as part of the proposed rule, a twoor three-year timeline of anticipated changes to the ASC Quality Reporting Program. Data Reporting Mechanisms CMS has previously sought comment on alternative data collection strategies for the ASC quality measures. Our societies welcome an opportunity to explore with CMS alternative reporting options for measures that cut across CMS quality reporting programs, namely, measures that are included in both the ASC Quality Reporting Program and the Physician Quality Reporting Program (PQRS). Our organizations maintain that it is not necessary to require reporting of the endoscopy measures at both the ASC and the physician levels, nor were these measures intended for reporting at the facility level. Nonetheless, at a minimum, we believe there is merit in exploring ways to reduce the reporting burden of these measures. Based on feedback from gastroenterologist-owned ASCs with smaller practice sizes, we believe some practices are not yet drawing a distinction between the requirements for reporting the endoscopy measures for the ASC Quality Reporting Program and for PQRS. We suspect the level of confusion will become more evident once the submission period for ASC-9 and ASC-10 begins. We will be sure to keep CMS apprised of feedback we receive from ASCs providing GI services in this regard. Data Reporting Timeframes As our societies have commented previously, we believe CMS should minimize reporting burdens associated with the ASC Quality Reporting Program. We believe that multiple submission requirements for the program (claims, QualityNet portal, the Centers for Disease Control and

6 Page 6 of 11 Prevention s National Healthcare Safety Network System) results in significant confusion among practices. We have, therefore, supported CMS previous data collection modifications, which have resulted in better reporting alignment and longer data collection times. We believe that CMS proposal to require reporting of ASC-8 (Influenza Vaccination Coverage Among Healthcare Personnel) by May 15 is inconsistent with these efforts. Under CMS proposal, ASCs would be required to submit their October 1, 2014-March 31, 2015 influenza vaccination data by May 15, CMS notes that moving the date from the previously considered August 15 deadline would allow reporting alignment between the ASC Quality Reporting Program and the hospital reporting programs. CMS also states the earlier deadline would enable ASCs to use data summarizing the results for their previous influenza vaccination campaign to set targets and make plans for their campaigns prior to the next influenza season. We do not believe these reasons provide a compelling argument for creating a different reporting deadline for ASC-8. We believe the reporting deadline for ASC-8 should mirror the August 15 reporting deadline for the other Web-based reported measures. Reporting Thresholds CMS is not proposing any changes to minimum thresholds, minimum case volume, and data completeness for successful reporting. We believe program stability is important and, therefore, support CMS decision to not make any changes at this time. Specifically, we support maintaining the sample size requirements for the endoscopy measures, ASC-9 and ASC-10. ASC-12 and OP-32: Facility Seven Day Risk Standardized Visit Rate after Outpatient Colonoscopy Meaningful Measurement In the proposed rule, CMS states that removal of a measure from the hospital outpatient and ASC quality reporting programs is appropriate when there is little room for improvement, as topped out measures do not provide meaningful information on the quality of care provided. CMS states that a measure should be considered topped out when performance is indistinguishable at the 75 th and 90 th percentiles. While those who developed measure ASC-12 and OP-32 state there is variability in performance, as a practical matter, the risk-standardized results indicate little room for improvement. As noted in the proposed rule, the reported hospital visit rate after all outpatient colonoscopies is 0.8 percent to 1.0 percent at 7 to 14 days post procedure. As such, our societies respectfully request that CMS use its proposed topped out measure analysis to assess the Facility Seven-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy (OP-32 and ASC-12) as it considers finalizing the measure s inclusion in the Hospital Outpatient Quality Reporting and ASC Quality Reporting programs To identify whether a measure has statistically indistinguishable performance at the 75 th and 90 th percentiles, CMS states it would determine whether the difference between the 75 th and 90 th percentiles for a measure is within two times the standard error of the full dataset. The coefficient

7 Page 7 of 11 of variation is a descriptive statistic that expresses the standard deviation as a percentage of the sample mean. According to the technical report on this measure, the 2010 data included 325,811 outpatient colonoscopies from 992 facilities meeting the inclusion and exclusion criteria. The mean rate of risk-standardized, all-cause, unplanned hospital visits was 12.3 per 1,000 colonoscopies; the 5 th and 95 th percentiles for unplanned hospitals visits were 10.5 per 1,000 and 14.6 per 1,000 colonoscopies, respectively. The measure developers identified a limited number of facilities as outliers out of the 992 outpatient facilities (ASCs and HOPDs). Using the 95 percent interval estimate, the developers classified four facilities as worse than expected (above the 95th percentile), one facility as better than expected (below the 5th percentile) and 987 facilities as no different than expected. The overwhelming majority of facilities, 99.6 percent, would receive a measure score indicating their performance was at, or better than, the expected level with the implicit indication that no improvement effort would be necessary. (http://www.cms.gov/medicare/quality-initiatives-patient-assessment- Instruments/HospitalQualityInits/Measure-Methodology.html) We respectfully request that CMS use its topped out measure analysis to assess Facility Seven-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy to determine if the measure would be a candidate for removal from both the Hospital Outpatient Quality Reporting and ASC Quality Reporting programs. Measure Validity and Reliability This measure is all-cause, unplanned hospital visits (admissions, observation stays, and emergency department visits) within 7 days of an outpatient colonoscopy procedure. The statistical risk adjustment model for ASC-12 and OP-32 includes 15 clinically relevant risk-adjustment variables that are strongly associated with risk of hospital visits within 7 days following colonoscopy. Given the low incidence of adverse events related to colonoscopy, our societies were concerned at the outset that the numbers required for this measure to be valid and reliable would not be readily attainable. As stated in the proposed rule, reported hospital visit rates after outpatient colonoscopy range from 0.8 to 1.0 percent at 7 to 14 days post procedure. This is less than one percent of all procedures, and these studies included patients outside the Medicare fee-for service population. Furthermore, since this measure includes all-cause, unplanned visits, this very small sample size includes all unplanned emergency room visits within 7 days after a colonoscopy for incidents that may be completely unrelated to the colonoscopy procedure such as an emergency room visit after car accident or fall, yet still fit into measure s numerator (unplanned emergency room visit), denominator (colonoscopy code), and other specifications. Our review of the measure s construction and testing has deepened these concerns. While our societies do not see an accounting of differences in claims architecture or coding practices, CMS states the measure is well-defined and precisely specified for consistent implementation within and between organizations that will allow for comparability. More importantly, measure scores have

8 Page 8 of 11 not been validated directly against outpatient medical records. To ensure measure results are truly attributable to differences in quality, the validity and reliability of a measure intended for public reporting and accountability purposes should be significantly higher than this measure has demonstrated to date. If implemented for the CY 2017 payment determination and beyond, our societies respectfully request that data obtained from the measure be withheld from public reporting until these concerns about its validity and reliability can be thoroughly assessed. We recommend that the measure performance results should be provided to our societies and ASCs so the measure can be better validated. Measure Usability As a measure derived from administrative claims, this measure presents multiple challenges relative to its ability to achieve the intended outcome. First, it lacks benchmarks. Second, the data used to generate the measure score may not be accessible to the facility where the colonoscopy is performed. We look forward to working with CMS so facilities can understand their performance and take steps when remediation is truly needed. We respectfully request, if CMS determines it will implement this measure, that CMS clarifies in the final rule its intent to report detailed patient-level data confidentially to ASCs that indicates whether the patient had a hospital visit, the type of visit (admission, emergency department visit, observational stay), the admitting facility, and the principal discharge diagnosis to assist facilities with quality improvement. Measure Topics for Future Consideration In the proposed rule, CMS states that in considering future measures for the ASC Quality Reporting Program, it will focus on identifying measures within the six National Quality Strategy Domains. In previous rulemaking, CMS has specifically noted its interest in measures that address clinical quality of care, patient safety, care coordination, patient experience of care, surgical outcomes, surgical complications, complications of anesthesia, and patient reporting outcomes of care. As our organizations have stated previously, as new measures are added to the ASC Quality Reporting Program, CMS should distinguish, when establishing reporting requirements, between an ASC that is equipped for the performance of sterile surgical operations and an ambulatory endoscopy center that is equipped to perform non-surgical endoscopy procedures. We ask that in the final rule that CMS provide additional guidance with respect to the process for suggesting and submitting future ASC Quality Reporting Program measures. Consistent with our past comments, we offer for CMS consideration the following measure topics for the ASC Quality Reporting Program. : Equipment Reprocessing High-level disinfection and sterilization, with a particular emphasis on endoscope reprocessing. We welcome an opportunity to work with CMS on the development of measures to ensure that appropriate cleaning and disinfection/sterilization

9 Page 9 of 11 processes are following during endoscope reprocessing, promoting patient safety. We believe such measures should be derived from multi-society endorsed endoscopy reprocessing guidelines. Sedation Safety A possible anesthesia-related measure could include the use of reversal agents to patients given moderate sedation agents (medications used to rescue patients from deeper levels of sedation than intended). Society Efforts to Improve Care and Reduce Adverse Events CMS states in the proposed rule that there are no publicly available quality of care reports for ASCs that conduct outpatient colonoscopies. Our societies remind the Agency through Physician Compare website, CMS includes data on endoscopy measures which provides a detailed look at the quality of endoscopy services provided. This data is collected through PQRS, and CMS is proposing to further enhance publicly available data by including measures captured by Qualified Clinical Data Registries, which will further increase the robustness of publicly available data on colonoscopy provided across all sites of service. COLLECTING DATA ON SERVICES FURNISHED IN OFF-CAMPUS HOSPITAL PROVIDER-BASED DEPARTMENTS Over the last few years, concerns about a reverse migration of services that were once provided in the physician office setting but are shifting back to hospital outpatient departments (HOPD) have arisen, particularly as hospital employment of physicians has increased. There are many contributors to this reverse migration, including payment rates in the ASC setting. The Medicare Payment Advisory Commission (MedPAC) has investigated the issue on multiple occasions and has considered recommendations that would equalize payment across settings for some services. Hospitals are also purchasing physician practices and designating them as off-campus providerbased HOPDs, which allows the same practice to bill for the same service at a significantly higher rate. The result is higher program spending and beneficiary cost sharing without a notable change in patient care or quality. In the CY 2014 fee schedule proposed rule, CMS stated that to better understand these trends it was considering new steps to collect information that would allow it to analyze the frequency, type, and payment for services furnished in off-campus provider-based hospital departments. To achieve this goal, CMS discussed several means by which this information could be collected and suggested either creation of a new place of service code (POS) for off-campus departments or a HCPCS modifier for both CMS-1500 claim forms and the UB-04 form. Our societies recommended the use of a new POS code as the most effective and least burdensome means of retrieving the data sought by CMS. CMS stated in the CY 2014 fee schedule final rule that most commenters agreed on the need to collect such information, but that no consensus solution was clear other than the importance of avoiding new administrative burdens that might not furnish the type of information sought. The

10 Page 10 of 11 lack of agreement on whether to endorse a new HCPCS code or POS code caused CMS to defer a decision on the issue while continuing to collect public input. CMS is proposing the use of a new HCPCS modifier that would be reported with every code for physician and hospital services furnished in an off-campus provider-based department of a hospital. We continue to believe that a new code-based reporting mechanism is superior to other options under consideration, including proposals that would require hospitals to break out charges for services in their cost reports. However, while we previously stated in our comments to the CY 2014 proposed rule that a code-based approach is the most reliable source of data sought by CMS, we noted that the HCPCS proposal is not ideal because it will require the use of a modifier for each individual service contained in a claim. For these reasons, we ask that CMS endorse the use of a new POS code to identify off-campus provider-based outpatient departments, rather than creating a new HCPCS modifier. Additionally, the proposed rule states the data collection would occur for facilities located more than 250 yards from the main hospital building. We ask CMS to clarify in the final rule the rational for the 250 yards, including why it is limiting the data collection to those facilities, as well as its decision not to require data collection for those facilities within 250 yards. Our societies advise that data collection apply to all such facilities. ASC INFLATION UPDATE CMS has the discretion to use an alternative update factor to the default adjustment based on estimates of the Consumer Price Index for All Urban Consumers (CPI-U). We have repeatedly sought an alternative update factor. Specifically, we have recommended that ASC payments be updated annually using the hospital market basket. As we have commented in the past, the continued use of what amounts to an arbitrary metric chosen more for its availability rather than its applicability creates an errant trajectory that varies further from true cost with each year it continues to be applied. The hospital outpatient mix of services and the HOPD structure closely resemble that of ASCs. The ASC and HOPD compete in the labor market for exactly the same clinical staff and compete in the market for the same medical supplies. The difference is that the ASC does not have the purchasing power of a hospital. Furthermore, the ASC and the HOPD must each comply with aspects of the Life Safety Code and changes to and costs associated with accreditation requirements as they pertain to the bricks and mortar of ASCs. These requirements increasingly mirror those of the HOPD. As we have stated in past comments, the CPI-U is highly volatile and incorporates the changes in prices for many goods and services making it difficult for the government to accurately forecast. Conversely, the hospital market basket has demonstrated predictability. Accordingly, we again request that CMS use the hospital market basket index for updating ASCs beginning in CY Until such time this occurs, we suggest CMS remove productivity gains from the CPI-U

11 Page 11 of 11 and allow the multi-factor productivity adjustment to be the method for reducing the update for changes in productivity. By exercising its administrative authority to update both ASC and HOPD payments using the same update factor, CMS would help minimize further payment divergence between the sites, which we believe significantly influences the market entry and exit of ASCs. We suggest that the health care system and patients benefit when there is competition in the marketplaces, which is compromised by the acquisition of ASCs by hospitals and health system or the closure of ASCs entirely. CONCLUSION The ACG, AGA, and ASGE appreciate the opportunity to provide comments on the 2014 physician fee schedule proposed rule. If we may provide any additional information, please contact Brad Conway, Vice President of Public Policy, ACG, at or ; Joshua Keepes, Director of Regulatory Affairs, AGA, at or or Camille Bonta, consultant to ASGE, at or Sincerely, Harry E. Sarles, MD FACG President American College of Gastroenterology Anil K. Rustgi, MD, AGAF Chair American Gastroenterological Association Colleen M. Schmitt, MD, MHS, FASGE President American Society for Gastrointestinal Endoscopy

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