PROPOSED UPDATES TO THE OPPS. September 11, Submitted electronically via:

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1 Submitted electronically via: Seema Verma Department of Health and Human Services Attention: P.O. Box 8013 Baltimore, MD Re: Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs () Dear Verma: The American College of Gastroenterology (ACG), American Gastroenterological Association (AGA) and the American Society for Gastrointestinal Endoscopy (ASGE) appreciate the opportunity to provide comments on the Centers for Medicare and Medicaid Services (CMS) proposed rule (CMS P), published on July 20, 2017 in the Federal Register, regarding the proposed policy revisions to the CY 2018 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems. Together, our three societies represent virtually all practicing gastroenterologists in the United States. There are several provisions in the proposed rule that impact practicing gastroenterologists and the Medicare beneficiaries they treat. Below, we offer comments that address these areas. PROPOSED UPDATES TO THE OPPS * * * Ambulatory Payment Classification (APC) for CPT Code For CY 2017, CMS moved Current Procedural Terminology (CPT) code ( Ileoscopy, through stoma; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed) ) from APC 5331 ( Complex GI Procedures ) to APC 5303 ( Level 3 Upper GI Procedures ). Our societies oppose assignment of CPT code to APC CPT code is a small bowel procedure that includes stent placement. The resources required to perform this procedure are similar to other small and large bowel procedures that include stent placement and should be included in the same APC (5331). As the cost of stent placement procedures is

2 Page 2 of 9 device-driven, placement of CPT code in APC 5303 results in an ambulatory surgical center (ASC) payment that is below the cost of performing the procedure. Because APC 5303 is not a device-dependent APC, the proposed ASC payment rate ($1,112) for CPT code is only 45 percent of the proposed APC payment, which is below even the cost of the stent ( $1,500). We urge CMS to move CPT code from APC 5303 to APC Date of Service (DOS) Policy Laboratory Medicare policy governing the date of service for clinical laboratory and physician pathology tests has long posed challenges for hospitals and laboratories around molecular pathology testing. In certain circumstances, the policy has resulted in delayed testing, diagnosis and treatment. As such, our societies support CMS proposal to modify current regulations. PROPOSED UPDATES TO THE ASC PAYMENT SYSTEM Definition of ASC Covered Surgical Procedures Since 2008, CMS has defined ASC covered surgical procedures as those described by Category I CPT codes in the surgical range from through 69999, as well as those Category III CPT codes and Level II Healthcare Common Procedure Coding System (HCPCS) codes that directly crosswalk or are clinically similar to procedures in the CPT surgical range that CMS has determined do not pose a significant safety risk, would not expect to require an overnight stay when performed in an ASC, and are separately paid under the Hospital Outpatient Prospective Payment System (OPPS). In the proposed rule, CMS is requesting public comments regarding this definition and specifically, seeks feedback regarding services that do not directly crosswalk and are not clinically similar to procedures in the CPT surgical range, but that nonetheless may be appropriate to include as covered surgical procedures payable when furnished in the ASC setting. 1 Strict adherence to the CPT surgical code groupings, as CMS notes in the proposed rule, does not properly account for advances in treatment and the dynamic nature of ambulatory surgery and the continued shift of services from the inpatient setting to the outpatient setting over the past decade. 2 The current definition is also inconsistent with how CMS defines surgery for other purposes. For example, in a National Coverage Determination in which CMS explains payment policies for certain surgical errors, the definition of surgery is much broader: 3 Surgical and other invasive procedures are defined as operative procedures in which skin or mucous membranes and connective tissue are incised or an instrument is introduced through a natural body orifice. Invasive procedures include a range of procedures from minimally invasive dermatological procedures (biopsy, excision, and deep cryotherapy for malignant lesions) to extensive multi-organ transplantation. They include 1 82 Fed. Reg Fed. Reg National Coverage Determination (NCD) for Surgical or Other Invasive Procedure Performed on the Wrong Body Part (140.7)

3 Page 3 of 9 all procedures described by the codes in the surgery section of the Current Procedural Terminology (CPT) and other invasive procedures such as percutaneous transluminal angioplasty and cardiac catheterization. They include minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar. They do not include use of instruments such as otoscopes for examinations or very minor procedures such as drawing blood. Our societies recommend that CMS revise the definition of an ASC covered surgical procedure to include invasive procedures that do not pose a significant safety risk, would not expect to require an overnight stay when performed in an ASC and are separately paid under the OPPS. Expanding the definition to include other invasive procedures would better accommodate not only existing procedures, but also future procedures made available through technical advances. As CMS undertakes its annual update to the ASC list of covered surgical procedures and covered ancillary services, and considering the interest in expanding the scope of covered services to certain surgery-like procedures, we request that CMS include the 16 codes shown in Table 1 on the list of ASC codes that are eligible for separate payment. Table 1 CPT Code Descriptor Rationale Esophageal motility (manometric study of the esophagus and/or gastroesophageal junction) study with interpretation and report; Esophageal motility (manometric study of the esophagus and/or gastroesophageal junction) study with interpretation and report; with stimulation or perfusion (eg, stimulant, acid, or alkali perfusion) Gastric motility (manometric) studies Duodenal motility (manometric) study

4 Page 4 of 9 CPT Code Descriptor Esophagus, acid perfusion (Bernstein) test for esophagitis Esophagus, gastroesophageal reflux test; with nasal catheter ph electrode(s) placement, recording, analysis and interpretation Esophagus, gastroesophageal reflux test; with mucosal attached telemetry ph electrode placement, recording, analysis and interpretation Esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation; Esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation; prolonged (greater than 1 hour, up to 24 hours) Rationale of catheter into a body cavity; performed in conjunction with other invasive procedures Esophageal balloon distension study, diagnostic, with provocation when performed Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum, with interpretation and report Invasive procedure involving introduction of instrument through a natural body orifice Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus with interpretation and report Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report Invasive procedure involving introduction of instrument through a natural body orifice Invasive procedure involving introduction of instrument through a natural body orifice

5 Page 5 of 9 CPT Code Descriptor Colon motility (manometric) study, minimum 6 hours continuous recording (including provocation tests, eg, meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report Rectal sensation, tone, and compliance test (ie, response to graded balloon distention) Rationale Invasive procedures involving placement of probes or catheters into a body cavity Anorectal manometry Invasive procedures involving placement of probes or catheters into a body cavity The services we propose are diagnostic procedures currently covered when delivered in the hospital outpatient department, but not in the ASC. Our societies further recommend that CMS revise the definition of an ASC covered surgical procedure to include infusion services. Today, infusion services are predominantly provided in the hospital outpatient department setting, because physician offices cannot support the level of nursing required to supervise these services. However, providing infusion services in the hospital outpatient department is not cost-effective. ASCs employ the appropriate nursing staff and could deliver these services at a lower cost, but they are not permitted to do so. We request that CMS also include on the list of ASC codes that are eligible for separate payment the two codes shown in Table 2. Table 2 CPT Code Descriptor Rationale Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Requires supervision of specialty trained nurses not available in typical physician office, but are available in an ASC Chemotherapy administration, intravenous infusion technique; each additional hour Requires supervision of specialty trained nurses not available in typical physician office, but are available in an ASC

6 Page 6 of 9 We strongly encourage CMS to move forward as quickly as possible with an expanded definition for ASC covered surgical procedures to make these services available to Medicare beneficiaries in a lower cost, more convenient and highly preferred site of service. Proposed Updates to ASC Covered Surgical Procedure Payment Rates Status Indicator Changes Affecting CPT Codes 43197, 43198, 45300, 45303, 45330, 46221, 46604, and In Addendum AA of the proposed rule, the payment indicator for several gastroenterology procedures has changed, but the addendum does not indicate that a change is proposed (i.e., no comment indicator is provided). The CPT codes impacted include: 43197, 43198, 45300, 45303, 45330, 46221, 46604, and For these codes, the proposed CY 2018 payment indicator is R2 ( Office-based surgical procedure added to ASC list in CY 2008 or later without MPFS non-facility PE RVUs; payment based on OPPS relative payment weight ). We believe that the proposed assignment of payment indicator R2 was made in error and we recommend that CMS restore the CY 2017 payment indicator for each of the codes. ASC Payment Reform Conversion Factor Most ASCs are small businesses, and as such, must run efficiently to remain viable. As of June 2017, there are 5,561 CMS-certified ASCs, and over 55 percent 3,077 only have one or two operating rooms. These facilities must purchase the same equipment, devices and implants as hospitals to perform surgery. In fact, smaller ASCs often pay more, since they do not have the same purchasing power of a hospital or large health system. ASCs must compete with hospitals and other health care providers for the same nurses and other staff, all while complying with similar state and federal regulations and an ever-growing Medicare quality reporting program. And yet, CMS continues to implement policies that drive a growing wedge in reimbursement rates for hospital outpatient departments and ASCs. While ASCs pride themselves on running efficiently, declining reimbursement jeopardizes the ability of ASCs to perform Medicare cases. Surgical care in too many markets continues to be predominantly provided in hospitals, which we attribute to Medicare s failure to pay competitive rates to ASCs. This lack of migration comes at a high price to the Medicare program, the taxpayers who fund it and the beneficiaries who needlessly incur higher out-of-pocket expenses. Our societies propose that CMS set ASC payments at a fixed percentage of the OPPS payment rate. Specifically, we recommend that CMS set ASC payment rates for all services at 55 percent the typical ratio between OPPS and ASC payments in CY 2014 when CMS policies, including expanded packaging and the creation of the Comprehensive APCs, contributed to further divergence between the payment systems. For device-dependent codes, we recommend that CMS maintain its current methodology, but adjust the non-device portion of the payment amount by 55 percent. Our proposal to fix ASC payment at 55 percent of OPPS payment rates would also eliminate current policy which uses Medicare Physician Fee Schedule (PFS) nonfacility relative value units (RVUs) to establish payment rates for certain ASC services. We believe

7 Page 7 of 9 addressing this issue will help shift more procedures into the ASC setting, reducing overall Medicare expenditures. CMS has the authority to implement either change. ASC Annual Update and Consumer Price Index for Urban Consumers (CPI-U) Our societies urge CMS to replace the CPI-U with the hospital market basket as the update mechanism for ASC payments. The OPPS update is based on the inpatient Hospital Market Basket (HMB), which is comprised of data that reflects the cost of items and services necessary to furnish an outpatient surgical procedure and has historically been higher than the CPI-U, the update factor used for ASCs. As our societies have previously noted, CPI-U is not a suitable inflation index to update ASC payments because it does not accurately represent the costs borne by facilities to furnish surgical procedures. The CPI is an index that measures the average change over time in the price of consumer goods goods and services that people buy for day-to-day living. The CPI-U represents the buying habits of the residents of the urban or metropolitan areas in the United States, not the ever-increasing costs of operating a health care facility. In addition to not being representative of the inflationary costs ASCs face, the CPI-U can fluctuate greatly up or down throughout the year, so CMS cannot provide a reliable sense of how ASC final payments will be impacted for the coming year. CMS acknowledges year after year in the OPPS/ASC payment rule that they are not statutorily required to adopt any particular update mechanism, so they continually default to the CPI-U since the CPI U must be used in the absence of any update implemented by the Secretary. According to the Medicare Payment Advisory Commission (MedPAC), growth in ASCs since 2009 has been relatively slow with roughly 100 centers merging or closing per year. 4 This slower growth in the number of ASCs for CYs 2009 through 2014 may be due in part to, according to MedPAC, the substantially higher rates that Medicare pays for ambulatory surgical services in the hospital outpatient departments than in ASCs. Since upper and lower endoscopy are among the most common procedure performed in the ASC setting, our societies fear that the consequences of CMS inaction have led to increased migration of gastroenterology endoscopic services to the hospital setting, resulting in higher costs for the Medicare program and its beneficiaries. Therefore, we urge CMS to replace the CPI-U with the HMB as the update mechanism for ASC payments. ASC Quality Reporting (ASQCR) Program Our societies support and appreciate CMS proposal to make optional participation in the Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery Survey (OAS CAHPS) beginning CY We urge CMS to finalize this proposal in the final rule. The OAS CAHPS contains 37 questions, which our members find repetitive, redundant and nonessential particularly the 13 patient demographic questions. Further, the survey includes 24 questions focused on patient experience, while allowing a facility to augment with up to 15 4 MedPAC; Medicare and Health Care Spending, June 2016

8 Page 8 of 9 additional questions, which contributes to the fact that it is a needlessly lengthy survey that patient s often refuse to complete, impacting scoring. The length of the survey is complicated by the lack of an electronic option to collect the required information. Another administrative burden for physicians practicing in ASCs is the required number of completed surveys. ASCs, which are typically small businesses, find the requirement of 300 completed surveys excessively onerous, particularly given that the survey is not user-friendly and unreasonably lengthy. CMS has created an exception process for facilities that treat fewer than 60 survey-eligible patients during the eligibility period, but this exception benefits few ASCs. It is also important to note, that inpatient hospitals are only required to complete 100 OAS CAHPS surveys. We do not think it is appropriate to set a higher bar for non-acute care healthcare facilities, such as ASCs, which are designed to offer reasonably priced and convenient surgical care to their communities. The direct and indirect costs of implementing and administering the OAS CAHPS survey is tremendous. ASC staff must contact each approved survey vendor to understand the services provided as well as the cost. Approved survey vendors are not required to provide this information in a transparent or standard format, complicating the task of comparing survey providers and selecting a survey vendor. These tasks are burdensome for ASC staff and often unproductive. Once a survey vendor is selected and contracted, the ASC s work is not finished. ASC facility staff must then provide and update patient contact information monthly, build and monitor computers files (which also has financial costs), monitor survey results to ensure CMS response requirements are met (an average of 30 surveys monthly), and conduct regular outreach to let the patients know that surveys are not unsolicited or suspicious activity. CMS, in this proposed rule, estimates that implementation of the OAS CAHPS costs each ASC (and hospital outpatient department) over $6, Our member experience suggests that the cost and time resources significantly exceed this estimate as it is difficult to estimate the burdens borne by ASCs once a facility contracts with a survey vendor. Voluntary participation in the OAS CAHPS will not eliminate measurement of patient satisfaction. Accreditation by the Accreditation Association for Ambulatory Health Care (AAAHC) 6 and other accreditation bodies, requires ASCs to measure and act on patient satisfaction data. For example, as part of the checklist for each accreditation survey, AAAHC assesses each ASC on the following: Organization assessment of patient satisfaction with services and facilities, review of results with the governing body and, when appropriate, corrective action taken. Methods in place to systematically collect information from other sources such as, but not limited to, patient satisfaction surveys as well as evaluation of the information and data obtained through the above data collection activities to identify the existence of unacceptable variation or results that require improvement. 5 This results in an estimated aggregate burden reduction of $19,533,260 (3,218 ASCs x $6,070 per ASC) across all ASCs meeting eligibility requirements for the ASCQR Program. As noted above, this burden reduction is included under OMB Control Number and is not included in our burden estimates for the ASCQR Program. 6

9 Page 9 of 9 Thus, although it is important to assess patient satisfaction, a single mandated survey is not necessary. As opportunities to repeal, replace, or otherwise modify burdensome regulations are considered, our societies urge CMS to finalize the proposal to make OAS CAHPS participation voluntary. * * * The ACG, AGA and ASGE appreciate the opportunity to provide comments on the CY 2018 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs proposed rule. If we may provide any additional information, please contact Brad Conway, Vice President of Public Policy, ACG, at or bconway@gi.org; Jessica Roth, Director of Regulatory Affairs, AGA, at or jroth@gastro.org; or Lakitia Mayo, Senior Director of Health Policy, Quality and Practice Operations at lmayo@asge.org or (630) Sincerely, Carol A. Burke, MD FACG President American College of Gastroenterology Timothy C. Wang, MD, AGAF Chair American Gastroenterological Association Karen L. Woods, MD, FASGE President American Society for Gastrointestinal Endoscopy