AMERICAN COLLEGE OF GASTROENTEROLOGY 6400 Goldsboro Road, Suite 200, Bethesda, Maryland ; P: ; F:

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AMERICAN COLLEGE OF GASTROENTEROLOGY 6400 Goldsboro Road, Suite 200, Bethesda, Maryland 20817-5842; P: 301-263-9000; F: 301-263-9025 BOARD

1 AMERICAN COLLEGE OF GASTROENTEROLOGY 6400 Goldsboro Road, Suite 200, Bethesda, Maryland ; P: ; F: BOARD OF TRUSTEES President RONALD J. VENDER, M.D., FACG New Haven, Connecticut President-Elect HARRY E. SARLES, Jr., M.D., FACG Rockwall, Texas , ext. 104 Vice President STEPHEN B. HANAUER, M.D., FACG Chicago, Illinois Secretary CAROL A. BURKE, M.D., FACG Cleveland, Ohio Treasurer KENNETH R. DEVAULT, M.D., FACG Jacksonville, Florida Immediate Past President LAWRENCE R. SCHILLER, M.D., FACG Dallas, Texas Past President DELBERT L. CHUMLEY, M.D., FACG San Antonio, Texas Director, ACG Institute EDGAR ACHKAR, M.D., MACG Cleveland, Ohio Co-Editors, The American Journal of Gastroenterology WILLIAM D. CHEY, M.D., FACG Ann Arbor, Michigan PAUL MOAYYEDI, M.D., FACG Hamilton, Ontario, Canada , ext Chair, Board of Governors DANIEL J. PAMBIANCO, M.D., FACG Charlottesville, Virginia Vice Chair, Board of Governors IMMANUEL K. H. HO, M.D., FACG Chester, Pennsylvania Trustee for Administrative Affairs JOHN W. POPP, Jr., M.D., MACG Columbia, South Carolina TRUSTEES NEENA S. ABRAHAM, M.D., FACG Houston, Texas R. BRUCE CAMERON, M.D., FACG Chagrin Falls, Ohio NAGA P. CHALASANI, M.D., FACG Indianapolis, Indiana FRANCIS A. FARRAYE, M.D., M.Sc., FACG Boston, Massachusetts DAVID A. GREENWALD, M.D., FACG Bronx, New York SUNANDA V. KANE, M.D., MSPH, FACG Rochester, Minnesota IRVING M. PIKE, M.D., FACG Walnut Creek, California MARK B. POCHAPIN, M.D., FACG New York, New York NICHOLAS J. SHAHEEN, M.D., FACG Chapel Hill, North Carolina SCOTT M. TENNER, M.D., MPH, FACG Brooklyn, New York Executive Director BRADLEY C. STILLMAN June 21, 2013 Inspector General Daniel R. Levinson Office of Inspector General United States Department of Health and Human Services 330 Independence Avenue, S.W. Washington DC Dear Inspector General Levinson, The American College of Gastroenterology (ACG or College ) is writing on behalf of its membership in response to the Office of Inspector General s (OIG) Advisory Opinion and other comments that we understand OIG has received from an industry stakeholder group. We are writing to refute unfounded allegations that have been made about our specialty as part of these comments on company model arrangements in the ambulatory surgical center (ASC) setting. We understand that some stakeholders have argued, without supporting evidence, that ASC owners have structured these company model agreements with the intention to commandeer anesthesia services and reimbursement and promote overutilization of unnecessary gastrointestinal procedures (and anesthesia services). These allegations of fraud in our specialty are inaccurate and without foundation. The gastroenterology community is committed to full compliance with all laws and regulations and is committed to high quality patient care. The College is compelled to comment and speak on behalf of our clinician members. Specifically: The Company Model May Provide Legitimate Clinical Benefits, Including Improved Coordination of Care; The Company Model Does Not Impact Patient Choice; The Company Model Does Not Uniquely Influence Utilization Rates of Either Gastroenterological or Anesthesia Services; and Gastroenterologists Determine Whether Anesthesia Services are Needed Based on Their Patient s Clinical Needs. ACG is an organization representing gastroenterologists and other gastrointestinal specialists. Founded in 1932, our organization currently numbers over 12,000 members. The primary activities of ACG have been, and continue to be, promoting evidence-based medicine and optimizing quality of patient care.

2 I. ACG S UNDERSTANDING OF THE CURRENT ENVIRONMENT OF COMPANY MODEL PRACTICE STRUCTURES The company model entity that OIG addressed in Advisory Opinion is an anesthesia services company, where the entity hires the anesthesia professionals. ACG understands that the OIG expressed concern with certain company model practice structures and the motives for creating these arrangements. ACG appreciates the OIG s guidance and opinion on the company model and strives to further educate our membership regarding the importance of structuring all practice relationships in a compliant manner. It is important for the College to educate our membership to ensure our members are abiding by federal laws and upholding the ethics of medicine. As an independent and nonprofit medical society, ACG cannot comment on any particular company model practice structure in detail. Instead, we would like to clarify inaccuracies that have been inserted into the conversation surrounding the company model and convey some potential clinical and business needs for these practice structures. As we hear from our members, many company model practice structures utilize a negotiated flat fee with anesthesia professionals and do not condition payments on the amount, volume, value of the services, or even profits in the entity. These practice structures often involve contracting with an anesthesia professional to provide services on certain days or times regardless of the volume of patients the anesthesia professional treats that day, or any reimbursement generated as a result of the billing. Anesthesia professionals entering into company model arrangements are free to contract with other providers and facilities. Likewise, the entity is free to contract with other anesthesia professionals but bears the risk of ensuring adequate and qualified staff is present when gastroenterologists perform endoscopic procedures. This suggests that these arrangements differ from others where all or substantially all of the anesthesia professional s services are derived from, and conditional upon, the company model arrangement. We understand that the anti-kickback statute has been interpreted to cover any arrangement where even one purpose of the remuneration is to generate or reward referrals for anesthesia services. We believe that the vast majority of gastroenterologists who utilize a company model practice structure do so because it is the right decision for their patients and not to effect referrals or payments. The College agrees with the OIG which notes in the June 2012 Advisory Opinion that the company model in general may serve a legitimate and bona fide purpose and may meet one or more of the statutory safe harbors. II. THE COMPANY MODEL MAY PROVIDE CLINICAL BENEFITS, INCLUDING IMPROVED COORDINATION OF CARE Improving coordination of care in the United States is a critical element in enhancing patient outcomes and reducing health care costs. Efforts to improve care coordination are at the core of the Obama Administration s health reform efforts and the Department of Health and Human Services has developed numerous initiatives to pursue new models for improving coordination between providers.

3 The company model may improve patient experiences and reduce barriers to medically necessary life-saving care. Medicare will also be incorporating more patient satisfaction quality measures in the near future, and to encourage providers to meet these objectives, these quality metrics will be directly tied to reimbursement in both the Medicare professional services and facility fee schedules. In our members experience, utilizing the company model practice structure has helped our practitioners improve patient care and patient satisfaction. For example, for many ACG members, the company model practice structure helps to ensure the availability of a qualified anesthesia professional on the day and time of a patient s procedure. In many small facilities and rural communities, this practice model may be necessary as it is otherwise difficult to convince an anesthesia professional to perform services in areas with few patients or cases on a given day. We understand that opponents of the company model allege that the purpose of forming certain arrangements is to capture the revenue stream from the delivery of anesthesia services in connection with the procedures performed by the owners of the anesthesia company. These critics do not understand, or choose to ignore, the simple fact that at least for gastroenterology, patients do not undergo anesthesia as the primary treatment, nor do patients typically seek to forgo sedation when undergoing an invasive procedure such as colonoscopy. While this may seem intuitive, ACG believes this is important to highlight in the context of the company model discussion. Gastroenterologists and facilities must have an anesthesia professional available to serve patients and must have appropriate business arrangements to meet the unique demands of various practice settings and areas. The anesthesia services and the underlying service are inexorably linked. Thus, we dispute any allegations that gastroenterologists or facilities have any leverage over the anesthesia professional because there is a need for both services in order to perform the procedure. III. PATIENTS SELECT A GASTROENTEROLOGIST AND A FACILITY. PATIENTS DO NOT SEPARATELY SELECT AN ANESTHESIA PROFESSIONAL WHEN UNDERGOING PROCEDURES Given the connection between anesthesiology and the underlying procedure, the College does not believe that the company model uniquely restricts patient-choice in a different manner than other arrangements where the physician and the anesthesia services provider work together. Opponents of the company model allege that these practice structure restricts patient-choice and access to care. However, the ability for a patient to choose anesthesia providers in a company model practice setting appears no different from any other practice arrangement in which a facility utilizes specific anesthesia professionals for the services provided to its patients. The College is also unaware of any patient complaint regarding a facility s selection of one professional administering anesthesia over another, or any complaint that an entity s use of a particular anesthesia provider restricts patient choice.

4 IV. THE COMPANY MODEL DOES NOT INFLUENCE UTILIZATION RATES While there may be Medicare providers who manipulate the healthcare system for their own profit it is likely the intentions of those individuals, not the practice model itself, that are driving inappropriate billing or overutilization. The College is as committed as OIG is to rooting out fraud and such unlawful activity. Regardless of the structure of their practice, the College believes gastroenterologists make their medical decisions regarding what procedures are needed and the use of sedation based on the medical necessity of a procedure and the best interest of their patients. We reject any anecdotal allegation that our members in a company model arrangement are engaging in overutilization or unnecessary procedures. ACG maintains that the treating physician is in the best position to determine whether a patient needs a specific treatment or procedure, including undergoing an endoscopic procedure that requires sedation. Gastroenterologists are also not in a position to drive high volumes of referrals or to push towards overutilization of unnecessary services. Primary care physicians are typically the practitioner who makes the front-line decision and refers patients to one of our members. Gastroenterology referrals from a primary care physician can range from an asymptomatic patient who is being referred for a colorectal cancer screening, to a patient with symptoms requiring an endoscopic examination. There are other patients who use their specialist as a primary care provider. However, even in this scenario, the specialist is the primary care provider for a reason usually it is because the patient has a chronic condition that requires routine specialty care. In gastroenterology, for example, many patients with inflammatory bowel disease (IBD) routinely undergo endoscopy for necessary surveillance and treatment. Given the nature of gastroenterology, which requires unpleasant bowel preparation that precedes colonoscopy, for example, few physicians and patients would seem to agree to perform/undergo these services unless it is a medically necessary service. As in other practice areas, there may be instances of overutilization of endoscopy and other gastrointestinal procedures, tests, and physician/patient interactions in the United States due to defensive medicine or practitioners not following appropriate clinical guidelines. However, it is misguided to attribute overutilization to any specific practice model without data to support such allegations. ACG is not aware of any data that demonstrates that the risk of overutilization under the company model is any different than it is in any other practice setting. There are many factors that can contribute to this spurious connection. Even critics of the company model admit that this supposed evidence is merely anecdotal.

5 V. GASTROENTEROLOGISTS DETERMINE WHETHER ANESTHESIA SERVICES ARE NEEDED BASED ON THEIR PATIENT S CLINICAL NEEDS There is evidence in the medical literature suggesting that certain anesthesia agents are preferable to patients undergoing procedures. Due to federal labeling restrictions and other regulatory policies, many endoscopies require the presence of the anesthesia professional during the procedure, notwithstanding the numerous articles and studies in the medical literature demonstrating that gastroenterologists can deliver those sedation agents currently used for gastrointestinal procedures with the same degree of safety as anesthesiologists. Patients frequently ask our members about the different types of sedation used during endoscopic procedures. Opponents of the company model allege that these arrangements require patients to receive anesthesia services even if they do not need them, including certain gastrointestinal procedures such as colonoscopy. While the patient is not required to receive anesthesia services while undergoing a colonoscopy, it is the recommended standard of practice. The College does not recommend patients undergo colonoscopy or other endoscopic procedures without some form of sedation unless there is a specific medical reason for doing so. High rates of sedation at ASCs that are structured in the company model are not an indication of overutilization of those services they merely indicate that the ASC s practitioners are following the clinical standard of care for their patients. What s more, ACG does not believe there is a practice of physicians choosing one type of sedation over another simply to generate a stream of revenue. The administration of sedation, and which sedative/narcotic to use, are complex issues that depend on the unique circumstances of each patient. ACG believes these decisions are best left for the treating physician and the patient. The College is unaware of any evidence demonstrating that gastroenterologists are engaging in this behavior and takes exception to this broad stroke characterization of gastroenterologists and ACG members in company model practice structures. If OIG findings suggest that certain physicians in a company model are selecting one form of anesthesia over another without a legitimate clinical reason, the OIG can and should take action to curb this abuse. ACG is happy to work with OIG to look into this issue further as it impacts gastroenterology. The College is also happy to assist in finding any anesthesia service provider willing to ignore the standards of care, medical ethics, and the best interest of the patient to administer unnecessary anesthesia services. Targeting these anesthesia providers would also expose certain bad-acting company model entities as these providers are agents of the entity. The College also welcomes the opportunity to work with the anesthesia community in this endeavor, as these alleged reports of over-use of anesthesia services actually means that members within their own associations or profession are choosing to practice medicine detrimental to patient care, the ethics of medicine, and potentially in violation of the law.

6 VI. CONCLUSION ACG appreciates the useful and important services that anesthesia professionals provide in our specialty. For many health services, anesthesia professionals substantially improve quality of care and procedural outcomes. This is particularly true in gastroenterology, where our members commonly perform endoscopic procedures requiring sedation. ACG believes that many patients would forgo necessary and life-saving procedures, such as colorectal cancer screening, but for sedation. For many cases, the presence of an anesthesia professional is medically necessary and clinically appropriate. ACG and its members strive to be leaders of patient care and quality in our specialty. We believe the vast majority of our members practicing in the ASC setting, including in those settings with a company model practice structure, have the very best interests of the patient in mind when performing gastrointestinal services and enter into commercial arrangements only for legitimate and bona fide reasons. ACG will continue to review OIG s guidance and educate our membership about how they can be certain to operate their practices in ways that do not violate the law or pose risks of fraud and abuse. We urge OIG to provide additional guidance on how integrated care models such as the company model practice structure can be appropriately implemented. The federal oversight process is designed to protect public health care programs and the health care system as a whole. The College shares these goals. Please contact Brad Conway, Vice President, Public Policy, Coverage & Reimbursement, at bconway@gi.org or to discuss further. Sincerely, Ronald Vender, MD, FACG President American College of Gastroenterology

Preparing GI ASCs for October 2012

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