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1 Gastroenterology 2016;150: An Episode Payment Framework for Gastroesophageal Reflux Disease: Symptomatic Gastroesophageal Reflux Disease, Dysplastic and Nondysplastic Barrett s Esophagus, and Anti-Reflux Surgical and Endoscopic Interventions Michael F. Vaezi, 1 Joel V. Brill, 2 Michael R. Mills, 3 Brett B. Bernstein, 4 Reid M. Ness, 5 William O. Richards, 6 Lili Brillstein, 7 Rebecca Leibowitz,8 Ken Strople, 9 Elizabeth A. Montgomery, 10 and Kavita Patel 11 1 Divison of Gastroenterology, Vanderbilt University Medical Center, Nashville, Tennessee; 2 Predictive Health, LLC, Paradise Valley, Arizona; 3 Arizona Digestive Health, Phoenix, Arizona; 4 Albert Einstein College of Medicine at Beth Israel Medical Center, New York, New York; 5 Division of Gastroenterology, Vanderbilt University Medical Center, Nashville, Tennessee; 6 University of South Alabama Health Services Foundation, Mobile, Alabama; 7 Horizon Healthcare Innovations, Maplewood, New Jersey; 8 American Gastroenterological Association Institute, Bethesda, Maryland; 9 Palisades Healthcare Solutions, LLC, Camarillo, California; 10 Johns Hopkins University, Baltimore, Maryland; and 11 Center for Health Policy, Brookings Institute, Washington, DC Health care currently constitutes approximately 17.4% of the Gross Domestic Product in the United States, with health care spending increasing by 6.2% annually, according to the US Department of Commerce. 1,2 Efforts to contain costs include reforms to the overall delivery system, such as Accountable Care Organizations and Patient- Centered Medical Neighborhoods, as well as a variety of modifications to fee-for-service payment. However, to date, efforts to incorporate value-based reforms into the delivery of care provided primarily by specialists have been limited. Public Law No: , the Medicare Access and Children s Health Insurance Program Reauthorization Act of 2015, repealed the Medicare Sustainable Growth Rate formula to provide long-term stability to the Medicare physician fee schedule. Medicare Access and Children s HealthInsur- ance Program Reauthorization Act of 2015 established the Merit-Based Incentive Payment System, a streamlined incentive payment program that focuses the fee-for-service system on providing value and quality and penalizes physicians and eligible providers for not reporting. Merit-Based Incentive Payment System consolidates existing incentive programs that focus on quality, resource use, and meaningful electronic health record use with clinical practice improvement activities to support alternative payment models (APMs). Professionals who receive a significant share of their revenues through an APM that involves risk of financial losses and a quality-measurement component will receive a 5% bonus from Medicare each year from The bonus payment for APM participation encourages professionals to consider participation and testing of new APMs recognizing that practice changes are needed to facilitate such participation and promotes the alignment of incentives across payors and physician providers. In response to policy imperatives and market dynamics that are moving physician payment from volume to value, the American Gastroenterological Association s (AGA) Roadmap to the Future of GI acknowledges the need for models to help gastroenterologists participate in and provide value-based care for both cognitive and procedural conditions. 3 Developing a model for an episode of care can help gastrointestinal (GI) practices whether solo or large, community, or academic, GI only, or focused-factory (eg, GI, anesthesia, pathology, surgery, and nutrition) participate in an APM. The episode of care model puts the patient at the center of all activity related to their particular diagnosis, procedure, or health care event, rather than on a physician s specific services. The model is designed to engage specialists in the movement toward fee for value, while facilitating improved outcomes and patient experience and a reduction in unnecessary services and overall costs. It encourages and incents communication, collaboration, and coordination across the full continuum of care, and creates accountability for the patient s entire experience and outcome. This article outlines a collaborative approach involving multiple stakeholders for practices to assess their ability to participate in and implement an APM for gastroesophageal reflux disease (GERD), a condition commonly encountered by gastroenterologists and other physicians. How Retrospective and Prospective Payments Are Both Pathways to Value-Based Care The terms episodes of care and bundled payments are often used interchangeably when addressing value-based Abbreviations used in this paper: AGA, American Gastroenterological Association; APM, alternative payment model; BE, Barrett s esophagus; GERD, gastroesophageal reflux disease; GI, gastrointestinal; ICD, International Classification of Diseases; PPI, proton pump inhibitor. Most current article 2016 by the AGA Institute /$

2 1010 Vaezi et al Gastroenterology Vol. 150, No. 4 care. We are choosing to specifically refer to this APM for GERD as an episode of care because it is a quality-based and data-reporting program, not simply a payment model. In addition, this GERD model is retrospective in nature. Providers utilizing this model will not receive prospective bundled payments and, therefore, will bear limited financial risk; rather, costs within this model should be measured during the assessment period to determine whether financial thresholds have been met. In comparison, true bundled payments are typically prospective payments, which carry up-side and down-side risks to the providers. In a retrospective episode, providers are reimbursed on a fee-for-service basis, in accordance with their contracted rates; there is no risk of reduced revenue to the provider. A retrospective episode is an up-side only risk model that affords the rare opportunity for providers and payors to truly collaborate. Providers continue to receive fee-forservice payments and have the opportunity to share in additional savings if quality and/or cost metrics are met. The ultimate goal for provider organizations seeking to practice value-based care is to migrate to a prospective model, which would carry financial risk for the providers. In a prospective model, payment is made up front for all costs associated with the episode, and it is up to the providers to manage within that cost. If they do, they share in the savings, which represents enhanced revenue for the practice. If they do not, they risk a reduction in revenue. Clinicians who incorporate a GERD episode into their care paradigm are creating a fundamental change that can improve patient care processes and operationally and financially benefit the health care delivery system through the standardization of patient care protocols. Deviation from standardized processes and variation in treatment and monitoring methodologies decrease efficiencies, increase costs, and can result in varied patient outcomes. Such results are not beneficial to the health care delivery system, providers, purchasers, or patients. Treatment, management, and monitoring protocols should be evidence-based and applied in a consistent manner to the patient population. Decreasing variation in treatment and management and eliminating unnecessary services should result in measureable, improved outcomes at both the individual patient level and the population level. The development of a GERD episode, which causes the assumption of financial risk by physicians and hospital/ health systems, creates the incentive to standardize the treatment and management, which will drive more efficient patient care, resulting in substantial cost efficiency and improved patient outcomes. Because the care delivery and accountability expectations are the same in the retrospective as prospective models, the retrospective model is a perfect opportunity for providers and payors to dip their toes in the water and work together to determine how to successfully migrate to the prospective, risk-based fee-for-value world. It takes time for the transformations to take place on both the provider and payor side of the equation. Each brings something to the table, including the ability to identify opportunities for improvement, which can be more easily learned in a retrospective, no down-side risk model, and then migrated to a prospective model. The Centers for Medicare and Medicaid Services has chosen the retrospective model for the Comprehensive Care for Joint Replacement pilot for many of the reasons outlined here. Once the episode has been completed, a retrospective review is conducted against established quality, patient satisfaction, and financial metrics. If quality and patient experience metrics are met or exceeded, and the costs come in under budget, the provider shares in the savings. This retrospective model envisions that payors move from simply paying claims and establishing coverage policies to facilitating transformation by sharing data and employing clinical transformation coaches. These coaches work with physicians to assess and identify opportunities to improve the quality and efficiency of care through reviewing outcomes, types of services, costs of services, and practice workflows. Here, the specialist acts as the episode conductor who orchestrates care across the full continuum of services related to the specific diagnosis. The focus is on all services provided to the patient, not only the services delivered by the specialist. Considering that the specialist s cost is typically <25% of the total cost of most episodes, there is a significant opportunity to deliver value through managing and optimizing care and cost across the full health care continuum. The goal is to incent and encourage communication, coordination, and collaboration among all providers to improve outcomes and reduce duplication of services, overutilization, and cost. The retrospective model creates the framework for the payor and provider to work together and prepare for migration of risk and accountability in a prospective model. It ensures that physicians, facilities, payors, and managed care organizations collectively and collaboratively understand their new roles as value-based care becomes the norm. This is particularly important for conditions such as GERD, which are prevalent and life-intrusive in our population. Why Gastroesophageal Reflux Disease as Focus for Payment Reform GERD is a common clinical condition affecting 30% 40% of the US population, with an annual health care expenditure of $12 billion for GERD (defined by typical symptoms such as heartburn and regurgitation) and nearly $50 billion for those with suspected extra-esophageal reflux (chronic cough, asthma, throat symptoms presumed to be GERD-related). 4,5 The cost of treating GERD continues to grow, both in terms of financial resources and in terms of the impact on the quality of life for many patients. GERD provides health care stakeholders with an opportunity to demonstrate how value-based care can relieve the suffering of patients, as well as reduce costs to the health care system by reducing and/or eliminating unnecessary services that do not contribute to improving outcomes. During 2014 and 2015, the AGA convened a workgroup that included academic and community gastroenterologists, surgeons, pathologists, payors, hospital executives, and health policy experts to develop a retrospective episode

3 April 2016 Implementing an APM for GERD 1011 framework for selected services and procedures related to the diagnosis and treatment of GERD. Included in this GERD episode framework are patients with esophageal and extraesophageal syndromes, including those with Barrett s esophagus (BE) with or without dysplasia, but excluding BEassociated adenocarcinoma. The episode framework is not an AGA guideline, rather, it addresses medical as well as surgical options for the management of GERD based on published specialty society guidelines, recent data, and current practice The episode framework does not include the costs of complications requiring surgical intervention, based on the AGA s bundled payment framework for colonoscopy. 3 Framework for Development of an Episode Payment Model for Gastroesophageal Reflux Disease GERD is defined by the Montreal consensus as a condition that develops when the reflux of gastric content causes troublesome symptoms or complications. 4 The following symptom complexes are included: Typical reflux syndrome defined by the presence of troublesome heartburn and/or regurgitation. Patients might also have other symptoms, such as epigastric pain or sleep disturbance. Reflux chest pain syndrome defined as episodes of chest pain that resemble ischemic cardiac pain, without accompanying heartburn or regurgitation. Patients should have previously been determined to be at low risk for ischemic heart disease. Extra-esophageal syndromes with established associations with GERD, including the following with or without typical GERD symptoms: cough, asthma, chronic laryngitis/voice disturbance, and dental erosion. Extra-esophageal syndromes with proposed associations with GERD, including the following with or without typical GERD symptoms: pharyngitis, sinusitis, idiopathic pulmonary fibrosis, and recurrent otitis media. As defined within this framework, the GERD episode excludes pediatric patients (age younger than 18 years) and certain pre-existing conditions: Esophageal carcinoma Anatomic esophageal anomaly Esophageal motility disorders Multiple endocrine neoplasia type 1 or Zollinger-Ellison syndrome The workgroup identified and defined the following components of the framework: 1. Evaluation and nonprocedural services performed by the health care professional, including initial consultation and subsequent visits for the diagnosis and treatment of GERD, excluding procedural services. 2. Procedural services for the evaluation and management of patients with GERD, such as: Upper endoscopy Ambulatory esophageal ph monitoring Esophageal manometry Esophageal impedance monitoring Functional imaging Cytology and anatomic pathology In the presence of indications, 3 6 such as: Non- or partial response to an empiric trial of twicedaily proton pump inhibitor (PPI) therapy GERD symptoms accompanied by troublesome dysphagia Patients at high risk for BE Patients discovered to have BE Transoral or ablative endoscopic procedures or surgical fundoplication. Procedural services include all preprocedural preparations, such as scheduling, communication with the patient, and any required diagnostic studies, labs, or preprocedural antibiotics. Services provided by the health care professional after a procedure to evaluate immediate postprocedural complications are also included in this episode. Recommendations for Evaluation and Management of Gastroesophageal Reflux Disease Episode, and Proposed Metrics for Data Capture and Reporting of the Gastroesophageal Reflux Disease Episode Symptomatic Gastroesophageal Reflux Disease Patients with suspected GERD who present with typical or extra-esophageal symptoms without troublesome dysphagia and/or high-risk for BE should initially be counseled on lifestyle modification and placed on empiric antisecretory therapy unless limited by drug interactions and/or a reported allergy to these medications. Consistent with recommendations by multiple specialty societies, endoscopic evaluation is recommended only for those patients with troublesome dysphagia, those at high risk for BE, and those who do not respond within 4 8 weeks to a standard-dose PPI or the most aggressive antisecretory therapy that the patient can tolerate without adverse side effects Within the episode, ambulatory ph monitoring might need to be considered for those unresponsive or partially responsive to pharmacologic therapy and without abnormal findings on upper endoscopy, where the results of the study could lead to a change in patient management. Endoscopy performed solely for the confirmation of proper ph probe attachment is

4 1012 Vaezi et al Gastroenterology Vol. 150, No. 4 not warranted. When developing the episode, ambulatory ph monitoring, esophageal manometry, and/or impedance might need to be considered for evaluation of the patient, before consideration of transoral or surgical (open, laparoscopic) intervention for GERD. 6 Appropriate use of upper endoscopy for surveillance should be considered when developing the retrospective episode. As esophagitis and/or BE at endoscopy is present in the minority of patients (20% 30%) undergoing endoscopy, current specialty society recommendations suggest that repeat endoscopy is indicated only in those with BE or those with high-grade (grades C or D) esophagitis to confirm the absence of BE Proposed Data Capture and Reporting Metrics for Patients With Symptomatic Gastroesophageal Reflux Disease These proposed data capture and reporting metrics were identified by the workgroup as potential measures for physicians to consider when developing a value-based framework for patients with GERD. The physician is encouraged to use these metrics as a starting point for assessing their current practice, and can choose to use all, some, or none when identifying the metrics they will be held accountable to within the GERD episode of care framework. What percentage of patients with GERD and without dysphagia or risk factors for BE have been empirically treated with PPI? After symptom control is achieved, what percentage of patients with GERD have been tapered to the minimal dosage required to control symptoms? What percentage of patients with suspected reflux chest pain syndrome have been evaluated for ischemic heart disease before initiating GERD therapy? What percentage of patients have undergone endoscopy to evaluate GERD without documentation of antisecretory treatment failure and/or dysphagia and/or risk factors for BE? What percentage of patients with GERD and a reflux stricture, BE, esophageal carcinoma, or esophagitis in an immunocompromised patient, or severe/proximal esophagitis (Los Angeles class C D) have undergone esophageal biopsy? What percentage of patients have undergone ambulatory ph monitoring to evaluate GERD without an empiric trial of antisecretory therapy and normal findings at endoscopy? What percentage of patients with Los Angeles class C or Dreflux esophagitis found at endoscopy have undergone repeat endoscopy looking for evidence of BE, and when? What percentage of patients determined not to have GERD by endoscopy with/without ambulatory ph monitoring have had their PPI therapy stopped? Nondysplastic Barrett s Esophagus Patients older than 50 years with chronic GERD symptoms of longer than 5 years duration, nocturnal reflux symptoms, hiatal hernia, elevated body mass index, tobacco use, intra-abdominal distribution of fat, and family history of esophageal cancer, are at the highest risk for BE and esophageal adenocarcinoma. 6,7 Specialty society recommendations suggest that screening for BE in these patients can be considered; screening for BE in asymptomatic patients is not recommended. BE can be present in up to 5% to 15% of high-risk patients undergoing upper endoscopy. The length of BE can predict the risk of progression to dysplasia or cancer. The Prague classification is a validated, descriptive system that describes both the maximal extent and circumference of the BE. 15 The maximal extent of the BE is defined as the distance from the top of the gastric folds to the most proximal extent of the circumferential involvement of the BE. BE is defined pathologically as the presence of specialized or intestinal epithelium with goblet cells in the tubular esophagus. 7 Only patients with these findings are deemed to be candidates for surveillance protocols. Recent data suggest that patients with intestinalized metaplasia of the esophagus are at a 5-fold increased risk for progression to high-grade dysplasia or cancer compared with those with columnar-lined esophagus without goblet cells. A definitive diagnosis requires pathology confirmation. Although the optimal number of biopsy specimens has not been defined, a common protocol is to obtain 4-quadrant biopsies every 1 2 cm throughout the length of the BE tissue 7 ; alternative methods for assessment, such as cytology brushing with immunohistochemical analysis or optical endomicroscopy, can also be considered. Literature suggests that the ability to detect dysplasia is reduced if fewer biopsy specimens than those suggested by the 4-quadrant protocol are obtained. Several authors have suggested that esophageal biopsy specimens obtained at one level should be submitted in one bottle; biopsy specimens should be submitted in separate bottles when obtained from different sites in patients with BE. Formalin fixation is standard and allows for molecular testing as well as routine H&E-stained slides. Most laboratories prepare 2 H&E-stained sections, usually with several levels of tissue on each slide; routine H&E stains without other special stains are adequate for high-quality evaluation of biopsies. The routine use of multiple special or immunohistochemical stains at the time of initial review is not needed to identify goblet cells. In some instances, detection of goblet cells can be enhanced by using Alcian blue staining, but such staining also marks cells that are not, in fact, goblet cells. While MUC antigens, Das-1, Cdx-2, Hepar-1, CD10, and other immunohistochemical stains have been touted as helpful in confirming Barrett mucosa (with goblet cells using US criteria), none of these markers have been shown to be sufficiently specific, or reproducible, to be of use in routine clinical practice, which should be considered by the physician when performing a retrospective analysis of practice patterns before entering into a value-based retrospective contract for GERD.

5 April 2016 Implementing an APM for GERD 1013 Data Capture and Reporting for Nondysplatic Barrett s Esophagus These proposed data capture and reporting metrics were identified by the workgroup as potential measures for physicians to consider when developing a value-based framework for patients with GERD. The physician is encouraged to use these metrics as a starting point for assessing their current practice, and can choose to use all, some, or none when identifying the metrics they will be held accountable to within the GERD episode of care framework. What percentage of patients with BE have been appropriately measured? What percentage of patients with nondysplastic BE eligible for PPI therapy are on PPI therapy? What percentage of patients with suspected BE have had biopsy specimens obtained? Dysplastic Barrett s Esophagus Dysplasia within intestinal metaplasia in BE is a histologic feature identified from biopsies obtained at an index or subsequent surveillance endoscopies. Specialty society recommendations note that dysplasia should be confirmed by another pathologist, preferably one with expertise in GI pathology. The routine use of special stains is not indicated. 7 When there is active inflammation noted during endoscopy, it is suggested that esophagitis first be treated with adequate PPI therapy for 6 8 weeks, and then endoscopy with repeat biopsies be performed. Indefinite dysplasia is a term used when unable to confirm dysplasia (usually low grade) vs reactive inflammation. If dysplasia is not confirmed by second opinion, the patient has nondysplastic BE. Based on histopathology features, confirmed dysplasia is categorized into either low-grade (LGD) or highgrade dysplasia (HGD), which have escalating predilection toward esophageal adenocarcinoma. In contrast to the surveillance recommendations for nondysplastic BE, for dysplastic BE, 4-quadrant biopsies should be taken at every 1 cm, with all specimens at one level submitted in one bottle. In addition, any raised nodule or other mucosal irregularities, enhanced with white-light endoscopy and narrow band imaging or optical endomicroscopy, should be targeted with biopsies and sent in a separate container. The routine use of multiple special or immunohistochemical stains is not needed to identify goblet cells. At present, specialty societies recommend endoscopic surveillance of LGD mucosa every 12 months, with anatomic pathology, with the patient on adequate PPI acid-control therapy. Intensive endoscopic surveillance of HGD mucosa is recommended every 3 6 months, with anatomic pathology, with the patient on adequate PPI acid-control therapy. 7 As current specialty society guidelines do not recommend a definitive surveillance interval for those with LGD and HGD, 7 the implications of more frequent surveillance will need to be taken into consideration within a retrospective episode care model. Ablative therapies, such as radiofrequency ablation. can represent an alternative option to endoscopic surveillance. 7 Radiofrequency ablation has demonstrated successful eradication of LGD in >90% of cases, and successful eradication of HGD in 70% 80% of cases. 11,12 Incorporating the management of patients with BE with HGD, or carcinoma in situ, one step from invasive cancer, into an episode can be challenging, as there are a number of therapeutic options with a lack of clear recommendations. 7 Those who are good operative candidates have traditionally been offered surgical resection because of the high risk that adenocarcinoma is already present or will soon develop. However, progression to adenocarcinoma is not universal, suggesting that an intensive surveillance program might be sufficient for some patients. In addition, esophagectomy is associated with significant short- and long-term morbidity and a 3% 13% rate of surgical mortality, depending on surgical expertise and hospital volume. Over the past decade, the volume of patients undergoing endoscopic treatment for HGD has increased in comparison with esophagectomy. 32 The use of endoscopic ablative and respective modalities is based on the observation that the destruction of intestinal metaplasia using chemical and thermal methods might be accompanied by regrowth of normal-appearing squamous epithelium, particularly if the patients are treated with PPI to keep them achlorhydric. Endoscopic resective therapies for HGD include endoscopic mucosal resection and endoscopic submucosal dissection; these procedures allow for the endoscopic removal of en bloc sections and raised nodules, which allows for staging. The current literature on long-term outcomes with cryotherapy for dysplastic BE is inadequate to make a recommendation for or against including this modality within the episode. 7 Data on photodynamic therapy suggests that allcause mortality is similar to surgery for dysplastic BE; the stricture rate appears higher, and rates of complete reversion to neosquamous epithelium are lower than that of radiofrequency ablation, although definitive comparisons are lacking. The use of radiofrequency energy delivered to the tissues of the distal lower esophageal sphincter and gastric cardia for patients with BE is not routinely recommended. 7,31 Esophagectomy is an alternative for the management of HGD when endoscopic therapies are not available, or if there is evidence of invasive cancer. Ablative and resective endoscopic treatments are more likely to be performed at referral centers where physicians have expertise in interventional endoscopy. These therapies might require overnight observation, as they are associated with complications of chest pain, bleeding, stricture, and perforation, some of which require surgery. Data Capture and Reporting for Dysplastic Barrett s Esophagus These proposed data capture and reporting metrics were identified by the workgroup as potential measures for physicians to consider when developing a value-based framework for patients with GERD. The physician is encouraged to use these metrics as a starting point for assessing their current practice, and can choose to use all,

6 1014 Vaezi et al Gastroenterology Vol. 150, No. 4 some, or none when identifying the metrics they will be held accountable to within the GERD episode of care framework. What percentage of BE patients with dysplasia have had the diagnosis confirmed by another pathologist, preferably an expert in esophageal histopathology? What percentage of BE patients received a repeat upper endoscopy with biopsies after 12 weeks of adequate PPI acid-control therapy if pathology is indefinite, LGD or HGD, and endoscopic or histologic sign of inflammation? What percentage of patients with known or suspected dysplastic BE underwent white-light endoscopy, with 4-quadrant biopsies every 1 cm of Barrett s mucosa, and any mucosal irregularities (ie, nodule) biopsied separately? Anti-Reflux Surgical and Endoscopic Interventions Most patients with GERD can be managed nonoperatively with pharmacologic therapy. 6 Advancements in endoscopic and laparoscopic surgery have expanded the options for patients with GERD who are referred for surgical/endoscopic intervention. 10 Surgical/endoscopic intervention is rarely a first-line therapy, and the cornerstone of treatment is PPI therapy. 6,10 When developing the retrospective analysis, it is important to note that surgical or endoscopic intervention is entertained only after considerable initial evaluation and therapy by primary care and specialty physicians. Patients might be referred to the experienced surgeon or gastroenterologist for consideration of surgical or endoscopic intervention. Indications for anti-reflux procedures are well established. Specialty society recommendations include anti-reflux procedures as an alternative when a patient with esophageal GERD syndrome is responsive to, but intolerant of, acid-suppressive therapy. 6 Anti-reflux surgery is also recommended with fair evidence in patients with an esophageal GERD syndrome with persistent troublesome symptoms, especially troublesome regurgitation, despite PPI therapy. The AGA, 6 Society of American Gastrointestinal and Endoscopic Surgeons, 33 and the American College of Gasteroenterology 10 have published indications for surgery that are incorporated into the episode recommendations. When a patient is referred for surgical/endoscopic intervention, the physician should take a thorough history and perform a physical examination to determine if the patient would benefit from a surgical or endoscopic antireflux procedure. Any need for additional diagnostic testing will be assessed at this time. The interventional physician should document pathologic acid exposure in the esophagus and define the pathology through the use of esophageal ph studies, esophageal manometry, barium radiographs, and upper endoscopy. Conditions to be excluded before consideration for anti-reflux intervention include diagnoses where symptom overlap exists with GERD, but GERD is not the underlying etiology; these conditions include achalasia, gastroparesis, eosinophilic esophagitis, functional dyspepsia, functional heartburn, rumination, and aerophagia. Preoperative esophageal manometry defines diagnosis that would contraindicate surgery (achalasia) and modify the type of fundoplication if abnormal esophageal motility is determined. Esophageal ph testing is needed when the diagnosis cannot be confirmed on EGD (lack of esophagitis). Barium swallow might be necessary to define anatomy in patients suspected of having a large hiatal hernia and short esophagus. The interventional physician should thoroughly document other medical problems that will alter the performance of the anti-reflux procedure (gastroparesis, morbid obesity, gastrinoma, achalasia, and scleroderma) and define the patients disease process. It is only with this thorough knowledge of an individual s unique anatomy, pathology, physiology, and confounding medical factors can the surgeon determine whether the patient will benefit from surgery and what surgical/endoscopic options best suit the individual patient. In patients with small to absent hiatal hernias, multi-year randomized, controlled trial data suggest that anti-reflux procedures, such as transoral endoscopic fundoplication and laparoscopic magnetic sphincter augmentation, might be considered in patients who fulfill the indications. Severely obese patients contemplating surgical therapy for GERD should be considered for bariatric surgery, where laparoscopic Roux-en-Y gastric bypass would be the preferred operation for these patients. Recent studies show that endoscopic procedures, such as transoral fundoplication, are safe and effective for treatment of patients with a hiatal hernia of 2 cm in length who have symptomatic regurgitation while taking a PPI. 23 The use of radiofrequency energy delivered to the tissues of the distal lower esophageal sphincter and gastric cardia for the management of patients with GERD is controversial; a recent meta-analysis of trials found that this therapy does not produce significant changes in physiologic parameters compared with sham therapy, including time spent at a ph <4, LESP, ability to stop PPIs, or health-related quality of life. 31 Advantages of endoscopic procedures are the minimally invasive nature of the procedures, with reduced risk of complications and troublesome side effects, such as gas bloat, dysphagia, and diarrhea, which can plague some patients after laparoscopic fundoplication. While the mainstay of surgical therapy for GERD is the laparoscopic fundoplication with hiatal hernia repair, an alternative procedure is the laparoscopic implantation of a ring of magnetic beads around the lower esophagus to augment the lower esophageal sphincter. 24,25 One-, 3-, and 5-year results show that patients had significantly reduced esophageal acid exposure, improvement in GERD-related quality of life, and significant reduction in use of PPIs. Dysphagia was common in the first few months after implantation, but present in only 4% of patients at 3 years. Operative anti-reflux procedures for GERD are most commonly performed laparoscopically, with a <24-hour hospital stay. Patients are discharged on a soft diet taking oral pain medications, and return at 2 6 weeks post operation for routine follow-up care. Open surgical techniques are

7 April 2016 Implementing an APM for GERD 1015 no longer the standard of care for surgical treatment of GERD, and they are not cost-effective compared with the minimally invasive transoral and laparoscopic fundoplication procedures. As surgical outcomes have been shown to be heavily dependent on surgical skill, the physician referring patients for surgical or endoscopic intervention should select a skilled, experienced surgeon or gastroenterologist. Cost savings and enhanced patient experience with fewer shortand long-term complications can be affected by tailoring the surgical and endoscopic procedures to the patients specific disease and anatomic considerations. Reductions in complications and in hospitalization through a shift to laparoscopic and endoscopic anti-reflux procedures will also reduce the overall cost of care. Data Capture and Reporting for Anti-Reflux Surgical and Endoscopic Interventions These proposed data capture and reporting metrics were identified by the workgroup as potential measures for physicians to consider when developing a value-based framework for patients with GERD. The physician is encouraged to use these metrics as a starting point for assessing their current practice, and can choose to use all, some, or none when identifying the metrics they will be held accountable to within the GERD episode of care framework. What percentage of patients who are undergoing surgery have had prior testing with esophageal ph monitoring, manometry, and endoscopy? What percentage of patients who undergo endoscopic anti-reflex procedures are discharged within 24 hours? What percentage of patients who undergo undergo laparoscopic anti-reflux procedures are discharged within 24 hours? What percentage of patients who undergo laparoscopic or endoscopic anti-reflux procedures develop serious complications, including wound infection, bleeding requiring transfusion, or pneumothorax? What percentage of patients who undergo laparoscopic or endoscopic anti-reflux procedures need esophageal dilation? What percentage of patients who undergo laparoscopic or endoscopic anti-reflux procedures report satisfaction with surgery or endoscopic treatment (would do it again) at 3 months post operation? Opportunities to Improve Care and Deliver Value In a value-based environment, ways to improve care and deliver value include following evidence-based best practices for the management of the patient; avoiding unnecessary tests, therapeutics, and/or procedures that do not improve care; and avoiding errors, hospitalizations, and other process failures that cause patients to incur unnecessary services and harm. The systematic development of an episode of care encourages the physician, hospital, and other health care professionals involved in the care of the patient to take a systematic look at what works and what does not in the management of the patient with that condition. Within this episode, there are a number of inflection points where the physician, in conjunction with the patient, can assess the benefits and risks of proceeding with a diagnostic or therapeutic intervention. The physician should address the following questions to determine what services might be unnecessary, wasteful, or inappropriate for the patient s particular condition. Has the patient been compliant with a trial of lifestyle modification and pharmaceutical intervention before proceeding with endoscopic evaluation? Do the patient s findings on endoscopy warrant additional diagnostic testing? If follow-up endoscopic surveillance is warranted, when should it be performed? Where can the services be performed in the most costefficient manner that does not pose a risk or harm to the patient (eg, hospital, ambulatory surgery center, office)? If a therapeutic intervention (transoral, laparoscopic, or open) is indicated, is the service being performed by a physician at a center that has experience and expertise with the service? Is this service necessary? These questions (and others) should be addressed by the physician into the prospective development of the care pathway for the patient, and the retrospective calculation of the cost of the episode by the provider and payor. In addition to the risks and benefits associated with therapeutic interventions and procedures, the physician will need to consider potentially avoidable complications, as these can have a significant impact on the financial assessment of the success of the providers in managing the episode. Hospitalizations and emergency room visits (and associated professional services, ancillary services, and pharmacy costs) are deemed potentially avoidable if they are due to acute exacerbations of the anchor condition; acute exacerbations of the patient s comorbid conditions; and patient safety failures, such as major infections, deep vein thrombosis, adverse drug events. 29 The gastroenterologist or surgeon who evaluates the patient with GERD needs to shift their focus from the orifice to comprehensive management of the patient, collaborating with other members of the care team to deliver person-centered, not just disease-specific, care. What Does an Episode Payment Model Look Like in Practice? Episodes of care include all of the care related to a defined medical event (eg, a procedure, an acute exacerbation of a chronic condition), including the care for the event itself (eg, procedures, professional claims, pharmacy), any

8 1016 Vaezi et al Gastroenterology Vol. 150, No. 4 precursors to the event (ie, diagnostic tests, preoperative visits), and follow-up care (eg, follow-up visits, medications, readmissions). They are built from the perspective of a patient journey through the health system, providing a more comprehensive view of care involved in treating a condition for a patient. For the GERD episode, the accountable provider primary care physician, gastroenterologist, or surgeon is held accountable for both the quality and cost of care delivered to the patient for the episode that they are responsible for. Episodes include relevant claims for care around a specific trigger event that defines an episode (ie, endoscopy for GERD). This includes all the claims generated during the actual trigger event, specific types of claims related to the trigger event that occur beforehand in the pretrigger window, and any follow-up care that occurs in a post-trigger window. Costs included in the post-trigger window can include planned care (ie, post-discharge follow-up visits, medications), or care resulting from complications in the episode (ie, readmissions). Types of costs included are professional claims, procedures (inpatient or outpatient), labs and imaging (inpatient or outpatient), rehabilitation or long-term care, and pharmacy. Under the retrospective episode payment model, providers are still paid at their contracted fee-for-service rates the way they are today, but they are held to a greater level of accountability for the cost of care that they deliver. The gain and risk-sharing incentives encourage physicians to coordinate with other providers to ensure that the care a patient receives is appropriate and of high quality. Providers continue to have the same administrative and financial relationships with payors as before, but the payments are structured to better align incentives to promote high-quality and efficient care. How Should a Physician Implement a Retrospective Episode Payment for Gastroesophageal Reflux Disease? Upside-Only Risk The first phase of episode payment implementation is upside-only risk. This means that if a given physician practice achieves savings compared with a predetermined benchmark (based on an examination of the practice s historic claims data), the practice and the payor share in the savings. Should the practice perform at or over budget, they will not be required to cover the loss. To begin implementing this phase, physician practices should examine the medical records of past GERD patients by looking them up by the relevant International Classification of Diseases (ICD)-9/ICD-codes in their practice management or billing system. Physicians are encouraged to crossreference these medical records with established clinical practice guidelines and the GERD care pathway accompanying this article with suggestions for procedures and tests to avoid. It is essential that providers identify opportunities to deliver higher-quality, more cost- and resource-effective care for patients with GERD before proceeding. Then, physician practices should examine their market and decide if piloting an APM will help gain or maintain patient business. Most practices will benefit from proving to payors and referring providers that they can provide higherquality, lower-cost care than their competitors. From there, the physician practice should approach a local payor or riskbearing provider organization to initiate discussions about piloting a retrospective model. In a retrospective model, all providers will continue to provide care, bill payors, and receive reimbursement as they do today. Based on an examination of the practice s historic claims data, the payor will calculate an average cost per case that provider s GERD patients will be measured against to determine savings. During the episode, the payor will identify the accountable provider and calculate the episode cost and performance against select quality targets. Initially, performance data should be shared with providers for information only, accompanied by a collaborative discussion to identify opportunities to improve care. The episode model incents providers by rewarding them with gain-sharing payments if actual costs for an episode within a defined time period fall below a predetermined threshold, providing quality and patient experience metrics are met. Up-Side and Down-Side Risk After a 12- to 36-month reporting period, the payment model might transition to a performance period that incorporates gain sharing for providers who, on average, have lower costs and meet data thresholds across their episodes. Providers whose average episode spending is above a predetermined high-cost threshold will be held responsible for this cost by paying back a portion of the excess cost. Throughout the episode, the payor should provide their physician partners with quarterly reports informing them of their cost and data performance relative to other providers, and highlighting areas for improvement. In this way, providers have a chance to improve their performance before gain and risk sharing begins. How Would a Payor Implement This Episode Payment Model? After an initial discussion with provider partners and a shared decision to move forward with piloting an episode payment model for GERD, the payor, in conjunction with its physician partners, will need to define a clinical algorithm and criteria outlining which patients/members qualify, which services are included, and the episode length. The provider organization is then responsible for identifying qualifying patients (based on their ICD-9 or ICD-10 codes) and identifying day 1 of each patient s episode. For payors to most easily implement the bundle, they could run all claims data (not just services related to GERD) for identified patients throughout the episode time period to build a case-mix adjusted, practice-level budget. When the budget is calculated this way, all members have the same target for a practice s episode (because it is not a

9 April 2016 Implementing an APM for GERD 1017 patient-level, risk-adjusted budget), which accounts for services related to and unrelated to the management of GERD. Payors with more sophisticated abilities can report on the agreed-upon included services only. In either case, however, the payor should build in outlier protection for medically catastrophic cases and should recalculate the budget if there are any significant changes in the episode continuum (eg, new providers enter the practice). To determine quality targets for the episode, payor and provider partners should examine the list of suggested areas for data capture and reporting outlined in this article to develop a mutually agreed upon list of metrics. Payors and providers will share in savings only if the agreed upon quality targets are met or exceeded. Shared savings are calculated by running the aggregated actual costs for the episodes in the measurement period against the aggregated budgeted costs for the period, using the same methodology they used to create the budgets. Similar to the way that this type of retrospective model does not interrupt a physician practice s patient, administrative, or financial relationships, this arrangement also allows payors to continue doing business in the same way they have been with very little risk involved. Conclusions The year 2016 marks a watershed year in the transformation from volume to value, as the purchasing of health care continues to move from a business-to-business to a business-to-consumer model. Developing familiarity with retrospective payment models with a common diagnosis such as GERD which afflicts a large number of patients, and has significant opportunity to improve outcomes and reduce services presents an opportunity for gastroenterology practices to transform their practices to ensure they are seen by purchasers and consumers as delivering highvalue, high-quality care. References 1. Centers for Medicare and Medicaid Services. National health expenditure data: historical. Available at: gov/research-statistics-data-and-systems/statistics- Trends-and-Reports/NationalHealthExpendData/National HealthAccountsHistorical.html. Published December 9, Accessed March Mataloni, L, Aversa J. Gross domestic product: first quarter 2015 (advance estimate). Bureau of Economic Analysis, US Department of Commerce. Available at: gdp1q15_adv.pdf. Published April 29, Accessed March Brill JV, Jain R, Margolis PS, et al. 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