Itemized Billing and Procedure Description for the AspireAssist

Transcription

1 Itemized Billing and Procedure Description for the AspireAssist The following describes the recommended therapy course for the first year for a patient undergoing AspireAssist therapy. Although providers generally follow these recommendations, providers may of course adjust the therapy to provide the optimal patient care in their professional opinions. The AspireAssist is a minimally invasive FDA-approved device (P ) for the treatment of morbid obesity and is an alternative to bariatric surgery. The AspireAssist is intended for adults who are at least 22 years old, with a Body Mass Index (BMI) of kg/m 2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The AspireAssist consists of the A-Tube, a percutaneous gastrostomy tube customized for efficient aspiration of gastric contents and an external device to facilitate drainage. The AspireAssist is intended for long-term use in conjunction with lifestyle therapy, to help patients develop healthier eating habits and reduce caloric intake, and continuous medical monitoring. The device is intended to be used three times per day after each major meal, and drains approximately 30% of each meal, allowing the remainder of the meal to be absorbed normally. 1. Initial consultation (typically 30 minutes). This consultation includes a full medical history and physical, including a metabolic panel, comorbidities, medications, weight and diet history, and any psychological disorder presently being treated or treated in the past. There is also a discussion on the patient s health goals and reasons for wanting a weight loss procedure. The consultation also included an explanation of AspireAssist procedure, including weight loss results, potential side effects, patient s responsibilities, and alternative therapies. 2. Gastrostomy (placement of A-Tube) includes typically the following items: a. Upper gastrointestinal endoscopy including visualization of esophagus, stomach, and duodenum assessing for abnormalities that would preclude safe placement of device; with directed placement of the AspireAssist A-Tube. Please note the following difference from placement of a conventional PEG tube: i. As the placement is performed on a patient with obesity (with associated comorbidities) the patient s abdominal tissue was substantially thicker than that of a normal-bmi patient, making transillumination more challenging than in a conventional PEG tube placement [and hence, requiring repositioning of the patient to achieve adequate transillumination to assist with safer access of the introducer needle]. Additionally, the oral airways in patients with obesity can be more compromised due to the risk of difficult intubations, and higher incidence of sleep apnea. Both factors may add to the procedure time. ii. Although conventional PEG tubes are sometimes placed with only one physician, the substantially larger abdomen and higher ASA classification (compared to a typical PEG tube placement) often requires two practitioners for placement: one to manage the endoscope and one to prepare the abdomen and manage the A- Tube placement.

2 iii. To ensure accurate placement, a repeat endoscopy is performed to confirm that the distal end of AspireAssist A-Tube is lying in the fundus region of the stomach and the internal bolster is against the stomach wall. iv. Placement of the external bolster on the AspireAssist A-Tube is more involved than placement of the external bolster on a conventional PEG tube. The distance from the stomach wall to the stoma is highly variable in a patient with obesity, depending upon whether the patient is lying down or sitting up. Careful placement is required to prevent complications such as a buried bumper. This procedure utilizes (i) a standard pull PEG kit, where all items of the PEG kit are utilized except the gastrostomy tube, and (ii) the AspireAssist A-Tube Kit, a specialized gastrostomy tube. v. CPT Code is available for use with this procedure. The May 2017 White Paper from the American Gastroenterological Association: An Episode-of-Care Framework for the Management of Obesity published in Clinical Gastroenterology and Hepatology 2017; 15: describes coding for the AspireAssist procedure. Endoscopic placement of a percutaneous gastrostomytype device for the management of obesity should be reported by using code (Esophagogastroduodenoscopy, flexible, transoral; with directed placement of percutaneous gastrostomy tube). b. Facility Fee associated with gastrostomy (see 2a above). c. Anesthesia. Administration of Propofol is typical; however, sometimes, depending on the patient s comorbidities and ASA classification, the patient is intubated for the A-Tube placement procedure to maintain the airway. d. Post-procedure instructions. Whereas conventional PEG tube placements are typically done on an in-patient basis, the patient is typically discharged to home the same day. Discharge instructions are given, focusing on self-care of wound care, pain control and signs and symptoms of potential complications. 3. Office visit for placement of Skin-Port. Patients typically return to the clinic 7 to 10 days post gastrostomy for Skin-Port attachment. The duration of this visit is typically 30 minutes. The AspireAssist Skin-Port is a low-profile button-valve that is placed on the external end of the A- Tube, which is cut so that the Skin-Port is 5-10 mm from the abdominal skin when the patient is in a sitting position. The AspireAssist Skin-Port Installation Tool Kit facilitates placement of the A- Tube. 4. Office visit for teaching AspireAssist Therapy. The duration of this visit is typically 60 minutes. In this visit, the patient is instructed on the need to chew thoroughly to have a successful aspiration, as well as on how to use the AspireAssist device. The patient is then given a small meal and asked to perform an aspiration (draining procedure) to verify his or her comprehension of device

3 function. At the end of the visit, the patient is given the AspireAssist First Year Kit, excluding the extra Connectors, the extra Skin-Port, and Skin-Port Installation Tool Kit which are kept at the clinic. 5. Follow-up office visits. A minimum of 6 follow-up visits are recommended for the first year, with an average length of ~45 minutes. If a patient needs more visits, most providers will allow additional visits free of charge. These office visits are of paramount importance for safe use of the device, as well for long-term effectiveness of the therapy. The AspireAssist is a tool that assists the patient in losing weight, but long-term success is maximized when patients make substantial changes in their lifestyles. In these visits: a. Vital signs/ updated history. The patient is weighed and vital signs are taken. The patient is also asked if there are any changes to medications since the last visit and if there are any problems or issues. b. Review of blood work. The following serum laboratory values should be checked regularly, particularly potassium. Aspiration of stomach fluids could cause hypokalemia, primarily due to renal potassium excretion. The following tests should be performed and monitored: i. Electrolyte Panel: Sodium, Potassium, Chloride (quarterly). Some patients, particularly those taking diuretics, may require additional electrolyte monitoring at the physician s discretion. Monitoring blood potassium concentration regularly is critical for medical safety of the patient particularly in patients who are prescribed diuretic therapy. If treatment is required, Aspire s Clinician Guide provides suggested care. ii. Complete Blood Count (CBC): hemoglobin, hematocrit, red blood cell count, white blood cell count and differential, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count (semi-annually and as deemed necessary based on medical history). iii. Complete Metabolic Panel (CMP): glucose, calcium, sodium, potassium, chloride, BUN, creatinine, albumin, total protein, alkaline phosphatase, ALT, AST, bilirubin and magnesium (semi-annually and as deemed necessary based on medical history). c. Stomal site check. Assess peristomal region. Review care and treat abnormalities such as granulation tissue, as needed. d. Shortening A-Tube. The A-Tube requires shortening after weight loss (and concomitant reduction in abdominal thickness). This procedure is painless and involves removing the

4 Skin-Port, cleaning the Skin-Port, cutting the A-Tube so that the Skin-Port will be approximately flush with the skin when reattached, and reattaching the Skin-Port on the A-Tube. Most patients will have their A-Tubes shortened around 6 times in the first year. e. Counselling of patient. The AspireAssist Connector allows for 115 uses before disabling. The Connector is checked at each visit to determine the number of times the patient has aspirated since the last visit. Additional Connectors are not distributed until after counts are assessed. If a patient s weight loss is less than anticipated, providers investigate with the patient why his or her weight loss is less than anticipated (inadequate chewing, infrequent aspirations, difficulty aspirating, excessive consumption of high caloric beverages, etc.) and work with the patient to develop solutions. Similarly, if a patient s weight loss is greater than anticipated, providers may suggest the patient reduce their frequency of aspirations or even opt not to give them another Connector at that visit. 6. Lifestyle Counseling. There are typically 10 Lifestyle Counselling sessions in the first year. Out of convenience to the patient, Lifestyle Counselling appointments are typically scheduled adjacent to standard visits. The goal of AspireAssist Therapy is for patients to reach their weight loss goals and be able to maintain their weight loss in the long-term, with or without use of the device. To achieve these goals, patients need to make significant improvements in their lifestyles. Topics during counselling sessions include developing specific and achievable goals, limiting portion sizes, reading and understanding food labels, making healthy food choices, understanding one s triggers for overeating and developing strategies to avoid these triggers, strategies to avoid overeating in restaurants, and developing an exercise program. Lifestyle therapy is an important part of AspireAssist Therapy. 7. AspireAssist System. The AspireAssist System consists of the following items: a. The AspireAssist A-Tube Kit (1) is a percutaneous gastrostomy tube customized for AspireAssist Therapy. The standard purchase price of the A-Tube Kit is $1,815. The A-Tube consists of three parts: an intragastric portion, an extragastric portion, and a leader portion. The intragastric portion of the A-Tube differs from a conventional PEG tube in that the intragastric portion includes a 15-cm 29-Fr/6mm ID fenestrated tube, in addition to the standard internal bumper. The internal end of the tube sits in the fundus and is necessary for successful aspiration. The wall thickness of this intragastric portion must be considerably thicker than a conventional PEG tube to prevent buckling. The extragastric portion of the A-Tube, a 25-cm 26-Fr/ 6 mm ID tube, has a larger inner diameter to accommodate efficient aspiration of gastric contents and a longer length than a conventional PEG to accommodate the wider abdomens of morbidly obese patients. The leader portion of the A-Tube is not significantly different from a conventional PEG. It contains a 52-cm long silicone leader, a dilator, and wire loop. After the A-Tube is placed, the leader portion is cut off and the external bolster is placed (see Paragraph 2.a.iv) b. The AspireAssist First Year Kit, consisting of all items needed for AspireAssist Therapy for the first year of use. The standard purchase price of the First Year Kit is $2,569. The components of the AspireAssist include the following:

5 Items that go home with patient i. AspireAssist Companion (1). An external device to facilitate aspiration that has two modes: drainage and irrigation. When the patient releases the drain-tube clamp ii. AspireAssist Tubing Set (2). The Tubing Sets attaches to the Companion, but is removable for easy cleaning. It contains two separate tubes: a drain tube that drains gastric contents into a toilet and another tube that connects to the Connector. iii. AspireAssist Reservoirs (5). The reservoirs hold approximately 0.75 liters of tap water, and is used to irrigate the system and clear the system of debris. iv. AspireAssist Carry Bag. This bag holds all items the patient needs to aspirate. v. Emergency Clamp. This clips to the A-Tube and is to be used by the patient in the event the Skin-Port becomes detached from the A-Tube. It prevents the A-Tube from falling into the stomach and also clamps off the A-Tube to prevent leakage of gastric contents until the physician is seen. vi. AspireAssist Users Manual (1) is a reference guide for patients. vii. AspireAssist Skin-Port (1 of 2). A low profile button valve ; it s designed so that it s normally closed, except when the Connector is attached for aspirations. Items that remain at the clinic viii. AspireAssist Skin-Port (1 of 2). Spare Skin-Port is provided for use in the event of a malfunction or excessive buildup of food particles within the Skin-Port. ix. AspireAssist Skin-Port Installation Tool Kit. Used to cut the A-Tube and place the Skin-Port. x. Clinician Guide (1) xi. AspireAssist Connectors (10). A device to open the Skin-Port when it engages with the Skin-Port allowing the patient to drain a portion of their ingested meal. It contains a counter that counts down by one count every time it engages with the Skin-Port. Each Connector allows for 115 counts, corresponding to 5-6 weeks of use. Once the Connector reaches 0 counts, it no longer can engage and hence open the Skin-Port, requiring the patient to return to the clinic to obtain a new Connector. The Connector, in essence, requires the patient to remain under the management of his or her doctor if he/she wishes to continue aspiration. The Connectors are typically kept at the physician s office and distributed to the patient as needed. As described above, AspireAssist Therapy requires substantially greater amount of professional time and material beyond a conventional PEG-tube gastrostomy from initial consult, to the actual gastrostomy procedure, to the ongoing patient evaluation and management to all the component parts of the AspireAssist.