Effectiveness of Bariatric Surgery in Type 2 Diabetes Mellitus Patients - Research Paper Example

EFFECTIVENESS OF BARIATRIC SURGERY IN TYPE 2 DIABETES MELLITUS PATIENTS Introduction Diabetes is a metabolic disorder characterized by absence of insulin, or presence of insulin but not functional to meet the metabolic pathways of the physiologic requirements of the body. Diabetes has been broadly classified into type 1 diabetes mellitus (insulin dependent) and type 2 diabetes mellitus (non- insulin dependent). Type 1 diabetes mellitus mostly occurs in young age, and is present in individuals with lean bodies. In contrast, type 2 diabetes mellitus is associated with elderly individuals and those with a BMI>40kg/m2. Type 2 diabetes mellitus accounts the larger proportion of diabetic cases (90-95%) and is exemplified by insulin resistance, while type 1 diabetes mellitus stems from immune mediated destruction of beta cells that are responsible for the production of insulin, and accounts for 5-10% of all diabetic cases (CMS, 2009). This therefore necessitates the need to emulate the National Coverage Analyses (NCA) as stipulated by Centers for Medicare and Medicaid Society (CMS) in a National Coverage Determination paper. This is in bid to assess the effectiveness of bariatric surgery in type 2 diabetes mellitus patients. Bariatric Surgery Overview Bariatric surgery entails two types of procedures. As a commencer, one surgery is referred to as a malabsorptive procedure that aims at diverting food from the stomach to a lower part of the digestive tract that inhibits the mixture with digestive fluids and deters absorption of nutrients. The other procedure is a restrictive approach that decreases the size of the stomach, restricting the amount of food ingested. There are surgeries that combine both procedures. Technology has bred the advancement of the procedures and has birthed the use of laparoscopic procedures as compared to open procedures (CMS, 2009). History of NCA; how it was selected for review by CMS, list of important dates, description of how its products and services are currently covered NCA was selected for review by CMS to evaluate the nature of scientific evidence that supported bariatric surgery for type 2 diabetes mellitus. It was also aimed at assessing and documenting evidence if the selected NCD was warranted as a result of the uncertainty as pertained to the necessity, effectiveness, and outcome of bariatric surgery among patients with type 2 diabetes mellitus (CMS, 2009). May 19, 2008 is an important date since it saw the CMS initiation of a NCD for the involvement of surgery in the management of diabetes. It was also in this day that the initial 30 day trial of garnering public comments began. CMS aimed at requesting the opinion of the public as pertained to the health benefits that were associated with bariatric surgery. CMS mainly concerns itself with comments that illustrate clinical evidences, scientific information, and technological advancement in the performance of bariatric surgery for type 2 diabetes mellitus (CMS, 2009). May 29, 2008 CMS ascertained the purpose of the NCA. It avowed that this NCA did not aim at altering NCD 100.1 which addresses coverage of types of bariatric surgeries that inculcated obesity co-morbidities including obesity. However, CMS avowed that through NCA, it aimed at assessing evidence for the ability of successfully performing intestinal bypass, and gastric surgeries to improve the status of individual who had diabetes regardless of the coverage in the bariatric surgery NCD (CMS, 2009). It was on November 17, 2008 that a proposed decision memorandum was posted and a 30 day public comment began. CMS sought the opinion of the public supported with clinical evidence, on the issue under review. The comments aimed at outlining the short and long term benefits of the initiative to the Medicare population (CMS, 2009). Decision memorandum as pertains to bariatric surgery in type 2 diabetes mellitus patients was posted on February 12, 2009 which is the closed review used to write this NCD paper (CMS, 2009). Currently as per the closed report, the coverage of bariatric surgery in type 2 diabetes mellitus has been presented in two decisions arrived at by the CMS. As a commencer, CMS concluded that there was no adequate evidence that: laparoscopic adjustable gastric banding (LAGB); open and laparoscopic Roux- en-Y gastric bypass (RYGBP), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) improved the health outcomes of patients who had type 2 diabetes mellitus with a BMI,35kg/m2. This is stipulated in the Social Security Act section 1862 (a) (1) (A) (CMS, 2009). However, CMS reported that there was conclusive evidence that LAGB, RYGBP and BPD/DS improved the health outcomes of individuals who had type 2 diabetes mellitus and had a BMI>35kg/m2. This is further elaborated in NCD Manual 100.1(Bariatric Surgery for the treatment of Morbid Obesity) where type 2 diabetes mellitus is outlined as a co- morbidity of obesity (CMS, 2009). What Lessons Can Products New To the Market Learn From NCA? To begin with, products new to the market should learn that there are evaluations that are carried out by CMS prior to making a NCD. The CMS evaluates if the product has sufficient and quality evidence that support the service it intends to implement. Also, the item as outlined by the new product should be within the benefit category and evidence should prove that it is necessary and reasonable as pertains to the treatment, diagnosis of an illness. Additionally, the intervention proposed should be able to improve the functioning of a member of the body that is malformed (CMS, 2009). The new product should know that the NCA needs this information to be ascertained that the assessment questions designed by the product will be answered. In addition, it serves as an illustration to CMS and CAN that the product will have beneficial outcome to the patients that it is administered to. The new products should also employ a good reference in its literature presentation, and aim at binding the readers and should stipulate the results it expects. This will aid in garnering higher public comment as pertains to its services (CMS, 2009). The new product should also know that the CMS relies on public comment especially one that outlines clinical evidence that has been published. The new product should also know that CMS bases its proposed decision on initial public comments it receives. It eventually responds in detail to the comments outlined by the public in issuing its final decision in the form of a memorandum (CMS, 2009). Description and Importance of Population That Can Benefit From the Service The prevalence of obesity among the populate of the United States has been documented as 7.9% among men and 6.8% among women. The prevalence of diabetes has been documented to increase with age from a considerable 6.6% prevalence in lower age group individuals, compared to 11-15% prevalence in individuals above the age of 50 years. Diabetes prevalence is consequently lower among whites (7.2%) and more common among the blacks (11.2%). It has been documented that adults that have a BMI of 35-39.9 have a 3.44 higher risk of developing type 2 diabetes mellitus, with those that have a BMI of 40 and above having 7.37 higher chance of developing diabetes. This translates to a prevalence of 14.9% among the former and a prevalence of 25.6% among the latter. This population qualifies a population that can benefit from bariatric surgery in type 2 diabetes mellitus individuals (CMS, 2009). How Place of Service Influence NCA Rationale? NCDs are arrived at by the secretary as pertains to whether or not a service or item is nationally covered under Social Security Act 1862 (1) (6) (A). In order to garner coverage by Medicare, the service should be within the benefit categories outlined in Part A or Part B of the title. Consequently, the item or service should not otherwise be excluded from the provision of coverage by other laws or regulations. Subsequently, with limited exceptions as stipulated, the expenses of undertaking the service or item should be necessary and reasonable. In addition, it should aid in the diagnosis and treatment of the hypothesized infirmity or illness, in bid to improve the physiological capacity of the deformed body member as outlined by 1862 9a) (1) (A) of the Act (CMS, 2009). Providers That Will Be Impacted By NCA Providers that will be negatively impacted by NCA are those who provide bariatric surgery procedures of which there was no adequate evidence provided for their justification. As a result, CMS outlined the following procedure as not covered for Medicare procedures: open sleeve gastrostomy, open vertical banded gastroplasty, laparoscopic sleeve gastrectomy, open adjustable gastric banding, and laparoscopic vertical banded gastroplasty (Chau et al. 2005). In addition, surgeons and facilities credited will also be impacted by the NCA. The Social Security Act that classifies bariatric surgery as a physician service hence its immediate qualification as a benefit with CMS supports this. In addition, since these patients are managed and evaluated by the physicians following bariatric surgical procedures, it qualifies to be a physician service and hence a viable benefit under CMS (CMS, 2009). Inpatient hospital services that inculcate provision of bariatric surgical procedures will also fall under the benefit scheme of the CMS and hence included in the NCA. This is also concurrent with hospitals that offer outpatient services if their supplies and services meet the requirements to be classified as physician service (Pope, et al. 2002). Stakeholders, Patient Advocacy Groups Involved, and Discussions with Professional Specialty Societies The public is a major stakeholder in NCA as undertaken by CMS. In the initial public comment, CMS received 21 comments that are electronically available. In addition, 26comments were received during the proposed decision as pertains to the coverage of type 2 diabetes with a BMI35 and their qualification for bariatric surgery. 20 respondents disagreed with the non-coverage of individuals with type 2 diabetes mellitus patients, 4 supported higher BMI as a predisposition to obesity, and only 1 with lack of coverage of individuals who had a BMI30. They also recommended that CMS carry out a NCD for individuals with type 2 diabetes mellitus with BMI35. However, they disagreed with CMS in non-coverage of individuals who did not have BMI Read More