Surgery News - December 2008 - (Page 14) GENERAL SURGERY SURGERY NEWS • D E C E M B E R 2 0 0 8 CMS Clarifies Bariatric Surgery Coverage Criteria Current evidence suggests ‘the risks outweigh the benefits’ of surgery for non–morbidly obese patients. B Y J OY C E F R I E D E N Else vier Global Medical Ne ws M edicare will not cover bariatric surgery for beneficiaries who have type 2 diabetes but do not have a body mass index greater than 35 kg/m2, according to a proposed decision memo issued last month. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, [the Centers for Medicare and Medicaid Services] did not find convincing medical evidence that bariatric surgery improved health outcomes for non–morbidly obese individuals,” according to a CMS statement. Dr. Barry Straube, the agency’s director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients whose BMI is less than 35 is part of Medicare’s ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.” The proposal also states that type 2 diabetes is one of the comorbidities that would be acceptable criteria for surgery. A 2006 national coverage decision for bariatric surgery issued by the CMS said that Medicare would cover only three procedures—open and laparoscopic Roux-enY gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI greater than 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. At that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures to improve diabetes status among obese, overweight, and nonoverweight diabetes patients. The proposed decision memo is an outcome of that query. The CMS accepted comments on the memo until mid-December and has up to 30 days to issue a final decision memo. (To see the proposed memo, go to www.cms.hhs.gov/mcd /index_list.asp?list_type=nca; click on “Surgery for Diabetes.”) Dr. Jeffrey Mechanick said that the CMS was responding to a trend in the medical literature and meeting presentations sug- gesting that bariatric surgery might be helpful for even those diabetes patients who are not overweight. “A lot of surgeons began noticing that after bariatric surgery, patients with diabetes had amelioration of their hyperglycemia. At first glance, it seems pretty easy—you lose weight and so your diabetes should be getting better. But they found that a lot of the improvement was independent of weight loss; there was something else,” said Dr. Mechanick, director of metabolic support in the division of endocrinology, diabetes, and bone disease at the Mount Sinai School of Medicine, New York. The causes include proximal changes, such as factors in the proximal small bowel, and distal changes, such as glucagonlike protein-1 and other factors made by the small bowel in the distal ileum, he explained. He noted that although the CMS currently is not covering the surgery for patients with a BMI under 35, that could change if long-term follow-up data on the procedure became available. “A growing number of reports in the literature suggest that bariatric surgery for diabetic patients who are not morbidly obese may be of benefit,” said Dr. Myriam J. Curet, who commented on the CMS decision memo. “A number of theories have been put forth, but definitive data are still lacking. Given the potential promise of metabolic surgery, hopefully CMS will be willing to revisit the issue as more data are published,” said Dr. Curet, an ACS Fellow and professor of surgery at Stanford (Calif.) University. Dr. Philip Schauer said he was not disappointed with the proposed decision memo. To the contrary, “we in the surgical community were somewhat surprised this came up at all because our organization was not necessarily pushing CMS to address the issue,” said Dr. Schauer, an ACS Fellow and director of the Bariatric and Metabolic Institute at the Cleveland Clinic. “However, there is increasing evidence on bariatric surgery for patients with diabetes and BMI 30-34. When more of this evidence emerges, I think CMS will look at the issue again.” Dr. Shauer was one of the organizers of the Diabetes Surgery Summit held in Rome in 2007 with the goal of developing consensus guidelines for gastrointestinal surgery to treat type 2 diabetes (see SURGERY NEWS November 2008, p. 16). The guidelines, which are expected to be published in the Lancet in 2009, affirm that uncontrolled type 2 diabetes patients with BMI greater than 35 should be strongly considered for surgical intervention; they also state that for similar patients whose BMIs are less than 35 but greater than 30, surgery may be a reasonable option. ■ Many Comorbidities Resolved Bariatric Surgery • from page 1 February 2006, these patients are covered if the procedures are performed at centers doing more than 125 operations per year and if those centers are certified by either the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery. The Case Western Experience The Case Western retrospective study, presented by Dr. Peter T. Hallowell, reviewed elderly and Medicare patients treated from 1998 through May 2006, with 30 months of follow-up on average (range 1-84 months). Investigators divided the population into two groups: 45 elderly patients aged 60-66 years (average age 62 years) and 31 Medicare clients aged 31-66 years (average age 48 years). Although Medicare commonly is associated with the elderly, it also covers a younger, disabled population, noted Dr. Hallowell, an ACS Fellow formerly of Case Western and now at the University of Virginia Health System in Charlottesville. In the elderly group, average body mass index (BMI) fell from 50.4 kg/m2 before surgery to 34.7 kg/m2 afterward. The Medicare group also saw a significant decline in average BMI: from 56 kg/m2 before to 38.1 kg/m2 afterward. The only death that occurred was in the Medicare group 4.5 years after surgery. Hypertension resolved in 62% of Medicare patients (13 of 21) and improved in 10% (2 of 21). Just half of 34 elderly patients with hypertension did as well; the condition resolved in 24% (8 of 34) and im- proved in 26% (9 of 34). Dr. Hallowell reported similar benefits for patients with other conditions: Diabetes resolved in 15 patients (75%) and improved in 2 others (10%) among 20 elderly patients on oral diabetes medications. In the Medicare cohort, 9 (81%) of 11 cases resolved and 1 (9%) improved. Insulin-dependent diabetes resolved in one of three cases in elderly patients and improved in one. Among six Medicare recipients on insulin, two cases resolved and four improved. Out of 32 cases of obstructive sleep apnea in elderly patients, 10 (31%) resolved and 13 (41%) improved. Among 22 cases in Medicare patients, 8 (36%) resolved and 10 (46%) improved. More than 90% of cases of gastroesophageal reflux disease resolved—23 of 25 in the elderly cohort and 16 of 17 in the Medicare group. None improved. “Though the numbers are small, the results are impressive,” Dr. Peter H. Kelly, an ACS Fellow in a group surgical practice in St. Paul, Minn., said in a discussion of the study. Hospital Discharge Data The second study mined a database of discharge data maintained by the University HealthSystem Consortium. Drawing on data from academic medical centers and affiliate teaching hospitals, Dr. Ninh T. Nguyen, an ACS Fellow, and his colleagues at the University of California, Irvine, reviewed Medicare or Medicaid patients who underwent bariatric surgery between Among the significant improvements Oct. 1, 2004, and Sept. 31, 2007. The investigators divided the largely fe- in outcomes, Dr. Nguyen reported that the male population into two groups: 3,196 mean length of stay fell from 3.5 to 3.1 patients treated during the 18 months be- days, overall complication rates from fore Medicare coverage was expanded, 12.2% to 10%, rate of deep vein thromand 3,068 patients during the 18 months bosis and pulmonary embolism from 0.9% to 0.4%, and pulmonary complications afterward. Dr. Nguyen reported the number of in- from 2.4% to 1.4%. Looking at just Medicare patients, the stitutions in the sample dropped from 60 before the certification requirement to 45 investigators saw small nonsignificant declines in 30-day readmission after. Although the number of rates, in-hospital mortality, and bariatric procedures dipped the observed-to-expected insharply in the 3 months after hospital mortality ratio. Tothe change, it returned to the gether, these translated into a pre-2006 level within 1 year significant cost reduction from and exceeded baseline within 2 $15,061 to $14,152 per patient. years. Further subgroup analyses The proportion of patients showed that complications fell aged 65 years and older infrom 50.1% to 40.2% in patients creased from 7.5% of the popwhose severity of illness was ulation before the change to In the elderly classified as major or extreme. 9.6% afterward. group, average Other significant demo- BMI fell from 50.4 Looking at the majority of patients undergoing laparoscopic graphic shifts include a decline kg/m2 before or open gastric bypass, the inin white patients from 67.6% surgery to 34.7 vestigators saw mean length of to 62.3% and an increase in kg/m2 afterward. stay decline from 3.9 to 3.3 days, Hispanics from 6.2% to 8.3%. DR. HALLOWELL the overall complication rate More patients had conditions classified as minor in severity after the pol- from 16.1% to 12.6%, and pulmonary icy change while fewer were classified as complications from 3.2% to 2%. Answering questions about the study, semoderate in severity. Fewer major or extreme case http://www.cms.hhs.gov/mcd/index_list.asp?list_type=nca http://www.cms.hhs.gov/mcd/index_list.asp?list_type=nca
Table of Contents Feed for the Digital Edition of Surgery News - December 2008 Surgery News - December 2008 Contents The 20/20 Vision: Health Reform News From the College: Nominations Thoracic: Breathing Easier Postop Management: Renal Failure Surgery News - December 2008 Surgery News - December 2008 - Contents (Page 1) Surgery News - December 2008 - Contents (Page 2) Surgery News - December 2008 - Contents (Page 3) Surgery News - December 2008 - Contents (Page 4) Surgery News - December 2008 - Contents (Page 5) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 6) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 7) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 8) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 9) Surgery News - December 2008 - News From the College: Nominations (Page 10) Surgery News - December 2008 - News From the College: Nominations (Page 11) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 12) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 13) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 14) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 15) Surgery News - December 2008 - Postop Management: Renal Failure (Page 16) Surgery News - December 2008 - Postop Management: Renal Failure (Page 17) Surgery News - December 2008 - Postop Management: Renal Failure (Page 18) Surgery News - December 2008 - Postop Management: Renal Failure (Page 19) Surgery News - December 2008 - Postop Management: Renal Failure (Page 20)
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