Medicare Announcement

The full text can be found on the CMS website for public comment. With luck this should open up coverage with private carriers. Gary Viscio ww.obesitylawyers.com "still the highest success rate nationwide" Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R) Decision Summary ww.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=160 The Centers for Medicare and Medicaid Services (CMS) proposes that National Coverage Determination (NCD) Manual sections 40.5 and 100.1 be modified to be consistent with the following conclusions: The evidence is adequate to conclude that open and laparoscopic Roux-en-Y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB) are reasonable and necessary for Medicare beneficiaries who are under 65 years of age, have a body-mass index (BMI) > 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. CMS is seeking comment on this evidence and its implications for coverage, and for the range of patients under age 65 who would be covered. We are particularly interested in comments on the potential to expand coverage for this population under the "Coverage with Evidence Development" (CED) option. In addition, the evidence is adequate to conclude that approved bariatric surgery procedures for Medicare beneficiaries are reasonable and necessary if the facility performing the procedure meets the following CMS facility standards: Each institution will have a credentialing program that ensures that surgeons performing bariatric surgery shall have; appropriate board certification, training and experience that meet approved nationally recognized guidelines, and training and clinical expertise in managing and treating morbidly obese patients prior to the decision to undertake surgery and have experience in managing post-surgery patients for at least one year after surgery. Each institution will ensure that individuals who provide services and/or supervise services in the bariatric surgery program are qualified to provide or supervise such services. Each institution will have an integrated program for the care of the morbidly obese patient that provides: ancillary services such as specialized nursing care, dietary instruction, counseling, support groups, exercise training, and psychological assistance as needed; a multidisciplinary bariatric surgery team with written descriptions of the responsibilities of each member of the team. The team must be composed of individuals with the appropriate qualifications, training and experience in the relevant areas of bariatric surgery, rehabilitation, critical care anesthesia, and nutrition counseling for the morbidly obese and post-bariatric surgery patients. Each institution will establish and implement written policies to address and document adverse events that occur during the management of a bariatric surgery patient. Each institution will have staff and readily available consultants in cardiology, pulmonology, rehabilitation and psychiatry who have prior experience with bariatric surgery patients. Each institution will have a written informed consent process that informs each patient of: 1) the evaluation process; 2) the surgical procedure; 3) alternative treatments; 4) national and center-specific rates for potential surgical risks, hospital lengths of stays, 30-day mortality and other relevant outcome measures; 5) risk factors that could affect the success of the surgery; 6) the patient's right to refuse the intervention. Each institution will have sufficient operating room tables, equipment, instruments and supplies specifically designed or appropriate for bariatric surgery; a recovery room capable of providing critical care to obese patients; an intensive care unit with similar capabilities; equipment with manufacturer's specifications, such as hospital beds, commodes, chairs, wheelchairs, etc., that accommodate the morbidly obese; and radiology and other diagnostic equipment capable of handling morbidly obese patients. The evidence is not adequate to conclude that open and laparoscopic Roux-en-Y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB) are reasonable and necessary for Medicare beneficiaries who are 65 years of age or older; therefore, CMS will non-cover these procedures in this population. The evidence is not adequate to conclude that the following bariatric surgery procedures are reasonable and necessary and they are therefore non-covered for all Medicare beneficiaries: open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, laparoscopic sleeve gastrectomy, open adjustable gastric banding, open biliopancreatic diversion with or without duodenal switch, and laparoscopic biliopancreatic diversion with or without duodenal switch. The two non-coverage determinations in the National Coverage Determination Manual (NCDM) remain unchanged: Gastric Balloon (NCDM Section 100.11) and Intestinal Bypass (NCDM Section 100.8). CMS is requesting comment on this proposed decision. We are specifically interested in comments on the potential to cover the 65 and older population under CED. Though we have not finalized the CED Guidance Document, we believe this issue does meet the general guidelines outlined in that draft guidance document. CED would also allow the expansion of national coverage to this older population, with some limitations. Adherence to Departmental regulations including the Health Insurance Portability and Accountability Act (HIPAA, Public Law 104-191) and human research protections (45 CFR Part 46) would, as with all CED, be a requirement. We are also asking for public comment on the facility criteria to include the potential to establish more definitive bariatric surgery volume criteria for facilities and surgeons. In addition, we believe these standards will best be applied by organizations experienced in this process. Therefore, as part of this proposed decision, we are requesting comment on appropriate entities to apply these standards. We are aware that the American College of Surgeons and the American Society of Bariatric Surgeons have developed accrediting programs and we are specifically asking for comments about their level of competence in performing this facility review. -------------------------------------------------------------------------------- Proposed Decision Memo