A Medical Device Daily

The Centers for Medicare & Medicaid Services (CMS; Baltimore) this week issued a decision to establish a nati-onal coverage policy for bariatric surgery targeting the health problems of the obese.

The policy will apply to all Medicare recipients, including those over 65 and Medicare-disabled who are morbidly obese (body mass index or BMI of 35 or greater) with any obesity related-condition or disease and previously unsuccessful with other medical treatments for obesity. The new coverage is binding on all Medicare contractors.

Medicare's previous policy only covered gastric bypass surgery and vertical banded gastroplasty for obesity, and only if the surgery was used to correct an illness “which caused the obesity or was aggravated by the obesity.“

The bariatric methods to be covered include laparoscopic and open gastric bypass, laparoscopic gastric adjustable banding, open and laparoscopic biliopancreatic diversion and the duodenal switch. There will be no specific criteria for prior dietary weight reduction programs, recognizing that almost all surgery patients have made numerous attempts to lose weight.

To ensure quality care, coverage will be provided only if the procedure is performed at an ASBS/Surgical Review Corporation Center of Excellence or American College of Surgeons (ACS; Chicago) Level One Center of Excellence.

For a center to receive an ASBS/SRC Center of Excellence designation, it must perform at least 125 bariatric surgeries per year collectively and the surgeon must have performed at least 125 bariatric surgeries himself or herself and at least 50 per year.

The center must also report long-term patient outcomes and have an on-site inspection to verify all data. In addition, the center must have a dedicated multi-disciplinary bariatric team that includes surgeons, nurses, medical consultants, nutritionists, psychologists and exercise physiologists.

The American Society for Bariatric Surgery (ASBS; Gainesville, Florida), which bills itself as the largest organization of bariatric surgeons in the world, submitted the request for a national coverage determination (NCD) last May.

Neil Hutcher, MD, president, ASBS, said, “This is a great day in the war against obesity. We expect many private insurers will take their lead from CMS and improve outdated coverage policies that severely restrict or even ban the use of bariatric surgery. This decision and the data that supports it are overwhelming.“

It is estimated that 8 million to 12 million people in the U.S. are morbidly obese, and is growing at double the rate of the rest of the obese population, according to ASBS. It also reports that in 2005 about 170,000 people had bariatric surgery.

“The Center of Excellence provision is important. The evidence shows that the best outcomes and the fewest complications occur in centers with the most experience,“ Hutcher said.

In July 2004, the Department of Health and Human Services eliminated the long-held Medicare policy statement that obesity was not a disease. In November 2004, a Medicare Coverage Advisory Committee concluded that there is significant scientific evidence supporting the safety and effectiveness of open and laparoscopic weight loss surgery and its ability to improve a number of life-threatening obesity-related conditions including diabetes, high blood pressure and high cholesterol in the general adult population.

“We believe bariatric surgery will help remove patients from disability status by improving their disabling arthritis, cardiovascular or pulmonary dysfunction. The cost savings would be significant for Medicare and the health implications would be enormous,“ said Harvey Sugerman, MD, immediate past president of ASBS.

The ASBS says that it encourages its members to investigate new advances in bariatric surgery, while maintaining an exchange of experiences and ideas that may lead to improved surgical outcomes for morbidly obese patients.

CMS in cooperation with NOPR

CMS reported that it will work with the Academy of Molecular Imaging-sponsored National Oncologic PET Registry (NOPR) to collect data to assist in managing patients with various forms of cancer.

“Working closely with NOPR is another example of CMS collaborating with the physician community to enhance the availability of innovative treatments and improve patient care,“ said Mark McClellan, CMS administrator.

The announcement follows CMS's decision early last year to expand coverage of PET scans for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers, as well as a broad range of other cancers not covered in prior national coverage determinations.

The NOPR is sponsored by the AMI and is managed by the American College of Radiology (Reston, Virginia) through the American College of Radiology Imaging Network and the AMI. The NOPR is a national, Internet-based, data repository that gathers PET data from beneficiaries and providers and to report on that data.

AMA backs 'pay for performance'

Pay for performance, a plan designed to link Medicare payments to quality and supporting President George Bush's promise to develop more public information concerning the quality of healthcare delivery, has been given a strong push by the American Medical Association (AMA; Chicago).

The AMA reportedly has signed a pact with Congress promising to develop more than 100 standard measures of performance intended to serve as a baseline for performance initiatives. The performance measures will focus on diagnostic tests and treatments that are known to produce better outcomes.

The idea has strong support in Congress and from AARP (Washington), which lobbies for older Americans.

Under the accord between leaders of Congress and the AMA, groups of doctors are to develop about 140 physician performance measures covering 34 clinical areas by the end of this year.