Dec 152011
 

It has taken almost two years, but government regulators finally woke up to the idea that those 1-800-GET-THIN billboards plastered all over Southland freeways may be dangerous to your health.

After four confirmed fatalities since 2009, the FDA is finally taking action against eight California surgical centers and a marketing firm for providing misleading information while advertising lap-band surgery.             

That’s the underlying meaning of the action announced Tuesday by the U.S. Food and Drug Administration against 1-800-GET-THIN and a bunch of affiliated surgical services and clinics. The FDA warned the marketing company and the clinics that they’re in violation of federal law by promoting the Lap-Band, a weight loss device that has been implanted in thousands of patients, through “false or misleading” advertising.

The FDA issued warning letters to Beverly Hills Surgery Center, Palmdale Ambulatory Center, Bakersfield Surgery Institute Inc., Valley Surgical Center, San Diego Ambulatory Center Valencia Ambulatory Center, Top Surgeons and Cosmopolitan Plastic & Reconstructive Surgery. The agency said the font size of information related to risks on the advertising inserts is too small to be read by consumers.

“It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices,” said an FDA representative. “If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties.” The companies involved have 15 days to respond to the FDA warning. The maker of the Lap-Band device, Allergan, did not receive an FDA warning letter.

Four people died after undergoing lap-band procedures at clinics associated with the misleading ads. A coroner’s ruling is still pending on the death of a fifth patient, who was rushed to the hospital immediately after receiving bariatric surgery at one of the clinics. Articles in the LA Times have pointed out inadequate sanitary and safety conditions at these clinics. Since bariatric surgery facilities such as these are officially categorized as performing a minor cosmetic service rather than major surgery, they fall into what the Times calls a “regulatory grey zone.” Another bariatric surgeon in the LA area described the situation as “the Wild Wild West out there when it comes to bariatric surgery.”

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Dec 112011
 

WASHINGTON — Medicare will pick up the tab for obesity screening and intensive behavioral counseling, the Centers for Medicare and Medicaid announced late Tuesday.                    

CMS, which first floated the obesity coverage plan last September, said it expects more than 30% of the Medicare population to qualify for the new benefit.

Beneficiaries with body mass index values of 30 or more can receive weekly in-person intensive behavioral therapy visits for one month, followed by visits every two weeks for an additional five months, fully paid by Medicare with no copayment.

Additional monthly sessions will be covered for up to six months afterward if the beneficiary has lost at least 6.6 pounds (3 kg) during the first six months.

The sessions should also include dietary counseling, the agency said.

Medicare patients who fail to lose the 6.6 pounds in six months may be reevaluated at the one-year mark after the initial screening. Those showing “readiness to change” and a BMI value still at 30 or more may receive another round of counseling paid by Medicare.

“It’s important for Medicare patients to enjoy access to appropriate screening and preventive services,” said outgoing CMS administrator Donald Berwick, MD, in a statement.

Counseling must take place in a primary care setting such as a physician’s office. It will not be covered when provided in skilled nursing facilities, hospitals, emergency departments, outpatient surgery centers, or hospices.

A primary care setting is defined as “one in which there is provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, developing a sustained partnership with patients, and practicing in the context of family and community.”

Peter Jacobson, JD, MPH, a health policy professor at the University of Michigan in Ann Arbor, told MedPage Today and ABC News in an email that the decision is important in its own right, but will be even more significant if private insurers follow suit to cover such counseling.

But he took issue with the benefit’s restriction to counseling provided only in primary care settings — referrals to specialty practices or centers for counseling will not be covered by Medicare.

“Primary care is necessary but not sufficient to address the obesity epidemic,” Jacobson said. “Without community-based services and referrals, the overall policy impact may not be as robust as would a policy linking medical care with public health.”

A former president of the American Heart Association was also not 100% pleased with the new coverage.

Robert Eckel, MD, of the University of Colorado’s medical school in Aurora, Colo., toldMedPage Today in a phone interview that he was skeptical that the counseling to be provided would achieve major, lasting improvements in patients’ health.

“The question is sustaining the benefit” of successful weight loss beyond the first year, he said. He said his initial reaction was that the coverage is “more money [paid out of Medicare] without proven benefit.”

Another health policy expert, Robert Field, JD, MPH, PhD, of Drexel University in Philadelphia, told MedPage Today and ABC News in an email that “if people are obese when they reach old age, they probably have a lifetime of bad habits that will be difficult to break.”

But both men said the move was positive on the whole. Eckel called it “a step in the right direction” that would “make me more capable as a clinician to deal with the [obesity] epidemic,” and said he expected that the AHA would be very pleased with the decision.

Gail Wilensky, PhD, currently a senior fellow at Project HOPE and formerly a top adviser to Pres. Bill Clinton, said it would be “important and useful to set up a mechanism to evaluate the program in three to five years,” modifying or killing it according to the results.

To qualify under the new benefit, counseling must be consistent with the “five A’s” listed in a U.S. Preventive Services Task Force recommendation, according to CMS’s decision memo:

  • Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods.
  • Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits.
  • Agree: Collaboratively select appropriate treatment goals and methods based on the patient’s interest in and willingness to change the behavior.
  • Assist: Using behavior change techniques (self-help and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports for behavior change, supplemented with adjunctive medical treatments when appropriate.
  • Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment.

 

The agency had published the proposal to cover obesity screening and counseling under Medicare in early September, with a 90-day comment period to follow.

It based the decision on a review of studies and other evidence indicating that such counseling is effective in helping obese patients to lose significant weight, which in turn reduces risk of cardiovascular events and other adverse outcomes.

read additional CMS language on post titled: Is Obesity and Illness?

article source: By John Gever, Senior Editor, MedPage Today

Dec 112011
 

For Immediate Release:

Obesity Diet Plans: Grand Rapids, MI. Local organization Obesity Diet Plans, an internet based Obesity Health, Help and Diet related website is accepting financial donations to help fight obesity.

“Each day we get dozens of calls and emails from people in tears and afraid that due to their obesity and related diseases are in fear of losing eye sight, having limbs amputated and even facing possible death, says Brent Vanderstelt, Owner”

Standard obesity diet plans are not often covered by insurance premiums, however; are usually covered by company sponsored Flex Plans. The problem is often those who are obese or suffer from obesity related diseases are often unemployed and unemployable.

It’s our goal to accept financial donations and offer financial assistance to those who cannot afford all or parts of our obesity diet plans which includes healthy nutritional meal replacement foods and obesity diet monitoring and health tips.

“The average cost of our Obesity Diet Plans run between $400 and $500 per month added Brent”. Participants actually will save money compared to regular groceries and be consuming a more nutritionally balanced meal.

Obesity affects the poorer and uneducated more often than those with a higher education and socio-economic level. This group tends to be more vulnerable to processing technology and is the highest recipients of U.S. government subsidies.

Obesity affects about one-third of U.S. adults (33.8%) are obese. Approximately 17% (or 12.5 million) of children and adolescents aged 2—19 years are obese.

Obesity affects poor and educated women 1.3 more times than women with a higher educational level. In fact, overall, obesity affects more women than men. African American women represent 17% of the of obese population.

Overweight and obesity and their associated health problems have a significant economic impact on the U.S. health care system. The medical care costs of obesity in the United States are staggering. In 2008 dollars, these costs totaled about $147 billion.

Obesity Diet Plans is dedicated to assisting obese people and those battling obesity related diseases such as diabetes and heart disease find affordable diet plans for those needing financial assistance.

To make a financial donation, please visit the organizations website or DONATE NOW!

 

For More Information:

Contact Us

Brent Vanderstelt

Obesity Diet Plans

1-877-971-0004