The Food and Drug Administration (FDA) in late February approved new guidelines that make millions of additional Americans eligible for Lap-Band surgery, providing a potential windfall for surgeons who specialize in the procedure. But some experts question the way the procedure is being marketed to overweight and obese patients.
The FDA lowered the minimum body mass index for Lap-Band surgery candidates from 35 to 30 so long as patients have at least one other obesity-related illness such as diabetes or high blood pressure. The change doesn't seem like much but according to some estimates, it qualifies up to 26 million additional overweight people in the U.S. for the surgery.
The decision presents a great revenue opportunity for providers, but some surgeons are concerned the new guidelines will produce a rush of "surgery mills" that promote the procedure as an easy fix. "The Lap-Band is the safest approved surgical procedure for weight loss, but traditional advertising doesn't send the right message," bariatric surgeon Ted Khalili told the Los Angeles Business Journal.
One ad campaign in California has come under scrutiny and has been hit with several lawsuits. The marketing campaign in Los Angeles uses billboards with the phone number 1-800-GET-THIN to promote Lap-Band surgery and refers callers to surgeons associated with the program. In February, a San Fernando Valley surgical center was sued by the husband of a woman who died after Lap-Band surgery and three other lawsuits are pending against the program.
In December, the Los Angeles Department of Public Health (LADPH) asked the FDA to look into the 1-800-GET-THIN campaign and others like it to determine whether they provide enough information about the risks involved in the surgery. "The advertising of this medical device by 1-800-GET-THIN Weight Loss Centers inadequately informs consumers of potential risks," wrote LADPH director Jonathan Fielding in aletter to the FDA.
A spokeswoman for Allergan, the manufacturer of the Lap-Band, said the company is in no way affiliated with the marketing campaign. An LA Timescolumnist tracks the campaign to a Beverly Hills clinic.
Bariatric surgeons such as Khalili, who has performed the Lap-Band procedure hundreds of times, worry that provocative campaigns like 1-800-GET-THIN promote surgery as a shortcut to weight loss. "The surgery is almost a secondary thing," said Khalili. "To make the operation successful, you have to have a lot of education and support before and after so that patients continue to make the right decisions to improve their health."
There's no doubt the FDA decision will generate a slew of new marketing efforts to promote the procedure, which usually requires an overnight stay in the hospital and can cost up to $30,000. The American Society of Metabolic and Bariatric Surgery estimates that gastric banding accounted for 40% of all gastric surgeries in 2009, a percentage that's expected to soar now that millions of new patients are eligible for Lap Bands.
But the legal woes of the 1-800-GET-THIN program should serve as a warning for all healthcare providers not to get caught up in marketing campaigns that provide an incomplete picture of any procedure and its inherent risks.
Blue Cross Blue Shield of Massachusetts board members, huddling in an emergency meeting yesterday, voted to suspend their five-figure annual directors' payments and to start discussions with the state attorney general's office and community leaders about the health insurer's status as a public charity. With the company facing mounting criticism over its pay for part-time board members, and Attorney General Martha Coakley set to recommend that nonprofit insurers stop compensating directors, the board's unanimous vote was an effort to restore the company's credibility as it presses hospitals to hold down medical costs. "Obviously, this has become a great distraction,'' Blue Cross CEO Andrew Dreyfus conceded. Dreyfus said he called for the board meeting because "it was important that they make a statement" following a week of complaints from the public and some elected officials over the board fees and an $11 million payout given to former Blue Cross CEO Cleve L. Killingsworth.
A lot more is riding on HCA's return to being a public company than raising a bunch of money to chip away at its hefty corporate debt as the hospital chain's stock starts trading on Wall Street again this week. The expected stock sale — probably the largest private equity-backed initial public offering in U.S. history — could have broader implications for the local and national health-care industries as it sparks the flow of tens of millions of dollars into the hands of corporate insiders and other investors cashing out a portion of their HCA holdings. As executives turn private ownership stakes into stock that trades readily on the New York Stock Exchange, that wealth could help finance new startup health-care companies or even fuel the sale of some high-end homes if investors reap large enough profits.
Patients are demanding doctors' orders for over-the-counter products because of a provision in the healthcare overhaul that slipped past nearly everyone's radar. It says people who want a tax break to buy such items with flexible-spending accounts need to get a prescription first. The result is that Americans are visiting their doctors before making a trip to the drugstore, hoping their physician will help them out by writing the prescription. The new requirements create not only an added burden for doctors, but also new complications for retailers and pharmacies. Though the new rules on over-the-counter drugs amount to a small part of the massive overhaul of the health-care system, the unintended side effects show how difficult it can be to predict how such game-changing legislation will play out in the real world. Some doctors, irked by the paperwork and worried about lawsuits, are balking at writing the new prescriptions. Pharmacists and retailers say the changes mean they have to apply a personalized label on some 15,000 different everyday products for customers paying with certain debit cards.
The nation's Republican governors are raising a new complaint against the 2010 national health overhaul, which they deride as "Obamacare." They say it would drive up their Medicaid costs dramatically at a time they're already slashing their budgets to cope with debt. There's no question that the healthcare law will force states to expand their Medicaid services, but how that ultimately will affect states' costs is a matter of considerable dispute. The 2010 law requires that state Medicaid programs in 2014 begin covering all non-elderly people who earn up to 133% of the federal poverty level, which would comprise people with incomes of up to $29,400 for a family of four this year.
A poll that gauged the views of 468 health IT stakeholders shows that they view the proposed Stage Two and Three meaningful use objectives and measures as too aggressive when considering the work to be done, the targets to be met, and the timelines in which to achieve the stated goals. The survey was sponsored by the Certification Commission for Health Information Technology, and was conducted to coincide with the Meaningful Use Workgroup of the Health IT Policy Committee's request for public comment on their proposed Stage Two and Three meaningful use objectives and measures. Survey participants were made up of providers (36%), EHR vendors (29%), and others (29%), and the results were summarized in a blog post by CCHIT chair Karen Bell.