Lap band surgery for morbidly obese children

Lap band surgery for morbidly obese childrenEvan Paul Nadler, MD surgeon at Children's National Medical Center and colleagues from New York University have found laparoscopic adjustable gastric banding (Lap band) to improve the health of morbidly obese adolescents.



The study, reported in the Journal of the American College of Surgeons, involved nearly 50 girls and boys ages 14-17. The participants showed significant decreases in total and android fat mass 2 years after surgery. Android fat has been associated with the development of obesity-related illnesses, such as diabetes, heart disease, and insulin resistance.

"This study is the first to demonstrate the improvements in overall health and distribution of weight loss after Lap band surgery in adolescents," said Evan Nadler, MD, the main author and pediatric surgeon at Children's National. "While weight-loss surgery should always be a last resort for adults and adolescents, these findings show us that surgery in adolescents reduces the risk of significant health complications".

The study observed that Lap band surgery improved glucose metabolism, reducing the adolescents' risk of developing insulin resistance. Additionally, bone mineral density was not impacted by the surgery, suggesting that bone growth is not affected.

Dr. Nadler is the co-director of the Obesity Institute at Children's National Medical Center, which is comprehensively addressing the epidemic of childhood obesity. Staff includes pediatricians, nutritionists, psychology experts, heart specialists, gastroenterologists, and surgeons who treat patients and families in a clinical setting. The Obesity Institute also includes scientists looking at genetic differences and racial disparities, especially among children and adolescents, as well as community-based research among different ethnic groups.

Dr. Nadler was an investigator for Allergan, which makes the device used in the study. Funding was provided by the Harris Obesity Prevention Effort at New York University and performed at NYU Medical Center.


Posted by: Evelyn    Source

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Senate panel adopts bill restricting generic drug delays

Washington The Senate Judiciary Committee on Oct. 15 approved a bill that would restrict brand-name drug companies' abilities to settle patent disputes by paying drugmakers to delay the introduction of generics -- an arrangement sometimes called "pay-for-delay."

The committee voted 12-7 to adopt the measure, known as the Preserve Access to Affordable Generics Act. The bill has eight co-sponsors, including two Republicans. One of them -- Sen. Charles Grassley (R, Iowa) -- said the legislation is a response to a flurry of pay-for-delay arrangements after two appellate court decisions in 2005 allowed such deals. Nearly half of all patent settlements in the two years after the decisions involved pay-for-delay, he said.

"Our bill takes direct aim at anti-consumer, anticompetitive agreements between generic and brand-name pharmaceutical manufacturers that line drugmakers' pockets at the expense of consumers," Grassley said.

The bill would presume that pay-for-delay deals are illegal. But the companies would have a chance to provide clear and convincing evidence in court that the settlement provides more pro-competition benefits than anti-consumer effects. If not, the Federal Trade Commission could issue a cease-and-desist order and pursue financial penalties against the parties.

Generic Pharmaceutical Assn. President and CEO Kathleen Jaeger said the bill needs a Congressional Budget Office cost estimate to help judge its merits. Sometimes patent settlements actually lead to the earlier introduction of generic drugs, which benefits consumers, she said. "Without the ability to settle litigation, generic companies are far less likely to challenge brand patents to the detriment of the health care system and consumers."

Sen. Orrin Hatch (R, Utah) said he agrees on the need to stop anti-consumer settlements, but he did not support the bill, partly because he believes it could discourage generic drugmakers from pursuing patent infringement lawsuits. "We've made some significant improvements to this bill, but I don't think we're there yet."

Sen. Herb Kohl (D, Wis.), the bill's sponsor, first introduced the measure in 2006. A House Energy and Commerce subcommittee approved its own legislation in June that would ban pay-for-delay agreements.

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Senate rejects plan to repeal Medicare physician pay formula

Washington Senate Democratic leaders took steps to move a stand-alone bill that would have repealed the widely criticized Medicare physician payment formula in advance of other health system reforms, laying the foundation for a new system to update doctor rates. But the legislation was blocked Oct. 21 by Republicans and Democrats who expressed worries about its cost.

The development means that a multiple-year Medicare payment solution will have to wait until after the Senate takes care of a national health system reform bill later this year, Senate Majority Leader Harry Reid (D, Nev.) said after the vote.

Sen. Debbie Stabenow (D, Mich.) on Oct. 13 introduced the Medicare Physician Fairness Act (S 1776), which would abandon the current physician pay formula and set future annual payment updates at zero, a revision that would cost roughly $245 billion over the next decade. By passing a bill that repealed the sustainable growth rate formula and eliminated its accumulated spending target debt, budget constraints that have hobbled permanent pay reform in the past would have been lifted, thereby allowing a new system to be crafted through future legislation.

"Enough is enough," Stabenow said before the vote. "Enough of running physicians up to the brink every year without them knowing what is going to happen. This legislation will wipe the slate clean."

But by a vote of 47 in favor to 53 opposed, the Stabenow bill failed to proceed beyond the first of possibly several procedural challenges that would have required 60 votes to overcome. A successful vote would have brought the legislation to the floor and limited debate on it.

The bill also would have been subject to a budgetary point of order. Because the costs of scrapping the payment formula wouldn't be paid for, the bill would have violated budget rules and raised the federal deficit.

"I don't know of a single person who wants to see reimbursement cuts to doctors who treat Medicare patients, but if Congress is going to step in and prevent it, we shouldn't do it by racking up more debt on the government's credit card," Senate Minority Leader Mitch McConnell (R, Ky.) said before the vote.

The deficit issue also resonated with some key Democrats. For instance, Senate Budget Committee Chair Kent Conrad (D, N.D.) said he could not support the Stabenow bill without finding money to offset its costs. He instead floated an offset, $25 billion measure that would prevent physician cuts and replace them with annual 0.5% pay increases for only two years, through 2011. At this article's deadline, Senate negotiators were considering Conrad's proposal or a one-year patch as a possible interim measure.

Democratic House leaders indicated earlier in October that they would take steps to strip a 10-year Medicare physician payment provision out of pending health system reform legislation and move it as a separate measure. That action also would have the effect of lowering the projected cost of the House reform bill.

But leaders in that chamber want to pass the payment solution in conjunction with statutory "pay-as-you-go" legislation. That move would allow the physician pay piece and several other measures to raise the federal deficit, but would require budgetary offsets for any other new spending going forward.

Doctors, seniors step up the pressure

The American Medical Association and other physician organizations came out in strong support of the Medicare Physician Fairness Act soon after its introduction. AMA President J. James Rohack, MD, said the Association was "deeply disappointed" with the vote and said the Senate had failed Medicare beneficiaries.

"There is widespread agreement among Republicans and Democrats that the formula is broken and needs to be repealed," he said. "Congress created the Medicare physician payment system, and Congress needs to fix this problem once and for all to fulfill its obligation to seniors, baby boomers and military families."

PhotoAn AMA ad calls for the Senate to pass legislation to preserve access to health care for America's seniors.[Photo from AMA video]

The AMA launched a television ad campaign Oct. 15 featuring seniors and physicians calling on the Senate to protect Medicare security by repealing the physician payment formula. The ad urged viewers to call their senators in support of the Stabenow bill.

Physician organizations also picked up key support from the seniors group AARP.

AARP and the AMA sent an Oct. 16 letter to the Senate urging lawmakers to pass the bill. "The continuing threat of steep Medicare payment cuts jeopardizes seniors' access to care and physicians' confidence in the government's commitment to funding a strong and reliable Medicare program," the letter stated.

Leaders of the AMA, AARP and the Military Officers Assn. of America appeared with Stabenow at an Oct. 20 news conference at the Capitol in an effort to push support for the legislation over the 60-vote margin.

But Rep. Wally Herger (R, Calif.) questioned AARP's endorsement of the measure, saying it was expected to result in more than $60 billion worth of Medicare premium increases for seniors. By law, 25% of any increases in Medicare Part B spending must come from beneficiaries' premiums unless Congress finds additional funds to keep premiums stable, he noted.

"It makes no sense for AARP to abandon their long-stated legislative priorities, which had included ensuring Medicare physician payment reform wouldn't increase seniors' premiums," Herger said.

A two-step process

Even if the Senate and House end up agreeing on some plan that involves repealing the current Medicare physician pay system, a new update formula would be needed if doctors were to receive rates that track their costs of providing care.

Congress could wipe the budgetary slate clean and eliminate reductions going forward, but Medicare still would need a new way to update physician pay, said Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians. "That will be a second piece of legislation that still needs to be developed. But you can't get to that step two until you get rid of the accumulated cuts."

Dr. Rohack reiterated the AMA's support for the permanent repeal language in the House health system reform bill. The House measure proposes establishing a new formula, starting in 2011, that would allow annual spending targets to grow based on a rate of the gross domestic product plus 1%. It also would provide a 5% Medicare bonus for physicians in specialties traditionally considered to be primary care.

The Senate Finance Committee version of health reform, which Democratic leaders still were busy merging with another bill, would replace the planned 21.5% cut in 2010 with a 0.5% increase, but it would not provide any additional updates in future years.

Dr. Rohack reiterated that a permanent Medicare pay overhaul -- not a temporary patch -- is an essential part of health system reform, regardless of the path it takes to enactment.

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Health co-op compromise might be part of final system reform bill

Washington -- Health insurance cooperatives are being pitched by some on Capitol Hill as a promising way to expand health coverage to the uninsured without giving the federal government too heavy a hand in the process. But some critics say the concept is too lightweight to do much good.

The health system reform bill approved by the Senate Finance Committee on Oct. 13 does not include a public insurance plan option favored by Democratic leaders and President Obama. Rather, it would implement member-owned health insurance co-ops that would operate at the state level to offer coverage for the uninsured.

At this article's deadline, Democratic leaders were still working on a final Senate bill for floor consideration based on the Finance legislation and a more liberal measure passed by the Senate Health, Education, Labor and Pensions Committee. Although the public option might be incorporated into the final bill, co-ops also might play a role, perhaps as a fallback for states that decide against participating in a federal plan.

But the co-op concept has its congressional detractors. Foremost among them is Sen. Jay Rockefeller (D, W.Va.).

"This is a dying business model for health insurance," Rockefeller wrote in a Sept. 16 letter to Senate Finance Committee Chair Max Baucus (D, Mont.) and Sen. Charles Grassley (R, Iowa), the panel's ranking GOP member. "Moving forward with health insurance cooperatives would expose Americans, who are hoping for a better health care system, to a health care model that has already been tried and largely failed in the vast majority of the country."

5 consumer health insurance co-ops are operating in 4 states.

Rockefeller ended up voting for the Finance reform bill, but he vowed to continue pushing for the inclusion of a public option in the final Senate legislation.

Over the summer, Rockefeller asked for more information on co-ops from the National Cooperative Business Assn., the U.S. Dept. of Agriculture and the Government Accountability Office. According to the NCBA, there are only five consumer health insurance co-ops, operating in four states. Baucus has proposed investing $6 billion in new co-ops to offer nonprofit, member-run health plans.

But Rockefeller said it would be unwise to invest that much money in a largely unproven concept.

Co-op executives speak out

Executives with the existing health insurance co-ops say they are running a viable model for providing premium health care to their customers. But some also question the rationale of duplicating the model on a national scale.

"The reason to look at the model is because it's a group that gathers together to provide comprehensive care built on a primary care model which has to operate on a budget because it's integrated with an insurance plan," said Eric Larson, MD, MPH, executive director of the Group Health Insurance Institute, the research arm of the Group Health Cooperative in Seattle. "Cooperatives can deliver high-quality care and presumably could do a better job of controlling costs than some of the inflationary models that exist otherwise. Having said that, to start from scratch and use the co-ops as a method that would solve the problems of nationwide access and cost is a tall order."

One reason Dr. Larson expresses hesitance with a national co-op model is that GHC was founded in 1947 and has been able to build up a base of 600,000 covered lives over the years only after a rough initial start. "In the early days, it was ostracized by the community," he said.

Still, Dr. Larson remains a big proponent of co-ops. He notes in particular the fact that physicians don't feel compelled to conduct unnecessary procedures under the member-owned plans.

"Where I was before, we were not encouraged to do transactions over the phone or to use electronic medical records. And here, if you can do as good a job or better without a person having to come in, the incentive is there to do that."

Some said Rockefeller and other critics are too focused on a public plan option to give fair consideration to co-ops.

"Cooperatives are not antiquated. They are a viable and tangible business model which services their members in a manner consistent with their needs," said Al Wearing, sales and marketing director for the Group Health Cooperative of South Central Wisconsin. It has been operating for 33 years and has roughly 55,000 members.

"In some respects, Sen. Rockefeller is correct in that just creating cooperatives would not solve the fundamental problems of delivering health care in this country, just as the public plan option has little chance of resolving the primary issue," Wearing said. "The fundamental issue here is the cost of medical care. All of the legislative proposals offer solutions to access, but there never seems to be any true understanding of the costs."

Co-ops as a compromise

Some policy experts said a national co-op model could be a manageable and efficient system if the government made certain changes in the way they treated the programs.

"This is not an issue of corporate structure or insurance regulation, but really a question of tax policy," said Ed Haislmaier, senior research fellow in the Center for Health Policy Studies at the Heritage Foundation, a conservative think tank based in Washington, D.C. "To the extent that the public feels it's a good idea, they may go there, because some mutual insurance companies have done very well."

The American Medical Association has signaled some openness to the concept of co-ops. "A co-op could be a good compromise," said AMA President J. James Rohack, MD. "More than two decades ago, physician delegates to the AMA voted to support co-ops. While the co-ops under discussion may not exactly match the original concept supported by AMA physicians in the '80s, the underlying rationale -- to help extend affordable coverage to as many people as possible -- remains the same."

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