A Medical Device Daily

The Congressional Budget Office said a slate of legislative options shaped in the Senate Finance Committee could be priced under $1 trillion within a 10-year timeframe and expand coverage to 97% of Americans.

"We are much closer on scores from CBO," Senate Finance Committee Chairman Max Baucus (D-Montana) said at a news conference. "In fact, CBO now tells us we have options that would enable us to write a $1 trillion bill fully paid for."

While a bill has yet to emerge from the committee, Baucus nevertheless said the number-crunching from CBO moves them closer toward a bipartisan agreement. Still, Sen. Orrin Hatch (R-Utah), a senior Republican on the Finance Committee, cautioned that the numbers could be premature and would likely change. "You can't really make decisions until you've seen the language and seen the scoring," he said, referring to the CBO cost assessment.

The announcement capped two weeks of tough going for healthcare negotiations on Capitol Hill as price tags as high as $1.6 trillion over 10 years sent senators back to the drawing board and forced deadlines to be repeatedly reset.

Lawmakers from both parties declined to comment on specifics of how the bill would be paid for or which options were tweaked in order to lower the overall cost.

Senate Budget Chairman Kent Conrad (R-North Dakota) said the committee had been able to lower costs by lowering the amount of money the federal government would pay to help subsidize some Americans as they transition from one payer group to another.

"By altering those subsidy levels, you get the more favorable scoring that shows the bill can be paid for," he said.

The Finance Committee had hoped to pass a bill by now, but given the setbacks of recent weeks the announcement was seen as progress. Of the five House and Senate panels writing healthcare bills, Finance is the only one with a real chance of producing a bipartisan bill, something President Barack Obama has repeatedly said he wants. The committee will resume work when lawmakers return to Washington after the July 4 holiday recess.

FDA warns Medtronic on two products

The FDA warned Medtronic (Minneapolis) about what the agency called a failure to properly report and remedy flaws in the company's Synchromed drug pump and its MiniMed insulin pump.

In a warning letter, the FDA said it took Medtronic almost two years to recall its Synchromed II pumps after discovering a missing propellant in some versions.

The agency said it is "concerned with [Medtronic's] failure to initiate a recall ... in a timely manner." In the letter, posted on the FDA's web site this past Wednesday, the agency also said the company didn't follow proper reporting procedures involving complaints about the insulin pump.

The warning letter was the result of an FDA inspection of a Medtronic Puerto Rican plant in late 2008. Medtronic said it is "working diligently to respond" to the FDA.

The bulk of the letter relates to the company's Synchromed drug-infusion pump. The company commenced correspondence with the FDA in January aimed at correcting the manufacturing violations.

The FDA said "multiple" pumps were released and implanted in patients even though they weren't filled with a propellant needed to operate correctly. The pumps are used to release pain medicine, as well as the drug baclofen to reduce spasticity in patients.

In "adverse-reaction" reports to the FDA, health professionals have reported cases with the drug pump such as a patient with "symptoms of overdose" such as "somnolence, drowsiness" and flaccid arms and legs. Another described "somnolence and respiratory problems." It couldn't be determined whether these events were caused by the pumps.

Medtronic said no deaths have resulted from any of the issues.

CDC unveils web site on workplace obesity

The Centers for Disease Control and Prevention (CDC; Atlanta) unveiled LEANWorks!, a web site designed to help businesses address obesity. LEAN stands for Leading Employees to Activity and Nutrition. The new web site was announced at a National Business Group on Health meeting in Washington.

"CDC LEANWorks! was developed in direct response to organizations asking CDC for help in addressing the obesity epidemic. Specifically they wanted to know what interventions were effective in helping employees maintain a healthy weight," said William Dietz, MD, PhD, director of CDC's Division of Nutrition, Physical Activity and Obesity. "CDC has identified science-based interventions that work to prevent and control obesity. CDC LEANWorks! provides the tools that employers need to take action."

The free web site was developed particularly for small and mid-size companies, which typically have more limited resources to devote to obesity prevention efforts. However, the tools and resources available on CDC LEANWorks! can benefit companies of any size. CDC LEANWorks! can help employers calculate the cost of obesity for their organizations and develop tailored approaches to help control these costs through interventions such as fitness classes, lunchtime health education sessions, weight management programs, and more.

Obesity is a risk factor for high blood pressure, Type 2 diabetes, stroke, and heart disease. Obese individuals spend 77% more money for necessary medications than non-obese persons.

"Obesity affects more than just healthcare costs. It also has a significant impact on worker productivity because the more chronic diseases employees have, the more likely they are to be absent from work, or less productive if they come to work sick," said Janet Collins, PhD, director of CDC's National Center for Chronic Disease Prevention and Health Promotion.

"Workplace obesity prevention programs can be an effective way for employers to reduce obesity and lower their healthcare costs, lower absenteeism and increase employee productivity," said Dietz. "Employers may also see other indirect benefits when they implement these programs such as improved employee morale, increased worker retention, and improved recruitment of new employees."