Medical Device Daily Washington Editor
Sen. Max Baucus (D-Montana), chairman of the Senate Finance Committee, finally published the committee's plan for healthcare reform as support for the various reform bills shows signs of fraying.
The Finance Committee bill, which runs 223 pages, includes the expected provision calling for device makers to cough up $4 billion each year to help fund the expansion of coverage (Medical Device Daily, Sept. 11, 2009). The bill also includes an overwrite of community ratings and other risk determination models with a federal standard for individual markets that allows premiums to vary only by age, tobacco use and family size.
The bill, dubbed America's Healthy Future Act of 2009, does not include a public option, but Baucus had stated prior to the speech last week by President Obama that he did not think the Senate would pass a bill with a public option (Medical Device Daily, Sept. 10, 2009,/a>). Baucus has also gone on record as saying that the U.S. would probably never be a single-payer nation (Medical Device Daily, Feb. 5, 2009) in remarks he made earlier this year at the National Health Policy Conference in Washington.
The Finance Committee bill is encountering headwinds from the Republican Party for a number of reasons. The Finance Committee's ranking minority member, Chuck Grassley (R-Iowa), said he sees the GOP being "pushed aside by the Democratic leadership so the Senate can move forward on a bill that, up to this point, does not meet the shared goals for affordable, accessible health coverage that we set forth when this process began." Grassley stated further that Republican concerns over cost and taxpayer funding for abortion services were also among the concerns several member of the GOP had.
However, Republicans are not the only ones concerned about the abortion issue. Bart Stupak (D-Michigan) expressed concern over the prospect that H.R. 3200, the House healthcare reform bill, would also allow federal dollars to be used for abortions. Stupak has gone on record as saying he will oppose the bill if he is unable to offer "a more explicit" exclusion of plans getting federal money if those plans offer abortions as part of the benefit package.
As for how much the legislation will cost, Baucus estimates that the tab will run to about $856 billion over 10 years, and estimates are that the legislation would provide coverage for 95% of Americans, excluding illegal immigrants. Part of the increased coverage would arrive in the form of a higher eligibility limit for Medicaid to 133% of the federal poverty level (FPL), another detail that had made its way into circulation recently. Families with incomes of as much as 400% of the FPL might be eligible for tax credits for enrollment.
Steve Ubl, President/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said in a Sept. 16 statement that the association sees "much to applaud in the proposal," but that AdvaMed still opposes "the inclusion of an unfair and counterproductive $40 billion tax on medical devices."
Ubl said that device makers are "already making substantial contributions to the cost of health reform through billions of dollars in cuts to our major customers such as hospitals, clinical labs, durable medical equipment providers and imaging services that will be passed on to manufacturers," characterizing the additional $40 billion in taxes as "particularly onerous." Ubl noted that "the majority of device companies combined spent a total of about $9.6 billion on research and development in 2007," and that the yearly tax "also exceeds the total amount of venture capital dollars invested in device companies in 2007 ($3.7 billion)."
Ubl promised that AdvaMed would "continue to work with congressional leaders and the White House to further health reform and to eliminate this counterproductive tax from any reform package considered by the Congress."
Maker of 'foot tanner' gets warning
Medical devices come in all shapes and sizes and for every use "under the sun," and a recent warning letter exemplified that understanding. A company called Solafeet (Sarasota, Florida) received a Sept. 2 warning letter stating that the company's product, an ultraviolet tanning unit used to impart a healthy glow to the feet, had a label that did not properly notify users of the maximum recommended time of usage. The operator's manual was also said to lack such information in addition to failing to inform the user of the need for protective eyewear. The unit looks similar to a footbath, just large enough to accommodate two feet.
The firm's president, William Johnson, confirmed to Medical Device Daily that FDA "had a problem with the label" regarding exposure time. He said firms can get a waiver if the requirement for the label "doesn't fit the circumstances," which he said pertained in this case "because its' a consumer product." He said other device makers have obtained waivers for similar situations.
"We're simply asking for similar treatment," Johnson said.
The origin of the problem, Johnson said, is that when the company filed its paperwork with FDA, "we sent them a picture with an older machine," which featured a label that did not limit the user to 15-minute episodes. "We had changed that about a year ago when we got our first ultraviolet exposure data," he said.
Johnson said the social scene in Florida, at least, is replete with those who spend time on the golf course and end up with a bad case of "sock tan," which he acknowledged is an especially annoying situation for women who prefer open-toe shoes. The product should do well in the nation's Sunbelt, he said.
Johnson remarked that the UVB rays used by the machine are also good at killing foot funguses and that Solafeet is developing a clinical trial in pursuit of such an application.
Mark McCarty, 703-268-5690;