Time running out for doctors to dispute device and drug makers' disclosures to feds

WASHINGTON – Dr. Julie Adams has signed up to see what medical device and drug makers have reported to the government about her financial ties with their industries.

But Adams, an orthopedic surgeon at the University of Minnesota, is worried about her peers. A Sept. 10 deadline is approaching for physicians to check and challenge new disclosures that will become public as part of national health care reform.

"The burden is on physicians to correct the data," Adams said.

If they don't, it becomes public on Sept. 30 as part of the Physicians Sunshine Act, a law that applies to hundreds of thousands of doctors and roughly 1,100 teaching hospitals across the country. It is intended to allow patients to see monetary links between their doctors and device and drug companies. It aims to cut down on conflicts of interest that can affect treatment decisions.

But there are major challenges in assembling and validating the data. As times runs out to review the accuracy of the information, the U.S. Centers for Medicare and Medicaid Services (CMS) will not say how many individuals and institutions have signed up to review the data or how many have disputed it.

While registration is voluntary, participation by individual physicians is critical, officials at the University of Minnesota stress, because those who don't play could pay with an unnecessary hit to their image.

"Someone with a research grant would not want to see it reported as speaking fees," explained Dr. Mark Paller, a senior associate dean at the University of Minnesota medical school. "Those have totally different implications."

"At this point there is a lot of uncertainty about how the data will be reported," said Dr. Richard Ehman, who chairs the Mayo Clinic's medical-industry relations committee. For instance, Ehman said, the way the rules are written, editorial support for a doctor writing a paper might be reported as a gift.

Incorrect data can be challenged and corrected after it becomes public. But having bad information in the public database for any amount of time could cause misunderstanding by patients and frustration among physicians.

That's why officials at the U have sent a series of blast e-mails to more than 3,000 medical and dental faculty members in recent months discussing what constitute gifts, consulting fees, royalties, licenses, perspective ownership, educational support and other categories of industry payments.

Mayo officials have directly contacted hundreds of doctors known to have consulting relationships with industry, made departmental presentations, posted information in internal publications and placed staff on standby to talk to physicians who need help registering.

In anticipation of the deadline, University of Minnesota sent out another reminder last week, said Lynn Zentner, who directs the school's office of institutional compliance.

For those who have paid attention, the registration process itself has been complicated by nonintuitive directions and a major reporting glitch.

Paller called his sign up "a very unpleasant experience." "It was just awkward," he said. "The instructions weren't clear. It wasn't obvious where to click on the website. Anything that could be difficult was."

Ehman said his registration was "terribly onerous," but that data he found reported about his ties with industry were accurate.

That has not been the case for everyone. CMS had to take the physician sunshine registration system offline Aug. 3 after a doctor using it reported a problem of mistaken identity. CMS found that device and drug manufacturers and group purchasing organizations had intermingled state licensing numbers and national provider identification numbers for physicians with the same first and last names. That mistake had in some cases attributed payments to the wrong people.

Finding a fix kept the system down for several days and forced CMS to extend its original Aug. 27 deadline for physicians to register, look at and challenge data until Sept. 8. But late Thursday CMS announced that it would have to take the registration system offline again for portions of two more days, forcing yet another extension, this one until Sept. 10.

Medtronic has "communicated with many of our customers about our disclosure of payments and to date have received inquiries or disputes on 0.3 percent of the payments we submitted to CMS," spokeswoman Cindy Resman said. "Context is important. Collaboration with physicians is critical. They should be reimbursed for the work they do."

Boston Scientific Corp., another devicemaker with a major presence in Minnesota, declined to release specific numbers about disputed payments. "Boston Scientific has received inquiries from some health care providers as to data we have submitted to CMS," the company said in an e-mail to the Star Tribune. "We intend to address all inquiries within the relevant timelines."

At the Minnesota Medical Association, CEO Dr. Robert Meiches believes most of the state's physicians have received information about the upcoming disclosures. Meiches said he has not yet heard any complaints from association members about bad data.

"What I can't tell you," he said, "is how many physicians have registered. Doctors are barraged with information, some clinical, some administrative."

Equally important, the onus for settling disputes rests with doctors and drug and device makers, not the government. Questioning the data within the Sept. 10 time frame does not guarantee resolution before the Sept. 30 posting date. If physicians and companies cannot agree on who was paid for what, the industry's numbers become public with a footnote that says they are in dispute, Zentner said.

"Otherwise," Zentner noted, "the data could be out there incorrectly."