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

  • Article by: JIM SPENCER , Star Tribune
  • Updated: August 30, 2014 - 2:00 PM

Sept. 10 is the deadline for doctors to dispute info.

– 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.”

Many doctors in Minnesota have had to make private institutional disclosures about financial ties to industry for years. Medtronic, the state’s largest medical device maker, began voluntarily disclosing financial ties to physicians on its website in 2010. Drug companies have also voluntarily reported financial ties to physicians to the state government for inclusion in a public database. But the Physicians Sunshine Act is a whole other level of transparency. Device and drugmakers must report to the federal government so-called “transfers of value” to doctors, osteopaths, dentists, podiatrists, optometrists and chiropractors of more than $10 in a single transaction and, cumulatively, more than $100 in a year.

“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.

“We have encouraged [faculty] to pay attention to this so they don’t get blindsided,” she said.

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.

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