Records in a congressional inquiry give insight into Dr. David Polly's billing records as consultant for Medtronic.
Dinners. Travel to foreign locales -- and not-so-foreign locales. Meetings with executives and occasionally members of Congress. Lots and lots of e-mails and phone calls. Grand total: more than $1 million.
Billing records released last week in a congressional investigation involving Fridley-based Medtronic Inc. provide a telling peek at the often-controversial relationships between medical device companies and physicians.
The 142-page document, which is part of an investigation by Sen. Charles Grassley, R-Iowa, focuses on the consulting work of Dr. David Polly, a surgeon who heads the spine division at the University of Minnesota's Department of Orthopaedic Surgery.
Such consulting agreements are common in the medical technology business, but recently they have attracted considerable scrutiny from Congress and the U.S. Department of Justice.
Companies argue that doctor input is crucial to make medical devices safer and better. Critics say that it constitutes a conflict of interest -- that consulting money may skew the brand of device used or the manner in which patients are treated.
The documents reveal that the doctors can be paid for activities that seem to have little to do with surgery or medical practice.
Grassley's July 24 letter, sent to U of M President Robert Bruininks, documents hundreds of charges incurred by Polly from 2003 through 2007. In that five-year period, Polly received $1.2 million from Medtronic for consulting, expenses and honoraria.
By 2007, Polly was paid $4,750 a day, or $594 an hour. The pact has a cap of $400,000 a year, which Polly has not exceeded, and an exclusivity clause that prevents him from engaging in product development for other companies.
In an interview last week, Polly said he works with Medtronic because "the company struck me as ethical and above-board. They have good products, and in some areas, the best products. ... I've seen their commitment to advancing our knowledge base [in treating the spine]. If a solution doesn't work, they won't bring it forward, so this led me to a certain comfort level with them.
"It's all about finding the best answers for the patient," he added.
But in the wake of the controversy, Medtronic said last week that it is taking a "hard look" at its practices for managing consulting relationships.
"We are investigating specific charges for which Dr. Polly billed us, and determining whether or not they fit our standards and policies, and if newly enhanced standards are required," Medtronic spokesman Steve Cragle said in a statement.
He declined to comment about Polly's line-by-line billing "at this time."
It's unclear whether Polly's contract is typical of those covering hundreds of consultants employed in medical technology companies. His billing sheets contain the date and time of each activity, the services provided, the amount due and the apparent cost center charged. On some, a Medtronic employee had apparently pored through the expenses line-by-line and hand marked "OK" or "NO" in the margins. (Most are marked "OK.")
Records indicate that Polly contacted Medtronic officials frequently. In 2006, for example, the year that Polly received his most compensation, $358,588, he billed Medtronic on 233 days -- sometimes multiple times in one day.
He billed to check e-mail, sometimes in 5-minute increments. He also billed to make phone calls; in 2006, there were roughly 125 calls.
On April 30, 2005, he charged the company $750 for 90 minutes of "summarizing thoughts and opportunities" after a medical meeting. And on Feb. 12, 2004, he charged the company $350 to update his consulting log.
Occasionally, calls and e-mails were placed to the highest echelons of Medtronic, including then-Chairman and CEO Art Collins; Michael DeMane and Pete Wehrly, both of whom previously headed the company's spine division; and Dr. Stephen Oesterle, senior vice president for medicine and technology.
Even William Hawkins, now the company's chairman and chief executive, shows up in the records on at least three occasions. On July 21, 2006, Hawkins (then chief operating officer) visited the operating room at Fairview-Riverside Medical Center. For that, Polly billed Medtronic $2,000.
In a statement last week, Cragle said that Hawkins frequently makes trips to view surgical procedures involving the company's products. "In this case, [he] was unaware that Medtronic would be billed," Cragle said.
There are some common patterns in the charges. Typically, if Polly traveled to medical conferences nationwide or abroad or to the Memphis headquarters of Medtronic's spine division, he was paid $4,000, his daily rate. Occasionally, he would charge $4,000 or $2,000 to return from a conference.
Dinner meetings were often billed at $1,250, sometimes less. Charges for breakfasts and lunches were billed at $500 and $750. (Polly said the payments were for his time and that he usually paid for meals after reaching the industry's suggested limit of $125.)
Polly appears to have travelled worldwide to attend medical meetings on the company's dime. In 2006, for example, he took 14 trips to meetings in places such as Japan, Paris and Phoenix, billing $187,313 for travel and preparation.
Several entries indicate that Polly was discussing topics such as the cost-effectiveness of medical devices and "lobbying" members of Congress for better care for the nation's veterans.
On April 15, 2005, he charged $1,000 (a sum later reduced to $500) to meet with U.S. Rep. Betty McCollum, D-Minn., on new technologies to treat veterans injured in the Iraq war. McCollum's chief of staff, Bill Harper, said the two discussed "musculoskeletal research and medical treatment for troops."
As a retired member of the military and the former head of orthopedic surgery at Walter Reed Army Medical Center, Polly says he told members of Congress about his "passion for taking care of the injured sons and daughters of Americans and Minnesotans injured in the war." He said he discussed developing better options for treating war vets, only a portion of which involved Medtronic products.
On at least two occasions, Polly contacted Dr. Reed Tuckson, now executive vice president and chief of medical affairs for Minnetonka-based insurer UnitedHealth Group. Polly says they discussed the cost-effectiveness of spine fusion surgery, noting that he's conducted research on the topic as far back as 2000.
A few items stand out from the patterns. On Dec. 2, 2006, for example, Polly decided not to charge Medtronic to wake up one of its spine executives, Jim Cloar, at 4:30 in the morning. But he did bill the company $287 for a subsequent discussion in the car about "spinopelvic fixation" with Cloar and another Medtronic executive.
On Oct. 28, 2003, he charged the company $4,000 to discuss "pedicle screw mechanics" with Cloar and a second executive while "awaiting plane/changing plane and on the plane" for a Memphis meeting.
In September 2005, he participated with the company's public relations team to craft a "media blitz" before a meeting of the North American Spine Society, a premier event in the spine field. The entry states that Polly called patients on Medtronic's behalf and then charged the company $375.
Occasionally, Medtronic pushed back. In 2006, for example, $22,261 in charges related to a Medicare meeting on spine fusion surgery were "disallowed because of a conflict of interest," the documents state.
Sometimes Polly documented work that he didn't bill. On July 11, 2004, he appeared on a WCCO radio show to talk about lower back pain. But on that occasion, he didn't charge for his time.
Janet Moore • 612-673-7752