By Ellie Hensley, Atlanta Business Chronicle
Georgia is home to hundreds of doctors who perform life-saving procedures and provide top-notch care. But what many don’t know is some of these doctors are hard-working inventors with lucrative side businesses that bring them hundreds of thousands of dollars a year.
Doctors in Georgia received $59 million in non-research medical payments and services in 2015, according to the Centers for Medicare and Medicaid Services, which has tracked and published these numbers for the past three years. The Affordable Care Act introduced the Physician Payments Sunshine Act in 2013, which mandates that medical device and pharmaceutical companies disclose how much they are paying doctors for royalties from patents, consulting work, speaking fees and even reimbursements for food and travel. The goal is increased transparency for patients in understanding how corporate payments to physicians might be influencing the care they receive, such as favoring one drug or device over another — a core concern in today’s tangled health care environment.
But these payments aren’t usually nefarious, as demonstrated by Georgia’s top-ranking doctors, who are focused on innovation, not entertainment.
“The highest paid physicians in Georgia have invented something that has been really helpful when it comes to improving health outcomes and capabilities in health care,” said Will Hamilton, a manager at Veralon, a health-care consulting firm. “Most of the people receiving this money have been involved with and often invented medical technologies.”
Take Dr. Regis Haid, a neurosurgeon at Atlanta Brain and Spine Care, who received $2.7 million in 2015 from royalties for his spinal implant devices from companies like Globus Medical and Medtronic. He has over 20 patents for various spinal technologies, like the Atlantis Plate and the Prestige Disc.
“Since 1988, I’ve designed implants that we rebuild spines with after trauma, after tumors or for degenerative conditions,” Haid said. “I’m only paid when an implant is put in a human being, and I’m not paid anything for implants that are placed in any hospital system I work at.”
Haid, who is affiliated with Piedmont Healthcare, became passionate about this field after he sustained an injury playing rugby in college at Notre Dame. One of his former students later implanted one of Haid’s own spinal devices in his neck, and he bears several small scars to prove it. He estimates that hundreds of thousands of others have been implanted with his devices over the years.
Drs. Reay Brown, an ophthalmologist at Atlanta Ophthalmology Associates, and Mary Lynch, an ophthalmologist at Emory Eye Care, are Nos. 2 and 3 on the list, with respective payments and services valued at about $1.7 million each in 2015. Brown said his payments come from selling he and Lynch’s patents to their main competitor, Glaukos Corp. He and Lynch have been developing devices together for years and have 25 patents, but Brown stresses that their success didn’t come quickly or easily.
“In research, there are some people who ultimately do very well and invent something that leads to a big payout, but I’ve done research and tried to develop things for 30 years and I can tell you that it’s really difficult,” Brown said.
Despite the hardships, Brown and Lynch didn’t give up, and now their patented shunt device for ocular disorders is owned by Glaukos. It is fundamental to the company’s flagship product, iStent, which Glaukos believes is the smallest medical device ever approved by the U.S. Food and Drug Administration.
“Every single thing, every device used in surgery was developed by somebody who took the time, made the investment and took the risk to develop something,” Brown said. “If no one does that, innovation doesn’t happen.”
Because of the way the Sunshine Act is worded, business people who have their MD can still show up in the database. Such is the case for Dr. Jay Yadav, who hasn’t been in clinical practice since 2008 but still has his medical license. The $1.3 million listed on CMS for Yadav actually comes from four escrow payments he received from selling his company,
CardioMEMS, which manufactures a paper clip-sized implant that helps physicians wirelessly manage heart failure and aneurysms. St. Jude Medical Inc.bought the company for $455 million in 2014.
“As long as you still have a license to practice medicine, which most doctors are going to keep because they worked so hard to get it, you’re going to get this reporting,” Yadav said.
Seven years ago, Dr. James Chappuis, owner and CEO of Spine Center Atlanta, sold a device called a fenestrated screw to Medtronic Sofamor Danek USA Inc.The device is a screw with holes to inject cement, which anchors the screw to the spine to prevent it from loosening during surgery.
“I saw screws loosening and backing out and thought, how can we anchor this screw and prevent that?” Chappuis said. “We did biomechanical studies and found that it does increase pullout strength and improves toggle.”
The majority of the $536,079 Chappuis received in non-research based payments last year are royalties from this device, which is used in 92 countries and was this year approved by the FDA.
“Now that it’s in the U.S., that number will probably double over the next year or two,” Chappuis said. “But probably the most satisfying thing to me is how many patients it’s hopefully helped. That’s as gratifying as anything, that some idea you came up with has helped people.”
Georgia doctors received $13.8 million in royalties and licensing fees in 2015, but the highest-ranking business purpose was compensation for services other than consulting, including speaking engagements. Georgia doctors received $16.1 million for these services in 2015.
This type of compensation is looked upon by some as a gray area.
“That was done a lot 10 or 15 years ago; I never did it then and I still have a little of an issue doing it now, because companies are really trying to influence you with their products,” Chappuis said. “It’s worthwhile if done properly, though I do have concerns.”
But some doctors, like Dr. Narendra Singh, an internal medicine and cardiovascular diseases physician at Atlanta Heart Specialists, give these speeches because they actually participated in clinical trials for the drug or device before it was approved by the FDA, and they believe it can improve lives.
“There are two types of speakers, and the first has no experience with the drug they’re selling,” said Singh, who received $334,941 in non-research based payments last year. “They’re just selling based on info they’re given… I speak for a number of companies, all of which I’ve done the research for, so I know the products very well.”
In 2015, Georgia doctors also received $6.9 million for food and beverage reimbursement, $5.7 million for travel and lodging, $359,367 in gifts and $9,843 for entertainment purposes. Such payments have drawn criticism from some in the health care field. Accepting expensive gifts from pharmaceutical companies and taking advantage of travel privileges to exotic locales can be seen as a conflict of interest. Companies have been required to disclose these payments since 2009.
“It’s like everything else in life,” Haid said. “There’s a few bad apples, then there are people that try to maintain integrity and get paid fair market value for things they actually contribute.”
Yadav said he believes this type of transparency should apply to all high-profile jobs, not just doctors.
”I think most physicians would say they wish there was more uniformity in some of these standards for lawyers, politicians and so forth,” Yadav said.
Although the data can be difficult to interpret, it is a very valuable resource for patients, according to Beth Stephens, health access program director for consumer advocacy group Georgia Watch.
“The data helps consumers get the answers they are seeking if they are concerned that their doctor may have a financial relationship with a drug or device company,” Stephens said in an email. “It shines a light on any conflicts of interest that might exist…We hope this level of required disclosure and transparency encourages manufacturers to invest more in research and less in marketing.”
But it’s important to keep in mind the data listed on CMS’ Open Payments website, https://www.cms.gov/openpayments/, isn’t always accurate.
Dr. Brian Pearlman, a physician at WellStar Medical Group Internal Medicine, said he received only $12,000 in non-research payments last year from speaking engagements. He plans to dispute the listed payment amount, $282,113, attributed to him on the CMS website. Dr. Ronald Goldstein, a dentist at Goldstein, Garber and Salama, is contesting the $337,366 listed, which he said includes supposed payments from companies he has never worked with. He said his true payment amount is $278,336, and it includes consulting fees from PeterBrasseler Holdings LLD and dental instrument royalties from Hu-Friedy Manufacturing Co.
After the Physician Payment Sunshine Act passed, many pharmaceutical companies slashed payments to speakers and some, like GlaxoSmithKline, announced they would stop paying doctors to speak about their drugs. This new transparency has forced both doctors and industry to pay more attention to the nature of their payments. But the relationship between the two will never go away, and that’s a good thing.
“Most of the recent developments in neurosurgery have been a partnership between surgeons and industry to bring things to market to help our patients,” Haid said. “A lot of advances are not coming from National Institutes of Healthdollars. Most of them are coming from partnerships in industry.”
Copyright © 2016 Atlanta Business Chronicle
Source: Atlanta Business Chronicle
