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Contents
In the Life Spine kickback settlement, Life Spine agreed to pay $5.5 million to resolve allegations that consulting fees, royalties and intellectual-property payments bought surgeons’ use of its spinal products. The company admitted that management reports compared surgeon payments with product use. One report calculated the return on those payments. When use fell, senior sales managers contacted surgeons or their distributors to push it back up.
The Justice Department based the company’s payment on its assessment of what Life Spine could afford. Life Spine designs and manufactures spinal implants and instruments used by orthopedic surgeons and neurosurgeons. The Justice Department announced the court-approved civil settlement on November 7, 2019. The company, its founder and chief executive, and its vice president of business development each admitted their part in the surgeon-payment program.
Life Spine admitted that it measured the sales associated with individual surgeons against the money it paid them. Between 2012 and 2018, it entered agreements with dozens of surgeons and paid them, and businesses they owned wholly or partly, millions in consulting fees, royalties and intellectual-property acquisition payments. Most substantially increased their use of Life Spine products after signing.
Approximately 21 of its top 30 product users received these payments. Surgeries performed by paid surgeons accounted for approximately half of domestic spinal-product sales during that period.
The admitted ROI calculation divided sales revenue associated with each surgeon’s product use by the consulting fees and royalties paid to that surgeon over the same period. The return being measured was product sales. The investment was money paid to the person choosing the implants.
The reports also prompted action. Life Spine admitted that senior sales managers contacted surgeons, or their distributors, when usage decreased and urged more frequent use. The payments showed what the company spent. The usage reports and follow-up showed what it expected back.
The whistleblower complaint alleged that sales-volume conditions sat underneath agreements described as consulting and product development. The written services included training, presentations, clinical papers and meetings with marketing and product-development staff. The complaint alleged that Life Spine paid consultants without requiring the promised product review, evaluation or feedback.
The complaint alleged that some patent agreements concerned products already on the market, with no intellectual property changing hands.
There is no transfer of intellectual property between a physician-consultant who signs a patent application purchase agreement and Life Spine. The agreements that the surgeons are parties to involve Life Spine medical device products that are already on the market and selling. The purpose of the agreements is to motivate surgeons to use Life Spine’s medical devices.
Whistleblower’s allegation, United States of America ex rel. BNHT LLC v. Life Spine, Inc., Butler and Loy, complaint, paragraph 36
The complaint also alleged that high-volume surgeons received below-market warrants to buy company shares through patent application purchase agreements. The alleged benefit extended beyond a consulting check to a stake in the manufacturer.
For the sales force, the alleged expectations were much more concrete than the contracts’ descriptions of services. The complaint described a surgeon with a $150,000 monthly sales quota. A sales executive allegedly instructed a representative to obtain the surgeon’s weekly surgery schedules to check Life Spine’s share of the procedures, then send weekly updates until usage increased.
Another alleged conversation tied annual renewal of a consulting agreement to a minimum volume of Life Spine implants. The surgeon was also expected to supply weekly surgical schedules. In that account, keeping the consulting job depended on the business the surgeon brought with it.
The complaint separately alleged that the company failed to report consulting arrangements and associated payments as required by the Physician Payments Sunshine Act.
A surgeon can determine which implant a hospital buys, while the hospital submits the bill for the procedure. The Department of Health and Human Services’ Office of Inspector General describes implants as physician preference items because physicians may make or strongly influence both the brand and the type of device.
Medicare usually includes the implant’s cost in payment for the hospital procedure or stay. A device sale can therefore reach the government through the hospital’s procedure claim. In Life Spine’s case, the government alleged that surgeons used the company’s products in procedures on Medicare and Medicaid patients, producing claims tainted by the kickbacks.
The 2020 Journal of Forensic and Investigative Accounting paper A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud emphasizes the bill sent to the government as the link between a scheme and a False Claims Act case. The paper explains that even when care was delivered, a claim can be false if the provider lied about meeting the government’s payment requirements.
The government’s allegation followed money from the manufacturer to surgeons, the surgeons’ implant choices, and the resulting health care claims. Patients depended on the surgeon’s judgment, while taxpayers faced bills for procedures the government alleged were influenced by kickbacks.
The founder and chief executive admitted involvement in choosing paid consultants, negotiating patent purchases and encouraging surgeons to increase product use.
According to the executive admissions in the settlement announcement, he helped identify and retain some surgeon consultants. He reviewed many patents the company considered buying and participated in some purchase negotiations, including initial acquisition fees and royalty rates.
He also received reports showing surgeon payments alongside product use on multiple occasions. When usage fell, he sometimes contacted the surgeons or their distributors to encourage an increase.
The chief executive agreed to a separate $375,000 civil payment.
The business-development executive admitted discussing continued funding of a surgeon’s product while encouraging greater use of Life Spine implants.
The executive helped review, select and approve surgeon consultants. He was also one of the managers who signed an agreement under which Life Spine licensed a static compression-plate patent owned by a company associated with a surgeon.
Life Spine spent hundreds of thousands of dollars attempting to develop and market the plate but encountered setbacks, while the surgeon accounted for over $3.7 million in Life Spine product sales from 2012 through 2016.
In 2016, the executive participated in two discussions covering both continued project funding and the surgeon’s recent decline in product use.
During those calls, he suggested that the surgeon increase use. The admissions describe one request to use Life Spine “more vigorously.” Later in the discussion, the surgeon suggested that they “renew our vows to each other.”
The company had spent real development money. Continued funding and the surgeon’s implant purchases nevertheless appeared in the same conversation. That is the part a product-development employee or sales representative might recognize: a project discussion becoming a discussion about how much the surgeon buys.
The business-development executive agreed to a separate $115,000 civil payment. The Justice Department based his settlement amount on its assessment of his ability to pay.
Innovasis provides a close parallel to Life Spine’s reporting system. The Innovasis whistleblower complaint alleged that spreadsheets kept off the company’s main computer drive compared surgeon use with compensation. Low purchase volume allegedly triggered pressure to increase use, threats to cancel contracts or termination of the agreements.
The complaint also alleged that surgeons seeking progress on inventions learned that Innovasis had refused to fund development. The government’s 2024 settlement announcement described alleged consulting and intellectual-property payments to induce implant use. It alleged that purchased or licensed intellectual property lacked a valuation before purchase and never supported meaningful product development.
SpineFrontier supplies a more direct admission about how supposed consulting work was counted. In a separate civil settlement, a surgeon admitted estimating consulting hours from the number of times he used the company’s products, without tracking actual consulting time.
The hospital side appears in Sanford Health’s settlement, which resolved allegations that it kept billing despite warnings about a surgeon’s financial interest in implants and unnecessary spinal surgery.
In a device kickback case like Life Spine, the useful evidence connects payments, product choice and the resulting claims. This case shows why sales and product-development employees can hold important parts of that connection.
The whistleblower complaint came from an entity whose members included current or former Life Spine employees with knowledge of its sales practices. The government joined the case. Their account reached inside the program to consulting terms, sales expectations and requests for surgery schedules.
Medicare claims may not identify the particular implant, making the connection between product use and the procedure especially important. Our whistleblower experts work with you to connect what you know about the agreements and sales decisions to the care billed to the government.
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.
If you saw implant targets attached to consulting agreements or development funding tied to a surgeon’s purchases, tell our whistleblower experts what happened. We build your case with you, bring in medical device kickback whistleblower lawyers who understand surgeon contracts and hospital claims, and stay beside you throughout the case.