5 Tips to Avoid Inappropriate (and Potentially Illegal) Use of Medical Devices
1.Don’t rely on company training. Many cases that land physicians in legal trouble begin similarly, said Ashley Morgan, JD, CPC, a partner with Liles Parker PLLC, a law firm in Washington, DC. “Physicians rely on outside consultants to provide them with information so they can focus on treating their patients.” Unfortunately, the information and training provided by sales reps and other consultants isn’t always accurate.
Acclarent was charged with causing healthcare providers to submit false claims to Medicare by marketing its Relieva Stratus Microflow Spacer as a drug delivery device, even though it wasn’t approved for that indication. Something similar happened in podiatry: At least two podiatrists had to pay back more than $180,000 to resolve liability under the False Claims Act after they used an electric stimulation device to treat neuropathy and followed sales reps’ advice to use certain CPT codes to bill for reimbursement, even though elective nerve stimulation treatments are excluded from Medicare coverage.
As stated by United States Attorney Jennifer Arbittier Williams, “Providers cannot blindly rely on a marketer’s advice or a medical billing service, especially when a healthcare billing scheme sounds too good to be true.”
2. Get educated. Verify any claims made by company reps. Look up peer-reviewed research. Talk with your colleagues. Seek additional training with new technology. Industry-sponsored training can be helpful, but also look for opportunities offered through specialty societies and schools of medicine. Attorney Morgan recommends “reaching out to somebody who has a background in coding and a lot of knowledge in the medical device area before you start utilizing a product and issuing claims to the government.”
3. Stay skeptical. “Do not be manipulated into thinking you have to be the first one to try a device,” said Melayna Lokosky, the former Acclarent sales rep turned whistleblower. “Companies need mass adoption; they want everyone to adopt their device from inception because that’s the way to make money.”
Do not give in to external pressure—even from your institution—to adopt a device if you’re not convinced of its benefits and comfortable with your skills.
4. Check your ego. “Companies seek out insecure, desperate-to-feel-superior surgeons to create ‘thought leaders’ and champions,” Lokosky said. “Doctors need to be aware that you’re a pawn in a bigger game.”
Retain a sense of humility, engage in regular self-reflection, and ask colleagues for feedback.
5. Be transparent with patients and payors. If you are using a device off label, you must clearly explain that to your patients. Lay out the research regarding benefits, risks, costs, and expected outcomes, and discuss other possible treatment alternatives. Make sure patients know that off-label treatment is typically not covered by Medicare or Medicaid (and many private insurers). Issue an advanced beneficiary notice of non-coverage (ABN), have the patient sign it, and use the appropriate modifier when billing to indicate issuance of the ABN.
Conduct regular compliance checks, and if you identify a billing or coding problem, contact experienced legal counsel so they can assist you in making a voluntary disclosure and refund to the government, if needed.