While data glitches and delays with the Open Payments program have caused headaches, legal experts warn of a larger looming problem: Financial relationships disclosed through the program could be used to fuel malpractice lawsuits.
"The law of unintended consequences could result in these types of disclosures causing further pressure on the system by encouraging plaintiffs’ attorneys to use reported data against doctors and to strengthen a plaintiff’s case," John E. Hall Jr., an Atlanta-based medical liability defense attorney, said in an interview.
Mr. John E Hall
The Open Payments program, adopted as part of the Affordable Care Act and often referred to as the Sunshine Act, requires makers of drugs, devices, and biologics who participate in federal health care programs to report payments and items of value provided to physicians and teaching hospitals. The information is scheduled to be made publicly available in a searchable database beginning Sept. 30.
The program has been rife with delays due to technical and data concerns. Most recently, the Centers for Medicare & Medicaid Services extended the review and dispute one additional day to midnight on Sept. 11 because of a maintenance and upgrade outage. The period for correcting disputed data will begin Sept. 15 and will last a minimum of 15 days, the agency said.
During medical malpractice cases, it’s not uncommon for plaintiffs to sift through a physician’s history to find information that might reinforce a negligence claim, Mr. Hall said.
"Plaintiffs’ attorneys already search for conflicts of interest in a physician’s background or other historical information that will make physicians look bad in court and attempt to tarnish their credibility," he said.
The Open Payments database may provide additional fodder. The plaintiffs’ bar already is promoting how trial attorneys can use the disclosures in medical malpractice cases, said Stefanie A. Doebler, special counsel for a Washington-based law firm’s health care and food and drug practice groups. Information about the law and how financial relationships can sway doctors’ medical decisions are popping up in articles and on plaintiffs’ attorney websites.
Possible arguments by trial attorneys include that a physician prescribed the wrong drug, downplayed a drug’s risks, or did not reveal an adverse event linked to a medication because of the doctor’s financial relationships, Ms. Doebler said.
"The allegation would be that a financial relationship between a maker and a doctor caused [the doctor] to act in [his or her] own interest, rather than in the interest of the patient," she said.
Conversely, Ms. Doebler pointed out that physician defendants could argue that they were better informed about a drug or device specifically because of their relationship with a manufacturer.
Ms. Stefanie A. Doebler
To mitigate the potential legal risks, make it a point to discuss payments or benefits from manufacturers with patients, counseled Carolyn M. Bruguera, general counsel and vice president for consulting services for a Princeton, N.J.–based health care compliance and software consulting firm. That way, the physician has a chance to explain his or her relationships before patients are surprised by online data. Additionally, drug and device makers can help doctors avoid the appearance of impropriety by providing contextual information in Open Payments reports, she said.
Ms. Doebler urged physicians to verify all reported information on the Open Payments website. Doctors also should have a full understanding of all data that applies to their practices and be able to articulate its details and purpose.
It’s critical, she said, to "know what the payment refers to so they can talk about the information intelligently and completely."
On Twitter @legal_med