Bill would require doctors to disclose payments from drug, device manufacturers

New legislation inspired by a Studio City woman’s failed breast reconstruction surgery would force doctors in California to tell their patients annually about any money or gifts they receive from drug and medical device companies.

The federal Physician Payments Sunshine Act, a law signed in 2010, already requires the companies to report such payments to a public “Open Payments” database run by the Centers for Medicare and Medicaid Services. But proponents of Assembly Bill 1278 say the federal act has one major flaw: most patients have no idea the database exists.

AB 1278 would remedy that by requiring doctors to give patients a notice each year explaining how to access the Open Payments database and listing any payments that doctor received from drug and device companies in the past three years.

Assemblymember Adrin Nazarian, D-Sherman Oaks, brought the bill forward in 2020 after meeting one of his constituents, Studio City resident Wendy Knecht. The pandemic stalled the legislation for a year, but it has now been approved by the Assembly and is expected to move to the state Senate later this month.

“The objective of this is to make sure patients know exactly what information is available to them,” Nazarian said.

Pain, disfigurement

The Southern California News Group detailed Knecht’s ordeal in 2018.

Her case showcases the obscurity of the Open Payments database. Her husband is a gastroenterologist, yet she didn’t know about the website until a device used in her breast reconstruction surgery failed and left her in chronic pain. The experimental device wasn’t approved by the U.S. Food and Drug Administration, and Knecht alleges the surgeon never offered her any alternatives.

Knecht was left disfigured and forced to undergo three additional surgeries to remove the device, called a SERI Surgical Scaffold, and repair damage caused by its failure. She still experiences pain today, likely from nerve damage caused by the surgeries.

She later learned the surgeon had received nearly half a million dollars over a four-year period from the company that made the device.

“Had she been aware of this website, she would have checked it and she would have asked questions about it,” Nazarian said. “She would have gone into the surgery much better informed and she may have chosen to go with another surgeon.”

Settled lawsuit for $1 million

Knecht, who underwent the breast reconstruction following a double mastectomy, sued her surgeon in 2016 and eventually settled the case for $1 million. She says she wouldn’t have consented to the surgery had she known about the surgeon’s financial tie to the device’s maker.

Still, AB 1278 isn’t about shaming or exposing physicians and surgeons, she stressed. It’s simply about transparency. Some patients might not care who takes their doctor out to lunch or pays them for consulting; they might even appreciate that a doctor is knowledgeable about a specific medication or a type of device.

“Patients don’t necessarily perceive those relationships as bad. It’s just information you need to have fully informed consent,” she said. “In my case, it would have changed everything.”

Key support, opposition

The Medical Board of California, the agency responsible for licensing and disciplining medical professionals, voted to support the legislation at its quarterly meeting in May, though some of the board members initially questioned whether the bill, in an earlier form that required disclosures before a drug or device could be prescribed, would require physicians to interrupt visits to check if they’ve received money from a specific company.

AB 1278’s proponents, however, say the bill — as written today — would require a simple list that could be included in the waiting room packets that patients already receive and have to sign.

They expect strong opposition from manufacturers and the California Medical Association when AB 1278 reaches the Senate. A spokesperson for the CMA did not return a call or email for comment.

During the Medical Board’s May meeting, Emily Hughes, a legislative advocate for the CMA, spoke against the bill. She said the association generally supports displaying information about Open Payments in doctors’ offices, but it worries the bill could create an administrative burden on doctors and distract from the reason a patient sought care in the first place. It could damage physician-patient relationships and disparage doctors for attending educational meetings paid for by companies, she said.

“When there is no context for that payment, we are worried that a setting that should be focused on health would be reconfigured in a way that we are not comfortable with and that we do not think would help patients ultimately,” she said.

In a letter to doctors, the CMA’s Political Action Committee stated the bill would “add to the litany of unnecessary burdens that divert physicians away from what they should be doing — providing care to their patients.”

Bill’s author dismisses opposition

Nazarian, the bill’s author, scoffed at the idea that doctors shouldn’t support the bill.

“I think most doctors’ offices will go ahead and provide this relatively simple sheet of paper,” Nazarian said. “The opposition to this bill is basically saying we shouldn’t let people know about a website that already exists. I just find that extremely difficult to accept, and I feel that any of my constituents would feel very offended by that level of thinking when these lobbyists are representing people who have taken a Hippocratic Oath to save lives.”

Dr. Charles Rosen, president of the Association for Medical Ethics and a spinal surgeon at UC Irvine Health, worked with Congress to get the original Physician Payments Sunshine Act passed in 2010. While researching a new artificial spinal disk years earlier, Rosen learned that a key study had been authored by doctors paid by the manufacturer. The artificial disks received FDA approved, but it was later revealed the clinical trial supporting their use had involved only at a small number of patients over a relatively brief period of time. The product failed, spawning hundreds of lawsuits against Johnson & Johnson.

Rosen, who supports AB 1278, blames the medical manufacturing and distribution industry’s strong opposition for the quiet rollout of the federal Open Payments database.

“You had to struggle the first few years to find where the database was,” he said. “It was in the industry’s best interest to make it hard to find.”

Passage of AB 1278 would cast a new spotlight on its existence and open the door for a similar disclosure law at the federal level, he said. Revealing these payments to patients will make bad actors more hesitant to take money, disguised as consulting fees, to push certain prescriptions or devices, he said.

“If it passes here, there’s a good chance it is going to the rest of the country,” he said.

Source: Orange County Register