On May 29, 2013, a television news reporter from Los Angeles posted a question on the message board of the Association of Health Care Journalists (AHCJ).
The reporter asked about a caller who had contacted her about the caller’s total knee replacement surgery. According to the caller, it had been paid for by Medi-Cal, California’s Medicaid program.
According to the reporter, the caller was having serious problems following knee replacement surgery. The caller gave the reporter access to her surgical report which noted the implant came from Zimmer. The report did not, however, indicate a model name or serial number of the Zimmer device.
The incision, placement, cementation and closure were all well documented in great detail, but no device identification. The patient was having a tough time getting information on her own.
So, asked this reporter, who is responsible for providing that information—the hospital or the surgeon?
“Seeing her case, I’m sort of amazed Medi-Cal even covers knee replacements considering all the risk and possibility of future expense, ” added the reporter.
Responses began to pour in from experienced health care reporters about the effectiveness of knee replacement surgery, HIPAA (Health Insurance Portability and Accountability Act) rules, inappropriate surgeries, informed consent, patient experience and even the age of the surgeon who performed the surgery.
The Orthopedic Narrative
The exchange between health care reporters provided insight into how the narrative of the current state of orthopedics is explained to the public by reporters. That narrative is informed by assumptions about device effectiveness, privacy rules, payer decisions, perceived human and corporate greed and, even altruism. All these assumptions were nakedly on display as responses to this Los Angeles reporter poured in.
Russian Roulette Odds
One of the first respondents asked why the reporter considered knee replacement a risky surgery.
“Knee replacement is one of the lower risk surgeries. A knee replacement can mean the difference between mobility and disability, including the ability to work and get off of Medi-Cal. By maintaining mobility one often can prevent or forestall obesity and associated disease such as diabetes, chronic conditions that can be very expensive over the long run, ” wrote one journalist.
However, another reporter responded that “apparently, only about half the patients are better off afterwards in terms of clinically significant differences in QOL (quality of life) and 15-20% of people with TKA’s [total knee arthroplasty] wind up with severe to extreme persistent pain (BMJ Open).”
”Some patients start with some mobility and wind up without any mobility at all, with pain at rest, worse than they were before. Isn’t that risky? That’s like Russian roulette odds, ” he added.
No Randomized Trials
“The striking thing about [TKA] is that there are 600, 000 procedures a year in the U.S, at a cost of $15, 000 per procedure, mostly paid by Medicare, (JAMA 308:1227). There is not a single randomized trial of its effectiveness and adverse effects with QOL endpoints like pain and mobility, ” he concluded.
He referenced a Danish group which started a prospective randomized trial last year (the MEDIC-study) and they will have results in 10 years. (BMC Musculoskelet Disord. 13:67).
Randomized Surgery?
“It would be nice if there was ‘good’ data, came back a response. “But how would you conduct the study? How would you randomize patients? Is it ethical to conduct surgery before they ‘need’ it? Is it ethical to delay surgery if they ‘need’ it? I know [hospitals] do have a metric they use to decide who gets surgery. My surgeon had to propose it, and a panel reviewed the request prior to surgery.”
Survey Says…
We asked Zimmer, the largest knee maker in the world, about the claim that only half of patients are better off and 10-15% of patients end up with severe to extreme persistent pain
In a written response, the company said the BMJ article used MEDLINE and EMBASE databases as data sources and was only a systematic review. “High quality meta-analysis publications use AMED, CINAHL, Embase, Medline, Cochrane library, PEDro that are more recognized to conduct these types of research.”
The study in the article, according to Zimmer, excluded studies that reported mean values of pain outcomes. “There is strong evidence in the literature that in appropriately selected THA [total hip arthroplasty] and TKA patients, significantly higher improvements in QOL are observed (Quintana et al, 2006). Earlier published studies (Rissanen et al 1996) demonstrated major improvements in pain, sleep and physical mobility and reported that on average, most patients attained a similar QOL as the comparable general population; and only 4.7% of hip and 9.7% of knee patients had a lower HRQOL.”
Poor Journalism
The reporter citing the BMJ article was also critical of his colleagues in the media who, he wrote, “aren’t doing a good job either.” He noted a New York Times writer’s glowing stories about the wonderful results of TKA…”They [reporters] go to orthopedics meetings and copy the glowing press releases right into their news stories, without following journalism 101 rules and getting an independent expert to comment on it…Patients simply can’t inform themselves by reading the newspapers or searching online.”
Ouch.
HIPAA
The television reporter said she contacted Zimmer but was told that without a serial number there was no information they could provide her and that their database is not searchable by name because of HIPAA.
“I don’t think this is true, ” replied the critical reporter. “HIPAA allows medical providers to exchange information for administrative and operational purposes.”
“This is a major tool in the bureaucrat’s toolbox of quick ways to dismiss questions that they don’t want to answer: ‘The law doesn’t let us give out that information.’ That’s an effective response because most reporters don’t understand law so they can’t follow up.”
Device Maker HIPAA Responsibilities
We asked Zimmer about a manufacturer’s HIPAA responsibilities.
The company said device makers are not HIPAA covered entities as they only sell implants to distributors and hospitals. To be considered a covered entity, a health care provider must conduct certain electronic standard transactions defined in HIPAA, all of which relate to the submission and payment of claims for health care goods and services.
“Hospitals and implanting surgeons are HIPAA covered entities. Under HIPAA, they are permitted to disclose a patient’s protected health information to Zimmer without patient authorization for treatment purposes and to comply with FDA oversight regulations for manufacturers of medical devices, ” said the company in a written response.
“Generally, Zimmer does not receive information about the patient receiving a specific implant—the information is captured in surgery planning schedules by distributors, but is not maintained in any database or registry. The only link Zimmer has to the specific product is the peel-and-stick label on the packaging identifying the serial number of the individual implant. This is kept by the hospital/and or passed along to the patient. With this information, Zimmer can confirm whether a patient had an implant and what kind of implant they have had.”
Post-Market Surveillance
The company said it cannot share patient information with a reporter without the authorization of a patient. “If a patient reached out to the company via our consumer contact centers, we have staff trained to conduct Product Event Reports (PER) in cases of complaints. The PER process involves identifying the serial number on the peel-and-stick label and using this information to confirm the implant a patient has received, and process any complaint related to its performance. This is an important part of our post-market surveillance process, as we can identify trends in product performance related to complaint rates.”
Hospital Stonewalling
In short, hospitals and physicians are required under HIPAA to give patients access to their health information. “The patient in question should be able to get copies of her medical records directly from her treating providers, ” concluded the Zimmer response.
Another reporter noted that if the hospital can’t dig up the serial number they would, “certainly be in violation—they have to record that information. They’re clearly not taking her seriously on her own, they already made a major omission by not having included the serial number on the surgical report, and they’re stonewalling if they’re telling her to get the device info from the device manufacturer…If this were a wealthy patient with private insurance, would she have to ask twice?”
High Pressure Docs, Malpractice and Consent
The same poster that questioned TKA effectiveness also cited a recent article from JAMA (Journal of the American Medical Association) that, he says, “describes a high-pressure sales job by an orthopedic surgeon to perform bilateral total knee replacements (among other things) on a 76-year-old woman with multiple sclerosis. The surgery was inappropriate and dangerous for the reasons the author gives. The surgeon recommended—and tried to schedule—surgery without even asking about cardiac history. “
“I’ve covered medical malpractice conferences. It’s malpractice to perform surgery without informing the patient of the risks. “
He said the larger issue is that doctors aren’t supposed to tell patients that they need elective surgery. They’re supposed to inform the patient of the risks and benefits and let the patient decide, according to the patient’s values and preferences.
The Lesson
The story of the poor woman in search of her device information opened a window into disparate views held by health care journalists about orthopedics as they inform patients, the public and each other. The message to providers and device makers is that even well informed journalists and patients are confused and often misinformed.
The lesson? How journalists write about orthopedics creates a general narrative about manufacturers, surgeons and hospitals. When that narrative does not align with reality and, as is increasingly the case in the U.S., disparages the system, then it can find expression in the form of increased government scrutiny and payer skepticism.
As we learned from the responses to one journalist’s question, some writers about orthopedics still do not understand their subject well.
