Interventional cardiology

Industry involvement in remote cardiac monitoring putting patients at risk

Cardiologists who provide remote cardiac monitoring are being forced to practice outside of clinical guidelines leaving them exposed to legal ramifications because the government provides virtually no funding to the doctors who provide the service, a Sydney cardiologist has said.

“I have no doubt in my mind that right now there is a lawsuit waiting to happen,” warns Sydney cardiologist Dr Bradley Wislmore.

Speaking to the limbic, Dr Wilsmore says the funding model associated with the service is unsustainable for cardiologists and has created an environment that has allowed the industry to become directly involved in the medical management of patients.

“I’ve seen a dozen massive issues that could have been court cases and I have no doubt that right now, or very soon, something is going to happen that will cause problems for doctors.

The big concern is that someone is going to have a stroke because cardiologists aren’t supported financially to monitor all of this data but the companies who are have a conflict of interest.”

Under the current model Medicare pays doctors just $50.15 for a year of remotely monitoring a pacemaker and $142.15 for a defibrillator. In contrast, the medical devices company in the private system will get $1960 from Medicare under the private prosthesis reimbursement.

Meanwhile there is no incentive at all for it in the public system and patients miss out altogether.

“In the public system patients get screwed … this is a standard piece of equipment that’s known to improve outcomes and save the government money but in public healthcare an extremely small proportion of patients are being offered remote monitoring – let alone getting it,” said Dr Wilsmore.

According to Dr Wilsmore, the device industries in Australia are now increasingly willing to fund a system within the private healthcare system where all remote monitoring occurs via their own trained industry representatives, who will generally educate the patient at implant, may contact the patient directly at home to facilitate the set-up and transmission process along with troubleshooting, then triage and report on the transmitted data, before providing this information to the physician.

“This is all being facilitated at no charge to the physician but utilises the reimbursement at implant paid to the industry,” he added.

But that set-up is at complete odds with clinical practice guidelines, which clearly advises that industry “should refrain from direct patient care, either within the clinic or at home” and “should not perform, collect, or triage data”.

While the guidelines do not go as far as to specify why, Dr Wilsmore said a company’s desire for profits could lead to up-selling or over-servicing.

Writing about his concerns in the MJA earlier this week Dr Wilsmore along with another cardiologist James Leitch, said many doctors were regularly allowing companies to perform remote monitoring because doctors do not have the resources to do it themselves 24 hours a day, 365 days a year.

“It takes a huge amount of time. I get more than 50 alerts a day. To look at all of those every day for a year for essentially no money is not cost effective and we can’t keep up – remote monitoring has become so big and so popular that we just can’t provide that service without the reimbursement and that causes me great distress.”

But Dr Wilsmore also warns that discouraging patients from remote monitoring could also leave doctors open to liability because patients could be exposed to the risk that an abnormality won’t be detected between the regular 6-monthly visits to their doctor to check the devices in a face-to-face consultation.

He says the situation presents cardiologists with a moral dilemma.

“The guidelines say remote monitoring is the standard of care – we have to offer it but we aren’t reimbursed to provide the service so we have to utilise the infrastructure offered by industry, but this also goes against the guidelines. It’s a lose-lose situation.”

Dr Wilsmore, along with other cardiologists from the Electrophysiology Heart Rhythm Society says its been lobbying the government to change the funding model for years.

“The benefits of remote monitoring are infinite – it saves lives it prevents strokes it prevents hospital admissions and that saves money and public resources. It makes sense to offer it to everyone, but for some reason the health fund pays the device company $2000 an implant and the doctor gets nothing for the whole three years of monitoring a link.”

He says what would help are local guidelines that acknowledge Australia’s funding arrangements, which are different to other countries, and the profession’s subsequent reliance on industry to support remote monitoring.

“Australia is different to the rest of the world – we don’t have the same funding arrangements as other countries and we don’t have the same geographical arrangements so lets put out some guidelines that support the electrophysicians providing the service here that relieve doctors of the burden of legal ramifications if they do or don’t provide it,” he told the limbic.

He also believes that funding hospitals to develop and manage the infrastructure to support remote monitoring would remove the conflict of interest that comes with an industry-supported model.

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