An MBS item number for HbA1c point of care (PoC) testing is on the horizon and awaiting a final decision from the federal Health Minister.

The Medicare Services Advisory Committee (MSAC) has supported the MBS listing of HbA1c PoC testing for the management and monitoring of established diabetes mellitus, including in pregnancy, at its March 2020 meeting.

The MSAC application from Pathology Technology Australia Limited was approved on the basis that there were essentially no differences in health outcomes between PoC testing for HbA1c and laboratory based testing.

CEO of Pathology Technology Australia Mr Dean Whiting told the limbic he envisaged PoC testing would mostly be adopted by large general practices, GPs with a high population of patients with diabetes, and perhaps country town general practices with more limited access to laboratory tests.

He said doctors and patients could expect a high quality service.

“The overriding criteria for HbA1c is the precision, especially between the 6-12% mark,” he said.

“Our recommendation is that the device needs to comply with the precision and calibration requirements and there are multiple devices in Australia that will do that. We are agnostic as far as devices are concerned; we are much more interested in the benefits to patients and the healthcare economy.”

However he said they were keen to ensure auditing of PoC testing in a GP setting was context specific.

“There is no point in applying a complex pathology laboratory quality framework and audit process on a PoC test.”

“There is not much point in my view of having two sets of audits in general practice, for example, one from NATA for your PoC testing process and one from whoever the GP uses to audit their regular practice.”

RCPA spokesperson Associate Professor Graham Jones told the limbic that PoC testing was very useful when performed properly and in the right setting.

“From the College of Pathologists point of view, we support doing the right pathology in the right place and really believe that point of care testing in some settings like EDs is essential.”

“In the GP environment, I think it is highly likely that it can make a consultation more effective but we are really very wary of it getting outside the regular quality environment. If it is done without the appropriate oversight, accreditation and training, things can go wrong.”

Associate Professor Jones, a staff specialist in chemical pathology at St Vincent’s Hospital, said overall cost will also be an issue.

“They’ve put a price on it which aims to be equivalent to the cost of getting it done in a lab.”

However due to the way GP pathology billing is structured – where with a few exceptions, pathology labs get paid for the three most expensive tests ordered – many HbA1c tests are “coned out” and basically done for free.

He said there was an argument that a PoC test for HbA1c would theoretically save on costs of transporting samples to the lab for processing.

“However if you just get one more test, say an A1c and a full blood count, then there is still a courier picking up a blood tube, carrying it to the lab etc. All of those costs are still there…and they haven’t gone away because you have done one of the tests onsite.”

“The kind of evidence that Medicare wants is that it saves money and that is very hard.”