Applying for public funding for diagnostic tests can be long and convoluted, but ultimately rewarding
If a medical service is not covered under the Medicare Benefits Schedule (MBS), applications can be made to the Department of Health (DOH) to consider whether the service warrants public funding. These applications may be submitted by those who have an interest in providing public funding for new medical services such as the medical profession, medical industry and organisations such as the RCPA. Unfortunately, this application process can be long, convoluted and at times, arduous. We spoke to Linda Mundy, the RCPA’s Medical Services Advisory Committee (MSAC) Project Officer*, who explains more.
“Applications are developed in-house by the College and can take anywhere from three to six months to finalise. Once submitted, the MSAC advises the Minister for Health on whether a new medical service should be publicly funded, based on an assessment of comparative safety, clinical effectiveness, cost-effectiveness, and total cost, using the best available evidence. This is a stepwise progression through a number of committees which can take considerable time. Over the past three years, applications by the College have taken an average of 23 months to complete, from point of submission to final outcome.
“Assessment of diagnostic tests is difficult and requires evidence not only of clinical validity (that the test works the way it is supposed to) but also of clinical utility (that the test is useful for the diagnosis and management of patients). One of the main reasons for long delays is because applications are becoming increasingly more complicated and there is a shift away from “simple” diagnostic tests to more complex genetic testing, where evidence of clinical utility is difficult to obtain. Often the main benefit of genetic testing for patients, especially those with rare conditions, is simply the ‘value of knowing,” said Ms Mundy.
In 2020, the MSAC considered a total of 46 applications, the majority of which (65%) were for non-diagnostic technologies, such as medical procedures. Of the remaining 16, eleven were co-dependent applications submitted by different industry players, where patient access to new drugs depends on the result of a diagnostic test. The remaining five applications were for standalone diagnostic tests, four of which were genetic, and all of which were submitted by the RCPA, making the College one of the single, largest stakeholders in the MSAC process.
Following MSAC’s consideration, the DOH is required to consider the financial impact to Government, consult with relevant stakeholders, seek Cabinet agreement and draft and implement legislative change(s) to amend or add an item to the MBS.[1]
“On average the College submits three to four applications per year, and in recent years has had great success, with 16 applications approved for public funding. Since May 2017 we have submitted 19 applications to the MSAC, 16 of which were for the detection of genetic variants. This shows a marked increase in the number of genetic test applications, emphasising one of the College’s core principles, which is to promote equity of access for all Australian patients, not just those who can afford to pay for testing out-of-pocket.
“Applications are usually unsuccessful for two main reasons. Firstly, a lack of evidence supporting the clinical utility of the test i.e., evidence of how the test changes clinical management and improves patient outcomes, or the test is not cost-effective in the context of the Australian health system. However, it is true to say that none of these applications would progress to a successful outcome if it wasn’t for assistance of the Fellows, who volunteer their time on working parties, often working on multiple applications across specialities.
“In particular, the late Doctor Melody Caramins was instrumental in the success of a number of applications. Most recently, she was clinical lead on an application for reproductive carrier testing for fragile X syndrome, spinal muscular atrophy and cystic fibrosis. Thanks to her hard work and expertise, MSAC has recommended to the Health Minister, Greg Hunt, that this is listed on the MBS which is a fitting legacy for Melody as it delivers equity of access and great benefits to all Australian women planning, or in the early stages of, pregnancy,” said Ms Mundy.
* This role is supported by the RCPA, Pathology Australia and Public Pathology Australia
