Positron Emission Tomography (PET) program

Positron Emission Tomography (PET) program

July 23, 2009

23 July 2009

Investigation into the Ministry of Health and Long-Term Care’s administration of the Positron Emission Tomography (PET) program.

Investigation into the Ministry of Health and Long-Term Care’s administration of the Positron Emission Tomography (PET) program

The Ministry of Health and Long-Term Care announced funding for Positron Emission Tomography scans for certain indications in the wake of this investigation of the Ministry's process for evaluating the technology, and practices in other provinces. Because the issue was resolved, no report was published.

Case update - Annual report 2009-2010

Almost eight years ago, the Ministry of Health and Long-Term Care decided to conduct clinical trials to determine whether it should fund Positron Emission Tomography (PET) scans for patients with certain cancers and other conditions. The lengthy delays in this evaluation and clinical trials prompted more than 45 complaints to the Ombudsman from doctors, patients and other stakeholders, many of whom argued that Ontario was lagging far behind other provinces in the use of this technology. Ontario has nine PET scanners in five cities across the province.

At the conclusion of his investigation in the spring of 2009, the Ombudsman met with the Deputy Minister to review his findings and recommendations, which focused on the need for clarity and speed when assessing new technologies, as well as expediting access to government funded PET scans for those who meet the Ministry’s criteria. The Ombudsman also stressed the need to increase awareness of the Ministry’s access program, which allowed other patients who did not meet its criteria to apply for special consideration to access PET scans.

In response to the Ombudsman’s findings, the Ministry announced on July 23, 2009 that it would make PET a publicly insured health service for certain cancer and cardiac indications. Previously, physicians had to request access to PET for their patients from the Ministry through a process that was not entirely clear or particularly well communicated. The Ministry also agreed to a reform of the PET Steering Committee, and to establish a process for considering additional indications to be insured for PET. It also committed to ensuring that there would be more openness and transparency in its communications with physicians and the public and that future technology assessments would be better planned and resourced, with appropriate accountability throughout.

In light of the Ministry’s response to his findings, the Ombudsman determined that the matter could be resolved without a published report. At the time this report was written, the Ministry was developing an accountability agreement with Cancer Care Ontario (CCO) to look at uninsured PET services.

In February 2010, Ombudsman staff met with representatives from CCO to discuss issues relating to PET. Once the accountability agreement is finalized, a process will then be developed with respect to considering other types of indications for an insured service. The Ombudsman will continue to monitor the Ministry’s progress in ensuring access to PET scans and in improving the evaluation of emerging technologies.

Case update - Annual report 2008-2009

In September 2007, after receiving complaints from doctors and patients, the Ombudsman launched an investigation into the Ministry of Health and Long-Term Care’s evaluation of the use of Positron Emission Tomography scans (commonly known as PET scans) in Ontario. The investigation focused on whether the Ministry’s evaluation process was reasonable and whether patients have had fair access to PET scans through clinical trials.

A PET scan is a diagnostic tool used for patients with cancer, cardiac problems and other diseases. For the past seven years, the Ministry of Health and Long-Term Care has evaluated the usage of PET scans through a number of clinical trials for specific indications, while other provinces have gone forward and listed them as an insured service. Ontario’s approach has been more cautious, preferring to wait for definitive clinical evidence of the utility of the technology.

It was initially expected that the clinical evaluations would take about two years, after which the Ministry would decide whether or not to cover PET scans through the Ontario Health Insurance Plan (OHIP) for specific indications. But things did not turn out as planned. Seven years since the process started, only two of the five clinical studies have closed.

The Ombudsman received more than 45 complaints and submissions from patients, family members, physicians and other stakeholders regarding the evaluation of PET technology in Ontario and delays in listing PET scans as an insured service under OHIP.

During the investigation, SORT investigators met with senior Ministry officials and spoke with 49 physicians, including current and former members of the PET Steering Committee. They interviewed patients, patients’ relatives and numerous other stakeholders, including representatives from the medical device industry, and reviewed the accessibility of PET scans in other provinces.

The investigative process was concluded in the fall of 2008 and the Ombudsman provided the Deputy Minister of Health and Long-Term Care with his preliminary findings and conclusions in December 2008 to allow the Ministry a chance to respond – as is required under the Ombudsman Act.

At the time this report was written, discussions with the Ministry were ongoing to determine whether the issues identified during the investigation can be resolved.

Case update - Annual report 2007-2008

Access to Positron Emission Tomography (PET) scans – or the lack thereof – has been controversial in Ontario over the past year. After receiving a complaint from a physician, the Ombudsman informed the Ministry of Health and Long-Term Care of his intention to investigate in September 2007. To date, the Ombudsman has received more than 30 complaints from physicians and patients concerned about access to PET scans in Ontario.

PET is a diagnostic tool used for patients with cancer, cardiac problems and other diseases. While the technology for PET has been around for many years and Ontario in fact has the second-largest number of PET scanners in Canada, it is also complex nd expensive. The province has not approved the procedure under the Ontario Health Insurance Plan. Access is available for some patients involved in clinical trials, which the Ministry undertook to fund in 2002 as part of its evaluation of PET technology. It also launched a program in 2007 that allows physicians to apply for PET scans for their patients.

The Ombudsman’s investigation is focused on two issues: Whether the process the province is using to evaluate the technology is reasonable and whether the access patients now have via clinical trials is fair.

SORT investigators met with senior staff at the Medical Advisory Secretariat at the outset of the investigation, and are reviewing extensive documentation from the Ministry. The investigation is expected to be completed in late summer 2008.