DEPUTY SECRETARY Mr Jason McNamara Executive Director Office of Best Practice Regulation Department of the Prime Minister and Cabinet One National Circuit BARTON ACT 2600 Email: helpdesk@obpr.gov.au Dear Mr McNamara Regulation Impact Statement for early assessment I am writing in relation to the attached Regulation Impact Statement (RIS) prepared for 'Improving the quality and safety of Medicare funded diagnostic imaging services through the enhancement of regulatory and accreditation requirements.' I believe the RIS meets best practice requirements and is consistent with the ten principles for Australian Government policy makers. The RIS has been developed to address issues with the current supervision requirements for diagnostic imaging services on the Medical Benefits Schedule (MBS). The issues addressed within the RIS have been identified by stakeholders as areas of concern and suggestions for change have been considered and further developed to create the options presented in the RIS. In particular, the RIS addresses the first four RIS questions: What is the problem? - The Governments objective is to ensure that Medicare benefits are claimed for diagnostic imaging services that are provided by appropriately qualified staff and that patients receive quality services that are clinically appropriate and safe. Inappropriate and/or sub-optimal use of diagnostic imaging can increase the risk of patient harm and contributes to unnecessary use of resources and expenditure. Stakeholders have raised concerns with the current supervision requirements and the ambiguity surrounding interpretation of the regulations. Why is government action needed? –Without any changes it is likely that Medicare will continue to operate inefficiently by funding inappropriate and unnecessary imaging which has no benefit to the patient. Some patients will continue to receive lower quality and potentially unsafe services as there will be inadequate supervision of these services by diagnostic imaging specialists. What policy options are you considering? – The three policy options proposed are o 1 –No change o 2 –Minor changes including clarification of current requirements. o 3 –Practice based approach These are three viable options for consideration, which contain a number of possible changes to the supervision requirements for diagnostic imaging services. The first option does not introduce any additional regulatory burden. However , it is not expected that stakeholders will be in favour of this option as feedback to date has highlighted concerns with the current supervision requirements and the ambiguity around the regulations. The second option is to make minor changes to the current supervision requirements. The current intention of the supervision requirements will not change. However, the wording of the regulations will be reviewed and revised to ensure the intention is clear. Option two also offers changes to the supervision requirements for musculoskeletal ultrasound services to align them with the rest of the ultrasound modality. Option three involves a significant change from the current model of diagnostic services, by introduction of a practice base approach. Both option two and three present changes to the current ultrasound requirements. What is the likely net benefit of each option? - The nature of these changes range from minor to significant. Without consultation with industry estimates of a net benefit for each option would only be speculation. Within the RIS are a series of questions to help determine the impact and benefit of the proposed changes. Option 2 would not involve significant changes however option 3 would result in significant changes into the supervision of diagnostic imaging services, and how practices are managed. Once the first round of consultation has commenced it is anticipated that both potential costs and benefits can be estimated using input from industry. In addition: the change in regulatory burden on business, community organisations and/or individuals has been identified ; and an appropriate consultation plan is described. I submit the certified RIS to the Office of Best Practice Regulation for early assessment , consistent with best practice. Yours sincerely Andrew Stuart Deputy Secretary February 2015