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News Bulletin : ADA News Bulletin December 2011
24 DECEMBER 20 11 CONE BEAM VOLUMETRIC TECHNOLOGY AND REGULATORY REQUIREMENTS (including prohibited diagnostic imaging arrangements) Editor's note: The following advice has been obtained for the benefit of members and is designed to alert them to the relevant legislative requirements that need to be considered if you wish to be involved with cone beam volumetric technology. INTRODUCTION Cone beam volumetric tomography (CBCT) is a medical imaging technique that has grown in use in international and Australian dental practices. During a scan, the scanner rotates around the patient's head, utilising a fan-shaped cone beam that produces 2-D images of an object. The images are then reconstructed by software to form a 3-D representation. There have been a number of scholarly articles on CBCT technology. These indicate that the advantages of CBCT include rapid scan time and a significant reduction in dose of radiation.1 There are a number of regulatory requirements in relation to CBCT technology. These include: (a) Registration of the CBCT equipment in the Australian Register of Therapeutic Goods (ARTG); (b) obtaining a Location Specific Practice Number (LSPN); (c) contracting with a healthcare practitioner who has applied for and been granted a Medicare Provider Number in relation to the relevant Medicare item numbers and compliance with the Health Insurance Act 1973 (Commonwealth) (the Act) and Medicare Benefits Schedule (MBS); (d) restrictions on bulk billing; and (e) last, but certainly not least, ensuring that you do not engage in prohibited diagnostic imaging arrangements under the Act. This article summarises the health law regulatory requirements for the information of dental practices referring patients to CBCT. However, as every arrangement is different, this article must not be relied upon as legal advice. It is strongly recommended that you obtain legal advice from a specialist health lawyer. The legislation constantly changes. This article is only current as at 14 November 2011. THERAPEUTIC GOODS ACT (TGA) REGISTRATION As a medical device, the CBCT device must be registered by the "sponsor" (usually the Australian manufacturer or distributor) on the Australian Register of Therapeutic Goods. The sponsor must comply with the relevant therapeutic goods laws. LOCATION SPECIFIC PRACTICE NUMBER In order to be eligible to provide Medicare-funded diagnostic imaging services, the diagnostic imaging practice operating the CBCT must have a Location Specific Practice Number (LSPN) for each site, and must be accredited under the Diagnostic Imaging Accreditation Scheme. The LSPN recorded on the claim for benefits must be current on the date of the service. MEDICARE BENEFITS SCHEDULE (MBS) ITEM NUMBERS The diagnostic imaging service provider will need to identify the relevant Medicare item numbers. Prior to 1 July 2011, there were no specific Medicare item numbers for CBCT technology and diagnostic imaging service providers used a combination of R-type diagnostic imaging item numbers, for example: • 60100* tomography; • 57927* temporo mandibular joints; • 57933* full teeth; • 57903* sinus; • 57912* facial bones; • 57915* mandible. * Under the MBS, the above Medicare items can be requested by all dental practitioners. NEW INTERIM ITEM NUMBER FOR CBCT Under the Health Insurance (Cone Beam Computed Tomography) Determination 2011, a new interim item for cone beam computed tomography became available from 1 July 2011. The item is treated as an item in Group 12 -- Computed Tomography on the Diagnostic Imaging Services Table of the MBS. The new CBCT Medicare item numbers are: • Item number 56025* -- for cone beam computer tomography of teeth and supporting bone structures (R ) (K) (Anaes.); • Item number 56026* -- for cone beam computed tomography of teeth and supporting bone structures (R ) (NK) (Anaes.). * Under the MBS, dental practitioners may request these items. Items 56025 and 56026 must comply with regulation 2.2.2 CT Services -- Eligible Services. In order to be eligible for Medicare benefits, regulation 2.2.2 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2011 requires that the service is: • performed under the professional supervision of a specialist in the specialty of diagnostic radiology who is available: • to monitor and influence the conduct and diagnostic quality of the examination; and • if necessary, to attend on the patient personally; and • reported by a specialist in the specialty of diagnostic radiology.
ADA News Bulletin November 2011
ADA News Bulletin February 2012