MSAC Public Summary Document
Application Ref 43 – Cone Beam Computed Tomography for
various dental / craniofacial imaging purposes
Sponsor/Applicant/s:
Australian and New Zealand Association of
Oral and Maxillofacial Surgeons (ANZAOMS)
and the Royal Australian and New Zealand
College of Radiologists (RANZCR)
Date of MSAC consideration:
MSAC 61st Meeting, 3-4 April 2014
1.
Purpose of application
The application requested Medicare Benefits Schedule (MBS) listing of Cone Beam
Computed Tomography (CBCT) for dental and craniofacial imaging in July 2010. A coapplication requesting MBS listing of CBCT for 21 indications reimbursable through four
separate MBS descriptors (sinus and facial bones; temporal bones, temporomandibular joint
(TMJ) and internal acoustic meatus; dental and sleep apnoea) was submitted by Dental and
Medical Diagnostic Imaging (DMDI) to the Department of Health in March 2011. DMDI was
dissatisfied with the Decision Analytic Protocol (DAP) for Reference 43 released in
September 2012, which was restricted to three indications, and elected to provide a
submission based assessment report covering two additional indications, which became
application 1345.
2.
Background
MBS interim items 56025 and 56026 were introduced from July 2011 for CBCT. These
interim items did not include CBCT of sinuses or of bone structures other than those
supporting dentition.
Application 1345, requesting MBS listing of CBCT for the assessment of sinuses and bone
pathology, was considered at the 28-29 November 2013 MSAC meeting.
3.
Prerequisites to implementation of any funding advice
The proposed MBS listing is consistent with the TGA listing that notes that CBCT is
approved for dental and medical diagnostic imaging.
4.
Proposal for public funding
Reference 43 was restricted to three indications which were identified as priority areas based
on consultation with the Department, RANZCR and ANZAOMS. The three proposed
indications were:
Indication1: To assess the bone quantity and quality as part of preoperative dental implant
planning and in the post-implant management of suspected complications, in patients with
missing teeth.
Indication 2: To assess structures identified clinically or on 2D radiographs as being in close
approximation to planned dento-alveolar surgical sites that may be at risk of damage during
surgery.
Indication 3: To further assess the dentition and associated dento-alveolar and TMJ pathology
that may not have been adequately assessed using 2D radiographic techniques
The application’s proposed MBS item descriptors are presented below.
Category 5 – DIAGNOSTIC IMAGING SERVICES
GROUP I2 – COMPUTED TOMOGRAPHY
MBS [item number]
CONE BEAM COMPUTED TOMOGRAPHY (R) (K)
Dental & temporo-mandibular joint imaging for diagnosis and management of mandibular and dento-alveolar fractures,
dental implant planning, orthodontics, endodontic, periodontal and temporo-mandibular joint conditions: without contrast
medium
NOTE 1: This item covers CBCT, or hybrid machines which meet accredited performance characteristics consistent with
dedicated CBCT.
NOTE 2: A CBCT scan may be requested by all medical and dental practitioners but must be performed by or under the
professional supervision of a specialist in diagnostic imaging.
Multiple services rule
Bulk bill incentive
(Anaes.)
Fee: $288.15 Benefit: 75% = $216.13 85% = $244.93
(See paras DID, DIQ of explanatory notes to this Category)
Category 5 – DIAGNOSTIC IMAGING SERVICES
GROUP I2 – COMPUTED TOMOGRAPHY
MBS [item number]
CONE BEAM COMPUTED TOMOGRAPHY (R) (NK)
Dental & temporo-mandibular joint imaging for diagnosis and management of mandibular and dento-alveolar fractures,
dental implant planning, orthodontics, endodontic, periodontal and temporo-mandibular joint conditions: without contrast
medium
NOTE 1: This item covers CBCT, or hybrid machines which meet accredited performance characteristics consistent with
dedicated CBCT.
NOTE 2: A CBCT scan may be requested by all medical and dental practitioners but must be performed by or under the
professional supervision of a specialist in diagnostic imaging.
Multiple services rule
Bulk bill incentive
(Anaes.)
Fee: $144.07 Benefit: 75% = $128.06 85% = $122.46
(See paras DID, DIQ of explanatory notes to this Category)
CBCT services are subject to the current professional supervision rules for conventional
(multidetector) computed tomography (hereinafter referred to simply as “CT”), which state
that the service must be performed under the professional supervision of a specialist in the
specialty of diagnostic radiology who is available to monitor and influence the conduct of the
examination, and to attend to the patient personally if necessary.
5.
Summary of Consumer/Consultant Feedback
Public consultation submissions received were supportive of the proposed technology. There
was some concern that there should be separate item numbers for each of the various
indications.
Feedback also indicated some disagreement with the comparator 2D panoramic imaging
[orthopantomography – OPG] as it is a two dimensional tomographic technique designed to
give a general baseline assessment and show apical root structures only. The Medicare rebate
should be limited to dedicated CBCT units and not hybrid machines (or at least the MBS
descriptor should specify the type of device that is eligible for reimbursement of CBCT
items). A preference was also noted that CBCT for maxillofacial services should not be
provided only by medical radiologists and that different codes should be available for simpler
versus more complex cases.
6.
Proposed intervention’s place in clinical management
The application proposed that CBCT was a direct substitute for currently subsidised CT, to be
used when lower-dose conventional dental radiology (including 2D panoramic imaging)
cannot resolve the clinical questions.
In addition to clinical assessment, with or without 2D imaging, it was claimed in the
application that CBCT would allow for a more accurate diagnosis (e.g. avoidance of
unnecessary treatment) through the provision of more detailed imaging, albeit with an
increased exposure to radiation.
7.
Comparator
The application proposed that use of CBCT is an addition to clinical assessment and 2D
imaging (intraoral ± panoramic radiographs) with or without CT or MRI, the proposed
comparators are set out below in Table 1.
Table 1 Comparators for the proposed service
Indication
Intended patient population
CA+2D
CA+2D+CT
CA+2D+MRI
1
Patients undergoing dental implant planning for
missing teeth or with suspected dental implant
complications
Yes
Yes
No
2
Patients undergoing planned dento-alveolar
surgery with a risk of injury (as diagnosed on
prior imaging).
Yes
Yes
No
3
Symptomatic patients with suspected dentoalveolar or TMJ pathology who require further
assessment after CA and 2D imaging
Yes
Yes
Yes
Abbreviations: 2D = 2-dimensioinal imaging (intraoral or panoramic radiographs); CA = clinical assessment; CT = computed tomography;
MRI = magnetic resonance imaging; TMJ = temporo-mandibular joint
The application purports the following specific items numbers that would be substituted for
the proposed services are set out in Table 2.
Table 2 MBS item descriptors and fees of likely substituted medical services
Item no
MBS item description and fees of likely substituted medical services
−
CATEGORY 5 - DIAGNOSTIC IMAGING SERVICES
−
GROUP I2 COMPUTED TOMOGRAPHY
−
HEAD
56022
COMPUTED TOMOGRAPHY - scan of facial bones, para nasal sinuses or both without intravenous contrast medium (R)
(K)
(Anaes.)
(See para DIQ of explanatory notes to this Category)
Fee: $225.00 Benefit: 75% = $168.75 85% = $191.25
56062
COMPUTED TOMOGRAPHY - scan of facial bones, para nasal sinuses or both without intravenous contrast medium (R)
(NK)
(Anaes.)
(See para DIQ of explanatory notes to this Category)
Fee: $113.15 Benefit: 75% = $84.90 85% = $96.20
−
GROUP I3 DIAGNOSTIC RADIOLOGY
−
SUBGROUP 14 - TOMOGRAPHY
60100
TOMOGRAPHY OF ANY REGION (R) (Anaes.)
(See para DIQ of explanatory notes to this Category)
Fee: $60.75 Benefit: 75% = $45.60 85% = $51.65
60101
TOMOGRAPHY OF ANY REGION (R) (NK) (Anaes.)
(See para DIQ of explanatory notes to this Category)
Fee: $30.40 Benefit: 75% = $22.80 85% = $25.85
−
GROUP I5 MAGNETIC RESONANCE IMAGING
−
SUBGROUP 12 - SCAN OF MUSCULOSKELETAL SYSTEM - FOR SPECIFIED CONDITIONS
−
NOTE: Benefits are payable for each service included by Subgroup 12 on three occasions only in any 12 month
period
MAGNETIC RESONANCE IMAGING performed under the professional supervision of an eligible provider at an eligible
location where the patient is referred by a specialist or by a consultant physician scan of musculoskeletal system for:
63334
- derangement of one or both temporomandibular joints or their supporting structures (R) (Contrast) (Anaes.)
(See para DIQ of explanatory notes to this Category)
Fee: $336.00 Benefit: 75% = $252.00 85% = $285.60
63346
- derangement of one or both temporomandibular joints or their supporting structures (R) (NK)(Contrast) (Anaes.)
(See para DIQ of explanatory notes to this Category)
Fee: $168.00 Benefit: 75% = $126.00 85% = $142.80
−
SUBGROUP 22 – MODIFYING ITEMS
−
NOTE: Benefits in Subgroup 22 are only payable for modifying items where claimed simultaneously with MRI services.
Modifiers for sedation and anaesthesia may not be claimed for the same service.
Modifying items for use with MAGNETIC RESONANCE IMAGING or MAGNETIC RESONANCE ANGIOGRAPHY
performed under the professional supervision of an eligible provider at an eligible location where the service requested by
a medical practitioner. Scan performed:
63494
- involves use of intravenous or intramuscular sedation on a patient
(See para DIQ of explanatory notes to this Category)
Fee: $44.80 Benefit: 75% = $33.60 85% = $38.10
Item no
MBS item description and fees of likely substituted medical services
63497
- on a patient under anaesthetic in the presence of a medical practitioner qualified to perform an anaesthetic
(See para DIQ of explanatory notes to this Category)
Fee: $156.80 Benefit: 75% = $117.60 85% = $133.30
8.
Comparative safety
None of the individual clinical studies identified during the literature search reported data on
the comparative safety of CBCT. Consequently, a summary of safety information was drawn
from two relevant systematic reviews identified by the literature search that focussed on
radiation exposure (De Vos et al. 2009 and Lorenzoni et al. 2012). Both reviews noted the
use of CBCT in addition to standard 2D radiography will expose patients to additional
radiation, although the estimated effective radiation dose from CBCT varied widely among
studies. The reviews also found that CBCT generally represents a lower-exposure alternative
to standard CT, although the exact difference between the two modalities was difficult to
quantify due to large variability and wide overlap in the reported radiation doses. The reviews
noted the importance of considering the contribution of CBCT to overall radiation exposure,
particularly when CBCT is used in children.
9.
Comparative effectiveness
The bulk of the comparative evidence lies with the proposed use of additional CBCT imaging
for the assessment of risk of inferior alveolar nerve (IAN) injury in patients undergoing
extraction of impacted third molar teeth (M3). For these patients, CBCT imaging resulted in
some improvements in diagnostic accuracy and treatment planning in some of the included
studies (Ghaeminia et al (2011)). However, there were no significant differences in clinical
outcomes in two randomised comparative studies (Guerrero et al (2012) and Gurrero et al
(2013)) comparing CBCT and 2D imaging. In other indications, no strong evidence for the
superiority of CBCT imaging over conventional 2D radiography was identified. There was
limited evidence to suggest that CBCT may be more effective in the diagnosis of root
fractures and in treatment planning for impacted canines (Wand et al. (2011)), although there
was no evidence of improved clinical outcomes in these patients.
10.
Economic evaluation
The economic evaluation conducted for the current assessment was a cost comparison
analysis, based on the proposed CBCT fee of $288.15 and assuming that there is no
significant difference in the safety and clinical effectiveness of CBCT and its comparators.
Results
When compared with no further imaging and CT imaging, the expected incremental cost
(MBS incl. EMSN) of CBCT was estimated to be $265.84 and $52.14 per additional CBCT
imaging respectively (Indications 1-3). When compared with MRI imaging, the expected
cost-saving (MBS incl. EMSN) was estimated to be $57.92 per CBCT imaging (Indication 3).
Summary
The proposed service costs more when compared to no further imaging or additional CT
imaging (expected average incremental cost $265.84 and $52.14 per service respectively), but
costs less when compared with additional MRI imaging (expected average cost savings of
$57.92 per imaging service). This is expected given (i) the difference in MBS fees between
CT/MRI and the proposed fees for CBCT and (ii) the assumption of similar clinical
effectiveness and safety among the modalities. A limited sensitivity analysis showed that the
application’s proposed fee for CBCT service is the key driver of cost differentials among the
imaging modalities.
11.
Financial/budgetary impacts
Estimation of future utilisation (number of services) of the proposed listing is based on a
linear projection of the actual utilisation of the interim-listed CBCT items since July 2011.
The utilisation pattern of the proposed service and co-administered services is based on actual
utilisation data of the interim items supplied in confidence by the Department.
Key assumptions
 Future utilisation of the proposed service is as projected (linear increase) from actual
utilisation data.
 The observed utilisation pattern of the interim items and co-administered services
would continue with the proposed listing.
 No significant change in utilisation of comparator CT or MRI imaging services with
the proposed listing, noting that indications covered by CBCT constitute a small
minority of all services encompassed by the comparator items.
The number of CBCT imaging services was estimated to be 96,648 in Year 1 (2014-15),
rising to 129,268 in Year 4.
The total cost (MBS incl. EMSN) of the proposed listing was estimated to be: $25.8 million
in Year 1, rising to $34.6 million in Year 4.
MSAC considered that the financial estimates and projected future utilisation of the proposed
services, including practice patterns, were highly uncertain.
12.
Other significant factors
Nil
13.
Summary of consideration and rationale for MSAC’s advice
MSAC previously considered Application 1345 requesting the MBS listing of CBCT for the
assessment of sinuses and bone pathology at the November 2013 MSAC meeting and advised
that it did not support a change to the current interim funding arrangements but did support
amending the descriptors for the for MBS items 56025 and 56026.
CBCT was proposed by the application for use in addition to the clinical assessment with or
without conventional 2D imaging (intraoral or panoramic radiographs) and in place of CT or
MRI, depending on the indication. MSAC agreed there was a lack of high-quality evidence to
inform decision-making in relation to the use of CBCT in dental applications.
MSAC noted that none of the individual clinical studies identified in the safety analysis
reported data on the comparative safety of CBCT and considered a summary of safety
information drawn from two systematic reviews of radiation exposure. MSAC noted that the
use of CBCT in addition to standard 2D radiography will expose patients to additional
radiation, although the range of estimated effective radiation dose from CBCT is wide (301073 μSv) and overlaps with that for CT (474-1410 μSv). MSAC accepted that, on balance,
CBCT generally represents a lower-exposure alternative to standard CT.
MSAC noted there was limited evidence of the comparative diagnostic and clinical
effectiveness of additional CBCT imaging under the three proposed indications with most
studies comparing 2D imaging + CBCT with 2D imaging alone. No studies were identified
that compared CBCT with either CT or MRI. MSAC noted that most of the available
evidence was in relation to the proposed use of additional CBCT imaging for the assessment
of risk of IAN injury in patients undergoing extraction of impacted M3s (Indication 2).
Three studies, reporting the diagnostic accuracy of CBCT compared to panoramic
radiography in the prediction of IAN injury (Ghaeminia et al (2009), Matzen et al (2013b)
and Tantanapornkul et al (2007)), demonstrated that both CBCT and panoramic radiography
had high negative predictive values. MSAC agreed that the results indicated CBCT is no
worse than panoramic radiographs. Two of these studies also evaluated the impact of
additional preoperative CBCT imaging on treatment planning. MSAC considered that CBCT
may change the surgical approach in in a minority of patients; however there was no evidence
of improved patient outcomes. MSAC noted that for the other indications there was no strong
evidence for the superiority of CBCT imaging over 2D imaging. Limited evidence was
presented to suggest that CBCT may be more effective in the diagnosis of root fractures and
in treatment planning for impacted canines. However, there was no evidence of improved
clinical outcomes.
MSAC agreed that there is no evidence to support the translation of any reported
improvements in diagnostic accuracy or treatment planning to patient outcomes for any
proposed indication. MSAC noted that the cost comparison analysis was based on the
assumption that there is no significant difference in the safety and clinical effectiveness of
CBCT and its comparators. This analysis showed that CBCT is less expensive than MRI but
more expensive than CT at the proposed fee; MSAC agreed with ESC that there was no
evidence to support the assumption of no difference in safety and clinical effectiveness and
noted the proposed fee for CBCT is the key driver of cost differentials. MSAC agreed there
was no adequate justification provided for the proposed increased fee of $288.15 over the
current MBS interim item fee of $113.15, particularly as no argument was presented stating
that the current interim MBS fee is too low. Therefore, MSAC supported maintaining the
current CBCT fee at $113.15.
MSAC noted that the utilisation and financial estimates were based on a linear projection of
actual utilisation data of the interim-listed CBCT items. The utilisation pattern of the
proposed service and co-administered services were based on actual data provided by the
Department. MSAC noted that the total cost (MBS incl. EMSN) of the proposed listing was
estimated to be $25.8 million in Year 1, rising to $34.6 million in Year 4. MSAC was not
convinced there would be no change in the observed utilisation pattern of the interim items
and co-administered services with the proposed listing and no change in the utilisation of
standard CT or MRI items. Therefore, MSAC considered that the financial estimates and
projected future utilisation of the proposed services, including practice patterns were
uncertain.
MSAC noted that under the current interim descriptor CBCT can be requested by any dental
practitioner and that the majority of CBCT services are requested by registered dentists.
MSAC reiterated its November 2013 concern about the potential for dentists to self-refer
CBCT, without direct radiologist involvement and at the patient’s expense. MSAC agreed
that CBCT should have the same restrictions which currently apply for CT (items 56022 /
56062) and therefore should be restricted to requests from specialist dental practitioners.
MSAC was concerned by data from the Department of Human Services, which showed 25%
of CBCT services were performed in patients aged 24 years and under, that 42% of CBCT
items were co-claimed with panoramic radiography services, and that 31% of patients
claimed for panoramic radiography, CBCT and an additional CBCT scan during a single
episode of service. MSAC questioned the safety and clinical appropriateness of such
practices and agreed that such co-claiming should be prohibited.
MSAC also considered advice from the Australian Radiation Protection and Nuclear Safety
Agency (ARPANSA) regarding anecdotal evidence that manufacturers may be providing
inexpensive CBCT units to dental practices at no cost in return for a portion of the income
generated by the unit. MSAC reiterated the need for all MBS-eligible CBCT sites to
participate in the Diagnostic Imaging Accreditation Scheme.
MSAC agreed with ESC that the amendments proposed in November 2013 to the current
interim MBS items for CBCT (56025 and 56026) establish precedence and equally apply to
the proposed MBS descriptor for this application. These amendments were:
 exclude hybrid machines, funding to be limited to dedicated CBCT machines; and
 exclude co-claims for more than one CBCT per day.
For the two new items MSAC also agreed to:
 exclude co-claiming with two dimensional imaging (intra-oral radiography and
panoramic imaging [OPG]) and CT during the same episode; and
 restrict requests to specialist dental practitioners only.
14.
MSAC’s advice to the Minister
After considering the available evidence in relation to safety, clinical effectiveness and costeffectiveness, MSAC supported:
 removing the current interim funded CBCT items (56025 and 56026) from the MBS;
and
 public funding for two new MBS items, incorporating the three indications for
dental/craniofacial imaging at the interim MBS fee of $113.15.
MSAC did not support the proposal to increase the current MBS interim fee for CBCT items.
However, MSAC supports amending the proposed MBS item descriptors to align with the
amendments proposed in November 2013 and April 2014.
MSAC proposed descriptors are:
Category 5 – DIAGNOSTIC IMAGING SERVICES
GROUP I2 – COMPUTED TOMOGRAPHY
MBS [item number]
CONE BEAM COMPUTED TOMOGRAPHY (R) (K)
Dental & temporo-mandibular joint imaging for diagnosis and management of mandibular and dentoalveolar fractures, dental implant planning, orthodontics, endodontic, periodontal and temporomandibular joint conditions: without contrast medium
NOTE 1: Benefits are payable for services rendered on dedicated CBCT equipment only (not hybrid
machines).
NOTE 2: A CBCT scan may only be requested by specialist dental practitioners and must be
performed by or under the professional supervision of a specialist in diagnostic imaging, in a practice
accredited under the Diagnostic Imaging Accreditation Scheme (DIAS).
NOTE 3: Benefits are payable once only per patient per day.
NOTE 4: Not a service associated with two dimensional imaging (intra-oral radiography and
panoramic imaging (items 57959 - 57969)
NOTE 5: Not a service associated with another service in Group I2 (items 56001 – 57361)
Multiple services rule
Bulk bill incentive
Category 5 – DIAGNOSTIC IMAGING SERVICES
(Anaes.)
Fee: $113.15 Benefit: 75% = $84.90 85% = $96.20
(See paras DID, DIQ of explanatory notes to this Category)
Category 5 – DIAGNOSTIC IMAGING SERVICES
GROUP I2 – COMPUTED TOMOGRAPHY
MBS [item number]
CONE BEAM COMPUTED TOMOGRAPHY (R) (NK)
Dental & temporo-mandibular joint imaging for diagnosis and management of mandibular and dentoalveolar fractures, dental implant planning, orthodontics, endodontic, periodontal and temporomandibular joint conditions: without contrast medium
NOTE 1: Benefits are payable for services rendered on dedicated CBCT equipment only (not hybrid
machines).
NOTE 2: A CBCT scan may only be requested by specialist dental practitioners and must be
performed by or under the professional supervision of a specialist in diagnostic imaging, in a practice
accredited under the Diagnostic Imaging Accreditation Scheme (DIAS).
NOTE 3: Benefits are payable once only per patient per day.
NOTE 4: Not a service associated with two dimensional imaging (intra-oral radiography and
panoramic imaging (items 57959 - 57969)
NOTE 5: Not a service associated with another service in Group I2 (items 56001 – 57361)
Multiple services rule
Bulk bill incentive
(Anaes.)
Fee: $56.60 Benefit: 75% = $42.45 85% = $48.15
(See paras DID, DIQ of explanatory notes to this Category)
Current MBS notes on DID (requests), DIQ (Bulk bill incentive) and Multiple services rule (DIJ) are available from the MBS website.
15.
Applicant’s comments on MSAC’s Public Summary Document
RANZCR welcomes the support of MSAC for public funding of CBCT, in particular the
requirements for dedicated CBCT equipment and professional supervision by a radiologist in
an accredited practice. This maintains arm’s length referral for these imaging services,
addresses the potential for over servicing, and will deliver expert opinion on the entire
volume examined for each patient and avoid unnecessary irradiation. However, there is
significant concern with regard to the proposal to exclude Medicare eligibility for requests
from “general” dental practitioners. The College estimates that up to 50% of dental implant
surgeries in Australia are currently performed by dental practitioners, many of whom have
internationally recognised training and experience in implant dentistry or removal of
impacted third molars but are not registered as dental “specialists” with the Australian Health
Practitioner Regulation Agency (AHPRA). Implant dentistry and the removal of third molars
are not restricted to dental specialists in Australia; therefore dental practitioners are
performing these procedures within their scope of practice. However, their patients will be
denied Medicare funding for the CBCT examination required to support the safety and
quality of these procedures, potentially placing patients at an increased risk of permanent
nerve damage. These “general” dental practitioners should be eligible to request Medicare
funded CBCT examinations as this will often be required to provide guidance on the next
appropriate phase of dental health care treatment required for the patient. We also hold
genuine concerns that the exclusion of general dental practitioners may lead to a growth in
CBCT services using inferior, often high-dose hybrid CBCT units without the expert
radiologist involvement required. Medicare eligible CBCT services will be subject to a more
appropriate standard of care, creating an issue of inequality for these patients. It is therefore
strongly recommended on the basis of safety and quality that Medicare benefits for CBCT
continue to be payable for referrals from all suitably credentialed dental practitioners.
Finally, we would like to reiterate the case for setting the CBCT rebate to a level closer to
that of CT. The capital expense, radiographer and radiologist time are similar and we are
unaware of any economic modelling that supports the current interim rebate.
16.
Linkages to other documents
Further information is available on the MSAC Website at: www.msac.gov.au.