Draft Protocol
Review of Medicare-funded
ophthalmology services
(second-stage)
July 2011
This protocol was commissioned by the Medical Benefits Division, Department of Health and Ageing,
the Australian Government.
Researchers:
Linda Mundy
Team Leader
Tracy Merlin
Managing Director / Senior Lecturer
Adelaide Health Technology Assessment
Discipline of Public Health
School of Population Health and Clinical Practice
University of Adelaide
TABLE OF CONTENTS
1.
INTRODUCTION .............................................................................................4
1.2
Purpose of this document .........................................................................................5
1.3
Objectives of the review ...........................................................................................5
2.
BACKGROUND ON Ophthalmology Services under Review .....................6
2.1
Description of current services .................................................................................6
2.2
Context .....................................................................................................................8
2.3
Justification for review ............................................................................................10
3.
KEY STAKEHOLDERS .................................................................................11
3.1
Protocol Advisory Sub-Committee..........................................................................11
3.2
Clinical Working Group...........................................................................................11
3.3
Clinical craft groups ................................................................................................11
3.4
Consumers and the general public .........................................................................12
3.5
Consultants ............................................................................................................12
3.6
The Department of Health and Ageing ...................................................................13
4.
REVIEW METHODOLOGY ...........................................................................13
4.1
MBS data analysis..................................................................................................14
Clinical/research questions .........................................................................................14
4.2
Guideline concordance...........................................................................................15
Clinical/research question ...........................................................................................15
4.3
Evidence-based review – mini-health technology assessments (mini-HTAs) .........16
Clinical/ research questions and literature selection criteria .......................................17
Literature search .........................................................................................................34
Critical appraisal of selected evidence ........................................................................39
Explanatory notes .......................................................................................................39
4.4
Stakeholder negotiation..........................................................................................42
4.6
Review outcomes ...................................................................................................46
5.
REVIEW TIMEFRAME ..................................................................................46
6.
REFERENCES ..............................................................................................47
Clinical Practice Guidelines ....................................................................................................48
1.
INTRODUCTION
A review of existing MBS ophthalmology items was commenced under the MBS Quality Framework in
2010, and is continuing under the Comprehensive Management Framework for the MBS. The primary
focus of reviews of existing items is to ensure that the MBS supports and encourages evidence-based,
cost-effective clinical practice and to identify and evaluate current MBS services that present
potential safety and quality issues. Given the large number of ophthalmology MBS items, this review
is being undertaken in two stages. This protocol relates to the second-stage of the review.
Adelaide Health Technology Assessment (AHTA), School of Population Health and Clinical Practice, at
the University of Adelaide, as part of its contract with the Department of Health and Ageing
undertook an initial review (Stage I) of 61 MBS items for specific ophthalmology services in March
2011. As part of the stage II review, a further 22 MBS item numbers (including one proposed new
item number) pertaining to ophthalmology services (see Table 1) were selected for review, for which
AHTA has developed this protocol to guide the review.
Table 1
Ophthalmological Services listed on the Medicare Benefits Schedule and under review
SERVICE NAME
MBS ITEM NOS
Orbital skin graft
Decompression of orbit
Temporary occlusion of punctum using electrical cautery
Conjunctivorhinostomy/ dacryocystorhinostomy
Corneal debridement
Corneal transplantation
Cataract surgery
Capsulotomy/ needling of posterior capsule
Needling for drainage of encysted bleb following trabeculectomy
Removal of Molteno valve (glaucoma)
Division of suture by laser
Laser coagulation of corneal or scleral blood vessels
Photoiridosyneresis
Resuturing of wound following intraocular procedure
Eyebrow elevation for paretic states
42524
42545
42621
42623, 42626, 42629
42650
42653, 42656, 42659
Ophthalmic diagnostic B scan ultrasound
Page 4
42716
42734, 42737
42744
42755
42794
42797
42808
42857, 4285x (new item)
42872
1123x (new item)
1.2
Purpose of this document
This document is intended to outline the methodology in providing evidence-based analysis to
support the review of MBS Items for specific ophthalmology services.
The objectives of the protocol is to:
•
define the relevant clinical questions that the review will focus on;
•
clarify the role of the identified ophthalmology services in current clinical practice;
•
clarify the mechanisms for identifying evidence and provide an opportunity for discussion of
clinical and methodological issues;
•
clarify timelines associated with this project; and
•
clarify roles and responsibilities of key stakeholders.
Once finalised, the protocol should not be altered as it provides the structure for the entire review
process.
1.3
Objectives of the review
To provide robust, evidence-based analysis to inform recommendations aimed at strengthening the
evidence-base for specific Medicare-funded ophthalmology items and their use.
Page 5
2.
2.1
BACKGROUND ON OPHTHALMOLOGY SERVICES UNDER REVIEW
Description of current services
The MBS services being reviewed are presented in Table 2, along with a description of each service,
and the conditions/diseases for which the service is most relevant or commonly used. Initial listing,
amendments to listings, setting of use of these services and the health professionals providing these
services are given below Table 2.
Table 2
Description of MBS Ophthalmological items under review
Conditions/diseases
relevant to the service
MBS item
number
42629
Blockage or malfunction
of lacrimal apparatus
42623
42626
42621
42650
42653
Treatment of the cornea
42656
42659
42797
Glaucoma
CONJUNCTIVORHINOSTOMY including
dacryocystorhinostomy and fashioning of conjunctival
flaps
DACRYOCYSTORHINOSTOMY
DACRYOCYSTORHINOSTOMY where a previous
dacryocystorhinostomy has been performed
PUNCTUM, temporary occlusion of, by use of electrical
cautery
CORNEA, transplantation of, second and subsequent
procedures
CORNEA, transplantation of, superficial or lamellar
42737
NEEDLING OF POSTERIOR CAPSULE
42755
GLAUCOMA, removal of Molteno valve
42744
NEEDLING FOR DRAINAGE OF ENCYSTED BLEB,
following trabeculectomy
DIVISION OF SUTURE BY LASER following
trabeculoplasty, each treatment to 1 eye, to a maximum
of 2 treatments to that eye in a 2 year period
PHOTOIRIDOSYNERESIS, laser
42808
Therapeutic
Therapeutic
LASER COAGULATION OF CORNEAL OR SCLERAL
BLOOD VESSELS - each treatment to 1 eye, to a
maximum of 4 treatments to that eye in a 2 year period
42734
42794
Type of service
CORNEA, epithelial debridement for corneal ulcer or
corneal erosion (excluding aftercare)
CORNEA, transplantation of, full thickness
CATARACT, JUVENILE, removal of, including
subsequent needlings
CAPSULOTOMY, other than by laser
42716
Cataract
Item descriptor for the service
Page 6
Therapeutic
Therapeutic
42524
4285x
Proposed
new item
ORBIT, decompression of, for dysthyroid eye disease, by
fenestration of 2 or more walls, or by the removal of
intraorbital peribulbar and retrobulbar fat from each
quadrant of the orbit, 1 eye
RESUTURING OF WOUND FOLLOWING
INTRAOCULAR PROCEDURES with or without excision
of prolapsed iris
RESUTURING OF WOUND (longer than 5mm long)
FOLLOWING INTRAOCULAR PROCEDURES with or
without excision of prolapsed iris or other intraocular
tissues (Anaes.) (Assist.)
42872
EYEBROW, elevation of, for paretic states
1123x
Diagnostic B scan ultrasound, for the comprehensive
evaluation of the globe or orbital structures not being a
service to which item 11237 or any other items in Group
D1 apply
42545
42857
Various eye procedures
ORBIT, SKIN GRAFT TO, as a delayed procedure
Proposed
new item
Therapeutic
Diagnostic
The MBS-funded services listed above are primarily performed in the hospital setting (both day
surgery and inpatient), and/or in the rooms of the consultant.
For all of the services being investigated, the consultant or health professional performing the service
is an ophthalmologist (specialist) only.
The MBS provides information on the year of introduction of each these ophthalmological items, and
the year in which the current description was formulated. Of the 22 items being analysed:






Twelve commenced in 1991 and have not been amended – relating primarily to blockage or
malfunction of the lacrimal apparatus, epithelial debridement of the cornea, three items
pertaining to cataract surgery, removal of a Molteno valve in patients treated for glaucoma,
orbital skin grafts, resuturing of wounds following an intraocular procedure and elevation of
the eyebrow for paretic states;
Five items commenced in 1991 and have since been amended – one glaucoma item in 1994,
three corneal transplantation items, with two amended in 1993 and the other in 2003, and
one for decompression of the orbit amended in 1998;
One commenced in 1996 for the temporary occlusion of the punctum, and has not been
amended;
One commenced in 1997 and has not been amended – pertaining to photoiridosyneresis in
glaucoma patients;
One commenced in 1998 and has not been amended – epithelial debridement of the cornea;
Two items are proposed new item numbers relating to re-suturing of wounds that are longer
than 5mm following an intraocular procedure, and B scan ultrasound.
Page 7
2.2
Context
Incidence and prevalence of diseases relevant to the services under review
Following the 2007-08 National Health Survey conducted by the Australian Bureau of Statistics, it was
determined that 52 per cent of the Australian population reported eyesight problems as a long-term
medical condition. An estimated 9.4 per cent of Australians aged 55 years or older are visually
impaired and 1.2 per cent are blind. Approximately 30 per cent of vision impaired Australians are
believed to have untreated cataracts, with 27 per cent having presbyopia (AIHW 2009).
Data available from the AIHW National Hospital Morbidity Database1, indicates that in 2008-09, the
number of hospital separations by principal diagnosis, for diseases of the eye and adnexa, was 70,660
in public hospitals and 172,995 in private hospitals; and for separations by procedure was 83,308 and
188,343 respectively. The total number of separations by AR-DRG increased steadily from 175,883 in
1998-99 to 280,824 in 2007-08. These data are similar to principal diagnosis data determined by ICD10-AM, with the number of separations for diseases of the eye and adnexa increasing from 160,340 in
1998-99 to 230,805 in 2007-08. Disorders of the lens accounted for approximately 70 per cent of
these eye diseases, with disorders of eyelid, lacrimal system and orbit the next highest at around 10
per cent. The increasing prevalence of eye disease in Australia reflects the ageing of the population.
Surgical procedures accounted for approximately 95 per cent of AR-DRG hospital separations, with
same day lens procedures making up about 65 per cent of these and retinal procedures being the
next most common (AIHW 2011). Medical procedures increased slightly from 12,045 in 1998-99 to
14,149 in 2007-08, with the largest individual separation rates being for hyphema and medically
managed trauma to the eye (AIHW 2011).
The total cost of hospital separations for MDC 02 (diseases and disorders of the eye) for 2008-09 was
$556,536,000, with 95,559 separations in public hospitals costing approximately $250m and 199,635
separations in private hospitals costing $305m (AIHW 2010).
As such, eye disease is a significant health problem for the Australian population and has a significant
impact on the national health system.
The most prevalent causes of blindness relate to ageing – macular degeneration, cataracts, glaucoma,
diabetic retinopathy, uncorrected refractive error, eye trauma and trachoma (Figure 1). Of the 1.2 per
cent prevalence of blindness in those aged 55 or older, 50 per cent have age-related macular
degeneration as the primary cause, 16 per cent glaucoma and 12 per cent cataracts.
1
http://www.aihw.gov.au/hospitals/datacubes/index.cfm
Page 8
b
b
% of population
% of population
a
Age group
Figure 1
Age group
a) Prevalence rates of visual impairment and blindness in the Australian
population, and b) its causes by age (DR = diabetic retinopathy, AMD = age-related
macular degeneration) (AIHW 2005)
The leading cause of visual impairment in Australia is cataracts, representing 40 per cent of all cases
(AIHW 2005). Approximately three per cent of the Australian population aged over 50 years has
glaucoma (Mitchell et al 1996). By contrast, disorders of the cornea affect relatively few individuals in
Australia. In 2009 there were 1,032 corneal donors in Australia and New Zealand, which resulted in
1,679 corneal transplants. The most common reason for a corneal transplantation is keratoconus,
which results in a loss of shape of the cornea and ultimately blindness. Approximately 1 in 2,000
Australians will develop keratoconus, tending to affect younger individuals, therefore the majority of
corneal transplants occur in individuals aged 15-30 years (CERA 2010; Keratoconus Australia 2010).
Corneal transplantation may also be performed to restore clarity to, or integrity of, the cornea, in
cases when the cornea becomes ulcerated in conditions such as bullous keratopathy, or the cornea
becomes infected or perforated (CERA 2010). The majority of corneal grafts are penetrating grafts
requiring a full-thickness corneal transplant (94%). Approximately five per cent of grafts are lamellar
grafts, where the superficial layers of an opaque cornea are replaced by a thin layer of clear cornea
from a donor eye and a small percentage of grafts are limbal stem cell transplants (Williams et al
2007). In 2007-08, the AIHW reported that 4,252 keratoplasty procedures were performed in
Australian hospitals and of these 888 were full thickness transplantations. During the same period, 38
limbal stem cell transplants were performed (AIHW 2011).
There is a paucity of data in the literature describing the incidence or prevalence of conditions such as
corneal ulcer or Grave’s disease. In 2007-2008 there were 20,731 hospital separations for conditions
of the eye lid, lacrimal system and the orbit (ICD-10 code H00-H06), however the majority of these
separations (13,608) were for disorders of the eyelid and 75% were for individuals aged over 45 years.
The number of separations for the majority of conditions increased slowly over time as in the case of
disorders of the lacrimal system (ICD-10 code H04) which increased from 3,311 to 3,691 separations
from 1998-99 to 2007-08. However, the number of separations for disorders of the orbit (ICD-10 code
H05) steadily decreased from 748 in 1998-99 to 556 in 2007-08 (AIHW 2010). During this same period,
there were 8,190 lacrimal system procedures performed in Australian hospitals, of which 64 were for
the occlusion of the lacrimal punctum by plug and 1,739 were for the insertion, replacement or
removal of a nasolacrimal tube. Of these, 131 were for the insertion of a glass nasolacrimal tube. A
Page 9
total of 1,081 procedures were performed on the orbit, including 72 for the extenteration of the orbit
and 156 for the removal and replacement of bone (AIHW 2011). During 2007-08 there were 3,466
separations for disorders of the sclera, cornea, iris and ciliary body (ICD-10 code H15-H22). Included in
this total were 979 separations for keratitis (H16), and of these 448 were for corneal ulcer (H16.0) and
five for corneal neovascularisation (H16.4) (AIHW 2010).
Although the ageing Australian population is driving the increasing prevalence of vision impairment,
eye disorders (short or long-sightedness) are still among the top five long-term health problems
experienced by children (AIHW 2009).
MBS item number usage and expenditure for ophthalmological items
Medicare Australia website statistics2 (item reports) indicate that the highest frequency of the
individual ophthalmology services under review in Stage II across the period 1994-2010 were:

Item 42650 Corneal debridement
35,044

Item 42623 Dacryocystorhinostomy
17,242

Item 42653 Full thickness corneal transplantation
11,325

Item 42794 Division of suture by laser
9,245
The highest cost individual items for 2010 were:

Item 42653 Full thickness corneal transplantation
$654,340

Item 42623 Dacryocystorhinostomy
$631,193

Item 42656 Second & subsequent corneal transplantation
$233,498

Item 42744 Needling for drainage
$229,489
For the 22 existing items being investigated, the total cost to Medicare for 2010 was $2,333,747. This
includes safety net expenditure.
2.3
Justification for review
Following amendments to the Schedule fee for several cataract items, it was agreed that a review of
existing ophthalmology items listed on the MBS would be undertaken as part of the MBS Quality
Framework. The review of ophthalmology items will inform recommendations aimed at strengthening
the evidence-base of Medicare-funded ophthalmology services and their use.
The relevant medical craft groups, the Royal Australian and New Zealand College of Ophthalmologists
(RANZCO) and the Australian Society of Ophthalmologists have been involved in the development of
the review approach, assisting in identifying existing items that may not appropriately reflect current
clinical practice. In addition, RANZCO has nominated several experts to provide clinical input to the
review.
2
https://www.medicareaustralia.gov.au/statistics/mbs_item.shtml
Page 10
3.
KEY STAKEHOLDERS
3.1
Protocol Advisory Sub-Committee
The Protocol Advisory Sub-Committee (a standing sub-committee of the Medical Services Advisory
Committee (MSAC)) will be consulted on the draft review protocol. The MSAC advises the Australian
Minister for Health and Ageing on evidence relating to the safety, effectiveness and cost-effectiveness
of new medical technologies and procedures. This advice informs Australian Government decisions
about public funding for new, and in some cases existing, medical procedures.
In relation to the review of ophthalmology services, it is envisaged that the MSAC and its
subcommittees will:
•
provide comment on the draft review protocol, with a particular focus on the clinical research
questions, prior to the protocol being released for public consultation;
•
consider the draft review report with a particular focus on the assessment of evidence; and
•
consider the outcomes of the review prior to advice being formulated for government.
3.2
Clinical Working Group
A Clinical Working Group has been established for the duration of the review of MBS items for specific
ophthalmology services to ensure the review reflects an understanding of current Australian clinical
practice and draws valid conclusions from the available evidence. While this working group will be
given the opportunity to comment on the review protocol and on the final report in their individual
capacity, it is not able to make recommendations on future financing arrangements.
Members will be experts in the field being reviewed and identified by, although not representing,
clinical craft groups.
The Clinical Working Group, which also includes a Medical Adviser from the Department, is chaired by
AHTA.
3.3
Clinical craft groups
The main clinical craft groups that are likely to be affected by this review of MBS items are the:
 Royal Australian and New Zealand College of Ophthalmologists (RANZCO)
The RANZCO is a professional body representing ophthalmologists and eye care
specialists practicing in Australia and New Zealand. The mission statement of RANZCO
indicates that the College’s role is to improve “the already high standard of eye care in
Australia and New Zealand. In pursuit of this mission, the College provides a variety of
services centered on its core roles as a higher educational institution and learned
society”.3
3
http://www.ranzco.edu/
Page 11
 Australian Society of Ophthalmologists (ASO)
The aim of the ASO is to represent the medico-political interests of ophthalmologists
within Australia. It has attracted 50 per cent of membership across all Australian states
and territories.4
 Royal Australasian College of Surgeons (RACS)
The RACS is a non-profit organisation with the responsibility of training surgeons and
maintaining surgical standards in Australia and New Zealand. “The College's purpose is
to be the unifying force for surgery in Australia and New Zealand, with FRACS standing
for excellence in surgical care”.5 Interest in the MBS Quality Framework Review of
Ophthalmology items will mainly come from the oculoplastic and paediatric
subspecialties represented within the College.
3.4
Consumers and the general public
Consumers and the general public, which may include individual services providers, will be given
multiple opportunities to comment on elements of the review, and to be involved in components of
the review activity (see Section 4.4). The Consumers Health Forum will be approached directly to
comment on the draft protocol and the draft review report. The protocol will be posted on the
Department of Health and Ageing website6 for public comment. Written submissions will be invited
and addressed individually by the consultants in a document that summarises the feedback received
and how it was addressed. Where relevant, the protocol will be revised on the basis of this feedback.
Following review of the draft report by the MSAC, the report will be released for public consultation.
Again, written submissions will be invited through the medium of the website and will be analysed
and addressed individually by the consultants, with incorporation of relevant information into the
report, where appropriate.
3.5
Consultants
Adelaide Health Technology Assessment (AHTA), School of Population Health and Clinical Practice, at
the University of Adelaide is responsible for drafting the review protocol.
As an academic applied research organisation, AHTA maintains an independent view of the
ophthalmology items being reviewed as part of the MBS Quality Framework budgetary measure.
AHTA has been conducting health technology assessments for a decade and has a wide experience of
all types of health/medical interventions for diagnostic, monitoring and therapeutic purposes –
having conducted health technology assessments on behalf of the Medical Services Advisory
Committee (MSAC) and the Pharmaceutical Benefits Advisory Committee. AHTA staff will apply bestpractice methodologies in their evaluation of all health services, in order to provide the most accurate
information to policy makers. AHTA is a non-profit organisation, without ties to industry, and is a
member of the International Agencies for Health Technology Assessment (INAHTA).
4
http://aso.asn.au/index.php?option=com_content&view=article&id=2&Itemid=20
http://www.surgeons.org/Content/NavigationMenu/WhoWeAre/Overview/default.htm
6
http://www.health.gov.au/internet/main/publishing.nsf/Content/MBRT-Public_consultationreviews_of_existing_MBS_items
5
Page 12
3.6
The Department of Health and Ageing
The Department of Health and Ageing (the Department) has contracted Adelaide Health Technology
Assessment (AHTA), School of Population Health and Clinical Practice, at the University of Adelaide to
develop the review protocol for specific MBS ophthalmology items and is responsible for the
management of this contract.
The Department is also responsible for ensuring that the draft protocol and draft review report are
made available online for public comment.
The Department will be responsible for negotiating with the relevant clinical craft groups with respect
to minor changes of specific ophthalmology items as outlined in Section 4.4.
Following the finalisation of the review report, the Department will be responsible for providing
advice to the Minister for Health and Ageing on future subsidy arrangements for the MBS Items
identified by this review of ophthalmology services. This advice will be informed by the review report
but will also draw on other information including budgetary considerations.
4.
REVIEW METHODOLOGY
The Schedule currently lists approximately 160 ophthalmology MBS items. Items to be included in the
second-stage of the review were identified by the RANZCO as: requiring deletion from the Schedule
(obsolete services); requiring amendment to reflect current clinical practice; or amendment to better
target the service to the most appropriate patient group.
Table 3 provides an overview of the methodology that will be used for each of the ophthalmological
items under review. The evaluation methodology that is proposed is a mixed method approach
consisting of MBS data analysis, mini-health technology assessments (HTAs) that are “fit-for-purpose”
and a guideline concordance analysis. Thirteen services will undergo an evidence-based analysis, 11 of
which will also undergo guideline concordance analysis. Minor amendments to four services will be
addressed through negotiation between the Department and the relevant stakeholders.
The draft protocol, including the defined review methodology for each service, has been discussed
with the Clinical Working Group and was amended as appropriate.
Page 13
Table 3 MBS item reviews and amendments
MBS ITEM
SERVICE
METHOD
Mini HTA review
Stakeholder
negotiation*
Guideline
concordance
Data analysis
42716
Removal of juvenile
cataract
42734,
42737
Capsulotomy /
Needling of posterior
capsule
x
42621
Punctum temporary
occlusion
x
x
x
42797
Laser coagulation
x
x
x
42524
Orbit skin graft
x
42653,
42656,
42659
Cornea transplantation
42744
x
x
x
x
x
x
Needling encysted bleb
x
x
x
42808
Photo-iridosyneresis
x
x
x
42629
Conjunctivorhinostomy
x
x
x
42623,
42626
Dacryocystorhinostomy
x
x
x
42650
Cornea epithelial
debridement
x
x
x
42872
Eyebrow elevation
42857,
4285x**
Resuturing of wound
42545
Orbit decompression
42755
Glaucoma, removal of
Molteno valve
42794
Division of suture by
laser
1123x**
B scan ultrasound
x
x
x
x
x
x
x
x
x
x
x
x
x
x
* The Department will undertake stakeholder negotiation, ** Proposed new item number
4.1
MBS data analysis
Clinical/research questions
For each of the services:
1. How frequent are claims for the MBS item numbers under review?
2. Are there any temporal or geographic trends associated with usage of these item numbers?
3. Are the Medicare claims data consistent with trends in the incidence/prevalence of the
conditions/diseases being addressed by the services?
Page 14
The project will commence with an analysis of Medicare claims data for the 22 MBS ophthalmology
item numbers being reviewed. Medicare Australia website statistics (item reports) will be canvassed
as these give details of the number of services provided (as counts) for each item since 1994, which
will enable time-trends to be established. The data will be analysed in terms of age group, gender,
and geographical spread (by states). The time trends will be represented in graphical form, and the
demographic data in tabular form. Data will also be requested from the Department of Health and
Ageing regarding claims on items associated with each of the items under review, along with urban
versus rural distribution of claims on each item number and a breakdown of claims by provider.
AIHW National Hospital Morbidity data will be investigated, as appropriate, to determine hospital
separations related to eye conditions, by diagnosis-related group AR-DRG (Major Diagnostic Category
02), principal diagnosis in ICD-10-AM (group VII, H00-H59), count of procedures ACHI (group III,
chapters 160-256) and cost. The data for each service will be presented graphically and in tables with
associated interpretive text.
The cost of the benefits paid by the government for each service will be obtained and reported for
the most recent calendar year, 2010, as well as separately for the first six months of 2011.
The analysis of data retrieved from all of these sources will provide insight into whether each of the
services under review can be equitably accessed, patient groups that are likely to be affected if
changes are made or items deleted in terms of age and gender breakdown, areas of under or overutilisation, and demographic implications for future demand for the services.
4.2
Guideline concordance
Clinical/research question
1. Is the descriptor for each MBS item number/service under review consistent with evidencebased (or in the absence of evidence, consensus-based) recommendations provided in
relevant clinical practice guidelines?
Concurrent with the MBS data analysis described above, an analysis of 11 ophthalmological services
(14 items) identified as requiring a guideline concordance analysis will be assessed relative to “best
practice” as recommended in Clinical Practice Guidelines relevant to practice in Australia (Table 4).
Table 4
Ophthalmology items receiving guideline concordance analysis
Service
Punctum temporary occlusion
MBS Item Numbers
42621
Laser coagulation
42797
Cornea transplantation
42653, 42656, 42659
Needling encysted bleb
42744
Photo-iridosyneresis
42808
Dacryocystorhinostomy / Conjunctivorhinostomy
42623, 42626, 42629
Cornea epithelial debridement
42650
Resuturing of wound
42857
Orbit decompression
42545
Division of suture by laser
42794
Page 15
Guidelines used in this concordance exercise are listed in Attachment 1, and will also be sourced from
the NHMRC Guidelines Portal (http://www.clinicalguidelines.gov.au/) and the National Guidelines
Clearinghouse (http://www.guideline.gov/).
Guideline quality will be rated according to the Appraisal of Guidelines for Research and Evaluation
(AGREE) appraisal instrument (http://www.agreecollaboration.org/instrument/), and the
recommendations regarding the services under review in those evidence-based Guidelines, with a
high AGREE score given more credence than lower rated Guidelines. Should the only available
Guidelines be of poor quality, then this will be noted when rating the service’s concordance with the
Guideline. The determination of Guideline concordance will be largely descriptive – firstly indicating
the quality of the Guideline which is being used as the benchmark for the concordance assessment,
describing the Guideline recommendations and relevant information presented in the Guideline text,
and then indicating how well the MBS item descriptors reflect the pertinent recommendations and
information in the Guideline, and finally suggesting revision or deletion of the MBS item descriptor.
One MBS item (42857) will be assessed with regard to a specific amendment suggested during the
guideline concordance exercise. The RANZCO has suggested that this item number should be changed
to two item numbers, on the basis that the existing item number is currently used for a procedure of
varying complexity depending on the nature and extent of the wound. The existing item number is
considered appropriate for smaller wounds (up to 5mm), whereas larger wounds (eg rupture or
revision of a penetrating keratoplasty) are more analogous to item number 42554.
The current definition of 42857 is:
"RESUTURING OF WOUND FOLLOWING INTRAOCULAR PROCEDURES with or without excision of
prolapsed iris (Anaes.) (Assist.). Fee: $390.70”
It has been suggested that item number 42857 be amended to read:
“RESUTURING OF WOUND (up to and including 5mm long) FOLLOWING INTRAOCULAR PROCEDURES
with or without excision of prolapsed iris or other intraocular tissues (Anaes.) (Assist.). Fee: $390.70”
and that a new item number, 4285x, be created: “RESUTURING OF WOUND (longer than 5mm long)
FOLLOWING INTRAOCULAR PROCEDURES with or without excision of prolapsed iris or other
intraocular tissues (Anaes.) (Assist.). Fee: $709.05”
Guideline concordance will be undertaken to determine whether this modification is consistent with
current clinical practice, in terms of whether there is additional complexity in resuturing longer
wounds . All other MBS items undergoing the Guideline concordance exercise will be reviewed more
generally, in terms of “best practice” in undertaking the relevant service. Following the MBS data and
guideline concordance analysis, specific services will receive an evidence-based review (see Section
4.3).
4.3
Evidence-based review – mini-health technology assessments (mini-HTAs)
Thirteen services (18 items) have been identified by the Department as requiring evidence-based
analysis (see Table 5). For the services identified as requiring revision by RANZCO, the review question
has been adapted to address the issue identified by RANZCO.
The analysis will be undertaken as a mini-HTA, with processes for literature searching and selection of
relevant information using criteria specified a priori in order to ensure transparency and reduce bias
in the selection of evidence to inform the respective clinical/ research questions.
Page 16
Table 5
Ophthalmology items receiving evidence-based analysis
Service
Capsulotomy / Needling of posterior capsule
MBS Item Numbers
42734, 42737
Punctum temporary occlusion
42621
Laser coagulation
42797
Orbit skin graft
42524
Cornea transplantation
42653, 42656, 42659
Needling encysted bleb
42744
Photo-iridosyneresis
42808
Dacryocystorhinostomy
42623, 42626
Conjunctivorhinostomy
42629
Cornea epithelial debridement
42650
Resuturing of wound
42857, 4285x
Orbit decompression
42545
Division of suture by laser
42794
The PICO (Population, Intervention, Comparator, Outcomes) criteria7 are used to develop welldefined questions for each review. This involves focusing the question on the following four elements:
•
the target population for the intervention;
•
the intervention being considered;
•
the comparator for the existing MBS service (where relevant); and
•
the clinical outcomes that are most relevant to assess safety and effectiveness.
The PICO criteria have been determined on the basis of information provided in the literature, as well
as clinical advice. These criteria will be applied when selecting literature to inform the mini-HTAs.
Additional criteria for selecting literature have also been outlined ie relevant study designs for
assessing the safety and effectiveness of the service, time period within which the literature will be
sourced, and language restrictions.
Clinical/ research questions and literature selection criteria
Three MBS item numbers (two services) will be reviewed that are aimed at improving or restoring
tear flow when the nasolacrimal duct is blocked or not functioning correctly. The item number 42629
for conjunctivorhinostomy will be investigated for amendment. Re-wording of the descriptor for item
42629 has been suggested: "Dacryocystorhinostomy with insertion of glass bypass tube (Anaes.)
(Assist.)”
7
Richardson WS, Scott MD, Wilson MC et al. (1995) “The well built clinical question: a key to evidence based decisions.”
ACP Journal Club, 123, ppA-12.
Page 17
Blockage or malfunction
of lacrimal apparatus
42629
CONJUNCTIVORHINOSTOMY including dacryocystorhinostomy
and fashioning of conjunctival flaps (Anaes.) (Assist.)
42623
DACRYOCYSTORHINOSTOMY (Anaes.) (Assist.)
42626
DACRYOCYSTORHINOSTOMY where a previous
dacryocystorhinostomy has been performed (Anaes.) (Assist.)
1. What is the relative safety and effectiveness of the different conjunctivorhinostomy
procedures? And is there evidence to suggest that item 42629 should be restricted to only
conjuctivodacryocystorhinostomy, with insertion of a permanent glass (pyrex) Jones tube?
Rationale for amendment: The relevant clinical craft group suggests that the
conjunctivorhinostomy procedure is outdated and the current descriptor inaccurate.
Note: Conjuctivodacryocystorhinostomy (CDCR) involves an external incision and the
permanent placement of a glass bypass tube, whereas items 42623 and 42626 – although not
specifically stating such – are likely to relate to the endoscopic use of DCR and temporary
placement of a bypass tube. It is expected that the relevant patient populations and
description of the interventions will emerge from the literature canvassed in the guideline
concordance analysis as well as from answering the research questions above – and will
inform amendments to these items.
Pre-specified criteria for selecting literature to address these questions are provided in Table 6.
Table 6
Criteria for selecting studies to assess the relative safety and effectiveness of
conjunctivorhinostomy procedures (item number 42629)
Characteristic
Inclusion Criteria
Study design
Effectiveness
Systematic reviews of randomised controlled trials (RCTs), RCTs, systematic reviews or
individual studies of a cohort and/or non-randomised design are eligible.
A hierarchical step-wise method will be used to select studies according to study design. If there
are no systematic reviews of RCTs available, then RCTs alone will be selected. Should trial data
be unavailable then systematic reviews of non-randomised and/or cohort studies will be selected.
In the event that these are not available non-randomised or cohort study designs alone will
become eligible. In the event that there are no comparative studies, then recent narrative reviews
of clinical practice guidelines will be sourced.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
People with a pathologic condition that results in obstruction of the upper lacrimal passageway.
Intervention
A conjunctivorhinostomy procedure
eg conjunctivodacryocystorhinostomy, canaliculodacryocystorhinostomy, flap reconstruction
techniques
Comparator
Any other conjunctivorhinostomy procedure different to the intervention
Page 18
Outcomes
Safety
Adverse physical health outcomes as a consequence of the procedure, eg infection, granulation
formation.
Effectiveness
Primary – reduction in epiphora or tearing, reduction or resolution of inflammation, removal of
blockage (dacryolith or benign mass) with resulting normal function of lacrimal passage, quality of
life
Secondary – reoperation
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
One MBS item concerned with the temporary occlusion of the lacrimal punctum will be investigated
for deletion from the MBS:
Malfunction of lacrimal
apparatus
42621
PUNCTUM, temporary occlusion of, by use of electrical cautery
2. Is occlusion of the lacrimal punctum with electrical cautery a temporary or permanent
treatment for patients with dry eye?
Rationale for deletion: The relevant clinical craft group suggests that electrical cautery is used to
achieve permanent occlusion of the punctum (MBS item number 42622), whereas temporary
occlusion of the punctum may only be achieved with a punctal plug. The type of plug may affect the
effectiveness of the procedure.
Pre-specified criteria for selecting literature to address this question are provided in Table 7.
Table 7
Criteria for selecting studies to assess the safety and effectiveness of lacrimal punctum
occlusion using electrical cautery.
Characteristic
Inclusion Criteria
Page 19
Study design
Effectiveness
Systematic reviews of RCTs, RCTs, systematic reviews or individual studies of a cohort and/or
non-randomised design are eligible.
A hierarchical step-wise method will be used to select studies according to study design. If there
are no systematic reviews of RCTs available, then RCTs alone will be selected. Should trial data
be unavailable then systematic reviews of non-randomised and/or cohort studies will be selected.
In the event that these are not available non-randomised or cohort study designs alone will
become eligible. In the event that there are no comparative studies, then recent narrative reviews
of clinical practice guidelines will be sourced.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
People with keratitis sicca or “dry eye”
Intervention
Electrical cautery
Comparator
N/A
Outcomes
Safety
Adverse physical health outcomes as a consequence of the procedures.
Effectiveness
Primary – permanent (long-term) resolution of the symptoms of dry eye (by production of tears
and reduction of tear drainage), temporary (short-term) resolution of the symptoms of dry eye,
quality of life
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
RCT = randomised controlled trial, N/A = not applicable
Three items regarding corneal transplanation will be reviewed. The majority of corneal
transplantation procedures currently performed are full thickness transplants. It has been suggested
that item number 42659 should be deleted and item number 42653 be reworded to: “ CORNEA,
transplantation of, full thickness”
Cornea transplantation
42653
CORNEA, transplantation of, full thickness
42656
CORNEA, transplantation of, second and subsequent procedures
42659
CORNEA, transplantation of, superficial or lamellar
3. Is deep anterior lamellar keratoplasty (DALK) as safe and effective as penetrating
keratoplasty?
4. Is descemets stripping endothelial transplant (DSEK) as safe and effective as penetrating
keratoplasty?
5. Is the use of a superficial or lamellar corneal transplantation a suitable procedure for all
patients who may currently be indicated for a full thickness corneal transplant ?
Rationale for deletion: Changes to surgical technique, in particular the increasing complexity of
Page 20
lamellar corneal transplantation techniques, mean that the distinction between full thickness and
lamellar grafting, in terms of surgical complexity and time, is no longer applicable. The usage of item
number 42653 is currently 10 times that of item number 42659, therefore the impact of all uses of
this item transferring to 42653 would be minimal.
Pre-specified criteria for selecting literature to address these questions are provided in Table 8.
Page 21
Table 8
Criteria for selecting studies to assess the safety and effectiveness of the lamellar
grafting procedure.
Characteristic
Inclusion Criteria
Study design
Effectiveness
Systematic reviews of RCTs, RCTs, systematic reviews or individual studies of a cohort and/or nonrandomised design are eligible.
A hierarchical step-wise method will be used to select studies according to study design. If there are
no systematic reviews of RCTs available, then RCTs alone will be selected. Should trial data be
unavailable then systematic reviews of non-randomised and/or cohort studies will be selected. In the
event that these are not available non-randomised or cohort study designs alone will become
eligible. In the event that there are no comparative studies, then recent narrative reviews of clinical
practice guidelines will be sourced.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
Intervention
People with:
1. Keratitis (inflammation of the cornea)
2. Fuchs' dystrophy
3. Keratoconus (protrusion of the cornea)
4. Corneal scarring caused by infection or injury
5. Thinning, clouding or swelling of the cornea
6. Corneal ulcers
1. Deep anterior lamellar keratoplasty
2. Descemets stripping endothelial transplant
Comparator
Penetrating keratoplasty (ie full thickness corneal transplant)
Outcome
Safety
Adverse physical health outcomes, graft failure, infection, neovascularisation.
Effectiveness
Primary – graft success as determined by graft clarity/survival, visual acuity, structural integrity of
the globe and quality of life including patient comfort.
Secondary – repeat corneal transplantation following graft failure, procedure time/duration.
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
RCT = randomised controlled trial
Page 22
One item number regarding debridement of the corneal epithelium will be reviewed. The item
number 42650 relating to epithelial debridement of the cornea will be investigated for amendment.
Re-wording of the descriptor for item 42650 has been suggested to: "CORNEA, epithelial debridement for
corneal ulcer, or corneal erosion, or suspected corneal infection (excluding aftercare) (Anaes.)”
Cornea epithelial
debridement
42650
CORNEA, epithelial debridement for corneal ulcer or corneal erosion
(excluding aftercare)
6. Does corneal debridement for diagnostic purposes, with identification of the causative
organism, contribute to improved patient care?
Rationale for amendment: Corneal scraping is an integral part of the management of suspected
corneal infection (microbial keratitis), and the item descriptor 42650 should reflect this common
indication.
Pre-specified criteria for selecting literature to address this question are provided in Table 9.
Page 23
Table 9
Criteria for selecting studies to assess the effectiveness of corneal debridement for
diagnostic purposes in patients with a corneal infection (item number 42650)
Characteristic
Inclusion Criteria
Study design
Effectiveness
Systematic reviews of RCTs, RCTs, systematic reviews or individual studies of a cohort and/or nonrandomised design are eligible.
A hierarchical step-wise method will be used to select studies according to study design. If there are
no systematic reviews of RCTs available, then RCTs alone will be selected. Should trial data be
unavailable then systematic reviews of non-randomised and/or cohort studies will be selected. In the
event that these are not available, non-randomised or cohort study designs alone will become
eligible. If direct evidence of diagnostic effectiveness is not available, then diagnostic accuracy
studies will be canvassed. In the event that there are no relevant empirical studies, then recent
narrative reviews of clinical practice guidelines will be sourced.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
People with suspected corneal infection.
Intervention
Debridement of the corneal epithelium
Comparator
No debridement of the corneal epithelium
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedure.
Effectiveness
Primary – resolution of symptoms, time to resolution of symptoms.
Secondary – identification of causative organism, resolution of infection.
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
RCT = randomised controlled trial
Page 24
One item number for laser coagulation of the cornea will be investigated for deletion from the MBS.
Laser coagulation of the
cornea
42797
LASER COAGULATION OF CORNEAL OR SCLERAL BLOOD
VESSELS - each treatment to 1 eye, to a maximum of 4 treatments
to that eye in a 2 year period
7. Is there evidence supporting the clinical effectiveness or safety of the service described by
item number 42797 - “LASER COAGULATION OF CORNEAL OR SCLERAL BLOOD VESSELS” – to
warrant its retention on the MBS?
Rationale for deletion: Advice from the Cornea subgroup of the College's MBS Review Committee is
that this procedure is seldom performed (43 uses in the 2009-10 year) and is of doubtful efficacy.
Pre-specified criteria for selecting literature to address this question are provided in Table 10.
Page 25
Table 10 Criteria for selecting studies to assess the safety and effectiveness of photocoagulation
of the cornea or sclera (item number 42797)
Characteristic
Inclusion Criteria
Study design
Effectiveness
Systematic reviews of RCTs, RCTs, systematic reviews or individual studies of a cohort and/or nonrandomised design are eligible.
A hierarchical step-wise method will be used to select studies according to study design. If there are
no systematic reviews of RCTs available, then RCTs alone will be selected. Should trial data be
unavailable then systematic reviews of non-randomised and/or cohort studies will be selected. In the
event that these are not available non-randomised or cohort study designs alone will become
eligible. In the event that there are no comparative studies, then recent narrative reviews of clinical
practice guidelines will be sourced.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
People with excessive neovascularisation or angiogenesis of the cornea or sclera
Intervention
Laser photocoagulation of the cornea or sclera
Comparator
Medical
1.
2.
3.
4.
Lubrication
NSAIDs
Topical corticosteroids
Anti-angiogenic agents - including angiostatic steroids, vascular endothelial growth factor
inhibitor, protein kinase-C inhibitor, matrix metalloprotinase inhibitor, Cox-2 inhibitor,
antioxidants, thalidomide, dietary derived inhibitor, ion channel blockers
Surgical
1. Peritomy
2. Diathermy
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedures including corneal
haemorrhage, corneal thinning, corneal perforation and atrophy of the iris.
Effectiveness
Primary – complete or partial occlusion of vessels.
Secondary – recanalisation requiring repeat treatment.
Search period
2006 – 9/2011. Should there be limited data available during this period; the search will be extended
back in five year increments until sufficient data are sourced.
Language
English language only
RCT = randomised controlled trial, NSAID = non-steroidal anti-inflammatory drug
Page 26
Two item numbers for the treatment of cataract will be reviewed. One item number, 42737,
regarding needling of the posterior capsule will be investigated for deletion from the MBS due to lack
of use. If this procedure is needed to be performed it could still be billed under item number 42734.
Cataract
42737
NEEDLING OF POSTERIOR CAPSULE
42734
CAPSULOTOMY, other than by laser
8. Is it reasonable that procedures previously performed under item number 42737 could be
performed under item number 42734?
Rationale for deletion: Item number 42737 is no longer routinely performed; however, if it is
performed it would be encompassed by item number 42734 “CAPSULOTOMY, other than by laser”.
Pre-specified criteria for selecting literature to address this question are provided in Table 11.
Table 11 Criteria for selecting studies to assess the safety and effectiveness of needling of the
posterior capsule for the treatment of cataracts (item numbers 42734, 42737) and its
similarity to capsulotomy.
Characteristic
Inclusion Criteria
Study design
Narrative and/or systematic reviews, intervention studies of any design, consensus or evidencebased clinical practice guidelines.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
People with cataract
Intervention
1. Needling of the posterior capsule (item number 42737)
2. Capsulotomy (item number 42734)
Comparator
NA
Outcome
Latest occurrence (date) of published research on both procedures, circumstances where these
procedures might be used, any safety and/or effectiveness concerns reported in the literature
regarding both procedures.
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
NA = not applicable
Page 27
One item number (42744) for the treatment of an encysted glaucoma bleb will be investigated for
amendment. Re-wording of the descriptor for item 42744 has been suggested: "NEEDLEING REVISION
FOR DRAINAGE OF ENCYSTED GLAUCOMA FILTRATION BLEB, following trabeculectomy glaucoma
filtering procedure (Anaes.)”
Glaucoma
42744
NEEDLING FOR DRAINAGE OF ENCYSTED BLEB, following
trabeculectomy
9. Is needle revision a safe and effective procedure for re-establishing a functional glaucoma
filtration bleb following a glaucoma filtration procedure?
Rationale for amendment: The item descriptor should be amended to more accurately reflect the
current terminology for this procedure.
Pre-specified criteria for selecting literature to address this question are provided in Table 12.
Table 12 Criteria for selecting studies to assess the safety and effectiveness of needle revision of
a glaucoma filtration bleb following a glaucoma filtration procedure (item number
42744)
Characteristic
Inclusion Criteria
Study design
Narrative and/or systematic reviews, intervention studies of any design, consensus or evidencebased clinical practice guidelines.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
Patients with glaucoma.
Intervention
Needle revision of closed glaucoma filtration bleb.
Comparator
NA
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedures including infection, too high
or too low (hypotony) intraocular pressure, cataracts, decreased visual acuity, loss of globe,
hyphaema (haemorrhage into anterior chamber, filtration bleb leaks, endophthalmitis, pain and
discomfort.
Effectiveness
Primary –reduction in intraocular pressure and improved bleb morphology.
Secondary – repeat procedure.
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
NA = not applicable
Page 28
One item number, 42808, relating to laser photoiridosyneresis for patients with closed angle
glaucoma will be investigated for amendment. Re-wording of the descriptor for item 42808 is
suggested to: "PHOTOIRIDOSYNERESIS, laser Laser peripheral iridoplasty”
Glaucoma
42808
PHOTOIRIDOSYNERESIS, laser
10. Is iridoplasty a safe and effective procedure for the treatment of closed-angle glaucoma?
Rationale for amendment: The item descriptor should be amended to more accurately reflect the
current terminology for this procedure.
Pre-specified criteria for selecting literature to address this question are provided in Table 13.
Table 13 Criteria for selecting studies to assess the use of iridoplasty for angle closure in
glaucoma patients (item number 42808)
Characteristic
Inclusion Criteria
Study design
Narrative and/or systematic reviews, intervention studies of any design, consensus or evidencebased clinical practice guidelines.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
Glaucoma patients with acute angle closure.
Intervention
Laser peripheral iridoplasty
Comparator
NA
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedures including: increased
intraocular pressure; corneal, lens, or retinal burns; posterior, and synechiae.
Effectiveness
Primary – opening of the angle, reduction in pain, reduction in IOP, visual acuity
Secondary – repeat procedure.
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
NA = not applicable, IOP = intraocular pressure
Page 29
One item number, 42794, relating to suture division with laser in glaucoma patients will be
investigated for amendment. Re-wording of the descriptor for item 42794 has been suggested:
“DIVISION OF SUTURE BY LASER following trabeculoplasty glaucoma filtration surgery, each treatment
to 1 eye, to a maximum of 2 treatments to that eye in a 2 year period (Anaes.)”
Glaucoma
42794
DIVISION OF SUTURE BY LASER following trabeculoplasty, each
treatment to 1 eye, to a maximum of 2 treatments to that eye in a 2
year period
11. Is suture lysis by laser following glaucoma filtration surgery a safe and effective procedure?
Rationale for amendment: The item descriptor should be amended to more accurately reflect the
current terminology for this procedure. The current descriptor has “following trabeculoplasty”, which
is a different procedure to trabeculectomy. The item number was intended to be written as
“following trabeculectomy”. The term “glaucoma filtration surgery” is now preferred to
“trabeculectomy”. The procedure of trabeculoplasty is a different operation.
Pre-specified criteria for selecting literature to address this question are provided in Table 14.
Table 14 Criteria for selecting studies to assess the safety and effectiveness of suture lysis by
laser following glaucoma filtration surgery (item number 42794)
Characteristic
Inclusion Criteria
Study design
Narrative and/or systematic reviews, intervention studies of any design, consensus or evidencebased clinical practice guidelines.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
1. Patients with glaucoma who have undergone glaucoma filtration surgery
2. Patients with glaucoma who have undergone trabeculoplasty
Interventions
Lysis of sutures by laser.
Comparators
NA
Outcome
Safety
Complications associated with the procedure including: flat anterior chamber, external aqueous
leak, malignant glaucoma, Iris incarceration, hyphaema, excessive bleb elevation, corneal dellen.
Effectiveness
Primary – reduction in intraocular pressure, visual acuity
Secondary – repeat procedure
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
NA = not applicable
Page 30
One item number, 42524, relating to orbital skin grafts will be investigated for deletion from the MBS.
Eye disease
42524
ORBIT, SKIN GRAFT TO, as a delayed procedure
12. Is it reasonable for patients requiring an orbital skin graft to be billed under item number
45439 as a split thickness skin graft?
Rationale for deletion: This procedure is no longer routinely performed and if necessary could be
billed under item number 45439 “FREE GRAFTING (split skin) to 1 defect, including elective dissection,
small”.
Pre-specified criteria for the selecting literature to address this question are provided in Table 15.
Table 15 Criteria for selecting studies to assess the safety and effectiveness of split thickness
skin grafts for patients requiring an orbital skin graft.
Characteristic
Inclusion Criteria
Study design
Narrative or systematic reviews or any study design, consensus or evidence-based clinical practice
guidelines
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
Patients who have undergone exenteration and who require an orbital skin graft
Intervention
1. Orbital skin graft
2. Split thickness skin graft
Comparator
NA
Outcome
Safety
Complications associated with the procedure including infection of donor and implantation site
Effectiveness
Primary – time to healing, skin graft patency
Secondary – repeat graft procedure after rejection
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
NA = not applicable
Page 31
One item number, 42545, relating to decompression of the orbit will be investigated for exemption
from the MBS multiple services rule when a bilateral orbital decompression is performed. Re-wording
of the descriptor for item 42545 is suggested to: “ORBIT, decompression of, for dysthyroid eye
disease, by fenestration of 2 or more walls, or by the removal of intraorbital, peribulbar and
retrobulbar fat from each quadrant of the orbit, 1 eye (Anaes.) (Assist.)
Exempt from aftercare when bilateral orbital decompression is performed”
Eye disease
42545
ORBIT, decompression of, for dysthyroid eye disease, by
fenestration of 2 or more walls, or by the removal of intraorbital
peribulbar and retrobulbar fat from each quadrant of the orbit, 1 eye
Multiple Services Rule
13. Is bilateral orbital decompression as safe and effective as unilateral orbital decompression
for the treatment of dysthyroid eye disease?
Rationale for amendment: ANZSOPS has previously requested that this item number be exempted from the
Multiple Procedure Rule when bilateral orbital decompression is performed.
Pre-specified criteria for selecting literature to address this question are provided in Table 16.
Table 16 Criteria for selecting studies to assess the safety and effective of unilateral verses
bilateral orbital decompression.
Characteristic
Inclusion Criteria
Study design
Effectiveness
Systematic reviews of RCTs, RCTs, systematic reviews or individual studies of a cohort and/or nonrandomised design are eligible.
A hierarchical step-wise method will be used to select studies according to study design. If there are
no systematic reviews of RCTs available, then RCTs alone will be selected. Should trial data be
unavailable then systematic reviews of non-randomised and/or cohort studies will be selected. In the
event that these are not available non-randomised or cohort study designs alone will become
eligible. In the event that there are no comparative studies, then recent narrative reviews of clinical
practice guidelines will be sourced.
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
Patients with dysthyroid or Graves’ eye disease
Intervention
1. Unilateral orbital decompression
2. Bilateral orbital decompression
Comparator
NA
Outcome
Safety
Complications associated with the procedure including loss of vision, double vision, infection,
bleeding, loss of facial sensation and retraction of the lower and/or upper eyelid.
Effectiveness
Primary – resolution of the symptoms of dysthyroid eye including bulging of the eye, redness, upper
eyelid retraction, conjunctivitis, inflammation and pain, visual acuity and quality of life
Secondary – repeat procedure, hospital admission/readmission, length of stay, cost
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Page 32
Language
English language only
RCT = randomised controlled trial, NA = not applicable
One item number, 42857, relating to the resuturing of wounds will be reviewed. It has been
suggested that item number 42857 be amended to read: “RESUTURING OF WOUND (up to and
including 5mm long) FOLLOWING INTRAOCULAR PROCEDURES with or without excision of prolapsed
iris or other intraocular tissues (Anaes.) (Assist.). Fee: $390.70” and that a new item number, 4285x,
be created: “RESUTURING OF WOUND (longer than 5mm long) FOLLOWING INTRAOCULAR
PROCEDURES with or without excision of prolapsed iris or other intraocular tissues (Anaes.) (Assist.).
Fee: $709.05”
Eye disease
42857
RESUTURING OF WOUND FOLLOWING INTRAOCULAR
PROCEDURES with or without excision of prolapsed iris
14. Is it reasonable to create a new item number reflecting the complexity of a wound
resuturing procedure based on the length of the wound?
Rationale for additional item number: The resuturing of wounds following previous intraocular
surgery can vary considerably in complexity depending on the nature and extent of the wound. The
existing item is appropriate for smaller wounds (up to 5mm), whereas larger wounds (eg rupture or
revision of a penetrating keratoplasty) are more analogous to item 42554.
Pre-specified criteria for selecting literature to address this question are provided in Table 17.
Table 17 Criteria for selecting studies to assess the complexity of the wound resuturing
procedure based on the length of the wound.
Characteristic
Inclusion Criteria
Page 33
Study design
Narrative or systematic reviews or any study design, consensus or evidence-based clinical practice
guidelines
Only the most recent, good quality literature will be selected and reported – as determined by the
NHMRC levels of evidence hierarchy (Table 19).
Population
Patients with previous intra-ocular surgery
Intervention
1. Resuturing of wounds up to and including 5mm long
2. Resuturing of wounds longer than 5mm
Comparator
NA
Outcome
Latest occurrence (date) of published research on both procedures, circumstances where these
procedures might be used, any safety and/or effectiveness concerns reported in the literature
regarding both procedures.
Duration of procedure data required to determine whether larger wounds are more complex.
Search period
2006 – 9/2011
Should there be limited data available during this period; the search will be extended back in five
year increments until sufficient data are sourced.
Language
English language only
NA = not applicable
Literature search
As outlined in the selection criteria for each clinical question, the approach to searching for literature
will be tailored according to the type of factors influencing usage of procedure described in each item
number –
A. if the service is still in regular use then a search for high level literature will be conducted using
the Cochrane library – including the Cochrane database of systematic reviews, Database of
abstracts of reviews of effects (DARE) and the HTA database. The economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) will be canvassed using
‘systematic reviews’, ‘meta-analysis’ or ‘trials’ filters, in the first instance (see Limits 1-2 in
Table 18). Literature searches will be restricted to the English language only.
B. if the service is only used infrequently, then a targeted search will be undertaken to determine
the current ‘state-of-play’ of the procedure. The most recent narrative reviews and/or
systematic reviews (if any) and Clinical Practice Guidelines will be identified and analysed to
determine what international opinion is with respect to the service and whether there are any
subgroups of patients where the technology might have a use. The literature will be sourced
from Embase.com (Medline and Embase) without a study design filter check but will be
searched chronologically (see Limit 3 in Table 18).
Search strategies generally include a combination of indexing terms (eg MeSH or Emtree headings)
and text word terms. Limits will be employed in a hierarchical manner according to the type of
literature being sourced ie Limit 1, and if no relevant literature then Limit 2 and if no relevant
literature, then Limit 3. This is outlined in Table 18.
Suggested search terms to identify economic studies are described in Table 22.
Page 34
Table 18 Suggested search terms for review of ophthalmological items
Clinical question
Search terms
1. blockage of the lacrimal
passage and the insertion of
either a permanent or
temporary nasolacrimal tube
Population – (‘lacrimal apparatus'/exp OR ‘lacrimal duct obstruction’/exp OR
'nasolacrimal tube' OR 'lacrimal passage*' OR 'lacrimal gland disease'/exp OR
dacryocyst* OR 'epiphora' OR ‘tear duct*’) AND
Intervention –('eye surgery'/exp OR 'eye surgery' OR ‘dacryocystorhinostomy’/exp
OR dacryocystorhinostomy OR conjunctivorhinostomy OR ‘flap reconstruct*’ OR
canalicul*) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
2. temporary occlusion of the
lacrimal punctum
Population – (‘keratitis sicca’/exp OR ‘dry eye syndromes’/exp OR ‘keratitis sicca’
OR ‘dry eye*’ OR ‘lacrimal apparatus'/exp OR ‘lacrimal punctum’) AND
Intervention – ((cautery/exp AND electr*) OR (electric* AND cauter*) OR
electrocautery OR (galvanic AND cautery)) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
3. corneal transplantation
Population – ('keratitis'/exp OR 'Fuchs' endothelial dystrophy '/exp OR ‘corneal
dystrophy, Fuchs' endothelial/exp OR ‘keratoconus’/exp OR ‘corneal ulcer’/exp
OR ‘dry eye’ OR (‘cornea* AND ulcer*’) OR (cornea* AND (thin* OR cloud*)) OR
(cornea* AND scar*)) AND
Intervention – (('corneal transplantation'/exp OR (cornea* AND transplant*)) AND
(superficial OR lamellar OR endothelial) OR DALK OR DSEK) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
Page 35
4. epithelial debridement of the
cornea
Population – (‘corneal ulcer’/exp OR infection/exp OR ‘ulcer*’OR ‘infect*’ OR
‘erosion’) AND
Intervention – (‘cornea’/exp AND ‘debridement’/exp) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
5. laser coagulation of the cornea
Population – (‘pathologic neovascularization’/exp AND (‘cornea’/exp OR
‘sclera’/exp)) AND
Intervention – (‘laser coagulation’/exp OR ‘photocoagulat*) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
6. needling of the posterior
capsule
Population – ('cataract'/exp OR 'cataract*’) AND
Intervention – ('capsulotomy'/exp OR (‘posterior capsule of the lens’/exp AND
‘needl*’) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
7. revision of a glaucoma filtration
bleb
Population – ('glaucoma'/exp OR 'glaucoma’) AND
Intervention – ‘trabeculectomy’/exp OR filtering surgery/exp OR filter* OR filtrate*
OR (needl* AND (glaucoma AND bleb)) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
Page 36
8. peripheral laser iridoplasty for
closed angle glaucoma
Population – ('glaucoma, angle-closure'/exp OR (‘close* AND angle AND
glaucoma')) AND
Intervention – (‘laser’/exp AND ‘iridoplasty’) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
9. division of suture by laser in
glaucoma patients
Population – ('glaucoma'/exp OR 'glaucoma’) AND
Intervention – ‘trabeculectomy’/exp OR ‘suture lysis’ OR ‘laser suture lysis’ OR
‘post operative management’ AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
10. orbital skin graft
Population – ('eye'/exp OR 'eye disease'/exp) AND
Intervention – ((‘skin transplantation’/exp AND ‘orbit’/exp) OR graft*) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
11. orbital decompression
Population – (‘Graves ophthalmopathy’/exp OR ‘Graves disease’/exp OR ‘orbital
diseases’ OR ((‘dysthyroid OR Graves) AND ‘eye disease’) OR ‘Graves ophthal*)
AND
Intervention –(‘decompression, surgical’/exp OR decompress*) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
Page 37
12. Resuturing of wounds following
an intraocular procedure
Population – ('eye'/exp OR 'eye disease'/exp) AND
Intervention – ‘suturing techniques’/exp OR ‘ophthalmologic surgical
procedures’/exp OR (ocular AND (‘wounds and injuries’/exp OR rupture/exp OR
lacerations/exp)) OR (‘post operative AND dehiscence) AND
Limits –
1. [English language]/lim AND [humans]/lim AND [2006-2011]/py AND
([systematic review]/lim OR [meta analysis]/lim)
2. [humans]/lim AND [2006-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled
trial]/lim)
3. [article]/lim AND [humans]/lim AND [2006-2011]/py
Page 38
Critical appraisal of selected evidence
The literature will be categorised according to NHMRC levels of evidence (see Table 19), critically
appraised using checklists relevant for each type of literature, and then synthesised according to the
evidence matrix for NHMRC Grades of recommendation (see Table 20). Relevant checklists include
PRISMA for systematic reviews and health technology assessments (Liberati et al 2009); SIGN
checklists for appraising randomised and non-randomised controlled trials and observational studies
(SIGN 2008); and the QUADAS checklist for appraising diagnostic accuracy studies (Whiting et al
2003).
Table 19 Designations of levels of evidence (Merlin et al 2009; NHMRC 2009)
Level
Intervention 1
Diagnostic accuracy 2
I4
A systematic review of level II
studies
A systematic review of level
II studies
II
A randomised controlled trial
A study of test accuracy with: an independent,
blinded comparison with a valid reference
standard,5 among consecutive persons with a
defined clinical presentation6
III-1
A pseudo-randomised controlled trial
(i.e. alternate allocation or some other method)
III-2
A comparative study with concurrent
controls:
 Non-randomised, experimental trial9
 Cohort study
 Case-control study
 Interrupted time series with a control group
A study of test accuracy with: an independent,
blinded comparison with a valid reference
standard,5 among non-consecutive persons with
a defined clinical presentation6
A comparison with reference standard that does
not meet the criteria required for
Level II and III-1 evidence
III-3
A comparative study without concurrent
controls:
 Historical control study
 Two or more single arm study10
 Interrupted time series without a
parallel control group
Diagnostic case-control study6
IV
Case series with either post-test or pre-test/posttest outcomes
Study of diagnostic yield (no reference standard)11
Explanatory notes8
1 Definitions of these study designs are provided on pages 7-8 How to use the evidence: assessment and application of scientific
evidence (NHMRC 2000b) and in the accompanying Glossary.
2 These levels of evidence apply only to studies of assessing the accuracy of diagnostic or screening tests. To assess the overall
effectiveness of a diagnostic test there also needs to be a consideration of the impact of the test on patient management and health
outcomes (Medical Services Advisory Committee 2005, Sackett and Haynes 2002). The evidence hierarchy given in the ‘Intervention’
column should be used when assessing the impact of a diagnostic test on health outcomes relative to an existing method of
diagnosis/comparator test(s). The evidence hierarchy given in the ‘Screening’ column should be used when assessing the impact of a
screening test on health outcomes relative to no screening or opportunistic screening.
8
Note - only evidence hierarchies relevant to this review have been reproduced in Table 19, therefore table notes 7 and 8
have not been reproduced
Page 39
4 A systematic review will only be assigned a level of evidence as high as the studies it contains, excepting where those studies are of
level II evidence. Systematic reviews of level II evidence provide more data than the individual studies and any meta-analyses will
increase the precision of the overall results, reducing the likelihood that the results are affected by chance. Systematic reviews of lower
level evidence present results of likely poor internal validity and thus are rated on the likelihood that the results have been affected by
bias, rather than whether the systematic review itself is of good quality. Systematic review quality should be assessed separately. A
systematic review should consist of at least two studies. In systematic reviews that include different study designs, the overall level of
evidence should relate to each individual outcome/result, as different studies (and study designs) might contribute to each different
outcome.
5 The validity of the reference standard should be determined in the context of the disease under review. Criteria for determining the
validity of the reference standard should be pre-specified. This can include the choice of the reference standard(s) and its timing in
relation to the index test. The validity of the reference standard can be determined through quality appraisal of the study (Whiting et
al 2003).
6 Well-designed population based case-control studies (eg. population based screening studies where test accuracy is assessed on all
cases, with a random sample of controls) do capture a population with a representative spectrum of disease and thus fulfil the
requirements for a valid assembly of patients. However, in some cases the population assembled is not representative of the use of
the test in practice. In diagnostic case-control studies a selected sample of patients already known to have the disease are compared
with a separate group of normal/healthy people known to be free of the disease. In this situation patients with borderline or mild
expressions of the disease, and conditions mimicking the disease are excluded, which can lead to exaggeration of both sensitivity
and specificity. This is called spectrum bias or spectrum effect because the spectrum of study participants will not be representative
of patients seen in practice (Mulherin and Miller 2002).
9 This also includes controlled before-and-after (pre-test/post-test) studies, as well as adjusted indirect comparisons (ie. utilise A vs B
and B vs C, to determine A vs C with statistical adjustment for B).
10 Comparing single arm studies ie. case series from two studies. This would also include unadjusted indirect comparisons (ie. utilise A
vs B and B vs C, to determine A vs C but where there is no statistical adjustment for B).
11 Studies of diagnostic yield provide the yield of diagnosed patients, as determined by an index test, without confirmation of the
accuracy of this diagnosis by a reference standard. These may be the only alternative when there is no reliable reference standard.
Note A: Assessment of comparative harms/safety should occur according to the hierarchy presented for each of the research questions,
with the proviso that this assessment occurs within the context of the topic being assessed. Some harms (and other outcomes) are
rare and cannot feasibly be captured within randomised controlled trials, in which case lower levels of evidence may be the only type
of evidence that is practically achievable; physical harms and psychological harms may need to be addressed by different study
designs; harms from diagnostic testing include the likelihood of false positive and false negative results; harms from screening include
the likelihood of false alarm and false reassurance results.
Note B: When a level of evidence is attributed in the text of a document, it should also be framed according to its corresponding research
question eg. level II intervention evidence; level IV diagnostic evidence; level III-2 prognostic evidence.
Note C: Each individual study that is attributed a “level of evidence” should be rigorously appraised using validated or commonly used
checklists or appraisal tools to ensure that factors other than study design have not affected the validity of the results.
Source: Hierarchies adapted and modified from: NHMRC 1999; Bandolier 1999; Lijmer et al. 1999; Phillips et al. 2001.
Page 40
The overall body of research evidence will be assessed and synthesised to address each clinical
question according to Table 20. An evidence rating from A (excellent) to D (poor) will be assigned to
the evidence, considering each of the components outlined in the body of evidence matrix. In the
absence of such literature, expert opinion and narratives will be synthesised according to the
credibility of the source of such material.
Table 20 Body of evidence assessment matrix (adapted from Merlin et al 2009; NHMRC 2009)
Component
A
B
C
D
Excellent
Good
Satisfactory
Poor
Evidence base1
one or more level I
studies with a low risk
of bias or several
level II studies with a
low risk of bias
one or two level II
studies with a low risk
of bias or a
SR/several level III
studies with a low risk
of bias
one or two level III
studies with a low risk
of bias, or level I or II
studies with a
moderate risk of bias
level IV studies, or
level I to III
studies/SRs with a
high risk of bias
Consistency2
all studies consistent
most studies
consistent and
inconsistency may be
explained
some inconsistency
reflecting genuine
uncertainty around
clinical question
evidence is
inconsistent
Clinical impact
very large
substantial
moderate
slight or restricted
Generalisability
population/s studied in
body of evidence are
the same as the target
population
population/s studied in
the body of evidence
are similar to the
target population
population/s studied in
body of evidence
differ to target
population but it is
clinically sensible to
apply this evidence to
target population3
population/s studied in
body of evidence
differ to target
population and hard to
judge whether it is
sensible to generalise
to target population
Applicability
directly applicable to
Australian healthcare
context
applicable to
Australian healthcare
context with few
caveats
probably applicable to not applicable to
Australian healthcare Australian healthcare
context with some
context
caveats
SR = systematic review; several = more than two studies
1 Level of evidence determined from the NHMRC evidence hierarchy – Table 19.
2 If there is only one study, rank this component as ‘not applicable’.
3 For example, results in adults that are clinically sensible to apply to children OR psychosocial outcomes for one cancer that may be applicable to patients
with another cancer
Page 41
4.4
Stakeholder negotiation
Four item descriptors for the ophthalmological items under review will be discussed and potentially
amended through negotiation between the Department and relevant stakeholders, with amendments
relating to corrections of terminology. Items to be addressed are in Table 21.
Table 21 Ophthalmology items potentially being revised through negotiation
Service
MBS Item Numbers
Removal of juvenile cataract
42716
Removal of Molteno valve in glaucoma patients
42755
Eyebrow, elevation of, for paretic states or visual field
42872
B scan ultrasound
1123x
Item 42716 provides for the removal of juvenile cataracts. It has been suggested that the current item
descriptor does not reflect current practice.
42716
CATARACT, JUVENILE, removal of, including subsequent needlings (Anaes.) (Assist.)
Fee: $1,150.40
Therefore, the following amendment has been identified: “CATARACT, JUVENILE, removal of,
including subsequent needlings (Anaes.) (Assist.)”
Item number 42755 describes the removal of a Molteno value in glaucoma patients. However, there
are now several glaucoma drainage devices approved for use in Australia (eg Baerveldt) in addition to
the Molteno device, therefore the item descriptor should include a generic term rather than a specific
brand. Rewording of the item number for the insertion of a Molteno valve (42752) was assessed in
Stage I of the ophthalmology review, therefore it has been suggested that similar wording for the
removal of the drainage device could be accepted after stakeholder negotiation.
42755
GLAUCOMA, removal of Molteno valve (Anaes.)
Fee: $159.15
It has been suggested that item number 42755 be reworded as follows: “GLAUCOMA, removal of
glaucoma drainage device incorporating an extraocular reservoir (Anaes.)”
With respect to item number 42872, it has been suggested that the current descriptor does not
reflect the indication for a brow lift where severe brow ptosis leads to hooding of brow skin resulting
in a visual field defect, similar to that seen in eyelid ptosis.
42872
EYEBROW, elevation of, for paretic states (Anaes.)
Fee: $231.55
It has therefore been suggested that this item number be amended as follows: “EYEBROW, elevation
of, for paretic states or visual field deficit (Anaes.)”
Page 42
The College has requested a new B scan diagnostic item be listed in Group DI – Subgroup 2 –
Ophthalmology, a ‘mirror’ service of item 55030.
55030
ORBITAL CONTENTS, ultrasound scan of, where: (a) the patient is referred by a
medical practitioner for ultrasonic examination not being a service associated with a
service to which an item in Subgroups 2 or 3 of this Group applies; and (b) the
referring medical practitioner is not a member of a group of practitioners of which the
providing practitioner is a member (R)
Fee: $109.10
The requested item is: “DIAGNOSTIC B SCAN ULTRASOUND, for the comprehensive evaluation of the
globe or orbital structures, not being a service to which item 11237 or any other items in Group D1
apply. Fee: $109.10’
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4.5
Economic evaluation
Only a preliminary economic evaluation of the services will be conducted, relying on literature
identified through the searches outlined in Table 22 and MBS item costs only.
In the literature searches, acceptable evidence would include trial-based costing studies, cost
analyses and economic modelling studies. Acceptable outcomes would include: Cost, incremental
cost-effectiveness ratio eg cost per event avoided, cost per life year gained, cost per quality adjusted
life year or disability adjusted life year. The applicability of any identified economic analyses to the
Australian health system would be assessed and the most recent and best quality literature will be
used. A formal modelled economic evaluation of the different ophthalmology items will not be
conducted during this review.
Table 22
Suggested economic search terms relating to ophthalmological items under review
Clinical question
Search terms
1. blockage of the lacrimal
passage and the insertion of
either a permanent or
temporary nasolacrimal tube
Population – (‘lacrimal apparatus'/exp OR ‘lacrimal duct obstruction’/exp OR
'nasolacrimal tube' OR 'lacrimal passage*' OR 'lacrimal gland disease'/exp OR
dacryocyst* OR 'epiphora' OR ‘tear duct*’) AND
2. temporary occlusion of the
lacrimal punctum
Population – (‘keratitis sicca’/exp OR ‘dry eye syndromes’/exp OR ‘keratitis sicca’
OR ‘dry eye*’ OR ‘lacrimal apparatus'/exp OR ‘lacrimal punctum’) AND
Intervention – ((cautery/exp AND electr*) OR (electric* AND cauter*) OR
electrocautery OR (galvanic AND cautery)) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
3. corneal transplantation
Population – ('keratitis'/exp OR 'Fuchs' endothelial dystrophy '/exp OR ‘corneal
dystrophy, Fuchs' endothelial/exp OR ‘keratoconus’/exp OR ‘corneal ulcer’/exp
OR ‘dry eye’ OR (‘cornea* AND ulcer*’) OR (cornea* AND (thin* OR cloud*)) OR
(cornea* AND scar*)) AND
Intervention – (('corneal transplantation'/exp OR (cornea* AND transplant*)) AND
(superficial OR lamellar OR endothelial) OR DALK OR DSEK) AND
Intervention –('eye surgery'/exp OR 'eye surgery' OR ‘dacryocystorhinostomy’/exp
OR dacryocystorhinostomy OR conjunctivorhinostomy OR ‘flap reconstruct*’ OR
canalicul*) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
4. epithelial debridement of the
cornea
Population – (‘corneal ulcer’/exp OR infection/exp OR ‘ulcer*’OR ‘infect*’ OR
‘erosion’) AND
Intervention – (‘cornea’/exp AND ‘debridement’/exp) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
Page 44
5. laser coagulation of the cornea
Population – (‘pathologic neovascularization’/exp AND (‘cornea’/exp OR
‘sclera’/exp)) AND
Intervention – (‘laser coagulation’/exp OR ‘photocoagulat*) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
6. needling of the posterior
capsule
Population – ('cataract'/exp OR 'cataract*’) AND
Intervention – ('capsulotomy'/exp OR (‘posterior capsule of the lens’/exp AND
‘needl*’) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
7. revision of a glaucoma filtration
bleb
Population – ('glaucoma'/exp OR 'glaucoma’) AND
Intervention – ‘trabeculectomy’/exp OR filtering surgery/exp OR filter* OR filtrate*
OR (needl* AND (glaucoma AND bleb)) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
8. peripheral laser iridoplasty for
closed angle glaucoma
Population – ('glaucoma, angle-closure'/exp OR (‘close* AND angle AND
glaucoma')) AND
Intervention – (‘laser’/exp AND ‘iridoplasty’) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
9. division of suture by laser in
glaucoma patients
Population – ('glaucoma'/exp OR 'glaucoma’) AND
Intervention – ‘trabeculectomy’/exp OR ‘suture lysis’ OR ‘laser suture lysis’ OR
‘post operative management’ AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
10. orbital skin graft
Population – ('eye'/exp OR 'eye disease'/exp) AND
Intervention – ((‘skin transplantation’/exp AND ‘orbit’/exp) OR graft*) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
11. orbital decompression
Population – (‘Graves ophthalmopathy’/exp OR ‘Graves disease’/exp OR ‘orbital
diseases’ OR ((‘dysthyroid OR Graves) AND ‘eye disease’) OR ‘Graves ophthal*)
AND
Intervention –(‘decompression, surgical’/exp OR decompress*) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
Page 45
12. Resuturing of wounds following
an intraocular procedure
4.6
Population – ('eye'/exp OR 'eye disease'/exp) AND
Intervention – ‘suturing techniques’/exp OR ‘ophthalmologic surgical
procedures’/exp OR (ocular AND (‘wounds and injuries’/exp OR rupture/exp OR
lacerations/exp)) OR (‘post operative AND dehiscence) AND
Economic terms – (‘economic aspect’/exp OR ‘cost benefit analysis’/exp OR cost*
OR ‘cost effective*’) AND
Limits – [English language]/lim AND [humans]/lim
Review outcomes
The conclusions regarding the ophthalmological services that are assessed will be provided in a
report. This report will be presented in chapters according to each service being reviewed. The results
of the MBS item data analysis, guideline concordance activity and mini-HTA evidence review will be
synthesised for each service under review. A summary statement and conclusion will be developed
for each “service” chapter. Following public consultation and feedback the report will be considered
by MSAC and its Evaluation Sub-Committee.
An Executive Summary will be developed in conjunction with the Department which outlines the
suggested changes or actions concerning each MBS item that was reviewed.
Where an evaluation suggests that an item under review is supported by the evidence, the likely
recommendation will be that the MBS listing will be retained in its current form. However, should an
evaluation suggest that listed MBS items or services are inconsistent with contemporary evidence in
relation to its clinical use or effectiveness, direct amendments to the MBS may be recommended.
These may include one or more of the following changes:
•
•
•
addition or removal of MBS items;
changes to the Schedule fee;
refinement of MBS item descriptors to better target patient groups, clinical indicators and/or
promote the use of optimal clinical pathways; and/or
• potential for interim-listing pending the collection of item-specific data.
Potential amendments to the MBS arising from reviews will be undertaken through consultation with
the relevant stakeholder groups.
5.
REVIEW TIMEFRAME
The following key milestones are associated with the development of the protocol for this review of
ophthalmological services:
Milestone
Time
Draft review protocol submitted to the Department for consideration
April 2011
Draft review protocol considered by the Protocol Advisory SubCommittee
December 2011
Evidence collection and development of report
To commence in 2012
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6.
REFERENCES
AIHW (2005). Vision problems among older Australians, Australian Institute of Health and Welfare,
Canberra, Available from: www.aihw.gov.au/publications/aus/bulletin27/bulletin27.pdf.
AIHW (2009). A guide to Australian eye health data, Australian Institute of Health and Welfare,
Canberra, Available from: http://www.aihw.gov.au/publication-detail/?id=6442468311&tab=1.
AIHW (2010). Australian hospital statistics 2008–09, Australian Institute of Health and Welfare,
Canberra, Available from: http://www.aihw.gov.au/publicationdetail/?id=6442468373&libID=6442468371&tab=2
AIHW (2011). Procedures data cubes [Internet]. Available from: http://d01.aihw.gov.au/cognos/cgibin/ppdscgi.exe?DC=Q&E=/AHS/proc_0708_v2 [Accessed 9th March 2011].
CERA (2010). Eye Donation and Corneal Transplantation [Internet]. Centre for Eye Research Australia.
Available from: http://www.cera.org.au/uploads/lcds_History.pdf [Accessed 20th October 2010].
Keratoconus Australia (2010). Common questions [Internet]. Available from:
http://www.keratoconus.asn.au/questions.html [Accessed 9th March 2011].
Liberati, A., Altman, D. G. et al (2009). 'The PRISMA statement for reporting systematic reviews and
meta-analyses of studies that evaluate health care interventions: explanation and elaboration', PLoS
Med, 6 (7), e1000100.
Merlin, T., Weston, A. & Tooher, R. (2009). 'Extending an evidence hierarchy to include topics other
than treatment: revising the Australian ‘levels of evidence’', BMC Medical Research Methodology, 9
(34 ).
Mitchell, P., Smith, W. et al (1996). 'Prevalence of open-angle glaucoma in Australia', Ophthalmology,
103 (10), 1661-1669.
NHMRC (2009). NHMRC levels of evidence and grades for recommendations for developers of
guidelines., National Health and Medical Research Council, Canberra, Available from:
http://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/evidence_statement_form.pdf.
SIGN (2008). A guideline developer's handbook [Internet]. Scottish Intercollegiate Guidelines Network.
Available from: http://www.sign.ac.uk/guidelines/fulltext/50/index.html
Whiting, P., Rutjes, A. W. et al (2003). 'The development of QUADAS: a tool for the quality assessment
of studies of diagnostic accuracy included in systematic reviews', BMC Med Res Methodol, 3, 25.
Williams, K. A., Lowe, M. T. et al (2007). Australian Corneal Graft Registry Report 2007, The Australian
Corneal Graft Registry, Adelaide, Available from:
http://dspace.flinders.edu.au/dspace/bitstream/2328/1723/3/FINAL%20COMPILED%20REPORT%202
007.pdf.
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ATTACHMENT 1
Clinical Practice Guidelines
Glaucoma
•
Guidelines for Screening, Prognosis, Diagnosis, Management and Prevention of Glaucoma
(Draft). Please note, it is expected these guidelines will be endorsed in August 2010. Access
from
http://www.nhmrc.gov.au/guidelines/consult/consultations/glaucoma_screening_guidelines.
htm
•
NICE Guidance: Glaucoma –diagnosis and management of chronic open angle glaucoma and
ocular hypertension (April 2009). Access from:
http://guidance.nice.org.uk/CG85/Guidance/pdf/English
•
RANZCO: Guidelines for Collaborative Care of Glaucoma Patients (undated). Access from
http://www.ranzco.edu/aboutus/ranzco-policies-andprocedures/policy/GUIDELINES_FOR_COLLABORATIVE_CARE_OF_GLAUCOMA_PATIENTS.pdf
•
American Academy of Ophthalmology Practice Patterns Open Angle Glaucoma
•
European Glaucoma Society guidelines. www.eugs.org/
•
World Glaucoma Association publications. www.worldglaucoma.org/
•
SEAGIG (Southeast Asian Glaucoma Interest Group) guidelines. www.seagig.org/
Cataracts
•
American Academy of Ophthalmology: Cataract in the Adult Eye – Preferred Practice Pattern
(September 2006). Access from http://one.aao.org/CE/PracticeGuidelines/PPP.aspx?p=1
•
Canadian Ophthalmological Society evidence-based clinical practice guidelines for cataract
surgery in the adult eye (October 2008). Access from http://eyesite.ca/english/program-andservices/policy-statements-guidelines/index.htm
•
RANZCO: Cataract and Intraocular Lens Surgery (March 2006). Access from
http://www.ranzco.edu/aboutus/ranzco-policies-andprocedures/policy/Cataract_Surgery.pdf
Page 48
Corneal transplantation
•
American Academy of Ophthalmology Cornea/External Disease Panel, Preferred Practice
Patterns Committee. Dry eye syndrome (2008). Access from
http://one.aao.org/asset.axd?id=e5e3ddff-13e7-414b-ba61-bbfe2112d86f
•
American Academy of Ophthalmology Cornea/External Disease Panel, Preferred Practice
Patterns Committee. Bacterial keratitis (2008). Access from
http://one.aao.org/asset.axd?id=b38ee930-f650-4011-a7ef-1f24e475d838
Eye Disease

American Academy of Ophthalmology, Preferred Practice Patterns Committee.
Comprehensive adult medical eye evaluation (2005). Access from
http://one.aao.org/CE/PracticeGuidelines/PPP_Content.aspx?cid=64e9df91-dd10-4317-81426a87eee7f517
Page 49