Determination under Schedule 1, paragraph (bj)




НазваниеDetermination under Schedule 1, paragraph (bj)
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AUSTRALIAN GOVERNMENT


National Health Act 1953


Determination under Schedule 1, paragraph (bj)


(HIB 10/2005)


I, LINDA JANE ADDISON, delegate of the Minister for Health and Ageing, acting under Schedule 1, paragraph (bj) of the National Health Act 1953 (the Act):


AMEND, with effect from 27 May 2005, the Determination made under Schedule 1, paragraph (bj) of the Act dated 30 June 1999 (as amended) by OMITTING Schedule 5 of that Determination and SUBSTITUTING the attached Schedule 5.


Dated this 17 day of May 2005.


Signed by


………………………………….

Linda Jane Addison

Assistant Secretary

Private Health Insurance Branch

Position No: 01202874

Delegate of the Minister for Health and Ageing


May 2005


SCHEDULE 5 – PROSTHESES AND HUMAN TISSUES



    1. Subject to any indications on the Australian Register of Therapeutic Goods (ARTG) in relation to a prosthesis specified in Part A, this Schedule sets out the prostheses and human tissues provided to a private patient of a hospital or day hospital facility for which benefits must be paid. Clinical choice remains a matter between the doctor and the patient and is not to be influenced by the manufacturer, supplier or the registered health benefits organisation (RHBO).




    1. In this Schedule:


hospital” includes a day hospital facility;


human tissues” means the items included in Part B;


prostheses” means the items included in Part A; and


references to a manufacturer, supplier, hospital or a RHBO include any agent acting

on their behalf.


Prostheses


5.3Subject to any indications on the ARTG in relation to a prosthesis specified in Part A, the level of benefit payable in respect of a prosthesis specified in Part A is the fee or charge agreed between the RHBO and one only of the manufacturer, supplier or hospital.

Note: Other than the fees or charges permitted under clause 5.3, no additional charges can be imposed on a patient by a manufacturer, supplier, hospital or a RHBO.


5.4Where the fee or charge is agreed between the RHBO and either the manufacturer or supplier under paragraph 5.3, then the RHBO and the manufacturer or supplier must advise all hospitals of the fee or charge agreed within two weeks of the date of the agreement.


5.5Where the fee or charge for an item cannot be agreed between the RHBO and one of the manufacturer, supplier or hospital the relevant parties may agree to request the Department of Health and Ageing to appoint a conciliator to assist them to reach agreement on the fee or charge for the item for the purpose of paragraph 5.3. If the parties so request they shall, in equal measure, meet all of the costs incurred by the Department of Health and Ageing in arranging and facilitating this conciliation process.


5.6If an agreement on the fee or charge for an item cannot be reached, the Minister will exercise his/her powers under paragraph (bj) of Schedule 1 to the National Health Act 1953 to determine the minimum level of benefit payable for the item in dispute.


Human tissues



5.7The level of benefit payable in respect of a human tissue supplied by a particular facility is the amount specified in the “Amount” field of Part B.


Notes:

The organisations specified in the “Facility” field of Part B must comply with any applicable State and Territory laws governing harvesting and processing of human tissue items to be eligible for the payment of private health insurance benefits.


Other than the fees or charges permitted under clause 5.7, no additional charges can be imposed on a patient by a manufacturer, supplier, hospital or a RHBO.


PART A - Prostheses List by Category, Groups and Sponsor February 2005

CARDIO-THORACIC Minimum Maximum

Benefit Benefit

Billing Code Product Name Description Size Level Level Notation

Annuloplasty Rings

Edwards Lifesciences Pty Ltd

EL028 Baxter Sterile Grafts, Implants & Carpentier-Edwards Classic Annuloplasty 24mm-40mm

Prostheses, Non-Animal Origin Ring. Composition: Titanium Alloy;

Annuloplasty: Ring-Mitral Ring with Silicone Rubber; Polyester Fabric

Holder; Mitral Cosgrove-Edwards Carpentier-Edwards Physio Annuloplasty

Annuloplasty System Model 4600; Classic Ring. Composition: Elgiloy Bands;

Polyester Film Strips; Silicone Rubber;

Polyester Cloth, Cosgrove-Edwards

Annuloplasty Band. Composition: Silicone

Rubber; Polyester Cloth. Carpentier-

Edwards Tricuspid Ring. Composition:

Titanium Alloy; Silicone Rubber;

EL049 Edwards Etlogix Annuloplasty Ring Titanium/silicon/dacron polyester 24mm/26mm/28mm/30mm/32mm/34mmd

cloth/plastic template Mitral valve annular

repair device designed specifically for

patients with Ischemic Mitral regurgitation

Medtronic Australasia Pty Ltd

MC005 Medtronic Posterior Annuloplasty Band; Annuloplasty Devices - Models 610B, Models 610B & 610R 25-35mm, Models

Medtronic Duran Annuloplasty Ring; 610R & 620B, 620R Silicone / Barium 620B & 620R 23-35mm, Model 638B -

Colvin - Galloway Future Band Model Sulphate, Dacron. Models 638B semi- 26-38mm

638B; Duran Ancore Band 620B; Duran rigid metal alloy core, silicone coating,

Ancore Ring 620R polyester knit fabric, kit includes - band,

malleable handle, template with suture

markers, sizers, molded tray.

St. Jude Medical Australia Pty Ltd

SJ034 SJM Seguin Annuloplasty Ring Semi Rigid 24mm - 40mm

SJ035 SJM Tailor Annuloplasty Ring Fully Flexible 25mm - 35mm

Tag Medical

TM001 AnnuloFlo Annuloplasty System Annuloflex Ring or AnnuloFlo Ring 26-36mm

PART A - Prostheses List by Category, Groups and Sponsor Page 1 of 666

CARDIO-THORACIC Minimum Maximum

Benefit Benefit

Billing Code Product Name Description Size Level Level Notation

Catheters, Angioplasty, Laser

Pacing Importers Pty Ltd

PI002 Excimer Laser Stent Polyester Fibre optic fibre catheter 0.457mm, 0.9mm, 1.4mm, 1.7mm and

Coronary Stents

Drug Eluting Stents

Boston Scientific Pty Ltd

BS074 Taxus on Express2 Coronary Stent balloon expandable stent with conformal Length 8 - 32mm; Diameter 2.25 -

System Models 38001-0822 to 0840; polymer/drug matrix coating, pre-

38001-1222 to 1250; 38001-1622 to mounted on high pressure monorail

1650;

38001-2022 to 2050; 38001-2422 to

2450; 38001-2827 to 2850; 38001-3227

Johnson & Johnson Medical Pty Ltd

JJ302 CYPHER Sirolimus-Eluting Stent & Stainless steel coronary stent with Diameter 2.25 - 5.0mm, length 8-33mm

Delivery System Model CRS - 23300, Rapamycin (an immunosuppressive and

08225, 08250, 08275, 08300, 28225, antiproliferative drug) bound to the stent

28250, 28275, 28300, 33225, 33250,

33275, 33300, 13225, 13250, 13275,

18225, 18250, 18275, 18300, 23225,

23250, 23275, 23350, 23400, 08350,

08400, 28350, 28400, 33350, 33400,

13300, 13350, 13400, 18350, 18400,

23450, 23500, 28450, 28500, 33450,

33500, 08450, 13450, 18450, 18500

General Purpose Bare Metal Stents

Abbott Australasia Pty Ltd

AY006 Bio-Divysio Stent SV/OC/AS Balloon expandable Phosophoryl-Choline Divysio Stent SV - Diameters: 2.0, 2.25,

coated stainless-steel endovascular 2.5 Lengths: 7mm, 10mm, 15mm,

coronary stent 18mm, 21mm; Divysio Stent OC & AS -

Diameters: 2.75, 3.0, 3.5, 4.0 Lengths:

8mm, 11mm, 15mm, 18mm, 22mm, 28mm

AY013 JoStent Coronary Stent Stainless Steel 9 - 26 mm x 2.5 - 4 mm

PART A - Prostheses List by Category, Groups and Sponsor Page 2 of 666

CARDIO-THORACIC Minimum Maximum

Benefit Benefit

Billing Code Product Name Description Size Level Level Notation

Atrium Australia-Pacific Rim Pty Ltd

AC022 Flyer RX Coronary Stent System Stainless Steel Coronary Stent Dia 2-5mm, Length 6-40mm

B Braun Australia Pty Ltd

BB171 Coroflex Coronary Stent System Electropolished stainless steel 316L; Laser 2.5 x 8mm; 3.0 x 8mm; 3.5 x 8mm; 4.0

cut slotted tube. Product includes: x 8mm; 2.5 x 13mm; 3.0 x 13mm; 3.5 x

Coronary stent mounted on delivery 13mm; 4.0 x 13mm; 2.5 x 16mm; 3.0 x

16mm; 3.5 x 16mm; 4.0 x 16mm; 2.5 x

19mm; 3.0 x 19mm; 3.5 x 19mm; 4.0 x

19mm; 2.5 x 25mm; 3.0 x 25mm; 3.5 x

BB172 Coroflex Theca Coronary Stent System Electropolished Stainless Steel 316L; Dia 2.5-4.0mm, length 8-25mm

Laser cut slotted tube, coated with

Polyzene-F; includes Coronary Stent

mounted on delivery balloon catheter.

BB173 Coroflex Delta Coronary Stent System Electropolished Stainless Steel 316L; Dia 2.5-4.0mm, length 8-25mm

Laser cut slotted tube, includes Coronary

Stent mounted on delivery balloon

BB244 Coroflex Blue Cobalt Chromium Alloy L605 2-4mm diameter, 8-25mm length

Biotronik Australia Pty Ltd

BT040 Lekton Intracoronary stent - balloon mounted Dia 2.5-4mm, length 10-30mm

BT058 Lekton Motion Coated flexible stent, Balloon mounted Diameter 2.5mm to 4mm, Length 8 -

BT059 Astron Flexible coated stent, Nitinol, self- Diameter 7-12mm, Length 30-80mm

Boston Scientific Pty Ltd

BS069 Express 2/Liberte Coronary Stent Consists of a balloon expandable stent, Stent lengths: 8,12,16,20,24,28 & 32 mm

pre-mounted on a Maverick 2 Monorail Stent diameters: 2.25, 2.5, 2.75, 3.0, 3.5,

delivery catheter. 4.0, 4.5 & 5.0 mm

PART A - Prostheses List by Category, Groups and Sponsor Page 3 of 666

CARDIO-THORACIC Minimum Maximum

Benefit Benefit

Billing Code Product Name Description Size Level Level Notation

Daralan Pty Ltd

DA001 S-Stent SRX1 316L Stainless Steel SRX1-2510 2.5 x 8.5mm; SRX1-3010

3.0 x 8.5mm; SRX1-3510L 3.5 x

8.5mm; SRX1-4010L 4.0 x 8.5mm;

SRX1-2512 2.5 x 11mm; SRX1-3012

3.0 x 11mm; SRX1-3512L 3.5 x 11mm;

SRX1-4012L 4.0 x 11mm; SRX1-2515

2.5 x 14.4mm; SRX1-3015 3.0 x

14.4mm; SRX1-3515L 3.5 x 14.6mm;

SRX1-4015L 4.0 x 14.6mm; SRX1-2520

2.5 x 18.7mm; SRX1-3020 3.0 x

18.7mm; SRX1-3520L 3.5 x 18.4mm;

SRX1-4020L 4.0 x 18.4mm; SRX1-2525

2.5 x 24.5mm; SRX1-3025 3.0 x

24.5mm; SRX1-3525L 3.5 x 23.2mm;

SRX1-4025L 4.0 x 23.2mm; SRX1-

2530 2.5 x 28.9mm; SRX1-3030 3.0 x

28.9mm; SRX1-3530L 3.5 x 28.2mm;

Guidant Australia Pty Ltd

GU102 Stents ACS Multilink Coronary Stent; ACS 1.5mm - 8.0mm

Megalink Peripheral Stent; ACS RX

Herculink Peripheral Stent. Stainless steel

GU105 Multilink Coronary Stent System Stainless Steel Length 1.5mm - 8.0mm

GU127 Multilink Coronary Stent System - Frontier 316L Stainless steel stent Length 1.5 - 8.0mm

GU128 Multilink Coronary Stent System - Vision Cobalt chrome stent Length 1.5 - 8.0mm

Johnson & Johnson Medical Pty Ltd

JJ026 BX Velocity with Hepacoat System Balloon expandable, stainless steel,

heparin coated

JJ200 BX Velocity Stent and Delivery System Stainless steel stent Diameter: 2.25-5.0 mm; Length 8 - 33

JJ239 BX Sonic Stainless steel coronary stent mounted on Dia 2.25 - 4.0mm, lengths 8 - 33mm

a balloon delivery system

Medical Vision Australia Pty Ltd

MF004 Vivant Z Stent Coronary stent made of alloyed medical Dia 2.5 - 4.0mm, length 9 - 28mm

grade stainless steel

Medtel Australia Pty Ltd

ME050 Antares Coronary Stent System Stent Length: 8mm - 32mm Diameter: 2.5mm -

4.0mm

PART A - Prostheses List by Category, Groups and Sponsor Page 4 of 666

CARDIO-THORACIC Minimum Maximum

Benefit Benefit

Billing Code Product Name Description Size Level Level Notation

ME071 Antares Starflex Coronary System Stainless steel Bare stent lengths 8, 12, 16, 20, 24,

32mm; Expansion range 2.5 - 4.0mm

Stent Delivery System, stent lengths

8mm, 12mm, 16mm, 20mm, 24mm,

32mm

ME073 Lunar Starflex Coronary Stent System Niobium alloy stent coated with layer of Balloon 2.25-4.0mm, stent 8-20mm

homogenous iridiumoxide (IrOx)

Medtronic Australasia Pty Ltd

MC197 Medtronic AVE S660 Coronary Stents, Stainless Steel S660 Coronary Stent - Diameter (2.5mm-

S670 Coronary Stents, S7 Coronary 2.75mm), Length (9mm-24mm); S670 &

Stents, BeStent2, S7 Coronary Stent - Diameter (3mm-

4mm), Length (9mm-30mm); BeStent2 -

Diameter (2.5mm-4mm), Length (9mm-

MC329 Medtronic Driver, Micro Driver Coronary Cobalt Alloy Driver Stent: diameter (2.25 - 4.5mm),

Stent System length (8-30mm); Micro-Driver Stent:

diameter (2.25 - 2.75mm), length (8 -

Pacing Importers Pty Ltd

PI003 Med-X-Flexy Stent Tubular Stent, Stainless steel 316L, Gold Dia 5 - 9mm length: 20 - 100mm

markers

Terumo Corporation Australia

TU001 Intra Coronary Stent Stainless Steel mounted on balloon Diameter 2.0mm - 4.0mm, Length 10mm

- 30mm length

Woodstock Biomedical Pty Ltd

WO031 Duraflex Coronary Stent System 316L Medical Grade Stainless Steel Stent Length 8, 11, 14, 18, 21, 25mm x

Premounted on Rail Design Catheter Diameter 2.5, 2.75, 3.0, 3.5, 4.0mm

Zynergy Medical Pty Limited

ZY001 Carbostent Coronary stent - includes Carbostent Dia 2.5mm x Length 9, 12, 15, 19,

Syncro & Carbostent Sirius 25mm; Dia 3.0mm x Length 9, 12, 15,

19, 25, 32mm; Dia 3.5mm x Length 9,

12, 15, 19, 25, 32mm; Diameter 4.0mm x

Length 9, 12, 15, 19, 25, 32mm

Special Purpose Stents

Abbott Australasia Pty Ltd

AY012 JoStent Coronary Stent Graft Stainless Steel/PTFE 9 - 26 mm x 2.5 - 5 mm

PART A - Prostheses List by Category, Groups and Sponsor Page 5 of 666

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