Federal Register of Legislation - Australian Government

Primary content

Determinations/Health as made
This instrument lists four new items to enable symptomatic patients who have moderate-severe or severe degenerative (primary) mitral valve regurgitation, or symptomatic patients who have moderate-severe or severe functional (secondary) mitral valve regurgitation to undergo a transcatheter mitral valve repair (TMVr) with the MitraClip system.
Administered by: Health
Registered 21 Jun 2021
Tabling HistoryDate
Tabled HR23-Jun-2021
Tabled Senate24-Jun-2021
Table of contents.

Commonwealth Coat of Arms of Australia

 

Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021

I, Travis Haslam, as delegate of the Minister for Health and Aged Care, make the following determination.

 Dated              17 June 2021

Travis Haslam

Acting First Assistant Secretary
Medical Benefits Division

Health Resourcing Group
Department of Health

 

 

  

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Definitions..................................................................................................................... 1

5............ Treatment of transcatheter mitral valve services............................................................. 2

6............ TMVr suitability case conferences................................................................................ 4

 


1  Name

                   This instrument is the Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 July 2021.

1 July 2021

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under subsection 3C(1) of the Health Insurance Act 1973.

4  Definitions

Note:          A number of expressions used in this instrument are defined in the Act, including the following:

(a)    clinically relevant service;

(b)    general medical services table;

(c)    hospital;

(d)    item;

(e)    practitioner;

(f)    professional service.

                   In this instrument:

Act means the Health Insurance Act 1973.

TMVr is short for transcatheter mitral valve repair.

TMVr accreditation committee means the committee of that name administered by Cardiac Accredited Services Limited.

TMVr suitability case conference means a case conference that meets the requirements set out in section 6.

5  Treatment of transcatheter mitral valve services

             (1)  A health service (the service) described in an item of the table in subsection (5) is to be treated, in the circumstances specified in subsection (2) and for the purposes of the provisions specified in subsection (3), as if:

                     (a)  it were both a professional service and a medical service; and

                     (b)  there were an item in the general medical services table in the location mentioned in subsection (4), corresponding to the item of the table in subsection (5) that describes the service, that:

                              (i)  related to the service; and

                             (ii)  specified a fee for the service, in relation to each State, that corresponds to the fee set out in the item of the table in subsection (5) that describes the service.

             (2)  For the purposes of subsection (1), the circumstances are that the service is provided as a clinically relevant service.

             (3)  For the purposes of subsection (1), the provisions of the following that relate to professional services, medical services or items are specified:

                     (a)  the Act and regulations made under the Act;

                     (b)  the National Health Act 1953 and regulations made under that Act.

             (4)  For the purposes of paragraph (1)(b), the location is:

                     (a)  for items 6082 and 6084—Part 2 of the general medical services table (which deals with attendances); and

                     (b)  for items 38461 and 38463—Subgroup 6 of Group T8 of Part 5 of the general medical services table (which deals with cardio‑thoracic surgical operations).

             (5)  For the purposes of subsection (1), the health services are as follows.

 

Transcatheter mitral valve services

Column 1

Item

Column 2

Description

Column 3

Fee ($)

6082

Attendance at a TMVr suitability case conference, by a cardiothoracic surgeon or an interventional cardiologist, to coordinate the conference, if:

(a) the attendance lasts at least 10 minutes; and

(b) the surgeon or cardiologist is accredited by the TMVr accreditation committee to perform the service

Applicable once each 5 years

52.95

6084

Attendance at a TMVr suitability case conference, by a specialist or consultant physician, other than to coordinate the conference, if the attendance lasts at least 10 minutes

Applicable once each 5 years

39.50

38461

TMVr, by transvenous or transeptal techniques, for permanent coaptation of mitral valve leaflets using one or more Mitraclips™, including intra‑operative diagnostic imaging, if:

(a) the patient has each of the following risk factors:

 (i) moderate to severe, or severe, symptomatic degenerative (primary) mitral valve regurgitation (grade 3+ or 4+);

 (ii) left ventricular ejection fraction of 20% or more;

 (iii) symptoms of mild, moderate or severe chronic heart failure (New York Heart Association class II, III or IV); and

(b) as a result of a TMVr suitability case conference, the patient has been:

(i) assessed as having an unacceptably high risk for surgical mitral valve replacement; and

(ii) recommended as being suitable for the service; and

(c) the service is performed:

(i) by a cardiothoracic surgeon, or an interventional cardiologist, accredited by the TMVr accreditation committee to perform the service; and

(ii) via transfemoral venous delivery, unless transfemoral venous delivery is contraindicated or not feasible; and

(iii) in a hospital that is accredited by the TMVr accreditation committee as a suitable hospital for the service; and

(d) a service to which this item, or item 38463, applies has not been provided to the patient in the previous 5 years

(H) (Anaes.) (Assist.)

1,490.25

38463

TMVr, by transvenous or transeptal techniques, for permanent coaptation of mitral valve leaflets using one or more Mitraclips™, including intra‑operative diagnostic imaging, if:

(a) the patient has each of the following risk factors:

 (i) moderate to severe, or severe, symptomatic functional (secondary) mitral valve regurgitation (grade 3+ or 4+);

 (ii) left ventricular ejection fraction of 20% to 50%;

(iii) left ventricular end systolic diameter of not more than 70mm;

 (iv) symptoms of mild, moderate or severe chronic heart failure (New York Heart Association class II, III or IV) that persist despite maximally tolerated guideline directed medical therapy; and

(b) as a result of a TMVr suitability case conference, the patient has been:

(i) assessed as having an unacceptably high risk for surgical mitral valve replacement; and

(ii) recommended as being suitable for the service; and

(c) the service is performed:

(i) by a cardiothoracic surgeon, or an interventional cardiologist, accredited by the TMVr accreditation committee to perform the service; and

(ii) via transfemoral venous delivery, unless transfemoral venous delivery is contraindicated or not feasible; and

(iii) in a hospital that is accredited by the TMVr accreditation committee as a suitable hospital for the service; and

(d) a service to which this item, or item 38461, applies has not been provided to the patient in the previous 5 years

(H) (Anaes.) (Assist.)

1,490.25

 

6  TMVr suitability case conferences

             (1)  This section sets out the requirements that a case conference must meet to be a TMVr suitability case conference.

             (2)  The requirements are as follows:

                     (a)  the conference must be for the purpose of determining if a patient is suitable for a service described in item 38461 or 38463;

                     (b)  the conference must last at least 10 minutes;

                     (c)  the conference must be conducted by a team of at least 3 participants, including:

                              (i)  a cardiothoracic surgeon; and

                             (ii)  an interventional cardiologist; and

                            (iii)  a specialist or consultant physician, neither of whom will provide a service to the patient to which item 38461 or 38463 applies;

                     (d)  at least one participant of the conference must be accredited by the TMVr accreditation committee to perform a service described in item 38461 or 38463;

                     (e)  the coordinator of the conference must ensure that the patient:

                              (i)  is aware of the purpose and nature of the conference; and

                             (ii)  has consented to the conference being held; and

                            (iii)  is made aware of the recommendations made as a result of the conference;

                      (f)  during the conference:

                              (i)  each member of the team must provide expertise in assessing the patient and informing the recommendations to be made; and

                             (ii)  the patient’s risk and technical suitability for a service described in item 38461 or 38463 must be assessed, including by taking into account the risk and technical suitability of the patient to receive a surgical mitral valve replacement and the patient’s cognitive function and frailty; and

                            (iii)  the team must make a recommendation as to whether the patient is suitable for a service described in item 38461 or 38463;

                     (g)  the coordinator must create a record of the conference, including:

                              (i)  the day the conference is held; and

                             (ii)  the time the conference starts and ends; and

                            (iii)  the names of each of the participants of the conference; and

                            (iv)  the details of the conference, including the particulars of the assessment of the patient during the conference and the recommendations made as a result of the conference.