Introduction
3. What is your organisation?
Organisation
Ramsay Health Care Australia
Part B Consultation Questions
4. As per Recommendation 1 - Do you agree with the proposed definition for Part B products? If you DO NOT support Recommendation 1, please explain why. If possible, provide alternative options for definitions.
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RHCA notes the proposed definition for Part B products, including the major change from ‘minimally’ to ‘substantially’. It is important the definition is fit-for-purpose but also broad to enable innovation, and the introduction of new technologies into the Australian market.
RHCA recognises the ethical issues associated with these reforms, including the use of key terms such as ‘manufacture’ and ‘benefit’. However, the Private Health Insurance Act 2007 (Cth) (the PHI Act), and associated rules are the main laws which set out the requirements for private health insurance and health insurers, including products and benefits. The PHI Act’s primary purpose is not to address ethical issues, but to address benefit and price setting.
RHCA emphasises Part B reforms should not be undertaken until further extensive consultation has occurred and other associated activities have been completed. For example, the PwC Report highlights the National Health and Medical Research Council (NHMRC) is currently undertaking work to review and update the ethical guidelines Organ and tissue donation after death, for transplantation: Guidelines for ethical practice for health professions, and further work must be undertaken to align the PL and Therapeutic Goods Administration requirements.
RHCA recognises the ethical issues associated with these reforms, including the use of key terms such as ‘manufacture’ and ‘benefit’. However, the Private Health Insurance Act 2007 (Cth) (the PHI Act), and associated rules are the main laws which set out the requirements for private health insurance and health insurers, including products and benefits. The PHI Act’s primary purpose is not to address ethical issues, but to address benefit and price setting.
RHCA emphasises Part B reforms should not be undertaken until further extensive consultation has occurred and other associated activities have been completed. For example, the PwC Report highlights the National Health and Medical Research Council (NHMRC) is currently undertaking work to review and update the ethical guidelines Organ and tissue donation after death, for transplantation: Guidelines for ethical practice for health professions, and further work must be undertaken to align the PL and Therapeutic Goods Administration requirements.
5. Do you support Recommendation 2 - that the Department consider whether the exemption from fees associated with Part B of the PL be restricted to Sponsors of Class 2 biologicals or Sponsors who are registered as a not-for-profit entity with the Australian Taxation Office? If you DO NOT support Recommendation 2, please explain why. If possible, provide alternative options for exemptions from fees.
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RHCA notes Part B of the PL broadly relates to cost recovery arrangements. As such, whether these are commercial or not-for-profit entities, should not matter. The PwC report itself notes commercial sponsors with more highly processed tissues products are likely to seek Part A listing as it will be more favourable as the benefits payable are not constrained by cost-recovery arrangements.
RHCA recommends the Department of Health and Aged Care undertake a review to identify the current number of not-for-profit versus commercial sponsors who have products listed on Part B. This will provide accurate and current data to determine whether the exemption is still appropriate. Should the Department deem an exemption is required, it should ensure the fees are set at an appropriate level.
RHCA cautions the Department of Health and Aged Care distinguishing between commercial sponsors and not-for-profit as this may stifle innovation or the introduction of new technologies / products into the Australian market.
RHCA recommends the Department of Health and Aged Care undertake a review to identify the current number of not-for-profit versus commercial sponsors who have products listed on Part B. This will provide accurate and current data to determine whether the exemption is still appropriate. Should the Department deem an exemption is required, it should ensure the fees are set at an appropriate level.
RHCA cautions the Department of Health and Aged Care distinguishing between commercial sponsors and not-for-profit as this may stifle innovation or the introduction of new technologies / products into the Australian market.
6. As per Recommendation 3 – do you agree with the updated structure for Part B products? (see Part B Proposed regrouping structure). If you DO NOT agree with this structure, please explain why. If possible, provide alternative options.
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RHCA emphasises several reports have been undertaken to review Part B of the PL which highlights significant work must be undertaken.
RHCA recommends the Department of Health and Aged Care undertake further work to update and amend the grouping proposed by hereco in 2019, noting they may be outdated and not reflective of the current listing. It is clear several concerns were raised by stakeholders in relation to the limited time given to provide feedback. As such, extensive stakeholder consultation should be undertaken to ensure the future list is appropriate and fit-for-purpose.
RHCA recognises the Department seeks to extend the reform methodology for Part A to Part B and bring appropriate and rationalised clinical logic to groupings. However, it is evident from several stakeholders the assumption ‘one medical device being used for a single indication, by a single surgical specialty’ is not applicable to tissue products where they may be utilised by different surgical specialities for different indications.
RHCA suggests the Department consider the structure of Part B, including the proposed additional categories and whether it would be more appropriate to categorise products by size, thickness. It would be worthwhile to determine whether the Department can work with sponsors to update product names to provide further ease in the structure of Part B. For example, 04.01.01 Split Skin sub-group contains measurements, whereas it may be more appropriate for these measurements to be listed under product name, like other categories.
RHCA recommends the Department of Health and Aged Care undertake further work to update and amend the grouping proposed by hereco in 2019, noting they may be outdated and not reflective of the current listing. It is clear several concerns were raised by stakeholders in relation to the limited time given to provide feedback. As such, extensive stakeholder consultation should be undertaken to ensure the future list is appropriate and fit-for-purpose.
RHCA recognises the Department seeks to extend the reform methodology for Part A to Part B and bring appropriate and rationalised clinical logic to groupings. However, it is evident from several stakeholders the assumption ‘one medical device being used for a single indication, by a single surgical specialty’ is not applicable to tissue products where they may be utilised by different surgical specialities for different indications.
RHCA suggests the Department consider the structure of Part B, including the proposed additional categories and whether it would be more appropriate to categorise products by size, thickness. It would be worthwhile to determine whether the Department can work with sponsors to update product names to provide further ease in the structure of Part B. For example, 04.01.01 Split Skin sub-group contains measurements, whereas it may be more appropriate for these measurements to be listed under product name, like other categories.
7. Do you support Recommendation 4 - that the Department establish a regular review process of the Part B groupings? If you DO NOT support Recommendation 4, please explain why. If possible, provide suggestions for a review process.
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RHCA strongly recommends the Department of Health and Aged Care establish a regular review process of the Part B groupings. This is important to ensure any changes align and achieve their intended outcomes. It will also provide the opportunity to ensure Part B remains fit-for-purpose and allows for the introduction of new technologies / products, providing Australians access to the latest products.
RHCA notes the Department of Health and Aged Care are committed to undertake post implementation reviews of the MBS, through the establishment of the MBS Continuous Review Framework and Post-Implementation Review Framework. As such, the Department should seek to undertake a strategic and consistent approach across the various funding mechanisms. This will ensure there is a common review approach across government funding mechanisms which will ensure stakeholders understand the next steps associated with reforms. In any reviews, it is crucial clinical autonomy and choice are maintained throughout these ongoing reviews.
RHCA notes the Department of Health and Aged Care are committed to undertake post implementation reviews of the MBS, through the establishment of the MBS Continuous Review Framework and Post-Implementation Review Framework. As such, the Department should seek to undertake a strategic and consistent approach across the various funding mechanisms. This will ensure there is a common review approach across government funding mechanisms which will ensure stakeholders understand the next steps associated with reforms. In any reviews, it is crucial clinical autonomy and choice are maintained throughout these ongoing reviews.
8. Do you support Recommendation 5 - that the Department proceed with implementing the three assessment pathways which mirror the pathways for Parts A and C of the PL? If you DO NOT support Recommendation 5, please explain why and, if possible, provide alternative assessment options.
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RHCA supports the Department of Health and Aged Care proceeding with implementing the proposed three assessment pathways which mirror the pathways for Parts A and C of the PL. It is crucial the Department maintains a consistent approach to the whole Prostheses List reform.
RHCA notes there may need to be slight adjustments to the three assessment pathways for Part B. However, to maintain consistency and limit complexity, it is recommended a ‘note’ or ‘exception’ be added within the pathway requirements, rather than developing different pathways for Part B. For example, ‘Note: For Part B applications, clinical effectiveness evidence is not required for Class 2 biologicals.’
RHCA emphasises this process relates to having tissue products added to the PL, it is not to provide assurance to insurers regarding appropriate stakeholder product usage.
RHCA (and all hospitals) will always support maintaining clinical autonomy and choice.
RHCA recommends the Department of Health and Aged Care work with the Therapeutic Goods Administration to review evidence requirements for the proposed assessment pathways and classification of biologicals. This alignment will make it more user friendly, less complex and avoid unnecessary duplicative efforts for sponsors.
RHCA notes there may need to be slight adjustments to the three assessment pathways for Part B. However, to maintain consistency and limit complexity, it is recommended a ‘note’ or ‘exception’ be added within the pathway requirements, rather than developing different pathways for Part B. For example, ‘Note: For Part B applications, clinical effectiveness evidence is not required for Class 2 biologicals.’
RHCA emphasises this process relates to having tissue products added to the PL, it is not to provide assurance to insurers regarding appropriate stakeholder product usage.
RHCA (and all hospitals) will always support maintaining clinical autonomy and choice.
RHCA recommends the Department of Health and Aged Care work with the Therapeutic Goods Administration to review evidence requirements for the proposed assessment pathways and classification of biologicals. This alignment will make it more user friendly, less complex and avoid unnecessary duplicative efforts for sponsors.
9. Do you support Recommendation 6 - that the Department provide additional support and guidance for Sponsors of Class 2 biologicals to navigate HTA pathways? If you DO NOT support Recommendation 6, please explain why. If possible, provide suggestions of the type of support and guidance that you would find useful.
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RHCA recommends the Department of Health and Aged Care develop appropriate education and support materials which can be used by all stakeholders to support navigate the pathways.
RHCA cautions the Department of Health and Age Care limiting support to only sponsors of Class 2 biologicals (most likely not-for-profit) to navigate the pathways as this may hinder innovation or competition in the market.
RHCA reminds the Department of Health and Age Care items listed on Part B are covered by cost-recovery arrangements.
Interestingly, RHCA notes the PwC report (page 14) itself notes most not-for-profit stakeholders who manufacture Class 2 biologicals will use the Tier 1 pathway or rarely the Tier 3 pathway. Based on this, not-for-profit stakeholders may only require support for Tier 3 – the full FTA Pathway given it will require much further information.
RHCA cautions the Department of Health and Age Care limiting support to only sponsors of Class 2 biologicals (most likely not-for-profit) to navigate the pathways as this may hinder innovation or competition in the market.
RHCA reminds the Department of Health and Age Care items listed on Part B are covered by cost-recovery arrangements.
Interestingly, RHCA notes the PwC report (page 14) itself notes most not-for-profit stakeholders who manufacture Class 2 biologicals will use the Tier 1 pathway or rarely the Tier 3 pathway. Based on this, not-for-profit stakeholders may only require support for Tier 3 – the full FTA Pathway given it will require much further information.
10. Do you support Recommendation 7 - that the Department undertake further work on the methodology for pricing including the development of costing standards? If you DO NOT support Recommendation 7, please explain why. If possible, provide suggestions for a methodology for pricing.
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RHCA is concerned costing and benchmarking were out-of-scope for this review, given the intricacies benefits play in the overarching PL policy.
RHCA supports the Department of Health and Aged Care, with relevant stakeholders, undertake further work on the methodology for pricing including the development of costing standards. Given items listed on Part B are covered by cost-recovery arrangements, it is crucial there is appropriate and consistent guidance on costing and pricing.
RHCA supports the Department of Health and Aged Care, with relevant stakeholders, undertake further work on the methodology for pricing including the development of costing standards. Given items listed on Part B are covered by cost-recovery arrangements, it is crucial there is appropriate and consistent guidance on costing and pricing.
11. Do you support Recommendation 8 - that the Department undertake a review of state and federal legislative requirements which prohibit trading in human tissue and its application to determining benefits for Part B? If you DO NOT support Recommendation 8, please explain why.
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RHCA strongly recommends the Australian Government harmonise and simplify existing legislation and regulations (Commonwealth, State, Territory) to ensure there is a consistent approach to human tissue and its application to determining the benefits for Part B. Streamlining and simplifying regulation in order to promote its effectiveness should be a priority for all governments and stakeholders, rather than introducing additional regulations to an already complex and burdensome system.
RHCA emphasises it is important for state-based legislation to align with national legislation (not vice versa) given the significance of human tissue products for Australians. However, it is clear this sector is fragmented, with differing models of collection, processing, pricing and distribution of tissues. It is important this is addressed to improve efficiencies in the system and avoid unsustainable future funding for an important component of the overarching Australian healthcare system.
RHCA emphasises it is important for state-based legislation to align with national legislation (not vice versa) given the significance of human tissue products for Australians. However, it is clear this sector is fragmented, with differing models of collection, processing, pricing and distribution of tissues. It is important this is addressed to improve efficiencies in the system and avoid unsustainable future funding for an important component of the overarching Australian healthcare system.
12. Do you support Recommendation 9 - that the Department retain the PL items for autologous skull flaps and femoral heads? If you DO NOT support Recommendation 9, please explain why.
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RHCA strongly recommends the Department of Health and Aged Care retain the PL items for autologous skull flaps and femoral heads to ensure there is a set minimum benefit, if the products remain clinically safe and effective.
13. Do you support Recommendation 10 - that the Department does not pursue restricting the use of Part B items to specific MBS items at this time? If you DO NOT support Recommendation 10, please explain why.
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RHCA strongly supports the Department of Health and Aged Care does not pursue restricting the use of Part B items to specific MBS items at this time. It is important the Department undertakes a consistent approach across the entire PL. Given the proposed approach is not being implemented across Part A and C, it should not be implemented for Part B.
RHCA (and all hospitals) strongly supports maintaining clinical autonomy and choice.
RHCA (and all hospitals) strongly supports maintaining clinical autonomy and choice.
14. Do you support the proposed restructure of Part B (attached)? If you DO NOT support the proposed restructure of Part B, please explain why and, if possible, suggest alternative options.
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Refer to Q6.
01–Cardiothoracic: RHCA notes the proposed changes to the Cardiothoracic structure.
02-Ophthalmic: Sclera (02.02): RHCA supports the proposed changes to the Ophthalmic: Sclera structure to ensure there is consistency across the category.
03-Orthopaedic: Fascia Lata (03.02.02): RHCA notes the proposed changes to the Orthopaedic: Fascia Lata structure.
03-Orthopaedic: Hemipelvis, Whole or Part (03.01.01.02): RHCA supports the proposed changes to the Orthopaedic: Hemipelvis, Whole or Part structure to ensure there is consistency across the category.
03-Orthopaedic: Long Bone, Distal, Proximal and Proximal with Soft Tissue (03.01.01.03.05): RHCA supports the intention behind the proposed changes to the Orthopaedic: Long Bone, Distal, Proximal and Proximal with Soft Tissue structure to ensure there is consistency across the category. It is clear further consultation must be undertaken to determine the appropriate subgroups.
03-Orthopaedic: Ligament, Medial (03.02.03.01): RHCA notes the proposed changes to the Orthopaedic: Ligament, Medial structure, and questions the addition of ligament patch, spinal given the suggested removal of ligament, medial.
04–Plastic and Reconstructive: Split Skin (04.01.01): RHCA notes the proposed changes to the Plastic and Reconstructive: Split Skin structure. It is clear further consultation must be undertaken to determine the appropriate subgroups.
04-Plastic and Reconstructive: Biological Scaffolds (04.02): RHCA notes the changes made to the Plastic and Reconstructive: Biological Scaffolds structure.
01–Cardiothoracic: RHCA notes the proposed changes to the Cardiothoracic structure.
02-Ophthalmic: Sclera (02.02): RHCA supports the proposed changes to the Ophthalmic: Sclera structure to ensure there is consistency across the category.
03-Orthopaedic: Fascia Lata (03.02.02): RHCA notes the proposed changes to the Orthopaedic: Fascia Lata structure.
03-Orthopaedic: Hemipelvis, Whole or Part (03.01.01.02): RHCA supports the proposed changes to the Orthopaedic: Hemipelvis, Whole or Part structure to ensure there is consistency across the category.
03-Orthopaedic: Long Bone, Distal, Proximal and Proximal with Soft Tissue (03.01.01.03.05): RHCA supports the intention behind the proposed changes to the Orthopaedic: Long Bone, Distal, Proximal and Proximal with Soft Tissue structure to ensure there is consistency across the category. It is clear further consultation must be undertaken to determine the appropriate subgroups.
03-Orthopaedic: Ligament, Medial (03.02.03.01): RHCA notes the proposed changes to the Orthopaedic: Ligament, Medial structure, and questions the addition of ligament patch, spinal given the suggested removal of ligament, medial.
04–Plastic and Reconstructive: Split Skin (04.01.01): RHCA notes the proposed changes to the Plastic and Reconstructive: Split Skin structure. It is clear further consultation must be undertaken to determine the appropriate subgroups.
04-Plastic and Reconstructive: Biological Scaffolds (04.02): RHCA notes the changes made to the Plastic and Reconstructive: Biological Scaffolds structure.
15. Any additional comments on the PwC report (optional)
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No comment.