PROVISION OF BLOOD CLOTTING FACTORS, INTRAVENOUS IMMUNOGLOBULIN AND SUBCUTANEOUS IMMUNOGLOBULIN BLOOD PRODUCTS TO MEDICARE INELIGIBLE PATIENTS Office of the Chief Medical Officer October 2014
Effective: 30 October 2014 TITLE: Provision of blood clotting factors, and intravenous and subcutaneous immunoglobulin blood products to Medicare ineligible patients in Western Australia. CONTENTS 1. BACKGROUND... 2 2. SCOPE... 3 3. POLICY STATEMENT... 3 4. PRINCIPLES... 3 5. GUIDELINES... 4 5.1 Operational Directive OD 0391/12 - Provision of treatment of Medicare ineligible patients in WA Public Hospitals... 4 5.2 Access to blood clotting factors... 4 5.3 Access to IVIg and SCIg... 5 5.4 Medicare ineligible patients access and payment for blood clotting factors or IVIg and SCIg produced and supplied in Australia... 5 6. DEFINITIONS... 6 7. ROLES AND RESPONSIBILITIES... 6 8. COMPLIANCE... 7 9. EVALUATION... 7 10. REFERENCES... 7 11. AUTHORITY... 7 Page 1
1. BACKGROUND Visitors to Australia from time to time require medical attention through Medicare funded, WA State funded or private health services. Some of these visitors will require fresh blood components or other blood products as part of emergency treatment or for an injury or illness, while others may enter Australia with chronic medical conditions requiring management with specialty blood products. The provision of health services to people in Western Australia is heavily subsidised through Medicare, the Pharmaceutical Benefits Scheme and the National Blood Agreement. Access to subsidised health care is not universal and in principle is reserved for Australian citizens or residents who are eligible for Medicare. Visitors to Australia may be eligible for Medicare if they come from a country with which the Commonwealth Government has signed a Reciprocal Health Care Agreement (RHCA). The general principle underpinning the access to services under RHCA s is that visitors receive treatment within Australia s public health system on the same terms as an Australian resident. OD 0536/14 RHCA - Amendment to the eligibility of foreign organ donors limited to kidney transplants provides detailed information on RHCA eligibility. However, all agreements exclude medical coverage for residents of one partner country who enters the territory of the other partner country for the specific purpose of seeking medical treatment. For those Medicare ineligible visitors who seek medical attention through public hospitals the Hospital and Health Services Act 1927 (WA), Hospital (Service Charges) Regulations 1984 and the National Health Care Agreement obliges these patients to pay for their care. Operational Directive (OD) 0391/12, Provision of treatment of Medicare ineligible patients in WA Public Hospitals, provides direction on the circumstances and processes for the recovery of associated treatment costs. However, there are special arrangements governing the supply and cost of blood and blood products and this Operational Directive is required to provide additional guidance to the management of Medicare ineligible patients who require treatment with specialty blood products, specifically blood clotting factors, Intravenous Immunoglobulin (IVIg) and Sub- Cutaneous Immunoglobulin (SCIg). Blood supply in Australia is governed by the National Blood Agreement (the Agreement). The Agreement establishes the National Blood Authority (NBA) which manages the collection and supply of blood and blood products included on the National Products and Services List, the cost of which is shared between the State and the Commonwealth Governments. Each year the WA Department of Health develops a blood supply plan that estimates the volume and cost of blood products required for treatment in the coming year. The NBA contracts the Australian Red Cross Blood Service and other providers to collect and supply the required blood and blood products. One of the aims of the Agreement is to provide blood and blood products to patients free of charge, based on clinical need and appropriate clinical practice. However, some blood products derived from human plasma donated in Australia, such as blood clotting factors and IVIg and SCIg are expensive and in short supply. The use of these products requires judicious management to ensure they are available to the citizens of Western Australia and that they are used in clinically appropriate ways for those patients likely to derive most Page 2
benefit. Each State and Territory is responsible for managing access to these specialty products. 2. SCOPE 2.1 This policy concerns the access of Medicare ineligible persons to blood clotting factors and the immunoglobulins IVIg and SIGg supplied through the WA Department of Health blood supply plan. These products are expensive and in short supply and need to be managed judiciously. 2.2 The policy does not apply to emergency care situations. 2.3 This policy applies to all persons employed in WA Health, which incorporates the following entities: Department of Health Metropolitan Health Services Peel Health Service WA Country Health Service. 3. POLICY STATEMENT Blood clotting factors and IVIg and SCIg are provided free of charge through the WA Department of Health prepared annual blood supply plan and should be prioritised to patients who are Medicare eligible. Visitors to Australia, including people on student and working visas and their families, who are Medicare ineligible and have a condition managed by prescribed clotting factors, IVIg, or SCIg should be supported to contact their treating medical practitioner in their country of origin and arrange for the supply of the necessary product. Alternatively they can buy it from the commercial supplier in Australia at their own expense. Medicare ineligible patients who are diagnosed for the first time with a condition requiring treatment by clotting factors, IVIg or SCIg should be supported to access the product from their country of origin or buy it from a commercial supplier in Australia at their own expense. Early provision of treatment may prevent the progression of illness. Decision making about the provision of blood products to Medicare ineligible patients should consider the impact and cost to WA Health of not doing so. The Office of the Chief Medical Officer (OCMO) is responsible for the management and funding of the WA State blood supply plan and may authorise the provision of blood products at no cost to Medicare ineligible patients. Public hospital administrators are able to approve the payment of the cost of clotting factors, IVIg and SCIg from within their budgets. However, when the cost is greater than $10,000 the approval of the Director General is required (OD 0391/12). 4. PRINCIPLES Emergency and urgent treatment is provided to all patients regardless of Medicare status as a duty of care and this includes the provision of blood and blood products. Blood clotting factors and IVIg and SCIg derived from fractionated human plasma are precious and expensive and their provision needs to be clinically appropriate and directed to patients most likely to benefit. Page 3
Blood and blood products provided free to the WA community through National Blood Arrangements and the State supply plan need to be well managed and prioritised to Medicare eligible Australian residents. 5. GUIDELINES To assist implementation of this policy, the following guidelines are provided. These guidelines are for situations in which access is sought to blood clotting factors and IVIg and SCIg produced and supplied in Australia from fractionated human plasma. 5.1 Operational Directive OD 0391/12 - Provision of treatment of Medicare ineligible patients in WA Public Hospitals Decision making on the provision of blood clotting factors and IVIg and SCIg products to Medicare ineligible patients must be consistent with OD 0391/12. OD 0391/12 outlines the responsibility of health services to have proper processes in place to identify and support Medicare ineligible patients and to recover associated treatment costs. Specifically, it provides guidelines that seek to: provide Health Services with references on determination of eligibility for Medicare funded treatment ensure Health Services identify Medicare ineligible patients on admission. ensure Health Services adequately assess the ability of non-medicare patients to pay for the full costs of medical treatment provide advice to Health Services about payment for treatment by non-medicare patients, including establishing a payment contract, requiring part or full payment before the provision of treatment and seeking departmental permission before the provision of high-cost treatment (non-urgent treatment only) provide advice to Health Services about debt recovery procedures. 5.2 Access to blood clotting factors Clinicians may order plasma derived blood clotting factors from the Australian Red Cross Blood Service. These plasma derived products are produced by the Commonwealth Serum Laboratories and are available under the National Blood Arrangements and WA State supply plan, and are consequently provided free to eligible patients. These products are not commercially available outside of the State supply plan. Recombinant technology derived blood clotting factors provided as part of the State blood supply plan are ordered through the Haemophilia Treatment Centre of WA. These products can be accessed outside of the State supply plan at the full commercial price. The Haemophilia Centre of WA provides a leadership role in ensuring optimal care and an equitable distribution of professional and therapeutic resources, together with responsible record keeping of people with haemophilia and similar conditions. It provides expert advice on the treatment of bleeding disorders and manages data entry for the Australian Bleeding Disorders Register in WA. Page 4
5.3 Access to IVIg and SCIg In WA, orders for government funded IVIg and SCIg are made to the Australian Red Cross Blood Service which is contracted by the NBA as the authoriser and distributor of these products. In seeking authorisation the requesting clinician will be required to provide information to establish that the request meets the Criteria for the Clinical Use of intravenous immunoglobulin in Australia (the Criteria) http://www.blood.gov.au/ivigcriteria. The Criteria identifies the conditions for which IVIg therapy is indicated and conditions for which IVIg therapy is not supported or funded. If it is uncertain that the request to access IVIg or SCIg meets the Criteria the request will be referred to the Blood, Technology and Drugs Unit, Office of the Chief Medical Officer (OCMO), for decision. If supported by the OCMO it will be provided at no cost under the National Blood Arrangements. If the use of IVIg or SCIg is clinically supported for a Medicare eligible patient but it is outside the Criteria then the requesting clinician will need to refer the case to Hospital Authoriser for approval to supply, with the product being purchased directly from the supplier through a Jurisdictional Direct Order (JDO). The hospital, the insurer or the patient will need to bear the cost of the product. 5.4 Medicare ineligible patients access and payment for blood clotting factors or IVIg and SCIg produced and supplied in Australia Having assessed the clinical need for IVIg, SCIg or clotting factors for a Medicare ineligible patient the treating clinician should endeavour to support the patient to access the product from their country of origin, where appropriate and practical. If it is necessary to use IVIg, SCIg or clotting factors supplied under the Sate Supply Plan, the clinician must: seek the necessary authorisations from the Australian Red Cross Blood Service in the first instance for IVIg and SCIg consult with the Haemophilia Centre of WA for patients with bleeding disorders and register them on the Australian Bleeding Disorders Register The clinician may then take the following actions: Support the patient to purchase the product directly from the commercial supplier. Seek the approval of the Hospital Authoriser to purchase the product directly from the commercial supplier through a JDO. There is no capacity under the National Blood Arrangements for cost recovery to be sought from Medicare as the Commonwealth Government already meets 63% of the cost of the National Blood Supply Plan. As the cost will be borne by the Health Service, the Health Service must approve the expenditure and seek recovery from the insurer or the patient (OD 0391/12) http://www.health.wa.gov.au/circularsnew/pdfs/12895.pdf. If the cost of the product over the course of treatment is greater than $10,000 per annum then the approval of the Director General is required (OD 0391/12 Guidelines Pp4, and Appendix 3 Template for submission to the Director General). Seek the approval of the Blood Technology and Drugs Unit for payment of the product at no cost to the patient through the State supply plan when the health Page 5
6. DEFINITIONS and wellbeing of the patient is at significant risk and / or to not do so is likely to see an additional treatment cost burden placed on WA Health. The Blood Technology and Drugs Unit may be contacted on (08) 9222 2066. This Unit is in OCMO and has the responsibility to prepare and manage the annual State blood supply plan. Blood clotting factors 7. ROLES AND RESPONSIBILITIES Chief Medical Officer In this document blood clotting factors refers to the following products that are produced through the fractionation of human plasma or via recombinant technology, either produced in Australia or imported, but supplied under the State blood supply plan. Factor VII Concentrate Factor VIIa Factor VIII Factor IX Factor XI Factor XIII Concentrate (Fibrogammin) Antithrombin III concentrate (Thrombotrol) Fibrinogen Concentrate Protein C Concentrate The CMO is responsible for the development and management of the State blood supply plan and its budget. Chief Executive Officers The Area Health Service CEO s are responsible for ensuring processes are in place to support cost recovery from Medicare ineligible patients as required by OD 0391/12, Provision of treatment of Medicare ineligible patients in WA Public Hospitals. Managers and Supervisors Manager and Supervisors are responsible for ensuring that staff are aware of this operational directive and that it is complied with. Where the use of a clotting factor or IVIg or SCIg is outside of the indications supported by the National Supply Plan, but remains clinically appropriate and in the best interests of the patient, the Office of the CMO may refer individual cases to the discretion of hospital Drug and Therapeutic Committees or Transfusion Committees for funding and access decisions. All Staff All medical staff are required staff members are responsible for determining the Medicare status of patients as noted in OD 0391/12. Page 6
8. COMPLIANCE Failure to comply with this policy may result in disciplinary action. 9. EVALUATION This policy will be monitored by the Blood Technology and Drugs Unit, OCMO through requests for blood products against State blood supply plan. 10. REFERENCES National Blood Authority Australia, 2012, Criteria for the Clinical Use of intravenous immunoglobulin in Australia http://www.blood.gov.au/ivig-criteria Accessed on the NBA web page August 2014. National Blood Authority, National Blood Agreement http://www.blood.gov.au/about-nba Accessed on the NBA web page August 2014. WA Department of Health, Operational Directive 0391/12, Provision of treatment of Medicare ineligible patients in WA Public Hospitals. http://www.health.wa.gov.au/circularsnew/pdfs/12895.pdf 11. AUTHORITY Title: Dr Audrey Koay Contact: 92222066 Directorate: Office Chief Medical TRIM Record Number: ED-CO-XX-XXXXX Officer Version: 1. Date Published: XX/XX/20XX Date of Last Review: Date Next Review: XX/XX/20XX This information is available in alternative formats for a person with a disability Page 7
This information is available in alternative formats for a person with a disability. Department of Health 2014 Copyright to this material is vested in the State of Western Australia unless otherwise indicated. Apart from any fair dealing for the purposes of private study, research, criticism or review, as permitted under the provisions of the Copyright Act 1968, no part may be reproduced or re-used for any purposes whatsoever without written permission of the State of Western Australia.