{"id":"F2022L00174","name":"Health Insurance (Section 3C General Medical Services – Extracorporeal Photopheresis for Chronic Graft Versus Host Disease) Determination 2022","slug":"health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102283,"registerId":"commonwealth-F2022L00174-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1. Name","sectionType":"section","heading":"1. Name","content":"#### 1. Name\n\n This instrument is the Health Insurance (Section 3C General Medical Services – Extracorporeal Photopheresis for Chronic Graft Versus Host Disease) Determination 2022.","sortOrder":0},{"sectionNumber":"3. Authority","sectionType":"section","heading":"3. Authority","content":"#### 3. Authority\n\n This instrument is made under subsection 3C(1) of the Health Insurance Act 1973.","sortOrder":1},{"sectionNumber":"4. Definitions","sectionType":"section","heading":"4. Definitions","content":"#### 4. Definitions\n\n(1) In this instrument:\n\nAct means the Health Insurance Act 1973.\n\nPharmaceutical Benefits Scheme means the scheme for the supply of pharmaceutical benefits established under Part VII of the National Health Act 1953.\n\nrelevant provisions means all provisions, of the Act and regulations made under the Act, and the National Health Act 1953 and regulations made under the National Health Act 1953, relating to medical services, professional services or items.\n\nrelevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in a Schedule.\n\nSchedule means a Schedule to this instrument.\n\nNote: The following terms are defined in subsection 3(1) of the Act:\n\n clinically relevant service;\n\n general medical services table;\n\n item;\n\n professional service.\n\n(2) Unless the contrary intention appears, a reference in this instrument to a provision of the Act or the National Health Act 1953 or regulations made under the Act or under the National Health Act 1953 as applied, adopted or incorporated in relation to specifying a matter is a reference to those provisions as in force from time to time and any other reference to provisions of an Act or regulations is a reference to those provisions as in force from time to time.","sortOrder":2},{"sectionNumber":"5. Treatment of relevant services","sectionType":"section","heading":"5. Treatment of relevant services","content":"#### 5\\. Treatment of relevant services\n\nFor subsection 3C(1) of the Act, a relevant service, provided in accordance with this instrument and as a clinically relevant service, is to be treated, for the relevant provisions, as if:\n\n(a) it were both a professional service and a medical service; and\n\n(b) there were an item in the general medical services table that:\n\n(i) related to the service; and\n\n(ii) specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.","sortOrder":3},{"sectionNumber":"6. Requirements on the rendering practit","sectionType":"section","heading":"6. Requirements on the rendering practitioner","content":"#### 6\\. Requirements on the rendering practitioner\n\n (1) Clause 1.2.7 of the general medical services table shall have effect as if the items contained in the Schedule of the Determination were also specified in the clause.\n (2) Clause 1.2.11 of the general medical services table shall have effect as if the items contained in the Schedule of the Determination were also specified in the clause.","sortOrder":4},{"sectionNumber":"7. Application of treatment cycle and se","sectionType":"section","heading":"7. Application of treatment cycle and session","content":"#### 7\\. Application of treatment cycle and session\n\n(1) For an item in the Schedule, treatment cycle means treatment that is required to deliver extracorporeal photopheresis that:\n\n(a) begins on the day in which the treatment begins; and\n\n(b) ends 12 weeks after the day specified in paragraph (a).\n\n(2) For an item in the Schedule, treatment session means a single extracorporeal photopheresis treatment in a series of sessions that make up a treatment cycle.","sortOrder":5},{"sectionNumber":"8. Restriction on items","sectionType":"section","heading":"8. Restriction on items","content":"#### 8\\. Restriction on items\n\nServices rendered in certain circumstances or for certain purposes\n\n (1) Clause 1.2.9 of the general medical services table shall have effect as if the items in the Schedule of the Determination were specified in the clause.\n\nServices provided with harvesting, storage, in vitro processing, or injection of non‑haematopoietic stem cells\n\n (2) Clause 1.2.10 of the general medical services table shall have effect as if the items in the Schedule of the Determination were specified in the clause.\n\nServices connected with provision of pain pump for post‑surgical pain management\n\n (3) Clause 5.1.1 of the general medical services table shall have effect as if the items in the Schedule of the Determination were specified in the clause.\n\nServices provided on the same occasion as certain attendances\n\n (4) An item in the Schedule does not apply to a service if it is associated with a service to which an item in Group A3 or Group A4 of the general medical service tables applies.","sortOrder":6},{"sectionNumber":"9. Indexation","sectionType":"section","heading":"9. Indexation","content":"#### 9\\. Indexation\n\n (1) At the start of 1 July 2025 (the indexation time), each amount covered by subsection (2) is replaced by the amount worked out using the following formula:\n ![1.024 multiplied by the amount immediately before the indexation time](image.002.png)\n Note: The indexed fees could in 2025 be viewed on the Department of Health and Aged Care’s MBS Online website (https://www.mbsonline.gov.au).\n (2) The amounts covered by this subsection are the fee for each item in a Schedule of this Determination.\n (3) An amount worked out under subsection (1) is to be rounded up or down to the nearest 5 cents (rounding down if the amount is an exact multiple of 2.5 cents).\n\nSchedule – relevant services\n\n```html\n

Group T1—Miscellaneous Therapeutic Procedures

Column 1

Item

Column 2

Description

Column 3

Fee ($)

Subgroup 8—Haematology

13761

Extracorporeal photopheresis for the treatment of chronic graft‑versus‑host disease, if:

(a) the person is:

(i) has received allogeneic haematopoietic stem cell transplantation; and

(ii) has been diagnosed with chronic‑graft‑versus host disease following the transplantation; and

(iii) steroid treatment is clinically unsuitable as the disease is steroid refractory or the person is steroid‑dependent or steroid‑intolerant; and

(b) the person has not previously received extracorporeal photopheresis treatment; and

(c) the service is delivered using an integrated, closed extracorporeal photopheresis system; and

(d) the service is provided in combination with the use of methoxsalen that is listed on the Pharmaceutical Benefits Scheme; and

(e) the service is provided by, or on behalf of, a specialist or consultant physician who:

(i) is practising in the speciality of haematology or oncology; and

(ii) has experience with allogeneic bone marrow transplantation.

Applicable once per treatment session (H)

1,908.35

13762

Extracorporeal photopheresis for the treatment of chronic graft‑versus‑host disease, if:

(a) the person is:

(i) has received allogeneic haematopoietic stem cell transplantation; and

(ii) has been diagnosed with chronic graft versus host disease following the transplantation; and

(iii) steroid treatment is clinically unsuitable as the disease is steroid refractory or the person is steroid‑dependent or steroid‑intolerant; and

(b) the person has previously received an extracorporeal photopheresis treatment cycle and had a partial or complete response in at least one organ in response to treatment; and

(c) the person requires further extracorporeal photopheresis; and

(d) the service is delivered using an integrated, closed extracorporeal photopheresis system; and

(e) the service is provided in combination with the use of methoxsalen that is listed on the Pharmaceutical Benefits Scheme; and

(f) the service is provided by, or on behalf of, a specialist or consultant physician who:

(i) is practising in the speciality of haematology or oncology; and

(ii) has experience with allogeneic bone marrow transplantation.

Applicable once per treatment session (H)

1,908.35

\n```","sortOrder":7}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The instrument narrowly adds extracorporeal photopheresis for chronic graft‑versus‑host disease as specified MBS items with eligibility, device, drug and provider conditions and an indexation rule. The Determination confines scope to the conditions and items listed; it does not indicate an expansion or contraction beyond those specified requirements."},"complexity_factors":["Cross-references to the Health Insurance Act 1973 s3C(1) and to clauses of the general medical services table (Authority: section 3; Treatment: section 5; Requirements: section 6) increase legal integration complexity.","Detailed clinical eligibility and repeat‑treatment rules are embedded in Schedule items 13761 and 13762 (Schedule), requiring patient history of allogeneic transplant, steroid failure/dependence/intolerance, and prior response for further cycles.","Technical and pharmaceutical conditions: requirement for an integrated closed extracorporeal photopheresis system and concurrent use of methoxsalen listed on the Pharmaceutical Benefits Scheme (Schedule items).","Provider qualification and delegation limits: service must be provided by or on behalf of a specialist/consultant in haematology or oncology with allogeneic bone marrow transplantation experience (Schedule; section 6).","Interaction with existing exclusions and billing rules: several general medical services table clauses are applied to limit when items may be claimed (section 8), including exclusion where Group A3 or A4 attendances apply.","Definitions and temporal rules for treatment cycles and sessions add operational complexity for billing and clinical scheduling (section 7).","Indexation formula and rounding rules for fees effective 1 July 2025 introduce an arithmetic adjustment mechanism to item fees (section 9)."],"plain_english_summary":"This Determination adds extracorporeal photopheresis for chronic graft‑versus‑host disease to the Medicare schedule under subsection 3C, so the service is treated as both a medical and professional service with specified MBS items and fees. It matters to patients, treating specialists and Medicare payers because it creates a funded billing pathway with set clinical eligibility, device and drug requirements and an indexation rule applying from 1 July 2025."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: establishing Medicare coverage for extracorporeal photopheresis specifically for chronic graft-versus-host disease. The scope has not expanded beyond this narrow clinical indication and patient population."},"complexity_factors":["Multiple nested eligibility conditions (5-6 criteria per item) including patient history, prior treatment response, equipment specifications, drug requirements, and practitioner qualifications","Cross-references to external documents: incorporates clauses 1.2.7, 1.2.9, 1.2.10, 1.2.11, and 5.1.1 from the general medical services table by reference rather than restating them","Defined terms with legal significance: 'treatment cycle' (12-week period) and 'treatment session' create a specific temporal framework for billing","Temporal indexation formula with mathematical calculation and rounding rules (nearest 5 cents, with specific tie-breaker for 2.5 cent multiples)","Two-tier item structure distinguishing initial treatment (13761) from continuation treatment (13762) based on prior response assessment","Incorporation by reference of the Pharmaceutical Benefits Scheme status for the required drug (methoxsalen), creating dependency on separate legislation"],"plain_english_summary":"This law adds extracorporeal photopheresis (ECP) for steroid‑refractory chronic graft‑versus‑host disease after allogeneic stem‑cell transplant to the Medicare Benefits Schedule via two new item numbers (first and subsequent 12‑week treatment cycles). It enables specialist‑delivered, equipment‑ and drug‑specified ECP to attract Medicare rebates, making an expensive, hospital‑based therapy more consistently affordable nationwide. Fees are indexed (2.4% increase from 1 July 2025)."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-","history":"/api/acts/health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-/history","analysis":"/api/acts/health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-/analysis","conflicts":"/api/acts/health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-/conflicts","importantCases":"/api/acts/health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-/important-cases","documents":"/api/acts/health-insurance-section-3c-general-medical-services-extracorporeal-photopheresis-for-chronic-graft-/documents"}}