Health Insurance (Section 3C General Medical Services – Extracorporeal Photopheresis) Determination 2020

The instrument defines a “treatment cycle” for a patient as “a single day of treatment, or consecutive days of treatment that is required to deliver extracorporeal photopheresis.” This definition is material because each item is “Applicable once per treatment cycle (H)”. The “(H)” notation likely indicates hospital or procedural setting. The instrument uses the term “relevant service” to mean a health service specified in the Schedule (i.e. the two items). The key statutory mechanism is section 5, which makes the relevant service treated as if it were a professional service and a medical service for the “relevant provisions”. That term is defined broadly in section 4 to include the Health Insurance Act, its regulations, the National Health Act 1953 and its regulations - and all provisions relating to medical services, professional services or items. The practical legal effect is that the service is brought within the full MBS regulatory framework including claiming, auditing, penalties for false claims, and benefit payment rules. The definition also includes the Pharmaceutical Benefits Scheme (PBS) provisions, because the service must be provided “in combination with the use of Pharmaceutical Benefits Scheme‑subsidised methoxsalen” (a photosensitising drug). This is a material condition linking the MBS item to the PBS. The instrument does not define “integrated, closed extracorporeal photopheresis system” but makes it a condition for both items. The clinical condition is “erythrodermic stage III‑IVa T4 M0 cutaneous T‑cell lymphoma” (CTCL). The items distinguish between initial treatment (item 14247 - first six months) and continuing treatment (item 14249 - after demonstrated response). The fee for both items is identical at $1,925.55. The indexation formula in section 7 uses a multiplier of 1.024 (i.e. 2.4% increase) at the indexation time of 1 July 2025, rounded to nearest 5 cents. This is a fixed, one‑time increase. The note directs readers to the Department’s MBS Online website for the indexed fees.

The Determination directly affects three main groups: patients, treating specialists, and public and private hospital administrators. Patients who suffer from erythrodermic stage III‑IVa T4 M0 cutaneous T‑cell lymphoma (a rare and advanced form of lymphoma) are the intended beneficiaries. They must be 18 years or older, and must have received prior systemic treatment for this condition and experienced either disease progression or unacceptable toxicity while on that treatment. This creates a requirement of ‘failed prior therapy’ before the MBS‑subsidised service can be accessed. For continuing treatment, the patient must have demonstrated a response to the initial six months of treatment. The instrument therefore sets a clinical gate: only patients who meet these strict criteria are eligible for the Medicare benefit. The treating specialist or consultant physician must be in the speciality of haematology. This limits the professional group who can supervise the service; dermatologists or oncologists who are not haematologists would not satisfy the condition. Hospital administrators in both public and private hospitals will be affected because the service is likely to be performed in hospital outpatient or day procedure settings. The “(H)” indicator confirms the item is hospital‑based. The item fee of $1,925.55 per treatment cycle is substantial; for patients requiring multiple cycles (e.g. two per month for six months) the cumulative Medicare benefit could be high, affecting hospital budgets and private health insurer outlays if the service is provided in private hospitals. The Department of Health and Aged Care will administer the items through the MBS and will be responsible for auditing compliance with the conditions, particularly around the use of the integrated closed system, the mandatory PBS methoxsalen, and the haematology supervision. The Pharmaceutical Benefits Advisory Committee indirectly has a stake because the service requires PBS‑subsidised methoxsalen - if that drug is not listed for this indication or is discontinued, the item conditions would become unfulfillable.

The Determination does not impose general duties; it sets conditions for a service to be treated as an MBS item. The key duty on providers is to ensure that every claim for item 14247 or 14249 meets all the listed conditions. For item 14247 (initial six months), the conditions are: the service is provided in the initial six months of treatment; delivered using an integrated, closed extracorporeal photopheresis system; the patient is 18 or over; the patient has received prior systemic treatment for this condition and experienced either disease progression or unacceptable toxicity; the service is provided in combination with PBS‑subsidised methoxsalen; and the service is supervised by a specialist or consultant physician in haematology. For item 14249 (continuing treatment), additional conditions apply: in the preceding six months, a service to which item 14247 applies has been provided; the patient has demonstrated a response to that service; and the patient requires further treatment. The right accruing to providers is the right to claim a Medicare benefit for the service if all conditions are satisfied. Patients have no direct rights under this Determination, but indirectly gain access to a funded therapy. The instrument also gives the right to the indexed fee after 1 July 2025. Providers must note that the service is applicable once per treatment cycle - meaning only one claim per cycle, not per day of treatment within a multi‑day cycle. The definition of treatment cycle (single day or consecutive days) means that if a patient requires two consecutive days of photopheresis to complete one cycle, only one claim can be made for that cycle. There is no right to appeal conditions within the instrument; any dispute would be under the Health Insurance Act’s review mechanisms. The duty to keep records is implicit: providers must be able to demonstrate compliance with each condition (e.g., documentation of prior systemic treatment failure, evidence of response, haematologist supervision, use of PBS methoxsalen) if audited.

The Determination itself creates no penalties. Enforcement and penalty provisions arise from the Health Insurance Act 1973 and the National Health Act 1953, which are incorporated by the definition of “relevant provisions” in section 4. The most relevant provisions are those dealing with false or misleading statements in Medicare claims, which can attract criminal penalties (including imprisonment) under Part IIA of the Health Insurance Act, and civil penalty provisions under Part IIB. Additionally, the Act provides for administrative action such as suspension or revocation of a provider’s Medicare eligibility, repayment of benefits received, and referral to professional bodies. The instrument’s conditions are part of the item descriptor; claiming a benefit for a service that does not meet one or more conditions could constitute a false claim. For example, claiming item 14247 for a patient who has not received prior systemic treatment, or who has not experienced progression or toxicity, would be a claim that does not satisfy the descriptor. Similarly, using a photopheresis system that is not an “integrated, closed” system would be non‑compliant. Because the Determination incorporates clauses of the general medical services table (clauses 1.2.6, 1.2.7, 1.2.9, 1.2.10, and 5.1.1), any breach of those clauses (e.g., time limits on claiming, rules about multiple services, or restrictions on claiming with other items) would also be enforceable under the Act. The indexation provision in section 7 is administrative and does not carry penalties. The presence of the “(H)” indicator may also affect hospital funding and could trigger compliance checks under state health agreements. The Department of Health and Aged Care is the enforcement body, and it conducts routine and targeted audits of MBS claims. The Determinations under section 3C are a common target for audit because they create new items with specific conditions that may be unfamiliar to some providers. There are no penalty‑specific provisions unique to this instrument; enforcement relies on the general law.

This Determination is made under subsection 3C(1) of the Health Insurance Act 1973. It sits within a framework of the Act, the Health Insurance Regulations, and the general medical services table. Section 5 of the Determination makes the service “treated, for the relevant provisions, as if it were both a professional service and a medical service; and there were an item in the general medical services table”. “Relevant provisions” is defined broadly (section 4) to include all provisions of the Health Insurance Act and the National Health Act 1953 and their regulations “relating to medical services, professional services or items.” This means the full MBS compliance and funding regime applies. The Determination expressly incorporates five specific clauses of the general medical services table: clauses 1.2.6, 1.2.7, 1.2.9, 1.2.10, and 5.1.1. These clauses relate to matters such as time limits for claiming, restrictions on claiming by certain provider types, and rules about concurrent services. By specifying that these clauses apply “as if items 14247 and 14249 were also specified in the clause”, the Determination brings these items within the same administrative rules that apply to standard MBS items. The interaction with the National Health Act 1953 is material because the service must be provided “in combination with the use of Pharmaceutical Benefits Scheme‑subsidised methoxsalen.” The PBS is established under Part VII of the National Health Act. This condition ties the MBS item to PBS supply: if methoxsalen is not prescribed or dispensed under the PBS for that patient, the MBS condition is not met. This cross‑statutory link creates a dual compliance requirement. The Determination also potentially interacts with state and territory health legislation, particularly in public hospitals where state funding arrangements and clinical governance requirements apply. The “(H)” indicator suggests the service is hospital‑based, which may trigger state purchasing arrangements or Health Service Agreements. There is no interaction with private health insurance except indirectly: if a service is provided in a private hospital, the Medicare benefit covers part of the cost, and the hospital may charge gap amounts. This Determination does not affect the Prostheses List or any other device funding schemes.

The source instrument, the Health Insurance (Section 3C General Medical Services - Extracorporeal Photopheresis) Determination 2020, as provided to the analyst, is the original instrument as registered. The source text does not include any amendment history, explanatory statement, or subsequent amending instruments. The instrument was made on a date not stated in the extracted text, but presumably in 2020 (as per its title). The instrument contains an indexation provision (section 7) that operates from 1 July 2025, which suggests the drafter anticipated a need to adjust fees once, but this is not an amendment per se - it is an automatic replacement mechanism. The Determination could have been amended between its making and the present date, but the source provided does not record any such amendments. Federal Register of Legislation records would need to be consulted to determine whether any amending instruments exist. The Determination’s structure (new items at 14247 and 14249) would likely have taken effect from a specified commencement date, but that date is not included in the extract. The indexation provision uses a formula that references “the amount immediately before the indexation time”. This implies that the original fee of $1,925.55 may have been varied by prior amendments if any occurred before 1 July 2025, but no such variations are disclosed. The instrument does not contain sunsetting clauses, so it remains in force indefinitely unless repealed or amended. Given the narrow scope of the service, it is possible that the Determination has not been amended, but the user should verify against the current version. The absence of amendment history in the source means we cannot comment on any changes to clinical criteria, fees, or administrative conditions.

The source instrument does not contain any reference to litigation. There is no mention of court cases, administrative reviews, or appeals relating to this Determination. Given that the Determination is a delegated legislative instrument creating two MBS items with highly specific clinical criteria, litigation could theoretically arise in three ways: (1) a provider or patient challenging the refusal of a Medicare benefit on the basis of non‑compliance with one of the conditions; (2) a challenge to the validity of the Determination itself (e.g., ultra vires subsection 3C(1)); or (3) a prosecution under the Health Insurance Act for false claims, leading to judicial interpretation of the item descriptors. No such cases are mentioned in the source. A search of public records (not provided) might reveal whether any cases have been litigated. The determination is a legislative instrument subject to disallowance by Parliament, but disallowance actions are not litigation. The Federal Court or the Administrative Appeals Tribunal could potentially review decisions of the Department or the Medicare Australia (now Services Australia) regarding claims under this Determination. Because the condition is rare (advanced CTCL), the number of claims is likely low, making litigation less probable. The source does not provide any administrative review history either. Therefore, the litigation history is essentially nil based on the instrument alone. The user should be cautious: absence of litigation in the source does not guarantee that no litigation has occurred, but there is no information in the instrument on this point.

Several traps in this Determination may catch unwary practitioners. First, the item fee of $1,925.55 applies only until 1 July 2025; after that date the indexed fee applies, but the instrument provides no automatic annual indexation thereafter - only a single 2.4% increase. If the fee is not updated by further amendment after 1 July 2025, it will remain at the indexed level indefinitely, which may erode in real terms. Second, the condition that the service is “delivered using an integrated, closed extracorporeal photopheresis system” is not defined. This could become a dispute point: what counts as “integrated, closed” if technology changes or if the provider uses a system that is not originally designed for photopheresis but modified? Third, the requirement that the service is “supervised by a specialist or consultant physician in the speciality of haematology” means that supervision by a dermatologist (even one experienced in photopheresis for CTCL) or an oncologist (non‑haematology) does not satisfy the condition. This may be overlooked where the treating physician is a dermatologist or medical oncologist. Fourth, the service must be provided “in combination with the use of Pharmaceutical Benefits Scheme‑subsidised methoxsalen”. If the methoxsalen is supplied privately (e.g., importer arrangement) or if the PBS listing for methoxsalen changes, the MBS condition may become impossible to satisfy. The instrument does not define what constitutes “use” - is administration required, or merely a prescription? Fifth, for item 14247 (initial treatment), the condition that the patient “has received prior systemic treatment for this condition and experienced either disease progression or unacceptable toxicity while on this treatment” requires documentation. There is no minimum duration of prior systemic treatment; a single dose could theoretically qualify, but that would likely be scrutinised. Sixth, for item 14249 (continuing treatment), the condition that the patient “has demonstrated a response” is subjective. The instrument does not specify objective criteria (e.g., 50% reduction in skin involvement). This ambiguity may lead to inconsistent claiming and audit risk. Seventh, the “once per treatment cycle” rule combined with the definition of treatment cycle (single day or consecutive days) means that if a patient requires a cycle of two consecutive days, only one claim per cycle is allowed. If the service is billed per day, that would be an over‑claim. Eighth, the indexation rounding rule (nearest 5 cents) could produce slight discrepancies when multiplied across multiple claims. Finally, the incorporation of clauses 1.2.6, 1.2.7, 1.2.9, 1.2.10, and 5.1.1 of the general medical services table may impose additional restrictions not immediately apparent from the item descriptor alone - for example, time limits on claiming after the service date, or restrictions on claiming with certain other items.

Compliance with this Determination requires meticulous adherence to the conditions in the item descriptors. For item 14247 (initial six months), a provider must: (1) confirm the patient has a diagnosis of erythrodermic stage III‑IVa T4 M0 cutaneous T‑cell lymphoma (documented by pathology and staging); (2) ensure the patient is ≥18 years; (3) document that the patient has received prior systemic treatment for CTCL and that they experienced either disease progression (objective) or unacceptable toxicity (subjective, but should be recorded in clinical notes); (4) use only an integrated, closed extracorporeal photopheresis system - the specific brand or model should be noted in the patient record; (5) ensure that the service is supervised by a haematology specialist or consultant physician (name and specialty recorded); (6) prescribe and supply methoxsalen through the PBS (i.e., the prescription must be written on a PBS prescription, and the patient should be advised to obtain it from a pharmacy that dispenses PBS medicines); (7) ensure the service is provided within the first six months of commencing this treatment (not from diagnosis of CTCL, but from initiation of extracorporeal photopheresis); and (8) claim only once per treatment cycle, understanding that a cycle may be one day or consecutive days. For item 14249 (continuing treatment), additional steps: (a) confirm that in the preceding six months, the patient received at least one treatment under item 14247; (b) document and evidence a response to that initial six‑month course (e.g., reduction in skin score, improved quality of life, imaging); (c) confirm that further treatment is required (clinical judgment supported by notes); (d) meet all other common conditions (system, supervision, PBS methoxsalen). Providers should maintain a comprehensive file for each patient including: histology and staging reports, prior systemic treatment details (drugs, dates, outcomes), a record of progression or toxicity, details of the photopheresis system used, haematologist supervision notes, a copy of the PBS prescription for methoxsalen, and evidence of response (where applicable). The provider should also be aware of the incorporated general medical services table clauses - for example, clause 1.2.6 may deal with time limits for claiming (e.g., within 12 months), clause 1.2.7 with claiming restrictions for hospitals, clause 1.2.9 and 1.2.10 with multiple procedures, and clause 5.1.1 with location restrictions. These should be reviewed manually because the instrument does not reproduce them. The claim must be made using the correct item number and with the “(H)” indicator as appropriate; billing systems should be updated accordingly. After 1 July 2025, the indexed fee applies, and providers should check MBS Online for the exact fee. No other compliance obligations beyond those for any MBS item arise.