Keywords

Introducing new medical procedures into the broad care system is a particular challenge that Richard Baum has accepted. I have been pleased to accompany him for some time on this long journey, which will be described here.

The recognition of the clinical relevance of a diagnostic procedure is best documented when it is recommended in an interdisciplinary guideline. Until this was the case for the first time in Germany for FDG-PET/CT in lung cancer, both the evidence from studies and the reimbursability had to be established in parallel.

Therefore, both the commitment in scientific task forces for guideline development as well as the participation in committees of the Joint Federal Committee (G-BA, “Gemeinsamer Bundesausschuss”) in an advisory function were necessary, which we have provided on behalf of the German Society of Nuclear Medicine.

The starting point in Germany is that a distinction is essentially made between the outpatient and inpatient care sectors. In the inpatient sector, new examination and treatment methods may be used and reimbursed as long as they are not explicitly prohibited (prohibition proviso). For non-invasive diagnostic procedures, however, there is generally no additional reimbursement in the inpatient sector. In the outpatient sector, new examination and treatment methods can only be used and reimbursed if they are explicitly permitted (subject to permission). This assessment is the responsibility of the G-BA, a body made up of representatives of the statutory health insurance funds (GKV, “Gesetzliche Krankenversicherung”) on the one hand and service providers, i.e., hospitals as well as physicians and dentists in practices for outpatient care on the other.

The G-BA’s consultations on PET and PET/CT have a long history and are still good for headlines today. On 26.05.1998, the GKVs requested consultations on PET. On 26.02.2002, the consultations led to the exclusion of all outpatient PET procedures for patients with statutory health insurance, fundamentally making individual decisions and selective contracts between GKVs and service providers impossible. Since 2003, there have been applications to the G-BA from the GKV and the Federal Association of Statutory Health Insurance Physicians (KBV, “Kassenärztliche Bundesvereinigung”) to review PET for all indications as mentioned in the drug approval of FDG.

The consultations in the G-BA were carried out comparably efficiently with a positive vote for useful indications of PET in lung cancer by decision of 20.12.2005. Richard Baum was intensively engaged at that time [1]. With this decision, FDG-PET could be included in the S3 guideline for lung cancer, on which we both participated as delegates of the German Society for Nuclear Medicine [2,3,4].

Shortly after the positive G-BA decision, a legal amendment with stricter requirements for health technology assessment (HTA) came into effect. The G-BA’s consultation practice now preferred randomized trials for the comparative evaluation of diagnostic procedures. On 24.01.2006, the GKVs applied for a new consultation of PET, also in the already reviewed indication of lung cancer.

PET imaging for lung cancer was again assessed by the G-BA and finally included in outpatient care by decision of 18.01.2007. However, the introduction of a billing code for outpatient PET/CT for those with statutory health insurance (and thus the possibility of reimbursement) lasted until 01.01.2016, i.e., more than 10 years after the first positive decision.

As can be seen, the process of HTA in the G-BA is difficult. In contrast to other healthcare systems, HTA in Germany requires prospective comparative proof of relevance regarding patient-related outcomes such as mortality, morbidity or quality of life, even for diagnostic procedures. The comparison of diagnostic test performance or the frequency of changes in patient management is not sufficient for the G-BA, and certainly not from retrospective studies. When strictly applied, the stringent formal rules of the G-BA are hard to bear for a clinically active physician, so I have a certain understanding for Richard Baum’s temperamental contribution in a session at which he criticized the consultations in a way not described here, so that he was exempted from further participation.

Over the years, it was possible to demonstrate the usefulness of FDG-PET/CT in Hodgkin’s lymphoma, namely for the diagnosis of the viability of residual lymphomas after chemotherapy in order to decide on the need for radiotherapy, so that the G-BA actually included FDG-PET/CT for this indication on 21.10.2010. However, according to the subsequently amended legal framework, at that time it was also imperatively prescribed to exclude a method that had been consulted by the G-BA if the usefulness of this method could not be proven by means of the strict methodological requirements. This mechanism led to the exclusion of FDG-PET/CT also on 21.10.2010 (even in the inpatient sector) for all other lymphoma indications, such as initial staging and restaging after chemotherapy for aggressive lymphomas, even if this is an internationally accepted standard of care.

Only some partial indications, such as the interim staging of aggressive lymphomas after 2 to 4 cycles of chemotherapy, were possible due to ongoing studies under the special guidelines of a so-called suspension order (“Aussetzungsbeschluss”).

As the legislature later recognized and corrected, the law at that time contained the risk of a type II statistical error (error of omission), i.e., not to find any usefulness in the testing, although this is actually present. The respective law was amended as of 01.01.2011, but the decisions on lymphomas from that time are still effective to a large extent and make our daily work more difficult.

After lengthy consultations, which cannot be presented here in an exhaustive manner, only a few PET/CT indications have so far been transferred to patient care and reimbursement in Germany.

The applications for HTA of PET and PET/CT were withdrawn by the previous applicants on 11.07.2018 and 20.09.2018, respectively, for all indications applied for except for the indications of PET in lung cancer, head and neck tumors, and malignant lymphomas. Following this withdrawal of the application, the G-BA decided on 20.11.2020 to largely discontinue the HTA of PET/CT. This termination of consultations is accompanied by the lifting of the categorical exclusion in the outpatient sector, but without the additional inclusion of further PET/CT indications.

Whether the termination of the consultation on PET/CT, which has been largely inconclusive for more than 20 years, is a systemic failure must now (status 21.11.2020) be assessed by the Federal Ministry of Health as the legal supervisor of the G-BA.

Perhaps the current “reset” offers the chance to bring urgently needed PET/CT indications into patient care and reimbursement by new targeted applications to the G-BA. This requires the cooperation of colleagues from the field of nuclear medicine who are as committed as Richard Baum can be for important tasks.