It does not appear sufficiently clear to the VDGH, but also to other stakeholders in the healthcare system, whether and to what extent the central elements of this legislation can achieve the objectives described. This is also due to the fact that, according to the draft of the KHVVG, the design of the central elements (introduction of a retention fee and reduction of existing DRG flat rates per case, definition of service groups, definition of minimum retention/quality criteria, further development of the structural fund into a transformation fund) is not yet included in the law itself, but will be assigned to the regulatory area of future ordinances. An impact analysis upstream of the legislation could at least counteract major risks arising from a failure to achieve objectives or undesirable side effects before they occur. Irrespective of this, the VDGH considers the evaluation provided for in the draft (Section 426 SGB V) to be correct and necessary in view of the scope of the proposed legislation.
The inadequacies in the investment financing of the federal states, which have existed for decades, remain the cause, even if the negative consequences for hospitals are to be mitigated with the KHVVG. Maintaining and further developing the structural and technical equipment of German hospitals in particular will therefore remain an enormous challenge in the coming years. We appeal to the federal states not to shirk their financial responsibility for providing needs-based inpatient medicine that is state of the art in terms of medical technology and remains open to innovation.
Healthcare
The draft bill states: "In order to be able to maintain quality-assured basic medical care, particularly in structurally and population-poor regions, the expansion of cross-sectoral and integrated healthcare will be promoted. By law, the federal states are given the opportunity to designate cross-sector care facilities whose range of services includes extended outpatient and medical/nursing services in addition to inpatient care."
From the VDGH's point of view, it is relevant here to enable cross-sector care facilities to continue to provide needs-based, quality-assured and innovative in-vitro diagnostics services. In the opinion of the VDGH, this is no longer adequately guaranteed in SHI-accredited medical care, particularly with regard to the implementation of the laboratory reform of the EBM on January 1, 2025 (resolution of the Evaluation Committee pursuant to Section 87 (1) sentence 1 SGB V at its 709th meeting). Particularly innovative diagnostics or rapid near-patient diagnostics using point-of-care testing (POCT) are inhibited by restrictions in the standardized assessment scale.
In the agreement on the catalog of services pursuant to Section 115f (1) sentence 1 no. 2 SGB V in conjunction with Section 115f (2) sentence 2 SGB V (hybrid DRG agreement) of 27 March 2024, material and laboratory costs are considered separately and the sector-specific material and laboratory costs are combined on a weighted basis using the degree of outpatient treatment. Incentives to promote innovation should be retained, as in the previous inpatient system, in order to reflect the constantly advancing medical-technical progress and to provide patients with optimal and, above all, comprehensive care. In particular, it must be ensured that innovative diagnostics can be quickly incorporated into the care provided by SHI-accredited physicians. The requirements and criteria for cost-effectiveness and medical necessity in the evaluation of new examination and treatment methods should be standardized and made more transparent. The possibility of using health data should be used to accelerate the assessment of new examination and treatment methods, for example through pre-trial phases.
§ Section 135e SGB V: Minimum requirements for the quality of hospital treatment, authorization to prescribe
For the future classification of hospital treatment services into service groups, standardized national quality criteria that include minimum requirements for structural and process quality are to apply. A diagnostic laboratory will not constitute a separate service group, but will be listed as "material equipment" for some service groups. The quality criteria to be defined are to be specified for the service groups (LG) 3 "Infectiology", 16 "Special pediatric and adolescent surgery", 27 "Special traumatology", 47 "Special pediatric and adolescent medicine" and 65 "Emergency medicine" in Annex 2 to Section 135e SGB V.
Providing patients with laboratory medicine services and related specialties is essential for decision-making and successful treatment. Approximately 70 percent of all clinical diagnoses are based on laboratory diagnostic tests. Therefore, in order to increase the quality of healthcare in the inpatient sector, it must be ensured that laboratory diagnostics are adequately defined as a minor requirement of the corresponding service groups and financed in inpatient care.
While certain minimum requirements for material and personnel resources with regard to the laboratory and microbiology are listed for the LG Infectiology, these are largely or completely absent for the other service groups. Additions are required within the framework of this legislation. In particular, the provision of an emergency laboratory 24/7 or appropriate equipment for point-of-care diagnostics should be mentioned as a structural requirement for LG 65 (emergency medicine). The mere mention of "blood gas analysis" is insufficient. To rule out/confirm suspected diagnoses, e.g. hypoglycemia, heart failure, myocardial infarction, acute renal failure, sepsis, further laboratory tests and the provision of appropriate tests and equipment are required. The same applies to testing for respiratory pathogens.
The minimum requirements/quality criteria for the respective service groups in accordance with Section 135e SGB V are to be determined after a transitional phase by the Federal Ministry of Health in the form of a statutory order with the approval of the Bundesrat. To this end, the BMG is to set up a committee that will decide on recommendations regarding the content of the ordinance. Proposals from the Association of the Scientific Medical Societies in Germany (AWMF) are to be obtained. From the VDGH's point of view, there is a particular need to adequately consider the interests of laboratory medicine and related disciplines in view of the planned composition of the committee. Although these specialties are comparatively small, they have important interfaces with almost all other medical fields (or service groups within the meaning of the KHVVG). It is proposed that the relevant medical/scientific societies be actively involved in the process of defining the content. It is proposed that the relevant medical and scientific associations should be actively involved in the process of defining the content of the minimum requirements/quality criteria.
The timeframe for issuing the legal ordinance (by March 31, 2025) appears ambitious. From the VDGH's perspective, the thoroughness and expediency of the content specifications should be a priority.
Berlin, 29.04.2024
VDGH - Association of the Diagnostics Industry
Neustädtische Kirchstraße 8
10117 Berlin
The VDGH is registered under the registration number R001035 in the lobby register for the representation of interests vis-à-vis the German Bundestag and the Federal Government.
