Outpatient specialist medical care (ASV) in the context of current health policy reforms

For many years, experts have been warning that the historically created sector boundaries and the associated false incentives with breaks in care and incorrect care in the German healthcare system should be addressed and eliminated (SVR 2012; SVR 2018; Nagel et al. 2017). The care areas of the medical care centers (MVZ) implemented in the Fifth Social Code (SGB V) according to § 95, the day hospital treatment according to § 115, the pre- and post-inpatient treatment according to § 115a, outpatient surgery according to § 115b, the authorization according to § 116 , outpatient treatment at the hospital (ABK) according to § 116b old version, the university outpatient clinic according to § 117, the social psychiatric outpatient clinics according to § 120, the affiliated doctor system according to § 121, the disease management programs according to § 137f, the previously integrated and now special Care in accordance with Section 140a SGB V, to name just a few, have neither eliminated the parallel care structures nor reduced sector boundaries nor equalized the differences between urban and rural areas (Dengler et al. 2018; Jacobs 2019; Wolf 2020). Since there was hardly any coordination or coordination between these systems, these individual measures, which did not work synergistically, did not contribute to the urgently needed harmonization of the care landscape and an adequate level of outpatient care compared to the OECD (OECD 2021), but rather made the structures even more complex and for many of those involved - service providers and patients – made more opaque. With the amendment of § 116b SGB V and the implementation of outpatient specialist medical care (ASV), a new attempt was made on January 1, 2012 to provide interdisciplinary and cross-sector treatment, at least for patients with rare diseases and those with a special or complex course of the disease ( German Bundestag 2011).

>> The ASV will gradually replace the ABK with a transition period of three years. For the first time, it includes a uniform regulatory framework for clinics and practices in outpatient care regarding participation, quality assurance and remuneration. On the one hand, this article aims to present the ASV in its development over time. For this purpose, data from the GOAL-ASV evaluation study, which was carried out on behalf of the Federal Joint Committee (G-BA) as part of the Innovation Fund (G-BA 2022a), is reported and the further developments that have occurred since then are presented. On the other hand, the current health policy activities regarding outpatient care, i.e. the new day-care treatment in hospitals, the further development of outpatient surgery and ward-replacing procedures as well as sector-level remuneration are presented and discussed.
The consideration takes place particularly with regard to the implementation, the harmonization between the constructs and the patient path.
The ASV as an interdisciplinary and cross-sector care model
Content and structure
The ASV was anchored in Section 116b SGB V on January 1, 2012 (German Bundestag 2011). It is suitable for patients with diseases with a particular progression (e.g. tumor diseases, rheumatological diseases) as well as rare diseases or diseases with small numbers of cases (e.g. cystic fibrosis, hemophilia). To date, regulations for twenty indication areas have come into force (G-BA 2023), and the G-BA is gradually transferring two further indication areas from the ABK to the ASV every year. The care structure consists of interdisciplinary teams with a team leader, a core team and doctors to be consulted; the details are defined by the G-BA in a guideline (ASV-RL) (G-BA 2013). Hospital doctors and contract doctors can take part. Participation must be reported to the regional extended state committees (ELA). Personnel (qualifications, minimum quantities) and structural (cooperation, team structure, emergency care) requirements must be demonstrated, on which the possibility of participation depends. There is no approval process in the strict sense and no requirements planning. Remuneration is currently unbudgeted according to the Uniform Assessment Standard (EBM).
Evaluation of development and
Status quo of the ASV
As part of the GOAL-ASV health services research study, the ASV was run from 2019 to 2021 by a research consortium consisting of the FOM University of Economics & Management, the Leibniz Institute for Prevention Research and Epidemiology, the Scientific Institute of Resident Hematologists and Oncologists and the Federal Association of ASV, evaluated. The aim was to examine the current status, hurdles and barriers as well as utilization and to develop recommendations for further development and optimization. The results report has now been published on the G-BA website (G-BA 2022a). We present partial results of the study here, as well as updated data collected after the evaluation was completed.
The basis for the study was the data from the ASV service center, the advertising forms from all 17 ELA, the answers to a structured survey by the ELA, interviews with ASV team leaders and patient representatives, surveys of doctors and clinic management as well as patients. Furthermore, anonymized GKV routine data from the GKV National Association and from the German Pharma-
coepidemiological Data Base (GePArD) (Pigeot and Ahrens 2008), incidence and prevalence figures from the Robert Koch Institute (ZfKRD 2020), the Institute of the Assessment Committee (InBA 2021), which are evaluated as part of the adjustment according to Section 87 SGB V Paragraph 1 , as well as figures determined as part of the bureaucracy cost assessment from the main reasons of the G-BA (G-BA 2019).
Results
Status quo, development, access procedures
The number of authorized ASV teams has increased continuously in most indications since the first specification came into force in 2014 and was 799 in quarter 1/2023. There is often a significant increase in the number of ASV teams at the time the old approvals (ABK) are terminated note. Fig. 1 shows the overall development across all indications.
Between four and 36 months pass between the entry into force of specification for an indication area and the establishment of the first teams. There was a great deal of variation in the size, composition and sector of the ASV teams. On average, 44 doctors are organized in a team. 95% of all teams are staffed across sectors; the proportion of contracted doctors across all indications is 42%. In the case of rheumatism (adults) and sarcoidosis, the majority come from the statutory health sector. Of the team leaders, 86% work in a clinic, 9% in a practice and 5% in an MVZ. The evaluation of the 17 ELA advertisement forms available on the Internet revealed a clear heterogeneity in terms of the requirements for the documents to be verified. This concerns the naming of the doctors to be consulted (namely or institutionally), the type and scope of the documents to be presented (certificates, organizational requirements), the minimum quantities (self-declaration, patient lists) and the possibility of authorizing the ELA to inspect the KV doctor's register. There were also clear differences in the rejection rates and the reasons given for each ELA. The procedure lasted between one and twelve months.
Since the beginning of the ASV, up to and including quarter 1/2023, a total of 1,871,544 quarterly patients (patients for whom services were billed by at least one ASV doctor in the quarter) have been cared for by approximately 39,000 doctors in the ASV (the individual "headcount " of patients is lower because the treatment usually extends over several quarters; the number of individual doctors is also lower because the same doctors can participate in more than one ASV team). In the last four quarters available for analysis, there were 182,918 insured persons in the ASV per quarter. The teams, doctor and patient numbers are distributed very differently depending on the federal state or KV region (Fig. 2), with the highest numbers per 1 million inhabitants in Schleswig-Holstein, North Rhine, Hesse and Berlin, and the lowest penetration can be found So far, not a single team has been established in Rhineland-Palatinate, Saxony-Anhalt and Mecklenburg-Western Pomerania. The differences are likely, among other things, can be attributed to the varying testing practice of the ELA, the extent of the ABK regulations and a too small number of potentially participating specialists. The proportion of patients in the potential total population is shown in Fig. 3. Penetration is extremely heterogeneous depending on the indication.
The expenditure volume now (as of the 4th quarter of 2022) amounts to 130,561,759 euros for ASV services from participating contractual doctors and 300,942,555 euros for services from ASV-authorized clinics (including the remaining provisions within the framework of the ABK) achieved (BMG 2022).

Motivation and hurdles
Those who had not yet taken part in the ASV stated that the most common potential motivation was an improvement in the areas of bridging sector boundaries, interdisciplinary care, cooperation with other specialists, patient care and billable services. Regarding obstacles and hurdles, those not (yet) taking part in the ASV and hospital management mainly cited the high organizational effort and lack of strategic or financial benefit.
Those taking part in the ASV saw patient benefits, interdisciplinarity and strategic competitive considerations as motivation. The loss of the old authorization (ABK) was also an important motivation for a majority of those surveyed from the clinic sector. Monetary aspects were rated as important or very important more often by those in private practice than by participants in clinics. The ASV participants described the required disciplines, the provision of all the necessary services of the number ring, the necessary quality certificates and the 30-minute distance regulation from the team leader's location as hurdles in the notification process. Overall, the majority rated the reporting process as unreasonably time-consuming and poor or very poor. For almost a quarter of the team leaders surveyed it took up to four months from the start of processing the notification form to the positive decision, for a little less than half it took between 5 and 12 months and for 15% it took longer than a year. According to the respondents, the administrative and documentation effort is a main obstacle during ASV participation; in addition, among other things, An inadequate range of remuneration - especially for rare diseases - was also stated.
recommendations
In order to further develop and optimize the ASV, a number of recommendations for adapting the ASV-RL were made in the study results report. The consultation and adoption of the clarifications should be accelerated, which would be possible by foregoing the detailed numbers in the appendices. New EBM numbers should also be transferred to the ASV more quickly. The notification procedure would be significantly simplified and reduced in bureaucracy and a nationwide electronic notification form would be advantageous. Evidence available to clinicians such as certificates, further training authorizations and existing certifications should also be recognized as quality assurance documents. The type and scope of evidence should be defined nationwide by the G-BA. The current distance rule of 30 minutes from the team leader's location should be eliminated in order to encourage the establishment of ASV teams in rural regions.
Current reforms to intensify outpatient care
Outpatient surgery and ward replacement procedures (AOP) according to Section 115b SGB V
By amending Section 115b SGB V in the law for better and more independent examinations (MDK reform law), the legislature initiated a comprehensive revision of the AOP catalog on January 1, 2020 (German Bundestag 2019). According to § 115 b paragraph 1 SGB V, the GKV-Spitzenverband (GKV-SV), the German Hospital Association (DKG) and the National Association of Statutory Health Insurance Physicians (KBV) have agreed on a new version of billing and uniform remuneration for hospitals and contract doctors as of January 1, 2023 (AOP contract) and as an appendix agreed on a further development of the catalog based on a report from the IGES Institute (Albrecht et al. 2022). The experts suggested 2,476 new services based on 208 OPS codes (operation and procedure codes), an increase of 86% to a total of 5,355 services. Most of the services proposed for expansion, around 60% (1,482 services), are operations. The second most common services, at 546, are diagnostic measures such as endoscopies. These services were provided on a fully inpatient basis around 15 million times in 2019. In the new area of ward-replacing (e.g. conservative) treatments, the experts recommend 65 DRGs (diagnosis related groups) for inclusion in the AOP catalog, including DRGs in the area of radiotherapy and conservative tumor treatments. These services accounted for a total of 632,786 annual inpatient hospital treatments in 2019. In order to be able to define the outpatient potential, so-called contextual factors were identified (e.g. general condition, severity of illness, days on ventilation, etc.) that require inpatient care. (Albrecht et al. 2022).

Day treatment in the hospital according to Section 115e SGB V
With the Hospital Care Relief Act (KHPflEG) passed on December 2nd, 2022, the so-called day inpatient treatment came into force on January 1st, 2023 with the amendment to Section 39 SGB V and the introduction of Section 115e SGB V on January 1st, 2023. Since then, in medically appropriate cases and with the consent of the patient, approved hospitals have been able to provide day-care treatment with at least six hours of treatment without an overnight stay instead of full-time inpatient care. Billing is carried out according to DRG coding based on the applicable flat rate catalog by the Institute for the Hospital Remuneration System (InEK). For the non-incurring overnight accommodation costs, a flat-rate deduction must be made from the total fees charged for the fully inpatient stay, which corresponds to 0.04 valuation ratios (approx. 150) per night, whereby the deduction does not exceed a proportion of 30 % of the fees for the total stay may. Treatments of less than six hours are not reimbursed as day-patient treatment, but are to be billed as outpatient treatment in accordance with the system of Section 39 SGB V. In accordance with the guiding principle of “outpatient before inpatient”, services that were previously provided on an outpatient basis in the hospital and could be reimbursed according to the EBM or through flat rates agreed at regional or local level may not be billed as day-patient services. The limit lengths of stay apply in the same way as for overnight treatment. Days on which the patient was not in the hospital are not taken into account when determining the length of stay and reimbursement.

Equal remuneration across sectors in accordance with Section 115f SGB V
The introduction of a special sector-equivalent remuneration in accordance with Section 115f SGB V (so-called Hybrid DRG) planned as part of the KHPflEG for service complexes that were identified as part of the IGES report and that can generally be provided on an outpatient basis in accordance with Section 115b SGB V should the separate outpatient and inpatient reimbursement systems are harmonized (German Bundestag 2022). So far, the pricing between EBM and DRG – as already mentioned – is very different. For example, E.g. outpatient services of the DRG group R with Major Diagnostic Category - MDC 17 Hematological and solid neoplasms, currently reimbursed on average according to EBM (Chapter 31) with Euro 267, but in the DRG system with Euro 1,897 per patient per quarter, corresponding to one Difference by a factor of 7.12 (Albrecht et al. 2022). The new system is intended to regulate remuneration across sectors, i.e. regardless of whether the service is provided on an inpatient or outpatient basis or in a hospital or a contracted doctor's office. In parallel to the expansion of the AOP catalog, a concrete proposal has been presented as part of a project “Uniform, cross-sectoral remuneration (ESV)” funded by the Innovation Fund under the consortium leadership of the Hamburg Center for Health Economics at the University of Hamburg (Schreyögg et al. 2022). Here a calculation was made from performance complexes, e.g. B. radiology, surgery, anesthesia etc., suggested. According to the ESV report, the depiction of the degree of severity should take into account the PCCL (patient clinical complexity level) established in the inpatient DRG system. Patient severity levels or PCCL values of 0 – 1 (non-complex situations with no or low severity) would indicate outpatient care, PCCL from 2 or 3 would indicate inpatient care. The amount of the remuneration should, among other things, take into account the current level of outpatient care. Consequently, this should be based more closely on DRG flat rates for services that have so far been carried out predominantly on an inpatient basis and more closely on the EBM for procedures that have so far mainly been carried out on an outpatient basis. In the first stage, the remuneration should be in the form of a flat rate. In a second step, a differentiated calculation should be carried out according to the modular principle with convergence to the AOP catalog. The identified DRGs are removed from inpatient care and can then no longer be billed in the DRG system. The adjustment of the morbidity-related total compensation is planned for the following year.
The legislature had commissioned the KBV, the GKV-SV and the DKG to select services from the AOP catalog by the end of March 2023 that can be remunerated with sector-level flat rates and to agree on the amount and content of the service flat rates. The negotiations on this then failed. Currently (as of August 1, 2023), the BMG therefore defines a corridor for services and remuneration as part of the replacement procedure.
discussion
From a care perspective, the participation of service providers from clinics and practices, the interdisciplinarity and the team structure of the ASV are unique in the healthcare system. Many aspects of the ASV (sector-equal access requirements, quality requirements and remuneration) already contain the prerequisites for an increase in outpatient care (Dengler et al. 2022, Froschauer and Straub 2023). The ASV has now established itself in everyday care and will continue to gain in importance as it is expanded to include two indication areas each year.
However, GOAL-ASV has shown that the intentions intended by the legislature, such as reducing access barriers, regional differences, maintaining treatment continuity, etc. (German Bundestag 2011), are overshadowed by bureaucratic formalities. The relatively high effort involved in reporting hinders the participation of practicing physicians, among other things. the now low proportion of ASV teams managed by local residents shows. For some service providers, especially the specialists involved and in the rare disease segment, the billable number range leads to an unfavorable cost/income ratio due to the low number of patients and lack of economies of scale (Diel and Mertsch 2019, Dengler et al. 2022).
The small number of ASV teams for the rare diseases, some of which fall short of the provisions under the ABK (Marfan syndrome, cystic fibrosis, Wilson's disease), could indicate that the access procedure under the ABK was less complex and the spectrum of treatment as well Remuneration may be more adequate. Since the ASV does not include any safety aspect, there is a risk of undersupply for some patients with rare diseases.
It is clear that there is no clear temporal connection to the entry into force of the specification regarding the proportion of ASV patients in the potential total population
(see Fig. 3). The reasons for this can currently only be speculated upon; These could be due to delays in the formation of ASV teams, e.g. B. the required specialist groups cannot be found (Dengler et al. 2022). Furthermore, ASV teams that have already been formed could have false incentives that favor inpatient care for patients, such as: B. in the indication area tuberculosis (Diel and Mertsch 2019). Health services research studies could provide more clarity here.
The legally required remuneration system for ASV services (Section 116b Paragraph 6 Sentence 3 SGB V) has not yet been developed. This affects the establishment of ASV as a genuine comprehensive supply solution.
The ASV is also limited in its development by the many adjacent, sometimes competing, outpatient and acute inpatient care areas, meaning that eligible patients do not always find the type of care that is right for them (Froschauer and Straub 2023). This is primarily due to the fact that the ASV was integrated into an existing system without taking into account, “thinking about” and further developing the adjacent supply structures and sectors. So there is, among other things: no harmonization with the attending physician system according to Section 121 SGB V and in the recent amendment to Section 117 SGB V (university outpatient clinics) it was determined that the service area according to Paragraph 1 Sentence 1 No. 2 has the same rank as other forms the provision of services (in particular Section 116b SGB V).
Some recommendations from GOAL-ASV have now been taken into account, including: Multimodal therapy was deleted as a prerequisite for patient inclusion in the oncological indications. The required adjustment of the service-specific quality requirements was also made to make it easier for clinicians to provide evidence of the necessary documents (G-BA 2023a).
In the update of the appendixes from March 2023, new billing figures were also added, e.g. B. for consultation services for cystic fibrosis patients. In order to ensure that billing according to the valid EBM is adjusted as quickly as possible in the ASV, the G-BA is currently discussing restructuring the procedure for annual appendix updates (G-BA 2023b).
With regard to the current reforms to intensify outpatient care, the question of whether the expansion of the AOP catalog within the framework of Section 115b SGB V actually leads to relevant additional outpatient care will depend primarily on which services are included in the second step planned for January 1st, 2024 Expansion of the AOP catalog will be defined and what the remuneration will look like within the framework of Section 115f SGB V (Hybrid DRG). The expansion of the AOP catalog alone will “…. have no relevant impact on the fundamental implementation difficulties” (BMG 2022b). An increased outpatient use of these services can only be expected when the corresponding DRG services are removed from inpatient care or adjusted and transferred to Section 115 f SGB V. It is also crucial which hospitals carry out the remaining inpatient treatments and at what level of quality. It is to be hoped that the quality requirements being prepared will lead to an adjustment here.
With regard to day-care treatment in hospitals in accordance with the new Section 115e SGB V, it remains to be seen to what extent the clinics will use this voluntary option. The requirements for day treatment are so vague that a large number of legal disputes about their existence are to be expected in individual cases (G-BA 2022). The relevant criterion “at least six hours of medical or nursing treatment” is likely to lead to uncertainties and distortions in practice and jurisprudence, not only with regard to the distinction from full-time inpatient care, but also from other forms of treatment such as day-care care and ward-replacing interventions in accordance with Section 115b SGB V and all outpatient forms for which the EBM provides billing options for more than six hours. There are also liability risks (G-BA 2022b, Sehy & Riese 2023). The justification in § 115e rightly points out that day-care treatment cannot be provided for patients for whom the necessary home care cannot be guaranteed overnight. This also means that the hospital has to get an idea of the home care situation, which in practice can only be done through the information provided by the patients. This requires a comprehensive educational discussion (Sehy & Riese 2023).
In addition, the hospital's decision not to care for patients overnight is likely to be associated with high logistical effort, which would tie up staff who could potentially be released due to the lack of overnight stay. Patients must be discharged daily and readmitted the following day. In addition, staff must be available to be able to readmit patients with problems after discharge at night.
Conclusion
In summary, it is unfortunately once again clear that the clear cut that is actually necessary and that most experts have been calling for for years, with a fundamental reorientation and harmonization of the existing structures, is currently missing. In any case, the constructs that have now been introduced are not coordinated with the many outpatient models that already exist, including the ASV. This leads to even more heterogeneous and confusing supply structures, which even compete with each other. This also increases the risk that competition for patients will be monetary and not based on the quality of treatment. The “jungle” of outpatient treatment options is becoming even more complex and opaque with the addition of additional small-scale offerings, especially from the patient’s perspective.
The expansion options for hospitals to care for patients on an outpatient basis, as contained in Sections 115b, e and f SGB V, also often affect existing hospital processes that are not designed for large-scale outpatient and, in this respect, resource-saving service provision. Therefore, in many cases the processes and infrastructure in the hospital need to be adjusted, which takes time.
In a consistent development towards cross-sector and interdisciplinary care in the sense of a patient path without breaks, service areas such as ASV should not be viewed in isolation, but rather embedded in an overarching overall concept. As part of the reforms currently underway at the interface between outpatient and acute inpatient care, the ASV approach could be meaningfully strengthened and further developed as a cross-sector model.
limitations
In the GOAL ASV study, it was difficult to estimate the number of insured persons who could potentially qualify for ASV due to limited data available on the reality of care, particularly from areas of care outside of standard care, such as: B. pre- and post-inpatient care (§ 115a SGB V), university outpatient clinics (§ 117 SGB V), special care (§ 140a SGB V) etc., are subject to uncertainties. In the surveys answered among service providers, there was an imbalance between the physicians participating in the ASV and those not participating, which is due to the different response rates. <<