Section 116b SGB V, in its new version of the cabinet draft of the Care Act of August 3, 2011, stipulates that specialized services that can be provided on an outpatient basis will be transferred to a separate care sector, “outpatient specialist medical care”. According to the draft law, the treatment of diseases with special courses of disease (e.g. oncological diseases), the treatment of rare diseases (e.g. tuberculosis), selected outpatient operations and other ward-replacing services from the catalog of Section 115b SGB V as well as highly specialized services ( such as CT/MRI-supported pain therapy services) will be integrated into the new care sector. To this end, the “Outpatient Special Medical Care” project group of the Federal Association of Managed Care e. V. developed a position paper under the leadership of Roger Jaeckel, Head of Health Policy, GlaxoSmithKline GmbH & Co. KG.

>> The Federal Joint Committee (G-BA) is authorized within the framework of its directive authority to define the services and clinical pictures of outpatient specialist medical care as well as the necessary qualification requirements for the service providers. In addition to personal qualification requirements, the G-BA can also issue procedural requirements for individual illnesses or therapies, which must then be proven by the service providers. These include:
• Requirements for mandatory cooperation between service providers; According to the law, these must be defined in the field of oncology.
• Definition of referral reservations as a prerequisite for access to outpatient specialist medical care.
• Decision aids for the treating doctor as to when such a special course of the disease should be assumed in the case of illnesses with a special course of the disease.
What is new is that the principle of prohibition from the inpatient sector is to be adopted for the outpatient specialist care sector. This means that new, innovative procedures can generally be used in outpatient specialist medical care, provided that the G-BA has not explicitly rejected these services as part of the statutory health insurance companies' service catalogue. In principle, practicing physicians and approved hospitals can take part in outpatient specialist medical care, provided they meet the qualification requirements and, if applicable, cooperation requirements of the G-BA for the respective clinical picture or service. The service providers demonstrate their qualifications to the responsible state authority; If there is no objection within two months, the service provider is approved for outpatient specialist medical care. Requirements planning is not explicitly carried out.
In the medium term, the National Association of Statutory Health Insurance Physicians, the German Hospital Association and the National Association of Health Insurance Funds are to develop their own fee schedule for the remuneration of outpatient specialist care services. On a transitional basis, the services under the EBM should be remunerated as individual services without any quantity limits at the amounts of the applicable regional Euro fee schedule. Hospitals receive a five percent discount on the EBM remuneration to compensate for the investment support as part of dual financing. As with the currently valid Section 116b SGB V, the services should be billed directly to the health insurance companies, which are also responsible for checking cost-effectiveness and quality. The morbidity-oriented total remuneration of the statutory health insurance associations must be adjusted for the service requirements transferred to outpatient specialist medical care.
Possible effects of Section 116b SGB V (new) on the health system as a whole
With the reorganization of Section 116b SGB V, the Federal Government is reacting to the dynamic performance development made possible by medical progress.
The increase in complex clinical pictures and highly specialized treatment methods in everyday medical care is countered by a provider structure that has evolved over time and which, with the traditional distinction between outpatient and inpatient treatment requirements, is no longer able to provide satisfactory answers to the required treatment structures. The sectoral separation that continues to be practiced in terms of structural policy also turns out to be an anachronism tainted by clientele, which cannot be justified either economically or in terms of supply policy. The focus of the reorganization of §116b SGB V is therefore the political concern to further develop the care structures by overcoming the sectoral boundaries between outpatient and inpatient medical care.
With a high degree of regulatory freedom, including in particular unforeseen expenditure control and the waiver of demand planning that is otherwise traditionally inherent in the healthcare system, the legislature is attempting to implement a new outpatient sector of specialist medical care. However, this approach turns out to be not entirely unproblematic. For example, the trend that has been observed for years that heavily populated regions are characterized by an oversupply of outpatient specialists could be continued by this new healthcare policy approach. On the other hand, there is the problem of undersupply in structurally weak areas, which the Health Care Structure Act is actually intended to eliminate. There are no incentives to counteract this in outpatient specialist medical care.
In any case, the fact remains that better interlinking of the sectors helps to reduce unnecessary hospital admissions, duplicate examinations and avoidable subsequent complications and can thus increase efficiency reserves in the German healthcare system. But it is also a fact that the phenomenon of over-, under- and incorrect care in the German healthcare system demonstrably exists despite years of existing needs planning in the outpatient and inpatient areas, otherwise readjustment within the framework of the Care Structure Act would not be necessary.
The design of the service catalog for specialist medical care is in the hands of the G-BA. However, the scope of services can be expanded at the request of third parties, such as patient advocacy groups. The G-BA's regulatory powers also include the creation of a uniform regulatory framework between the outpatient and inpatient sectors with regard to the necessary quality and qualification requirements.
The actual health policy challenge of the new Section 116b SGB V is therefore less to clarify whether a new outpatient specialist medical care sector is absolutely necessary, but rather whether and how it will be possible to create equal participation requirements for the outpatient and inpatient service sectors.
For this reason and taking this objective into account, the catalog of services specified by the legislature and which is inherently inhomogeneous, ranging from outpatient surgery to the treatment of rare diseases, should be subjected to a further technical review.
In addition, the interaction of the new, largely unregulated sector with the adjacent, established sectors of classic outpatient and inpatient care should be monitored in order to be able to counteract undesirable effects at an early stage.

...on the patients
From the patient's perspective, outpatient specialist medical care offers the opportunity to improve the care situation, especially for rare or difficult illnesses, as the approval of service providers to provide care is made much easier. However, there is a risk that there will continue to be an undersupply of these services in rural regions, or that this may in some cases worsen.
Since there is no limit on the quantity of services, the artificial rationing of services caused by budgets could no longer apply in the future, especially at the end of an accounting quarter. From the patient's perspective, the principle of prohibition offers, on the one hand, the opportunity for faster access to innovations, but on the other hand, it also presents the risk that non-validated procedures will be used. From the patient's perspective, transparency about the range of services appears difficult, as it is currently unclear whether, by whom and in what way information is provided about approved specialist medical care providers and their range of services.

... to resident doctors
The current fee system with the standard service volumes creates difficult conditions for many practicing doctors to be able to offer highly specialized services economically. From the point of view of practicing physicians, the prospective development of a separate fee schedule for these services and the short-term abolition of quantity limits are seen as an opportunity.
The specification of uniform participation requirements and framework conditions for outpatient and inpatient service providers in outpatient specialist medical care is fundamentally positive from the perspective of practicing physicians, even if the current legal formulation does not yet implement this in a consistent manner. The principle of personal service provision is currently not envisaged in hospitals. The possibility of delegating services can result in competitive advantages for hospitals that contradict the basic idea of uniform requirements.
The unregulated access to the new care sector means that the economic protection provided by demand planning for existing practices in this service area is eliminated. This could lead to a higher supply, particularly in metropolitan areas, and thus to an increased competitive situation from the perspective of contract doctors.
From an organizational point of view, the billing of outpatient specialist medical care could be difficult for private practices, as this has to be done bilaterally directly with the individual health insurance companies. Bundling via the regional association of statutory health insurance physicians, for example, would be advantageous here.
The requirement to only adjust the total outpatient remuneration for the services provided by specialist medical care offers potential for conflict. A shortage of resources to ensure basic outpatient care cannot be ruled out. Promoting specialist medical care at the expense of basic outpatient care is therefore not a suitable solution.

... on the hospitals
The new version of Section 116b SGB V makes it easier for hospitals to access selected outpatient services because the previously required state approval requirement will no longer apply in the future. This generally offers hospitals the opportunity to expand their field of activity and thus expand the supply chain beyond purely inpatient care to include further therapy steps. In view of falling bed occupancy, this could be an increasingly important contribution to the profitability of clinics in general and of cost-intensive facilities and large equipment in particular.
This expansion of the field of activity could also be attractive for hospitals in rural areas. These regions in particular are often not covered or not adequately covered by a contractual doctor when it comes to highly specialized services or the care of rare diseases. The introduction of outpatient specialist care could make it easier for hospitals to close these gaps in care.
On the other hand, from the clinics' perspective, there is a risk that further expansion of hospitals into the outpatient sector will exacerbate the conflict with resident doctors. Referring boycotts could be the result - especially in metropolitan areas where several hospitals are in competition. If there are referral criteria for individual service areas of specialist medical care that are defined by practicing doctors, a conflict between hospitals and contracted doctors should be viewed even more critically.

... on the health insurance companies
From the perspective of the health insurance companies, the introduction of outpatient specialist medical care will generally be viewed critically.
The easy access of service providers to the new supply sector could lead to a significant expansion of the range of services - especially in metropolitan areas that are already well supplied. This could result in a significant increase in volumes. This risk is exacerbated by the fact that there are no regulations for budgeting or other quantity control in specialist medical care. Although the health insurance companies are supposed to take over the examination of quality and cost-effectiveness as part of specialist medical care, they ultimately lack effective instruments to counteract an unindicated increase in volume.
Selective contracts, which are also fundamentally possible in the area of outpatient specialist medical care, will hardly be a suitable instrument for controlling volume development. Since selective contracts are voluntary for service providers, the health insurance companies would have to offer significant financial incentives for participation, which would lead to a further increase in the costs of these services.
It is also questionable whether and with what effort double billing for services can be avoided. It is unlikely that services that are assigned to outpatient specialist medical care will be completely omitted from the general catalog of services and will therefore continue to be billed via the statutory health insurance associations. There is therefore a risk that services will be billed both as specialist medical services directly to health insurance companies and as contract medical services via the respective statutory health insurance association. Ultimately, a billing audit is only possible for the health insurance companies, as they are the only ones involved in both billing processes. The new version of § 116b SGB V also leads to organizational challenges for the health insurance companies: If all specialist medical care providers are billed directly to the health insurance companies, the health insurance companies would have to deal with a much larger number of direct billing partners than before. This statement also applies to specialist service providers.

...on the industry
The new provisions of Section 116b SGB V generally result in an indirect impact on industry. The early provision of innovative diagnostic and therapeutic procedures due to the current ban can be seen as a positive effect. This is likely to have a positive effect on the willingness of such specialized institutions to invest, especially in structurally weak and underserved areas. Another positive effect arises from the fact that, to a much greater extent, patients gain direct access to new procedures even without an inpatient stay and thus valid data can be generated directly from outpatient care. However, due to the lack of quantity limits for specialist medical services, industry is also faced with the challenge of not over-steering this new service sector economically and thus accepting uncontrolled increases in quantities. Experience shows that in such cases, political actors have repeatedly demonstrated their willingness to take action, if necessary, to take effective countermeasures at short notice (more on this in the upcoming issue of “Market Access & Health Policy” 01/12).

Positioning the BMC
For the BMC as a pluralistic interest group, market and performance-oriented competition in the healthcare system on the basis of a solidarity-financed healthcare system corresponds to the regulatory objectives. The realization of the efficiency requirement is seen primarily in overcoming the interface problem between outpatient and inpatient care in the long term.
The BMC therefore fundamentally supports the path proposed by health policy to introduce an outpatient specialist medical care sector with a cross-sector care approach. On the one hand, this takes into account the principle of “outpatient before inpatient”. On the other hand, the proposed legal regulation contains good approaches to sustainably promote outpatient specialist medical services and to resolve existing contradictions at the sector boundary. The experience of the last decades has shown that past attempts at reform have led to inconsistencies and thus to frictional losses at the interfaces between the sectors. There is therefore a need for new forms of care that guarantee health care across all care sectors with identical requirements for all qualified service providers. In this context, the establishment and further development of quality and results-oriented remuneration systems is also necessary in order to do more justice to the principle of performance orientation.
Finally, better promotion of interprofessional cooperation can also create a positive incentive to secure human resources. A greater expansion of institutional and personnel connections through expanding contractual options and intersectoral cooperation is essential.
Outpatient specialist medical care can represent an important innovative structural feature in health care in the future. However, it is absolutely necessary to design numerous structural aspects even more precisely in order to implement functional, care-relevant treatment processes while taking economic efficiency into account. <<

out of: BMC position paper on §116 SGB V (new) - Outpatient specialist medical care: