Supreme court case law on structured treatment programs according to Section 137g SGB V

In its judgments of June 21, 2011 (ref.: B 1 KR 14/10 R and B 1 KR 21/10 R), the Federal Social Court (BSG) decided for the first time on the approval of structured treatment programs to be granted by the Federal Insurance Office (BVA). There is no legal definition of the term “structured treatment program”, nor is there a legal definition of the term “disease management program”, abbreviated DMP, which is often used by the BSG and has the same content.

>> From the multitude of definitions, Lauterbach's (2001: 23) should be quoted here.
“Disease management is a systematic, cross-sectoral and population-based approach to promote continuous, evidence-based care for patients with chronic diseases across all disease stages and aspects of care. The process includes continuous evaluations of medical, economic and psychosocial parameters as well as the resulting continuous improvement of the care process at all levels.”

The following can be found in the justification for Section 137f of the Social Code, Fifth Book - SGB V (Bundestag printed matter 14/6432, page 11):
“Disease management is a form of medical care that can, among other things, improve the prevention and treatment of an illness and reduce the impairments caused by this illness. This is also linked to the goal of using the available resources as effectively as possible in the interests of high-quality medical care with an appropriate cost-benefit ratio. DMP requires binding and coordinated treatment and care processes across disease processes and institutional boundaries, which are determined on the basis of medical evidence.”
The legal proceedings
Both lawsuits concerned the approval of structured treatment programs for the indication of breast cancer.
The BVA set the date for approval of a structured treatment program for the care of breast cancer patients in two regions (Bavaria and Schleswig-Holstein) later than the health insurance companies had requested.
The background was the so-called sentinel lymph node problem: since July 1, 2002, the requirements for the approval of structured treatment programs for breast cancer were in the Risk Structure Compensation Ordinance (RSAV), the legal regulation relevant for the approval of DMP, in section 1.4.3.6 of the appendix 3 determines:
“Axillary dissection should be performed in all patients with invasive, operable breast cancer. A total of at least ten lymph nodes (LNs) from levels I and II should be removed and examined. Level III lymph nodes should only be removed if there is clinical involvement of this level. Axillary lymphadenectomy can be dispensed with for microinvasive carcinomas (≤ 2 mm), for tubular carcinomas that are smaller than 1 cm and for DCIS that has extirpated in a healthy person.

Only the version of the RSAV that came into force on February 1, 2006 provided for a sentinel LN biopsy as an alternative. The sentinel (“sentinel”) LN biopsy is based on the assumption that sentinel lymph nodes provide particular information about metastases in axillary lymph nodes and that if the result is negative, the removal of the lymph nodes from the armpit can be dispensed with. If sentinel lymph nodes are not found to be tumor-involved during an examination, there should be no need to remove further lymph nodes.
In both procedures, the health insurance companies had concluded contracts to carry out a DMP breast cancer with the respective hospital company in the state and with the respective association of statutory health insurance physicians. The contracts were then submitted to the BVA with the application for approval of the DMP. In particular, in the hospital contracts, an appendix as part of quality assurance when describing the indicators stated: “As many treatment cases as possible with the removal of at least ten LNs in the event of axillary dissection for all invasive carcinomas (except patients in studies on sentinel LN biopsy).”
The BVA took the legal view that the DMPs should only be approved with effect from the point in time since the addition regarding exceptions for sentinel LN biopsy was removed “in the concluded contracts”. With their lawsuit, the health insurance companies sought approval from an earlier date, namely from 2004, or alternatively from February 1, 2005. While the lawsuit in Bavaria was unsuccessful in the first two instances, the Kiel Social Court granted the lawsuit in full Scope and sentenced the BVA to approve the DMP from July 1, 2004. The State Social Court changed the judgment and limited the approval with the following argument: Since the DMP was approved without the addition contained in the contracts regarding the exception of patients in studies in which Sentinel LN biopsy was used, should have been approved, approval could have been granted with a corresponding condition from July 1, 2004. The BSG changed or overturned these judgments in the appeal and also dismissed the lawsuit in this legal dispute.
The judgments of the BSG
From the perspective of the BSG, the contracts concluded to carry out the DMP Breast Cancer did not initially fully meet the requirements stated in the RSAV.
The contract originally concluded to carry out the DMP Breast Cancer contradicted the requirements of Section 28b Paragraph 1 Sentence 2 RSAV. In all versions applicable since 2004, this regulation expressly stipulates, among other things, that the requirements in Section 1 of Appendix 3 to the RSAV must be observed for the approval of a DMP. The quality assurance requirements in the contracts concluded to implement the DMP therefore also had to be RSAV-compliant. This was missing in the present case, because the above-quoted number 1.4.3.6 (surgical treatment of the axilla) of Appendix 3 in the version of the 4th RSA-Amendment Ordinance did not contain an exception to the removal of at least 10 lymph nodes for patients in studies on sentinel LN. Biopsy.
The doctrine of the seven
Admission requirements
The requirement that the concluded DMP contracts meet the requirements stated in the RSAV is one of seven admission requirements for the BSG, listed as the sixth of seven in the list of reasons for the judgment. Cumulatively, the following seven admission requirements must be met:
1. An admissible application must have been submitted.
2. The application must refer to a program in accordance with Section 137f Paragraph 1 SGB V (DMP).
3. The DMP specified in the application must have met the requirements specified in the RSAV (legal ordinance according to Section 266 Para. 7 SGB V).
4. The designated DMP must make it clear which contracts must be concluded for its implementation.
5. The contracts necessary for the implementation of the designated program must have been concluded.
6. These concluded contracts must have met the requirements stated in the RSAV.
7. The RSAV must have come into force.

With regard to the DMP, this new “doctrine of the seven admission requirements” shows a parallelism with another admission procedure that may be much better known to the population. It is the approval of the motor vehicle (motor vehicle) scrappage bonus of 2,500 euros, which was paid when an old vehicle was scrapped and a new vehicle was purchased and registered. The purchaser of the new vehicle was eligible to apply. The adopted regulation also stipulated seven (was changed to: eight on March 11, 2009) requirements for application approval for the application to the Federal Office of Economics and Export Control.
As part of the seven admission requirements that have now been set for the DMP for the first time, the BSG (in the judgment no. B 1 KR 14/10 para. 22 with reference to the judgment no. B 1 KR 21/10 R) penetrates the requirements for the Approval of the DMP relevant legal situation up to the use of provisions of the Civil Code (BGB). This becomes particularly clear when the BSG states:
“For the effectiveness of a contract concluded between several contractual partners, the declaration of acceptance by the last contractual partner is fundamentally important (cf. accordingly § 145, 147 BGB). Nothing different applies to a contract under public law between those present, such as here, in which the contractual partners have regard to the written form requirement (§ 56 SGB X) in conjunction with
§ 126 Para. 2 Sentence 1 BGB) successively submit their consistent declarations of intent on a uniform document.”
With regard to future necessary adjustments of DMP contracts to the RSAV or to guidelines of the Federal Joint Committee (G-BA), which may be required instead of the RSAV after the GKV Care Structure Act (GKV-VStG) comes into force on January 1, 2012. Regulations apply, the health insurance companies must have concluded DMP contracts in accordance with these regulations in a timely manner. In other words: There is no DMP without a (legally compliant) contract.
Since, with regard to the time of conclusion of the contract, the decisive factor is when the last contractual partner signed the contract, the aforementioned finding “no contract, no DMP” can be expressed even more clearly in the words: “Without the signature of all contractual partners, there is no DMP “.
The condition:
“concluded contracts”
In addition, the BSG states that contracts for the implementation of DMP cannot come into force retroactively. The contracts must already be “closed”, as required by Section 137g Paragraph 1 Sentence 1 SGB V.
The legislature consciously met this requirement. It was not yet provided for in Article 1 No. 1 of the draft law to reform the risk structure equalization in statutory health insurance of the SPD and Alliance 90/THE GREENS factions (see Bundestag printed matter 14/6432). It was only the Committee on Health (14th Committee) that decided to expand the scope of the Federal Insurance Office's audit to include the contracts “concluded” to implement the programs (see Bundestag printed matter 14/7355, page 6).
The legislature has clearly placed the responsibility for the compatibility of the contracts to be concluded in the hands of the contractual partners, ie the health insurance companies and service providers. It is therefore their job and not the job of the licensing authority to revise the contracts in accordance with the law if necessary. This is the only way to ensure that the contractual contents and thus the legal requirements of the RSAV are subsequently “lived” as a supply reality.
This view is only logical given the fact that the health insurance companies benefit financially from DMP, since they were included in the risk structure equalization (RSA) when they were introduced and result in an advantage for those health insurance companies that can persuade many chronically ill insured people to enroll in a DMP . At the point in time relevant to the decision, before the introduction of the health fund and the further developed morbidity-oriented RSA, the RSA financial effectiveness of DMP in the RSA resulted from Section 266 Paragraph 4 Sentence 2 SGB V, Section 267 Paragraph 2 Sentence 4 SGB V, Section 2 Paragraph 1 Sentence 3, 4 and 7, Paragraph 2, Sentence 4 RSAV and Section 4 Paragraph 1 Sentence 1 No. 11 RSAV old version
Designing the approval of the DMP as a bound decision by the authorities, which is preceded by an examination of the legal conformity of the respective DMP, therefore also serves to ensure legal certainty in view of the not insignificant financial effects of an approval and the time of approval. This still applies today with regard to the flat rate program costs.
From the perspective of the BSG, there are no disadvantages for the health insurance companies due to the requirement that the contracts must be “closed”. The health insurance companies have the opportunity to have the BVA confirm in advance that their DMP complies with the requirements regulated in the RSAV (and/or soon in the G-BA guidelines) before they enter into contractual negotiations with the service providers on this basis occur (see Bundestag printed paper 14/7395, page 6). However, it remains unclear why the BSG even weighs up interests so that there are no disadvantages for the health insurance companies.
It remains to be seen whether health insurance companies will make greater use of the option of a so-called preliminary check in the future because of this advice from the BSG. In an initial analysis of the judgments (Padé 2011), the conclusion is drawn that when concluding DMP contracts after this decision, the health insurance companies have an interest in “orienting themselves as faithfully as possible to Section 28b ff. RSAV and the appendix thereto “in order to minimize the risk that your contracts are not taken into account in the risk structure adjustment”. Apart from the fact that DMPs were only taken into account in the risk structure equalization according to the previous, now outdated legal situation (according to the current legal situation, the health insurance companies are only entitled to the so-called program cost allowance), health insurance companies still have an economic interest in the DMPs they have concluded -Contracts are eligible for approval and you gain knowledge of this at an early stage.
The all-or-nothing principle as an obstacle to partial approval
Finally, in both judgments, the Federal Social Court declared partial approval of a structured treatment program to be inadmissible and justified this as follows:
Partial approval cannot be derived from the possibility of subjecting the approval to requirements and conditions (Section 137g Paragraph 1 Sentence 4 SGB V or, after the GKV-VStG comes into force, Section 137g Paragraph 1 Sentence 3 SGB V). A suspensive condition that the concluded contracts meet the requirements of the RSAV due to precisely specified changes only has a control effect for the future, but does not help for the past.

An approval under the condition that the concluded contracts are adapted to the requirements of the RSAV within a certain period of time contradicts the requirements set out in Section 137g Paragraph 1 Sentence 1 SGB V. DMP approvals are permanent administrative acts which - according to the BSG - can be divided over time be. It is not necessary to decide here whether this explanation in the reasons for the judgment is correct, even if the BSG justified this with reference to the fact that the time limit on admission is no longer possible (§ 137g para. 1 sentence 3 SGB V, which was introduced as a result of the entry into force of the GKV-VStG has been deleted due to the general limitation of the DMP approvals).
In any case, it is not legally possible to grant objective partial approval of a DMP with regard to closed parts of the contract. Section 137g Paragraph 1 Sentence 1 SGB V, which is relevant for the substantive law, requires that the contracts concluded for the implementation of DMP overall meet the approval requirements for the approval of DMP. In this respect, the BSG postulates an all-or-nothing principle. Therefore, there was no possibility of partial approval of the DMP breast cancer only for patients who were not treated after sentinel LN biopsy. A relaxation of this all-or-nothing principle would in fact have resulted in the “complicated interpretations of the concluded contracts” mentioned by the BSG.
No fictitious approval or: exclusion of breaching the DMP system
Going even further (Padé 2011), it is pointed out that it would probably contradict the purpose of a structured treatment program to only allow parts and thus risk breaking the structure (more likely the DMP system). Finally, the plaintiff health insurance company cannot demand that it be determined that it has a fictitious license. The health insurance company wanted to derive this fictitious approval from the fact that the Federal Insurance Office had not decided on their application in a timely manner.
The BSG also rejects this argument. The acceptance of fictions for admission requires a corresponding regulation such as in Section 135 Paragraph 1 Sentence 5 SGB V. That's what's missing here.
DMP as an open and adaptive system
Overall, the BSG confirms the administrative practice of the BVA as a licensing authority. For example, in the past the BVA also considered partial approval of a DMP to be inadmissible in other cases. Therefore, there is no DMP CHD without pensioners, no DMP Asthma without children. As stated in the BSG rulings on the DMP breast cancer, a restriction on the group of people eligible to take part in a DMP with the legal consequence of partial approval is inadmissible. This in turn could be summarized in the words: DMP as an open and adaptive system.
The respective DMP is open to all eligible chronically ill people who would like to take part voluntarily. In this respect, the circle to the definition of DMP quoted at the beginning closes here. The DMP serve to improve the care of chronically ill people. In order to enable the health insurance companies to control DMP within the framework of the legal requirements, for example to support the insured, the contracts concluded must ensure the effective operation of the DMP. Only when the contracts concluded by the health insurance companies guarantee this does a DMP receive the “TÜV seal” from the BVA.
The improvement in health care for the chronically ill that the legislature is aiming for with the introduction of the DMP requires the existence and binding validity of scientifically proven, evidence-based guidelines and treatment concepts. The contracts concluded for implementation must also take this into account. If the evidence changes later - as in the case of the sentinel LN biopsy - the treatment concepts will be adjusted and then the corresponding DMP contracts within a year. DMPs are also a learning system.
Conclusion
Although sometimes declared dead, structured treatment programs have now found their place in the German healthcare system. In 2011, even foreign delegations that were working on transforming the DMP system into their healthcare system were interested in DMP. But first in Germany it will be a question of how the DMP will continue to prove itself after the GKV-VStG comes into force. The BSG rulings have created legal certainty on some questions regarding the approval of DMPs, but not on all of them - especially not in view of the constant demand for further de-bureaucratization of DMPs. It remains to be seen whether the doctrine of the seven admission requirements postulated by the BSG sets new practical testing standards with regard to the approval of the DMP.
For example, the BSG left open what is meant by the admission requirement of the “permissible” application for approval of a DMP. Even if the admissibility of the applications was not problematic in the cases before the BSG, the BSG felt compelled to clarify this. This means that cases of inadmissibility of DMP authorization applications are conceivable. However, an independent admissibility check as part of the approval process must not lead to additional bureaucratic effort in the approval of the DMP. Ultimately, the content of the respective DMP is decisive for the approval of the DMP, as the BSG impressively established for all DMPs beyond the individual cases using the example of the inclusion of the sentinel LN biopsy in a DMP breast cancer. <<