A systematic approach to billing laboratory services – the legal framework: Supplement and update to the article in J Lab Med 2014; 38(4):179–205

1.1 Changes in legal framework

The new version of Section 116b SGB V^[4] created the services sector under ASV, where in addition to the hospitals that had already been eligible under the former Section 116b SGB V, service providers were now also eligible to participate in panel-doctor-based medical care, that is, panel doctors, medical care centers (MVZ), authorized physicians and facilities. ASV comprises, in accordance with Section 116b para. 1 SGB V, the diagnosis and treatment of complex, difficult-to-treat diseases that require special qualifications, interdisciplinary collaboration and special equipment depending on the disease. More detailed regulations on ASV can be found – as provided for in Section 116b paragraph 4 SGB V – in the directive of the Federal Joint Committee on outpatient specialist care according to Section 116b SGB V^[5] (“ASV Directive”), whose schedules specify the diseases covered by ASV and define the scope of treatment. To date, four of these schedules have been adopted: on tuberculosis,^[6] on gastrointestinal tumors,^[7] on gynecological tumors^[8] and on Marfan’s syndrome.^[9] Other schedules – for example, concerning rheumatism and heart failure – will follow.

To date, numerous hospitals still have privileges for outpatient treatment according to Section 116b SGB V (old version) based on a state provision in accordance with Section 116b para. 2 SGB V (old version). The new Section 116b para. 8 SGB V provides that those provisions of the federal state will continue to be valid until their repeal by the state. This repeal must occur no later than 2 years after entry into force of the directive resolution of the Joint Federal Committee regarding the respective disease. For ASV in connection with tuberculosis, for example, the state provisions will therefore have to be repealed by 23.04.2016, but may be repealed sooner as well. For hospitals providing outpatient care under the former regulations, this now raises the question whether they will be able to participate in ASV and meet the legal requirements in the future.

1.2 Requirements for participation in ASV

The ASV-eligible parties defined in Section 2 para. 1 of the ASV Directive (service providers that are part of panel doctor care and hospitals licensed under Section 108 SGB V) can participate in ASV if and where they meet the personnel, material and organizational requirements for the individual diseases under the ASV Directive and the respective directive resolutions. The key requirements are presented below.

1.3 Relevance of changes in law to the laboratory

In view of the changed legal framework, it is not only the hospitals (still) authorized under the former Section 116b SGB V that must decide whether and, if so, how and with what cooperation partners they can meet the requirements for future ASV participation. Laboratories, too, are faced with the decision as to whether they want to participate in ASV and how they can go about ensuring the applicable requirements. As Table 1 shows, for them, depending on the respective schedule of the ASV Directive, it is possible to participate as part of the core team or as a consulting physician. To regulate and prove cooperation to the state committee, cooperation agreements must be entered into that should reflect the content of services as well as the cooperation arrangement (regarding place of activity, billing, etc.). As for the place of performance, it should be noted that members of the core team must generally perform specialist medical services at the place of activity of the team management or at specific times at least 1 day a week at the place of activity of the team management. Only services tied to non-portable equipment as well as the preparation and examination of sample material taken from patients are excluded in this context. However, the place of performance for services to be performed directly on patients must be at an appropriate distance (as a rule, 30 min) from the place of activity of the team management – both for core team members and consulting physicians (Section 3 para. 2 sentence 4 et seq. ASV Directive).

1.4 Referral and settlement of services under ASV

Rules regarding referrals in the ASV context are specified, in particular, in Section 2 para. 4 and Section 8 ASV Directive. According to Section 2 para. 4 sentence 1 ASV Directive, there is no referral requirement between members of the core team. Consulting physicians perform their services, according to Section 2 para. 4 sentence 1 ASV Directive, in line with the respective treatment scope on referral (definition or indication order). All other details on the referral of laboratory services in connection with ASV are shown in Table 1. A distinction must be made, however, between the core team pursuant to Section 3 para. 2 sentence 2 ASV Directive and the interdisciplinary ASV team (consisting of team management, core team and consulting physicians).

The services under ASV will be reimbursed directly by the health insurance under Section 116b para. 6 sentence 1 SGB V. Panel doctors, however, may instruct the statutory health insurance association to handle the billing of these services against reimbursement of expenses. Until a separate billing system has been introduced under Section 116b para. 6 SGB V, billing will have to be done on the basis of the uniform rating scale^[14] (EBM). Services and examinations allowed in the ASV context, but not implemented in EBM, can be identified by pseudo codes (uniform across the country) and submitted for billing until such time as they have been incorporated into EBM (chapter 50).^[15] Because there are no corresponding EBM codes, service codes from the fee schedule for physicians (“GOÄ”) are applied in this exception. The services must be indicated in the ASV invoice and identified by the ASV team number. The GOÄ codes used as pseudo codes are entered in the IT system in the field “Non-Personnel Expenses Designation” (field ID 5011), and the prices in the field “Material Costs in Cents” (field ID 5012). Payment is made according to fees set for ASV under GOÄ (laboratory: factor 1.0). Excluded from the provision are ASV services that are also included in the oncology agreement.^[16] Until they are included in EBM, they will be reimbursed according to the regional flat rates as per Schedule 2 of the oncology agreement.

Section 2 para. 1 sentence 3 ASV Directive provides that each service provider (no matter whether as team leader, core team member or consulting physician) remains ASV eligible and performs his/her ASV services independently within the context of the cooperation, which is why invoices to the health insurance or via instructions to the respective statutory health insurance association must also be settled separately by each ASV-eligible provider. There is no internal compensation and/or settlement between ASV cooperation partners.

One exception is the settlement of laboratory services that hospitals with an ASV authorization under Section 116b SGB V (old version) request from the lab. As before, and as illustrated in our review article, the lab must settle these services with the hospital. As soon as the provisions of hospitals under Section 116b SGB V (old version) have been repealed by the states, this settlement approach will be abandoned, and only the aforementioned ASV provisions will apply.

2.1 Differentiation of general conditions

Our article has given various examples of the billing and settlement of laboratory tests in connection with services subject to a complex of services codes and/or service complexes in general.^[17] Apart from the general conditions already described there, we believe a further differentiation of the key service complexes in the area of statutory health insurance (GKV) is necessary, as is a compilation of the information that should be as definitive as possible.

Generally, doctors are reimbursed a flat fee for a services complex, with which all individual services contained in the complex service code are compensated. This means that these individual services cannot be billed and settled again outside the settlement via complex service codes. Consequently, the doctor who bills the complex service code must reimburse the laboratory for services that he/she does not perform or cannot perform and therefore orders these services from the lab. Such services complexes in connection with laboratory services are found in the context of so-called selective agreements, but also, indirectly, in EBM – often they are not apparent as such at first sight.

Since the laboratory, which only acts upon a referral, cannot know itself whether the lab services ordered concern such services complexes, making sure that the consulting physician orders the services correctly is key. Unfortunately, the general conditions for such compensation by complex service codes change at irregular intervals, particularly for selective agreements. What is more, this also affects primarily groups of physicians that order lab tests. Therefore, the following examples can only describe the basic system, but do not relieve the requesting doctor – as part of his/her request, which is always indication-based – of the regular need to ask whether and, if so, when lab services are already included in the services complex to be performed and billed by him/her.

2.2 Compensation by service codes for selective agreements

Probably the most prominent example of selective agreements may be the medical care centered on family physicians (“HzV”) under Section 73b SGB V. The family physician participating in such a selective agreement is paid for each patient registered under such agreement a flat fee, with which he/she must cover the various services. The services contained in the flat fee and thus paid are listed in the respective “range of codes” attached to the selective agreement. Among other things, these include laboratory services that the doctor can perform in his/her own practice (services under Section MI GOÄ) or procure from a private group laboratory (services under Section MII GOÄ) and/or from a specialist laboratory (services under Sections MIII and MIV GOÄ). If the doctor performs lab services himself/herself, or procures them from a private group laboratory, he/she will have to cover the costs incurred with the flat fee under the selective agreement.

Since the “ranges of codes” of selective agreements contain some services that are classified as basic laboratory services in EBM under chapter 32.2, while in GOÄ they are deemed specialist lab services under Section MIII, this oftentimes creates the problem that these services cannot be procured from a panel-doctor or a private group laboratory. This is so because a panel-doctor group lab requires direct billing to the health insurance (KV) and because a separate settlement at the expense of KV that exceeds the flat fee is not allowed under HzV agreements, while a private group lab can only perform services under Section MII GOÄ. As a result, these services can only be referred to a specialist lab as a specialist lab service under Section MIII GOÄ; that lab, then, bills the doctor.^[18]

Overall, the number of existing selective agreements that also include laboratory services – even if one were to limit oneself only to HvZ agreements – is already quite extensive. In light of this, we have compiled an exemplary list of lab services in Table 2, which are part of the (German public health insurance company) AOK family physician contracts in force as of March 2015.

The differences in the AOK ranges of codes show that each selective agreement must be checked for lab services included and their proper requisitioning in order to avoid subsequent recourses or reclaims in connection with the settlement of remuneration under collective agreements.

2.3 Compensation by service codes under EBM

There are also various service complexes in EBM. These include lab services for

• Nephrology (dialysis);

• Reproductive medicine (in-vitro fertilization, IVF);

• Gastroenterology (colonoscopy);

• Obstetrics (maternity guidelines);

• Preoperative care;

• Cardiac catheter examination.

The lab tests contained in these service complexes are summarized in Tables 3A–F. Based on the assignment in the respective EBM service legend, the following distinctions are made there:

• Mandatory => these services must have been performed;

• Optional => these services may be performed, but are then paid;

• Billing exclusion => these services are not reimbursable in conjunction with the complex code or service complex;

• Mentioned in the Federal Joint Committee directive.

Here, too, and for any further EBM service complexes, attention must be paid to the correct requisitioning by the treating, ordering physician as well as the correct billing to the requester by the commissioned lab performing the services.

4.1 Laboratory as an operational unit of the hospital

If the laboratory is an integral part of the hospital’s operations, the lab services must be settled by the hospital directly with the competent panel doctors’ association in a manner previously agreed between the hospital and the association.

4.2 Laboratory as an outsourced external operation without separate license

If the laboratory is an external operation outsourced from the hospital that does not have its own license for panel-doctor care, the hospital will be billed by the laboratory performing the services for lab services requested via a hospital-specific order form. The hospital then usually settles the services with the panel doctors’ association in accordance with a method previously agreed between the hospital and the association.

4.3 Laboratory as an outsourced external operation with separate license

If the laboratory is an external operation outsourced from the hospital that has its own license for panel-doctor care (e.g. MVZ with panel-doctor license), the laboratory will settle lab services directly with the competent panel doctors’ association following a referral by the emergency room on the basis of the Model 10 form.

Since basic lab services are often performed by the hospital’s own, on-site laboratory, while specialist lab services are procured from an external specialist laboratory, such cases create mixed constellations that fall in between the billing options described.

4.4 Scope of billable emergency services

Regarding the question of the billable scope of emergency services, the Federal Social Court decided on 12.12.2012 (Ref.: B 6 KA 5/12 R) that lab tests on blood alcohol content and on C-reactive protein are not generally part of emergency services, because they usually are not medically indicated or useful in primary care.

In light of this, and from the perspective of emergency rooms and/or hospitals, it might be useful to clarify with the competent panel doctors’ association the services that can be settled as part of emergency care, and to what extent.