List of abbreviations:
BAG, Professional association; BMV-Ärzte, Federal master agreement with doctors; BSNR, Establishment number; DKG-NT, German Hospital Federation – Regular rate; EBM, Statutory uniform rating scale; GKV, Statutory health insurance; GOÄ, Physician Fee Schedule; GOP, Fee schedule item (according to EBM); HzV, Family physician-centered care; IgeL, Individual health services; ITS, Intensive care unit; IVF, In-vitro fertilization; KHEntG, Hospital Remuneration Act; KV, Association of Statutory Health Insurance Physicians; LANR, Lifetime physician number; LG, Laboratory center; MBO-Ärzte, Model Professional Code for doctors; MVZ, Medical care center; PKV, Private health insurance; POCT, Point-of-care testing; RiliBÄK, Guidelines of the German Medical Association; SGB, Social Code; ÜBAG, Pan-regional professional association; UstG, Sales Tax Act; UV, Accident insurance; VAG, Insurance Supervision Act; VVG, Insurance Contract Act; ZA, Admissions committee for doctors.
Introduction and preliminary observations
With the decision of the German Federal Court on 25.01.2012 (File no.: 1 StR 45/11), a review was launched in many places of all billing channels that had thus far been established for laboratories. In the aforementioned decision, the Federal Court confirmed the criminal offense of commercial fraud under Section 263 StGB (German Penal Code) in a case that involved a doctor who billed patients for non-delegatable special laboratory services under MIII and MIV of the Doctors’ Fee Schedule1 (hereinafter: “GOÄ”) as his own services, even though he had obtained those services from a specialist laboratory. Furthermore, he had billed patients a higher GOÄ rate than he himself paid to the specialist laboratory.
However, the general review of laboratory services billing that followed the decision did not only concern services under GOÄ. Billing for outpatient services by panel doctors under the uniform rating scale2 (hereinafter: “EBM”) and the billing for laboratory orders from clinics were also reviewed critically.
In the following, the legal framework conditions for the billing of services will be summarized, working out a systematic approach to allow for an overview of the applicable billing rules without comprehensive study of the relevant legislation, regulations and directives. Of course, reference to the respective legal standards will be made at the crucial points. The framework conditions described do not only apply to laboratory medicine, but by and large also to molecular genetics and cytogenetics (human genetics) as well as pathological-cytological laboratory diagnostic testing.
In general, the following explanations only pertain to medical laboratory, human genetic or pathology services that are rendered under all relevant conditions and requirements. For the purposes of this paper, we do not consider laboratory services provided without medical direction and medical diagnosis.
The term “laboratory”, or “lab”, is used to enhance the readability of the text, and refers to medical service providers (e.g., specialist doctors of laboratory medicine, microbiology, human genetics or pathology), who can be organized in a wide range of constellations.
Furthermore, the framework conditions described apply only to services and billing in the Federal Republic of Germany. Cross-border provision of services is not covered by this paper.
1.1 Requirements for the provision and billing of laboratory services
1.1.1 Outpatient care by panel doctors
In order to provide laboratory services and bill for them under EBM in connection with outpatient care by panel doctors for patients with statutory insurance, the laboratory and the doctors working there must be qualified (licensed) by a decision of the admissions committee for doctors (ZA) [Section 95(1) of the German Social Code V3 (hereinafter: “SGB V”)]. Most medical laboratories are by now probably organized as medical care centers (MVZ) under Section 95 SGB V, but other forms are still possible (e.g., group practice = professional association).
1.1.2 Outpatient care by private doctors
However, when it comes to providing and billing for laboratory services in the field of outpatient care for privately insured patients within the scope of GOÄ, requirements must also be met that must be ensured via the qualification of medical laboratory staff pursuant to the specialist training organization (designation of field or certificate of specialized knowledge). Since the vast majority of laboratory services are provided for patients with statutory insurance, and the doctor employed at the laboratory has to meet the relevant requirements for approval of his/her employment anyway [approval and successful completion of specialist training or corresponding qualification under Sections 95(1) and (2), 95a SGB V], the requirements for private doctors are usually met “automatically”.
1.2 Special organizational forms
1.2.1 (Pan-)Regional professional association
A licensed laboratory may be organized as a local professional association (BAG) at a shared registered office of a panel doctor under Section 33(2) Sent. 1 of the Licensing Regulation for Panel Doctors4 (hereinafter: “Ärzte-ZV”). But it is also possible for several established doctors or laboratory-medical care centers to make up pan-regional professional associations (ÜBAG) with several registered panel doctor offices in accordance with Section 33(2), Sent. 2 Ärzte-ZV. The “mixed” combination of doctors and medical care centers must be examined on a case-by-case basis, because the respective applicable professional law may be opposed to it [e.g., Section 18(2a) of the Medical Professional Code of Conduct of Bavaria5 (hereinafter: “BO-Ärzte Bayern”)]. The advantage of such a pan-regional professional association is that doctors at different laboratories can trade places and also work at the other registered panel doctor offices of the ÜBAG. However, this is permitted only to a limited extent in terms of time, and must not jeopardize compliance with the obligation of service of the respective member at his/her panel office, also taking into consideration the involvement of the other doctors employed [Section 33(2), Sent. 2 Ärzte-ZV]. ÜBAGs have a main office (e.g., the registered panel doctor office of one of the member medical care centers) and one or several subsidiary offices (the registered panel doctors’ offices of the other members). Application for approval must be filed with the admissions committee under Section 33(3), Sent. 1 Ärzte-ZV.
1.2.2 Branch office
A laboratory licensed by the ZA may open a branch office with the prior consent of the ZA. The advantage here is that services can be rendered at a location other than the main office of the laboratory. However, this requires, under Section 24(3) Ärzte-ZV, that patient care is improved at the branch office and that the proper care of the insured at the registered panel doctor office is not impaired. This is determined by, among other things, a needs survey of the ZA among the local laboratories.
1.2.3 External premises
Under 24(5) Ärzte-ZV, there is also the option of using external premises. After notifying the Association of Statutory Health Insurance Physicians (KV), such external premises allow for special testing and treatment services to be performed and billed. However, this is subject to the condition that there must not be any service duplication [i.e., performance/billing of the same fee schedule items (hereinafter: “GOP”)] with the main office.6 Furthermore, such premises must not be used for seeing patients for the first time, and may be no further from the main office than 30 min by car. In addition, according to the rulings of numerous admissions committees, only services in specializations may be rendered at such premises that the main office has been licensed for.
1.2.4 Laboratory center (LG)
Apart from the above organizational structures, a common form is that of laboratory centers (under public and/or private health insurance). According to the definition contained in the Federal Master Agreement for Doctors7 (hereinafter: “BMV-Ärzte”), a (panel) laboratory center is a shared facility of panel doctors for the purpose of performing medical laboratory services regularly at the same shared establishment (Section 25 BMV-Ärzte). In this way, premises, equipment, etc., can be shared in a meaningful and cost-saving manner. Thus, a laboratory center is a special form of a group practice, which is characterized by the shared use of practice rooms, equipment, etc., among several doctors. In terms of professional law, the group practice represents a shared administration pursuant to Section 18 of the Model Professional Code for Doctors in Germany8 (hereinafter: “MBO-Ärzte”). Only doctors with their own practices who require laboratory services can participate.
A laboratory center of panel doctors provides services according to chapter 32.2 EBM, while a center of private doctors provides services under MII of the GOÄ. There are also “mixed” laboratory centers that perform both panel and private medical services.
Upon application, usually accompanied by a laboratory center agreement (articles of association), a laboratory center may be given an establishment number by the KV. This number must be used for submitting quarterly billing, and is also used for the purposes of quarterly billing assessment notices. A special qualification of the requesting doctor who obtains basic laboratory services from a laboratory center and thus renders these services himself/herself – under Section 25(3) BMV-Ärzte9 and/or Section 4(2), Sent. 2 GOÄ, “delegatable” services – is not required. However, the doctor in question must be a member of the laboratory center. The above statutory provisions also require that the laboratory center be managed by a physician (but not necessarily a laboratory physician). The costs of a laboratory center of panel doctors will be reimbursed by the KV up to the simple EBM rate; proof of costs must be furnished.10
A laboratory center, as a shared facility of the (panel) doctors involved, may be distributed across several locations as part of the shared facility. Thus, the laboratory center is operated at several locations that, taken together, constitute one single establishment. Each site, however, must have a physician present. The services performed by the laboratory center and/or its sites must be identified by the establishment number of the laboratory center and the establishment number of the receiving laboratory center member.
In the private sector, doctors may obtain basic laboratory services from a laboratory center under MII of the GOÄ, and may bill them directly to patients as tests [deemed to have been performed by the doctors themselves; pursuant to Section 4(2) GOÄ]. This option is excluded for special laboratory services.
1.2.5 Hospital laboratory
Hospital laboratories can perform laboratory tests not only for inpatients, but also for outpatient care (public system) of outpatient clinics and local physicians. For billing services to the KV, the hospital laboratory, regardless of its operator, must also be authorized accordingly11 and have a KV establishment number assigned by the ZA.
Billing in the outpatient and inpatient private sector is tied to the medical director of the hospital laboratory and his/her qualification (see 1.1.2 and 1.4).
1.3 Employment and billing approval in public outpatient care; principles of representation in case of absence
Every specialist doctor employed by a licensed laboratory who participates in the performance and billing of laboratory services must also be approved by a decision of the admissions committee and/or by way of an employment approval. For this purpose, the licensed laboratory (MVZ) and the doctor in question must file an application. Proof must be provided of the doctor’s qualification (specialist in laboratory medicine, microbiology, etc.).
In order to bill for the specialist laboratory services provided (chapter 32.3 EBM), the employment approval alone will not be enough. For each specialist doctor employed, an application for billing approval must also be filed with the respective KV [cf. preliminary remarks EBM chapter 32.3, No. 2 and Section 135(2) SGB V]. Only once the billing approval has been issued, which defines precisely the EBM GOPs that the specialist may bill for, is the doctor allowed to bill for his/her services. An overview of the services to be approved is summarized in Table 1.
What is more, to ensure billing capability in the case of the licensed panel doctor’s absence, his/her representation must be regulated as well. In summary, the applicable principles of representation under Section 32 Ärzte-ZV are as follows:
In case of illness, vacation, participation in professional development, participation in military exercises or childbirth, the doctor can be replaced for a period of up to 3 months within 12 months.
If the absence is for more than a week, the KV should be notified. On the respective form of the competent KV, in the field set aside for naming a replacement, one can merely refer to the other doctors that share the absent doctor’s specialization and who are employed at the MVZ. Naming a specific replacement is not required in this case. The procedure in the various KV districts must be clarified with the competent KV staff on a case-by-case basis.
The activities of the replacement will be credited to the doctor being represented as his/her own service, also in terms of billing. The services of the replacement must therefore be billed using the LANR of the doctor represented.
The doctor represented and the replacement must be from the same specialization, or at least a similar and related specialization. In other words, the replacement must be able, and allowed, to perform the specialist services of the doctor represented. If services require special qualifications for the doctor, they may be performed by the replacement only if he/she also has the necessary qualifications.
1.4 Billing requirements in private medical care
In the private medical sector, the laboratory must be managed by a (specialist) physician with the proper qualifications, who then bills for the services rendered according to the GOÄ. With respect to such billing, Section 4(2), Sent. 1 GOÄ requires that the doctor perform the medical services himself/herself or that they be performed under his/her expert supervision and instructions. In light of changing rules for professional development, it is important to arrive at a standard interpretation of these requirements, and particularly of the concept of “specialist instructions”. As a result, the Board of the German Medical Association adopted the following interpretation in February 1996:
“All doctors who have thus far provided laboratory services under MIII/MIV in their own laboratories (the mere membership in a laboratory center is not deemed compliance with this requirement) can continue to perform and bill for these services — provided they are not extraneous to the doctors’ areas of specialization — on the basis of their approval (without professional development) or their professional development even after entry into force of the (Model) Professional Development Regulation of 1992 (grandfathering), provided they also meet the further statutory requirements under Section 4(2), Sent. 1 GOÄ. Accordingly, they can also issue specialist instructions. In future, doctors who complete their professional development according to the (Model) Professional Development Regulation of 1992 will have to provide a certificate of specialist knowledge.”
Thus, there are three equal options for demonstrating the qualification for issuing specialist instructions:
Subsequent acquisition of specialist knowledge
Grandfathering = prior (before 1996) provision of laboratory services under MIII/MIV in one’s own laboratory as long as these services are part of the doctor’s area of specialization
2. Billing of laboratory services via cost units (payers)
2.1 EBM — Uniform rating scale
The EBM mainly applies to outpatient care under the statutory health insurance system, and determines the content and remuneration of the billable services as part of medical care provided by panel doctors [Section 87(2) SGB V].
In addition, the individual KVs have some leeway in their discretion concerning the distribution of fees, which is specified in the respective fee distribution scale (hereinafter: “HVM”) pursuant to Section 87b SGB V by the respective KV.
2.1.1 Basic laboratory – EBM Section 32.2
Under Sections 24, 25 BMV-Ärzte,
These services can be referred to a specialist laboratory using the Model 10 form (also known as Model 10BF if printed at the practice), which then settles directly with the KV (for requirements regarding the “referral”, see 2.1.2);
These services can be obtained from a group laboratory of panel doctors using the model 10A form (also known as model 10ABF if printed at the practice), which then settles directly with the KV. The billing must state, among other things, the LANR of the group laboratory member. Some GOPs are excluded from being obtained from a group laboratory, such as GOPs 32025–32027 or GOP 32097 (BNP and/or NT-Pro-BNP);
These services can be performed at one’s own practice. The practice then settles directly with the KV.
When performed at the doctor’s practice, GOPs 32025 (glucose), 32026 (thromboplastin time) and 32027 (D-dimer – not by means of carrier-bound reagents) can be billed, but only if the test result is obtained within 1 hour of the material being sampled. These tests cannot be obtained from a group laboratory.
2.1.2 Laboratory medicine, human genetics and pathology – EBM chapters 1.7, 11, 12, 19 and 32.3
These services must be referred to a specialist laboratory using the Model 10 form (in the case of human genetics except for GOPs 11310–11322 and 11.4 EBM and unclear diagnosis, also Model 6 form, with “Co-/Further treatment” being checked), including a note for “preventive” or “curative”, which then settles directly with its KV. One must keep in mind that referral forms must include, in particular, the diagnosis. As is written in the preliminary remark No. 14 for chapter 32 EBM:
“When ordering tests under chapter 32, the referring panel doctor must communicate the diagnosis, suspected diagnosis or findings, and must define the type and scope of the services by means of the fee schedule items and/or legend of the fee schedule item (definition order), or specify the test objective (indication order). The executing panel doctor may only bill for these fee schedule items. Any extension of the order is subject to the consent of the ordering panel doctor. (BMÄ and E-GO).”
This is also clear from the explanations on the agreement on preprinted forms used in public medical care 12:
“The referring panel doctor must specify precisely the services ordered in the order field according to type and scope after defining the diagnosis/suspected diagnosis citing, where possible, the ICD code, the findings and/or medication [...].”
It13 continues as follows:
“The physician executing a service ordered is authorized to contract out parts of the order that he/she cannot perform to another physician by ‘referral’. In such case, he/she must also complete a referral form for laboratory tests to be performed as contract services and provide the necessary information, particularly that of the original initiator [...].”
Effective 01.10.2013, Section 24(2) BMV-Ärzte provides that newly authorized facilities managed by physicians and/or newly authorized physicians may only issue referrals from that date forward if the ZA has issued the referral authorization using the definition of the services to be referred (for “authorization”, also see footnote 11 of 1.2.5). Therefore, where referrers are facilities or physicians that obtained their authorization only after the above effective date, it is recommended that the referrers should be informed about this regulation and that one should obtain a copy of the authorization decree in order to verify the doctor’s referral authorization.
Where a practice performs such services itself, and also has the relevant license, there is no referral – this is generally described as “self-referral”. Billing is then settled directly between the practice and the KV. In this case, the principle of personal performance of services under Section 25(2)(2) BMV-Ärzte applies. This is true, for example, of human genetics when a human genetic consultation requires human genetic testing that is performed at one’s own practice.
Apart from the settlement of technical, diagnostic services, laboratory physicians’ basic flat rates – preventive GOP 01700 and curative GOP 12220 – will be remunerated by the KVs in accordance with the provisions described in the respective service legends of the EBM fee scedule item. GOPs 01701 and 12225 will be remunerated for non-laboratory physicians.
Under 11 EBM, human geneticists invoice the corresponding basic flat rates in case of personal doctor-patient contact.
2.1.3 Efficiency bonus
GOP 32001 – efficiency bonus under EBM 32.1 – basic services, as well as the preamble of 32.2 No. 2–9 and preamble of 32.3, No. 3–10, are designed as a control mechanism for the purpose of the efficient and medically indicated initiation of laboratory tests, concerning the services that one performed, initiated and/or referred oneself. Billing involves three components:
GOP 32001 => defines the amount for each treatment under Section 21 BMV-Ärzte that is then remunerated to the practice ordering the lab tests in the full amount, provided that the sum total of all laboratory costs of the practice does not exceed the quarterly laboratory budget. If the laboratory budget is exceeded, the remuneration for GOP 32001 will be reduced.
Laboratory budget => defines the amount that the lab test-ordering practice may (can) order in a quarter without the remuneration for GOP 32001 being reduced.
Laboratory costs => this amount is derived from the number of laboratory services ordered by the practice, multiplied by the remuneration per laboratory service shown in the EBM (EBM code). The laboratory costs are a charge on the laboratory budget. It should be noted that there are illnesses that do not burden the laboratory budget (exceptional indication, e.g., diabetes).
The individual laboratory budget of each original initiator of laboratory services is charged with the value of the laboratory services ordered, that is, the laboratory costs “caused”. It may be that the initiator is paid a smaller efficiency bonus, or none at all, depending on the utilization of the laboratory. The statement of the exception codes 32005–32023 listed in Table 2 has a direct effect on the amount of the efficiency bonus, because cases subject to exception codes do not represent a charge on the laboratory budget. Accordingly, there is no laboratory budget available for treatment cases with exception indications, and there is no remuneration for GOP 32001 either. At this point, it should be noted that the exception codes for special indications must be stated pursuant to the EBM. There is no discretionary choice.
Treatment cases with remuneration via selective contracts under Sections 73b and 73c SGB V will be considered for the purposes of the efficiency bonus only if the laboratory services ordered are from outside the range of codes under the selective contract. The doctor’s practice must provide proof thereof to the KV, which is generally done by means of billing a special “pseudo-code” if the selective contract is not already processed via the KV anyway in organizational terms.
The efficiency bonus is currently the only mechanism for controlling the volume of laboratory services ordered under EBM chapter 32. However, the specialist laboratory, which may perform services only on the basis of an order and/or referral, does not have any significant control over the volume ordered and, thus, the laboratory costs.
2.2 GOÄ – doctors’ fee schedule
When services are not performed under the statutory health insurance system, the GOÄ applies. This is mandatory for settling laboratory services directly with patients. Under Section 1(1) GOÄ, the GOÄ must always be applied where there are no other federal provisions. Such federal provisions may include the EBM for panel doctor services or the German Court Payment and Reimbursement Act (JVEG). The latter regulates the remuneration for medical reports for courts and public service providers.
In Section 5, the GOÄ provides for a fee framework of minimum and maximum rates. There are different rates depending on the underlying services. Laboratory services under Section M of the GOÄ are subject to a fee framework ranging from the simple rate to 1.3 times the rate (Section 5(4) GOÄ). Thus, the minimum rate to be billed under the GOÄ is the simple rate. Under Section 5(4), Sent. 2 GOÄ, the margin within which the fee for services under Section M must be ranges from the simple rate to 1.15 times the rate. Exceeding 1.15 times the rate, up to a maximum of 1.3 times the rate, is permitted only if this is justified by special circumstances in the assessment criteria (difficulty and time expenditure of the individual service, circumstances concerning the execution) mentioned in Section 5(2), Sent. 1 GOÄ. Pursuant to Section 12(3) GOÄ, the physician has to include the justification in clear and comprehensible terms in his/her bill. Such circumstances may include emergencies requiring laboratory services outside regular business hours.
Generally, Section 2(1) GOÄ allows for deviations from the GOÄ, but according to Section 2(3) GOÄ, this does not apply, among other things, to services under Section M of the GOÄ. Thus, in the context of laboratory services, the GOÄ does not provide for any deviations up or down from 1.3 times the rate and/or 1.0 times the rate, respectively. An exception is permitted under Section 12(2) of the Model Professional Conduct (MBO) for physicians, and is limited to specific groups of persons:
“Physicians may waive their fees, in whole or in part, for family members, colleagues, their relatives and indigent patients.”
However, there are special general conditions when it comes to the basic PKV rate, which has been mandatory since 01.01.2009 for private health insurers under Section 12(1a) of the Insurance Supervision Act (VAG)14 and Sections 192, 193 of the Insurance Contract Act (VVG).15 Section M services, pursuant to the “agreement on fees for outpatient care delivered by physicians and consultants with hospital privileges applicable to patients insured at the basic rate”, have had to bill patients at 0.9 times the GOÄ rate since 01.04.2010, but can also be settled directly with the insurer. The basic PKV rate must be distinguished from the standard PKV rate, which was designed and defined primarily for older insured patients. While the standard rate is merely comparable to the services under statutory health insurance, almost the entire range of statutory services was incorporated into the basic rate. Thus, the base rate represents a larger catalog of services than the standard rate. Since 01.01.2009, it has been impossible to enter into new PKV contracts at the standard rate. Only patients with private insurance prior to 31.08.2008 are still allowed to switch to the standard rate. There is also a grandfathering provision for existing contracts at the standard rate.
Furthermore, the GOÄ permits the laboratory to bill for expenses pursuant to Section 10(3) GOÄ where the laboratory has to bear the entire costs for shipping material, shipping containers, shipping or transport of samples as well as postage and where the corresponding services were neither performed within a laboratory center or within a hospital’s premises nor the same transportation route was used.
There are no special requirements for the referral of private orders. In general, the order forms are based on the model 10 forms, binding for the KV.
2.2.1 Practice’s own laboratory – GOÄ Section MI
The services must be made available and performed by the established practice’s own laboratory. The practice then settles directly with the patients. These services cannot be outsourced to a laboratory or obtained from a group laboratory/laboratory center and then billed by the practice by way of the MI codes. If these services are not performed at the practice, the MI billing/settlement process cannot be used.
2.2.2 Basic laboratory — GOÄ Section MII
can be outsourced to a specialist laboratory using a private order form, which then settles the account with the patients directly. Patients submit the private bill to their insurer for reimbursement.
can be obtained from a group laboratory using a private laboratory center (LG) order form. The physician who obtains such delegatable “technical” services will then bill them to his/her patients following the findings.
2.2.3 Laboratory medicine, microbiology, human genetics and pathology – GOÄ Sections MIII, MIV and N
These services must be outsourced to a specialist laboratory using a private order form, which then settles the account with the patients directly. Patients submit the private bill to their insurer for reimbursement.
Where a practice performs such services itself, and meets the relevant requirements (specialist knowledge pursuant to the Professional Development Regulation), the practice can settle accounts directly. In this case, the principle of personal performance of services under Section 4(2), Sent. 1 GOÄ applies.
Generally, what the Federal Court confirmed in its aforementioned ruling on 25.01.2012 (file no.: 1 StR 45/11) applies: specialist laboratory services may be billed and settled only by the laboratory providing the services. As the billing of specialist laboratory services by the physician ordering the services – as the physician who does not himself/herself perform the services – is not permitted, it is not possible either for the specialist laboratory to bill the ordering party for private and IGeL laboratory orders. Exceptions to this principle, which allow the specialist laboratory to bill the ordering party for specialist laboratory services obtained, exist only in the following cases:
In connection with patients who are domiciled abroad, if the treating physician has agreed with the patient a pre-payment for the laboratory test ordered. However, the billing between the treating physician and foreign patient must match the invoice of the laboratory. This means that the pre-payment made by the patient must be compensated after receipt of the laboratory invoice.
In the field of occupational medicine if laboratory tests are done on the basis of special agreements for a company or an employee of such company.
Pre- and post-inpatient testing as part Section 115a SGB V (see 3.4).
Complex of services codes (see 3.7)
Expert’s opinions outside the GOÄ.
Studies outside the GOÄ.
To ensure correct billing, specialist laboratory services, therefore, must always be ordered by means of the appropriate forms, and any of the aforementioned exceptions must be expressly noted.
3. Special billing terms
3.1 Definition of correct billing codes (EBM and GOÅ)
If a laboratory wishes to add a new test to its range of services, or if there is doubt about the billing for an established test, one must first determine the correct billing code under the EBM or GOÄ via the precise definition of the laboratory method. Various aspects come into play here, some of which are shown in Table 3 by way of examples.
If there is no explicit GOP for a test and/or analyte in the EBM, it may be possible to settle the account via a GOP as a “similar test”. However, it must be ensured that the test to be billed is recognized by the KVs as part of statutory outpatient care. At this point, there is no regularly updated, definitive catalog of laboratory tests that do not represent recognized services by panel doctors, except for the KBV laboratory compendium dated 01.04.201416 and Appendix 4 of chapter 32 EBM about “services not, or no longer, billable”. Thus, when in doubt, this leaves only a decision on a case-by-case basis, perhaps in coordination with the respective competent KV. A solution would be a list of services not recognized at a federal level in connection with panel doctors. A laboratory test not included in such a negative list would then be deemed a panel doctor service. Currently, there is always a risk that laboratory tests are ordered and/or referred that may not be recognized as panel doctor services and, therefore, cannot be remunerated later on. However, there is no binding documentation of this for physicians ordering and/or performing such services. To make matters worse, one laboratory test may be recognized as a panel doctor service by one KV, but not by another. Particularly where two KVs are involved – service is recognized by the ordering physician’s KV but not by the KV of the performing physician – this may create acceptance problems for the physician who requires the service. In some cases, it is possible to consult an EBM commentary.17
If there is no explicit code for a test and/or analyte in the GOÄ, analog billing is applied. Under Section 6(2) GOÄ and the General Provisions No. 8 of Section M, independent medical services not listed in the fee schedule may be settled using a service of the fee schedule that is equivalent to the service in question in terms of type, cost and time expended. For services under sections MII to MIV, the fee schedule item chosen for the purpose of analog billing for a service not listed in the schedule must be identified by prefixing it with the letter “A”. In case of doubt, the GOÄ commentary18 will be consulted.
However, such analog billing is not binding for private health insurers; reimbursement problems may arise with private insurers even in the event of correct billing. Insurers frequently reimburse a lower amount, saying that a different analog code, for a lower-priced service, should have been used in their view.
At this point, it should be noted that laboratory tests are generally billable only if the requirements under the “German Medical Association Directive on the quality assurance of medical laboratory examinations”19 (hereinafter: “RiliBÄk”, cf. EBM chapter 32 preliminary remark No. 1 and Section 75(7) SGB V) are met.
3.2 Particularities in determining fees
First, there are maximum values under EBM and GOÄ: several tests as part of one order may be reimbursed only up to a maximum value (see Table 4 for EBM) or may not be billed above a maximum value (see Table 5 for GOÄ).
Apart from maximum values, there are also further rules under EBM that (can) lead to cuts by the KV in connection with fee billing. The most important are:
GOP more than x times per case (illness and/or treatment under Section 21 BMV-Ärzte)
GOP X cannot be billed in combination with GOP Y
GOP billable only from/to the age of X
Flat rate GOP 40100 if the same treatment case is used to bill for fee schedule items under Sections 32.2.1–32.2.7 (services under EBM chapter 32.2)20
Apart from this, the following provisions cause payment for services rendered and billed (payment of the fee) to be reduced:
when exceeding 450,000 GOPs billed per practice and quarter, services above that limit will be remunerated at a 20% reduction21
reduced payout ratios for services under chapters 11, 19 and 3222 EBM (determined by state KVs and/or KBV).
Variable point value for services under chapters 1.7, 11 and 19 EBM (was harmonized to a standard EUR 0.10/point with the EBM reform on 01.10.2013 by adjustment of the computational point value and orientation point value)
Allocation of doctor and/or practice “budgets” per quarter regarding chapter 11 EBM and adjusted payout if the volume of services billed is above the allocated “budget” (in addition, on 01.10.2014, a basic flat fee and/or basic fee “genetic laboratory” was introduced per patient insured)
For non-laboratory physicians with a laboratory authorization (also see “self-referral” in 2.1.2), case-specific budgets apply with respect to EBM 32.3 services (treatment case code of the practice x federal reference case values per physician group), with some leeway on the part of the individual KVs
Regarding some immunological tests, one must consider, in connection with the GOÄ that, according to the preliminary note No. 9 for chapter M, only two-thirds of the fee may be billed for the service legend “including double determination and current reference curve” (mandatory double determination) if the test was done with a single determination.
The commencement and discontinuation of laboratory services remunerated as part of panel doctor care is decided by resolution of the plenum of the Federal Joint Committee. The resolutions are then incorporated into the EBM, with the EBM arrangement being decided by the evaluation committee under Section 87 SGB V. The assessment of laboratory services with respect to their inclusion in chapter 32 EBM is performed by the parties to the BMV-Ärzte.
Since the GOÄ directory of services is updated only over long intervals by official regulations, the German Medical Association publishes a directory of analogous assessments. Only specific services agreed upon with the Federal Health Ministry, Ministry of the Interior and the Association of Private Health Insurance Companies are included in that directory.
3.3 Individual health services (IGeL)
There is no legal definition of individual health services. The Federal Association of Statutory Health Insurance Physicians, however, has provided a definition that makes it clear that this is not a medical term, but a service-based definition. According to this, individual health services
are services that are not part of the statutory health insurance system,
but which can nonetheless be requested by patients holding statutory health insurance, and
which are recommended by doctors or, depending on the intensity of the insured patient’s request, are at least medically justifiable.
When billing for individual health services, one must consider the fee framework under Section 5 GOÄ. With individual health services, in particular, the question arises as to whether they may be offered at a rate lower than the minimum GOÄ rate. Applying a rate lower than the minimum rate is not entirely excluded in Section 12(1) MBO-Ärzte, but it must not be done in an “unfair manner”. Together with Section 12(2) MBO-Ärzte, it becomes clear that a rate below the minimum rate should be the exception. The section provides for waiving the fee, in full or in part, for relatives, colleagues and their families as well as indigent patients. However, if the simple GOÄ rate is undercut systematically for the purpose of patient loyalty, this will have to be deemed impermissible against the background of the legal situation described (a price lower than the minimum rate being an exception). Such undercutting in the case of individual health services cannot be justified on the grounds of the patient being indigent either, because this can be used as an argument only if the patient would not otherwise have access to necessary medical care. However, IGeL patients are covered under the public insurance system and, as such, are entitled to necessary medical care as well as medically necessary services. Patients covered under the public system and social indicators, therefore, cancel each other out in the IGeL context. In the case of patients without insurance cover, who are entitled to medical care under social welfare regulations pursuant to Sections 47 ff SGB XII, undercutting the minimum GOÄ rate due to social indicators is not permissible, because payment is guaranteed by the welfare system, which means the patient is not indigent. What is more, the assistance provided under Sections 47 ff SGB XII is equivalent to the services under statutory health insurance according to Section 52(1) SGB XII.
When IGeL billing is used to invoice expenses under Section 10 GOÄ, one must ensure that the patient confirms with his/her signature the corresponding costs in the agreement on elective services under Section 1(2), Sent. 2 GOÄ already at the time of requesting of the individual health services. However, since the precise costs will not be known until after the test has been completed, only the costs known prior to the test can be billed. In addition, IGeL tests are often done from the same material that is used at the same time for referrals under the public system and settled with the KV. In this context, therefore, costs are assumed that must not be claimed a second time via the route of cost reimbursement. This means that one must always check whether the same material was used for IGeL and KV services at the same time.
3.4 Special general conditions for consultant physicians
The referral and billing procedure for consultant physicians is regulated in Section 121 SGB V in connection with Section 18 of the Hospital Remuneration Act23 (hereinafter: “KHEntgG”) and Section 41 BMV-Ärzte.
Under Section 121(2) SGB V, consultant physicians are panel doctors, not employed by the hospital, who have been given privileges to treat their patients (external patients) at the hospital and to use the services, facilities and resources of the hospital, both for inpatient and partial inpatient care, without being remunerated by the hospital. Consultant physicians’ services are paid from the total panel doctor compensation under Section 121(3), Sent. 1 SGB V. The services in question are defined in Section 18(1) KHEntgG. According to this, consultant physicians’ service comprise:
the consultant’s personal services
the medical on-call service for external patients
the services ordered by the consultant from other doctors of the hospital who, in the treatment of the consultant’s external patients, are active in the same specialization as the consultant
the services ordered by the consultant from doctors and physician-managed facilities outside the hospital.
More details on the distinction between inpatient and outpatient care provided by consultant physicians, as well as on the billing of such services, can be found in Section 41 BMV-Ärzte. It also contains the explicit provision that attending panel doctors settle their services by way of a referral form where the field “with treatment by consultant physician” is selected (Model 6 and/or Model 10) issued by the treating consultant physician via the electronic health card or as part of the so-called replacement procedure. To meet this standard, consultant physicians must refer services under EBM chapter 32.3, as described.
3.5 Special general conditions applicable to pre-/post-inpatient and outpatient care at the hospital (KH)
For a more precise distinction, the individual treatment areas have been defined according to Section 39 SGB V:
(Complete) inpatient => admission to KH and stay for at least 1 day and one night and/or if less than that, a scheduled hospital treatment over several days
Partial inpatient => admission to KH and stay for at least 1 day and one night (not “round the clock”)
Pre-inpatient => 3 days of treatment within 5 days prior to the start of inpatient treatment (Section 115a(2) SGB V)
Post-inpatient => 7 days of treatment within 14 days; longer in case of organ transplants (Section 115a(2) SGB V), i.e., at the hospital without room and board in close connection with a prescribed inpatient treatment
Outpatient => not inpatient, not partial inpatient, not pre-inpatient, not post-inpatient
Where services under PKV and/or doctor-of-choice agreements in areas 1.–4. are involved, these will have to be settled under Section 6a GOÄ. A choice-of-doctor agreement enters into effect only after having been signed by the patient.
Pursuant to Section 115a SGB V, hospitals may include established laboratory physicians as part of pre- and post-inpatient treatment. This requires a prior written order for the established medical service provider by the clinic. Only if such order or assignment exists can and/or must the clinic’s services (if necessary, via the sender of the order for organizational reasons) be settled in accordance with GOÄ. Without such an assignment, the services rendered in connection with outpatient care provided by panel doctors must be settled with the KV. Post-inpatient treatment at the hospital is considered only when the treatment falls within the maximum length of stay of the flat rate per case for the complete inpatient treatment, or if post-inpatient treatment is necessary. Post-inpatient treatment is necessary only if the same treatment cannot be administered as part of outpatient care provided by panel doctors.
The settlement of Section 115b and Section 116b services is based, in the former case, on a direct agreement between the National Association of Statutory Health Insurance Funds, the German Hospital Federation and the KBV, and in the latter case, on a public-law agreement between the health insurance funds or their state associations and the licensed hospitals. Section 115b SGB V regulates services in connection with outpatient surgeries at hospitals. Section 116b SGB V regulates services in connection with specialist outpatient care, for example, at hospitals. The laboratory to which services are outsourced, therefore, must invoice the hospital. The laboratory cannot settle the services with the KV. Instead, the hospital must reimburse the laboratory directly for the services listed in the invoice and then include them in its own billing vis-à-vis the health insurance company.
3.6 Special billing/settlement conditions in connection with (complete) inpatient care at hospitals
The GOÄ (inadmissibility of fee agreement for Section M services that deviates from the GOÄ) generally applies also to the settlement of laboratory services vis-à-vis hospitals for complete inpatient care of patients with statutory insurance. In this context, too, one must consider the principle of reasonableness with respect to the fee under Section 12 MBO. This principle refers also to the lower limit of the fee framework, which must not be undercut in an unfair manner by any deviating fee agreements.
However, courts now predominantly recognize24 the undercutting of minimum rates as permissible, given that undercutting the minimum GOÄ rate is now customary practice with respect to hospitals. If the GOÄ is specified as the settlement catalog (“price list”), as well as a special reduction factor, the further general conditions are not binding, which should be spelled out in the agreement.
This also includes the maximum value rules and the 2/3 rule (see 3.1). The same applies to the settlement in connection with budget agreements with installment payments and settlement of residual amounts, as well as to other settlements outside the scope of GOÄ, such as occupational medicine.
Laboratory services between hospitals are settled on the basis of the “regular rate” of the German Hospital Federation (DKG-NT).
3.7 Laboratory services in connection with point-of-care testing (POCT)
The private GOÄ settlement of point-of-care testing (POCT) laboratory services between patients and laboratories, which are performed by clinical staff without supervision and/or specialist instructions of a laboratory physician, is not permitted (Section 4(2), Sent. 1 GOÄ) if:
the POCT lab services are rendered by the clinic itself in the outpatient clinics and wards of hospitals
the clinical staff performs analyses themselves at the corresponding decentralized POCT equipment.
Billing for these POCT laboratory services by the laboratory as part of the private GOÄ settlement is not permitted either even if the laboratory has been given shared responsibility, under a management/service agreement, in the quality assurance system pursuant to RiliBÄK through incorporation of the POCT equipment.
3.8 Complex of services codes
The “dialysis-immanent” laboratory services contained in the EBM GOPs of chapters 4.5.4, 13.3.6 and 40.14 as well as GOÄ codes 790–793 of Section F are examples of the settlement of laboratory services on the basis of complex of services codes. The dialysis-immanent laboratory services are represented in detail in Table 6, together with the settlement system. These services must not be billed additionally by the executing laboratory, the dialysis facility and/or nephrologist on top of the services billed in connection with the dialysis and/or by the nephrologist. Consequently, the laboratory will settle the accounts with the sender (also see 2.2.3).
This is comparable to the in-vitro fertilization (IVF) GOPs 08550, 08551, 08552, 08560 and 08561 in gynecology: additional lab tests are excluded and/or deemed compensated by virtue of the complex of services codes. If an IVF doctor orders diagnostic lab tests for a patient under the complex of services codes, he/she must state so explicitly on the order, so that the laboratory can settle the account with the doctor via a collective invoice, rather than settling the services once again with the KV.
The complex of services codes can also be used for services for patients that are performed in connection with selective contracts (contracts of family physician-centered care (HzV) under Section 73b SGB V) and that are part of the contract (“range of codes”). Accordingly, they will have to be settled with the ordering practice. The costs to be billed must be agreed with the practice. As a rule, the remuneration for basic laboratory services is geared to the “private” laboratory center (MII services), and the doctor must obtain the services from there.
Another example is the urine sediment analysis in connection with prenatal care. In this case, the treating gynecologist settles the service, EBM GOP 01770 (care of a pregnant patient), with his/her KV. The legend for GOP 01770 defines as the mandatory service content “consultations and examinations pursuant to the directives on maternity”. Among other things, the maternity directives list urine sediment analysis as a standard diagnostic tool, to be settled as GOP 01770. If the gynecologist, despite the recommended analytics, cannot or will not do the test himself/herself, he/she will have to obtain it from the laboratory, taking into consideration the pre-analytical requirements. A referral is not permitted in this case, as this would result in double billing.25 The test should therefore be ordered from the specialist laboratory using a GOÄ form showing the diagnosis “care of a pregnant patient” and the designation “invoice to be sent to sender”.
An example of a complex of services codes under the GOÄ is code 437 – laboratory testing as part of intensive treatment following code 435. Up to 24 h (EUR 29.14), this is a complex of services codes with the following scope: all services under Section M, except services under Sections M III 13 (blood group characteristics, HLA system) and M IV (testing for the presence and characterization of pathogens). As a rule, this code is settled by the clinic itself (e.g., blood gases in intensive care). Laboratory services outsourced to a specialist laboratory (internal or external) would also have to be billed using this code. However, this is not possible, because parts of services are compensated through the same fee even if they are provided by different doctors. In general, the service provider who has carried out the majority of the required tests is the one to bill for code 437. Where the clinic settles code 437 and there are no other contractual provisions, the ordered laboratory services for a private intensive-care inpatient must be billed by the lab to the clinic. Any different approaches must be agreed between the clinic and the laboratory.
3.9 Accident insurance
All tests ordered and performed in connection with (work-related) accidents must be settled with the respective accident insurance company and/or professional association pursuant to UV-GOÄ (GOÄ Accident Insurance). An accident insurance doctor is required for ordering tests only where the consequences of the accident persist beyond the day of the accident – in other words, when the accident has not just been a “minor” one. Tests for work-related accidents can generally always be ordered from the lab, which then settles the accounts with the respective accident insurance company. However, for more “severe” work-related accidents, an accident insurance doctor must always be consulted. This is a given in such a situation anyway, because otherwise the clinic would not be able to settle the accounts with the insurance company.
Special conditions apply to needlestick injuries, for which the range of tests is limited. Only the following tests are eligible for reimbursement from the professional associations in connection with needlestick injuries involving unknown infectious agents. However, the range may differ from one association to another, and must be clarified beforehand.
GOT, GPT (immediately, after 6 weeks, after 6 months)
Anti-HCV (immediately, after 6 weeks, after 6 months)
Anti-HIV (immediately, after 6 weeks, after 6 months)
HCV PCR (only in case of proven contact with Hep C-positive blood: after 2 weeks, after 6 weeks with negative initial findings)
Anti-HBs (immediately; only if immunity to hepatitis B is unclear – document!)
The following tests must be ordered if the patient insured has NOT been vaccinated against hepatitis B:
Anti-HBs (immediately, after 6 weeks, after 6 months)
Anti-HBc (immediately, after 6 weeks, after 6 months)
3.10 Occupational medicine
All tests ordered and performed in connection with occupational medicine must be settled with the respective established physician or the physician employed by and/or acting on behalf of a company. Where the services are ordered by a company’s medical service, the accounts will generally be settled with the company. The settlement conditions are mostly in line with the GOÄ, but can also be agreed individually.
3.11 Exemption of medical services from value-added tax
According to the jurisprudence of the European Court of Justice, a tax exemption is considered when the services are provided in connection with medical treatment. The services are VAT-exempt if they are provided for the purpose of prevention, diagnosis, treatment and, where possible, healing. The exempted services must serve to protect the individual patient’s health. Essentially, services are exempt from the value-added tax under Section 4(14) of the Sales Tax Act (UStG) if they are prescribed by a doctor and medically indicated. This is also true of occupational medicine or drug tests. The latter case, when ordered as part of an expert’s opinion to demonstrate to authorities an individual’s driving ability, is an example of services subject to value-added tax. Thus, when both conditions – prescribed by a doctor and medically indicated – are not met, one must assume the service is subject to value-added tax.
However, services in the field of human medicine are tax-exempt only if they are provided by the professional groups listed in Section 4(14a) UStG. They include:
Similar medical professions.
In addition, sales are tax-exempt only if they are typical and characteristic of the professional activities mentioned. Medical services, therefore, are tax-exempt only if the focus of the activity is a therapeutic one. If they aim, for example, merely at improving general well-being (e.g., wellness program) or involve cosmetic surgery that does not serve any therapeutic purpose, they will not be exempt from value-added tax.
3.12 Summary of general conditions
The entire range of varied options for billing laboratory services is summarized in one final matrix. In preparing the matrix, it does not matter whether a laboratory operator maintains a hospital laboratory with the customary range of basic analytical lab tests for clinical chemistry, hematology and coagulation, or whether specialist analytical lab tests are performed on external samples received. Table 7 shows the system of billing for lab services on the basis of a matrix. The individual cases are described below. Starting with the initiator of a laboratory order and the insurance status of the respective patient, the conditions are defined that the laboratory must meet in order to be able to bill for lab services in the context of the applicable fee schedule. This, and coupled with the previous correct order, will finally lead to the payer (cost unit) with whom the lab services must be settled.
Case 1: The sender is an established medical practice, and the patient is covered under statutory health insurance. The laboratory services (regardless of whether they are 32.2 or 32.3 EBM services) must be ordered via a Model 10 form and settled by the laboratory with the KV in accordance with EBM (see above, 2.1 EBM – Uniform rating scale). The laboratory performing the respective tests must be KV-approved (see above, 1. Qualification).
Case 2: The sender is an established medical practice, and the patient is covered under statutory health insurance. The laboratory services ordered (usually under chapter 32.3 EBM) are not remunerated under the GKV. In this case, the lab services must be ordered as self-payer services using a special form (see above, 3.3 Individual health services), and invoiced to the patient under the GOÄ applying an incremental factor of 1.0. The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications. The same settlement process applies if the sender is not KV-approved (e.g., private practice).
Case 3: The sender is an established medical practice, and the patient is covered under private health insurance (elective physician). The lab services must be ordered as self-payer services using a private order form, and invoiced to the patient under GOÄ (for incremental factors see above, 2.2 GOÄ – doctors’ fee schedule). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 4: The sender is an established medical practice and the patient is covered under statutory health insurance, but part of a selective agreement (see above, 3.8 Complex of services codes). The lab services must be ordered from a private laboratory center using a private LG order form, and invoiced to the sender on LG terms and conditions. The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 5: The sender is an established medical practice, and the patient is covered under statutory health insurance. The sender is also at the same time a member of a panel doctors’ group laboratory. The basic laboratory services under EBM chapter 32.2 must be ordered using the Model 10A form, and settled directly between the KV-LG and KV. The laboratory performing the analytical tests must be managed by a physician with the necessary qualifications, and must have a KV establishment number.
Case 6: The sender is an established medical practice, and the patient is covered under private health insurance (elective physician). The sender is also at the same time a member of a private group laboratory. The basic laboratory services under Section MII of GOÄ must be ordered using a private LG order form, and settled between the private group lab and the sender, i.e., the LG member. The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 7: The sender is a hospital unit and the patient is covered under statutory health insurance. All services must be ordered using a hospital-specific order form (designated as GKV-inpatient), and settled with the sender (the hospital) on terms and conditions agreed between the lab and the sender. The sender (hospital) settles the account with the health insurance companies via the DRG system, with the lab costs constituting part of the DRG remuneration. The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 8: The sender is a hospital unit, and the patient is covered under private health insurance (elective physician). All services must be ordered using a hospital-specific, individual order form (designated as private/elective doctor, inpatient), and invoiced by the service provider directly to the patient as self-payer services under GOÄ (for incremental factors, see above 2.2 GOÄ – doctors’ fee schedule). In this context, the reduction under Section 6a GOÄ must be considered. The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 9: The sender is a hospital unit and the patient, being treated by a consultant doctor, is covered under statutory health insurance (see above, 3.4 Special general conditions for consultant physicians). The specialist lab services under EBM chapter 32.3 must be ordered using both the hospital-specific order form (designated as GKV-inpatient, consultant physician) and Model 10 form, and settled between the laboratory and KV according to EBM. Basic laboratory services under EBM chapter 32.2, however, are part of the DRG system and therefore can only be settled with the hospital. The request is regularly made using the hospital-specific order form (designated as GKV-inpatient, consultant physician).
Case 9a: If the lab is not KV-approved, all services must be ordered using a hospital-specific order form (designated as GKV-outpatient), and settled with the sender (the hospital) on terms and conditions agreed between the lab and the sender.
Case 10: The sender is a hospital unit, and the patient is covered under private health insurance (elective physician). The laboratory is no longer operated by the clinic (outsourcing). However, the head physician wants to bill MII services for this patient as his/her own services for various reasons. In this case, the services must be ordered from the private group laboratory, as is done in Case 6. The group laboratory will bill these services to the sender and/or head physician. This requires that the lab performing the services is a site that belongs to the group laboratory (see above, 1.2.4 Laboratory center). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 11: The sender is a hospital emergency room and the patient is covered under statutory health insurance. Both the basic lab services under EBM chapter 32.2 and the specialist lab services under EBM chapter 32.3 must be referred using the Model 10 form. The lab then settles these services via the KV, provided that both the emergency room and the lab are KV-approved.
Case 11a: If the lab or the emergency room is not KV-approved, all services must be ordered using a hospital-specific order form (designated as GKV-outpatient), and settled with the sender (the hospital) on terms and conditions agreed between the lab and the sender.
Case 12: The sender is a hospital emergency room, and the patient is covered under private health insurance (elective physician). The lab services must be ordered as self-payer services using a hospital-specific order form (designated as elective doctor/private, outpatient) or a private order form, and invoiced to the patient under the GOÄ (for incremental factors see above, 2.2 GOÄ – doctors’ fee schedule). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 13: The sender is a special/specialist hospital clinic, and the patient is covered under statutory health insurance. Both the basic lab services under EBM chapter 32.2 and the specialist lab services under EBM chapter 32.3 must be referred using the Model 10 form. The lab then settles these services via the KV, provided that both the emergency room and the lab are KV-approved.
Case 13a: If the lab or the emergency room is not KV-approved, all services must be ordered using a hospital-specific order form (designated as GKV-outpatient), and settled with the sender (the hospital) on terms and conditions agreed between the lab and the sender.
Case 14: The sender is a special/specialist hospital clinic, and the patient is covered under private health insurance (elective physician). The lab services must be ordered as self-payer services using a hospital-specific order form (designated as elective doctor/private, outpatient), and invoiced to the patient under GOÄ (for incremental factors see above, 2.2 GOÄ – doctors’ fee schedule). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 15: The sender is a special/specialist hospital clinic, and the patient is covered under private health insurance (elective physician). The laboratory is no longer operated by the clinic (outsourcing). However, the head physician wants to bill MII services for this patient as his/her own services for various reasons. In this case, like in Case 6, the services must be ordered from the private group laboratory, which will bill them to the sender and/or head physician. This requires that the lab performing the services is a site that belongs to the group laboratory (see above, 1.2.4 Laboratory center). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 16: The sender is an established medical practice, and the patient is covered under statutory health insurance. In addition, this involves pre- or post-inpatient services ordered by a clinic under Section 115a SGB V. All services must be ordered using a private order form (designated as GKV, pre-inpatient/post-inpatient under Section 115a SGB V). The lab then bills the sender for these services via a GOÄ invoice (see above 3.4). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 17: The sender is a hospital department under Section 115b SGB V (outpatient surgery in a hospital) and the patient is covered under statutory health insurance. All services must be ordered using a hospital-specific order form (designated as GKV outpatient under Section 115b SGB V). The lab then bills the clinic for these services via an EBM invoice, and the clinic settles the account with the health insurance companies by submitting the EBM invoice (see above 3.5 Special general conditions applicable to pre-/post-inpatient and outpatient care at the hospital (KH)). The laboratory performing the analytical tests must be managed by a physician with the necessary qualifications.
Case 18: The sender is a hospital department under Section 116b SGB V (outpatient specialist care) and the patient is covered under statutory health insurance. All services must be ordered using a hospital-specific order form (designated as GKV outpatient under Section 116b SGB V). The lab then bills the clinic for these services via an EBM invoice. The clinic settles the account with the insurance companies by submitting the EBM invoice (see above 3.5 Special general conditions applicable to pre-/post-inpatient and outpatient care at the hospital (KH)). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 19: Regardless of the sender, the patient suffered a (work-related) accident (an accident insurance doctor is required for the order only if the consequences of the accident persist beyond the day of the accident). All services must be ordered using a hospital-specific order form or a private order form (designated as work-related accident/professional association), and settled with the competent professional association and/or accident insurance company under UV-GOÄ (see above 3.9 Accident insurance). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Case 20: The sender is an occupational health physician. All services must be ordered using an individual order form or a private order form (designated as occupational medicine), and settled with the sender in accordance with the agreement (see above 3.10 Occupational medicine). The laboratory performing the respective analytical tests must be managed by a physician with the required qualifications.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Legal sources and References
Doctors’ fee schedule, as published on 09.02.1996, as amended by the Act dated 04.12.2001.Google Scholar
Uniform rating scale, as amended with effect from 01.10.2013.Google Scholar
Social Code Book V, dated 20.12.1988, as amended by the Act of 07.08.2013.Google Scholar
Regulation approving panel doctors dated 28.05.1957, as amended by the Act of 20.02.2013.Google Scholar
Professional Code of Conduct for the doctors of Bavaria, as amended on 09.01.2012.Google Scholar
Federal master agreement with doctors, as amended on 01.10.2013.Google Scholar
Model Professional Code of Conduct for physicians working in Germany, as amended by the resolutions of the 114th German Congress of Physicians in 2011.Google Scholar
Notes to the agreement on forms for panel doctor care, as of 01.01.2013.Google Scholar
Insurance Supervision Act, as published on 17.12.1992, as amended by the Act dated 15.07.2013.Google Scholar
Insurance Contract Act, as published on 23.11.2007, as amended by the Act dated 15.07.2013.Google Scholar
German Medical Association Directive on the quality assurance of medical laboratory examinations in accordance with the resolution of the Board of the German Medical Association dated 23.11.2007, as amended/supplemented by the resolution of the Board of the German Medical Association dated 23.08.2013.Google Scholar
Hospital Remuneration Act, as published on 23.04.2002, as amended by the Act dated 15.07.2013.Google Scholar
Kölner Kommentar zum EBM, 3rd edition, Deutscher Ärzte-Verlag Cologne, Germany.Google Scholar
Kommentar zur Gebührenordnung für Ärzte, 3rd edition, Deutscher Ärzte-Verlag Cologne, Germany.Google Scholar
Bäune/Meschke/Rothfuß, Kommentar zur Zulassungsverordnung für Vertragsärzte, ed. 2008.Google Scholar
KBV laboratory compendium, Directive of Federal Association of Statutory Health Insurance Physicians, entry into force on 1 April 2014.Google Scholar
Original German online version at: http://www.degruyter.com/view/j/labm.2014.38.issue-4/labmed-2014-0015/labmed-2014-0015.xml?format=INT. The German article was translated by Compuscript Ltd. and authorized by the authors.
At least, this is what most admissions committees still require, even though one does not find a strict prohibition of service duplication in the relevant laws; cf. Bäune/Meschke/Rothfuß, commentary on Licensing Regulation for Panel Doctors, Section 24, Recital 72 ff.
The details of this are regulated in the procedural directive of the National Association of Statutory Health Insurance Physicians (KBV) pursuant to Section 75(7)(1) SGB V concerning the implementation of proof of costs of laboratory centers under Section 28(3) BMV-Ärzte/health insurance companies and/or Section 25(3) BMV-Ärzte.
The authorization under Section 31 Ärzte-ZV is different from that of Sections 18 ff. Ärzte-ZV. Both licensed doctors/MVZ and authorized doctors/facilities (e.g., hospitals, rehabilitation facilities, etc.) are part of public medical care, but authorizations are subordinate to licenses. Therefore, public medical care must be ensured primarily through licensed panel doctors and MVZ. Authorizations may be granted only if the situation of licensed panel doctors and MVZ cannot ensure public outpatient care.
Directive of the Federal Association of Statutory Health Insurance Physicians pursuant to Section 75(7) SGB V: “Regulation and information concerning the correct ordering and billing of laboratory services in the context of statutory outpatient care, as well as recommendations for laboratory-medical stepwise diagnostics”.
In accordance with the resolution of the Board of the German Medical Association dated 23.11.2007, as amended/supplemented by the resolution of the Board of the German Medical Association dated 23.08.2013.
In our interpretation of the law, the removal of the shipping flat rate under No. 40100 in treatment cases with test orders under section 32.3 EBM, where one or several services under section 32.2 have been performed and billed in the same quarter, is impermissible. Please refer to the legal proceedings before the Social Court (SG) Hanover file no. S 61 KA 177/10, S 24 KA 178/10; SG Bremen S 1 KA 27/10; SG Gotha S KA 3694/10; SG Marburg S 12 KA 166/11.
In our legal opinion, the reduction and/or adjusted payout of fees for services under EBM chapter 32, as well as of services under EBM chapters 11 and 19, is impermissible. We refer to the legal proceedings before the Social Court (SG) Munich file no. S 28 KA 678/12, S 38 KA 677/12, S 28 KA 678/12.
Higher Regional Court of Karlsruhe dated 07.03.1985, 4 U 214/84; Regional Tribunal for Health Professionals at the Higher Administrative Court of Münster, ruling dated 11.12.1996; Regional Tribunal for Health Professionals at the Higher Administrative Court of Münster, ruling dated 11.12.1986