Prequalification
The PFI has been accredited by the German Accreditation Body (DAkkS) in accordance with DIN EN ISO/IEC 17065 as a prequalification body for service providers in the supply of medical aids and is therefore authorised to carry out prequalifications. We offer you our extensive expertise in this process. The PFI’s prequalification body supports approximately 450 clients in the fields of pharmacies, emergency call systems, hearing acoustics, optics, orthopaedics, footwear technology, rehabilitation technology, and medical supply stores.
What is prequalification and why is it required?
According to Section 126 (1) of the German Social Code Book V (SGB V), medical aids may only be provided to insured persons following the conclusion of contracts pursuant to Section 127 (1), (2), and (3) SGB V between health insurance funds and service providers. In accordance with Section 126 (1a) SGB V, health insurance funds must ensure that service providers meet the requirements specified in the recommendation of the National Association of Statutory Health Insurance Funds (GKV-SV).
Service providers who wish to become contractual partners of health insurance funds must fulfil the specified requirements for the proper and professional exercise of their profession and provide evidence of their technical and personal suitability. The prequalification process enables service providers to demonstrate this suitability in a manner valid for all health insurance funds. To avoid the need for individual suitability assessments by each health insurance fund, the prequalification process was established. The confirmations issued within this framework must be recognised by all health insurance funds.
Do you have any questions? Feel free to contact our representatives.
Vanessa Sees
Prequalification
Eric Görgen
Prequalification
Process of the Prequalification Procedure
1. Information
As preliminary information regarding the fundamentals of prequalification, its process, the requirements to be met, and the necessary supporting documents, the following key details are provided:
2. 2. Application
The application can be submitted via email to pq@pfi-germany.de by post using the following documents:
3. Processing and Review
Upon receipt, the application is checked for completeness. For new clients, a framework agreement is subsequently concluded. The necessary documents are requested for prequalification. We provide a checklist listing the required documents. Any missing or incomplete documents will be requested. The suitability criteria can also be found on the website of the GKV National Association before submitting your application.
4. On-Site Inspection
Depending on the area of service provision and operational circumstances, it may be necessary, according to the applicable law, to conduct an on-site inspection to verify the required spatial and material conditions. Any necessary corrective measures must then be implemented. Service areas requiring an inspection are marked with “B)” on the application form.
5. Decision
A decision on prequalification will be made no later than eight weeks after all required documents have been submitted.
6. Notification of Results
Upon successful completion of the prequalification process, the prequalification body issues a certificate valid for all statutory health insurance funds and electronically transmits the data to the GKV National Association.
7. Monitoring
During the five-year validity period of the certificate, at least two monitoring procedures (approximately every 20 months) must be carried out. These include either a document review (for service providers not requiring an on-site inspection) or an on-site inspection (for service providers requiring an on-site inspection). The necessity of monitoring activities is legally established in Section 126 (1a) SGB V and required by DIN EN ISO/IEC 17065. We will contact you in advance via email or telephone.
8. Changes to an Existing Prequalification
In the event of changes relevant to prequalification (e.g., changes to professional management, address, institution identification number, company rebranding, etc.), the prequalification body must be informed immediately. The necessary documents will then be requested, and a chargeable certificate amendment will be carried out. The applicable costs can be found in the price list.
9. Complaints and Appeals Procedure
Complaints against the prequalification body and appeals against its decisions regarding prequalification matters may be submitted by customers or third parties. Appeals must be lodged no later than four weeks after receiving the decision from the PFI prequalification body. All complaints and appeals are documented.
The handling of complaints, appeals, and disputes regarding the prequalification process follows the procedure outlined in Chapter 9.7: Complaints and Appeals.
Complaints and appeals should be addressed to: beschwerdestelle-cert@pfi-germany.de
Testing and Research Institute Pirmasens e.V.
Certification Body – Complaints Office
P.O. Box 2225
66930 Pirmasens
The procedure will be concluded within a maximum of six weeks from receipt.
FAQ – Frequently Asked Questions
What is prequalification? Why is prequalification necessary? Who requires prequalification?
“According to Section 126 (1a), Sentence 2 of the German Social Code Book V (SGB V), service providers must undergo prequalification if they wish to enter into contracts with health insurance funds for the provision of medical aids under Section 127 (2) SGB V.
Once the prequalification body makes a positive decision, service providers receive a certificate that must be recognised by all health insurance funds. This certification serves as proof that the service provider meets the necessary requirements to become a contractual partner of the health insurance funds.
The prequalification process is designed to assess service providers based on defined standards regarding their fundamental suitability to provide specific medical aids. This process ensures uniform legal application, significant administrative simplification, and greater transparency and planning security in the medical aid sector.” (Source: GKV National Association: Information for Service Providers, [online] https://www.gkv-spitzenverband.de/krankenversicherung/hilfsmittel/praequalifizierung/hinweise_fuer_leistungserbringer/hinweise_fuer_leistungserbringer.jsp [retrieved on 18.11.2024])
Which locations must be prequalified?
“According to Section 126 (1), Sentence 2 SGB V, the fulfilment of the requirements must be demonstrated for each business location (main business, branch, subsidiary, or affiliated company) where the provision of medical aids takes place. The legal status of the business location within the corporate structure is irrelevant—what matters is whether services are provided at that location. If no physical business premises are required, the responsible business location is the one overseeing the provision of medical aids, for example, when field staff supply medical aids in a patient’s home or general living environment.” (Source: Recommendations of the GKV National Association under Section 126 (1), Sentence 3 SGB V, dated 26 February 2024, p. 4)
Where can I find the requirements for service providers?
The requirements can be found in the criteria catalogue and the recommendations of the GKV National Association, available on its website. The most recent version of the criteria catalogue can be downloaded as an Excel file. Each service area has its own column in the table, where the necessary criteria are marked with a cross. Additional explanations and specifications are provided in the GKV National Association’s recommendations.
In what format should supporting documents be submitted?
Supporting documents should preferably be sent via email to pq@pfi-germany.de or to your assigned case officer. Postal submission is also possible.
When must an on-site inspection by the prequalification body take place?
For service areas that require an on-site inspection, a site visit must be conducted for initial prequalification, re-prequalification, and monitoring. You can find information on which service areas require an inspection in our application forms. These areas are marked with “B)”.
How long is a prequalification valid?
Prequalification is valid for a maximum of five years. If a certificate is amended during this period, its validity is not extended. After five years, a re-prequalification is required.
What are monitoring procedures, and why must they be conducted?
During the five-year validity period of the certificate, at least two monitoring procedures, approximately every 20 months, must be conducted. These may take the form of either a document review for service providers not requiring an on-site inspection or an on-site inspection for those that do.
The requirement for monitoring activities is legally anchored in Section 126 (1a) SGB V and mandated by DIN EN ISO/IEC 17065.
You will be contacted by us in due time via email or telephone regarding the necessary monitoring procedures.
What changes must be reported to the prequalification body?
Any prequalification-relevant changes must be reported immediately.
These include modifications to details listed on the certificate, such as business name, legal entity, address, institution identification number, and professional management, among others.
Upon notification, the necessary documents will be requested, and a fee-based certificate amendment will be carried out. The associated costs can be found in the price list.
If the service provider no longer meets the prequalification requirements, for example, due to the closure of a branch, this must also be reported immediately.
How much does prequalification cost?
The costs depend on whether an on-site inspection is required. For service areas not requiring an inspection, the cost corresponds to Position 1 of our price list. For service areas requiring an inspection, costs include Positions 1, 4, and 9. Monitoring costs also vary.
A distinction is also made in monitoring between service areas requiring an on-site inspection and those that do not. For monitoring without an on-site inspection, Position 3 applies. For monitoring with an inspection, Positions 2, 4, and 9 apply.
Additional costs, such as for amendments, can also be found in the price list.
How do health insurance funds receive prequalification confirmation?
The prequalification body transmits the prequalification data to the GKV National Association, which makes it available to health insurance funds. Additionally, we issue a certificate that you can present. If you require XML data, for example, for a billing service provider, we can provide this upon request.
What does equivalence of a qualification mean?
“An equivalent qualification is recognised if it imparts knowledge and skills comparable in content and duration to those listed in the GKV recommendations. Each case is assessed individually, based on training regulations, certificates of continuing education, and professional experience records.” (Source: Recommendations of the GKV National Association under Section 126 (1), Sentence 3 SGB V, dated 26 February 2024, pp. 7-8) Please note than an assessment of equivalence may involve additional costs due to the complexity of the review process. The applicable costs can be found in the price list.
How can professional experience in the provision of medical aids be demonstrated in accordance with the qualification requirement “FS”?
“Certificates or other confirmations with job descriptions from the company or specialist trade where the professional experience was gained can be recognised as proof. If the business owner or management also serves as the professional supervisor, a self-declaration is not sufficient to prove relevant professional experience. In such cases, relevant professional experience must be demonstrated through authorisation under Section 126 SGB V (former version) or a comparable dispensing authorisation, or through contracts for the requested service areas. Ultimately, third-party confirmation must verify that the provision of medical aids has actually taken place within the specified service area. Alternatively, relevant professional experience can also be demonstrated through the provision of medical aids approved by health insurance funds for the required period and the requested service area.” (Source: Recommendations of the GKV National Association, 26 February 2024, pp. 6-7)
How can new service areas be added to an existing prequalification?
Submit the relevant prequalification application and select “Amendment of service scope” on page 2. Then, tick the additional service areas you wish to be prequalified for. Expanding the service scope is subject to a fee. (price list position 8)
Must all supporting documents be resubmitted for re-prequalification?
Yes. Re-prequalification is a new application process, and we are not permitted to reuse documents from previous submissions. All supporting documents must be resubmitted.
What are the deadlines for re-prequalification to avoid a service gap?
For service areas requiring an inspection, we recommend submitting the re-prequalification application six months before the current certificate expires.
For service areas not requiring an inspection, a three-month lead time is generally sufficient.
What are the changes regarding the new service area 19C (emergency call systems)?
As part of the 17th revision of the criteria catalogue, emergency call systems have been designated as a separate service area. There is a transition period during which emergency call systems can still be billed under service area 19B, provided that no certificate amendment (e.g., due to a change in professional management or relocation) is made. For re-prequalification, the new service area VB 19C must be applied for without exception.
What is new?
- The professions of paramedic, emergency medical technician, and emergency assistant are now accepted as qualifications for professional management.
- Proof of two new self-declarations with descriptions of measures is required:
- “Emergency call centre with 24-hour telephone availability of qualified personnel.”
- “Ensuring the functionality of the emergency call centre during power outages.”
- Proof of separate storage areas for refurbished and non-refurbished emergency call devices is required (photos). This requirement must be met even if no rental devices are issued at the time of prequalification. The ability to store them separately must still be demonstrated.
What are pharmacy-standard medical aids?
Pharmacies are exempt from prequalification for certain pharmacy-standard medical aids. These are marked with “A)” in the application forms. A comprehensive list of pharmacy-standard medical aids can also be found in the agreement on the definition of pharmacy-standard medical aids pursuant to Section 126 (1b) SGB V, as of 01/04/2024.
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