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28-06-2023

The health insurance funds: questions and answers on orthopaedic devices

Iliustracija

Addressing the problems arising from the public when purchasing orthopaedic devices, dissatisfaction with the quality of the devices and the lack of attention from the responsible authorities, the specialists of the Health Insurance Funds respond to the most pressing questions from patients and patient organisations.  

What are the requirements for issuing and contracting orthopaedic devices?  

These requirements continue to become more strict. Between 2019 and 2023, amendments to the Minister of Health’s Orders have been drafted and adopted, providing that:

1. Only doctors from healthcare institutions contracted with Territorial Health Insurance Funds can issue referrals for orthopaedic devices. 

2. Orthopaedic companies must additionally submit the following when applying for a contract: 

  • a certificate stating that they have no debts to the State Tax Inspectorate and SODRA;
  • a catalogue of orthopaedic devices, with photographs of the devices. The catalogues shall be made publicly available on the websites of the National Health Insurance Fund (NHIF) under the Ministry of Health and the company; 
  • list of shareholders of the company.

3. A standard contract draft  for the reimbursement of orthopaedic devices from the Compulsory Health Insurance Fund (CHIF) has been drawn up, with strict provisions for termination and suspension of contracts. 

4. New contracts are only concluded with companies that meet certain reliability requirements set by the party to the orthopaedic device contract:

  • the company or institution has not been fined by an enforceable decision in the three years preceding the date of submission of the application (tax offences);
  • the company or institution and/or its head has not been convicted of fraud, unlawful enrichment, economic and business offences, or offences against the financial system in the last three years; 
  • the head of the company or institution or other responsible person has not been fined in the last year for an administrative offence under Articles 57 or 58 of the Code of Administrative Offences or in the last three years for an offence under Article 83; 
  • the contract concluded by the company or institution with the NHIF has not been terminated in the last year due to irregularities, etc. 

Who is responsible for the quality of orthopaedic devices?  

Manufacturers are responsible for the quality of orthopaedic devices, and the State Accreditation Service for Health Care Activities (Accreditation Service) under the Ministry of Health monitors compliance with quality requirements. The NHIF concludes contracts for the provision of orthopaedic devices to insured persons only with orthopaedic companies to which the Accreditation Service provides notifications of the registration numbers assigned to custom-made devices.  

Orthopaedic devices and medical aids are repaired free of charge for the duration of their use, that is, until the patient covered by compulsory health insurance is entitled to a new orthopaedic device or medical aid of the same type, namely at the expense of the orthopaedic companies that manufactured and/or adapted them. 

Are patients consulted about the availability of orthopaedic devices?  

Availability of orthopaedic devices is regularly discussed with associations of people with disabilities. Most recently, they were discussed at a roundtable discussion at Seimas of the Republic of Lithuania on 16 December 2022.  

In order to improve the accessibility of orthopaedic footwear reimbursed by the Compulsory Health Insurance Fund budget, the NHIF has set up a working group to examine the issues of frequency and allocation of reimbursement for particularly complex custom-made orthopaedic footwear and to make proposals to improve accessibility. The working group includes not only representatives of the NHIF, MOH and the Accreditation Service, but also medical specialists and representatives of associations of people with disabilities, who have raised questions about the accessibility of orthopaedic devices. 

Does the NHIF receive complaints from the patients? 

The amount of orthopaedic devices reimbursed each year is very high. For example, in 2022, orthopaedic devices and medical aids were reimbursed to 66,487 people. The majority of patients have chronic illnesses or congenital or acquired limb deformities. 

The NHIF receives and handles complaints from patients, but the number of complaints is extremely low. There are also very few returns of devices to orthopaedic companies. 

  • In 2019, 13 complaints were received about the quality of orthopaedic devices (mainly limb prostheses). In all cases, the patients had not previously contacted the companies about the quality of the devices. The products were repaired or refunded (by 5 companies) and the patients ordered the products from other orthopaedic companies. 
  • In 2020, 3 complaints were received about the quality of orthopaedic devices. In two cases, the companies refunded the money.
  • In 2021, there were no complaints about the quality of orthopaedic devices.
  • In 2022, 3 complaints were received about the quality of orthopaedic devices. In two cases, the companies were ordered to repair the devices or refund the money. 
  • In 2023, no complaints were received.

Do employees of orthopaedic companies have the right to go to the homes of insured persons and demand/offer/request to order orthopaedic devices?  

The NHIF, as data controller, has contacted all orthopaedic companies contracted by the NHIF in 2020 to remind them that employees of orthopaedic companies are not allowed to go to the homes of the insured persons and demand/offer/request to order orthopaedic devices. 

In 2021, the NHIF contacted the State Data Protection Inspectorate (SDPI) after noticing that a company unjustifiably and possibly illegally was checking patient data. The State Data Protection Inspectorate investigated the NHIF on the basis of the information provided by the NHIF and, after finding that the company had processed the data unlawfully, imposed a fine of EUR 5 000 on the company by decision of 10 February 2022. The company appealed this decision to the Vilnius Regional Administrative Court, which ruled in favour of the NHIF because the company did not prove the lawfulness of the data processing and did not provide evidence that patients had contacted the company. However, the company is currently appealing against this decision to the Supreme Administrative Court of Lithuania.  

The NHIF responds to suspicious activities of companies in the Orthopaedic Information System and informs the State Data Protection Inspectorate to ensure the protection of patient data.

What is done when orthopaedic companies are found in breach? 

NHIF takes action and suspends contracts when it finds irregularities in the control procedures of orthopaedic companies contracted by the NHIF, but the companies appeal to the judiciary against such actions. The outcome of the cases is often in favour of the companies.  

In 2019, the NHIF immediately suspended the contracts of three companies with which the NHIF has contracts after being informed by the Financial Crime Investigation Service that pre-trial investigations had been opened, but the companies have since appealed the suspension and one of the companies’ suspension has already been declared illegal by the courts, while the other company whose contract has been suspended is still undergoing legal proceedings. This case law shows that the NHIF has difficulties in enforcing sanctions against companies for infringements, as the courts accept that infringements by companies are not sufficient grounds for terminating or suspending contracts. 

In the view of the Courts, the control expert’s certificate cannot be the subject of an independent dispute before the Administrative Court and is not binding on orthopaedic undertakings. The control procedure documents adopted by the Territorial Health Insurance Funds, namely the expert’s certificates, are not to be regarded as having independent legal effects. Following this interpretation of the courts, the NHIF has to litigate with the undertakings before the courts of general jurisdiction following the control procedures.  When bringing a civil action before a court of general jurisdiction, the THIF or the NHIF has to prove all the circumstances anew. The legal proceedings take a long time, by which time most of the evidence is no longer available, leading to decisions in favour of the companies.  

If, as a result of a large number of breaches, a contract has been suspended or terminated (even if this is provided for by the Minister’s orders in force) and the breaches identified in the Certificate of Expertise are not proven in court, the companies go to court to claim compensation for the loss of revenue for the period of suspension or termination of the contract, and the courts award hundreds of thousands of euros to be paid by NHIF. 

(Freepik photo)

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Last updated: 09-08-2023

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