Need for an insurance system

Two of the objectives of World Marrow Donor Association (WMDA) are to facilitate the international exchange of hematopoietic stem cells for allogeneic transplantation, and to standardize the ethical, technical, medical, and financial aspects of such exchange. This document discusses the insurance related to the ethical aspects of international transplants.

Any medical intervention, from a collection of blood samples to performing an operation, carries a certain level of risk. It is not only imperative to reduce the risk to the lowest possible level for any intervention, but the person undergoing the procedure, as well as the persons and institution performing the procedure, also have to be properly insured. While a given patient with a serious disease is willing to take certain risks to be cured by a given treatment, this is not the case with a healthy volunteer donor. Thus, it is particularly important that the interest of the donor is sufficiently met when he or she is asked to donate cells to a given patient. Also, it is important that any limitations in meeting these interests are adequately clarified for the donor. In case these limitations might interfere with a donor's ability to complete a full stem cell donation, e.g. a second or a third apheresis, this should be communicated to and accepted by the transplant center. Finally, the person and institution performing the procedure have to be properly insured against any claim for damages due to malpractice or accidents. Fundamental in these respects is an open dialogue, comprehensive information, and low risk procedures.

It is important to emphasize that comprehensive donor insurance does not eliminate the donor centre's (DC) obligation to ensure that individual donors receive the highest available level of care and support. This issue is addressed in other WMDA publications.^1,2,3 The DC must notify the donor of available insurance cover prior to any procedure, and must clearly state the notification limits due to established time limits. When an event occurs, it is the responsibility of the donor's primary collection physician and/or the donor to notify the DC. At this point, the DC should guide and support the donor throughout the entire reimbursement process.

The general impression is that more than 95% donors of bone marrow and peripheral blood stem cells (PBSC) do very well with only temporary minor complaints, and that another 3–5% of donors suffer more intensively and/or for a prolonged period of time, but eventually become free of complaints. The incidence of major complications and side effects, or death, following bone marrow or peripheral blood stem cell donation is extremely low, probably at the level of 1–5 per 10 000 donations. There has up to now been an organized reporting system by the National Marrow Donor Program (NMDP), but no reporting system at a global level. Therefore, the WMDA started an international data reporting system Serious Events and Adverse Effects Registry (SEAR) in 2001 to meet the need for an anonymous, systematic, centralized, and authorized data base for severe adverse effects.

This document deals with insurance issues related to all activities of a donor registry and a donor center, as well as a blood and cell collection center. First, definitions and a brief review of a small survey on insurance policies performed in the fall of 2000 are presented. Then, the different aspects of insurance policies are discussed. Finally, the recommended insurance policies are presented, together with a suggestion for a particular insurance model. Patient insurance and transplant center liability insurance are not dealt with in this document.

Definitions

Donor registry (DR):

is a centralized registry and coordinating unit, facilitating and coordinating stem cell donor search, donor and umbilical cord blood (UCB) evaluation and workup, and stem cell donations. The registry may also function as a donor center.

Donor center (DC):

is a center where donor recruitment, donor registration, donor contact, donor evaluation, blood and umbilical cord blood (UCB) sampling, and therapeutic cell donation coordination are performed.

Collection center (CC):

is a blood bank, medical unit or hospital, where collection of cells for diagnostic or therapeutic use (bone marrow, PBSC, UCB, T lymphocytes, whole blood, platelets, blood samples) is performed.

Transplant center (TC):

is the hospital where treatment of the patient with therapeutic cell products from the donor is being performed.

Donor insurance:

is the insurance to cover the complaints of the donor following blood-letting, evaluation, workup, and collection.

Liability insurance:

is the insurance to cover the interests of the DR, DC, and CC against donors' and patients' claims for malpractice or accidents related to any administrative act, service or treatment provided, e.g. donor typing, evaluation, workup, and cell collection, or to the therapeutic cell transfer to the patient.

Insurance policy – a survey

A small survey was initiated by the WMDA Ethics Working Group in August 2000 to investigate both the institutional insurance policy (e.g. hospital policy) and the insurance policy covering the center's activities. A questionnaire containing questions related to insurance of the DR, DC, and CC was sent to 41 DRs listed in Bone Marrow Donors Worldwide (BMDW). In all, 26 (63%) registries replied. The survey indicated that one out of four DRs who replied to the questionnaire had no donor insurance, and many centers stated that they did not have liability insurance. Thus, it is clear that many DRs, DCs, and CCs need to review their insurance policies carefully in order to obtain a reasonable level of insurance cover.

Professional liability insurance

Professional liability insurance is an insurance for individual DR, DC, and CC to ensure that any malpractice or accident causing damage to the patient or the donor would allow for sufficient compensation in the event of a complaint to the DR, DC, or CC.

Insurance regarding donor complaints – malpractice or accident

Donor insurance, i.e., insurance to cover donor complaints despite the completion of a normal and uneventful procedure, is discussed on the next page. Professional liability insurance concerns any center's responsibility for malpractice or accident caused by the center, and affecting the donor's health and integrity or the interest of his/her relatives. When dealing with malpractice, the level of cover may be significantly higher than a regular donor insurance, and legal actions as well as removal of WMDA credential membership may be taken as a consequence of malpractice.

Insurance regarding patient complaints – malpractice or accident

Any DR, DC, or CC may cause harm to a patient, e.g. by providing cell therapy from the wrong donor, damaging the cell product, etc. Some accidents or malpractice may have life-threatening consequences. It is therefore required that all centers involved should have adequate professional liability insurance and that the level of compensation should be at a high, but reasonable level. This level should also be communicated to the TC and accepted by the TC. Thus, there is a great need for international standards regarding the coverage and level of compensation, especially since there is an extensive international exchange of stem cells and other cell products for therapy. A uniform professional liability insurance package would allow the TC to inform the patient of its content and limitations. It is recommended that the same principles are applied for domestic, unrelated donation.

If a particular TC cannot accept the level of compensation defined in the DR's, DC's or CC's professional liability insurance for malpractice, the involved centers must find a way to resolve the particular problem prior to donation. In the worst case, the donor may have to travel to another center or the donation may have to be cancelled.

This type of professional liability insurance requires that the party responsible for the collected product be defined for each aspect and every point of time throughout the procurement process. For instance, the CC's responsibility for a harvested product, such as bag damage, ends when the TC representative (a TC-provided courier or a medical professional at the site of the TC) receives the product and signs a receipt stating that the bags were received in a good condition. If, however, it can later be proven that the content of the bag did not meet quality standards, e.g. was found to have contaminated or coagulated contents, the responsible party must be clearly identified.

Often, there will be a dispute between involved centers. The patient and/or his/her relatives should not be involved in these disputes, but in due time, be sufficiently compensated by the responsible party.

In many instances, it is possible to limit the liability of the DC by a standard declaration by the transplant center and the patient stating that they are aware of the existence of such limitations. These limitations may include the maximum amount of coverage, the terms and provisions or the length of period for filing the claim. We are not aware of any liability claims filed at the DC by the patient or the TC. The standard declaration may be a helpful tool to help the DC to manage their liability horizon in relation to the potential risks of a claim from the donor.

Comprehensive donor insurance

A comprehensive donor insurance is a lump sum insurance to cover financial loss related to any physical harm or loss of income caused by any of the medical events related with the donation or predonation evaluation. A liability claim to be brought by the donor is not necessary, because this type of insurance only require the existence of a direct relationship between the cause and the injury. Complaints from the donor may be directed to the DR, DC, or CC. The insurance language has to incorporate that a complication may occur despite normal and uneventful completion of a given procedure.

Premises

A healthy individual who altruistically donates a stem cell graft or any other kind of cell product for cell transfer therapy to an anonymous patient must be covered at a reasonable and locally acceptable level of damage compensation, and for everything that directly or indirectly can, beyond reasonable doubts, be connected to the donation itself or evaluation for donation. Doubts about such connections have to be solved in the most favorable way possible for the donor, and representatives from the DR, DC, or CC involved should, as a principle, advocate the donor's interests. If possible, the DR, DC, or CC should guide and assist the donor in his or her efforts. If the insurance policy does not permit such assistance, one would have to consider alternative means of assistance, e.g. assistance by a third party advocate, etc. The aim is to avoid instances wherein a donor might have to participate in lengthy and costly disputes with the DR, DC, CC, or the insurance company about compensation.

Any damage which makes the donor chronically ill or causes a reduced quality of life requires a compensation, which provides a financially secure and adequate psychosocial and somatic quality of life for the period of the disablement, if necessary for the rest of the donor's life. In addition, the interests of a donor's family must be adequately taken care of in the event of a donor death or a chronic or serious illness.

As always, there is a gap between the ideal situation indicated above and the reality. Thus, it is impossible to guarantee that every aspect of a donor's needs and interests can be taken care of by any insurance policy, and all insurances will have limitations in accordance with national (and international, if necessary) laws and regulations as well as insurance company strategies. Thus, there will continue to be areas of events that cannot be covered by current insurance policies, e.g. subjective complains without objective grounds. Therefore, it is pivotal that any limitation in insurance which compromises the ideal coverage must be made clear to the donor orally as well as in writing. At the time of workup for stem cell donation, the content and the incurral period of the insurance policy should briefly be outlined for the donor in an easily understandable way before the informed consent is signed. Secondly, donor information sessions, particularly prior to the donation of therapeutic cells, have to be conducted in a way that potential somatic, psychological, and psychosomatic risk factors are uncovered and considered, and anything that could place the donor at risk for complications or prolonged post- donation complaints should be regarded as contraindications unless they can be effectively and irreversibly removed.

Situations may occur where it is not possible, beyond reasonable doubt, to link a donor's complaints directly or indirectly to the cell harvest itself. It is recommended that the DC avoid collecting cells from any donor who is at risk for these kinds of post-donation complaints, e.g. individuals with long records of diffuse complaints and frequent medical attentions who may seem more at risk for psychosomatic or somatic problems. A preharvest medical examination should therefore also focus on identifying these contraindications. However, when post-donation complaints are recognized, the donor has to be aware that the involved center will do everything possible to support the donor. Eventually, the final conclusion might still be that the donor will not receive any insurance compensation and the donor should then be assisted to accept the reasons for the dismissal of the complaint. This is dependent upon an initial good and comprehensive understanding of the procedure requested as well as the content, including limitations, of its insurance and of a good and open dialogue between the centers involved.

It is in the interest of any DR, DC, and CC to ensure that damages, accidents or diseases caused by any procedure requested or events related to the procedure do not compromise national and international unrelated stem cell transplantation programs and donor recruitment campaigns. Thus, it is in everyone's interest that all donors are satisfied with the support and understanding provided by the involved centers.

Cover

Donor insurance cover and/or direct center-to-donor compensation should cover damages and illness caused by or related to the following events: blood sample collection; autologous blood collection; health examination; mobilization of PBSC; general, spinal or local anesthesia; stem cell collection (bone marrow, PBSC, or UCB); lymphocyte collection (whole blood or apheresis); platelet collection (whole blood or apheresis); extended absence from work (prolonged income loss, extended employer expenses); accidents that may occur during travel back and forth to events asked for by the DR, DC, and CC, being that from and to home, working place, school, etc; accidents that may take place while present in the hospital or another facility, where a procedure asked for is being performed.

In addition, any other protocol or procedure envisaged has to be considered for insurance coverage.

The period covered should be as long as possible. This period may vary between insurance policies of individual countries, from some weeks or months to a year or longer. Although the insurance company may restrict this period to a short period, one should negotiate a longer term because this type of insurance would anyway require a causa between the donation and the damage.

Conclusion

WMDA strongly recommend that each of DR, DC, and CC establishes an insurance policy which is in line with the principles given above. Such polices might either be developed nationally or by an international broker. WMDA strongly urges the involved centers to obtain proper donor insurance contracts, also taking into account that a sufficient donor insurance level has been required to achieve WMDA credential membership of good standing. WMDA further recommends that the centers should have proper medical professional liability insurance, which complies with national and international standards.

References

1. Goldman JM, for the Executive Committee of the World Marrow Donor Association. Special report: Bone marrow transplants using volunteer donors – recommendations and requirements for a standardized practice throughout the world – 1994 update. Blood 1994; 84: 2833–2839. | PubMed | ISI | ChemPort |
2. Rosenmayr A, Hartwell L, Egeland T, on behalf on the Ethics Working Group of the World Marrow Donor Association. Informed consent – suggested procedures for informed consent for unrelated haematopoietic stem cell donors at various stages of recruitment, donor evaluation, and donor workup. Bone Marrow Transplant 2003; 31: 539–545. | Article | PubMed | ISI | ChemPort |
3. Bakken R, van Walraven A-M, Egeland T, for the Ethics Working Group of the World Marrow Donor Association. Donor commitment and patient needs. Bone Marrow Transplant 2003; 33: 225–230. | Article | ISI |