S.L. 528.3 Art. 11Refusal of prior authorisation.

(1) Prior authorisation may be refused for the following reasons:

(a) the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross-border healthcare;

(b) the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question;

(c) this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment;

(d) this healthcare can be provided in Malta within a time-limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned.

(2) Without prejudice to the provisions of paragraphs (a) to (c) of sub-regulation (1), prior authorisation may not be refused when this healthcare cannot be provided in Malta within a time-limit which is medically justifiable, based on an objective medical assessment of the patient’s medical condition, the history and probable course of the patient’s illness, the degree of the patient’s pain and, or the nature of the patient’s disability at the time when the request for authorisation was made or renewed.

(3) There shall be established a Committee, to be appointed by the Minister and to be known as the Cross-Border Prior Authorisations Committee, whose function shall be to ascertain whether all the conditions laid down under the Act and under these regulations have been met and to decide whether such prior authorisations shall be granted.

(4) Any request for cross-border healthcare shall be dealt with within a period of six weeks from the date such request is received, unless the urgency of the case or the particular medical condition requires a shorter period.

(5) Any decision taken regarding the use of cross-border healthcare and, or reimbursement, shall be properly reasoned and forwarded to the patient, and subject to appeal under the provisions of the Act.