CROSS-BORDER HEALTHCARE REGULATIONS

SUBSIDIARY LEGISLATION 528.03

CROSS-BORDER HEALTHCARE REGULATIONS

25th October, 2013 *

LEGAL NOTICE 389 of 2013, as amended by Legal Notice 473 of 2014

and 173 of 2019.

General Provisions

(1) The title of these regulations is the Cross-Border

Healthcare Regulations.

(2) These regulations implement the provisions of Directive

2011/24/EU of the European Parliament and of the Council of 9

March 2011 on the application of patients’ rights in cross-border

healthcare.

In these regulations, unless the context otherwise requires -

"Commission" means the European Commission;

"cross-border healthcare" means healthcare provided or

prescribed in a Member State other than the Member State of

affiliation;

"Government Formulary List" shall have the same meaning as is

assigned to it in regulation 5 of the Availability of Medicinal

Products within the Government Health Services Regulations;

"healthcare" means health services provided by health

professionals to patients to assess, maintain or restore their state of

health, including the prescription, dispensation and provision of

medicinal products and medical devices;

"healthcare provider" means any natural or legal person or any

other entity legally providing healthcare on the territory of a

Member State;

"insured person" means an insured person under the Social

Security Act, as well as their dependent member of the family as

defined under the Regulation (EC) No 883/2004 of the European

Parliament and of the Council of 29 April 2004 on the coordination of

social security systems, residing with the insured person, as well as,

any person entitled to a pension under the Social Security Act, and

where applicable, survivors as provided for under the Social Security

Act, residing with the insured person immediately preceding the death

of the insured person;

"local private healthcare provider" means any healthcare

provider established under whatsoever form on the Maltese

territory;

"medical device" means a medical device as defined in the

Medical Devices Regulations;

*see regulation 1(3) of these Regulations, as originally promulgated.

"medicinal product" means a medicinal product as defined in the

Medicines Act;

"Member State of affiliation" means the Member State that is

competent to grant to the insured person a prior authorisation to

receive appropriate treatment in another Member State;

"Member State of treatment" means the Member State on whose

territory healthcare is actually provided to the patient. In the case

of telemedicine, healthcare is considered to be provided in the

Member State where the healthcare provider is established;

"Minister" means the Minister responsible for health;

"national contact point" means the national contact point for

cross-border healthcare established by regulation 4;

"patient" means any natural person who seeks to receive or

receives healthcare in a Member State;

"prescription" means a prescription for a medicinal product or

for a medical device issued by a member of a regulated health

profession;

"Register" means the register established by article 25 of the

Health Act.

The Department for Policy in Health shall be the

competent authority responsible for all matters pertaining to cross-

border healthcare.

The National Contact Point for Cross-Border Healthcare

There shall be a national contact point for the purposes of

cross-border healthcare, hereinafter called the national contact

point, having such powers and functions as set out in these

regulations.

The national contact point shall have its office at such

address as the Minister for Health m ay, from t ime to ti me,

determine.

It shall be the mission of the national contact point to be

the main point of reference for all matters related to information on

cross-border healthcare, including the provision of information to

patients, patients’ organisations, healthcare providers, healthcare

insurers and other contact points of other Member States.

(1) The national contact point shall have those functions,

in general, as may be prescribed by the Minister from time to time,

but in particular these shall include

(a) the cooperation with the Commission and with the

other contact points of other Member States on matters

relating to cross-border healthcare;

(b) the consultation with patient organisations, healthcare

providers and healthcare insurers;

(c) the facilitation of the exchange of information referred

to in paragraph (d) and the cooperation with other

contact points;

(d) the provision to patients and health professionals, on

their request and in accordance with established

practices, of information related to

(i) the contact details of national contact points in

other Member States;

(ii) their rights and entitlements related to receiving

cross-border healthcare including the terms and

conditions for prior authorisation and the

reimbursement of costs;

(iii) procedures for accessing and determining those

entitlements;

(iv) healthcare providers, including information on a

specific provider’s right to provide services and

any restrictions on its practice;

(v) patients’ rights in relation to cross-border care in

accordance with these regulations;

(vi) complaints procedures and mechanisms for

seeking remedies in relation to cross-border

healthcare in accordance with these regulations;

(vii)

the legal and administrative options available for

settling disputes, including those related to harm

arising from cross-border healthcare;

(viii) the standards and guidelines on quality and

safety laid down by the Member State of

treatment, including provisions on supervision

and assessment of healthcare providers,

information on which healthcare providers are

subject to these standards and guidelines and

information on the accessibility of hospitals for

persons with disabilities;

(ix)

the elements to be included in prescriptions

issued in a Member State other than the Member

State where they are dispensed, as provided for

in the Prescription and Dispensing Requirement

Rules.

(2) The national contact point shall ensure that all relevant

information requested under the Act and under these regulations,

including all contact details, shall be readily available to the public,

including by electronic means and in formats accessible to persons

with a disability, as appropriate.

(3) The national contact point shall act as the Technical

Secretariat for the Cross-Border Prior Authorisations Committee

established under these regulations. It shall also be the function of

the national contact point to communicate to the patient whether

authorisation has been granted or not in accordance with regulation

11(5).

(4) The national contact point shall be responsible to receive

claims for reimbursement and for determining whether such claims

fulfil conditions for reimbursement under these regulations.

Reimbursement of Cross-Border Healthcare

(1) The costs related to cross-border healthcare shall only

be reimbursed to an insured person after all the conditions laid

down in these regulations have been satisfied and if the healthcare

for which reimbursement is being requested forms part of the

Register provided for in the Act

Provided that notwithstanding the above, for the purpose of

cross-border care, organ transplants, vaccination programmes

against infectious diseases, long-term and community care services

are excluded.

In respect of medicines, medicinal products and medical

devices, reimbursement of cross-border health care shall refer only

to those instances where these are provided in the context of a

health service and where such products form part of the

Government Formulary List.

(2) An insured person who is resident in a Member State other

than in Malta, and for whom Malta is the competent Member State

under Regulation (EC) No. 883/2004, shall be entitled to the

services offered by the Maltese public healthcare system at the

same conditions of other insured persons residing in Malta, if such

a service

(a) is not a service requiring prior authorisation in the

Member State where the insured person resides; and

(b) is not provided in accordance with Chapter 1 of Title

III of Regulation (EC) No 883/2004.

(3) No costs shall be reimbursed in relation to healthcare

provided by local private healthcare providers.

(1) The maximum amount of costs to be reimbursed shall

be either the amount of the relative healthcare service or services

costs according to the Register provided for in the Act, or the actual

costs of the healthcare service or services received, whichever is

the lowest. No ancillary or related costs shall be reimbursed.

(2) Reimbursement of the costs of cross-border healthcare shall

be subject to the same conditions, criteria of eligibility and

regulatory and administrative formalities, as applicable if this

healthcare was provided under the Maltese public healthcare

system

Provided that notwithstanding the above, the Directorate

for Policy in Health shall retain the right to limit the application of

the rules on reimbursement for cross-border healthcare based on

overriding reasons of general interest, such as planning

requirements relating to the aim of ensur ing sufficient and

permanent access to a balanced range of high-quality treatment in

Malta or to the wish to control costs and avoid, as far as possible,

any waste of financial, technical and human resources

Provided further that the same conditions, criteria of

eligibility, tariffs and regulatory and administrative formalities

shall apply in the case of a person insured in a Member State, other

than Malta, seeking cross-border healthcare under the Maltese

public healthcare system.

(3) Notwithstanding anything contained in these regulations,

any cross-border healthcare for which a prior authorisation has

already been granted, even before the entry into force of these

regulations, shall be reimbursed in accordance with that same

authorisation.

(4) Notwithstanding the provisions of this regulation, the

Minister shall retain the right to adopt measures regarding access to

treatment aimed at fulfilling the fundamental responsibility to

ensure sufficient and permanent access to healthcare within Malta

and that are justified by overriding reasons of general interest.

Healthcare subject to Prior Authorisation

(1) No insured person seeking to exercise his rights under

these regulations shall be required to seek prior authorisation for

the treatment sought save under the following circumstances

(a) if it involves hospital accommodation of the patient in

question for at least one night; or

(b) if it requires use of highly specialised and cost-

intensive medical infrastructure or medical equipment;

or

(c) if it involves treatments presenting a particular risk for

the patient or the population, or

(d) if it is provided by a healthcare provider that could

give rise to serious and specific concerns relating to

the quality or safety of the care, with the exception of

healthcare which is subject to European Union

legislation ensuring a minimum level of safety and

quality throughout the European Union.

(2) For the purpose of this regulation, the Directorate for

Policy in Health shall publish a list of procedures which shall be

known as the List of Procedures Requiring Prior Authorisation for

Cross-Border Healthcare, and which may be updated from time to

time, that require prior authorisation under sub-regulation (1).

(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.

Healthcare providers shall provide relevant information to

help individual patients to make an informed choice, including on

treatment options, on the availability, quality and safety of the

healthcare they provide in Malta. They shall also provide clear

invoices and clear information on prices, as well as on their

authorisation or registration status, their insurance cover or other

means of personal or collective protection with regard to

professional liability.

A person receiving cross-border healthcare shall be

entitled to the medical follow-up in Malta, as prescribed, but only

insofar as such a follow-up is provided for in the Register and

insofar as it forms part of the Government Formulary List. Such a

medical follow-up shall also be subject to the same access criteria

required for similar follow-ups for healthcare provided in Malta.