Cross-Border Healthcare Regulations, 2013

L.N. 389 of 2013

HEALTH ACT, 2013

(ACT XI of 2013)

Cross-Border Healthcare Regulations, 2013

IN EXERCISE of the powers conferred by article 31 of the

Health Act, the Minister for Health has made the following

regulations:-

General Provisions

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

Healthcare Regulations, 2013.

(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.

(3) These regulations shall be deemed to have come into force

on the 25th October, 2013.

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;

"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;

"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.

The Department for Policy in Health shall be the The competent

competent authority responsible for all matters pertaining to cross- authority.

border healthcare.

The National Contact Point for Cross-Border Healthcare

There shall be a national contact point for the purposes of Establishment

cross-border healthcare, hereinafter called the national contact point, of

contact point.

having such powers and functions as set out in these regulations.

The national contact point shall have its office at such Seat of the

address as the Minister for Health may, from time to time, determine. national

point.

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

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

point.

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.

(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.

(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 Conditions for

only be reimbursed to an insured person after all the conditions laid reimbursement.

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) No costs shall be reimbursed in relation to healthcare

provided by local private healthcare providers.

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

shall be either the amount of the relative healthcare service or reimbursement.

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 ensuring 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 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 Refusal of prior

authorisation.

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.

€0.63