3331. Deputy Ken O'Flynn asked the Minister for Health to examine the situation facing families of children with congenital heart disease who require lifelong anticoagulation therapy, specifically in relation to the cost of INR testing strips for home monitoring devices; whether these strips can be made available or reimbursed under the medical card scheme or the drug payment scheme; whether consideration will be given to reviewing the current classification of INR testing strips as medical equipment, given that their function is intrinsically linked to the management of life-critical medication; and if she will make a statement on the matter. [61239/26]

The Health Service Executive (HSE) has statutory responsibility for pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. The Minister for Health has no role in these decisions.

The HSE have advised that CoaguChek® meters and International Normalised Ratio (INR) self-testing strips are not reimbursable under the General Medical Services (GMS) scheme, the Community Drug Schemes, or the Community Funded Schemes.

Whilst a range of diagnostics are available on the HSE's formal Reimbursement List for use in Diabetes, a change in HSE policy would be required to expand this to other therapeutic areas such as INR testing ancillaries.

The HSE have further advised that on very rare occasions, CoaguChek® strips were approved for reimbursement in the most exceptional circumstances under Discretionary Hardship Arrangements where it was clear that there was no other option for the patient i.e., the person was bed bound or could not travel to the INR clinic.