Research, page-2234

Hi @MikesLM

The classification itself is not directly relevant to reimbursement. It is for regulation of the device in specific jurisdictions.

However the question of value is relevant to the medical insurers and providing a more compelling value in terms of reducing cost for diagnosis, treatment and less longer term claims is of critical interest to insurers.

That said there is usually a long road to convincing payers (in the US) that they should fork out for tests and treatments before the Company can show incontrovertibly that they will save the payer money.

Often there will be challenges made by claimers that the vendor will support and guideline inclusions or clinical practice recommendations that tip the balance. Sometimes other payers start providing coverage and that encourages an industry-wide change as they review their policies(annually usually).
Large hospitals and buying groups can also have impact
Other countries that have national health management systems will usually have some form of government review and inclusion based on clinical and fiscal benefit as in the NHS and Medicare.