[sanarothe]

Reimbursement is the #1 barrier to bringing a novel therapy to market in the US for the company I'm working for. The technology is decades old and proven (the novel part is where it's being put in the body) - the clinical benefits are now proven.

But it's a battle to get US insurance to cover the therapy - we have about 3x more patients confirmed as clinically eligible than actually get the therapy. (That is to say, US insurance rejects ~75%+ of claims).

As a result, there is an entire segment of the org dedicated to reimbursement. We have a team of professional insurance-bullshit-waders - they call, they file claims, they follow up, and I hear them asking for Document Control Numbers and Call Reference Numbers. There are 'Government Affairs' people who lobby with the VA and Medica{re, aid?}.

The payer barriers outside of US have been much lower. (But EU has it's own problems with medical device barriers... a rant for another day.)