After preparing for three key issues, follow these recommended strategies when pursuing the market in Japan.
Payer organizations face a host of issues in the conversion to ICD-10.
Identify the roadmap through which you’re evolving with the changing healthcare landscape.
What you need to learn before thinking about seeking Medicare reimbursement for a clinical trial.
Successful accountable care organizations consist of a superior confluence of quality efforts, physician engagement, patient engagement, the right administration and the ability to keep costs down. The challenge comes in balancing these efforts while keeping costs to a minimum.
While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.
Prior “aggressive” tactics of manufacturers launching new technology can poison the reimbursement environment for a related, but distinct technology occupying the same space. This discussion traces the history of two of the most challenging reimbursement environments: wound healing and spine technologies.
Billing in clinical trials has changed recently, so here is a summary of where it has been and where it is heading.
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.