Edward Berger's blog
Demonstrating clinical evidence is the place to begin ensuring that your new medical technology can win reimbursement.
If "Do you have a code?" is the wrong question to ask when assessing the reimbursement prospects of an innovative device, drug, or diagnostic, is there a right one — a single question that can separate the life science reimbursement gold from the technological base metals that insurers won't likely pay for? Yes there is, and it's a question I don't often hear asked in a clear and concise way:
"Can you demonstrate, with evidence strong enough to withstand rigorous review, predictable clinical benefits to a defined patient population?"
Stated even more simply: "Can you prove your technology's clinical utility?"
"Do you have a reimbursement code?" is wrong question when it comes to ensuring reimbursement for a new medical technology. Here's what you need to know to clear a path to reimbursement for an innovative device.
When pitching to potential life sciences technology investors, entrepreneurs know that they need to demonstrate a clear path to reimbursement. Angels, VCs and strategic partners don't want to commit resources to develop something that won't get adequately paid for in a reasonable timeframe. That makes perfectly good sense. Indeed, I'd argue that the need to assess a technology's likely reimbursement status begins even earlier than the investment pitch.
Will comparative effectiveness research change the nature of the competitive landscape for medical device companies?
If healthcare reform legislation now before Congress becomes law, it will certainly contain a clearly articulated organization structure and a fairly generous flow of funds to develop and implement a robust comparative effectiveness research program.
The flap over proposed mammography screening guidelines exposes the difficulty of rational discourse on healthcare reform.
Public furor, professional hand-wringing and political posturing over a revised recommendation on mammography screening for breast cancer issued this month by the U.S. Preventive Services Task Force points to a pair of little-discussed but critical impediments to real progress in improving the efficiency and the effectiveness of our healthcare system:
- Our primary media sources of information are increasingly incapable of dealing effectively and informatively with complex or subtle issues.
A pair of examples, one public and one private, of innovative programs aimed at improving the healthcare system.
While Harry Reid dithers about the final shape of the Senate's reform legislation and industry quivers over the prospect of a federal excise tax on medical devices, some key actors – both public and private – are forging ahead with creative initiatives to control health care costs and improve quality and consumer choice.
The so-called single-payer option might be the health insurance industry's single best option.
The likely shape of a healthcare reform bill that the Congress will be debating come Thanksgiving — give or take a week or two — is becoming clearer, and those hoping for something that will significantly "bend the cost curve" right away have reason to be disappointed.
Not at all. In fact, it just might be a compelling rationale for the public option.
Healthcare is increasingly a data-driven enterprise. The accelerating adoption of evidence-based medicine, the coming revolution in personalized medicine, the advent of the electronic health record and the dedication of stimulus funds and reformers' political capital to the institutionalization of comparative effectiveness research all speak to the growing centrality of empirical data in medical practice.
