A successful marketing strategy for medical technologies takes into consideration the impact of the ‘message’ on all relevant stakeholders: patients, providers and payers. Med tech companies can create challenges for themselves regarding coverage and/or payment by not integrating a reimbursement strategy into their sales/marketing approach.
That depends on where you sit.
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.
As accountable care models become more prevalent, and as life science companies look for ways to partner with ACOs and demonstrate the value of their technologies, it is critical to know how these organizations are structured, how decisions are made and by whom.
ACOs are an important part of the new model of health care delivery and payment in the U.S., and it is important that stakeholders looking to work with these organizations understand the measures and metrics for their success.
A manufacturer-sponsored hotline for providers using a new technology can be a valuable tool in demonstrating medical necessity and supporting patient access to care; but there are federal and state regulations that every manufacturer should know about when developing this type of support service.
Understanding how predicate technologies have been perceived by payers can be a critical step in the launch of a new product or service. Here, two areas of medicine – spine and wound care – are used to illustrate the challenges that manufacturers may face related to technologies that have come before.
The following question-and-answer session reveals important information and attitudes toward coverage of new/existing technologies and standards of evidence.
Billing in clinical trials, which can include the device itself and any routine care associated with the procedure/product use, can be advantageous for two primary reasons.
FDA defines a humanitarian use device (HUD) as one that is “intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.”
Human cells, tissues and cellular or tissue-based products (HCT/Ps) are defined by FDA as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient.
FDA’s PMA approval process is required for those medical devices “that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
The U.S. Food and Drug Administration's 510(k) program was introduced 38 years ago, when FDA was first granted regulatory authority over medical devices.
How can manufacturers and providers get payers to revise their evidence requirement(s) and accept the existing body of evidence?
The development of minimally invasive technologies appears to be a winning scenario for everyone: typically, no hospitalization is required (in fact the procedure may be done in the office setting), reducing costs; patients are more comfortable and can get on with their lives more readily; and employers love the fact that patients can usually return to work more quickly.
Reimbursement for medical technologies has always been a complicated process involving coding, coverage and payment.