Regulatory approval by the FDA is considered a critical goal by manufacturers and their investors, which is understandable, since there can be no commercialization without it. However, adequate payer reimbursement is clearly the final goal. Without it, commercialization stalls. The following blog is the first in a series of posts that examines the relationship between reimbursement and the type of regulatory approval for medical devices, i.
The k process is the most common of FDA regulatory pathways; it is estimated that some 3, to 4, devices receive FDA
Validating non fda through the k process, compared to about 30 to 40 devices that receive FDA approval through the more rigorous premarket approval PMA process.
Specifically, the device must have the same intended use and technical characteristics of the predicate device. Therefore, clinical data submitted to FDA, if it is required at all, typically focuses on safety and on demonstrating the substantial equivalence between the two devices, rather than the clinical efficacy.
It is estimated that only about 10 percent Validating non fda k submissions include clinical data. Many of the k cleared devices represent next generation devices, such as design modifications to existing devices.
However, sometimes a k cleared device will represent a new use for the technology that will come to the attention of a payer. These are the types of devices that will come to the attention of a payer. While manufacturers may appreciate the shorter pathway to commercialization associated with a k clearance, in many instances this can also be a direct route to payer non-coverage. There are a couple of observational studies, and perhaps a small randomized study that meets some, but not all of its outcomes.
The payer begins to receive inquiries from providers about coverage, so the manufacturer distributes a clinical dossier to the payers. The medical policy staff at the payer organization notes the relative paucity of literature and that the device was approved through the k process. They also note the very large target market population for this device, thus creating implicit concerns about the budget impact.
This is an easy medical policy for Validating non fda payer to create.
There is no need to wade through large volumes of literature — an investigational status can be easy to implement and will say something along the lines of: Initial data are promising, but larger well-controlled trials with long-term follow-up are required to validate the safety and effectiveness of the technology.
The implications of such a policy are ominous.
Right at the start of commercialization, the manufacturer is saddled with a very high evidence requirement that would be difficult to meet under the best of circumstances. Furthermore, as the device begins to be used, the narrow window for a randomized trial closes quickly, as physicians may be reluctant to enroll Validating non fda. Now manufacturers are in the situation of a negative policy with an evidence requirement that may be very challenging to meet.
The typical next step for a manufacturer is to commit significant resources to a campaign of grass roots support, including a reimbursement hotline, support for an appeal process, and support for the publication of additional observational studies. These efforts are expensive and Validating non fda take years to turn this situation around.
Over time, the literature base may expand to include multiple observational studies that consistently report positive results. However, each time the payer policy comes up for its annual review, the payer merely notes the ongoing lack of randomized studies with long-term follow-up, and the investigational status remains unchanged. Typically, the manufacturer and the physician champions repeatedly point out to the payer that it is time for the payer to consider the weight of the evidence rather than the limitations of each individual study, but to no avail.
However, the regulatory path can sometimes make or break a reimbursement pathway for that technology. Validating non fda trials are expensive to conduct and can delay commercialization for years, but this has to also be balanced with the hefty price tag of a long-term grass roots effort after commercialization, coupled with a Validating non fda multi-year delay in coverage and payment.
Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a k product. Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular "Validating non fda" tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.
Billing in clinical trials has changed recently, so here is a summary of where it has been and where it is heading.
The reality is that often data cannot speak for itself. Even a Validating non fda randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.
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