Against my better judgment, I have once again trie
Post# of 7795
What I picked up right away was how easily the process could get derailed by someone (or group) for nefarious purposes. For a while even TENS was fully reimbursed thru CMMS so how high could the standard be? TENS was, and is, crap with no comparison whatsoever to PEMF BIEL Actipatch & RecoveryRx or any other PEMF BIEL product.
Another thing is how very dependent the process is on the AMA. These are the very same boys and girls who singlehandedly, and very nearly, obliterated naturopathic (Chiropractic, Acupuncture, Yoga, etc.) medicine in favor of surgery and drugs (Allopathic). And we have paid a very dear price for that ever since (e.g. - the Sackler / Opioid billion dollar crime spree). The TENS fit perfectly in with that - minimally effective, clunky, but looked really cool and impressed the hell out of poorly informed patients.
Remember, you are a Revenue Generating Unit (R.G.U.) in the eyes of the medical establishment. Treat the symptoms and they have you as a patient for life. Treat the cause and severely limit the income. In a perfect world (ha!) we will sail thru to getting a CPT code. So, read it, get an idea of what's it all about and let's keep our fingers crossed. Getting this would mean the floodgates will open wide and moolah (lots of it) will follow.
Reimbursement Strategies and CPT Codes for Device Development
https://repository.upenn.edu/cgi/viewcontent....ontext=ace
Summary
● Reimbursement refers to the complicated process by which physicians and hospitals deliver products and services and then receive payment from third-party payers.
● Reimbursement consists of three factors: coding, coverage, and payment.
● The Current Procedural Terminology (CPT) codes include category I, II, and III codes, each with a different purpose and criteria.
● Requesting a new CPT code for a new device is a complicated and lengthy process, so an early understanding of the process is important to identifying the necessary resources.
● Working with CPT code consultants and a medical specialty society can help a startup obtain new CPT codes to ensure reimbursement for new medical devices, or determine if the new device fits within an existing CPT code.
Introduction
Bringing a medical product or service to market is a challenge. An academic entrepreneur needs to understand the entire commercialization process and manage multiple tasks related to earlystage research and development, clinical trials, regulations, and reimbursement. The goal of receiving Food and Drug Administration (FDA) approval is often considered the ultimate endpoint that leads a new technology to commercial success.
However, getting marketing approval does not guarantee market success. For example, if new products do not obtain the desired amount of reimbursement or, even worse, are not covered by payers, then physicians and hospitals are highly unlikely to buy and utilize the new products. Therefore, ensuring reimbursement for the new product can be as important as obtaining regulatory approval. It usually takes several years to plan and execute a successful reimbursement strategy. Hence, instead of waiting for market launch, the company should start reimbursement planning in parallel to developing the regulatory strategy.
Conclusion
Academic entrepreneurs devote considerable effort and time to developing innovative medical devices. The ultimate goal is distributing the new technology to the market successfully so that it can benefit patients. A sound reimbursement strategy with appropriate CPT codes can help a medical device be widely adopted, create value for physicians and patients, and generate revenues for the company. Three categories of CPT codes (I, II, and III) are used to track mainstream services/procedures, measure performance, and monitor emerging technologies, and each category has its own criteria and literature requirement. Fitting a product into the CPT code schema requires the support of physicians and medical societies. Working with a reimbursement consultant early on maximizes the likelihood of commercial success and saves time and costs.
Hope this helps - later, WBeacham