This sounds very complex, possibly too complex to answer on a forum such as this one.
It is the new HCPCS code that requires market data and proof of a market share of at least 3 %. I do not know about CPT codes.
Also, the link I posted is only for HCPCS codes, not CPT codes. Those are not the same things. CPT codes are used to coding procedures, HCPCS codes are used for reimbursement of durable medical goods supplied to patients,
I suggest you try searching using the name of a competitor device. Having an external party advise you to get your own HCPCS code is all well and good, but that will cost a lot of money and typically takes ten years. I advise clients to use an existing HCPCS code if at all possible and make sure that the reimbursement rate is consistent with anticipated cost.
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Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
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Original Message:
Sent: 11-Sep-2017 08:41
From: Anonymous Member
Subject: Coding and Reimbursement
This message was posted by a user wishing to remain anonymous
Thanks very much for the response. I am still trying to understand process, so the question is aimed at understanding the steps I must follow. Do I have to go get a HCPCS code first through CMS, and then go get the CPT code from AMA which will take the 3 years and require all the evidence?
My IVD is one that is aimed at one therapeutic drug that is similar to an IVD for a different therapeutic drug that already has a CPT code, but I have been cautioned by an external party that new HCPCS and CPT codes should be obtained for the new device because using those for the similar device is too risky, and I don't know where to start in doing that.
Interestingly, when I search that similar device code (I used the CPT code which is presumably the HCPCS code) on the DME link that you provided, it is not found, so I am not sure what that means?
Original Message:
Sent: 10-Sep-2017 07:08
From: Jean Bigoney
Subject: Coding and Reimbursement
It wasn't clear from the question what you are looking for.
If you hope to get a new code established for your device, please be aware that this takes years and a significant amount of data for justification. Plus your device will need marketing data to show that you've captured at least 3 % of the available market. This information is rarely available for a recently cleared device.
The first place to start would be doing a search here:
DME Classification System
try to see if similar devices already have a HCPCS code. If so, the process is fairly simple. You only need to submit a "Coding Verification Request" to have your device included in an existing code.
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Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
Original Message:
Sent: 08-Sep-2017 07:31
From: Anonymous Member
Subject: Coding and Reimbursement
This message was posted by a user wishing to remain anonymous
Looking for a good, inexpensive resource to learn more about the PROCESS required for a new clinical lab IVD to obtain coding and reimbursement. For instance, focus on obtaining CPT code first or focus on obtaining a HCPCS code first? Can only find application information at CMS.gov for a level II HCPCS, but what if I am a level I with no CPT? Understanding the requisite steps and timing for before, during and after 510(k) review would be helpful. Thanks!!