There are several questions here so let me answer them one-by-one:
What are the differences one needs to consider in developing a clinical trial that proves safety and effectiveness for a PMA device versus the end points required for reimbursement? PMA is primarily concerned with safety under the narrow scope of the Class II eligibility for a PMA. It depends upon the device as to what is needed. Look for any possibilities that the upgrade being considered will have a different effect on the patient and include measurement of this. More generally, for reimbursement, more payers are looking at similar clinical outcome variables to drug trials. This is beyond the PMA, however.
How successful has the FDA/CMS Parallel Review process been in getting a reimbursement ? Keep in mind that the processes are for different purposes so that while some of the decision-making data needed overlap, the key information needed for each agency's decision does not overlap (or there would not be a need for two agencies.) As with the similar attempt in the EU, it hasn't solved the time problem. The FDA primarily cares about safety but includes some efficacy for Class III devices because they arehigh risk. Think of them as a free market facilitator. That is, if it doesn't hurt anyone, why not let it be available ? CMS wants to determine how to allocate their budget. So their approach is, fine, it is available but do I want to pay for it ? Therefore, don't expect that that the Parallel Review to improve access to new treatments in a fundamental way.
What is the difference between a Category I CPT code vs a Category III CPT Code? Category I is for nearly all procedures (inpatient, outpatient, it doesn4t matter). Category III is a temporary code for a new procedure that is under review.
What are some of the challenges with payors when it comes to a Category III CPT Code? The category itself doesn't pose a problem. It can be useful for monitoring the use of the technology. Payers' issues are around costs and outcomes of the new procedure to determine payment. The CPT codes are not relatied to these elements.
How does one go about establishing the medical device was utilized by many qualified health professionals if we have a retrospective clinical trial? Of course it depends upon the data collected in the retrospective clinical trial. If the database does not have provider IDs, it cannot be used for this purpose. The manufacturer could go back and ask the facilities details on their staff and try to retro-fit an estimation of the number of professionals involved. This has been done successfully.
How does one go about establishing a new novel technology is consistent with current medical practice if the technology is being introduced for the first time ? This is pretty much the situation in most cases and the rationale for using CMP (Current Medical Practice) as the clinical study comparator. The argument is simply, all patients are getting CMP but our patients There are limitations to this because CMP is not the same in all geographies, the comparator is a bit of a black box so determining what is really going on has methodological limitations, and if there is known obvious competition, payers will prefer the competition to CMP.
Do you need a certain number of peer reviewed publications on the effectiveness of your technology to get a Category I CPT code? No, there is no relation whatsoever between publications and CPT codes.
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Jenifer Ehreth
Professor and consultant
Paris
France
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Original Message:
Sent: 14-Mar-2018 13:27
From: Margaret Mucha (FRAPS)
Subject: Ask Me Anything Session: Global Reimbursement Strategies
What are the differences one needs to consider in developing a clinical trial that proves safety and effectiveness for a PMA device versus the end points required for reimbursement?
How successful has the FDA/CMS Parallel Review process been in getting a reimbursement decision at the same time as a medical device approval?
What is the difference between a Category I CPT code vs a Category III CPT Code?
What are some of the challenges with payors when it comes to a Category III CPT Code?
How does one go about establishing the medical device was utilized by many qualified health professionals if we have a retrospective clinical trial?
How does one go about establishing a new novel technology is consistent with current medical practice if the technology is being introduced for the first time?
Do you need a certain number of peer reviewed publications on the effectiveness of your technology to get a Category I CPT code?
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Margaret Mucha (FRAPS) [Senior Leader RAQA
Original Message:
Sent: 14-Mar-2018 13:16
From: Jenifer Ehreth
Subject: Ask Me Anything Session: Global Reimbursement Strategies
A whole lecture is needed to cover VB-contracting because there are no rules published on what to do. It is a contract between payer and manufacturer and often not available to the public. Some countries have some constraints but not many. The reason metrics are specifically not prescribed is that they depend on three things : variables that are proxies for clinical outcomes, variables available on a regular basis during patient treatment, and variables that show sensitivity to changes in clinical outcomes within a time-frame of payment decisions. These requirements are often not used in labeling decisions.
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Jenifer Ehreth
Professor and consultant
Paris
France
Original Message:
Sent: 14-Mar-2018 13:14
From: Anonymous Member
Subject: Ask Me Anything Session: Global Reimbursement Strategies
This message was posted by a user wishing to remain anonymous
I've been getting a lot of questions about value-based contracting (particularly when proposed metrics are not in the drug's approved labeling). Any advice?
Original Message:
Sent: 14-Mar-2018 13:08
From: Ginger Cantor
Subject: Ask Me Anything Session: Global Reimbursement Strategies
Jenifer,
If a code already exists, how does a manufacturer get their specific device listed for that code, if cleared by FDA for the same indications the innovator has. The innovative device helped get the original code established.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 14-Mar-2018 12:57
From: Heather Arkwright
Subject: Ask Me Anything Session: Global Reimbursement Strategies
Hello members,
Last week, RAPS released the first of its quarterly compendia, which focuses on Global Reimbursement Strategies. Today, we have one of the authors, Jenifer Ehreth, available for the next hour to answer any questions you have in real-time. Please use this thread to post your questions and she will respond.
Can't wait to read the discussions!
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Heather Arkwright
Community Manager
RAPS
regex@raps.org
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