Below is the transcript from our On-Demand Micro-Webinar:
Where is my NDC?
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Laura: Welcome, and good day. Thanks for joining us. Today we would like to help you by answering the most frequently asked question about RJ Health Data; Where is my NDC? I’m Laura, Clinical Informatics Pharmacists with RJ Health, and joining me today is Chris Webb.
Laura: He’s our Director of Product Development. There are several reasons why an NDC or National Drug Code may not be searchable or found in either our website, or in an application or within a file. A few of the reasons are listed, and they can include formatting of the actual data, inclusion parameters within the database, and movement of the data within that database over time.
We will attempt to help you understand how to work with these limitations, and help you to find what you’re looking for.
First, I’d like to address formatting. An NDC or National Drug Code is made up of three segments which identify first by label or by manufacturer, the product itself, and finally the package size. Many NDCs are displayed on drug packaging with a 10-digit format because of the FDA standard, current standard. However, proper billing of an NDC actually requires an 11-digit number in a 5-4-2 formatting. 5 being the manufacturer, 4 being the product code, and 2 being the actual package size. Converting from an NDC from a 10-digit to an 11-digit format requires a strategically placed 0. This is illustrated in the table on this page. Depending on where the missing digit is from the 10-digit number on the label. Adding a leading 0 to the proper segment may be required for billing. Chris, can you help us by taking a look at how to apply the compatible NDC formats within the RJ Health application?
Chris: Sure can. Reimbursementcodes.com uses a global search, which allows us to do a number of levels of entry points to get the corresponding information that I’m looking for. So, we’re going to focus on the NDC information that we can load into the site to get the proper cross-walking as well as a reimbursement for that particular NDC. Okay, so for that first example, I’m going to add in, with dashes, our 10-digit NDC. All right, this is the Inflectra NDC, or the Renflexis NDC from the previous slide. You’ll notice that I’ve done a label of code of 4 digits, the product code of 4 digits, and then the package size of 2 digits. Reimbursement codes will add in the leading 0 in that first product segment. So, in this case, for Inflectra, it’s added the leading 0 to make it a 5-digit labeler code. I continue onto the proper HCPCS code, and the NDC will populate on the right-hand side. It will provide both an NDC-level pricing unit, package size, and package quantity levels.
Let me go back to the global search, and we’ll do another NDC. This case, with a missing digit in the product level. All right, this case is NDC for Rituxan. There are two codes that are appropriate for this; one reactive, J9310, and then the new J9312 that’s going to be coming effective January 1st of 2019. Again, once I select a code, then you see what we populate on the right-hand side. I’ll be able to get those various available HPCPS code units. Using reimbursement code is appropriate and needed to add in the dashes for a 10-digit NDC. Or, we’ll go through the same example, and I know that I’m missing a middle product digit, and go ahead and enter in, enter the leading serial, this will also return me to that proper NDC.
So, based off the information that you have, whether it be from the package itself, or from something that’s coming through a claim system, we do accept a 10-digit NDC with those dashes, or you apply the leading 0 as Laura spoke of before, either at the product level, the manufacturer level, or the package size. Laura, could you show how this would be related on a data file?
Laura: Sure, Chris. If when you go into our files, our pricing file, you can go to the, “NDC Crosswalk,” tab, which will contain your NDC information. In this particular instance, you are restricted to the formatting of the actual field itself, and these fields are formatted with the complete 11-digit formatting, so you have to add in the leading 0’s in the appropriate segment. And, there are no hyphens accepted when you’re searching within the file, or working with this file.
Chris: So, once you’re sure of the correct format, it is important to understand the inclusion parameters for the data that you’re working with. Here at RJ Health Systems, we focus on medically covered pharmaceuticals. For example, RJ Health Data is HCPCS and CPT code driven. Drugs for inclusion in the database should be assigned to a code. Codes are typically for drugs billed via the medical claim, and are typically professionally administered. However, due to plan policies, some self-administered drugs may be included. Not otherwise classified codes or NOC codes like J3490, or J9999 are included, based on these parameters. However, exceptions do exist.
We will go over some examples to help you understand these inclusion criteria.
Laura: All of the following drugs are used to treat psoriasis. However, not all psoriasis drugs will appear in the RJ database. Generally, drugs not assigned to a HCPCS or CPT code will not be included in the database, such as orally administered drugs. This exclusion from the database includes most self-administered or oral drugs, however, some plan coverages include drugs under the medical claim, which may be professionally administered, such as ones given via the subcutaneous route. Our example here is Simponi, which is available both in the IV and self-administered subcutaneous route. Chris, can you please show us which of these NDCs will appear on the RJ Health database, using the SaaS application?
Chris: Okay, so let’s take a look at those three NDCs. Adding in the leading 0, let’s take a look at that oral medication. You’ll notice that the SaaS product will say, “No results returned for this search.” Again, this is an oral formulation used for psoriasis, which would be covered underneath our D benefit; it would not have a linking to a proper HCPCS code.
Now, if we look at the various form-relations and NDCs for Simponi, let’s see how they could be different. Adding the leading digit in this case into the product level. All right, now we have Simponi Aria, which is the intravenous use. You’ll notice that the individual HCPCS code mentions that in its description, so this NDC has 1 HCPCS code that crosswalks back, and it’s J1602.
Let’s compare that to the subcutaneous route. So, we’ll enter in the same labeler code, add the leading 0 to the product, hit enter, and we’ll notice that this version of Simponi will crosswalk back to the CNOC code for outpatient hospital use, as well as J3590 for unclassified biologic.
Other considerations besides code assignment influence if a drug is in the database. This includes whether a drug may be administered as part of a more complex regime, such as a chemotherapy IV infusion. All the drugs listed may be administered prior to, or during an IV infusion of a chemotherapy agent. So, in this case, all of these products will be listed on reimbursementcodes.com.
Laura: So, let’s briefly cover how actual plan policy can determine drug inclusion in a HCPCS or CPT code.
For the examples listed in this table, these drugs all meet CMS rules for self-administered drugs eligible for reimbursement via Part B coverage. So, they are also included within the database, even though they are all orally and self-administered.
In the case of oral Temodar, there is an IV version which is payable under Part B, so CMS has determined that the oral version should be also payable under Part B. Xeloda is a similar situation, but it’s payable not because it has the same drug component as the IV version, but it’s a pro-drug, or a chemical precursor to the drug which is payable under Part D. The third drug is similar, so it’s pretty obvious right now that all of these would appear under the RJ database, even though they are all orally administered and self-administered, and this is due to CMS plan policy.
However, there is another determination of whether or not an NDC will appear, and that is data retention rules and policies defined by the maintainer of that data. This also can determine what NDCs will be found in the database. It’s important to know that drugs, or NDCs that currently don’t have pricing available do not appear on the RJ Health database. Also, if an NDC is given a termination date by the manufacturer, that NDC is removed 30 months post the termination date. Also, only 5 years of active data is included. So, Chris, can you show us an example of this?
Chris: Sure. So, let’s take the example we have up here for Remicade. There are a number of biosimilars that are now on the market. So, we’re showing Inflectra here, but we also have other Inflexis. In the third one below is the European biosimilar. So, this can show you how some coverage rules may determine whether an NDC is added or removed from the database.
Laura: Another thing that determines whether an NDC is included is the data retention policies of those who maintain the database. Can you discuss with us how that might affect whether or not we can find our NDC?
Chris: Certainly. Here at RJ Health, you do maintain an active and inactive status for each NDC we have on the site. If a manufacturer changes an NDC to an inactive status, we leave it on the website 30 months to allow retroactive claim level. After that 30-month period, it will drop off of our dataset. Additionally, you are able to go back up to 5 years to price an individual claim at a code level or an NDC level using our SaaS product.
Also, new NDCs to market, there may be a little bit of a lag time between the entry to market and the publication price until it logs into reimbursement codes. Pricing manufacturers, or manufacturers will set those prices with the major sources, and then they will filter through into the system. So, because a drug has become FDA approved, the manufacturer might not have reported pricing or any information regarding that NDC to the pricing sources as of yet. Once you get that information, it is then linked to the proper HCPCS code and added into our data set.
Laura: Chris, can you show us an example?
Chris: Sure. So, in this case, we’ll have Remicade. So, Remicade has been around forever, I think the code goes back prior to January 1st of 2000 when we launched the product reimbursement codes. However, recently, there has been a number of biosimilars that have hit the market. Inflectra being the first one, and then also Renflexis following. There is also a European version on the marketplace that is not available in the United States, and does not have pricing.
So, in these three examples here, the first two will be listed on reimbursementcodes.com. So, what I’ll do is I’ll do a search off the generic product name. So, I’ve entered in the generic product name, and I’ve been returned the appropriate HCPCS codes. The first is the active J1745 for the brand name, and you’ll notice that it says, “Excludes biosimilars”. So, if I go to this particular HCPCS code, and go down to my NDC crosswalk, we’ll see the branded Remicade by Janssen Biotech.
If I go back to my search results, you’ll notice that the next two Q codes are for Inflectra, as well as Renflexis. Since these are marketed in the United States, we will have pricing for them. So, I’ll have the AWP and also acquisition price, at the unit level, package size, and package quantity levels.
All right, and lastly, we do have a HPCPS or CPT code for that third NDC listed. So, the interesting thing here is that there is not an NDC that is being published. Even though the manufacturers did do an FDA approval, and went through the whole pathways to do that, they did not launch the product for the US market, thus no pricing, so we don’t have the crosswalk back to the dataset. I can find it through the global search, again, going through the product name or the generic product name in this case, but again, since there’s no NDC information through the major pricing sources, or on the marketplace, we will not include it in our dataset.
All right, some final considerations that may make it difficult to locate an NDC on our database, as well as the marketplace in general, can include the code or NDC changes in termination dates. By design, dates are included at the code-level descriptions, as well as further information that can be found by hovering over the question marks that you see on our NDC crosswalk. These are known as, “Tool Tips.” So, in the first example, if I typed in J9000 in the global search, I would be returned to active HPCPS code J9000, but then also a terminated C code. Here at RJ Health, we will add on to the description, this was for the brand name Doxorubicin that was on the marketplace previously, and we’ll refer you to the active code. So, this case, C9415 became deleted 1/01/2006 and it will refer you to the active J9000 code.
The second example here is an inactive NDC. So again, you’ll catch the theme of having a strike-through means inactive date, or inactive information. So, by Mylan Institutional, they have stopped publishing a rate, or a stopped manufacturing this particular NDC. On the website, if I hovered over the tool tip, this would give me the exact date when this particular NDC became inactive. Additionally, as I mentioned earlier, after 30 months of an inactive status, it will drop off from our website.
Finally, below, for our Remicade example, if I typed in J1745, two results are being returned. So, in this case, effective 1/01/17, CMS added the term, “Excludes biosimilars,” so that changed the crosswalk to remove the Inflectra and Renflexis NDCs. If I’m pricing a claim previous to 1/01/17, I would take a look at the old description. In this case, the biosimilars did not exist at the time of the code change, however, sometimes those code changes can change the NDCs that are appropriate to bill, underneath that NCPCS code. So, always take a look at the time date associated with the data service, and then also those indicators on the website.
Hopefully this presentation gives you an idea of which NDCs are included and excluded in our database. However, we do pride ourselves on our customer service, so if you have any questions, feel free to send us an e-mail at firstname.lastname@example.org or take a look at some of these additional resources, the FDA website, Daily Med, as well as going to our base reimbursementcodes.com site. There is a, “Contact Us,” section. You’ll be linked into our team of Pharmacists, certified Pharm Techs and Registered Nurses. They can answer any questions you might have.
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