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Medical billing, depending on whether you are billing paper claims or electronically, is a totally different animal for each. Electronic claims have one thin

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

g that paper claims don't have. And while they pay faster, thus the reason for billers to bill electronically, they can also be a royal pain in the backside

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ecause of all the restrictions and requirements. One of the strictest of these requirements is claim records hierarchy. We're going to briefly explain that

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ierarchy in this installment, as a detailed explanation will probably leave you confused and running for the nearest exit.

If you're billing claims by paper

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ou simply take each paper claim, stick it in an envelop and leave it in the hands of your trusted mailman. Not so with electronic claims. Not only does the

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

nvelop of electronic claims have to be properly addressed, but it better have every piece of paper in just the right place and totals for everything from how

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

much you're billing to how many pieces of paper you have. The key to all this is that it all has to be in a certain order.

To simplify this process, think o

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

your claim file as a wrapper for sticks of gum. Each individual stick of gum is a record specification such as your CA0, DA0, EA0, FA0, G and H records. Th

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

se are your records for each individual patient. Any claim file can have as many patients as you like stuffed into it. This means that you can have an infin

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

te number of C, D, E, F, G and H records. However, each patient's records must all be together. So, to keep this simple, if you have two patients in your fi

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e, you would have their records transmitted in this order; C, D, E, F, G and H records for patient 1 and then C, D, E, F, G and H records for patient 2. If a

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

C record from patient 2 ends up falling with the C, D, E, F, G or H records from patient 1 then the whole batch will fail and nothing will get paid.

But, th

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

s isn't the end of it. For each patient, there is a trailer record. The trailer record for the patient is the XA0 record. This record gives the totals for

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

hat particular patient. So there needs to be an X record for patient 1 and one for patient 2. This record MUST come after the H record of each patient. The

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

, there is a trailer record for the batch, which is all the patients submitted in the batch. This is the YA0 record and MUST come after the last X record in

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

he batch.

Finally, we have the outer wrappers, which are the AA0 and BA0 records at the beginning of the file and the ZA0 record, which is the file record tr

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ailer at the end of the file. This record gives the totals for every record in the whole claim file. So the whole hierarchy for a two patient claim file wou

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

d have the following record series, AA0, BA0, CA0, DA0, EA0, FA0, G record, HA0, XA0, CA0, DA0, EA0, FA0, G record, HA0, XA0, YA0, ZA0.

If these records are

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ot transmitted in exactly this sequence, the whole file will be rejected. Obviously, this is quite simplified as their can be multiple items and payers for e

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ch patient. But you get the general idea.

When it comes to medical billing, records hierarchy can be a real nightmare, especially if it's not done correctly

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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