Subjects - Business

If it seems that the FA0 specifications go on forever, they pretty much do. In this medical billing installment, concentrating on electronic bil

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

ling of claims using NSF 3.01 specifications, we'll be focusing on FA0 record fields 48 through 55.

FA0 field 48, positions 224 - 230, is the ob

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

Examples of combination products may in

ligated to accept amount. If this sounds like strange English then a little explanation is in order. When billing a medical carrier or payer su

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

h as Medicare, most doctors are what are called participating providers. This means they participate in the universal Medicare program. As part

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

icipating providers, one of the things that they are bound to is the fees set by the Medicare administration for each service provided. By accep

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

Combination pro

ing this agreement, when sending a bill to Medicare there is what they call an obligated to accept amount. This means that regardless of what th

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

e doctor wants to charge for the service, this is the amount that he agrees to receive from Medicare when payment is made. This is the amount th

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

at is transmitted in this field.

FA0 field 49, positions 231 - 237, is the drug discount amount. For claims where there are drugs or medication

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

involved, this is the amount of discount that the patient is entitled to for that particular drug. This field is not used too often but it is a

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

vailable and functional.

FA0 field 50, position 238, is the type of units indicator. This is an indicator that is also seldom used to show how

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

he units are being billed, whether it be box, carton or single unit.

FA0 field 51, positions 239 - 245, is the approved amount. When all is sai

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

Following aspects would a

d and done, this is the amount that is approved by the payer, whether it be Medicare, Medicaid, or a private payer. In most cases, this is the a

dd to the challenges in developing combination products:

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

mount that will be paid to the provider or the patient.

FA0 field 52, positions 246 - 252, is the paid amount. This is the amount for this clai

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

, if it was billed prior, that was already paid. In most cases, this will be an initial claim and this field will go over with all zeros. It mu

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

st be filled in and cannot be left blank or the claim will be denied.

FA0 field 53, positions 253 - 259, is the beneficiary liability amount. T

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

is is where things get a little hairy. If a claim is not paid in its entirety and there is an amount that needs to be paid by the patient and th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e patient is no longer living (patients do die during procedures) this is the amount that the patient's beneficiary is responsible for paying. T

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

his gets into legal areas that we won't touch here.

FA0 fields 54 and 55, positions 260 - 273, are the balance billing limit charge amount and p

.

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

rcentage fields. This also gets into an area that is beyond the scope of this article. Let's just say that it is rare that these fields are use

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

Companies that provide selfless information through particip

d so let's just leave it at that.

In our next installment on medical billing of electronic claims, we'll pick up with FA0 record field number 56

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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