Advice You - Business

When doing medical billing and electronically transmitting claims, trailer records may only be a bunch of totals to some of us. But to the

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

insurance carrier who is being billed, these trailer records could very well mean the difference between your whole claim file being accep

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

Examples of combination products may in

ted or rejected. In this installment we resume our review of the XA0 claim trailer record, picking up with field number 9.

XA0 field 9, p

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

sitions 33 - 34, is the HXX record count. This is the number of H records, or narrative records being transmitted to the carrier. Because

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

narrative information can be required for just about any reason, this count can be just about anything.

XA0 field 10, positions 35 - 37,

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

Combination pro

s the claim total record count. This is the total number of C, D, E, F, G and H records being transmitted to the carrier. The max number

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

allowed to be transmitted in a batch for one patient is 999. If more records need to be sent then it has to be sent in a separate batch.

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

A0 field 11, positions 38 - 77, is reserved and not supported. This is a very strange mapping since there is nothing in this area that con

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

flicts with any other record. No explanation is given in the manual as to why this area is not used.

XA0 field 12, positions 78 - 84, is

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

he total claim charges. This is the total of all billable charges to the carrier, taken from all the F records, or line item records. The

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

max amount billable is $99,999.99. If more than this has to be billed, which is rare, then the claims must be broken up into two batches.

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

Following aspects would a

XA0 field 13, positions 85 - 91, is the total disallowed cost containment. This is the total number of charges that are not allowed by t

dd to the challenges in developing combination products:

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

e carrier. This figure can't be greater than the total number of charges in field 12.

XA0 field 14, positions 92 - 98, is the total disal

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

lowed other. This is the total number of other charges that are not allowed by the carrier. This figure plus the figure in field 13 canno

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

be greater than the total number of charges.

XA0 field 15, positions 99 - 105, is the total allowed amount. This is the total amount of

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

the charges that are allowed by the carrier. This total MUST be equal to the total number of charges minus all disallowed totals or the wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

le claim file will be denied.

XA0 field 16, positions 106 - 112, is the total deductible amount. Most insurance policies come with a dedu

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

ctible that needs to be met by the patient. This field is the total of all deductibles owed.

XA0 field 17, positions 113 - 119, is the to

.

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

al coinsurance amount. This is the total amount that is covered by other insurance that the patient has.

In our next installment of medic

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

Companies that provide selfless information through particip

al billing and the electronic transmission of claims using NSF 3.01 specifications, we'll be covering the last six fields of the XA0 record

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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