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We're almost to the end of our review of oxygen billing for medical billing practices. So far, we have covered the GX0 record and the GX1 reco

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

rd for NSF 3.01 specifications. In this installment, we're going to cover the GX2 record, which is facility information.

Usually facility inf

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

Examples of combination products may in

ormation is covered in the E records of a claim. So why do we have to include facility information in a CMN for oxygen billing? The reason is

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

because of the nature of oxygen therapy. Oxygen therapy is strictly regulated because, quite honestly, working with oxygen can be very dangero

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

us. The number of regulations for working with oxygen are enough to choke a horse. That's why there is all this red tape when submitting clai

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

Combination pro

s. Therefor, facility information is not only required in the E records but also in the GX2 record for any oxygen claim. In this installment

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

we cover all the fields of the GX2 record.

GX2 field 1, positions 1 - 3, is the record type. This must be filled in with GX2. This record mu

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

st follow the GX0 and GX1 records in that order or the claim will be denied.

GX2 field 2, positions 4 - 5, is the sequence number. Because th

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

re can be as many as 99 CMNs in a claim file, a sequence number is required for each one. The GX2 records are transmitted as GX2-01, GX2-02 an

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

d so on. These cannot be out of sequence or the claim will be denied.

GX2 field 3, positions 6 - 22, is the patient control number. This mus

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

be the same number that is transmitted in the CA0 record and all subsequent records sending patient information.

GX2 fields 4 - 8, positions

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

Following aspects would a

23 - 113, is the test facility information. This is the information that tells the carrier where the facility is located for testing. This mu

dd to the challenges in developing combination products:

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

st be the actual location where the testing was done and not the parent company address. The reason is because these facilities have to be lic

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

nsed to dispense and test oxygen.

GX2 fields 9 - 14, positions 114 - 237, is the patient facility information. These fields tell the carrier

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

where the patient resides, if not at home. This can be the same as the facility where the testing is done, but in any case the information mus

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

be entered in both places.

GX2 field 15, positions 238 - 320, is national filler and must be filled with spaces or the claim will be denied.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Oxygen billing is a very complex process because the treatment of a patient with oxygen is heavily regulated. Because of all the lawsuits bei

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

ng brought against healthcare professionals these days, insurance carriers are even more cautious about medical claims. It may seem like overk

.

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

ll, but an approved claim that results in a lawsuit because if malpractice only ends up costing us all more money in the long run with higher p

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

Companies that provide selfless information through particip

remiums, higher medical costs and higher administrative costs.

This concludes our series on the G records for medical billing of oxygen claims

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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