Advice You - Business

Medical billing of oxygen claims is not for the mentally challenged. Medical billers should really be paid a lot more money than they are, bu

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

t that is not the focus of this article. Our focus is to try to make heads or tails out of one of the most complex records in the medical bil

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

Examples of combination products may in

ling industry, which is the GX0 record. In this segment, we resume our discussion of this record with field number 24.

GX0 field 24, positio

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

s 218 - 225, is the date tests performed. Honestly, this is a very poorly worded field. What tests? Well, you'll have to read the manual to

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

figure this out, but in brief, this is the date that the arterial blood gas and oxygen saturation tests were performed. Under normal conditi

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

Combination pro

ns, these tests are performed at the same time. But things happen. In the case where you have two different dates, consult with your carrier

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

to find out which date to use. Trust me, it will happen. The date itself can be transmitted in either yyyymmdd or mmddyyyy format, dependin

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

g on the requirements of the carrier. Again, check your manual.

GX0 field 25, positions 226 - 258, is the entity performing the oximetry tes

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

ing. This field tells the carrier the name of the entity who performed the ABG and/or oximetry tests. To properly fill out this field, pleas

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

e see the general instructions in your manual for "NAME 2" entry.

GX0 field 26, position 259, is the test conditions field. This is another

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

ne of those fields where the name doesn't tell us much of anything. This field tells the carrier the condition of the patient when the tests

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

Following aspects would a

were given. The valid responses are 1 for at rest, 2 for exercising and 3 for sleeping. This is a required field and cannot be left blank.

dd to the challenges in developing combination products:

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

GX0 field 27, positions 260 - 262, is the clinical findings field. This field tells the carrier if certain conditions existed when doing the

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

ests. These are as follows:

If the patient's arterial PO2 is over 55 mm Hg and under 60 mm Hg.

If the patient's oxygen saturation is over 8

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

8%.

If either of these is true then the field is transmitted with a Y. If not, then the field is filled with an N. If it doesn't apply then

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 field is left blank.

Okay, it gets more complicated. As you can see, it is a 3 character field. The reason is because you can have up t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o three responses. Position 1 is if the patient has dependent edema due to congestive heart failure. Position 2 is if the patient has pulmon

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

ary hypertension as shown by either a gated blood pool, or direct pulmonary artery pressure measurement. Position 3 is if the patient has a h

.

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

macrit greater than 56 percent. It is therefor possible to have a response such as YYN or YNY or any valid combination of the three possible

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

Companies that provide selfless information through particip

responses.

In our next installment on medical billing, we'll be continuing with our review of the GX0 record, picking up with field number 28

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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