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Medical billing can be a real nightmare. No wonder the turnover with medical billers is so great. Between the number of regulations, pi

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

le of forms and tons of red tape, it's enough to make anybody crazy. One of the worst culprits is the DMEPOS CMN, or the GU0 record, whi

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

Examples of combination products may in

h is used for electronic transmission of claims using NSF 3.01 specifications. In this installment, we'll be covering the GU0 record, pi

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

king up with field number 8.

GU0 field 8, positions 32 - 33, is the HCPCS modifier. The HCPCS modifiers are one of the big reasons that

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

medical billers lose their minds so quickly. Having to keep track of which modifier goes with what month can be a real pain in the backs

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

Combination pro

de. Fortunately, most electronic billing software packages take care of this for you. This field is used to tell the carrier which mont

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

of billing you're in for the item or service in question.

GU0 field 9, position 34, is the warranty reply field. This field tells the

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

arrier if the item being billed for this CMN is under warranty or not. If it is, the field is transmitted as a Y. If it isn't, it is tr

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

nsmitted as an N. If this doesn't apply, then the field is transmitted as a D.

GU0 field 10, positions 35 - 36, is the warranty length.

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

If the item is under warranty, as designated by field number 9, then this field tells the carrier what the warranty period is in months.

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

GU0 field 11, position 37, is the warranty type. This field tells the carrier what type of warranty the item comes with. There are fou

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

Following aspects would a

valid entries for this field. A 1 is entered if the item comes with a full replacement warranty. A 2 is entered if the item comes with

dd to the challenges in developing combination products:

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

a pro rated replacement. A 3 is entered if the item comes with a parts and labor warranty. A 4 is entered if the warranty is for parts

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

nly. This field must be entered if required by the payer.

GU0 fields 12 - 15, positions 38 - 57, are the diagnosis codes. These fields

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

tell the carrier what the diagnosis codes are, related to the piece of equipment that the CMN has been issued for. At the time of this w

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

iting, these are still ICD-9 codes and not the new ICD-10 codes. That may change at any time.

GU0 field 16, positions 58 - 59, is the p

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

Professional from academic institutions, pharmaceutical industries, health care indust

tient height. This field tells the carrier what the patient height is in inches. Unlike many of the other height fields in the NSF spec

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

fications, this field is only two characters in length.

GU0 field 17, positions 60 - 62, is the patient weight. This field tells the ca

.

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

rier what the patient weight is in pounds. If the weight is under 100 pounds then the field is sent left zero filled. For example, 99 p

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

Companies that provide selfless information through particip

unds is transmitted as 099.

In our next installment on medical billing, we'll be covering the GU0 record picking up with field number 18

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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