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In this maze of medical billing and the countless number of forms, specifications and red tape, the GU0 record ranks up near the top of the list

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

of things that drive billers crazy. The number of fields alone that need to be filled are enough to make you pull your hair out of your head.

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

Examples of combination products may in

Add to that the convoluting mapping of these forms and you're in for a two aspirin night after you've come home from work. Hopefully, this seri

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 of articles on the GU0 record will help make the biller's life a little easier. In this installment, we cover the GU0 record picking up with

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

ield number 54.

GU0 field 54, positions 159 - 166, is Reply ALN L08 N02. This is the response to the second question on any DMERC certificatio

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

Combination pro

n requiring an eight position response. This is another date field, similar to field number 53. This field is filled in under the following co

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

ditions: For form number 06, the date is filled in to show the start of a TENS trial. For form number 08, the date is filled in to show the dat

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

the patient was discharged from the hospital after transplant surgery. This date is ONLY filled in if the surgery was for a transplant of any

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

ind, including heart, liver, etc.

GU0 field 55, positions 167 - 174, is Reply ALN L08 N03. This is the response to the third question on any D

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

MERC certification requiring an eight position response. This is another date field, similar to field number 54. This field is filled in under

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

the following conditions: For form number 06, the date is filled in to show the end of a TENS trial.

GU0 field 56, positions 175 - 182, is Repl

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

Following aspects would a

ALN L08 N03. This is the response to the fourth question on any DMERC certification requiring an eight position response. This is another dat

dd to the challenges in developing combination products:

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

field, similar to field number 55. This field is filled in under the following conditions: For form number 06, the date is filled in to show w

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

hen the ordering physician saw and evaluated the patient following a TENS trial.

GU0 field 57, positions 183 - 202, is Reply ALN L20 N01. This

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

is the response to the first question on any DMERC certification requiring a twenty position response. For form 05, this field is reserved for

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

uture use. For form 08, this applies to question 9, the city where the transplant facility was located. For form 09, this applies to question

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

Professional from academic institutions, pharmaceutical industries, health care indust

, name of drug with non specific HCPCS code. For form 10, this applies to question 10, the product name.

GU0 field 58, positions 203 - 262, is

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

Reply ALN L60 N01. This is the response to the first question on any DMERC certification requiring a sixty position response. For form 08, th

.

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

s applies to question 8, the name of the transplant facility, which is limited to 30 characters. For form 10, this applies to question 15, whic

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

Companies that provide selfless information through particip

is additional information when required by the policy.

In the next installment of medical billing, we'll continue our review of the GU0 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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Digg It - Medical Billing - GU0 Record Fields 54 Through 58

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