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The endless road that is medical billing and trying to make heads or tails of CMNs, is enough to drive even the most sane of us totally out of

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

our minds. It seems that there is a CMN for every possible item. Some CMNs are fairly simple to understand and then there are those, like the

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

Examples of combination products may in

DMEPOS CMN, or as is known in electronic billing circles as the GU0 record, that are about as convoluted and confusing as they come. This 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.

ow our tenth installment on the GU0 record with no end in site. It's no wonder medical billers are frustrated. We pick up our review of the G

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

U0 record with field number 62.

GU0 field 62, positions 266 - 269, is Reply NUM L04 N01. This field is the reply to the first question on any

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

Combination pro

DMERC certification requiring a four position numeric response. The following forms are supported for this field. For forms 02 and 09, the va

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

lid responses are 0001 - 0024. For forms 03, 08 and 10, the valid responses are 0000 - 9999. For form 04, the valid responses are 0001 - 0099

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

For form 06, the valid responses are 0001 - 0099. However, these responses are only valid if field GU0-27 is filled with N or D. Forms 01 a

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

nd 05 are reserved for future use.

Further clarification is needed for these values. For form 02, this is the number of hours in the day that

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

the patient spends in a wheelchair. For form 03, this is the number of episodes of sleep apnea during testing that last for ten seconds or mor

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

e. For form 04, this is the number of months prior to ordering the device that the patient sustained the fracture. For form 06, this is the n

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

Following aspects would a

umber of months that the patient has been in considerable pain. For form 08, this is the milligram dosage of the drug being given to the patie

dd to the challenges in developing combination products:

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

t. For form 09, this is the number of hours during the day that the patient is infused with the drug. Form for 10, this is the milliliters pe

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

r day that the patient is given the amino acid.

For those who need to know where these actual questions come from, here is a brief explanation

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

and mapping. For form 02, the question is number 5 from that form. For form 03, the question is number 12 from that form. For form 04, the q

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

uestion is number 6.B from that form. This is an osteogenesis stimulator CMN. For form 06, the question is number 4 from that form. For form

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

Professional from academic institutions, pharmaceutical industries, health care indust

08, the question is number 1.B from that form. For form 09, the question is number 6 from that form. And finally, for form 10, the question i

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

s number 4.A from that form.

As you can see, it can take quite a bit of time and space to explain even one field of the GU0 record. This is w

.

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

y medical billing is so confusing, complicated and ultimately, so expensive. If the process could be simplified, maybe medical costs would com

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

Companies that provide selfless information through particip

e down a bit, at least from the billing end.

In our next installment on medical billing, we'll pick up with the GU0 record and field number 63

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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Set aside one day out of the week to handle your invoices for your medical billing business. This way you do not risk the chance of sending out duplicates or not sending one out at all.

Are you having enough fun with your work or your volunteer activities? If not, maybe you need to reevaluate where your passion is. When we are working on things we are passionate about, time and effort seem to fade away and work becomes fun again.

International trade has been rapidly developing due to business globalization and technologies innovations.

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