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In our previous installment on medical billing, we covered the basics of enteral nutrition and billing and how it got to be such big busi

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

ness. In this installment we're going to review the GE0 record, fields 1 through 8, which is the CMN that has to be sent to the carrier

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

Examples of combination products may in

ith each enteral bill that is submitted for payment via electronic means using NSF 3.01 specifications.

GE0 field 1, positions 1 - 3, 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.

the record type. This field needs to be filled in with GE0. If it is not, the claim will be denied by the carrier. Also, this record m

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

st come after the F record in the claim file that is specifically for the enteral product being billed.

GE0 field 2, positions 4 - 5, is

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

Combination pro

the sequence number. Because there can be up to 99 CMN records in a claim file, the sequence number, or CMN number must be transmitted,

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

such as GE0-01, GE0-02, etc. If these are out of sequence, the claim will be denied.

GE0 field 3, positions 6 - 22, is the patient ID n

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

mber. This is the same number that is transmitted in the CA0 record and all subsequent records. If this field is not filled in, the cla

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

m will be denied.

GE0 field 4, position 23, is the certification type. This field is transmitted as either I, for initial or R for rece

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

rtification. The carrier needs to know this because billing for each cert type is different.

GE0 field 5, positions 24 - 31, is the dat

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

therapy began field. This is the date that enteral nutrition therapy for the patient began. The format for this date is either yyyymmd

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

Following aspects would a

or mmddyyyy, depending on the requirements of the payor.

GE0 field 6, positions 32 - 33, is the therapy duration. This is the number o

dd to the challenges in developing combination products:

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

months that the patient is expected to be on enteral nutrition. Unlike other procedures that are done and completed, enteral nutrition

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

is not so easy to pinpoint down to a time since it is impossible to say how long it will be until the patient is able to go without it.

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

hat's why this is an estimate. If the physician believes this will be for the life of the patient then they fill this field with the num

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

er 99.

GE0 field 7, positions 34 - 41, is the last date of certification. This is the last date that this particular treatment was cert

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

Professional from academic institutions, pharmaceutical industries, health care indust

fied and must be filled in if required by the payer. The format is either yyyymmdd or mmddyyyy, depending on the payer requirements.

GE

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

0 field 8, positions 42 - 43, is the number of months of this certification. Most CMNs are good for a year. However, some initials are

.

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

ood for only 3 months. This is going to vary from payer to payer and from item to item.

In our next installment of medical billing via

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

Companies that provide selfless information through particip

lectronic media, using NSF 3.01 specifications, we're going to continue with our review of the GE0 record, picking up with field number 9

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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