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Medical billing is hard enough. Throw into the mix enteral billing, which requires all kinds of calculations and conversions and it's enough to m

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

ake anybody crazy. In this installment we're going to continue our review of the GE0 CMN, which needs to be sent with each enteral claim, picking

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

Examples of combination products may in

up with field number 15.

GE0 field 15, position 63, is the ambulatory indicator. This indicator tells the carrier if the patient is able to mov

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

or not. There are only two valid responses to this field. The letter A is entered if the patient is ambulatory. The letter N is entered if the

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

patient is non-ambulatory. The field is mandatory and must be filled in with something.

GE0 field 16, position 64, is the other forms of nutrie

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

Combination pro

t indicator. This field tells the carrier if the patient is receiving other forms of nutrition besides what this CMN is being prescribed for. Th

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

is is needed because in some cases, if the patient is receiving other forms of nutrition, this claim may be only partially payable.

GE0 field 17,

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

position 65, is the method of administration indicator. This field tells the carrier exactly how the patient is receiving the nutrition. There

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

re only three valid responses for this field. If the patient is receiving the nutrition via a pump, a P is entered. If the patient is receiving

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 nutrition via a syringe, an S is entered. If the patient is receiving the nutrition via gravity, a G is entered.

GE0 field 18, position 66,

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

s the administration technique indicator. This field tells the carrier exactly how the nutrition is being administered. There are only four vali

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

Following aspects would a

d responses for this field. If the patient is being administered via a nasogastric tube, an N is entered. If the patient is being administered v

dd to the challenges in developing combination products:

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

ia gastrostomy, a G is entered. If the patient is being administered via jejunostomy, a J is entered. If the patient is being administered via s

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

me other means, an O is entered.

GE0 field 19, positions 67 - 70, is the total calories per day field. This field tells the carrier how many cal

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

ories per day the patient is required to have. This is not as easy as it sounds. This must be calculated based on how many cans per day the pati

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

nt gets and how many calories are in a can. If the number is more than 2000 then a narrative explanation must be included in field 26, which will

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

Professional from academic institutions, pharmaceutical industries, health care indust

be covered in a future installment.

GE0 field 20, positions 71 - 85, is the product name for product 1. This is the actual legal name of the pr

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

oduct being given to the patient. Nicknames or abbreviations are not allowed. The field has been made long enough to account for all current pro

.

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

ucts on the market.

GE0 field 21, positions 86 - 89, is the calories for product 1. This tells the carrier the total number of calories per day

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

Companies that provide selfless information through particip

the patient is to get from product 1.

In our next installment of medical billing, we'll pick up our review of the GE0 record with field number 21

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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