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Medical billing of parental nutrition claims, as with enteral nutrition claims is relatively new in comparison to other billable services.

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

The parental nutrition CMN is electronically transmitted using the GP0 record. In this installment we're going to cover the GP0 record, s

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

Examples of combination products may in

arting with field number 8.

GP0 field 8, positions 42 - 43, is the number of months of this certification. This field tells the carrier h

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 long this CMN is going to be good for. An initial CMN is usually good for about 3 months. After the initial expires, the first recerti

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

ication is usually for 9 months. After that, each recertification is usually for a year. There are of course exceptions.

GP0 field 9, po

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

Combination pro

itions 44 - 51, is the date last seen by physician. This field tells the carrier when the last date it was that the physician who prescrib

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

ed this CMN saw the patient. If the period of time is too long before the certification, the CMN may be denied by the carrier.

GP0 field

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

0, position 52, is the non-physician visit indicator. This field is identical to the indicator for enteral nutrition claims. This tells t

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

he carrier what the medical evaluation of the patient was based on. There are only four possible entries. An N is entered if the evaluati

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

n was made by a visiting nurse. An L is entered if the evaluation was made by lab or clinical reports. An O is entered if the evaluation

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

as made by other means. The field is left blank if it is not applicable.

GP0 field 11, positions 53 - 55, is the patient's age. This tel

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

Following aspects would a

ls the carrier how old the patient is in years. Enough space is left should the patient be over 100 years old. If however the patient is

dd to the challenges in developing combination products:

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

nder 100, the field must be left zero filled. In other words, an age of 72 would be transmitted as 072.

GP0 field 12, positions 56 - 58,

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

is the patient's height. This field tells the carrier how tall the patient is in inches. If the patient is under 100 inches, which is mor

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

likely than not, then the field must also be left zero filled. A height of 72 inches, or six feet, is transmitted as 072.

GP0 field 13,

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

ositions 59 - 61, is the patients weight. This field tells the carrier how much the patient weighs in pounds. If the patient is under 100

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

Professional from academic institutions, pharmaceutical industries, health care indust

pounds the field needs to be left zero filled. A weight of 99 pounds would go over as 099.

GP0 field 14, position 62, is the level of co

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

sciousness indicator. This field tells the carrier what the patient's level of consciousness is. There are two possible entries for this

.

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

field. C is entered if the patient is conscious and an I is entered if the patient is conscious impaired.

In our next installment of medi

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

Companies that provide selfless information through particip

al billing, covering electronic submission of claims and the GP0 record, we'll be covering the parental CMN picking up with field number 15

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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