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When it comes to submitting medical insurance claims to the insurance companies, it is important to file the claims o

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

n the appropriate forms. The most common medical insurance form is the HCFA 1500.

The HCFA 1500 form is a 8 ?”by 1

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

Examples of combination products may in

1” white paper printed with red ink. It contains many fields that must be completed. In an effort to standardize th

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

medical industry, HIPAA (Health Insurance Portability and Accountability Act of 1996) mandated that all medical serv

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

ice providers use the HCFA 1500 form when submitting insurance claims.

It is crucial that the fields on the HCFA for

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

Combination pro

are filled out accurately and completely. If any information is missing or incorrect it can cause the entire claim

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

to be denied. In some cases they will return the incomplete or inaccurate claim with an explanation as to why it is

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

ot being paid. Other times, you just don’t hear anything. Did they end up with your socks that never returned from

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

the dryer?

There are some instances that a HCFA wouldn’t be used. If the claim is for an on the job injury, or a wo

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

kers’ compensation claim, then a workers’ compensation form would be used. These forms vary from state to state, but

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

can usually be found on the state’s workers’ compensation website.

In many states forms can be downloaded and print

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

Following aspects would a

ed or purchased in quantity by private suppliers. Some medical billing software comes with the capability of printin

dd to the challenges in developing combination products:

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

the workers’ compensation forms. The workers’ compensation forms are white with black print and have fields similar

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

to the HCFA 1500 form. As with the HCFA 1500, it is important that these fields are filled out accurately and compl

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

tely.

Facilities such as hospitals, outpatient clinics, and ambulatory surgery centers use a UB92 form. It is the f

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

acility version of the HCFA 1500. UB92 forms are also white with red ink, but the fields are different.

When claims

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

Professional from academic institutions, pharmaceutical industries, health care indust

are submitted electronically, no forms are needed as the claims are not ever printed to paper. The claims are actual

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

ly put into the correct format and sent on to the insurance companies in a file. The claims can either be sent via t

.

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

e internet, or thru the phone lines.

HCFA and UB92 forms can be purchased from a variety of suppliers and they vary

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

Companies that provide selfless information through particip

greatly in price. The higher the quantity purchased, the lower the price per form. Shop around to find the best buy

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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