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Many people believe that the NPI number was initiated by the HIPAA Act of 1996. Actually, the NPI number was initiated

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

by CMS (Centers for Medicare & Medicaid Services) in July of 1993. CMS wanted a national identification system for all

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

Examples of combination products may in

ealthcare providers and many of the existing identifiers did not meet the standards for national standards. The HIPAA A

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

ct of 1996 required the adoption and use of a standard unique identifier for healthcare providers. All covered healthca

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

e providers will be required to have an NPI number by May 23, 2007.

The National Provider Identifier, or NPI, is a 10 p

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

Combination pro

sition, all numeric, identification number assigned by the NPS to uniquely identify a healthcare provider. If you are a

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

n individual healthcare provider you will need to apply for an NPI number under your individual name. If you belong to

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

medical group, you will need an NPI number for the group and an NPI number for each individual healthcare provider in t

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

e group.

Medical Billing Services are not eligible for NPI numbers because they are not a covered healthcare provider.

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

A covered healthcare provider is any provider who transmits any health information in electronic form.

NPI numbers wil

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

replace the healthcare provider’s Medicare provider number, Medicaid provider number, Champus provider number, UPIN num

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

Following aspects would a

er, and all other payors’ unique provider numbers (such as Blue Cross Blue Shield). NPI numbers will not replace tax id

dd to the challenges in developing combination products:

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

number or social security number, DEA number, taxonomy number, or license number.

Once an NPI number is assigned to a

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

overed healthcare provider it will not change. NPI numbers will travel with a healthcare provider if they move from one

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

geographical location to another. NPI numbers can be deactivated if the healthcare provider is deceased or goes out of

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

business. NPI numbers will not be reissued to a different healthcare provider once they have been deactivated.

Covered

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

Professional from academic institutions, pharmaceutical industries, health care indust

healthcare providers can apply for their NPI number from now until May 23, 2007. Applications began being accepted in M

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

y of 2005. I strongly recommend that you apply immediately. There is no reason to put it off. The closer it gets to 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

he deadline, the busier the application process will become.

Any changes in information need to be reported to NPPES wi

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

Companies that provide selfless information through particip

hin 30 days of the change.

NPI numbers can be obtained by completing an online application which takes about 20 minutes

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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