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The 1996 Health Insurance Portability and Accountability Act (HIPAA) established national privacy and security standards for e

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

lectronic health care transactions, including a national identifier for providers, health plans and employers. Accordingly, by

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

Examples of combination products may in

May 23, 2007, healthcare providers and all health plans and clearinghouses must change both their processes and information sy

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

tems to implement HIPAA’s National Provider Identifier (NPI) regulations.

Background on the NPI regulation

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

i> HIPAA mandated regulation

Effective nationwide on May 23, 2007

The compliance date for hea

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

Combination pro

th care payers with less than $5 million in annual revenue is May 23, 2008

What is the NPI?

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

A unique 10-digit identification number

Assigned for life to a provider and de-activated only upon death,

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

etirement, or identity theft

Replaces multiple legacy provider identification numbers, including Medicare UPINs,

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

commercial payer IDs and state Medicaid IDs

Contains no identifying information related to the provider - random

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

y generated

Independent of key provider information changes, such as practice location or specialty

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

i> Providers have 30 days to update their NPI record

Who is affected by the NPI mandate?

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

Following aspects would a

i> Payers

Health plans

Clearinghouses

Providers

Organ

dd to the challenges in developing combination products:

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

zational providers

Individual providers

Why is the NPI necessary? <

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

NPI delivers two-fold benefits for payers and providers:

Simplifies communication and administration
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Facilitates efficient electronic transmission of certain health information

Streamlines

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

detection of billing fraud and abuse

Improves debt collection efforts

What are the challen

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

Professional from academic institutions, pharmaceutical industries, health care indust

ges of NPI implementation for payers and providers?

Providers and payers must exchange information

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

Technological implementation cost within organizations

What should payers and providers do now to pr

.

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

pare for the NPI?

Organize project teams to ensure a smooth transition
Identify and address pr

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

Companies that provide selfless information through particip

cesses and information system changes

Evaluate outsourcing solutions offered by technology vendors

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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