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The Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated the adoption of standard uni

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

que identifiers for health care providers, as well as the adoption of standard unique identifiers for health plans. They become mandatory on May 23, 2007.

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

Examples of combination products may in

The purpose of these provisions is to improve the efficiency and effectiveness of the electronic transmission of health information. The Centers for Medicare

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

& Medicaid Services (CMS) has developed the National Plan and Provider Enumeration System (NPPES) to assign these unique identifiers.

CMS has contracted wi

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

th Fox Systems, Inc. to serve as the NPI Enumerator. The NPI Enumerator is responsible for dealing with health plans and providers on issues relating to uni

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

Combination pro

ue identification.

HCFA Timetable

Changes in the HCFA 1500 form to accommodate the NPI number took place January 1, 2007. Until March 30, 2007, us

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

ing NPI number on the HCFA form is optional but as of April 2, 2007, using NPI becomes mandatory.

Getting an NPI is free - Not Having One Can Be Costly: If

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

you delay applying for your NPI, you risk your cash flow.

Enumerate: Enumeration is mandatory for both individual providers and organizat

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

ions and subparts. When applying for your NPI, CMS urges you to include your legacy identifiers, not only for Medicare but for all payors. If reporting a M

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

edicaid number, include the associated State name. This information is critical for payors in the development of crosswalks to aid in the transition to the N

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

Update: Make sure to upgrade your software, HIPAA Transactions, CMS1500, UB04, and/or Dental claim form changes.

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

Following aspects would a

mmunicate: Notify your payers once you have obtained your NPI number. As outlined in the Federal Regulation (The Health Insurance Portability and Accou

dd to the challenges in developing combination products:

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

ntability Act of 1996 (HIPAA)) you must also share your NPI with other providers, health plans, clearinghouses, and any entity that may need it for billing p

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

urposes -- including designation of ordering or referring physician.

Collaborate: Check the readiness of your payment partners (such as

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

health plans, TPAs, clearinghouses, etc...)? Not all payers are ready to accept the NPI number at this time. Use both your existing (legacy) number and the

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

PI number when submitting electronic claims.

Test: Test transactions well before the deadline. Make sure to test HIPAA Transactions, e.g

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

Professional from academic institutions, pharmaceutical industries, health care indust

., 837 Claims, 835 Remittance Advice, and, if you submit paper claims, verify that the data is printed in the correct fields. The new HCFA form has new fiel

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

ds for identifier numbers on lines 17b, 32a and 33a.

Educate: Focus on staff working on insurance verification of eligibility and clai

.

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

m denial or underpayment follow up.

Implement: Once you obtain your NPI, it might take about 120 days to do the remaining work to use it

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

Companies that provide selfless information through particip

. This includes working on your internal billing systems, coordinating with billing services, vendors, and clearinghouses, testing with payers.

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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