Actual - Legal

In its January 2007 issue, Today's Chiropractic examines an unprecedented growth of post-payment

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

audits by insurance companies. Such audit growth is apparent in terms of both audit frequency and jud

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

Examples of combination products may in

ments.

The study was conducted by Brian Capra, Doctor of Chiropractic and an owner of chiropractic cli

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

nic, Yuval Lirov, PhD, patent inventor in Artificial Intelligence and Computer Security and book author

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

of “Mission Critical Systems Management,” and Jeffrey Randolph, Esq., Legal Counsel of Association of

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

Combination pro

ew Jersey Chiropractors.

The surge in audits is motivated by a combination of three factors, na

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

mely, continued pressure to turn higher profit by insurance companies, inability to raise insurance pre

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

iums, and timely payment laws. Premium wars preclude them from raising rates, and recently enacted tim

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

ly payment laws limit how long they can withhold repayment to earn interest as they had in the past. T

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

o meet profit expectations and still play within the new rules, insurers have decided to go after the r

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

imbursements after they are paid.

The means to identify the easiest and most profitable audit t

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

Following aspects would a

rgets is facilitated by a Big Brother system, built automatically during claims processing. As provide

dd to the challenges in developing combination products:

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

rs submit claims to be paid, insurers simply add each claim to their growing database. The system auto

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

atically pinpoints providers that are doing something differently from the pack.

While the motive <

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

b> is money and the means is a gargantuan statistical database, every provider is an opportun

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

ity. To manage audit risk, providers need a Big Brother system of our own. Such a system, modeled

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

Professional from academic institutions, pharmaceutical industries, health care indust

on the insurers' own, stores claims data and generates reports for the benefit of participating provide

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

s.

”With teamwork, discipline, and state-of-the-art infrastructure, chiropractors unite and transform

.

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

disparate stand-alone billing operations from the many into the mighty and become a powerful community

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

Companies that provide selfless information through particip

f profitable and compliant managers focused on patient care and practice growth,” says Dr. Brian Capra

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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