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Qui tam is a legal term used to describe whistle blower claims. Qui Tam is actually an abbreviation f

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

or the Latin phrase “qui tam pro domino rege quam pro seipse,” which means “he who sues for the king a

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

Examples of combination products may in

s for himself.”

Qui tam, or whistle blower, claims were developed to allow employees to bring lawsuit

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

s against their employers for defrauding the government. If an employee has knowledge of their employ

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

r defrauding the government, they can file a lawsuit, assisting the government in recovering the funds

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

Combination pro

they deserve, and recovering compensation for bringing the lawsuit.

One of the most common frauds be

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 committed is that of healthcare facilities. All too often government health programs are defraude

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

d out of money. In fact, it is estimated that close to 10% of all Medicare charges are fraudulent. S

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

me of the most common forms of fraud include:
§ Billing multiple times for one service
§ Bil

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

ling for expensive equipment, when less expensive equipment is purchased
§ Patterns of waiving pa

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

tient’s co-payments
§ Obtaining Medicaid or Medicare numbers in return for free services or produ

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

Following aspects would a

cts
§ Charging for treatments that were never actually performed

dd to the challenges in developing combination products:

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

w.ppl-law.com/qui_tam.html">Qui tam claims are now easier for employees or informants to file, but

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

there are many difficult statutes that must be followed in order for the claim to be settled. If the

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

claim is settled, however, the employee or informant is usually awarded a percentage of the total amo

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

unt recovered by the government.

If you are an employee of a business or healthcare facility that is

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

Professional from academic institutions, pharmaceutical industries, health care indust

efrauding the government, you may be able to file a qui tam claim and be rewarded for coming forward w

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

ith your information, and you can also serve the public by stopping fraud.

Contact an experienced qui

.

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

tam lawyer today if you have information about fraud against the government in your workplace. A qui

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

Companies that provide selfless information through particip

tam attorney will help you follow all the applicable statutes and recover compensation for your claim

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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