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There are over seven million on people that are un-insured in the state of California. Most of them have been declined by multiple insurance companies and gave up on their search in finding health insura

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

nce. It seems like it is unfair system if you do not know what is available to you. I you have been declined by one insurance company in the state of California the chances are you will get declined by 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

ll of them. Most of the insurance companies use similar underwriting guidelines.

There is a way to get Health Insurance in the state of California without insurance companies even looking at your medica

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

l record. There is a way to get a guarantee issue plans from any insurance company of your choice without underwriting. It is also guaranteed that all of the pre-existing conditions and prescription drug

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

s will be covered. It is even guaranteed by the state of California insurance commissioner that you will be guaranteed coverage and all of your pre-existing conditions will be covered, no exceptions… non

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

Combination pro

e. You might be thinking, well how much is that kind of coverage going to cost. The answer is not more than what you will be paying for a regular individual medically underwritten plan. If fact in most c

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

ases it will probably cost you less.

How can you get coverage like that? It is not simple process and it will require some work on your end. If you a kind of person that complains and procrastinates all

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

the time, chances are you are not going to do anything and you still will be without coverage whining on how evil the insurance company are and that they do not want to insure you. The process is simple

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

and might not be easy for lazy people. In the state of California all the group plans are guarantee issues plans. That means that you are accepted without medical underwriting. To have a group plan start

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

ed all you need is two or more people. If it is a group of two which could be husband, wife, friends, relatives… and anyone who has a pulse. If it is a group of two one of them can be the owned and the s

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

econd person in most cases must be on the payroll. That means that person must be W-2 employee. I can hear some of you might be whining that, do I have to do that?... Yes. Like I mentioned before if you

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

Following aspects would a

are going to whine stop reading this and keep doing what you were doing before. I have some one on the payroll is very simple process you can do it your self or you can get one of the payroll companies t

dd to the challenges in developing combination products:

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

o do it for you and it can be as little as $39 per month for pay-roll company to do that for you.

Next we need some kind of proof that you have some kind of business. It could be anything, no one cares.

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

Say you sharpen pencils, make staples, watch snails, say you are in home couch tester, who cares, remember, no one cares. You can go to your county and get a business permit. It cost almost nothing and

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

hat will be a sufficient proof to insurance company that you have a legitimate business. Last thing we are going to need is a record from a payroll journal for the first month only to submit it to insura

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

nce company. Ask your accountant what that means. Since insurance companies will ask you for two primary things DE-6 form (Quarterly Wage Report) and some kind of business license, that’s it. It takes 3

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

Professional from academic institutions, pharmaceutical industries, health care indust

month for you to get DE-6 (that is the proof that you have legitimate payroll) that is why you are going to need a payroll journal record for the past or current month. Some insurance companies will even

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

accept a payroll stub.

The absolute best way to get this handled and get it all in place is to contact health insurance broker. Most brokers avoid small group like that, because the people who are tryi

.

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

ng to get group like that going are extremely difficult to work with. If you want to have insurance broker to get it all set up for you be cooperative and get the paperwork mentioned above in the timely

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

Companies that provide selfless information through particip

fashion to them. Good insurance broker could be extremely valuable to you. If you would like to get more information or need assistance setting up a group plan see resource box below for more information

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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