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Among the benefit programs of the government, the most applicable one for the retirees is the medicare benefits. However, most of us do not

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

understand the fundamentals of the medicare program. How does the government establish it? How can we benefit from it? This write-up will tr

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

Examples of combination products may in

y to educate those who are in need of such basic and essential information about medicare benefit. This will also serve as a guide for those

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

who are planning to retire and apply for the said program.

Primarily, the medicare is one of the products of former U.S. President Lyndon

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

. Johnson’s “Great Society” idea which was signed into a law on July 30, 1965 as an amendment to the Social Security laws. Hence, this plan

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

Combination pro

aims to impart the senior citizen of the U.S. a stable and effective healthcare system which will greatly support their medical needs. But,

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

the medicare benefits can also be given to those individuals who are disabled and not only to those who have reached the retirement age of 6

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

5 years provided that they have met the requirements set by the Social Security Agency.

In order for a disabled individual to qualify for t

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

e medicaid benefits, he or she is required to file an initial claim for title II benefits to the nearest Social Security Administration offi

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

ce. Title II is under the title 2 of the Social Security Act which is commonly known as the social security disability benefits (SSD). This

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

benefit is handed over to disabled individuals who fail to meet the standard income.

Once the claimants’ applications for SSD benefits were

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

Following aspects would a

approved, they will be able to receive their medicaid benefits after two years prior to the date of approval. This would mean that they wil

dd to the challenges in developing combination products:

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

be ensured of financial support from the government for their daily basic needs.

On the other hand, medicare benefits are given to those w

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

ho are disabled or have already reached their retirement age regardless of their income. This is different from supplemental security income

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

and medicaid benefits which are basically needs-based programs. The medicare has the following coverage 1) Medicare part A – covers hospita

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

l visits and staying in nursing homes; 2) Medicare part B – covers outpatient care and services which may include doctor visitations, labora

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

Professional from academic institutions, pharmaceutical industries, health care indust

ory reports and x-rays; and 3) Medicare part D – covers prescription drugs. This, however, is only available for those who are already eligi

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

ble for medicare part A & B benefits.

The medicare program of the government has some complicated aspects. If the petitioner still finds th

.

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

e process of applying for the said benefits, then, it is very much recommendable to hire the expert assistance of a qualified social securit

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

Companies that provide selfless information through particip

y attorney to help them in pursuing their claims. This will ensure them of acquiring their much needed financial support from the government

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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