Advice Pool - Legal

When we first speak to a potential client, or concerned family member, we always ask:

“Is your loved receiving Medicare or Medicaid benefits?”
“Is your health insurance provided by your employer?”
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
li>
“Were you injured on the job?”

These may seem like strange and somewhat irrelevant questions but they are essential for determining whether to file a lawsuit.

Medicare
If you ar

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

Examples of combination products may in

sixty-five years old or older, then you are entitled to Medicare insurance coverage through the federal government. If so, and often without your knowledge or notice, Medicare will be billed for and pay for a portion

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

of your medical care and treatment. Medicare may even pay for a portion of your nursing home stay. If so, any lawsuit you file where you seek repayment for medical care necessary as a result of another’s negligence,

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

edicare has a right to seek repayment for the services they paid for on your behalf.

For example – Edna, age 65, falls on an open can of soup at her local grocery store. The store manager calls 911 when Edna is unabl

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

Combination pro

e to walk and the ambulance arrives. The rescue squad takes Edna to Local Community Hospital where Edna is evaluated in the emergency room. She is admitted to the hospital when her doctors realize she has fractured he

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

right hip and requires surgery. Edna has surgery and two days after surgery she is discharged to a nursing home for rehab after the hip surgery.

If Edna files a lawsuit against the grocery store for negl

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

igence and personal injury and recovers $25,000, Medicare will seek repayment of any monies paid on her behalf for injuries related to the fall. Under Federal law, Medicare does not have to provide Edna notice that th

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

y plan on seeking repayment. See 42 CFR §411.26. But how much will Medicare seek in repayment? Sadly, we cannot answer that question for Edna or her family. Each lien is determined on a case by case basis

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

… but by law, Medicare should reduce their demand, taking into consideration there were costs with filing a lawsuit or seeking a settlement (including attorneys’ fees, expert’s fees, etc.). But what if the ambulance b

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

ll was $400; Emergency Room $2000; Surgery $8000; Four day hospital Stay $7000; and twenty days in the Nursing Home getting rehab, $4000. Medicare will have paid at least $21,400.00 for Edna’s care, and effectively ca

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

Following aspects would a

n take almost every penny of her $25,000 settlement after attorneys’ fees and costs…so we warn clients, right away – THERE IS A POTENTIAL LIEN ON YOUR RECOVERY… AND WE WON’T KNOW HOW LARGE OF A LIEN UNTIL THE END. Not

dd to the challenges in developing combination products:

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

only is this scary for many clients, it will often be enough of a deterrent the family will decide not to file suit.

And Medicare is not the only party who can claim a lien.

Medicaid
In Virgini

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

a, and most other states, programs exist to provide a level of healthcare for those who cannot afford it. There is no age limit to Medicaid, but rather an income cap. Like Medicare, Medicaid has a right to seek repaym

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

nt for monies paid on behalf of a beneficiary. If you file a lawsuit against a nursing home, doctor, or even as a result of a car accident, if Medicaid paid for a portion of your care, they will seek repayment. And he

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

re is the real-kicker – both Medicaid and Medicare can seek repayment on the same lawsuit…. So if Edna in the above example was on disability or had an income qualifying her for Medicaid benefits, Medicare could seek

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

Professional from academic institutions, pharmaceutical industries, health care indust

lien for the $21,400 it paid, and Medicaid could do the same if it paid any of her related bills.

Other possible liens
If you receive health insurance benefits through your employer as a result

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

of a qualified ERISA plan, the plan will likely be entitled to reimbursement if you are successful in pursuing a claim against a negligent party. It is very important to discuss these issues with your attorney.

.

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>Conclusion
Our office staff spends weeks after a case has concluded, trying to work with Medicare and Medicaid on liens. Sometimes they are more than we anticipate and on good days, they are less…. Bu

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

Companies that provide selfless information through particip

t the existence and amount of liens is always a factor in our discussions on whether to take a case, settle a case, etc. If you know the lien could be overwhelming, sometimes legal action is not the appropriate choice

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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