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One of the most confusing things to medical billing personnel is rental modifiers. Most billers don't even know what a modifier is unless they

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

have at least had some experience with rental billing. Hopefully, after reading this installment, you'll have a decent idea of what modifiers 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

e, how they work and what you have to be aware of when doing your medical billing duties.

Rental items are a strange breed in the world of medi

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

al billing. Unlike a purchase item that is sold and then that's the end of it, a rental item is kind of like the gift that keeps on giving. It

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

is a medical billing agencies main source of income, especially if they do a lot of oxygen billing which requires patients to have an oxygen con

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

Combination pro

entrator for many months if not years.

Because of this, insurance carriers need to know, every step along the way, just how long a piece of equ

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

pment has been rented. Why? Well, this has to do with certain regulations. See, once an item has been rented so many months, usually 12, it t

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

hen goes on what is called maintenance billing. Maintenance billing is usually cheaper than regular billing because by the time the 12 months h

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

ve passed, the supplier of the equipment has already gotten their due profit from the item and because of this, the insurance company begins to

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

ay less starting with month 13. What does all this have to do with modifiers?

From months one through 12, the modifier for the particular rent

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

l item will be one set of letters, usually beginning with the letter K. When month number 12 hits, the item is then transferred to a different

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

Following aspects would a

tatus called maintenance. While this is happening, the modifier that is stored with the item is changed from a K modifier to something else, ag

dd to the challenges in developing combination products:

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

in, depending on the item. When the insurance company sees this modifier come over on month 13, they know the item is on maintenance and now pa

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

a different allowable for it. Usually, when this happens, the item also stops billing monthly. Depending on what it is, it may bill every six

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

months or even every year.

The thing that most medical billing personnel don't understand is how this process happens. How does the software

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

now when to change the modifier from a K to a maintenance modifier? It does this by looking at the number of rebill pages that are in the syste

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Each time the system bills a rental item, because it is not a one shot deal, it creates another billing page, called a rebill page. So if th

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

system has billed 11 months and that's the key, it knows when it is billing month 12 and at that time it changes the modifier AFTER it sends 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

month 12 bill. That is the key, to do it after and NOT before. Otherwise, the item goes on maintenance too soon.

It's a tricky process but i

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

Companies that provide selfless information through particip

all happens behind the scenes. So if your DME software is functioning properly, you shouldn't run into any problems with your rental modifiers

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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