Advice You - Business

Chairing a Pathology Department at Centrastate Hospital in New Jersey and simultaneously running two laboratories in two remote states (Oklahoma a

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

nd New Jersey) require Dr. Michael McGinnis to match his medical expertise with savvy business sense.

"A pathologist must track workflow of the e

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

Examples of combination products may in

tire laboratory from receiving a sample and requisition form, to accessioning, to patient demographics, to history, to gross, dictation, proof, di

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

stribution, and billing," says Dr. McGinnis. "I need to know precisely what unfinished work is left at each stage in every lab. I need to track e

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

ery step and know exactly who has done what regardless of their location. And I need this information in real time. For instance, I need the lis

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

Combination pro

t of signed off reports arranged by requesting doctor, date, patient, or payer, in real time."

Information Systems Challenges in a Pathology

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

aboratory

Pathology billing is especially complicated because it requires:

Data flowing between
1. Hospital s

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

ystem,

Multiple requesting doctors,

Internal laboratory system,

External billing service, and

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

ultiple insurance companies

A system of checks and balances to

Prevent losing a case
E

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

nsure full and timely payment

Continuous Measurement

Billing quality is best understood by observing the d

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

stribution of Accounts Receivable. A well-performing service will have half of the claims paid within 15 days, with over 90% of all claims being

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

Following aspects would a

paid within 45 days. The narrower "bell-curve" of Accounts Receivable means better cash flow predictability while its lower "tail" means added re

dd to the challenges in developing combination products:

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

enue.

Software-as-a-Service (SaaS)

"Gone are the disk crashes and software maintenance. No more office staff moods and conflicts to r

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

esolve or benefits to pay. I now pay only for performance, which makes perfect business sense," says Dr. McGinnis. "Finally, I can replace my adm

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

nistrative assistants with medical specialists that can take over some of my workload and add revenue."

Mission-Critical System Features
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
>

The following seven features are critical for accomplishing the benefits listed above:

Comprehensive integrated functionality cover
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ng entire laboratory workflow
Internet-based access to data entry and reporting

An interface between hospital internal syste
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
m and external billing service
Arbitrary aggregation and comprehensive analysis of all laboratory and billing data

Full and
.

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
transparent access to each and every claim, from accession number to coding to payment
24x7 status reports about received payments, sub
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
mitted claims, rejections, follow-ups, and delays
HIPAA compliance. Role-based access control to clinical and billing data

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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Advice You - 7 Key Features Of Integrated Pathology Lab Workflow And Electronic Medical Billing Software

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