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Quality credentialing verification organizations (CVO’s) create an environment beyond simply generating credentialing reports for medical providers. A CVO with good customer service responds quickly to questions; has tr

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

ained staff that is assigned to a particular client; can streamline the credentialing process; has good technology resources; and offers extra support, such as internal audits and tracking license renewals. An emphasis o

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

Examples of combination products may in

customer service means that the CVO can supply substantive information and support to establish a true working relationship with a medical organization.

There are five areas of a CVO’s customer service to consider: fle

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

xible credentialing processes which can be adapted in response to client needs; a range of quality services; quick responses to clients; individual support; and solid technology practices. Although some service points, s

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

ch as a fast response to questions, can seem small, these areas display the quality of the CVO, which will define the long-term relationship between the CVO and its clients.

Adapting credentialing services to client

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

Combination pro

eeds.
CVOs should be responsive to their clients’ needs. The CVO should be accredited by either accrediting organization: National Committee for Quality Assurance (NCQA) or the Utilization Review Accreditation 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

ouncile (URAC) or comply with their credentialing standards. In addition, the CVO should add new credentialing standards for their clients and should also be able to adapt their credentialing processes by adding special

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

criteria or using a subset of criteria. This flexibility includes making recommendations to streamline processes and working with clients to determine what they need rather than following a preset checklist.

Individu

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

alized support and quality controls.
Individualized service means that there is a dedicated representative for each client. There should be a known manager to handle difficult situations and an established route

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

to lodge complaints. All personnel should be trained to perform credentialing reports according to the accrediting organization’s standards.

There should also be an established quality control system and regular interna

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

audits for managing feedback, rewarding good service, and evaluating bad practice. The CVO should be able to supply a copy of their quality control policies and practices documentation. If they are accredited by NCQA or

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

Following aspects would a

URAC, then there is a guarantee that these practices have been reviewed and audited and that their service meets industry standards.

High quality services.
Two attributes of quality work are timeliness and

dd to the challenges in developing combination products:

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

horoughness. Good CVOs will return credentialing reports as quick as industry norms, meaning around 60 days for hospital standards (JCAHO) and 30 days for managed care standards (NCQA and URAC). The credentialing reports

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

will also be complete – no missing data or criteria and with full supporting documentation. CVOs should have an established maximum number of requests they make to organizations for information and other avenues of find

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

ng information. Problem files should be brought immediately to the review committee’s attention. All of these practices work together to make a thorough credentialing report.

Additionally, good CVOs offer services such

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

s tracking licensing dates and requirements (expirables) and disciplinary actions by various organizations (surveillance); consulting and training classes about credentialing processes; and support during internal audits

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

Professional from academic institutions, pharmaceutical industries, health care indust

.

Quick response to client contact.
Good CVOs respond to questions within 24 hours. They should answer any questions fully and as quickly and directly as possible rather than postponing or transferring them.

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

Technology resources.
CVOs should be using the most recent technology, such as databases, paperless credentialing, and web access with adequate security and access control.

Customer service is key to creati

.

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 a good relationship between CVOs and medical organizations. Quality control policies, flexible credentialing processes and criteria, quick response time, good technology use, and responsiveness to questions and reques

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

Companies that provide selfless information through particip

s are five major areas where a CVO develops good customer relations. All these areas mean the CVO is responsive – that the CVO is paying attention to individual customer needs and consistently doing its best to meet them

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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