Main Subject - Business

Managed care organizations like health management organizations (HMO) and independent provider associations (IPA) are required to credential their providers, meaning they have to verify the medical provider’s professional hi

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

story. Because of the dispersed nature of managed care organizations and the resource requirements of the credentialing process, credentialing verification organizations (CVO) step in to provide these credentialing services.

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

Examples of combination products may in

Overview of Credentialing
The two major accrediting organizations for managed care organizations are the National Committee for Quality Assurance (NCQA) and Utilization Review Accreditation Council (URAC) As p

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

rt of their accreditation requirements, both URAC and NCQA require managed care organizations to credential their providers according to their published standards.

While it is less common for preferred provider organization

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

s (PPO) to credential their practitioners, credentialing lowers risk and liability, while improving patient care. As an example of how important these standards can be for PPO quality, more than 10% of the organizations cert

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

Combination pro

fied by NCQA are PPOs.

Credentialing verification requirements for both NCQA and URAC require that the work history, disciplinary actions, and malpractice claims history of the provider be checked for the previous five year

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

s, and then rechecked every three years. The additional areas that are verified are similar for both organizations, including the following information:

Education and post-graduate training
Hospital affiliatio

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

Board certifications

State licenses

DEA certificate

Medicare/Medicaid sanctions

Adverse actions in NPDB or HIPDB records

The above listed organizations must be contacted an

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

verifying documents, such as copies of certificates, sent to the CVO. This information is used to create the credentialing report that the CVO submits to the managed care group’s review committee.

The type of information t

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

hat the CVO collects can be modified to meet the needs of the managed care group. For instance, if a PPO wants to verify that a physician has the appropriate licenses and malpractice insurance, but does not need to comply wi

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

h URAC or NCQA standards for accreditation, a CVO will adapt the credentialing process to find that information.

Selecting a Good CVO
Managed care organizations have long depended on CVOs to provide credentialin

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

Following aspects would a

g services because CVOs tend to be faster and less expensive than credentialing in-house. Using CVOs help reduce staff time and training for managed care groups, as well as lowering their liability and lessening the risk of

dd to the challenges in developing combination products:

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

penalties for errors during NCQA/URAC audits. CVOs not only credential physicians, but all types of medical personnel, such as midwives, respiratory therapists, nurses, and physical therapists.

There are certain characteris

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

ics that can help distinguish a good CVO:

CVOs should adapt their credentialing criteria to accommodate the managed care group’s needs, such as verifications with fewer criteria than NCQA/URAC standards for PPOs or ad

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

ding verification criteria for other managed care groups.

The CVO should be certified by either NCQA or URAC, preferably both, which means the CVO complies with the accrediting organization’s practices and standards.

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

/li>

The completed reports, with no unverified data, and supporting documentation should be complete and available on file.

Turnaround time should be within industry averages; for NCQA/URAC standard credentialing,

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

Professional from academic institutions, pharmaceutical industries, health care indust

this is about 30 days.

Any problems with a provider should be brought quickly to the managed care organization’s review committee.

The CVO should offer extra services, such as tracking expirables like licens

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

e renewals and recredentialing deadlines, and support through routine NCQA/URAC compliance audits.

The CVO should have solid customer service practices, including a single, named CVO representative; customer satisfac

.

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

ion and quality assurance practices; and a quick response time to questions.CVOs offer better turnaround time, lower overhead and expense, reduced staff time, and lowered liability to managed care groups. Even grou

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

Companies that provide selfless information through particip

ps, like PPOs, which are not required to meet NCQA/URAC standards for accreditation still benefit by making better provider choices, meaning improved patient care and liability, by credentialing their providers through a CVO

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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