Frequently Asked Questions

About Intelaform Services, LLC. (Intelaform) 

FREQUENTLY ASKED QUESTIONS | UPDATED March 30, 2021

1. What is Intelaform?

Intelaform is an auditing service company that uses new and proprietary software and systems to identify aberrant and potentially suspect products within pharmaceutical claims data.  Previously unidentified suspect drug products exist within drug claims and are not easily identified with current auditing systems.  Intelaform uses a uniquely different approach to identify these claims within drug claims data.

2. How long has Intelaform been around?

The early elements of Intelaform Services, LLC. (“Intelaform”) were established in 2001. Intelaform, Inc. was founded in the wake of 9-11 as a mechanism to identify and prevent potential bioterrorists risks to the US pharmaceutical supply chain.  Intelaform, Inc. owned the system design for this new service called “Surveillance Preparedness Awareness and Response” (SPARx) used to identify and prevent attacks to the US drug supply.  Subsequently and because of the implementation of the 2013 Drug Supply Chain Security Act (DSCSA), Intelaform recognized the government’s awareness of potentially diverted and counterfeit drugs and exclusively licensed a system to track pharmaceuticals within the US supply chain. 

3. Why was Intelaform created?

Supply chain integrity is central to the wellbeing of every American.  The ability to depend on safe and effective pharmaceuticals is inherent within the responsibilities of the FDA.  The creation of the DSCSA in 2013 reflects the FDA’s commitment to drug product safety.  Intelaform intends to help patients and payors have confidence that the monies spent on pharmaceuticals are spent wisely.  Intelaform’s primary focus is the auditing of pharmaceutical claims to determine the legitimacy of the drugs submitted for payment to patients and payors.  When needed, Intelaform also offers on-site audits of supply chain participants to validate prescription processing claims.

Intelaform has an exclusive license for prescription product pedigree analysis tools. This software is embedded as a key component of our solutions set to help uncover unnecessary claim payments for pharmaceuticals.  We already are tracking over one million Rx shipping notices (ASNs) each quarter, enhancing the predictive analysis of our services.

The DSCSA legislation was passed in 2013 with deadlines for compliance of specific articles occurring throughout its 10-year implementation period. The deadline for full compliance is 2023 for all providers and dispensers.

4. How is Intelaform different?

Intelaform has an exclusive license of the Advasur 360 prescription product pedigree analysis tools and has imbedded this software within a claims processing analysis protocol to uncover unnecessary claims payments for pharmaceuticals.  Detailed information of the contents of prospective shipments of pharmaceuticals to other supply chain partners is required by the Food and Drug Administration (FDA) to be delivered to pharmacies when products are shipped.  These data are contained in Advance Ship Notices (ASNs).  In the US alone, there are roughly 67,000 pharmacies and 20 million ASNs sent each year – so the magnitude of the issue is tremendous.

5. Who are our customers?

We work with:

  • commercial insurance companies
    • group health plans
    • employers, including self-insured and captive arrangements
    • insurance brokers and consultants
    • third-party claims administrators
    • reinsurers

6. Describe your management team and office location.

Our leadership team is spearheaded by the original founders of Intelaform and strengthened recently with knowledge experts from different sectors of the industry. Complete bios of our team can be found on our website, including:

  • Todd Barrett, RPh., Managing Director, Intelaform Services, LLC
    • Liam Dunn, Director of Sales
    • Robert Terracciano, Advisor
    • Gregory Arms, Advisor
    • Sid Stolz, Advisor

Intelaform’s offices are located at Johns Hopkins University, MCC-Academic and Research Building, in Rockville, Maryland.

7. How is the Drug Supply Chain Security Act (DSCSA) relevant?

The percentage of counterfeit drugs worldwide is significant.  The World Health Organization estimate is that up to 1% of medicines available in the developed world are likely to be counterfeit[1].  As recently as December 2020, counterfeit versions of medications used to treat HIV were found to be distributed within the US pharmaceutical supply chain.[2]

This federal act was passed by Congress in 2013 to grant the FDA more authority to regulate and monitor the manufacturing of compounded drugs.   Composed of two sections; Title I addresses the security of preparations used in pharmaceutical compounding while Title II (DSCSA) focuses on the pharmaceutical supply chain and the safety and security of manufactured pharmaceuticals.  This legislation was created to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. 

Title II of the DSCSA is designed to identify and quarantine potentially illegitimate or counterfeit drugs – sometimes called ‘track and trace.’

8. Which pharmacies are affected?

Pharmacies and patients throughout the US pharmaceutical supply chain are subject to the implications of adherence to the law.  One study sought to identify the impact of the DSCSA on small pharmacies in the US and found that 40% of those affected would be small, non-chain dispensers[3].

9. Which portions of the DSCSA have been implemented since passage of the legislation?

Manufacturers, repackagers, wholesalers, and dispensers (pharmacies) have begun implementation of most of the legislative directives.  All requirements except for participation in an electronic interoperability database were to be implemented as of November 27, 2020.  Compliance of this last requirement is due by November 27, 2023.

10. What is ‘electronic interoperability’ and how does it apply to participants within the supply chain?

Electronic interoperability is the term used within the DSCSA that describes the ability of supply chain partners to exchange drug product information and ownership history within a data base or process.  This functional capability is needed for full compliance by the overall Rx supply chain by November 2023.

11. How are drugs tracked as they move through the supply chain?

Beginning in November 2017, all pharmaceuticals distributed within the US must be serialized.  The smallest saleable unit of a medication (generally, the smallest bottle that can be purchased by a dispenser) must have a serial number and other data embedded in a 2D barcode as well as printed in a legible format on the outside of the container.  Investigation by FDA or other authorities may require collection of serial numbers for submission and documentation of prior ownership.

 ‘Product identifiers’ also must be affixed or imprinted on Rx packages as a standardized graphic that includes a human readable form with lot number and expiration date of the product.

The Intelaform Value Proposition and Distribution Strategy

12. What are Intelaform’s core competencies?

Intelaform’s management team has meaningful experience in the pharmaceutical industry and understands the complexities of its supply chain components, including: 

  • specific expertise in manufacturing, delivery, and claims payments.
    • creation and delivery of medication and dispensing to patients. 
    • cost and complicated payment modalities.
    • expertise to proactively identify fraud, waste and abuse (FWA).
    • DSCSA process knowledge of data delivery across the supply chain.
    • participation in relevant FDA studies[4].

13. What separates you from the competition?

Intelaform has an exclusive license of the Advasur 360 system and an exhaustive understanding of data requirements and data delivery within the pharmaceutical supply chain.  The Intelaform team has analyzed millions of data transfers since the inception of DSCSA and the associated data submission requirements.  Using this expertise, experience, and technology Intelaform is ready to move to a new level of auditing capability.  Accountability for maintaining the integrity of the US drug supply chain is now available with Intelaform.

14. What are the benefits of a claims audit?

Payment for counterfeit drugs is not beneficial for the patient or the payor responsible for the claim.  Counterfeit drugs are a growing threat.  Newer technologies make counterfeit drugs indistinguishable from legitimate pharmaceuticals.  The estimate of the incidence of counterfeit drugs ranges from one (1) percent to seventy (70) percent.  While the US supply chain is more protected and toward the lower end of the scale, the risks are still significant.[5] 

15. What is the cost to the employer or insurer?

Intelaform does not charge for an audit or assessment, but invoices based on the potential savings to the insurer.  Invoices for claims audits are on a percentage basis and depend on the type of audit.

16. Can your service be white labeled?

We offer an auditing service. Our technology, processes, and associated intellectual property are proprietary and are integrated into the auditing process.  We are unable to decouple the individual processes into a white label offering that would be beneficial.

17. How many clients do you currently have in your portfolio?

Intelaform’s database includes numerous large clients with several million audited transactions.  These data provide an excellent perspective of the ability of supply chain partners’ ability to provide documentation of pharmaceutical supply chain integrity.

How does the audit process work and what are the costs and impact?

18. Describe the Intelaform audit process: How do members initiate service and what are the next steps?

Our service is simple to use – we typically follow a seven-step process:

  1. Intelaform works on behalf of insurers to perform audits on claims submitted for reimbursement.  
  2. Intelaform contacts the prescription payment processor of the insurer.
  3. Claims data from the payment processor is compared to Intelaform’s database.
  4. Our robust data analysis includes search for aberrant / suspect Rx products. 
  5. Rx products without documented pedigree are ‘flagged’ for deeper search.
  6. Submitted claims are then matched to ‘flagged’ Rx products and cost valued.
  7. Value of all ‘flagged’ items are computed, totaled, and processed by Intelaform for potential recoupment. 

19. Is there any market research or analysis by recognized third parties that would lend support to the Intelaform designed audit approach?

Yes, there are two recent reports worth highlighting. 

First, in February 2021, Johnson & Johnson released a position paper on counterfeit healthcare products.  The focus here was on the public risk and extra cost associated with counterfeit medicines.  Their paper estimated trade in counterfeits at $75 – 200 billion annually – and upwards of 250,000 child deaths each year from fake medicines. J&J’s guiding principles distinguish ways to identify and mitigate the risks associated with counterfeit healthcare products – especially improving controls in the drug supply chain[6].

Second, Milliman the global actuarial consulting firm, released a 5-page report in August 2020 about optimizing PBM contracts in a dynamic and complex pharmacy landscape.  The report gave a strong endorsement for plan sponsors to regularly examine their pharmacy programs under a microscope: “Audit and ongoing monitoring are key processes plan sponsors should use regularly to help understand and manage drug (cost) trend.”[7]

Copies of both reports are available on request.

20. How can I learn more about Intelaform?

 

For more information, contact info@intelaform.com or visit www.intelaform.com


[1] https://pubmed.ncbi.nlm.nih.gov/21789919/ (Golocorbin Kon S, Mikov M. [Counterfeit drugs as a global threat to health]. Med Pregl. 2011 May-Jun;64(5-6):285-90. Serbian. doi: 10.2298/mpns1106285g. PMID: 21789919.)

[2] https://www.fda.gov/media/144858/download (FDA, counterfeit medications, accessed 30 Mar 2021)

[3] https://www.fda.gov/media/133147/download  (FDA, accessed 30 March 2021)

[4] https://phthealth.com/blogs/news/pht-amp-hrg-complete-fda-small-dispenser-study (Providence Health Technologies, accessed 30 March 2021.

[5] https://www.japha.org/article/S1544-3191(15)31873-2/fulltext (Journal of the American Pharmaceutical Association, accessed 30 March 2021.

[6] https://www.jnj.com/about-jnj/policies-and-positions/our-position-on-counterfeit-healthcare-products, accessed 14 April, 2021

[7] https://www.milliman.com/en/insight/pbm-contracts-understand-then-optimize, accessed 14 April, 2021

[1] https://www.jnj.com/about-jnj/policies-and-positions/our-position-on-counterfeit-healthcare-products, accessed 14 April, 2021 [1] https://www.milliman.com/en/insight/pbm-contracts-understand-then-optimize, accessed 14 April, 2021