Optum Rx/VAWD Questions & Answers from July Webinar

1. Are there states other than NY that have legislation that makes it difficult for Optum to enforce VAWD requirement?

At this time, we have only verified that New York State has a bill in place to limit the control a PBM has over reimbursements in regards to the source of drugs.

2. Can a wholesaler owned by a pharmacist obtain VAWD accreditation?

Yes, absolutely. The concern of pharmacists and wholesale drug distributors centers around the potential for diversion, specifically that wholesale drug distributors will purchase product on restricted pricing contracts.

3. Can you please go over the point about a chain pharmacy owner also owning a wholesale company?

We have seen a few wholesale drug distributors pop up that are aiming to fill the vacuum created by those wholesale drug distributors who used purchases from pharmacies to obtain favorable pricing. Chain pharmacy owners and GPOs utilize guaranteed volume from within their network to start building their business.

4. Does the Distributor’s software being used need to have specific credentials/functionality to achieve VAWD?

VAWD is often referenced as the “gold-standard” within the wholesale drug distribution industry. As such, it is important that companies looking to achieve VAWD Accreditation put systems in place to, at minimum, meet Federal/State laws and, ideally, meet industry best practices. In regards to Federal/State laws, a company will want Serialization/DSCSA capabilities and reporting functions. For industry best practices, a company should think of additional features such as user-specific access, security time-outs, and more.

5. Have you experienced instances where VAWD demands a full cold chain process analysis in order to receive accreditation.

VAWD is often referenced as the “gold-standard” within the wholesale drug distribution industry. As such, a company will be required to demonstrate their ability to guarantee the quality of drugs physically handled by such company – whether that is done using validated packaging materials and processes or self-validating is a management decision.

Pharma Solutions provides cold chain validation services for some of the leading companies in the United States!

6. If a drug manufacturer is VAWD accredited and sells to a non-VAWD accredited distributor, can a pharmacy get reimbursed through Optum if they buy through the non-VAWD accredited distributor?

We believe that Optum Rx will be strict on requiring pharmacies to only purchase product from VAWD Accredited distributors.

*Pharma Solutions is not a law firm and cannot provide legal advice*

7. If a pharmacy buys direct through a non-VAWD accredited manufacturer, but warehouses the product in a VAWD accredited 3PL and then distributes the product to its wholly-owned pharmacies, will the pharmacy get reimbursed through Optum?

We believe that Optum Rx will allow pharmacies to buy direct from manufacturers.

*Pharma Solutions is not a law firm and cannot provide legal advice*

8. If you just applied to VAWD, How do you go about requesting the Optum Rx extension letter?

Please reach out to us – hello@fiveriversrx.com.

9. Is there a list available showing wholesalers who are VAWD accredited?

Yes – an updated list is always available on the NABP website.

10. Is there any VAWD type accreditation at the government level?

No – the NABP is a private entity and is not affiliated with any branch of the government.

11. Is VAWD for 3PL’s different than wholesalers? Different requirements?

VAWD Accreditation is applicable to many different business models and is tailored accordingly. For example, a Virtual Manufacturer will have limited SOPs on the actual physical handling of product whereas a 3PL will have limited SOPs on DSCSA compliance.

12. Outside of VAWD, have you seen any PBM’s that are raising issues with buying direct from drug manufacturers or is there any guidance there in things an independent pharmacy would want to be aware of?

To our knowledge, only CVS Caremark requires pharmacies to purchase from “Authorized Distributors” (AD); please note that the definition of AD has changed with the passing of the DSCSA. Prior to the enactment of the law, AD was a private designation made by pharmaceutical manufacturers whereas after the enactment of the law, AD is now defined as being properly licensed to do business.

*Pharma Solutions is not a law firm and cannot provide legal advice*

13. Please provide more detail on NY state law regarding considering invoice in audits.

Please see our article here.

14. What about the reverse scenario…if a drug manufacturer is not accredited, but the distributor is?

We believe that Optum Rx is not concerned with the VAWD status of the manufacturer as diversion would occur at the wholesale level.

*Pharma Solutions is not a law firm and cannot provide legal advice*

15. Why do some states require and/or recognize VAWD Accreditation while other states are not?

NABP is a private organization; each state board, depending on its leadership, can recognize a third-party. At this time, 24 of 50 states recognize VAWD Accreditation.

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