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Frequently Asked Questions

About Hudson Headwaters 340B & Our Services

How many years has Hudson Headwaters 340B been active in the 340B program?

We've been working with 340B since 2001.

When did Hudson Headwaters 340B start offering services to other health care organizations?

We began offering 340B third party administrative and consulting services in 2006. In 2015, we began offering independent audits and other compliance services.

What types of clients does Hudson Headwaters 340B serve?

We can manage 340B programs for all entity types.

340B Third Party Administration

How does the replenishment model work?

Drugs are replenished when the pharmacy has dispensed a full package size to 340B-eligible patients. Drugs are purchased on the entity’s 340B account and shipped to the partner pharmacy.

Under the Hudson Headwaters 340B system, what does the pharmacist need to do at the point of sale to distinguish a 340B script?

Integration into the 340B program should be seamless for the pharmacy. No special action is needed at the point of sale to identify a 340B-eligible script.

340B Audits

Is an annual independent audit required?

For covered entities participating in 340B with contract pharmacy arrangements, HRSA recommends an annual independent audit.

Are your audits similar to HRSA audits?

An independent audit conducted by Hudson Headwaters 340B mimics a HRSA audit.

Where does Hudson Headwaters 340B get their auditing experience from?

Hudson Headwaters Health Network underwent a HRSA 340B program audit in June of 2015, which resulted in no adverse findings. Additionally, we assist our clients through their own HRSA audits.

Reporting & Systems

Who at Hudson Headwaters 340B handles my reporting?

Each of our clients is assigned a dedicated client representative who handles all reporting.

How often will I receive reports from Hudson Headwaters 340B?

Standard reports are sent when data is received and processed by the client representative. Reports can be on a weekly, biweekly, or monthly basis, depending on the client’s needs.

Does Hudson Headwaters 340B offer specialized reports?

Yes, custom reports can be provided upon request.

How often does Hudson Headwaters 340B reconcile financially?

Financial reconciliation is completed once a month.

How does Hudson Headwaters 340B ensure that scripts accepted into my program are compliant?

We maintain robust filters based on patient, prescriber, price list, and other information to ensure that only 340B-eligible scripts are accepted for replenishment.

Does Hudson Headwaters 340B help track and manage my pharmacy’s inventory?

One of our primary focuses is tracking and managing inventory.

Can Hudson Headwaters 340B interface with all the different systems used in pharmacies today?

Yes, we have experience working with a variety of pharmacy software vendors.

How does Hudson Headwaters 340B prevent clients from being over charged for 340B drugs?

Our vendor specialist team reviews invoices and price lists for all clients. We pursue credits and rebills on behalf of our clients if any discrepancies are discovered.

340B Program

What is the 340B Drug Pricing Program?

A federal program that requires drug manufacturers participating in the Medicaid drug rebate program to provide outpatient drugs to enrolled “covered entities” at or below the statutorily defined ceiling price.

How can 340B help my organization?

340B can provide a qualified health care entity with a solid financial foundation to support existing patient services and help expand their scope of care. In some areas, the program can help providers offer patients convenient access to local medical services. It is designed to eliminate any barriers to care for patients who otherwise could not afford necessary medication.

How many locations can an entity have registered with the Office of Pharmacy Affairs (OPA)?

There is no limit to the number of locations that can be registered with the OPA. It is important to register all relevant child sites — required for compliance with the 340B program.

How many pharmacies can be contracted with by a single entity?

There is no limit to the number of contracted pharmacies. However, an entity should determine whether a potential pharmacy partner would offer improved access for patients.

What is an average transaction fee for a contracted pharmacy?

There is no set transaction fee schedule. Fees should be determined on an individual basis. The transaction fee should be based on the patient population and pharmacy drug mix, taking into consideration the steady increase of specialty drugs in the market. It should mirror the pharmacy’s average retail margin, plus a small add-on for their services, and can be a flat fee or percentage based. It is up to the pharmacy to substantiate their fee.

Where can I find additional FAQ resources?

HRSA/OPA: www.hrsa.gov/opa/faqs
340B Prime Vendor Program: www.340bpvp.com/faqs/

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