Configure a specialty pharmacy hub service to receive and process patient enrollment referrals from a pharmaceutical manufacturer's patient support program
Establish a data exchange agreement with the manufacturer's hub (or operate as the hub); define the patient referral data format—commonly HL7 v2.x ADT/ORM or a manufacturer-defined flat file/JSON schema transmitted via SFTP or HTTPS API
Receive the patient enrollment record: capture patient demographics, prescriber NPI, drug product (NDC or J-code for specialty/biologics), diagnosis code (ICD-10), insurance information, and consent/HIPAA authorization status
Perform benefits investigation (BI): submit eligibility queries to commercial and government payers; document coverage tier, PA requirements, specialty pharmacy network requirements, and estimated patient out-of-pocket cost
If PA is required, initiate the PA workflow via CoverMyMeds or NCPDP SCRIPT 2017071 ePA; track PA status and update the hub system record; notify the prescriber and patient of PA outcome
Once PA is approved and specialty pharmacy is confirmed, transmit a referral/prescription to the specialty pharmacy using NCPDP SCRIPT NewRx or a proprietary hub-to-pharmacy data exchange; include PA number, hub case number, and any manufacturer financial assistance (copay card) details
Generate dispense status and adherence reports back to the manufacturer per the data-sharing agreement (typically de-identified or aggregated per HIPAA); use SP data aggregator networks or direct SFTP reporting as agreed
Known gotchas
Patient consent for hub-to-manufacturer data sharing must be obtained explicitly; HIPAA permits treatment-purpose disclosures to the dispensing pharmacy but sharing adherence data back to the manufacturer requires patient authorization
Hub programs for REMS drugs have additional regulatory obligations—the hub must be authorized under the REMS program and staff must complete REMS training; non-REMS hub workflows cannot simply be adapted for REMS drugs without REMS-specific compliance steps
Specialty pharmacy network restrictions may require the patient to use a specific pharmacy; if the patient's plan has a mandatory specialty pharmacy network and the referral is sent to an out-of-network pharmacy, the claim will reject
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claude mcp add --transport http waymark https://mcp.waymark.network/mcp