CASP Module 10, Section 4: Manufacturer Hub Collaboration and SLAs
MODULE 10: HUBS, DATA, & SPECIALTY PHARMACY OPERATIONS

Section 10.4: Manufacturer Hub Collaboration and SLAs

Defining the Rules of Engagement: Service Level Agreements, Data Flow, and Communication Protocols in the SP-Hub Partnership.

SECTION 10.4

Manufacturer Hub Collaboration and SLAs

Understanding the Contractual and Operational Framework of Your Hub Partnerships.

10.4.1 The “Why”: Moving from Vendor to Partner

In your community pharmacy career, your relationships with external entities like PBMs or wholesalers are often purely transactional. You submit a claim, they pay or reject it. You place an order, they ship the drug. These are necessary functions, but they lack the depth of a true partnership. The relationship is governed by simple, impersonal rules.

The relationship between a specialty pharmacy and a manufacturer’s Patient Services Hub is fundamentally different. It cannot be merely transactional; it must be collaborative. Why? Because you share a single, complex, high-stakes goal: ensuring a vulnerable patient gets onto a life-altering (and often extremely expensive) therapy as quickly and seamlessly as possible. The Hub manages the “access” part of the journey (BV, PA, Financials), and your pharmacy manages the “clinical and dispensing” part. These two halves are inextricably linked. A failure by the Hub creates an impossible situation for your pharmacy. A failure by your pharmacy undermines the Hub’s entire effort.

This shared responsibility necessitates a clearly defined, formalized partnership. This partnership is not built on handshakes and good intentions; it is built on contracts, data feeds, and rigorously measured performance metrics known as Service Level Agreements (SLAs). As an advanced specialty pharmacist, you are not just a clinician dispensing drugs; you are an operational leader responsible for managing these complex partnerships. Your pharmacy’s ability to remain in a manufacturer’s limited network, to receive referrals, and ultimately, to be profitable, hinges on your ability to understand and execute the terms of this collaboration.

This section provides the blueprint for that collaboration. We will dissect the key components of the SP-Hub partnership, focusing on the SLAs that define “good performance,” the data reporting that proves it, and the communication protocols that keep the partnership healthy. This is the “business of specialty pharmacy” at its most operational level.

Pharmacist Analogy: The General Contractor & The Master Plumber

Think of building a luxury custom home. The Manufacturer is the Homeowner paying for the project. The Patient Services Hub is the General Contractor (GC) hired by the homeowner to manage the entire build.

Your Specialty Pharmacy is the Master Plumber, a critical, highly skilled subcontractor hired by the GC. You are responsible for installing all the intricate pipes (dispensing the drug) and ensuring the water flows correctly (clinical management).

This relationship requires intense collaboration governed by clear rules:

  • The Blueprint (The Contract): The GC provides you with the detailed architectural blueprints. You must follow them precisely.
  • The Schedule (The SLAs): The GC gives you a strict timeline: “The rough plumbing must be installed by Tuesday (AOR), and the fixtures must be set by Friday (Dispense).” Missing these deadlines delays the entire project.
  • Progress Reports (Data Reporting): You must report your progress back to the GC daily: “Pipes delivered,” “Rough-in complete,” “Inspection passed.” Without this data, the GC cannot manage the overall project.
  • Communication Lines (Protocols): If you hit a snag (e.g., a wall stud is in the wrong place), you have a specific foreman (Hub Case Manager) to call immediately. You don’t just stop working.
  • Problem Solving (Escalation): If the foreman can’t fix the problem, you know exactly which project manager (Hub Supervisor) or even the architect (Manufacturer Rep) to call to get a decision.

You are not just a plumber showing up to install a faucet. You are a critical partner in a multi-million dollar project. Your performance, your communication, and your adherence to the schedule directly impact the success of the entire build. This section is your masterclass in being an exceptional subcontractor within the complex “build” of specialty patient access.

10.4.2 The Rulebook: Deconstructing Service Level Agreements (SLAs)

Service Level Agreements are the cornerstone of the SP-Hub relationship. They are the contractually defined, measurable performance standards that your pharmacy must meet to remain in good standing within a manufacturer’s network. SLAs transform subjective goals (“get patients on therapy quickly”) into objective, reportable metrics (“Acknowledge Receipt of 95% of referrals within 4 business hours”).

Manufacturers and Hubs live and die by these metrics. They are used to:

  • Measure Hub Performance: How quickly is the Hub processing referrals?
  • Measure SP Network Performance: Which pharmacies in the network are the fastest? Which are the slowest?
  • Identify Bottlenecks: Where in the process are delays occurring?
  • Make Network Decisions: Which SPs should receive more referrals? Which should be put on a performance improvement plan or removed from the network?

As an advanced pharmacist, you must not only understand these metrics but also champion the internal pharmacy workflows needed to meet them. Your team’s performance against these SLAs is constantly being monitored.

Masterclass Table: Common Hub & SP SLAs

These are typical targets. Actual SLAs vary by manufacturer and drug, but the concepts are universal. Note the distinction between Hub SLAs (measuring the Hub’s performance *before* the handoff) and SP SLAs (measuring your pharmacy’s performance *after* the handoff).

Metric Definition Who Owns It? Typical SLA Target Pharmacist’s Role & Impact
Time to Triage Time from Hub receiving the initial referral packet to assigning a case manager. Hub < 4 Business Hours Indirect: A slow Hub triage creates downstream delays for you. You monitor this via the overall TTT.
Time to BV Completion Time from case assignment to completing the full Benefits Verification (PBM + Medical). Hub < 24 Business Hours Indirect: This is often a major bottleneck. A Hub’s BV speed directly impacts when you receive the referral.
Time to PA Submission Time from identifying PA requirement to successfully submitting the completed PA form to the payer. Hub (dependent on Prescriber response) < 48 Business Hours (post-BV) Indirect: You rely on the Hub to manage this efficiently. Delays here stall the entire process.
Time to Handoff Time from receiving final PA approval & resolving financial barriers to sending the “Clean Referral” to the SP. Hub < 8 Business Hours Indirect: This measures the Hub’s final “packaging” efficiency. Delays here are frustrating as the patient is technically “approved.”
Time to AOR (Acknowledgement of Receipt) Time from SP receiving the “Clean Referral” (via API, Portal, SFTP) to sending the AOR status back to the Hub. Specialty Pharmacy (YOU) < 4 Business Hours CRITICAL SP METRIC. This is 100% within your control. Requires efficient intake workflows (checking portals/feeds frequently) and prompt status updates. Missing this SLA is the easiest way to get flagged for poor performance.
Time to First Patient Contact (Welcome Call) Time from sending AOR to making the first outbound call attempt to the patient to schedule delivery. Specialty Pharmacy (YOU) < 24 Business Hours Measures your pharmacy’s patient engagement speed. Requires efficient workflow from intake queue to pharmacist/tech outbound call queue.
Time to Dispense (TTD) / Time to Ship (TTS) Time from sending AOR to the first fill being shipped/delivered. Specialty Pharmacy (YOU) (dependent on Patient response) < 48-72 Business Hours The core measure of your dispensing efficiency. Impacted by clinical review speed, inventory availability, patient scheduling success, and fulfillment speed.
Overall Time-to-Therapy (TTT) Total time from Prescriber submitting initial referral to Patient receiving the first dose. SHARED (Hub + SP) Highly variable (e.g., < 7 days, < 14 days) The ultimate measure of the program’s success. Both Hub and SP performance contribute. Your job is to minimize *your* portion (AOR to Dispense) of the overall TTT.

Defining “Business Hours” and “Clock Stops”

SLAs are almost always measured in Business Hours (e.g., Monday-Friday, 8 AM – 6 PM ET, excluding holidays). A referral received at 7 PM on Friday night does not start its “4-hour AOR” clock until 8 AM Monday morning.

Crucially, SLAs often include defined “Clock Stops.” These are legitimate reasons why the clock measuring a specific SLA should be paused. Common clock stops include:

  • Pending Prescriber Action: The Hub submitted the PA, but the prescriber hasn’t signed it yet. The “Time to PA Submission” clock stops.
  • Pending Payer Review: The PA is submitted, but the insurance company is taking 5 days to review it. The “Time to Handoff” clock stops.
  • Pending Patient Response (SP): Your pharmacy called the patient to schedule delivery, left a voicemail, and is waiting for a call back. Your “Time to Dispense” clock stops.

Your Role: You must meticulously document these clock stops. If your TTD is 5 days, but 3 of those days were spent waiting for the patient to call you back, you need to prove that to the Hub/Manufacturer. Accurate status coding in your pharmacy system is essential for accurate SLA reporting.

10.4.3 The Language of Partnership: Data Reporting Requirements

Meeting SLAs is only half the battle. You must also prove that you are meeting them. This requires a robust, accurate, and timely flow of data from your specialty pharmacy system back to the Hub and, ultimately, to the manufacturer. This data reporting is not optional; it is a core contractual obligation.

Think back to our integration levels (10.1.5). The *method* of reporting depends on the integration level:

  • Level 0 (Fax): Manual faxing of dispense confirmations (inefficient, error-prone).
  • Level 1 (SFTP): Uploading daily/weekly batch files (e.g., CSV) of key status updates and dispense records.
  • Level 2 (Portal): Manually updating patient statuses in the Hub’s web portal throughout the day.
  • Level 3 (Unidirectional API): Still requires manual portal updates or batch file uploads for reporting *back* to the Hub.
  • Level 4 (Bidirectional API): Automated, real-time status updates sent from your system to the Hub’s system. (The Gold Standard).

Masterclass Table: Standard SP Data Reporting Fields

Regardless of the *method*, the *content* required is generally consistent. Your pharmacy system must be configured to capture and transmit these key data points for every referral.

Data Category Key Fields to Report Back Why It Matters to the Hub/Manufacturer
Referral Status Updates
  • Unique Patient ID / Hub Case ID
  • Referral Status Code (e.g., AOR, PENDING_CLINICAL, PENDING_PATIENT_SCHEDULING, DISPENSED, CANCELED)
  • Status Date/Time Stamp
  • Cancellation Reason Code (if applicable)
 This provides real-time visibility into the patient’s journey *after* the handoff. It allows the manufacturer to measure your SLAs (AOR, TTD) and understand *why* delays are occurring (e.g., Is the patient unresponsive? Is the prescriber slow to provide clinical info?).
Dispense Records
  • Unique Patient ID / Hub Case ID
  • Fill Number (First Fill vs. Refill)
  • Prescriber NPI
  • Dispense Date
  • Ship Date / Delivery Date
  • NDC Dispensed
  • Quantity Dispensed
  • Days Supply
  • Primary Payer Adjudicated Amount
  • Secondary (Copay Card) Amount
  • Patient Out-of-Pocket Cost
 This is critical for the manufacturer’s financial tracking (copay card utilization), sales reporting (which prescribers are writing?), and adherence monitoring (is the patient refilling on time?). Accuracy here is paramount.
Clinical Data (Program Dependent)
  • Adherence Assessment Results
  • Clinical Intervention Codes (e.g., Side Effect Management, Dose Titration Support)
  • Adverse Event Reporting Confirmation
  • Patient Reported Outcomes (PROs – rare)
 For high-touch clinical programs, the manufacturer may require you to report back specific clinical activities performed by your pharmacists. This demonstrates the value of your clinical services beyond just dispensing.

The Importance of Data Dictionaries & Field Mapping

Data reporting only works if both systems speak the same language. A Data Dictionary is the “Rosetta Stone” provided by the Hub/Manufacturer that defines every single field they expect you to send back.

Example:

  • The Hub’s Data Dictionary defines “Referral Status” Code 05 as “Dispensed”.
  • Your pharmacy system (CPR+) uses status code DSP for “Dispensed”.
  • Field Mapping is the process (usually done by your IT team) of telling your system: “When our status is DSP, translate it to 05 before sending it to the Hub.”

Without accurate field mapping, your automated data feeds (SFTP or API) will fail or send incorrect information, leading to compliance issues and potentially jeopardizing your network contract.

“Garbage In, Garbage Out”: The Criticality of Front-End Accuracy

All the sophisticated APIs and data feeds in the world are useless if the data entered by your technicians and pharmacists at the front end is incorrect. Your pharmacy’s performance metrics are a direct reflection of your team’s accuracy.

Common Front-End Errors That Kill Your Metrics:

  • Incorrect Status Coding: A technician forgets to update the status from “Pending Patient Scheduling” to “Dispensed” after shipping. The system reports a massive TTD delay, even though the drug went out on time.
  • Wrong Date Entry: The AOR date is accidentally entered as yesterday instead of today. Your “Time to AOR” metric looks terrible.
  • Missing Copay Card Data: The technician processes the primary claim but forgets to run the secondary copay card claim. The data feed shows a $2000 patient cost, triggering alerts at the manufacturer about affordability issues.

As a leader, you must ensure your team understands that every click and every data field matters. Consistent training and quality assurance checks on status coding and data entry are essential for meeting your reporting requirements.

10.4.4 Staying Connected: Communication Protocols

While data feeds handle the routine updates, inevitably, non-standard issues arise that require human-to-human communication between your pharmacy team and the Hub case managers. Establishing clear “rules of engagement” prevents confusion, duplicate work, and unnecessary phone calls.

The goal is efficient, effective, and compliant communication. The manufacturer contract and Hub program guide will typically outline the preferred channels.

Preferred Communication Channels (Hierarchy)

  1. Secure Web Portal (Highest Preference):
    • Use For: Routine status updates (if no API), non-urgent questions (“Can you confirm the PA end date?”), attaching documentation, sending standardized messages.
    • Why Preferred: Creates a centralized, time-stamped audit trail within the patient’s case file. Messages are typically routed directly to the assigned case manager.
  2. Secure Email (Use Sparingly):
    • Use For: Situations where documentation needs to be attached *and* a portal isn’t available, or for communicating with specific Hub leadership (outside of a patient case).
    • Why Sparingly: Email lives *outside* the Hub’s primary case management system, making it harder to track. Requires encryption (e.g., ZixMail). High risk of messages getting lost or delayed.
  3. Dedicated Phone Line (For Urgent Issues):
    • Use For: Urgent clinical issues (“Patient reporting severe side effect, need to confirm dose adjustment protocol”), immediate barriers to dispensing (“FedEx says delivery exception, need Hub to confirm alternate address”), complex case discussions.
    • Why Urgent Only: Phone calls create no automatic audit trail. Requires the Hub case manager to manually document the call. Ties up phone lines for non-urgent matters.
  4. Fax (Avoid At All Costs):
    • Use For: Only when contractually mandated or as an absolute last resort if all other digital methods fail.
    • Why Avoid: Insecure, inefficient, no audit trail, prone to errors, delays.
Tutorial: Effective Communication with Hub Case Managers

Hub case managers are juggling dozens, sometimes hundreds, of patient cases. Your ability to communicate clearly and efficiently makes their job easier and gets your issue resolved faster. Think like a reporter: Who, What, When, Where, Why.

The “Golden Rules” of Hub Communication:

  1. ALWAYS Have the Hub Case ID Ready: This is their primary key. Start every phone call or message with: “Calling regarding Hub Case ID #1234567, patient John Smith.”
  2. Be Specific About Your “Ask”: Don’t just say “Checking status.” State clearly what you need: “Requesting confirmation of PA approval status,” or “Need clarification on the attached lab results,” or “Reporting patient unreachable after 3 attempts.”
  3. Reference Previous Communication: “Following up on my portal message from yesterday at 2 PM regarding…”
  4. Use the Correct Channel: Don’t call for a simple status update that should be in the portal. Don’t use the portal for an urgent clinical issue that needs a phone call.
  5. Document Your Attempts: If you leave a voicemail or send a portal message, document the date/time in your pharmacy system. This is crucial if you later need to escalate.
  6. Be Professional & Collaborative: Remember, the case manager is your partner, not your adversary. A collaborative tone (“How can we work together to solve this?”) goes much further than an accusatory one (“Why haven’t you done X yet?”).

10.4.5 When Things Go Wrong: Escalation Pathways

Despite best efforts, processes break down. PAs get stuck, data feeds fail, patients become unresponsive. A critical part of the SP-Hub partnership is having a predefined Escalation Pathway—a clear roadmap for how to raise an issue “up the chain” when routine communication fails to resolve it.

Escalation is not about “tattling”; it’s about activating the next level of resources to overcome a barrier that is impacting patient care or violating an SLA. Knowing *when* and *how* to escalate is a key operational skill.

Mapping a Typical Escalation Pathway

Most Hub programs will provide their SP network partners with a formal escalation contact list.

Standard SP-to-Hub Escalation Levels
1
Level 1: Assigned Case Manager

Trigger: Routine inquiry, initial attempt to resolve an issue (e.g., missing data, status clarification).

Method: Preferred Channel (Portal, Phone).

Expected Response Time: < 24 Business Hours.

Action: Clearly state the issue and your desired resolution. Document the communication attempt.
2
Level 2: Hub Team Lead / Supervisor

Trigger: No response from Case Manager after 24-48 hours; Case Manager unable to resolve the issue; urgent patient care issue requires immediate attention.

Method: Dedicated Supervisor Phone Line or Email (provided by Hub).

Expected Response Time: < 4 Business Hours.

Action: Reference the Case ID and prior communication attempts. Clearly explain the barrier and the urgency. (“Patient needs therapy started by Friday for chemo cycle.”)
3
Level 3: Manufacturer Account Manager / Field Reimbursement Manager (FRM)

Trigger: Failure to resolve at Level 2; Systemic Hub performance issues (e.g., data feed errors, consistent SLA misses); Critical patient access barrier requiring manufacturer intervention (e.g., complex payer policy issue).

Method: Direct Email or Phone Call to your assigned Manufacturer contact.

Expected Response Time: Variable, but usually within 1 Business Day.

Action: Provide a concise summary of the issue, the patient impact, and the failed attempts at Levels 1 & 2. Frame it as a partnership issue needing resolution.
Escalation Etiquette: Don’t “Cry Wolf”

Escalation pathways are essential, but they lose their effectiveness if overused or used inappropriately. Do not escalate to Level 2 just because a case manager didn’t call you back in 3 hours. Do not escalate to the Manufacturer Rep (Level 3) for a single patient issue that the Hub Supervisor (Level 2) hasn’t had a chance to address yet.

Key Principles for Appropriate Escalation:

  • Follow the Chain of Command: Always start at Level 1 unless it’s a true emergency.
  • Allow Reasonable Response Times: Give each level adequate time to respond before escalating further (unless patient care is imminently at risk).
  • Document Everything: Keep meticulous records of who you contacted, when, and the outcome. This is your evidence when you do escalate.
  • Be Solution-Oriented: When you escalate, don’t just complain. State the problem clearly and suggest a potential solution or the specific action you need taken.

Using the escalation pathway judiciously and professionally builds trust and ensures that when you *do* have a critical issue, it gets the attention it deserves.

10.4.6 Your Role as an Advanced Pharmacist: Operational Excellence

Understanding Hub collaboration, SLAs, data reporting, and communication protocols moves you beyond the role of a clinical dispenser into the realm of operational excellence. Your ability to manage these partnerships directly impacts:

  • Patient Outcomes: Faster TTT means better clinical outcomes.
  • Pharmacy Performance: Meeting SLAs keeps you in the network and positions your pharmacy as a preferred partner.
  • Financial Viability: Efficient workflows (enabled by good integrations and communication) reduce your pharmacy’s labor costs and improve profitability.
  • Team Morale: Clear processes, reliable data feeds, and effective communication channels reduce frustration and burnout among your pharmacy team.

As a CASP-certified pharmacist, you are expected to be a leader in this area. You should be able to:

  • Analyze Performance Data: Review your pharmacy’s SLA reports. Identify trends, bottlenecks, and areas for improvement.
  • Optimize Workflows: Design internal processes to ensure prompt AORs, efficient patient outreach, and accurate data capture.
  • Advocate for Better Integration: Work with your IT team and Hub partners to push for API integrations that reduce manual work.
  • Train Your Team: Ensure every technician and pharmacist understands the importance of SLAs, data accuracy, and proper communication protocols.
  • Manage Partner Relationships: Build professional, collaborative relationships with your key contacts at the Hubs and manufacturer teams.

Mastering the operational partnership with Hubs is not just an administrative task; it is a core competency of advanced specialty pharmacy practice, directly enabling the clinical care you provide.