CASP Module 23, Section 3: Infusion Center Collaboration & Continuity of Care
MODULE 23: THE HSSP AS A SYSTEM-WIDE ASSET

Section 3: Infusion Center Collaboration & Continuity of Care

Exploring the vital partnership between the HSSP and the hospital’s ambulatory infusion centers. We’ll analyze “white-bagging” vs. “brown-bagging,” managing buy-and-bill vs. pharmacy benefit medications, and ensuring seamless care transitions for patients receiving IV specialty drugs.

SECTION 23.3

Infusion Center Collaboration & Continuity of Care

Bridging the Gap Between Oral and Infused Specialty Therapies.

23.3.1 The “Why”: The Infusion Suite – Where Medical and Pharmacy Benefits Collide

In the first section of this module, we established the HSSP’s power through EMR integration, primarily focusing on orally administered or self-injected specialty drugs dispensed for home use. In the second section, we explored the 340B program, the financial engine often crucial for the HSSP’s viability. Now, we arrive at a critical intersection: the Ambulatory Infusion Center (AIC) or hospital outpatient infusion suite. This is where some of the most complex and expensive specialty medications—monoclonal antibodies, chemotherapies, enzyme replacement therapies—are administered intravenously or via complex injections under medical supervision.

Why is this setting so pivotal for an HSSP? Because it represents a major point of potential fragmentation and a massive opportunity for integrated management. Unlike the relatively straightforward world of “dispense-for-home-use” drugs typically covered under the pharmacy benefit, infused drugs often fall under the patient’s medical benefit. This triggers a completely different set of procurement, billing, and reimbursement rules, often referred to as the “buy-and-bill” model. Furthermore, payers frequently try to dictate how these drugs are sourced, leading to the confusing and often detrimental practices of “white-bagging” and “brown-bagging.”

Your community pharmacy experience likely shielded you from this complexity. A patient needing Remicade simply didn’t show up at your counter. But as an advanced HSSP pharmacist, you are now part of the system that manages these patients. Your HSSP’s success is inextricably linked to how well it collaborates with the infusion center. A fractured relationship leads to therapy delays, billing errors, safety risks, and lost revenue for the health system. A seamless partnership, however, creates a powerful engine for optimal patient care, operational efficiency, and financial health. This section is your masterclass in building that bridge.

Pharmacist Analogy: The OR Pharmacy & The Surgical Suite

Think about the relationship between the Operating Room (OR) pharmacy satellite and the surgical suite in your hospital. They are two distinct departments with different staff (OR pharmacists/techs vs. surgeons/nurses/anesthesiologists) and different primary functions (drug preparation vs. performing surgery). Yet, they must function as one integrated team for a successful, safe operation.

Imagine the chaos if they were siloed:

  • The surgeon needs a specific antibiotic wash, but the OR pharmacy isn’t aware of the case schedule. (Operational Disconnect)
  • The anesthesiologist draws up a paralytic, but the OR pharmacist, who has access to the patient’s full EMR profile, knows the patient has a rare enzyme deficiency that makes this drug dangerous. However, there’s no communication channel. (Clinical/Safety Disconnect)
  • The OR bills for a high-cost clotting factor used during the case, but the OR pharmacy procured it under a different account, leading to billing reconciliation nightmares. (Financial Disconnect)

This scenario is unthinkable in a modern hospital because the OR pharmacy and surgical suite are deeply integrated. They share schedules, communicate constantly, often use the same EMR module for documentation, and have clear protocols for drug management. The OR pharmacist is often physically present or immediately available, acting as the medication expert within the surgical environment.

The HSSP and the Ambulatory Infusion Center must achieve this same level of symbiosis. The HSSP acts as the “specialty OR pharmacy,” managing the complex procurement, financial clearance, clinical oversight, and dispensing/delivery coordination for many high-cost infused drugs, even if the final administration occurs in the AIC. Failure to integrate leads to the same chaos: delays, safety risks, and financial losses. Success requires building robust bridges across operations, clinical care, and finance.

23.3.2 The Players & The Setting: Understanding the Infusion Ecosystem

Before dissecting the processes, let’s clearly define the key players and the environment involved in managing infused specialty medications within a health system.

The Key Roles
Role Primary Responsibilities Typical Location Key Interactions with HSSP
Prescribing Provider (MD/NP/PA) Diagnoses patient, selects therapy, writes infusion orders (often via EMR protocols/order sets). Specialty Clinic (e.g., Oncology, Rheumatology, Neurology) Sends referral/prescription to HSSP (for pharmacy benefit drugs) or infusion center queue (for buy-and-bill). Relies on HSSP for PA support, clinical recommendations, and patient status updates.
Infusion Center Nurse (RN) Establishes IV access, administers medication, monitors patient during/after infusion, manages immediate adverse reactions, patient education on infusion process. Ambulatory Infusion Center (AIC) Receives drug from HSSP (if white/brown bagged), confirms orders, documents administration in EMR. Communicates with HSSP pharmacist regarding scheduling, missing doses, or patient reactions.
Infusion Center Pharmacist (RPh) (If present) Clinically verifies infusion orders, oversees compounding (if applicable), manages infusion center drug inventory (for buy-and-bill), acts as drug expert for nurses/providers within the AIC. Ambulatory Infusion Center (AIC) or Central Pharmacy Collaborates on protocol development, clinical verification handoffs, inventory management strategies (especially for buy-and-bill vs. dispensed), communication on shared patients.
HSSP Pharmacist (Clinical Specialist) Performs clinical review, secures PA/financial assistance (for pharmacy benefit drugs), develops monitoring plans, counsels patients (often before first dose), manages therapy across transitions (IV to SC/oral). Central HSSP Hub or Embedded in Clinic Is the primary owner of pharmacy benefit drugs administered in the AIC. Coordinates delivery/timing with AIC, provides clinical oversight, communicates therapy plan/updates to AIC pharmacist/nurses via EMR.
HSSP Liaison / Technician Intake/triage of referrals, benefits investigation, PA submission, financial assistance coordination, patient scheduling/communication for pharmacy benefit drugs. Central HSSP Hub or Embedded in Clinic Coordinates scheduling and delivery details with AIC schedulers/nurses. Handles the complex “front-end” work for pharmacy benefit drugs.
Revenue Cycle / Billing Team Submits claims to payers using appropriate codes (J-codes for buy-and-bill, NDCs for pharmacy benefit), manages denials and appeals. Hospital Billing Office Relies on accurate documentation from AIC (for administration) and HSSP (for dispensing/billing units) to ensure correct claims are submitted for both medical and pharmacy benefit drugs.
The Setting: The Ambulatory Infusion Center (AIC)

The AIC is a unique outpatient environment designed for medically supervised administration of IV medications. Key characteristics include:

  • Staffing: Primarily highly skilled infusion nurses, often with specialized pharmacists and advanced practice providers available.
  • Equipment: Multiple infusion chairs/bays, infusion pumps, vital sign monitoring equipment, emergency crash carts.
  • Drug Storage: Secure medication rooms, often with refrigerators/freezers. Inventory may include “buy-and-bill” stock owned by the AIC and patient-specific doses delivered from the HSSP. USP <797>/<800> compliance is essential if any compounding occurs.
  • Patient Flow: Patients arrive for scheduled appointments, receive their infusion (minutes to hours), are monitored, and then go home.
  • EMR Integration: Typically uses the same EMR as the hospital/clinics (e.g., Epic Beacon for oncology, standard modules for others) for scheduling, orders, documentation (MAR, nursing notes), and billing.

Understanding these roles and the AIC environment is crucial for the HSSP pharmacist to design effective workflows and communication strategies. You need to know who owns each step of the process and how your pharmacy’s functions integrate with theirs.

23.3.3 The Great Divide: Medical Benefit (“Buy-and-Bill”) vs. Pharmacy Benefit

This is the single most important concept to grasp when collaborating with an infusion center. The pathway a drug takes—from manufacturer to patient administration—is fundamentally determined by which “benefit” it falls under. Getting this wrong is the primary source of billing errors, denials, and compliance headaches.

Think of it like two different highways with completely different toll systems. You need to know which highway your drug belongs on.

Masterclass Table: Medical Benefit vs. Pharmacy Benefit for Infused Drugs
Feature Medical Benefit (“Buy-and-Bill”) Pharmacy Benefit (HSSP-Dispensed)
Who Takes Financial Risk? The Provider/Infusion Center buys the drug upfront, hoping for adequate reimbursement after administration. The Pharmacy/HSSP adjudicates the claim before dispensing. Financial risk is largely mitigated before the drug leaves the pharmacy.
Coverage Determination Requires a Medical Prior Authorization, typically based on diagnosis codes (ICD-10) and clinical criteria reviewed by the payer’s utilization management team. Focus is on “medical necessity.” Requires a Pharmacy Prior Authorization, typically based on NDC, diagnosis, formulary status, and step-therapy edits reviewed by the PBM. Focus is often on formulary compliance.
Procurement & Inventory AIC buys drug inventory (often via GPO or WAC accounts) and maintains physical stock. HSSP orders patient-specific drug after claim adjudication, often via specialty distributors. Minimal stock kept (“Just-in-Time”). Uses 340B pricing if eligible & applicable.
Billing Code Billed using specific HCPCS codes (e.g., J-codes) based on the drug and dosage administered. Claim submitted by the AIC/hospital billing office. Billed using the National Drug Code (NDC). Claim submitted by the HSSP via NCPDP standards.
Reimbursement Method Typically based on a percentage of Average Sales Price (ASP) + Add-on (e.g., ASP+6% for Medicare Part B). Can vary widely by payer contract. Typically based on a contracted rate related to AWP (Average Wholesale Price) minus a discount, plus a dispensing fee (e.g., AWP-15% + $5). Governed by PBM contracts.
Common Drug Examples (Administered in AIC)
  • Most IV Chemotherapies (e.g., Paclitaxel, Carboplatin)
  • Many IV Biologics for Oncology (e.g., Keytruda, Opdivo, Herceptin)
  • Some IV Biologics for Autoimmune (e.g., Remicade – often payer dependent)
  • IV Iron, IVIG (often)
  • Many SC/IV Biologics for Autoimmune (e.g., Entyvio, Stelara IV, Tysabri)
  • Enzyme Replacement Therapies
  • High-cost Hematology Factors (sometimes)
  • Drugs that require complex REMS or limited distribution often default here.
HSSP’s Primary Role Supportive. Manage associated oral medications, clinical monitoring, side effect management, adherence for oral components. May assist AIC with access issues if expertise is needed. Primary Owner. Intake, BI/PA, clinical review, financial assistance, procurement, dispensing, coordination with AIC for administration, clinical monitoring & follow-up.
The Payer is King: Benefit Determination is Not Always Logical

You cannot determine the correct benefit based solely on the drug or the diagnosis. Benefit determination is 100% payer-driven and often arbitrary. One payer might cover Remicade under the medical benefit (buy-and-bill), while another covers the exact same drug under the pharmacy benefit (requiring HSSP dispensing). A new drug might launch under pharmacy benefit and then switch to medical benefit a year later.

Your HSSP’s #1 Operational Imperative: You MUST have a robust, accurate, and constantly updated Benefits Investigation (BI) process at the very front end of your workflow. The BI team’s first job is to determine: “Is this drug covered under medical or pharmacy benefit for this specific patient and payer?” Sending a drug down the wrong pathway is a recipe for delays, denials, and write-offs.

23.3.4 Buy-and-Bill Deep Dive: The Infusion Center’s World (and the HSSP’s Supporting Role)

Let’s put ourselves in the shoes of the Infusion Center manager. For drugs covered under the medical benefit, they operate under the “Buy-and-Bill” model. This means:

  1. Procurement: The AIC (or the hospital’s central purchasing department) buys the drug inventory, typically from a wholesaler, using a specific “medical benefit” account. This might be a GPO account or a WAC account. They now physically own the drug.
  2. Inventory Management: The drug is stored securely in the AIC’s medication room. They manage expiration dates, lot numbers, and quantities on hand. This is a significant inventory cost and risk for the hospital.
  3. Order & Preparation: The provider places an order (e.g., “Keytruda 200mg IV Q3 weeks”). The AIC pharmacist verifies it. The AIC nurse or technician prepares the dose (e.g., draws up the Keytruda into an IV bag).
  4. Administration: The nurse administers the drug to the patient and documents it meticulously in the EMR MAR, including start/stop times and exact quantity administered.
  5. Billing: The hospital’s billing office generates a claim for the drug (using the J-code, e.g., J9271 for Pembrolizumab) and a separate claim for the administration service (using CPT codes). This claim is sent to the medical payer (e.g., Aetna).
  6. Reimbursement (The Hope): Weeks or months later, the hospital receives reimbursement, hopefully at a rate that covers the drug cost, overhead, and provides some margin. Denials for medical necessity or coding errors are common and require significant effort to appeal.
Where Does the HSSP Fit In? (Supporting Buy-and-Bill)

Even when the HSSP doesn’t dispense the buy-and-bill drug, it plays a vital supporting role, leveraging its integration and expertise:

  • Managing the “Whole Patient”: Oncology regimens often involve IV buy-and-bill chemo PLUS oral pharmacy benefit drugs (e.g., oral targeted therapies, antiemetics, growth factors). The HSSP is essential for coordinating the oral components, ensuring they are approved, dispensed, and timed correctly with the IV cycles managed by the AIC.
  • Clinical Expertise & Safety Net: The HSSP clinical pharmacist, with full EMR access, can provide crucial oversight.
    • Example: An HSSP pharmacist reviewing an oral chemo order sees the patient’s ANC (Absolute Neutrophil Count) from yesterday’s lab results is dangerously low (0.4). They know the patient is scheduled for IV chemo (buy-and-bill) today. They immediately message the oncologist and the AIC pharmacist: “Hold today’s IV chemo – ANC is 0.4.” This prevents a potentially fatal administration.
  • Financial Assistance Bridge: While the AIC handles medical benefit billing, patients often face high deductibles or coinsurance. The HSSP’s financial counselors are often experts in navigating foundation assistance and manufacturer programs that can help patients afford their total cost of care, including the medical benefit drugs.
  • Transitions of Care: When an IV buy-and-bill drug transitions to a subcutaneous pharmacy benefit drug for home use (e.g., Herceptin IV transitioning to Herceptin Hylecta SC), the HSSP manages this transition seamlessly, handling the new PA, dispensing, and education.

The key is collaboration, not competition. The HSSP supports the AIC’s buy-and-bill function by managing the surrounding complexity and providing integrated clinical oversight.

23.3.5 Pharmacy Benefit Deep Dive: HSSP-Managed Drugs in the Infusion Center

Now let’s flip the coin. What happens when a drug administered in the AIC is covered under the pharmacy benefit? This is where the HSSP takes the lead, but the AIC remains the site of administration. This requires exquisite coordination.

The workflow mirrors the standard HSSP process (Section 23.1.3) but with added logistical complexity:

  1. Referral & Intake: Provider e-prescribes (e.g., “Entyvio 300mg IV”) to the HSSP queue.
  2. BI/PA & Financial Clearance: HSSP team determines it’s pharmacy benefit, secures the PA, adjudicates the claim, and resolves the copay. The HSSP bills the PBM for the drug product.
  3. Clinical Review: HSSP pharmacist verifies dose, labs, etc., writes EMR note.
  4. Coordination with AIC: This is the crucial extra step.
    • The HSSP liaison/pharmacist communicates with the AIC’s scheduling team: “Mrs. Jones’s Entyvio is approved. She needs her first infusion. What day/time works?”
    • Once scheduled, the HSSP coordinates the delivery of the patient-specific dose to the AIC, ensuring it arrives before the appointment.
  5. Dispensing & Delivery: HSSP procures the Entyvio, labels it for Mrs. Jones, and arranges secure, temperature-controlled delivery to the AIC’s medication room (often via hospital courier).
  6. Administration: AIC nurse receives the patient-specific drug, verifies it against the EMR order, administers it, and documents on the MAR.
  7. AIC Billing: The AIC submits a claim to the medical payer only for the administration service (CPT code), not for the drug itself (since the HSSP already billed the PBM).

This pathway keeps the drug procurement and billing under the HSSP’s control (leveraging potential 340B savings and pharmacy expertise) while utilizing the AIC’s specialized staff and facility for safe administration.

23.3.6 White-Bagging vs. Brown-Bagging Masterclass

The clean workflow described above assumes the health system controls the process. However, payers (PBMs and health plans) often try to dictate where pharmacy benefit drugs administered in the AIC are sourced from, leading to the practices of “white-bagging” and “brown-bagging.” As an HSSP pharmacist, you must understand these terms, their implications, and how to advocate against them.

Definitions
  • White-Bagging: The specialty drug is dispensed by an external specialty pharmacy (often owned by the PBM) and shipped directly to the infusion center (the “white mailer bag”). The AIC receives it, stores it, and administers it, but never owned or billed for it.
  • Brown-Bagging: The specialty drug is dispensed by an external specialty pharmacy and shipped directly to the patient’s home (the “brown box”). The patient is expected to store it correctly and bring it with them to the infusion center for administration.
Masterclass Table: White vs. Brown Bagging vs. HSSP Model
Factor White-Bagging Brown-Bagging Integrated HSSP Model
Who Dispenses? External SP (PBM-owned) External SP (PBM-owned) Internal HSSP
Who Ships To? Infusion Center (AIC) Patient’s Home Infusion Center (AIC)
Who Bills PBM for Drug? External SP External SP Internal HSSP
Who Bills Medical for Admin? AIC AIC AIC
Chain of Custody / Temp Control Relies on external SP & courier. AIC receives drug “as is.” Risk of temp excursions during shipping. Worst Case. Relies on external SP, courier, and the patient. High risk of improper storage/transport by patient. Best Case. HSSP uses internal, validated couriers or processes. Drug remains within the health system’s control.
Inventory Management (AIC) AIC must manage/store patient-specific inventory from multiple external SPs. Logistical nightmare. No AIC inventory, but huge scheduling/workflow disruption if patient forgets drug or it’s unusable. AIC manages only patient-specific doses arriving predictably from one internal source (HSSP). Streamlined.
Waste / Dose Adjustments If dose is changed last minute, white-bagged drug is often wasted. Cannot be returned or used for another patient. Same as white-bagging. High waste potential. If dose changes, HSSP can potentially adjust/prepare new dose quickly. Waste minimized.
Safety Risks AIC administers drug they didn’t dispense. Limited visibility into external SP’s clinical review. Risk of transcription errors from external Rx. Highest Risk. AIC administers drug stored/transported by patient. Risk of tampering, damage, incorrect drug. Verification burden on AIC nurse. Lowest Risk. Closed loop. HSSP pharmacist reviews in EMR, AIC nurse administers based on same EMR order. Clear accountability.
Health System Revenue Capture ZERO drug margin captured by health system. Only admin fee collected. ZERO drug margin captured by health system. Only admin fee collected. Drug Margin Captured by HSSP (incl. potential 340B savings), reinvested in patient care. Admin fee collected by AIC. Total revenue stays within the system.
Why Payers Mandate White/Brown Bagging (and Why You Must Fight It)

Payers (especially PBMs who own their own specialty pharmacies) mandate white or brown bagging for one reason: to capture the pharmacy revenue themselves. They steer prescriptions to their own pharmacy, preventing the health system’s HSSP from accessing the drug margin.

As an HSSP pharmacist and leader, you must be prepared to articulate the significant safety risks and operational burdens created by these practices. Your arguments should focus on:

  • Patient Safety: Broken chain of custody, risk of temperature excursions, inability to verify product integrity (especially brown-bagging), increased risk of medication errors when administering externally-dispensed drugs.
  • Care Delays: Shipment delays from external SPs, workflow disruptions if brown-bagged drugs are forgotten or unusable, inability to make last-minute dose adjustments.
  • Waste: Inability to return or repurpose expensive drugs if therapy changes.
  • Operational Burden: AIC staff forced to manage inventory from dozens of different pharmacies, track deliveries, handle patient-supplied drugs.

Your goal is to convince payers and employers that the “savings” they think they achieve by forcing external dispensing are outweighed by the safety risks, care delays, and potential for waste, ultimately leading to higher total medical costs. Advocating for HSSP exclusivity (“keep our patients internal”) is a patient safety and financial imperative.

23.3.7 Operational Integration: The Seamless Handoff for HSSP-Managed Infusions

Achieving a seamless workflow for pharmacy benefit drugs administered in the AIC requires meticulous planning and clear communication protocols between the HSSP and the AIC. The EMR is the key facilitator.

Visualizing the Ideal Integrated Workflow (HSSP Dispense -> AIC Admin)

This expands on the workflow in 23.3.5, highlighting the critical handoff points.

1. Referral (EMR)

Provider e-prescribes Pharmacy Benefit drug (e.g., Tysabri) directly to HSSP EMR queue.

2. HSSP Intake & Clearance (HSSP Team)

HSSP Liaison/BI team performs BI/PA, adjudicates claim, secures financial aid. HSSP Pharmacist performs clinical review in EMR.

3. Scheduling Coordination (HSSP <-> AIC)

Once approved, HSSP liaison contacts AIC scheduler (via EMR message or phone) to book patient’s infusion appointment. Appointment details confirmed back to HSSP.

Critical Handoff #1: Clear communication of approved drug, dose, frequency, and desired start date. AIC confirms chair availability.

4. Dispense & Delivery (HSSP Team)

HSSP procures drug, labels patient-specific dose, schedules secure, temp-controlled delivery to AIC Med Room in advance of appointment (e.g., day before).

5. AIC Receipt & Verification (AIC Staff)

AIC nurse/tech receives delivery, verifies patient name/drug/dose against delivery ticket and EMR order, stores appropriately in secure Med Room.

Critical Handoff #2: AIC confirms receipt (electronically or via signed log). HSSP has proof of delivery. Clear process for discrepancies.

6. Administration (AIC Nurse)

Patient arrives. Nurse retrieves patient-specific drug, performs standard checks (rights of med admin), administers drug per EMR order, documents on EMR MAR.

7. Billing (HSSP & AIC Rev Cycle)

HSSP claim for drug (NDC) already submitted at dispense. AIC claim submitted for administration (CPT code) after administration documented on MAR.

Key Tools for Operational Success
  • Shared EMR Work Queues: For referrals, scheduling requests, clinical alerts.
  • Standardized EMR Messaging Templates: For clear handoffs (e.g., “Ready to Schedule,” “Drug Delivered”).
  • Delivery Tracking System: Barcode scanning, electronic proof of delivery.
  • Shared Policies & Procedures (P&Ps): Clearly defining roles, responsibilities, timelines, and escalation paths for both departments.
  • Regular Interdepartmental Meetings: HSSP and AIC leadership meet monthly to review metrics, troubleshoot issues, and optimize workflows.

23.3.8 Clinical Integration: The Shared Patient, The Shared Plan

Operational integration ensures the drug gets there safely. Clinical integration ensures the patient thrives. This involves shared ownership of the patient’s therapeutic plan, leveraging the unique expertise of both the HSSP and AIC teams.

Strategies for Clinical Collaboration
  • Joint Protocol Development: HSSP and AIC pharmacists collaborate with providers to build standardized EMR order sets for infused specialty drugs. This includes pre-medications, infusion rates, monitoring parameters, and management of infusion reactions.
  • Shared EMR Documentation:
    • HSSP pharmacist documents their clinical review, counseling notes, adherence assessments, and side effect management calls directly in the patient’s EMR chart.
    • AIC nurse documents administration details, vital signs during infusion, and any immediate reactions in the same EMR chart.
    • Result: Everyone involved has a complete, real-time picture of the patient’s status.
  • Coordinated Patient Education:
    • HSSP Pharmacist: Provides disease state education, explains the drug’s mechanism/goals, reviews potential side effects (especially delayed ones), discusses REMS requirements, teaches self-injection technique if applicable for future doses.
    • AIC Nurse: Explains the infusion process itself, what to expect during the visit, how to manage immediate infusion reactions, reviews site care.
    • This avoids duplication and ensures consistent messaging.
  • Proactive Side Effect Management: The HSSP pharmacist, doing follow-up calls, identifies a delayed side effect (e.g., rash from Ocrevus appearing 3 days post-infusion). They assess severity via phone/EMR photos, message the provider with recommendations (e.g., “start hydroxyzine”), and alert the AIC team via EMR message (“FYI, Pt experienced delayed rash, consider pre-medicating next cycle”).
  • Therapeutic Interchange & Optimization: The HSSP pharmacist identifies an opportunity based on payer formulary or new guidelines (e.g., switching from IV to SC formulation). They discuss with the provider. If agreed, the HSSP manages the transition, including PA, counseling, and coordinating the last IV dose with the AIC and the first SC dose training.
Clinical Pearl: The Infusion Reaction Huddle

A best practice for complex biologics is a pre-infusion “huddle” for the first dose. This involves the AIC nurse, the HSSP pharmacist (even if remote via phone/video), and sometimes the provider.

Agenda:

  1. Confirm patient readiness (baseline labs okay?).
  2. Review specific infusion reaction risks for this drug.
  3. Confirm pre-medications ordered/given.
  4. Confirm correct starting infusion rate and titration schedule.
  5. Review protocol for managing mild/moderate/severe reactions (e.g., “Stop infusion, give IV diphenhydramine, call provider”).
  6. Ensure emergency meds (epinephrine, steroids) are readily available.

This brief huddle significantly improves safety and ensures everyone is on the same page before a high-risk infusion begins. The HSSP pharmacist’s drug expertise is invaluable here.

23.3.9 Financial Integration & Optimization: Capturing Value Across Benefits

A strong HSSP-AIC collaboration isn’t just good clinical practice; it’s good financial strategy for the health system. By working together, these departments can optimize revenue capture, manage costs, and demonstrate value in ways that siloed departments cannot.

Key Financial Synergies
  • Optimizing Site of Care: Payers increasingly prefer certain infused drugs be given in the lowest-cost setting (often home infusion or physician office). The HSSP, with its view across benefits and relationships with external partners, can help the IDN navigate these payer pressures, keeping appropriate patients within the system’s AIC while transitioning others smoothly to external sites when mandated or preferred.
  • Accurate Benefit Determination: As discussed, the HSSP’s expert BI team ensures drugs are routed down the correct medical vs. pharmacy benefit pathway from the start, preventing costly denials and write-offs for the AIC (buy-and-bill) and the HSSP (pharmacy benefit).
  • Maximizing 340B Savings (Pharmacy Benefit): For eligible CEs, drugs dispensed by the HSSP under the pharmacy benefit (even if administered in the AIC) can be purchased at 340B pricing. This generates significant savings that stay within the health system. Note: Standard buy-and-bill drugs procured by the AIC typically cannot use 340B pricing due to the GPO exclusion.
  • Reducing Drug Waste: Coordinated scheduling and just-in-time delivery from the HSSP minimizes the amount of expensive drug sitting in the AIC. Clear communication prevents waste due to last-minute therapy changes or missed appointments.
  • Comprehensive Financial Assistance: The HSSP’s dedicated financial counselors can secure assistance for the patient’s entire regimen—copays for pharmacy benefit drugs, coinsurance for medical benefit drugs, and even premiums or administration fees—reducing bad debt for the hospital.
  • Data for Payer Negotiations: By combining HSSP data (adherence, interventions) with AIC data (drug administration) and hospital data (ER visits, admissions), the IDN can build a powerful value proposition for payers, demonstrating reduced total cost of care and justifying better reimbursement rates for both drug and administration.
The 340B Buy-and-Bill Nuance: A Compliance Alert

It is crucial to reinforce: The 340B discount generally applies only to Covered Outpatient Drugs dispensed by the CE (or its contract pharmacy). Drugs purchased by the hospital/AIC for the traditional “buy-and-bill” model under the medical benefit are typically procured via a GPO account (for DSH hospitals) or standard WAC accounts.

Due to the GPO Exclusion (Commandment #3 from Section 23.2), DSH hospitals cannot use GPO pricing for covered outpatient drugs. Therefore, even if a drug could theoretically be either buy-and-bill or pharmacy benefit (like some biologics), the hospital must be extremely careful. If the AIC buys it on a GPO account for buy-and-bill, it cannot also be dispensed as a 340B drug by the HSSP. Maintaining separate, clean purchasing accounts and clear benefit determination pathways is essential to avoid major compliance violations.

The HSSP’s main 340B opportunity in the infusion space lies with those drugs definitively covered under the pharmacy benefit, which the HSSP dispenses and delivers to the AIC for administration.

23.3.10 Compliance, Safety, and Quality in the Integrated Model

The integrated HSSP-AIC model enhances safety, but also introduces unique compliance and quality considerations that must be proactively managed.

Key Considerations
  • REMS Program Coordination: Many infused specialty drugs have complex Risk Evaluation and Mitigation Strategies (REMS) requirements (e.g., Tysabri TOUCH program for PML risk). The HSSP and AIC must have a clearly defined process for ensuring all REMS requirements (prescriber certification, patient enrollment, lab monitoring, dispensing requirements) are met before the drug is delivered and administered. The HSSP often takes the lead role in tracking and coordinating REMS compliance.
  • USP <797> & <800> Compliance:
    • If the HSSP prepares sterile compounds (e.g., reconstituting a biologic) before sending to the AIC, the HSSP must comply with USP <797>.
    • If the AIC handles hazardous drugs (e.g., chemotherapy, some biologics), both the HSSP (delivery/transport) and the AIC (storage, preparation, administration, disposal) must adhere to USP <800> standards for hazardous drug handling. This requires coordinated P&Ps.
  • Billing Accuracy & Audits: Robust processes are needed to ensure the HSSP bills only for the drug (pharmacy benefit) and the AIC bills only for the administration (pharmacy benefit) or both drug + admin (buy-and-bill). Clear documentation in the EMR MAR is critical to support these claims during payer audits. Using distinct EMR orderables for “Drug + Admin” vs. “Admin Only” can help prevent errors.
  • Temperature Control & Chain of Custody: For drugs delivered from HSSP to AIC, there must be a validated process for temperature-controlled transport (calibrated coolers, temperature monitors) and a clear handoff/receipt confirmation log in the AIC to maintain the chain of custody.
  • Medication Error Reporting: A shared system or clear communication pathway is needed for reporting and investigating any medication errors or near misses that occur, regardless of whether the error originated in the HSSP or the AIC. A joint Medication Safety committee review is often beneficial.
  • Accreditation Standards: Both the HSSP (e.g., URAC, ACHC Specialty Pharmacy) and the AIC may have separate accreditation requirements (e.g., Joint Commission). Integrated P&Ps and quality monitoring should meet the standards for both areas.

23.3.11 Section Summary & Key Takeaways

The Ambulatory Infusion Center is a critical node in the specialty care continuum. Effective collaboration between the HSSP and the AIC is essential to prevent the fragmentation, safety risks, and financial losses inherent in siloed external pharmacy models.

  • Benefit Matters Most: The distinction between Medical Benefit (Buy-and-Bill) and Pharmacy Benefit dictates workflow, billing, and risk. Accurate, upfront Benefits Investigation is paramount.
  • HSSP Role Varies by Benefit: The HSSP is the Primary Owner for pharmacy benefit drugs administered in the AIC, but plays a crucial Supportive Role for buy-and-bill drugs.
  • Avoid White/Brown Bagging: These payer-mandated practices fragment care, introduce significant safety risks (especially brown-bagging), create operational burdens, and siphon revenue from the health system. HSSPs must advocate for internal management.
  • Integration is Key: Seamless workflows rely on shared EMRs, clear communication protocols (especially for scheduling and delivery), and defined handoffs between the HSSP and AIC teams.
  • Clinical Collaboration Maximizes Value: Shared documentation, joint protocol development, coordinated education, and proactive side effect management demonstrate the power of an integrated team.
  • Financial Synergy: Working together optimizes site-of-care, ensures accurate billing, allows capture of appropriate 340B savings (on pharmacy benefit drugs), reduces waste, and strengthens the IDN’s position with payers.
  • Safety & Compliance are Shared: REMS, USP standards, error reporting, and accreditation require joint ownership and coordinated policies.

By mastering the complexities of benefit design and building strong, integrated partnerships with their infusion center colleagues, HSSP pharmacists become indispensable assets, ensuring safe, efficient, and financially sustainable care for patients receiving infused specialty medications.