Section 6.4: Copay, Foundation, and Manufacturer Assistance

6.4.1 The “Why”: Affordability is Adherence

In your career, you have seen a patient abandon a prescription for atorvastatin because the copay was $45 instead of $10. You have seen a patient choose not to fill their antibiotic, hoping their infection will “just get better.” You already know, deep in your clinical bones, that cost is the single greatest barrier to adherence.

Now, multiply that $45 barrier by one hundred. In specialty, the “sticker shock” is not an inconvenience; it is a life-altering financial catastrophe. After you, the CASP, have successfully navigated the “Great Divide” (Section 6.3) and won the “PA battle” (Section 6.2), the patient is faced with the EOB. The insurance has “covered” their $10,000/month drug, but the patient is still responsible for their 20% coinsurance. They now have a bill for $2,000. For one fill. This is not a barrier; it is a brick wall. The patient will not, because they cannot, start therapy.

This is the moment where your role fundamentally transcends that of a traditional pharmacist. Your job is no longer just to quote the price. Your new role is that of a Financial Aid Officer. You must never accept a high patient cost as a final answer. A high copay is not an endpoint; it is the starting point for your next investigation. The patient, scared and overwhelmed, sees an impossible bill. You, the calm, expert CASP, must see a solvable puzzle.

This section is your deep dive into the “Financial Aid Toolkit.” We will master the three primary sources of funding—the “Three Pillars”—that you will use to “stack” assistance and build a complete affordability package for your patient. Your goal is simple: to get every patient’s out-of-pocket cost to a manageable level, ideally $0. This is not an “add-on” to your job. This is the job. In specialty, affordability is adherence, and adherence is the ultimate clinical outcome.

6.4.2 Pillar 1: The Manufacturer Copay Card (The “Merit Scholarship”)

This is the most common, most powerful, and most legally restrictive tool in your kit. A manufacturer copay card (or “coupon”) is a program funded directly by the drug manufacturer to “buy down” the out-of-pocket cost for their specific drug.

Why Do They Do It?

It’s simple economics. A $5,000 drug with a $1,000 coinsurance will be abandoned by most patients. The PBM gets $0, the pharmacy gets $0, and the manufacturer gets $0. By offering a copay card, the manufacturer agrees to “cover” $990 of that coinsurance. The patient now pays $10, starts the drug, and the PBM/Payer is now on the hook for their $4,000 share. The manufacturer loses $990 on the copay card, but gains $4,000 in revenue from the payer. It’s a win-win-win. The patient gets their drug, the pharmacy makes the fill, and the manufacturer secures their market share.

Masterclass Table: Anatomy of a Manufacturer Copay Card

A copay card is, in reality, a “secondary insurance” plan run by a pharmacy switch (like RelayHealth, McKesson, or Argus). It has all the same billing information as a PBM, which is why you process it as a Coordination of Benefits (COB) claim.

Card Element	What It Is	CASP Action & “Gotcha”
Patient Name / ID	The patient’s unique enrollment ID for the program.	You must enroll the patient first on the manufacturer’s portal (e.g., “Humira Complete”) to get this ID.
RxBIN	(e.g., 610524) The Bank Identification Number. This routes the claim to the correct switch (e.g., RelayHealth).	This is the most important piece of data. It is not the patient’s primary PBM BIN.
RxPCN	(e.g., ADV) The Processor Control Number. The secondary router.	Often a “vanity” name, like “COPAY” or the drug name.
RxGroup (Group #)	(e.g., 50776939) The specific “plan” for this drug.	This identifies the drug, the offer, and the benefit year.
Max Annual Benefit	“Max benefit of $15,000 per calendar year.”	This is the “Time Bomb.” You must track this. A patient taking a $5k/month drug will exhaust this $15k benefit in 3-4 months. You must have a plan for what to do in Month 5.
Patient Responsibility	“Patient pays first $10. Program pays the rest.”	This is the “Patient Pays” amount you will enter in your software. This is the only part the patient is responsible for.

CASP Tutorial: How to Process a Copay Card (The “COB Stack”)

This is a core technical skill. You are not “applying a coupon.” You are performing a “Secondary Payer” claim adjudication.

6.4.3 Pillar 2: Independent Copay Foundations (The “Need-Based Grant”)

This is your primary tool for Medicare patients. Because the Anti-Kickback Statute forbids manufacturers from directly helping Medicare patients, a different, legal model was created: the independent 501(c)(3) charitable foundation.

The “Legal Firewall” Explained

Here is why this model is legal and essential:

1. A manufacturer (e.g., AbbVie) cannot give a Medicare patient a “Humira Copay Card.” This is a direct, illegal inducement.
2. However, AbbVie can make a large, unrestricted charitable donation to an independent, non-profit organization like the “HealthWell Foundation’s Rheumatoid Arthritis Fund.”
3. This foundation is now legally “firewalled” from AbbVie. When a patient with RA applies to this fund, the foundation must offer them a grant that can be used for any RA drug (Humira, Enbrel, Xeljanz, etc.). The foundation cannot “steer” the patient to Humira.
4. Because the grant is “disease-specific” and not “drug-specific,” it is not considered an inducement. It is a legitimate charitable grant.

This legal distinction is the key. Your Medicare patient with a $2,000 coinsurance for Humira cannot use the Humira copay card, but they can apply to the “Rheumatoid Arthritis Fund” for a $5,000 grant to cover their costs.

Masterclass Table: Copay Card vs. Foundation Grant

Feature	Manufacturer Copay Card (Pillar 1)	Independent Foundation (Pillar 2)
Eligible Patients	Commercial / Private Insurance ONLY.	ALL insurance types. This is the primary tool for Medicare patients.
Legality	ILLEGAL for Medicare/Medicaid (Anti-Kickback).	LEGAL for Medicare/Medicaid (as a 501(c)(3) charity).
Funding Source	Directly from the drug manufacturer.	Donations from many sources (including manufacturers) to a non-profit.
Coverage Scope	Drug-Specific. (e.g., “Humira Copay Card”).	Disease-Specific. (e.g., “Rheumatoid Arthritis Fund”).
Eligibility Basis	Insurance type (must be commercial). No income check.	Financial Need. Patient’s Household Income must be below a % of the Federal Poverty Level (FPL), e.g., < 400% FPL.
Billing Method	Electronic COB Claim. Processed at the point of sale in seconds.	Manual Invoice / Portal Claim. You dispense the drug, then submit a claim for reimbursement from the grant after the fill.
Key Challenge	Benefit maximums ($15k/year) and Accumulators (Section 6.5).	Funds are limited and time-sensitive. Funds open and close daily.

CASP Tutorial: The Foundation Enrollment Workflow (A Race Against Time)

This is one of the most high-stakes, time-sensitive tasks you will perform. A fund that is “open” at 9:00 AM can be “closed” by 9:30 AM, having exhausted its multi-million dollar budget for the quarter. You must be fast, prepared, and persistent.

6.4.4 Pillar 3: Patient Assistance Programs (PAPs) (The “Full-Ride Scholarship”)

This is the third and final pillar. PAPs are the ultimate safety net. They are programs run directly by the manufacturer to provide 100% free drug to patients who have no other option. This is not a “copay” program; it is a “free drug” program.

Who Qualifies for a PAP?

PAP is the “program of last resort.” Eligibility is strict:

• The Uninsured: The #1 group. The patient has no insurance at all.
• The Functionally Uninsured: The patient is in a Medicaid “non-expansion” state. They make too much for Medicaid, but not enough to afford an ACA/Marketplace plan.
• The “Exclusion” Patient: The patient has insurance, but the plan has a permanent, non-appealable “exclusion” for the drug.

Like copay cards, PAPs are generally NOT for Medicare patients (Anti-Kickback). A Medicare patient who cannot afford their copay must use a Foundation (Pillar 2), not a PAP.

CASP Tutorial: The PAP Enrollment & Dispensing Workflow

This process is heavy on paperwork and patience. It is not fast.

1. Step 1: Identify the Need & Program. You have an uninsured patient with a new Rx for Ocrevus. You go to the Genentech patient assistance website and find the “Genentech Patient Foundation” application.
2. Step 2: The Application (A Team Effort). This is a 10-20 page application.
   • The Patient’s Part: Signs the form, provides proof of income (last year’s tax return or 3 months of pay stubs), and attests to household size.
   • The Provider’s Part: Signs the form, provides the prescription, attests to the diagnosis, and often has to provide a clinical justification.
   • Your Part (The CASP): You are the “quarterback.” You get the forms to the patient, you get them back, you send them to the provider, you get them back, and you are the one who faxes or uploads the final, completed packet to the manufacturer.
3. Step 3: The Review. The PAP reviews the packet. This can take days or weeks. They may “pend” it, asking for a “missing pay stub” or a “clarification from the doctor.” You are responsible for managing this “pended” queue.
4. Step 4: The Approval. The patient is approved for 12 months of free drug. The manufacturer will send an approval letter to you, the patient, and the provider.
5. Step 5: The “Dispense” (The Two Models). This is where it gets different. You are not billing for this drug.
   • Model A: “Direct-to-Patient.” The manufacturer ships the drug directly to the patient’s home via a central PAP-only pharmacy. You (the specialty pharmacy) are now cut out of the loop, but you have successfully connected the patient to their therapy.
   • Model B: “Dispense for a Fee.” The manufacturer ships the drug (labeled “PAP-ONLY, NOT FOR SALE”) to your pharmacy on consignment (you don’t pay for it). You then “dispense” it to the patient for a $0 copay. The manufacturer pays your pharmacy a small “dispensing fee” (e.g., $15) for your clinical services (counseling, follow-up).

6.4.5 The “Stack”: Assembling the Full Affordability Package

Your true skill as a CASP is not just knowing these three pillars, but knowing how to stack them. A patient’s financial journey is not static. You must know which pillar to use, and when to add another.

Masterclass Scenarios: Building the “Stack”