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Legal Strategy Guide
Don’t Collaborate for Free
Converting CPAs into revenue contracts without creating Stark or Anti Kickback exposure
Published: February 3, 2026
For Independent Pharmacy Owners
Compliance note: This resource is educational and not legal advice. Any financial relationship between a pharmacy and a prescriber should be reviewed for compliance with federal and state law, payer contract terms, and the specific facts of your program.
Strategy Snapshot
The Mistake
Treating a CPA as a business contract. A CPA defines clinical permissions, not compensation.
The Solution
A Management Services Agreement (MSA) that structures the relationship to satisfy AKS safe harbors and Stark exceptions.
Pricing Pillar
Fair Market Value (FMV) is non-negotiable. Avoid percentage-of-reimbursement splits.
Executive Summary
A common operational mistake is treating a Collaborative Practice Agreement (CPA) as if it were a business contract. A CPA is primarily a clinical delegation framework under state law that defines what patient care functions a pharmacist may perform under specified conditions. It is not, by itself, a compensation framework.
If you are performing care management work that supports a physician or other eligible billing practitioner (for example, care management operations that sit behind RPM, CCM, or APCM), you need a separate written services agreement that defines compensation, responsibilities, documentation expectations, and compliance constraints. Many organizations use a Management Services Agreement (MSA) for this purpose.
Key correction: An MSA does not magically “create a safe harbor.” Safe harbors are regulatory constructs under the federal Anti Kickback Statute (AKS). Stark is a separate statute with separate exceptions. What an MSA can do is structure the relationship so it has a chance to fit an applicable AKS safe harbor and, where Stark applies, a Stark exception.
I. The “Free Labor” trap (CPA only)
What a CPA does
A CPA creates a formal collaborative relationship that can expand pharmacist-delivered patient care functions, such as initiating, modifying, or managing medication therapy under defined protocols, depending on state law.
What a CPA does not do
A CPA typically does not define a payment model, a fee schedule, fair market value methodology, invoicing terms, or the compliance guardrails that make a payments trail defensible during scrutiny.
Why this matters operationally: If you deliver ongoing clinical work and the prescriber bills Medicare for services that your work supports, a CPA alone does not obligate the prescriber to compensate you. Even if the prescriber wants to pay you, paying “after the fact” without a written agreement and a set in advance methodology makes it much harder to defend the arrangement as legitimate services compensation rather than remuneration intended to influence referrals.
II. What an MSA is in this context
An MSA is a written services agreement where one party provides defined operational services to another party for compensation. In a pharmacy to practice relationship, the MSA typically describes how pharmacy staff support the practice’s care management operations, how work is documented, how compliance constraints are handled, and how the pharmacy is paid.
Avoid the “fee splitting” trap: Whether something is illegal fee splitting depends heavily on state law and the structure of the arrangement. The safe posture is to pay for services rendered at fair market value, not to share a percentage of collections.
III. AKS and Stark: what you are actually trying to satisfy
AKS safe harbor: personal services and management contracts
The AKS safe harbor (42 CFR 1001.952(d)) requires:
- Written agreement, signed by the parties
- Agreement covers all services and specifies the services
- Term is not less than 1 year
- Compensation methodology is set in advance, consistent with FMV, and not determined by volume or value of referrals
- Aggregate services do not exceed what is reasonably necessary for the business purpose
Stark exception: personal service arrangements
The Stark exception (42 CFR 411.357(d)) requires:
- Arrangement in writing, signed, and specifies services
- Covers all services
- Aggregate services do not exceed reasonable and necessary for legitimate business purpose
- Duration at least 1 year
- Compensation set in advance and does not exceed fair market value
Meeting a safe harbor is voluntary. Failing to meet a safe harbor does not automatically mean an arrangement is illegal; it means you fall into a facts and circumstances analysis zone.
IV. The three pricing rules that actually matter
Rule 1: Fair Market Value
Compensation must be consistent with FMV in arm’s-length transactions. Avoid percentage of collections or "splitting Medicare reimbursements," as these vary with the value of business generated.
Rule 2: Set in Advance
The methodology must be set in advance. You cannot “true up” because reimbursement was high this month. The agreement must define the calculation before services begin.
Rule 3: No Linkage to Volume
Both frameworks prohibit taking into account the volume or value of referrals. Do not tie discounts or fees to where prescriptions are filled.
V. The dual-document structure that actually works
Document 1: The CPA
Clinical Authorization
Defines what clinical functions are delegated, under what protocols, and with what oversight under state law. Answers: What clinical work can the pharmacist do?
Document 2: The MSA
Financial & Operational Authorization
Defines services, deliverables, compensation methodology, and compliance constraints. Answers: What services is the pharmacy providing and how is it paid?
VII. Common failure modes that trigger scrutiny
Fee is pegged to reimbursement, collections, or code value.
Fees change month to month based on what Medicare paid.
Fees drop if the practice agrees to send prescriptions to the pharmacy.
“Consulting” payments with no defined deliverables.
Services that are really marketing or patient steering.
No written agreement, expired agreement, or work outside scope.
References
- 42 CFR 1001.952(d), Personal services and management contracts safe harbor elements.
- OIG FAQ: Safe harbor compliance is voluntary; failure to meet a safe harbor does not mean an arrangement is illegal.
- 42 CFR 411.357(d), Stark personal service arrangements exception requirements.
- APhA Foundation overview of CPAs as formal relationships defining expanded pharmacist services.
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