Compliance

Telehealth Platform Fees, Anti-Kickback and EKRA: Flat FMV vs. Take-Rate vs. Spread

Fee structure encodes legal risk: why flat fair-market-value fees are defensible, why take-rates and drug spread are not, and what to ask a platform before you sign.

The neolife editorial desk·Published Jul 27, 2026·11 min read

Quick answer

Charge flat, fair-market-value fees fixed in advance in a written agreement, and never let the fee move with the price of the drug, the volume of orders routed, or the money the pharmacy makes. Percentage-of-revenue take-rates and drug spread are the structures that create anti-kickback exposure. Flat SaaS and flat per-order technology fees are the defensible baseline.

Key takeaways

  • The federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), is criminal - up to a $100,000 fine and 10 years - and subsection (h) says a person need not have actual knowledge of the statute or specific intent to violate it.
  • Courts apply a one-purpose test: if even one purpose of a payment is to induce referrals, other legitimate purposes do not cure the arrangement.
  • EKRA, 18 U.S.C. § 220, reaches all payors including cash-pay, but only for recovery homes, clinical treatment facilities and CLIA laboratories - a compounding pharmacy is not a laboratory, so EKRA bites on your lab orders, not your Rx routing.
  • "We are cash-pay so anti-kickback law does not apply" is wrong: Cal. Bus. & Prof. Code § 650 and Fla. Stat. § 817.505 are criminal, all-payor, and have no federal-program limitation.
  • The OIG personal services safe harbor at 42 C.F.R. § 1001.952(d)(1) is the design template: written and signed, one-year minimum term, compensation methodology set in advance at fair market value and not varying with volume or value of referrals.
  • Ask every platform in writing whether the pharmacy pays them anything per order routed - a pharmacy paying for order flow is paying for referrals, whatever the invoice calls it.

Charge flat, fair-market-value fees that are fixed in advance in a written agreement, and never let the fee move with the price of the drug, the volume of orders routed, or the money the pharmacy makes. Percentage-of-revenue take-rates and drug spread are the structures that create anti-kickback exposure. Flat SaaS and flat per-order technology fees are the defensible baseline.

That is the answer. Everything below is where the line actually sits and what to ask a platform before you sign an agreement built on the wrong side of it.

Anti-kickback law does not regulate healthcare software. It regulates payments that move with referrals. A fee that rises when more prescriptions get routed, or when a more expensive prescription gets routed, starts to look like compensation for the referral itself. A fee that does not move looks like the price of a product.

That distinction is why two platforms doing identical technical work can sit in completely different risk positions. The code is the same. The invoice is not.

What does the federal Anti-Kickback Statute actually say?

The AKS, 42 U.S.C. § 1320a-7b(b), makes it a felony to knowingly and willfully offer, pay, solicit, or receive "any kickback, bribe, or rebate ... directly or indirectly, overtly or covertly, in cash or in kind" to induce referrals of, or purchases of, items or services for which payment may be made under a federal health care program. Penalties run to a fine of not more than $100,000 and imprisonment of not more than 10 years.

Three features matter more to operators than the headline:

  • Intent is easier to establish than people assume. Conduct must still be "knowingly and willfully" undertaken, but subsection (h) provides that "a person need not have actual knowledge of this section or specific intent to commit a violation of this section." You do not get to say you had never heard of the AKS.
  • One bad purpose is enough. Courts apply the one-purpose test, traced to United States v. Greber, 760 F.2d 68 (3d Cir. 1985): if even one purpose of a payment is to induce referrals, legitimate purposes alongside it do not cure the arrangement. "We also provide real software" is not a defense on its own.
  • It converts into False Claims Act liability. Subsection (g) states that "a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim" under the FCA — the mechanism that turns a contract-structure problem into treble damages and a qui tam relator.

Enforcement attention on this sector is not hypothetical. In its July 20, 2022 Special Fraud Alert on telemedicine arrangements, HHS-OIG listed seven suspect characteristics, one of which is purely a payment-design problem: a company that "compensates health care practitioners based on the volume of items or services ordered or prescribed." Note what is flagged. Not the clinical encounter. The compensation formula.

Does EKRA apply to a telehealth fulfillment platform?

Sometimes, and the honest answer is narrower than most vendors imply. EKRA, 18 U.S.C. § 220, is the statute operators fear because it is not limited to federal programs — it reaches services covered by any "health care benefit program" as defined in 18 U.S.C. § 24(b), which includes commercial plans. Penalties run to a $200,000 fine and 10 years, per occurrence.

But EKRA's reach is bounded by who receives the referral. It covers recovery homes, clinical treatment facilities, and laboratories, and "laboratory" takes its meaning from section 353 of the Public Health Service Act, the CLIA definition. A 503A compounding pharmacy is not a CLIA laboratory, and a general telehealth clinic is not a substance-use clinical treatment facility. On a straightforward read, routing a compounded prescription to a pharmacy does not put you inside EKRA.

Where it does bite is labs, and most hormone, longevity, and men's health programs order labs. If any part of your platform economics moves with diagnostic testing volume — a per-panel share, a commission tied to test counts, a rebate from the lab — you are in EKRA territory regardless of payor, and the cash-pay argument evaporates entirely.

The scope debate is live and it moved recently. A district court in S&G Labs Hawaii, LLC v. Graves (D. Haw. 2021) read EKRA's "induce a referral" language narrowly, which vendors quoted for years as comfort. On July 11, 2025, in United States v. Schena, the Ninth Circuit rejected that reading, holding that payments to marketing intermediaries can induce a referral even where the marketer never touches a patient. The same decision declined to treat percentage-based compensation as unlawful per se; as reported by Mintz, the government conceded at argument that a percentage payment to a marketer is not automatically an EKRA violation. Read the pair together and the lesson is uncomfortable rather than reassuring: percentage compensation is not automatically criminal, and it is also not safe. In Schena the percentages became unlawful because they sat alongside directed deception. Structures are judged in full context, not by label.

How do the common fee structures rank on risk?

Flat, value-blind fees sit at the safe end; anything indexed to drug price or pharmacy revenue sits at the dangerous end. The table below is the version a healthcare regulatory lawyer will draw on a whiteboard in your first meeting, and it is worth reading before you take a term sheet rather than after.

Fee structure How it works Why platforms use it Risk posture What makes it defensible
Flat monthly SaaS + per-seat Fixed subscription, set in advance, unrelated to order volume or drug price Predictable revenue, easy to benchmark Lowest Written agreement, stated term, priced at FMV against comparable software
Flat per-order technology fee Fixed dollar amount per order routed, identical for a $40 and a $400 prescription Prices to the real marginal cost of processing an order Low, if genuinely value-blind Never varies with drug price, payor, or pharmacy margin; documented cost basis
Percentage of revenue / take-rate Platform keeps a percentage of each prescription or of clinic revenue Uncapped upside; imported from e-commerce without healthcare review High Very difficult; the fee is defined by the value of what was referred
Drug spread Platform buys from the pharmacy low, bills the clinic higher, keeps the difference The margin is invisible to the clinic, so it is never negotiated Highest Nearly nothing; the platform profits on the drug it directed you to buy
Pharmacy-paid routing fee Pharmacy pays the platform per order it receives Lets the platform market itself as free to clinics High The pharmacy is paying for order flow, which is paying for referrals

When is a per-order fee a technology charge, and when is it a bounty?

This is the subtle part. A per-order fee is not automatically suspect. Processing an order has real marginal cost: eligibility and identity checks, provider review workflow, pharmacy transmission, exception handling, status tracking, support. Charging for that per unit is ordinary commercial pricing.

It becomes a referral bounty when the amount stops describing the work and starts describing the referral. Four tests:

  1. Does the fee vary with the value of what was prescribed? If a $400 prescription costs more to route than a $40 one, you are charging for the prescription, not the routing.
  2. Does the fee vary with the payor? Different pricing for insured versus cash patients is indexing to reimbursement.
  3. Who pays it? A clinic paying a vendor for software is a customer relationship. A pharmacy paying per order received is buying order flow.
  4. Is there a cost story you could defend in a deposition? If nobody can explain the number beyond "that is what the market bears," it is not an FMV technology fee.

The economics of compounded prescription pricing make the temptation obvious: the spread between pharmacy cost and patient price is large, and it is easy for a platform to sit quietly in the middle of it. That is why the question deserves a direct answer in writing.

Why is "we are cash-pay, so anti-kickback law does not apply" a dangerous shortcut?

Because it is only true of one statute. The AKS is limited to federal health care programs. Almost nothing else operators face is.

State law is the gap most cash-pay operators miss. California Business and Professions Code § 650 makes it unlawful for a licensee to offer, deliver, receive, or accept "any rebate, refund, commission, preference, patronage dividend, discount, or other consideration ... as compensation or inducement for referring patients," with no federal-payor limitation anywhere in it. Subsection (b) saves payment for services other than referral only "if the consideration is commensurate with the value of the services furnished." A first conviction carries up to a year in county jail and a fine of up to $50,000. That is a fair-market-value test written directly into a state criminal statute.

Florida's Patient Brokering Act, Fla. Stat. § 817.505, is similarly payor-agnostic and escalates with patient count, reaching a first-degree felony with a fine of up to $500,000 where 20 or more patients are involved. Its federal-law exception at (3)(a) covers practices "expressly authorized by 42 U.S.C. s. 1320a-7b(b)(3) or regulations adopted thereunder." As DLA Piper noted when Florida narrowed that language in 2019 from "not prohibited by" to "expressly authorized by," the change made compliance materially harder to demonstrate for private-pay arrangements, because federal safe harbors were written for federal programs in the first place.

Then there is corporate practice of medicine and professional fee-splitting, which many states treat as misconduct independent of any kickback analysis. If your platform sits inside your MSO-PC structure and takes a percentage of professional fees, you may have a fee-splitting problem before anyone reaches the kickback question.

What does a fair-market-value analysis actually involve?

Not a feeling about what the market bears. The OIG personal services and management contracts safe harbor at 42 C.F.R. § 1001.952(d)(1) is the best available design template, and its standards are concrete: the agreement is set out in writing and signed; it specifies the services and covers all services the agent provides; the term is not less than one year; and the methodology for determining compensation "is set in advance, is consistent with fair market value in arm's-length transactions, and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties." Aggregate services must also not exceed what is reasonably necessary for a commercially reasonable business purpose.

Two caveats vendors rarely volunteer. Safe harbors are voluntary, and falling outside one is not itself a violation — the arrangement is judged on its facts. And they are creatures of federal program law, so fitting the template does not resolve state all-payor statutes. Use paragraph (d) as an engineering specification, not a certificate.

In practice a defensible FMV file contains a benchmark against comparable software priced at arm's length in adjacent verticals, a cost-plus analysis of what the service costs to deliver, a written rationale, and a date. Contemporaneous documentation is most of the value. Reconstructing your reasoning three years later, after a subpoena, is not the same exercise.

What should you ask a platform before you sign?

Ask these in writing, and put the answers in the contract rather than in a sales email. If a vendor will not answer them plainly, that is itself the answer. This list pairs with the broader diligence questions before signing a fulfillment platform.

  1. Is any part of your fee a percentage of prescription value, patient revenue, or pharmacy revenue?
  2. Do you purchase medication and resell it to me at a markup? Show me the pharmacy's actual invoiced price.
  3. Does the pharmacy pay you anything at all — per order, per connection, rebate, marketing fee, or data fee?
  4. Is the fee set in advance in a written agreement with a stated term, or can you reprice it unilaterally?
  5. Does my fee change if I route a $400 prescription instead of a $40 one, or if I route ten times more volume?
  6. If I leave, what happens to my patient records and my pharmacy relationships?

That last one is not a kickback question, but it belongs on the same page. Fee structure and switching costs tend to be designed by the same instinct, and an operator trapped in a bad structure cannot exit it cheaply.

How neolife charges, and why

We price as flat fair-market-value SaaS with a per-order buy-down: Starter at $699/month plus $4 per order routed, Growth at $1,999 plus $3.50, Scale at $6,000 plus $3, Enterprise from $2.50, and additional provider seats at $149. The per-order fee is a fixed dollar amount, identical whether the prescription is worth $40 or $400. We take no spread on the drug and no percentage of your revenue.

Pharmacies pay nothing to connect, and that is a structural position rather than a promotion. A platform that takes money from a pharmacy per order routed is taking payment for order flow, whatever the invoice calls it. We decline the revenue because we do not want the argument. It is also why pharmacy margin stays between you and your pharmacy — we are not in that transaction.

To be exact about what that claim is not: we designed the structure against the standards in 42 C.F.R. § 1001.952(d)(1), but no regulator has blessed it, we hold no OIG advisory opinion, and none of this substitutes for your own counsel reviewing our agreement against your states, payor mix, and entity structure.

neolife is the fulfillment rail underneath the clinic you already run — AI-native intake, compliance, and cross-pharmacy routing that overlays your existing pharmacy rather than replacing it, with a licensed provider approving every order and your patient data staying yours as the system of record. To see the actual fee schedule and the contract language behind it, talk to us.

This article is for informational purposes only and is not legal, medical, or regulatory advice; consult qualified counsel and licensed clinicians for your specific situation.

Frequently asked questions

Is a per-order fee automatically a kickback?

No. Processing an order has real marginal cost, and charging per unit for it is ordinary pricing. It becomes a problem when the amount stops describing the work and starts describing the referral - if the fee varies with the drug's price, with the payor, or with the pharmacy's margin. A flat dollar amount that is identical for a $40 and a $400 prescription is describing infrastructure, not value referred.

We only take cash. Do we still need to care about this?

Yes. The federal AKS is limited to federal health care programs, but state law generally is not. California Business and Professions Code § 650 prohibits any consideration paid as inducement for referring patients with no payor limitation, and Florida's Patient Brokering Act is a felony that escalates with patient count. Both are criminal statutes that reach purely cash-pay arrangements.

Does EKRA apply if we route compounded prescriptions to a pharmacy?

On a straightforward read, no. EKRA covers recovery homes, clinical treatment facilities, and laboratories as defined by section 353 of the Public Health Service Act. A 503A compounding pharmacy is not a CLIA laboratory. But if your program orders diagnostic panels - and most hormone and longevity programs do - any economics that move with lab volume put you squarely inside EKRA, for every payor.

Our platform says percentage pricing is fine because a court said so. Is that right?

That reads too much into the case. In United States v. Schena, decided July 11, 2025, the Ninth Circuit declined to treat percentage-based compensation as unlawful per se under EKRA. It also affirmed the conviction, because those percentages were paired with directed deception. Not automatically criminal is a long way from safe, and the AKS analysis is separate.

How do I tell if a platform is taking spread on my medication?

Ask for the pharmacy's actual invoiced price and compare it to what you are billed. If the platform will not show you the pharmacy invoice, or contracts so that you never see it, assume there is a margin in between. Spread is the structure that is hardest to defend precisely because it is invisible to the party paying it.

Does fitting inside an OIG safe harbor make us safe?

It helps, but it is not a certificate. Safe harbors are voluntary, so falling outside one is not itself a violation - the arrangement is judged on its facts. And safe harbors are federal-program constructs, so meeting 42 C.F.R. § 1001.952(d)(1) does not resolve state all-payor statutes. Treat paragraph (d) as an engineering spec for the agreement, then have counsel review your specific states.

This article is operator education, not medical, legal, or tax advice. Telehealth and pharmacy regulation vary by state and product and change frequently. Verify the specifics for your business with qualified counsel and your pharmacy partner.

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