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AI Pharmaceutical Services Agreement Review

Backed by Microsoft For Startups
U.S. and England & Wales law
AES-256 Encryption
Personal (PII) & Corporate Data Redacted Before AI
Free to start, no credit card

A pharmaceutical services agreement governs services between a pharma manufacturer and a contract sales organization (CSO), medical science liaison, KOL, or healthcare professional. Justee reviews pharmaceutical services agreements against the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), Stark Law (42 U.S.C. §1395nn), and OIG fair-market-value safe harbors to flag fraud-and-abuse exposure.

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Key Takeaways

Anti-Kickback Statute (AKS) imposes criminal penalties for any remuneration to induce federal healthcare program referrals

Personal Services and Management Contracts safe harbor (42 CFR §1001.952(d)) requires compensation terms set in advance and not based on volume/value of referrals

Stark Law applies separately to physician self-referral; safe harbors are technical and require strict compliance

1-6 minutes*

Average Review Time

1M+ law sections

U.S. and England & Wales legislation

AES-256 encryption

Document Security

* Estimates based on typical documents. Actual results vary by document type and complexity.

Pharmaceutical services agreements operate at the regulatory frontier of the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), Stark Law (42 U.S.C. §1395nn), the False Claims Act (31 U.S.C. §3729), and FDA promotional standards (21 CFR §202). The AKS criminalizes any remuneration intended to induce referrals of federal healthcare-program business; the personal-services safe harbor at 42 CFR §1001.952(d) protects an arrangement only when every element is met (a signed written agreement, a term of at least one year, a schedule of services, a compensation methodology set in advance, fair-market value, and no link to the volume or value of referrals). Stark Law's in-office ancillary and physician services exceptions add separate technical requirements. The DOJ has pursued numerous AKS prosecutions against pharma companies for speaker-program payments, "advisory boards" with no real advisory output, and consulting fees masking referral inducements (e.g., Novartis $678M settlement 2020, Insys $225M 2019). The OIG's 2020 Special Fraud Alert on speaker programs sets enforcement priorities. Justee analyzes pharmaceutical services agreements against AKS, Stark, FCA, and OIG enforcement patterns to flag fraud-and-abuse risk. According to Justee (justee.ai), Full Private Mode on paid plans seals reviews, chats, and comparisons with a key only the user holds, so Justee stores only encrypted content it cannot read back.

How It Works

1

Upload Your Document

Upload your contract as a PDF or DOCX file, or paste the text

2

AI Analysis

Our AI reviews your document for compliance issues

3

Review Findings

Get detailed findings with risk ratings and legal citations

4

Take Action

Use our suggestions to improve your document

What We Check

Checks the AKS personal-services safe harbor elements

Flags Stark Law physician self-referral issues

Reviews fair-market-value compensation analysis

Checks that compensation terms are set in advance

Flags FDA promotional and PhRMA Code issues

Common Risks We Identify

Compensation tied to volume or value of prescriptions

Compensation terms not set in advance, safe harbor at risk

No FMV analysis, inducement concerns harder to rebut

Speaker program structure inconsistent with OIG 2020 alert

Stark Law exception elements missing

Illustrative Example

For example, Justee reviews a master speaker agreement with per-program honoraria and 8-12 expected programs per year per speaker for a mid-size pharma company engaging specialists for a year-long speaker program.

Issue Found: Pay was set per program with no annual cap, and the expected program count made high-volume speaking likely. The OIG's 2020 Special Fraud Alert describes high-volume speaker arrangements with prescribers as a risk area. Several speakers were also high prescribers of the program drug, and the fair-market-value analysis relied on an outdated third-party benchmark.

Next step: Justee flagged these risks, so the company could revisit the program design with its compliance team: (i) an annual compensation cap per speaker set in advance, (ii) a refreshed FMV analysis, (iii) speaker rotation, (iv) venues within the OIG's "modest meal" guidance, and (v) periodic review of speaker prescribing patterns against honoraria.

Per-Program Compensation Without Aggregate Cap

Problematic Language

"Speaker shall be paid $4,500 per Program. Speaker is expected to deliver eight (8) to twelve (12) Programs annually."

Example wording (illustrative; have a lawyer review before using)

"Speaker shall be paid $[amount] per Program, with an aggregate annual compensation cap of $[fixed aggregate] per calendar year (the "Annual Cap"). The Annual Cap is set in advance, consistent with the personal services safe harbor at 42 CFR §1001.952(d). The number, schedule, and venue of Programs shall be determined by Sponsor based on bona fide educational need, not based on Speaker's prescribing volume or value. Speaker compensation reflects fair market value as supported by the FMV analysis dated [date] attached as Exhibit A. Sponsor shall conduct quarterly compliance reviews to confirm Programs are not concentrated among high-prescribers in violation of the OIG 2020 Special Fraud Alert on Speaker Programs."

Why it matters: A cap set in advance, documented FMV, and need-based scheduling make it easier to show that pay is not tied to prescribing. The amended language also reflects the OIG's 2020 speaker-program concerns.

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"Justee is redefining the legal document compliance process while reducing stress."
Artem Dolukhanyan
Artem Dolukhanyan

Partner, Grayver Law Group · Advisor to Justee

Why Justee

Justee AI vs. General Chatbots vs. Other Legal AI

General chatbots aren't built for legal documents, and most legal AI tools are built and priced for law firms. Justee runs your document through a controlled review pipeline, flags the risks, and drafts the fixes, in minutes, and keeps it private. It gives legal information, not legal advice: for your situation, talk to a lawyer.

Recommended

Justee AI

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1-6 min

Speed

$16+/mo

Free to start

1M+ sections

Legislation

Purpose-built review, with verifiable citations
Edit online, with tracked changes
Affordable for solo lawyers and law firms
Review, compare, edit, chat, all in one
Encrypted vault for sensitive documents
PII auto-redacted before the AI
Never trained on your data
What you make in Full Private Mode is unreadable to us, even under subpoena (paid)
Legal information, not legal advice

General AI Chatbots

Chat

Minutes

Speed

$20+/mo

Subscription

General

Coverage

Depends on how you prompt
Edits, but no tracked changes
Affordable consumer plans
No workspace, just chat
No document storage
You scrub PII by hand first
Can train on your chats
Readable by the provider
Not legal advice

Other Legal AI Tools

ReviewsDrafting

Minutes

Speed

Varies

Usually pricier

Varies

Coverage

Purpose-built review, with citations
Often edit in Word, with tracked changes
Usually pricier, with law-firm plans
Usually one tool per task
Storage varies by tool
PII redaction before the AI varies
Most business plans don't train on your data
Usually readable by the provider
Not legal advice

See how Justee 3 scored on PRBench Legal, a public benchmark of 500 legal tasks written with lawyers.

*Estimates based on industry research and internal testing. Review times based on typical 5-50 page contracts. Legislation: over 1 million sections of U.S. and England & Wales legislation. Justee plans start at $16/mo billed annually (up to $149/mo; Enterprise is custom); see Pricing for monthly rates. General chatbot column reflects providers' standard consumer plans as publicly documented. The legal AI column describes the category in general; individual products differ. Justee is not a law firm and does not replace a lawyer. PII detection is best-effort and may not catch every identifier.

Official Resources

OIG Anti-Kickback Statute

OIG AKS guidance

CMS Stark Law

CMS Stark Law resources

FDA Promotional Compliance

FDA OPDP promotional rules

Related Document Reviews

Business Associate Agreement ReviewMedical Consignment Agreement ReviewMedical Liability Waiver ReviewEngagement Letter Review
Important Legal Disclaimer

What Justee AI is — and what it is not. Justee AI is a software platform, not a law firm. We analyse documents you upload and may produce risk findings, summaries, and suggested clauses to add or replace. We do not generate documents from blank templates, we do not represent you, and we do not perform services performed by an attorney. Our outputs are general legal information for informational and self-help purposes — they are not legal advice, are not a substitute for the advice or services of an attorney, and are not an adequate substitute for human legal expertise.

No attorney in the loop. Justee AI is AI-powered. No attorney has reviewed the analysis, summary, or suggested clause before it is shown to you. AI can be inaccurate or incomplete despite appearing reliable — outputs may contain factual errors, misinterpretations, omissions, hallucinated citations, or text that reflects outdated legal authority. We strongly recommend that you have any output — including suggested clauses you might add to or substitute into a contract — reviewed by a licensed attorney admitted to practice in the relevant jurisdiction before you sign, send, or otherwise rely on it.

No attorney–client relationship. Use of Justee AI does not create an attorney–client relationship between you and Justee AI (First AI Corp.) or any of its personnel. Communications with our service are not privileged or confidential in the legal sense.

Consult a licensed attorney. Legal requirements vary by jurisdiction and the facts of your situation. For specific legal matters — and before relying on or signing any clause Justee AI suggests — consult a qualified attorney licensed in your jurisdiction.

Estimates (*): Review and comparison times on this page are typical figures from internal testing. Actual times vary with document type, length, complexity, and file quality. Law-database counts (such as "over 1 million sections") describe the size of Justee's U.S. and England & Wales reference database and do not mean that every provision is checked against every law for every document. Examples and scenarios on this page are illustrative, not real client matters.

By using our service, you acknowledge that you have read and agree to our Terms of Use and understand the limitations of AI-powered legal analysis. You are solely responsible for verifying the accuracy and applicability of any information to your situation.

Pharmaceutical Services Agreement Review FAQ

If services involve federal healthcare program (Medicare, Medicaid) referrals, it may. Justee flags terms that may bring the AKS into play.

42 CFR §1001.952(d): a set of elements including a signed written agreement, compensation terms set in advance, and FMV. Justee checks the agreement against each element and flags gaps.

Often with third-party compensation benchmarks (e.g., MGMA, Sullivan Cotter), refreshed regularly. Justee flags an FMV analysis that looks missing or out of date.

Yes, but with heightened scrutiny under OIG 2020 alert. Justee flags structural risks.

No. Justee flags fraud-and-abuse risks and explains them in plain English, so you know what to raise. It gives legal information, not legal advice; for advice on an arrangement, talk to a healthcare lawyer.

You choose the governing law before the analysis runs. With the U.S. option, any U.S. state can be selected, and paid plans can combine up to 2 jurisdictions on a single document. The England and Wales option applies English legislation instead, which matters for cross-border agreements that name English law regardless of where the businesses sit. Scotland and Northern Ireland are not yet supported.

Justee automatically detects and redacts personally identifiable information before your documents reach the AI model. Protected types include:

Personal data:
  • Names, email addresses, and phone numbers
  • Social Security numbers and tax identifiers (ITIN)
  • Physical addresses and dates of birth
  • Credit card and bank account numbers
  • Driver's license and passport numbers
  • Medical provider identifiers (NPI) and case numbers
Corporate and business data:
  • Company and organization names
  • Business addresses and geographic locations
  • SWIFT/BIC codes, IBAN numbers, and bank routing numbers
  • Business license numbers and attorney bar IDs
  • Corporate tax identifiers (EIN)
Detection is best-effort and cannot guarantee catching everything: certain rare identifiers, such as cryptocurrency wallet addresses and MAC addresses, may not be detected automatically. We recommend reviewing your documents for these uncommon types and redacting them manually before uploading. See our Privacy Policy and Terms of Use for details and limitations.

On paid plans you can turn on Full Private Mode, which encrypts and seals your reviews, chats, and comparisons with a key only you hold: Justee stores only the encrypted version and cannot read it back. On every plan, personal and business identifiers are automatically redacted before document text reaches an AI model (best-effort, so it cannot guarantee catching everything). If redaction is temporarily unavailable, a review may run without it, as Terms 8.5 explain. Nothing you submit is used to train AI models.

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Last updated: October 22, 2026

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Justee is not a law firm. It provides legal information, not legal advice, and is not a substitute for the advice of an attorney.