🇺🇸 Live Medical Devices & Diagnostics

Anti-Kickback (42 CFR 1001)

Prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals of items or services covered by federal healthcare programs. Relevant to healthcare providers, suppliers, and entities participating in Medicare or Medicaid.

View official source document

Rules extracted

1,238

Obligations decomposed

32.6x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

1,238

Obligations

32.6x

Decomposition ratio

Each rule is decomposed into an average of 32.6 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 1,238 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in Anti-Kickback Statute is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: Anti-Kickback (42 CFR 1001)
Regulatory body: HHS Office of Inspector General
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: August 21, 1997
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

healthcare providerspharmaceutical companiesmedical device manufacturershealth planslaboratories

Key requirements

prohibition on kickbacks for referrals
safe harbors for legitimate arrangements
intent-based liability standard
exclusion penalties
OIG advisory opinions

Frequently asked questions about Anti-Kickback Statute

What is Anti-Kickback Statute?

Who does Anti-Kickback Statute apply to?

Anti-Kickback Statute applies to healthcare providers, pharmaceutical companies, medical device manufacturers, health plans, laboratories.

How many obligations does Anti-Kickback Statute contain?

AuditDSS has decomposed Anti-Kickback Statute into 1,238 atomic obligations from 38 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of Anti-Kickback Statute?

The key requirements include: prohibition on kickbacks for referrals, safe harbors for legitimate arrangements, intent-based liability standard, exclusion penalties, OIG advisory opinions.

How can I assess my Anti-Kickback Statute compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 1,238 Anti-Kickback Statute obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces Anti-Kickback Statute?

Anti-Kickback Statute is enforced in United States by HHS Office of Inspector General.

When did Anti-Kickback Statute come into effect?

Anti-Kickback Statute became effective on August 21, 1997.

What industry does Anti-Kickback Statute apply to?

Anti-Kickback Statute is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

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Policy

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AI maps against 1,238 obligations

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Risk-scored gap report

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