Important Disclaimer

This tool is for educational and informational purposes only.

  • This is not legal advice and does not create an attorney-client relationship.
  • You select which screening tools to use. The availability of a tool does not mean it applies to your situation, and the tools presented are not a comprehensive list of all potentially applicable requirements.
  • These tools address only preliminary threshold questions. Many other requirements may apply.
  • A favorable screening outcome does not mean an arrangement complies with all applicable law.
  • An unfavorable outcome identifies potential areas warranting further analysis.
  • You should consult qualified counsel before acting or refraining from acting based on these results.

This tool is not a compliance program. The OIG General Compliance Program Guidance (2023) describes elements of an effective compliance program. This tool does not replace a compliance program and is not designed to satisfy compliance program requirements.

Compliance is an ongoing process. Using this tool does not constitute a compliance review or audit. Healthcare regulatory requirements change frequently. This tool reflects general federal requirements and does not address all state-specific laws that may apply.

Help improve this tool: If you notice an error, outdated citation, or inaccurate information, please contact me at [email protected]. This tool is provided as a free resource and your feedback helps keep it accurate.

Fraud & Abuse

Stark Law (Physician Self-Referral)

42 U.S.C. § 1395nn; 42 U.S.C. § 1396b(s)

Screen for potential physician self-referral issues involving designated health services.

Fraud & Abuse

Anti-Kickback Statute

42 U.S.C. § 1320a-7b(b)

Screen for potential kickback issues involving remuneration and federal healthcare program referrals.

Fraud & Abuse

EKRA

18 U.S.C. § 220

Screen for kickback issues specific to recovery homes, clinical treatment facilities, and laboratories.

Fraud & Abuse

Beneficiary Inducement

42 U.S.C. § 1320a-7a(a)(5)

Screen for potential issues with offering items or services to Medicare/Medicaid beneficiaries.

Fraud & Abuse

Criminal Health Care Fraud

18 U.S.C. § 1347

Screen for potential criminal health care fraud elements involving schemes to defraud health care programs.

Fraud & Abuse

Exclusion Screening

42 U.S.C. § 1320a-7; 42 C.F.R. Part 1001

Screen for exclusion checking requirements and processes for employees and contractors.

Fraud & Abuse

Self-Referral Disclosure Protocol

Section 6409, ACA; 42 C.F.R. § 401.305

Screen for potential use of CMS's SRDP to self-disclose Stark Law violations.

Overpayment

False Claims Act

31 U.S.C. §§ 3729-3733

Screen for potential False Claims Act liability involving claims submitted to federal programs.

Overpayment

Overpayment Obligations

42 U.S.C. § 1320a-7k(d); 31 U.S.C. § 3729(a)(1)(G)

Screen for overpayment identification, reporting, and return obligations.

Privacy & Security

HIPAA Applicability

45 C.F.R. Parts 160, 164

Screen to determine if an entity is subject to HIPAA as a covered entity or business associate.

Privacy & Security

Business Associate Agreements

45 C.F.R. § 164.504(e)

Screen for when a Business Associate Agreement may be required.

Privacy & Security

Information Blocking

21st Century Cures Act; 45 C.F.R. Part 171

Screen for potential information blocking issues under the Cures Act.

Billing & Payment

Conditions of Payment

42 C.F.R. Part 424

Screen for basic Medicare conditions of payment requirements.

Billing & Payment

Incident-To Billing

42 C.F.R. § 410.26

Screen for incident-to billing requirements for services performed by auxiliary personnel.

Billing & Payment

Medical Necessity

42 U.S.C. § 1395y(a)(1)(A)

Screen for basic medical necessity considerations under the reasonable and necessary standard.

Billing & Payment

ABN Requirements

42 C.F.R. § 411.404

Screen for when an Advance Beneficiary Notice of Noncoverage may be required.

Billing & Payment

Telehealth Requirements

42 C.F.R. § 410.78

Screen for Medicare telehealth coverage and billing requirements.

Billing & Payment

Medicare Secondary Payer

42 U.S.C. § 1395y(b); 42 C.F.R. Part 411

Screen for Medicare Secondary Payer applicability and coordination of benefits.

Billing & Payment

Coverage Determination

42 C.F.R. Part 405; NCDs/LCDs

Screen for coverage determination considerations including benefit categories and coverage policies.

Provider Standards

Conditions of Participation

42 C.F.R. Parts 482-486

Screen for Medicare/Medicaid conditions of participation certification status.

Provider Standards

Provider Enrollment

42 C.F.R. Part 424 Subpart P

Screen for Medicare provider enrollment requirements and status.

Provider Standards

CLIA (Laboratory Certification)

42 U.S.C. § 263a; 42 C.F.R. Part 493

Screen for Clinical Laboratory Improvement Amendments certification requirements.

Provider Standards

EMTALA

42 U.S.C. § 1395dd

Screen for Emergency Medical Treatment and Labor Act obligations.

State Considerations

State Healthcare Regulatory

Various State Laws

Checklist of state-specific regulatory considerations that may apply beyond federal requirements.