Important: Please Read Before Proceeding

This resource presents illustrative issue-spotting prompts commonly discussed in healthcare compliance literature. These materials are provided for educational and informational purposes only.

Non-Reliance Disclaimer: Users should not rely on these questions, individually or collectively, to determine compliance, risk exposure, or legal obligations. Any reliance on this material for decision-making is expressly disclaimed.

No Compliance Determination: No combination of responses indicates compliance or non-compliance with any law or regulation. These prompts are designed solely to illustrate common compliance considerations—not to provide individualized assessments or legal conclusions.

Completeness and Accuracy Disclaimer: The questions presented are non-exhaustive, may omit critical facts or legal nuances, and may not reflect current law, sub-regulatory guidance, or enforcement priorities. Healthcare regulatory requirements change frequently. This resource may be outdated and may be jurisdictionally irrelevant to your specific situation.

Not Legal Advice or Client Intake:

  • This is not legal advice and does not create an attorney-client relationship.
  • Completion of these materials does not constitute an evaluation of your organization.
  • This does not substitute for engagement of qualified legal counsel.
  • You select which topics to explore. The availability of a topic does not mean it applies to your situation.

Not a Compliance Program: This resource is not a compliance program and does not satisfy compliance program requirements under the OIG General Compliance Program Guidance (2023) or any other standard. Using this resource does not constitute a compliance review or audit.

Consult Qualified Counsel: You should consult qualified legal counsel before acting or refraining from acting based on any information presented here.

Help improve this resource: If you notice an error, outdated citation, or inaccurate information, please contact me at [email protected]. This resource is provided free of charge 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)

Common considerations frequently raised in physician self-referral enforcement actions involving designated health services.

Fraud & Abuse

Anti-Kickback Statute

42 U.S.C. § 1320a-7b(b)

Common considerations involving remuneration and federal healthcare program referrals discussed in AKS enforcement.

Fraud & Abuse

EKRA

18 U.S.C. § 220

Considerations specific to recovery homes, clinical treatment facilities, and laboratories under EKRA.

Fraud & Abuse

Beneficiary Inducement

42 U.S.C. § 1320a-7a(a)(5)

Considerations when offering items or services to Medicare/Medicaid beneficiaries.

Fraud & Abuse

Criminal Health Care Fraud

18 U.S.C. § 1347

Elements commonly discussed in criminal health care fraud cases involving schemes to defraud health care programs.

Fraud & Abuse

Exclusion Considerations

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

Common questions about exclusion checking requirements and processes for employees and contractors.

Fraud & Abuse

Self-Referral Disclosure Protocol

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

Considerations for CMS's SRDP to self-disclose Stark Law violations.

Overpayment

False Claims Act

31 U.S.C. §§ 3729-3733

Common considerations in False Claims Act cases involving claims submitted to federal programs.

Overpayment

Overpayment Obligations

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

Considerations regarding overpayment identification, reporting, and return obligations.

Privacy & Security

HIPAA Applicability

45 C.F.R. Parts 160, 164

Common questions about covered entity and business associate status under HIPAA.

Privacy & Security

Business Associate Agreements

45 C.F.R. § 164.504(e)

Considerations for when a Business Associate Agreement may be required.

Privacy & Security

Information Blocking

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

Common considerations regarding information blocking under the Cures Act.

Billing & Payment

Conditions of Payment

42 C.F.R. Part 424

Common questions about basic Medicare conditions of payment requirements.

Billing & Payment

Incident-To Billing

42 C.F.R. § 410.26

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

Billing & Payment

Medical Necessity

42 U.S.C. § 1395y(a)(1)(A)

Common medical necessity considerations under the reasonable and necessary standard.

Billing & Payment

ABN Requirements

42 C.F.R. § 411.404

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

Billing & Payment

Telehealth Requirements

42 C.F.R. § 410.78

Common considerations for Medicare telehealth coverage and billing requirements.

Billing & Payment

Medicare Secondary Payer

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

Considerations for Medicare Secondary Payer applicability and coordination of benefits.

Billing & Payment

Coverage Determination

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

Considerations for coverage determinations including benefit categories and coverage policies.

Provider Standards

Conditions of Participation

42 C.F.R. Parts 482-486

Information about Medicare/Medicaid conditions of participation certification.

Provider Standards

Provider Enrollment

42 C.F.R. Part 424 Subpart P

Common questions about Medicare provider enrollment requirements and status.

Provider Standards

CLIA (Laboratory Certification)

42 U.S.C. § 263a; 42 C.F.R. Part 493

Considerations for Clinical Laboratory Improvement Amendments certification requirements.

Provider Standards

EMTALA

42 U.S.C. § 1395dd

Common considerations 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.