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 This resource may be outdated and may be jurisdictionally irrelevant to your specific situation. Important topics may be omitted entirely or lack a dedicated workflow (for example, Open Payments / Physician Payments Sunshine Act).

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.
  • This does not replace legal research databases or independent primary-source review.
  • 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), HIPAA administrative requirements (including Security Rule risk analysis and risk management obligations), 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.

Educational issue-spotting only. Not legal advice. No response combination determines compliance. This tool does not satisfy OIG or HIPAA compliance program requirements. Consult qualified counsel before relying on any output.

Help improve this resource: If you notice an error, outdated citation, or inaccurate information, please contact us at contact@barberintel.com. 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.