Clinical Trials Billing Compliance

Assessment for Medicare Coverage Analysis and billing compliance for clinical trial services separating research costs from standard care

ResearchHealthcareClinical-trialsBiotech minutes18 questions

1. Medicare Coverage Analysis

Is Medicare Coverage Analysis (MCA) performed for all clinical trials before enrollment?*

MCA: Determine which services are routine care (Medicare covers) vs research (sponsor covers)

Are qualified clinical trials (QCT) defined per Medicare NCD 310.1 criteria?*

QCT criteria: Therapeutic intent, NIH/CDC/CMS/DOD funded OR FDA IND/IDE, IRB approved, registry posted

Is coverage determination documented with billing matrix before patient enrollment?*

Billing matrix: Itemize all trial procedures, assign payer (Medicare/sponsor), update with protocol amendments

2. Research vs Standard Care Distinction

Are routine care costs clearly separated from research costs in budgets?*

Routine costs: Items/services typically provided for condition outside trial; research: experimental intervention, extra tests

Are research-only procedures (protocol-required, not standard care) identified?*

Research procedures: Investigational drug, extra PK draws, research biopsies, registry participation; billed to sponsor

Are complications arising from investigational interventions assigned to appropriate payer?*

Complication coverage: Research-related adverse events covered by sponsor; standard care complications by insurance

3. Billing & Coding

Are diagnosis codes (ICD-10) accurately reflecting standard of care vs research participation?*

ICD-10 coding: Primary diagnosis for standard care; Z00.6 (encounter for clinical research) as secondary when applicable

Are CPT/HCPCS codes for routine care services billed to Medicare/insurance per MCA?*

Coding: Use standard CPT codes for covered services; do not bill research procedures to Medicare

Is modifier usage correct (e.g., Q0/Q1 for FDA-required tests, research modifiers)?*

Modifiers: Q0 (investigational clinical service), Q1 (routine clinical service), institutional policies

4. Sponsor Coverage

Are clinical trial agreements (CTA) specifying sponsor payment responsibilities executed?*

CTA: Itemized budget, payment schedule, invoicing procedures, sponsor coverage of research costs

Is investigational drug/device provided by sponsor at no cost to patient/institution?*

Sponsor responsibility: Investigational product, protocol-required procedures, research labs, imaging

Are invoices to sponsors reconciled with actual services provided per protocol?*

Invoicing: Track study visits, procedures performed, match to budget, holdback provisions, closeout reconciliation

5. Documentation Requirements

Are MCA and billing determinations documented in regulatory binders/eReg systems?*

Documentation: MCA rationale, billing matrix, payer assignments, version control with protocol amendments

Is trial participation clearly documented in medical record with research vs care distinction?*

Medical record: Protocol enrollment, research procedures performed, standard care services, patient informed

Are patient financial notifications provided per Medicare beneficiary requirements?*

Patient notification: Inform Medicare beneficiaries of coverage, potential costs, no patient obligation for research services

6. Compliance Program

Is clinical trials billing reviewed by compliance committee or external auditors?*

Compliance oversight: Annual audits, billing review, error rate tracking, education on findings

Are staff trained on clinical trial billing, MCA requirements, and fraud/abuse risks?*

Training: Annual billing compliance, Medicare rules, Stark/AKS exceptions, documentation requirements

Are billing errors self-disclosed and refunds processed per institutional policy?*

Error correction: Identify overbilling, refund to payer, root cause analysis, systemic corrections

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