Clinical Trial Billing Procedures

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Questions and Answers

What should be included in the notes section if hospitalization is required by the study?

Sponsor budget cost language

Details of the hospitalization

Standard comment regarding Medicare claims processing (correct)

Requirements for imaging procedures

Which type of designation will be added for clinically indicated lab procedures?

SOE designation

Billing designation

R-INV designation (correct)

CA designation

When should the billing grid include separate columns for pre-dose and post-dose?

Only in specific imaging assessments

For every treatment visit regardless of definition

When defined separately in the budget document (correct)

When using the standard comment

What is the minimum number of cycles that should be created in the billing grid if the budget/CTA is not available?

12 cycles Signup and view all the answers

What should not be included in the justification for any procedure in the billing grid?

Sponsor payment cost language Signup and view all the answers

What type of document has the CA built in the template document?

Excel template document Signup and view all the answers

In coverage analysis set-up, when should the documents utilized be indicated in the notes section?

When the budget/CTA documents are not shared Signup and view all the answers

Which modifier requirements are not applicable to inpatient clinical trial claims?

Q0-Q1 modifiers Signup and view all the answers

What should be indicated on the billing grid for an open-ended treatment?

A plus symbol Signup and view all the answers

How should a billing grid handle procedures with multiple CPT codes?

Split into individual line items Signup and view all the answers

What is the implication of not having a budget document for a study?

The number of grids depends on the study schema Signup and view all the answers

How should occurrences to visits be recorded on the billing grid?

As multiples like x2, x3, etc. Signup and view all the answers

What designation should be followed for clinically indicated procedures?

R-INV designation Signup and view all the answers

What should be done if the information for billing associations is extensive?

Add it as an additional footnote Signup and view all the answers

In the example study, which group of subjects is noted to have a separate SOE?

Subjects in the food effect cohort Signup and view all the answers

Which aspect should a disease-specific billing grid focus on?

The study design Signup and view all the answers

What is the purpose of initiating a Rescreening Period according to the protocol?

To assess eligibility due to failure in the initial screening or time constraints. Signup and view all the answers

When should venipuncture not be billed separately according to the protocol?

When it is combined with other laboratory tests that are covered. Signup and view all the answers

How should medical history, height, weight, and initial vital signs be documented?

Combined as a single entry along with the physical examination. Signup and view all the answers

What is the correct way to record vital signs when they are collected multiple times?

A separate line item labeled 'Vital signs' should be created. Signup and view all the answers

What indicates that hospitalization is considered routine care?

When it is required as clinically indicated or at the physician's discretion. Signup and view all the answers

Which statement about ophthalmic assessments is accurate?

They should be documented as a single line item according to the standard operating environment (SOE). Signup and view all the answers

When is hospitalization designated as R-INV?

When monitoring is required after the administration of study drugs for at least 24 hours. Signup and view all the answers

Which of the following statements about screening and retesting is incorrect?

Retesting is considered billable if it occurs during a rescreening visit. Signup and view all the answers

What should be done with individual CPT codes that are not part of a panel for local labs?

They should be split based on individual CPT codes. Signup and view all the answers

In what scenario should CBC and CMP labs be billed?

Once per cycle if there are no potential side effects related to drugs. Signup and view all the answers

What is required to replace coagulation panel testing?

A series of individual line items. Signup and view all the answers

When should a pregnancy test be billed separately?

When specified as required by the protocol. Signup and view all the answers

What distinguishes microscopic urinalysis in billing?

It should be split as a different item when specified in the protocol. Signup and view all the answers

How should individual line items for Hepatitis B testing be handled?

They need to be broken into specific tests defined in the protocol. Signup and view all the answers

What should be done if labs are performed within 7 days prior to treatment start?

Labs at C1D1 should be designated as R-INV. Signup and view all the answers

What needs to be included as separate line items for WOCBP assessments?

Pregnancy tests and hormone levels if defined by the protocol. Signup and view all the answers

What designation should be entered for central lab items if an assessment is applicable for all patients?

R Signup and view all the answers

Which imaging procedure guideline should be followed for confirmatory imaging?

Confirmatory Imaging-Guidelines XXX Signup and view all the answers

What is the recommended frequency for confirmatory scans after initial documentation of response?

≥ 4 weeks after the first response Signup and view all the answers

When is imaging not routinely recommended during survival follow-up?

If the patient has no smoking history Signup and view all the answers

What justifications need to be included for imaging procedures?

A specific sequence of guidelines Signup and view all the answers

In what condition are confirmatory scans considered not billable?

If performed before the next scheduled assessment timepoint Signup and view all the answers

According to the NCCN Imaging Appropriate Use Criteria, which cancer type's imaging is only recommended as indicated for oral cavity patients?

Head and Neck cancers Signup and view all the answers

What is necessary for coverage of an imaging procedure at a specific frequency by a treating provider?

It must be deemed standard of care Signup and view all the answers

Study Notes

Documents and Templates

Coverage Analysis (CA) is created using an Excel template; do not hide extra rows/columns.
CA is independent of sponsor budget except for imaging procedures.
Justifications for billing should not include sponsor payment costs.

Billing Designations

R-INV designation applies to clinically indicated lab procedures and unscheduled visits.
Billing grids should not merge cells and must reflect treatment visits, indicating cycle lengths.
Minimum of 12 cycles in billing grids if the budget/CTA is unavailable.

Study Information and Design

Create disease-specific billing grids based on study design and population (e.g., solid tumors).
Clinically indicated procedures should be associated with all visits on the billing grid.

Procedures and Assessments

Multiple CPT codes for procedures should be listed as separate line items.
Include detailed notes for protocols, especially if they provide additional information beyond footnotes.
Rescreening for participants must follow protocol guidelines and is not billable if repeated for research purposes.

Laboratory Services

Venipuncture is considered medically necessary and billable if related to covered lab tests.
Group medical history, height, weight, and initial vital signs as part of physical examinations; do not separate them.
Assign separate line items for specific procedures like serum pregnancy tests and individual components of panels.

Imaging Services

Imaging procedures justifications must follow a specific sequence for billing; e.g., Screening, Treatment, and Follow-Up stages.
Confirmatory imaging after treatment response documentation is not billable if scheduled beyond defined assessment timepoints.

Hospitalization Guidelines

Hospitalization deemed routine is billable if it is clinically indicated; research-related hospitalization may be billed under R-INV.
Assessments like nutritional consultations and neurological exams are routine care unless clinically required by the study.

Special Considerations

Local and central lab items must be listed separately based on protocol guidance.
Include total occurrences for visits as multiples rather than integers for clearer billing.
Specific lab items must be split based on individual CPT codes, distinguishing between tests like PT/INR and viral serology.

Footnotes and Additional Information

Additional footnotes regarding specific requirements or clarifications must be detailed in the billing grid.
Exclude individual CPT codes from the procedure name within the billing grid for clarity.
for central labs, specify if assessments are applicable for all patients, with the appropriate designation (R or R-INV).

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Description

This quiz covers essential billing procedures and guidelines for clinical trials, focusing on coverage analysis, billing designations, and study information. Participants will learn about the importance of disease-specific billing grids, CPT code listings, and the requirements for billing documentation.