Clinical Context
A 58-year-old patient with advanced solid tumor enrolls in a Phase II clinical trial evaluating a novel targeted therapy. The patient presents to an academic oncology clinic for study-related visits that include protocol-directed assessments: baseline and on-treatment history and physical exams, collection of safety labs, administration of investigational drug under study-specific procedures, documentation of adverse events, and collection of research-specific specimens. Study coordinators schedule visits per protocol; the treating clinician documents medically necessary evaluations and determines continued study eligibility. Billing uses HCPCS Level II code S9990 to report services provided as part of the Phase II clinical trial when those services are distinct from standard-of-care and are billed to the study sponsor or as permitted by payer policy. Typical sites of service include hospital outpatient departments, physician offices, and freestanding cancer centers. Common scenarios include initial enrolment visit with informed consent and baseline testing, interim safety visits with physical exam and toxicity assessment, and end-of-treatment visits documenting response and disposition.
Coding Specifications
| Modifier | Description | When to Use |
|---|
22 | Increased procedural services | Use when work or resources substantially exceed usual for a study-related service. |
23 | Unusual anesthesia | Use when medically necessary anesthesia is provided for a study procedure.
52 | Reduced services | Use when a procedure required by protocol is partially reduced or not completed.
53 | Discontinued procedure | Use when a study procedure is terminated due to patient condition or safety.
54 | Surgical care only | Use when the billing clinician provides only the surgical portion of a study procedure.
55 | Postoperative management only | Use when the billing clinician provides only postoperative follow-up per protocol.
56 | Preoperative management only | Use when only preoperative evaluation is performed for a study procedure.
62 | Two surgeons | Use when two surgeons of different specialties are required for a protocol procedure.
QK | Medical direction of two, three, or four technicians | Use when the physician directs multiple qualified technicians for study-related services.
QX | Services performed by assistant surgeon | Use when an assistant surgeon participates in a protocol surgical procedure.
QY | Medical direction of one qualified individual | Use when the physician directs a single qualified health professional under trial procedures.
AS | Ambulatory surgical center facility | Use on facility claims when services occur in an ASC setting per payer rules.
CQ | Service furnished under an arranged hospice plan | Use when trial services intersect with hospice arrangements as allowed.
CO | Cast change or removal (facility) | Use only if applicable to a study-related orthopedic procedure in facility billing.
| Taxonomy Code | Specialty | Notes |
|---|
207RC0000X | Medical Oncology | Primary treating specialty managing systemic therapy in oncology trials. |
208000000X | Hematology/Oncology | Combined specialty often responsible for investigational cancer therapies.
207L00000X | Internal Medicine | Hospitalists or internists providing general medical management during trial visits.
208D00000X | Surgical Oncology | Surgeons performing protocol-directed operative procedures related to the trial.
3336C0002X | Clinical Laboratory | Laboratory directors overseeing study-specific sample processing and reporting.
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|
Z00.6 | Examination of participant in clinical trial | Used to document encounters performed specifically for clinical trial participation. |
C80.1 | Malignant (primary) neoplasm, unspecified site | Applicable when the trial enrolls patients with advanced or unspecified primary malignancy.
C79.9 | Secondary malignant neoplasm, unspecified | Used when patients have metastatic disease being treated within the Phase II trial.
Z85.3 | Personal history of malignant neoplasm of breast | Relevant when enrolling patients with prior cancer history into a new investigational protocol.
Z51.11 | Encounter for antineoplastic chemotherapy | Used when study-related chemotherapy or systemic therapy is administered as part of the trial.
R53.1 | Weakness | Symptom code commonly documented as an adverse event or toxicity during trial follow-up.
R50.9 | Fever, unspecified | Frequently reported symptom requiring assessment during study visits.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|
36415 | Collection of venous blood by venipuncture | Commonly performed at study visits for safety and pharmacokinetic testing. |
99024 | Postoperative follow-up visit, routine; included in global | Used for routine postop follow-up that may overlap with protocol visits when applicable.
96365 | Intravenous infusion, initial, up to 1 hour | Used when intravenous investigational medications are administered during a study visit.
96372 | Therapeutic, prophylactic, or diagnostic injection (specify substance) | Used for intramuscular or subcutaneous study drug administrations.
99213 | Office/outpatient established patient visit, moderate complexity | Common E/M level for routine protocol follow-up visits documenting toxicity and response.