SCRI CA Handbook Version 1.3 July 2024 PDF

Version 1.1_19APR2024 Sl. No. Section 1 Documents 2 Template 3 Sponsor Reimbursement 4 Study Info Tab 5 Billing Designation Billing grid 6 Calendar Specifications 7 Modifiers 8 J...

Version 1.1_19APR2024 Sl. No. Section 1 Documents 2 Template 3 Sponsor Reimbursement 4 Study Info Tab 5 Billing Designation Billing grid 6 Calendar Specifications 7 Modifiers 8 Justification/ Comments 9 Evaluation and Management Services 10 Laboratory Services 11 Imaging Assessments 12 Biopsy and Anesthesia 13 Pre-medications/ Prophylaxis/ Supportive medications 13 Amendment Specifications RBG Conversion Amendments  Sarah Cannon ISG Specifications Specifications Protocol ICF and/or IB document CTA/ Budget document. The CA has been built in the excel template document placed in the article. NOTE: Do not hide the extra rows and columns in the template. The CA will be built independent of sponsor budget except for imaging procedures. Refer to imaging section below for further details. The billing grid should not include the sponsor payment cost language in the justification for any procedure. SCRI team will include these details if required. Add the following standard comment in the notes section only if hospitalization is required by the study. For example, if subjects are hospitalized for infusion of IV study drug, Heme studies, etc. "Hospitalization: Per Medicare Claims Processing Manual Chapter 32, Section 69.6, "HCPCS modifier requirements (i.e. Q0-Q1) as outlined in the outpatient clinical trial section are not applicable to inpatient clinical trial claims" The documents utilized for coverage analysis set-up have been indicated in the "Notes" section ONLY when the budget/ CTA documents are not shared at the time of request. R-INV designation will be added for the following procedures: a. Clinically indicated/ as needed/optional/per investigator's discretion lab procedures. b. All serology procedures. c. Pregnancy test, FSH, Estradiol, etc.,. d. Unscheduled/ Re-screenings visits SOE will be duplicated in excel template and the same will be utilized for CA set up. Any treatment visit having pre-dose and post-dose mentioned in SOE will only be split into separate columns when defined separately in budget document. The treatment cycles should be mirrored as per the budget/ CTA document. However, when the budget/ CTA is not available then a minimum of 12 no of cycles should be created in the billing grid. The treatment visits should include cycle length when defined in protocol in the billing grid (i.e. 21 days/ 28 days/ 42 days). Additionally, if the treatment is open ended then the same should be indicated by “+” symbol on the last cyclic visit on the billing grid. The billing grid should not have any cells merged. Any procedure with ranged schedule should be associated at respective visits indicating the frequency in each cell. When budget document is not available for a particular study, the number of billing grid(s) should be dependent on the protocol defined study schema and built out 12 cycles or until cycle repeats and the same should be confirmed with SCRI team. Disease specific billing grid should be created based on the study design. Example: In the below mentioned study, based on the protocol study design subjects with all solid tumors will be enrolled for the dose escalation part and subjects with NSCLC, CRC and pancreatic cancer are being enrolled for the dose expansion part of the study. Additionally, the protocol includes separate SOE only for subjects in food effect cohort and a single SOE is defined for all other subjects in dose escalation and expansion. Please see below the screenshots indicating the patient population and corresponding billing grids in the CA template for your reference. As clinically indicated procedures should be associated to all available visits on billing grid per schedule of events. The designation for the as clinically indicated procedures should follow R-INV. NOTE: Please refer to imaging section for the designation to be followed for imaging procedures when performed as clinically indicated. Any procedure with multiple CPT codes should be split into individual line items. For example, ECHO/MUGA should be added as 2-line items, that is one for ECHO & other for MUGA as the CPT codes are different for each. Any additional notes mentioned in protocol SOE beyond the SOE footnotes should be included as additional footnotes and associated accordingly in the billing grid. If the underneath information provided for the associations is bulky then this information should be included as a footnote. However, schedules or short information especially for imaging procedures may be included underneath the billing designations. Occurrences to visits should always be added as multiples (x2, x3, etc.) rather than including just the integer along with designation (2R, 3R, etc.). Procedures Beyond SOE- Additional procedures should be referenced from across the protocol sections and included in the billing grid. The protocol sections include but not limited to I/E criteria, study assessments, appendices corresponding to contraception, management of toxicities, and imaging guidelines, etc. If the protocol doesn’t provide sufficient information about these then add the best of the procedures and include the same as note while delivering the study. RECIST, RANO, Central EKG review, Cheson, Central radiology review, etc. should be included in the billing grid as required by the protocol and will be designated as R-INV. Unscheduled and Rescreening Visit: Do not include additional columns for unscheduled and rescreen visits when defined only in budget. However, when a separate column for unscheduled visit is defined in SOE the same can be included in the billing grid. The modifiers should be added along with the designation in the parentheses as mentioned in the screenshot below. The justifications are structured in the MCA as mentioned below: Time and Effort Assessments: “All Visits: This is not a billable item or service.” Bundled Services: “All Visits: This is not a billable item or service. Please Note: If performed during a billable physical exam, the vital sign assessment is not separately billable.” Billable Assessments (includes PE, local labs, ECG, ECHO/ MUGA, any other clinical assessment): “All Visits: The study regimen is known to cause cardiotoxicities (IB, Pages 16-17, 86-97 and 101-105). However, NCD 20.15 restricts the coverage for patients in the absence of present signs and symptoms of a change in heart function. Additionally, according to LCDs L33669 (FL, PR, VI) and L34315 (AK, AZ, CA, HI, ID, MT, ND, NV, OR, SD, UT, WA, WY), an ECG is only indicated for symptoms, signs, or a history of heart disease; or systemic conditions that affect the heart. As a 12 lead ECG is limited in coverage, this item is research related and not billable. Rescreening: As per section 8.11.1 of protocol document, "If a study assessment needs to be repeated, the investigator may perform a retest of screening procedures to assess the eligibility of a participant or if the screening Period is not sufficient to permit eligibility of a participant for any reason (eg, screen fail, time constraints), the investigator may initiate a Rescreening Period per Sections 1.3 and 5.4." If this item is repeated at rescreening visit, it is considered to performed for research purpose and not billable.” Venipuncture: “All Visits: The venipuncture is a medically necessary component of the laboratory tests. To the extent that the laboratory tests are covered, so is the venipuncture.” Physical Examination when performed more than once per cycle will be directed to research irrespective of the schedule of drug infusion. [NOTE: Include this as a note to customer upon delivery] Medical History, Height, Weight and Initial Vital Signs- Always combine medical history, height, weight and initial vital signs along with physical examination and do not add as separate line items as these would usually be performed along with physical examination assessment. Pulse oximetry- Pulse oximetry will be added separately and not combined with physical examination. Vital Signs- When multiple occurrences are defined for vital signs collection, e. g. pre-dose, 1hr, 2hr, etc. then create a separate line item as “Vital signs” to account the occurrences for the post dose time points. Ophthalmic Assessment- When protocol mentions ophthalmic assessment includes visual acuity, slit lamp, intraocular pressure, fundoscopy, etc. then do not add these items as individual line items. Rather, just add a single line item "Ophthalmic assessment" as mentioned in SOE. Include the CPT code as range (99172-99173; XXXXX). In-Patient/ Out-Patient Hospitalization- If the protocol states that hospitalization is required as clinically indicated and/or at the discretion of the physician then hospitalization should be considered routine care. However, if hospitalization is required for study purposes, then the same will be directed to research. Additionally, in scenarios where 24 hour hospitalization is required for observation and monitoring after study drug dosing then it will be designated as R-INV. Nutritional consultation, Neurological exam and dermatological exam- The following evaluation and management assessments should be considered routine care only if it is performed as clinically indicated and/ or at physician’s discretion. However, if these assessments are required for study purposes, then the same will be directed to research. In scenarios where all labs are performed centrally however, may be performed locally at the site’s discretion then just create CBC and CMP as separate local lab items in addition to the central labs created as per SOE. All the local labs not part of panel should be split based on individual CPT code, including PT & aPTT and Viral serology based on specific items defined in the protocol. (Note: This excludes CBC and CMP). Example 1: For coagulation panel, it needs to be replaced by following individual line items based on specific items defined in the protocol– Prothrombin Time/ International Normalized Ratio (PT/INR) Partial thromboplastin time (PTT) Example 2: Viral Serology like Hepatitis B, it needs to be replaced by following individual line items based on specific items defined in the protocol– Hepatitis B Surface Antibody (HBsAb) Hepatitis B Core Antibody (HBcAb) Hepatitis B Surface Antigen (HBsAg) Urinalysis- Microscopic urinalysis should be split as a different item when specified in the protocol. Note: Include 24 hr protein as a separate procedure when called out in the protocol. Serum and/or urine pregnancy test should always be added separately in the billing grid as required by protocol based on their CPT codes. CBC and CMP labs- In scenarios when there are no potential side effects related to drugs or no supporting guidelines reference are available then labs should be considered reasonable and necessary and billed once per cycle (day 1 of each cycle) to patient/ insurance. In scenarios when labs need not have to be repeated at C1D1 if performed within 7 days prior to treatment start then, labs at C1D1 should be designated as R-INV. Individual CPT codes should not be referenced in the billing grid for CMP in the procedure name. CBC, CMP and Blood Draw- The following assessments should be named as CBC with Differential and Platelets, Comprehensive Metabolic Panel and Venipuncture in the billing grid. Pregnancy tests, FSH, LH, Estradiol- if the protocol defines these assessments to be performed for WOCBP, then add these as separate line items and associate to only screening visit as invoiceable item. The designation for the same should be entered as “R-INV”. Central labs- All the central lab items should be designated as R if an assessment is applicable for all patients and R-INV if an assessment is conditionally being performed. The following justification should be added “All Visits: This item is sent to a central lab, and it is not billable.” The justifications for imaging procedure should follow the below sequence: Screening-Guidelines XXX On TX-Guidelines XXX EOT-Guidelines XXX Follow Up/Progression-Guidelines XXX Confirmatory Imaging-Guidelines XXX Finance comments "Screening: Either a CT scan or an MRI may be performed (Protocol, p. 54). According to the NCCN Imaging Appropriate Use Criteria, "Head and Neck Cancers, v.1.2023, ("NCCN AUC"), imaging is only recommended as indicated for patients with cancer in the oral cavity (NCCN AUC). Treatment cycles: A CT scan is conventional care post systemic therapy during treatment response assessment (NCCN AUC). Therefore, this item is reasonable and necessary at the protocol required frequency during treatment. Coverage supported by NCD 220.1 and LCD L34415 (NC, SC, TN, VA). Survival follow-up: Imaging is not routinely recommended during follow-up absent smoking history (NCCN AUC). As it cannot be guaranteed all patients will have a history of smoking, this item is not billable during follow-up. Confirmatory Imaging: If bone lesions are identified on a PET or bone scan, a confirmatory CT or MRI should be performed (Protocol, p. 54-55). Additionally, "After initial documentation of response (CR or PR), confirmation of tumor response should occur ≥ 4 weeks after the first response or at the next scheduled assessment timepoint" (Protocol, p. 55). Confirmatory scans are not used for the clinical management of the patient. Therefore, this scan is not billable if performed prior to the next scheduled assessment timepoint. If procedure is deemed non-SOC at study specific frequency and/or indication by treating provider, and is being performed Solid Tumorforstudies- research purposes only,care If conventional it can be covered cannot by the sponsor be determined for ALLaspatient invoiceable. Review population CTA forwith enrolling specifics." scan frequency of every 8 weeks or greater scans should be considered Routine Care across all the visits. “This protocol requires imaging at 'X' week frequency, if performed, this item will be reasonable and necessary for the clinical management of the patient and meet all billing criteria per