Billing Compliance Rules
What Medicare rule allows for the billing of some items in clinical trials?
NCD 310.1
Which Guideline does START utilize per institutional policy for information related to indications?
The NCCN
Per institutional policy, when a frequency for monitoring is not recommended in The Guidelines, how often do we designate items SOC?
Once per cycle
Per institutional policy, when a frequency for monitoring is not recommended in The Guidelines, how often do we designate items SOC?
Every 12 weeks
Which resource(s) should be checked first when analyzing a drug?
The ICF/Protocol to see whether it is provided by the Sponsor.
What are the two major types of Medicare rules that need to be checked/referenced in analysis?
NCDs (National Coverage Determinations) and LCDs (Local Coverage Determinations)
For FDA approved drugs, where can side effect information be found and in what section(s)?
DailyMed - Warnings and Precautions
Which line item(s) may be reasonable and necessary based on the following side effect(s): febrile neutropenia
CBC, physical examination
If The Guidelines are unclear, which additional resource can be utilized to check whether imaging is conventional care?
The NCCN Imaging Appropriate Use Criteria (NCCN AUC)
Per institutional policy, how are premedications designated and analyzed?
Research - "per institutional policy, this item is considered research related and is non-billable"
When in doubt, do we designate something as standard of care or research?
Research
Which types of visits do The Guidelines have the most recommendations for?
Screening and Follow-Up
Which line item(s) may be reasonable and necessary based on the following side effect(s): renal toxicity, transaminasemia, diarrhea
CMP, physical examination
Name a guideline that is helpful for designating imaging as research in an advanced/metastatic solid tumor study. - why are they helpful?
Ovarian, Endometrial, Breast, Head and Neck (and probably others)
Do drugs have to be FDA approved as administered in the Protocol to be billable to insurance? - Why?
No, they can be medically accepted as defined by Medicare
Which Medicare document includes rules about billing drugs?
Medicare Benefit Policy Manual Chapter 15
If The Guidelines include a recommendation for a test at Workup "as indicated" or "(optional)," what should the designation be and why?
Research - no guarantee it will be indicated for all patients
True or False: if only "electrolyte testing" is recommended and both a CMP and magnesium testing are required, both the CMP and magnesium may be designated as SOC - why?
False - there is already electrolyte testing in the CMP; there is no recommendation for additional electrolyte testing
If a CT scan of the chest is recommended at Workup, what should the designation be at Screening - why?
"SEE DETERMINATION" - SOC unless previously performed within prior 12 weeks
If a drug is not provided/reimbursed by the Sponsor, what quality of the drug should be checked next and why?
Whether it is an oral drug - self-administered drug coverage is limited by Medicare
Can Sponsors pay for items that have been denied by Medicare; what rule(s) supports/limits this?
No -- Medicare No Legal Obligation to Pay/Secondary Payor rules
If a combination therapy drug is a PD-L1 checkpoint inhibitory, what additional Guideline should be utilized?
The NCCN Clinical Practice Guidelines in Oncology, "Management of Immune Checkpoint Inhibitor-Related Toxicities"
Which part(s) of the Medicare Clinical Trial Policy allows for the billing of items related to side effects? What phrase do we use to reference this?
NCD 310.1 - "items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications" -- "[x] is performed to detect, monitor, and treat potential side effects"
Walk through how you would analyze imaging of the abdomen every 8 weeks (28 day cycles) for advanced/metastatic non-small cell lung cancer patients.
RAN OUT OF TIME HOPE THE ANSWER WAS GOOD
Walk through how you would analyze IV oxaliplatin (administered in combination with fluorouracil) for previously untreated HER2- gastric cancer patients.
Oxaliplatin is not FDA approved for the treatment of gastric cancer (DailyMed - Oxaliplatin).
However, oxaliplatin in combination with fluorouracil is recommended as first-line therapy for patients with unresectable locally advanced or metastatic HER2 overexpression negative gastric, GEJ, and esophageal cancer (NCCN Gastric, p. 46; NCCN Clinical Practice Guidelines in Oncology, "Esophageal and Esophagogastric Junction Cancers," v4.2025, ("NCCN GEJ"), p. 59). Therefore, oxaliplatin is medically accepted, and is billable to the patient. Coverage supported by Medicare Benefit Policy Manual Chapter 15, Section 50.4.5.