Can we charge a subject for a diagnostic test not done as part of the IRB approved protocol?

September 12, 2019

Question:

Can we charge a subject enrolled in a clinical trial for a diagnostic test that not being done as part of the IRB approved protocol?

- Physician researcher, clinical research site

Response: 

Guest response from Brad Gruener, Director or Clinical Research Administration at PFS Clinical

When it comes to billing for items and services provided in clinical trials, research institutions typically perform a coverage analysis based on Medicare since they have widely available and standardized regulations. Improperly billing Medicare can cause significant compliance issues; so, we use Medicare regulations when working with our clients on these questions. Medicare’s national coverage determination related to clinical trials, NCD 310.1, provides the general guidance for what is and isn’t covered by Medicare in a clinical trial.

This response, to specifically address question about billing for tests to measure circulating tumor cells (CTC), is based on a Local Coverage Determination (LCD) from Palmetto GBA.  Palmetto GBA is the Medicare contractor that has jurisdiction for administering Medicare claims in North Carolina. LCDs provide guidance regarding whether specific tests and procedures are reimbursed by Medicare.  Based on that language from the LCD, we would not consider this to be a test that is billable to Medicare:

 “Although the detection of elevated CTCs during therapy is a definitive indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer, no data subsequent to Palmetto GBA’s limited coverage policy (L35071) has been forthcoming to demonstrate improved patient outcomes, or that the assay changes physician management to demonstrate improved patient outcomes.”

"CTC testing for all malignant diagnoses will be denied as not reasonable and necessary under Title XVIII of the Social Security Act, §1862(a)(1)(A).  There are been no substantive articles demonstrating clinical utility for this assay – prospective studies that demonstrate improved patient outcomes based on testing results, or that testing changes physician management to change patient outcomes.”

It is possible that some private payers may cover the test, but many providers do not bill differently for clinical trials based on insurance coverage. If Medicare will not cover a test or procedure, they will not attempt to bill it to any patient regardless of their insurance provider.


Brad Gruener – Director, Clinical Research Administration 

Brad leads the Initiate teams at PFS Clinical, providing study initiation/pre-award administrative services including coverage analysis, clinical trial budgeting negotiation, clinical trial agreement review, and Clinical Trials Management System support. He joined PFS Clinical in 2013 and has worked with many research institutions to support their start-up processes and create efficiencies. Prior to joining PFS Clinical, Brad worked at Healthcare Business Insights, providing best practice research for leaders in revenue cycle, IT, and other healthcare areas.

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