By Derek McCormick, Lead Clinical Research Analyst; Amanda Miller, Lead Clinical Research Analyst/Training Program Manager

Q: Can you talk about how the funding source of the clinical trial study impacts the coverage analysis (federally funded vs. industry funded)? Do you propose different billing determinations based on the sponsor (industry vs. government) regardless of medical necessity/guidelines/Medicare rules?

A: We talked about how NCD and LCD interpretation is one of the trickiest parts of completing a coverage analysis. When developing the coverage analysis, items/services with applicable NCDs/LCDs can be limited in coverage based your sites interpretations policy. For industry funded studies, these limited items/services can be negotiated into the study budget during the negotiation process with the sponsor/CRO. In contract, for cooperative or federal funded studies, the cost of the limited items/services may fall onto the research department and/or patient. Therefore, sites may decide to have a more risk orientated interpretation policy for cooperative or federally funded studies, which will affect billing designations when developing the coverage analysis.

Q: Are you seeing more sponsors providing CA, similar to what SWOG has initiated? – Consistency in billing. Internal operations, etc.

A: Yes. We have observed a higher frequency of cooperative groups providing a study level coverage analysis. However, we still recommend developing a coverage analysis at a site level. This will ensure you are optimizing the coverage analysis to support site specific operations (e.g. interpretation policies, consistency in billing practices, etc.).

Q: Are Phase 1 trials treated differently by Medicare?

A: Phase 1 studies present a challenge for Medicare coverage. Medicare does not have a specific policy regarding Phase 1 studies, however, many Phase 1 studies are non-qualifying. This means that NCD 310.1 no longer applies. If the Phase 1 trial does qualify, it is important to examine the frequency of testing and reason for testing. Many of our clients have specific coverage analysis policies for Phase 1 trials.

Q: Do you have the clinical investigators sign off on the analysis?

A: When we perform coverage analysis for clients, we let the site determine whether or not the PI will need to sign off. PFS Clinical recommends that the PI and/or their nurse/coordinator should see the coverage analysis even if they do not sign off. Sometimes, PI education is required in order to explain that even though a test is medically appropriate, Medicare may not pay for the test.

Q: How do we find out who our MAC is?

A: Information regarding Medicare contractors can be found in the following link: https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC.html.

Q: Does any of the NCD 310.1 apply to device trials or is that completely separate?

A: NCD 310.1 does not apply to device trials. Coverage of routine care and medical devices furnished in an FDA approved device trial are outlined in the Medicare Benefit Policy Manual, Chapter 14.

Q: What document do you reference for device trials?

A: Medicare Benefit Policy Manual Chapter 14 should be referenced for device trials. Additionally, NCDs and LCDs should be reviewed. Many items required by device trials, including the implant procedure, have NCDs and LCDs.


Disclaimer: PFS Clinical has made reasonable efforts to ensure the accuracy of the information contained in this document; however, this document is provided “as is” without any express or implied warranty. This document does not constitute legal advice. If you require legal advice, please consult with your attorney.