By Megan Tenboer, Director of Strategic Site Operations

Q: If the routine service is needed for the provision of the investigational item or to treat side effects & this service has an NCD or LCD would you consider the NCD/LCD diagnosis coverage criteria during your coverage analysis or would you automatically consider this routine service covered via the 310.1 NCD if billed with the V70.7, Q1 & NCT#?

A: The Clinical Trial Policy includes the statement: “Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.” This means that the item or service must meet Medicare coverage rules, e.g. NCDs and LCD, in order to be billable to Medicare. So, in essence, you should review these first and then if there are no limitations or non-coverage rules, you can apply the Clinical Trial Policy statement in which routine care includes the items or service provided such as for the prevention and/or treatment of side effects.

Q: Who is responsible when fraud is involved? Would this fall on the PI?

A: The responsibility would fall to the billing entity. Whoever is submitting the claim and receiving payment is ultimately the entity that needs to pay back the money. This could be the hospital/clinical site and/or the Physician/Physician Investigator. There are, of course, downstream effects such that if the hospital is submitting incorrect claims, there are other risks, e.g. reputational, loss of funding, etc. for the PI who is ultimately responsible for the research.

Q: Are Phase IV clinical trials a qualifying clinical trial? As now looking into safety/efficacy to the drug- but are FDA approved/ mandated?)

A: Phase IV trials are NOT excluded from qualifying for Medicare coverage. You do need to prove benefit category, therapeutic intent, diseased patient population, and “deemed” status, but if it meets these requirements it could still qualify.

Q: Is it acceptable to use LCD language that is outside of jurisdictions for justifications of the Coverage Analysis?

A: When we perform a Coverage Analysis, we have been instructed by certain clients to use other MAC LCDs to support or limit a service. However, we do advise that you (or someone in your billing office who works directly with your MAC) to discuss other jurisdiction LCDs with your MAC prior to using it for justification. Some clients have taken a PDF of the LCD and provided it to their MAC to start a discussion about the interpretation of the coverage. They may or may not disagree with the document, but at the very least, you’ll have a deeper understanding of their thought process. The hope is that you gain confidence in determinations moving forward.

Q:  How will the new healthcare policy influence clinical trial billing? Are patients that have government insurance able to participate in clinical trials and have their routine costs covered?

A: Medicare’s Clinical Trial Policy already provides coverage for Medicare patients, so I assume you are referring to Medicaid when you say “government insurance”. Unfortunately the ACA requirements do not apply to Medicaid patients. There are some state insurance commissions that oversee the Medicaid program and have enacted regulations that provide patients some coverage, e.g. California. Unfortunately, Virginia law covers only state employees’ health insurance plans and managed care health insurance plans generally, but does mandate certain coverage for patient costs incurred during participation in clinical trials for treatment studies on cancer

Q: Under the definition it states that items/services required solely for the provision of the investigational item are considered a routine cost. Does that apply to all therapeutic areas or just oncology? If a patient with cardiac failure is having investigational agent injected into the heart muscle in the cath lab, or patients with endocrine disorders are receiving infusions of investigational agents, are all these scenarios billable to insurance?

A: The Clinical Trial Policy states the following in the definition for routine cost: Items or services required solely for the provision of the investigational item or service and then provides an example of administering a chemo drug, (e.g. administration of a non-covered chemotherapeutic agent) but does not state that this only applies to chemo drugs. Therefore it does apply to all therapeutic areas, not just oncology. So in the examples you provided below, the administration, e.g. injection or infusion, is billable to insurance, although the actual investigational drug is not.


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.