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Q&A – How Medicare’s New Imaging Program Affects Clinical Trials in Oncology

In a recent webinar, Jake Meyer, Business Operations Manager at Advarra, presented How Medicare’s New Imaging Program Affects Clinical Trials in Oncology. Billing compliance is essential to clinical trial operations, and organizations may soon need to update their billing practices to align with Medicare’s Appropriate Use Criteria (AUC) Program for advanced diagnostic imaging services. Due to time constraints, we weren’t able to answer all audience questions during the Q&A period, so Jake has responded to additional questions in this blog.

Q: Our organization uses AIM for our AUC needs, and it states this is only for traditional Medicare programs. Do we not need to use this for Medicare Advantage plans?
A: Within the scope of clinical trials, it is important to base coverage on traditional Medicare programs. Many patients may have Medicare Advantage plans or some form of private insurance, but we should determine coverage based on traditional Medicare programs. This is because traditional Medicare is seen as “baseline” coverage – anything Medicare covers should be covered by private insurance or Medicare Advantage. It is important to keep designations within a study consistent across the patient population, so traditional Medicare should be your first and only stop needed when determining coverage in a clinical trial. If an item falls outside of traditional Medicare coverage within a study, this should be covered by the sponsor rather than billed to the patient.

If determining coverage for an individual patient’s needs outside of the scope of a clinical trial, it may still help to confirm coverage based on your AIM Specialty Health Provider Portal information. If an imaging service is performed outside of the AIM information, your Medicare Administrative Contractor (MAC) or Centers for Medicare & Medicaid Services (CMS) representatives should be able to provide further information on Medicare Advantage coverage.

Q: Are Via pathways considered a provider led entity (PLE)?
A: Per Medicare’s list of approved PLEs and clinical decision support mechanisms (CDSMs), Via pathways are not yet considered an approved AUC resource.

Information on CDSMs

Information on PLEs

Q: Are eviCore guidelines considered an AUC resource?
A: Yes, eviCore looks to be an approved CDSM as listed on CMS’s website.

Q: How do you anticipate existing enrolling trials may be impacted by AUC determination in January 2022 (grandfathered previous National Coverage Analyses (NCA), local coverage determinations (LCDs) if protocol was written to include abdominal/pelvis when protocol approved)? Cooperative group trials rarely cover non-standard of care (SOC) in budgets for imaging.
A: Based on the information available, scans which do not meet AUC requirements (but were previously considered to be SOC) should not be billed to Medicare post-2022. I would recommend either reviewing your past coverage analyses or performing a new coverage analysis on these existing studies. If any scans are now considered to be non-billable to Medicare, reach out to your sponsor/CRO to discuss potential resolutions. Explain the situation and see if they are willing to cover the costs of these non-covered imaging services.

Q: Do you recommend we start with AUCs?
A: When determining coverage of imaging services (CTs, MRIs, PET scans, nuclear medicine) performed within a qualifying clinical trial, yes. AUC will confirm when scans are deemed routine costs/SOC. However, it is important to then confirm coverage through national coverage determinations (NCDs), LCDs, and any other applicable Medicare policy affecting coverage.

Q: Not for imaging specifically; pregnancy test in women of childbearing potential is considered best practice and widely reimbursed by various insurers. National Cancer Institute (NCI) trials almost always come with a national coverage analysis that says so. However, per Medicare, this test can also be considered as “screening.” We make great effort and have been getting industry sponsors to pay for this test, but any suggestions to handle the NCI trials?
A: At Advarra, we treat pregnancy tests in the same manner as other local labs. Unless indicated by the patient’s disease or known human side effects of the study regimen, this is considered a research cost. Within NCI trials, this is a difficult decision, and one which may vary depending on the institution. However, many sites opt to make this service non-billable.

As a word of warning, I would not assume the national coverage analysis provided by the cooperative groups is perfect. We catch many billing compliance oversights throughout (ex., pregnancy tests, NCDs missing for viral serology), and coverage does not factor in state-specific LCDs. Additionally, exceptions should not be made within NCI studies. For example, if you never bill ECGs to insurance, but the national coverage analysis indicates this as a covered assessment, this is not an indication you should change your institution-specific standard operating procedures (SOPs) and now consider this to be a covered assessment.

Q: Does this program abide by the National Comprehensive Cancer Network (NCCN) guidelines?
A: The NCCN has released a separate imaging tool, which abides by this program.

To that extent, the NCCN guidelines align with the NCCN imaging AUC. I have yet to see significant differences between these two resources. However, to be on the safe side, I would recommend pointing to the NCCN imaging AUC over the guidelines when possible. The NCCN imaging AUC is a free resource and is quite easy to navigate compared to the guidelines.

Q: Does this only apply to patients with Medicare as a primary insurance only, or is the AUC going to be required for all insurance types?
A: This program is specifically for patients with Medicare. However, as Medicare is a “baseline” for coverage; whatever Medicare covers must be covered by other types of insurance. Coverage for other insurances may be affected as well. If you do have any questions regarding coverage for private insurance, I would recommend reaching out to an insurance representative for further details.

When determining coverage in clinical trials, it is important to base coverage on Medicare policies. Coverage should be consistent throughout the patient population, regardless if the patient receives Medicare or is on private insurance.

Q: Where do we find the AUC resources? Are there additional AUC resources outside of the NCCN AUC?
A: Medicare has published a list of approved resources for both PLEs and CDSMs as noted below, which extends well past the NCCN resource I provided:

Information on CDSMs

Information on PLEs

Q: How do you handle a situation in which there are guidelines supporting a scan/test to not be billed to insurance as routine (in terms of frequency), but the physician disagrees and wants to bill Medicare or patient’s insurance for the test?
A: Great question, and a common scenario in our line of work.

It is important to note to your physician or clinical team that our “non-covered” designation does not correlate with their definition of SOC, or medical “common sense.” An item or service very well may be an SOC, but not covered by Medicare. Rather than bill the patient and put them at risk of paying out-of-pocket for the full cost of the service, it is best to seek sponsor-reimbursement. This way, the patient will not be subject to copays, will not be at risk of a claim denial, and will keep your institution compliant with billing standards.

Again, our determinations do not mean items or services are not needed whatsoever. We are simply showing what is and what is not considered to be covered by Medicare.

Q: If a participant is struggling financially, and the sponsor is willing to pay for some of their procedures, is there an issue since no other participants would have gotten that same benefit?
A: Depending on how this is worded in the contract, this may be a concern. It sounds like the reasoning behind this is philanthropic, so I would confirm this does not conflict with Medicare’s Second Payer policy as noted below.

Additionally, per NCD 310.1, “items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial” are not covered within a clinical trial. Further details would be needed prior to confirming whether this conflicts with either the second payer rule or NCD 310.1.

To learn more about Medicare’s Appropriate Use Criteria Program for advanced diagnostic imaging services, watch the webinar How Medicare’s New Imaging Program Affects Clinical Trials in Oncology.

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