I think sometimes when we start developing big programs or try to implement new initiatives, we do not pull in all stakeholders. We have a tendency to work from the top down. However, it is the people actually doing the work who can provide great insight into how to actually operationalize something since they understand the workflow best. So, making sure all your stakeholders are represented or included at different key points is important.

I think oncologists are well-placed to do this. But there has to be an operations team that works hand-in-hand with the physician champion. For me, the ideal operations team would have a pathologist, pulmonologist, nurse navigator, and administrator.

Sometimes we do not always realize all the people who need to be involved when it comes to implementing a new initiative like this. People you will need to engage with may include nursing staff, electronic medical record managers, finance staff in terms of insurance compliance, and people from the external companies you may want to partner with. It is important to first identify all key stakeholders and then list them out to make sure you have all the right people in place.

Suggested list of stakeholders to implement biomarker testing:

• • Administrators
  • Clinical staff (oncologists, pulmonologists, thoracic surgeons, physician assistants, nurse practitioners, nurse navigators, nurses, social workers)
  • Insurance/billing staff
  • EMR/IT staff
  • Laboratory staff (pathologists, laboratory managers, senior technicians)
  • Non-clinical staff (patient navigators, financial navigators)

For advanced non-small cell lung cancer, biomarker testing determines the first-line treatment path. Also, if we are truly practicing based on the evidence, then we need to be doing biomarker testing. It is in the guidelines. If it is not incorporated into the clinical pathway, patients are going to question whether this is truly their best place to receive care.

My lung cancer patients now come in and ask, ‘What is my testing? What have you found?’ This is even before we have had a thorough conversation as to why it is important or why it is not appropriate now (i.e., small cell).

Patients are becoming quite astute regarding biomarker testing. Even patients who do not know if they have non-small cell or small cell, one of the first questions they ask is about testing. Patients are looking for it. If they end up in someone’s office who has no desire or intention of doing biomarker testing, the patient is not going to stay.

We use third-party outside labs for testing. We have great working relationships with them. We use their financial navigators to assist in obtaining any prior authorizations that may be required. We work with patients to ensure their out-of-pocket costs are in alignment with what they can truly afford.

For any institution wanting to implement biomarker testing, there are associated costs. However, there are ways to navigate the system so patients and institutions are not put at financial risk.

For our program, when we interviewed external laboratories, we wanted to make sure patients would not be charged for a test if they could not afford it. For our in-house testing, we have negotiated with payers to cover gene panels (e.g., paying for a 50 gene panel but not a 200 gene panel).

It is important to note that external laboratories are using FDA approved tests. In-house tests are not always put through the rigors of FDA approval, so from an insurance perspective they may not always be inclined to pay for something that has not gone through the same demonstration process.

Oncologists order biomarker tests, review and interpret results, and recommend the optimal therapy for a given patient based on standard of care and guidelines.

It is important for oncologists to work with a pathologist with a molecular knowledge base to help interpret challenging cases.

My network has molecular pathologists available to oncologists and the care team. Many of the third-party laboratories also provide access to molecular pathologists. In fact, my group has a monthly molecular tumor board that we all attend.

Pulmonologists are not involved in interpreting results, but they may be helpful in ordering biomarker testing. They also must order the right testing. It is important for every pulmonologist to be aware of biomarker testing and their role in caring for patients with advanced lung cancer.

There may be times when a thoracic surgeon encounters a patient who needs biomarker testing. It is important for thoracic surgeons to be aware of biomarker testing and their practice’s process for ordering biomarker tests. As the field of lung cancer treatment continues to evolve, thoracic surgeons may take a larger role in the biomarker testing process.

In our practice, our advanced practice providers (APPs) sometimes see patients before their molecular studies are back. It is important for APPs to understand the importance of biomarker testing and why patients are not starting treatment until their results are received.

We have had some instances in which patients are self-referring in to meet with a provider to discuss next steps and what to expect before results are back. Our APPs are meeting with these patients to say, ‘We understand you have had more than one sleepless night, but it is important to follow steps A through Z before jumping into a treatment plan.’

Interventional Radiologists (IRs) typically obtain patient tissue and then send it out for testing. IRs can order biomarker testing when desired, but testing procedures should ideally be part of a care path that indicates when IRs would order testing. For tissue collection and handling, it is critical that IRs use the College of American Pathologists’ ‘Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies’ guideline.

For pathologists, it is important to:

• Learn how to assess and triage tissue samples to ensure adequacy for molecular testing
• Identify opportunities to minimize immunohistochemical testing
• Preserve material for molecular testing
• Facilitate procedures through rapid on-site evaluation if feasible
• Identify opportunities to maximize tissue management strategies (e.g., knowing if a third-party laboratory accepts a particular type of specimen, or prefers a particular type of specimen)

It is important for community pathologists and oncologists to be connected to molecular pathologists. Molecular pathologists provide expertise for challenging cases and should be viewed as part of the care team.

That may mean identifying different routes to access molecular pathologists, such as contacting those aligned with network-derived molecular tumor boards, nearby academic medical centers, or third-party laboratories that do biomarker testing.

Lab staff not only help process slides and specimens, but they also sending out tissue samples. Our transcriptionists did not realize the importance of expediting specimens for biomarker testing. We would request specimens be sent to our third-party laboratory, but we noticed there was a six-day delay in sending them out.

We realized no one had educated send-out staff about their role in the process. Once send-out staff were clear on their role and why it was important to expedite specimens, we were able to reduce delays.

Nurses should be educated about the purpose of biomarker testing. Subsequently, they should be able to educate their patients on the importance of biomarker testing and implications for treatment.

Nurses should also know when to expect laboratory results and how to share those results with the patient.

Nurses should be familiar with their program’s processes for ordering biomarker tests. They should know what documentation should accompany a sample, how to handle patient billing issues, and how to obtain patients’ slides from other organizations to send to third-party labs. Nurses should be able to identify resources within the program that can assist with any of these items.

We use our navigators as the portal for the biomarker test results coming in. As an oncologist, if you sign into the different portals every day to retrieve results, it becomes time-prohibitive. I forward emails from laboratories that say testing results are available to nurse navigators, and they enter the test results into the patient portal and EMR. By having nurse navigators aware of what has gone out and what has come in, it helps facilitate and coordinate communication with patients about the status or results of biomarker tests.

At our institution we use navigators to put biomarker test results into the EMR. We also link the nurse navigators to the requisition form that goes to the third-party laboratory. The form is linked to the provider and at times the patient as well. So when the results come in, everyone is notified. It would be great if the results would automatically populate in the EMR, but this is our workaround.

I have talked to a lot of nurses, particularly in places where they have the PA pulmonologist order tests, and the nurses liaison between departments to make sure all results are in the oncologist’s hands. That way, nothing gets ordered that does not need to be ordered because it is already done.

There are numerous roles for administrators in biomarker testing. First, administrators should help determine which services the laboratory can provide (e.g., pre-authorization support, patient assistance programs).

Administrators should also help provide clinical staff the resources they need to facilitate testing. This includes:

• Identifying which laboratories your institution will use
• Ensuring the ordering process for clinical teams is documented
• Outlining what documentation should accompany the requisition and sample
• Ensuring a process is in place for labeling and collecting samples (e.g., working with the lab for proper labeling and specimen collection)
• Identifying who is responsible for facilitating the send-out and how to best handle the results

Another key responsibility of an administrator in biomarker testing is payment for such testing. This includes:

• Identifying who is responsible for initiating the authorization and ensuring all key billing aspects are aligned
• Establishing a set process for staff to bring forward patients’ concerns regarding EOB or billing questions
• Working closely with the laboratory that performs biomarker testing to identify key personnel within that company (e.g., billing, laboratory leadership, medical director) who can ensure resources are available to patients and staff in order to provide a seamless service

The big thing for the insurance/billing staff—and I am in an organization where I am fortunate to be able to hand off the authorization pieces—is to make sure the ICD-10 codes are correct so reimbursements can be processed.

It is important for patient advocates to help patients by:

• Reinforcing education on what biomarker testing is and how results can inform treatment options
• Addressing the potential financial impact of biomarker testing (e.g., required preauthorization, out-of-pocket costs)
• Helping mitigate the potential financial impact of biomarker testing (i.e., connect patients to financial assistance programs)

One strategy is to adopt a policy where multidisciplinary team members, such as pulmonologists, interventional radiologists, and thoracic surgeons, can order biomarker testing as soon as there is a strong clinical suspicion of advanced non-squamous NSCLC. This type of strategy has been adopted in surgeon-initiated biomarker testing in breast cancer, reducing time to receipt of test results as well as time to initiation of chemotherapy.

A step further in boosting efficiency and compliance with that policy would be to implement reflex testing. Reflex testing is a process where the pathologist automatically carries out the biomarker testing order immediately after histological diagnosis of non-squamous advanced NSCLC.

Reflex testing is standard practice with other solid tumor types (e.g., breast cancer), reducing test result times. However, billing for reflex testing can create significant cost barriers for the Medicare population. According to the date of service (DOS) or the ‘14-Day Rule’ set by the Centers for Medicare & Medicaid Services (CMS), any laboratory tests, including biomarker testing for advanced NSCLC, ordered within 14 days of patient discharge are considered to overlap with the claim submitted by the hospital or hospital-owned facility and are therefore considered part of the payment for inpatient care. Consequently, some laboratories and oncologists have not order testing until after 14 days, causing delays in biomarker results.

It is important to determine what standard operating procedures you need. Standard operating procedures can be used to help train staff before biomarker testing is implemented or expanded.

Processes regarding biospecimen acquisition and reporting biomarker testing results are important for a program to be successful. For standard-of-care treatment purposes, the workflows developed by the operations team contribute to the successful acquisition of tissue.

Access to the interventional or operative suite and associated provider further drives the feasibility of obtaining enough high-quality tissue in an acceptable timeframe. Ensuring that the team has the appropriate contacts in the scheduling, billing, and preauthorization office dramatically reduces the time from biopsy order to completion.

First, it is important to figure out who is going to be accessing and using the order sets. Once you have established that, make the order sets as specific and defined as possible so they are more likely to be used. For lung, ideally have dropdown boxes or check boxes so everything automatically populates.

I would comply with the recommendations of NCCN and CAP. We use standardized guidelines, but we recognize they are evolving. However, unless we have another new FDA targeted therapy approved, we follow our biomarker algorithms.

For lung, since we know there has been such a testing gap, we are incorporating the NCCN guidelines into our EMR template so we can audit testing a little bit better.

For us, forms became an issue for reflex testing. Because if a pulmonologist uses the code that says ‘lung mass,’ and then in the pathology report it does not specifically say, ‘non-small cell pulmonary carcinoma,’ then the coder might not want to assign a lung cancer code. Most request forms are relying on people to just know the appropriate ICD code.

However, it can be fixed at the level of the request form. We recently created a separate requisition form specifically for lung cancer. We made a drop-down menu where the only ICDs you can fill come from lung cancer.

Patient education is crucial, but many times this information can be a lot to take in. So it is important to identify a trusted caregiver, partner/spouse, or family member who can help the patient process this information.