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Clinical Connection Is the Key to Effective Reimbursement

A Conversation with Niesha Griffith, RPh, MS, FASHP

Feb 25, 2016

Niesha Griffith, RPh, MS, FASHP is the Administrator of Oncology Pharmacy and Infusion Services at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University (The James). In webinars and presentations for the Institute for Clinical Immuno-Oncology (ICLIO), Ms. Griffith has reviewed a range of immunotherapy coverage and reimbursement issues. Here, she discusses practical strategies for ensuring coverage and reimbursement in community oncology settings.

What are some of the practical steps that community oncology practices can take to support coverage and reimbursement for immunotherapy?

Ms. Griffith: One of the things we’ve learned as ICLIO has evolved is that many oncology practices aren’t fully utilizing existing manufacturer support programs for access to immuno-oncology agents, and some aren’t utilizing them at all. Although The James is not the largest cancer center in the United States, Bristol-Myers Squibb (BMS) recently shared that we are the largest user of the patient assistance program for their immuno-oncology agent.

Bristol-Meyers Squibb screenshot
I do find it surprising that even large oncology practices and are not utilizing these programs. One explanation may be lack of resources/staff to support these activities; another may simply be challenges with justifying the need for assistance. Whatever the reason, it’s unfortunate because as we have found the time and resources spent assisting patients is far outweighed by the benefits gained for both patients and providers.

We enroll all of our immuno-oncology patients, regardless of whether the use is on- or off-label, into the manufacturer programs and check all the applicable boxes on the patient assistance form. There’s a box for the benefits investigation, including prior authorization and appeal support. There’s a box for copay support, and one for manufacturer assistance/replacement medication.

Additionally, if the use is for an off-label indication, it goes through our formal off-label process, including payer pre-determination (where applicable). If it’s an on-label indication, it goes through our high-dollar process, where we do our own pre-certification and benefits authorization (this is in addition to what the assistance programs provide). Although we still conduct our own approvals, should something happen with the claim, enrolling the patients in the manufacturer programs assists us with either getting the claim paid or potentially allowing us to receive replacement medication.

MAP enrollment form Could you tell us more about the high-dollar medication process flow algorithm at The James?

Ms. Griffith: The process involves having the resources to do the benefit investigation research and to provide patient support if a payment issue is identified. We do a lot of homework upfront for all high-dollar medications (anything identified as greater than $50,000 for an expected course of treatment, with expected course being determined by what the majority of patients received in the clinical trials).

Even though they’re on-label, because of the significant cost entailed, from a fiscal perspective we are trying to protect both the organization and our patients. We don’t want patients to get a large bill they weren’t expecting. Once we find out what the patients’ portion of the bill is going to be, we let them know. That conversation informs them of their financial responsibility but also serves as an opportunity to find out if a patient may need financial assistance and a time for them to learn that we have resources that can assist them.

The pharmacy department follows all of the high-dollar and off-label medication claims. We ensure that everything is done correctly both on the front-end and back-end. We hired three oncology nurses into the department to handle all of our off-label approvals, all of our high-dollar approvals, and any associated denials/appeals. These nurses (i.e., reimbursement specialists), working collaboratively with our clinical specialist pharmacists (located in all of our clinical areas), assemble all of the clinical information necessary to support the claim and to provide to the payer.

They connect patients with our Medication Assistance Program Coordinators (MAPCs) if patients are eligible for free medication or copay assistance through the manufacturer. They also work with the pharmaceutical company support programs to appeal denials and, in some cases, depending what the indication is and which company, to obtain replacement medication. Investing in the front-end and the back-end pays off in dividends because immuno-oncology agents are so expensive (over $100,000 per year of treatment). This type of program is vitally important, even for oncology practices working on a smaller scale and with a different level of resources.

When you’re talking about following the claim, it seems as though it’s that blend of administrative and clinical expertise that is especially important.

Ms. Griffith: It is. We have considered moving all medication-related approvals into the department to ensure clinical staff are involved and the correct information is provided initially. As mentioned, the high-dollar approvals, the off-label approvals, and all appeal/denial work is already completed in the department; however, our colleagues in Financial Services continue to support pre-certification for all other medications provided in our oncology infusion centers.

We’re finding that even with standard on-label pre-certification for drugs like Neulasta (pegfilgrastim) and Xgeva (denosumab) that really aren’t as expensive in comparison(although, they are used frequently) that payers are asking for more clinical information. So, even “routine” pre-certification is becoming challenging. That is why we have decided to follow all the medication rejections, not just the high-dollar and off-label medication claims.

The Reimbursement Specialist's Role

  1. Verify medical insurance
  2. Obtain copies of pertinent information from patient medical record (treatment plan, diagnostic studies, etc.)
  3. Retrieve supporting literature (if not already provided by team)
  4. Verify compendia and NCD/LCD support;
  5. Identify appropriate ICD-10 code(s) and HCPCS code(s) for medications
  6. Draft letter of medical necessity
  7. Fax letter and supporting evidence to payer
  8. Confirm payer has received information
  9. Continue to follow up until approval/denial received
  10. Request approval number and individual name


The fact that payer policies are out of date or non-existent creates further challenges. Recently, the approval of a new medication for multiple myeloma called daratumumab1 highlighted those challenges. We had a number of patients scheduled to receive it as soon as we had it available. When we called for the pre-certification, we had some of the payers say, “We haven’t even looked at that drug yet,” or “We don’t have a policy yet,” or “We can’t give you an answer.” Our physicians want to be able to provide novel therapies to our patients as soon as they become available, but what do you do when payers are saying, “I’m sorry, I can’t give you an answer”?

With on-label indications, we take our chances, since we’re not going to deny patients a new therapy. If a medication offers a survival or quality-of-life advantage, any large cancer center that’s following the evidence is going to want to have those drugs available as soon as they can get them.

In a presentation I gave at the ICLIO meeting in October, I reviewed Anthem and Aetna policies, because those are two of the biggest payers. One had a policy updated in August and one was [updated] in September, but both I-O medications had received expanded indications in October that weren’t reflected in the policies. So it puts providers in a very difficult position, which is why having this infrastructure on the front-end and the back-end is so critical.

Coding Terminology

  • CGS administrators provide administrative services for CMS in 38 states
  • Healthcare Common Procedure Coding System (HCPCS) code C9399 pertains to new drugs and biologicals that are approved by the FDA on or after January 1, 2004, for which an HCPCS code has not been assigned
  • Drugs and biologicals appropriately billed using C9399 are separately payable and priced by CGS using average wholesale price (AWP) and the Centers for Medicare & Medicaid Services (CMS) pricing methodology2

When new drugs lack a J-code, what can community oncology practices do to protect cash flow? Are there things that community practices can do to support the reimbursement process before they actually have that J-code?

Ms. Griffith: We’ve been keeping a close eye on nivolumab and pembrolizumab, as our pharmacy reimbursement manager has been following all claims for these medications. We noticed that for the Medicare C9399 claims we were only getting paid 10 percent of our expected reimbursement. So we began to look at what we were doing internally. We already have double checks on everything that we do related to setting up the medications correctly in our system, and then we also work with our colleagues in billing to ensure everything is set up appropriately on their end.

When the informatics team reviewed the system that the claim goes through when the bill goes out, the multipliers and everything else were correct, so we expected there may be a problem at CGS with drugs that were coded as C9399. We reviewed claims for all the new drugs that didn’t have J-codes yet, and found the same issue, so we immediately alerted CGS of our concerns. The corrections have been since made in the CGS system, and we are awaiting the corrections to all of our previous claims that were underpaid. Although this is good news, it highlights the concern that we were the ones to identify the issue. We couldn’t help but wonder if other Ohio providers don’t have similar robust processes in place and aren’t following medication claims on the back-end.

This finding tells an important story. It is imperative that billing units are correctly reflected in all billing systems, that all the information that goes out on the claim is correct, and that follow-up occurs to make sure that you got paid what you expected to get paid. Smaller community practices likely do this better than large organizations because comprehensive benefits checks and claim follow-up have been part of their practice for many years. Many hospitals still have “evolving practices” because this type of work is much more challenging to conduct when serving a large number of patients on a daily basis.

This finding tells an important story. It is imperative that billing units are correctly reflected in all billing systems, that all the information that goes out on the claim is correct, and that follow-up occurs to make sure that you got paid what you expected to get paid. 

Is there a role for specialty pharmacies in immuno-oncology?

Ms. Griffith: There really isn’t a role for specialty pharmacies in our organization, because these are clinic-infused medications. We have a policy here that we don’t accept anything from outside of our secure wholesaler supply chain. We don’t allow brown bagging and we don’t allow white bagging. If a patient is going to get treated here, we procure the medication ourselves.

We introduced legislation in Ohio to protect hospitals that are concerned about breaches to the integrity of the supply chain (which has since passed). The only exception that we are willing to make regarding accepting medications from outside of our own wholesaler is specifically related to the manufacturer assistance programs, because those are heavily regulated by the manufacturers. But when you’re talking about specialty pharmacies that have different operations/policies all across the country, it’s just a risk we don’t want to accept.

Do you see a lot of denials after pre-determined authorization?

Ms. Griffith:
Not a lot, but it still happens, which is really part of the reason that we brought pre-determinations for off-label and pre-certification for on-label high-dollar medications into the pharmacy department. We custom-built a database where we enter our off-label medication uses along with all of the supporting clinical literature, which assists us with tracking these claims. We have also created a report that allows us to follow all high-dollar claims. Our impression is that some payers create obstacles that can make payment for medications a challenge, so we want to make it easy for our own staff to follow these claims.

If you just provide all the information and have the approval number from the payers and then assume all is well, you may have problems. Payers can still reject things that they’ve given you approval for. So a pre-certification or pre-determination is not [a] 100 percent guarantee, and I think some people believe that it is.

So it’s important to build up the infrastructure and assiduously track claims. Anything else that you can share for community practices?

Ms. Griffith:
One of the things that’s really beneficial for us is having a clinical specialist pharmacist in each of our disease-specific clinics. At The James we have a breast pharmacist, a lung pharmacist, a melanoma, multiple myeloma, leukemia pharmacist, etc. in the clinic. These are the clinical staff who are involved in getting the information for the off-label pre-determination to our Reimbursement Specialists.

Whether [you are] a large organization or smaller community practice, we all have to think differently about reimbursement than we have in the past when we were just calling for permission, or simply “checking a box” that the approval was completed. Those days are gone! You absolutely must have clinical people involved in ensuring appropriate reimbursement, making sure that the peer-to-peer conversations occur, following up on the claims, and getting any requested clinical information back to the payer.

Even though you may have provided information to them with the initial pre-certification or pre-determination, you may still end up writing a letter and providing additional information. That being said, it’s more efficient and more effective if you involve people who know what they’re doing, and have clinical people involved both on the front- and the back-end.

You absolutely must have clinical people involved in ensuring appropriate reimbursement, making sure that the peer-to-peer conversations occur, following up on the claims, and getting any requested clinical information back to the payer.

We believe it’s important to bring our patients into the process. Of course, that’s actually required if a Medicare patient is receiving a medication for an off-label indication, an advance beneficiary notice (ABN) must be provided and signed by the patient. Even if the off-label indication has become standard of care or has significant supporting evidence, an ABN is required. Our MAPCs do this for medications instead of the financial counselors (who do [this] for procedures, etc.), because they can verbalize the options available to assist if the claim is denied (copay or replacement options).

It’s really important that you empower not only the patient, but all of the staff. Everyone needs to change their way of thinking and be able to have financial conversations with patients. When our providers want to prescribe something off-label, our policy requires that they discuss both the risks and benefits with the patient, and then the MAPCs follow up and give the patient a reasonable expectation of what they could pay if it’s not covered. Not only are they [the MAPCs] knowledgeable about the assistance programs, but they can also speak to our previous experience with getting reimbursement and manufacturer support for that indication with previous patients.

Everyone needs to change their way of thinking and be able to have financial conversations with patients.

Engaging the patients is also important for some medications that are prescribed for the patient to take at home. For instance, out-of-pocket payments for oral chemotherapy can be anywhere for $2,000 to $5,000 (payer dependent), so part of the education provided by the pharmacist includes education on potential out-of-pocket payments. Doing this during the initial education session allows the team to identify any potential payment issues, avoid “sticker shock” at the pharmacy, and link patients with the appropriate resources.

As mentioned earlier, copay assistance is available for many of the high-dollar infused medications provided in oncology practices. With our high-dollar process and assessment of benefits upfront, we can easily identify patients who may benefit from these programs. However, for lower-cost infused supportive care medication where a copay may not be significant for one dose, these copays may add up over time. Identifying these patients in advance (as required by the programs) is difficult to do.

It’s also a challenge to operationalize the copay assistance itself, because it can only be issued after the Explanation of Benefits (EOB) is received. A big kudos to my team, working in collaboration with our finance colleagues, for finally figuring out a way to make it work.

Tips for Ensuring Coverage & Reimbursement

  1. Consider enrolling all patients in manufacturer-provided patient assistance programs for benefits investigation and copay support.
  2. Discuss the costs of high-dollar medications upfront with patients – make them partners in the financial conversation.
  3. Track reimbursement for claims.
  4. Identify core staff with clinical skills as reimbursement specialists for immuno-oncology claims.
  5. Require patients to sign an Advanced Beneficiary Notice or Notice of Non-Coverage for off-label indications.
  6. Identify a clinical specialist pharmacist (or other appropriate clinical staff) at the point of care to support and engage the clinical team.


We often hear from patients who have been previously treated elsewhere that these types of support services were not available.  Without this level of support, patients could end up making a choice to forgo what the physicians believed was the most appropriate therapy because they couldn’t afford it. We work hard to support our medical staff and support whatever evidenced-based treatment they believe is the best for their patient—they know we will work hard to find a way to help their patients.

Assisting patients with copay support for both oral and infused medications has taken on a new importance with the expansion of the Medicaid program in the United States. Ohio is one of the states that has expanded Medicaid, so our MAPCs—who were primarily challenged to assist the uninsured patient population—are now being very challenged to assist the underinsured. It’s really changed the focus of our work. A lot more time and effort is involved with assisting the underinsured. Unfortunately, it seems like we are able to help patients a lot easier if they have no insurance at all.

Are you talking specifically about pharmacists and the profession of pharmacy?

Ms. Griffith: When we teach other organizations/practices to do the things that we do, we tell them it doesn’t matter in many cases which healthcare professional is providing these services. We feel ownership in our department, but the work happens through various members of our staff all working together—we’ve got MAPCs (previous backgrounds include financial counselors, social workers, pharmacy technicians), reimbursement specialists (nurses), and pharmacists.

Having the positions sit in pharmacy is not as important as ensuring the clinical connection is there. It’s important that clinical people are involved and that someone has ownership of the process. Our medication budget is hundreds of millions of dollars, so we take the responsibility of ensuring that they [medications] are paid for very seriously. I feel a personal responsibility to the organization, the patients, and our providers, which is why my team and I have continued to build this infrastructure and ensure we have all of our bases covered.


  1. Lokhurst HM, Plesner T, Laubach J, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. New Engl J Med. 2015;373:1207-1219.
  2. CGS. Correct Billing and Coding for Hospital Outpatient Drugs, Biologicals and Radiopharmaceuticals under the Outpatient Prospective Payment System (OPPS): Bill Types 12X and 13X. March 3, 2011. Available at: http://www.cgsmedicare.com/parta/pubs/news/2011/0311/010.html