CMS starts paying for patient navigation; ACS offers navigation credentialing program

Medicare has started to pay for navigation for guiding patients through the maze of health care services in settings where treatment involves multiple specialties.

Under the Biden Administration’s Cancer Moonshot initiative, the Centers for Medicare and Medicaid Services, has created four CPT codes that will allow health care providers to bill for services known collectively as “patient navigation.”

“This is one of the biggest celebrations  we’ll possibly have in my time at the American Cancer Society. This truly is a major step forward toward improving outcomes from cancer,” Karen Knudsen, CEO of the American Cancer Society, said to The Cancer Letter. “We’re super passionate about this, as you can tell. We’re not going to have wins like this every year.”

Here’s what this means: The new CMS rule shows that Harold Freeman’s workaround to the problems he faced as he tried to cut cancer out of Harlem in the 1960s is of utmost relevance today. This is the proof of principle that when you help the poorest of the poor you address systemic problems—including those that afflict the rich.

Robert Winn

A conversation with Knudsen and Arif Kamal, the ACS chief patient officer, appears below. 

Patient navigation originated in Harlem in the 1960s. It was developed by Harold Freeman, an African American surgeon who attempted to “cut cancer out of Harlem,” but found that, for reasons that were largely societal and economic, patients were unable to show up for detection and treatment procedures (The Cancer Letter, Feb. 11, 2022). 

Now, data show that offering patients guidance, education, and assistance with practical matters can improve the outcomes for the rich and poor alike, lowering the cost of care–and, potentially, increasing enrollment in clinical trials. 

“Here’s what this means: The new CMS rule shows that Harold Freeman’s workaround to the problems he faced as he tried to cut cancer out of Harlem in the 1960s is of utmost relevance today,” Robert Winn, the director and Lipman Chair in Oncology of VCU Massey Cancer Center, senior associate dean for cancer innovation at VCU School of Medicine, and a member of the ACS board of directors, said to The Cancer Letter. “This is the proof of principle that when you help the poorest of the poor you address systemic problems—including those that afflict the rich.”

In conversations with the Office of the First Lady and the White House Moonshot Office, ACS and ACS Cancer Action Network influenced the inclusion of patient navigation in the new CMS rule.   

The health charity, which has championed patient navigation for decades, has also developed a standardized training and credentialing program for professional navigators that meets the CMS requirements for reimbursement.

Knudsen recalls her elation on getting the news last year that CMS, at behest of the White House, would put together a proposed rule for paying for patient navigation:

The 2024 Physician Fee Schedule includes four new codes that specifically refer to Principal Illness Navigation, or PIN for short. The new codes–G0023, G0024, G0140 and G0146–reimburse individualized help to identify appropriate practitioners, particularly in settings that involve multiple specialties.

Navigation services can be provided by auxiliary personnel, including survivors who have obtained certification, and offered under the direction of a medical practitioner.

Here is how the CMS rule defines diseases and conditions eligible for coverage: 

• One serious, high-risk condition expected to last at least 3 months and that places the patient at significant risk of hospitalization, nursing home placement, acute exacerbation/decompensation, functional decline, or death;
• The condition requires development, monitoring, or revision of a disease-specific care plan, and may require frequent adjustment in the medication or treatment regimen, or substantial assistance from a caregiver. 

With the new payment rule, providers will be able to bill for the services of lay navigators, auxiliary personnel who do not offer medical advice. 

“This [rule] provides access to lay navigators, and that is a great first step,” Knudsen said. “We know lay navigators can make a world of difference from cancer prevention all the way through cancer care.”

In the future, navigation could be strengthened to include clinical navigators—those who give medical advice that may be informed by guidelines and pathways. This approach can also improve enrollment in clinical trials, experts say. 

“We can close gaps—like clinical trial enrollment—by realizing that some patients really need a clinical navigator to get them into a clinical trial, because it’s going to require a little bit more conversation and thought and logistical support, to move the blood draw around, and the CT, and so on,” Kamal said to The Cancer Letter. “For others, it’s really information navigation that’ll get them into a clinical trial. They just want to know what’s the difference between a phase II and a phase III clinical trial. You answer the question and they’re ready to move forward. And everything in between. 

“We believe that the entire continuum really needs to have reimbursement power behind it.”

Payment will create “durable workforce” 

Data show consistently that patient navigation provides an opportunity to address health disparities in cancer. 

“To Harold Freeman’s point, you would want lots of professional nonclinical navigators in place in Harlem, as an example,” ACS’s Kamal said. “But often what we find is that health systems who can afford to hire this workforce without having a Medicare reimbursement were oftentimes the ones who weren’t necessarily geographically in the places with the largest disparities, that the disparities are also financial in nature sometimes. The ebbs and flows of money that would fund that workforce was one of the reasons that programs like this couldn’t take off.”

With the new rule in force, the patient navigation workforce will be paid in a consistent, standardized way, rather than through intermittent funds squeezed out of the budget or garnered through philanthropy. 

“We were always concerned about the durability of funding, because there was no way to reimburse for it,” said Knudsen, who, prior to leading ACS, was the director of the Sidney Kimmel Cancer Center at Jefferson Health. “The CMS ruling is incredible, in that now there will be a durable mechanism for lay navigators, or certified navigators in concert with a clinical team, to be reimbursed. So, it will create a durable workforce.”

The importance of patient navigators has always been apparent to Bobby Green, an oncologist and president and chief medical officer at Thyme Care, a company that focuses on patient navigation. Thyme Care partners with risk-bearing entities and oncologists to bring more value-based arrangements to patients (The Cancer Letter, Oct. 7, 2022). 

Thyme Care has partnerships with 75 oncology practices, representing 450 oncologists. The company has contracts with health plans and other risk-bearing entities, including commercial health insurance companies, Medicare Advantage plans, and at-risk primary care groups. In total, Thyme Care covers more than 500,000 patient lives.

“I think it’s relevant that CMS has said, ‘Not only do we think it’s important, but we are also willing to reimburse for it.’” Green said to The Cancer Letter. “CMS coming out and saying, ‘We’re going to pay for stuff that’s new or different,’ doesn’t happen every day. So, I think that sends a very important message and is very validating about navigation in general, and specifically navigation for cancer patients.” 

Thyme Care participated in an ACS pilot program for patient navigation accreditation, and will likely seek ACS patient navigation accreditation for its navigators.

Some states offer patient navigation program certification, and ACS has established a standardized training and credentialing program for certifying navigation programs across the country in time for CMS’s Jan. 1 final rule. With this patient navigator training and credentialing program, called Leadership in Oncology Navigation, or LION, ACS could end up playing a key role in harmonizing the system of cancer care. 

The finalized CMS rule stipulates that navigators must be credentialed to participate in the CMS reimbursement program.

Previously, ACS has funded patient navigators and navigation programs, developed navigation training curricula, and united organizations through the American Cancer Society National Navigation Roundtable. 

“Patient navigation has been widely recognized as having a meaningful impact on patient lives, and can play a substantial role in helping patients get access to best possible care, including clinical trials,” Jonathan Hirsch, chief strategy and growth officer of Paradigm Health Inc., a company that focuses on enabling equitable and more efficient access to clinical trials, said to The Cancer Letter. “The need for navigation services is massive, and I’m excited ACS is stepping into a proactive, standard-setting role. The oncology community needs a group with the reach of ACS to take this on.”

ACS, through its venture fund, is an investor in Paradigm. Hirsch is an investor in Thyme Care. 

Standards for credentialing are designed to keep the system functioning properly while making sure that patients receive appropriate treatment, Kamal said.

“What Dr. Knudsen and I, and the American Cancer Society, are very interested in is making sure that we keep the bar high, so that there’s not a race to the bottom,” Kamal said. “Obviously, that’s always a concern when CMS comes out with a new program and there’s a set of dollars; right?

“We want to make sure that people get the right care and what’s not happening is ‘What’s the least amount of care to be eligible for getting that reimbursement?’ We’re all very interested in making sure people don’t get the least amount of care. What the credentialing program really says is not only, ‘Here’s the skills and expertise,’ but ‘Here’s what good, high quality navigation looks like.’”

ACS’s LION program meets the CMS training requirements for “Principal Illness Navigation” reimbursement and is aligned to professional oncology navigation standards, Kamal said.

“To our knowledge, there’s no other program that is aligned to both the [Professional Oncology Navigation Task Force] standards, which are the well accepted standards, and to the CMS rule,” Kamal said. “The CMS rule actually requires certain things you have to credential around and talk about; for example, things like billing and coding and ethics and compliance, because you’re now talking about a billable thing, not just sort of the clinical practice of delivery. So, we’re, to our knowledge, the only one who’s aligned to both of those.”

According to a 2022 survey by the ACS Cancer Action Network, an overwhelming majority of patients and survivors (91%) agree that having access to a patient navigator is very important for cancer patients. However, only 54% of surveyed individuals had encountered a patient navigator.

Nicholas J. Petrelli, medical director of the Helen F. Graham Cancer Center and Research Institute at Christiana Care, credits patient navigators for contributing to the progress the state of Delaware has made to reduce cancer disparities and improve outcomes (The Cancer Letter, Dec. 15, 2023). 

“As I step down as medical director of the Helen F. Graham Cancer Center and Research Institute at Christiana Care later this year… I can reflect back on the success of cancer care in Delaware,” Petrelli said to The Cancer Letter. A full editorial by Petrelli appears in this issue.

“This collaboration involved many individuals, but one of the key teams involved were the patient navigators. As opposed to the recent CMS reimbursement for these navigators, this was not the case during this 20-year collaborative effort. This recognition of the tireless work of patient navigators is long overdue,” Petrelli said.

Patient navigation is also an effective strategy to increase enrollment in clinical trials.

“This is one of those ‘rising tide lifts all ships’ kind of thing,” Hirsch said. “Everyone who engages, including us, with oncology provider organizations benefits from this because the oncology care providers now have more robust capabilities that they have to bring to bear.”

ACS hopes that the reimbursement structure for patient navigators expands to those with clinical training.

“We want patient navigation to be a gateway for people to be considered for clinical trials and to have an opportunity for people to talk to them about clinical trials,” Knudsen said. “That’s one of the reasons also that we are so emphatic about eventually getting to clinical navigators.”

Last September, as part of the rulemaking process, ACS CAN and 58 other organizations described their vision for certification and maintaining quality of patient navigation programs. The comment states:

Knudsen and Kamal spoke with Paul Goldberg, editor and publisher of The Cancer Letter. The conversation is also available as a video. 

Paul Goldberg: Thank you both for finding the time to talk with me about patient navigation.

Karen Knudsen: ACS actually has quite a history with patient navigation, and in this particular instance, it’s getting the breakthroughs—that have already been discovered through research—to people. 

There have been such rich research programs that have been done by the University of Alabama, by the whole state of Delaware—I’d love to talk about both of those examples—that showed the importance of patient navigation. 

And ACS, previously, actually funded patient navigators in a very different way than we do right now. 

But when I came to the American Cancer Society, Dr. Kamal and I agreed early on that getting patients access to patient navigation was one of our main goals. 

And that actually rose beyond patient support, all the way to the top level of the organization, our entire executive team. 

When we looked at what are the programs that we could run that would really accelerate our ability to improve the lives of cancer patients and families and get us toward our vision of ending cancer as we know it, for everyone, and understanding that “for everyone” is really what ACS is about, patient navigation, without question, rose to the top of what it is that we wanted to give people access to. 

So, we’ve been very passionate about it. I know Arif is, too.

Arif Kamal: We really saw the challenge as about capacity-building, and we’ve done that in various different ways. 

As Dr. Knudsen mentioned, one, we’ve funded navigators within health systems, and those are not long-term strategies. They’re certainly sort of short-term ways to help us learn and build the evidence base. 

But, really, we’ve met an inflection point now, where the evidence base is very clear in various audiences, in various contexts, both standard of care and clinical trials, as well as various diseases, that navigation works and it improves outcomes at the patient level, caregiver level, health system level, and total cost of care, which is really something we all care about. 

It was important for us, as we saw this opportunity to continue to build capacity, that we raised our hand and said, “We’re going to help do this through the national infrastructure that we have.”

And as a trusted partner—we have been in this space for over 30 years—it made natural sense for us to come in and start thinking about how to standardize the delivery of care and make sure that the bar is high, because patients deserve a high quality of navigation.

KK: If I could just pause, I do want to make a distinction about something at the outset that I want to make sure anybody watching this really is clear on. 

This ruling for CMS provides access to lay navigators, and that is a great first step. We know lay navigators can make a world of difference from cancer prevention all the way through cancer care.

But there’s an “and” that needs to happen—and that’s clinical navigators, and that’s what we have been funding as ACS. 

Even before I came to ACS, ACS had a history of funding patient navigators. We had one at Jefferson Health previously, but the challenge there is they were employed by ACS, so they were unable to, for example, access the electronic health record.

When I came to ACS and Dr. Kamal came to ACS, and we put together these patient navigator grants, which are being funded, it’s 20 different health systems across the country. 

Those are clinical navigators. 

So, we’re still learning. So, the learning collaborative continues that Dr. Kamal was talking about. We still have work to do on patient navigation. 

This first win is for lay navigation, and we’ve got a lot of experience with that as well. 

But the North Star? 

Clinical navigation.

KK: Well, there’s strong evidence that disparities can be eradicated, even through lay navigation. 

So, the whole state of Delaware leaned in with money from a tobacco settlement, as I understand it, understanding that Delaware previously had some of the worst, if not the worst, cancer death rates in the country. 

So, circa 2018, I think, they leaned in and provided lay navigation individuals out in communities who are trained to help people get through cancer screening and cancer care. 

They were able to not only reduce cancer death rates within the state, but significantly close the gap on cancer disparities. So, that’s what we mean by some of these experiments already being done. 

Dr. Kamal knows better than anybody, because ACS runs the National Navigation Roundtable that looks at all of these best practices and looks at all the evidence, but certainly with both lay and clinical navigators, I think there’s strong support for reducing cancer disparities, which is one of the reasons we’re so high on it. 

AK: Very much. And you can think about navigation on a continuum. 

On one end is information navigation. 

So, for people who have a question and need an answer, they can call our contact center at +1 800-227-2345. We get a quarter million calls per year. Those are people at 2:00 p.m., 2:00 a.m. who have a question and need to be navigated to the answer. 

We were always concerned about the durability of funding, because there was no way to reimburse for it. The CMS ruling is incredible, in that now there will be a durable mechanism for lay navigators, or certified navigators in concert with a clinical team, to be reimbursed. So, it will create a durable workforce.

Karen Knudsen

That’s very clear. We’ve been doing that for a long time. 

Other types of navigation include peer navigation, where someone finds a person like them in an unpaid setting, and we’ve created an app now called ACS Cares. The idea there is to find people who have something in common to navigate each other. 

Let’s say a person who’s been through a prostate cancer experience can say to a person newly diagnosed with prostate cancer, “OK, well let me tell you how to manage your journey.”

But that’s a very lay type of approach. 

The new CMS changes now allow for reimbursement for what is professional nonclinical navigation. That’s going to be people who work for health systems, work for county health departments, and are employed, but whose background is not clinical. 

So, they’re not nurses, they’re not social workers. This is sometimes called community health workers. Various vernacular is used across the country. That workforce had oftentimes been funded by philanthropy. 

So, to your question of disparities is yes—to Harold Freeman’s point, you would want lots of professional nonclinical navigators in place in Harlem, as an example.

But often what we find is that health systems who can afford to hire this workforce without having a Medicare reimbursement were oftentimes the ones who weren’t necessarily geographically in the places with the largest disparities, that the disparities are also financial in nature sometimes. The ebbs and flows of money that would fund that workforce was one of the reasons that programs like this couldn’t take off.

So, now that CMS has allowed for reimbursement in this space, what we see is an enormous opportunity to close disparity gaps, because now you can find people with similar lived experiences who come from the communities of the patients they serve, who now can get paid to do this work in a consistent, standardized way. 

So, not necessarily relying on philanthropy, but really having a continuous mechanism of reimbursement through Medicare.

When you mentioned CMS, what does it do that hasn’t been done before?

KK: Well, maybe I can start and pass over, but having had a lived experience of running oncology for a 16-hospital system across two states, including the only safety net hospital in center-city Philadelphia, patient navigators make all the difference. 

And to Dr. Kamal’s point earlier, patients who are navigated understand their care, and they’re able to complete their care as planned, so, they have better outcomes and also lower cost of care. 

They don’t end up in your emergency department and their overall cost of care is lower. 

The whole University of Alabama experiment showed this as well. The overall, net ROI—even economic—for patient navigation was just incredibly strong. But it’s so hard to find those dollars to pay for a patient navigator. 

Philanthropy is one mechanism. 

Those of us that were on the oncology care model, understanding that value-based care is coming, delved into those dollars to pay for navigation at some of our sites, but we were always concerned about the durability of funding, because there was no way to reimburse for it.

The CMS ruling is incredible, in that now there will be a durable mechanism for lay navigators, or certified navigators in concert with a clinical team, to be reimbursed. So, it will create a durable workforce.

AK: So, this is the first time ever that CMS has recognized this workforce in a reimbursement mechanism; right? Because CMS, in the proposed rule, identifies who can bill Medicare for services. 

Historically, community health workers or professional, nonclinical navigators have not been identified as a workforce that could do that. 

So, as Dr. Knudsen mentioned, what people had done was a bit of creativity. So, you could have clinical navigators bill chronic care management codes and other things. So, people were kind of trying to piece together the right way to do this to make sustainability. 

Now, we’re outside of that creativity zone to a place where it’s mainstream to be able to—as of Jan. 1—deliver navigation services, both incident two, as is currently written in the rule, and then going beyond. 

So, what that means is that the patient still has to be under the care of the physician. That physician has to see that patient at least once. Then, associated with that clinical visit, will be navigation services that can be delivered either in person or through telehealth. 

That can happen a couple times per month over the next subsequent months. And some of those rules are still being finalized in terms of how we interpret them. 

But what that means is that navigation is not dependent upon the primary clinical team delivering the services—the physician doesn’t have to be involved in every delivery of the services—and that the navigation team can tailor the dose of the navigation services to the patient that they’re taking care of. 

What’s also clear in the rule is that the rule is applied from the point that a person has a suspected finding. So, though it doesn’t include cancer screening per se, the moment that an abnormality is detected, this rule can be applied, meaning that navigation services for complex care can go through the course of treatment and even through survivorship, end of life care, palliative care—wherever the patient goes. 

So, it’s really a longitudinal model where you can create relationships and you can create a trusted series of events that are going to happen. For example, we’ll check in with the patient once every two weeks and then every month and then maybe every quarter while they’re into survivorship. 

So, that’s the real big difference that’s coming from this rule.

KK: Consider the woman who goes in for her mammogram and has an atypical finding. 

Now, she’s not a cancer patient, but she now has a very different life than she had before. Maybe she’s on tamoxifen for chemoprevention. She also needs a very different screening cadence than someone who is of average risk. Now, she’s in a very high-risk zone. 

So, this is why this ruling is so important. It starts for people who are in this early phase of pre-cancer or cancer identification to help make sure that they don’t fall through the cracks. 

It is so important to have cancers detected early if we want to maximize outcomes for people. So, it is so critical that the timing and the language allows for that early engagement of a patient navigator.

When does the proposed rule become a final rule, and how does money begin to flow?

KK: Jan. 1. 

This is one of the biggest celebrations  we’ll possibly have in my time at the American Cancer Society. This truly is a major step forward toward improving outcomes from cancer. 

If what’s been seen—in the instances where navigation has been employed in health systems that could afford it or use philanthropy, and the studies have been done—if that replicates in the places where navigators then come on board, this is a huge win for people.

You must have advocated for this, yeah?

KK: Oh, yeah. 

Early on—actually I’m going to say it was even the first day—I remember interviewing Dr. Kamal to come to be the first ever chief patient officer of the American Cancer Society. 

One of the things that we both agreed on right out of the gate is patient navigation is one of the most important things that we can do outside research. But to get that done, we needed to advocate. 

So, President Lisa Lacasse, who heads our ACS CAN advocacy arm, which is a 501(c)(4)—that means we can take very bold steps to advocate on behalf of cancer patients and families—we got to work in terms of publishing opinions. 

But I was invited to the White House multiple times during the planning of the re-ignition of the Moonshot. And each time I walked through the door, I had patient navigation at the top of my agenda, of this is something that we can and should do.

And then I actually had the good fortune to write an opinion piece with Dave Frederickson and we call them “ground shots:” Here are four things we think the Biden administration can do to significantly accelerate ending cancers as we know it. Patient navigation was one of them. 

And Dr. Kamal, in parallel with all of these efforts, has been working tirelessly in his own team to fund patient navigation, and also running the navigation roundtable. That’s a really powerful organization that’s told us what navigation can and should be, but also emphasized the importance of what navigation can do for people.

AK: What we recognized through that work with the National Navigation Roundtable, which, you mentioned Dr. Freeman, who has been both chair and member and now honorary chair for our organization. 

What we recognized is that we first needed a sustainable reimbursement pathway that’ll lead to capacity in the United States, because it was so varied, because of the reasons we talked about. 

Then, shortly after that, we would need to make sure there’s standardization of good practice, because as it turns out, there was a bit of variability in terms of how it was delivered, and how people are trained. 

What we found from our own work is that the majority of people doing this work today receive very little training, very little oversight, and much of that training is done in-house. So, the ability to compare and contrast best practices outside of one’s own institution was quite limited.

You can imagine there’s sporadic activity happening throughout the country. Now, what this is really about is building capacity, because what we want to make sure is that it’s great that the rule is in place, that there’s a reimbursement pathway, but just because that exists doesn’t mean that everyone’s going to sort of show up tomorrow and start doing this work. And yet patient need is very high. 

So, what we did at the American Cancer Society is raised our hand from the very beginning. 

This rule really came out in August or so, and was not finalized until November. During that period of time, we said, “Well, look, we’re a trusted member of the ecosystem. We have relationships with all the health systems in the country. That’s how we do our work—through that collaboration. Why not build an easy button for how to make this work?”

That involves standardization, ongoing continuous education, and sharing of best practices through a partnership where we can be the neutral third party, we can be there to bring people together. Our goal, our objective, as ACS is to make sure every cancer patient has access to high quality navigation services, period. 

How health systems want to do it, where they want to focus clinical trials, which diseases, so on and so forth—that’s up to them to decide. But we want to bring them together. 

What we created is something called ACS LION. It’s the Leadership in Oncology Navigation: LION. And we believe that’s the right imagery, actually, to think about bold leadership to move this forward. 

We want people to stand up really quickly and think about the capacity in their own health systems and then how to create the right services for them.

So, in addition to providing credentialing work, that’s what our LION program does, we’re also creating convenings to bring people together to teach them about the new rule, teach them about how to do an environmental landscape of their community, their patient population, and their existing services, and then create a community so that they can learn from each other. 

We recognize that there are going to be early adopters, those who say, “Great, we’re ready to go. We’ll get credentialed through ACS LION and we’ll move forward.” 

But there will also be a group of health systems who are going to say, “Well, we want to do this, but we need a little help. We want to learn how others have done it before we jump in, because it’s still a financial investment to take on and we want to fit our services to the patients that we serve.” 

So, what we’re also creating is a learning collaborative, in early 2024, that will bring together folks who are in sort of the contemplative stages of this, to say, “Let’s think about how to build this so that they can have a runway towards starting their own navigation programs, Q3, Q4 of 24.” 

So, that’s part of our overall program of capacity building for navigation across the country. That’s both standardization of services, community building, and then helping people to set up their programs and move forward.

What is the Patient Navigation Roundtable?

KK: Maybe we can just talk about roundtables. 

So, this is something that, even before I came to ACS, I knew about roundtables. I didn’t realize they were run by the American Cancer Society and they’re actually a major investment for us. 

So, it precedes both Dr. Kamal and myself. It has been a strategy to bring like-minded organizations to the table to share best practices to learn, often resulting in a white paper or a position that’s not just an American Cancer Society position, but a joint position on what things should be. 

In fact, our most recent roundtable, which was the Breast and Cervical Cancer Roundtable, we actually launched at the White House at the invitation of Dr. Biden because the first one had been 30 years prior. 

It was a Colorectal Cancer Roundtable, which really significantly advanced knowledge and awareness about colorectal cancer screening across the United States. So, all of this lives in the current era of ACS now as one organization underneath Dr. Kamal as the chief patient officer.

AK: It’s one of our superpowers. I think that this idea that we can bring people together who are the experts, who need an opportunity to get together and talk and create work groups and really move work forward. 

I mean, it’s one thing to have a conversation. Roundtables are about action. So, you’ll see that all of them, everything from, as Dr. Knudsen mentioned, the Colorectal Cancer Roundtable started the first 80 by 20 campaign—that was 80% of adults who are eligible for colorectal cancer screening receive screening by the year 2020. 

That campaign came out from the roundtable. 

Not only that, all the tactics, the toolkits, the individual reach outs to health systems, the QI projects—all that emanated from these groups. 

So, the National Navigation Roundtable has been around for a couple of decades. The idea is to bring together everything from payers to pharma to health systems, anyone who’s touching this problem, this very big elephant in their own way, into the room together to talk about it.

What was clear is that the roundtable got together and created one of the first sets of standards called the PONT [Professional Oncology Navigation Task Force] standards, the Oncology Navigation Standards. 

What we also recognized through the roundtable work is that for navigation to truly grow, it needs fidelity. And fidelity comes from making sure that the right best practices that have been shown in those studies are the ones that people are implementing. 

What we need is implementation science, not the formative research. The formative research has been done and is very strong; it’s very compelling. But just like everything else, it’s about how is it actually implemented in particular communities? 

That’s what was brought up through the round table as the next big challenge: How do we make sure there’s fidelity in the implementation? 

So, in the creation of the ACS LION program, it’s really around creating credentialing so that every professional navigator in this country has a basic set of knowledge and expertise and a community by which they can run things by.

So, we’re kind of doing this all in a way where we can trust what’s being delivered, where patients can understand that they can trust what’s coming their way, and that we’re also paying attention to the quickly changing regulatory landscape, the quickly changing clinical trials landscape. 

So, in fact, for us, credentialing is not an event, it’s a process. So, what that means is that we initially credential them, but then every year make sure we have regular touchpoints with this credentialed workforce to make sure they understand that as the CMS rule changes—which, it might evolve—that they are first in line to that information as the evidence-based changes. 

And because as we, as the American Cancer Society, have inroads into the White House Moonshot, into various other organizations, we can bring to them—as soon as there’s late breaking news—what those evolutions in clinical practice should be.

Because fundamentally, navigation is rapidly changing as well, in terms of how we do it, and so on. And you might have seen Dr. Bertagnolli—who was previously on our board, and then NCI director, and now NIH director—talk about a big focus on bringing people into trials. 

So, you can imagine a big emphasis in this navigation workforce is on bringing people into clinical trials, but there’s going to have to be some new and different methods, or new and different thinking. 

We are here to help distribute that to this credentialled workforce as well.

KK: And if I can just layer on just a tiny bit to that, I totally agree with everything Dr. Kamal said. 

One of the things that’s so important about the LION program is the standardization. We previously talked to a lot of different stakeholders. One of those stakeholders are payers, and we talked to payers or large primary care networks. 

They worry a lot about mission creep, because in their experience, to Dr. Kamal’s previous point, when they brought on navigators, they brought them in for one skill set, and it started to drift. 

The credentialing allows a very clear vision of what a navigator does and doesn’t do, but it’s also the case that we’re going to need to continue to understand what are the needs and add to those skill sets. 

So, in addition to the round table, Dr. Kamal worked very closely with AACI to listen to 106 larger cancer centers in the United States—which come in very different flavors, urban, rural—and say, “OK, what are you guys needing in navigation?” 

They served as a great sounding board, I would say, for how it is that the LION program was structured. And that’s just an example of Dr. Kamal reaching out to other organizations even beyond the round table. 

So, we feel really, really good about this first iteration, because it’s been shared with so many, and the idea is shaped by so many.

What are the principal illnesses, as defined by CMS? How does this rule address high risk conditions like cancer?

AK: Principal Illness Navigation is the term that the rule talked about. 

CMS is really allowing health systems to define patient populations who are at high risk for poor outcomes, particularly because of trajectory and how they move through the system. 

So, you can imagine that’s also going to include other organ dysfunctions, but we know that a large part of this rule is really focused on cancer, because cancer is increasingly becoming, as we know, an illness with a chronic illness type flavor to it. 

So, neuroendocrine tumors start to look a little bit more like heart failure than they were 10 years ago or five years ago. 

So, those challenges can compound on each other, can be longitudinal, can be interactional with other things that are happening. 

And what we recognize is that a core component of navigation will be assessment of social determinants of health because we recognize is that social determinants of health are really just a function of circumstance and time.

So we can have all the resources at our fingertips right now as individuals, but if I give you a cancer diagnosis that goes on for six months and then 16 months and then six years, it’s hard to imagine that at six years any one of us doesn’t have some sort of logistical, financial, social, emotional, relational barrier that we’re going to come up against. 

And that’s really what this navigation’s about is to get people to and through the right care, but also to be a trusted partner as they’re going through the system and as they’re going through their care. Because that can oftentimes now, so we see particularly in cancer, just like in heart failure or liver disease last for several months or years at a time, and that recognition that there’s similarities there really makes it so that navigation is not an event, but in and of itself is a longitudinal process.

KK: I think the other thing about this ruling to note, though—and we talked about just really briefly, but I think deserves some emphasis—is that it includes telemedicine or telehealth for navigation. What a great win there too, so that people aren’t necessarily having to travel into the health system to get access to the patient navigator! 

That’s so important.

There are companies, a few of them, that are trying to do this as well. How does the private sector fit into this? Is there another model to work through?

KK: Well, the challenge is there are a lot of functions that people sweep into calling navigation. 

That’s, again, why it’s so important that we have the credentialing process—because some of these things that people are calling navigation wouldn’t necessarily meet the criteria of what oncology navigation, in the strict sense, looks like and what we’re certifying people to do. 

Does that sound fair, Dr. Kamal?

AK: It does, and we are here to make sure that the quality is high. The tax status of an individual organization is not really of our concern. 

I will say this. We had a very robust pilot for our ACS LION program as a soft launch in November, and we included vendors as well who will likely participate in this space after Jan. 1. 

So, we wanted to see their experiences. Across the board in our pilot, there was high satisfaction by users of the credentialing program, both from academic health systems, community-based organizations, but also in the vendor space as well. 

What Dr. Knudsen and I, and the American Cancer Society, are very interested in is making sure that we keep the bar high, so that there’s not a race to the bottom.

Obviously, that’s always a concern when CMS comes out with a new program and there’s a set of dollars; right?

CMS, the Moonshot, us, everyone. We want to make sure that people get the right care and what’s not happening is “What’s the least amount of care to be eligible for getting that reimbursement?”

We’re all very interested in making sure people don’t get the least amount of care. What the credentialing program really says is not only, “Here’s the skills and expertise,” but “Here’s what good, high quality navigation looks like, day-to-day, week to week, month to month.”

That’s really what needs to happen. And this is why we believe it’s so important to have credentialing, because remember that in any other sort of clinical space—everyone who is a physician, you know that they went to school, they went to residency, they went to fellowship to be an oncologist. 

They’re credentialed by the state, then they’re also, I have a DEA number, I have an NPI number.

So, CMS has credentialed me. The DEA has, the state has, my health system has, and I have to show all this documentation, of all the places I went to school. 

The same thing with Dr. Knudsen as a cancer researcher and as administrator; the same thing has always been the case. 

Now, imagine a workforce where there’s a lot of variability—and there’s beauty in that—in terms of their professional background, how they were educated, and so on. 

But it also means that we just have to pay attention to the standardization of the workforce and the delivery of what’s happened.

So, the role of ACS is to establish standards and a credentialing system, which is what you’re rolling out right now?

KK: Luckily, we were able to learn from others who’d done research on this in the past. We’re able to vet our ideas through the roundtable through AACI and really assess how it would be received. 

But it’ll still be an iterative process, where as oncology care delivery changes, we’ll constantly need to refresh the credentialing strategy. But luckily, the meat of it was already there, and we were already helping to train navigators across the country. 

So, lifting it up really just required some formalizing of what it is that we do right now. 

It was one of the greatest phone calls I’ve ever made, because when I got the tip that the CMS rule was going to be proposed, I called Arif immediately like, “Oh my gosh, we have a lot of work to do before January!” 

He and his team basically abandoned all the things that could be abandoned in order to prioritize this to make sure that we weren’t missing a day of someone being able to access credentialing strategies and training strategies, so that they could be deployed as a patient navigator. 

We considered it one of our most critical goals outside the transportation, lodging, and all of the other activities we do every day at patient support. But in terms of an ACS priority, this is right to the top.

But it would be really up to the participants in the program whether to seek your seal of approval, even though it would be prudent?

AK: Well, in fact, the finalized CMS rule states that for navigators to participate in the CMS reimbursement program—now, private insurers can do what they want to do—but to participate in the CMS program, they have to be credentialed. So, that is a requirement. 

And ours is, as of Jan. 1, stood up and ready to take people into the credentialing program and into the community of our learners to learn from each other in terms of how to do that. 

So, that’s really clear. What we want to make sure people understand is that this opportunity exists, that there are proven methods of how to do this. There’s a community from which you can learn. 

There are standards which will help you learn and then get you approved so that you can bill CMS. But that’s one of those things that can start in January.

You come to our program, get credentialed, start billing Medicare and moving forward, for those early adopters, and then others will sort of pick up from that. That opportunity starts Jan. 1. 

What’s really clear is this is not a concept, a philosophy, a thought, an idea. This is actually happening. And to Dr. Knudsen’s point, we believe this is going to be the right momentum to build up a lot of energy and force behind the idea that clinical navigators need to also have the same reimbursement pathways. 

You could imagine that we will be there to think about how to standardize that practice as well, so that you really do see this as a continuum. You can imagine for some patients, clinical navigation—really in depth clinical navigation—is what they’re going to need. 

For others, maybe it’s going to be professional nonclinical navigation.

Maybe for others, it’s information navigation, which has been reimbursed for now. For others, it’s peer-to-peer support, like we provide. That sort of comprehensive menu of navigation options is what we really believe people should have access to.

I think that what you’ll find is we can close gaps—like clinical trial enrollment—by realizing that some patients really need a clinical navigator to get them into a clinical trial, because it’s going to require a little bit more conversation and thought and logistical support, to move the blood draw around, and the CT, and so on.

For others, it’s really information navigation that’ll get them into a clinical trial. They just want to know what’s the difference between a phase II and a phase III clinical trial. You answer the question and they’re ready to move forward. And everything in between. 

We believe that the entire continuum really needs to have reimbursement power behind it.

KK: One of the things to know in terms of demand, Paul, is because we’ve studied this so long at ACS, ACS CAN had done surveys. 

We work with a large number of cancer survivors, millions of cancer survivors every year across the country. 

And 91% of cancer patients and survivors say that they wish they had had a navigator. So, the demand is high to get this done. And one of the things that I would be remiss if I didn’t point out was how grateful we are to the American Heart Association for Nancy Brown, who’s their CEO, and their team being willing to lean in and talk to us about lifting up certification. 

Of course, there’s a long history at the American Heart Association of providing CPR training, something that people don’t often think about. 

Where is that coming from? And it’s very appropriate that it comes from a neutral third party, evidence-based, with only one goal in mind: to help people. No financial interest in where anybody gets cardiology care.

In the same way, we don’t have an interest in where anybody gets oncology care. We just want them to get access to the best possible quality care that’s going to give them an opportunity for a positive outcome.

But that’s why you need ACS—to establish this. But when CMS says you must be credentialed, does it [mention] ACS [as the standard-setting organization]?

KK: You don’t have to be credentialed through the American Cancer Society, but, certainly, it is an important role for us to take up that responsibility and provide credentialing services that are well-studied, easy to access, and that will provide standardization across the country. 

We feel really passionately about the fact that that’s one of our major roles.

But if I were to get certified, where else would I be credentialed? Where else would I get credentialed, other than by ACS? Is there another place to go?

AK: To our knowledge, there’s no other program that is aligned to both the [Professional Oncology Navigation Task Force] standards, which are the well accepted standards, and to the CMS rule. 

The CMS rule actually requires certain things you have to credential around and talk about; for example, things like billing and coding and ethics and compliance, because you’re now talking about a billable thing, not just sort of the clinical practice of delivery. 

So, we’re, to our knowledge, the only one who is aligned to both of those.

We would expect that vendor groups would come to us too. So, it’s really anyone who wants to bill Medicare for the delivery of professional nonclinical navigation, regardless of who the employer is, vendor health system, community organization. 

It could be a state health department who is also looking, whoever that is. We see this as sort of the central point for them to come into. 

And then, like I said, in addition to the knowledge and the standardization and the testing, part of it is also the building of the community. And what we want to make sure is that we learn from this cohort as well. 

So, part of our work in ACS LION is also to survey these participants to understand what does that look like in delivery, because there will be challenges. Reimbursement is but one challenge that’s being solved here, the other is really going to be the workforce itself.

We recognize that healthcare right now is already in a tough spot. It’s already hard to find nurses and frontline workers for any number of things. You’re talking about a workforce that’s extraordinarily important, that’s providing frontline care, that’s going to see a lot of difficult things like other healthcare workforces do as well.

And we want to make sure that that workforce is robust, that there’s not high turnover, that there’s adequacy in that workforce that’s going to be a part of this work. 

And we’re going to learn from each other about what are the best practices to retain and recruit this important workforce.

KK: And get feedback from the health systems, too. So, we already talked to Rob Winn, Dr. Winn, who is now the president of AACI, and will be for two years, six months—12 months in—we’d like to do a pulse survey. 

Not that they represent every cancer center, they certainly don’t. But the power of 106 is a lot of voices to tell us what worked, what do we need to think differently about. So, there’s learning at the system level. There’s learning at the individual navigator level. We see a lot of upside, to Dr. Kamal’s point, not just launching LION, but making sure that LION evolves with evolving needs.

We want patient navigation to be a gateway for people to be considered for clinical trials and to have an opportunity for people to talk to them about clinical trials. 

That’s one of the reasons also that we are so emphatic about eventually getting to clinical navigators—because my dream scenario is that there is an opportunity to assess and evaluate someone for a clinical trial before they walk in the door. 

So, I mean, this is a great best practice that, when you can achieve it, is done by saying to someone, here’s where we are in your treatment plan, or here’s where we are with your diagnosis. Here are all the options available to you. 

And one of the things that you may want to consider is that unless we do something fundamentally different in the country, we can’t just keep doing the same thing and hope that we’re going to enhance enrollment of adults in clinical trials. 

What would cancer outcomes look like if enrollment in clinical trials for adults, understanding that they are the vast majority of people with cancer in this country, match with what happens in pediatric cancers? Reports are a little bit all over the place, but it could be up to 85% of pediatric patients.

We’re super passionate about this, as you can tell. We’re not going to have wins like this every year.

I love this. But what happens with, for example, for-profit, non-CMS stuff?

KK: Well, in terms of what happens outside the scope of CMS, typically as CMS goes, the payers go, and we hope that this follows suit. But I’m back to the demand, that 91% of profiled cancer patients wanted a navigator. 

And so, one would think that forward-thinking payers are going to take this up. 

Now, we do take this as part of our responsibility as well, to speak to the payers about the importance of patient navigation we have before we will continue to do so. But this gives them a real reason and opportunity to get going.

We have had some early discussions with some payers about doing demonstration projects to cover navigation. I’d love it if they’d cover clinical navigation, right? TBD; more to cover.

AK: That’s right.

So, like an Aetna, or whatever, would be paying for clinical navigation as well?

KK: Wouldn’t that be nice and would give an opportunity to experience for themselves what the impact is on that patient in terms of outcomes, the most important thing, and also an opportunity to get an experience of how it impacts overall cost of care?

But if you’re pushing people towards, let’s say, towards clinical trials, that would be clinical navigation? Or what kind of navigation is it?

KK: If you’re talking about evaluating someone’s eligibility for trial, Dr. Kamal, tell me if you disagree, that’s likely a clinical navigator to do the evaluation ahead of time. But if you’re talking about educating someone about how to discuss clinical trials—here’s what a clinical trial is, here’s what you may want to ask—that’s something that can get done in the professional nonclinical sense.

And what you’re doing right now is nonclinical navigation? LION is not clinical navigation? That’s something you’re going to go for later?

KK: Well, the LION is professional nonclinical navigation, and it is really important, massive win high impact and is ultimately clinical navigation. And that should happen too. And we were very clear about that with the Biden administration as well. We love this. This is a huge step forward. 

But the North Star is an addition of oncology clinical navigation.

AK: And it may help, Paul. So. it depends on how you’re using the word clinical. So, clinical refers to the training and the expertise of the person delivering the care, not the setting of which the care is being delivered. 

So, a professional nonclinical navigator can work in a clinical system, in a clinical environment, but what they’re going to talk about are things that they’re comfortable talking about. 

So, it may be what is a clinical trial? What are the difference between a phase I, II, III, IV trial? Who do I talk to if I want to learn more about it? But you can imagine it’s going to be a nurse. 

So, that’d be a clinical navigator who could actually then see if they’re eligible by looking through their chart, making sure their labs are in line, the physical exam in line. So, those are clinical assessments, but the environment that you’re in is still a clinical environment.

KK: They would work together, they would be close colleagues here in navigating me as a cancer patient.

AK: That’s right.

Right. But how does one get paid through CMS right now for this starting Jan. 1? How much money can you make? Which is a crass question that everybody is asking.

AK: Well, we think that it’s enough by our understanding of the RVU assignments to these codes enough to make it worthwhile to do it. I mean, this is important to do. It’s the right thing to do, but it’s also a good business opportunity to do it as well. 

What Dr. Knudsen and I, and the American Cancer Society, are very interested in is making sure that we keep the bar high, so that there’s not a race to the bottom.

Arif Kamal

Now, the value not only comes from the revenue, which is what we’re talking about here, but also cost avoidance. Because as you know, cancer care is driven by two major things. One is drug costs, which is not what we’re talking about here. The second part is going to be those sort of low value, I mean low value to the patient. 

No patient thinks it’s going to, the emergency room is a high value activity. So, avoiding ED visits, long-term hospitalizations, particularly near the end of life or when there’s complexity and making sure that those side effects, for example, are handled prior to them becoming out of control, where we have to stop treatment for a period of time.

That happens, for example, in immunotherapy where we have to stop. 

So, the idea here is that you’ve got someone keeping tabs on you throughout this process who by themselves are not a clinician, but are trained by folks like ourselves at ACS to be watching for particular things. And then to connect into the clinical system. 

When you see something, so a patient calls or you call a patient as a navigator, and you hear them say, “I’m having a lot more rash and itch,” well, that’s important to bring to the attention of the clinical team. 

Maybe they reduce the dose, stop something, give some steroids and skin cream, whatever that is, before it gets to a point where the rash is so bad, the patient has to come to the ED, be hospitalized, and then be off treatment for a period of weeks to months. 

So, that sort of early warning system, the eyes and ears on the ground, is really what these professional nonclinical navigators are providing. But it’s important that they stay connected with the clinical team and ideally in a future state that’s not too far off a clinical navigation workforce that can come in as the next layer and say, okay, well let me talk to them about what to do about their rationale that we know that they have.

And that feeds right into the pathways.

KK: Yes, it does. It does.

I got it!

KK: Exactly. And to Arif’s point about the emergency department, this is the least efficient place to get cancer care. It is not where you want your cancer patients landing. And it’s also very expensive. 

It’s expensive and inefficient. Nobody wants it. And one of the outcomes that has been very clear downstream of patient navigation is that it does prevent people from landing in this high cost, low efficiency setting for cancer care.

But how do you get somebody like, I don’t know, US Oncology, to play?

KK: I think a lot of forward-thinking community practices already do it. So, US Oncology, so let’s just talk about that; right? They have the joint venture with Sarah Cannon, because they know they need more access to trials. And guess who already provides navigators in the HCA system for all of their sites, Sarah Cannon and HCA, because they know it’s the right thing to do for patients?

There’s no question. But it’s also the right thing to do from a business perspective, take away that it’s the right thing for the patient, and it still is a good business decision, but it’s the case because you have better outcomes because there’s overall lower cost of care.

But it’s the case that if there was no mechanism to reimburse for it, it was hard sometimes to piece together for some health systems. 

But I’m just back to it’s the right thing to do for your patients. And I think most organizations are driven that way. At least the oncology teams are.

How fascinating…

KK: And patients want it; right? Back to the demand issue. It’s clear patients want it.