How to Adapt as Clinical Pathways Change Managed Care

How to Adapt as Clinical Pathways Change Managed Care

As more and more costly medications are being pushed through the drug development pipe­line, clinical pathways are being viewed as a tool for managed care executives and practitioners to find common ground to provide the best care at the highest clinical and economic value.

First Report Managed Care (FRMC) recently sat down with Winston Wong, PharmD, who developed the first plan-derived clinical pathway program. Dr Wong talks about what went into laying the groundwork for that program and what has been learned along the way. He discusses managed care’s role in developing and imple­menting effective pathways, reveals the key to getting buy-in from physicians, and explains the settings in which pathways are most effec­tive. Dr Wong goes onto provide his thoughts on data collection and analytics, overcoming the 1 big limitation of clinical pathways, and what makes the best pathway programs tick.

Dr Wong is president of W-Squared Group, a con­sultancy that supports small health care innovators in developing their value statements before launching their technology in the government or commercial marketplace. He was previously the Associate Vice President of Pharmacy Management with CareFirst BlueCross BlueShield, where he received numerous accolades for the implementation of his pharmacist-driven Medication Therapy Management pro­gram that expanded to include the entire prescription benefit commercial population in late 2011. Dr Wong was awarded the APhA-APPM Pharmacy Practice Merit Award and the MPhA Honorary President’s Award in 2009 to recognize his efforts to promote medication therapy management in the commercial sector.

Dr Wong is also the founding Editor-in-Chief of Journal of Clinical Pathways—a platform for original research, insights, and perspectives in the pursuit of attaining quantifiable value in health care.

Journal of Clinical Pathways features peer-reviewed educational and informational articles on topics including optimizing clinical pathway implementation, compliance, and adherence. As Dr Wong adapts to his new role as the Editor-in-Chief, he spoke with FRMC about what works best and why, from development to implementation to measurement.

FRMC: How you did get involved in clinical pathways?

Dr Wong: I started out 17 years ago as pharmacy director for CareFirst BlueCross BlueShield. I was charged with building and managing the prescription benefit. My boss wanted to integrate medical and pharmacy practices and build a true comprehensive medical management program. It did not matter to him who was paying for it or under which benefit the drug was being utilized. A medication was a medica­tion. So he expanded my scope of oversight to cover all medication utilization in the plan, under both the medical and the pharmacy benefit.

At that point we started looking for low-hanging fruit. Our biggest spend was in oncology. Realizing that there is a difference in the world of pharmacy management vs that of medical management, I was tasked with figuring out how to manage the oncology spend. I quickly learned that the best way to do that was to start working with the oncologists. After many, many different discussions with different oncologists and different third-party vendors, we settled upon the concept of clinical pathways. We worked closely with a third party vendor to develop the pathways, imple­ment them, and recruit the network of oncologists to participate in the program. We ended up with an oncology pathway program that was implemented in 2008. This was the first pathway program that was sponsored by a health plan and pushed out to network oncologists.

FRMC: There were other oncology pathway programs at the time, right?

Dr Wong: Yes there were. The most notable was US Oncology. But we were the first one to push it from the plan standpoint. After our success in the oncol­ogy program, we expanded it in 2012 to rheumatoid arthritis and pushed that out to the rheumatologists. We also had plans to extend it into gastroenterology.

FRMC: Can you briefly explain what a clinical pathway is, how it’s different from a clinical guideline, and how they work together?

Dr Wong: The differentiation between a clinical guideline and the clinical pathway is very important. As most know, clinical guidelines are consensus statements that are developed to assist physicians and patients on how to treat a specific disease. For oncology, there are the NCCN (National Comprehen­sive Cancer Network) and ASCO (American Society of Clinical Oncology) guidelines that spell out the various treatment options and drug sequencing. For chronic diseases, you have similar guidelines for high blood pressure, cholesterol, diabetes, etc.

A clinical pathway builds upon clinical guidelines. Pathways tend to be much more multidisciplinary, involving different parameters. A portion of the pathway deals with the drug, another deals with the psychosocial impact upon the patient, and yet another portion addresses the ancillary services that go with that treatment.

So in the end what you have is a multidisciplinary treatment plan.

FRMC: In some ways that sounds like an aggregation of various clinical guidelines for a specific disease condition.

Dr Wong: That’s true, but what really defines it as a clinical pathway is how it is used, as well as its versatil­ity. A well-designed pathway can be used for clinical management, just as a guideline can. But it can also be used for nonclinical management, clinical audits, quality audits, as well as financial management. Au­diting is the key, because that brings a certain degree of accountability. That is what separates a pathway from a guideline.

FRMC: What is the number one aspect to keep in mind when developing a clinical pathway?

Dr Wong: It is most important to make sure that it provides benefit. Now that seems rather obvious, but the reason that I stress its importance is because physicians tend to be resistant to clinical pathways. They feel that pathways are going to limit their ability to treat appropriately. That’s not the proper mindset for a clinical pathway, nor is it the intent. The intent is to optimize the medical evidence to identify the best treatment path, and keep using that path. The pathway should be applicable to approximately 80% to 85% of your population. If done correctly, you end up with high-quality care, your best outcomes, and hopefully, you control costs. Providers have to buy into that.

FRMC: So are you saying the onus is on the providers to make them work?

Dr Wong: That’s a great question because when you look at payers you might think that. A lot of payers think of clinical pathways as using guidelines to set treatment protocols, step therapies, and prior authorizations. Of course that’s important, but the key to the implementation is to get collaboration with your providers. If you simply develop them internally and you push them out, no matter how much you say that it’s based on medical evidence,

because you’re a payer, it’s going to be looked at as you choosing the cheapest regimens to save costs. If you don’t get buy-in, you’ve tainted the integrity of the pathway program from the start.

FRMC: So that begs the question: How do you get that buy-in?

Dr Wong: The key is to base the clinical pathway on an objective review of the medical evidence. Even in a 100% objective situation, payers will never be viewed as completing an objective review, for reasons we’ve already discussed. But it works the other way too. If the providers develop them, payers will be suspicious that the providers are choosing the regimen that is going to give them the largest revenue margin to maintain a cash flow.

FRMC: So what’s the answer?

Dr Wong: The process needs to be facilitated by a third party who first objectively evaluates the medi­cal evidence, and then gets that collaborative effort going between the payer and the provider. This is extremely crucial, and it goes beyond just getting buy-in. A good pathway is built on a 3-legged stool.

One, physicians have to agree to use the pathway. Two, the payers have to agree to provide the incen­tive to the physicians to participate. The third leg is the analytics that demonstrate improved outcomes and patient satisfaction, as well as controlled costs.

FRMC: That all sounds great, but many physicians make the argument that clinical pathways feel like “cookbook medicine.” Is there anything that can be done to help physicians feel as if they are not losing control of the art of medicine when implementing a clinical pathway?

Dr Wong: Actually, I think there is. Let’s look at basic chronic conditions such as high cholesterol, diabetes, or hypertension. A physician will tell a new patient with high blood pressure to control their diet and come back in 6 months. If things are not improved by then, the physician will start the patient on the basic first-line therapies. About 80% to 85% of patients will be managed the same way.

It doesn’t really change all that much with oncol­ogy. Yes, for oncology we’re talking about much more acute types of diagnoses, and patients experience a much more rapid outcome. But you are still dealing with a very high consistency among your first and second-line therapies.

It’s usually when you get to the third or fourth line treatment options where you start seeing some variability driven by the patient’s clinical situation. That’s where the art of medicine comes in.

FRMC: So you are saying that when you get to third and fourth line options the physician has more freedom to choose.

Dr Wong: Sometimes, but not always. If a pathway is comprehensive enough, there should be recommen­dations on how to treat even those subpopulations. But there are also clinical pathway programs that have an 80% to 85% compliance threshold, leaving the physician with 15% to 20% of patients for which they don’t have to strictly follow pathways. They can exercise best judgment.

The point for payers is to get physicians to use more cost-effective therapies first in the vast majority, and reserve the nuance and art of medicine for the rest.

FRMC: So you are saying that clinical pathways are actually an opportunity to practice the art of medicine on those for which it is most appropriate?

Dr Wong: That’s exactly what I am saying. Managed care needs to make this point to clinicians in order to get that very important buy-in.

FRMC: Anything else about getting buy-in?

Dr Wong: It’s really all about the approach. You can go in with your big club and lay down the law, but to me that’s not very effective. Some choose to hold out a carrot and say “Here’s my pathway program, take it or leave it.” That’s a softer approach, but I still think there’s a better way.

FRMC: Which is?

Dr Wong: Let physicians spend time with the pathway, and compare it with their normal prescrib­ing habits. I think that 7 out of 10 will sign up for the program because what you’ve laid out for them is what they are already doing. In reality, this gives you 70% compliance, therefore, hitting that 80% to 85% threshold is not as big of a stretch as it appears to be at face value. If the threshold is set higher, then there needs to be an easy process in place to allow for the special clinical situations to be reviewed and treated appropriately.

FRMC: What is managed care’s role in developing and implementing clinical pathways?

Dr Wong: There are 4 keys:

• Make sure the development process is completely transparent. It has to be open and collaborative.

• Two, once the pathway is developed, managed care needs to encourage and promote it to pro­viders, using incentives.

• Third is to appreciate the impact a pathway pro­gram has on a physician’s office. This is especially true if the office doesn’t have the infrastructure in place to manage to the clinical pathway. This often gets lost on managed care organizations, which fail to realize and understand that it may take time to get workflows established.

• Finally, make sure that the analytics used for analysis are completely transparent.

FRMC: What about special cases?

Dr Wong: There has to be a process in place that allows the physician to question and provide feedback on the pathway, especially if they have a patient who has a unique clinical situation. They need an easy way to submit a treatment plan so that the patient can be treated appropriately. That’s common sense, but the problem is timing. It has to be set up so it can be accomplished in a timely fashion and the patient is not compromised.

FRMC: Do you see clinical pathways as an innovation in managed care?

Dr Wong: It depends on how you look at it. It’s not innovative in the sense that clinical pathways rely heavily on clinical guidelines that have already been developed. That’s not breakthrough stuff. But when stakeholders work together to achieve the same goal, that’s innovative. So too is holding accountability.

FRMC: Are there certain arrangements where clinical pathways work better than others? I’m speaking of ACOs, IPAs, PBMs, patient-centered medical homes, etc.

Dr Wong: It does differ from stakeholder to stake­holder. It really depends upon 2 things: the true level of control and the quality and financial risk that the organization takes on.

Clinical pathways are great for an ACO that has high control over the quality of services being provided and significant financial risk. Pathways will drive the quality of care, and they will control cost—as long as you have the right processes in place.

On the other hand, a PBM is focused just on the prescription benefit and has no interface on the medi­cal side. PBMs have tried, but have not succeeded in developing collaborations with physicians on medi­cal utilization. So anything a PBM comes up with is going to be protocol-driven and cause workflow disruption. Plus, PBMs are not at risk, which makes them a third party administrator with no clout in terms of incentives.

Patient-centered medical home programs are very good in controlling the cost of primary care services and conditions. I haven’t seen where they’ve been really successful in controlling cost of specialists.

FRMC: What other areas besides oncology are well-suited for the use of clinical pathways?

Dr Wong: As I mentioned earlier, we now have a pathway for rheumatoid arthritis and we have looked into gastroenterology. The fact is, any disease state that has a treatment guideline can be turned into a clinical pathway. Pathways are based upon the triad of efficacy, tolerability, and cost. Guidelines already have efficacy and tolerability folded in. So it’s a mat­ter of adding the cost component.

At the risk of oversimplifying it, you take a guideline, have it reviewed, tweak it—taking cost factors into account, and hold stakeholders accountable. That’s it in a nutshell, and it is adaptable to most disease states.

FRMC: What is the best way to go about collecting data to measure accountability?

Dr Wong: The easy answer is there is no best way, because we’re not there yet. We don’t have the com­prehensive databases or claims system integration necessary for good analysis. The EMR (electronic medical records) industry is working toward that, with an aim to be interconnected by the end of this decade. My concern is that by then the database will be so big that we won’t have enough expertise to handle all that data. Nor will there be a computer system powerful enough to hold it all.

FRMC: It sounds daunting. What’s the short-term answer for those in the trenches?

Dr Wong: It’s really pretty basic. As you start your program, write down your goals and key metrics. Then design your system to evaluate the metrics everyone has agreed upon. Until there’s a standard, it’s going to have to be homegrown and based on consensus.

FRMC: What are the limitations of clinical pathways?

Dr Wong: I see 1 major limitation. Today, when you have so many stakeholders trying to have input on how a patient is being treated, pathways can impose a delay of therapy. Different stakeholders use differ­ent tools to manage a “so-called” pathway. Tools can range from medical policy, to case management, pre-certification, or prior authorization. For example, prior authorization programs and processes are not as smooth as they should be. And because of that, delays in therapy do occur.

In some instances where oncology drugs are placed under a prior authorization type process, you don’t always have the expertise on the other side of the phone evaluating the patient’s clinical situation. They are merely looking at a checklist or criteria set that has been developed. When you see this, it usually means the program has not been developed with collaboration from oncologists.

It’s a real problem in oncology because if the patient has an aggressive cancer, and he or she needs to be treated quickly, any significant delay is a detriment to the patient. All too often, as I talk to my colleagues, I hear that even in situations where there are defined timeframes in which cases must be reviewed and a determination rendered, the timeframe for oncology reviews take much longer.

FRMC: Another potential limitation is conflicting instructions, especially when there are multiple pathways to follow. Is this a real issue?

Dr Wong: Sure. Here’s a scenario where that can occur. You have a practice that has clinical pathway embedded into their EMR. This practice could also be seeing patients from Anthem and Humana, both of which have their own clinical pathway programs in place. The flavors of these 3 programs are very different, but at the end of the day Anthem has a clinical pathway program, Humana has a clinical pathway program, and there is the practice pathway embedded into the EMR. So there is the possibility that the pathway program that’s embedded into the EMR will not be consistent with Anthem’s program, nor it would be consistent with Humana’s program.

FRMC: So how do practices deal with that?

Dr Wong: It’s no different than what a primary care office faces when seeing patients from 4 or 5 different health plans, and each one has a different formulary.

The thing is, if you take time to look at those formu­laries in the primary care practice, or the pathways in the oncology practice, you’ll find a good amount of consistency across those so-called “competing” programs. I come back to the first and second line therapies we talked about earlier. All of the pathways will have some consistency among them. So 70% of the patients will fall in this bucket. The challenge might come with the third or fourth-line therapies.

But even then, with oncology moving into preci­sion medicine, you have companion diagnostics and prognostic genomic profiling that can drive to a very specific therapy. Many argue that personal­ized medicine is counter to clinical pathways, but from my perspective, I believe that personalized medicine can be very much incorporated into the clinical pathway. Personalized medicine can help strengthen the integrity of the clinical pathway.

FRMC: Can you talk about what good clinical pathway programs look like in practice?

Dr Wong: Since our program was put into place in 2008, different oncology pilot programs have been implemented and reported upon. The best ones decrease variability of the treatment regimens, and offer more cost-effective treatments upfront. They also include a good triage program, where patients are monitored. Follow-up may be as simple as a phone call the day after chemotherapy to check on the patient and provide an opportunity to ask questions, as well as to make sure they’re not having excessive amounts of nausea, vomiting, or any other adverse effects.

The best programs experience a decrease in the amount of emergency room visits and inpatient admissions simply because the patients were man­aged more comprehensively and not allowed to get into a severe situation.

Finally, the best clinical pathway programs provide more opportunities for end-of-life discussions. You don’t see as many patients getting salvage therapies because physicians are feeling more empowered to have those discussions with patients, as opposed to just treating the patient because the patient wants to be treated.

Put that together, and the results will be good.

Nursing Treatment Plans: Where It All Started

The genesis of clinical pathway programs can be traced back to hospital care in the mid-to-late 1980s, according to Dr Wong. “It was something you’d see a lot at very large facilities,” he noted. “Back then they might have been called nursing treatment plans.”

“When a patient entered the medical-surgical area, there would be a specific set of orders and sequences,” explained Dr Wong. “Exactly what should be done for that patient pre- and post-operatively was precisely spelled out.”

Just as with today’s pathways that grew out of them, nursing treatment plans were designed to be multidisciplinary. “Pre-op orders would come from the surgeon. Pharmacy monitoring was a part of it too,” Dr Wong said.

Out of this genesis, pathways made their way from institutions to very large specialty practices in the middle part of the last decade, continued Dr Wong. “This was facilitated by the spread of electronic medical records.”

Dr Wong helped develop the first plan-driven pathway in 2008 at CareFirst BlueCross BlueShield. “From there, as the cost of care continued to increase, more payers needed to control high specialty spending,” he said. “They realized clinical pathways were the best way to get spending under control without sacrificing quality.”