Strategic Use of Clinical Pathways

Abstract

Clinical pathways are detailed, evidence-based processes for delivering cancer care for specific patient presentations. Some oncologists have embraced clinical pathways, while others resist.

What's involved in using clinical pathways in oncology practice? Who's using them, and why? Are they something your practice should consider?

Some oncologists have embraced pathways, while others have resisted. “Some physicians will say it's too much of a cookie-cutter approach,” comments oncologist Bruce A. Feinberg, DO, vice president and chief medical officer of P4 Healthcare, which develops oncology pathway programs and was acquired by Cardinal Health earlier this year. He goes on to say, “I always derived my greatest satisfaction from making the diagnosis, managing toxicity, and managing patient care throughout the process. That's where the art of medicine is—not in selecting which three-drug combination I'm going to prescribe.”

Oncology Physician Resource (OPR), a physician-owned practice management entity created by the Michigan Society of Hematology and Oncology, partnered with BlueCross BlueShield of Michigan (BCBSM) to launch a pathways initiative. Kurt H. Neumann, MD, OPR vice-president, says the pushback he heard initially involved concerns about how much extra work it would be and how it might affect the practice's bottom line. The program responded to these concerns with a $5,000 participation fee and other financial incentives. With 80% of Michigan oncologists participating, Neumann says, “We've been successful beyond what we targeted.”

Kansas City Cancer Center (KCCC) achieved buy-in from its physicians because everyone had a role in developing the recommended clinical pathways, according to John Hennessy, MBA, the group's executive director. Groups of two to three physicians were charged with going through the evidence to develop best practices and presenting recommendations to the partners. “I have a distinct memory of that 4-hour meeting,” Hennessy says. “Everyone was unanimous in adopting the pathways.”

Other practices report that acceptance of pathways simply takes time. J. Russell Hoverman, MD, PhD, vice president of managed care at Dallas-based Texas Oncology, says that some of the practice's physicians feel that using pathways limits choices. “But as they learned that exceptions are allowed, this has become less of an issue.”

What Is Included in Pathways?

First, let's define some terms. Clinical pathways are detailed, evidence-based processes for delivering cancer care for specific patient presentations, including the state and stage of disease. A regimen for treatment is specified, including the names of the drugs, dosing levels, and schedule for administration, according to Feinberg.

The scope, granularity, and available options of pathways vary. For example, Via Oncology, a subsidiary of the University of Pittsburgh Medical Center, has pathways that cover 17 types of cancer and include prognostic testing such as KRAS and OncotypeDX, chemotherapy and biologic therapy, supportive care, and radiation therapy. Via is adding an end-of-life pathway in early 2011. Via's pathways have a single treatment protocol for each specific patient presentation, including stratification for scenarios such as poor performance or elderly status.

In contrast, Michigan's OPR did not want to be that proscriptive, according to Neumann. Thus, three regimens are options on the OPR pathway for treating adjuvant low-risk breast carcinoma. Treatment protocols are eliminated only if they are significantly more expensive and the other choices have the same efficacy and toxicity, Neumann says. In 2010, OPR had pathways only for breast, colon, and lung cancer; for 2011, additional pathways for lymphoma, myeloma, and ovarian and prostate cancer are slated. The Michigan pathways include some genomic tests but do not include diagnostics except for some pathology requirements.

OPR contracted with P4 Healthcare to develop OPR's pathways, educate physicians about them, and monitor and report adherence. P4's Feinberg argues that allowing some variation in the pathways' accepted treatment regimen makes sense, as in two regimens for treating breast cancer—one developed at Memorial Sloan-Kettering and one at the University of California at Los Angeles. “Both are considered standard, and oncologists tend to favor one or the other on the basis of their training. I don't think the intent of a pathway is to make that choice for them.”

Why Use Pathways?

A number of practices began looking at pathways after the passage of the 2003 Medicare Prescription Drug, Modernization, and Improvement Act. “Everyone was concerned that we would be seeing commercial payers reducing reimbursement and also launching utilization management programs,” says Kathy Lokay, president of Via Oncology. “Pathways was an option to improve quality and have oncologists, rather than payers, lead the solution.”

Echoing that perspective is Glenn Balasky, executive director of the Zangmeister Center in Columbus, OH. “In 2006, we felt it was the right thing to do to get out in front of the challenge. Pathways gave us a framework to respond to future demands from payers or other entities concerned with cost or quality of cancer care.” A practice with 11 medical oncologists, Zangmeister Center developed its own pathways that standardize medications, diluents, and mixing and delivery instructions. The pathways are incorporated into the practice's electronic medical record (EMR) system. Balasky notes that pathway use has additional benefits of error reduction, increased efficiency, and better reimbursement processes. “It is now as easy as possible to deliver the right agent to the right patient at the right time. Limiting our regimen choices in our EMR also helps avoid the chance for off-label uses that are difficult to precertify or will likely lead to payment denials and appeals.”

At KCCC, the use of pathways emanated from a recommendation from the practice's quality assurance (QA) committee. A consultant who was an ethicist “got us to understand that QA is not something you do, but it's an ethical commitment you make to your patients to make tomorrow's care better than today's,” Hennessy reports. With approximately 25 medical oncologists in nine locations, the practice decided that eliminating needless variation was a good way to improve care.

Texas Oncology adopted clinical pathways as a strategy to be successful and competitive, according to Hoverman. “We face competition from hospitals and from other, larger centers. We can maintain our position by demonstrating that we consistently deliver good care, whether it is in Midland, Amarillo, or Dallas.” The practice, an affiliate of the US Oncology network, has 248 medical oncologists at more than 90 sites across the state and has been using pathways for several years. “The pathways are designed to be appropriate 80% of the time,” Hoverman says. “We expect that 20% of the time there may be other mitigating factors, such as comorbidity or drug toxicity.”

Who Is Using Pathways?

The number of individual practices that are using pathways is unknown. CareFirst BlueCross BlueShield, serving the Mid-Atlantic, began working with P4 Healthcare in 2008 to develop and monitor pathways. Within the CareFirst market, the physician participation rate by practice type is 88% of community-based oncologists, 44% of hospital-based oncologists, and 6% of academic-based oncologists, according to vice-president of pharmacy management, Winston Wong, PharmD.¹

In Michigan, 80% of the medical oncologists, representing community practices as well as three of the state's four largest academic centers, began using pathways in 2010, the first year of the program. P4's chief executive officer, Jeffrey Scott, MD, says that the combined total of oncologists using pathways in the Michigan program and the Carefirst program is approximately 500.

Lokay reports that more than 200 physicians are using Via Oncology pathways in Texas, Florida, New Jersey, and Pennsylvania. This number includes oncologists in a pilot program with Horizon Blue Cross Blue Shield of New Jersey and approximately 120 oncologists in the University of Pittsburgh Medical Center system, which has nearly 40 outpatient clinics in western Pennsylvania.

US Oncology developed its Level I Pathways program using the pathways developed at KCCC, one of its affiliate practices. The pathways are available to all of the more than 1,300 physicians in the US Oncology network.

The number of pathway users is growing. For example, P4 Healthcare has new contracts with BlueCross BlueShield of Tennessee and Capital BlueCross, which covers 21 counties in Pennsylvania. WellPoint, which insurers members in 14 states recently announced a plan to roll out an incentive-based clinical pathways pilot in major markets.

Arrangements With Payers

In Michigan, BCBSM funds the development of pathways, covers the costs of updating them and monitoring adherence, and provides incentives to oncologists for participation in the pathway program. OPR and BCBSM agreed on three ways to reward physicians for using the pathways. First, each oncologist who signed up in January 2010 received $5,000. Physicians who began participating later received a prorated amount. Second, the reimbursement rate for generic therapeutics was increased. Finally, BCBSM has promised to pay physicians a certain percentage of any overall savings realized in its expenditures for chemotherapy and supportive medications. Neumann comments, “Increasing the reimbursement for generics removes the perverse incentive for physicians to use a more expensive drug. It benefits the physician, who doesn't have to pay for the inventory; it benefits the payers, because they don't have to pay for the more expensive drug; and it benefits the patient, whose copayments are significantly less.”

For the first year of its pathway program, CareFirst rewarded physicians who complied with the pathways 70% of the time by paying them at a higher rate than the standard fees paid to physicians who did not comply. In subsequent years, an 80% compliance rate was required to receive the additional money. P4 Healthcare tracks the compliance and reports the results through a Web portal that physicians can access. Carefirst's Wong reported that in the first 17 months of the program, the company saved more than $7 million for treatment of breast, colon, and lung cancer. Additional savings in supportive care and service costs brought the total savings to more then $10.5 million.¹ This represents approximately 15% of Carefirst's total expenditures for these three types of cancer, according to P4 Healthcare's Scott.

Aetna Health Care has a pilot project in place with Innovent Oncology, a subsidiary of US Oncology, and Texas Oncology. In this project, Texas Oncology's 248 oncologists are using Innovent's comprehensive cancer care program, which includes pathways, patient support services, and advance care planning. Physicians are paid on a per-member, per-month basis for Aetna members who qualify for the program. At the end of the pilot phase, physicians will share in the savings achieved in the areas of drug utilization, hospitalizations, and emergency department visits for patients in the program versus a control group, according to a formula worked out among Aetna, Innovent, and Texas Oncology.

Because using pathways lowers costs, oncology practices may be able to use pathway implementation as leverage with payers. Noting that a dominant payer may balk at making any monetary concessions, Lokay says payers may be willing to make other concessions if a practice uses pathways. For example, a payer may waive prior authorization for on-pathway treatment, or it may reconsider a move to use only drugs from a specialty pharmacy. Some payers will give practices special “gold card” recognition in the payer network, thus driving patients to the practice.

Implementation and Monitoring

Having an EMR system is not a requirement for using pathways. Many of the practices we talked with do not have an EMR or started using pathways before they had an EMR. “It's not about a tool or a manual, it's a process,” stresses P4's Feinberg.

Practices that use Via Oncology's pathways use a Web-based portal in which the physicians answer questions about each patient. On the basis of those answers, the Web tool recommends pathway treatment for the patient; provides links to the evidence supporting the recommendation; gives the physician the option of treating the patient on or off the pathway; and provides order sets, patient education materials, and other decision support information. Calling the portal the hallmark of the Via program, Lokay says, “We felt it was critical to build something that is a nimble decision support tool for use in daily practice.” Screenshots of each page of the portal for a patient with breast cancer are available on the Via Oncology Web site. Via provides quarterly reports of the rate of adherence for the individual physician, the physician's entire group, and all pathway practices. Via also reports the reasons given for choosing off-pathway treatment, such as the fact that a second opinion was received, comorbidities precluded the pathways option, the treatment was started by an oncologist outside the practice, or the physician does not agree with the pathway.

Rather than collecting input from the physician, P4 Healthcare uses an output measurement approach to monitor adherence to its pathways. Practices that use P4 Pathways submit claims via P4's proprietary software. P4 then analyzes the information about the treatment regimen used and provides quarterly compliance reports to users and the payer. “We did surveys and canvassing and found physicians preferred a seamless, effortless process that wouldn't increase time spent in patient management,” Scott points out. Neumann agrees that this approach works acceptably well as a first step: “In Michigan we have all sizes of practices with different billing systems—very few are electronic. This was a mechanism to collect the information with no additional work for the practice whatsoever.”

Physicians who use US Oncology pathways receive support either through the US Oncology EMR system or through a Web-based portal. The pathways program provides decision support including the identification of appropriate clinical trials, which is the first-line recommendation. In addition to receiving adherence reports from Innovent, Texas Oncology has built in a peer-review process to monitor adherence to the pathways concurrently; exceptions to the pathway have to be approved before the drug is mixed or the patient is scheduled.

Resources for Pathway Information

Innovent Oncology: www.innoventoncology.com

Oncology Physician Resource: www.oprservices.com

P4 Healthcare: www.p4healthcare.com

Via Oncology: www.viaoncology.com

Summary

Pathway users say that pathways reduce errors, reduce costs, and increase efficiency. Hennessy notes that KCCC regularly monitors patient satisfaction and has also found that since implementing pathways, patient satisfaction has increased. “It's clear that you can have pathways and high patient satisfaction at the same time.”

Michigan's Neumann says the big issue for the future is who will drive the process of cancer care: the payer, the providers, or a commercial third party. He comments, “We realize there are savings to be made in managing chemotherapy better and in efficient management of disease, including such things as diagnostic approach, end-of-life care, and emergency department visits. Better management of all of these areas is in the sights of these pathway programs. We need to figure out how to do that in a way that aligns physician incentives with cost-efficient medicine.”

Authors' Disclosure of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

Author Contributions

Conception and design: Dean H. Gesme, Marian Wiseman

Administrative support: Dean H. Gesme, Marian Wiseman

Provision of study materials of patients: Dean H. Gesme

Collection and assembly of data: Marian Wiseman

Data analysis and interpretation: Marian Wiseman

Manuscript writing: Dean H. Gesme, Marian Wiseman

FInal approval of manuscript: Dean H. Gesme, Marian Wiseman