Oncologists Say Clinical Pathways Are Too Confining

Melissa Dillmon, MD

Clinical pathways have been embraced by insurers and many oncologists as a way to standardize the use of evidence-based chemotherapy treatments, measure physician compliance, and create a preference for the least expensive of equally effective regimens, but some oncologists say they are overwhelmed by the diversity of pathways and payers are too often using them to micromanage decision making.

The first practices to use pathways created them about a decade ago to reduce treatment variability and structure their work around their commitments to both quality and value. Based on test results and other variables, a pathway pointed the doctor to the best drug regimen for that patient.

At the Kansas City Cancer Center, a US Oncology affiliate, pathways were instituted following a medical ethicist’s call for the staff to do the “right thing for patients,” said John Hennessy, MBA, former head of the center who now serves as senior vice president at WillRithms, a claims auditing firm.

“He sat down with us and said, ‘You have an ethical commitment to your community to do this better than you did the day before. The community is giving you the privilege of delivering cancer care. You need to live up to that.’ That was a real wake-up moment for us,” Hennessy recalled.

The practice’s 28 oncologists unanimously agreed to start using pathways, which prioritized measures of efficacy and toxicity before considering the cost to the patient and finally the cost to the practice. But soon after, in anticipation of the next wave of payment reform, the practice also went to its payers and asked to be rewarded for doing a better job of treating patients, Hennessy said.

Other organizations began developing pathways, either for their own doctors or to market to practices and insurers. The best-known are P4 Pathways, now part of Cardinal Health; Via Oncology, which originated at the University of Pittsburgh Medical Center; and US Oncology’s Innovent Oncology, which is now part of McKesson. They are also offered by vendors including Eviti and New Century Health, and Anthem developed its own in-house versions.

Oncologists have largely accepted clinical pathways, which studies have shown can safely cut cost, but substantial resistance remains. Many doctors are uncomfortable with insurers’ widespread adoption of pathways as a way to reduce costs, saying that a tool for managing the complexity of chemotherapy options can be used to effectively punish doctors when a patient doesn’t fit into the system’s rigid confines requiring the physician to use an off-pathway regimen (Figure 1).

Figure 1. Pros and Cons of Clinical Pathways

Source: CMS Alliance to Modernize Healthcare, Brookings, MITRE.

Melissa Dillmon, MD, an oncologist at the Harbin Clinic in Rome, Georgia and president of the Georgia Society of Clinical Oncology, alleged that an insurer she often deals with uses pathways to pressure doctors to use less effective but cheaper drug combinations.

Figure 2. Impact of Enhanced Reimbursement and Support for Pathways

Source: Anthem. Anthem has developed its own set of pathway programs and pays physicians a monthly incentive for their use.

Winnowing the Medicine Chest

“They have a set group of treatment regimens that they have determined are the least expensive. They’re not for improving care,” Dillmon said. “I mean, this is a cynical medical oncologist speaking: They’re not for improving care. They’re about saving money. If you choose 1 of those regimens—and often the lists are not adequate and not based on clinical evidence—then you get a bonus back (Figure 2).” The idea of “critical pathways” can be traced back to quality management processes in the aviation and construction industries in the 1950s.¹ In the 1980s, a pair of Boston nurses translated them into case management plans and then clinical pathways, and over time health care organizations around the world adapted the concept to their own needs.

As opposed to clinical guidelines developed by ASCO, NCCN, and other organizations, which describe treatment approaches, pathways help the practitioner sift guidelines and variables to settle upon a treatment for a specific patient.²

Pathways emerged as oncologists were facing an expanding medicine chest stocked with increasingly tailored drugs, said Ray Page, DO, PhD, president of The Center for Cancer and Blood Disorders in Fort Worth, Texas. They could no longer practice “alchemy” with the handful of relatively inexpensive pharmaceuticals available for a specific cancer, he said.

“Today we have hundreds of drugs out there, and very targeted drugs that only work in certain subsets of tumors. Drugs are very sophisticated, very targeted, have very limited indications, and are very expensive,” Page said. “I can’t just go pull a drug off the shelf and say, well, it’s got an indication for lung cancer so let’s just give it. It’s not going to work unless you use it in the right population.”

“Given the amount of knowledge you need to maintain an understanding of when to use the drug, we need a pathway system that’s evidence-based, that helps guide you, in today’s society,” he said.

Pathways, along with accountable care organizations and other new payment models, were embraced by payers seeking to manage the high cost of cancer care. A 2012 survey found that 39% of payers surveyed had already implemented oncology pathways, and another 59% were planning to do so within 2 years.³

A McKinsey analysis found that 15% of insured persons were covered by oncology pathways in 2010 and projected that the figure could rise to 25% by 2015.⁴ Breast and lung cancer pathways are the most common, with 68% of surveyed payers using them as of 2014, followed by prostate and colon/rectal cancer pathways at 57%, multiple myeloma at 43%, and chronic leukemias at about 40%. ⁵ They were followed by renal cell, non-Hodgkin lymphoma, melanoma, and ovarian cancer (Figure 3).

Figure 3. Payer Adoption of Clinical Pathways

Source: Zitter Health Insights

Creating fixed plans for treating common malignancies promises to make the work of nurses and other staff more predictable and practiced, increasing efficiency and reducing errors that could lead to poor outcomes and hospitalization. For payers, pathways also gave them another way to insert awareness of costs directly into the examining room.

“The way the pathways are constructed does promote consideration of value-driven practice, which is to say that the pathways vendors all take into account cost of care, but only after considering efficacy and toxicity,” said Michael Kolodziej, MD, national medical director of oncology solutions at Aetna, and a former medical director at US Oncology. “So there is an element here of reduction of cost of care, by trying to encourage physicians to consider the relative value of various treatment options. This has now become the mantra in oncology.”

Studies found that using pathways can indeed cut costs substantially without hurting outcomes.

A Superabundance of Pathways

Two studies of non-small cell lung cancer and colon cancer patients conducted by US Oncology and Milliman found that on-pathway chemotherapy treatment cost 35% less than off-pathway, with no impact on survival rates.⁶ One study by Cardinal Health found that a pathways program it developed saved 15% in costs and reduced hospitalizations by 7%, while another Cardinal study found an 18% cost reduction.⁷ Payers have a variety of pathway development and incentive strategies. Aetna’s medical home initiative allows practices that are already using a pathway to keep it, and provides performance bonuses for on-pathway treatment, Kolodziej said. Anthem developed its own pathways and pays a monthly incentive for their use. United Healthcare has experimented with different payment models that include pathways.

Dillmon and Page said they have seen little direct financial benefit from using pathways, though Page said having them helped his practice negotiate terms of its participation in United Health’s episode-based payment pilot, which includes a shared-savings element.

John Hennessy, MBA

Theoretically, all pathways should be similar, because they are based on the same evidence. In reality, some are stricter than others on doses, they have different procedures for off-pathway treatment authorization, and they have different Web-based interfaces that do not communicate with electronic medical records systems Dillmon said she knows of a practice that uses differently colored clipboards to remember which pathway is required for which patient.

“It’s extremely difficult to deal with numerous pathways,” Page said. “You can’t keep track of them. You have to look at who the payer is to determine which pathway system you’re going to use.”

Having to use several different pathways for each cancer subtype creates a substantial administrative burden and subverts the original goal of settling on a single set of standardized treatments, providers said.

“It is a big issue. Practices are not saying we don’t want any pathways, but could we just have 1? Could it be the same?” Hennessy said. “In particular, when you get into this generic versus that generic, it gets to the transactional level. It doesn’t make a lot of sense for non-payment if you pick the wrong sets of generics. The outcomes are the same, the costs are about the same. It’s just becoming burdensome.”

Page is a member of an ASCO task force that is working on a policy to address the proliferation of pathways, preauthorization and administrative burdens. He said they hope to publish the policy by October.

“Someone’s got to speak up for us and say we can’t continue to have 1 set of pathways for Blue Cross, 1 set of drugs we use for Humana patients,” Dillmon said. “To me that’s the same thing as racism, you know? I’m going to treat 1 person differently from another because of something that, in this case, is in their wallet, which is their insurance card. That’s ethically wrong.”

References

1. Vanhaecht C. History of Clinical Pathways. http://bit.ly/1UHcmvG. Accessed August 14, 2015.
2. Carlson B. Controlling the cost of care through clinical pathways. Biotechnology Healthc. 2009;6(1):23-26. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2702812/. Accessed August 14, 2015.
3. Greenapple R. Rapid expansion of new oncology care delivery payment models: results from a payer survey. American Health and Drug Benefits. 2013;6(5). http://ahdbonline.com/issues/2013/july-2013-vol-6-no-5/1443-feature-1443. Accessed August 14, 2015.
4. McKinsey and Co. Strategies in oncology: spotlight on clinical pathways. Oncology Knowledge Bulletin. http://bit.ly/1K0FHHa. Accessed August 14, 2015.
5. Habura C. Prostate cancer leads in clinical pathway adoption and preferential treatment. Zitter Health Insights. http://zitter.com/blog/prostate-cancer-leads-in-clinical-pathway-adoption-and-preferential-treatment/. Accessed August 14, 2015.
6. Kolodziej M, Hoverman J. Ranking value in cancer care: analysis of a “pathways” approach. OncLive. https://www.onclive.com/publications/oncology-live/2012/july-2012/ranking-value-in-cancer-care-analysis-of-a-pathways-approach/. Accessed August 14, 2015.
7. Cardinal Health. New studies show cardinal health specialty solutions’ clinical pathways improve cost effectiveness and quality of treatment of cancer and rheumatoid arthritis. http://ir.cardinalhealth.com/news/news-details/2014/New-Studies-Show-Cardinal-Health-Specialty-Solutions-Clinical-Pathways-Improve-Cost-Effectiveness-and-Quality-of-Treatment-of-Cancer-and-Rheumatoid-Arthritis/default.aspx. Accessed August 14, 2015.