	Medical costs associated with cancer have increased dramatically, and they are projected to rise much further—to more than $173 billion per year by 2020.

 Many factors are responsible for this rapid rise: greater use of specialty drugs, more patients with cancer as the population ages, and more costly care environments, as more cancer care moves out of community settings and into hospitals.

 Another challenging factor—the variability in costs of care as well as practice&mdash;is being addressed through the evolution of oncology practice guidelines into oncology clinical pathways.

	The wide variation in treatment patterns and costs among oncologists has been long documented and is apparent in many cancer types.

 In the treatment of thyroid cancer, for example, Haymart and colleagues

 found significant variation in multiple aspects of management, in central lymph node dissections, in pre-treatment scans before radioactive iodine treatment, and in all aspects of long-term thyroid cancer management. This included different applications of ultrasound and radioactive iodine scans. Another group of researchers found high variation among physicians in basic items, such as how often surveillance occurred after initial therapy in breast cancer.

		Researchers from the Dartmouth Institute found important differences among patients being treated within the final 2 weeks of life with active chemotherapy (

 which has important implications for the cost of care.

		The move from oncology practice guidelines to clinical pathways in the commercial sector is under way, judging from the deals being announced and consummated. Vendors like McKesson (which owns US Oncology), Via Oncology, and Cardinal Health have been active for several years in the clinical pathways arena. Twenty-eight percent of health plans responding to a 2013 survey indicated that they currently utilize oncology clinical pathways. Another 50% indicated that they would do so within 3 years.

 According to McKesson, up to 1500 oncologists are using its oncology pathways, and Aetna has been a customer for its clinical pathways for about 7 years.

		The reason for this move toward clinical pathways may be that the treatment options listed by today’s practice guidelines are too broad, and these guideline recommendations are not usually based on adequate evidence (see Highlight Box). As an example, Bruce A. Feinberg, DO, chief medical officer of Cardinal Health Specialty Solutions, reported in the National Cancer Institute

		Bulletin that of the 16 possible ways to treat metastatic HER2-negative, estrogen-receptor negative breast cancer, “most of them will never be tested head-to-head to determine which are the most effective, least toxic, and least costly.”

 The idea is to not to wring all variation out of oncology practice, but, according to Via Oncology, to strive for 80% adherence to any single pathway.

		In general, oncology clinical pathways are programs that clinicians can access in real time, during consultations with the patient. For example, McKesson’s “Clear Value Plus” pathway product can connect and work automatically with any electronic health record (EHR).

		As more genomic information is deciphered on a patient-by-patient basis, it makes sense that oncology pathways may become even more popular, to help guide clinicians in their treatment of individual patients with different genetic tumor characteristics. In this case, the number of options in a specific pathway will narrow further to those known to be most effective for a patient with a particular tumor genotype. This can only occur with more evidence-based medicine and comparative effectiveness research. Even traditional providers of oncology practice guidelines, the professional associations, have started to look toward clinical pathways. Recently, McKesson has partnered with the National Comprehensive Cancer Network (NCCN), whose guidelines drive

		government reimbursement. “McKesson has partnered in the last year with NCCN to deliver clinical decision support, including NCCN guidelines and Value Pathways with our Clear Value Plus product,” said Matt Brow, McKesson’s vice president for business development and public policy. “With ready access to NCCN guidelines and Value Pathways Powered by NCCN in the physician’s work flow, physicians and practices have more ways to demonstrate quality when working with payers.” He added that payers would gain more value in this setting if use of oncology clinical pathways means that clinicians are always “green lighted” through the prior authorization system when on pathway.

		A busy oncology practice may have commercial, Medicare, and Medicaid patients. Today, there is little standardization, and this is a difficult problem for community there is little standardization, and this is a difficult problem for community oncologists. As pathways become more popular, there’s a recognition that practices will face administrative challenges if every payer works off a different clinical pathway type. Therefore, it would be preferable to have a common pathway format and approved approach. But so far, the biggest payer of all, the Centers for Medicare & Medicaid Services (CMS), has not moved in this direction.

		In 2011, Medicare spent $34.4 billion for cancer care.

 This represents 10% of its total fee-for-service payments for the year. As 

shows, the majority of patients being diagnosed with cancer are Medicare beneficiaries

; some estimate that 65% of all patients with cancer may be covered by Medicare by 2020. It is well known among payers that commercial plans generally follow Medicare’s lead on reimbursement and coverage, in part to reduce the confusion surrounding distinct and separate policies for many technologies.

		“Most of the progress in reimbursement around clinical pathway development and adoption has been on the private payer side,” according to Brow. As McKesson supports the US Oncology Network, its influence extends throughout this oncology network. “But the federal market is a bit behind the times,” Brow said. “We’ve been pushing CMS to do this for years,” he said, “but they had been more focused on primary care.”

		Finally, CMS is reviewing a proposal by McKesson and NCCN to utilize their oncology clinical pathways. If the proposal is accepted, McKesson believes that CMS will roll it out as a pilot project in certain oncology practices and hospital settings sometime in 2014. “We may be able to work on a framework in the first quarter, and start organizing the pilot perhaps 6 months later,” Brow said. If the pilot is successful after 2 or 3 years, “We hope Medicare will look to roll it out more broadly.”

		McKesson and others are working with CMS to develop a structure for Medicare value-based reimbursement that can be used across oncology practices, using the clinical pathways. Brow also suspects that, if its shared savings programs in primary care are successful, CMS will shift this structure to work with specialty care, like oncology and cardiology, in an effort to drive efficiency and cost-effectiveness in these and other specialties. “We think that, for the most part, the oncologist acts like a primary care provider (or at least a principal care provider) for the patient with

		cancer. A narrower clinical focus may help yield more savings than seen with the primary care model,” he said.

Aligning Incentives to Use Clinical Pathways

		By following clinical pathways, or practice guidelines for that matter, under historical fee-for-service reimbursement structures, community oncologists may be jeopardizing the health of their own

		group practices, based on the type of therapy, where it is administered, and how it is reimbursed. If one considers the usual prompt pay discount of 2% on chemotherapy, and generally a 2-quarter lag in reimbursements, Medicare’s reimbursement formula of average sales price (ASP) + 6% makes it difficult to break even if chemotherapy is administered in the physician’s office.

 The effect of the federal budget sequester has been to lower reimbursement to ASP + 4.2%, forcing many practices to either take a financial loss or direct patients to receive care at an infusion center or hospital outpatient facility, which costs taxpayers more than if the care took place in a community practice.

		“A number of providers could be financially penalized for doing the right thing. If you consistently choose the right drugs,” said Brow, “you could lose money on your business—if the reimbursement system is set up so that using a more expensive drug can be more profitable, or a loser than using a less-expensive drug. The solution is to align across the payment spectrum for efficacy first, safety second, and cost-effectiveness third,” he stated. The incentives in the system, especially on the fee-for-service commercial side, are currently to use more expensive products, services, and drugs, and receive more in reimbursements. Even in Medicare, where hospitals get bundled part A payments and don’t receive additional fees for more diagnostic testing, for example, the hospitals don’t receive financial bonuses for doing the right thing, such as improving readmission rates.

		Brow noted, “Drugs account for about 25% to 35% of the cost of cancer care. The hospital is the greatest cost center. Therefore, we shouldn’t focus on drugs alone. It is not productive to put blinders on and forget that the other 60% exists; all of these costs can be effectively managed.” Clinical pathways must therefore be incentivized across the cancer care spectrum to produce their most beneficial improvements, both in care and expenditures.

		A 2013 study pointed out the potential savings from the use of an oncology pathways program. Using Cardinal Health’s pathways solution, CareFirst Blue Cross and Blue Shield found that total

		costs for cancer care were 15% lower than anticipated costs (without the use of oncology clinical pathways). Inpatient admissions were projected to be 7% lower using the oncology pathways, a major contributor to cost savings.

		However, the question of whether clinical pathways improve care, through reduced variation in oncology care methods, has not been answered. Feinberg, at Cardinal Health, had stated previously that this is “largely an act of faith… You have to look for behavioral changes that you believe represent better care.”

There’s hope that through the use of an oncology pathway system, one can support the use of evidence-based interventions, and these proxies for quality care may lead to real, documented proof that more personalized oncology care guidelines do translate to better outcomes. 

	1. Smith TJ, Hillner BE. Bending the cost curve in cancer care. N Engl J Med. 2011;364(21):2060- 2065.

	2. Brow M, Okon T, Brooks B, Thompson M. Policy prescriptions to fix our ailing delivery system. Community Oncology. 2013;10:368-370.

	3. Dilts DM. Practice variation: The Achilles’ heel in quality cancer care (editorial). J Clin Oncol. 2005;23(25):5881-5882.

	4. Goodman DC, Fisher ES, Chang C-H, et al. Quality of end-of-life cancer care for Medicare beneficiaries: regional and hospital-specific analyses. Dartmouth Institute for Health Policy and Clinical Practice. http://www.dartmouthatlas.org/ downloads/reports/Cancer_report_11_16_10.pdf. Published November 16, 201. Accessed December 18, 2013.

	5. Haymart MR, Banerjee M, Yang D, et al. Variation in the management of thyroid cancer. J Clin Endocrinol Metab. 2013;98(5):2001-2008.

	6. Parmeshwar R, Margenthaler JA, Allam E, Chen L, Virgo KS, Johnson FE. Patient surveillance after initial breast cancer therapy: variation by physician specialty. Am J Surg. 2013;206(2):218-222.

	7. Clinical pathways: an evolutionary approach to cancer care. Oncology Business Review. http:// www.onclive.com/publications/oncology-business-news/2013/april-2013/clinical-pathwaysan-

	evolutionary-approach-to-cancer-care/1. Published June 14, 2013. Accessed December 18, 2013.

	8. Phillip C. Clinical pathways in cancer care catching on. NCI Cancer Bulletin. 2012;9(17):1-5.

	9. Stockdale H, Guillory K. Lifeline: why cancer patients depend on Medicare for critical coverage. American Cancer Society Cancer Action Network 2013. http://www.acscan.org/content/wp content/uploads/2013/06/2013-Medicare- Chartbook-Online-Version.pdf. Accessed December 23, 2013.

	10. Mehr SR. Sequester forcing chemo treatments into hospitals costing taxpayers more in the end. Am J Manag Care. 2013;19(SP6):SP207-SP208.

	11. Feinberg BA, Milligan S, Cooper J, et al. Third-party validation of observed savings from an oncology pathways program. Am J Manag Care. 2013;19(SP4):SP127,153-157.

Articles

Evidence-Based Oncology

Is Medicare Ready for Oncology Clinical Pathways?

	Few places put as much emphasis on value-based healthcare as Washington state does. From a governor whose workplace wellness program for state employees requires progress reports every 6 months,

to the Health Care Authority’s quest for $51 million from the federal government to revamp Medicaid delivery,

 words like “prevention” and “outcomes” populate every message.

	Healthcare reform, as envisioned by the 2010 Affordable Care Act, was a process both the former and current governors fully embraced. Like his counterpart in Kentucky, Washington Governor Jay Inslee presents the expansion of coverage as both a moral imperative and competitive necessity; he says the ACA rollout “has presented us with the ideal opportunity to implement the

	kinds of costsaving, health-improving reforms that will help us achieve those goals.”

	In the realm of cancer care, Washington state’s relative success in adding nearly 250,000 to the ranks of the insured by January 1, 2014,

 including 121,258 adults previously not eligible for Medicaid,

 would seem to put the state on a course of continuing its better-than-typical response to the disease. Washington’s early enrollment numbers, along with the governance and performance of its exchange, have put it among a handful of states receiving good reviews in the ACA rollout.

		Data from 2010 show Washington’s cancer story is mixed. It is among the top 10 states in the nation for cancer incidence, at 472.2 cases per 100,000, compared with 445.5 nationally. But its death rates are lower: 169.6 per 100,000, compared with 171.8 nationwide, according to the Centers for Disease Control and Prevention (CDC). Except for slightly elevated rates of melanoma, the types of cancer seen in Washington mirror the nation’s (see 

		In 2001, Washington formed the Comprehensive Cancer Control Partnership and has a statewide blueprint, the Washington State Comprehensive Cancer Control Plan, which is updated every

		4 years. Prevention and screening are emphasized, and both are a natural for a culture with greater focus on fitness and health than some parts of the country. Still, Washington state has issues with disparities; low-income pockets suffer higher rates of cancer, and tribal and rural health merited special notice throughout the Health Care Authority’s recent federal grant application.

Tobacco use is common among lower-income groups, and Native Americans suffer high rates of lung cancer, for example.

		There’s a new concern, too. A reorganization of state funding for healthcare programs generally will mean a phaseout of state funding to Washington’s Breast, Cervical and Colon Health Program (BCCHP), which through the end of 2013 provided free screening for these diseases to low-income residents. Women diagnosed with cancers were moved immediately into treatment.

		As of January 1, 2014, Washington’s BCCHP is still screening some patients, but the potential for gaps exists, according to Megan Celedonia, program manager. Those screened and diagnosed with cancer no longer have access to the companion treatment program, and BCCHP can no longer screen patients with insurance. About 75% of the program’s former target population will be eligible for Medicaid under ACA. The rest would have to sign up for subsidized coverage, but Celedonia cautions that not all will be eligible, and some will not have funds

		“We can’t expect that all will enroll on to insurance programs immediately,” Celedonia said. “We expect that our clients will continue to need our program. Some will be diagnosed and will need

		access to treatment. We need safety net services.”

		Is the phaseout of the screening program an anomaly in a state that, from all other appearances, puts a high value on healthcare? Or is this what the transition of healthcare reform is all about:

		Moving the population away from the mind-set of safety net “services” into one in which being insured is the safety net?

		What’s evident is that Washington state is in the process of embracing value-based care, of which the expansion of coverage under the ACA is merely a part. In December, Washington’s

		Health Care Authority, which runs Medicaid and other state healthcare programs, unveiled its State Innovation Plan,

 a venture that involved multiple agencies and Governor Inslee’s office.

		• move 80% of Medicaid spending into outcome-based models

		• create regional “accountable communities of health,” for measuring clinical and community factors that affect Medicaid populations

		• better integrate physical and behavioral health

		• promote better healthcare IT. For cancer, this will include basic items like ensuring that tumor data from Washington’s rural counties are reported to the National Cancer Institute’s Surveillance, Epidemiology and End Results program. A map for 2010 had no data from the eastern counties

		In rolling out their plan, officials from Washington’s Health Care Authority vowed that whatever the result of their pursuit of the grant, the commitment to value-based healthcare is here to stay. “We’re getting geared up for implementation efforts with or without federal dollars arriving,” Nathan Johnson, director of healthcare policy at the HCA, told a Puget Sound publication.

		Some insurers like Group Health Cooperative, which accounts for about 10% of the state’s market share, already take value-based practices quite seriously; Melinda Hews, executive director, health insurance exchanges, at Group Health, said all members, regardless of how they access Group health coverage, “receive care through a capitated medical home model.” (E-mail communication, January 2014.)

		In the first year of benefit design, not all insurers are as advanced, but Hews expects this will change. “I think this will mature in subsequent years as new pay-for-performance models of provider contracting gain traction and benefits may be designed differently to support that,” Hews said.

		If Washington state’s efforts take hold, more cancer care will be delivered the way it is within the Group Health Cooperative, which covers 600,000 people in Washington and Idaho.

 The cooperative’s use of clinical pathways has a national reputation, one that Eric Chen, MD, PhD, a medical oncologist who practices within the plan, appreciates not only for its ability to deliver good care but for his ability to help his patients understand their disease.

		The pathways approach created evidence- based treatment approaches that go beyond therapies that are approved by the US Food and Drug Administration (FDA) or within guidelines of the National Comprehensive Cancer Network (NCCN). Pathways prevent outliers from allowing poor quality care or driving up costs unnecessarily.

		“If there is a new standard of care, we can implement something so that everyone does the same thing,” Chen said. “It’s very easy for everyone to get on the same page.” He said pathways help doctors and payers overcome the “inertia” that works against doing things differently.

		Chen has spent his entire post training career practicing medicine this way; to him, it allows the best therapies to rise to the top without external pressure. He knows, however, that not everyone

		“There are people who criticize pathways; they say, ‘that’s robot medicine.’ There’s a lot in medicine that we can do by algorithm, but the algorithm can only carry you so far. It takes a human being to make the decisions,” Chen said.

		Getting people to see the value proposition of being insured is going to take time, and it’s going to take education, according to Michael Marchand, communications director at the Washington State Health Benefit Exchange. Marchand spoke to Evidence-Based Oncology last fall, after surveying Washington’s experience compared with the first rocky weeks of the federal website, healthcare.gov. He attributes Washington’s early success to strong bipartisan leadership that recognized the state would be best served if it tailored an exchange to its unique qualities. Given its workforce, that meant creating a user experience that didn’t feel like government.

		Marchand said Washington’s exchange creators made a key decision to reject a recommendation from a technology conference—attended by all the major exchanges including healthcare

		.gov—to require users to register before they could browse for coverage. “That single recommendation drove a lot of the decision making for healthcare.gov,” Marchand said. “We chose to ignore it…We wanted to set up a consumer experience more like Amazon.com.”

		In the first few weeks, Washington saw 17% of the purchasing among consumers aged 55 to 64 years, which did not surprise Marchand at all. “These are people who have been insured at some other point in their life. They probably need it, so they are the quickest to react,” he said. Many of the so-called “young invincibles” will wait until the last minute before penalties begin this spring, because that’s “human behavior.”

		“Insurance isn’t top of mind—until you get sick. Then, it’s important,” Marchand said.

		To change that mind-set, Washington state’s exchange staff meet with small businesses to link healthcare reform to economic health. Being insured goes hand-in-hand with being productive,

		Marchand said; there’s nothing wrong with getting insurance at your job, but if that’s the only place you can get it, it limits self-employment and entrepreneurship. Washington state is creating a system that will allow its “start-up” mentality to flourish, he said, because small businesses will have a way to cover employees that did not previously exist.

		Washington state’s strong start has been helped by community support, Marchand said. Ten lead organizations, 1400 in-person assisters (or navigators), 2000 agents and brokers, and scores of customer service personnel have all done their part to get the process off the ground, he said. “I have never seen anything like it,” said Marchand, who has worked in healthcare for a long

		“People understand that if you have healthcare, it helps with everything. Everyone wins when people are insured,” he said. “We all benefit as a state, and as a society if people can have healthcare.” 

	1. Governor Inslee directs Health Care Authority, Department of Health to streamline state’s approach to employee wellness [news release]. Olympia, WA: Office of Washington Governor Jay

	Inslee; November 21, 2013. http://governor. wa.gov/news/releases/article.aspx?id=174 Accessed January 14, 2014.

	2. Washington State Health Care Authority. State Health Care Innovation Plan. http://www.hca.wa.gov/shcip/Documents/SHCIP_InnovationPlan_121913.pdf Published December 2013. Accessed

	3. Office of Governor Jay Inslee website. Issues, health care. http://www.governor.wa.gov/issues/ health/default.aspx Accessed January 14, 2013.

	4. Washington Healthplanfinder enrollment increases to nearly 250,000 [news release]. Olympia, WA: Washington Health Benefit Exchange; January 7, 2014. http://www.wahbexchange .org/news-resources/press-room/press-releases/jan-7-enrollment-report. January 14, 2014.

	5. Vestal C. The Pew Charitable Trusts. Why some state-run Health Exchanges worked. http://www.pewstates.org/projects/stateline/headlines/why-some-state-run-health-exchangesworked-

	85899525479 Published December 10, 2013. Accessed January 14, 2013.

	6. Centers for Disease Control and Prevention. 2010 State Cancer Facts. http://apps.nccd.cdc.gov/StateCancerFacts/state.aspx?state=Washington. Accessed January 14, 2014.

	7. Centers for Disease Control and Prevention. 2010 State Cancer Facts. Washington, Lung andbronchus, data by race and ethnicity. http://apps.nccd.cdc.gov/StateCancerFacts/RaceAnd-Ethnicity.aspx?Group=2a&SelectedState=Washington&TableType=INCI&Gender=mf&CancerType=Lung%20and%20Bronchus&SurveyInstanceQuestionID=6672. Accessed January 14, 2014.

	8. Washington State Department of Health. Impact of Health Reform on the Breast, Cervical, and Colon Health Program. https://www.citrinehealth.org/images/PDF/BCCHP/Partner_Training/HCRandBCCHP-FactSheet-Print.pdf. Published August 2013. Accessed January 14, 2013.

	9. Musazay A. Washington’s Innovation Plan seeks federal grant to overhaul health care system. Puget Sound Business Journal. http://www.bizjournals.com/seattle/blog/health-careinc/2013/12/states-innovation-plan-seeks-federal.html?s=print. Published December 20, 2013. Accessed January 14, 2013.

	10. Group Health Cooperative website. Overview. https://www1.ghc.org/html/public/about/overview. Accessed January 14, 2014.

In Cancer and Beyond, Washington State Making the Transition to Value- Based Care

	As cancer increasingly becomes a disease of survivors, oncology sees a need for navigators to help patients identify and pay for appropriate treatment. Navigators also help patients deal with the often overwhelming pressures of maintaining a normal life while managing a potentially fatal disease. So far, however, there is little agreement on how narrow or broad a patient advocate or navigator’s work should be—or how to measure the results.

	While the idea of a patient navigator is at least 2 decades old,1 the role has garnered more attention since the 2005 Institute of Medicine (IOM) report, “From Cancer Patient to Cancer Survivor: Lost in Transition,”

 which detailed the myriad new challenges to providing quality care to patients who are living longer.

	Patient navigators are often oncology social workers; some have special training in helping cancer patients from medically underserved populations overcome barriers to appropriate care. Studies of Latino patients suffering from breast and colon cancer found “The presence of patient navigation can be an effective means to reto care in minority populations and can improve outcomes.’’

 A survey of impoverished African American women diagnosed and treated at a public hospital for breast cancer found that their patient navigation needs began with improving their access to quality care, but evolved to include addressing their emotional and practical problems, as well as family concerns.

 The best results came from a sustained relationship with the patient, from diagnosis into long-term survivorship.

	The concept of training patient navigators was created by Harold P. Freeman, MD, of Harlem Hospital Center in New York City. Freeman, as president of the American Cancer Society, in 1989

	chaired public meetings to hear from impoverished cancer patients in all 50 states. Freeman wrote that the hearings revealed how “Poor people experience substantial barriers when seeking timely screening, diagnosis, and treatment of cancer.’’

	Freeman founded the nation’s first patient navigation program in 1990 at Harlem Hospital to address the problems uncovered by patient testimony. In a widely cited 2006 paper,

	that patient navigators helped improve the 5-year survival rate among poor women treated at the hospital, about half of whom lacked health insurance, due to the assistance of patient navigators.

	The 5-year survival rate for breast cancer patients at Harlem Hospital Center, prior to the patient navigation program, was 39%, but that figure rose to 70% for a demographically similar group

	of patients aided by patient navigators. Freeman attributed the results to 2 factors: first, effective public education efforts increased the number of women receiving affordable mammograms; second, the navigators’ work in aiding patients in overcoming barriers to prompt, appropriate treatment, as determined by the screening results.

	The 2005 IOM report recognized survivorship as “a distinct phase of cancer care.”

 The recommendations stressed that every cancer survivor requires a “survivorship care plan,’’ understandable

	to the patient, to coordinate care and also advise the survivor about support groups and similar resources.

 Ellen Stovall, senior health policy advisor for the National Coalition for Cancer Survivorship and a 3-time cancer survivor, said the services of a skilled navigator are required most when the patient is receiving the diagnosis.

	“The diagnosis slams you against the wall,’’ she said. “The most important decision is the first round of treatment. Before a person decides that, they need a patient navigator to demystify what

	will happen and help them articulate their goals so the patient can navigate his or her own cancer treatment. If you are diagnosed with acute leukemia, you need to start treatment quickly, but if you have a solid tumor, you likely have weeks to decide what to do. But the reality is, people usually decide in the first 40-minute extended office visit. Most people would take longer to decide on

	Stovall said there are no agreed-upon core competencies for a “patient navigator,” but notes some hospitals advertise the service.

	“The job definition isn’t clear but the process is helping people with decision making, coordination of care, working with local agencies, finding the right referrals, helping special populations,’’ she said. “A hospital I know that is very well ranked and respected advertises one of the best navigator programs around, but people working there tell me the navigator mostly gets the person through the billing department. In some places, the patient navigator is in charge of coordination of care, with the work relegated sometimes to people who are not trained for it, but sometimes to people who are overqualified. The term is used very broadly.’’

	The LIVESTRONG Foundation offers wide-ranging navigator services, at no charge, online, by telephone, and in person. Its website offers information in lay terms in categories with titles such

	as just diagnosed, preparing yourself, and insurance/financial assistance.

 The LIVESTRONG Guidebook for the newly diagnosed patient includes practical advice like lining up help with driving,

	“Nobody should be alone when they have cancer,’’ said Sarah Gomez Wauters, LIVESTRONG outreach coordinator. “Cancer throws a person into a new chapter of life. People don’t know everything that comes along with the diagnosis. Nobody is thinking if you have cancer you might not be able to have children, depending upon your diagnosis. You think you are covered, until you find out not everything is paid for. If you are the breadwinner, you might be unable to work, and that income is gone. No diagnosis is the same, no journey is the same, so we provide individualized care.’’

	Rose Gerber, now director of communications and patient advocacy for the Community Oncology Alliance (COA), was thunderstruck in 2003 when, at age 39 years with 2 young children, she received her diagnosis of early onset breast cancer with cancer in the lymph nodes, large tumor, HER2+ and BRCA abnormality. Her ultimately successful treatment was a grueling regimen of intravenous chemotherapy and radiation, followed by participation in a 52-week clinical trial of Herceptin, Zoladex injections for 4 years, and Tamoxifen for 5 years. There was no system in place for coordinating care with the dozen specialists, primary care physicians, and complementary care providers she saw over the years, but the informal monitoring was good.

	“About 5 years after my diagnosis, I was having a routine exam with my ophthalmologist. He made a note about my cancer treatment,’’ recalled Gerber. “The first thing he said to me after the

	examination was ‘The good news is there is no metastasis to the eye.’ That almost knocked me over. I didn’t go to the ophthalmologist because I was worried about cancer. That was the first time I learned my cancer could metastasize to the eye.’’

	Anne Slam, administrator for 23 years at Eastern Connecticut Hematology and Oncology where Gerber has been treated since her diagnosis, said coordinating care and assisting patients in finding help paying for care were not part of patient care years ago, but are now.

	“There are more treatments, better treatments, and patients are now treated for years, which is all good but has its own challenges,’’ Slam said. “People need help. A lot of it is time consuming, and we can’t get paid for everything all the time, but we do it.’’ 

	1. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61(4):237-249.

	2. Institute of Medicine. From cancer patient to cancer survivor: lost in transition. http://www.iom.edu/Reports/2005/From-Cancer-Patient-to- Cancer-Survivor-Lost-in-Transition.aspx. Released November 3, 2005. Accessed January 10, 2013.

	3. Robie L, Alexandru D, Bota DA. The use of patient navigators to improve cancer care for Hispanic patients. Clin Med Insights Oncol. 2011; 2(5):1-7.

	4. Davis C, Darby K, Likes W, Bell J. Social workers as patient navigators for breast cancer survivors: what do African-American medically underserved women think of this idea? Soc Work Health Care. 2009;48(6):561-578.

	5. Freeman HP. Navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006;83(2):139-141.

	6. LIVESTRONG website. LIVESTRONG Cancer Navigation Services. http://www.livestrong.org/ we-can-help/navigation-services/. Accessed January 11, 2014.

	7. LIVESTRONG website. LIVESTRONG Guidebook. http://www.livestrong.org/we-can-help/guidebook/. Accessed January 11, 2014.

Defining, Measuring, and Paying for the Work of Oncology Patient Navigators

	If a man who has symptoms of prostate cancer but a negative biopsy could use a test to avoid a second biopsy, wouldn’t that test make sense? It might, but it might not. The decision to pay for the test could rest on whether the man’s insurer, which often is Medicare, thinks his doctor will act based solely on the test’s outcome.

	This is the world of “clinical utility,” where in recent years, proving a test’s accuracy no longer pushes it past the finish line for payers.

	Recent efforts by MDxHealth, based in Hertsal, Belgium, and Irvine, California, to market its ConfirmMDx epigenetic test for prostate cancer—and to gather data to support broader availability&mdash; crystallize the competing forces at work in the molecular diagnostic marketplace, as clinical utility has emerged as the new bar for reimbursement.

	Why the change? It comes down to a single word: Cost.

	In the decade after the sequencing of the human genome, there’s been an explosion in personalized medicine, along with a rapid rise in new cost categories that didn’t exist just a few years ago.

	A March 2012 white paper published by UnitedHealthcare said the payer spent $500 million on genetic and diagnostic testing in 2010, which represented 14% more per person than in 2008. Extrapolating on its own data, United Healthcare pegged the 2010 total for Medicaid and Medicare at $5 billion, or 8% of all national spending on clinical laboratory tests.

	The concept of personalized medicine—matching the right drug to the right patient at the right time&mdash;holds out the promise of driving down costs over time, as therapies are used with precision, leaving less waste and fewer side effects. But for a test like ConfirmMDx to save money demands that physicians practice medicine differently, relying on a test instead of a second biopsy.

	As new genetic and biomarker-based tests emerge, not all payers are convinced that physicians are ready for change. The bar of clinical utility requires test makers to prove that their diagnostic tool is the factor that drives decisions, not a belt-and-suspenders add-on that simply gives doctors more information.

	Therein lies the conundrum. Beth Davis, senior director of health policy and reimbursement for MDxHealth, said “clinical utility” means showing that a test has value to doctors in real-world settings. And proving that value can be difficult if payers won’t reimburse for the test, because that has the practical effect of making it unavailable to most patients.

	Clinical utility, Davis said, “is a big, evolving discussion right now, because it means different things to different people.” Essentially, she said, “You’re measuring physician behavior.”

	In the case of ConfirmMDx, the test maker is not only making the clinical argument that the test works, but also the economic argument that it saves money by preventing unnecessary second

	and third biopsies. Davis made her case December 4, 2013, at the Philadelphia meeting, Oral Oncolytics, including data that show 700,000 men have repeat biopsies annually because the standard 12-core method can miss a growing cancer

	Used in lieu of repeat biopsies, ConfirmMDx could save $588 per patient on average, or $500,000 a year for a commercial health plan with 1 million members, according to results published in

The MDxHealth website has a growing list of commercial plans that reimburse for the test, and it continues to highlight results about the test’s validity.

	Prostate is the most common cancer among men, except for skin cancer; it is the leading cause of cancer deaths among men behind lung cancer. The American Cancer Society estimated that

	238,590 new cases would be diagnosed in 2013, with 29,720 deaths.

	At the same time, the rise of cancer screening with the prostate-specific antigen (PSA) test over the past 20 years means that 2.5 million men who have had prostate cancer are alive today.

	Widespread screening has saved lives but also increased costs and for some, complications. There is increased promotion of a “wait and watch” approach to those tumors that are not aggressive, and questions about the value of PSA testing led the US Preventive Services Task Force (USPSTF) to issue a highly controversial D rating for the popular screening.

	Since most prostate cancer diagnoses occur among older men, cost implications of large-scale PSA testing are huge. A study published just this month in 

tracked almost 95,000 men in Medicare, aged 66 to 99 years, who had never had prostate cancer, for 3 years.

 Just over half, or 51.2%, had PSA tests during the period, with 2.9% having a biopsy.

article noted, 72% of the costs associated with PSA screening came from “downstream biopsy-related procedures,”

 and not from the screening itself; if those costs could be mitigated, discussion over the controversial D rating from the USPSTF might shift from how to not screen to how to limit the number of biopsies that result.

	ConfirmMDx still relies on biopsy as what Davis called the “gold standard,” but it recognizes that the standard 12- core method might miss cancerous tissue. ConfirmMDx seeks to confirm the presence of an epigenetic “halo” that exists around a tumor, which might be present even though the cells look normal under a microscope.

	The test relies upon DNA methylation, a biochemical process that can alter gene expression as cells divide and result in the silencing of tumor suppressors. When DNA methylation goes awry, unfolding either too quickly or too slowly, cancer can result. This process does not happen all at once; thus, DNA methylation can be used as a readout for a pre-cancerous or cancerous state.

	If a patient has a negative biopsy but a positive result with ConfirmMDx, the doctor can either treat as if the patient had a positive pathology result, or limit additional cores to the area of known “hot spots,” reducing costs, discomfort, and side effects, according to Davis. Thus, the ConfirmMDx test can not only limit costs but also improve quality of life.

	Epigenetic test results may also help determine how aggressive the prostate cancer is and guide treatment, based on data presented at the American Society of Clinical Oncology Genitourinary

	(ASCO GU) Cancers Symposium in San Francisco on January 31, 2014. In the results, low methylation levels corresponded to low Gleason scores

; this is significant because the same material collected at biopsy and used to determine if treatment is needed could also be used to determine if the cancer is aggressive, Davis confirmed.

	Given the uproar over the USPSTF rating of D, however, multiple methods are emerging to spot prostate cancer and gauge its aggressiveness. On the detection front, a study published just this

examined the use of multiparametric magnetic resonance (MR) imaging to detect prostate cancers in low-risk patients.

 Not surprisingly, researchers found that MR imaging was more reliable in detecting larger cancers (1 cm3 and Gleason score of 7 or above) than smaller cancers, but was reliable overall.

	ConfirmMDx has competition in the realm of testing for cancer aggressiveness. At the same ASCO GU symposium, Myriad Genetics presented results from the PROCEDE 500 registry study, which measured clinical utility for its cell-cycle progression signature test, marketed as Prolaris. So far, data are available on 294 patients across 15 urology practices, with physicians indicating that test results would lead to a definite or possible change in 32% of cases.

	A discussion of clinical utility appeared in the literature in December 2010, when Bruce Quinn MD, PhD, an influential contributor to discussions of payment reform in Medicare and Medicaid, wrote an article in 

 that addressed decision-making frameworks for payers to use when evaluating companion diagnostics.

	Over the course of 2011, the ground shifted for test makers from clinical validity, which asks whether the test correctly measures what it is supposed to measure, to clinical utility, which asks if the test is the critical item that guides or even changes physician behavior.

	By 2012, the Baltimore-based Center for Medical Technology Policy (CMTP) began an effort to develop an Effectiveness Guidance Document, or EGD, in the area of molecular diagnostic testing.

 This process, which was supported by leaders in the pharmaceutical and diagnostic testing industries as well as by payers, represented a multi-stakeholder effort to develop criteria for evaluating tests used in personalized medicine.

	A report published May 1, 2013, outlines in its executive summary 10 items in the areas of reporting, clinical validity, and clinical utility to be used when evaluating tests, and notes that the very nature of such tests requires innovative payment approaches, including some that must be approved on a case-by-case basis.

	Davis noted that clinical utility is only measured after a diagnostic test is commercially available. “For diagnostics in general, it can sometimes be more difficult to prospectively randomize testing due to variance in practice,” with urology being a good example, she said. The CMTP report, she said, provides a “balanced framework” for creating avenues for reimbursement while evidence of clinical utility is still being developed. 

	1. Crawford JM, Aspinall MG. The business value and cost-effectiveness of genomic medicine. Personalized Medicine. 2012;9(3):265-286.

A Test to Prevent Repeat Prostate Biopsies? Perhaps, if the Bar of 'Clinical Utility' Can Be Met

 convened an expert panel to address emerging issues in the treatment of prostate cancer. According to a 2012 report from the American Cancer Society, prostate cancer is the most common cancer among men, accounting for 43% of all cancer cases among men in the United States.

 Panelists addressed current controversies over when and how often to screen men for prostate cancer, as well as which treatments should be given to which patients. This transcript has been condensed.	

 head of Urologic Oncology at The University of Colorado at Denver, University of Colorado Hospital,	

medical director, The Carolina Urologic Research Center, Myrtle Beach, SC.	

Prostate Cancer Screening: Is the PSA Test Still Valuable?

A. Mark Fendrick, MD, opened the discussion by asking panelists to respond to the controversy surrounding the 2011 recommendation from the US Preventive Services Task Force (USPSTF), which called for not screening men without symptoms using the prostate-specific antigen (PSA) test.

 The recommendation has been criticized in some circles and was followed with a separate recommendation from the American Urological Association (AUA) that screening on asymptomatic men not occur until 55 years.

 As Fendrick explained, the apparent competing recommendations “have made it quite confusing for general internists like myself,” as well as stakeholders—including payers who must decide whether the PSA test will be covered. Dr Fendrick invited comment from Neal Shore, MD, and E. David Crawford, MD. Dr Crawford has published on this topic and is currently involved in the PLCO trial (prostate, lung, colorectal, and ovarian screening).

 This is one of the more controversial areas in prostate cancer and early detection. In 1989, prostate cancer became the most common cancer in American men, and the second leading cause of death. Most of the cases that were diagnosed were advanced. When the maximum PSA test came out, the thinking was that mortality rates could be reduced with screening for early detection.

	What happened was we were too successful—the pendulum swung from late diagnosis to an over-diagnosis of cancer. We were finding small cancers and overtreating people. The real controversy is very simple, I think, you need to separate diagnosis from treatment.…

	The backlash occurred, and it needed to occur, but now we need to get some equilibrium and really identify who will benefit from treatment. Thirty thousand men are still dying from prostate cancer, and we need to whittle away at that.	

 I completely agree. We have this conundrum: We have many patients who do not need treatment, and yet we have many patients who need aggressive treatment. We have 250,000 men who get newly diagnosed with prostate cancer, and much of the data would suggest anywhere from 30 to 50% have a very unaggressive or low-grade form of the disease and would benefit from monitoring, or what some call active surveillance. We have not done a great job of that, but we now are on the cusp of doing a much better job with additional biomarkers and assays.	

	At the same time, there are 50 to 60% of men who need active interventional treatment, whether it is surgical removal or radiation or cryoablation. And so the task force recommendation of D (which states there is “moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits”) has uniformly been met with disdain and shock by the urologic community, because it was just too severe.	

Dr Fendrick asked for comment on the emerging concept of a “team-based” approach to cancer treatment, which encourages greater integration and cooperation among all those involved in a patient’s care, including medical oncologists, urologists, radiologists, and even nurse practitioners.

 We have had a multidisciplinary team in place for several decades.… It is tough to get all of the specialities together, and we do not all agree. Now what we have shown, and this has been shown not only with our group… is that folks who are treated in our multidisciplinary clinic actually have better survival rates than do patients in Colorado who do not. It is not just that selection bias, because we do get some tough cases.…This does make a difference, and men appreciate it.	

	What sometimes happens, unfortunately, is that if the practice has a robotic machine and everybody needs to get a robotic prostatectomy, you think it is great. If you have IMRT (intensity-modulated radiation therapy) or protons, then that is what you do.…	

February 2014

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