	If palliative care were a new cancer drug on the market it would be broadly embraced, heralded for its ability to improve the quality of life of cancer patients and, in the case of those with metastatic lung cancer, extend life by 2.7 months.

 Instead, palliative care is a process unevenly funded by insurers and far from universally available, said Marian Grant, DNP, RN, CRNP, and assistant professor at the University of Maryland School of Nursing.

	Grant’s talk, “When Is the Right Time for Palliative Care?” began the first evening of Patient-Centered Oncology care in Baltimore, November 13, 2014. She answered her own topic question unequivocally: “The right time for palliative care is the sooner the better, and the evidence supports that,” she said Grant’s talk at the 2-day session hosted by The American Journal of Managed Care outlined the many barriers to making palliative care a standard practice in cancer treatment. A lay person often confuses the term with hospice, which is a form of palliative care limited to those within the last 6 months of life, though in practice few patients get the full 6 months of hospice. One big reason is that the patient must make the wrenching decision to cease curative treatment to enter hospice.

	“I have a background in sales and marketing,” Grant said. “I am a pretty good salesman, but I can’t sell anyone on the idea of ceasing treatment they believe is extending their life.” 

	Palliative care, taken more holistically, is “an extra layer of support,” she said, that meets the emotional and spiritual needs of both patients and their families, who both suffer from a wide range

	of stress in addition to pain and other physical symptoms. “That sounds a little fluffy, but when you explain it to patients and their families, it sounds pretty good to them,” she said. Palliative

	care supports patients and families as they consider how to manage end-of-life treatment before events sweep the patient into intensive care they don’t want and which can’t extend their lives,

	Grant explained. In that way, palliative care saves money, but increasingly, the evidence shows that it actually extends life as well.

	Grant cited a well-known study of lung cancer patients published in the 

 in 2010. Half the patients were given usual standard of care and half were given an intervention of palliative care. The finding that those who received palliative care had better quality of life and less depression was not a surprise; but the improved survival time caught the attention of the medical world, including the American Society of Clinical Oncology.

To fully achieve those benefits, palliative care needs to begin as early as diagnosis.

	“I get called all the time very late in the game,” Grant said, adding that she is often not consulted until patients are in intensive care. “Families often tell me, ‘You know, she never would have wanted any of this.’”

	Options are changing with the Affordable Care Act. Pediatric patients can have curative treatment and hospice at the same time. The Center for Medicare and Medicaid Innovation is running trial studies to allow this option for adults, too, Grant said.

	Grant believes the biggest challenge is the seemingly impossibile one of training enough specialists. There will never be enough specialists, and they will be concentrated in large hospitals and academic medical centers, so nurses and oncologists need to be “deputized” with training in the basics of palliative care to make it available in outpatient clinics and rural communities, Grant said. “There’s no evidence of harm, or excessive costs for doing so,” she said. “There are a lot of pros and very few cons.” 

	1. Temel JS, Greer JA, Muzikansky A. Early palliative care for patients with metastatic non-small cell lung cancer. N Engl J Med. 2010;363(8):733-742.

Articles

Evidence-Based Oncology

For Better Quality of Life, Start Palliative Care Early in Process

	Payers can do more to promote survivorship, but most have already made a significant start, said Ira Klein, MD, MBA, FACP, national medical director, Clinical Thought Leadership, Aetna. Klein’s talk, “Making the Grade on Survivorship: How are Payers Performing?” helped open Patient-Centered Oncology Care 2014, hosted by The American Journal of Managed Care in Baltimore, Maryland. While his remarks were specific to initiatives at Aetna, most insurers have a similar focus. The shift toward supporting survivorship is a natural result of more effective treatments, which means that cancer has become a chronic disease for many patients, requiring holistic, long-term management.

	Patients receiving cancer treatment take an average 90 to 120 days of disability, and employers are looking for ways to help these patients return to work earlier to be fully productive, Klein said. Patients naturally seek “more peace, a longer life, and a more productive life.” Grounding treatment in evidence-based approaches and survivorship programs can begin prior to chemotherapy to meet the goals of all concerned. Holistic survivorship begins with screening and informing individuals of their cancer risk. Screening requires educating patients and their families about genetic testing and whether a cancer has a hereditary component. To gauge patients’ cancer risk, the Aetna website allows them to provide information on their family history of cancer. “Education on

	the genetics of cancer is an important part of screening,” Klein informed attendees.

	Aetna’s approach to wellness includes risk identification, encouraging changes in diet and exercise, self-directed online virtual care, and 24-hour nurse support. “If you have cancer and you understand you need to keep taking a daily walk, you need to keep eating well, you can’t pick up smoking again, you are going to come out better on the other end,” Klein said. Physicians invariably believe they are using evidence-based treatment, but Klein cited data from an internal Aetna study that found this was true just 62% of the time, The percentage increased to 87% in a pilot program within Aetna that provided doctors with a clinical decision support system, based on guidelines from the National Comprehensive Cancer Network and the American Society of Clinical Oncology.

	A study centered on patients with non-small cell lung cancer found that providers following guidelines and documenting their treatment reduced costs up to 35%. “The value equation is, ‘What can you do to improve the quality and reduce the cost?’ We’ve seen in studies you can reduce costs and have the same or better outcomes,” Klein said. The insurer is paying physicians for preparation of care summaries. “A lot of patient information” is an important aspect of evidence-based treatment to improve outcomes. “This is important because if the patient has a chaotic journey through their cancer treatment, they are not set up for good survivorship care,” he said.

	Effective case management is acutely important at diagnosis and discharge, the crucial transitions for patients. Navigators are important for guiding the patient through bewildering and often frightening treatments, and the practical considerations of undergoing chemotherapy. Aetna has programs to begin case management prior to chemotherapy, a time when navigators play an important role in helping patients with practical matters and setting the stage for survivorship. The conclusion of treatment is a key juncture, particularly for patients requiring palliative care that is “still applied extremely unsystematically,” Klein said. “Any time you see something that is not applied systematically and is all over the place, you can guess there are not best practices and efficiency applied.”

As Cancer Becomes a Chronic Condition, Payers Shift Focus to Survivorship

	Jan Berger, MD, MJ, moderator of the panel discussion “Payer, Provider, and Patient Roles for Understanding the End-of-Life Care Equation,” opened the session asking the room filled with

	oncology health professionals and insurers for a show of hands: How many had advance directives?

	About half did. She then told the story of a curious family dinner at her parents’ home a dozen years earlier; her parents had invited an attorney, unknown to any of them, and instructed every family member to work with him to complete an advance directive before any could enjoy wine and the meal. “We made fun of it for years. None of us realized that within the following 10 years, twice, with my father and my brother, we would need those advance directives,” she said.

	The panel was part of the November 13, 2014, session for Patient-Centered Oncology Care, held in Baltimore, hosted by The American Journal of Managed Care. Panelists included Amy Berman, BS, RN, of The John A. Hartford Foundation, who has received palliative care the past 4 years for her stage 4 inflammatory breast cancer; Bruce Feinberg, DO, of Cardinal Health Specialty Solutions; and Patti Forest, MD, MBA, senior medical director at Blue Cross Blue Shield of North Carolina. Each described a thicket of barriers—personal among patients and providers, institutional among payers, and cultural for all&mdash;that prevent the discussion of advance directives with cancer patients before it’s too late for them to control the course of their treatment.

	Berman began her remarks by telling the story of a pin she wore that belonged to her grandmother, Shirley Dinnerstein, the plaintiff in a landmark 1978 Massachusetts case that determined

	a person does not have to go to court to have his or her end-of-life wishes honored. “It is the precedent for the advanced directive,” Berman said. She attributed the fundamental resistance

	to making advanced directives a normal part of healthcare planning, well before need, to a deep cultural reluctance to accept the inevitability of death. “Death is simply part of the life cycle, and we

	Feinberg said palliative care needs must become part of the curriculum for training doctors while, more broadly, a general shift in the culture must occur to accept advanced care planning as a

	normal part of medicine. He described data that showed 75% adults 65 years and older are not “health literate.” Feinberg asked, “What is the education we can provide (patients), and can that

	education be received as it needs to be received so the patient can make the decision? I struggle with how to convey the information to them because, in the end, if it becomes the doctor making

	the decision, we have not accomplished the goal.”

	Said Forrest, “The fear from the payer perspective is even bringing (palliative care) up, for fear the patient or provider will think we are just trying to save money. That has held back many

	organizations in the past, but the time is ripe for the conversation around it.” She said one thing payers can do is to simply begin to pay doctors for having conversations with patients about palliative care. Berger, who said her family experience has made her “a passionate zealot” for advance directives, noted the allegation made during debate over the Affordable Care Act that compensating doctors for discussions of palliative and hospice care amounted to creating “death panels.” “We took a few steps backward then,” she said.

	Forrest, summarizing the consensus of the panel, said the best rebuttal to those who denigrate discussion of palliative care is the research that supports it. “I would say ‘look at the evidence.’ Not only can quality of life be improved, but survival can be improved. It’s not about withholding care. The more we educate people, the better,” she said.

Cost, Survival Time, or Quality of Life: the Debate in End-of-Life Care

	The rising cost of cancer care in the United States, and the need to listen to what cancer patients want, is not only transforming the way Americans deal with health insurers, but also the way physicians practice medicine, Peter P. Yu, MD, FACP, FASCO, president of the American Society of Clinical Oncology (ASCO), told a multistakeholder meet at Patient-Centered Oncology

	Yu gave the morning keynote address, “Value in Cancer Care: Achieving Patient Centered Care in Today’s Environment,” which offered the providers’ view to the third annual gathering of payers, providers, policy leaders, and representatives from the pharmaceutical sector sponsored by The American Journal of Managed Care. The meeting in Baltimore, Maryland, aimed to seek better solutions for cancer patients at a time when patterns of insurance coverage are changing, and as payers demand proof that new therapies are worth the high cost.

	The changing value proposition is causing oncologists to ask, “What does it mean to be a doctor in the United States?” Yu said in opening his talk. A physician, he said, can no longer be someone who does things 

 patients, but must be someone who does things 

 patients to try to achieve an outcome. Yu emphasized that the cancer patient must be part of the decision-making because the implications of care have changed so much.

	Citing an Institute of Medicine report, Yu reviewed elements that are driving up healthcare spending in the United States without adding value: $210 billion in unnecessary medical interventions, $190 billion in excess administrative costs, and $130 billion in inefficient care delivery. He dubbed this, “Doing the right thing, but doing it the wrong way.”

	To stop this trajectory, healthcare reformers seek to measure quality. However, “We don’t really have robust outcomes measures, and this is a major problem,” Yu said. “If you don’t have outcomes measures, how can we decide what value is? We focus mostly on process measures.” In cancer care, diagnostics have added a new, expensive element to the cost equation. “Diagnostics are as important, if not more important, than therapeutics because they increasingly drive the decision for therapeutics,” Yu said.

	The ASCO president said the rising cost of cancer care has changed the dynamic between doctors and patients. Historically, discussing the price of therapy with patients was verboten for physicians, but in 2014, ASCO took on the dual issues of value and quality as priorities. Last spring, CMS agreed to use ASCO’s quality standards as a clinical data registry. ASCO collected data from payers and engaged in extended discussions, and the group is now working with Congress to redesign Medicare reimbursement to be less complex and to reward quality.

	There’s simply no avoiding that rising prices for specialty drugs are the biggest cost drivers in cancer care, Yu said. He shared data from Blue Cross Blue Shield Association showing a 900% escalation in cancer drugs between 1996 and 2010, and data from PriceWaterhouse Coopers showing that the current $87.1-billion expenditure on specialty drugs is expected to quadruple

	On a more critical note, out-of-pocket costs for patients are rising: 34% of employers now charge at least a $60 co-pay for specialty drugs. How does that play out in cancer care? It means a patient who needs to take 1 pill a day for chronic myeloid leukemia might take that pill every other day, and that person becomes likely to relapse when there’s no reason for that to happen, Yu said. “We need to consider more than the price of the drug,” he said. “We need to consider using or not using the drug.”

	At the practice level, regulatory pressures, the price and delivery of cancer drugs, and the trend toward consolidation have made it difficult for small oncology practices to stay afloat, Yu said. This can hurt access to care in rural areas, where the community oncology clinic may be the only option. Clinical care pathways, which payers use to control the costs, can be designed with software that incorporates patient preferences, Yu said. He was optimistic about the role of Big Data in the future of cancer care.

	Yu then discussed principles of the payment reform initiative that ASCO is pursuing with Congress: 

	• Reimbursement must not only move away from fee-for-service toward value, but also from the idea that payment must be tied to the physician touching the patient. Work by nurses, nutritionists, and other team members is essential and should be reimbursed. • Contact with the patient outside the office visit—especially during the survivorship stage&mdash;needs to be recognized.

	• Flexible payment models must match the transition to valuebased care. Excessive documentation is wasteful. Documentation should be streamlined and predictable.

	• A model advocated by ASCO trims codes from 58 to 11.

	• A bundled model can work, but the period of the bundle should be 1 month, since cancer patients’ status can change rapidly.

	• The model must support clinical trials and transitions in care.

ASCO's Yu Outlines How the "Changing Value Proposition" Is Redefining the Oncologist's Role

	The transition to payment models in cancer care that reward quality might do more than save money. In some cases, the change might improve relationships between patients and oncologists. Whether this happens or not, there’s no denying that therapy costs are driving decisions in cancer care, both by patients and, in some unpleasant cases, by the institutions pledged to serve them. The economics of cancer care are playing out on the front lines, and they do affect outcomes, according to a panel moderated by Jan Berger, MD, MJ, editor-in-chief of The American Journal of Pharmacy Benefits.

	The panel, featuring Ted Okon, MBA, executive director of the Community Oncology Alliance; Debra Patt, MD, MPH, of Texas Oncology; and Stacie Dusetzina, PhD, an epidemiologist from the University of North Carolina at Chapel Hill, covered “Perspectives on Economics and Outcomes of Community vs Hospital Oncology Practice.” 

	At the start, Berger observed that today’s movement toward measuring quality and building payment structures around quality metrics stands apart from past reform efforts in that it seeks to build on the best of prior models rather than discard everything and start over. To that end, she asked the panelists how current reforms might change patient-provider relationships, especially from the perspective of cancer treatment in a community practice compared with a hospital. Dusetzina, who has studied the impact of therapy cost on patients, said that the difference in setting can have a compelling effect on relationships. “Care costs more for everyone in hospital-affiliated clinics,” she said, due to facility charges. Getting that extra bill, she said, can negatively harm the relationship with the oncologist.

	Okon expressed concern about the consolidation and “corporatization” of hospital-based care, especially with the expansion of the 340B drug pricing program. This initiative, run by the Health Resources and Services Administration, was set to allow “safety net” hospitals to obtain cancer drugs at deep discounts so those medications can be offered to vulnerable patient populations. However, he asserts that 340B has been allowed to expand far beyond its intended purpose, at the expense of community practices unable to obtain drug discounts. The situation, he said, is forcing the closure or consolidation of community oncology practices, leaving some remote areas without coverage, and “is unsustainable.”

	Okon said he hears “horror stories” of patients being asked to sign waivers agreeing to cover drug costs for off-label uses at prices well above what the hospital would have paid. “The bottom line is, this is really bad medicine,” he said. This corporate culture in hospital-based cancer care, he said, is coming “in an era when we’re thinking more about quality, when we’re thinking more about value and more about measurement for the first time.”

	“There’s no question,” said Patt, that oncology care needs a transition from current incentives to a “more population-based model.” Her theme throughout the panel discussion was the need for oncology practices to embrace a team-based approach, one that does not require all information to flow from the oncologist, but instead distributes care and decision making among several professionals, including social workers, nurse practitioners, care coordinators, and even psychologists. But Patt acknowledged this is hard on a community practice. “This requires infrastructure investments. Most oncology clinics have small margins by which they derive revenue. For each incremental investment you make, you have to demonstrate return,” she said.

	Without reimbursement reform that rewards practices for a team-based approach, hospitals alone might find it easier to make these investments. And yet, Patt said, she sees more innovation happening at the community level because it comes from practice culture and is not seen as a directive from the hospital administration. She would be concerned if an oncology home model became just a set of metrics for a practice to follow. “Then you’re not really changing how you’re delivering care,” she said. 

	But change has to come, and community oncology practices do, as a group, deliver care at a lower cost than hospitals and academic centers. “The cost issue is real,” Patt said. “I’ve had patients say, ‘I can’t pay for that oral chemotherapy for my renal cell carcinoma. I’ve decided it’s in the best interest for my family for me to die.’” 

	Berger than asked the panel to address some of the tougher issues in oncology care today: how to educate patients and providers on when palliative care might be best and how to deal with transparency issues, so that “doing less” does not come across as “withholding care.” Change in healthcare is never easy, Patt said. “There is always the ‘New York Times’ test,” she said. For some audiences, any mention of palliative care will come across as a “death panel” conversation. “Nothing like cancer pulls more at your heart strings…society is very polarized about it.” That reality, she said, means it’s the oncology community’s job to change how people think about cancer care. For some today, it can become a chronic disease, “but many people do die of cancer.”

	Okon agreed that education is very much needed, but also among providers: both on what he called the “macro level,” about the business of cancer care, and on the “micro level,” about issues such as end-of-life planning. Dusetzina said one of the barriers to having good conversations with patients about their options is the lack of understanding about the associated risks. 

	The average person equates high cost with high value, she said, and doesn’t grasp that when an insurer might want to withhold an expensive therapy, it’s because of evidence it won’t work, “not because it’s expensive and the insurer doesn’t want to pay for it.” The panelists agreed that the oncology medical home model, with a team-based approach, should be the wave of the future.

	Okon said change must start with the oncologist, who must abandon the “queen bee” model of being the only decision maker, because it’s too inefficient. “They have to change their mind-set,” he said.

Cost Matters to Cancer Patients, and Care Costs More in Hospitals, Panel Agrees

	Evidence is mounting that the oncology medical home (OMH), in which cancer patients receive all of their treatments in a coordinated fashion through a single practice, lowers costs and maintains, or even improves, the quality of care. In his presentation, “Early Findings of the Oncology Medical Home,” Ted Okon, MBA, executive director of the Community Oncology Alliance, told stakeholders at Patient-Centered Oncology Care 2014, hosted by The American Journal of Managed Care in Baltimore, Maryland, that surveys, pilot studies, and conversations with patients, payers, and providers fundamentally agree on what each wants from cancer care—and the OMH satisfies them all.

	Both Medicare and commercial insurers are clamoring for quality, cost control, accountability, and predictability, Okon said. In fact, surveys find that patients and providers want improvements in how care is delivered. The OMH, where one primary focus is avoiding unnecessary emergency department (ED) visits and hospital admissions, meets all of these goals. For example, surveys find patients want to be educated about their diagnosis and treatment; physicians want to be paid for cognitive services, such as treatment, survivorship planning, and end-of-life care; and providers demand productivity with a focus on survivorship.

	“It is remarkably similar what the 3 stakeholders want,” Okon said. He presented a summary of a 3-year pilot study by UnitedHealthcare of 5 medical oncology groups that treated 810 patients with breast, colon, and lung cancers. The oncologists were reimbursed upfront for an entire cancer treatment program, regardless of the drugs administered to the patient, based on the expected cost of a standard treatment predetermined by the doctor. Patient visits were individually reimbursed using the fee-for-service contract rates, and chemotherapy treatments were reimbursed based on the average sales price. Although the pilot was designed to remove any incentive for prescribing costly cancer drugs, drug spending actually increased 275%, while overall costs per patient shrank 34%, primarily from reduced ED visits and hospital admissions.

	Oncology practices typically coordinate care with all physicians treating their patients, which is a key feature of the OMH, but don’t provide 24-hour access for triage, the same level of information support, or measurements of quality, value, and patient satisfaction. The UnitedHealthcare pilot study found all of these factors to be essential for maintaining quality of care while simultaneously reducing costs.

	“You have to change basic care processes,” Okon said. “This isn’t just saying you are going to change. You really have to change. The practice has to focus on change that, for example, keeps patients out of the ER and hospitals, and that requires an investment in technology and people. Timely, regular feedback from the payer are key.”

	The Commission on Cancer has set a target of early 2015 for accrediting OMHs, which will include infrastructure and process requirements, specific measures of progress, data submission with benchmarking, and site surveys. “You can contain costs and increase quality, but don’t kid yourself; this takes work,” Okon said.

Surveys Find Agreement in What Stakeholders Want From Cancer Care, and Oncology Medical Homes Deliver

	Efforts to improve quality in cancer care by creating standards of measurement abound, including the Quality Oncology Practice Initiative (QOPI), launched in 2006 by the American Society of Clinical Oncology (ASCO).

 But although measuring quality with the goal of improving patient care is important, it’s essential for healthcare leaders to grasp what is being measured and to ensure that it actually matter to patients.

	That was the message from John Fox, MD, MHA, associate vice president of Medical Affairs at Priority Health, who gave the talk, “Payer Perspectives on the Role and Impact of QOPI Certification.” At the outset, Fox said that healthcare tends to value those things that are easiest to measure, although “They are not necessarily the things that are the most important.”

	So which measurements matter? “We have to measure things that are important to patients,” he said, rather than what matters most to providers and payers. Doing this likely means integrating data from sources beyond the doctor’s office or the healthcare system itself, such as death registries that will tell healthcare systems exactly when and where patients died. 

	The triple aim of increased patient satisfaction, improved population health, and a downward pressure on healthcare costs can be achieved, Fox said. The challenge is that while various parts of

	the system may want to work cooperatively, “The imperative today is for each to satisfy our primary stakeholders and not society as a whole.” That challenge has created an upward tick in healthcare spending, in general, and cancer care, in particular, something that ASCO is determined to address.

	Fox pointed to a graphic that showed that the amount middle-class Americans are spending on healthcare is simply not sustainable, especially with a diagnosis like cancer. He referenced the 2001 Institute of Medicine (IOM) report, “Crossing the Quality Chasm,”

 which calls for a healthcare delivery system along 6 domains that Fox said are still relevant today: according to the IOM care must be safe, effective, patient-centered, timely, efficient, and equitable.

	Fox elaborated on the elements of safety and efficiency in cancer care, defining efficiency as “the absence of waste.” He shared a figure showing how waste in the system contributes to healthcare’s rate of spending continuing to outpace the US gross national product: fraud, along with failures in care delivery, care coordination, and pricing, all contribute, but the biggest problem areas were overtreatment and too much administration. Does any of this matter to patients?

	Some of it might, Fox said, noting the example, “overtreatment that patients wouldn’t have wanted had they known differently.” What patients care most about, however, are outcomes. However, most quality care measurements focus on process and structure, not outcomes, he said. He listed the 10 core QOPI quality measures, of which 8 are process measures (See Table), while 2 measure outcomes. Within the IOM framework, 7 involve effectiveness, and 3 concern whether care is patient-centered.

	All this might speak to why payers are not yet funding QOPI, he explained. It’s not that QOPI may not be important; Fox said, it’s that payers don’t care as much about process or structure unless there is a clear correlation with how it affects patient outcomes. QOPI, he said, has 200 measures, and Fox said it can be difficult to see at first how many of these, which are process measures, translate to things  that bring value to patients. Fox went through numerous other examples, including research that highlighted spectacular disconnects between what he called “box-checking” by physicians and what patients understood to be happening in their care. By contrast, other research involving practices that received Patient-Centered Medical Home (PCMH) designation form the National Committee on Quality Assurance reported a 5% reduction in total Medicare payments compared with their nonaccredited counterparts, with 62% of the decline due to a reduction in payments to acute care hospitals.

	Fox sees hope for PCMHs, but he also warned that the conflicting standards of measurement being put forth by QOPI, the Commission on Cancer, the Community Oncology Alliance, and CMS’ Center for Medicare and Medicaid Innovation could create confusion among oncologists. “We have to measure things that matter to patients,” he said. “Not everyone can measure everything—it takes collaboration between oncologists and payers. We will get farther, faster, if we can agree on a common set of metrics.”

Payers Seek Quality Measures That Matter to Patients, Fox Says

	Today’s cancer specialist faces a proliferation of clinical care pathways, which payers see as a way to help control costs. Pathways, which may offer incentives if physicians follow them, exist alongside guidelines from the National Comprehensive Cancer Network (NCCN) or the American Society of Clinical Oncology, and now quality measures. All are well intended, but how much is too much? And where do patients fit in? Moderator Jan Berger, MD, MJ, editor-in-chief of The American Journal of Pharmacy Benefits, explored these themes with panelists who had different perspectives on cancer care guidelines and measurement in the discussion, “Defining Quality in Oncology:Is There a Common Ground?”

	Berger started the discussion by comparing adult cancer care with pediatric cancer care, noting that guidelines for children have existed for more than 30 years without the pushback or complaints of “cookbook medicine” sometimes heard among oncologists who treat adults. She invited thoughts on this dynamic. Phyllis Torda, vice president for quality solutions at the National Committee for Quality Assurance, said this may be because pediatric oncology was historically concentrated in “centers of excellence” and involved fewer cancers; pediatric oncology offered a haven for clinicians to develop patient registries and best practices.

	The issue behind Berger’s question—the juxtaposition between the “wiggle room” within guidelines and the need for precise measurement&mdash;is a huge challenge, Torda said. It is very difficult to develop measurements that can accurately gauge quality while allowing for varied, though legitimate, choices for doctors in consultation with patients. These disconnects are wider in some cancers than in others, Torda said.

	Dennis Scanlon, PhD, professor of health policy and administration at Penn State University, drew distinctions among the types of measures and reasons for them, some of which do not relate to quality. Measurements occur for accountability, quality improvement, surveillance, and payment, and these are not always “synergistic,” he said. "Measures for accountability tend to be low bar…not measures that necessarily get us to innovation, which is what this field is striving for.” Getting to innovation in patient-centered care requires innovation in measurement itself, he noted, “and is something we probably can’t strictly regulate.” He mentioned the Geisinger Health System in Pennsylvania, where the OpenNotes project is an example of engaging patients in order to improve quality. 

	Laura Long, MD, MPH, chief medical officer and vice president of clinical innovation at BlueCross BlueShield of South Carolina, said the “good news” is that unlike a decade ago, today she rarely experiences pushback over clinical guidelines. The “bad news,” however, is that the healthcare system lacks the technology to adequately measure what’s meaningful.

	It’s not enough just to measure how well clinicians or practices are delivering evidence-based care, or providing access or efficiency; it’s also necessary to know whether what they are delivering is important to patients, Long said. “We’re just figuring this out; we’re in our infancy,” she said.

	Assuming that compliance with these criteria can be measured, how can the resulting information be given back to physicians at the point of care in a timely way? At NCCN, guidelines are hardly “cookbook medicine,” said Jessica DeMartino, PhD, the network’s manager of health policy programs. Guidelines often include choices, including those based on what patients want, and NCCN now includes material to help engage patients in decision making. Evidence-based guidelines can suffer implementation due to a lack of robust data, DeMartino said. NCCN is trying to get its guidelines integrated into electronic health record systems and into pathways to improve care and curtail costs.

	Berger invited comment for how to better engage patients in their care. At the point of care, Torda said, measurements are tracking patient-reported outcomes and whether patients understand treatment. Some practices are working with patient advisory councils with surprising success: Scanlon added that his colleagues are experimenting with measures that ask only a few critical questions, but ask them more frequently, including questions from cancer patients’ families. Healthcare policymakers and practice teams should ask whether the doctor is always the best person to deliver certain news, Scanlon said. “If we really want to understand how the patient is doing, there are untapped measurement opportunities,” he added.

	Long agreed with this patient-centered approach: physicians may not have been trained to engage patients in the most effective way, or to understand their goals. She and Scanlon both spoke about issues of health literacy and meeting divergent patient needs based on language barriers, education levels, cultural differences, and the distance a patient must travel for care.

	During the question period, the panel was also asked how to get payers, professional societies, and accrediting groups to set common standards for adult oncology. Torda pointed to the demonstration project at the Center for Medicare & Medicaid Innovation (CMMI), since Medicare handles 51% of the patients who have cancer, and CMMI is also working with commercial payers. (In 2012, CMMI awarded $19.8 million to Barbara McEneny, MD, and Innovation Oncology Business Solutions to launch the Community Oncology Medical Home or COME HOME project at 7 sites.)

	Long echoed the sentiment that physicians desperately need consensus on what constitutes quality. “Less is more,” she said. “It is too overwhelming for physicians in practice today.” Alignment is critical; fortunately, it is starting to happen, with specialty societies playing an important role, she added. “The patient is still a little left out. This conversation is exactly what is needed.”

	1. Burns J. COME HOME program set to save $33.5M over 3 years. OncLive. http://www.onclive.com/publications/oncology-businessnews/2014/August-2014/COME-HOME-Program- Set-to-Save-335M-Over-3-Years. Published August 25, 2014. Accessed January 27, 2015.

Resistance to Guidelines Ebbs, but "Less Is More" Approach May Help Cancer Care Providers

	The Affordable Care Act (ACA) is still relatively new, but it’s already changing the way patient populations gain access to healthcare coverage. This has important implications for oncology, according to Burton VanderLaan, MD, FACP, medical director for Priority Health.

	VanderLaan delivered the afternoon keynote—the payer perspective&mdash;on November 14 at Patient-Centered Oncology Care 2014, and he offered an early view of how the payer mix is changing as the ACA takes hold. In looking at the population of Michigan, where Priority Health is based, VanderLaan presented data showing that 900,000 people joined the ranks of the insured, while Medicaid enrollment grew by 600,000. “Some of the movement into Medicaid is from employers, but most of it is from the newly insured,” he said (Figure 1). Many who signed up on the health insurance exchange websites were able to do so because of “the attractiveness of the subsidies,” which held down the cost, VanderLaan said.

	As a group, those signing up for insurance on the exchanges tend to be older—most of those who signed up in Michigan were between the ages of 45 and 64 years. Data from Priority Health’s pharmacy benefit managers show those who signed up also tended to be sicker, based on the number of prescriptions they were having filled. “Many had some prior insurance, but because they were able to get a premium subsidy, there was an impetus to move to the exchanges,” VanderLaan said, asking, “What are the implications of that? Think of those implications to an oncology practice.”

	VanderLaan walked the audience through projections, showing that eventually up to two-thirds will be covered as individuals, not through their employers (ie, through a group plan). As a group, those with individual coverage are less likely to pay premiums on time, less likely to buy full coverage, and more likely to change coverage frequently. “An individual is more likely to miss a payment than a corporation,” VanderLaan said. “For terms of the ACA, if an individual doesn’t pay, the insurer honors the claims for 30 days. If you’re that provider seeing that patient, you see them for 30 days; then it pends for 60 days. It raises the whole issue of bad debt that might be injected into the system.”

	VanderLaan is not the first to raise this issue. Groups, including the Community Oncology Alliance, along with oncologists from academic medical centers who spoke last spring at the National Comprehensive Cancer Network annual meeting, raised the specter of challenges from the “underinsured.” This group, distinct from those who are known upfront to need charity care, might  have some coverage but face steep deductibles or co-payments for cuttingedge therapies. “Lower cost plans come with a lot of cost sharing,” he said.

	With the ACA Silver plans being the most popular, the out-of-pocket costs when a patient faces a cancer diagnosis might be more than the person can handle. “Most Silver plans come with a $3000 deductible,” he said. “Out-of-pocket maximums may offer some protection, but that may be in-network only.” (Figure 2.) Thus, VanderLaan raised another emerging issue: “narrow networks,” which are efforts by exchanges in some states to limit where patients seek care, all done in an effort to control costs. “Academic medical centers and cancer centers are particularly vulnerable,” he said. VanderLaan discussed an Associated Press survey that found only 4 of 19 nationally recognized cancer centers reported that patients had access to care through their exchanges.

	“There has been a backlash,” he said. "CMS has definitely had a backlash.” Indeed, VanderLaan cited outcry in California over access-to-care issues, which that state’s exchange said it tried to address by adding more choices for consumers in 2015. With an aging population, oncology is going to face ever-increasing demands. “It’s unclear where this is going to end up,” VanderLaan said.

	1. Bernard-Kuhn L. Health plans may omit top cancer hospitals. Cincinnati.com. http://www.cincinnati.com/story/news/2014/03/27/acacancer-obamacare/6957237/. Published March 28, 2014. Accessed January 19, 2015.

How the ACA Is Changing Oncology Practice on the Ground

	What is the optimal solution for the healthcare industry if it must address the increased complexity and cost of cancer care at a time when labor is scarce? Perhaps harness the power of that cellphone most people already have with them, according to Meg Maley, RN, BSN, who gave the talk, “The Role of mHealth in Oncology,” at the third Patient-Centered Oncology Care Meeting hosted by The American Journal of Managed Care.

	When Maley hears of the need for stakeholders to work together to address patient needs, she sees a vital role for mobile health, or “mHealth,” in large part because it takes advantage of technology that patients already have at their fingertips. Bringing mHealth into the cancer care equation starts with understanding where patients are emotionally when they receive a cancer diagnosis, Maley said. “Many patients describe their inaugural experience, as well as repeat experiences in their cancer journey, as being enveloped in a dense fog. That fog breeds uncertainty and anxiety.” Each patient’s cancer journey is different, Maley said. Even though patients may know that others have treaded the path before them, “It is still your singular experience.”

	For all the information that the Internet provides, it can also overwhelm patients, Maley said. With mobile technology, an app designed for cancer patients to give bite-size pieces of information tailored to individual needs can provide just the right level of support without leaving patients confused. Maley discussed such an app, called CanSurround. mHealth can help patients manage the feeling of being overwhelmed, of having to deal with multiple doctors, appointments, nurse navigators, and even well-intentioned family and friends. Maley said patients in metropolitan areas often have providers in multiple healthcare delivery systems; 

 told her that managing cancer “has become her fulltime job. That is a sad statement.”

	Why is mHealth the answer? Because cell phones are already ubiquitous, Maley said. Studies show that people check their cell phones 150 times a day, she pointed out. And mHealth isn’t just about an app that lets a patient manage a schedule; it’s also about sensors that take vitals or an electrocardiogram. The FDA is clearing medical devices, and other agencies are protectingc consumers from illicit advertising. mHealth will be big business, and Maley Maley said it’s already seen a huge investment. What’s key, she said, is that mHealth isn’t just grabbing data for data’s sake. With today’s analytics, “Data can be analyzed and served back to the provider, the case manager,” Maley said. “Data are transformed into knowledge that has the power to influence actions

	“There is wisdom here,” she said. Apps are no longer experimental; they are being “prescribed” and listed on formularies. With CanSurround, mHealth has the potential to help with medica-tion management, symptom management and documentation, scheduling, and patient education on a schedule that suits the patient. Some cancer patients cannot absorb information about treatment choices in their physicians’ offices and need time for it to sink in, perhaps after the shock of the bad news has worn off.

	The CanSurround technology can even take patients through meditation exercises, give nutrition information, or provide instructions on dealing with stress based on feedback from the patient, she said. Patients can connect with others in similar circumstances for emotional and social support; they want “someone to pay attention to me as more than a tumor.”

	Providers and payers are embracing mHealth, Maley said, because they know they need new tools to drive better outcomes and reduce costs. They need to improve communication, and they need new ways to collect patient reported data. As much as mHealth helps on the patient side, it also can help providers and case managers triage patients. In the home health sector, mHealth can collect data from patients and feed them to a nurse who receives alerts on which patients need immediate attention; this process eliminates hours of phone calls to make status checks. This way, when the nurse sees the patients, there’s already a threshold understanding of what’s happening.

	“By the time the patient shows up, there’s time for a deeper conversation,” Maley said.

Turning That Cell Phone Into a Tool for Oncology Care

	Increasingly, molecular diagnostic tests direct which therapy is best for cancer treatment or whether a therapy should even be used. This fact has raised a host of issues in cancer care: how do payers decide which tests they will cover? How can oncologists and genetic counselors involve patients in the testing process without overwhelming them? Most of all, how can physicians keep up with this fast-moving field, so that the promise of precision medicine moves beyond academic centers and into community practices?

	Panelists led by moderator Ira M. Klein, MD, MBA, FACP, national medical director, Clinical Thought Leadership, Aetna, examined these questions in “The Road to Personalized Medicine: Clinical Utility and Reimbursement in Molecular Diagnostics,” an area in which regulators are racing to keep pace with developments in science. Panelists included Bruce Quinn, MD, PhD, MBA, a former Medicare official who is now senior health policy specialist for Foley Hoag, LLC; Rina Wolf, MHA, vice president for Commercialization Strategies with Xifin, a revenue cycle management company that supports about 70% of the molecular diagnostics claims in the United States; Howard L. Kaufman, MD, FACS, associate director for Clinical Sciences at Rutgers Cancer Institute of New Jersey; and Joy Larsen-Haidle, MS, CGC, president of the National Society of Genetic Counselors.

	The promise of personalized medicine—the opportunity to tailor treatments to patients&mdash;has run headlong into cost concerns from payers, CMS chief among them, as diagnostics have become a major part of balance sheets in oncology care. Especially since 2011, payers have begun to demand not just proof of clinical validity&mdash;that is, evidence that a test showed what it said it would show&mdash;but also clinical utility, or proof that tests shape physician decision making and patient outcomes.

	Klein referenced earlier speakers’ descriptions of how data that shape physician decisions don’t always get to the right place, or meet patient needs. How, he asked, can the field of molecular diagnostics fill some of these gaps, and what are the challenges? Wolf said cancer patients are most helped when there is a truly definitive diagnosis, and it is the predictive value of molecular testing that helps physicians decide on the best course of treatment. She said she had been surprised earlier in the conference to learn that 51% of patients were not receiving tests for EGFR mutations, “which is standard of care.”  

	Educating physicians, in addition to payers and regulators, so they stay abreast of scientific advances in molecular diagnostics and next-generation sequencing (NGS) is a huge challenge, Wolf said, and all stakeholders must work together on this. While the scientific community races ahead with NGS, Wolf said her firm still struggles with CMS and its contractors, in addition to commercial payers, just to get molecular diagnostic claims paid. Wolf and Quinn also discussed specific examples of bundling rules and other policies that work against patients by discouraging tests from happening in a timely manner. It would be better to take a public health approach in certain common cancers and test everyone who is diagnosed, Quinn said, rather than risk costly delays. “Turnaround times are a much bigger problem than people think,” he said.

	At Rutgers, precision medicine is proving its value, Kaufman said, and that is making discussions with payers easier. “On complicated tumors and resistant  cancers, we are doing full genomic sequencing and finding unexpected mutations, and there may be drugs available that target that specific mutation,” he said. In some cases, academic physicians must work with patients to include them in a clinical trial so they gain access to drugs that will work on those mutations. “We looked at the first 100 patients in the precision medicine program, and we changed the clinical treatment plan for 40% of the patients based on the diagnostic information that came in,” Kaufman said.

	While he said Rutgers’ discussions with payers have been fruitful, he recognized that what gets approved in an academic center might not get approved in a community setting. Rutgers is now working to move its precision medicine model into community hospitals. “If it becomes more widespread, I am not sure what will happen,” Kaufman added.

	Quinn is not surprised that payers want to see evidence before they are willing to offer reimbursement. He described instances in which early clinical results looked promising but time proved otherwise, so waiting for convincing evidence is prudent. But patients suffer, he and Wolf agreed, when Medicare policies discourage or delay testing, so there needs to be a better framework for who is tested and under what circumstances.

	Larsen-Haidle said that genetic counselors are increasingly working side-by-side with oncologists to guide treatment. Counselors start the process by talking with patients about their family history, asking, “What are the odds there is a genetic component to the cancer you have developed?”It’s important for patients to be empowered and to understand what tests can and cannot tell them. “Most important,” Larsen-Haidle said, “how are they going to use it?” Tests also provide information for family members, “So for that same healthcare dollar, we have the opportunity to provide information for more people.”

	Kaufman said that at Rutgers, he is sending more patients to genetic counselors to identify germline mutations that could affect other family members. Testing is becoming more mainstream.

	“We have to balance what’s experimental and still needs to be done under the guise of a clinical trial, but we also have to push the field forward,” he said. Oncologists “have the ability to get this data now,” and should start using it.

As Use of Diagnostics Rises, Challenges Remain in Education, Reimbursement

	A key CMS contractor has issued an apparent precedent-setting decision outlining how it will make coverage determinations for laboratory developed tests (LDTs) that use sequence-based genetic profiling to guide treatment for persons with non-small cell lung cancer (NSCLC). However, the decision, known as a local coverage determination (LCD), came with no warning, press release, or announcement, so it remains to be seen if the policy will become standard across Medicare.

	As reported in The Cancer Letter January 23, 2015, Palmetto GBA posted on its website on January 22, 2015, “well after the close of business,” an LCD titled “Comprehensive Genomic Profiling for Non-Small Cell Lung Cancer.”

 The move came in the aftermath of President Obama’s State of the Union address, which mentioned a precision medicine initiative later outlined at the White House. While the Obama administration did not draw a link between the 2 items, The New York Times mentioned the Palmetto policy change in its coverage of the larger effort to develop treatments tailored to patients’ individual genetic characteristics.

	Bruce Quinn, MD, PhD, MBA, a former Medicare official and consultant for Foley Hoag, told the Times that the LCD was a “watershed event.”

What does the Palmetto change mean? Strictly speaking, it applies only to treatment decisions in the Carolinas, Virginia, and West Virginia. In a broader sense, as The Cancer Letter notes, Palmetto’s decision to develop the MolDx program and gain expertise in developing standards for making payment decisions in molecular diagnostics could elevate its status due to a 2014 law that would allow CMS to use its LCDs to establish policies for all such tests.

	According to The Cancer Letter, the decision focuses on coverage of somatic comprehensive genomic profiling for patients with metastatic NSCLC. Tests are limited to those who are lifetime nonsmokers or former light smokers and who have tested negative for EGFR mutations and EML4-ALK rearrangements. This will allow patients to be treated with a targeted therapy for which they would have been ineligible.

 and as Quinn and Rina Wolf, MHA, vice president of XIFIN, told stakeholders gathered in Baltimore at Patient-Centered Oncology

	Care in November 2014, sponsored by The American Journal of Managed Care,

 the issue of reimbursement in next-generation sequencing is increasingly important.

	Both Wolf, in addressing the Baltimore meeting, and sources who spoke to The Cancer Letter, said the comprehensive sequencing technologies could render moot challenges that arise when tissue samples are depleted before all tests are run.

Vincent Miller, chief medical officer of Foundation Medicine Inc, a company that stands to be a winner under the Palmetto decision, called it “potentially transformative,” and specifically cited the distinction between a comprehensive genetic profile and panels of multiple genes.

 In mid-January, Roche spent just over $1 billion

	for a 56% share in Foundation Medicine, Forbes reported.

	If Palmetto’s move is a harbinger of what CMS will do more broadly, it could signal less uncertainty in both the reimbursement and regulation of diagnostic testing, which may not make everyone happy. In early January, the FDA held a 2-day workshop to outline a framework for regulating up to 11,000 LDTs that fall under a relatively small number of Medicare codes. Most reach the market with oversight from agencies, although the FDA has granted clearance for some companion diagnostics.

	Pharmaceutical firms have sought to bring order to this situation, and reports indicate they were represented at the White House announcement of the precision medicine initiative.

 Some funding in the $215-million plan will aid FDA efforts to regulate to the industry.

	1. Goldberg P. CMS opens door to coverage of comprehensive genomic sequencing. The Cancer Letter. 2015;41(3):1-6.

	2. Pear R. Obama to request research funding for treatments tailored to patients’ DNA. The New York Times website. http://www.nytimes.com/2015/01/25/us/obama-to-requestresearch-funding-for-treatments-tailored-to-patientsdna.html?_r=0. Published January 24, 2015. Accessed February 2, 2015.

	3. The American Journal of Managed Care website.The Road to Personalized Medicine: Clinical Utility and Reimbursement in Molecular Diagnostics. Patient Centered Oncology Care 2014. http://www.ajmc.com/ajmc-tv/live/pcoc14/panel4. Produced November 14, 2014. Accessed February 3, 2015.

	4. Herper M. Roche spends $1.03 billion for majority stake in cancer genomics firm. Forbes website. http://www.forbes.com/sites/matthewherper/2015/01/12/roche-spends-1-03-billion-formajority-stake-in-cancer-genomics-firm/. Published January 12, 2015. Accessed February 2, 2015.

	5. Caffrey MK. Arguments taking shape for and against FDA regulation of diagnostic tests. Am J Manag Care. 2015. In press.

	6. Tirrell M. Drugmakers receive mysterious invitations to the White House. CNBC website. http://www.cnbc.com/id/102377618. Published January 28, 2015. Accessed February 2, 2015.

	7. Office of the press secretary. FACT SHEET: President Obama’s precision medicine initiative. Whitehouse website. http://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheetpresident-obama-s-precision-medicine-initiative. Published January 30, 2015. Accessed February 2, 2015.

Groundbreaking Decision on Genomic Profiling Coverage Comes With No Fanfare

	Certain patients can now receive Medicare coverage for lung cancer screening with low-dose computed tomography (LDCT), after CMS issued a national coverage determination (NCD) on February 5, 2015.

	The decision will allow Medicare beneficiaries to receive LDCT screening once a year if they meet all of the following criteria:

	• They are age 55 to 77 years and are either current smokers or have quit smoking within the past 15 years. 

	• They have a tobacco smoking history of at least 30 pack years, which is at least a pack a day for 30 years. (If a person smoked 2 packs a day for 15 years that equals 30 pack years.)

	• The person receives a written order from a physician or qualified nonphysician practitioner that meets certain requirements, which are contained in the NCD.

	According to a press release from CMS, coverage will include a visit for counseling on the benefits and risks of LDCT screening. The announcement also included requirements for data collection

	and eligibility requirements for radiologists and imaging centers, consistent with the National Lung Screening Trial (NLST) Protocol. 

	The CMS announcement comes a little more than a year after the US Preventive Services Task Force (USPSTF) finalized its “B” recommendation for annual lung cancer screenings with LDCT; that recommendation was for adults ages 55 to 80 years who had smoked 30 pack years.

 USPSTF’s recommendation was based on results of the NLST, which found that patients who received screening had a 15% to 20% lower risk of dying from lung cancer; results published in 2013 showed that the targeted screening toward those at greatest risk produced the most effective results.

	However, the decision to pay for widespread screening is not without controversy. In a paper published in JAMA Internal Medicine in December 2014, authors SH Woolf, et al, expressly discouraged CMS from paying for screening. This is difficult under the Affordable Care Act, since the law requires commercial insurers to pay due to the B recommendation. The authors argued

	that screening in the general population may not be limited to high-risk smokers outside a clinical trial, and may cause unnecessary harm due to radiation and false positives.

	1. National coverage determination (NCD) for screening for lung cancer with low dose computed tomography (LDCT) [press release]. Baltimore, MD: CMS; February 5, 2015. http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releasesitems/2015-02-05.html.

	2. Moyer, VA. US Preventive Services Task Force. Screening for lung cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;160(5):330-338.

	3. Kovalchik SA, Tammenaqi M, Berq CD, et al. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013;369(3):245-254.

	4. Woolf SH, Harris RP, Campos-Outcalt D. Lowdose computed tomography screening for lung cancer: how strong is the evidence? JAMA Intern Med. 2014;174(12):2019-2022.

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