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On March 30, 2006, a subcommittee of the Medicare Coverage Advisory Committee (MCAC) was convened by the Centers for Medicare and Medicaid Services (CMS) to evaluate the existing drug compendia and to identify the criteria that should guide compendia recommendations about the appropriate use of drugs. The meeting was called to specifically address issues regarding establishing coverage policies by CMS and its intermediaries and carriers for drugs and biologics in cancer care. The focus of these coverage decisions is an issue that has long been referred to as “use beyond FDA-approved labeling” or “off-label” use. Approximately half of the use of drugs and biologic agents in cancer treatment is off-label. This fact should not be surprising in that drugs have historically been approved most often for a single indication and then used for others, not only in cancer care but also in other fields such as psychiatry. Further, in cancer treatment, one is dealing with both life-threatening diseases and fast-paced and abundant research advancement. The U.S. Food and Drug Administration (FDA) has often stated the position that physicians, in the exercise of good clinical judgment, may prescribe drugs for indications other than those explicitly approved by the FDA. Indeed, the issue of “off-label use” attracted substantial attention only in the late 1980s, when insurance companies, as they morphed into managed care companies, began to scrutinize such use more closely. Increased scrutiny was further stimulated in 1987 when interferon was approved for the orphan indication of hairy cell leukemia. That this...

Our world has lost a good, caring, and dedicated man; a husband, father, grandfather, doctor, and leader. Rodger J. Winn, MD, died a few weeks ago, after fighting the good fight against esophageal cancer. My earliest remembrance of the good Dr. Winn was walking down the cavernous halls of an American Society of Clinical Oncology (ASCO) meeting. I had not “grown up” in the world of oncology, so Rodger set out to introduce me. I marveled that we could not travel more than 3 steps when a colleague, friend, or student would greet Rodger warmly and pause for a few moments to catch up. Watching Rodger then and through the years made me realize that while he may not be President of ASCO, he certainly was the long-term “Mayor of ASCO”. Rodger moved earnestly and with ease and grace among the many constituencies of the oncology community. People looked up to this jovial, short, stocky man for leadership. He was a master at dissolving and resolving differences and bringing groups together in ways that would benefit patients. Nowhere was this leadership and skill more evident than in the development of the NCCN Clinical Practice Guidelines in Oncology. Dr. Winn is the “Father of the NCCN Guidelines.” Recognizing the needs to address variability in oncology practice and affirm a scientific, evidentiary basis for practice, he led and nurtured a guideline program that has become the most successful, important, and influential of any of the 35,000 attempts at developing, communicating, and implementing...

I recently gave a lecture at a well-known graduate school of business, and I was struck by how much it was like a lecture I had given more than 10 years ago, when I was employed by a large national payor. On my last slide, entitled, “Déjà vu all over again: 90s to 00s,” the final line read: “This will be your lecture in 10 years—as we will still be dealing with this, you can borrow my slides.” Indeed, the pressures and tensions currently at work in our nation's health care system are much like those experienced in the early 1990s. Our nation's expenditures on health care could reach $3.6 trillion in 2014 and could then account for 20% of the nation's gross domestic product. Large employers are again expressing substantial concern about the impact of providing health benefits at a high cost to their companies, in an era of global economy in which foreign competitors are not burdened with such costs. Cost concerns within the Medicare and Medicaid programs dominate public policy debate. Nowhere in medicine is the concern about rising expenditures greater than in oncology. Large national private payors tell NCCN that oncology costs represent 12% of a typical payor's overall medical expense budget. Furthermore, these costs for cancer care are growing annually at a rate of 14%, almost double the average growth of a plan's medical costs. One major national insurer has informed me that, in cancer care, the costs of drugs and biologics now exceed all...

In this new JNCCN feature, experts will address issues and programs that will influence the delivery system for cancer care over the next decade. Individual submissions for this new section of JNCCN are most welcome. The return of substantial rates of rise in national health care expenditures, health insurance premiums, and employer contributions is beginning to make the current environment feel a lot like the health care system in the late 1980s and early 1990s. In those days, rising health care costs brought tremendous tension and pressure to bear on both employers and patients in their roles as purchasers of care. These pressures were translocated to health insurers, who were charged to reduce the pressures and, thus, sought to morph into companies that could manage health care. Hence, a managed care industry emerged. Managed care companies did have some modest and transient success in moderating the rate of rise of health care expenditures in the mid to late 1990s. The one successful mechanism used to accomplish this was a focus on aggressively negotiating down the reimbursement for services provided by facilities and by professionals. Managed care companies used the specter of provider exclusion of from “narrow networks” to extract pricing concessions. These pricing concessions from providers were achieved in the early years of the 1990s, when managed care companies rode the crest of power. However, that power began to recede in 1995. The Clinton Health Care Reform debate of 1994 provided one conclusive result, and that was the affirmation of...

The entry of the United States health care system into the “era of accountability” was heralded by Arnold Relman, MD, then editor of The New England Journal of Medicine, in 1987. This new era of medicine was envisioned to involve a greater emphasis and reliance on evidence in setting policies and, most especially, a system whereby provider groups or even individual providers could be evaluated on the quality, effectiveness, and efficiency of the care that they delivered. Since that widely acclaimed heralding, health care constituencies have entered this “house of accountability,” but they have not made it much past the front foyer. Clearly, considerable resources and efforts have been invested in making decision-making in health care based more on evidence. Although all clinical researchers have long lived by the “evidence-based decision-making” credo, one of the two major accomplishments of managed care in the 1990s was enhanced integration of this basis for decision-making into processes for establishing clinical policies, health policies, and coverage policies. However, the brief era of managed care in the United States did not establish substantial capabilities to evaluate the quality or value of care delivered. Rather, the focus of the managed care environment in the 1990s was on micromanagement rather than on more global analyses and interventions. Managed care companies attempted to improve the value of the care that they managed for patients and employers, as purchasers, through focus on and scrutiny of individual care decisions, often at the point of delivery. Although such attempts at point-of-care...

On November 3, 2005, the Centers for Medicare and Medicaid Services (CMS) announced the Medicare Quality in Cancer Care Demonstration Project for 2006. Expanding on the chemotherapy demonstration project of 2005, the demo project is guided by the objective of encouraging high-quality care in all facets of management for patients with cancer. In the project, physicians are asked to 1) identify the primary focus of the evaluation and management (E & M) service from one of several categories defined by specific CMS-provided G codes, 2) report the status of the patient's cancer (e.g., characterize the extent of cancer spread), and 3) report whether the treatment adheres to guidelines developed by either the National Comprehensive Cancer Network (NCCN) or the American Society of Clinical Oncology. The demonstration project focuses on the application of guidelines recommendations for 13 cancer diagnoses. Practices reporting on all 3 categories listed above will qualify for an additional payment of $23 per visit. Clearly, the NCCN Clinical Practice Guidelines in Oncology pertain directly to this project. NCCN guidelines are recognized and applied nationally as the standard for clinical policy in oncology in both community and academic practice settings and are available for all 13 disease states included in the CMS demonstration project. The most up-to-date set of guidelines in medicine today, the NCCN guidelines are continually updated. They are also comprehensive, addressing the full continuum of multi-disciplinary cancer care. The NCCN has made these guidelines widely available free of charge, online at www.nccn.org and in othe formats,...

The issue of insurance coverage for the use of drugs and biologics in cancer care for indications beyond Food and Drug Administration (FDA)-approved labeling is one that has been important to the oncology community since interferon was approved for use in hairy cell leukemia in the late 1980s. Today, the research pipelines of the pharmaceutical and biotech industries are replete with innovative and promising agents to treat solid tumors and hematologic malignancies and for supportive care. The approval and use of these important new therapies usually come with significant price tags in addition to improved therapeutic indices. Recent articles1,2 focus on the added cost created by integrating new agents into existing regimens. Thus, introducing new agents into practice coincides with a resurgent and growing concern about the rate that health care expenditures rise in both the public and private sectors, with particular emphasis in the Medicare program. This commentary provides historical perspective on the issue of payment for uses beyond the FDA label, describes the issue within the context of today's environment, discusses related issues that may impact access to improved therapies, and describes the NCCN's response. The introduction of interferon in the 1980s focused the attention of payors on an already common practice in oncology. This biologic agent was approved for the aforementioned ``orphan'' indication but was quickly also studied and used in patients with a range of solid tumor types and hematologic malignancies. Insurers morphing into managed care companies began to assert their new orientation and managed to...

In the fast-moving field of cancer care, the use of drugs and biologic agents beyond the FDA-approved label accounts for 50% to 75% of the total use of such agents. Since the introduction of interferon in the late 1980s, the provision of coverage for such uses by insurers and managed care companies has been a major and, sometimes, contentious issue. This issue was highlighted again lately by the introduction of innovative, promising biologic agents with high price tags. Additionally, concerns have arisen regarding the adequacy of the 3 compendia recognized by federal and state statutes and federal regulation as mandated references for Medicare and private payors in the setting of coverage policies. One, AMA Drug Evaluations, went out of existence in the early 1990s, and further concerns exist about whether the others (USP-DI, AHFS-DI) can keep pace with innovation to reflect appropriate uses for new agents. Therefore constituencies of the cancer care community have been concerned that appropriate access to effective drugs and biologic therapies might be compromised. The NCCN Drugs & Biologics Compendium (NCCN Compendium) can fill the breach as an authoritative, evidence-based, and timely source of recommendations for the appropriate use of drugs and biologic agents, including use beyond FDA-approved labeling. On March 30, 2006, a sub-committee of the Medicare Coverage Advisory Committee was convened to study the adequacy of existing compendia as basic mandated references for setting coverage policy. The NCCN testified in strong support of the need to recognize the NCCN Compendium as one of several...

Recent decisions about the optimal frequency and population age for screening mammography and the appropriate uses of bevacizumab and sipuleucel-t have raised questions, if not concerns, about both the decision-making processes and the level of expertise used in these processes, which can result in limiting access to interventions for patients in need. Were no authoritative scientific body and process available, one might acquiesce to such “third-party” decisions. However, the existence of the transparent, credible, and authoritative NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and NCCN Drugs & Biologics Compendium (NCCN Compendium) begs the question, “why don't all policy decision-makers rely on the evaluative capacity and expert judgment of the 900 or so multidisciplinary experts who serve on the NCCN tumor-specific panels?” UnitedHealthcare, Aetna, and many other organizations, as described below, already rely on and follow the recommendations of the NCCN Guidelines Panels—panels that are composed of multidisciplinary experts who are both leading researchers and treat patients every day. The Pendulum Swing Over the past several years, policy development has shown a steady flight from reliance on the judgment of practicing clinicians and on the judgement of experts, in particular. To some extent, the clinical community brought this situation on itself with the variations in care and unnecessary procedure rates that were documented in the late 1980s. Now, unfortunately, the pendulum has swung too far, as those who would intellectualize medical decision-making compound simple concepts into grandiose “schema” that only others in the same circles can pretend to understand and...