Celebrating more than 35 years of service
On December 23, 1971 President Richard Nixon signed the National Cancer Act, formally initiating the National Cancer Program. Cancer centers were being erected within the major academic medical centers across the country. The cooperative groups, benefiting from a great influx of funding, expanded their reach to the university cancer centers.
By 1972 the medical specialty of oncology had been formally established, creating a new corps of physicians specifically trained in multidisciplinary oncology practice and clinical research. The emigration of these physicians from the academic institutions in which they were trained to the community hospital setting would spark a transformation in cancer care delivery in the United States.
These community oncologists soon found themselves set apart from the mechanisms that had supported them throughout their training-nurses with specific knowledge of oncology, access to experimental therapies and clinical research, and a multidisciplinary approach to case management.
"These physicians came out of their training and into the community feeling extremely isolated," explained John W. Yarbro, M.D., Ph.D., a medical oncologist and a founding member of ACCC. "They were interested in producing the same high level of cancer care in the community, but they had no mechanism for dealing with the National Cancer Institute, with the cooperative groups, and with each other."
In 1974 a small group of physicians seeking to dispel the myth that community physicians were uninterested in and incapable of participation in state-of-the-art cancer care came together to form the Association of Community Cancer Centers (ACCC). ACCC would become the mechanism through which clinical protocols and other oncology standards of care were developed and disseminated to community cancer programs across the nation. Led by ACCC, the community cancer provider would emerge as an equal partner in the war against cancer.
In 1975 ACCC was awarded a grant of just under $100,000 from the National Cancer Institute to plan for the establishment of clinical investigation programs at the community level, in cooperation with NCI-supported cancer centers throughout the country. Yarbro, who at that time was director of NCI's Cancer Centers Program, was a chief proponent of community oncology and was instrumental in awarding the grant, which signaled the first time physicians in the community setting had received funds earmarked for clinical research directly from NCI. As part of the grant, ACCC took the first steps in establishing criteria for membership and participation in a national clinical investigation program as well as identifying the types of clinical protocols that could be conducted in the community. Yarbro would later serve as ACCC president from 1984 to 1985.
In the early 1970s ACCC was steadfast in calling for increased government funding for the National Cancer Program to increase research opportunities for community cancer programs across the country. ACCC organized an effective network of community oncologists to educate their representatives in Congress about community cancer care issues. Led by ACCC, hospitals across the country began to apply for planning grants in their communities.
These early efforts resulted in a number of crucial gains for community oncology. In 1975 NCI initiated the Community Oncology Program (COP), an early precursor to the Community Clinical Oncology Program (CCOP). The COP was designed to fund communities that would then pool their resources to develop community cancer centers. The Grand Rapids Community Oncology Program (now the Grand Rapids CCOP), a consortium of hospitals in the greater Grand Rapids, Mich., area and a longtime ACCC member, was one of seven initial communities awarded COP funding in 1975.
Led by the late Edward L. Moorhead, M.D., the Grand Rapids program pioneered the development of patterns of care guidelines in the community and as a result became the model for the NCI's next incarnation, the Community Hospital Oncology Program (CHOP). The CHOP program, which evaluated community physician use of the patterns of care, opened the door for clinical trials in the community by establishing that community physicians were providing a level of care equivalent to their university-based colleagues. Moorhead, who would go on to serve as ACCC president from 1985 to 1986, barnstormed the nation, traveling across the country to press the case for community involvement in clinical trials.
Despite these gains, ACCC leaders believed that further NCI funding for community clinical research would be limited without increased community participation within the ranks of NCI itself. Community representation on the National Cancer Advisory Board (NCAB) was imperative. In 1978 Congress renewed the National Cancer Act, which was amended to include, for the first time, an emphasis on community care. The act also called for community representation on the National Cancer Advisory Board. One year later J. Gale Katterhagen, M.D., a medical oncologist from Tacoma, Wash., and a past president of ACCC (1976-1978), became the first community physician appointed to the NCAB. Katterhagen credited the vision of Vincent DeVita, M.D., director of the NCI from 1980 to 1988, as driving community participation on the NCAB. "Community representation on the NCAB was a significant step in vying with the academic centers for NCI research funding," Katterhagen stated.
By the late 1970s, community clinical research was still a work in progress. In 1981, frustrated by the community hospital's dependence on academia medical centers for research funding, Moorhead organized ACCC's Ad Hoc Clinical Research Committee to more effectively facilitate clinical trials dialogue with NCI. The committee promoted a mechanism that would elevate community physicians as equal partners in clinical research with their university colleagues. In 1982 NCI responded with the Community Clinical Oncology Program.
As then-chair of the NCAB's Committee on Cancer Control and Prevention, Katterhagen played a major role in developing the CCOP. "We convinced NCI that we could do decent cancer research, that our data matched that of the academic centers, Katterhagen stated. "[Then-NCI Director] Vincent DeVita took a chance on us that really paid off for oncology."
According to Robert W. Frelick, M.D., a medical oncologist and ACCC president from 1980 to 1981, the CCOP program offered hospitals a theretofore unprecedented level of fiscal autonomy with which to run their research programs. Previously, community hospitals had been dependent on academic institutions, which controlled the purse strings and often the patient referral patterns. "The CCOP gave community hospitals the authority to provide state-of-the-art care in the communities where patients lived," Frelick said.
The CCOP program continues to evolve today. ACCC remains a part of that evolution, with members having served on various NCI committees and subcommittees throughout the years and currently participating on NCI's Clinical Trials Implementation Committee and Chemoprevention Implementation Committee.
From the beginning, community oncology sought to emulate the multidisciplinary environment inherent to the university hospital setting. By the late 1970s and early 1980s, community hospitals were forming dedicated oncology units, which became the hub of multidisciplinary cancer care. From this unit the oncology team began to form. The oncology inpatient unit would also foster the participation of oncology nurses, social workers, pharmacists, nutritionists, pastoral care givers, and other disciplines.
In the 1980s, rising health care costs would soon challenge this health care delivery paradigm. The economics of oncology began to dictate how and when patients would be treated, as well as how hospitals and physicians would be reimbursed. With the advent of the DRG reimbursement system and the growth of managed care, site of care for most cancer diagnoses would shift to the more economical outpatient hospital setting and to physician practices, late 1980s early 1990s made possible by a wave of innovation in cancer therapies and treatment. Keeping the multidisciplinary aspect of oncology care intact in all treatment settings would become a major ACCC priority.
The membership of ACCC, an organization founded by oncologists, soon began to reflect the changing face of oncology. Included among its membership were oncology nurses, hospital and physician practice administrators, medical directors, social workers, and cancer registrars employed in a variety of settings, including hospitals, physician practices, hospice and home care, and freestanding cancer centers. By 1991 the ACCC membership elected Jennifer L. Guy, R.N., B.S., as ACCC president, the first nurse (and the first woman) to serve in that capacity.
Guy reflected on her role within ACCC. "Having a woman and a nurse leading the Association made a statement about the diversity and multidisciplinary nature of ACCC," Guy said. According to Guy, her term was one step in the overall maturation of the specialty of oncology nursing. "Twenty-five years ago, oncology nursing was in its infancy," she said. "Within the past ten years especially, oncology nursing has flourished within ACCC and has become fully integrated into the organization." Guy credits ACCC's oncology nurse constituency with building strong ties to allied organizations such as the Oncology Nursing Society.
In its early years the specialty of radiation oncology had endured a relative isolation of its own; many departments were located in hospital basements and lacked a distinct identity as the core of the cancer program. With the rise of the multidisciplinary cancer center, radiation oncologists, as well as radiation therapists and technicians, gained a renewed visibility within their institutions and within ACCC. "Before ACCC, community oncologists tended to exist within their own disciplines," remembered Simeon Cantril, MD, who was with ACCC at the beginning as an original founding member and the Association's first Secretary/Treasurer. "ACCC promoted interdisciplinary networking, which had never really happened before." According to Cantril, this interdisciplinary networking would prepare all disciplines for the collaboration that future advancements would require, such as multimodality treatment, as well as clinical protocol requirements for interdisciplinary collaboration.
Thus, ACCC developed into the only national organization promoting the collective concerns of the oncology team as a whole. Beginning with its first annual meeting in 1974, ACCC has facilitated multidisciplinary oncology collaboration in a variety of forums dedicated to diverse aspects of cancer program management, including general sessions, small group discussions, and networking events. In 1983, ACCC held its first oncology economics conference, which for the first time explored the economics of cancer program management from a multidisciplinary perspective.
While community cancer programs sprouted up all over the country, ACCC soon recognized the need to establish a set of standards that would provide its members with tangible guidance on just how to go about setting up oncology programs. Under the leadership of ACCC President Herbert Kerman, M.D. (ACCC President 1981—1982), ACCC initiated development of standards for cancer programs in 1981. In 1985, led by Robert Enck, M.D. (ACCC President, 1987-1988), the newly formed Ad Hoc Committee on Standards culled the collaborative contributions of the eight committee members and representatives of more than twenty ACCC Delegate institutions. On March 13, 1987, the Standards for Cancer Programs were unanimously approved by the House of Delegates at ACCC's 13th Annual National Meeting.
ACCC's Standards for Cancer Programs, first published in 1988, expand upon the standards of the American College of Surgeons' Commission by offering more detailed information on what the major components of a cancer program are, regardless of setting, and how those components relate to each other. Former ACCC President (1999-2000) Margaret A. Riley, M.N., R.N., C.N.A.A., was a member of the Standards Committee that oversaw the development of ACCC's first published set of standards. "The standards enabled ACCC to deliver its own stamp on what a cancer program should be," Riley said. "Our central point was, and has always been, that no matter the setting, a quality cancer program offers, either directly or indirectly, access to the core components of oncology care as outlined in the Standards."
The Standards were the first of many tools ACCC would provide to its membership to help them deliver the most effective and efficient care possible to patients with cancer. In 1997 the first editions of ACCC's patient management guidelines were developed to reflect the standard of care for the majority of cancer patients who benefit from conventional therapy. The guidelines, which were developed in conjunction with a large number of national specialty and state oncology societies, are a mechanism by which a physician can inform payers of the standard of care that is accepted in his or her state. In addition, ACCC has published three editions of Critical Pathways, a compilation of clinical pathways used by various ACCC member institutions.
Perhaps one of ACCC's most daunting challenges and most significant contributions to oncology was a project to determine the most practical approach to measuring quality of care. ACCC had previous experience in measuring quality with the CHOP and CCOP programs, through the development of standards of treatment and utilization. The ACCC Clinical Indicators Initiative would explore both process and results as a measure of quality cancer care.
In 1988 ACCC established a Clinical Indicator Core Committee, comprised of representatives from a variety of cancer organizations and treatment centers. These institutions offered a wide range of treatment and support modalities necessary for cancer management. The committee was charged with identifying and testing clinical cancer indicators in the community hospital oncology program setting. An initial twenty-one indicators were presented to a JCAHO task force, which was chaired by ACCC Past President John Yarbro, M.D., and included Irvin D. Fleming, M.D., F.A.C.S. (ACCC president, 1989-1990), and Robert E. Enck, M.D., among its membership. Data from this initiative would play a major role in JCAHO's efforts to redirect its accreditation process from a system that monitored the structural elements of health care organizations to an outcome-oriented evaluation process that monitors the quality of care delivered.
By the late 1980s, the nation was witnessing an overall belt-tightening approach to health care spending. Between the mid-1980s and the early 1990s, the cost of health care and pharmaceuticals had risen at about twice the rate of general inflation. The payers of health care-the federal government, insurance companies, employers, and the growing number of HMOs and managed care companies-sought to curb the rising costs of health care, primarily by changing the way health care was reimbursed. Prospective payment systems, gatekeeper mechanisms, and stricter definitions of coverage theoretically were intended to protect patients and enhance quality of care by improving efficiency and reducing inappropriate and/or "experimental" treatment. These measures have contributed to some extent to a higher level of efficiency and decreased health care costs. However, many hospitals and physicians-and patients-have held that too often these cost savings have been derived at the expense of patient care. For the first time, hospitals and oncologists found their decisions regarding patient treatment being weighed against the economic feasibility of carrying them out.
In 1989 ACCC conducted a survey of medical oncologists that found that, as a result of an increasingly restrictive reimbursement environment, patients were being denied access to therapies administered as part of both standard treatment and clinical research. In particular, a growing number of physicians reported reimbursement difficulties surrounding off-label uses of FDA-approved drugs. "Third-party payers were in effect trimming costs by moving off-label drugs into an 'experimental' category, and then refusing to pay for them," remembers David K. King, M.D., F.A.C.P., a medical oncologist at Good Samaritan Medical Center in Phoenix, Ariz., and chair of ACCC's Ad Hoc Committee on Reimbursement. Dr. King served as ACCC President from 1988 to 1989.
By refusing to cover off-label indications, King said, third-party payers were disregarding the work of the national compendia-at that time the U.S. Pharmacopeial Convention's USP Drug Information, the American Medical Association's Drug Evaluations, and the American Society of Hospital Pharmacists' Drug Information-which were nationally recognized for establishing standards for off-label uses. (As of January 1, 1996, the American Medical Association stopped publishing its Drug Evaluations. The AMA transferred its Drug Evaluation files to the U.S. Pharmacopeial Convention, Inc.)
The increasing restrictiveness of third-party payers in covering the cost of patient care propelled a new oncology movement-this time at the state level-in the form of local oncology societies. This move came at a time when more and more legislative issues, especially those related to health care, were focused at the state level. The formation of state oncology societies would enable oncologists to establish a more effective dialogue with state insurance regulators. They would also serve as a platform for the development of legislation to counteract those insurer policies deemed by the oncology team as detrimental to patient care.
As state oncology societies across the nation were forming, many looked to ACCC for leadership in the areas of legislative assistance, meeting events, and overall society management. By 1990 ACCC had expanded its categories for membership to include state societies as Chapter members. ACCC would go on to assist in the development of numerous state societies.
In 1989 the state of Michigan had become the first in the nation to pass legislation requiring insurers to cover off-label indications. However, the legislation lacked any provision for referencing the three compendia-a stipulation ACCC would steadfastly promote as part of its legislative agenda. In 1990 ACCC developed uniform health insurance language in an attempt to influence payers to revise their policies for coverage of off-label indications. The language called for payment coverage for off-label indications when their use is recognized by one of the three compendia or when data within the peer-reviewed literature supports off-labeled use as safe and effective therapy. ACCC's uniform health insurance language would become the basis for legislation in many states guaranteeing patients access to off-label indications.
In 1991 a GAO survey reported that 50 percent of responding physicians were experiencing reimbursement problems for the off-label use of drugs. The study, which was conducted at the request of the Senate Committee on Labor and Human Resources, was developed by the GAO in consultation with ACCC and its members, including Dr. David King. The study called national attention to the problem of denied coverage for off-label use and its ramifications on quality of patient care.
In 1991 ACCC inaugurated the Compendia-Based Drug Bulletin, a quarterly compilation of all cancer-related drugs and indications listed in the major compendia. According to King, the Bulletin was created to alert insurance companies to the information offered by the compendia and to close the gap between the time a new indication or drug is recognized by one of the compendia and when it is recognized by payers.
This sequence of events sparked a nationwide movement to legislate what physicians, nurses, and other oncology care givers view as a central tenet of quality care. Since 1989 ACCC has assisted more than thirty states to in developing legislation and regulations requiring coverage for off-label drug indications. This state reform movement soon led the way for similar reform on the federal level: The language within the Rockefeller-Levin provision passed as part of the Omnibus Budget Reconciliation Act (OBRA) of 1993 to ensure Medicare coverage of off-label indications closely mirrors ACCC's legislative model.
Concurrently ACCC has also lobbied for payer coverage of the patient care costs of clinical trials. Rhode Island became the first state to pass clinical trials legislation in 1994. In 1998 Maryland enacted legislation requiring payers to cover the patient care costs for patients in all phases of clinical trials. Georgia also passed legislation covering the costs of pediatric patients on clinical trials. ACCC continues to support the Rockefeller-Mack initiative to create a demonstration project in which the patient care costs of clinical trials would be covered by Medicare.
Since the early 1990s, ACCC has worked to help all its members stay abreast of state and regional trends. Each year ACCC offers a series of oncology symposia held in various locations across the country. The symposia bring together representatives from the local or regional Medicare carriers, physicians, and office staff to discuss reimbursement policies, legislative initiatives, and other issues specific to their region. As of the turn of the millennium, ACCC had conducted more than 100 oncology symposia.
More than 35 years later, oncology remains a perplexing paradox. Tremendous opportunities in cancer biology and genetics offer the potential for significant changes in what we can do for our patients. Yet these advances are occurring against a backdrop of payer restrictions that may seriously hinder our ability to deliver quality cancer care.
The new millennium offers few guarantees. However, this much is certain: as the baby boomer population ages, the incidence of cancer will only increase. Cancer will soon overtake heart disease as the leading cause of death in persons over 65. By 2030 a record number of Americans will be age 65 or older. More than ever, there will be a need for quality, comprehensive oncology care administered by a qualified, dedicated, interdisciplinary team of oncology professionals.
The new century saw ACCC continue its role as a national forum for addressing issues that affect community cancer programs, such as regulatory and legislative issues, measurements of the quality of care, and clinical research. ACCC continued to promote timely access to quality medical and psychosocial care from pre-diagnosis through all phases of the cancer experience. It encouraged comprehensive multidisciplinary community cancer program development and provided education about approaches for the effective management, delivery, and financing of comprehensive cancer care. The Association continued to work proactively with state and federal governments on behalf of cancer patients and their families on issues of access to appropriate treatment and to clinical trials.
In the latter part of the decade, ACCC worked closely with leaders in Centers for Medicare & Medicaid Services (CMS) and on Capitol Hill. We commented on a number of issues of concern to members: drug reimbursement, the packaging of certain imaging services, the packaging threshold, physician supervision, quality measures, and the date of service rule, among others.
ACCC can count a number of finalized provisions as victories based on ACCC’s meetings with and suggestions to CMS. After three years of concerted efforts from ACCC and other stakeholders, in 2009 CMS finally recognized that its formula for determining the average sales price (ASP) + number is flawed and needs readjustment. CMS recognized that charge compression affects the calculation, and that pharmacy services are not adequately reimbursed.
ACCC and other stakeholders provided new data to CMS in private meetings that demonstrated the need to better account for pharmacy services and also to push for proper coding of packaged drugs.
ACCC continued to work with other advocacy groups in the oncology community on issues ranging from pharmacy overhead payments to the introduction of chemotherapy teaching codes.
Throughout the first decade of the 21st century, the Association expanded its support of state-level oncology organizations. These organizations of oncologists and other healthcare providers offer a forum for discussion of patient care, local reimbursement, and legislative issues on the state and national levels. In 2009, 24 state oncology societies were ACCC Chapter Members, and 14 oncology societies used ACCC management services. These states are Arizona, Colorado, Hawaii, Illinois, Indiana, Iowa, Minnesota, Missouri, Nevada, North Carolina, South Carolina, Tennessee, Texas, and Virginia.
ACCC also greatly expanded its educational programs and projects, including " Cancer Care Patient Navigation: A Call to Action;" "Cancer Survivorship Project;" "Prostate Cancer 'Best Practices' Project;" "Cancer Care Trends in Community Cancer Centers" (our annual survey of membership); and "Transitions Between Care Settings 'Best Practices' Project," among others.
No doubt, the decades ahead will offer their own set of challenges. Community oncology programs can expect the Association of Community Cancer Centers to help them face the changes ahead.