The word “landmark’’ is not in the title, and strictly speaking it is not the Surgeon General’s report but that of an advisory committee to US Surgeon General Luther Terry. Yet “the landmark 1964 Surgeon General’s report’’ is shorthand for the document that would change America’s mind about cigarettes, and, in time, the habit of smoking.

“It was a big deal,” Tom Glynn, 66, senior director of cancer science and trends for the American Cancer Society, said of the report, which is approaching the 50-year anniversary of its release on January 11, 1964.

 Glynn grew up in a New York City apartment where both parents smoked and his grandfather puffed a pipe. His father died of lung cancer.

“I remember clearly it got a lot of news ... 1964 was the highpoint, depending on your point of view, for smoking in the United States. Most people don’t remember, but if you sat in a movie theater, people smoked next to you. People smoked on airplanes; homes were filled with smoke.’’

As the advisory committee worked feverishly for most of 1963 to prepare the report, the nation’s cigarette consumption per capita peaked at 4345, having risen steadily for decades from just 54 in 1900.

 What Terry referred to in his foreword as the “tobacco-health controversy,’’ the decades-long lockstep increase in cigarette consumption and lung cancer, was officially unresolved in the view of the US Public Health Service, but Terry was determined that it would be. “The subject does not lend itself to easy answers. Nonetheless, is has been increasingly apparent that answers must be found,’’ he wrote.

Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service, 

 on a Saturday, timed to roil the Sunday newspapers but not the stock market. The committee’s conclusion, that cigarette smoking causes lung cancer in men and probably women, and is among the causes of chronic bronchitis, resounded like a voice from

the sky. As Terry expected, headlines with the report’s findings blared across the Sunday papers, with 

 front page referring to the cigarette “peril” and “cancer link cited.”

“I remember debating the news with a group of teenagers the day it came out,’’ recalled Gregory N. Connolly, 64, director for the Center for Global Tobacco Control and professor at the Harvard School of Public Health. “My father eventually quit smoking. The report was a transfer of science to the public that touched every individual.’’

While the report was a thunderous end to the official uncertainty about whether smoking is unhealthy, its conclusions were not an abrupt departure from medical opinion. In the neutral language of a government report, the committee outlined an unfolding shift in global public health opinion about smoking from studied to alarmed. The committee noted the 1962 report of the Royal College of Physicians in England, which stated, “Cigarette smoking is a cause of lung cancer and bronchitis and probably contributes to coronary heart disease and various other less common diseases.’’

By the time Terry appointed his advisory committee, the committee noted, the nations of Denmark, Italy, and Great Britain had banned or limited tobacco advertising. Those reports and actions abroad, along with a request from the Federal Trade Commission (FTC) on whether the science required that cigarettes carry a health warning, were among the reasons Terry listed for appointing the advisory committee. Beginning in the 1930s but accelerating through the 1950s, a mountainous body of research had accumulated correlating lung cancer with smoking cigarettes.

In 1956, then—surgeon general Leroy E. Burney appointed a scientific study group on smoking and health, drawing from the National Cancer Institute, the National Heart Institute and the American Heart Association, marking the Public Health Service’s first involvement in the question. Guided by the study group’s conclusion, Burney in 1957 published a statement declaring, “It is clear that there is an increasing and consistent body of evidence that excessive cigarette smoking is one of the causative factors in lung cancer.”

What constituted “excessive’’ Burney did not say, and he dropped the adjective in a second official statement in 1959, writing “the weight of evidence at present implicates smoking as the principal factor in the increased incidence of lung cancer.’’

In June 1961, a reevaluation of smoking and health was suggested by the American Cancer Society, the American Heart Association, The National Tuberculosis Association (later the American Lung Association) and the American Public Health Association in a letter to President John F. Kennedy.

The letter suggested that Kennedy appoint a committee to find “a solution to this public health problem that would interfere least with the freedom of industry or the happiness of individuals.’’

Terry invited representatives of those same organizations in June 1962

 to a meeting for “objective assessment of the nature and magnitude of the health hazards’’ of smoking after President Kennedy responded to their request for a committee.

“We are very proud, as an organization, that we were at the table at that meeting when it was agreed to make an objective assessment of the health effects of tobacco,’’ said Erika Sward,  assistant vice president of National Advocacy for the American Lung Association. “The 1964 Surgeon General report states very clearly that cigarette smoking is causally linked to lung cance in men, and they established it as the most important cause of chronic bronchitis and emphysema, which is now known as COPD (chronic obstructive pumonary disease). It was a landmark report, the first time there was a massive declaration by the federal government that tobacco use was becoming an epidemic.”

Terry appointed a committee of 10 eminent specialists, none with expertise in smoking, to work with a small staff and a wide range of consultants to evaluate the available research, draw conclusions, and make recommendations. “The committee’s assignment has been most difficult,’’ the Surgeon General wrote in his foreword, a statement bordering on understatement. Between November 1962 and publication in January 1964, the committee reviewed 7000 studies and consulted with more than 150 experts. The list of acknowledgments covers 9 pages of names.

The committee’s primary job was to determine if the enormous amount of evidence associating cigarette smoking with disease, particularly but not exclusively lung cancer, supported the conclusion that smoking “caused’’ the disease. The committee accepted the challenge, stating “statistical methods cannot establish proof of a causal relationship in an association. The causal significance of an association is a matter of judgment which goes beyond any statement of statistical probability.’’

The committee established 5 criteria for building a bridge from association to causation: (1) the consistency of the association; (2) the strength of the association; (3) the specificity of the association (4) the temporal relationship of the association; and (5) the coherence of the association. “Science at the time was looking at the mechanistic link,’’ said Connolly, of the Harvard School of Public Health.

“We wanted to know what in smoking triggered what cell in the lung so we could show cause. It was a very clinical perspective. This report really invented modern epidemiology, determining cause by looking at large population data.’’

The economic significance of the tobacco industry and the ubiquitous nature of smoking caused the committee to shroud its deliberations in secrecy. Most of its work was down deep in the National Library of Medicine (NLM). The import of the committee’s work soon became apparent to Don Shopland, who in the spring of 1962 was newly graduated from high school and beginning his first adult job at the NLM.

“There were locked files, administrative confidential files, that sort of thing,’’ said Shopland, who only months before had begun working at the library. Soon, he was working full time for the committee. In 1966, he joined the National Clearinghouse on Smoking and Health, and he later became director of the Office of Smoking and Health (OSH), where he helped write 20 more reports on smoking to Congress.

“There was constant tension around the work,’’ Shopland said. “We worked 7 days a week from August or September when I stared, for the rest of the year, often until midnight. I recall having off Christmas Day, Thanksgiving, and a half-day the day of Kennedy’s funeral. It was a very intense time.’’

The legendary investigative journalist, Drew Pearson, outlined in an October 1963 column the pressure on the committee, and the federal government’s lack of enthusiasm for regulating tobacco and smoking. Pearson correctly reported the committee would link smoking and cancer. He quoted US Secretary of Health, Education, and Welfare (HEW) Anthony Celebrezze, a pack-a-day smoker, who didn’t “consider it the proper role of the federal government to tell people to stop smoking.’’ Pearson cited concerns of the US Department of Agriculture on tobacco crop prices, as well as the FTC’s need for guidance on the need for warning labels and other regulatory issues.

“When we submitted the report to the government printing office, it was the only non-military report that was printed ‘Top Secret,’ ’’ Shopland said. “The tobacco companies were major industries, almost like General Motors. (The committee) took great pains to make sure nothing leaked out that would affect the stock market. They were afraid what would happen to the tobacco industry and related industries for paper, packaging, Wall Street. Tobacco reached deep into society.’’

As it turned out, the regulatory fallout from the 1964 report had little immediate effect on most smokers, with the per capita consumption remaining around 4000 cigarettes for another decade,

or on the industry, which remained profitable and politically potent. In June 1964, the FTC relied upon the surgeon general’s report to require health warnings on cigarettes while it considered restrictions on cigarette advertising.

 In 1965, Congress passed the Federal Cigarette Labeling and Advertising Act (which precluded any package warning except “Caution: Cigarette Smoking May Be Hazardous to Your Health.”) The law required the FTC to report annually on the effectiveness of the warning, and for HEW, of which the surgeon general was a part, to report annually to the Congress on the health consequences of smoking.

The Public Health Cigarette Smoking Act of 1969 banned cigarette advertising on television and radio, and the package label changed to the sterner “Warning: The Surgeon General Has Determined that Cigarette Smoking Is Dangerous to Your Health,’’ but precluded states and localities from regulating other forms of advertising such as billboards and promotions.

 The industry remained largely unregulated by the federal government

 until 2009, when President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act that brought cigarettes under purview of the US Food and Drug Administration (FDA), although this groundwork was laid in 1996 by former FDA commissioner David Kessler, MD, a pediatrician.

“After the 1964 report Terry called for remedial action. What happened was Congress exempted tobacco from every health and safety law,’’ said Connolly of the Harvard School of Public Health.

One of the first studies to link cigarette smoking and cancer was coauthored in 1939 by Alton Ochsner, MD, founder of the famed Ochsner Clinic in New Orleans, Louisiana. Early on, Ochsner was ridiculed for his aggressive promotion of his findings, but he became one of the nation’s earliest advocates against cigarette smoking.

 Most in the medical profession did not see much harm in moderate cigarette use, and many doctors smoked themselves, a fact that the tobacco companies would use to their advantage as health concerns about cigarettes grew.

Tobacco companies courted physicians as soon as health concerns arose. One way was placing advertising in the 

Journal of the American Medical Association

 (JAMA), which accepted tobacco ads for 20 years starting in 1933.

 Eventually, tobacco companies used depictions of physicians in the ads themselves; “More doctors smoke Camels” became a classic. When research by Ochsner and others led to a December 1952 

 it caused a temporary dip in cigarette sales and an immediate response from both JAMA and the tobacco companies.

JAMA stopped accepting tobacco ads. But the industry formed the Tobacco Industry Research Committee (TIRC) to both award research grants and advance the industry’s position.

 Advertising strategy shifted from overt representation of doctors to the promotion of filtered or “safer” cigarettes, which were buoyed by their “studies” and Hollywood actresses who crowed that these new models were “just what the doctor ordered.”

The connections among Big Tobacco, the advertising industry, and physicians did not ebb overnight. Pushed by Ochsner, in 1952 the American Cancer Society began a long-term study to prove cigarettes caused cancer.20 JAMA published Ochsner’s findings and Burney’s 1959 statement on tobacco, but when necessary the industry simply bypassed this outlet and sent favorable study results directly to physicians. Big Tobacco was so entrenched in American culture that Ochsner was warned before an appearance on Meet the Press not to state that there was a causal link between cigarettes and lung cancer.

By 1964, as Smoking and Health rocked the country, the AMA seemed poised to issue a report on cigarette smoking and cancer. For 2 years, however, the physicians’ group had been fighting another battle: President Kennedy’s proposal to create Medicare. Although the AMA denied the charge, US Rep. Frank Thompson (D-NJ) and others accused the group of striking a deal with lawmakers from the tobacco states: if the AMA held its tongue on cigarettes, the legislators would fight Medicare.

On February 7, 1964, less than a month after the Surgeon General’s report was unveiled, the AMA accepted $10 million A Permanently Altered Landscape Knowledge of the dangers of cigarette smoking have seeped into the public consciousness to a degree unthinkable in 1964. This has allowed research priorities to shift as well, as studies turn to issues surrounding public education and health disparities; it is well documented that the effects of smoking hit hardest on low-income groups and the developing world.

 In fact, in October 2013, the American Thoracic Society and the European Respiratory Society published a statement in The American Journal of Respiratory Critical Care Medicine announcing the creation of a committee to address the fact that lower-level socioeconomic groups are 14 times more likely than higher-level groups to suffer from respiratory ailments, with cigarette smoking being a major reason.25

In recent decades, the AMA has joined with other medical groups to combat cigarette smoking, especially among the young. In September 2009, the AMA praised the FDA for a ban on flavored cigarettes, after numerous studies in which “the evidence shows that young smokers are the primary users of flavored tobacco products.”

Much of today’s policy focus is on stopping young people from picking up the habit; last month, the New York City Council raised to 21 the age at which it is legal to buy cigarettes.

Clinically, smoking still kills. The most recent data sheet from the Centers for Disease Control and Prevention (CDC), published August 1, 2013, states that 440,000 deaths, or 1 in 5 in the United States, are caused by smoking.28 This includes 90% of all deaths from COPD.28 Many were already smokers in their twenties when the 1964 report came out, who have been unable to quit, and now suffer its health effects in their old age.

The 1964 report was the first big step in a very long trek to a smoke-free society, said Glynn of the American Cancer Society, who is working on commemorating the 50th anniversary.

“I grew up in a small New York City apartment with 2 cigarette smokers and my grandfather smoking a pipe. No one thought a thing about it,’’ Glynn said. “We went from 42% of the population then (smoking) to 19% now. That is a huge public health success. Probably between 8 and 12 million lives have been saved since the publication of that report, but we still have 44 million people smoking, even though 70% of them say they want to stop. Our work remains to get people to stop smoking, period. I know that sounds obvious, but that’s the work, still.’’

from tobacco companies, which it would combine with $500,000 of its own funds for research grants. Ochsner publicly called the AMA “derelict.”

 A decade would pass before the AMA would issue an official statement on smoking and health, and the group opposed early efforts to regulate cigarette advertising.

While the 1964 report told smokers the dangers of cigarettes, in the 1970s the Surgeon General began warning America’s nonsmokers about the dangers of  smoke-filled rooms. Shopland recalled Surgeon General Jesse Steinfeld mentioning the health effects on nonsmokers when presenting the 1971 report to the National Interagency Council on Smoking and Health.

“The entire report was about smokers, but at the end of his presentation he said it was his opinion nonsmokers needed a bill of rights, that nonsmokers had the right to clean air instead of smokers having the right to pollute the air,’’ Shopland recalled. “We started getting mail from around the country supporting him. That first raised the idea that being around smoking was not a good idea.’’

 contained 3 chapters on “environmental tobacco smoke,’’ giving momentum to the nascent movement to restrict indoor smoking. By the end of the 1970s, 18 municipalities around the nation had passed indoor smoking ordinances.

The 1986 report was entirely about secondhand smoke,

 accelerating the momentum of nonsmokers pressing for clean indoor air. In 1995, California became the first state to pass a law regulating indoor smoking. Currently, 81.5 percent of the US population lives in a locality where indoor smoking is restricted; in many places, outdoor smoking is restricted as well

“You saw America acting as it usually does on social change,’’ said Connolly.  “At the community level people said they’d had enough; they deserved clean indoor air, they wanted an end to marketing to children. They combined the science from the Surgeon General with moral virtue. Smoking rates plummeted in America because of what common citizens did, not what Washington did. It’s the best public health story of the last century.’’

The single greatest blow against cigarette sales in the United States was landed in 1998 when the nation’s 4 largest manufacturers—Phillip Morris USA, R.J. Reynolds Tobacco Company, Brown & Williamson, and the Liggett Group&mdash;signed the “master settlement agreement’’ with 46 states. The agreement guarantees billions of dollars in annual payments to offset Medicaid costs for smoking-related disease. The agreement limits tobacco advertising, with particular restrictions on the use of cartoon characters and other devices for marketing to children. And, it forced the permanent dismantling of the Council for Tobacco Research, the successor to the TIRC. 

Knowledge of the dangers of cigarette smoking have seeped into the public consciousness to a degree unthinkable in 1964. This has allowed research priorities to shift as well, as studies turn to issues surrounding public education and health disparities; it is well documented that the effects of smoking hit hardest on low-income groups and the developing world.

October 2013, the American Thoracic Society and the European Respiratory Society published a statement in 

The American Journal of Respiratory Critical Care Medicine

 announcing the creation of a committee to address the fact that lower-level socioeconomic groups are 14 times more likely than higher-level groups to suffer from respiratory ailments, with cigarette smoking being a major reason

Articles

Evidence-Based Oncology

Smoking and Health: A Public Health Milestone

Surgeon General's 'Smoking and Health' Turns 50

The wide variety and high cost of available treatments for patients with cancer can present challenges to clinicians for deciding upon the most appropriate and cost-effective care.

 These challenges will only increase with time because recent data show that there are now nearly 1000 medicines and vaccines in the oncology pipeline.

 Moreover, the cost for currently available cancer medications increased 22.3% in 2012, with utilization increasing 3.4%.3 Genetically targeted therapies represent much of the increase in the cost of cancer medicines. In 2012, specialty conditions accounted for 24.5% of the drug spend in the United States, with many of the 22 new specialty drugs approved that year costing more than $10,000 per month of treatment.

 The increasing number, type, and cost of cancer therapies confront healthcare providers and payers alike with a pressing need for a method to identify the most effective treatments and reduce cancer care—related costs.

Clinical pathways are a means by which clinicians can arrive at appropriate treatment decisions in cancer care and, at the same time, help reduce costly treatment variation and improve quality of care.

 In addition, oncology care providers who adhere to clinical pathways can benefit from financial and administrative incentives offered by payers.

 When pathways were first introduced, however, oncologists were concerned that they would face payer-imposed limitations to exercising their clinical judgment when treating patients.

 Nevertheless, clinical pathways have gained traction in the healthcare marketplace as payers have sought to collaborate with providers in the design and implementation of clinical pathways. Accordingly, physician involvement in the development of clinical pathways is now recognized as critical to their adoption and success.

Reimbursement Intelligence (RI), a market access consulting firm, completed an online survey in August 2013 of 50 oncology providers representing independent community practices, hospital-affiliated practices, physician network—affiliated practices, and hospitals/academic medical centers. In addition, 20 in-depth interviews were conducted with a subset of respondents responsible for pathway design. The objective was to learn more about the decision-making process in clinical pathway development.

The Model of Cancer Care Is Shifting to Clinical Pathways

The development of clinical pathways can be seen as a shift toward a new model for making cancer care treatment decisions, based on increasingly restrictive decision-making criteria. At the broad end of the decision criteria spectrum, for example, are earlier models such as that used by Medicare. This decision model determines coverage using the compendia of authoritative sources, which determines the level of clinical evidence to support on- and off-label uses of oncology drugs. Somewhat more focused recommendations for treatment, although still broad in nature, are those written by professional societies with National Comprehensive Cancer Network (NCCN) guidelines most prominent. These recommendations are utilized to determine coverage of a product by a private payer. Now, with the advent of clinical pathways, we are seeing highly specific recommendations for patient management being developed by providers for use in their particular organizations.

Pathways are becoming increasingly prevalent, as evidenced by the majority of RI survey respondents reporting that they currently utilize pathways in the treatment of breast, lung, and colorectal cancers.

Oncology Providers Lead the Way in Developing of Pathway Design

There has been an influx of pathway design companies available to assist payers and oncology practices. Pathway companies can track and report utilization and identify benchmarks of adherence to pathways. They can also identify where there may be inappropriate or excessive utilization of treatments and services such as colonystimulating factors and imaging. Survey questions about pathway design showed that 45% of the pathway users developed their own pathways, with the remainder of pathway users receiving pathway design assistance from pathway vendors such as US Oncology and Via Oncology (28% and 14% of users, respectively). This extensive use of pathway design assistance may reflect oncology providers’ ability to customize their pathways even within a system that uses a pathway vendor.

Oncology providers want to make sure the pathways reflect the needs of the patient population within their practice, and many pathway design companies allow some flexibility regarding drugs that are not on pathway. 

 reinforces that oncologists, not payers, are the key players in pathway design. Those who participated in the design of clinical pathways were most often oncologists within the practice (77%), followed by pathway vendors (27%), pharmacists (27%), and payer representatives (15%). Oncologists’ leadership ensures the pathways reflect the latest clinical treatment.

Safety and Efficacy Are Top Considerations for Inclusion of Treatments, Followed by Cost

So how do pathway users decide upon a given treatment regimen versus another in designing a clinical pathway?

In mid-2009, a statewide collaboration between Blue Cross Blue Shield of Michigan (a single-state, not-for-profit BCBS plan), Physician Resource Management (a state physician organization), and Cardinal Health Specialty Solutions (an oncology benefit management company) created a clinical pathway program in which physicians developed the content, structure, and implementation of the program.

 In this program, pathway regimen selections were considered in order of descending priority starting with treatment efficacy, then toxicity, then cost.

Decision making was similar in the 2010 program, a collaboration between Aetna and The US Oncology Care Network, wherein efficacy was given first priority, toxicity was second, and if both efficacy and toxicity were similar, then the lower-cost regimen was preferred for incorporation into the pathway.

Given that many pathway designers placed safety immediately after efficacy as a consideration in selecting treatment, a natural question arises as to which factors carry the most weight in evaluating the relative safety and tolerability of different drugs being considered for placement on pathways. The RI survey results shown in

 indicated that clinical trial design was the top safety/tolerability consideration for pathway placement, followed by the amount of time a drug was on the market, and real-world performance of the drug.

Interestingly, the aforementioned 2 successful pathway collaborations reflect trends later identified in the RI survey, which found that clinical data showing clear treatment superiority were most influential on the decision to place a product on pathway for 67% of pathway designers surveyed. Also, 

 shows that if both efficacy and safety of 2 active therapeutics were equivalent, cost then became a consideration for 38% of pathway designers surveyed, and 29% considered cost after efficacy alone was shown to be equivalent. Similar results were found when both efficacy and safety of 2 supportive care agents were equivalent, with cost then becoming a consideration for 48% of pathway designers surveyed, and 24% considering cost after efficacy alone was shown to be equivalent.

It has been well documented that the high cost of cancer care can be an impediment to patients receiving necessary treatment.

 Physicians must necessarily be cognizant of expensive costs that might impact their patients’ ability to adhere to treatment. For this reason, cost is becoming an increasingly important consideration in clinical pathway design. The RI survey found that when cost factors became a consideration, drugs costs were ranked as the greatest contributing cost consideration for on pathway placement, followed by overall cost of care, and the cost to patient.

Financial and Administrative Incentives Are Primarily Performance-Based and Tied to Organizations

As previously mentioned, payers are of offering financial and administrative incentives to oncology care providers who adhere to clinical pathways. Examples of such incentives can be found in the pathway collaboration between Blue Cross Blue Shield of Michigan and Oncology Physician Resource, a physician-owned practice management entity. Each oncologist who signed up to use the pathway received a $5000 incentive payment; also, the reimbursement rate for generics was increased, and physicians were promised a certain percentage of any savings related to expenditures for chemotherapy and supportive medications.

The responses to the RI survey showed that incentives for adherence to clinical pathways were tied to the oncology practice as a whole for 46% of pathway users surveyed, while 29% of pathway users had incentives tied to both the oncology practice as a whole and the individual oncologists in the practice.

 details the variety of incentives most commonly offered to providers, as indicated by the respondents to the RI survey. Incentives were performance-based in 39% of the organizations surveyed, suggesting that payers and providers place great importance on patient outcomes.

The creation of a case management fee to replace drug margin incentives was found in 25% of provider organizations surveyed. Shared savings between payer and provider was an incentive for 25% of pathway users surveyed, and more generous reimbursement for the use of generics was an incentive for 21% of users. Payer coverage was pre-approved for 18% of provider organizations, essentially creating another incentive: removal of the requirement for prior authorization for on-pathway treatment. Finally, risk-sharing between payer and provider was an incentive among 11% of pathway users.

Clinical pathways represent a shift in how cancer care decisions are made, moving from the use of general guidelines for providing treatment to more specific considerations based upon efficacy safety, and cost. Pathways utilization is increasing, particularly in the treatment of breast, lung, and colorectal cancer. Pathway design companies can provide assistance in pathway design, monitoring services, and may offer some flexibility to oncologists in making treatment decisions. Oncologists’ buy in is seen as essential to the success of pathways and the primary participants in pathway design are most often the oncologists within the practice adopting the pathway. Participation in pathways is being incentivized by payers who offer incentive payments, increased reimbursement rates, case management fees, shared savings, pre-approved coverage, and risk sharing. 

Rhonda Greenapple, MSPH, is founder and chief strategic officer for Reimbursement Intelligence, 2 Shunpike Road, Third Floor, Madison, NJ, 07940.

Funding for the survey was provided through the Cancer Center Business Summit, held October 24-25, 2013, in Chicago, Illinois.

Ms. Greenapple reports a recent collaboration with the Cancer Center Business Summit.

 Ms. Greenapple is responsible for the acquisition, analysis, and interpretation of data, drafting, critical revisions and supervision of the manuscript.

 Rhonda Greenapple, MSPH, Reimbursement Intelligence, 2 Shunpike Road, Third Floor, Madison, NJ 07940. E-mail: rgreenapple@reimbursementintelligence.com

1. Feinberg BA, Lang J, Grzegorczyk J, et al. Implementation of cancer clinical care pathways: a successful model of collaboration between payers and providers. Am J Manag Care 2012;18(5 spec No. 2):e194-e199.

2. Pharmaceutical Research and Manufacturers of America. PhRMA: nearly 1000 medicines in development to help patients in their fight against cancer [press release]. Washington, DC: May 31, 2012. http://www.phrma.org/media/releases/nearly-1000-medicines-developmenthelp-patients-their-fight-against-cancer. Accessed November 30, 2013.

3. Express Scripts. 2012 Drug Trend Report. The increasing challenge of specialty prescription-drug spending. March 5, 2013. http://lab.express-scripts.com/prescription-drugtrends/2012-drug-trend-report/. Accessed November 30, 2013.

4. DeMartino JK, Larsen JK. Equity in cancer care: pathways, protocols, and guidelines. J Natl Compr Canc Netw. 2012;10:S-1-S-9.

5. Neubauer M, Gosse N, Verrilli D, et al. Clinical pathways: are we there yet? Commun Oncol. 2013;10:96-98.

6. Ramsey SD, Fedorenko CR, Kirchhoff AC, et al. Cancer diagnosis as a risk factor for personal bankruptcy. J Clin Oncol. 2011;29:(suppl). Abstract 6007.

7. Zafar Y, Goetzinger AM, Fowler R, et al. Impact of out-of-pocket expenses on cancer care. J Clin Oncol 2011;29:(suppl). Abstract 6006.

8. Gesme DH, Wiseman M. Strategic use of clinical pathways. J Oncol Pract. 2011;7:54-56.

Current Thinking Behind Decision Making in Oncology Clinical Pathway Design

  Over the past 20 years, advances in cancer treatment have created a new challenge: How does medicine meet the needs of increasing numbers of patients who survive the disease? Thanks to earlier detection and more effective therapies, roughly 14 million cancer survivors are now living in the United States, with this population expected to reach 18 million by 2020.

The challenges of survivorship were first spotlighted in the 2005 Institute of Medicine (IOM) report, 

From Cancer Patient to Cancer Survivor: Lost in Transition

 The study estimated that 10 million cancer survivors were then alive in the United States; that number had tripled complex physical and psychosocial conditions. The study found primary care physicians (PCPs) seldom received explicit guidance from oncologists for survivors in remission and lacked evidence-based best practices.

A 2012 report on survivorship published by the American Cancer Society (ACS)

 estimated 13.7 million Americans with a history of cancer were alive on January 1, 2012, and nearly 18 million will be alive January 1, 2022. Prostate cancer is the most common diagnosis for men; at 43% of all cancers for men it is almost 3 times as common as the next 2 diagnoses combined, which are colorectal (9%) and melanoma of the skin (7%). Similarly for women, breast cancer at 41% is more than twice as common as uterine corpus (8%) and colorectal (8%) cases combined.

The 2012 ACS report concluded, “It is increasingly important to understand the unique medical and psychosocial needs of survivors and be aware of resources that can assist patients, caregivers, and health care providers in navigating the various phases of cancer survivorship.”

“We are going from the Big C, that automatically killed people and we couldn’t do much about it, to cancer as a chronic disease or a disease we can cure. It is still scary, but it is not the automatic death sentence it once was,’’ said Crystal Denlinger, MD, an oncologist at Fox Chase Cancer Center in Philadelphia, Pennsylvania. Denlinger, who specializes in treating gastrointestinal cancers, chaired the National Comprehensive Cancer Network (NCCN) panel on survivorship guidelines and coauthored their publication in the Journal of the National Comprehensive Cancer Network in May 2013.

 A patient-friendly version now appears on the NCCN website

“We are getting better at what we are doing, but we were all focused on treating the cancer and not the fallout of the treatment,” she said.

The NCCN guidelines for cancer survivorship planning and care are intended for both oncologists and PCPs treating cancer survivors. The algorithms in the guidelines make recommendations for addressing anxiety and depression, cognitive function, exercise, fatigue, immunizations and infections, pain, sexual function, and sleep disorders in patients who have survived breast cancer, chronic myelogenous leukemia (CML), colon cancer, Hodgkin lymphoma, melanoma, non-Hodgkin lymphomas, non-small cell lung cancer (NSCLC), prostate cancer in 30 years. About two-thirds, or more than 6 million people, were older than 65 years.

A large percentage of survivors, particularly those who are older, suffer chronic conditions in addition to cancer. The IOM report detailed systemic shortcomings in coordinating the nation’s notoriously uncoordinated healthcare system to provide cancer care for aging patients with cancer, small cell lung cancer, and thyroid carcinoma.

 Denlinger said the guidelines will help care providers fulfill a crucial recommendation from the 2005 IOM report: each cancer patient should receive a “survivorship care plan” that includes diagnosis and content of followup visits, tips on maintaining a healthy lifestyle and preventing recurrent or new cancers, legal rights affecting employment and insurance, and the availability of psychological and support services.

“The survivorship care plan that delineates what is required for follow-up has gained a lot of traction,’’ she said. “A lot of people are struggling with how to put together these care plans when, for many patients, the information is scattered across multiple offices and multiple systems.’’

The Commission on Cancer, which certifies most US cancer care centers, has made survivorship care plans a certification requirement beginning in 2015.

 “A few decades ago, a patient surviving cancer 5 years was a success,but now people are surviving longer and longer,” said Sarah R. Arvey, PhD, director of Research and Evaluation at the LIVESTRONG Foundation in Austin, Texas. “Once treatment is completed, patients and the primary care physicians should receive a list of what happened to you in the hospital, and the known risks of those medicines and treatments. You need to walk out of there with a plan. With electronic medical records this will become easier.’’

LIVESTRONG has developed a survivorship care planning template that, along with templates from the American Society of Clinical Oncology (ASCO) and National Coalition for Cancer Survivorship, is recommended in the new survivorship care plan requirement.

Survivorship planning and care is rising as a priority, because the transition from a fee-for-service reimbursement system to an accountable care system demands increasing correlation between results and what gets paid for, said Bo Gamble, director of strategic practice initiatives for the Community Oncology Alliance (COA).

“Healthcare is the last industry without metrics to determine what is good care or not such good care,’’ Gamble said. “We’ve seen a mass exodus of oncologists from community practice to hospitals, mainly for reasons of reimbursement. Patients and their insurers are paying almost double for hospital care. We want to develop the measures to make valid comparisons and create some healthy competition to improve care.’’

In 2012, Gamble and COA launched the Oncology Medical Home Initiative to explore with medical providers and payers what constitutes quality cancer care. He reports a high level of agreement and strong commitment to developing survivorship as part of standard care. “We asked the question, ‘What do you need in cancer care?’ The answer from everybody is the best quality care at the least cost with a good survivorship program that includes quality of life,’’ Gamble said.

“Payers, providers, patients, everyone answered the same. The payers said—and this was profound&mdash;they don’t want to give the impression (they) are about withholding care.’’

In fact, when Gamble detailed COA’s effort to develop 19 standards of cancer on October 30, 2013, at the meeting Value-Based Oncology Management in Chicago, Illinois, he noted that payers were the first to ask that survivorship be included in the standards.

Ira Klein, MD, chief of staff to the chief medical officer for Aetna and active in the Oncology Medical Home Initiative, said survivorship programs will succeed by empowering patients with  information they can both understand and apply, while providing metrics for evaluating the costs and benefits of various treatments.

“We are looking for where what makes the most sense financially is what’s best for the patient. We want to arrange things so we encourage health, because being healthiest is what is cheapest, and when we have illness we pay for what works and not just everything people do,’’ Klein said.

“As we move from the very individualistic model of health care to population health care, the people who pay for the service recognize continuity of care is important,’’ he continued. “Once cancer patients are in remission they need a navigator to help with selfmanagement, help organizing records of their treatment, access to information on how to improve their health, how to manage long-term side effects. Maybe anxiety and depression will be issues; they may still be obese; they may not exercise and still smoke.’’ Dexter Shurney, MD, is chief medical director for Cummins, Inc, a leading global corporation headquartered in Columbus, Indiana, designing, manufacturing, selling, and servicing diesel engines and related technology. The company’s healthcare system covers 110,000 people and is about equally divided between employees and their families, Shurney said. The company is lending its perspective to the Oncology Medical Home Initiative because it already follows that mode for coordinated primary and cardiac care.

“We have a lifestyle approach to primary and cardiac care that encourages wellness. We know foods that contribute to heart disease contribute to obesity and diabetes,’’ Shurney said. “We would expect the oncologists to have a lifestyle approach to survivorship, particularly making sure patients don’t get a second cancer or it is caught early if they do. Our population will include children, some very young who require long-term follow up, and employees who want to get back to work as much we want them back. “Once people are in remission, what are the lifestyle adoptions they need to make? That is the conversation we are looking to measure, to see if that haphappens,” he said. “We don’t want people discharged without looking at what they might be doing that contributed to their cancer.’’

Lack of information is not the obstacle to writing a survivorship care plan. The biggest barriers are logistical and institutional; they include the technical challenge of coordinating the specifics of patient treatment with established best practices and documented side effects of medicines and treatment, and then paying care providers for it. “There is no reimbursement for putting together a plan the patient can take away. ... Physicians aren’t paid for it, so it just doesn’t happen,’’ said Shelley Fuld Nasso, chief executive officer of the National Coalition for Cancer

Survivorship. “For this to be common practice, we have to compensate physicians for their time.’’

Avery, of LIVESTRONG, said it takes about 3 hours per patient to assemble their survivorship care plan. “How can you get this done and get reimbursed for it?’’ she asked. “We have tools, the jewel being our free patient navigation services. We can help cancer clinics meet the needs of survivors.”

Nasso pointed to Journey Forward, a project to integrate data from cancer registries to speed plan preparation for 2 audiences, the patient and the primary care physician (PCP) who will care for the survivor once the cancer is in remission. “We need the NCCN guidelines to reach primary care physicians who are treating cancer survivors, and we need patients to get something, understandable to them, that says, ‘This is what you are facing; these are the side effects you should expect; this is when you need to call us,’’’ Nasso said. “I think it will get easier to create survivorship care plans as electronic record keeping improves.’’

In 1959 the British Medical Journal published a study that found cancer patients did better when doctors told them the truth about their diagnosis.

 Today, cancer is not always the disease doctors sometimes hide from doomed patients, but, even with better results from oncology, it remains perhaps the most dreaded diagnosis. A new IOM report issued this year, 

Delivering High Quality Cancer Care: Charting a New Course for a System in Crisis

 tempers optimism nurtured by increasingly effective treatments. The nation can anticipate 1.6 million new cancer cases annually with more than half striking people older than 65 years, with comorbidities common in this population. Treatment, already costly, is skyrocketing with each new therapy. The 2013 IOM report found that living with cancer is frequently grueling mentally, emotionally, and financially for patients and their families.

Screening programs have led to more overdiagnosis than cures while encouraging overtreatment of patients faced with bewildering and scary choices.

 For all the progress, cancer will likely surpass heart disease as the nation’s leading cause of death this decade.

  “We are in a new payment environment that presents a great opportunity to raise the quality floor,’’ said Amy Berman, a senior program officer at the John A. Hartford Foundation. Her focus is on the health and healthcare of older adults, evaluating both the cost and effectiveness of care.

Berman has become her own best case study. Three years ago she was diagnosed with stage IV inflammatory breast cancer. The first oncologist she consulted recommended aggressive treatment including surgery, chemotherapy, and radiation that he conceded would not cure her. She declined, pursued palliative care, and remains at her job. During her keynote address in Baltimore, Maryland, at Patient-Centered Oncology Care 2013, sponsored by 

, Berman told a rapt audience about visiting the Great Wall of China and staying active as an advocate for palliative care.

The NCCN survivorship guidelines are a good start, she said, toward a frank discussion about what outcomes survivors can expect in exchange for the misery and cost of cancer treatment. She cites research that found patients who received palliative care frequently had better outcomes with standard treatment than patients who did not.

“People need an open conversation about the likely course of the disease,not just their diagnosis,’’ she said. “My prognosis, the likely course of my disease, is that about 11% of people live 5 years. What do I want my next couple of years to look like and feel like? A curative approach that doesn’t cure will take away time from my family, cause me pain, and put me in the hospital where I am exposed to other infection.

“I take medications with the least side effects to hold the cancer at bay and, 3 years out, I feel great, I’ve saved about $500,000 and I have a great life,” Berman said. “But if I hadn’t understood the likely course of this disease, I might have thrown everything at it.’’

1. Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220-241.

2. Institute of Medicine. From cancer patient to cancer survivor: lost in transition. http://www.iom.edu/Reports/2005/From-Cancer-Patient-to-Cancer-Survivor-Lost-in-Transition.aspx Published November 3, 2005. Accessed November 18, 2013.

3. American Cancer Society. Cancer Treatment and Survivorship Facts and Figures, 2012-13. Atlanta: ACS; 2012. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-033876.pdf. Accessed November 2, 2013.

4. Ligibel JA, Denlinger CS. New NCCN guidelines for survivorship care. J Natl Compr Canc Netw. 2013;11(5 Suppl):640-644.

5. National Comprehensive Cancer Network. DFCI/NCCN Cancer Survivorship Information. http://www.nccn.org/professionals/survivorship/default.asp. Accessed December 2, 2013.

6. American College of Surgeons. Commission on Cancer, Cancer Program Standards 2012:Ensuring patient-centered care, continuum of care services. http://www.facs.org/cancer/coc/programstandards2012.pdf. Accessed November 24, 2013.

7. Aitken-Swan, J, Easson, EC. Reactions of cancer patients on being told their diagnosis. Br Med J. 1959;1(5124). Accessed November 20, 2013.

8. Levit L, Balogh E, Ganz, PA. Delivering high quality cancer care: charting a new course for a system in crisis, a report of the Institute of Medicine. Washington, DC: National Academies Press. http://www.nap.edu/catalog.php?record_id=18359. Published 2013. Accessed December 2, 2013.

9. Esserman LJ, Thompson IM, Reid B. Overdiagnosis and overtreatment in cancer: an opportunity for Improvement. JAMA. 2013;310(8):797-798.

10. Ganz, PA. Survivorship: adult cancer survivors. Prim Care. 2009;36(4):721-741. 11. Temel JS, Greer JA, Muzikansky A, et al. Palliative care for patients with metastatic non—small-cell lung cancer. N Engl J Med.soo 2010;363:733-742.

The Quest for Better Survivorship: Guidelines Promote More Accountable Cancer Care

The eyes of America’s doctors will be fixed this month on the nation’s capital, as Congress appears poised to repeal the Medicare Sustainable Growth Rate, or SGR. Should lawmakers fail to undo the much-maligned formula, physicians would face Medicare cuts of at least 24% on January 1, 2014.

While this seems unlikely, doctors—and oncologists in particular&mdash;are learning the cure is hardly without side effects. A bipartisan proposal unveiled October 30, 2013, would replace SGR with a reimbursement scheme that moves doctors away from fee-for-service and closer to compensation based on quality of care, as envisioned under the Affordable Care Act (ACA). But, to keep a lid on spending, Congress included some pills that doctors may find hard to swallow: a 10-year payment freeze, and, for oncologists, a system of winners and losers; some fear this will discourage sharing best practices and penalize some physicians who are generally doing a good job.

The fact that the American Medical Association’s (AMA’s)

 House of Delegates supports the proposal and the American Society of Clinical Oncology (ASCO) is “encouraged”

 by its broad outlines speaks to the need to get rid of SGR, which has consistently failed to keep up with Medicare Part B expenditures. Doctors want an end to the annual uncertainty of waiting for the Congressional “patch” to cover the mounting SGR shortfall.

 Still, both AMA and ASCO, as well as the Community Oncology Alliance (COA),

 have expressed reservations with elements of proposal.

The oncology groups cite details of the plan they say will undermine its goal of moving from fee-for-service to payment for quality, as well as aspects they say will hasten the march of cancer treatment into expensive hospital settings.

 The AMA joins the oncologists in asking whether the 10-year payment freeze, coming on top of Medicare cuts physicians have already endured, will allow practices to invest in technology and other changes needed to move toward new payment models.

After years of waiting for an SGR remedy, however, oncology groups appear willing to work with the current proposal. At the meeting Value-Based Oncology Management in Chicago, Illinois, Ted Okon, executive director of COA, spoke a day before Congress’ proposal was announced. Okon outlined the “destructive” effects that current Medicare reimbursement policies have had on community clinics.

Since 2005, after Congress altered Medicare cancer drug reimbursement formulas—pegging to average sales price instead of average wholesale price&mdash;Okon said 288 clinics have closed, and 469 have been acquired or have a physicians’ services agreement with a hospital. “The community share of oncology patients is declining,” Okon said. “More and more I hear physicians say, ‘I give up.’ These are well-run practices.”

Years of uncertainty over Medicare reimbursement have left practices unwilling or unable to make long-term investments, he said. “They say, ‘We strategic plan day-by-day.’ ”

The problem with SGR dates to 1997, when Congress created the formula in an effort to control spending. The formula was supposed to set realistic yearly and cumulative spending targets; if the cost of care exceeded the target in any given year, rates would be cut the following year to make up the difference.

However, inaccurate forecasts meant actual Medicare Part B spending has exceeded the target for more than a decade. Each year, the “sword of Damocles,” as UCAMA president Ardis Hoven, MD, called it,

 would hang over physicians’ heads as they waited for Congress to pass legislation to thwart the automatic triggers that would absorb the accumulating shortfall. Yet the longer Congress failed to fix SGR, the worse the problem grew.  In May 2012, in an interview with 

 ASCO chief executive officer Allen S. Lichter, MD, called the situation “the classic kick-the-candown-the-road.”

How big is the problem? Estimates for getting rid of SGR include $377 billion for 2012 and $139 billion for 2013,

 and there are no good answers on how to address it. When asked how the repeal would be funded, AMA’s Hoven said, “I don’t think we really know.”

Problems with Medicare’s dysfunctional reimbursement model have hit oncology especially hard, and the effects of the federal sequester have only made things worse, Okon explained in Chicago. Oncology’s buy-and-bill system of administering increasingly expensive medications, the diversity of disease states, and the fact that so many cancer patients are older and reliant on Medicare mean an outdated reimbursement model is acutely felt in oncology. According to the American Cancer Society’s 2013 report, 77% of all new cancers are diagnosed in persons 55 years or older.

 ASCO’s Lichter outlined just how an unreformed fee-for-service payment model fails the oncologist, since the total amount of Medicare funding is capped. “Over time, the number of things physicians can do, and the number of patients and the number of medical conditions that we can now affect, has just grown and grown and grown. If the amount of funding to pay the fees is finite, and to some extent the number of things we can do keeps growing and growing, then the fee for each unit of service needs to be cut. That’s essentially, in very broad brush strokes, how the SGR dug the hole that we’re in,” he said.

Meanwhile, the scientific side of cancer treatment—including new therapies and the impact of genetics on treatment&mdash;has been transformed. With that transformation has come the call for oncology to move with the rest of medicine toward a payment model that rewards quality. But while multiple pay-for-quality demonstration programs exist in cancer care, as long as Medicare stuck with SGR, change would be difficult.

The lack of resolution has not been good for doctors or patients, Okon told the Chicago gathering. More and more patients have been pushed into hospitals for chemotherapy, where costs are higher. Shortages of key chemotherapy drugs, especially generics, have emerged, along with parts of the country where care is limited.

“If you look at a state like Wyoming, you see we’ve created treatment cracks in rural areas,” Okon said. “Drug shortages have cost lives in this country.”

This year, Congress vowed to craft a permanent fix; however, the proposal as drafted did not appear to commit any new funding to closing the shortfall. AMA’s Hoven told 

, “We understand the fiscal issues very clearly, and we understand there are going to have to be offsets,” she said. “But … to ask physicians to sustain a freeze for another 10 years on top of what they have already sustained, when the cost of care continues to rise … is not reasonable either. You have to balance the two.”

Beyond the concern with the rate freeze, both ASCO and COA have raised issues with the proposal that the groups feel undermine its expressed goal of moving away from fee-for-service. ASCO president Clifford A. Hudis, MD, raised many issues in a letter to chairs and ranking members of the Senate Finance and House Ways and Means committees.

• The use of a proposed Value-Based Performance (VBP) payment program could end up penalizing practices that are doing good work—and, in fact, improving&mdash;but still rank slightly below their peers. Denying these practices resources, especially those located in underserved areas, risks putting them out of business and adding to shortages of oncologists.

• Imposing a VBP program and a rate freeze at once would give practices little time or ability to transition to a pay-forperformance model, including making investments in information technology.

• Lack of detail about quality measures concerns oncologists, who have many subspecialties; ASCO seeks to govern the standards that Medicare will use. For this same reason, ASCO wants to test alternative payment models (APMs) before they are fully implemented.

• Instead of creating a system of winners and losers, ASCO seeks “thresholds”: if the physician or practice met certain standards, reimbursement would be granted; more would be paid to providers that meet a higher standard.

November/December 2013

Surgeon General's 'Smoking and Health' Turns 50

Current Thinking Behind Decision Making in Oncology Clinical Pathway Design

The Quest for Better Survivorship: Guidelines Promote More Accountable Cancer Care

Oncology Groups Active in Effort to Repeal SGR

Genetic Testing Should Come With Counseling: American Cancer Society CMO, Supreme Court Plaintiff Among Experts Who Warn of Consumer Risks

FDA Tells Direct-to-Consumer Genetic Testing Company to Halt Marketing

Safety Concerns Halt Ponatinib Development

FDA Approves Ibrutinib for Mantle Cell Lymphoma