As CEO of the American Society of Clinical Oncology (ASCO), Clifford A. Hudis, MD, is always on the go—and not just between his home in New York and ASCO headquarters in Virginia. 

With his team, he constantly searches for ways to support ASCO’s more than 45,000 members and their practices, ensuring that all patients receive the quality cancer care they deserve, working with elected and appointed officials on public health initiatives, and developing continuing education programs and workshops to keep cancer doctors around the world at the top of their game. 

But at least once a month, Hudis will spend a Friday afternoon at Memorial Sloan Kettering (MSK) Cancer Center in New York, New York, where he served as chief of the Division of Breast Cancer Medicine for 18 years. There he meets new patients and manages the care of existing ones, satisfying his desire to be a physician and keeping himself up to date on the evolving challenges doctors face. 

“Over the years, I’ve been in rooms where people are discussing and deciding profound policy issues related to clinical care, sometimes they had not, themselves, touched a patient in years or even decades. Given the privilege of representing ASCO’s diverse membership, I always want to retain at least some connection to real-world clinical care,” Hudis said. “Not only is it emotionally and professionally rewarding to sit and talk with patients, but it is also useful for my role at ASCO. I always want to relate to our members as a peer, sharing some of the same day-to-day challenges and representing their needs accurately.” 

Hudis took the helm at ASCO in 2016 after more than 30 years as a practicing physician. He had spent most of those years at MSK, first as a fellow, then as a collaborative clinical and translational researcher focused on drug development. This included developing the practical dose-dense adjuvant chemotherapy regimens for breast cancer. 

He rose to the rank of attending physician and full member at MSK while becoming a professor of medicine at Weill Cornell Medicine. There’s a big difference between the clinical work and research that marked the bulk of his career and managing what is functionally a large, nonprofit corporation with multiple connected entities and international reach. Yet Hudis believes a background in medicine can be great preparation for leadership and administration, be it at a business or a nonprofit. AS CEO, he’s asked to make decisions every day that affect thousands of ASCO staff and members. 

“This is where practicing medicine is a useful training ground,” he added. “I do think my clinical experience gives me some comfort with decision-making in the face of imperfect information.” 

Hudis grew up in a middle-class neighborhood in Northeast Philadelphia, Pennsylvania. His mother was a public school teacher, and his father built and owned a food distribution business. From a very young age, Hudis remembers, his parents nudged him toward a career in medicine and encouraged his interest in science and math. 

Hudis considered specializing in psychiatry until he started his oncology rotation in a clinic run by MCP professors Rosaline R. Joseph, MD, and Emmanuel C. Besa, MD. “The combination of cutting-edge technologies, a reliance on the scientific method, and the strong bond that developed between doctors and their patients greatly appealed to me,” Hudis said. 

After medical school, applying for a fellowship at MSK was a no-brainer for Hudis. As a boy, he’d seen the 1971 movie Brian’s Song, which is based on the true story of Chicago Bears running back Brian Piccolo and his battle with an aggressive form of germ cell testicular cancer. Piccolo, who was just 26 when he died in 1970, sought treatment at MSK. 

“When I applied to medical oncology fellowships, it was my first choice, and I think that seed was planted by Brian Piccolo’s story,” he said. 

At MSK, Hudis was one of the first fellows to work with the legendary Larry Norton, MD, as Norton developed the center’s breast cancer program. Hudis found a lifelong friend and mentor in Norton, who today serves as senior vice president, medical director at the Evelyn H. Lauder Breast Center, and the Norna S. Sarofim Chair in Clinical Oncology at MSK. Norton, and won a Giants of Cancer Care® award in 2016. 

“What that really meant was that all of the academics, the science, the learning, the hard work and study can only make us experts up to a certain point. The life and experience of individuals with cancer is another most critical form of expertise,” Hudis said. “They know the impact the disease has on their lives. They know what they want to achieve with treatment. That’s always stuck with me.” 

Hudis said 2 “accidents of history” helped further his career. The first was the early development of filgrastim (Neupogen), a recombinant, nonpegylated human granulocyte colony-stimulating factor analogue that stimulates the growth of white blood cells. MSK helped develop curative breast cancer regimens that incorporated filgrastim. 

The second big break also involved a treatment drug, paclitaxel. When the FDA approved the cytotoxic agent in 1992, paclitaxel was the first new conventional chemotherapy introduced in decades found to have broad use and clinical efficacy. Hudis and his colleagues further developed paclitaxel-based chemotherapy into a standard postoperative adjuvant treatment regimen. 

“When I started in the oncology clinic at MCP, I could list all of the known effective drugs for the treatment of cancer and, in short form, it would fill only 2 sides of 1 page,” Hudis said. “The subsequent expansion of effective options, which is only growing faster today, is really exciting and is exactly what I hoped to see during my career.” 

When ASCO’s CEO position became available in 2016, Hudis had been exploring the links between obesity and breast and other cancers with colleagues at MSK and Weill Cornell Medicine for about 10 years. That research convinced him that public policy and awareness would have to be part of any solutions. ASCO offered the possibility of effective intervention on a global scale. 

Hudis steered ASCO as it launched some of its boldest initiatives to date, including CancerLinQ, the only physician-led big data platform in the country. He worked with other research and medical institutions to boost federal support for cancer research, which was stalled for almost a decade. 

“I recognized that science was important but so, too, was evidence-based public policy,” he said. “And to engage political leaders in Washington, you have to be there; ideally, backed by strong data.”

Articles

As CEO of the American Society of Clinical Oncology, Clifford A. Hudis, MD, is always on the go—and not just between his home in New York and ASCO headquarters in Virginia. 

Making a Difference Face to Face and Across the Globe With Cancer Policy Efforts

Limited financial and medical resources available to cancer treatment centers in developing nations often make it difficult for physicians there to follow best practices widely adopted in the United States and other highly affluent countries. The National Comprehensive Cancer Network (NCCN) is working to change that by developing modified guidelines for specific regions that offer less-costly and less—technologically intensive alternatives.

In developing these sets of Harmonized Guidelines, the NCCN has recognized the growing international use of its core set of guidelines on treating multiple cancer types. These were downloaded globally more than 10 million times in 2018, although not as frequently in less-developed countries. Overall usage is rising—downloads in 2018 were up 26% from 2017. Modified guidelines from the NCCN have already been developed for sub-Saharan countries and the Caribbean (

“We recognize that just having the guidelines on the web isn’t sufficient. They were initially developed for those with high resources at US comprehensive cancer centers. They need to meet the needs of patients and care providers at different locations where medical resources vary,” said Wui-Jin Koh, MD, the NCCN’s senior vice president and chief medical officer.

“We’re working on translations and with experts from around the world to adapt and harmonize the guidelines for [physicians’] specific regions, to give them novel ways of implementing guidelines-concordant care tailored to resource availability and to provide a platform for advocacy of improving care delivery systems with their governments,” he said.

NCCN care recommendations, determined by multidisciplinary panels from 28 leading academic cancer centers, cover about 97% of all cancers. They include recommendations for treatment of cancer by site and provide information on prevention and risk reduction and supportive care. There are also guidelines tailored to specific populations and patient educational products.

In addition to the Harmonized Guidelines already established in sub-Saharan Africa and the Caribbean, a related harmonization effort called the Middle East and North Africa (MENA) NCCN Adaptation Project was concluded in January. The NCCN also plans to update the Harmonized Guidelines to keep up with changes in the NCCN’s core guidelines.

The core guidelines are constantly refreshed. In 2018, for example, the NCCN’s “parent” breast cancer guidelines were updated 4 times and its non—small cell lung cancer (NSCLC) guidelines got 6 updates. Its Harmonized Guidelines are based on the parent guidelines but are modified to reflect the general standard of care (SOC) in specific regions of the world. In addition, less-sophisticated care options are provided for physicians who may not be able to provide regional SOC.

The NCCN is now working closely with experts in Latin America, the Pacific Basin, and Spain. In late April, for example, NCCN representatives met with health leaders in Bolivia to begin crafting guidelines that could be optimized for varying resources. The first 3 adaptations will focus on breast, cervical, and rectal cancers based on the highest incidences and greatest need for the region.

“We want to take advantage of every opportunity we have to advance the standard and accessibility of care globally,” said NCCN Chief Executive Officer (CEO) Robert Carlson, MD. “We have a process we’ve used in multiple settings, going through the guidelines page by page, decision by decision, to see what’s possible and what’s not for a specific setting. And if something’s not possible, we look at what pragmatic and evidencesupported alternatives can be used instead. Sometimes doctors don’t have access to a certain cancer drug, so we might have to find the next most successful drug.”

All versions of the NCCN Harmonized Guidelines come with 3 levels of recommendations: Black text indicates generally available SOC for that locale; gray text refers to care that may be costly, technically challenging, and/or have a lesser impact on oncologic outcome; and blue text provides regional options to consider when best practices aren’t available.

A Look at NCCN Harmonized Guidelines in Sub-Saharan Africa

Life expectancy in sub-Saharan Africa is rising partly due to better control of infectious diseases like HIV, malaria, and cholera. Cancer rates, however, are also increasing due to the longer life expectancy. The incidence of cancer is expected to double by 2040 to 1.6 million cases per year.

 In this region, more than 50% of patients with cancer die within a year of diagnosis, as most patients—about 80%&mdash;seek care only when the disease is advanced, according to Abubakar M. Bello, MD.

Further complicating the situation is that few people have insurance and drug costs are high. Certain oncologic drugs may not be available. Residents also have limited access to cancer care centers, although that is improving. Not long ago, Bello, of the National Hospital in Abuja, Nigeria, was the sole oncologist serving about 16 million people. His slim cancer-fighting arsenal included an occasionally faulty 17-year-old linear accelerator.

Without “the privilege of specialization,” Bello said, he was expected to know how to diagnose and treat multiple cancers, “and you tend to be a bit confused if you don’t have something to fall back on.”

Bello and the NCCN worked with the African Cancer Coalition and Nigerian Health Minister Isaac Adewole, MBBS, an oncologist, on the creation of guidelines for sub-Saharan Africa that focused on how to achieve the best results with limited resources and provide a pathway for further development of cancer care systems.

They first determined which cancers were among the most prevalent in their area. In Nigeria’s case, this included breast, cervical, and prostate cancers. They then determined what treatments were available. There are now 19 NCCN Harmonized Guidelines for sub-Saharan Africa. The governments of Ethiopia, Nigeria, and Tanzania have formally endorsed the guidelines.

One example of sub-Saharan Africa— specific guideline harmonization is the treatment of cervical cancer. Pelvic external beam radiation therapy and brachytherapy are the NCCN’s primary recommendations for locally advanced cancer. But in recognition of limited resources in the area, the guidelines suggest the alternative of neoadjuvant chemotherapy followed by radical hysterectomy if there is no access to radiotherapy.

Another example can be found in breast cancer. A chest CT with contrast is the NCCN’s primary, or “black text,” recommendation for systemic staging, but because such technology may not be readily available, the guidelines in blue suggest using a pragmatic alternative of chest x-ray with abdominal ultrasound.

“It’s a bit early, but we do know this is a step in the right direction. There’s a lot of enthusiasm to follow the guidelines, and practices are changing because of the guidelines,” Bello said. “Patients are properly staged before starting treatment because doctors are downloading the guidelines and trying to follow them.

“In a few years, maybe 5, we hope to have cancer centers that are NCCN-accredited so we can use all of that expertise to lower the death rates of patients in sub-Saharan Africa,” Bello said. “We’re getting cancer care, and it’s becoming more affordable, and it’s almost on par with developing nations, even if it’s not [on par with] the United States.”

NCCN Harmonized Guidelines for the Caribbean

Marisa Nimrod, MD, chair and CEO of the Caribbean Association of Oncology and Hematology (CAOH), said adaptation and implementation of the NCCN guidelines will be a regional goal this year. There are currently 7 NCCN Harmonized Guidelines for the Caribbean.

“The Caribbean Harmonized Guidelines present a more hand-in-glove fit for the resources available within this area,” said Owen Gabriel, MD, a consultant oncologist at Victoria Hospital in Saint Lucia and chair of an NSCLC guideline initiative. “Although there is no formal adoption, these guidelines are being promoted via their use as the backbone of multidisciplinary tumor boards as well as individualized patient care.”

Still, the changes were not extensive, according to Gilian Wharfe, MD, clinical chair of the NCCN CAOH guideline development initiative. “Most of the changes made were related to lacking certain technology [and] skilled surgeons and, most of all, the unavailability/affordability of the medications used in the treatment of these conditions,” she said. “The cost of medication has a huge impact on how we treat our patients.”

One example of how the guidelines have been harmonized for the Caribbean is a recommendation for neoadjuvant platinum- based chemotherapy in advanced cervical cancer if initiation of SOC chemoradiation must be delayed.

Figure. Sample of NCCN Harmonized Guidelines for Sub-Saharan Africa: Version 2.2017, Breast Cancer

“The NCCN Caribbean Harmonized Guidelines afforded the evidence and justification for this option, which is not typical for the more advanced stages of disease,” Gabriel said. “The results have been astounding, with generally no difference in outcome when compared with patients who underwent the [SOC] option.”

 In Jamaica, Sophia Edwards-Bennett, MD, chair of the NCCN/CAOH guideline harmonization initiative, said the guidelines were modified to “reflect the current technologies available in Jamaica at this juncture.” Thus, clinical practice generally aligns with the new construct. “Although not empirically determined, the gap between aspiration and reality has been largely addressed,” she said.

Physicians in Jamaica are preparing to distribute the guidelines electronically and via pamphlets, a process that will be complemented by medical conferences.

Edwards-Bennett echoed Wharfe’s comment about the high cost of anticancer drugs in Jamaica, noting that “this challenge is not only applicable to novel targeted therapies, such as immunotherapy, but [includes] conventional regimens as well.”

Abdul-Rahman Jazieh, MD, MPH, chairman of the MENA NCCN Adaptation Project, said doctors in this region turn to the NCCN guidelines because they cover most common cancer and clinical scenarios, are continuously undated to incorporate recent evidence, and are easy to access and understand. Harmonization, he said, required minimal changes, “as our aim is to practice medicine similar to US oncologists. We kept changes at a high level as resource-stratified guidelines give choices to oncologists to choose adaptation at different levels.”

One example of a MENA-adapted guideline is for the treatment of NSCLC. Lung cancer has the highest incidence among cancers in 7 of 13 Arab countries, and data indicate that NSCLC is on the rise.

Primary NCCN guidelines recommend molecular testing for metastatic NSCLC. The MENA adaptation recommends establishing an independent molecular tumor board (MTB) or including experts in thoracic MTB meetings to carefully assess the need for, and results from, molecular testing.

Primary NCCN guidelines also recommend either completing or interrupting systemic therapy in patients who are found to have molecular biomarkers, such as 

rearrangements, during first-line chemotherapy. The MENA adaptation clarifies that chemotherapy should be interrupted in the event of serious adverse events and appropriate tyrosine kinase inhibitor therapy should be initiated.

The rollout of the adapted guidelines has encouraged many cancer care centers in the region to enhance their practices, Jazieh said. “They accelerated the adoption of the latest treatment options, especially when it comes to precision medicine, including workup and management,” he said. “We use the NCCN guidelines to convince hospital leaders to have access to medications on formulary” or that are not on formulary but are part of the NCCN guidelines.

National Comprehensive Cancer Network Harmonized Guidelines for sub-Saharan Africa: breast cancer, version 2.217. NCCN website. Updated November 3, 2017. Accessed May 1, 2019. www.nccn.org/ professionals/physician_gls/pdf/breast_harmonized-africa.pdf.

Dent J, Manner CK, Milner D, et al. Africa’s emerging cancer crisis: a call to action. BIO Ventures for Global Health website. bvgh.org/ wp-content/uploads/2017/07/Africas-Emerging-Cancer-Crisis-ACall- to-Action.pdf. Published June 2017. Accessed May 1, 2019.

Salim EI, Jazieh AR, Moore MA. Lung cancer incidence in the Arab League countries: risk factors and control. 

. 2011;12(1):17- 34. researchgate.net/publication/51074223_Lung_Cancer_Incidence_ in_the_Arab_League_Countries_Risk_Factors_and_Control.

The NCCN is working to develop modified guidelines for specific regions that offer less-costly and less–technologically intensive cancer treatment alternatives.

NCCN Goes Global With Guidelines Tailored for Treatment Capabilities Abroad

When the FDA approved its first biosimilar drug in 2015

—filgrastim-sndz (Zarxio), for compromised white blood cell count&mdash;there was talk of the benefits of competition in the pharma industry; increased access to medications for patients; and, of course, the all-around savings. After all, the cost of developing and guiding a biosimilar through the approval process is a fraction of the cost of developing a reference biologic: in the range of $100 million to $250 million versus $2.6 billion for a new prescription medicine.

Four years later, those benefits haven’t been fully realized, according to Gary Lyman, MD, MPH, senior lead of health care quality and policy at the Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center in Seattle, Washington. “There is some evidence of price reduction, but it’s too early to tell if biosimilars will fulfill expectations,” he said. “As people become more comfortable with biosimilars and we see multiple agents competing with originators, we hope we see meaningful price reductions. We’re not going to see 80%, like generics, but even 10% to 15% reductions, at the national level, would represent billions of dollars in potential savings.”

Biosimilars are complex molecule agents that bear almost identical resemblance to original biologics that have lost their patent exclusivity. Just 3 years out of the starting gate, biosimilars in the United States are too hazy a target for precise savings analysis. The Rand Corporation has been studying this emerging market since before Sandoz’s filgrastim-sndz became the first biosimilar challenger on the American scene. Rand estimated potential biosimilar savings of $44.2 billion over the 2014-2024 period (range, $13 billion-$66 billion), or 4% of total biologic spending.

 In a 2017 update, the estimate was just marginally higher, although adjusted downward for degree of market penetration: $54 billion (range, $24 billion-$150 billion) over the 10-year period ending in 2026, or about 3% of estimated total biologic spending.

 Other estimates put the potential 10-year savings as high as $250 billion.

These estimates, in fact, are significantly more optimistic than what has been achieved in the European Union (EU), where biosimilars were first introduced in 2006 and those approved by the European Medicines Agency (EMA) numbered 54 by the start of 2019.

 A report by IMARC indicated sales of biosimilars in the EU reached just US$2.9 billion in 2018 and projected a total of US$11.7 billion by 2024.

 Biosimilars are taking hold in other regions of the globe, such as Korea, where a significant manufacturing industry dedicated to biosimilars has sprung up, and India, where more than 25 biosimilars have been approved for marketing.

Observers cite multiple reasons for the slow uptake stateside: There are a limited number of biosimilars on the market—18 have been approved thus far, including oncologic agents and supportive medications (

 In addition, manufacturers of originator products, upon which biosimilars are based, have been accused of blocking the market entry of these competitor products and discouraging public acceptance of them. Further, some providers hesitate to change a patient’s treatment plan if costly reference biologic drugs are working, for fear the biosimilars won’t be as successful.

“I’m a practicing oncologist, and some of us have used [originator biologics] for 10, 15, 20 years, and we’ve gotten very comfortable with them,” Lyman said. Given the very nature of biologics— the complex manufacturing involved and the difficulty of preparing identical batches of drugs&mdash; it is doubtful that parallelism of quality between biosimilars and biologics can be maintained over the long haul, Lyman said: “I would argue that all biologics are prone to drift with changes in conditions, and studies have shown original biologics on the shelf today are not the same as they were 15 years ago. The originator drugs we’ve gotten really comfortable with are really biosimilars to the ones we started using years ago.”

Biologics have led to breakthroughs in oncology and other serious diseases, and they typically cost tens of thousands of dollars for a year of treatment, and with this amount of money at stake, manufacturers of original biologics are suspected of deliberately trying to thwart the introduction of lower-cost biologics, according to a news report earlier this year. Outgoing FDA Commissioner Scott Gottlieb, MD was quoted expressing concerns about “deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of biosimilars, which the FDA examines for reliability and efficacy as part of marketing approval.

 Gottlieb in July announced that the FDA had created a Biosimilars Action Plan as part of its mandate to encourage innovation and spur price-lowering competition in the drug market. The report indicated that generic drugs, facilitated by the Hatch-Waxman Act of 1984, for instance, now represent 90% of all prescriptions in the United States and generated $265 billion in savings in 2017 alone.

 It was only recently that the FDA launched a statutory pathway to approve follow-on versions of biological products, which amount to 40% of all prescription drug spending and 70% of the growth in drug spending from 2010 to 2015.

In tandem with the action plan announcement, Gottlieb was “worried that the market for these products still isn’t established,” he explained. “The ability for these products to penetrate clinical practice and gain acceptance is still not firm. That doesn’t mean that the future doesn’t hold a lot of promise for biosimilars. It just means that the future is uncertain.”

Biosimilars are one way to address the increasing cost of prescription medicine. In November 2018, Pfizer began offering the anemia treatment drug epoetin alfa-epbx (Retacrit), a biosimilar to epoetin alfa (Epogen/Procrit; Amgen), at the wholesale acquisition price of $11.03 per 1000 U/mL. That’s 57% lower than Procrit ($25.72 per 1000 U/mL) and 33% lower than Epogen ($16.58 per 1000 U/ mL). In July 2018, Pfizer received FDA approval for neutropenia biosimilar filgrastim-aafi (Nivestym), the company’s second oncology supportive care biosimilar.

 Pfizer also has 4 other drug candidates in mid-to late-stage development for the treatment of cancer or as supportive care.

The steep discount connected with the launch of epoetin alfa-epbx helps fulfill expectations and hopes that the entry of biosimilars in the US market will challenge current pricing levels and improve access to medications, although there are no guarantees that prices even for biosimilars will not be scaled up along with the general march of drug cost inflation. “By introducing [epoetin alfa-epbx ] in the US market at a significant discount to its reference products, Pfizer is offering immediate savings to the healthcare system in hopes that patients and their physicians will have access to additional high-quality treatment options,” said Thomas Biegi, director of Global Media Relations at Pfizer, adding that the company couldn’t predict future pricing for epoetin alfa-epbx or other new biosimilars. “Each molecule has specific drivers that determine market price, including number of competitive entrants, so we expect pricing to naturally evolve differently for each biosimilar.”

Studies show that biosimilar competition has driven down overall prices in Europe. For example, epoetin biosimilars have contributed to price declines per treatment day averaging 31% across a wide selection of EU countries, according to a recent report.

 However, epoetin sales in the EU have been adversely affected by a warning that for patients with cancer, the preferred method of correcting anemia should be blood transfusion. There are other examples of the success of biosimilars abroad. In the United Kingdom, use of granulocyte colony-stimulating factor biosimilars eventually surpassed the originator drug in market share.

But that success didn’t happen overnight. Similar to how the FDA is working to encourage biosimilar adoption, the EMA in essence put its thumb on the scale when, in 2009, it updated clinical guidelines to encourage the use of biosimilar versions of filgrastim.

 That led to a significant increase in use, with a larger number of patients selecting the lower-cost drugs in earlier stages of their therapy. The EMA continues work to promote biosimilars: In September 2018, EMA and the European Commission published an animated video available in 8 languages for patients that explains what biosimilars are and how the EMA works to ensure they are as safe and effective as their reference drugs. At the same time, it released a guide to biosimilars for healthcare professionals in 7 languages after previously publishing it just in English.

Similar efforts would make a difference in the United States, too, said Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina and vice president of the Community Oncology, Alliance (COA). Patel is leading COA’s new biosimilars committee, an initiative aimed at providing high quality, accessible, and affordable cancer care.

“One reason we decided to create this committee is to identify the barriers facing biosimilars,” Patel said. “Not very many physicians are familiar with what they are or what the FDA process is. We feel that COA has the resources, plans, and, perhaps, obligations to work with the different stakeholders to reduce hurdles and to help facilities understand how biosimilars can reduce overall cost without affecting outcomes.”

According to Biegi of Pfizer, the company maintains that “uptake and utilization of biosimilars in the United States will be dependent upon multiple factors, including trust on the part of physicians and patients that the biosimilar will perform as well as the reference product.”

“Uptake of biosimilars typically begins in new patients, and as experience builds, existing patients are considered,” Biegi said. “Pfizer’s position is that all switching decisions regarding biosimilars should be made by the treating physician, on an individual patient basis, supported by scientific evidence, and with full patient awareness. It’s crucial that we continue to educate physicians and patients to create confidence and—to be honest&mdash;[and to correct] wrong information that is spread, causing fear and doubt of biosimilars among patient and provider groups.”

That’s a sentiment echoed by Molly Billstein Leber, PharmD, manager of medication policy and formulary management at Yale New Haven System in Connecticut. She adds that “solid basic and clinical science will serve as the backbone of biosimilar acceptance.”

 Billstein Leber has noted that lawsuits filed by originator companies have kept would-be biosimilars locked up in the starting gate. A recent lawsuit filed against Johnson & Johnson and Janssen by Walgreens and Kroger alleges that the biopharmaceutical companies engaged in anticompetitive practices to stop payers from covering biosimilars of infliximab.

However, Billstein Leber acknowledges that based on the slow uptake of generics, it’s understandable that biosimilars in the United States are still sitting on the launchpad despite their moonshot potential in terms of savings and improved access for patients. “I am not surprised by the current biosimilar situation and overall adoption rates, especially when you look at our previous experiences with generic medications. It took 30 years after the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984 for 89% of prescriptions now to be filled with generic medications,” she said. “Even today, many provider MDs still prefer using the branded/originator product for therapies with a narrow therapeutic range. This acceptance took a significant amount of work and was driven by the need to mitigate prescription drug expenses.”

Education, Billstein Leber concluded in her research, is “the key driver of biosimilar acceptance.” She cites the results derived from a 2016 survey of more than 1200 US physicians across specialties who are high subscribers of biologics.

 Among the most striking findings: 20.5% of responders incorrectly said a pharmacist could substitute a biosimilar without prescriber permission, 43.8% of physicians were not aware that biosimilars must be comparable in safety and efficacy to the originator biologic, 35.9% believed that biosimilars were less safe than the originator biologic, and 38.9% were interested in learning more about the FDA approval process for biosimilars.

Similarly, patients also lack information about biosimilars, Billstein Leber said. She believes an agency on the federal level should be responsible for baseline education. The FDA, individual doctors and practices, and medical associations also need to promote it. There is a noticeable lack of educational materials available, and Billstein Leber thinks that COA’s new committee could fill that gap. Education will lead to more biosimilar usage and more savings, she said. “The more often we see [biosimilars], the more comfortable everyone will be. We all need to share our successes and what barriers we have overcome in our journey for biosimilar adoption.”

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Biosimilars action plan: balancing innovation and competition. FDA website. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf. Published July 2018. Accessed February 25, 2019.

Cultivating a vibrant U.S. market for biosimilars: a conversation with FDA’s Scott Gottlieb. Brookings website. brookings.edu/events/u-s-market-for-biosimilars-fda-scott-gottlieb/. Published July 18, 2018. Accessed February 25, 2019.

U.S. FDA approves Pfizer’s biosimilar Nivestym (filgrastim-aafi) [press release]. New York, NY: Pfizer Inc; July 20, 2018. pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_biosimilar_nivestym_filgrastim_aafi-0. Accessed February 25, 2019.

IQVIA. The impact of biosimilar competition in Europe. google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwi_jNHLqNfgAhUrmeAKHZykCCEQFjAAegQICBAC&url=https%3A%2F%2Fec.europa.eu%2Fdocsroom%2Fdocuments%2F31642%2Fattachments%2F1%2Ftranslations%2Fen%2Frenditions%2Fnative&usg=AOvVaw29beGo7y5l0rDapUeBqsuL. Published September 2018. Accessed February 25, 2019.

Billstein Leber M. Optimizing use and addressing challenges to uptake of biosimilars. Am J Manag Care. 2018;24:-S0. ajmc.com/journals/supplement/2018/managing-costs-advancements-biosimilars/optimizing-use-and-addressing-challenges-to-uptake-of-biosimilars. Published November 19, 2019. Accessed February 25, 2019.

Patel KB, Arantes Jr LH, Tang WY, Fung S. The role of biosimilars in value-based oncology care. 2018;2018(10):4591-4602. doi: 10.2147/CMAR.S164201.

Improving understanding of biosimilars in the EU [press release]. Canary Warf, London, UK: European Medicines Agency; September 13, 2018. ema.europa.eu/en/news/improving-understanding-biosimilars-eu. Accessed February 25, 2019.

DiGrande S. Walgreen, Kroger file antitrust suit against J&J, Janssen over Remicade. The Center for Biosimilars website. centerforbiosimilars.com/news/walgreens-kroger-file-antitrust-suit-against-jj-janssen-over-remicade. Published June 11, 2018. Accessed September 6, 2018.

Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. 

. 2017;33(12):2160-2172. doi: 10.1007/s12325-016-0431-5.

When the FDA approved its first biosimilar drug in 2015&mdash;filgrastim-sndz, for compromised white blood cell count&mdash;there was talk of the benefits of competition in the pharma industry; increased access to medications for patients; and, of course, the all-around savings. Four years later, those benefits haven’t been fully realized,

US Market Is Still Waiting for Biosimilars to Produce Meaningful Price Reductions

When hurricane Irma hit Florida in 2017, it churned its way up the western coast of the state and moved directly over the largest cluster of independent practices in the Florida Cancer Specialists (FCS) group. Nevertheless, the chain was able to reopen 86 of its 100 offices within just a few days of the storm’s passing, and it got the remainder open a couple of days later. Almost a year later, FCS narrowly avoided another direct hit when Hurricane Michael moved up through the Gulf with astonishing power and destructiveness, making landfall in the Tallahassee, Florida, area.

With hugely destructive storms now almost routine—3 of the 5 costliest hurricanes on record occurred in 2017&mdash;the secret to practice readiness is constant review and analysis, said Todd Schonherz, chief operating officer of FCS. “The plan isn’t about micromanaging every detail&mdash; it has to be fluid&mdash;but there are major things to be accomplished,” Schonherz noted. “It seems we have a hurricane or tropical storm hit a few times each year. We do a postmortem after each event to see what we could have done better.”

Across the country, many oncology centers have experienced major storms that forced them to take a hard look at their emergency planning. In some cases, practices have worked to ensure that patients are prepared in the event they are cut off from treatment.

Following Hurricane Katrina in 2005, which displaced over 1 million residents of the Gulf Coast, Children’s Hospital of New Orleans initiated an education program to make sure that families of oncology and hematology patients have supplies of medicine and evacuation plans in readiness when other storms hit. “Interventions instituted to allow greater access to care by our hematology/oncology patients after Hurricane Katrina resulted in better preparedness, easier acquisition of information, and possibly better continuity of care,” Raulji et al wrote in an April 2018 study of that effort (

Katrina devastated the New Orleans healthcare safety net, utterly transforming the city’s healthcare landscape and leaving many without access to care even a year after the storm. The storm’s impact reduced the number of hospital beds in New Orleans by more than half and forced nearly 4500 physicians to relocate, with just 1200 returning in the year after the storm. Shrinking patient volumes also caused healthcare centers to lose federal funding.

Table. Post-Katrina Surveys Show Impact of Hurricane on Patient Emergency Planning

The continuance of extreme weather events augurs similarly disruptive events. The year 2018 began with a crippling blizzard with unheard-of “thundersnow” that dumped more than 2 feet of snow on the East Coast. That was followed in April by tornadoes across the Midwest. An active hurricane season saw North Carolina and South Carolina battered by Florence in September and Florida taking the brunt of Michael’s force in October. In November, the largest and most destructive wildfires in California history devastated entire towns and killed dozens. “As the incidence of cancer and the frequency of extreme weather events rise, disaster mitigation is becoming increasingly relevant to oncology care,” noted the authors of a September climate report in 

 Robert “Bo” Gamble, director of strategic practice initiatives for the Community Oncology Alliance (COA), said the association works to prepare its member practices for adversity. The best way to do this is to educate them with examples of practices that have overcome such challenges. “That’s probably the most enlightening,” Gamble said. “Some people think about disasters and say, ‘I have to back up my computer system and keep my fingers crossed.’ It’s so much more than that.”

Practices need to be ready to field unexpected requests for assistance from their patients. These may take the form of needs that go well beyond the scope of oncology care. Gamble has found that some patients turn to their doctors for guidance and help with issues beyond treatment, such as coping with an imminent storm. “The role goes beyond caregiver because of the relationship they have with patients,” he said.

One way to do that is by ensuring there are multiple communication methods in place. “Two-way communications are important in a disaster,” Gamble said. “Patients need efficient, up-to-date communications. How can they communicate with their care teams? How can teams make sure timely information is going out to patients and staff?”

Communication is a challenge that Oncology Consultants of Houston, Texas, dealt with during August 2017’s Hurricane Harvey, a category 4 storm that caused extensive flooding and forced 20 Texas hospitals to close or evacuate.

Oncology Consultants’ practice administrator Alti Rahman, MHA, MBA, CSSBB, said the storm was a learning experience. “We had a very limited disaster plan prior to the storm. We’ve now put a lot of effort into our disaster plan, hoping we’ll never need to use it,” Rahman said. “This year, we ran a storm drill like schools run fire drills.” Oncology Consultants has 20 providers—16 doctors and 4 midlevel to advanced nurse practitioners&mdash; working in 11 locations in the Houston area. Harvey wasn’t the first storm to threaten Houston, so as the hurricane approached, the practice decided to follow the same plan that had worked previously: Luis T. Campos, MD, the organization’s president, would make the call about practice operations once the storm made landfall and it was possible to assess its effects.

But Harvey hit harder than anticipated, recalled Susan Sabo-Wagner, clinical director of Oncology Consultants. A day earlier than planned, she fielded calls from employees who were very concerned about conditionos. “It was, ‘I gotta go. My house is ready to flood,’” she said. The next day, the city unleashed 2 reservoirs before they burst, sending floodwaters into neighborhoods previously undamaged by the storm. Campos and Sabo-Wagner were also affected.

“My whole family was moving stuff upstairs because we thought the water was going to come in, and I’m trying to keep in touch with and communicate with staff,” Sabo-Wagner recalled, adding that Campos’ home was flooded. “I realized we couldn’t wait, and I tried to call Dr Campos, and I couldn’t get him.” When Sabo-Wagner finally did get the go-ahead to cancel the upcoming week’s appointments, she notified the business’s answering service so patients calling in would get the message. Then the service’s primary building flooded. So, too, did its backup facility.

As a result, the team at Oncology Consultants now tells others preparing for a natural disaster to have multiple plans in place to keep in touch with staff and patients and to make sure the vendors they use have similar contingencies in place. “Make sure they think about things like what they’ll do if the primary and secondary systems go out,” Rahman said.

Oncology Consultants wasn’t hindered just by the condition of its physical facilities. Staffing was an ongoing issue. “I’d see staff members on the news being evacuated. A medical assistant whose son was being treated for leukemia lost her house,” Sabo-Wagner recalled. “There were few ways to get new supplies of drugs. There were no flights,” she said.

But the group had a system that kept track of its existing drug inventory. Sabo-Wagner reached out to physicians and asked which treatments their most critical patients needed. She then checked to see whether the drugs were in stock. “We had enough medical assistants and a few imaging people and radiation folks on a limited basis,” she said. “We were driving drugs between offices. If your normal way to get from A to B is underwater, it could take a long time.”

Other Texas oncology groups stepped in and offered help. That worked well for patients who had evacuated to other metropolitan areas. Rahman also reached out to vendors to ask them to be flexible with accounts payable and to insurance companies about paperwork for payment deadlines. Almost all were willing to make accommodations in light of the disaster. “It certainly helped make our case that the storm captured the national media spotlight,” Rahman said. “It wasn’t only the top story in Texas but in the entire country, with pictures everywhere.”

The Center for Preparedness and Response at the Centers for Disease Control and Prevention in Atlanta, Georgia, recommends that patients in emergency situations be ready to protect their own health, have a plan to stay informed and in contact with others, and work with neighbors and friends to increase resilience. That information can also be applied to healthcare providers.

Jose R. Davila, MD, an oncologist/hematologist in Arecibo, Puerto Rico, said partnering with outside oncology institutions was critical to recovery in the wake of Hurricane Maria in September 2017. Most cancer care on the island is delivered by small practices in community settings. The catastrophic storm knocked out not only electricity and internet service but also the cellular phone network. The only way patients in his largely rural area could find out whether a doctor’s office was open was to travel there, and doctors couldn’t communicate with each other, he said. “Having no communication, no electricity… it really felt like we were in a movie,” Davila said. “And when you’re dealing with an island and you want to help, you need a boat or a plane, and that made it even more challenging.”

Davila and other doctors reached out to organizations on the American mainland, including the Florida Society of Clinical Oncology, CancerCare, and COA. The response was swift. “The biggest need in Puerto Rico was money…. At one point, we helped them acquire [satellite] phones,” Gamble recalled. “We had to ask the question ‘What is your biggest need right now?’ The sat phones happened because they said, ‘We need to be able to talk to people.’ If we hadn’t asked that question, we wouldn’t have gotten that answer.”

Davila said the satellite phones made a huge difference. Island doctors were also able to use their mainland connections to make arrangements there for their most critically ill patients, confident they’d be well cared for. “We were very fortunate, given how bad things were.” Things got back online slowly, Davila said. Doctors also had success using WhatsApp, the free messaging phone app. They also began using the radio airwaves to let patients know which offices were open and when. Some moved their practices to hospitals, many of which had generators and were priorities as workers scrambled to restore power. To Davila’s surprise, access to cancer drugs on the island was not a problem. Many doctors were able to keep their stores from being damaged, and local supply companies were up and running fairly quickly. “We were lucky that medication for our cancer patients was not a problem,” he said. “One of the most inspiring stories is that we were able to treat patients.”

More than a year later, Davila said, Puerto Rico is still dealing with damaged infrastructure and a power grid in desperate need of upgrades. Doctors are planning for the next natural disaster. “Once it’s over, you can only be grateful. Then you have to look for ways to make the system better,” he said. “It’s going to happen again. We just need to be prepared.”

Raulji C, Velez MC, Prasad P, Rousseau C, Gardner RV. Impact of Hurricane Katrina on healthcare delivery for New Orleans patients, 2005-2014. 

. 2018;65(12):e27406. doi: 10.1002/pbc.27406.

Rodowitz R, Rowland D, Shartzer A. Health care in New Orleans before and after Hurricane Katrina. 

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With hugely destructive storms now almost routine&mdash;3 of the 5 costliest hurricanes on record occurred in 2017&mdash;the secret to practice readiness is constant review and analysis.

Heightened Risk for Natural Disasters Necessitates Advance Preparation in Oncology Community

An increasing number of oncologists are choosing to specialize, affecting how patient care is delivered and the futures of small practices and large cancer clinics.

In its 2018 oncology trend report, California-based biotech company Genentech found that more than a third of participating oncologists (38%) specialized in particular tumor types.

 In the previous 5 years, 40% of general oncologists and 64% of specialized oncologists have seen their mix of patients become more concentrated by tumor type, according to the survey. Just 6% of general oncologists and 1% of specialized oncologists reported treating a wider mix of tumor types.

The report’s conclusions were based on more than 630 completed surveys from 100 managed care organizations, 30 specialty pharmacies, 200 oncologists, 202 oncology practice managers, and 101 employer health benefit sponsors.

 Genentech spokeswoman Courtney Aberbach said the specialization trend is a result of oncology treatment innovations and the increasing adoption of personalized medicine and digital technologies.

“Our growing understanding of the biology of cancer has made the disease more complex to manage and treat. Today there are more than 100 identified types of cancer, and some, such as breast and lung cancers, have even further subtypes, often requiring different diagnostic tests and treatments. Specialization allows oncologists to gain expertise in treating specific types of cancer, with the goal of improving patient care,” she said.

This shift is contributing to another trend: Smaller practices are consolidating or being purchased by larger hospitals and care centers. “It has the potential to improve the quality of care that patients receive because the specialist oncologist will be more knowledgeable about a specific type of cancer. From an economic and cancer-care delivery standpoint, it may be most efficient to have centralized availability of specialist oncologists who work with oncology generalists in the community and in rural areas,” Randall F. Holcombe, MD, director of the University of Hawaii Cancer Center in Honolulu, said.

“Insurance coverage for seeking second opinions from specialist oncologists, or to allow patients to transfer care to these specialists, will be important to facilitate patient choice and under stress, and a reliever is to consolidate,” said Frederick M. Schnell, MD, medical director of the Community Oncology Alliance (COA). “There’s a very active movement to consolidate, and there are burgeoning networks around the country.”

Many of these networks are based in or near major population areas, which could mean the very specialized immune and targeted thera- pies that now define modern oncology might not be available to rural populations. “The biggest risk is to patients in more remote areas, rural America,” Schnell said. “These consortiums don’t reach there.”

The specialization trend seems destined to continue and gain momentum. And although there may be drawbacks, many doctors believe it’s a good thing.

“It has the potential to improve the quality of care that patients receive because the specialist oncologist will be more knowledgeable about a specific type of cancer. From an economic and cancer-care delivery standpoint, it may be most efficient to have centralized availability of specialist oncologists who work with oncology generalists in the community and in rural areas,” Randall F. Holcombe, MD, director of the University of Hawaii Cancer Center in Honolulu, said. “Insurance coverage for seeking second opinions from specialist oncologists, or to allow patients to transfer care to these specialists, will be important to facilitate patient choice and access,” he added.

FIGURE. ONCOLOGIST SPECIALIZATION IN TUMOR TYPES

Figures are based on survey of 200 oncologists for the 2018 Genentech Oncology Trend Report Survey.

The explosion of knowledge about tumor types is a major driver of the specialization trend. With cancer care, “there’s an increasing degree of knowledge and sophistication and dramatically more therapeutic options and [ways] to use them,” said Martin J. Edelman, MD, professor and chair of the Department of Hematology/Oncology at Fox Chase Cancer Center in Philadelphia, Pennsylvania. “With lung cancer, as recently as 2000, you had small cell and non—small cell, and all our studies were based on those. Now there are more and more subsets, and you need to know the options for each."

Martha P. Mims, MD, PhD, associate director of Clinical Research at Baylor College of Medicine’s Dan L. Duncan Comprehensive Cancer Center in Houston, Texas, said her orga- nization now has clinics devoted to certain cancers—such as breast, head and neck, and gastrointestinal&mdash;and within those clinics there are multiple subspecialties.

“Older oncologists, who were trained to be generalists, have had to evolve,” said Mims, who is also chief of the Section of Hematology and Oncology at Baylor College of Medicine. “Younger oncologists, earlier and earlier in their training, are branching off into subspecialties. Although they are learning everything, they point their futures in certain directions.” When recruiting, Mims looks to fill specific needs. A recent hire specializes in melanoma and sarcoma.

“Having 1 person focused on 2 relatively rare tumors is a way to leverage your hiring,” she said. Mary Kruczynski, director of policy analysis for COA, said some seasoned doctors have told her they welcome into their practices new physicians who show a desire to specialize in blood or solid tumor types, “as they can be proclaimed the ‘practice expert’—armed with the most current knowledge of how best to treat those tumor types utilizing recent FDA-approved agents, combination therapies, genetic mutations, and next-generation sequencing.”

By necessity, oncologists working in resource-poor rural areas need to remain generalists. That could make it harder for specialization to reach communities where advanced knowledge and skills are needed.

“This may impact quality of care in rural areas where the mortality rate from cancer already exceeds that seen in urban areas,” Holcombe said. The solution, he said, “will be to train advanced practice nurses [nurse practitioners] in oncology and then for physicians to make use of their expertise to assist in patient care.” Kruczynski noted that a hospital in rural South Carolina recently closed, leaving area residents without nearby care. Perhaps, she said, such isolated facilities could use J-1 visas—nonimmigrant visas issued to visitors seeking medical or business training in the United States.

 “With the status of immigration today, perhaps we can redirect those bright young men and women completing their fellowships and needing employment to positions in those underserved areas,” she said.

Edelman said he worries that some oncologists are less well rounded because they’re choosing to specialize very early on in training. He has seen this in both academics and the practice world. “In some ways, we bemoan the loss of a good, outstanding generalist with a broad range of knowledge,” he said. “But that’s true in everything and goes well beyond oncology.” Still, he believes the specialization trend is a positive one, and he looks for doctors who have shown interest and ability in specialized areas.

Although medical school has always been costly, modern graduates are entering the workforce hundreds of thousands of dollars in debt. That has led them to seek employment in urban areas and with major cancer centers, which tend to offer higher salaries.

Years ago, Schnell said, doctors graduated with less debt and could take jobs in the countryside and in the cities where there wasn’t enough care. “There were more economic opportunities outside the big universities, and you could be more entrepreneurial—beyond the Emorys and the Sloan Ketterings. That’s changed now.”

He wondered whether New York University School of Medicine’s recent decision to eliminate tuition

 for all its students would encourage graduates to take jobs as general oncologists in more remote parts of the country. Without overwhelming school loans, these practitioners could accept lower salaries and still enjoy a high quality of life. “If the expense burden is underwritten at large medical schools, [graduates] won’t be so deeply in debt, which will be great for America,” Schnell said. “If you’re in rural America, you don’t need superspecialized doctors. You need a broad spectrum of knowledge for patients who aren’t going to travel hundreds of miles for care.”

Richard L. Schilsky, MD, senior vice president and chief medical officer of the American Society of Clinical Oncology, agreed that the lack of crippling loans could “hopefully encourage more people to be willing to take on these important general can afford to do so.” Schilsky, a 2018 Giants of Cancer Care

 award winner, encourages oncologists to consider their career trajectory early in their training.

“The sooner you decide where you want to end up, the sooner you can organize the rest of your training program for success,” he said. “If you decide you want to practice oncology in rural Montana, you’re going to learn as much as you can about every type of cancer because that’s what you’re going to see.”

Specialization is difficult if not impossible for small practices. In larger practices, specialization can occur without significant disruption in operations as long as all the practitioners are willing to cross-refer patients to oncology specialists.

“We’re witnessing a continuing consolidation of small practices; they’re merging or being bought up by larger entities,” Schilsky said. “That’s caused increasing concern that access to care is declining.” Savvy patients with means, however, will most likely still be willing to travel to find the right doctor for their cancer. “Patients are increasingly aware that there’s really not a single disease called cancer,” Schilsky said. “Every cancer type is different, [and] every patient [with cancer] is different, and to get the optimal treatment for your cancer, you want the oncologist who spends most of their time seeing patients with your type of cancer.”

Gesme DH, McClelland S, Sherman B, et al. The 2018 Genentech oncology trend report. 10th edition. genentech-forum.com/content/dam/gene/managedcare/forum/pdfs/Oncology-Trends/2018_Genentech_Oncology_Trend_Report.pdf. Published April 2018. Accessed September 17, 2018.

J-1 visa exchange visitor program. US Department of State website. j1visa.state.gov/basics/. Accessed September 17, 2018.

Chen DW. Surprise gift: free tuition for all N.Y.U. medical students. 

. August 16, 2018. nytimes.com/2018/08/16/nyregion/nyu-free-tuition-medical-school.html. Accessed September 17, 2018.

Specialization Trend Is Changing the Oncology Landscape

When the Centers for Medicare & Medicaid Services (CMS) released performance reports for the 181 practices enrolled in the Oncology Care Model (OCM) earlier this year, the action had the effect of creating as much confusion as it resolved. Practices were looking forward to finding out whether they qualified for bonus payments for exceptional performance. What some found out, however, was that they had to pay money back to CMS. Now, as participating practices anticipate the second round of performance reports, due at the end of August, they hope things will go more smoothly.

Two years into the OCM pilot, practices in February received their performance period 1 (PP1) reconciliation reports—detailed accounts regarding the 6-month period from July to December 2016 when the 5-year OCM pilot was initiated. Some practices were unhappy with not only the reports’ conclusions and the methodology used by CMS but also the fact that they learned their full PP1 results just as period 4 got under way.

“You don’t know how you’re going to be judged, and you just got the results from more than a year ago,” said Bo Gamble, director of strategic practice initiatives for the Community Oncology Alliance (COA). “It’s so complicated, people can’t make timely, conscious decisions about how to improve their care while lowering costs.” The OCM is a patient-centric program that CMS says will allow for “better care, smarter spending, and healthier people.” It aims to move practices from volume-based to value-based care by structuring Medicare payments around the full range of services an oncology patient needs. A practice that can both provide good treatment and spend less money than Medicare expected will be financially rewarded.

Figure. CMS' Timing of Performance Reconciliation Reports has Caused Adjustment Difficulties for Practices

Barbara McAneny, MD, a managing partner of New Mexico Oncology Hematology Consultants Ltd and president of the American Medical Association, said her practice was among those that received a $23,000 performance-based payment for achieving savings below the targets set by CMS.

About 25% of participating practices received such payments, according to the Center for Medicare and Medicaid Innovation (CMMI); however, COA estimates that those particular practices account for just 10% to 15% of patients and doctors. Gamble said that based on an informal COA poll, just 15% of responding practices received performance-based payments.

Although practices were happy to receive performance-based payments, many were dismayed to find that they had to return MEOS payments, which oncologists receive only if they are their patients’ primary care physicians. When patients see other physicians for health issues, CMS assigns or “attributes” the patient to the doctor who provided the most in-office care. CMS calculated that some oncologists had not served as primary care providers and asked for the money back. Some practices successfully appealed and got the MEOS payment cuts reduced.

Terrill Jordan, president and chief executive officer (CEO) of Regional Cancer Care Associates, which has 110 physicians and 30 local offices in Maryland, New Jersey, and Connecticut, said that about 27% of the network’s patients were attributed to other doctors. After an appeal to CMS, that figure fell to about 16%. “We provided coordinated care to a large group of patients who were not attributed to us, and we did not get full payment for this work,” Jordan said. “You can imagine our discomfort with that result.”

McAneny’s practice had to return $11,000. Even with the performance-based payment, she said, losing the MEOS funds for patients who’d received her practice’s treatment was a tough hit financially. She believed her practice qualified for a performance- based payment in part because it was already doing much of what the OCM required, she said. Still, making the switch to the OCM was costly; to meet the electronic health record requirements, the practice had to pay a large amount of overtime to staff members. “If we truly added up what it cost to do this model, the MEOS payments were insufficient,” she said.

She also contends the formula Medicare uses to determine an individual patient’s care costs does not adequately address rising drug prices or new therapies. McAneny said this discourages physicians from using expensive drugs and punishes those who take on patients with more complex health problems.

“If you came in with a melanoma and I treated you with standard old chemotherapy, you’d be dead in 3 months,” McAneny said. “If I treat you with the new expensive drug that costs $100,000 per year, you could live for years. Not to use that drug would be unethical, but I would get punished [financially]. If I get a lot of people who are inexpensive to take care of, then I look like a genius because I saved money. If I go over the target, I’m a bad doctor and I’m losing money.”

Problems aside, many stakeholders said they remained enthusiastic about the program and wanted to see it succeed. Gamble of COA, the peerto- peer support organization working with 80% of the practices participating in the OCM, said his organization has sent 2 letters to CMMI describing concerns with the model. The issues included complicated errors in the performance methodology, excessive delays in the receipt of periodic report cards, and calculation errors. CMMI has made some of the requested changes to the model.

The Oncology Care Model is a patient-centric program that the Centers for Medicare & Medicaid Services says will allow for “better care, smarter spending, and healthier people.”

Natalie Pompilio