All patients with colorectal cancer being considered for treatment with the epidermal growth receptor (EGFR) inhibitors cetuximab and panitumumab should undergo extended 

 mutational testing to predict their response to the drugs, according to a new molecular marker testing guideline being developed by the American Society of Clinical Oncology (ASCO) and three leading pathology organizations.

The draft guideline calls for extended mutational analysis that includes 

 codons 12 and 13 of exon 2, codons 59 and 61 of exon 3, and codons 117 and 146 of exon 4.

The guideline, which is scheduled to be finalized later this year or early next year, also recommends 

 mutational analysis in conjunction with deficient mismatch repair/microsatellite instability (dMMR/MSI) testing for patients with metastatic colorectal carcinoma (mCRC), and dMMR/MSI testing in all patients for prognostic stratification and identification of Lynch syndrome.

The project is the first attempt to draw up a comprehensive guideline in the fast-moving area of CRC molecular testing, the authors said.

“This guideline addresses all current molecular markers that can impact treatment decisions for patients with colorectal cancer. To date, there isn’t an evidence- based guideline that’s quite as all-encompassing and patient-centered as this one,” said Stanley R. Hamilton, MD, The University of Texas MD Anderson Cancer Center, who serves as project co-chair on behalf of College of American Pathologists (CAP).

Existing CRC biomarker guidelines have tended to focus on one marker or a small panel of markers for one specific clinical use, he said.

At the same time, the guideline advises that there is currently insufficient evidence to recommend 

 status as predictive marker for response to anti-EGFR inhibitors; 

 mutual analysis for therapy selection outside of a clinical trial; and 

 analysis for therapy selection outside of a clinical trial.

If the guideline provokes any controversy, it would likely stem from that dearth of evidence, said Carmen J. Allegra, MD, a medical oncologist at the University of Florida Health Cancer Center and the project co-chair on behalf of ASCO.

“There are some areas where the mutations don’t occur very commonly, so there isn’t a lot of information out there in the literature to help guide us,” he said. “The default is to say there just isn’t enough to have a definitive position. There are others who would say, well, wait a minute, there seems to be enough information. That’s a little bit in the eye of the beholder.”

By acknowledging molecular markers and tests on the horizon, the authors have “future-proofed” the documents, and they will continue meeting and updating the guideline as necessary, he said.

The draft was released jointly on March 30 by ASCO, CAP, the American Society for Clinical Pathology (ASCP), and the Association for Molecular Pathology (AMP). The public comment period ended April 22 and some recommendations are being modified to address issues that were identified. New evidence found during an updated literature search is also being reviewed for possible inclusion.

The guideline is being offered as developments in research on molecular markers continue to make their way into clinical practice. They include findings that patients who have mutations in 

 exon 2 and 3 do not benefit from anti-EGFR therapy and could suffer harm from those agents. “Really, the most powerful piece of information we have about these mutations is focused around

,” Allegra said. “And that is not a positive predictor; it’s a negative predictor.”

National Comprehensive Cancer Network guidelines recommend that all patients with mCRC have tumor tissue genotyped for 

 mutations. In March, the FDA approved updated labeling for panitumumab to indicate that 

mutation status should be assessed before treatment is initiated and that patients whose tumors harbor the mutation or whose 

 status is unknown should not receive the drug.

With research into newly available genomic data constantly reshaping the frontier of oncology, Allegra said the guideline drafted by the four organizations aims to bridge the gap between research and individual physicians.

“When you are in practice, it is not always easy to keep up with all the nuances in the field, so these guidelines really provide a convenient mechanism for oncologists to keep up with the latest,” he said.

“Given that an oncologist isn’t going to have the time to read through or think about the literally thousands of papers that went into this guideline, it’s essential that somebody interrogates the literature very deeply and comes up with a set of opinions and guidelines based on that literature.”

The dissemination of the draft, and eventually of the finalized guideline, may also help improve physician awareness of molecular marker testing as a diagnostic tool, Allegra said.

While the document recommends molecular marker testing to guide selection of targeted therapies, it does not address how or when in the course of treatment the therapies should be used. The field is moving in the direction of identifying additional targeted therapies and the best ways to use them, but Allegra said those determinations are outside the project’s scope.

The draft also provides an expert consensus opinion on sampling, saying that testing of primary colorectal carcinoma tissue is acceptable but metastatic CRC tissue is preferable in patients with mCRC. Formalin-fixed paraffin-embedded tissue is acceptable, while use of cytology or other specimens will require additional adequate validation, as would any changes in tissue-processing protocols.

			Bokemeyer C, Van Cutsem E, Rougier P, et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: pooled analysis of the CRYSTAL and OPUS randomised clinical trials [published online March 23, 2012]. 

			Cui D, Cao D, Yang Y, et al. (2014). Effect of 

 mutation on tumor response of anti-EGFR monoclonal antibodies for first-line metastatic colorectal cancer treatment: a meta-analysis of randomized studies [published online January 4, 2014]. 

			Guastadisegni C, Colafranceschi M, Ottini L, Dogliotti E. Microsatellite instability as a marker of prognosis and response to therapy: a meta-analysis of colorectal cancer survival data [published online June 4, 2010]. 

			Karapetis CS, Jonker D, Daneshmand M, et al. 

status and benefit from cetuximab in the treatment of advanced colorectal cancer—results from NCIC CTG/AGITG CO. 17 [published online November 11, 2103]. 

			Sorich MJ, Wiese MD, Rowland A, et al. Extended RAS mutations and anti-EGFR monoclonal antibody survival benefit in metastatic colorectal cancer: a meta-analysis of randomized, controlled trials [published online August 12, 2014]. 

			Wang ZH, Gao QY, Fang JY. (2012). Loss of PTEN expression as a predictor of resistance to anti-EGFR monoclonal therapy in metastatic colorectal cancer: evidence from retrospective studies [published online May 18, 2012].

			Wong NA, Gonzalez D, Salto-Tellez M, et al. RAS testing of colorectal carcinoma—a guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Group.

Articles

All patients with colorectal cancer being considered for treatment with the EGFR inhibitors cetuximab and panitumumab should undergo extended RAS mutational testing to predict their response
to the drugs.

New Molecular Testing Guidelines Pending for Colorectal Cancer

Whether you call them narrow, tiered, or high-performance networks, insurance plans that limit which doctors have in-network status have become a mainstay of healthcare, helping keep costs down but stoking concerns and complaints from hospital administrators and regulators about patients’ access to care.

On the federal and state healthcare exchanges, 45% of insurance networks nationwide fall into the “narrow” category, according to a recent McKinsey study.

 That includes the 17% that are considered ultra-narrow, meaning they cover 30% or less of area hospitals.

Insurers have been creating narrow-network HMOs and similar offerings for at least 2 decades, but like high deductibles and other cost-containment strategies, they have become more prominent in the last few years. Their relatively low premiums have proved attractive to consumers who are now required by law to buy health insurance and increasingly to employers trying to keep a lid on benefits spending.

Between 2007, when 15% of companies that offered workers health insurance included a so-called “high performance” provider network, and 2013, the figure climbed to 23%, according to the Kaiser Family Foundation.

The plans really are cheaper, at least as far as premiums are concerned: on the exchanges, median premiums this year are 15% to 23% higher for traditional broad network plans than for the equivalent narrow network plans, the McKinsey study found. That’s a bigger difference than in 2014, illustrating their growing appeal. Narrow networks have become a common feature of the less expensive bronze and silver exchange plans.

The study also concluded that there is no “meaningful performance difference” between the broad and narrow networks based on Centers for Medicare & Medicaid Services (CMS) hospital metrics. Yet critics argue that by excluding major hospitals and cancer centers from popular, less expensive plans, insurers are at the very least inconveniencing patients who must travel farther for treatment, and in some cases forcing them to forsake their best options at the risk of being saddled with huge debts for out-of-network care.

“We find often that patients say they selected their insurance based just on the lowest cost at the time. All of a sudden you're diagnosed with cancer and then when you actually research the policy, there's very little coverage, horrible benefits, high co-pays and now, the new scenario is a very limited network,” said Terrie Kothe, vice president of managed care at Roswell Park Cancer Institute in Buffalo, New York.

The cost-cutting focus of narrow networks is particularly blind to the need for high-cost care for rare and complicated conditions treated at cancer centers and other specialty providers, critics say.

Roswell Park initially found itself excluded from 2 of the 7 exchange plans in its region and 11 of 16 statewide, the Associated Press reported last year.

 Since then the institute has seen some cancer patients opt to get treated elsewhere, only to receive inadequate treatment and subsequently return to Roswell Park sicker and in need of more intensive care, hospital executives said.

“After they make a decision not to be seen here because of co-pays or out-of-pocket payments, they go into the community, they get the care, and then in some instances they end up back here and we are working to manage their complications,” said chief of clinical services Victor Filadora, MD, MBA. “As you can imagine, the cost of care due to complications is high.”

“For a patient who tries to come to Roswell and is unable to, that can be devastating to them personally as well as financially and medically; that's our major concern,” Kothe said. “We're an entity that was set up to treat cancer and be available to everyone in the community, across the state or across the country. By virtue of these new narrow networks, there seems to be a new restriction on that. It's not fair to those people.”

Roswell Park is among a number of leading cancer centers that found themselves out of network for many local patients when the first exchange plans were released late in 2013, apparently because insurers considered them too expensive. MD Anderson Cancer Center said it was in less than half of the plans in the Houston area, and Memorial Sloan Kettering was included by just 2 of 9 insurers in New York City, according to the Associated Press.

Of 19 nationally recognized comprehensive cancer centers surveyed, only 4 said they were in all the insurance networks on their state exchange.

The situation may have improved slightly since then. In a more recent survey of 20 National Cancer Institute—designated centers in 19 states, all but 1 said they were in as many or more exchange plans as last year.

 Still, the survey by Avalere Health and the National Comprehensive Cancer Network (NCCN) found that a quarter of the centers said they were excluded from most networks in their state exchanges, and just 13% were covered by all the plans.

In states with tiered networks, a variation of a narrow network in which a patient’s out-of-pocket costs vary according the provider’s tier, most of the centers were stuck in tiers 2 or 3, resulting in greater expense for patients. Thirty percent of centers actually rejected offers to be included in certain plans because the reimbursement rates were too low, said NCCN CEO Robert Carlson, MD.

“Some of the centers stated they believed that they actually had been offered contracts with rates that were so low that the carrier knew that they would not agree,” he said. “It was really a lowball offer so they would not have to cover the NCI-designated cancer center.”

Exclusions from narrow networks have led to lawsuits and calls for regulatory reforms. In October 2013, Seattle Children’s Hospital sued Washington’s state insurance commissioner when it learned it was not in-network for 5 of the 7 plans in its county. A month after the exchanges opened, the hospital said it had already treated 125 children whose families had lost contracted access to Seattle Children’s.

“This is a dire situation for our patients,” senior vice president Sandy Melzer, MD, said at the time. “We can’t continue providing services to these patients without reimbursement from their insurance companies. Eventually, these patients will have to seek care elsewhere, and for the treatment of many conditions, there is nowhere else to go in the region.”

Two of the companies soon agreed to include the hospital in its plans, while 2 others gave in shortly before the trial was to begin, Melzer said in a recent interview. The state insurance commissioner also approved new rules on network adequacy designed to ensure that enough providers are in-network near the areas where plan members live.

“When you have a situation where very highly specialized services are offered, you have to be very careful that the unintended consequence of narrow networks doesn't happen, which is that basically people can't get the care that they need, care that's only available at a specialized facility, be it cancer or pediatrics,” Melzer said. “That's what people really have to guard against.”

As insurers started excluding providers, some were accused of not telling the truth about their networks. In California, 2 insurers were accused of a bait-and-switch in which they listed out-of-network doctors as being in-network, leaving consumers with newly purchased policies in the lurch. The group Consumer Watchdog filed class-action lawsuits against 3 insurers, and state investigators alleged that Anthem Blue Cross of California and Blue Shield of California had violated state law by listing doctors in online directories who were not actually in their networks.

The Affordable Care Act attempts to head off the problem of insurance networks with insufficient numbers or types of providers through its list of essential health benefits (EHBs). Among other requirements, the Act states that insurers must cover mental health and substance abuse services and include providers who predominantly serve low-income patients.

A number of states also have their own rules on the proximity of members to doctors, appointment wait times, patient-doctor ratios, and office hours. After the complaints in Washington state, standards for all those factors were made more detailed; for example, 80% of plan enrollees must have providers within a set distance, which varies according to the type of provider and whether the area is rural or urban.

 The state also began requiring monthly updating of provider directories.

The implicit and sometimes explicit criticism of cancer centers’ high costs that has accompanied the battle over narrow networks has left them defending the expensive comprehensive services they provide, including treatment of rare cancers, clinical trials, psychosocial support, and charity care. Carlson, for example, cited a 2014 study that found higher survival rates among patients treated at NCI-designated cancer centers.

“If you then exclude people for whatever reason from accessing a major cancer center, it may be you're disadvantaging them in terms of their likelihood of surviving their disease,” he said.

Implicit in such arguments is the suggestion that the group oncology practices that narrow networks more frequently do include do not provide treatment that is sufficiently specialized or high-quality. Community oncologists naturally reject that claim, saying they are highly effective at relatively low cost.

“You're going to see more narrow networks, you're going to see more tiering come down the road, and in an odd way, that actually may end up benefitting community cancer clinics,” said Ted Okon, executive director of the Community Oncology Alliance.

Contrary to the view of the cancer center representatives, Okon said narrow networks could be “good and bad” in that they restrict patient options but can steer patients toward more efficient providers. But he admitted that those networks, along with high deductibles and other cost-saving features of cheaper plans, could become a bigger issue as demand for oncology care grows in the aging population.

“Under-insurance is a huge problem that is rearing its ugly head already, and I think will even more so as we go on further with the growth of the exchange plans, especially if the growth keeps on occurring in those low-premium plans like the bronze and silver,” he said.

			Bauman N, Bello J, Coe E, Lamb J. Hospital networks: evolution of the configurations on the 2015 exchanges. McKinsey Center for US Health System Reform. http://healthcare.mckinsey.com/2015-hospital-networks. Published April 2015. Accessed June 15, 2015.

			Kaiser Family Foundation, Health Research and Educational Trust. Employee health benefit survey. https://kaiserfamilyfoundation.files.wordpress.com/2013/08/8465-employer-health-benefits-2013-chartpack.pdf. Published August 20, 2013. Accessed June 15, 2015.

			Associated Press. Nation’s elite cancer hospitals off-limits under Obamacare. 

; March 19, 2014. http://nypost.com/2014/03/19/nations-elite-cancer-hospitals-off-limits-under-obamacare/. Accessed June 15, 2015.

			Pearson C, Choe SH. Leading cancer centers may be more widely included in exchange networks than expected. Avalere. http://avalere.com/outlook/life-sciences/insights/leading-cancer-centers-may-be-more-widely-included-in-exchange-networks-tha. Published April 22, 2015. Accessed June 15, 2015.

			Seattle Children's Hospital. Majority of Washington’s health benefit exchange insurance plans fail to cover care at Seattle Children’s. http://www.seattlechildrens.org/Press-Releases/2013/Majority-of-Washington%E2%80%99s-Health-Benefit-Exchange-Insurance-Plans-Fail-to-Cover-Care-at-Seattle-Children%E2%80%99s;-Hospital-Sues-Seeking-Adequate-Network-Coverage-for-Children-and-Families/. Published October 4, 2013. Accessed June 15, 2015.

			Consumer Watchdog. State audits confirm Blue Shield and Blue Cross misled consumers about doctors available under Obamacare plans. http://www.consumerwatchdog.org/newsrelease/state-audits-confirm-blue-shield-and-blue-cross-misled-consumers-about-doctors-available. Published November 19, 2014. Accessed June 15, 2015.

			Seipel T. Two covered California health insurance plans misled consumers, regulators say. San Jose Mercury News; November 19, 2014. http://www.mercurynews.com/health/ci_26965329/two-covered-california-health-insurance-plans-misled-consumers. Accessed June 15, 2015.

			Schwartz S. Washington State’s network adequacy rules: a step forward for children and families. Georgetown University Health Policy Institute. http://ccf.georgetown.edu/all/washington-states-network-adequacy-rules-a-step-forward-for-children-and-families/. Published April 29, 2014. Accessed June 15, 2015.

			Wolfson J, Sun C, Kang T, Wyatt L, Hurria A, Bhatia S. Impact of care at NCI comprehensive cancer centers (NCICCC) on cancer outcome: results from a population-based study. 

. 2014;32:(5 suppl); abstr 6541). http://meetinglibrary.asco.org/content/127520-144. Accessed June 15, 2015.

Insurance plans that limit which doctors have in-network status have become a mainstay of healthcare, helping keep costs down but stoking concerns and complaints from hospital administrators and regulators about patients' access to care.


Narrow Networks: Great Cancer Centers Need Not Apply

At Edward Cancer Center in the affluent Chicago suburbs, patients generally have good insurance, donors have contributed millions of dollars to capital campaigns, and sophisticated services like multi-disciplinary care coordination and patient navigators are supported by the center’s parent hospital.

Yet despite its healthy finances, Edward is eagerly hoping to be selected to participate in the Centers for Medicare & Medicaid Services’ new Oncology Care Model (OCM), a pilot program that will require the cancer center to measurably cut costs even as it beefs up its services and analytical capabilities.

“We've always worked in a situation where our only concern has been the care of the patient, which is fine. That's the way it should be,” said Alexander Hantel, MD, the center’s director of medical oncology. “But at the same time we also are realizing as physicians that the value of what we prescribe for patients has to be more carefully assessed.”

The push for greater efficiency comes at a time of growth for the center, which was established a decade ago when Edward Hospital in Naperville, Illinois brought its visiting oncologists onto its staff. A second site opened nearby in Plainfield in 2009. From 2005, when the center treated 1135 cases, volume at the two sites grew to 1386 in 2011 and to 1850 last year, said administrative director Jenna VanGilder.

The center has 7 medical oncologists, 4 radiation oncologists, 2 surgical oncologists and 7 advanced practice nurses. A third surgical oncologist is coming on in August.

Hantel said he wants to join the Oncology Care Model to address the ever-increasing cost of cancer drugs, or at least to help CMS assess the merits of a new approach. VanGilder said participating would give Edward the jump on cost-containment mandates that all oncology practices could be forced to adopt a few years from now.

“There's obviously some scary things about the model that we know that we don't do that great, but we also realize that we probably should. So why not learn along the way and figure it out now, rather than wait?” she said.

Despite its money-saving potential, the Oncology Care Model has taken some criticism for preserving traditional fee-for-service (FFS), tying incentive payments to factors the oncologist does not control, and for paying according to “arbitrary” 6-month treatment episodes.1 ASCO’s preferred alternative, called Consolidated Payments for Oncology, would depart from FFS by switching to relatively large payments at the start of treatment and every month, as well as payments during treatment holidays and after treatment ends.2 Pay would be cut for practices that don’t follow guidelines for prevention of complications, end-of-life care, and use of drugs, testing and imaging.

Edward, however, has embraced the OCM. In addition to moving to the edge of payment reform, Edward would benefit from the model’s $160 monthly per-patient fee, which is intended to cover coordinated care and other improvements in treatment of chemotherapy patients, VanGilder said.

“We offer a lot of these things already, and we're not getting the extra per-beneficiary payment per month. We do provide a lot of that care coordination,” she said. “Not that we're going to make money by any means, but to get some reimbursement to assist with these resources would be nice.”

The care coordination comes via specialized clinics for lung, brain, breast, gastrointestinal and genitourinary cancer. The lung clinic, for example, has a dedicated surgeon, medical oncologist, radiation oncologist, pathologist, radiologist, and psychosocial and research staffers, VanGilder said. The physicians meet weekly to discuss cases and plan treatment, and an advanced practice nurse arranges appointments and shepherds the patient through.

The cancer center and Edward Hospital have also been on the forefront of meeting quality standards of the type required by the Oncology Care Model, Hantel said. They include ASCO’s Quality Oncology Practice Initiative Certification.

“We're probably a relatively high cost practice just because we are in a high-reimbursement and high-utilization region of the country. But at the same time, we have always done all of the quality improvement measures,” he said. “We're way ahead of the curve in terms of really trying to give good quality care and do it in a measurable way in our practice. So we have every certification you could think of.”

Hantel said his only major concern about the OCM relates to the long-term sustainability of the model’s incentive scheme.

“In the short term there's no real downside for us to participate. It's a carrot and stick approach. The carrot is coming out right now,” he said. “The question is, what's the stick going to be down the road? And how many percentage points are we going to be asked to ratchet things down every year beyond that point? If you're really, really efficient, it's going to be hard for you to ratchet things down after a while. That's the problem.”

“If you become accustomed to the revenue from the program and then you don't get it all of a sudden, that's a bigger hit,” he said.

The OCM has attracted significant interest so far. About 450 practices have submitted letters of intent, though some may back out once more details of the model are released. CMS has suggested it will enroll about 100. There are four selection criteria, worth up to 100 points: 40 for implementation plan, 25 for financial plan, 30 for payer participation and 5 for patient diversity.

The criteria pose some hurdles for Edward. The center may not score well for diversity, VanGilder said, and it has so far not confirmed that any of its insurers will agree to set up their own payment arrangements similar to the OCM, which could hobble its application. She said the center is in discussions with its second biggest payer, Blue Cross and Blue Shield of Illinois, and is hopeful that the company will sign on.

If Edward is selected, it will face a set of complex administrative challenges as it works to meet the OCM’s goals. One is survivorship, which is basically care coordination after treatment ends and patients stop coming to the cancer center. Such efforts ensure patients get recommended follow-up care to minimize recurrence of disease while avoiding duplicative testing, and should ultimately reduce unnecessary costs.

“Survivorship is just a huge ball of wax, and we haven't quite gotten that all together yet,” VanGilder said. “You should give be able to give patients a printout of everything that's happened to them and recommendations for follow-up care and health promotion activities. That can be very cumbersome, because no electronic record is pulling in all that information like you would want it to. You have to spend 2 hours filling out a form for a patient.”

“And it's difficult to catch patients at the point of survivorship, too. Every cancer patient is unique. Some get chemo and they're done; those might be easier to catch, so you can make sure they get their survivorship care plan. But then maybe others end up going to radiation, or then they go to surgery. How do we make sure we can catch them at those points? Those are things we struggle with,” she said.

Among other requirements, OCM practices will have to start providing new patients with accurate upfront estimates of their out-of-pocket costs before treatment begins. That requires understanding the vagaries of every patient’s insurance plan. And even though Edward has lately expanded its palliative care program, as part of OCM it would probably also have to allocate more staff time to discussing end-of-life issues with patients, VanGilder said.

The biggest unknown stems from the Oncology Care Model’s shared savings component. CMS will set benchmarks for the cost of chemotherapy episodes and make incentive payments to practices that come in at 4 percent below the target. Practices that don’t meet benchmarks and performance measures could be booted from the program. Yet the target prices have not yet been announced, making planning tricky.

At the same time, Edward’s relatively high cost structure suggests it does have opportunities to become more efficient and spend less regardless of the targets.

Some of that will involve counseling savvy, well-insured patients not to demand care that may not be necessary, such as after-hours emergency room visits or imaging for unexpected pain, VanGilder said. Data analysis suggests that Edward’s staff need to initiate discussions about hospice care sooner, which can be particularly difficult with the center’s large cohort of younger breast cancer patients, she said.

“Are you giving chemotherapy in the last week of somebody's life? Is that the best practice? We don't do very well on that measure,” VanGilder said. “That's why we probably need more advanced care planning and more frank discussions with patients.”

For now, Edward is focused on the success of its application, which was due June 30. CMS will notify applicants of their status around the end of year. If the center is not selected it may pursue an OCM-like strategy anyway, VanGilder said, because oncology is inexorably moving in the direction of better understanding and tighter control of the costs of care.

“Quite honestly, if we aren’t chosen we're really hoping maybe another payer will be interested in doing it with us, or we will try to look at this model and implement things on our own, knowing that this is going to happen,” she said. “Do we really understand the cost to care for cancer patients? We haven’t figured out a great way to give patients an estimate of total costs and out of pocket costs. The model is making us really think about that.”

			Polite BN, Miller HD. Medicare innovation center Oncology Care Model: a toe in the water when a plunge is needed. 

. 2015;11(2):117-119. http://jop.ascopubs.org/content/11/2/117.full. Accessed June 14, 2015.

			American Society of Clinical Oncology. Patient-Centered Oncology Payment: payment reform to support higher quality, more affordable cancer care (PCOP). http://www.asco.org/advocacy/asco-releases-payment-reform-proposal-support-higher-quality-more-affordable-cancer-care. Published May 21, 2015. Accessed June 14, 2015.

Edward Cancer Center is eagerly hoping to be selected to participate in the Centers for Medicare & Medicaid Services' new Oncology Care Model, a pilot program that will require the cancer center to measurably cut costs even as it beefs up its services and analytical capabilities. 

Illinois Cancer Center Looks to Get Ahead of the Value Curve

Just 2 years after oncologist Raul Storey, MD, finished his training and joined a private practice in Vero Beach, Florida, he was already eager to make another change.

He and his partner Noor Merchant, MD, who founded the practice 30 years ago, found themselves battling a familiar set of confounding problems: patients who had to be turned away over insurance issues, limited access to new drugs, narrowing profit margins, and the demands of office administration.

So last October they took the plunge and merged with Florida Cancer Specialists & Research Institute, the nation’s largest independent, physician-owned medical oncology practice. Now they have relationships with 6 times as many insurers, a centralized business office, and access to more than 100 clinical trials, which Storey called “a dream come true for hematology-oncology.”

“We are able to basically focus on the clinical part of the treatment of patients with hematological diseases and cancer, instead of all the administrative business and work you have when you run a practice on your own,” he said.

The array of services and opportunities with which Florida Cancer Specialists & Research Institute provides its physicians, while still allowing them a high degree of autonomy, has proved a powerful draw since the group was founded as a solo practice by William Harwin, MD, in 1984.

The organization now boasts 180 doctors, most of whom are or will become partners, and 120 nurse practitioners, at more than 85 locations around the state. The total staff numbers more than 2000 across a variety of professions. The firm treats 50,000 new patients and takes in more than $1 billion in fees each year, more than 3 times the amount it collected in 2012.

The company has a practicewide electronic medical record (EMR) system, a central pathology laboratory, an oral oncolytics pharmacy, and on-site radiation facilities at many locations, as well as access to clinical trials through its partnership with Sarah Cannon Research Institute in Tennessee. Thanks to its size, the company can negotiate better drug prices and guarantee patients access to all FDA-approved chemotherapy and immunotherapy treatment options, Harwin said.

Harwin said he did not originally intend to turn his solo practice into a “great entity.” Initially it grew slowly, to just 48 doctors in 17 offices as of 2008. Over time, however, mounting economic pressures on small practices,the advantages of size, and a reputation for good management allowed Florida Cancer Specialists to become a merger machine and a poster child for the consolidation trend of recent years. By 2011 it had doubled in size to 40 sites and close to 100 doctors, and since then it has nearly doubled again.

 Another factor contributing to Florida Cancer Specialists & Research Institute's growth may be the state’s size and its large elderly population. Florida’s cancer rates are among the highest in the nation and it has the second-greatest number of people with cancer after California, according to National Cancer Institute data.

 The state has the fifth-highest number of oncologists after New York, California, Texas, and Pennsylvania, according to the Kaiser Family Foundation.

Florida also has seen the most mergers and acquisitions: from 2008 to 2014, at least 30 oncology practices have been acquired by hospitals and 46 by group practices and other non-hospital entities like Florida Cancer Specialists & Research Institute, according to the Community Oncology Alliance’s most recent Practice Impact Report.

Harwin, who practices in Fort Myers and serves as the company’s president, described its initial expansion as serendipitous. A radiation therapy group in adjacent Charlotte County told him the area needed better oncologists, so his practice started consulting there and eventually hired 2 doctors out of training to staff a new office, he said. Then a staff physician who wanted to be closer to family opened an office in Bonita Springs, a struggling practice in Naples asked for help and was acquired, and many others followed.

“In the early ‘90s, there was a lot of concern about managed care and how that was going, and the thought was, well, if we were a little bit larger we’d be in a better position to compete in what appeared to be a new healthcare environment,” Harwin said.

Unlike some other large groups, the business had a head start on the merger trend because it was already growing and benefiting from its billing efficiencies and economies of scale when the Medicare Modernization Act, passed in 2003, began slashing the profit from drug margins on which small oncology offices had survived. Florida Cancer Specialists & Research Institute was poised to start absorbing such practices as the financial pressures tightened.

The partners made the key decision to turn down acquisition offers from 2 companies that were precursors of US Oncology in favor of remaining independent, Harwin said. Florida Cancer Specialists & Research Institute also started making merger deals with larger groups of several doctors each, and growth further accelerated after CEO Brad Prechtl, a CPA who previously worked at US Oncology, joined the company in 2009.

“We’re enamored with the idea of still being a private practice group that’s physician-centric and patient-centric. We were never interested in becoming a publicly traded company,” Harwin said. “It doesn’t matter if it’s US Oncology or a hospital-based system; we just really like being in charge of our own business.”

And the growth continues. Among other projects, in December the group launched construction of an $11-million cancer center in Brandon, near Tampa, that will house a linear accelerator, PET/CT, and high dynamic range imaging equipment.

 The company is also spending $2.5 million to expand its corporate headquarters in Fort Myers, adding 21,000 square feet for administration and its Rx to Go specialty pharmacy.

Harwin said he’s much prouder of his work as an oncologist than his success as a businessman. He maintains a busy practice, dedicating just a day a week to his managing partner duties, and said that for 4 years he’s led the company in the number of patients participating in clinical trials.

But he said that all the back office support and infrastructure the company has built up over the years has helped Florida Cancer Specialists & Research Institute stand out in the field and prosper despite the headwinds the profession is facing.

Working on behalf of 180 doctors, specialized staffers handle contract negotiations, purchasing, drug regulations, purchasing, human resources, and the whole range of regulatory and compliance issues, he said.

“We have to be so careful with healthcare compliance. We feel like because we’re big there’s a target on our back. So we’re just so ultra-careful about everything,” he said. “Every bill that goes out for an office visit, there’s someone measuring and checking to make sure there’s a documentation that goes with that. If somebody billed an office visit and forgot to dictate or forgot to document, we’ll catch it. We have people really checking every little thing.”

Despite that vigilance, the firm was singled out in a 

 article last year for its oncologists’ frequent use of the anemia drug Procrit, which increases red blood cell levels but carries significant health risks.

Use of the drug declined nationally after 2007, when the FDA warned it was linked to increased stroke risk, tumor growth, and early death in cancer patients. Yet a number of Florida Cancer Specialists & Research Institute doctors continued using it frequently, and in 2012 one-sixth of Medicare payments to oncologists to administer the drug went to the company, according to the article.

Harwin responded that the group’s use of the drug was medically correct, Florida Cancer Specialists & Research Institute doctors were using it less often since 2007, and doctors had no financial incentive to choose a drug based on its margin. The firm also described the cited data as skewed because Florida Cancer Specialists & Research Institute's high volume of patients in various stages of cancer and with multiple conditions made use of Procrit necessary.

The company got in the news for a different reason when insurer Humana announced it would drop the group from its network in March 2014. Harwin said the insurer gave little explanation and didn’t respond to requests to discuss the decision. He noted that Humana CEO Bruce Broussard formerly headed US Oncology, a competitor that has lost 3 groups to Florida Cancer Specialists & Research Institute over the years.

The firm plans to keep growing and is currently talking to more doctors who are likely to join up, Harwin said. It recently came close to acquiring some groups in North Carolina, but big hospitals in the Charlotte area threatened to start hiring their own oncologists rather than work with Florida Cancer Specialists & Research Institute, scotching the deal, he said.

Expanding to another state is also tricky because, for regulatory reasons, practices in other states could not use the central laboratory in Florida, and the company would not immediately have a large enough presence in the new state to justify building another lab, he said.

While growth has many advantages, he admitted that he misses recruiting and knowing all his colleagues personally. “It’s impossible to have as personal a relationship with every doctor as I once had,” Harwin said. But he said that does not affect patients’ perspectives on their own doctors.

“The small, homey, close to home approach, that doesn’t change,” he said.

Storey said that when he and his partner were contemplating a merger, they weighed the potential downsides of being swallowed up by a large health provider. They considered joining a hospital but rejected that option.

“You are coming from having an independent practice, where you are your own boss and you make your own decisions, and then you become part of a big monster, you know?” he said. “We were worried about the potential of losing our autonomy and then having someone try to rule what you do or what you don’t. But that was not the case at all with Florida Cancer Specialists & Research Institute.”

Storey said he believes that in the near future small independent practices will no longer be able to survive, and that large groups like his company, offering many community oncology offices scattered throughout a multitude of towns, are the best solution to serve Florida’s population. The state’s handful of giant cancer centers are far from many people’s homes, he said, and on their own they cannot provide the access patients require.

Gordon M. Get bigger. Business Observer. http://www.businessobserverfl.com/section/ detail/get-bigger. Published July 11, 2014. Accessed May 15, 2015.

National Cancer Institute. State cancer profiles. http://statecancerprofiles.cancer.gov. Accessed May 15, 2015.

The Henry J. Kaiser Family Foundation. Physicians by specialty. http://kff.org/other/ state-indicator/physicians-by-specialty-area. Accessed May 15, 2015.

Rotolo C. Florida Cancer Specialists coming to Brandon in fall 2015. 

; December 12, 2014. http://www.tampabay.com/news/health/florida-cancer-specialists-coming- to-brandon-in-fall-2015/2210022.

Weaver C, Mathews AW, McGinty T. Cancer doctors ring up big Medicare bills for tarnished drug Procrit. 

; June 19, 2014. http://www.wsj.com/articles/ cancer-doctors-ring-up-big-medicare-bills-for-tarnished-drug-procrit-1403203821.

Florida Doctors Trade Independence for Security in Epicenter of Merger Wave

The growing popularity of high-deductible health insurance plans has created a range of increasing pressures on oncologists and hematologists. According to doctors and administrators at a number of practices, more and more patients find themselves unable to afford their deductibles, payment plans are routinely extended by years, bad debt and write-offs of losses are ubiquitous, practices must hire additional financial counselors and business staff, and patients are more dependent on financial assistance programs.

High-deductible plans, which require larger out-of-pocket spending by patients, are becoming more prevalent in part because of the insurance mandate and coverage requirements of the Affordable Care Act (ACA). Both employers and people buying individual insurance on the state and federal health exchanges have responded to rising costs by choosing plans with the lowest monthly premiums, which typically come with annual deductibles of a few thousand dollars that patients pay up front before their treatment begins.

At North Shore Hematology Oncology Associates in New York, bad debt now amounts to “hundreds of thousands of dollars per year,” said Jeff Vacirca, MD, the practice’s CEO and vice president of the Community Oncology Alliance. “It’s gone up 10-fold in the past decade. I probably get a half a dozen letters a week from patients who can’t afford their care and don’t know what to do.”

“Obviously, the first thing we do is call them and say, ‘We’ll take care of it, we’re going to work something out. The last thing we want is for you not to get treated,’” said Vacirca. “But in the end it’s a tough burden to carry. Doctors are having trouble staying in business.”

High-deductible health plans, or HDHPs, were for years found mostly in the small market for individual insurance. They grew more common as rising medical costs led insurers to boost premiums in both individual and group plans, and became a new norm when the health exchange expanded the individual market. The law’s benefit requirements further pressured insurers’ bottom lines, accelerating the trend.

The number of Americans using HDHPs has risen about 15% a year since 2011, according to survey results announced last July by the insurance industry trade association America’s Health Insurance Plans.

 Of the 17.4 million people enrolled in those high-deductible plans in January 2014, 74% were in large group plans.

“I understood going into this that we were going to be dealing with a lot more patients getting high-deductible plans. But what I didn’t take into account was the fact that so many employers would be switching over to these plans, including even hospitals,” said Ricky Newton, director of financial services and operations for the Community Oncology Alliance in Washington, DC.

According to the Large Employers’ 2015 Health Plan Design Survey by the National Business Group on Health, 35% of employers are considering moving retirees and active employees to private exchanges in 2016. The lure of private exchanges is in large part the savings that can be achieved through high deductibles.

Healthy people may ignore the fine print and simply buy the cheapest plan. Lower-premium plans can include narrow provider networks, drug exclusions, and higher deductibles, co-pays, and coinsurance requirements. Many buyers may not consider the possibility of serious illness.

“When you’re getting an insurance plan, you’re not thinking, I’m going to get cancer, or some kind of blood disorder,” said Newton, previously practice director at Cancer Specialists of Tidewater and Riverside Cancer Center in Virginia.

For a patient who assumed insurance would cover most expenses, the cost of a cancer drug regimen and their out-of-pocket obligation can come as a tremendous shock, amplified by confusion over how their policy terms dictate the payment calculation. Coming up with a $3000 copay so that a round of chemotherapy can begin, for example, is simply not in the cards for many patients, Newton said.

Yet physicians say such scenarios are common now and practices must be prepared if they are to provide the appropriate treatment and recover payment.

As a result, financial counseling has become “a big deal” in cancer practices, said Kenneth Adler, MD, vice chair of the American Society of Hematology’s Committee on Practice. Vacirca said his practice’s financial counselor went from part time to full time two years ago, while Thomas Gallo, executive director of the Virginia Cancer Institute, said each of his eight offices has a counselor.

“We have more people working in our office now—not that we’re getting paid to pay them&mdash;to counsel patients, saying this is what it’s going to cost to get this treatment, this is what your coinsurance is going to be, you have meet this deductible,” said Adler, a hematologist at Regional Cancer Care Associates in New Jersey. “Here we have somebody dealing with a leukemia or lymphoma, their head is spinning from the new diagnosis; and now, you have be a PhD to figure out what the heck it’s going to cost you.”

Counselors and business staff play crucial roles beyond helping patients understand their medical bills. For example, they take on the time-consuming task of seeking pre-authorizations from payers and appealing denials, which Vacirca and others said some insurers use as a delaying tactic, even when a patient’s treatment meets National Comprehensive Cancer Network guidelines.

To avoid creating even more work for staff and still losing out on payments, doctors need to avoid accepting exchange plans that throw up roadblocks, Vacirca said.

“I would make sure, if they’re going to look into any of the ACA plans, that they speak to someone who’s already in the plan to see what the plan’s track record is,” Vacirca said. “It’s really difficult to go at risk with a multitude of different plans. They should pick and choose the ones that they know are run the right way, so they’re not going to end up not getting paid, getting delayed, and going into debt.”

Once the insurance coverage is clear, counselors discuss the patient’s ability to pay his or her portion of the bill. A quarter of all non-elderly Americans with private insurance coverage do not have sufficient liquid assets to pay even a midrange deductible of $1200 for single coverage or $2400 for family coverage, according to a Kaiser Family Foundation study (see chart).

 More than one-third can’t afford a higher-range deductible of $2500 single/$5000 family, and among households at 100% to 250% of the poverty line, 68% lack sufficient resources.

“We do have people that have issues with paying deductibles, and we do set up a payment plan and don’t charge interest,” said George Kovach, MD, a hematologist-oncologist with Iowa Cancer Specialists and past president of the Association of Community Cancer Centers. “We give them statements monthly and ask them to try to make a payment, and sometimes it’s five bucks a month! It’ll take 20 years, but at least they’re making some effort toward it, rather than not doing anything. We certainly don’t want to deny them care.”

Practice staff must continuously monitor a long list of individual payment plans, tracking multiple streams of micro-payments and contacting patients when they fall behind. At that point, using third-party collection agencies is an option, as reflected in figures showing that medical expenses account for more than half of overdue debt on credit reports.

Newton said his former practice would send nonpaying patients collection letters to prod them to contact the office, without officially putting them in collections. Doctors said they preferred not to use third-party firms because of the risk of alienating patients, and beca use yields are extremely low and are shared with the agency.

One worrisome twist is that the ACA gives subsidized enrollees a 90-day grace period before their insurance coverage can be canceled for failure to pay the monthly premium. If it is canceled, the insurer is responsible for the first 30 days of medical costs and the provide s for the rest, retroactively eliminating coverage for 60 days of past treatment. Vacirca said the rule has created challenges in his practice, while Newton and others said it has not yet become a significant problem.

As greater financial demands are being made of patients, more of them need financial help from foundations and pharmaceutical company assistance programs, which creates even more work for counselors, practices find.

“The demand has increased over the past few years, particularly with the cost of some of the new agents out there,” Gallo said. “It’s quite often the case that our financial counselors will get aid from multiple places to cover pieces of it, and try to put together a package for the patient. On the business office side, there is a higher administrative expense to track the payments from the foundations and apply them correctly to the different individuals.”

While bringing on counselors to manage the trend of greater patient financial responsibility boosts payroll costs, meeting those challenges helps ensure steady cash flow and provides other benefits.

“We found it to be advantageous to the practice to hire those people,” Kovach said. “When you assist a patient who has financial difficulties, there is a very positive feedback to the community. Those people go back and say, ‘You know, they helped me get my coverage. They were interested in helping.’ It has a positive impact on the appearance of the practice.”

If all else fails, a smaller practice or group that cannot afford to eat the cost of a cash-strapped patient’s drug treatment may instead have the patient undergo infusion therapy at a hospital that has access to higher reimbursements. Adler sometimes sends patients to his neighboring hospital, but like other doctors, he would much prefer to keep their therapy under his nurses’ direct supervision.

Every practice eventually has to write off bad debt, but there are ways to keep it in check. One is to take care of billing and insurance before treatment begins in order to prevent reimbursement problems, instead of struggling to fix them later on. Vacirca advises keeping on top of accounts receivable. He also said his group purchasing organization, ION Solutions, has provided invaluable help in reducing avoidable costs.

“There are a lot of resources out there for practices, but they gotta pick the phone up,” he said. “That’s the biggest mistake—a lot of oncologists just continue to suffer, and they see an erosion of their finances and don’t reach out, until they end up selling to the hospital for pennies on the dollar.”

Oncologists also advocate policy changes that would ease their financial strain, including a Medicare payment fix, an end to sequester cuts, price regulation of oral oncolytics, standardization of payer electronic records systems, and especially recognition of the cost-effectiveness of non-hospital providers.

“That’ll be the theme of 2015,” Vacirca said. “The payers recognizing better-quality care and our ability to take more of a driver role in patient care.”

			America’s Health Insurance Plans Center for Policy and Research. January 2014 Census shows 17.4 million enrollees in health savings account— eligible high deductible health plans (HSA/HDHPs). https://www.ahip.org/2014/HSA-Census-Report/. Accessed March 23, 2015.

			Kaiser Family Foundation. Consumer assets and patient cost sharing. http://kff.org/private-insurance/issue-brief/consumer-assets-and-patient-cost-sharing/. Accessed March 23, 2015.

			Consumer Financial Protection Bureau. CFPB spotlights concerns with Medical debt collection and reporting. http://www.consumerfinance.gov/newsroom/cfpb-spotlights-concerns-with-medical-debt-collection-and-reporting/. Accessed March 3, 2015.

The growing popularity of high-deductible health insurance plans has created a range of increasing pressures on oncologists and hematologists.

Meir Rinde

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