Radiation therapy, a foundation of cancer treatment for decades, remains fertile for continued technological innovation that can improve patient outcomes. Some of the newest technologies, however, may be practical for only the largest institutions. For example, particle-based radiation therapy—specifically, proton therapy&mdash;has generated lots of buzz, but the majority of radiation oncology practices lack the financial resources and expertise needed to purchase and operate the equipment for this. Fortunately, the continued evolution of legacy technologies enables clinicians to offer excellent patient care. Advancements in stereotactic body radiation therapy (SBRT) and image-guided radiation therapy (IGRT) exemplify how radiation oncologists can deliver excellent outcomes using familiar tools that are already widely deployed.

A critical challenge in radiation oncology is effectively destroying cancer cells while minimizing damage to nearby healthy tissue. This is similar to the challenges associated with the use of chemotherapy agents that disrupt mechanisms that are present in both malignant and nonmalignant cells. Medical oncologists increasingly rely on targeted chemotherapies to increase cytotoxic effects within cancer cells while minimizing them in normal cells. Similarly, radiation oncologists can utilize SBRT and IGRT to deliver high doses of precisely targeted radiation.

SBRT focuses multiple radiation beams on a defined target area. Although the dose along any given beam path is relatively low, the dose at the focal point where the beams converge is sufficient to cause cell death. Recent advances in SBRT technology have increased the precision and accuracy with which radiation doses can be targeted. The now-standard use of smaller, more dynamic multileaf collimators allows the radiotherapy beams to better conform to the 3-D structure of the tumor, increasing delivery of radiation within the tumor while protecting healthy tissue from exposure.

IGRT has undergone a similar evolution. Computed tomography (CT) has improved the localization of tumors from surrounding tissue with more detailed 3-D images and 4-D images that demonstrate target motion over time. Continued improvements have also been made to magnetic resonance imaging (MRI) technologies, which are increasingly integrated into radiotherapy departments. Compared with CT scans, MRI technologies make it possible to more accurately discriminate between tumors and adjacent soft tissues. MRI-guided linear accelerators will be the ultimate marriage of these advances and are already under clinical evaluation.

Combining SBRT with IGRT allows better visualization of the target area and more precise delivery of radiation to the target, increasing our ability to precisely eliminate tumor cells with little to no effect on normal tissue. As the volume of healthy tissue in a field decreases, we are able to shorten treatment courses while delivering tumoricidal doses. This concept of hypofractionation, or the delivery of higher doses in fewer sessions, is changing how we treat patients who have a variety of cancers.

The Willis-Knighton Health System in Shreveport, Louisiana, first adopted IMRT in 1998. It was 1 of the first 5 centers in the United States to use IGRT in 2003 and is currently among a select few centers with an MRI simulator dedicated to planning radiation therapy. We have continually upgraded our systems for both technologies, allowing us to offer patients hypofractionated regimens that can reduce treatment times while maintaining excellent safety and tolerability profiles. For more than 12 years, patients with breast cancer treated at our center typically underwent 6.5 weeks of radiation therapy. Today, using the Versa HD image-guided linear accelerator from Elekta, patients with breast cancer often receive hypofractionated regimens that allow them to complete their treatment in only 4 weeks. Similarly, for more than 10 years, most patients with lung cancer at our center received radiation therapy over 6 weeks. Now, in select cases, we can treat some patients with lung cancer safely in only 2 or 3 weeks.

Today’s precise SBRT and IGRT technologies also enable the use of radiation to complement cytotoxic and targeted agents in the treatment of limited systemic disease. More effective management of metastatic lesions through the use of hypofractionated radiation therapy may extend survival even for patients who have not achieved complete remission.

A growing body of data supports the use of hypofractionated regimens in several common cancer indications, including breast, lung, and prostate. In February 2017, the 

International Journal of Radiation Oncology • Biology • Physics

 published a commentary calling for the use of hypofractionated regimens for prostate cancer that can be administered over just 4 or 5 weeks, compared with the current standard regimen administered over 9 weeks.

Shortened treatment times offer multiple benefits. Patients spend less time in the hospital and more time engaged in activities that are meaningful to them. Fewer treatments also mean we are able to reduce the cost of care for patients and payers and utilize staff and instrument time more efficiently.

New technologies will be critical to extending long-term survival and achieving cures for patients with cancer. However, there is much that radiation oncologists can do now to leverage the best of today’s technologies to improve patients’ lives during and following treatment. 

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Radiation therapy remains fertile for continued technological innovation that can improve patient outcomes, but of the newest technologies may be practical for only the largest institutions.

Reduce Costs By Using Less Radiotherapy

Terra Universal, an environmental solutions company based in Fullerton, California, came to a point recently where it was no longer willing to sell and design clean-room setups for oncology practices unless potential clients first sat down with a consultant who could give them reliable guidance on what they needed. The problem was a set of standards from the US Pharmacopeial Convention (USP <800>) on hazardous drug management that was so complex and so potentially costly that Terra Universal did not feel confident that it would be selling its clients what they needed unless an expert thoroughly versed in the new standards was involved.

USP <800>, which is not yet finalized and is due for implementation in July 2018, was forcing clients who had only recently made purchases of clean rooms and equipment from Terra Universal to come back and ask about the possibility of returning or exchanging equipment for higher levels of protection, said Miriam selling a lot of USP rooms,” she said. “The problem was they weren’t compliant because we were only going with what the customer was asking for. They would come up with designs and later they found out they couldn’t use the clean room any longer because the regulations were changing.” The stainless-steel rooms that Terra Universal supplies to oncology practices can cost in the tens of thousands of dollars. They are designed to create a “negative” air flow that prevents airborne toxins from migrating to other rooms in a building.

The company solved the problem by engaging a regulatory expert who works with the California State Board of Pharmacy to consult with customers prior to any purchase, for a fee of $2500 for a 1-hour call. That money is credited toward purchases above a certain level, and the consultation can save a lot of frustration down the road, so it’s a wise investment for the oncology practice and it means Terra Universal will have fewer dissatisfied customers, Magaña said. “We will not quote a price without the consultation,” she said. “We got to the point where we just wouldn’t do it. It’s not in the customer’s interest to not do it.”

Figure. Federal Involvement in Toxic Drug Management

USP <800> has the potential to be a game-changer in the field of oncology practice. It is a set of standards for hazardous drug handling that has been developed and has moved toward adoption at a relatively rapid pace compared with its predecessor, USP <797>, which is a set of sterile drug compounding standards that only touches on hazardous drug management (Figure). The new set of standards addresses the type of equipment that should be used for mixing chemotherapy drugs, facility layouts, room air-exchange requirements, and venting standards. These involve huge expense and add to the economic burden already faced by independent cancer centers across the country. Dispensary and pharmaceutical administrators from oncology practices who spoke with 

 said many practices have been caught flat-footed by the advent of USP <800>. Many are scrambling to bring their facilities up to the higher level in time for adoption. The problems encountered along the way include financing, diversion of practice resources, and disruption to clinic operations.

By itself, USP <800> will not carry the force of law. However, the standards are likely to be endorsed by state boards of pharmacy and medicine, which have regulatory power. The US Occupational Health and Safety Administration (OSHA) also is expected to put its heft behind the hazardous drug management guidelines, which were developed over years of increasing evidence that higher standards are essential to protect not just patients but also clinical workers who come into prolonged, daily contact with toxic drug compounds. “The USP <800> standards that are going into effect in July 2018 will be enforceable by a variety of organizations,” said Josh Cox, PharmD, BCPS, director of pharmacy at Dayton Physicians Network, a Dayton, Ohio-based string of 8 oncology centers.

Many regulatory bodies are taking USP <800> very seriously, which has given oncology practice administrators a strong hint that they will have no choice but to comply. “In the state of Ohio last year, the Ohio Board of Pharmacy passed a set of rules that mirror the requirements of USP <800>, so those are actually enforceable now,” Cox said. He serves as a co-chair of the Community Oncology Alliance’s Community Oncology Pharmacy Association and said that although many state boards of pharmacy have yet to take a position on USP <800>, many are considering how they should adjust their rules or what new rules they should write to allow themselves to have jurisdiction to enforce USP <800>.

Wanting to Be Sure That USP <800> Will Happen

Queens Medical Associates of Fresh Meadows, New York, is among many practices that are grappling with the specter of USP <800> standards. The practice is confident that it has much of the appropriate equipment and compliant facility space already in place to protect its workers and patients to the level of USP <800>; however, closing the gap to bring the practice into total conformance would involve huge additional expense and significant disruption, said Howard Levine, PharmD, pharmacy director at Queens Medical.

For the practice to justify the cost of full transition, it has to know for certain that USP <800> actually is going to be adopted by the US Pharmacopeial Convention, Levine said. It seems very likely that that will happen, but Queens Medical doesn’t want to make the investment until it is sure. Within the next 6 months, Levine estimated, the practice will have to decide whether to start renovations. Beyond that point, there won’t be enough time to complete the work before the projected July 1, 2018 adoption of USP <800>.

Even though the practice feels that its facilities already are very modern and safe, compliance is important from a legal standpoint, Levine said. With the certainty that many regulatory bodies including OSHA will hold practices accountable, even a small departure from standard could be too much of a risk. “Do we protect our patients to the best of our ability? Yes, we do. Do we protect our workers? We give them any protections they specifically request. So that’s not the issue. The issue is did you follow that regulation?” Levine said.

Even somebody who accompanies a patient for infusions could conceivably make a defensible legal argument that a personal illness resulted from exposure to toxins at the practice that weren’t controlled or contained according to standard, Levine said. “What are you going to do if you can’t prove that you were following regulations? That’s where the concern comes in. You put yourself at risk by not doing the appropriate things. The ultimate endpoint could be you now lose a lawsuit because you couldn’t prove you took steps to protect someone.”

Some Practices Are Further Behind Than Others 

Queens Medical sees about 125 to 150 patients each day, has 5 pharmacists on staff, and provides both infusion and oral chemotherapy. Its facility is 12 years old and was designed with the expectation of having to meet USP <797>. In 2014, USP <800> began to loom and the practice engaged a consultant to review the proposed standards and anticipate what would be needed to bring the facility up to the new level. “This would mean moving the entire pharmacy operation; reconstructing the area we would move into; and moving the heating, ventilation, and air conditioning systems to that new area. We would potentially need a prefabricated room to make it easier for cleaning. This would cost us a half a million dollars,” Levine said. This is why the practice wants to be sure that the new standards will take effect before making the investment.

Queens Medical is more fortunate than other cancer treatment centers whose drug management practices and facilities are less modern. For them, compliance with USP <800> may be a much more rigorous transition, Levine said. “I would suggest that the smaller practices can’t afford to do a lot of this.”

Among oncology practices large and small, there is already wide disparity in the worker and patient protection afforded by existing facility design and equipment. “Do they have (air-removal) hoods that vent out to the highest point on the roofs? The answer is probably not, because those exhaust fans cost $15,000 a piece, and then the engineering to get that done costs a fortune.” It’s more likely that such practices are using hoods that recirculate air [indoors] through a filter. That’s not a good standard,” and it likely won’t be legally defensible if the practice gets sued, Levine said.

Cox agreed that small and medium-sized practices have “a long way to go” in meeting the standards of USP <800>. “Many are scrambling to try to put things in place and some are not confident that they’ll meet the deadline,” he said, citing an estimate he came across recently that 20% of practices are not going to be prepared in time. “Many larger practices are still tweaking their processes and rewriting policies and generating different operating procedures to better meet the standards.”

Whereas Queens Medical is taking a wait-and-see position, Dayton forged ahead several years ago to bring its facilities up to the anticipated standards of protection. “We anticipated these rules coming into effect, and we prepared, which reduces the burden, but we’ve spent hundreds of thousands of dollars on building completely new infrastructures for a number of sites and then retooling a number of those sites with new equipment,” Cox said.

It took very detailed planning to avoid disruption to patient treatment, but even then some inconvenience could not be avoided, he added. “We went through that scenario at a practice location late last year, where we redesigned our IV infusion suite, and it was very painful for a number of months. It created a significant disturbance and was very inconvenient to our nurses and physicians and patients.”

Cox noted that, in addition to the investment in new plant and equipment, the ongoing staff training, environmental monitoring, and cleaning standards will add to the time and expense involved in USP <800> compliance. “Cleaning procedures are very costly. The costs of having a clean room certified twice a year is thousands of dollars. Just to do a surface contamination study can cost $2000 to $3000, and these are recommended to be done on a regular basis. The ongoing maintenance costs are significant as well.”

Practices are not alone in this struggle, Cox said. There are many helpful resources available, including some very good consultants. “My advice is not to be overwhelmed, but to really focus on doing a self-assessment—a gap analysis&mdash;to determine where a particular organization is and then start addressing those issues that pose the highest level of risk. The gap analysis is the first step and a critical one.”

Terra Universal, an environmental solutions company based in Fullerton, California, came to a point recently where it was no longer willing to sell and design clean-room setups for oncology practices unless potential clients first sat down with a consultant who could give them reliable guidance on what they needed. 

Practices Rush to Prepare for USP 

In April, I prepared to attend the 2017 American Association of Cancer Research (AACR) meeting expecting that the breakthrough discoveries presented would offer my patients greater hope to defeat the dreaded disease we call cancer. I was not disappointed. The research presented at AACR focused on the fundamentals of cell biology, cell aging, and cell death; how the immune system recognizes and kills cancer cells; and how, in turn, cancer cells avoid immune system detection. It is easy to understand how the body of this research will apply to and benefit other aspects of medicine, such as aging, diabetes, rheumatologic disorders, inflammatory bowel disease, infectious diseases, and neurodegenerative diseases.

The explosion of knowledge sometimes makes you feel as though you were drinking from a fire hose, but no one is complaining. No one I have ever met, regardless of political perspective, wants someone they love to receive anything other than state-of-the-art care for serious illnesses—particularly cancer. In the United States, we have the best science and the best healthcare, notwithstanding opinions to the contrary. What we do not have are rational leaders who are willing to put the health and well-being of our citizens first.

Where do we go from here? Why not start with both parties working together to create a consensus on the problems facing healthcare in America today? This would be a long-butfinite list. We all know we spend too much overall, but we do not know where we spend too much and where we spend too little, which results in less-than-optimal outcomes and waste. Simultaneously, we Americans engage in habits and lifestyles that adversely affect our health and add considerably to costs of care. We have doctors burning out largely because of administrative requirements and payment obstacles. We have inequality in care caused in part by insufficient hospital capacity and variations in technological sophistication. Our laws and regulations impede innovation and physician-hospital relationships that otherwise would improve healthcare delivery. We want new and effective therapies but without the risk or adverse outcomes associated with them. We have so many entities that derive profit from the healthcare system but add little value. In addition to these problems, many patients struggle with the high cost of health insurance or go without.

The state of healthcare today reminds me of the disorganized state of cancer care 30 years ago when I began practicing. We knew very little about the root causes of cancer, and so we applied therapies and technologies that were aimed at the wrong things. We had many flawed ideas about what might work and argued about who had the correct approach without any real data to know for sure. Sound familiar? Now, 30 years later, thanks to science, our medicine is better targeted, outcomes are improving, and arguments among clinicians are diminishing. My greatest hope is that our political leaders also use a scientific approach to improve healthcare policy by focusing on the desired outcome—better clinical outcomes and lower costs of care&mdash;studying the data, trying evidence-based solutions, and taking credit only for what works.

The research presented at AACR focused on the fundamentals of cell biology, cell aging, and cell death; how the immune system recognizes and kills cancer cells; and how, in turn, cancer cells avoid immune system detection. 

Science Marches On and Policy Lags Behind

Recent results for medical practice performance in accountable care organizations (ACOs) don’t give Charles Saunders, MD, great confidence that physicians are making significant strides toward value-based care. Saunders is CEO of IntegraConnect, which has just launched a suite of electronic data management services to help oncology practices meet the requirements of the Merit-based Incentive Payment System (MIPS) and the Oncology Care Model (OCM). His company is one of many that have developed Big Data solutions in response to CMS’ demands for a better-quality experience for patients with cancer and reduced dependence on fee-for-service payment.

Practices that meet the goals for improvement in savings and outcomes will be eligible for performance incentive payments. Some physicians have argued it will be difficult for them to demonstrate improvement because they already are highly efficient, but Saunders contends that they may be mistaken. If average performance is not high to begin with, it shouldn’t take that much effort to distinguish yourself from the pack or even from your own past performance, he said in an interview. “The state of the industry is relatively low right now. Let’s say that you went to school and the average score was 30 out of 100. You’d have to get a 45 to stand out, and a 45 is still not very good,” Saunders noted.

Saunders said he has enough experience to know that his assessment is correct. Before taking the helm of IntegraConnect, he served as CEO of Healthagen, an arm of Aetna that focuses on improving the health of populations of patients. “We managed more than 70 ACOs, 350 medical homes, and several million medical lives,” he said. “It’s not that difficult to generate savings between 10% and 30% for these practices.”

The key is to work hard on bringing a few common cost drivers under control. If you can do that well, your practice will easily improve its performance, he said. The first job is to reduce the number of patients who end up in the hospital and the emergency department. The second task is to improve the timing of end-of-life services so that patients don’t die in the hospital. “These things are surprisingly not that difficult to do. It just requires a patient-focused process, a certain mindset, and a different technology. I don’t think that’s going to be difficult for practices that are motivated and that make the necessary investment to do it, and that actually step up in capabilities,” Saunders said. Along the way, patients enjoy a better healthcare experience, he noted, which is also one of the goals that CMS has established for practices to meet.

A glimmer of how oncology practices may perform with the OCM and MIPS is offered by a CMS report on ACO performance for the year 2015.1 ACOs are the forerunners to the OCM, as they encourage coordinated medical care across different provider specialties and emphasize a higher-quality experience for individual patients. The same study results garnered widely different assessments of practice performance. For its part, CMS has declared ACOs a success, partly because of the savings that have been achieved: $1.29 billion between 2012 and 2015. However, industry observers have noted that of the 392 ACOs included in the 2015 survey, just 29% (n = 115) achieved performance levels high enough to share some of the money they had saved CMS on claims payments.2 In addition, roughly one-third of the $646 million in total shared savings was achieved by only 10 of the practices surveyed, which shows that good performance was not evenly distributed and was, in fact, rare.

The overall performance was lackluster even though “the ACOs that volunteered for the program thought they were great,” Saunders said. Based on outcomes like this and his own observations, Saunders predicted the challenge of excelling in the OCM and MIPS programs is going to be an eye-opener for practices. “They’ll probably be surprised when CMS starts writing the checks that maybe they’re not as prepared as they thought they were.”

Of 195 practices enrolled in the OCM, the majority are in a 1-sided risk model of performance, which means that they do not share financial risk for failure to meet performance targets. Because CMS wants all oncology practices to share upside and downside financial risk, those in the 1-sided risk model OCM must also participate in the MIPS program of performance measurement, which involves financial incentives and penalties that are being phased in through 2026. The OCM has 7 basic requirements: practices must provide around-the-clock patient access to clinical support, use certified electronic health records (EHR) management, use performance measures and set targets, initiate patient management services, document care plans for patients, follow generally approved treatment pathways, and report on performance progress.

This is where IntegraConnect has stepped in with its Big Data, cloud-based package of services that the company says can help practices meet these requirements with greater ease and success than if they were using only standard EHR platforms and the “elbow grease” of physicians and practice administrators. The difference between standard EHR systems and what IntegraConnect is offering is a system that helps practices to interpret data rapidly and to identify ways to focus efforts for greater success, Saunders said. The software is a “bolt-on” to the standard EHR platform, he said. The supplement enables patient data from diverse sources to be integrated with claims information provided by CMS and then analyzed effectively, providing an understanding of the patient population and improved coordination of care. Practices are able to see where the weaknesses are in care management, he said. “About 20% of your patients will drive about 60% of your costs. That’s what our data show,” he said. “You need to find out which 20% of patients they are so that you can really focus your attention on those to hold costs down.” An EHR, he said, would fall short on meeting this need because it’s not designed to manage care. “The EHR is really designed to chart a visit for the purpose of generating a bill.”

Market competitors have developed similar tools for addressing CMS’ requirements. McKesson Specialty Health, for instance, offers a trio of products with much of the functionality that Saunders described: iKnowMed, an advanced EHR for documenting OCM-required information; Clear Value Plus, for keeping patient treatment in accord with nationally recognized guidelines; and Practice Insights, designed to optimize both clinical and financial management.

The market for products like this is expected to grow because CMS has indicated that it wants most practices to become involved in models of care like the OCM. In addition, many oncology providers have been developing versions of the OCM they believe would meet their own specialty-care needs more closely. Saunders said that IntegraConnect can easily be adapted to accommodate these additional models. “The specialty industry in general is going to be increasingly reimbursed on an alternative payment model basis, and this software in our platform is highly flexible,” he said. “We have a number of customers that are large oncology groups, but they are also part of a multispecialty group that might also have urology, primary care, and some other specialties represented.”

However, it won’t be enough to simply plug in the software these companies offer and expect to achieve good results, Saunders said. Many practices will go through a period of transformation during which they learn how to use these new tools and start doing things differently, which Saunders said will be key to successful adaptation to CMS standards of practice. “In my previous role with Healthagen, what I found was that putting the technology tools in people’s hands was not enough,” he emphasized. “At the end of 6 to 9 months, if they still weren’t generating savings, it was because they weren’t doing anything differently. For instance, they hadn’t brought on board any nurse navigators or any care managers. They were still just seeing patients, and they expected somehow that the technology would drive savings.

somehow that the technology would drive savings. “What we do is we combine the technology tools with what we call practice transformation services and support. We actually go in and spend a lot of time up front teaching them what to do differently—what is care management? What is the design of a care management program? If they need it, we’ll help them set up a care management program and teach and train their nurse navigators and care managers,” Saunders said. That support extends to the use of analytics tools, he added.

The point is, it’s not all about more technology and business-as-usual. “It requires a little bit of cultural and practice transformation, which at the end of the day is what CMS is after,” Saunders said. “The OCM program provides a huge carrot but also a significant stick to get them to transfer to value-based care.”

Physicians and health care providers continue to improve quality of care, lower costs. [news release] Washington, DC: CMS; August 25, 2016. www. cms.gov/newsroom/mediareleasedatabase/press-releases/2016-pressreleases-items/2016-08-25.html. Accessed April 2, 2017.

Introcaso D. ACO performance year three: what happened and what does it mean? The Health Care Blog. October 1, 2016. thehealthcareblog.com/ blog/2016/10/01/aco-performance-year-three-what-happened-and-whatdoes-it-mean/. Accessed April 7, 2017.

Practices that meet the goals for improvement in savings and outcomes will be eligible for performance incentive payments.

Software That Does More Than Document Care

As recently as the late 1990s, a practice could charge enough for chemotherapy drugs that it could easily afford to treat patients who had Medicare coverage and no additional insurance. Today, that is often no longer the case. "It's just gotten worse, little by little, over time," said David Eagle, MD, of Lake Norman Oncology in Huntersville and Mooresville, North Carolina. "Some patients have medicare only and we're underwater on the drugs, and the patients have really hard times affording that 20% co-pay responsibility. Sometimes with Medicare and the coinsurance we're still underwater on Medicare drugs. That can happen with some private plans too." Payment rates for Medicaid patients have deteriorated to the point that the practice loses money on at least half of the drugs provided to them, Eagle said.

Infusion chemotherapy has been a core element of community oncology for decades, but for the past several years hospital networks and large cancer centers have been taking over this market. Administering intravenous therapies in-house in the community setting brings a number of advantages—lowering total costs of care and affording close monitoring of patients&mdash;but thin drug margins, the inequities of the 340B Drug Pricing Program, fierce competition for patients, and industry consolidation are making it difficult for all but the most efficient practices to stay in business and maintain viable infusion programs.

Infusion economics are also changing due to the growing use of oral drugs. Despite growing demand for cancer care and an expanding market for infusion for various other medical conditions, the chemotherapy infusion business is shrinking slightly, according to infusion industry expert Mark Huizenga, managing director of Huizenga Consulting of Grand Rapids, Michigan. Use of value-based payment models could lead to further change if cost-conscious oncologists decide to make greater use of home infusion, a rapidly growing option that is less expensive and more convenient for patients. Another potential factor is the growth of ambulatory infusion centers (AICs), though they currently provide almost no chemotherapy.

Table. Outpatient Centers Capture Increasing Share of Chemotherapy Infusion Market

Among oncology providers, the recent shift in chemotherapy siting has been dramatic. In 2004, private practices accounted for more than 80% of Medicare spending for chemotherapy infusion, but by 2014 the practices made up less than 60%, according to a Milliman study commissioned by the Community Oncology Alliance (COA).

 The change was even more stark among commercial payers, who previously paid 90% of chemotherapy claims to private practices; now, that amount totals less than 50% of claims.

Once a highly profitable, primary form of revenue for independent practices, infusion income was curtailed by the Medicare Modernization Act of 2003, which limited the amount practices can charge for drugs to 6% over average sales price (ASP). Some practices pay less than ASP for drugs and earn a bigger margin, but some—particularly smaller practices with less power to negotiate drug costs&mdash;inevitably pay more than ASP. Medicare reduced payments by another 2% following congressionally mandated sequester cuts in 2013, slicing practice revenues even thinner.

Jeff Vacirca, MD, COA’s board president and CEO of New York Cancer and Blood Specialists in East Setauket, said his practice earns about a 3% margin on drugs after a distributor takes a fee, and that doesn’t account for inventory management, bad debt—including unpaid Medicare bills&mdash;waste disposal, management, and other costs. Drug manufacturers also regularly hike their prices and it takes Medicare months to adjust its payments accordingly. “We’re seeing price increases and bad debt and all the associated practice expenses. It’s a losing situation,” Vacirca said.

Practices have the option of sending patients with insufficient coverage to a hospital for chemotherapy, but to minimize loss of oversight, such transfers generally occur only for very complex cases, patients whose payers require it, and, in some cases, indigent patients. “We always like to treat people in the office That’s our preference,” Eagle said. “It’s much easier to manage and the patients prefer it. There’s less waiting time, we have more control over the process, and there’s better coordination of care.”

Rather than send patients away, financial counselors work to get them help from charitable foundations or drug manufacturers’ assistance programs. Practices also survive by focusing diligently on billing to make sure they don’t lose out on any opportunity for revenue from payers or patients. “You can do it if you have zero room for error,” Eagle said. “Hospitals can make mistakes and stay in business. We can’t.”

Eagle and other oncologists say many hospitals worry less about running a tight ship financially because they have the cushion of the 340B program. Created by Congress in 1992, 340B allows for deeply discounted drug purchases by hospitals that serve vulnerable populations, enabling them to earn much more on each infusion than a private practice or non-340B institution. “Hospital outpatient clinics have discovered that 340B is the virtual pot of gold at the end of the rainbow,” COA executive director Ted Okon, MBA, said. Hospital networks can also use their market dominance to compel payers to agree to higher drug charges.

The profits from oncology under 340B have driven hospitals in a number of urban areas to expand their oncology programs and acquire local groups, reducing the number of independent practices in those regions. “A hospital can acquire an oncologist who accounts for upward of $4 million or $5 million in drug administration, and get [significant] discounts,” Okon said. “That oncologist represents anywhere from $2 million to $3 million of pure bottom-line profit for the hospital.” Hospital networks typically purchase practices outright, though in some cases they acquire only a practice’s unprofitable infusion services. In the latter situation, the same doctors and nurses may continue to oversee the infusions, but the new owner can boost revenue by taking advantage of 340B, the hospital’s sway over payers, and volume purchasing power.

Hospital networks also pressure other types of small practices to accept buyouts, in part so the hospitals can control where patients are steered for cancer care. In the Charlotte area, where Eagle practices, the city’s second-largest hospital recently cut ties with a large neurosurgery group and built out its own neurosurgery program, heightening worries among private oncologists in the region about a trend of declining referrals.

Because hospitals can charge payers more for the same services than independent practices do, the shift of chemotherapy site of service increases the overall cost of cancer treatment, running counter to the movement toward more efficient value-based care. As oncologists adopt the CMS Oncology Care Model and other new payment models that emphasize population management and cost savings, alternative methods for delivering chemotherapy could gain more currency, oncology consultant Dawn Holcombe said at a recent World Congress Oncology Market Access Summit in Philadelphia. “We may decide we don’t want patients coming in the office for infusions anymore,” said Holcombe, of South Windsor, Connecticut. “We may decide we want to figure out how to manage them at home.”

The rising incidence of cancer already plays a large part in the rapidly expanding home infusion market. According to a report by Grand View Research, the global home infusion therapy business for all diseases was worth $13 billion in 2015 and is growing 6% annually.

 The market for infusion pumps specifically is projected to grow from $8.1 billion in 2016 to $10.8 billion in 2021, the MarketsandMarkets research firm said in a report.

Chemotherapy accounts for the largest share of the pump market, exceeding diabetes, gastroenterology, and other applications.

Infusion therapies, including antibiotics and biologics for various chronic conditions, such as autoimmune diseases, are increasingly delivered at freestanding AICs run by physicians, but their chemotherapy offerings are minimal. Huizenga said that, in addition to preferring to keep patients inhouse, oncologists have more expertise in administering complex, often toxic therapies, and those oncologists in practice networks know how to make infusion work financially despite the sequester and other pressures. “Oncology physicians really do know how to do infusion and they know how to do it well. It’s very protocolized and they kind of ‘get it.’ They’ve been doing it for the longest time,” said Huizenga. Eagle said that transferring patients out of his control to a freestanding center sounded like “a terrible idea.”

Huizenga noted that succeeding in the broader infusion business for multiple diseases can be difficult and is highly dependent on the structure of the healthcare industry in a center’s local area. He pointed to Walgreens’ decision to spin off its Option Care chain of infusion centers in 2015, saying it is difficult to assemble a management team that understands the business well enough to make it profitable.

That said, AICs are succeeding, and entrepreneurial practitioners continue to show interest in opening new ones. Sending patients to an outside center for infusions can be attractive to a small practice that has only 1 or 2 infusion chairs of its own, Huizenga said. Patients with moderate disease states can go to an AIC that is less expensive and much easier to navigate than a large hospital complex, and unlike a hospital, the AIC won’t try to poach them away from the practice. Meanwhile, the sending physician can focus on treating more complex patients in-house. The practice is also able to devote less staff time and other resources to infusing drugs that provide relatively little revenue, while focusing more on other important tasks. Infusion is more profitable for the AIC because it buys drugs in volume and services a large and steady flow of patients, including on nights and weekends at some centers, Huizenga said.

Milliman. Cost drivers of cancer care: a retrospective analysis of Medicare and commercially insured population claim data 2004-2014. Community Oncology Alliance website. http://www.communityoncology.org/pdfs/ studies/Trends-in-Cancer-Costs-White-Paper-FINAL-20160403.pdf. Published April 2016. Accessed March 24, 2017.

Garloch K. Charlotte’s brain surgery battle reveals the fierce, high-dollar competition in health care. The Charlotte Observer website. http://www. charlotteobserver.com/living/health-family/karen-garloch/article134482029. html. Published February 23, 2017. Accessed March 24, 2017.

Home infusion therapy market Is anticipated to witness lucrative growth [news release]. San Francisco, CA: Grand View Research, Inc; June 2, 2016. https://globenewswire.com/news-release/2016/06/02/845513/0/en/ Home-Infusion-Therapy-Market-Is-Anticipated-To-Witness-Lucrative-GrowthCost-Saving-Attributes-To-Act-As-Major-Growth-Drivers-Till-2024-Grand-View-Research-Inc.html. Accessed March 24, 2017.

MarketsandMarkets. Infusion pump market by product (volumetric, syringe, enteral, insulin, implantable, PCA, accessories), application (oncology, diabetes, gastroenterology, analgesia, pediatrics, hematology) & end user (hospital, home care) — global forecast to 2021. MarketsandMarkets website. http://www.marketsandmarkets.com/Market-Reports/infusion-pumpsaccessories-market-90374506.html. Published February 2017. Accessed March 24, 2017.

As recently as the late 1990s, a practice could charge enough for chemotherapy drugs that it could easily afford to treat patients who had Medicare coverage and no additional insurance. Today, that is often no longer the case.

Independents No Longer Dominate the Chemotherapy Infusion Market

The clock is ticking on the anticipated implementation of the US Pharmacopeial Convention Chapter 800 (USP <800>) standards for hazardous drug (HD) management, which are expected to become widely enforceable starting July 1, 2018. These standards are so much more rigorous than existing ones that they have the potential to keep oncology practice administrators awake at night. Indeed, there has already been much angst over USP <800>. Administrators, interviewed for our lead story on the subject, on page 10, described the need for extensive renovations costing hundreds of thousands of dollars and causing widespread disruption to practice operations.

One representative of a company that sells clean rooms and related equipment said there was widespread confusion last year as practitioners who thought they were properly pre- pared came to realize that their investments would not conform to USP <800>. Many needed to start over. At that point, the company changed its policy and refused to sell more equipment unless practices spoke first with a consultant well versed in the newer standards.

Well-financed practices with room to expand are finding it easier to accommodate these changes, which in many cases involve creating separate rooms with managed air ow for HD compounding. Those we interviewed speculated that there are many oncology groups facing difficulty bringing their facilities up to the new level of acceptability. For some, the transition may require that they get out of the business of HD handling altogether. Patients would be referred to hospital outpatient centers instead.

For a Queens, New York, practice, meeting the new standard will cost $500,000, which they would prefer not to spend, an administrator said. The issue is not so much whether they have an environment that is modern and safe for patients and staff, but whether they can demonstrate that they are in full compliance with USP <800> if it becomes enforceable in New York. Someone may be able to argue in court that an illness could have originated from noncompliant facilities at the Queens practice, the administrator explained.

The new standards weren’t invented to bring grief to oncology practices. There has been a growing understanding of the dangers of HDs and the need for heightened controls on exposure. Our companion story on HD management discusses some of the milestones in this journey of discovery and the importance of staff training to not only educate workers on proper handling methods but spur them to become vigilant about their own safety. Read about it on page 12.

For some practices, USP <800> compliance may already be a moot topic. The infusion business is rapidly migrating to hospital outpatient centers, many of which are better financed, enjoy greater margins on payment than independent practices, and have the advantages of high volume. In a story on page 14 we discuss the drivers of this transformation in the infusion care landscape, rounding out this month’s focus on a dynamic and challenging aspect of oncology care. Be sure to read all 3 stories. Also check out our other coverage this month in

. It includes software for successful Oncology Care Model management, radiotherapy savings, and the value of real-world evidence.

The clock is ticking on the anticipated implementation of the US Pharmacopeial Convention Chapter 800 (USP ) standards for hazardous drug management, which are expected to become widely enforceable starting July 1, 2018.

May 2017 | Oncology Business News®

Reduce Costs By Using Less Radiotherapy

Practices Rush to Prepare for USP

Science Marches On and Policy Lags Behind

Software That Does More Than Document Care

Independents No Longer Dominate the Chemotherapy Infusion Market

It Takes a Big Mess to Create a Clean Room