Major pharmacy companies are paying attention to the movement toward value-based care in oncology, but recent comments from representatives of 2 top firms suggest this sector is wary of risking capital to lower costs and improve patient outcomes. The representatives questioned how such risk-bearing mechanisms could even be structured, and would not speculate on how to reform the costly 340B Drug Discount Program, which has boosted revenues in specialty pharmacy while contributing to the soaring cost of cancer care.

Speaking on a panel at the World Congress Oncology Access Summit in March, executives from Walgreens and Accredo-Express Scripts said they do take measures to keep costs down for the payers they have contracts with, such as creating custom drug formularies and participating in limited pharmacy networks. While physicians and nurses often express frustration over the requirement to send patients to specialty pharmacies that do little to ensure adherence or monitor for side effects, the pharmacy company representatives said their pharmacists do work to educate patients and make sure they take their medications as prescribed.

Yet the speakers said it is unlikely their companies will accept risk in the near future for making sure such interventions actually help patients or save money. Matthew Farber, senior director for oncology disease state management at Walgreens, said it was unclear how his company could participate in an alternative payment model (APM) such as CMS’ Oncology Care Model (OCM), which rewards doctors financially for meeting performance measures and potentially sanctions them for falling short. Farber said pharmacy issues are not a prominent part of the OCM, although the model does mention the importance of medication therapy management (MTM). “So, it kind of goes back to the question, what’s our role in all of it? How do these practices track MTM when it has to go to an external specialty pharmacy?” he asked.

He was similarly skeptical about pharmacies participating in some version of a clinical pathway. Payer pathways discourage doctors from prescribing more expensive drugs and often reward them for choosing less-costly alternatives. Farber said involving pharmacies doesn’t “necessarily make sense” because any new pathways would also have to be adopted by practices, which are already struggling with excessive administrative burdens.

He did say the growth of APMs and costly oral therapies will eventually make pay-for-performance contracts “something that we need to start looking at” in the pharmacy business, but he questioned how they would work. “How do you measure that? At what point does it start becoming my doing, and not the doctor’s doing?” Farber asked. In addition, “if patients are staying out of the emergency room or they’re staying on their therapy, it’s not the easiest thing to measure.” If a practice and a payer together decided they wanted a pharmacy to engage in more patient outreach, the pharmacy company would have to ask, “Are we able to affect patient care that way?” Farber said.

Bill Martin, a vice president and general manager at Accredo-Express Scripts, a mail-order pharmacy and the nation’s largest pharmacy benefit manager (PBM), had a similar message. When asked about the prospect of pay-for-performance models for pharmacy companies, he said his company is in a number of “innovative contract structures” with payers but is not being held financially accountable for patient outcomes. The risk for “the provider making good decisions…is still not being transferred to the pharmacy,” Martin said. “We haven’t hit that point.” He did not describe the existing contracts in detail but said the structures relate to reporting data on prescriptions and support provided to patients.

Express Scripts does have some value-based partnerships with drug manufacturers, including the Oncology Care Value (OCV) program it launched last year. Under the OCV, Express Scripts steers patients toward preferred medications for multiple myeloma, non—small cell lung cancer, prostate cancer, and renal cell carcinoma in exchange for discounts from the drug makers.

 For certain drugs, the company varies the cost it charges payers according to the drug’s efficacy and the patient’s disease, and refunds payers if patients stop taking their medicine. Express Scripts also says its therapeutic resource center boosts patient adherence rates by 5% compared with other pharmacies.

Another speaker on the World Congress panel, Marc Richmond, MD, of Blue Shield of California, noted that a number of risk-sharing agreements directly between payers and drug manufacturers have been attempted. The agreements did not involve pharmacies or pharmacy benefit managers; they typically rewarded manufacturers for a medication’s effectiveness or patient adherence.

Farber and Martin also discussed the higher spending resulting from the federal 340B Drug Pricing Program, which boosts hospital revenues while raising total healthcare costs and contributing to higher drug prices. The growing use of 340B “puts even more pressure on the top-line cost of the drugs” and is unsustainable, Martin said. “It will either eat the world, or it’s going to have to be changed.” Yet he and Farber did not offer solutions to the problem. Walgreens is the country’s leading operator of 340B contract pharmacies, but Farber said it acts strictly as a middleman. “We have absolutely zero say in how those savings are determined and get passed on through the system,” he said. He also said Walgreens contract pharmacies are mostly corner retail outlets that handle few oncology prescriptions.

Richmond and the fourth panel speaker, Brandon Hunter of Blue Cross and Blue Shield of North Carolina (BCBSNC), said their companies are involved in numerous programs to promote value-based care. These include accountable care organizations, risk-sharing with physician groups, incentives to encourage use of clinical pathways and less expensive drugs, and efforts to promote community oncology.

Hunter, manager of care redesign at BCBSNC, said the company just launched an oncology data project with AIM Specialty Health to better understand what constitutes a quality outcome. Starting April 1, 2017, AIM began collecting clinical data from oncologists in BCBSNC’s network that the payer will combine with claims data to help it build incentive programs and pathways. The information will be made available to practices so they and BCBSNC can “start talking about what value looks like,” Hunter said.

Hunter acknowledged that community oncology is generally much less expensive than hospital oncology but said a number of factors make it difficult to encourage patients to go to community practices. One is 340B, which provides hospitals with additional revenues they spend to advertise their oncology services, helping them pull patients away from community practices, he said. Private practices are ineligible for 340B discounts, further hurting their revenues.

But when Hunter’s company organized a summit of community oncologists 2 years ago, it became clear that inequitable drug costs were not the only issue putting them at a competitive disadvantage. For example, despite the clear financial benefits of having patients go to community practices in Charlotte and Durham rather than Duke University Medical Center, it’s an uphill fight persuading them to do so, he said. “A patient gets cancer, and they know they have Duke in their backyard. ‘Why wouldn’t I go to Duke? I want to go to Duke because Duke is better.’ Well, do we know that they’re better? I don’t know that they’re better. All these people went to medical school together,” he said.

Hunter said he lacks the data on patient outcomes that could convince the employers that buy his company’s insurance plans that private-practice oncologists are just as effective as their hospital counterparts. “How do we figure out a way to advertise that? I have to have some way to measure what that quality is,” he said. “I need to determine some way, hopefully a third-party objective way, to say that Dr Smith in his community practice in downtown Durham is just as good an oncologist and has as good outcomes as they do at Duke. But until I have a way of doing that, I can’t overcome that sense that (Duke) is better.” An employer can require his workers to use community practices in a way that a payer cannot, Hunter said.

Kelly LF. Express Scripts leads indication-specific pricing with launch of OCV program. Drug Benefit News. https://aishealth.com/archive/ndbn020516-02. Published February 5, 2016. Accessed March 29, 2017.

Express Scripts. Enhancing our industry leading SafeGuardRx programs. http://lab.express-scripts.com/lab/insights/drug-options/enhancingour-industry-leading-safeguardrx-programs. Published December 12, 2016. Accessed March 29, 2017.

Good CB. Pharmaceutical risk sharing agreements. Veterans Health Administration. http://www.amsus.org/wp-content/uploads/2014/05/ RxRiskSharingAgreements_Good1.pdf. Published June 2014. Accessed March 29, 2017.

Articles

Major pharmacy companies are paying attention to the movement toward value-based care in oncology, but recent comments from representatives of 2 top firms suggest this sector is wary of risking capital to lower costs and improve patient outcomes.

Pharmacies Are Wary of Risking Revenues to Promote Value-Based Care

The shift in healthcare from fee-for-service to value-based reimbursement took a giant leap on January 1, 2017, when the Quality Payment Program (QPP) officially started. Under the QPP, Medicare providers have 2 tracks from which to choose: the Merit-based Incentive Payment System (MIPS) or an Advanced Alternative Payment Model. Most providers, including community oncologists, are expected to fall under MIPS for the 2017 performance year.

Choosing the correct MIPS measures for a practice can be complicated (

). For instance, the Quality category contains more than 270 measures that practices must narrow down to just 6. A new category, Improvement Activities, has more than 90 measures to choose from and practices must select 2 to 4. The last category, Advancing Care Information (ACI), is the rebranded Meaningful Use (MU) program. While providers already have a certain degree of familiarity with these measures, the scoring has become complicated.

Practices Must Choose Value Measures for 2017

Quality measures examine how well a provider performs certain tasks. Many of the measures that can be specialty-specific are similar to those in the Physician Quality Reporting System and Clinical Quality Measures from the MU program. In past years, performance thresholds were not observed, but in the new program, providers are graded on how well they perform compared with their peers. They can either receive a penalty or a positive payment adjustment based on their performance.

Selection of Quality measures depends on which are supported by the practice’s electronic health record (EHR). For example, McKesson’s iKnowMed EHR supports 16 measures. Providers need to select 6 measures that best match their practice’s services and capabilities.

Working from the list of supported measures, providers should assess their current performance and determine where they are doing well and where they need improvement. Providers should choose a variety of measures where performance is excellent, specialty-specific, or may be in need of minor adjustment

Providers must also select at least 1 outcome measure, but selecting more than 1 will earn bonus points. Examples of outcome measures commonly used in oncology are Proportion of Patients in Hospice and Controlling High Blood Pressure. The selection of outcome measures should be based on current performance, priority, and specialty.

Lastly, providers should ascertain which submission methods are supported by their EHR. Data can be submitted by claims, direct EHR, registry, or attestation. All measures within the Quality category must be submitted using the same method.

Improvement Activities are the actions the practice takes to accomplish and perform well on Quality and ACI measures. By selecting Improvement Activities that may cross into other MIPS categories, requirements for the entire MIPS program can be met efficiently. An example of this is Manage Medications: it is an Improvement Activity, and it can cross over to a Quality measure, Documentation of Current Medications, and to an ACI measure, Medication Reconciliation.

Practices should review the list of Improvement Activities and select measures based on their current processes and participation in improvement efforts. For example, if the practice conducts patient surveys or has a quality improvement committee, there are several Improvement Activities that, conveniently, relate to patient surveys and quality improvement, respectively. Practices using iKnowMed, as well as some other EHR systems, will have the option to participate in a Qualified Clinical Data Registry (QCDR) to meet their public health registry measure.

Some activities have multiple bullet points, but only 1 of the bullets from the list needs to be met to fulfill the requirement. The unfulfilled items provide insight into how the practice can further enhance processes or services in the future.

Practices should select at least 1 activity, from several options, that indicates a certified EHR was used. Choosing at least 1 adds an additional 10 points to the ACI score while providing some cross-coverage on scoring.

Avoid certain types of measures. Stay away from those with thresholds, as it is often difficult to prove the requirement was met. Also, avoid measures that do not pertain to the practice. For example, the activities specific to Rural Health Clinics, Indian Health Service, and Federally Qualified Health Centers should be avoided unless the practice serves many patients who would be in those categories.

ACI is the new MU category, and for 2017, most of the measures are very similar to the old MU. Although the new program does not have performance thresholds, providers should continue to perform at the previously set thresholds because this will allow them to earn the maximum number of points for ACI without much difficulty.

For providers who have struggled with portions of MU, such as the health information exchange or patient portal measures like electronic access or secure messaging, the new program provides the opportunity to focus on other measures while improving upon those with which they had difficulty in the past. These providers should now concentrate on such measures as patient education or medication reconciliation to raise their performance results as high as possible. Since CMS will most likely conduct an audit to verify that activities were performed, practices should carefully document their activities. Proofs of performance can include Standard Operating Procedures, policies in place, proof of qualified clinical data registry participation, quality improvement committee meeting minutes, or similar documentation.

Providers can achieve success with MIPS through careful analysis, planning, and flexibility. By thoroughly assessing the measures in all categories, they can determine which are best for their practice. A plan should be developed that will serve as a roadmap to meet the requirements.

Although it is important to have a plan, it is equally important to be flexible while executing it. Practices should remain flexible throughout 2017, adjusting workflows and processes and even replacing measures if necessary. Providers need to realize that MIPS is a journey with many twists and turns in the road.

Selecting the right measures can mean the difference between success and failure within the program, and substantial revenue is at stake. With careful analysis and planning, community oncology practices can choose measures that are a good fit and hold the most opportunity for revenue enhancement. Here are a few points to consider when selecting MIPS measures.

Under the new Quality Payment Program, most providers, including community oncologists, are expected to fall under Merit-based Incentive Payment System for the 2017 performance year. With careful analysis and planning, community oncology practices can choose measures that are a good fit and hold the most opportunity for revenue enhancement.

Assess, Plan, and Be Flexible for MIPS

I have had the privilege of forging several partnerships of physician groups and, more recently, hospitals and hospital systems. Not surprisingly, I have found the core reasons for merging—scale and efficiencies&mdash;are no different whether it involves small groups of physicians (my first merger involved NNJCA Capital and Hackensack Medical Center in 1994) or a partnership between big healthcare systems (Memorial Sloan Kettering Cancer Center and Hackensack Meridian Health in 2016). Some scale may be needed to determine the value of any business initiative. An analysis of work flow to improve office efficiencies can be done successfully in a small group of 5 to 7 physicians. However, determining the best pattern of care for the best clinical outcome at the lowest total cost may take over 1000 physicians working together. To get physicians to work together, you need an organizing structure and the drive to create partnerships.

In merging the 10 largest practices in New Jersey to create Regional Cancer Care Associates (RCCA), of which I am a member, our intention was to work together to create value for our patients and society. We have done that partly be addressing one of the most vexing problems facing medicine and society today—the cost of end-of-life care. Nononcologists should tread carefully here. It is so easy to try to solve this problem through simplistic measures such as, “Did you administer chemotherapy within 3 days of death?” Ten years ago, when we did not have immunotherapy or targeted therapies or genomic analysis for potential driver mutations, it might have been plausible to think in terms of being able to predict the date of death of your patient. Today, with the power to extend life with new drugs, it is not possible to reliably predict the date of decease, and we can never forget that without a validated predictive tool to guide physicians we place our physicians in moral jeopardy by making them choose whether to save the life of a patient or conserve precious healthcare resources.

Through the power of operational scale, the RCCA physicians and their colleagues at the data analysis startup COTA have developed a tool for guiding timing of palliative care consultations. COTA created a patient-reported instrument called “Living with Cancer” and completed assessment on overall survival in advanced cancer patients. According to a 2015 study, the tool was able to identify patients for whom end-of-life-care discussions would be appropriate. A larger, 1024-patient survey was completed at 7 cancer care centers in October 2016 and the findings will be reported at the 2017 ASCO Annual Meeting, June 2-6 in Chicago. The results are striking and will be helpful. This is a small but significant example of using partnerships and big data to improve clinical outcomes and reduce total cost of care. There is much more to come.

To get physicians to work together, an organizing structure is needed and the drive to create partnerships.

Solve Big Questions by Joining Forces

If your oncology practice is suffering from the rising costs of equipment and facilities, staffing costs are going up, and administration expenses are through the roof, you're not alone. More than half (54%) of practices are struggling with these pressures, according to ASCO's 2017 State of Cancer Care in America report released in March.

 Much of that pressure is due to the money being spend on quality-reporting activities, which cost 1000 practices $15.4 billion, according to a 2016 study, ASCO said.

It isn't just the costs of running an oncology practice that physicians and administrators are grappling with. Oncologists are finding themselves chained to their electronic health reporting (EHR) systems and their desks because of copious amounts of administrative work. ASCO reported that 49% of physician time is now dedicated to EHR and administrative activities, whereas time spent with patients represents a mere 27% of a physician's day.

These strains on practice time and finances are making it increasingly harder for practices to survive. “Increasing administrative duties and expenses will continue to challenge practices, especially small independent practices,” said Robin Zon, MD, chair-elect of the ASCO Government Relations Committee, in comments about the annual report. Zon said ASCO remains committed to working with independent oncology practices by providing educational activities and other assistance to help them manage rapidly changing conditions in the sector.

Among physician-owned practices, certain factors constitute significantly greater pressures than they do for other types of providers, including academic and hospital- or health system-owned practices (Figure 1). In 2016, practice and facility expenses, drug expenses, and competitive pressures were powerful stressors for physician-owned practices, the ASCO report said. For hospital-based practices, however, EHR systems and staff- ing issues were the chief problems. And academic centers were more likely to cite facility and practice expenses, staffing issues, and payer pressures. Overall, after facility and practice expenses, drug pricing was the most frequently cited pressure, followed by EHR implementation.

Different types of practices face similar problems but in different proportions.

The ASCO report, now in its fourth year, also discussed many achievements in the war on cancer, such as new drugs and recently approved indications for established therapies. Last year, 5 new drugs and biologic therapies were added to the armamentarium of the more than 200 FDA-approved cancer fighting drugs, ASCO said. In addition, indications were expanded for 13 cancer therapies, and diagnostic tests that included liquid biopsy for lung cancer mutations and next-generation sequencing to identify patients with advanced ovarian cancer who would be eligible for a particular cancer treatment were approved.

Looming challenges to cancer care delivery posed by the rising incidence of cancer and the growing US population were another important element of the report. There are not enough oncologists to go around, the report noted and, although practices are now using advanced practice providers (APPs) to bridge the gap, many nononcologist providers have indicated they feel unprepared to incorporate the needs of patients with cancer into their medical activities.

Many cancer centers that responded to the 2016 ASCO Oncology Practice Census said they were using APPs to perform care functions normally performed by doctors: 334 (75%) of 443 centers. The number of APPs em- ployed by those respondents included 3022 nurse practitioners and 1157 physician assistants. ASCO said it is working to more clearly understand the roles of these supplemental practitioners and plans to submit results of the study for publication sometime this year.

One problem that may add to the difficulty of providing sufficient care is the graying of the oncology workforce (Figure 2). In many states, between 18% and 29% of oncologists are ≥65 years, the report said. This is true throughout the Southwest and the Northeast, but is even more apparent in such states as New York, Montana, New Mexico, and West Virginia.

The graying of oncologists, indicated by darker colors on the above map, creates a more urgent recruitment problem for practices. Source: ASCO.

Oncologists are also more likely to be found in urban centers, the report said. Whereas 19% of the US population lives in rural America, only 6% of oncologists do. “Montana and Oklahoma are the most extreme examples, with each having high levels of rural residents [(44% and 33%, respectively)] and no oncologists with rural practice sites,” ASCO said. ASCO suggested that telehealth may be one answer to the problem of getting care to the regions of the United States that most need access. ASCO said that 46 (27%) of 170 practices surveyed were already using telehealth to provide oncological guidance in remote communities. “Although the survey findings indicated modest use of telehealth in oncology, several participating practices indicated high satisfaction with their programs,” the report said. Telehealth was de ned as encompassing 2-way video, e-mail, smart phones, and wireless tools.

Zon said that telehealth is not the only answer to extending care to underserved communities, although some of the innovative efforts that practices have developed to answer this need are hampered by the same pressures that are afflicting the oncological community in more affluent areas, she said. “Some oncology practices have satellite clinics that provide care in otherwise underserved or rural communities. However, these clinics are under stress, as cost and administrative burdens rise, and some have had to close. We are hopeful that innovative payment models will better support team-based care and other creative solutions that remove access barriers for individuals in rural and underserved areas.”

Women practitioners seem poised to take on a larger role in oncology across the United States, according to the report. Overall, women represented just 32% (n = 3859) of oncologists in 2016, but under the age of 40 they were 46% (n = 739). The majority of pediatric oncologist/hematologists in 2016 were women (52%).

Minorities also remain underrepresented in oncology practice, the report said. Although 18% of the US population is Hispanic, just 5.8% (n = 519) of oncologists are Hispanic. Blacks represent 13% of the US population, but among practicing oncologists, only 2.3% (n = 400).

“The oncology workforce should reflect the underlying population of patients with cancer,” ASCO said, noting that it has established an action plan to improve diversity.

Although genetic testing is becoming a much larger element of practice in targeted medicine, ASCO findings suggest that only a small proportion of oncology practices are employing on-site genetic counselors. The report stated that 29 (24%) of 122 practices surveyed said they have genetic counselors on staff and 67 (55%) provide referrals.

Whereas practices are under many pressures, patient access to care could undergo significant change based on the outcome of the Republican-led effort to replace the Affordable Care Act (ACA), ASCO said. From the act’s inception in 2010 through early 2016, “20 million fewer people were uninsured because of the ACA, and the rate of uninsured Americans dropped to an all-time low of 8.6%,” the report said. “The long-term success of the ACA is uncertain given the motions to repeal and replace.” This year marks the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), which introduces the Oncology Care Model and incentive-based payment systems designed to lower costs and improve quality of care and outcomes, and ASCO remarked that physicians will undergo a period of financial risk and uncertainty related to this rollout. “Although MACRA encourages movement away from fee for service into new payment models and alternative payment models (APMs), the rules for these payment pathways remain poorly defined, and only a limited number of oncology-specific APMs are available for oncologists who want to move to this payment pathway.”

ASCO. The state of cancer care in America, 2017: a report by the American Society of Clinical Oncology. 

Casalino LP, Gans D, Weber R, et al. US physician practices spend more than $15.4 billion annually to report quality measures. 

2016;35(3):401-406. doi: 10.1377/hlthaff.2015.1258

More than half (54%) of practices are struggling with rising costs of equipment and facilities, staffing costs, and administration expenses.

ASCO Says Administrative Burdens Divert Time, Resources From Patients

The rapidly growing use of oral oncolytics has provided a powerful incentive for independent practices to open in-house dispensaries. By dispensing these drugs, physicians can make sure patients are taking their medicine, monitor side effects, and recover some of the revenue no longer coming from chemotherapy, which has become less profitable in recent years. The Community Oncology Alliance (COA) counts at least 820 practices that have in-house dispensaries or pharmacies, many of which were started within the last several years (

This figure shows drug distribution shares, by percentage, of the major channels in oncology. Source: Genentech.

However, the transition to newer agents can lead to a number of challenges, many of them tied to the very high cost of the new generation of therapies. Practices may find themselves carrying more short-term debt while they wait for money from payers. They may also experience financial losses if coverage is denied after drugs are purchased or if medicines are spoiled because of refrigerator malfunctions and other mishaps. In addition, there are the daily battles with pharmacy benefit managers (PBMs), which steer members toward their own specialty pharmacies, reducing practices’ revenue opportunities and complicating oversight of patient compliance with treatment plans.

Careful management of pharmaceutical spending has always been necessary in order for a practice to manage its financial health. However, this has become even more critical now because targeted therapies can be so expensive. When new agents become available, payers may take up to 1 year to integrate them into their systems, leaving pharmacy managers waiting months for reimbursement. “I have seen a smaller practice get into a situation where it had major issues associated with cashflow because of denials or lag times in reimbursements for some of the expensive products that are out there,” said Josh Cox, PharmD, BCPS, director of pharmacy at Dayton Physicians Network, a Dayton, Ohio-based string of 8 oncology centers, and co-chair of the COA Community Oncology Pharmacy Association. “Those problems tend to be on the front side when a new drug is developed. Reimbursement and coverage tend to catch up, and the problem resolves itself.”

Even for established drugs, slow bill processing by payers can compound problems caused by eligibility determinations for expensive therapies, which can end up making denials even more costly, said Jeff Liticker, PharmD, oncology pharmacy manager at University of Texas Southwestern Medical Center in Dallas. “You could be into a treatment 3 or 4 cycles before you find out from the insurance company that you’re missing a piece of information or they’re now going to deny it because a marker wasn’t drawn or a marker didn’t fit with their guidelines,” he said. For example, a physician may obtain authorization to use pembrolizumab (Keytruda) for a patient whose PD-L1 levels satisfy the requirements described in the drug package insert, only to see payment denied because the payer finally reviewed the patient’s test data and found the levels did not meet the payer’s own higher cut point. “The costs can add up very quickly before you realize there is an issue,” Liticker said.

In addition to payer logistics, practices that dispense newer medicines must reckon with the high cost-sharing responsibilities common in commercial insurance policies. Plans that mandate bigger co-pays for today’s more expensive agents demand careful attention to collections and diligent financial counseling. “Years ago, if we didn’t collect the co-pay from some patients, it wasn’t that big a deal. Now, if we’re missing 2 or 3 patient co-pays, that quickly adds up,” Liticker said. However, many patients cannot afford a co-pay of several thousand dollars, forcing conscientious practices to work hard to obtain charitable funds. Christina Patterson, a physician assistant who manages the dispensary at Cancer Care Associates of York in Pennsylvania, said co-pay assistance from foundations seemed to dry up last summer, and money is particularly scarce for patients with certain common cancers. “There are so many men on Zytiga or Xtandi, and prostate funding is very, very low, if it’s even available. You can hardly ever find funding for colorectal cancer,” she said.

Refrigerators Must Be Insured Against Malfunction

When foundations do offer grants, it may take months of calling and resubmitting paperwork before payment arrives, during which time practices are carrying the drug debt. If assistance is ultimately denied, the practice takes a loss. “There have been times in our practice when the deadline to submit claims has been missed and then we are out of luck,” said Lisa Day, pharmacy technician at Ventura County Hematology Oncology Specialists in California. “We appreciate the programs so much and they are such a blessing to our patients in need, but the reimbursement process is not always smooth.” Liticker noted that manufacturers run programs that can help by pressing payers to approve reimbursements and, after denials, giving practices replacement drugs to make up for a loss. But he said that process can also take months and consume substantial staff time as requests move back and forth between multiple parties.

Yet another type of loss amplified by the high cost of newer agents is spoilage, particularly of IV drugs that need to be refrigerated. Installing systems to prevent such losses adds up, as does responding to accidents. Liticker said a refrigerator thermostat once failed at his pharmacy, allowing the drugs to get too cold and forcing sta to quarantine the medicine while they evaluated whether it was usable. A staff member had to spend time conducting an inventory, checking temperature logs to see how long the drugs were too cold, and calling manufacturers for stability data, which was not always available. “First, you’re having to purchase new drugs immediately for the patients coming in that day,” Liticker said. “Second, can you get what was in the refrigerator replaced or do you have an insurance policy that will cover it? Insurance policies are becoming more common for refrigerators and freezers for pharmacies. There are some really unique concerns that we didn’t have before.”

Competition Adds to the Difficulty of Drug Management

Many drugs do not require refrigeration, but nearly all require a temperature-controlled environment that avoids extremes of cold or heat, Cox said. In addition to insurance, his practice has purchased expensive temperature-tracking software and devices that send out real-time alerts when refrigerators malfunction or temperatures in storage areas transgress desired limits, which has occurred a few times, he said. Some practices buy emergency generators. Accidents may be less of a problem at smaller practices because, for the most part, they purchase only preauthorized products, keeping their inventories minimal. Day recently reported having about $80,000 of medications on hand, while her practice spent $5.4 million on oral oncolytics alone last year. Total pharmaceutical spending at Patterson’s office was almost $8 million last year, but she rarely has more than $50,000 of unaccounted drugs on her shelves, she said.

As practices have adapted to the practical requirements of operating pharmacies, they have also struggled with competition from incumbent distributors who are reluctant to share the cancer drug business. Most drug coverage in the United States is managed by a few large PBMs that also own retail or mail-order pharmacies to which they steer business. Day said her practice used to fill prescriptions for members of Tricare, the military coverage program, whose claims were handled by the nation’s largest PBM, Express Scripts. But in 2011, Express Scripts canceled its contract with the practice and pushed patients to switch to Accredo, its own specialty pharmaceutical provider, she said. Caremark, the PBM that owns CVS pharmacies, announced last year that it would no longer allow members to use physician dispensaries, a decision that was reversed after protests by COA and other groups.

Oncology practices are accustomed to making sure patients are taking their meds, adjusting doses as needed, and responding to side effects. The move to targeted therapies has put these goals in conflict with the larger pharmacy industry, which is focused more on delivering drugs efficiently than treating patients. Dispensary staffers complain bitterly about specialty pharmacies that try to monopolize prescription revenues and then fail to serve patients the way they would be by the practice. The staffers say the specialty pharmacies take much longer to fill prescriptions, sometimes fail to fill them, lose track of paperwork, are not assiduous about finding co-pay assistance, do not notify practices when a prescription is not picked up, and are not set up to manage toxicities.

“We’re dealing with a medication class that has some very unique properties, very unique toxicities, and unique monitoring parameters,” Liticker said. “Specialty pharmacies don’t have access to the patient medical record, don’t have ready access to the healthcare team to discuss issues, and often don’t even have access to the patient other than by telephone. When you’re forcing a patient into that scenario, it’s difficult to make a case that they could do it just as well as the clinic could.”

“Our profit margin on oral oncolytics is very, very low for the work we have to do for it. But I will take that low profit margin because clinically it makes sense,” Patterson said. “It’s far more difficult for me to manage a patient who’s getting their drug from a specialty pharmacy. If I can keep it in-house, even though it might only be a 1% to 2% profit margin, I’ll take it, because in the long run, it saves the practice time and money. My staff spends a lot more time on the phone with the specialty pharmacy and the patient making sure the drug got there.”

Oral oncolytics can bring increased revenue to a practice but are inherently difficult to manage because of their high cost.  


New Agents Make Inventory Management More Difficult and Precarious

Recalling the emotional exhaustion of his early months on the job, University of Oklahoma oncology fellow Sarbajit Mukherjee, MBBS, wrote an article exhorting colleagues to acknowledge the issue of burnout among oncology fellows.

"The first and most important step toward solving this problem, as with any other problem, is to acknowledge that it exists," Mukherjee wrote in the 2016 Asco Connection story.

Since the 1970s, when psychologists began publishing research on developing language for occupational burnout, conversation about the phenomenon has grown. Mukherjee's article referenced a study published in 2014 indicating that about 40% of first-year oncology fellows experience burnout.

 The same year, results of another study indicated that 44.7% of practicing oncologists show signs of burnout.

 Citing “a clear need for interventions,” ASCO promised to continue the conversation, primarily by studying and hosting public discussions on the issue.

But while psychologists have identified many of the causes and effects of burnout, practicalities often complicate the process of fighting it at independent oncology practices, said Robin Zon, MD, of Michiana Hematology Oncology in Elkhart and Mishawaka, Indiana, in a recent interview with 

Burnout is often caused by too much work, which can be linked to inadequate staffing, Zon said. Psychologists identify “a persistent imbalance of demands over resources” as a perennial cause of burnout, as a 2008 research paper put it.

Demand for oncology services is growing. In 2016 an estimated 1.7 million new cases of cancer were diagnosed, up 2% from 2015, according to ASCO. Cancer was the leading cause of death in 22 states in 2016 and is projected to overtake cardiovascular disease as the leading cause of death by 2020, ASCO said.

“There will be a deficit of oncologists and a surplus of patients. Burnout is part of that whole formula and needs to be paid attention to,” Zon said. Burnout is also often associated with nonproductive work, such as “administrative burden, authorizations, pre-authorizations, notes,” said Linda Bosserman, MD, a medical oncologist at City of Hope in Rancho Cucamonga, California, speaking to 

“There’s a potential for increased burnout because of increased regulations. Doctors are starting to do more and more secretarial work just to prove that we’re quality doctors. On top of that, we’re looking at an increased number of cancer patients and survivors, and now we’re dealing with a workforce shortage,” Zon said. “It’s a real concern, because if you’re looking at a shortage already, and doctors are going to have to work harder, what are you going to do?”

What practices can do depends upon the resources available to them, Zon said. Practices can support mitigating strategies such as self-care and an understanding atmosphere regardless of size, but those tactics address burnout’s effects, not its causes.

Larger practices can hire more support staff to take on administrative work, giving oncologists more freedom to focus on patient care, Zon said. If they can afford it, individual oncologists can also try hiring scribes, as she and others at her practice have done.

Overall, “the cultural changes needed to fight burnout are multifaceted. Does a practice have the resources to support the delegation of tasks? Your resources are becoming leaner and leaner, so how are you going to have the resources to hire more people if your reimbursement is going down?” Zon asked. Florida Cancer Specialists & Research Institute, a large network of community practices spread across Florida, has been able to take some of the pressure off its physicians by delegating responsibility for nondoctoring tasks, CEO Bradley Prechtl, MBA, said. For example, he makes a point to hire reimbursement specialists who know the ins and outs of negotiating on drug pricing. Prechtl said he deems this particularly important, considering that drugs are both the biggest expense and the biggest source of revenue for most practices. Prechtl acknowledged that such hires are more difficult at small practices.

This kind of delegation helps put and keep specialists where they’re needed, which improves the bottom line at Florida Cancer Specialists & Research Institute, Prechtl said. “A small practice would have to be negotiating on drug pricing, which is something that’s highly complex and changes literally daily,” Prechtl said. “Keeping up with all of those contracts is highly complex. You might be managing upward of 80 different contracts, each which can be different by drug.”

“You have to have somebody ... who knows the clinical aspects of the business, but you also have to have somebody who’s very savvy from a business standpoint, because you’re constantly having to ask whether you’re going to be reimbursed,” Prechtl said.

At Florida Cancer Specialists & Research Institute, “we take away a lot of that work” from oncologists,” Prechtl said. An administrative team handles the interaction with commercial payers and contract negotiation. Oncologists don’t have to deal with compliance issues, billing and collecting, or researching the newest drugs, either—administrators take care of all of that. At smaller practices that self-manage, paperwork related to federally mandated reporting piles up next to the paperwork that goes into running a business, Prechtl said. He said that handling turnover, workers’ compensation, and daily staffing needs can exhaust a practice without a human resources department to manage those issues.

“It’s overwhelming, the amount of work that a physician or a few physicians at a small practice have to take on administratively,” Prechtl said. At Zon’s practice, oncologists regularly work 12-hour days, followed by meetings and paperwork. Hiring scribes has helped ease the burden somewhat, but some documentation requires specific medical expertise to complete, she said.

Having a robust electronic medical records (EMR) system can help with that, Prechtl said. His practice doesn’t use scribes, although it does employ nurse practitioners and physician assistants who help with documentation. ONCO-EMR, which Florida Cancer Specialists & Research InstituteS helped develop, is “very efficient at documentation,” Prechtl said.

This is a big plus not only for a practice’s existing oncologist staff but also for its ability to attract new hires, Bosserman said. “Whoever develops more supportive electronic medical records and more supportive methodologies will be able to hire the best people,” Bosserman told 

 in 2015. “That’s what they go to work to do—perform high-level analytics, and then assess and educate patients and engage them in the best healthcare for their needs.”

Retaining employees is important from a business standpoint, said Prechtl, who holds accounting and finance degrees. He estimates that it costs Florida Cancer Specialists & Research Institute about $8000 to replace an employee—and that’s an administrator, not a physician.“I think oncology is a very difficult specialty,” Prechtl said. “You’re going to win battles, but you’re going to lose some as well, and when you don’t cure a patient, it takes a toll on the physician.”

Burnout research has stimulated research on job stress, particularly in the “helping” professions, psychologists wrote in a 2008 paper summarizing 35 years of burnout research.

 Stress can lead to burn- out, and many of the “helping” professions are both high-stress and high-stakes.

What’s more, many healthcare providers gravitate toward the profession with an intrinsically high level of dedication. When researchers looked at burnout in the 1960s, they found that “frustrated idealism was a defining quality of the burnout experience.”

 Long hours, excessive work, and frustration with limited treatment success can lead to oncologists burning out, and frustration with the effects of burnout can worsen the condition.

Frustrated idealism “was critical to the concept’s momentum: service providers were appalled at their diminished capacity to perform or to show compassion towards their recipients,” the psychologists wrote. “The experience of burnout was not merely an inconvenience or an occupational hazard, but a devastating attack on their professional identity.”

The main symptoms of burnout are depersonalization, emotional exhaustion, and decreased personal accomplishment. In oncology, these symptoms can have deleterious effects on a practice.

“One of my biggest concerns with burnout is the depersonalization. The patient’s not happy because the doctor’s not communicating as well, and it just kind of snowballs,” Zon said.

So how to combat this process? Mukherjee, the oncology fellow, suggested that training in palliative care and end-of-life discussion could do a great deal of good in “empowering [oncologists] with essential communication and self-care skills.” Adequate vacation and rest time could also help, he said, though Zon warned that on its own, this could amount to “putting a Band-Aid on it.”

Zon and Mukherjee both spoke of the benefits of having a supportive staff network. “If somebody is for whatever reason having a really tough time, they need to know it’s not shameful and it’s recognized as a concern,” Zon said. “We show all this empathy to our patients. We need to show this empathy to each other and ourselves.”

Part of practicing that self-compassion is allowing yourself to grieve when a patient dies, Laurie Lyckholm, MD, said in a 

 Lyckholm is a professor of hematology/ oncology in the department of internal Medicine at Carver College of Medicine in Iowa and a Giants of Cancer Care

“You need closure. You should grieve in your own private way, and it helps to grieve with the family,” Lyckholm wrote. “Few physicians deal with death and grieving as often as oncologists.”

Jimmie C. Holland, MD, the Wayne E. Chapman Chair of Psychiatric Oncology at Memorial Sloan Kettering (MSK) Cancer Center in New York, New York, offered similar advice in the article. “In terms of your own survival, it is important to recognize that the death of some patients can affect you much more deeply than others,” she wrote. “You can often recognize a resemblance in appearance or age or temperament of the patient that reminded you of someone in your past, and you can see why the death affects you so much more deeply.”

Writing of ways to combat burnout on the ASCO blog in 2011, oncology physician assistant Heather Marie Hylton, PA-C, of MSK in New York, New York, opined that “the visibility of the impact of cancer on our patients, their families and friends” takes a toll on providers. ”If we do not take care of ourselves, renew ourselves, it will be exceedingly difficult to care for our patients.”

Some of the tactics Hylton uses are talking about stressful situations with colleagues, sleeping and eating well, exercising, recording her thoughts, and keeping her life dynamic.

She also wrote that she likes to remember Lyckholm’s words: “Remember how much value there is in what you do, and how much you are valued. Every day, you directly and indirectly affect ... hundreds of people’s lives.”

Mukherjee S. Burnout among oncology fellows: a personal perspective. 

 2016. https://connection.asco.org/magazine/career/burnout- among-oncology-fellows-personal-perspective. Accessed February 22, 2017.

Shanafelt TD, Raymond M, Horn L, et al. Oncology fellows’ career plans, expectations, and well-being: do fellows know what they are getting into? 

 2014;32(27):2991-2997. doi:10.1200/JCO.2014.56.2827. February 22, 2017.

Shanafelt TD, Gradishar WJ, Kosty M, et al. Burnout and career satisfaction among US oncologists. 

 2014;32(7):678-686. doi:10.1200/JCO.2013.51.8480. February 22, 2017.

ASCO takes initial steps in developing interventions to improve physician wellness. ASCO. 2015. http://am.asco.org/asco-takes-initial-steps- developing-interventions-improve-physician-wellness. February 22, 2017.

Schaufeli W, Leiter M, Maslach C. Burnout: 35 years of research and practice. Career Development International. 2008;14(3):204-220. http:// www.wilmarschaufeli.nl/publications/Schaufeli/311.pdf. February 22, 2017.

 doi: 10.1200/JOP.2016.020743. Accessed February 22, 2017.

Hagen T. ASCO takes initial steps in developing interventions to improve physician wellness. 

. 2015. http://www. onclive.com/publications/oncology-business-news/2015/august-2015/ scribe-value-in-easing-burnout-is-an-ongoing-debate. February 22, 2017.

Managing stress and burnout in oncology. 

 2006;2(3):130- 131. http://ascopubs.org/doi/pdf/10.1200/jop.2006.2.3.130. February 27, 2017.

2011. http://connection. asco.org/blogs/renewal. Accessed February 22, 2017.

Results of a study indicate that 44.7% of practicing oncologists show signs of burnout.

Don't Let Physician Burnout Threaten Your Practice's Health

The practice of medicine has undergone innumerable changes since Barbara McAneny, MD, graduated from medical school 40 years ago. Diagnostics have improved, treatments have improved, and patients are living longer. But not all the changes have been positive. Regulations have proliferated, treatment costs have skyrocketed, and the control of medical decision making has largely shifted from doctors to hospital administrators and insurance companies.

Many doctors complain about such trends, but McAneny hopes she can help fix American healthcare’s shortcomings while also promoting its strengths, which is why she’s running for president of the American Medical Association (AMA).

McAneny has donated countless hours to various medical associations over the decades, honing her understanding of how they can get things done while working to limit public health hazards such as second-hand smoke. She has also succeeded in making her practice, New Mexico Cancer Center, demonstrate the feasibility of what many people believe to be the future of American healthcare: outcome-based compensation that improves patient health, reduces total healthcare costs, and provides fair compensation for physicians and nurses.

McAneny developed the Community Oncology Medical Home (COME HOME) practice model, implemented it at New Mexico Cancer Center, and helped to implement it at 6 other practices across the country. The program has generated several years’ worth of data indicating that the model improves outcomes and reduces total expenditures.

“Many physicians are skeptical about any transition to outcome-based payments. They worry that payers will pocket any savings from reduced hospitalizations while putting them on the hook for unexpected and unavoidably high costs. I understand that fear, but the pilot projects have shown such cost reductions and such health improvements that payers have a huge incentive to strike fair deals,” said McAneny, who is running against Stephen R. Permut, MD, JD, a family physician from Delaware.

The vote will be cast by the AMA’s House of Delegates during an annual meeting in Chicago, which will take place June 10 to 14. Permut is endorsed by groups such as the American Academy of Family Physicians and the American College of Physicians.

McAneny has strong support from ASCO and the American Society of Hematology.

“If compensation is fair, then outcome-based payment is great for physicians and patients alike,” McAneny said. “The current system forces medical practices to waste a huge amount of time and effort documenting services and requesting payment. It also pays nothing for many services that clearly help patients, things like telephone consultations or Barbara responding to patient e-mails. With outcome-based payments, practices don’t have to justify everything they do. The system automatically rewards physicians for providing any service that helps patient health and discourages them from providing any service that doesn’t. And that’s really what basically everyone should want.”

Analyses of trial programs funded after the ACA’s passage have concluded that most experiments using these basic ingredients simultaneously improve outcomes while reducing costs. One analysis of 7 oncology practices that adopted McAneny’s COME HOME blueprint reported a reduction of 10 ED visits and 3 hospitalizations per 1000 patients per quarter and a savings of $673 per patient per quarter.

Hospitals will likely fight the adoption of such programs for fear of reduced utilization of both ED and in-patient facilities, said McAneny, but she believes the AMA should still push to speed up the transition because it will be good for patients and physicians.

“Any substantial reform to an industry that represents a sixth of the nation’s entire economy will always be very difficult. Savings for 1 group of people represents lost livelihoods to another group of people,” McAneny said. “Outcome-based payment will almost become the norm at some point, though, because the nation simply doesn’t have the money to keep paying more for the same quality of care.”

McAneny also believes the AMA should do more to make use of another factor that could shift payment away from hospitals and toward physicians in private practice: site-of-service compensation differentials.

Hospitals in many markets have negotiated significantly higher payment rates for many types of diagnoses and treatments. This extra money, McAneny said, has allowed those hospitals to increase their lobbying power, upgrade their facilities in ways that independent physicians cannot afford, and pay physicians more than they can make in private practices that receive lower payments for the same work.

However, the discrepancy in payment rates is now so great that third-party payers have a strong incentive to encourage patients to use independent medical practices for any work that can safely be done outside of hospitals. Some payers have already begun to act upon this incentive, but McAneny believes the AMA can encourage the trend by working with the payers them- selves as well as legislators and regulators.

Even if hospitals responded by giving payers better deals, McAneny thinks that independent practices ultimately would have a cost advantage. Such practices may lack the economies of scale that major hospital chains enjoy, but they have lower fixed costs, less internal red tape, and none of the administrative bloat that comes with having hundreds of employees.

A shift away from hospital-based treatment would likely decrease the number of physician employees at America’s hospitals and increase the demand for partners at the nation’s independent practices—and McAneny believes such a transition would bene t both patients, whose treatment would be guided by their MDs rather than hospital MBAs, and physicians, who would regain lost autonomy. The shift could also lower total costs and benefit third-party payers and the taxpayers and policyholders who ultimately bear medical costs.

“Over the course of my career, hospitals have bought up a huge number of medical practices and transformed physicians into employees whose medical decisions must conform with corporate policy,” said McAneny, who was once told by a dominant payer and provider in Albuquerque to choose between accepting a buyout o er and being put out of business. “The increased market share has been good for hospitals, but it hasn’t been good for anyone else.”

McAneny was born in Kansas City and raised in southern Illinois. Her father was a physicist, her mother was a mathematician, and she was a math major as an undergraduate at the University of Minnesota. She did not become interested in medicine until her junior year of college, when she realized that she didn’t want to teach math, work as an actuary, or pursue any other career associated with her major. A friend suggested medical school, and McAneny took to the idea.

She decided to specialize in treating patients with cancer after working her way through rotations in various specialties during her third year of medical school, and she chose clinical practice over research during her years as a resident, when she often made up excuses to see patients rather than write papers. “My involvement with medical associations started when I was complaining to a colleague in a hospital cafeteria that a product like tobacco—1 that kills people when used as instructed&mdash;was entirely legal. A third doctor overhead me and asked whether I intended simply to complain or whether I intended to do something about it. I asked what a single doctor could possibly do. He said I could join him in the state medical society,” McAneny recalled.

“A few weeks later, I was on the society’s public health committee, working to ban smoking in public buildings 1 city at a time with clean indoor air acts. It took 10 years to get the entire state on board, but we did it, and that success taught me that physicians really can shape health-related issues when they band together and speak with 1 voice.” McAneny believes there are many areas where the AMA can use that power to improve healthcare for both physicians and their patients.

She said the AMA should push for reforms that allow physicians like her to spend more time with patients and less time filling out paperwork and jumping through bureaucratic hoops. She acknowledged the benefits of some regulations that have been implemented during her years in practice, but believes that the vast majority of them actually reduce the quality of care that patients receive.

She hopes President Donald Trump’s administration, which has spoken strongly and repeatedly about the need to reduce regulation in nearly all facets of American life, will work with the AMA to lower the regulatory burden that many physicians feel has transformed them from caregivers to form fillers. On other issues, such as the first Republican proposal for modifying the Affordable Care Act, McAneny believes the AMA is correct to oppose the Trump administration on grounds that the proposal would greatly reduce the number of Americans covered by health insurance.

“The AMA has typically worked for or against particular pieces of legislation or regulation rather than giving blanket support or resistance to individuals,” McAneny said, “and I think that’s wise.”

Barbara McAneny, MD, hopes she can help fix American healthcare’s shortcomings while also promoting its strengths by running for president of the American Medical Association (AMA).

Oncology Value Reformer Seeks AMA Post

When it comes to achievements in the war against cancer, there’s much to celebrate, ASCO said in its fourth annual report on the state of cancer care in America, which we discuss in our lead story this month for Oncology Business Management

. For one thing, in recent months, there have been several drug approvals, new indications granted for established drugs, and go-aheads for liquid biopsy testing and next-generation sequencing. All of this gives physicians a broader armamentarium for fighting cancer. More patients than ever before are winning their personal struggles with cancer thanks to advancements in medicine.

However, there is still room for improvement, ASCO noted. There are fewer oncologists to treat rural patients than urban ones, information blocking is preventing useful information from being shared among research organizations that need data to achieve cancer discoveries and improve patient care, and physicians are spending too much time in front of their computers and not enough time working directly with patients, ASCO explained. Read about it on page 10.

The great deal of time that physicians spend behind their computers, as a proportion of their total workday, has long been acknowledged as depriving patients of quality time with providers and contributing to physician burnout. It is also acknowledged that overstressed physicians may deliver lower quality care to their patients. One of the victims of this problem is the oncology practice itself, writer Emily Brill explains in this month’s story on physician overload. Brill’s story discusses some of the strategies that busy oncology practices have employed to keep physician burnout at bay. Read about it on page 12.

Our practice profile this month looks at a group of practitioners in southeastern Pennsylvania, where independent urologists are increasingly targeted by hospital recruiters as the consolidation trend continues. The focus of the profile, Lancaster Urology, is holding its own against the competition. The practice is proud of its clinical trials access, steady growth, unique clinical programs, and innovation. This story is on page 40.

There’s much more in this month’s issue—from a story on immuno-oncology drug inventory financing to status reports on CMS’ value-based program for improving out- comes and lowering costs. Don’t miss any of it!

When it comes to achievements in the war against cancer, there’s much to celebrate, ASCO said in its fourth annual report on the state of cancer care in America, which we discuss in our lead story this month for Oncology Business ManagementTM.

April 2017 | Oncology Business News®