Just over a week before CMS revealed some of its thinking on the future of oncology value-based care,1 oncologists and others who crowded into a Nashville, Tennessee, ballroom at the end of October shared their thoughts, successes, and frustrations regarding the current Oncology Care Model (OCM).

At certain points during the latest installment of the Institute for Value-Based Medicine®, an initiative of 

, it was hard to tell if the physicians and healthcare executives were thinking about January 2020 or January 2021. Next month, oncology practices participating in the OCM must

decide whether to accept 2-sided risk. Come January 2021, CMS plans to start Oncology Care First (OCF), the successor to OCM; on November 1, it released a request for information (see 

“It sounds scary, but I hope you leave tonight inspired, because I think we’re ahead of the game on this,” said Stephen M. Schleicher, MD, MBA, cochair of the meeting, an oncologist at Tennessee Oncology, and chair of the Quality and Value Committee of OneOncology, a network of community oncology practices. According to Schleicher, the oncology community should focus on 3 steps:

• Understanding the models in-depth because value-based care (VBC) is here to stay.

• Educating payers on how to improve their models to make sure that cost control does not come at the expense of patients.

• Optimizing care coordination to prevent avoidable emergency department (ED) visits and hospitalizations, facilitate end-of-life care planning, and avoid unnecessary tests and pharmaceutical use.

“Think before that PET [positron emission tomography] scan if you need it, think before that expensive drug, if we have a biosimilar instead,” he said, offering up  examples.

Darin Gordon, who is widely credited with turning around TennCare, the state’s $10.5 billion Medicaid managed care program, described how it took him a few years to “lean into” the idea of VBC and value-based purchasing (VBP).

As part of his presentation, he reviewed a VBP framework, created by the Health Care Payment Learning & Action Network, which created a pathway for describing alternative payment models. The 4 classifications include category 1, fee for service (FFS); 2, FFS and a link to quality and value; 3, alternative payment models built on an FFS architecture; and 4, population-based payment.

Gordon said that even after he “fully embraced” VBP, he had to again change his thinking. “I’ll just say this: As a self-diagnosed value-based purchasing zealot…where I literally thought we should buy light bulbs on a value-based purchasing agreement, after going through it, you discover there is a lot of stuff that valuebased

At the same time, he said, “there’s a big belief in the industry that we don’t arrive [to VBP] until we get everyone to category 4. I don’t think that’s right, either.”

Although the categories may seem like a continuum, with some organizations falling into category 2 or 3 because it works best for them, the only thing you won’t find, he said, is anyone defending FFS. There is plenty of evidence that FFS does not work, even if the evidence on VBP is not yet conclusive.

Instead, fueled by rising healthcare costs, there is an overwhelming sense from payers that “we have to try something different,” he said. Oncology is spread among all 4 categories—commercial, Medicare, Medicaid, and the exchanges.

In Tennessee, Gordon said he saw wide variability in cost from provider to provider, a diff erence of as much as 3 to 6 times that couldn’t be explained.

“We needed more tools to incentivize quality improvement,” he said. However, he said, he didn’t want to tell doctors what to do or how to do it: “I wanted to…create a dynamic [in which] the provider could start asking diff erent questions, should be asking diff erent questions.”

At the time, Vanderbilt University had a tool to connect patients to doctors via text. Although they didn’t get reimbursed for it, the institution was large enough to absorb the cost, according to Gordon. At that point, he said, he realized he could use the state’s Medicaid program to change reimbursement for physicians who had already told him, “We know what we need to do for patients, and we also know we won’t get paid for doing those things.” 

“That was a big driving force for this,” he said.

Gordon addressed some advocacy groups’ concern that VBP agreements can be used to restrict access to certain treatments: “Actually, it’s just creating diff erent questions that the providers themselves—that clinician&mdash;[will] ask themselves in ensuring that they have the best possible outcome for that member.”

When VBP functions at its highest level—when payers, providers, and patients work together to improve health&mdash;he said, “quite frankly, a lot of discussions about prior authorizations are meaningless.” He added, “I don’t care as much, because you’re fully at risk.”

Although Gordon said he believes that VBP will remain firmly on landscape, Michael Kolodziej, MD, FACP, vice president and chief innovation offi cer at ADVI Health, was decidedly less upbeat. “I’m going to disagree with just about everything you just said,”he told Gordon, then said commercial payers look at oncology practices the same way Willie Sutton looked at banks: “That is where the money is.”

“How did we get into this mess?” Kolodziej asked. “The cost of taking care of cancer patients in the [United States] has exploded largely as a consequence of the cost of drugs that have brought great value for our patients but at a signifi cant price, and the rate of the trend so far exceeds the average person’s income that nearly everybody says [it is] unsustainable,” he said, launching into a review of the first alternative payment models in oncology. 

When Kolodziej was in charge of oncology strategies at Aetna, he participated in the OCM when it launched. “As a care delivery model, the OCM is awesome, but Medicare did not go into this to improve the quality of cancer care. They went into this to save money,” he said. “The payment is based on this goofy methodology that they developed, and I think anybody who spent time thinking about this recognizes that the model is way too complicated, just way too complicated.”

So, after 4 performance periods, what have oncologists learned? There are problems with various parts of the model, Kolodziej said, which has been adjusted several times. Yet, even as savings increased, in his view, 90% of the participating oncology practices have no idea why they generated savings. “This model does not fix their pain,” he said, because it does not address the cost of drugs.

When he was at Aetna in a partnership with Texas Oncology, using the ClearPlus pathway saved 20% of the cost of care. He attributed that to the use of pathways, not Aetna’s medical home. He also challenged the notion that payers consist only of health insurance plans. The employers are the payers, he said, and they are complaining loudly to health plans.

“We have a long history [over the past] 20 years of paying too much for stuff that doesn’t work. We got some stuff now that works. That makes it really challenging,” he said, citing study findings that showed no link between the marginal added benefit of new drugs and the launch price.

Referring back to the next iteration of the next oncology care model to come out of the Center for Medicare and Medicaid Innovation, Kolodziej was pessimistic: “I think that they cannot have a care model in which 85% of oncologists in the [United States] cannot participate, and that’s what OCM is right now.” Alternative payment models are not cutting it, he said.

Hearkening back to the idea of using new tools to drive improvement, Robert Daly, MD, MBA, of Memorial Sloan Kettering Cancer Center (MSKCC), explained how the center uses predictive data analytics to improve care for patients by meeting CMS quality measures for avoiding preventable hospitalization due to 9 conditions: neutropenia, fever, pain, dehydration, anemia, pneumonia, sepsis, nausea, and diarrhea.

With proactive care and increased communication, these can be managed in outpatients, he said. 

Why is this an issue? Patients on active treatment have 1 hospital admission and 2 ED visits per year; about 50% of those ED visits and 40% of the admissions

are related to treatment toxicities, for 3 main reasons, Daly said:

• Patients are not being equipped to manage adverse eff ects at home.

• Patients assume little can be done to help them and don’t seek care until symptoms worsen.

• Communication varies between the patient and the clinician.

“As anyone who has treated cancer patients knows, they’re not just coming in with 1 symptom—they’re coming in with clusters of symptoms, “ Daly said.

Daly said the MSKCC pilot study was inspired by the work of Ethan Basch, MD, MSc, on the effect of patient-reported outcomes (PROs) on survival and quality of life. The 2017 study found that proactive self-management resulted in better outcomes for patients compared with standard of care, including a 30% improvement in quality of life, 7% fewer ED visits, and 5 months’ longer survival.

The pilot project, called InSight Care, combines PROs with data and proactive care and case management to prevent hospitalizations and ED visits, keeping the patient “in sight” of the provider 24/7 through the use of digital technologies. Data analytics identifi es the highest-risk patients—the 25% of new antineoplastic patients

most at risk of arriving at MSKCC’s urgent care center. The risk model helps providers stratify patients to identify who is at high risk of a potentially preventable visit within the fi rst 6 months.

The model combines data from the electronic health record, including laboratory tests, home medications, comorbidities, and psychosocial data, to create a risk score. Doctors can add patients to the high-risk group using an override feature. In addition, Daly said, the interface that the patient sees is designed to lower barriers to patients’ completion of assessments. The questions have binary answers (yes or no), and the patient can give more details and use an avatar to provide a visual description of symptom location. The MSKCC staff can tell instantly tell if the alerts are mild, moderate, or severe. If necessary, the team can see the patient through a specialized video portal, instead of making the person drive into New York City from the suburbs.

As the pilot nears the 1-year mark, Daly said, the results show an eff ect, with a 59% reduction of high-risk patients visiting the urgent care center. Within the program’s first 30 days, there was a 60% adherence rate of completing assessments; for patients being treated for more than 3 months, a 50% adherence rate.

“That means we’re getting the symptom data from patients every other day on active treatment. That really helps to take better care of them,” Daly said.

Patients love the system, he said, because they know a member of the care team will get back to them within minutes. “They feel that they’re never alone, that there’s this team that is responding to them and helping to get them through their treatment. And they like the remote consultation,” Daly said. Oncologists like the system because they know that their patients are being taken care of while they are busy in the clinic, he added.

Some of the issues that have arisen include trust, Daly said. “This is an extension of the primary team working with the primary oncology teams to manage those symptoms,” he said. “How do we build trust with the primary oncology teams so that they feel those symptoms are being managed in a way that they would want them

In addition, MSKCC initially hired clinicians with experience in palliative, supportive, and symptom care for the project, but as time went, it became clear that patients prefer someone with disease-specific experience.

Of note, when CMS held a listening session November 4 about the OCF model, officials announced that electronic PROs will be required to participate.

1. Innovation Center. Public listening session: informal RFI on Oncology Care First model. CMS website. innovation.cms.gov/resources/oncology-listening-session.html. Updated November 14, 2019. Accessed November 20, 2019.

2. What is the Health Care Payment Learning & Action Network? Health Care Payment Learning and Action Network website. hcp-lan.org/.Accessed November 21, 2019.

3. Prasad V. Do cancer drugs improve survival or quality of life? BMJ. 2017;359:j4528. doi:10.1136/bmj.j4528.

4. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318(2):187-198. doi: 10.1001/jama.2017.7156.

Articles

Evidence-Based Oncology

Coverage from the Institute for Value-Based Medicine® session held in Nashville, Tennessee.

Hope and Some Skepticism Whether Oncology Payment Models Will Work

As CMS prepares to move forward with new models of value-based cancer care, a radiation oncologist, speaking at the Institute for Value-Based Medicine®, an initiative of 

, discussed her findings regarding whether accountable care models had an effect on cancer care spending.

Miranda Lam, MD, MBA, presented a 2018 study

 looking at Medicare accountable care organizations (ACOs) for patients with cancer; Lam, of  Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, said the results, which found an $11 difference per beneficiary, indicate models created for primary care may not be applicable for oncology purposes.

Lam examined national Medicare claims from 2011 to 2015; practices that became part of ACOs were identified and matched to non-ACO practices within the same region. She and her coauthors looked at whether the introduction of ACOs led to lower overall spending, lower spending by service type, and spending on cancer-specific services (radiation therapy, chemotherapy, hospitalizations, emergency departments, and hospice).

A difference-in-difference analysis showed that the introduction of ACOs had no meaningful impact on overall spending (-$308 per beneficiary in ACOs vs -$319 in non-ACOs; difference, $11; 95% CI, -$275 to $297; 

Within the 11 different cancer types examined, there was no change in total spending. And changes in spending and utilization did not meaningfully differ between ACO and non-ACO patients within cancer-specific categories. 

Lam used the study as a prelude to her thoughts about CMS’ Radiation Oncology (RO) Model, which CMS proposed in July. Unlike the ACOs she studied, participation in the 2-sided risk model will be mandatory and, as of this writing, is slated to begin January 1, 2020.

 Currently, the plan proposes to randomize 40% of radiation providers and hospitals into the mandatory model, based on zip code. 

There are some other differences between this model and previous bundle-type models as well. For instance, the  payments will be site neutral between freestanding and hospital outpatient departments, and payments will be prospective (payment will be up front once an episode begins, for 90-day episodes of care) rather than retrospective. 

The 2-sided risk model will be risk-adjusted and differ by geographic location, for 17 types of cancer. Three percent of the payments will be earned based on patient satisfaction and quality measures, which will include a care plan for pain, depression screening and a follow-up plan, an advanced care plan, and a treatment summary communication.

Lam acknowledged why CMS was taking the road of mandatory participation, saying “we might even benefit from having an initial sort of voluntary pilot phase to work out the some of the kinks.” But, Lam said, she knew that so few providers and practices join voluntary models.

In addition, CMS wants quality metrics, which some radiation oncologists might hesitate to supply. But Lam said this is not only CMS’ fault, “This is also on us as a field, in that we don’t have great quality metrics.” 

“I think quality metrics in oncology are difficult—and definitely in radiation oncology, we often don't have [them]. We use process measures or structural measures [as] their surrogates for actual quality measures. The things that probably people care about are really hard to measure&mdash;local control, overall survival, those take time,” Lam said, adding that “they don't fit into that bundle as well.”

In addition, she said she “worries a little bit about potential skimping on care, certain areas where you may not get paid more for something that’s much more resource intensive, but maybe better for the patient.”

Another area of concern: innovation and clinical trials, which are not included in bundling, with the exception of  trials funded by the National Institutes of Health. And, she noted, “Our field is really based in technology,” saying that during the past “decade or two radiation oncology has really made great strides in changing the way we deliver care that I think is really good for patients.”

There are other worries as well: the risk that without adjustments, that the bundles might widen disparities, which are already known to affect cancer care and outcomes more broadly. The other is that bundled payment would not work in palliative care, where the 90-day timeframe might disincentivize a provider from treating some patients. 

Lastly, she said, not all cancers are the same, even if they seem to be. Yet as she understood the model as proposed, CMS would pay one price for treating lung cancer.  “What does it mean to treat lung cancer? Does that mean stage I lung cancer, or someone who is stage III or IV, or someone whose lung cancer has metastasized to the bone?”

However, she said, “I think many of us agree that the way we pay for healthcare is not sustainable,” adding that she hopes CMS listens to stakeholders who have provided feedback about the RO model.

Lam MB, Figueroa JF, Zheng J, Orav EJ, Jha AK. Spending among patients with cancer in the first 2 years of accountable care organization participation. 

. 2018;36(29):2955-2960. doi: 10.1200/JCO.18.00270. 

Innovation Center. Radiation Oncology Model. CMS website. innovation.cms.gov/initiatives/radiation-oncology-model/

. Updated August 7, 2019. Accessed November 20, 2019.

As CMS prepares to move forward with new models of value-based cancer care, a radiation oncologist, speaking at the Institute for Value-Based Medicine®, discussed her findings regarding whether accountable care models had an effect on cancer care spending.

Radiation Oncologist Discusses Concerns With Incoming CMS Payment Model

The 2019 Medicare Trustees report forecasts insolvency of the Hospital Insurance Trust Fund in 2026, sooner than prior projections.

 A significant contributor to this unsustainable healthcare cost curve for Medicare beneficiaries is cancer-related spending.

 To address this challenge, Medicare is engaging oncologists through new, value-based programs to identify ways to reduce inefficiency and unwarranted variation in spending.

On November 1, 2019, CMS released an informal request for information (RFI) on Oncology Care First (OCF), the highly anticipated successor to the current Oncology Care Model (OCM), which sunsets in 2021. The RFI, which solicits feedback through the extended deadline of December 13, 2019, is an important step in the development of successful models with robust engagement.

OCF is built on the same framework as other recently announced Medicare “First” models, including Primary Care First

 These models off er prospective payments for providing enhanced care services to an aligned patient population and hold provider participants accountable for quality and cost through retrospective performance-based payments (PBPs). The OCF RFI retains many of the favorable facets of the OCM program, including its voluntary status, the opportunity for oncologists to earn additional revenue by reducing expenditures for 6-month episodes of care for Medicare benefi ciaries undergoing chemotherapy, and its qualifi cation as an advanced alternative payment model (APM) under the Quality Payment Program, created by the 2015 Medicare Access and CHIP Reauthorization Act (MACRA).

The second-generation oncology bundled payment model also strives to improve key aspects of the original program that unintentionally created disincentives for providers. One notable change is a potential revision to how CMS adjusts for new, high-cost drugs. In OCM, one of the only Medicare risk models holding participants accountable for Part D drug expenditures, the novel therapies adjustment is applied at the participant level across all cancer types in aggregate. Because novel therapies are not consistently or uniformly available among diff erent cancer types, the single novel therapy adjustment has created advantages and disadvantages for OCM participants at the practice level because of variation in the mix of cancer types among peer practices and within a singular practice over time. CMS’ consideration in OCF to apply the novel therapy adjustment separately for each cancer type would improve this misalignment. Similarly, a trend factor applied separately by cancer type would remove unfair rewards or penalties that result from variation in patient mix, both internally over time and compared with other groups.

Archway Health’s analysis of 20 OCM practices suggests that to successfully use cancer-specifi c trend factors and novel therapies adjustments, covariates in the model need to be better calibrated. For example, attributes such as radiation therapy or lung cancer are too strongly correlated with PBPs instead of price, pointing to a fl aw in the OCM model. We expect that running a separate regression for each cancer type, similar to how CMS runs a separate regression for each episode of care in the Bundled Payment for Care Improvement (BPCI) Advanced program, will better calibrate covariates.

In OCF, CMS also proposes to improve the alignment methodology for the prospective monthly management payments. In OCM, Monthly Enhanced Oncology Services payments are not available for patients receiving only hormonal therapy when no evaluation and management visit occurs within the 6-month episode period, which led to attribution-related frustration among participants early in the model. In OCF, aligned benefi ciaries covered in the Monthly Population Payments (MPPs) include patients undergoing hormonal therapy only, as well as those under active surveillance or survivors of cancer undergoing care management from their oncologist.

CMS is also changing its approach to getting providers to take risk in OCF. The potential model would have 3 risk tracks that allow providers to pick their pace of assuming risk. Two of these tracks would force downside risk onto current OCM participants immediately, and the third would allow new providers to stay in an upside-only arrangement for 2 performance periods. This contrasts with OCM, in which participants originally could stay in the upside-only arrangement indefi nitely. After the program launched, CMS amended the program and required practices to earn a PBP to stay in the upside-only track. In December 2019, OCM practices that have yet to earn a PBP will be required to switch to the 2-sided risk track or be forced to drop from the program. The OCF RFI indicates that CMS is pushing providers

toward assuming downside risk and also recognizing that some organizations need to get their bearings fi rst in a new program before being held accountable.

Although the OCF RFI incorporates learnings from OCM, it does not seem to take into account the social determinants of health (SDOH), a critical consideration for any care management model and today’s healthcare environment. Social determinants, including access to transportation and healthcare services, aff ect a wide range of health outcomes and risks.

 As an example, oncologists treating patients who live in rural areas may face greater barriers to having patients attend visits and appointments than providers treating patients in areas with more transportation options and less burdensome commutes. Greater consideration for SDOH should be a goal of the OCF RFI process.

The OCF RFI comes on the heels of another major alternative payment policy proposal aiming to improve the value of care received by Medicare benefi ciaries being treated for cancer. In contrast to the voluntary OCF program, the proposed Radiation Oncology (RO) model, announced in July 2019, would be mandatory and affect payment for 40% of the radiation therapy volume provided to Medicare benefi ciaries nationwide, if finalized.

The model proposes a fixed prospective payment, which includes both professional and technical components, that would vary based on 17 cancer types. Early analysis suggests that this model may incentivize more effi cient treatment schedules, and the final rule is expected in late 2019 or early 2020.

CMS’ goals of reducing care costs and improving care quality are evident through the proposed OCF and RO models. For maximum provider engagement in both oncology payment models, it is imperative that CMS’ payment models continue to make adjustments that do not penalize historically effi cient providers and create value-based innovators across the continuum of care. As providers consider their participation in these programs, they should be aware that frequent and robust data and appropriate quality measurement are critical pieces of a successful program. Additionally, we at Archway encourage providers considering the models to engage with CMS during the comment periods to help the agency build models that align incentives with high-quality patient care.

Keely Macmillan, MPH, is senior vice president of Policy and Solutions Management at Archway Health. A recognized expert in alternative payment models, she has more than 12 years of healthcare experience in guiding specialty providers to success in accountable care organizations (ACOs), bundled payments, value-based purchasing, and MACRA’s Quality Payment Program.

Archway Health works with providers and employers to design and execute care and risk management initiatives that improve care and reduce costs. Archway is currently working with leading healthcare providers participating in risk-based contracts including bundled payment programs under the Center for Medicare and Medicaid Innovation such as BPCI Advanced, OCM, and the Comprehensive Care for Joint Replacement model. Archway also works with Medicare and commercial ACOs, self-insured employers, and commercial payers. To support these programs, Archway collaborates with organizations to analyze their opportunities and risks and deploys a comprehensive platform of analytics, patient tracking tools, Value-Based Risk Protection stop-loss programs, and advisory services.

1. Fact sheet: 2019 Social Security and Medicare trust fund reports [press release]. Washington, DC: US Department of the Treasury; April 22, 2019. home.treasury.gov/news/press-releases/sm665. Accessed November 20, 2019.

2. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020 [erratum in J Natl Cancer Inst. 2011;103(8):699].J Natl Cancer Inst. 2011;103(2):117-128. doi: 10.1093/jnci/djq495.

3. Innovation Center. Public listening session: informal RFI on Oncology Care First model. CMS website. innovation.cms.gov/resources/oncology-listening-session.html. Updated November 14, 2019. Accessed November 20, 2019.

4. Innovation Center. Primary Care First options. CMS website. innovation.cms.gov/initiatives/primary-care-first-model-options/. Updated November 19, 2019. Accessed November 20, 2019.

5. Innovation Center. Kidney Care Choices. CMS website. innovation.cms.gov/initiatives/kidney-care-choices-kcc-model. Updated November 19, 2019. Accessed November 20, 2019.

6. Advanced Alternative Payment Models (APMs). Quality Payment Program website. qpp.cms.gov/apms/advanced-apms. Accessed November 20, 2019.

7. Office of Disease Prevention and Health Promotion. Social determinants of health. Healthypeople.gov website. healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. Updated November 21, 2019. Accessed November 20, 2019.

8. Innovation Center. Radiation Oncology Model. CMS website. innovation.cms.gov/initiatives/radiation-oncology-model/. Updated August 7, 2019. Accessed November 20, 2091.

A senior vice president of Archway Health discusses challenges and opportunities of the proposed Oncology Care First model.

Can Cancer Care Lead the Way Toward a Value-Based Future?

Oncology practices see the toll financial toxicity

exacts on patients and their families every day. The financial burdens of cancer treatment are damaging even when they don’t directly affect care—and research shows that all too often, they do. Patients struggling under the burdens of cancer care are more likely to be nonadherent with their prescribed treatment regimen, failing to fill prescriptions, delaying office visits, and forgoing critical diagnostic tests.

More affordable care is better care, and payers should empower providers to steer patients toward superior-value options whenever available. When it comes to oncology biologics, this means giving providers the power to prescribe biosimilars.

Biosimilars offer lower-cost alternatives to the biologic agents driving up the cost of prescription drugs. Biologics accounted for nearly 75% of the annual increase in net US spending on medicines in 2018.

 The availability of biosimilars introduces competition based on price, offering a lower-cost alternative in the short term and helping to restrict—or even reverse&mdash;longer-term price growth. As a growing number of biologics used in oncology treatment, such as trastuzumab, encounter biosimilar competition, providers have the opportunity to significantly reduce prescription drug costs for their patients. Where biosimilars, which are certified as clinically equivalent by the FDA, are the correct treatment option, failure to prescribe them is a failure to address financial toxicity. Ultimately, it’s a failure to hold the oncology profession to the highest, most comprehensive standard of patient care.

Although provider education can play an important role in biosimilar uptake, in certain cases, patients’ insurers prevent providers from prescribing these products. Anticompetitive rebating practices (“rebate walls”) by originator manufacturers incentivize payers to adopt “fail-first” preferences for costlier originator drugs, eliminating a patient’s option to choose a lower-cost biosimilar when available. Because biosimilars are clinically equivalent, a fail-first policy preferencing an originator is an effective ban on coverage of its biosimilars. In a higher-profile case of rebate-induced limiting of patient and prescriber choice, UnitedHealthcare adopted a fail-first preference for Amgen originator biologic Neulasta over pegfilgrastim biosimilars Udenyca and Fulphila.

 This summer, the Federal Trade Commission initiated an investigation of Johnson & Johnson’s contracting practices surrounding infliximab originator Remicade, examining potential exclusionary conduct against Pfizer biosimilar Inflectra.

Ironically, in October, UnitedHealthcare granted Amgen’s own oncology biosimilars, Mvasi and Kanjinti, preferred status on its commercial and community plan formularies. It seems payers do not have a formulary preference against all biosimilars, just those of manufacturers unable or unwilling to offer more attractive rebate contracts.

Payers can argue that the savings from larger rebate packages accrue to the benefit of their entire insured population. However, any savings from contracts that exclude oncology biosimilars come at the direct expense of the patients who are forced to pay higher out-of-pocket costs for expensive originator biologics. It’s a cruel trade-off and one that denies physicians the ability to alleviate the financial toxicity of oncology treatment and harms the quality of care delivered to patients. Moreover, these policies inhibit the multiproduct biosimilar competition that can generate greater savings over time.

In May, the FDA finalized guidance on how biosimilars can achieve interchangeability, which would give pharmacists the ability to substitute them for originator biologics without the express guidance of the prescribing physician, as they can for small molecule generics.7 Although this is a step in the right direction, it won’t extend full biosimilar access for patients being treated today or for some time in the future. Today, however, payers have the option to simply do the right thing, rejecting attempts to block biosimilar access and respecting physicians’ ability to prescribe as they know best. If only they’re allowed to compete on a level playing field, biosimilars may hold the key to savings for patients struggling with financial toxicity. The oncology provider community should demand better, making clear that antibiosimilar formulary policies infringe on providers’ ability to offer care in a manner that promotes the best outcomes for our patients.

Kathy Oubre, MS, is the chief operating officer of Pontchartrain Cancer Center, with locations in Covington and Hammond, Louisiana.

1. Zafar SY, Abernethy A. Financial toxicity, part I: a new name for a growing problem. Oncology (Williston Park). 2013;27(2):80-81, 149.

2. Knight TG, Deal AM, Dusetzina SB, et al. Financial toxicity in adults with cancer: adverse outcomes and noncompliance. J Oncol Pract. 2018;14(11):e665-e3673. doi: 10.1200/JOP.18.00120.

3. Medicine use and spending in the US: a review of 2018 and outlook to 2023. IQVIA website. iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023. Published May 9, 2019. Accessed November 19, 2019.

4. Owens C. How a cheaper prescription drug is getting boxed out. Axios website. axios.com/drug-prices-nulestaudenyca-cancer-unitedhealth-6bca53af-0ec1-45fb-a373-ec57d6ea7b0c.html. Published June 3, 2019. Accessed November 19, 2019. 

5. Inserro A. FTC seeking information about J&J’s strategy for brand-name infliximab, Remicade. The Center for Biosimilars® website. centerforbiosimilars.com/news/ftc-seeking-information-about-jjs-strategy-for-brandname-infliximab-remicade Published July 30, 2019. November 19, 2019.

6. Davio K. UnitedHealthcare will prefer Amgen’s anticancer biosimilars beginning in October. The Center for Biosimilars® website. centerforbiosimilars.com/news/unitedhealthcare-will-prefer-amgens-anticancerbiosimilars-beginning-in-october. Published August 15, 2019. Accessed November 19, 2019.

7. Statement from Acting FDA Commissioner Ned Sharpless, MD, on policy advancements to help bring interchangeable biosimilars to market [press release]. Silver Spring, MD: FDA; May 10, 2019. www.fda.gov/newsevents/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-policy-advancementshelp-

bring-interchangeable. Accessed November 19, 2019.

The availability of biosimilars introduces competition based on price, offering a lower-cost alternative in the short term and helping to restrict&mdash;or even reverse&mdash;longer-term price growth.

Empower Physicians to Fight Financial Toxicity With Biosimilars

This interview is edited slightly for clarity.

Participants in the Oncology Care Model (OCM) have speculated greatly about what will come after the 5-year pilot program ends on June 30, 2021.

 The suspense ended November 1, 2019, when the Center for Medicare & Medicaid Innovation (CMMI) unveiled a request for information (RFI) regarding Oncology Care First (OCF), a proposed successor model that would build on the lessons learned from OCM. When the RFI was released, CMMI had already scheduled a listening session for November 4, 2019, on the future of the OCM, and the short comment period left some stakeholders uneasy (The orginal 3-week comment period was extended to December 13, see 

But Kashyap Patel, MD, the chief executive officer of Carolina Blood and Cancer Care Associates—a leading OCM practice&mdash;and associate editor of 

), said he’s optimistic. As cochair of the Payment Reform Committee for the Community Oncology Alliance, Patel took part in the listening session with CMMI’s Christina Ritter, director of the Patient Care Models Group, as well as Lara Strawbridge and Hillary Cavanaugh, who are developing the successor model for CMMI. A few days later, Patel shared his early thoughts on the OCF with 

: Everyone has been waiting to see what will happen with the OCM as we look toward the end of the 5-year model. What do you think have been its biggest successes?

 That’s a very nice question. You’ve touched my heart, because I always believed we have the resources, technology, and intelligence to shift care from volume to value—and the OCM was the primer for that. There has been a large learning curve over the past 3 years. After the model was announced, we had 197 practices become a part of that. It took a learning curve of about 2 years, so far, for everyone to figure out what was expected of us, but now almost 80% of practices have reached success in addressing the benchmark prices [for cancer therapies], as well as improvement in the quality of care. So, the OCM has really allowed us to explore the road map to success in the transition from volume to value.

 There was an element of surprise when CMMI released the RFI for Oncology Care First. Can you discuss the nature of the RFI and your initial reaction?

It was very interesting. I was speaking on 2-sided risk at the Association of Community Cancer Centers conference in Orlando, Florida, in the last session. I was talking about the OCM and the future of the OCM, and we also had Alexandra Chong [PhD,] from CMMI, speaking right after I was done. And as I headed out of the room, I saw this [news] flash saying that CMMI had announced the RFI for Oncology Care First. So, it was a surprise, but it was a pleasant surprise for me. I am an eternal optimist. As an oncologist, I deal with the chance of 15% to 20% survival every day of my life, and so to see something like OCF coming out on Friday afternoon made my weekend. The reason is because we’re all worried about what is going to happen after 5 years. We’ve made a substantial improvement in the way we are dealing with care, but it’s coming with a price—we’ve had new employees, we’ve changed the way we work; [there are] new technology investments, new CT [computed tomography] scan machines. And when I look at all the investment, I was getting anxiety [to the point] where I was losing sleep: What will happen once the summer of 2020 comes and OCM is kind of over? And when I saw the OCF model, I was happy.

There is a little skepticism because CMS had scheduled a listening session for Monday [November 4, 2019]. Now, when there is an announcement from CMMI on Friday afternoon at 4 p.m. [November 1, 2019], the first reaction from many of my colleagues was “Oh, so they didn’t want to give us time to ask questions.” And I put it

differently. I said, “Look, they actually designed the model. We asked for an extension [for deciding whether to move to 2-sided risk]. Lara Strawbridge [of CMMI] and Dr [Anand] Shah [of CMS], as well as other stakeholders, designed a new model pretty much along the same line of what it is right now. They’ve incorporated a large number of elements that we requested, and they’ve continued to work with us. And at the listening session, they opened up the podium to continue to work, and this is not onetime.…They’ll be writing comments, we’ll be writing comments—it’s more like a collaborative work.

One concern that everyone had was the short turnaround time for the comment period (later extended). [From] the time they announced the model, there is a 3-week timeline....People are getting ready for travel, so these were some of the elements of surprise. But I still feel that there has been a genuine intention on the part of CMMI, as well as the team, to consider what has progressed over the past 3 years to accommodate continuation of the model.

 During the listening session, it appeared that CMMI tried to incorporate feedback from oncologists about appropriate ways to hold practices accountable for drug costs. Can you discuss areas where OCF reflects provider feedback?

 OCF is built on the success of the OCM as a pilot experiment. One of the challenges we had was patient attribution—we did not know when it was going to happen. In the OCF model, CMMI has promised us they will be updating [attribution data] every month so there will not be an element of surprise. Second, we were struggling with the drug costs. For example, the newer therapies, such as immunotherapies, could be much higher compared with benchmark prices, and they’ve actually looked at novel therapies in a much more robust way. And the third thing was the trend factor&mdash;the cancer-specific trend factor. [These are] 3 big elements that we’ve always been struggling with in the original model, and CMMI has promised and considered how they will adjust the pricing model based on these 3 factors.

A point that you raised during the listening session, with support from Barbara McAneny, MD, who developed the COME HOME model, was the concern about the handling of electronic PROs [patient-reported outcomes]. Disbursement of technology among cancer patients is very uneven. Can you discuss your concerns with ePROs?

Absolutely. As soon as Lara Strawbridge said they were incorporating ePROs, my eyes went all over—I said, “I have patients who don’t have a smartphone. They still use a flip phone.” They live in areas where there aren’t even cell phone towers. Depending on the access to the technology, the ePRO reporting could be quite variable. At the same time, I want to be sure we respect technology, so our suggestion and request to CMMI&mdash;and we will be commenting on this, as well&mdash;will be to collect the ePROs at the point of care, when the patient comes to the clinic. We would invest more in the technology; we could buy some iPads so our employees could sit down with the patients to help them [record responses]. But we don’t want to make it very burdensome. Patients are sick. They have many more issues. To ask them to answer a hundred questions [at every appointment] may make them very tired. So, we want to create a balance between the expectations of the technology and dissemination of knowledge, and at the same time respect the patients’ ability and capacity to work with us.

Is it appropriate to have caregivers take part in the ePRO initiative?

 Caregivers could be a critical part of ePROs, but if patients have flip phones, then I don’t expect caregivers will have smart phones, either. We’re talking about patients living paycheck to paycheck. They don’t have secondary insurance. They don’t have transportation. So, for them to have technology and pay $100 a month for access to the internet may be too much to expect. But we definitely would work with them, or our employee would work with them, to figure out how to do the ePRO. Or, maybe at some stage, we could have that done at a home visit, taking the technology along with creating a temporary hot spot to ensure that we fulfill the expectation. At the same time, we want to have some sort of balance between the expectation of the ePRO and what we can deliver.

 What other takeaways did you have from the listening session?

 I was elated to see the enthusiasm among my colleagues—with skepticism. Whenever government comes in with some program, there is always some skepticism.…But on the whole, I see an environment of collaboration, a cooperative and conducive environment to improve the quality of care for cancer patients.

There’s also an element of risk they expect us to take—small downside risk. And although that could be a matter of concern for many practices, when you look at the alternate path, the MIPS [Merit-based Incentive Payment System] track, MIPS has a 9% downside going from 2021 onward anyway.

 So, with either track, you have risk involved.

1. Oncology Care Model. CMS website. innovation.cms.gov/initiatives/oncology-care/. Updated November 13, 2019. Accessed November 13, 2019.

2. MIPS overview. Quality Payment Program website. qpp.cms.gov/mips/overview. Accessed November 13, 2019.

Kashyap Patel, MD, the chief executive officer of Carolina Blood and Cancer Care Associates&mdash;a leading OCM practice&mdash;and associate editor of Evidence-Based Oncology™ (EBO), said he’s optimistic about Oncology Care First.

Provider Perspective: Kashyap Patel, MD, Sees Collaboration Going Into Oncology Care First

The interview is edited slightly for clarity.

On October 31, 2019, authors from Tennessee Oncology, OneOncology, and Tuple Health published an article in JAMA Oncology that offered a stunning conclusion: Even if a practice in the Oncology Care Model (OCM) complied precisely with current guidelines from the National Comprehensive Cancer Network (NCCN) for metastatic non—small cell lung cancer and did everything right, drug costs would make it impossible to meet the financial targets spelled out in the model.

 The authors offered a solution: Instead of being judged against unattainable benchmarks, OCM practices should be measured based on their adherence to

clinical pathways or ability to document why a pathway didn’t make sense for a particular patient.

Almost on cue, the next day, the Center for Medicare & Medicaid Innovation (CMMI) released its proposal for Oncology Care First (OCF), the would-be successor to the OCM.

 One of the paper’s authors, Tennessee Oncology’s Stephen M. Schleicher, MD, MBA, was pleased to see that OCF reflected some of the issues he had his colleagues had discussed. Schleicher, who also serves as medical director for value-based care for OneOncology, a network that includes 242 providers, discussed the findings and CMMI’s proposal with E

 Please describe your practice’s overall experience with the OCM. What changes have had the biggest impact on clinical outcomes?

: I’m a medical oncologist at Tennessee Oncology; we are part of OneOncology, where I am chair of the Quality and Value Committee. I’ve been very passionate about value-based payment for the past 5 to 6 years since the Affordable Care Act came out and, specifically, as an oncologist, when the OCM came to fruition. Our experience with the OCM, most importantly, has been a learning experience. I think that’s one of the biggest benefits of the model and why it has been a voluntary pilot. We’re getting lots of information about how we’re doing in keeping patients out of the emergency room when we can and how we’re using hospice.

We’ve had the opportunity to get rewarded through the care-management fees to provide nurse navigators, to help be the bridge between when the patient is in clinic and when the patient is at home. We’ve learned how to continue that communication and help direct patients to the clinic for fluids instead of to the emergency [department], to help assess a patient’s pain and act quickly before the pain gets out of control—similarly with nausea and constipation. So, we’ve been able to, through the resources provided from Medicare as part of the OCM, hire some additional staff to help with that. Staff is one thing; secondly, with the analytic capabilities we’ve been encouraged to develop through our partners with Flatiron Health and now with OneOncology, as I mentioned, an understanding of our utilization patterns and how they compare with our peers’, both within the Oncology Care Model and without. Those are some huge benefits of the model, and one of the most exciting aspects of the model involves all we have learned to improve the care we’re delivering to our patients.

,1 one of the central points you and your co-authors make is that practices should be held accountable for adhering to clinical pathways or documenting good reasons the pathway does not make sense. How did you arrive at that conclusion?

So, it’s a great question. The impetus for putting this paper together was the whole issue of accountability versus control. As oncologists, we want to be accountable for things we do incorrectly, of course—even if that’s not on purpose. But delivering a more expensive chemotherapy to a patient when there’s a better option, using an emergency room instead of a clinic for things that could be handled outpatient&mdash;those are things we can be accountable for, that we can control, and we should be accountable for. But there also are aspects of cancer care that we have no control over, and the main thing there&mdash;the elephant in the room&mdash;is the price of drugs.

New drugs have tremendous benefit for patients. We want to be able to give new drugs to our patients. Immunotherapy is really the big thing that has boomed since the start of the OCM. But those drugs that have good benefits also have high price tags, and we want to make sure we can give those drugs to patients without being penalized, because in the current OCM, the total cost of drug use is something we are accountable for and could be penalized for. What we wanted to do with the paper and this research is understand how well the OCM is incorporating the new prices of drugs into their expected costs of treating cancer patients. We looked at lung cancer.…The field has [advanced] even since the time of the data that we looked at for this paper. But since the start of the OCM, immunotherapy made its way into the second-line treatment of metastatic non—small cell lung cancer with both Keytruda [pembrolizumab] and Opdivo [nivolumab], which both have survival benefits. We thought that was a good opportunity to look and see if, when we used these drugs correctly—which we can control&mdash;we are still over target on what we should be spending, and if it’s due to the price alone, we cannot control that. And that’s a problem with a value-based care model&mdash;trying to improve the quality of care and the cost of care if we can’t control that.

So, that’s why we looked at lung cancer. We looked at all our cases where Medicare told us we had spent more than expected, and within that, where we had prevented everything that was the goal of the OCM. [We looked at cases where] we prevented emergency [department] visits, we prevented hospitalizations, postacute care, inappropriate chemotherapy at end of life—all these aspects that we can control and one should be able to prevent. We saw that in many of our cases&mdash;over half&mdash;we had done all that, but we were still over target because we had used either Keytruda or Opdivo in the second-line setting for metastatic non—small cell lung cancer. That was NCCN compliant at the time and is still standard of care, although we now often use immunotherapy first line. We found in that group of patients that we were over target for using the right drug at the right time for patients that deserved to have that drug, yet the model, despite Medicare’s best attempts, couldn’t account for that, and that is what we are trying to communicate with the paper. Our conclusion was that we were pathway or guideline concordant, which is what we can control and that’s what we should be doing; the cost was higher because of the price, which we can’t control. So maybe the pathway concordance&mdash;following pathways we can all agree on&mdash;is a better measure of us using the right drug than the cost of care itself, from a drug perspective.

 And the data you present were consistent across the practices that you surveyed?

Exactly. We have 30 clinics in Tennessee Oncology right now—OneOncology has over 100&mdash;but we were looking at Tennessee Oncology, and this was not clinic specific; this was across all our providers at the different clinical sites.

The day after your paper appeared, CMMI released a request for information on a model that is being called Oncology Care First, or OCF, which will be the successor to OCM when it expires in 2021. What are your observations so far about OCF?

OCF, I think, is an example of Medicare being very thoughtful—of recognizing that we need to change the way care is delivered but also recognizing that cancer is a very difficult disease because it is very heterogeneous&mdash;every patient with cancer is different, every cancer is different. We have high costs of care both from utilization and drugs. So, I think they tried to come up with a thoughtful model to do this.

There were 2 components of the OCF model that I thought are definite improvements from OCM that relate to our paper in terms of the accountability versus control. The first is how they calculate the expected cost of treating cancer care and how drug costs are incorporated into that; there are 2 mechanisms for that through the trend factor that accounts for overall implementation of healthcare costs, and the novel therapy adjustment, which is how a practice is using new drugs that have been FDA approved compared with their peers.

In the OCM, they applied this across all cancer types and all patients in conglomerate; OCF, they will look at the specific cancer itself. When a new drug or a new indication comes to that disease, they will try to account for that change at the [level of the] disease itself—which, hopefully, improves the accuracy of predicting the cost of care as healthcare standards of care change in oncology. That’s a benefit and shows that Medicare was listening to us as we all provided feedback during the OCM, and it is clearly very relevant to the paper we just published in 

A second improvement is how providers should be accountable for some of the low-risk cancers, such as low-risk breast, low-risk bladder, and low-risk prostate. Let’s take low-risk breast cancer—that could be a patient who had surgery, chemotherapy, and radiation therapy 4 to 5 years ago but still requires antiestrogen therapy&mdash;a hormonal pill. In that case, the provider might be seeing the woman every 6 months to prescribe that pill; standard of care might be a mammogram once a year for a patient who still has her breasts intact, with an exam. In the current setting, if we are treating a patient like that but they go to the emergency room because they have a stroke or because they need a hip replacement or they have a heart attack&mdash;something completely unrelated to their disease&mdash;we are still accountable for that care under the current OCM. They have corrected this in the current OCF by removing these patients from the accountability portion of the total cost of care, such that we are more accountable for patients for whom we are providing intense chemotherapy, seeing them regularly and really are responsible for their care, versus patients we are seeing every 6 months who have other unrelated health problems that could throw off our ability to succeed in the value-based care model.

: That would seem to make sense. Do you have any other observations as you move forward with alternative payment models?

 It’s important for groups to be in these models, even if they are voluntary, just to learn about how they are doing compared with their peers and find opportunities for improvement. And as long as groups can publish on these matters and make it known to their other colleagues across the country interested in improving the value of care of cancer—if we can communicate that through publications such as ours [in 

], through conferences, through Medicare, to help these models get better over time, that’s really how we succeed: all of us coming together versus working independently. REFERENCES

1. Lyss AJ, Supalla SN, Schleicher SM. The Oncology Care Model-why it

works and why it could work better: accounting for novel therapies in

value-based payment [published online October 31, 2019]. JAMA Oncol.

2. Oncology Care Model. CMS website. innovation.cms.gov/initiatives/

oncology-care/. Updated November 13, 2019. Accessed November 13, 2019.

An article Schleicher co-wrote in JAMA Oncology, which appeared the day before the announcement of Oncology Care First, offered insights into the need for changes to the original OCM.

Provider Perspective: Stephen M. Schleicher, MD, MBA, Addresses Accountability Versus Control in Oncology Care First

In 2018, The FDA approved 19 drugs, 4 biosimilars, and added 38 indications for therapies that fight cancer.

The pace continued in 2019: of the 41 new agents approved through November, 15 are used in cancer  or blood disorders.

This period of innovation is likely to continue, and even accelerate, due to the FDA’s willingness to examine real world data and alternative approval endpoints, 1 off ering evidence that research focused on rare cancers, or improving outcomes and reducing toxicities, is having an impact.

However, innovation has come at a price. In 2018 spending on cancer medicines rose by 12.9%,

while the overall US infl ation rate was only 1.9%.

Controlling healthcare costs dominates nearly all other considerations in the political debate over healthcare reform. For federal policymakers, ensuring the sustainability of the Medicare Trust Fund is central to all considerations for future CMS care and reimbursement models.

 These concerns have delayed CMS’ development of reimbursement models for emerging cancer treatment technologies, such as chimeric antigen receptor (CAR) T-cells. 

Fears about the Medicare Trust Fund and healthcare related infl ation have propelled CMS leadership to increase the level of risk that clinicians and healthcare systems bear in care delivery. The inclusion of advanced alternative payment models (APMs) within the Medicare Access and CHIP Reauthorization Act of 2015 show the importance of bringing greater cost accountability and transparency to physicians and healthcare systems.

Unfortunately, this adds administrative burdens and ironically hold physicians accountable not only for the costs that they can control, but also for those they cannot control, such as the proper use of high-cost pharmaceuticals.. Thus, physicians and healthcare systems are disempowered from leading meaning, sustainable innovation efforts and have at best highly imperfect models through which they can follow the lead of the agency.

™ we examine this issue from multiple perspectives. Kathy Oubre, MS, provides perspective on biosimilars that may provide an innovative paradigm for blunting the cancer pharmaceutical rate of inflation. Keely Macmillan, MPH, provides an overview of the proposed Oncology Care First (OCF) model and how it may or may not lead to better incentives for physicians to practice value-based cancer care. Finally, Associate Editor Kashyap Patel, MD, provides one of 2 physician perspectives on the OCF model.

We must not forget that physicians and healthcare systems that actually provide care to patients are essential incubators for transformational ideas that bring us closer to realizing the full potential of the value-based cancer care paradigm. For physicians and cancer care systems to lead this transformation, they need to be allowed to lead and innovate in an unfettered way. Alternative APMs must give physicians fl exibility to succeed in the pursuit of economically sustainable care excellence.

Physicians should never be penalized for delivering the most appropriate care to their patients, even if it is more expensive. The future of increasing eff ective cancer care that better serves patients and their families is dependent upon ensuring that physician and healthcare system leaders are allowed to move forward, at speed and empowered to succeed in making this future a reality. 

1. Dietz C, Bin Han Ong M. FDA approves 19 new cancer drugs and biologics in 2018—and don’t forget two new endpoints and “real-time” review. The Cancer Letter. cancerletter.com/articles/20190125_2/. Published January 25, 2019. Accessed November 30, 2019.

2. US Food and Drug Administration. Novel drug approvals for 2019. www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019. Accessed November 30, 2019.

3. IQVIA Institute for Human Data Science. Global Trends 2019. iqvia.com/-/media/iqvia/pdfs/institute-reports/global-oncology-trends-2019.pdf?_=1575154005513. Published May 2019. Accessed November 30, 2019.

4. US Inflation Calculator. Current US inflation rates: 2009-2019. usinflationcalculator.com/inflation/current-inflation-rates/. Accessed November 30, 2019.

5. Cubanski J, Neuman T, Freed M. The facts on Medicare spending and financing. Kaiser Family Foundation.. kff.org/medicare/issue-brief/the-facts-on-medicare-spending-and-financing/. Published August 20, 2019. Accessed November 30, 2019.

Dr Alvarnas is editor-in-chief of Evidence-Based Oncology.™ He is vice president of Government Affairs, senior medical director for Employer Strategy, and associate clinical professor, Hematology & Hematologic Cell Transplantation, City of Hope, Duarte, Califonia.

December 2019