Telehealth, a universal term for the use of digital information and communication technologies to remotely

 access healthcare services, is improving availability of healthcare services, particularly for patients in rural areas. Data from a wide range of medical specialties have demonstrated that telehealth can improve access while maintaining quality.

Private payers have been influential in supporting telehealth initiatives, with more than 30 states mandating coverage.

 Yet limitations on Medicaid and Medicare reimbursement of telehealth have hampered broad implementation of this promising service delivery model.

HR 1892, the budget agreement signed into law in February 2018,

 is being hailed for removing some of these limitations and improving access to care for Medicare recipients. The law contains provisions from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act of 2017

 and other telehealth bills that seek to expand Medicare coverage of telehealth services. Previously unrecognized uses of telehealth under Medicare Part B will now be appropriate benefits, assuming they are clinically relevant and meet established requirements (section 303). In addition, accountable care organizations can access a variety of telehealth services with fewer restrictions (section 304). The bill also allows beneficiaries to choose whether they want to use telehealth options.

The potential for expanded coverage of telehealth is welcome news for several medical specialties, particularly those that offer limited access in rural areas. One such field is genetic counseling. Genetic counselors help people understand and adapt to the medical, psychological, and familial implications of hereditary cancer.

 They also help identify patients who may benefit from genetic testing and direct them to the most appropriate test(s). The process of genetic counseling is particularly well suited for telehealth as it is primarily conducted via consultations that involve a communication process that can occur by phone or video. Cancer genetic counselors have seen a rapid expansion of telehealth services (telegenetics) in recent years. Although patient access to cancer genetic counseling varies widely across the United States, the demand for genetic counseling is increasing, as cancer patients’ germline mutation status increasingly has implications for cancer treatment decisions.

 For instance, individuals with germline pathogenic variants in 

 genes and a growing list of cancer types (eg, ovarian, prostate) are eligible for treatment with poly ADP ribose polymerase (PARP) inhibitors.

 Accordingly, cancer genetic counselors have reported increased referral volume due to the FDA approval of PARP inhibitors in the settings of treatment-resistant ovarian cancer.

 Additionally, the immunotherapy pembrolizumab has now been approved by the FDA to treat tumors that exhibit mismatch repair deficiency, a hallmark of Lynch syndrome, and have progressed on prior treatment.

 Further, a broadening list of cancer presentations are being recognized as being associated with higher likelihood of germline etiology, including metastatic prostate cancer.

In keeping with the growing number of indications for referral to cancer genetic counseling, professional organizations are now requiring that cancer centers provide access to cancer genetics expertise. For example, in 2012 the American College of Surgeons began requiring that, to receive accreditation, cancer treatment centers provide patients with access to a qualified genetics professional.

 Some health insurance companies now require that a genetics expert be involved in the ordering of certain cancer genetic tests (eg, 

 Private telegenetics companies have formed to help meet the growing number of recommendations and requirements for genetic counseling services.

Early research on patient outcomes in cancer telegenetics shows that it is acceptable to patients and can decrease costs to health systems and patients. A randomized comparison of clinic-to-clinic telegenetics with in-person cancer genetic counseling found that telegenetics was substantially less expensive for the institution and was associated with comparable patient satisfaction.

 This service delivery model has also been compared with telephone genetic counseling, showing comparable patient satisfaction. One difference that was perceived by genetic counselors was that patients pay better attention to a videoconferencing consult than to a phone consult.

 Patients have reported high satisfaction with cancer telegenetics

 Telegenetics has been associated with positive psychosocial outcomes, including improvements in cancer genetics knowledge and in anxiety, depression, and cancer worry.

 A model of telegenetics that connects genetic counselors to patients’ home computers or devices has also shown promising psychosocial outcomes and favorable patient satisfaction

 while being deemed acceptable by genetic counselors.

 What’s more, a recent study of cancer genetic counselors showed high acceptance and usage of telegenetics, with two-thirds of respondents having conducted telegenetics consults.

 This is a striking increase in the use of telegenetics from 5 years ago, when the results of 2 studies of cancer genetic counselors showed that fewer than 15% had conducted a telegenetics consult.

However, in spite of the new budgetary provisions for telehealth reimbursement, professional recommendations, and high acceptance of telegenetics services, significant barriers to broad implementation of cancer telegenetics persist. First and foremost, genetic counselors are not CMS-recognized practitioners. Therefore, the changes under HR 1892 will have very limited impact for Medicare beneficiaries seeking genetic counseling. Efforts are underway to introduce a bill to address this, but until it passes, genetic counselors cannot seek reimbursement from Medicare for their services. For third-party payers, companies can use the Current Procedural Terminology code modifier 95 to identify telemedicine services. However, not all payers will reimburse for genetic counseling services. The second barrier that must be overcome to provide national coverage to cancer patients relates to genetic counseling licensure. Genetic counselors must obtain licenses for every state currently issuing licensure in which their patients reside. This leads to increased provider time and cost to ensure that genetic counselors are able to practice legally for all of their patients throughout a network. Additionally, reports on the effectiveness of cancer telegenetics frequently note technical glitches as barriers to delivery of care.

 Lastly, continuity of care is a concern for genetic counselors who play a key role in coordinating patients’ care within and among institutions.

 Because genetic counseling providers may be employed by other health systems and companies rather than by a patient’s main healthcare facility, the lack of a point person within that main healthcare facility could leave patients without referrals, follow-up care, and long-term medical management. In cancer care, this is especially important when guidelines recommend changes in medical management based upon genetic testing results (eg, increased frequency of screening using mammography and breast magnetic resonance imaging in 

 carriers and colonoscopy in patients with Lynch syndrome

Delivering telehealth services will be an efficient and scalable means to providing quality healthcare and education to all patients, despite the barriers stated above. Overcoming these barriers is particularly important as genetic counselors are increasingly needed to assist in the care of patients who are at increased risk to develop cancer. As the etiology of cancer is better understood and the use of genetic-based therapies expands, genetic counselors will remain an integral part of care and are particularly suited to meet these mounting needs. Advances in access and in reimbursement to genetic counselors will aid in the deployment of telegenetic services nationally. Ultimately, it is hoped that this will result in increased patient care, satisfaction, and outcomes.

Heather Zierhut, PhD, MS, CGC, is the assistant professor and the associate director of the Graduate Program of Study in Genetic Counseling at the University of Minnesota — Twin Cities. Dr Zierhut has expertise in clinical, research, and public health genetic counseling. She has served as chair of the National Society of Genetic Counselors Access and Service Delivery, where she developed a passion for increasing efficiency and access to genetic counseling. She serves as senior advisor for GeneMatters to provide expertise on the integration and implementation of innovative, evidence-based genetic counseling services and testing into new and growing markets.

Adam Buchanan, MS, MPH, LGC, is assistant professor and genetic counselor in the Geisinger Genomic Medicine Institute in Danville, PA. Previously, he was a research associate at Duke Cancer Institute. He is an National Institute of Health—funded investigator with research interests in outcomes of genomic screening programs, service delivery models for genetics services, clinical decision support based on family health history, and assessing cancer risk management behaviors. His clinical expertise includes intimate knowledge of recommended risk management for hereditary cancer syndromes. He is co-leading Geisinger’s MyCode genomic screening program for medically actionable genomic results, and he is helping to develop a health services research portfolio on patient-participant, family, and system outcomes of this program.References:

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Articles

Evidence-Based Oncology

Telehealth, a universal term for the use of digital information and communication technologies to remotely access healthcare services, is improving availability of healthcare services, particularly for patients in rural areas.

The Impact of New CMS Rules for Telehealth on Cancer Genetic Counseling

Prostate cancer is the most common cancer diagnosed in men, second only to skin cancer.

 However, the gravity of a diagnosis is highly variable and difficult to predict. Some men will have more aggressive disease and should receive definitive treatments, while many others will have indolent disease and may best be followed with active surveillance. Active surveillance, which is the careful observation of patients to make sure the cancer shows no signs of becoming more aggressive, is much less expensive than definitive treatments; however, scientific literature and guidelines to help physicians make this choice don’t always agree. Historically, the decision whether to pursue treatment or active surveillance has relied solely on clinical and pathologic features, such as Gleason score, baseline prostate-specific antigen level, clinical stage, and extent of disease based on core biopsies. Clinical and pathologic features are important, but some of these features have been shown to be highly variable. The combination of these features to create nomograms, such as CAPRA (Cancer of the Prostate Risk Assessment),

 improves upon the use of these features alone, but still leaves many men with inadequate information to make a treatment decision.

Accurate prediction of the natural history of prostate cancer is necessary to avoid overtreatment, which increases the morbidity rate in men

 and is costly to the healthcare system. Biomarkers, or molecular testing of the prostate cancer tumor tissue, can more accurately predict the aggressiveness of prostate cancer and help physicians determine who needs definitive treatment and who can safely pursue active surveillance.

Prolaris is a biomarker test that assesses the expression levels of 31 cell cycle progression (CCP) genes, normalized by 15 housekeeper genes. CCP genes are actively expressed during cell replication and division. The higher the expression of these genes, the more quickly tumor cells may be dividing. The expression levels of CCP genes are used to generate a CCP score, which is then combined with the clinical and pathologic features to create a Combined Clinical Risk (CCR) score that refines the risk of prostate cancer mortality. The Prolaris assay was found to be highly prognostic, with the combined score being a better predictor of disease-specific mortality than standard clinical and pathologic features alone.

Of note, Prolaris is the only biomarker for prostate cancer that has been validated in patients who have not undergone immediate treatment, because they are being conservatively managed. Once validated in this group, CCR scores are evaluated to develop a threshold that can be used to guide patient selection for active surveillance. The chosen threshold was validated in a cohort of 585 conservatively managed men with low-, intermediate-, or high-risk features and a modified cohort of 284 men with high-risk features. There were no observed deaths in men with CCR scores at or below the threshold selected in either cohort.

With 80% of prostate cancers diagnosed at a clinically localized stage and still treated with definitive surgery before the introduction of biomarkers, Crawford et al examined the clinical utility of Prolaris.

 In a prospective study of 305 patients with newly diagnosed prostate cancer, the authors sought to evaluate the impact of Prolaris on treatment decisions. Overall, 65% of cases showed a change between intended treatment prior to the Prolaris test and treatment recommendations following the test. In 37.2% of cases, men who were planning to have radical prostatectomy changed to active surveillance. Prolaris helps to identify men who can safely pursue active surveillance, reducing the number of patients who pursue definitive treatment options and the healthcare costs associated with overtreatment.

In March of 2018, the National Comprehensive Cancer Network (NCCN) updated its Prostate Cancer Guidelines

 to support the use of biomarkers, including Prolaris, in prostate cancer tumors. The guidelines suggest that tissue-based molecular testing should be considered for low- and favorable intermediate-risk men who have a life expectancy of at least 10 years. The guidelines also suggest that germline testing should be considered for men with localized disease and a strong family history as well as men with high-risk or metastatic disease, irrespective of family history. Research suggests that up to 24.1% of men with prostate cancer may harbor germline mutations that contributed to the development of their disease

 and may have implications for the aggressiveness of the disease.

Following the support of the NCCN, the American Association of Clinical Urologists (AACU) published a position statement with respect to genomic testing in prostate cancer.

 AACU supports the use of tissue-based molecular testing for prostate cancer to help guide treatment decisions and strongly encourages providers to take a family cancer history and offer germline genetic testing for appropriate patients to help clarify hereditary cancer risk.

Most recently, the Large Urology Group Practice Association (LUGPA) acknowledged and endorsed the AACU position statement

 andthe NCCN Guidelines, providing more direction for LUGPA providers who utilize genomic and genetic testing for men with prostate cancer. Neal D. Shore, MD, FACS, LUGPA president, said in a statement, “LUGPA and AACU are proud to represent more than 6000 American urologists who strive to provide patients with quality, personalized care. Together our organizations are sending a message to policy makers, researchers, payers, and, most importantly, patients and their families, that we are committed to applying the best and most current science to the detection, risk stratification, and appropriate treatment of prostate cancer.”

The support of the NCCN and 2 prominent urologic professional societies represents the most direct guidance to date for practicing clinicians who treat prostate cancer on these 2 important components of risk stratification. With the utilization of a validated algorithm of clinical, pathologic and genomic variables, as well as a patient’s germline genetic information, healthcare providers are poised to provide the best care to patients with prostate cancer.

Robert Finch, MS, CGC, is a certified genetic counselor specializing in the genetics and genomics of cancer. He currently serves as a medical science liaison at Myriad Genetic Laboratories, where he provides education and clinical support to healthcare providers treating men with prostate cancer.References:

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Crawford ED, Scholz MC, Kar AJ, et al. Cell cycle progression score and treatment decisions in prostate cancer: results from an ongoing registry. 

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Rosenthal E, Brown K, Kidd J, et al. Outcomes of clinical testing for 76,000 patients utilizing a panel of 25 genes associated with increased risk for breast, ovarian, colorectal, endometrial, gastric, pancreatic, melanoma and prostate cancers. Presented at: 2015 American Society of Clinical Oncology Annual Meeting; May 29-June 2, 2015; Chicago, IL. Poster 338.  ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.1515.

Castro E, Goh C, Olmos D, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer. 

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American Association of Clinical Urologists. Position statement: genomic testing in prostate cancer. AACU website. aacuweb.org/docs/position-statements/ps_genomic-testing-in-prostate-cancer.aspx. Accessed April 17, 2018.

LUGPA endorses AACU policy statement on genomic testing [press release]. Chicago, IL: LUGPA; March 7, 2018. lugpa.org/lugpa-endorses-and-supports-new-cancer-guidelines-from-nccn/. Accessed April 17, 2018.

Accurate prediction of the natural history of prostate cancer is necessary to avoid overtreatment, which increases the morbidity rate in men and is costly to the healthcare system. Biomarkers, or molecular testing of the prostate cancer tumor tissue, can more accurately predict the aggressiveness of prostate cancer and help physicians determine who needs definitive treatment and who can safely pursue active surveillance.

National Comprehensive Cancer Network, American Association of Clinical Urologists, and Large Urology Group Practice Association Endorse Biomarkers in Prostate Cancer

In 2013, my partner Ric was diagnosed with stage IIIA non-Hodgkin lymphoma. The pronouncement that we were facing a fast-growing cancer felt like a slow-motion nightmare; it was disorienting, devastating, scary, and completely out of nowhere. Cancer came crashing into our lives like a tsunami and we were left scrambling to find anything that might help us stay afloat.

Ric did not feel sick. He had been a vegetarian for more than 15 years, was feeling great, was running 5 to 6 miles a day, and was in great shape. We noticed a small lump on his neck but decided not to worry about it after consulting with a doctor who ordered a computed tomography (CT) scan and subsequently advised us that it was “nothing to be concerned about.” We tried to ignore it, but over the next few weeks it continued to grow and eventually became uncomfortable, so we scheduled an appointment to have it removed. At this second appointment, a different doctor inspected Ric’s neck, ordered a new scan, and soon after informed us that this “lump” actually was something to be very concerned about—we were facing cancer. Within days, we found ourselves in the hospital starting the first of 6 aggressive rounds of chemotherapy, rituximab with cyclophosphamide, hydroxydaunomycin, oncovin and prednisone, the regimen known as R-CHOP.

After the initial shock, we tried to educate ourselves. We dove into a sea of resources and information about Ric’s treatment options and potential side effects. We sorted through tips upon tips about what to expect and how to manage it all, but it was difficult to determine what would apply to Ric’s situation and even harder to reconcile so much contradictory information. We paid for apps and digital services that did not deliver the promised benefits. We sought advice from others who’d received a similar diagnosis and been through the same treatment; but time and again, Ric’s personal experiences did not resemble what these well-meaning acquaintances warned us to expect. And we began to get more confused. We soon realized that even though many of the cancer treatments and protocols are standard, every patient is unique.

We now understand that most of the symptoms and side effects patients experience while undergoing chemotherapy can be managed, if not avoided all together. Throughout treatment, doctors ask patients questions about how they feel and patients do their best to remember what happened during the previous weeks. However, patients struggle to recall details of when they felt good and how long ago they felt poorly. It becomes increasingly difficult to remember the specifics of a skin rash or point to the exact moment of discomfort with nausea by the time a one-on-one visit with the doctor occurs. Patients’ memories fade. Or “chemo brain” takes over and patients can’t remember the details at all. Ric and I realized we needed to take daily notes to keep track of the details.

As we plodded through the ups and downs of Ric’s chemo treatment, I noticed that Ric’s various activities and encounters seemed to have an impact on his physical and emotional state from day to day. He clearly felt better on days after he’d been more physically active, and the benefits of visits or calls from Ric’s nephews and nieces were undeniable. He was more easily aggravated when he took certain medications and too much sleep seemed to make him feel worse.

Then something clicked for me. With a background in market research, I’d spent much of my career using data driven insights to help big companies identify opportunities, reduce risks, and become more efficient. I decided to use my research and data analysis skills to help Ric in his time of need. With a goal of helping Ric get through treatment, I created a system on my computer to keep a detailed record of Ric’s activities and experiences, which could help me identify things that might make him feel better or worse.

At first, Ric would get annoyed at my insistence to answer questions while he was struggling to not throw up his food. My constant inquiries seemed useless to him. And truth be told, I wasn’t sure if my system would help. But I was determined to help us regain control in what seemed like an uncontrollable situation and to give our doctor information that would let him intervene earlier to resolve issues.

Our doctor quickly acknowledged the benefits of the system. During an appointment when Ric had been dealing with severe constipation, we shared charts that highlighted an anti-nausea drug might be related to the issue he was experiencing. Ric’s doctor saw what we did. He could see the exact day and time when the negative side effect started—and so he prescribed Ric a different anti-nausea medication. Almost immediately, Ric’s symptom was relieved. We were excited that our system helped to identify the relationship between the constipation and Ric’s anti-nausea medication. We also realized for the first time that we had medication options and that doctors had choices if they had enough data.

Ric was resigned to the fact that he would feel terrible throughout the process. After all, “I have cancer,” he would say. But having the doctor easily change a drug designed to manage one side effect that might be causing another was a real revelation—and motivation for both of us. He could depend on our information to determine if a drug was working as intended or if Ric was drinking enough water, doing enough physical activity, or taking his medications on time. We now felt like we had an advantage in this fight&mdash;and a purpose. We knew with greater accuracy what Ric experienced and when. We now had individualized information. And we could give our doctor actionable and personalized insights. So, we started tracking everything we could think of: visits from family members, sleep patterns, weather, moon phases, moods, activities, and more.

We had discovered that far from being powerless throughout Ric’s treatment, that we could play an active role. We later learned that some healthcare organizations had been exploring the benefits of tracking symptoms between doctor appointments. The industry calls this type of symptom tracking patient reported outcomes (PROs).

We also learned that while the industry talks a lot about PROs, some executives are reluctant to integrate this type of patient information into their current systems, despite the benefits that have been proven through clinical research. Their reluctance stems from the overwhelming government and legal requirements that have turned too much of their work into silly administrative tasks. Also, electronic health records (EHRs) have been dumped into doctors’ files with little regard for the impact they have on patients. The doctor—patient relationship has greatly suffered because of the administrative tasks EHR systems have introduced into their face-to-face time. While many doctors feel the benefits of monitoring patient experiences or PROs are worth the added work, many hospital administrators have been reluctant to integrate PROs because this would add another layer to the record keeping process.

But the valuable daily information patients have about their care cannot be ignored if providers want less trial and error and better outcomes. Results from a recent 7-year clinical trial revealed that a system that enabled patients to record and report symptoms to doctors in real time resulted in higher survival rates among patients and helped patients to live longer with an improved quality of life and less emergency department visits.

 The healthcare industry is just beginning to realize the power of this immediate real-time tracking and monitoring of symptoms reported by patients. Many doctors see they can intervene with their patients when necessary, instead of allowing their patients to suffer in silence until their next in-person visit.

After Ric finished his treatment and was pronounced cancer free, and at the encouragement of his doctor, we decided to take the analytics program I created and put it into an app that could be accessed by anyone. The lessons we learned through 6 rounds of R-CHOP in the summer of 2013 needed to be shared with others dealing with cancer. And we were committed to making our program available for free.

After consulting with digital experts and healthcare professionals, I quit my full-time job, took money from our savings, and built a PROs system called chemoWave.

 After years of studying the technology options, hiring consultants, talking to researchers, and learning to comply with the Health Insurance Portability and Accountability Act, we are now harnessing the power of patient engagement and how they can drive better care using their own individualized information.

Today, our free app has gone through multiple upgrades and is now helping thousands of people. We’ve partnered with patient support groups such as the Look Good Feel Better Foundation and the CaringBridge non profit social network, and we have a resource collaboration with Cancer.net from the American Society of Clinical Oncology.

 We are working with major cancer hospitals to provide real-time, actionable chemoWave data to doctors and valuable aggregated/de-identified data to researchers. Our technology solution is less about the cancer diagnosis and more about identifying what makes each patient unique. An individual’s DNA is important, but so are psychosocial factors, their support system, their activities, and lifestyle.

Technology advances have prompted patients to demand this more immediate give-and-take with their doctor. Cancer patients are currently not equipped to be active participants in their care, and many tell us they feel like guinea pigs relegated to deal with cancer’s side effects on their own. They feel like they must put their heads down and endure it until their next face-to-face appointment with their doctor. But the more patients can get timely and accurate data to their healthcare team, the more likely the doctor can adjust treatment to significantly reduce or avoid side effects.

Today, chemoWave has learned much from the thousands of patients using our technology in all 50 states, representing 70 plus types of cancers.

Some users have said, “This is the first time I understand what’s going on with my body and my emotions,” and “I am motivated to get up and do more by seeing how closely tied my activity levels are to feeling better.” chemoWave is equipping patients and their caregivers with personal data-driven insights to better manage the physical and emotional rollercoaster of chemotherapy. And doctors who are treating patients using chemoWave are telling us that chemoWave has helped to improve their communication and made them feel more connected outside the office visit. This personal, real-time information on patient experiences means doctors can be more confident about their choices and spend less time on trial-and-error strategies.

chemoWave’s timely and specific data, and its system of ongoing data collection represent an underutilized trove of information not represented in the literature. Technology has revolutionized many industries, and it should be used to update patient protocols and their reactions to standardized healthcare. It is time for patients to have more control over what is prescribed to them and technologies like chemoWave are giving them that power.Author Information:

Matt Lashey, MBA, is the CEO of Treatment Technologies and Insights, which distributes the mobile application chemoWave. He founded the company working as a leader in market research and branding in the entertainment industry.

A 4-year cancer survivor, Richard Grenell assumed office as the US Ambassador to Germany on May 8, 2018. He was previously the longest serving US spokesman in United Nations history and is a former partner with Los Angeles-based Capitol Media Partners. Grenell is also a former Fox News contributor.References:

Basch E. The rise of patient-reported outcomes in oncology. American Society of Clinical Oncology website. am.asco.org/daily-news/rise-patient-reported-outcomes-oncology. Published May 26, 2016. Accessed April 6, 2018.

Basch E, Deal A, Dueck A, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. 

. 2017;318(2):197-198. doi:10.1001/jama.2017.7156.

Our partners. chemoWave website. chemowave.com/partners. Accessed April 6, 2018.

"It is time for patients to have more control over what is prescribed to them and technologies like chemoWave are giving them that power." A cancer diagnosis leads to chemoWave, an app for recording patient-reported outcomes. 

Riding the Wave Through Chemo: Cancer Journey Leads to chemoWave App for Reporting PROs

In software development, there’s a concept of a “retro.” Short for a retrospective, the process asks the engineering and product teams to review what’s been working, what hasn’t, and what they’ll commit to improving in the future. As we near the 2-year mark of the Oncology Care Model (OCM),

 we’ve had a chance to reflect on the results and reactions from the first performance period. The completion of the first performance period cycle presents an opportune time to step back to do a retro on how the model has reshaped participating practices and influenced the technology developers supporting them.

The OCM now covers 150,000 Medicare beneficiaries in 200,000 to 300,000 episodes per year,

 and we believe the sustained success and potential expansion of the model can best be driven by incremental iteration that reflects ongoing stakeholder feedback. The OCM, or any future model, will continue to have significant implications for technology developers and participating practices, as requirements become increasingly complex, practices try to mutually optimize quality and cost, and risk-sharing decisions (or obligations) loom. There’s no doubt the model has accelerated the transition from volume to value, particularly in more agile community practices, and its innovation will continue to serve as the foundation of newly proposed models. These include the Making Accountable Sustainable Oncology Networks model,

 which has been submitted to the Physician-Focused Payment Model Technical Advisory Committee.

Although oncologists may feel they’re straddling 2 divergent payment systems, only 1 is here to stay. HHS Secretary Alex Azar recently pointed out, in remarks to US hospitals, that the value-based transformation of our healthcare system

is one of his department’s top priorities.

 Given this, let’s look at what’s been working, what hasn’t, and what could improve in the near term for the OCM specifically and value-based care more broadly.

To kick off the retro process, let’s start with reflecting on the successes of the OCM thus far, namely greater collaboration with CMS, investment in foundational infrastructure, and the implementation of care processes that can be consistently measured and adapted.

While the program continues to evolve with each consecutive reporting period, CMS has worked to cultivate collaborative partnerships, both with oncology practices and electronic health record (EHR) developers. As oncologist Barbara McAneny, MD, president-elect of the American Medical Association, said at the Association of Community Cancer Centers Annual Meeting in March,

 CMS’ constant communication and willingness to incorporate feedback from practices is fostering a more collaborative relationship with oncologists. Through their monthly EHR vendor calls or regular “Support Lunch Hours” sessions with practices, CMS has built and maintained an entire apparatus to seek program feedback and consider program adjustments. This willingness to not only seek, but also implement, feedback has materialized most recently with the adaptation of quality measure criteria (eg, the removal of the OCM-7 measure) and the adjustment of patient-level clinical data submission requirements. This partnership among practices, EHR developers, and CMS will be imperative for the development of required technology infrastructure, to make performance more predictable, and ultimately assuage practice concerns about risk sharing.

Further, although the scope seemed insurmountable when the 160-page OCM Final Rule document was released, practices have made substantial progress within all 3 areas of foundational transformation, discussed in an earlier issue in 

: program administration, care process development, and performance measurement.

 In many cases, given the OCM’s rigorous quality and infrastructure requirements, practices have created new roles that focus on the program’s administration. For example, according to Toni Perry, director of quality and regulatory affairs at Tennessee Oncology, “To ensure success in accurately reporting quality metrics, Tennessee Oncology’s Quality and Regulatory Department added 4-5 full-time data abstractor positions, specifically devoted to validating, mining, and reporting quality data.”

The Monthly Enhanced Oncology Services (MEOS) payments have also enabled practices to expand both administrative and clinical resources to their broader population. “As a practice, we have increased our investment in organizational staff resources in areas such as patient advocates and navigators in order to implement the OCM principles to both OCM and non-OCM patients,” Perry said.

Within Flatiron’s network of over 50 OCM practices, we observed that many began administering their OCM program like a clinical trial: Patients must be screened for eligibility, they must be closely monitored, and detailed clinical data must be captured and reported on a regular basis. To support this imple- mentation, Flatiron leveraged its clinical trial technology to develop a screening tool that allows practices to identify, track, and manage OCM patient episodes. From this, all reporting and EHR-linked identification flows (Figure 1).

With the ability to more precisely identify patients and manage episodes, practices and EHRs have made significant investments in optimizing and codifying necessary processes for quality measurement and care planning. These workflows range from the familiar, like capturing pain, to the new and complex, like ensuring each provider referral loop is closed. EHR developers have deployed technology to make these processes as measurable, actionable, and frictionless as possible. For example, Flatiron’s OCM practices are able to quantify and track screening for pain and depression directly from clinical workflows. Similarly, practices have been able to standardize and streamline delivery of the required care plan to their patients. Flatiron’s care plan is autocompleted from existing data in the EHR, allowing physicians to focus more on patient engagement. Since the start of the program, Flatiron practices have delivered over 68,000 unique patient care plans.

Redesigning products and workflows to enable practices to more effectively implement the OCM has the added benefit of encouraging data capture with maximum ease of use and reporting efficiency. This is evident in our network; for breast cancer alone, structured data completeness doubled less than 2 years from the start of the OCM program compared with a marginal increase in structured data completeness for non-OCM Flatiron practices (Figure 2).

Although there’s been progress integrating foundational components of the OCM, the nuances of the model’s logic requirements and administrative burdens have tempered the pace of transformation, hindering a full pivot to cost-reduction initiatives.

To date, practices have focused on the program elements that are well defined though not easily achieved: identifying patients, billing and collecting MEOS, and reporting registry data. These requirements have created management duties that previously did not exist, and have significantly increased administrative burdens. In particular, practices struggle with the OCM patient identification and clinical data submission components; they have trouble tracking patients on oral oncolytics, a task compounded by inconsistent access to prescription fill data outside the purview of the clinic. This pain point will continue to be burdensome with the increasing adoption of oral therapies.

From July 2016 to July 2017, the percent of Flatiron network OCM episodes initiated by an oral therapy increased by about 10% to over 24,000 episodes (Figure 3). Besides patient identification, CMS has outlined significant requirements for data completeness. To avoid penalties, practices have invested significant resources in abstraction and data backfill, an operational burden that is now necessary but costly.

 study revealed that “administrative costs of care (activities relating to planning, regulating, and managing health systems and services) accounted for 8% in the [United States] versus a range of 1% to 3% in the other countries.”

This is evident across Flatiron’s OCM network: Over 2 million data elements were reported for almost 41,000 OCM patients to the OCM registry during the last submission period. Based on an analysis of the timing of data entry, we estimate that over 36% of breast cancer staging data were entered into the EHR via data abstraction and backfill. While executing these processes is imperative to enable the focus on more esoteric objectives of the model, these administrative components have taken over a year to fully implement for sites and have distracted practices from understanding how to approach the components that more directly affect patient care. The reality is that while collecting, reporting, and measuring high-fidelity data is arduous, much like the adoption of an EHR, they are fundamental enablers of administering value-based models. With the significant administrative investments in the program focused on tackling the OCM on ramp, the vast majority of practices have not yet demonstrated savings below their target spend.

The focal shift away from the administrative execution of the model toward higher-value activities, including gaining a deeper understanding of the financial model and exploring practice-specific opportunities to reduce costs, will be key to the OCM’s durability and ongoing practice success. This shift requires administrative and physician engagement to align on care coordination opportunities, enable productive conversations with the local healthcare ecosystem, and tailor care to each patient’s goals. Anne Marie Rainey, the compliance and quality control officer at Clearview Cancer Institute in Huntsville, Alabama, agrees. “Everyone at the practice—from the concierge to the physician board&mdash;needs to be aware of the program and future implications. Through the use of data-driven tools, detailed clinical reporting, and individual education we are beginning to notice shift in physician engage- ment. We’re now investing in more clinical staff and supportive care services to better address the needs of our patient population and provide higher quality, patient-centered care.”

The OCM, among other quality programs, has shown that point-of-care technology is where and how clinicians experience alternative payment models (APMs) and can be an effective means to engage physicians. They’re where policy is translated into technology that is used to manage patients in value-based models. As such, EHRs must be held accountable for doing their part to reduce the administrative and bureaucratic friction that clinicians experience so they can better spend their time optimizing patient outcomes. During the first year of the model, our clinical team received significant feedback on the cumbersome nature of diagnosing conditions and staging patients in the EHR. Shortly after, the team employed a physician-centric approach when conducting user research with doctors and redesigned the interface to ensure these workflows were intuitive, user friendly, and encouraged structured data capture for programs like the OCM. Now it takes less time to diagnose a patient’s disease, clinicians see consolidated clinical information, and content is more easily updatable for when standards or reporting requirements inevitably change.

However, developing more physician-centric products to enhance usability isn’t enough. Point-of- care data products that leverage the scale of cancer networks must be developed with the data that’s being so meticulously captured for these models. For every patient with cancer who walks into a clinic, a cohort of the most similar patients in a network, and their treatments and outcomes, could be generated. These types of predictive cohorts could enable physicians

to make more personalized treatment decisions by learning from the experience of every patient with cancer. Outcomes of similar patients with cancer could become the evidence required to make a more value-based decision or the stories physicians use to have difficult end-of-life discussions with their patients.

The onus will continue to be on EHR developers to gain an empathetic understanding of users and build intuitive products they need to succeed in this new paradigm. Meanwhile, policymakers must see healthcare technology providers not merely as secondary constituents or APM facilitators, but rather as key stakeholders who must be engaged early and often throughout model design and implementation.

In examining the OCM through the lens which engineering and product teams use to reflect on their performance, the retro, it becomes clear just how much value-based care itself is a team effort. It starts with the care team and goes far beyond, relying upon novel partnerships between payer and provider, government and health information technology, and hospital and clinic. As we enter the second, and more trying, half of the OCM, we’ll soon know if this experiment is a collective win: if patients with cancer across the country have access to higher-quality, more affordable care.

All authors are affiliated with Flatiron Health, a healthcare technology and services company focused on accelerating cancer research and improving care based in New York, New York. Ryan Holleran is a manager of product marketing and strategy; Arif Gilani is a manager of product operations; Abigail Orlando is a data insights engineer; and Brenton Fargnoli, MD, is the medical director of value-based care and director of product marketing and strategy.References:

Oncology Care Model. CMS website. innovation.cms.gov/initiatives/ Oncology-Care. Updated April 5, 2018. Accessed April 11, 2018.

Kline R, Adelson K, Kirshner JJ, et al. The Oncology Care Model: perspectives from the Centers for Medicare Medicaid Services and participating oncology practices in academia and the community. 

Educ Book. 2017;37:460-466. doi: 10.14694/EDBK_174909.

McAceny B. MASON - Making Accountable Sustainable Oncology Networks. Assistant Secretary for Planning and Evaluation/HHS website. aspe.hhs.gov/ system/files/pdf/255906/ProposalIOBS.pdf. Accessed April 13, 2018.

Physician-Focused Payment Model Technical Advisory Committee (PTAC). ASPE/HHS website. aspe.hhs.gov/ptac-physician-focused-pay-ment-model-technical-advisory-committee. Updated March 10, 2017. Accessed April 13, 2018.

Azar A. Remarks on value-based transformation to the Federation of American Hospitals. HHS website. hhs.gov/about/leadership/secretary/ speeches/2018-speeches/remarks-on-value-based-transformation-to-the-federation-of-american-hospitals.html. Published March 5, 2018. Accessed April 13, 2018.

Flatiron Health recently conducted a retrospective review of the Oncology Care Model, discovering what's working, what isn't, and what this could mean for the future.

June 2018

The Impact of New CMS Rules for Telehealth on Cancer Genetic Counseling

National Comprehensive Cancer Network, American Association of Clinical Urologists, and Large Urology Group Practice Association Endorse Biomarkers in Prostate Cancer

Riding the Wave Through Chemo: Cancer Journey Leads to chemoWave App for Reporting PROs

A Retrospective on the Oncology Care Model

Perspective: FDA/CMS Parallel Review Advances Coverage for Cancer Comprehensive Genomic Profiling

From the Editor in Chief: Making Disruptive Technology Less Disruptive

With the Oncology Care Model, "Everyone Has to Be Engaged," Including Patients

Population Health Council Discusses Progress in Payment Reform, Ongoing Barriers in Oncology Care

Medical World News: Managed Care Updates

Medical World News: Clinical Updates