Abstract: It is widely recognized that the quality of medical care received in the United States is suboptimal, and poor-quality care may contribute to disparities in cancer incidence and mortality. While governmental and nongovernmental groups have developed a road map and implemented quality metrics for several common cancers and other aspects of cancer care, only one endorsed quality measure is available for assessing the quality of care for patients with multiple myeloma (MM). We sought to investigate how a large community oncology practice in the United States views quality in MM care, the gaps in care they perceive, and potential solutions and measurement opportunities. This report from the field chronicles the initial results of that work between a community oncology practice and a drug manufacturer to improve MM care quality.
Key Words: multiple myeloma, quality improvement, care coordination
Mortality rates from the most common cancers in the United States have declined by over 2% in the last decade, driven by continued improvements in prevention, screening, and treatment.1 Not all segments of the population have, however, benefited equally. Beyond sociodemographic and access-to-care differences, it is widely recognized that the quality of care received in the United States is suboptimal, and poor-quality care may contribute to disparities in cancer incidence and mortality.2-4 Quality measures are one tool that can quantify health care processes, outcomes, patient perceptions, and organizational structure and/or systems, and which can be used for quality improvement, public reporting, and pay-for-reporting programs for providers.5 Early attempts to tie reimbursement to quality (so-called “managed care”) did not lead to significant improvements over the traditional fee-for-service model.6 The Affordable Care Act, passed in 2010 as the largest health care system reform since the introduction of Medicare, mandated the development of alternative payment models (APMs) to increase access to services, to lower costs, and to improve quality.7
APM participation options for oncologists and other cancer care providers include the Oncology Care Model (OCM), which seeks to improve care and lower costs through a chemotherapy episode-based payment model that financially incentivizes high-quality, coordinated care.8 The OCM includes six quality measures across two National Quality Strategy domains: communications and care coordination, and person- and caregiver-centered experience and outcomes.
More than one-third of health care payments nationally are now tied to APMs.9 Groups like the American Society of Clinical Oncology (ASCO) and the American Society of Hematology have worked to support APMs and cancer quality improvement by developing quality measures for physician benchmarking. The ASCO Quality Oncology Practice Initiative includes more than 150 evidence-based quality measures from domains spanning general oncology care to end of life and also includes disease-specific measures for breast, colorectal, prostate, lung, and gynecologic cancers.10 While many measures have been implemented, there are important gaps in measures for other less prevalent cancers.
One cancer where there is a gap in quality measures is multiple myeloma (MM), a chronic, proliferative bone marrow neoplasm affecting more than 30,000 individuals in the United States each year. Only one quality measure specific to MM, NQF 0380—Hematology: Multiple Myeloma: Treatment with Bisphosphonate, has been endorsed by the National Quality Forum (NQF),11 a consensus-based health care organization that endorses measures or health care practices as the best, evidence-based approaches to improving care. With the approval of orally administered lenalidomide in 2007 for the treatment of newly diagnosed MM, there have been dramatic improvements in patient prognosis.12-14 Since then, new treatment combinations (such as daratumumab or bortezomib plus lenalidomide and dexamethasone) that combine different routes of administration and dosing schedules, and which have complex safety-monitoring requirements, have also been approved.15-18 For lenalidomide, the US Food and Drug Administration required the implementation of a risk evaluation mitigation strategy (REMS) program to reduce the risk of embryo-fetal exposure. Prescribers and pharmacies must be certified to dispense lenalidomide and must adhere to specific patient-counseling and dispense-timing requirements. Community oncology practices that dispense lenalidomide face complexity in coordinating the care between orally administered and intravenous (IV) regimens, educating patients, and delivering (or administering) lenalidomide and its combination partners to derive the greatest clinical benefit without compromising safety. To identify areas for quality improvement, recommend interventions to improve quality, and identify opportunities for new measures to benchmark care quality and drive improvement in MM care, we employed the narrative method of qualitative research to understand gaps in quality and measurement facing community oncology practices from the physician, supporting staff (including nurses), and pharmacy point of view.
Methods
A pilot partnership between a large community oncology practice (Tennessee Oncology) and the manufacturer of lenalidomide (Bristol Myers Squibb) was initiated to understand gaps in quality facing practices treating patients with MM, to find solutions that practices have implemented or could implement to address these gaps, and to identify ways to measure quality improvement performance. The practice selected is one of the largest community oncology practices in the country with over 30 locations and 90 physicians across Tennessee. Tennessee Oncology treats more than 70,000 new patients annually including approximately 1100 patients with MM. Two independent contractors, Discern Health and Cardinal Health, were responsible for gathering qualitative and quantitative information on MM care quality from the practice.
Data Collection and Analysis
Based on data from the electronic medical record (EMR) system, five providers treating 304 patients with MM between January 2016 and December 2018 were selected and asked to participate in in-depth interviews. Interviews were conducted with those physicians (5 including the recognized practice lead for MM and community oncologists treating the largest number of MM patients at the sites), support staff (at the provider’s discretion), and members of Tennessee Oncology’s in-practice, specialty pharmacy (IP-SP; distinct from any external SP supplying medication to patients).
Interviews examined how these individuals view quality MM care, gaps in care delivery, improvement opportunities, and potential measures for benchmarking and improving care covering the following domains: access to care or clinical advice/communication, care coordination, disease management for MM, patient education, medication management, and data and quality improvement.
The five providers and associated staff participating in the interview practiced at five different sites including both urban and rural locations (Table 1) with physicians and support staff interviewed simultaneously in person or via phone while IP-SP staff were interviewed separately one at a time. The IP-SP was responsible for dispensing drugs across all sites. Two individuals, one research coordinator and an additional registered nurse and former primary care practice manager with patient-centered medical-home certified content expertise, developed the interview guide and conducted the interviews. Patients were not interviewed during this phase of the pilot project.
Findings
Access to Care or Clinical Advice/Communication
IP-SP staff identified challenges in determining and documenting patients’ insurance coverage for a therapy (Figure 1). IP-SP staff believed this was a significant factor that could contribute to delays between prescribing and receipt of first oral chemotherapy. Furthermore, the ability of the IP-SP to access consistent foundation funding for at-risk patients was cited as a factor contributing to delays in receiving approval for medication. Competing priorities between the pharmacy and practices to obtain limited foundation funding for oral chemotherapy and intravenously administered drugs were cited as factors further contributing to delays in treatment initiation.
Care Coordination
Providers as well as IP-SP staff reported that meeting all applicable REMS-consenting activities posed a significant challenge through existing workflows. Providers reported inconsistent approaches for educating patients about the role of the IP-SP in coordinating the REMS processes. Some practices reported not educating patients about the IP-SP process for calling and engaging patients about their medications, and providers reported that patients preferred to engage the practice directly, rather than the IP-SP, to resolve prescription-related concerns. This communication is complicated as a significant proportion of patients may receive prescriptions from an external SP as mandated by their insurance provider (qualitative data provided by IP-SP leadership). The extent to which coordination with the IP-SP vs the external SP drives any perceived or real miscommunication could not be determined.
Disease Management for Multiple Myeloma and Patient Education
The majority of providers gave feedback that shared decision-making in MM treatment selection is difficult to achieve because of the complexity of disease management and treatment options. Treatment decision-making is variable, depending on the patient’s performance status, age, etc, and there is a lack of standardized tools to aid in shared decision-making discussions. Providers reported consistent use of Via Oncology (now Elsevier’s ClinicalPath) materials, available through the practice’s EMR, to educate patients about treatment. Overall, practices reported a consistent approach to patient education that emphasizes side effects, REMS safety, and medication intent and use. One point of discussion concerned the utility of creating a calendar tool to aid in communicating the timing of treatment administrations. Feedback from practice staff was mixed on the value and utility of such a calendar tool (paper- or EMR-based) and providers and pharmacy staff did not believe this type of tool would provide significant value.
Medical Management
While significant attention is given to adherence to oral therapies, practice staff reported limited concern for medication nonadherence. There is a lack of adherence-related data for actionable quality improvement in the EMR/prescription management system with the ability to track nonadherence in the clinic or for real-time views into delays in the initiation of therapy. Furthermore, metrics to assess adherence to combination oral/IV therapies do not exist. This lack of data is further complicated by providers reporting workflow challenges using the practice’s EMR system to modify treatment dosing. Providers reported that, if delays for oral agents are known, they will often begin other therapy regimens.
Data and Quality Improvement
All practice and IP-SP staff identified a lack of meaningful measures to monitor quality for MM care. Furthermore, both groups acknowledged a lack of understanding of other quality-improvement initiatives at the practice, with limited visibility among staff of continuous quality-improvement reporting. Providers reported receiving data regarding clinical pathway adherence rates but that no MM-specific quality measures were available to benchmark practice performance.
Opportunities for Quality Improvement
To improve access to care or clinical advice/communication, staff sought to develop processes to ensure data gathering on insurance status and coordination of practice/IP-SP applications for foundation funding integrated into workflows. Workflow-process improvements identified as being beneficial were those that clearly delineate which staff members (practice nurse, practice provider, IP-SP staff) are responsible for providing treatment education to patients and for directing them to resources best suited to answer specific types of questions. This could advance patient foundation support and reimbursement verification.
To improve care coordination, staff indicated that streamlining the workflow to minimize the number of days between prescription and treatment initiation is critical. To achieve this, improved accuracy and transparency in anticipated receipt of medication between pharmacy and practice are needed.
For disease management and patient education in MM, IP-SP staff should retain primary responsibility for the patient-consenting process for REMS-related dispensing, and practice staff should prioritize and emphasize the role of the IP-SP in coordinating the REMS process to patients. Centralization of the REMS processes to licensed practical nurses (LPNs) within the IP-SP allows LPNs to be the first line of contact for patients, while pharmacists remain the experts on medications. Following pharmacy REMS centralization, LPNs can also carry out reimbursement verification and foundation support, ensuring patient affordability and continued treatment. Providers perceived limited utility for IP-SP LPNs to directly engage patients to identify potential issues affecting treatment (eg, adverse events) as they perceive patients will approach the practice directly. Collaborative meetings between the IP-SP LPNs and practice staff are needed to further define this role and associated responsibilities. Additionally, patient educational materials that effectively communicate the role of the LPN in the care team need to be developed.
For medical management, workflow challenges to simplify dose modifications occurring during treatment are needed. An EMR-integrated regimen calendar tool to print and share with patients may be beneficial; however, further research is needed to understand the utility for patients. Interviewees expressed limited concern for medication adherence likely due to a lack of data. Simple adherence metrics for the oral component of a treatment regimen could be developed and reported by the IP-SP to the patient’s care team. This collaboration could ensure optimal adherence and reporting of nonadherence allowing for better assessment of the patient response to therapy given that nonadherence to oral therapies reduces efficacy.
Opportunities for Quality Measurement
The most clinically meaningful potential quality measure identified by the providers and practice staff was assessment of any delay in initiation of the first MM treatment. Providers noted that factors causing delays in therapy may lead to suboptimal care, such as poor coordination of visits to monitor treatment if the patient has not received medication or receipt was after the intended start date. Providers subjectively reported treatment initiation delays (ie, the time from diagnosis until first therapeutic intervention), and, using the pharmacy claims and EMR data, our analysis showed that, for patients treated with lenalidomide, there was a gap in treatment initiation (although we did not explore differences between treatment regimens with and without a REMS component as the majority of patients with MM receive lenalidomide-based induction therapy). To address this concern, the practice centralized the REMS authorization process during the year prior to the initiation of this pilot project. We found the time to initiation of a lenalidomide-based regimen (days from prescribing the therapy in the clinic to the actual date of initiation of cycle 1 day 1) decreased in relation to the centralization of the IP-SP. The proportion of patients initiating therapy within 30 days increased from 51.4% in 2016 to 80.0% in 2018, with substantially fewer patients having delays in treatment initiation of > 60 days (from 27.5% in 2016 to 10.0% in 2018) (Figure 2). Other factors which may have resulted in a reduction in the time to therapy start, such as changes in prior authorization procedures, faster approval of foundation funding for therapy, or other coverage-related issues, were not available to be examined but may also contribute to these improvements.
Other potential measures identified by the providers to benchmark MM quality of care included assessing the use of triplet vs doublet therapy, duration of therapy, and adherence to therapy.
Discussion
Several areas for quality improvement in MM-related care were consistently reported across sites and care teams that were founded upon the interaction between the IP-SP and the practice site. These included the timely receipt and initiation of therapy and improvement of care coordination between the centralized IP-SP and the practice. Timely receipt of oral medication to ensure that the medical management of the patient was consistent with the providers’ treatment plan was a frequently cited gap in delivery of MM care. This is particularly important given that most patients with MM will at some point receive treatment with lenalidomide, requiring use of the REMS process. Timely receipt of medication could reduce patient stress related to delays in treatment and reduce symptom burden more quickly, both of which may directly impact patients’ quality of life.
We found that there is a significant opportunity to improve coordination of care and patient education between the centralized IP-SP and individual practice sites. While we did not interview patients at this time, their future participation could help to identify gaps in quality and potential solutions. The observed decrease in time to first treatment suggests that REMS centralization has been successful, but regardless of this improvement, interviewees continued to indicate further improvement is needed. The extent to which IP-SP centralization was successful within certain clinical practices was not evaluated. Furthermore, as MM treatment regimens become more complex, care coordination becomes more critical, and treating providers, nurses, care coordinators, and LPNs can all educate the patient about their disease and treatment, including the importance of therapy adherence.
Based on the results of our interviews and analysis we believe that measurement of the delay in treatment initiation is a potential MM-specific quality care measure, however, further research is needed to uncover the associations between this measure and clinical- or patient-reported outcomes. Other research has identified symptom reporting, supportive care, and information on palliative care as other important aspects of quality care in MM, which can improve health-related quality of life.19,20 In particular, the older age of the MM patient population, compared to many other malignancies, means a focus on reducing morbidity and improving quality of life, and could have robust effects on MM quality care.
Limitations
There are important limitations to this evaluation that should be noted. First, our program was limited to a single, large, multidisciplinary cancer practice with dispensing pharmacy in one US state and may not be representative of other similar institutions in other states or those practices of different sizes. Next, we did not undertake a quantitative approach to measurement of constructs or opinions, and our sample was restricted to selected providers and staff willing and able to participate. Finally, our assessment of the timing of treatment initiation relied on data from the pharmacy dispensing system and may not reflect the actual timing of initiation of therapy by the patient themselves.
Conclusion
Through qualitative interviews with physicians and other staff, we found that providers believe quality MM care at a large, multidisciplinary oncology practice can be improved through better coordination between pharmacy staff and site-based providers. In addition, treatment delay may be used as an appropriate measure to develop a cyclic quality improvement process reflective of many aspects of care coordination between practices and pharmacy staff important to MM quality care. To advance MM quality improvement initiatives, further research, including incorporation of the patient voice, is needed to understand how care coordination can be improved and how treatment delays impact patient-reported and clinical outcomes.
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