True care coordination essential to achieve best outcomes in a value-based system.

I've been meeting with physicians nationwide about their planned, ongoing and potential transitions from fee-for-service to value-based reimbursement. It's certainly a work in progress.

Roundtable--the changing oncology landscape: evolution or revolution?

Complex challenges face all players in the oncology landscape, from health care policy leaders and third-party payers, to practicing physicians and nurses, to patients and their families. In these unsteady economic times, possible answers proposed by some may represent part of the problem to others. A distinguished panel assembled at the NCCN 18th Annual Conference: Advancing the Standard of Cancer Care to explore the changing oncology landscape. This article is the synopsis of that discussion, with panelists shedding light on such issues as the astronomic cost of medical care, the need for clinicians to think outside the formulary, and the therapeutic decision-making process in the new world of "big data."

A phase II open-label trial of bortezomib in patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant and failed to achieve a complete response.

BACKGROUND: A majority of multiple myeloma (MM) patients fail to achieve complete response (CR) to peripheral blood stem cell transplantation (PBSCT); effective options following autologous transplantation are needed. Bortezomib (B) is active against MM. This study was conducted to determine the feasibility, safety, tolerability, and efficacy of B following high-dose melphalan therapy and PBSCT. Methods Fifty patients enrolled (48 evaluable) and 49 were treated (safety population). TREATMENT: 4 cycles B 1.3 mg/m(2) Days 1, 4, 8, and 11/21-days; 4 additional cycles were permitted for stable or responding patients. Results Median age was 55 years (range, 38-73), 68% male, 64% ECOG PS = 0, 44% Durie-Salmon Stage IIIA prior to induction, 42% had symptomatic IgG MM; 74% had prior single transplant (26% tandem). Responses post-transplant: 70% PRs, 18% MRs. A median of 4 cycles (range, 2-8) of B were administered. Responses: CR 8%, uCR 2%, PR 23%, uPR 19%, MR 10%, and no change 35%; median time-to-treatment failure (TTF) was 6.2 months (range, 1.0-19.4). Three deaths occurred (n = 1 sepsis, n = 2 disease progression). Grade 3-4 treatment-related toxicities included: thrombocytopenia, neuropathy (14%, each); asthenia, neutropenia (10%, each); and nausea (4%). Twelve patients (24%) discontinued treatment due to toxicity and 30 patients (60%) completed the study; 20 patients started new treatment (median 5.8 months [range, 1.5-20.3]). CONCLUSIONS: The study closed early due to widespread availability of B, and the lack of B-naïve patients. Bortezomib monotherapy after melphalan and autologous PBSCT was feasible, safe and well-tolerated (toxicities were manageable), but failed to produce the hypothesized response rates.

Palliative care and oncology partnerships in real practice.

This article addresses the practical application of palliative care (PC) in the outpatient oncology setting. While information on this topic is scarce, data published by a few outpatient practices provide the basis for potential models of integrated care. In general, the perceived impact of integrating PC into standard oncology practice is positive for patients, providers, oncology practices, and the healthcare system as a whole. As the benefits of integrating PC into oncology practice continue to be realized, more data will become available.

Seeking Consensus on the Terminology of Value-Based Transformation Through use of a Delphi Process.

Collaboration among diverse stakeholders involved in the value transformation of health care requires consistent use of terminology. The objective of this study was to reach consensus definitions for the terms value-based care, value-based payment, and population health. A modified Delphi process was conducted from February 2017 to July 2017. An in-person panel meeting was followed by 3 rounds of surveys. Panelists anonymously rated individual components of definitions and full definitions on a 9-point Likert scale. Definitions were modified in an iterative process based on results of each survey round. Participants were a panel of 18 national leaders representing population health, health care delivery, academic medicine, payers, patient advocacy, and health care foundations. Main measures were survey ratings of definition components and definitions. At the conclusion of round 3, consensus was reached on the following definition for value-based payment, with 13 of 18 panelists (72.2%) assigning a high rating (7- 9) and 1 of 18 (5.6%) assigning a low rating (1-3): "Value-based payment aligns reimbursement with achievement of value-based care (health outcomes/cost) in a defined population with providers held accountable for achieving financial goals and health outcomes. Value-based payment encourages optimal care delivery, including coordination across healthcare disciplines and between the health care system and community resources, to improve health outcomes, for both individuals and populations." The iterative process elucidated specific areas of agreement and disagreement for value-based care and population health but did not reach consensus. Policy makers cannot assume uniform interpretation of other concepts underlying health care reform efforts.

An observational, retrospective analysis of retreatment with bortezomib for multiple myeloma.

PURPOSE: The aim of this retrospective chart review of patients with multiple myeloma (MM) was to describe patterns of retreatment with bortezomib-based therapy and responses to retreatment in a community-based setting. PATIENTS AND METHODS: Data were retrospectively extracted from the medical records of patients treated in US Oncology-affiliated community oncology clinics who received 2 separate treatments with bortezomib-based therapy. Eligible patients had > or = 60 days between treatments and > or = 4 bortezomib doses during initial treatment. Responses were determined primarily by laboratory values. Response categories included (1) very good partial response (VGPR), > or = 90% M-protein decrease; (2) partial response (PR), 50%-89% decrease; and (3) less than PR (< PR), < 50% decrease, excluding progressive disease (PD). RESULTS: Retreatment response data were available for 82 patients; 5 (6%) had VGPR, 12 (15%) had PR, 52 (63%) had < PR, 5 (6%) had PD, and 8 (10%) died. Among 62 patients with response assessments for initial treatment and retreatment, VGPR/PR rates to retreatment were 44%, 23%, and 13% among patients with VGPR, PR, and < PR to initial treatment, respectively. Median time between bortezomib treatments was 9.7 months; 29% of patients received non-bortezomib therapy between treatments. The most common treatment pattern (58% of patients) was single-agent bortezomib at initial treatment and retreatment. Toxicity contributed to discontinuation in 38% of patients during initial treatment and 22% during retreatment; rates of neuropathy contributing to discontinuation were 18% and 6%, respectively. CONCLUSION: Retreatment with bortezomib-based therapy is feasible, with predictable toxicities. This observational analysis supports bortezomib alone or in combination as a retreatment option after initial bortezomib treatment in patients with relapsed MM.

Family Physician Readiness for Value-Based Payments: Does Ownership Status Matter?

Value-based payments are rapidly replacing fee-for-service arrangements, necessitating advancements in physician practice capabilities and functions. The objective of this study was to examine potential differences among family physicians who are owners versus employed with respect to their readiness for value-based payment models. The authors surveyed more than 550 family physicians from the American Academy of Family Physician's membership; nearly 75% had made changes to participate in value-based payments. However, owners were significantly more likely to report that their practices had made no changes in value-based payment capabilities than employed physicians (owners 35.2% vs. employed 18.1%, P < 0.05). This study identified 3 key areas in which physician owners' value-based practice capabilities were not as advanced as the employed physician group: (1) quality improvement strategies, (2) human capital investment, and (3) identification of high-risk patients. Specifically, the employed physician group reported more quality improvement strategies, including quality measures, Plan-Do-Study-Act, root cause analysis, and Lean Six Sigma (P < 0.05 for all). More employed physicians reported that their practices had full-time care management staff (19.8% owners vs. 30.8% employed, P < 0.05), while owners were more likely to report that they had no resources/capacity to hire care managers or care coordinators (31.4% owners vs. 19.4% employed, P < 0.05). Owners were significantly more likely to respond that they do not have the resources/capacity to identify high-risk patients (23.1% owners vs. 19.3% employed, P < 0.05). As public and private payers transition to value-based payments, consideration of different population health management needs according to ownership status has the potential to support the adoption of value-based care delivery for family physicians.

2005 to 2014 CT and MRI Utilization Trends in the Context of a Nondenial Prior Authorization Program.

PURPOSE: Reducing unnecessary testing may benefit patients, as some computed tomography (CT) and magnetic resonance imaging (MRI) expose patients to contrast, and all CTs expose patients to radiation. This observational study with historical controls assessed shifts in CT and MRI utilization over a 9-year period after a private health insurer's implementation of a nondenial, consultative prior authorization program. METHODS/MATERIALS: Normalized rates of exams per 1000 person-years were plotted over 2005 to 2014 for people with commercial and Medicare Advantage health plans in the San Antonio market, with 2005 utilization set as the baseline. The program was implemented at the start of 2006. Computed tomography and MRI utilization changes were compared with contemporaneous changes in low-tech plain film and ultrasound utilization. RESULTS: Growth in high-tech imaging utilization decelerated or reversed during the period. In 2006, CT utilization dropped to between 76% and 90% of what it had been in 2005, depending on the plan. In 2014, it was between 52% and 88% of its initial level. MRI utilization declined to between 86% and 94% of its initial level in 2006, and then to between 50% and 75% in 2014. Ultrasound utilization was greater in 2014 than in 2005 for some plans. Plain film utilization declined between 2005 and 2014 for all plans. CONCLUSION: There was an immediate and sustained decline in CT and MRI utilization after the introduction of the program. While many factors may have impacted the long-term trends, the mixed trends in low-tech imaging suggest that a decline in low-tech imaging was not responsible for the decline in CT and MRI utilization.

Does a Free Office Visit Affect Primary Care-Seeking Behavior? A Study of New Exchange Health Plan Enrollees in Mississippi.

BACKGROUND: Given the positive association between primary care and overall health, several health plans are offering doctors' visits without patient copay, with the intent to increase primary care use. However, the effectiveness of these offers has not been established in the literature. OBJECTIVE: To evaluate the impact of a free primary care provider (PCP) office visit offered by a health plan on primary care-seeking behaviors. METHODS: This nonrandomized concurrent control study used event/trials logistic regression to compare the differences in primary care utilization between new exchange enrollees in Mississippi who were offered a free nonpreventive PCP visit and concurrent controls from Georgia and Tennessee who were not offered a free visit, between January 1, 2014, and December 31, 2014, which was the first year of the exchange plans. Regression models adjusted for age, sex, plan type, rural-urban designation, and enrollment month. Visits to alternative sites of care were also assessed. RESULTS: The adjusted number of nonpreventive PCP visits did not differ between the states (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.97-1.00). Mississippi residents were significantly more likely to go to the emergency department than the Georgia-Tennessee cohort (OR, 1.33; 95% CI, 1.28-1.39), but they were less likely to visit an urgent care center (OR, 0.10; 95% CI, 0.09-0.11) or a retail clinic (OR, 0.13; 95% CI, 0.11-0.17) than their counterparts. CONCLUSIONS: Despite being eligible for a free nonpreventive visit, enrollees in Mississippi were no more likely than their counterparts in Georgia and Tennessee to visit a PCP. These findings suggest that removing the cost barrier alone may be insufficient to change primary care-seeking behaviors, and other barriers to care should be addressed.

Mortality Differences Between Traditional Medicare and Medicare Advantage: A Risk-Adjusted Assessment Using Claims Data.

Medicare Advantage (MA) has grown rapidly since the Affordable Care Act; nearly one-third of Medicare beneficiaries now choose MA. An assessment of the comparative value of the 2 options is confounded by an apparent selection bias favoring MA, as reflected in mortality differences. Previous assessments have been hampered by lack of access to claims diagnosis data for the MA population. An indirect comparison of mortality as an outcome variable was conducted by modeling mortality on a traditional fee-for-service (FFS) Medicare data set, applying the model to an MA data set, and then evaluating the ratio of actual-to-predicted mortality in the MA data set. The mortality model adjusted for clinical conditions and demographic factors. Model development considered the effect of potentially greater coding intensity in the MA population. Further analysis calculated ratios for subpopulations. Predicted, risk-adjusted mortality was lower in the MA population than in FFS Medicare. However, the ratio of actual-to-predicted mortality (0.80) suggested that the individuals in the MA data set were less likely to die than would be predicted had those individuals been enrolled in FFS Medicare. Differences between actual and predicted mortality were particularly pronounced in low income (dual eligibility), nonwhite race, high morbidity, and Health Maintenance Organization (HMO) subgroups. After controlling for baseline clinical risk as represented by claims diagnosis data, mortality differences favoring MA over FFS Medicare persisted, particularly in vulnerable subgroups and HMO plans. These findings suggest that differences in morbidity do not fully explain differences in mortality between the 2 programs.

The physician-insurer dynamic must shift to successfully implement value-based payments.

Decades of practice under a system that set the financial interests of physicians and insurers at odds, has resulted in physician distrust of insurers being cited a key obstacle to value-based arrangements. Insurers must work to shift the insurer-provider relationship from one that's transactional to a partnership built on trust. Even when physicians and insurers agree philosophically on quality over quantity, there are practical challenges. Insurers can provide the data, systems and analytical insights that help inform the physician's care strategy. Implementing value-based payments requires the two groups to build trust and work together to change long-established systems.

The effects of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) on platelet recovery in breast cancer patients undergoing autologous bone marrow transplantation.

OBJECTIVE: To assess the safety and efficacy of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) administered after autologous bone marrow transplantation (ABMT). PATIENTS AND METHODS: Two randomized, double-blind, placebo-controlled studies were done. In the phase 1/2 study, 75 breast cancer patients underwent a bone marrow harvest and myeloablative STAMP V chemotherapy and were randomized to receive placebo or one of three doses of PEG-rHuMGDF. In the phase 3 study, 64 patients were randomized to receive placebo or the minimally effective dose of PEG-rHuMGDF. The study drug was administered daily starting on the day of bone marrow infusion until the platelet count was greater than or equal to 50 x 10(9)/L (without transfusion) or for a maximum of 28 days. All patients received 10 microg/kg/day filgrastim starting on day 2 until neutrophil count recovery. RESULTS: PEG-rHuMGDF appeared to be safe and well tolerated. No significant differences were noted in mortality or disease progression rates. Antibodies to MGDF were not observed. In the phase 1/2 study, the time to platelet recovery to greater than or equal to 20 x 10(9)/L and platelet transfusion requirements were significantly reduced for patients treated with PEG-rHuMGDF compared with placebo (p < 0.05). In the phase 3 study, no significant differences in the kinetics of early thrombopoiesis or platelet transfusions after ABMT were observed. CONCLUSIONS: PEG-rHuMGDF was not consistently efficacious in reducing the duration of severe thrombocytopenia. The maximum platelet counts for PEG-rHuMGDF-treated patients occurred a median of 2 weeks after the last dose of drug, suggesting that the biologic effects of this hematopoietic cytokine are delayed compared with other hematopoietic cytokines.

Cost differential by site of service for cancer patients receiving chemotherapy.

OBJECTIVES: To compare the costs of: 1) chemotherapy treatment across clinical, demographic, and geographic variables; and 2) various cancer care-related cost categories between patients receiving chemotherapy in a community oncology versus a hospital outpatient setting. STUDY DESIGN: Data from the calendar years 2008 to 2010 from the Truven Health Analytics MarketScan Commercial Claims and Encounters Database were analyzed. During 2010, the data set contained approximately 45 million unique commercially insured patients with 70,984 cancer patients receiving chemotherapy. These patients were assigned to cohorts depending on whether they received chemotherapy at a community oncology or hospital outpatient setting. METHODS: Cost data for 9 common cancer types were extracted from the database and analyzed on a per member per month basis to normalize costs; costs included amounts paid by the payer and patient payment. Community oncology and hospital outpatient setting chemotherapy treatment costs were categorized and examined according to cancer diagnosis, patient demographics, and geographic location. RESULTS: Patients receiving chemotherapy treatment in the community oncology clinic had a 20% to 39% lower mean per member per month cost of care, depending on diagnosis, compared with those receiving chemotherapy in the hospital outpatient setting. This cost differential was consistent across cancer type, geographic location, patient age, and number of chemotherapy sessions. Various cost categories examined were also higher for those treated in the hospital outpatient setting. CONCLUSIONS: The cost of care for patients receiving chemotherapy was consistently lower in the community oncology clinic compared with the hospital outpatient setting, controlling for the clinical, demographic, and geographic variables analyzed.

A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy.

The invasion and colonization of oral cavity mucosal tissues by microflora may contribute to the pathophysiology of ulcerative oral mucositis (UOM). Iseganan is an analog of protegrin-1, a naturally occurring peptide with broad-spectrum microbicidal activity. A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of iseganan in preventing UOM after stomatotoxic therapy. Patients received an oral rinse, consisting of iseganan 9mg or placebo, to be swished/swallowed six times daily, starting with stomatotoxic therapy and continuing up to 21 days. Patients were assessed for stomatitis and UOM, and administered a questionnaire evaluating mouth pain and difficulty swallowing thrice weekly. The primary study efficacy endpoint was the proportion of patients who did not have peak stomatitis NCI-CTC grade >or=2. Between November 2001 and June 2002, 502 patients were randomized to receive iseganan (251) or placebo (251). Equivalent numbers of patients in both cohorts received bone marrow or peripheral blood allogeneic or autologous stem cell transplantation (SCT). Forty-three percent and 37% of iseganan and placebo patients, respectively, did not have peak stomatitis grade =2 (P = 0.182). There was no significant difference between the cohorts in stomatitis severity, incidence of UOM, peak mouth pain, peak difficulty swallowing, amount of opiate analgesics used, or adverse event type or incidence. A major impact of Iseganan on reducing stomatitis, UOM, or its clinical sequelae in patients receiving stomatotoxic therapy was not detected on this study.

A phase III, randomized, double-blind, placebo-controlled, multinational trial of iseganan for the prevention of oral mucositis in patients receiving stomatotoxic chemotherapy (PROMPT-CT trial).

Microfloral invasion and colonization of oral cavity mucosal tissues contribute to the pathophysiology of ulcerative oral mucositis (UOM). Iseganan is an analog of Protegrin-1, a naturally occurring peptide with broad-spectrum microbicidal activity. A randomized, double-blind, placebo-controlled study was conducted to evaluate iseganan in preventing UOM after stomatotoxic therapy. Patients received an oral rinse of iseganan 9 mg or placebo, swished/swallowed 6 times daily, starting with stomatotoxic therapy and continuing for 21-28 days. One hundred sixty three and 160 patients, respectively, were randomized to receive iseganan or placebo. One hundred and two patients (32%) were affected by a drug dispensing error, caused by a flawed computerized allocation system. Among all 323 patients, analyzed according to randomization assignment, 43% and 33% of iseganan and placebo patients, respectively, did not develop UOM (P = 0.067). On an 11-point scale, iseganan patients experienced less mouth pain (3.0 and 3.8 (P = 0.041), throat pain (3.8 and 4.6 (P = 0.048)), and difficulty swallowing (3.9 and 4.7 (P = 0.074)), compared to placebo patients. On the 5-point NCI CTC scale, iseganan patients experienced lower stomatitis scores (1.6 and 2.0 (P = 0.0131). Iseganan was well tolerated; no systemic absorption was detected. Iseganan is safe and may be effective in reducing UOM and its clinical sequelae.

Impact of long-acting growth factors on practice dynamics and patient satisfaction.

OBJECTIVE: To quantify time expended, patient satisfaction, and econometrics associated with short-acting (sargramostim, epoetin alfa) and long-acting (darbepoetin alfa, pegfilgrastim) growth factors. DESIGN: Retrospective resource utilization and prospective two-phase observational study. METHODS: During week 1, time-motion measurements related to patient treatment and drug preparation were collected for scheduling; check-in; phlebotomy; laboratory; and drug preparation, administration, and recording. Drug utilization for one chemotherapy cycle during weeks 2 and 3 was assessed for sargramostim, pegfilgrastim, epoetin alfa, darbepoetin alfa, sargramostim plus epoetin alfa, and pegfilgrastim plus darbepoetin alfa. Patients completed a satisfaction survey. RESULTS: Among 140 patients (mean age 58 yrs), mean chemotherapy cycle duration was 19 days. A total of 268 events were observed. Mean total staff time/patient visit for drug administration was 22.1 minutes, with most time spent on scheduling (5.5 min) and drug preparation, administration, recording (5.2 min). For sargramostim only versus pegfilgrastim only, pegfilgrastim resulted in a 37% reduction (p < 0.01) in all visits and an 85% reduction (p < 0.01) in mean number of doses. For epoetin alfa only versus darbepoetin alfa only, darbepoetin alfa resulted in a 48% reduction (p < 0.01) in mean number of doses. The most common dosage of epoetin alfa was 40,000 U/week (63.6%) and that of darbepoetin alfa was 200 microg every other week (92%), but complete blood counts were obtained weekly. For pegfilgrastim plus darbepoetin alfa versus sargramostim plus epoetin alfa, a 45% reduction (p < 0.01) in total visits and a 77% reduction (p < 0.01) in mean number of doses were noted in the former group. In 69 patients converted to long-acting drugs, 65 actual hours for a single treatment cycle were saved. For patients receiving pegfilgrastim plus darbepoetin alfa, there was a 45% reduction in total clinic visits, 77% reduction in doses, and staff time savings of 1.9 hours/patient/cycle of chemotherapy. Fifty-four patients completed the survey and trended toward neutral in their responses, with moderate disagreement that receiving injections is painful. CONCLUSION: Long-acting growth factors resulted in significant time savings for staff and providers by reducing the number of necessary office visits for drug administration. These time savings can significantly improve the quality of life for patients, as well as nurses, physicians, and caregivers.