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Articles/items published ahead of print or only online.
Thursday, August 14, 2014
BY KURT SAMSON
The National Cancer Institute has awarded the first research grants to community-based researchers under the new National Community Oncology Research Program (NCORP), a five-year, $93 million initiative.
The plan was initially proposed in 2012, and the NCI’s Board of Scientific Advisors approved creation of the program in June 2013 with the aim of bringing state-of-the art cancer prevention, control, treatment, and imaging clinical trials; and cancer care delivery research and to local communities, and help eliminate disparities in trials among minorities.
Earlier this month NCORP awarded 53 new five-year grants to investigators to conduct multi-site clinical trials and cancer-care delivery studies in communities across the country through a national network of researchers, providers, academic institutions, and other organizations that care for diverse populations in community-based cancer care. Grants were awarded to the top 40 institutions that had a demonstrated track record of meeting or exceeding the study goals along with exhibiting leadership and commitment in communities.
The program replaces and builds on two previous NCI community-based clinical research programs: the NCO Community Clinical Oncology Program (CCOP) and the NCI Community Cancer Centers Program (NCCCP). Ongoing trials under these programs will be integrated into NCORP to ensure completion, and CCOP sites that were not included as NCORP sites will receive support to allow patients to complete their studies and receive appropriate follow-up care.
Research will focus on a range of diverse and multi-level factors, including social outreach, financing systems, processes, technology, and other factors that affect access and quality of care, NCORP Director Worta McCaskill-Stevens, MD, said in announcing the awards.
NCORP will allow NCI to take advantage of recent advances in understanding cancer and bring this new knowledge into clinical trials at the community level, she said, adding that the program will identify and evaluate critically needed interventions that reduce cancer risk and incidence, enhance cancer patients’ quality of life, and increase access to clinical trials and care delivery in minority, rural, and other underserved patient populations.
The 53 awards fall into three categories:
- Seven sites will serve as hubs for the NCORP network, to design and conduct multicenter clinical trials and cancer care delivery research, as well as provide overall administration, data management, scientific leadership, and regulatory compliance.
- An additional 34 community sites have received funding to recruit clinical trial participants for program-funded studies, as well as for the NCI National Clinical Trials Network (NCTN) treatment and imaging trials, quality of life studies, and cancer care delivery research.
- Twelve sites have been chosen to also recruit clinical trial participants, with a mandate to include at least 30 percent of subjects from racial/ethnic minorities or rural residents.
According to the NCI, “ongoing clinical trials will be seamlessly incorporated into NCORP and continue to completion to achieve continuity of care for patients.”
‘Big Deal, Changes the Funding Structure’
“This has been a long time coming,” said oncologist Michael A. Thompson, MD, PhD, Medical Director of Early Cancer Research at Aurora Cancer Care, in Racine, Wisconsin. “I think that because there is more access to care in other parts of the country, especially in western states, NCI may be beefing up its support for clinical trials in the Midwest.”
Aurora will receive $3.8 million from NCORP over five years to improve cancer research and expand patient access to clinical trials in Wisconsin. National accrual of adult cancer patients into clinical trials is less than five percent, but the center’s wide reach -- Aurora offers services at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois, he said -- will allow increased trial access for approximately 60 percent of Wisconsin’s population.
Thompson noted that many of the ongoing clinical trials that were previously under CCOP and NCCCP will continue, but the shift to NCORP will add necessary infrastructure and help with more dedicated delivery research.
“I think we have demonstrated a proven track record of success, and those research institutes that have not received awards will now have a harder time, but we will have NCI’s support through NCORP. This is a big deal because it changes the funding structure, and between 80 and 85 percent of cancer patients are seen at community centers.”
Aurora works with a number of other centers in the area, including Milwaukee, which Dr. Thompson says has the highest rate of racial segregation of any state. Empowering community centers through NCORP should greatly increase access and recruitment on minorities, he said.
Reaching Minorities in the South
As the only NCORP Minority/Underserved Community Site in Georgia, and one of just 12 selected nationally, Georgia Regents University’s Cancer Center, in Augusta, has been involved for a decade in the CCOP consortium, providing cancer care and recruiting minority patients from underserved populations, said Samir N. Khleif, MD, Director of the Cancer Center and Professor of Biochemistry and Molecular Biology.
“I think there are many reasons we were chosen,” he said in an interview. “We are well placed to help recruit minority patients for clinical trials and have an excellent infrastructure in place, as well as expertise in different areas. Not only do we serve many low-income African-American and Hispanic patients but we are part of a really good network on cancer centers in the state, including Morehouse College, Georgia Southern University, and the University Cancer and Blood Center, in Athens. These are very good cancer centers with a real interest in treatment disparities.”
He said GRU will use the funds to increase awareness and participation in NCI-sponsored clinical trials, especially cancer care delivery research throughout Georgia. It will also contribute to the design and translation of NCORP’s research agenda among minority and underserved populations.
“Georgia has a high rate of minority cancer patients,” he said. “There are about four million patients in Atlanta alone, and 90 percent of them are minorities. This award will help us build upon more than a decade of experience serving as a Minority-Based CCOP, which NCORP is replacing. This grant is in perfect alignment with our shared commitment to serve all Georgians with the best possible cancer care.”
He noted that the incidence of prostate cancer, for example, is two times higher in African-American men and that they have three times greater mortality than their Caucasian counterparts. Similarly, triple-negative breast cancer incidence and mortality is also higher.
“Although there are multiple clinical trials, African-American subjects represent only about eight percent of the overall study population,” he said. “African-Americans are severely underrepresented in most clinical trials, but I think we can really answer a lot of questions in this population with greater outreach and recruitment efforts in our state.”
‘Affirmation and Recognition’
In South Carolina, the Greenville Health System Cancer Institute was another recipient.
“Transportation, technology, finances, and pre-existing chronic diseases are all examples of factors that contribute to poor health outcomes,” the Medical Director, Larry Gluck, MD, said in a statement. “This grant is an affirmation and recognition of our ongoing efforts to find and develop innovative ways to improve all aspects of cancer care delivery. It is also a vote of confidence in our ability to take research to the next level.”
The center has participated in NCI-sponsored research since 1988 and has had one of the highest rates of patient recruitment, with more than 270 clinical trials each year.
Gary Goodman, MD, a senior investigator at the Swedish Cancer Institute-Medical Oncology, in Seattle, said that the NCORP grant will help him and his colleagues in the Northwest continue to accrue patients into clinical trials, something they have been doing successfully for more than 30 years. He holds a joint membership with the Fred Hutchinson Cancer Research Center.
The Swedish Cancer Institute is the largest nonprofit health-care provider in the Seattle area and one of the largest cancer treatment centers in the Northwest. The Institute is affiliated with cancer centers in Oregon, Alaska, and Idaho, and also works to accrue patients with oncologists in personal practice and at small hospitals, in addition to Providence Portland Medical Center and St. Luke’s Mountain States Tumor Institute, in Boise, Idaho.
Goodman said that when the NCI first announced the merger of its earlier programs into NCORP and began soliciting grant applications, he was unsure of his institution’s ability to qualify. “Because we are non-academic, we were initially ineligible to apply for NCORP funding. Fortunately, we have a long-standing relationship with NCI, and accrued the largest number of patients for clinical trials involved in NCI’s SWOG [formerly the Southwest Oncology Group] partnership.
“We currently have more than 30 affiliates, so we are very pleased and hope to expand cancer treatment and recruitment within the communities we all serve and are hoping more hospitals will join us,” he said. The center recruits some 400 cancer patients into clinical trials each year, more than most of the other individual grant recipients.
A list of all 53 grant recipients can be viewed at: http://ncorp.cancer.gov/about/sites.html#research-bases
Wednesday, August 13, 2014
BY MARK FUERST
Women with breast cancer who are assigned a patient navigator are more likely to receive anti-estrogen therapy than patients without a navigator, according to the first national, multicenter study to evaluate whether patient navigation can improve the quality of breast cancer care.
“Patient navigation may have a direct benefit on the delivery of quality breast cancer care, particularly among low-income, minority women,” the study’s first author, Naomi Ko, MD, MPH, AM, Instructor of Medicine in the Hematology Oncology & Women's Health Unit at Boston University School of Medicine, said in an interview.
Patient navigation programs have emerged as a potential solution to assist with cancer care delivery for underserved patients. Ko explained that while traditionally, patient navigation targeted the cancer screening process, it has rapidly evolved within oncology practice so that navigators are expected members of oncology teams. Recent studies suggest a benefit of patient navigation within time to diagnosis and follow-up from an abnormal screening.
“Poor and underserved women face barriers in receiving timely and appropriate breast cancer care,” she said. Patient navigators can help these women overcome these barriers, but little is known about whether patient navigation improves quality of care.
For the study, the national Patient Navigation Research Program, the results of which are now available online ahead of print in the Journal of Clinical Oncology (doi: 10.1200/JCO.2013.53.6037), she and her colleagues set out to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care.
Breast cancer patients were examined to determine whether the care they received included three breast cancer standards of quality care:
- initiation of anti-estrogen therapy in patients with hormone receptor–positive breast cancer;
- initiation of post-lumpectomy radiation therapy; and
- initiation of chemotherapy in women younger than age 70 who had triple-negative tumors more than one cm in size.
Of the 1,004 patients in the study, 761 were eligible for anti-estrogen therapy, 552 were eligible for radiation therapy, and 158 were eligible for chemotherapy (the categories were not mutually exclusive). About half the patients in each of these groups were assigned a patient navigator while the other half received no navigation. More than one-third of the patients were African American and about one-quarter were Hispanic.
The researchers performed a secondary analysis of a multicenter “quasi-experimental” study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants.
A multivariable analysis found that, among participants eligible for anti-estrogen therapy, navigated participants had a statistically significant higher likelihood of receiving anti-estrogen therapy compared with the non-navigated controls. Among the participants eligible for radiation therapy after lumpectomy, navigated participants were no more likely to receive radiation than controls were. Because of the small sample size and limited variation in the receipt of recommended chemotherapy treatment, the value of the addition of a navigator was inconclusive from the data available, the researchers said.
“The results suggest that patient navigation can be a promising solution/intervention, particularly because the current literature suggests that minority women of low socioeconomic status are at risk of low adherence to anti-estrogen therapy.”
“Patient navigation is a promising intervention to help women who have challenges navigating medical care get timely and appropriate care. We still need to understand how and where patient navigation can have its biggest impact,” Ko said.
The researchers noted that questions remain regarding the specific tasks or barriers addressed that may help to facilitate treatment. For example, the navigator tasks could vary by the type of therapy (anti-estrogen treatment, radiation treatment, or chemotherapy) and specific navigator interaction (financial assistance, transportation, or patient education). It is possible, the team said, that patient navigators may have helped with obtaining prescriptions or increasing patient understanding of the benefits of anti-estrogen treatment.
The Avon Breast Health Initiative at Boston Medical Center research unit has developed a tool kit to help assist in the design and implementation of patient navigation programs. Available in three volumes for three different audiences—program planners, supervisors, and patient navigators, the kit includes case studies, tools, and resources from cancer care navigation that can be applied to reduce the impact of the target disease, health disparities, and barriers to care.
Asked for her opinion about the study, Daleela Dodge, MD, Medical Director of the Breast Service at Lancaster General Health in Pennsylvania, said, “What makes this interesting article unique is the use of the original three criteria developed by the American Cancer Society to compare hospitals as cancer centers. These particular criteria were started in 2005. We now have seven criteria, and as of 2015 this will go up to 12 criteria against which quality metrics can be looked at.”
In 1990, Harold Freeman, MD, established the nation’s first patient navigation program at Harlem Hospital Center in New York City looking to help African American women with breast cancer gain access to health care. “Patient navigation was created for low socioeconomic patients, and has evolved over time to include all women,” Dodge said. “What also makes this paper unique is how many minority patients were included. Historically, this goes back to the beginnings of patient navigation.”
Patient navigators, usually oncology nurses, provide a single point of contact, and act as advocates and personal care coaches, said Dodge, who is the cancer liaison physician for her center for the American College of Surgeons Commission on Cancer (COC).
Remove Barriers, Both Real and Perceived
“The primary role of the navigator is to remove barriers, both real and perceived. Low socioeconomic groups maintain high levels of fear of side effects and feelings about why medicine may not be good for them. When I prescribe tamoxifen, for example, one of the first things patients say to me is ‘I’m not going to take it. I’ve heard bad things about it.’ This is magnified among lower socioeconomic groups. The level of understanding they need is huge, and navigation plays an important role.”
Cultural considerations may also get in the way of successful treatment--for example, a patient who believes she can no longer consider herself a woman if she has breast-removal surgery.
Navigators often have very personal relationships with patients. “Patients will often ask navigators questions they won’t ask me, no matter how open I try to be,” Dodge noted. “The navigator may reframe an issue that I thought I had explained very well, and come back to me with the patient’s questions.
“In addition, each navigator is with the patient most of the time, and is available nearly all the time. The surgeon may be in the operating room and therefore not available to answer questions.”
Navigators may also help fill out the treatment summary required for each patient by the CoC. “The surgeon usually presents cases to the breast cancer tumor board. An efficient, focused navigator can also present cases. That role has morphed from patient advocate to the organizational wheel behind the breast cancer patient program,” Dodge explained.
“We now have five patient navigators--two who work with breast cancer patients and three who work in other areas. Every patient who has cancer deserves navigation.”
She pointed out that patient navigation is an unreimbursed resource by insurers, and is generally not available through an oncology-only practice. Most navigators come into an oncology practice as health care system employees. The vast majority of nurse navigators are not certified. Most of them are nurses coming off oncology wards in an either inpatient or outpatient setting, said Dodge, who added that in most situations clinicians hire good nurses with oncology knowledge to act as navigators.
In an oncology practice, navigators “do not necessarily have to be certified. You just need to fulfill the role of navigator and have the ability to support patients,” she said. “The quality of patient care can improve by the navigator asking some simple early questions—for example: Is the patient getting the consultations she needs? Does she understand enough about the therapy to accept it?”
Dodge noted that her facility is a comprehensive community cancer center, and that as of 2015, CoC guidelines will require a certified nurse navigator for the facility to receive such certification. “Many cancer centers have so many functioning clinical trial nurses that they do not need to put in a specific navigation program,” she noted.
“In our institution, one point of contact for navigators is a Category 0 reading on a mammogram. It may take a week or two to get the patient back into the office to discuss the result, which can be hugely upsetting. We have an imaging nurse navigator call the patient, support her through the biopsy process, and then hand off her off to a breast cancer navigator.”
Dodge noted that one limitation of the Ko et al study is that it did not define navigation, which is used in many different ways from institution to institution. “For example, some programs use navigation exclusively in the initial treatment-planning process, while others provide survivorship navigation, including a new navigator in the post-treatment phase.”
In addition, Dodge said, the study shows a positive impact for navigators in situations when compliance can be low, but long-term outcomes are also important to care: “What percentage of patients got all phases of care? It is not clear cut that the patients had everything done or that they saw all the doctors, who then followed through with care,” she said. “It’s crucial that patients see all subspecialists and receive the care they are supposed to get.
“Breast cancer is hugely complex,” she concluded. “With so many folks in the diagnostic and treatment pathway, navigation becomes even more crucial. In addition, with the Affordable Care Act, the need for navigation will increase since we have so many more people going through the system.”
For additional information see OT’s four-part 2012 series about the history, concept, and ongoing status of patient navigation as a key resource for cancer patients: http://bit.ly/OT-PtNavigation
Tuesday, August 12, 2014
BY ROBERT H. CARLSON
BARCELONA, Spain – Three abstracts selected for presentation in a session on pancreatic cancer here at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer each featured something unusual – positive news.
“That isn't something we hear often in pancreatic cancer,” said the Discussant for all three papers, Jordan Berlin, MD, Professor of Cancer Research and Clinical Director of the Gastrointestinal Oncology Program at Vanderbilt University Medical Center.
That may have stretched the point a bit, as two of the trials were not positive in their primary endpoints, but he found value in those anyway.
The trials were:
· Napoli-1, a positive trial of MM-398, a liposomal irinotecan, in second-line therapy;
· the RECAP trial, in which ruxolitinib did not improve overall survival but which Berlin said had a “possible positive twist” in showing an association between inflammation and outcome; and
· a biomarker analysis of the MPACT trial, negative for finding SPARC prognostic, although Berlin said it was still a positive trial in that it identified performance status as a predictive marker.
Nanotherapeutic Activity in Napoli-1
MM-398 is a “nanotherapeutic,” consisting of irinotecan encapsulated in a liposomal sphere. Andrea Wang-Gillam, MD, PhD, Assistant Professor in the Division of Oncology, Section of Medical Oncology, at Washington University in St. Louis, who presented the results of the randomized Phase III Napoli-1 trial, explained that this delivery system allows for longer drug exposure in the circulation and more accumulation of the drug and its active metabolite, SN38, at the tumor site.
First author was Daniel Von Hoff, MD, Physician-in-Chief and Director of Translational Research at TGen, Translational Genomics Research Institute, in Phoenix. Napoli-1 compared the use of MM-398 (151 patients) versus fluorouracil/leucovorin (149 patients) versus MM-398 plus 5-FU/leucovorin (117 patients). All 417 patients had metastatic pancreatic cancer and had received prior gemcitabine-based chemotherapy.
The primary endpoint of overall survival was met for the MM-398-5FU/leucovorin combination, although not for single-agent MM-398.
Median survival times were 6.1 months for the combination, 4.9 months for MM-398 alone, and 4.2 months for 5FU/leucovorin.
“Median survivals are important here,” Berlin said in his discussion. He compared the median survival of patients in Napoli-1 with those in two Phase II trials with FOLFIRI (leucovorin, 5-FU, and irinotecan) as second-line treatment for metastatic pancreatic cancer: GISCAD had an 8% rate and a median survival of 5.0 months (Zaniboni A et al: Cancer Chemother Pharmacol 2012; 69:1641-1645); and a French trial in patients resistant to gemcitabine had a median survival of 6.6 months (Neuzillet C et al: World J Gastroenterol 2012; 18:4533-4541).
He cautioned that comparing uncontrolled Phase II trials with a Phase III trial has to be done with caution, because there tend to be decreases in efficacy going from Phase II to III--“as we all know.”
Nevertheless, he said Napoli-1 is certainly a positive trial and a viable option, presuming regulatory approval.
“But oxaliplatin-5FU looks about as good,” he said. “There is clear benefit to the patients [in Napoli-1], but it is not clear if this is better than what we already have with FOLFIRI or FOLFOX.
“In the long run, we have yet to find something other than chemotherapy to treat this disease.”
Combination therapy led to more gastrointestinal side effects than standard treatment alone in Napoli-1. Diarrhea occurred in 12.8, 21.1, and 4.5 percent of the combination trial arm, MM-398-alone arm, and 5FU/leucovorin arm, respectively. Vomiting occurred in 11.1, 13.6, and 3.0 percent, respectively; and fatigue occurred in 13.7, 6.1, and 3.7 percent, respectively.
Side effects may have been “manageable” in Napoli-1, Berlin said, but he added that “manageable does not mean tolerable; it means you have to change the regimen or dose modify when you get some serious side effects--The definitions of Grade 3 fatigue or Grade 3 diarrhea all sound pretty bad to me.”
Ruxolitinib: Inflammation Influences Outcomes
In the placebo-controlled randomized Phase II RECAP study of capecitabine with or without ruxolitinib as second-line therapy for metastatic disease, the ruxolitinib combination showed clinical activity compared with capecitabine-placebo. Response rates were 7.8 percent for the combination versus zero percent for placebo.
Overall survival and progression-free survival “favored the combination therapy, but the effect size was small,” said Herbert I. Hurwitz, MD, Professor of Medicine at Duke University, who presented the data.
Importantly, though, evidence of overall survival and progression-free survival was observed in a subgroup of patients with elevated levels of the systemic inflammation marker C-reactive protein (greater than the group median of 13 mg/L). Overall survival rates at three and six months were 48 and 42 percent, respectively for the gemcitabine-ruxolitinib arm (31 patients), versus 29 and 11 percent with gemcitabine-placebo (29 patients).
Ruxolitinib, a JAK1/JAK2 inhibitor, inhibits STAT through JAK and also reduces inflammatory cytokines, a predictor of survival in pancreatic cancer, Berlin explained, noting that there have been consistent preclinical data showing that blocking the STAT pathway results in growth inhibition in pancreatic cancer.
The hypothesis around inflammation is a key point and well worth investigating further, he said. “The science that ruxolitinib reduces inflammation may have exposed a weakness in pancreas cancer. If we were to reduce inflammation, cancer-cachexia, or whatever kills the patient, it might prolong life and it might give us more of a chance to treat the cancer itself.”
SPARC Is Poor Prognostic Indicator
The Phase III MPACT trial (NEJM 2013; 369:1691-1703) with 861 patients showed superior overall survival rates for use of nab-paclitaxel plus gemcitabine versus gemcitabine alone as first-line treatment for patients with metastatic pancreatic cancer.
At this meeting, Manuel Hidalgo, MD, Vice Director of Translational Research at Centro Nacional de Investigaciones Oncológicas in Madrid, presented an analysis of SPARC (secreted protein acidic and rich in cysteine) expression in MPACT patients to determine if it might be a prognostic factor. Daniel Von Hoff was senior author.
Although high expression of SPARC has been associated with worse overall survival rates in patients with resectable pancreatic cancer, Hidalgo reported here that stromal SPARC was not prognostic of overall survival in MPACT, with a hazard ratio of 1.02 between patients with high- and low-SPARC scores.
Three significant predictors of overall survival were identified: treatment, Karnofsky performance status, and the presence of liver metastases.
Hidalgo concluded that while “nab-paclitaxel is currently a new standard of care that has demonstrated a clinical benefit across all patient subgroups,” treatment decisions in the metastatic setting should not be based on SPARC expression.
“Every way Dr. Hidalgo tested it, SPARC was not predictive,” Berlin said in his discussion. “So we do not have a biomarker for gemcitabine and nab-paclitaxel, and we can probably stop testing SPARC in advanced disease.”
But based on the CONKO-001 adjuvant therapy study, where stromal SPARC was prognostic for gemcitabine-treated patients (Oettle H et al: JAMA 2013;310:1473-1481), it would still be reasonable to test for SPARC in the adjuvant setting, he added.
On the one hand, Berlin said, it probably isn't necessary to continue testing SPARC in metastatic pancreatic cancer “because pancreatic cancer is a disease where we don't need to seek prognostic markers for poor outcomes.”
The money could be better spent elsewhere. “On the other hand, a predictive marker would be valuable, which is a reason to test further.”
‘Use Resources Wisely’
Berlin said there had been very few prospective collections of SPARC until MPACT, and while Hidalgo's report was negative in its primary endpoint, the study was valuable in that it collected “a large number of precious samples from patients with metastatic pancreatic cancer, which is difficult to do.
“A lot of people gave a lot to get this data,” Berlin concluded, speaking to all oncology researchers. “It is our responsibility not only to report it, but to use it wisely.”
Monday, August 11, 2014
BY PEGGY EASTMAN
WASHINGTON -- As more and more previously uninsured Americans sign up for coverage under the Affordable Care Act (ACA), concerns have been raised about the adequacy of the health plans in which they enroll. That is because the ACA has led to health care plans sold on the exchanges that use narrow, tightly organized provider networks that exclude certain physicians, other health care professionals and hospitals.
At a briefing hosted by the Alliance for Health Reform at the National Press Club here, speakers shared insights on issues surrounding the concept of network adequacy, and gave a preview of concerns the new National Association of Insurance Commissioners (NAIC) national model plan needs to address
As described at the briefing, worries have been raised about limited networks that exclude specialists (including those who treat children) and academic health institutions with comprehensive cancer centers, because these are seen as too expensive. According to a report in May prepared jointly by the Center on Health Insurance Reforms at Georgetown University’s Health Policy Institute and the Urban Institute, the fields of oncology, primary care, and mental health are the ones that have traditionally prompted concerns about health network adequacy.
The American Society of Clinical Oncology has identified the need for network adequacy standards under the ACA, since vulnerable populations (children with cancer and adults with rare cancers) may require oncologists out of their network for appropriate treatment options. ASCO also supports an appeals process for patients who realize following treatment that their insurance does not cover the services provided to them.
Advocates of narrow networks, also called value networks – which were marketed as health maintenance organizations (HMOs) in managed care during the late 1980s and early 1990s – see these smaller health networks as a way to create competition and control costs. Critics say they limit consumer choice, because if a patient chooses to go out of network, he or she may pay thousands of dollars out-of-pocket in uncovered care.
The ACA creates new national rules designed to protect consumers by requiring that insurers provide a minimum level of access to local health care providers. But the ACA also gives states flexibility in establishing network adequacy.
New Model Health Plan
NAIC is currently in the process of drafting a new model health plan for states to use – which updates its 18-year-old model plan – to ensure that patients receive adequate care under the ACA. And the National Committee for Quality Assurance (NCQA) in late July of this year released Health Plan Accreditation 2015, a new model of network adequacy that sets forth network transparency requirements; quality measures that emphasize value and health outcomes; and the need for annual rescoring of the plan’s network on a common set of quality measures.
The NAIC health plan model should be completed by the end of 2014 or early 2015, said Theodore K. Nickel, Wisconsin Commissioner of Insurance, Chair of the NAIC Midwest Zone, a member of the NAIC Executive Committee and Governance Review Task Force, and Chair of the NAIC Health Care Reform Regulatory Alternatives Working Group. Because health insurance is regulated at the state level, the NAIC regulatory model on network adequacy will have to be voted on and adopted by state legislatures.
“This is a very important discussion, and one that’s going to continue for some time in the future,” he said. “The issue of network adequacy is “accelerating at a rate that we didn’t anticipate. This is all new to folks; this is the first time we’ve had a national mandate to buy health insurance.”
He noted that for physicians and other health care providers, the wider the health plan networks, the greater the reimbursement rates. But, Nickel said, insurers are constantly trying to narrow the networks used in their plans to save money.
“Higher prices for services do not necessarily mean better outcomes,” he said.
However, the new NAIC model plan for insurers will probably contain certain specified out-of-network exemptions for emergencies or specialized care – a rare cancer, for example. (The ACA prohibits insurers from charging consumers out-of-network cost sharing for emergency services, even if the patient goes to an out-of-network provider.)
Nickel said that because of the diversity and complexity of health insurance plans – given the geographical diversity of states – determining the adequacy of a given health network is not a simple matter. “There may be different standards for different products,” he said. “It’s clear that this business of state-to-state differences needs to be recognized.”
Some states have multi-tier plans. Some states may offer plans with higher standards than federal regulations require. “Are narrow networks even a problem?” he asked. “How narrow is too narrow? What is the appeals process for going out of network? What if a doctor or hospital leaves a network?” And what should the appeals process be if a patient in a health network believes he has been treated unfairly?
Also speaking, Joel Ario, JD, Managing Director of Manatt Health Solutions, former insurance commissioner of Pennsylvania and of Oregon, a member of NAIC’s executive committee for 10 years, and the first director of the U.S. Department of Health and Human Services Office of Health Insurance Exchanges (2010-2011), said that narrower networks were intended by the ACA to manage the costs of care -- “You could call them ‘Kaiser-like’ plans,” he said, noting that these integrated health-delivery systems are intended to ensure price controls without sacrificing quality.
Ario emphasized the need for health plan transparency, stating that “Consumers have to understand what they’re buying,” to avoid an unwelcome shock. As a hypothetical example of a lack of health plan transparency, a patient might have surgery by a surgeon in the network, but because the anesthesiologist may not be in the network, the patient may receive an unanticipated separate bill for the anesthesiologist, which he is expected to pay out of pocket.
In addition to transparency, there need to be “safety valves” for patients who go out of network for health care services, Ario emphasized.
“Value and narrow are not synonymous,” said Michael Chernew, PhD, the Leonard D. Schaeffer Professor of Health Care Policy at Harvard Medical School, former Vice Chair of the Medicare Payment Advisory Commission and a member of the Congressional Budget Office’s Panel of Health Advisors. He noted that narrower, tightly organized networks strengthen the hand of the negotiating buyers (health plan administrators), especially with large medical plans and hospitals, because the administrators can choose providers they believe are more efficient and provide good value for the price.
‘Bait and Switch’
But, Chernew said, “There are a lot of legitimate concerns about these products.” The main problem is that a consumer usually chooses a plan before he becomes ill. One major concern is a so-called “bait and switch” tactic; a healthy consumer chooses a plan and then selects a health care provider from that plan when he gets sick, only to be told that his bills will not be covered because the physician is no longer in the plan’s network.
“We need to reduce the consequences when a doctor or hospital goes out of network,” Chernew said.
“I think we should really differentiate ‘narrow’ from ‘value,’” said Diane P. Holder, MS, Executive Vice President of UPMC, President of the Insurance Services Division, and President and CEO of the UPMC Health Plan, which provides insurance coverage to some 2.3 million Pennsylvanians.
What is Adequate?
Asked by OT whether it is prudent for health plan networks to exclude cancer centers of excellence – since their upfront care might save costs down the road – Holder said, “One of the things at the heart of this debate is, what is adequate?” Holder, who serves on the adjunct faculty of the University of Pittsburgh’s Graduate School of Public Health, said the issue of network adequacy is really about what patients need.
He added: “I think there are certain minimal standards that have to be met.” Chernew said he would be “very, very wary” of forcing health insurers to include certain medical centers of excellence, a tactic he called “on the road to some kind of price regulation” or monopoly. He said he opposes the idea of giving a “blank check” to certain medical centers even if they have a reputation and track record of excellence.
What really worries him about narrow health networks, he said, is access to the physicians that patients want and trust. He told OT that his late mother had lymphoma, which was diagnosed in 2001. She had two physicians of whom she was very fond: her primary care physician and her oncologist. Because his mother had Medicare, she did not have to worry about whether these two physicians were in the same network. But what if a non-Medicare patient wanted to go to a primary care physician and to an oncologist who were not in the same network? (Chernew said his mother was successfully treated for lymphoma and its recurrences, and died of another condition.)
All speakers at the briefing agreed that in this time of uncertainty, complexity, and ferment as the ACA is implemented, it is very important to give consumers shopping for health insurance the information they need to make informed choices about coverage: “The key is, what plan is better for me?” Chernew said.
Physicians themselves also need to be well informed, Chernow said, so they can inform their patients.
“They [physicians] are the key to the information flow,” he added. “Providers are the ones who are dealing with the patients…they are the face of the medical profession.” Thus physicians need to know who is in and out of the network, for they are the ones who make referrals.
Holder agreed: “Historically patients have trusted their physicians more than anyone” when it comes to matters of health insurance. And when they are informed, “Ultimately consumers will be the barometer on this issue,” Ario said.
Monday, August 11, 2014
The U.S. Food and Drug Administration has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma who have previously received and responded to Velcade therapy and have then relapsed at least six months after the completion of that treatment.
The drug is a proteasome inhibitor that was first approved for treatment of myeloma in 2003 (OT 8/25/03 issue), and it was approved for injection in 2008 (OT 8/25/08 issue). Velcade was approved in 2006 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. And, the drug’s label was updated in 2012 to include the subcutaneous method of administration in its approved indications including multiple myeloma and mantle cell lymphoma after at least one prior therapy (OT 2/25/12 issue).
The recent actions for the drug follow data from the single arm, open-label, Phase II RETRIEVE trial of 130 patients who had previously received and responded to Velcade-based therapy and had relapsed at least six months after that prior Velcade treatment. The data showed one patient had a complete response and 49 patients had a partial response; and the median duration of response was 6.5 months.
The most common adverse effects reported in patients receiving Velcade were thrombocytopenia, diarrhea, herpes zoster, and pneumonia. Adverse reactions that led to discontinuation of treatment occurred in 13 percent of the patients. Other common side effects included fever, decreased appetite, fatigue, and rash.
Velcade is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies.