Opinion
VIEWPOINT
Norman L. Foster, MD Center for Alzheimer’s Care, Imaging, and Research, Department of Neurology, University of Utah, Salt Lake City. Karen Mottola, MA Clinical Research Compliance and Education, University of Utah, Salt Lake City. John M. Hoffman, MD Department of Neurology, University of Utah, Salt Lake City, Department of Radiology, University of Utah, Salt Lake City, and Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, Salt Lake City, Utah.
Supplemental content at jamaneurology.com
Coverage With Evidence Development What to Consider Coverage with evidence development (CED) is a reimbursement mechanism the Centers for Medicare and Medicaid Services (CMS) is increasingly using for new technologies.1 The September 2013 CMS coverage decision for amyloid positron-emission tomography (PET) indicated that amyloid PET imaging under most circumstances will not be reimbursed. Reimbursement is possible only through CED in a CMS-approved study. Thus, many neurologists for the first time will face the decision of whether to participate in CED. We hope that sharing our experience with CED for use of 18fluorodeoxyglucose (FDG)-PET in the treatment of mild cognitive impairment through the Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID) Study (eAppendix 1 in Supplement) will be instructive. The goal of CED is to provide data for CMS national coverage decisions.2 Drug approval in the United States, based on Food and Drug Administration review, is distinct from decisions about reimbursement that are made by insurers such as CMS (eAppendix 2 in Supplement). While most research studies enroll highly selected individuals, CMS seeks outcomes in Medicare recipients. Thus, CED does not automatically reimburse use in all research studies, but only those meeting CMS needs (eAppendix 3 in Supplement). Such pragmatic research is important for translating advances into community practice.3,4 However, CED trials present many challenges.5 Sometimes CED simply requires enrollment in a registry, but the focus here is CED reimbursement contingent on participation in a prospective, longitudinal study, as in the MCI-ID Study and as required for amyloid PET (see Supplement).
Demands on the Health Care Provider
Corresponding Author: Norman L. Foster, MD, Department of Neurology, University of Utah, 650 Komas Dr, Ste 106-A, Salt Lake City, UT 84108 (norman [email protected]).
The determination of CED extends CMS coverage to nonroutine clinical services, creating a hybrid of clinical care and research. The Centers for Medicare and Medicaid Services only reimburses clinical care excluding research-only activities (eBox 1 in Supplement). Only in CED does CMS pay for investigational clinical services. Although most CED payments may go for the new technology being tested, for those providing these services, reimbursement rates may be less profitable than other options and can be below cost. Health care providers should scrutinize all study requirements when considering CED participation (eBox 2 in Supplement). Participating in CED services has advantages, potentially increasing prestige and referrals, while offering the satisfaction of providing cutting-edge patient care and advancing medical knowledge. On the other hand, disadvantages abound. Disruption to usual patient flow is costly. Identifying and counseling potential participants and obtaining informed consent require consid-
erable effort and patients may decline to participate or may prematurely withdraw. Even for enthusiastic clinicians, CED involvement may be difficult to justify to employers or practice partners. If patient and health system barriers are too great, CED simply may not be feasible. In the MCI-ID Study, we anticipated study partners of patients would be consented for data collection. We did not foresee the need for frequent reconsent or the challenges occurring when the Food and Drug Administration changed FDG-PET regulations midstudy. After 6 years, fewer than 100 participants, most from only 2 sites, completed the trial, and the CED restriction on FDG-PET for mild cognitive impairment continues.
Patient Barriers Not all CMS patients automatically qualify for CED; application for reimbursement is time consuming. Patients with only Part A coverage are not eligible for practitioner services. Because CMS does not coordinate CED with regional Medicare administrative contractors, which generate all Medicare payments, a Medicare administrative contractor may require documentation before allowing billing and decide on its own whether to reimburse non-CED–specified services. Although Medicare Advantage plans are funded by CMS, they each have their own approval process. Ultimately, we stopped enrolling Advantage patients in the MCI-ID study, having confronted repeated appeals and ill-defined administrative procedures. The trade-off between acceptable patient burden and required effort for data collection and regulatory procedures is inevitable. Although CED studies are intended to reflect the Medicare population, practical considerations may intervene. The MCI-ID 2-year protocol required study partners to accompany patients for all visits excluding patients who lacked supporting relationships or whose family members, friends, or caretakers had inflexible schedules. Protocol adherence was impractical for patients with significant comorbidities who had many other medical visits or hospitalizations. Reducing the number of visit dates by combining service provision was insufficient to overcome barriers to participation because visits became too long to support or too rushed to ensure completion of data collection. Patients and their study partners were puzzled by CED study requirements, including strict visit windows, which particularly frustrated our snowbirds. Patients frequently received bills they had difficulty understanding, generating multiple calls. Patients often had difficulty distinguishing clinical and research aspects of care and were disappointed when they incorrectly presumed that being in a study would mean free care.
jamaneurology.com
JAMA Neurology April 2014 Volume 71, Number 4
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archneur.jamanetwork.com/ by a University of Birmingham User on 06/01/2015
399
Opinion Viewpoint
Billing mentoring, rescheduling, and protocol deviations became the norm. Over time, our participants began to resemble the highly selected population typical in traditional dementia research. Patient and family cost and inconvenience, without tangible benefit, have sparked controversy about the ethics of CED studies.1,6
Although institutional personnel were dedicated to resolving confusion, lack of CED-study experience, staff turnover, billing requirement complexity, and inconsistency of nonresearch and research requirements added up to significantly more time and effort than anyone could have predicted—for a study that had no funding for administration.
Health System Inflexibility and Hurdles Investigators and institutions experienced with sponsored research may have difficulty understanding the hybrid nature of CED studies. Medicare is not a sponsor for CED studies. Although our institution deploys sophisticated research management and billing systems, it was not prepared for CED. Clinical and academic administrators often were puzzled. Some expected involvement of the office of sponsored projects and payments for administrative effort and indirect fees. Others believed that no study information should be in the medical record. Managers and staff initially objected to the use of clinic resources for research. Even after issues were resolved, they would reappear when personnel changed in any of the several involved departments. Billing complexity accounted for half of our experienced study team’s effort. They at first believed that deductibles and copayments did not apply. Because programmers were unaware that a new diagnosis was allowed for CED billing, the first study bills were rejected internally. Patients surprised to receive bills for studyrelated services contacted the billing office to request reversals. Billing clerks with little experience with research often did not know how to proceed or who to ask. Our study team had to rectify all of this and maintain vigilance.
Final CMS decisions are critical because private insurers often deny reimbursement while CED remains in effect. Unfortunately, few technologies assigned to CED have subsequently emerged, in part, because there are no clear standards for revision (eAppendix 4 in Supplement). In the case of FDG-PET, for years, CED has prevented meaningful patient access. Over time, patients and health care providers become increasingly frustrated with the additional requirements and, as interest wanes, collecting requisite data becomes more difficult. Why did we participate in the MCI-ID Study? As the Intermountain West’s only academic program for dementing diseases, we are committed to providing patients in our region access to the latest research advances. We thought we should provide leadership in pragmatic trials. Eventually, however, we could not sustain unexpected, unreimbursed costs even with strong institutional and philanthropic support and we no longer participate. Would we participate in another CED trial? Financial sustainability and confidence in a successful outcome would be critical. Now that we understand CED, at least we will be able to make a knowledgeable decision.
manuscript; and decision to submit the manuscript for publication.
ARTICLE INFORMATION Published Online: February 3, 2014. doi:10.1001/jamaneurol.2013.5812. Conflict of Interest Disclosures: Dr Foster receives research support from GE Healthcare, Avid Radiopharmaceuticals, and the Center for Health Improvement, and has served as a consultant to GE Healthcare, Lilly USA, and Bristol-Myers Squibb. Dr Hoffman receives research support from GE Healthcare and has served as a consultant to GE Healthcare. No other disclosures were reported. Funding/Support: This work was supported by an anonymous donor to the University of Utah Center for Alzheimer’s Care, Imaging, and Research and by the Center for Quantitative Cancer Imaging of the Huntsman Cancer Institute. Role of the Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the
400
Conclusions
Disclaimer: The views expressed herein are those of the authors and do not necessarily represent the views of the University of Utah. Additional Contributions: We thank the numerous study coordinators and administrative staff (University of Utah, Salt Lake City) who assisted with the Metabolic Cerebral Imaging in Incipient Dementia Study, and site co-investigators Edward Zamrini, MD, Richard D. King, MD, PhD, and Gordon J. Chelune, PhD (Center for Alzheimer’s Care, Imaging, and Research, Department of Neurology, University of Utah, Salt Lake City) for assisting with data collection. None received compensation for their contribution to this study. REFERENCES 1. Relyea-Chew A. Ethical considerations in CMS’s coverage with evidence development. J Am Coll Radiol. 2011;8(12):838-841.
2. Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare’s ‘coverage with evidence development.’ Health Aff (Millwood). 2006;25(5):1218-1230. 3. Jones L, Wells K. Strategies for academic and clinician engagement in community-participatory partnered research. JAMA. 2007;297(4):407-410. 4. Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA. Practical clinical trials for translating research to practice: design and measurement recommendations. Med Care. 2005;43(6):551-557. 5. Ware JH, Hamel MB. Pragmatic trials: guides to better patient care? N Engl J Med. 2011;364(18):1685-1687. 6. Pearson SD, Miller FG, Emanuel EJ. Medicare’s requirement for research participation as a condition of coverage: is it ethical? JAMA. 2006;296(8):988-991.
JAMA Neurology April 2014 Volume 71, Number 4
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archneur.jamanetwork.com/ by a University of Birmingham User on 06/01/2015
jamaneurology.com
VIEWPOINT
Norman L. Foster, MD Center for Alzheimer’s Care, Imaging, and Research, Department of Neurology, University of Utah, Salt Lake City. Karen Mottola, MA Clinical Research Compliance and Education, University of Utah, Salt Lake City. John M. Hoffman, MD Department of Neurology, University of Utah, Salt Lake City, Department of Radiology, University of Utah, Salt Lake City, and Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, Salt Lake City, Utah.
Supplemental content at jamaneurology.com
Coverage With Evidence Development What to Consider Coverage with evidence development (CED) is a reimbursement mechanism the Centers for Medicare and Medicaid Services (CMS) is increasingly using for new technologies.1 The September 2013 CMS coverage decision for amyloid positron-emission tomography (PET) indicated that amyloid PET imaging under most circumstances will not be reimbursed. Reimbursement is possible only through CED in a CMS-approved study. Thus, many neurologists for the first time will face the decision of whether to participate in CED. We hope that sharing our experience with CED for use of 18fluorodeoxyglucose (FDG)-PET in the treatment of mild cognitive impairment through the Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID) Study (eAppendix 1 in Supplement) will be instructive. The goal of CED is to provide data for CMS national coverage decisions.2 Drug approval in the United States, based on Food and Drug Administration review, is distinct from decisions about reimbursement that are made by insurers such as CMS (eAppendix 2 in Supplement). While most research studies enroll highly selected individuals, CMS seeks outcomes in Medicare recipients. Thus, CED does not automatically reimburse use in all research studies, but only those meeting CMS needs (eAppendix 3 in Supplement). Such pragmatic research is important for translating advances into community practice.3,4 However, CED trials present many challenges.5 Sometimes CED simply requires enrollment in a registry, but the focus here is CED reimbursement contingent on participation in a prospective, longitudinal study, as in the MCI-ID Study and as required for amyloid PET (see Supplement).
Demands on the Health Care Provider
Corresponding Author: Norman L. Foster, MD, Department of Neurology, University of Utah, 650 Komas Dr, Ste 106-A, Salt Lake City, UT 84108 (norman [email protected]).
The determination of CED extends CMS coverage to nonroutine clinical services, creating a hybrid of clinical care and research. The Centers for Medicare and Medicaid Services only reimburses clinical care excluding research-only activities (eBox 1 in Supplement). Only in CED does CMS pay for investigational clinical services. Although most CED payments may go for the new technology being tested, for those providing these services, reimbursement rates may be less profitable than other options and can be below cost. Health care providers should scrutinize all study requirements when considering CED participation (eBox 2 in Supplement). Participating in CED services has advantages, potentially increasing prestige and referrals, while offering the satisfaction of providing cutting-edge patient care and advancing medical knowledge. On the other hand, disadvantages abound. Disruption to usual patient flow is costly. Identifying and counseling potential participants and obtaining informed consent require consid-
erable effort and patients may decline to participate or may prematurely withdraw. Even for enthusiastic clinicians, CED involvement may be difficult to justify to employers or practice partners. If patient and health system barriers are too great, CED simply may not be feasible. In the MCI-ID Study, we anticipated study partners of patients would be consented for data collection. We did not foresee the need for frequent reconsent or the challenges occurring when the Food and Drug Administration changed FDG-PET regulations midstudy. After 6 years, fewer than 100 participants, most from only 2 sites, completed the trial, and the CED restriction on FDG-PET for mild cognitive impairment continues.
Patient Barriers Not all CMS patients automatically qualify for CED; application for reimbursement is time consuming. Patients with only Part A coverage are not eligible for practitioner services. Because CMS does not coordinate CED with regional Medicare administrative contractors, which generate all Medicare payments, a Medicare administrative contractor may require documentation before allowing billing and decide on its own whether to reimburse non-CED–specified services. Although Medicare Advantage plans are funded by CMS, they each have their own approval process. Ultimately, we stopped enrolling Advantage patients in the MCI-ID study, having confronted repeated appeals and ill-defined administrative procedures. The trade-off between acceptable patient burden and required effort for data collection and regulatory procedures is inevitable. Although CED studies are intended to reflect the Medicare population, practical considerations may intervene. The MCI-ID 2-year protocol required study partners to accompany patients for all visits excluding patients who lacked supporting relationships or whose family members, friends, or caretakers had inflexible schedules. Protocol adherence was impractical for patients with significant comorbidities who had many other medical visits or hospitalizations. Reducing the number of visit dates by combining service provision was insufficient to overcome barriers to participation because visits became too long to support or too rushed to ensure completion of data collection. Patients and their study partners were puzzled by CED study requirements, including strict visit windows, which particularly frustrated our snowbirds. Patients frequently received bills they had difficulty understanding, generating multiple calls. Patients often had difficulty distinguishing clinical and research aspects of care and were disappointed when they incorrectly presumed that being in a study would mean free care.
jamaneurology.com
JAMA Neurology April 2014 Volume 71, Number 4
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archneur.jamanetwork.com/ by a University of Birmingham User on 06/01/2015
399
Opinion Viewpoint
Billing mentoring, rescheduling, and protocol deviations became the norm. Over time, our participants began to resemble the highly selected population typical in traditional dementia research. Patient and family cost and inconvenience, without tangible benefit, have sparked controversy about the ethics of CED studies.1,6
Although institutional personnel were dedicated to resolving confusion, lack of CED-study experience, staff turnover, billing requirement complexity, and inconsistency of nonresearch and research requirements added up to significantly more time and effort than anyone could have predicted—for a study that had no funding for administration.
Health System Inflexibility and Hurdles Investigators and institutions experienced with sponsored research may have difficulty understanding the hybrid nature of CED studies. Medicare is not a sponsor for CED studies. Although our institution deploys sophisticated research management and billing systems, it was not prepared for CED. Clinical and academic administrators often were puzzled. Some expected involvement of the office of sponsored projects and payments for administrative effort and indirect fees. Others believed that no study information should be in the medical record. Managers and staff initially objected to the use of clinic resources for research. Even after issues were resolved, they would reappear when personnel changed in any of the several involved departments. Billing complexity accounted for half of our experienced study team’s effort. They at first believed that deductibles and copayments did not apply. Because programmers were unaware that a new diagnosis was allowed for CED billing, the first study bills were rejected internally. Patients surprised to receive bills for studyrelated services contacted the billing office to request reversals. Billing clerks with little experience with research often did not know how to proceed or who to ask. Our study team had to rectify all of this and maintain vigilance.
Final CMS decisions are critical because private insurers often deny reimbursement while CED remains in effect. Unfortunately, few technologies assigned to CED have subsequently emerged, in part, because there are no clear standards for revision (eAppendix 4 in Supplement). In the case of FDG-PET, for years, CED has prevented meaningful patient access. Over time, patients and health care providers become increasingly frustrated with the additional requirements and, as interest wanes, collecting requisite data becomes more difficult. Why did we participate in the MCI-ID Study? As the Intermountain West’s only academic program for dementing diseases, we are committed to providing patients in our region access to the latest research advances. We thought we should provide leadership in pragmatic trials. Eventually, however, we could not sustain unexpected, unreimbursed costs even with strong institutional and philanthropic support and we no longer participate. Would we participate in another CED trial? Financial sustainability and confidence in a successful outcome would be critical. Now that we understand CED, at least we will be able to make a knowledgeable decision.
manuscript; and decision to submit the manuscript for publication.
ARTICLE INFORMATION Published Online: February 3, 2014. doi:10.1001/jamaneurol.2013.5812. Conflict of Interest Disclosures: Dr Foster receives research support from GE Healthcare, Avid Radiopharmaceuticals, and the Center for Health Improvement, and has served as a consultant to GE Healthcare, Lilly USA, and Bristol-Myers Squibb. Dr Hoffman receives research support from GE Healthcare and has served as a consultant to GE Healthcare. No other disclosures were reported. Funding/Support: This work was supported by an anonymous donor to the University of Utah Center for Alzheimer’s Care, Imaging, and Research and by the Center for Quantitative Cancer Imaging of the Huntsman Cancer Institute. Role of the Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the
400
Conclusions
Disclaimer: The views expressed herein are those of the authors and do not necessarily represent the views of the University of Utah. Additional Contributions: We thank the numerous study coordinators and administrative staff (University of Utah, Salt Lake City) who assisted with the Metabolic Cerebral Imaging in Incipient Dementia Study, and site co-investigators Edward Zamrini, MD, Richard D. King, MD, PhD, and Gordon J. Chelune, PhD (Center for Alzheimer’s Care, Imaging, and Research, Department of Neurology, University of Utah, Salt Lake City) for assisting with data collection. None received compensation for their contribution to this study. REFERENCES 1. Relyea-Chew A. Ethical considerations in CMS’s coverage with evidence development. J Am Coll Radiol. 2011;8(12):838-841.
2. Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare’s ‘coverage with evidence development.’ Health Aff (Millwood). 2006;25(5):1218-1230. 3. Jones L, Wells K. Strategies for academic and clinician engagement in community-participatory partnered research. JAMA. 2007;297(4):407-410. 4. Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA. Practical clinical trials for translating research to practice: design and measurement recommendations. Med Care. 2005;43(6):551-557. 5. Ware JH, Hamel MB. Pragmatic trials: guides to better patient care? N Engl J Med. 2011;364(18):1685-1687. 6. Pearson SD, Miller FG, Emanuel EJ. Medicare’s requirement for research participation as a condition of coverage: is it ethical? JAMA. 2006;296(8):988-991.
JAMA Neurology April 2014 Volume 71, Number 4
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archneur.jamanetwork.com/ by a University of Birmingham User on 06/01/2015
jamaneurology.com
