Developing a Pilot Project for Private Sector Coverage with Evidence Development 6.14.10
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The document discusses developing a pilot project for coverage with evidence development (CED) in the private sector. A stakeholder workgroup selected pharmacogenetic testing for estimating initial warfarin dosing as the topic. The workgroup discussed operational and study design issues, such as coverage models, communication with patients and providers, funding, and informed consent. Conducting private sector CED poses challenges but payers remain interested to generate better information for coverage decisions through this mechanism.
Developing a Pilot Project for Private Sector Coverage with Evidence Development 6.14.10
- 1. Developing a pilot project for private sector coverage with evidence development Sonnad SS 1,2, Seidenfeld JD 1 , Bergthold L 1 1 Center for Medical Technology Policy, Baltimore, MD, USA, 2 Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia, PA, USA Research Objectives Coverage with Evidence Development (CED) is a policy tool for health plans to offer provisional coverage for a promising but unproven intervention while data are being collected to generate the evidence needed to inform coverage policy. This study reports on an effort led by the Center for Medical Technology Policy (CMTP) to launch a pilot CED initiative in the private sector. Principal Findings The stakeholder workgroup was initially convened in September 2009. Participants were asked to: Select an appropriate technology for a CED initiative and Identify operational and study design issues that will need to be addressed to design and implement the project. TOPIC SELECTION The workgroup was given background information on three cardiovascular technologies identified by CMTP as particularly suitable for a CED pilot: Catheter-based ablation for the treatment of atrial fibrillation, Pharmacogenetic testing for estimating initial warfarin doses, and Percutaneous aortic valve replacement (AVR) Participants chose the topic of pharmacogenetic testing for estimating initial warfarin dosing , citing a number of reasons: Advantageous opportunity to work in parallel with recent efforts from the Center for Medicare and Medicaid Services to provide genetic testing for warfarin dosing under their own CED authority Prospect of adapting new research studies in development or early stages of implementation. A wide range of decision-makers (both patients and clinicians) will face questions about genetic tests for warfarin dosing, while other potential technologies for a CED were limited by availability in settings. High operational feasibility Can be a short trial to examine adverse effects, Unambiguous outcomes, Will serve as precedent for evaluating other genetic tests. Numerous payers have conveyed apprehension about the deluge of new genetic tests coming to the market, and would welcome a framework for covering genetic tests before the marketplace demands coverage even without appropriate evidence. OPERATIONAL AND STUDY DESIGN ISSUES The latter half of the stakeholder meeting was devoted to discussing operational topics that must be addressed to produce a successful CED initiative in the private sectors, including: anti-trust concerns coverage model options, interface with state regulatory requirements, identification and communication issues with both patients and providers, funding issues, informed consent and other ethical issues, and study design options. Conclusions Conducting private sector CED using rigorous research design and involving multiple payers is not without challenge. However, payer representatives remain interested in the possibilities of generating better information for coverage decisions through this mechanism and remain committed to the project. Populations Studied Representatives of CMTP’s multi-stakeholder CED workgroup: Implications for Policy Both CMS and private insurers have used CED with limited success in the past. Previous work by CMTP demonstrated broad support for the concept of CED among stakeholders in the private sector, but unclear leadership for coordinating such a CED project until this pilot effort undertaken by CMTP and participants. Widespread application of CED in the private sector could significantly impact the adoption and dissemination of new technologies in a broader range of patients than those covered by CMS. This could have significant implications for the cost and efficacy of new technology use in the United States healthcare system. Design of a private sector CED pilot Primary Funding Source: California Healthcare Foundation Stakeholder position Name Organization Patient/consumer Larry Sadwin President, Friends of the World Heart Federation Foundation Patient/consumer Susan Goodreds President, MarketPower, LLC Private Health Plans Bob McDonough Head of Clinical Policy Unit, Aetna Private Health Plans Dick Justman National Medical Director, United Healthcare Private Health Plans Virginia Calega VP, Medical management and Policy , Highmark, Inc. Private Health Plans James Adamson Vice President/Chief Medical Officer, Arkansas BCBS Private Health Plans Tricia Nguyen Senior Medical Director, Blue Cross Blue Shield Florida Public Plans Louis Jacques Director, Coverage and Analysis Group, CMS Public Plans Tamara Syrek-Jensen Deputy Director, Coverage and Analysis Group, CMS Self-insured employer Jim Knutson Risk Manager and HR Director, Aircraft Gear Corporation Physician Janet Wright VP for Science & Quality, American College of Cardiology Physician Wells Shoemaker Medical Director , California Association of Physician Groups Clinical Research Eric Stanek Senior Director of Research in Personalized Medicine, Medco Clinical Research Brian Gage Associate Professor, Washington U School of Medicine Clinical Research Steve Kimmel Director, Cardiovascular Epidemiology , U Penn Medicine Government research Yves Rosenberg Division of Cardiovascular Sciences, NHLBI Legal representative Jeff Miles Partner, OBER | KALER Study Design Phase 1: Research and Topic Identification Phase 2: Convene Multi-Stakeholder Workgroup Phase 3: Design Research & Implementation Protocol Develop research criteria and protocol Identify researchers to implement research study Identify funding sources for research cost Address operational issues and find plausible solutions Assemble a workgroup of stakeholders, including: Private health plans Consumers Physicians Self-insured employers Clinical researchers Legal experts Convene workgroup to Select final topic Identify operational issues Develop criteria to evaluate research topics for CED suitability Implement priority-setting process to select 3 appropriate topics Develop a business case to recruit stakeholders