Discussion of National COVID-19 Surveillance System and a Roadmap to Reopening Please be advised, all participants are muted on entry. To April 27, 2020 unmute/mute yourself during the call, please press *6. Thank you!
AHIP Antitrust Compliance Policy It is the policy of America’s Health Insurance Plans (AHIP) to conduct all of its activities in compliance with federal and state antitrust laws. During AHIP meetings and other association activities, including all informal or social discussions, each member shall refrain from discussing or exchanging competitively sensitive information with any other member. Such information includes, but may not be limited to: • Prices, premiums, or reimbursement charged or paid for products or services • Allocation of customers, enrollees, sales territories, sales of any product or contracts with providers • Refusal to deal with any customer, class or group of customers • Refusal to deal with any provider, class or group of providers • What products or services will be offered to enrollees • Any other competitively sensitive information that is proprietary to a member company If you have any questions or antitrust concerns related to AHIP programs, meetings, or activities, consult with AHIP legal counsel or your own counsel. Reviewed on January 09, 2020 2
National COVID-19 Surveillance System and a Roadmap to Reopening Dr. Mark McClellan, M.D. Director of the Robert J. Margolis Center for Health Policy, Duke University
Achieving Containment 1) Test and Trace Infrastructure: Capacity for Widespread Diagnostic Testing and Data Sharing to Enable Rapid Case-Based Interventions 2) Syndromic Surveillance: Integration of Test and Trace into an Enhanced National Syndromic Surveillance System 3) Serologic Testing: Capacity to Conduct Widespread Serologic Testing to Identify Reliable Markers of Immunity 4) Rapid Response: Capacity for Isolation, Contact Tracing, and Quarantine 4
Referral Analysis & Reporting Population risk • Modeling • Key data assessment and elements for Assessment of local • outreach response and risks and trends Timely referral of all • epidemiology • Integration with appropriate patients Strong privacy • (symptoms, close syndromic and contacts, surveillance) protections serology data Ensuring Test Rapid Testing Tracing and Evidence-Based Availability Containment Policy Adjustments • Reliable tests • Local • Rapid tracing • Public availability reporting of • Testing sites • Tech-enabled with no co-pay new cases, • Protective • CARES Corps outbreaks, • Timely test equipment • Quarantine and potential performance • Collection testing of close outbreaks, and (lab, point-of- materials contacts trends care) • Reagents • At-home • Adjustments in isolation and extent of social monitoring of distancing cases • Revisions in testing policies
Health care engagement in COVID-19 detection, management, and containment • Scaling up test and trace capacity will be very challenging without active engagement of health care providers and health plans • Some primary care groups, hospitals, and academic centers are already supporting various pieces of test and trace – but most have limited capacity, especially with COVID- 19 financial challenges • Health plans are augmenting these capabilities for many providers – but generally do not have direct connections to public health surveillance and response networks • CMS with CDC and states would provide range of ways that providers could support test and trace based on available tools and best practices • Part of provider COVID-19 relief funding • Part of CMS payments
Policy supports for comprehensive test and trace • Expansion of contact tracing workforce – 180,000+ individuals, $12 billion • Voluntary self-isolation facilities – vacant hotels or other options in each region for people who can’t/won’t self -isolate at home, $4.5 billion • Income support or paid leave for voluntary self-isolation - $30 billion • Health care provider referrals and support – especially through primary care, through health care stimulus payments or CMS payment initiatives
Potential payments for test and trace For Test Sample Collection: For Testing: For Case Management For Quarantine and Symptom • • Set at level to encourage Labs (hospital, physician at Home: Monitoring: • • broad participation of office based, commercial) Augment telemedicine Enable timely access to • providers who do not have Pharmacies and other payment with a per-case appropriate testing to rule labs but could support “providers” performing payment to include out COVID-19 • convenient collection in POC tests monitoring symptoms, Monitor patient symptoms • the community Linked to timely reporting connection to needed to help assure appropriate • Consider supplemental requirement of key test medical services from further treatment payment for using information to ordering home, and other steps to better/more accurate tests provider and relevant avoid hospitalization • and providing complete state/Federal public health May include assistance information to labs system, including sufficient with collection of identifying information for information for contact public health contact tracing tracing
Key questions • What are best practices for health care providers and payers in implementing effective, comprehensive test and trace systems and syndromic surveillance? • What policy reforms can encourage and expand these best practices?
Serology testing • Viral infection usually confers immunity to reinfections • If it happens with COVID-19, may be able to loosen social distancing restrictions for individuals with immunity • Early studies indicate infected patients produce neutralizing antibodies, but... • Unclear if this indicates total protection from reinfection, or from being infectious • Duration of immune protection is unclear • Unknown if a certain level of antibodies needed • Herd immunity with COVID-19 contagion requires 60-70% + to be immune 11
Serology Tests Available • Updating list on FDA's diagnostic test FAQ page; as of April 23: • 23 labs notified FDA they validated a serological test • 139 manufacturers notified FDA they validated a serological test • 2 are listed as FDA authorized (EUA granted); outdated? • None are authorized as POC tests; some may be once non-expert user studies are completed • At-home tests still must have EUA • FDA, NIH, CDC, and BARDA are working to assess the performance of serological tests, as a complement to FDA review • Performance assessment protocol for evaluation of lateral flow SARS-CoV-2 serological tests using positive and negative plasma and serum samples • "a balanced attempt to provide a reasonable understanding of the potential performance of a significant number of the tests within a short time period" • FDA will be releasing a EUA template for serology tests soon 12
How can serology results be used? AFTER tests of sufficient accuracy are validated: • Understand population exposure levels • Case fatality rate • Modeling AFTER scientific questions are answered: • Use with essential workers at high risk of exposure • Task-shift, strategic placement • Conserve PPE • Combination of serology and diagnostic testing to help with contact tracing • Quarantine measures not required if seropositive • Immunity certification to allow broader reopening of economy • Will require careful implementation planning to avoid fraud and intentional self-infection 13
Access and payment for COVID-19 therapies • Payers can start planning now for supporting development of and access to COVID-19 therapeutics and vaccines • Precommitments for large-scale purchases of effective therapies could help companies ramp up manufacturing capacity and reduce uncertainty about the scale and cost of new COVID-19 therapeutics • Commit payers to purchasing a minimum amount of a product that meets minimum specifications for effectiveness for a population-based price • Payers who participate in such contracts could potentially receive matching funds through CMS • Advance planning for post-approval real-world studies could build out the infrastructure for closing evidence gaps on effectiveness - ideally well ahead of product approval • FDA, NIH, sponsors, payers, and health systems to align on critical questions, common data elements or outcomes, and shared evidence development efforts • CMS could work with private payers to develop model contracts for coverage and evidence development
Recommend
More recommend
