Surveillance System and a Roadmap to Reopening Please be advised, - - PowerPoint PPT Presentation

Discussion of National COVID-19 Surveillance System and a Roadmap to Reopening

April 27, 2020

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Reviewed on January 09, 2020

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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

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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

Ensuring Test Availability

• Reliable tests
• Testing sites
• Protective

equipment

• Collection

materials

• Reagents

Rapid Testing

• Local

availability with no co-pay

• Timely test

performance (lab, point-of- care) Tracing and Containment

• Rapid tracing
• Tech-enabled
• CARES Corps
• Quarantine and

testing of close contacts

• At-home

isolation and monitoring of cases Evidence-Based Policy Adjustments

• Public

reporting of new cases,

• utbreaks,

potential

• utbreaks, and

trends

• Adjustments in

extent of social distancing

• Revisions in

testing policies

Referral

• Population risk

assessment and

• utreach
• Timely referral of all

appropriate patients (symptoms, close contacts, surveillance)

Reporting

• Key data

elements for response and epidemiology

• Strong privacy

protections

Analysis & Modeling

• Assessment of local

risks and trends

• Integration with

syndromic and serology data

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:

• Set at level to encourage

broad participation of providers who do not have labs but could support convenient collection in the community

• Consider supplemental

payment for using better/more accurate tests and providing complete information to labs For Testing:

• Labs (hospital, physician
• ffice based, commercial)
• Pharmacies and other

“providers” performing POC tests

• Linked to timely reporting

requirement of key test information to ordering provider and relevant state/Federal public health system, including sufficient identifying information for public health contact tracing For Case Management at Home:

• Augment telemedicine

payment with a per-case payment to include monitoring symptoms, connection to needed medical services from home, and other steps to avoid hospitalization

• May include assistance

with collection of information for contact tracing For Quarantine and Symptom Monitoring:

• Enable timely access to

appropriate testing to rule

• ut COVID-19
• Monitor patient symptoms

to help assure appropriate further treatment

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?

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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

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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

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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

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
• r outcomes, and shared evidence development efforts
• CMS could work with private payers to develop model contracts for coverage and evidence development