02-18-2021 Clinical Advisory Committee Minutes


Attendees

 

Name

Affiliation

 

Name

Affiliation

 

 

 

 

 

 

Shane, Frank Opelka, John, Cary, Dhruv, Lee,

Agenda and Minutes

Document any tasks here, Document any decisions on group page

Agenda Item

Lead

Minutes

Agenda Item

Lead

Minutes

Updates

 

  • Connect a Thon, 1-5 March

    • Virtual session; IHE USA; IT arm of HIMSS

    • Reminder of four components

      • Jumpstart BPM+ Health

      • Advanced Consent Form

      • Bending Cost Curve (review)

    • Ask: please push/like/etc via social media

    • All to be offered as standing webinar going forward

    • Major impacts of this CAC for Connect a Thon

  • Objectives for 2021 to address after March; direction of this group; make ourselves available and good value-partner; August….real!

    • How to look towards, prep for August HIMSS

    • Make ourselves available; CAC is behind you, lets bring the key discussions to this group to help amp up the outcomes

  • March Meeting Prep

Value Based Care, ACS Equation (Frank)

 

  • Quality over cost, elevate quality to value of cost

  • Care in a value based direction, with cost in mind

  • Issue: fatigue around value based care concept…evolution in how it is perceived

  • To deliver at Enterprise level, some hurdles to overcome

  • Frank inputs:

    • Thrive Program with Harvard, episodes of care

    • Expressing through Value Expression

    • How to define Value Based Care and its subcomponents?

    • Viewing value as a judgement; we each apply different perception components; it is personnel; difficult then to express from a data perspective

    • Quality/Price; Costs required for this episode of care

    • How to represent patient’s judgement; experiences and sensitivities; are we meeting their expectations and goals?

    • Through: patient reported outcomes…get rid of pain, treated respectfully…respected end of life wishes…etc; series of plots like a radar plot/chart

    • Outcome: add all the pieces of and then map them out

    • Sensitivities: race, gender, background, etc….and how they overlay each other; expectations of health care system are very different; not sure what to expect vs. just want a good outcome vs other

    • Clinical success is not always equal to value

    • PROs as elements of the formula; PRO to be tailored to population being worked with; some are in place by researchers

  • Lee notes

    • Value based care equated to bundled payment

    • Quality of patient care for entire episode for least amt of $ being spent

    • Drives better patient outcomes and drive down cost for patient care; outcome is that more of these are being rolled out more broadly

    • National standard for bundles (Frank) in process, key for scaling; care is episodic once you get past transactions; did the outcome achieve the results?

    • Note on price: match to disease, not being done (for most part) today; must consider overall amortized price eg 1 yr of outcomes vs 10 yr of outcomes (cost in the end for bad care)

    • Corporation bundle model - required to be pitched to ind insurance companies, drives lack of standard for payment

    • Where bundles working well? Poorly?

      • Danville - profitable and high quality of care, seen as the gold standard

      • Simple, procedural bundles 600 and conditioned bundles 200; conditional level is really the opportunity for savings moving forward

      • CHF bundle this year as well

      • not necessarily same as “carve-outs”

  • Final thoughts

    • Frank: care model for each episode, resource model, come together with data models, all to inform, payment model, compensation model, competition, (value based); roles to play for several different aspects for implementation to be successful (ACTION: more discussion)

    • How CAC to help? focus on quantification…make it a reality

    •  

ONC

 

Broad discussion, how transition occurs, policy related, how best to structure;

  • Overview

    • Clear message through advocacy

    • papers etc to help drive the standardization

    • Also relates to brief/coordinate w FDA related to beneficial patterns (safety concern)

    • Frank leading the policy workgroup

    • How are we able to take CAC efforts to support Policy Group? How to make sure we don’t complicate?

  • Policy points

    • ONC, FDA, CDC, CMS

    • Looking to conversation with each agency, they each have public comment that will each hit WGs in different ways; how do they promote what we are doing; engage, be active, public comment both ways

    • New ONC leadership - may not be as BPM tuned; so how do we engage? Behind the scenes, policy papers, public comment;

  •  

FDA, CDC and CMS (both to add)

 

  • John FDA thoughts

    • Need to engage w FDA

    • Some processes are low risk, operational, procedural outside of FDA domain (eg scheduling)

    • FDA has clear rules re drug prescription, etc with high regulation;

    • Digital medicine is the group to engage with

    • Need to meet certain criteria;

    • Challenge with FDA - each drug or device requires separate submission, each taking two years to go through; that is big challenge for process automation

    • FDA will approve the company, but not necessarily each individually; narrow set of models will be approved, so many processes not being brought forward

    • Other issue is liability; challenge if components not aligned, there could be legal blame for failure; Davide has significant knowledge in this space

  • Davide

    • two ways to engage: consumer of regulations, software as medical device, and second is do we need to encourage FDA to relax the rules/approach; FDA looking for AI guidance; Mayo contributed on this

    • After FDA sets rules, how do we as producers of models relate to those rules?

    • Most CDS is human in the loop, never considered FDA medical device, so issue is when we have full automation for safety, liability, etc…many nuances there

  • Shane notes

    • Automation bringing for external sources forward, recs for forward pathways for clinicians, supplying them with info and they make decision necessary

    • Provides loose decoupling between the system and the human making the decision; is this defensible?

    • Davide - from agency perspective, they need to hear the message more; potentially new concept for them

    • Frank - From FDA perspective, open and available for review, subject to interpretation, not to require any further FDA involvement; if beyond, FDA sees as medical device which may or may not be under approval, standards to be met

    • Davide - broader discussion, what is the message on new ways to do automation, John - who is right to address: Authoring, Automation, Chairs? Need engagement with all agencies, who will address from BPM perspective?

    • Frank - important to know that the agencies do not communicate (necessarily); Shane - how do we approach as a campaign perspective, to come with one voice, across the agencies?

    • ACTION: determine WHO and HOW to move forward for BPM in coordination with agencies as a community;

    • FHIR - coordination on approach; CPG on FHIR

      • need wins on contracts and pilots

Paper Criteria

Davide

AMIA, Causeway, call out for help, the ask

  • June deadline

  • Paper abstract underway

  • ASK: Causeway - now until AMIA submission, Shane and Cary to help support, need someone to help work this!