CED in the Private Sector: Lessons in Design and Implementation Steve E. Phurrough, MD, MPA September 29,

CED – What is it, and why do it? Temporarily reimbursement contingent on participation in an organized research study Reconciles tension between strict evidence standards and being responsive to rapid medical innovation Some version of CED is probably inevitable One tool to improve relevance and quality of evidence about the best use of emerging medical technologies 2

Part 1: Model Benefit Language Project CHCF provided a grant to CMTP in early 2008 to develop model benefit language for CED CMTP convened a multi-stakeholder workgroup, which proposed model benefit language as well as a process for implementing CED and identified a need for a neutral “organizing entity” to facilitate the CED initiatives 33

Options for Incorporating CED into Plan Language 4 1) adding language to the current “Experimental and Investigational” exclusion language 2) using extra-contractual payments, and 3) creating a supplement to existing clinical trial policy language 4) establish CED outside of benefits as a special research project (with foundation funding)

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Part 2: Pilot CED Initiative in the Private Sector Priority-setting process Multi-stakeholder workgroup Design research & implementation protocol 66

1. Priority-setting - Lessons Decision-maker input Early and often, particularly health plans Selection of patient/patient advocate participants More than one, at least one from an advocacy group Scoping priority-setting efforts Use of technology briefs Priority-setting methods CED-specific criteria 7

2. Stakeholder Engagement Private payers, self-insured, public plans, patients, patient advocates, clinicians, researchers balance perspectives achieve stakeholder commitment provide opportunities for discussion ongoing participation 8

3. Design/Implementation Issues Anti-trust concerns Procedure codes to identify the CED service Selection of benefit design IRB approval Informed consent Recruitment of providers and patients Coordinating data collection Costs 9

3. Design/Implementation Issues Anti-trust concerns: No anti-competitive behavior, discussions or agreements related to coverage decisions, pricing, premiums, discounts, reimbursement to providers. Procedure codes: Might need to get a new category 1 or 3 Current Procedural Terminology (CPT) code from the AMA’s CPT Editorial Panel or CMS 10

3. Design/Implementation Issues Benefit design Plans prefer to create CED programs that are implemented outside of coverage language (as an extra-contractual benefit or special program). Easier to work with health plans in their Administrative Services Only (ASO) role, so start with self-insured employers. Large employers with union employees pose a unique situation if the CED program is created as a type of benefit. Coverage might be subject to union negotiations even if evidence from a study indicates that the health plans should not cover the technology. 11

3. Design/Implementation Issues IRB Approval: Up to the co-investigators of a selected study to obtain IRB approval in their respective regions across multiple study sites that work with different participating payers. Conflict of Interest/Informed Consent: Legal departments will review the CED study and ensure that it does not contradict established policy (e.g., if the technology is already covered, access only through CED could not be required with a extra contractual benefit/program) 12

3. Design/Implementation Issues Recruitment of providers and payers: Health plans will undoubtedly choose independent means of identifying and recruiting providers and patients to participate. If the study does not include an adequate number of facilities and physicians, the plan would need to develop those contracts. If the plan and the employer are already paying for the test or intervention, it makes it easier to cover under CED, but the plans will need to notify the employer clients and allow them to opt out if that is their preference. 13

3. Design/Implementation Issues Coordinate data collection Study investigators should develop a method for identifying and tracking patients across different providers, plans, and labs. For them, the single most important issue is to make sure that claims are submitted properly and to avoid unlisted (-99) CPT codes. Three areas on the claims form that can be used to identify and track participants in a CED study – the procedure code (e.g., the CPT or HCPCS code), the trial identification number, and/or a trial-specific modifier. 14

3. Design/Implementation Issues Costs: Health plans expect to fund three costs when devising a CED policy: 1) the costs of the experimental treatment, 2) the costs of gaining acceptance among self- insured clients and developing a mechanism for them to ‘opt-out’ of the trial; and 3) the administrative costs connected to claims processing which might include the costs of modifying their claims processing system to identify an exceptions process for coverage under the trial if needed. 15

Part 3: Bridge to Implementation Submission of a study protocol for research funding by a federal agency, designed and approved by a multi-stakeholder group Issuance of CED policy language on the study by multiple health plans. 16

Questions to be resolved Operational issues How will health plans will be able to identify who is enrolled in a clinical trial and eligible for coverage? Should CED be implemented with insured or self- insured products? How will network providers be notified? How can the selected technology be coded for reimbursement? Funding sources? Communication issues Who is responsible for communicating to members? Coverage and payment issues Which approach is most feasible and legally robust 17

Pharmacogenetic testing for estimating initial warfarin doses FDA recommended pharmacogenomic testing in the warfarin label. Despite this, clinicians are reluctant to use these tests high costs and lack of clear benefit. Workgroup participants noted: Few prospective studies showing effectiveness and no rigorous RCTs Potentially large clinical impact, inappropriate warfarin dosing is a common cause of hospital readmission and ER presentation CMS has also issuing a CED decision on the same topic 18