TABLE 2.

Considerations for Addressing Needs for Successful Value-Based Agreements

Needs	Strategies
Data-sharing issues
Identification of needed data	Use predictive analytics to identify at-risk and outlier populations for designing interventions Identify appropriate time frames to analyze data for the intervention being assessed Measure variability in the provision of care by different providers within the system to establish targets that are appropriate for the VBA Ensure adequate infrastructure to integrate and access data as needed for contracts Provide access to internal and external benchmarks as a baseline for contracts when historic trend data are insufficient
Provisions for data sharing	Use unit cost caps for budget predictability Develop trust and transparency by identifying data elements to be recorded and shared among the partners to the contract (ensure HIPAA compliance) Consider including terms in the contract that allow the ability to terminate contracts based on data issues
Role of value-based partners to support costs	Conduct a preliminary analysis based on real-world evidence and past positive experiences Utilize external benchmarks Provide adequate in-house resources
Legal and compliance issues
Sharing data externally	Determine limits regarding which types of data may be shared with downstream vendors
Use of data in VBA contract	Stakeholders could collaborate to clarify and standardize regulations and policies in contracts
Need for well-informed legal advice about VBAs	Facilitate education about VBA requirements for legal and regulatory compliance personnel Consider a certificate that attorneys can earn to demonstrate competence regarding VBA requirements Collaborate with other associations (e.g., American Society of Pharmacy Law, American Health Lawyer Association, Food and Drug Law Institute) to develop educational initiatives Ensure that individuals who have the authority to approve contracts are involved in their development
Stakeholder knowledge	Raise awareness and understanding about VBAs among stakeholders through educational initiatives Facilitate stakeholder collaboratives to formalize definitions and create templates for VBAs
Legal and regulatory barriers	Advocate to CMS to address issues related to Medicaid Best Price and the Anti-Kickback Statute and create safe harbors
Managing risk
Variation in clinical outcomes	Focus on outcomes that are supported through clinical evidence Determine appropriate time frames for various outcomes, including leading and lagging indicators (e.g., A1c outcomes have a shorter time frame than amputations)
Variation in network provider performance	Include provisions in the contract that recognize and address variation among providers Include provider benchmarking and align incentives to change provider behavior Consider which stakeholders are responsible for changing provider performance
Variation in the population of interest	Determine whether to use a fixed or evolving cohort (i.e., can new patients join after the contract is initiated?)
Other	Potential for paradigm-shifting treatments to be approved during the term of the contract Changes in legal and regulatory requirements during the term of the contract
Informing and reporting
Emerging best practices	Electronic prior authorization processes Care pathways to identify gaps in care Data transfer to provide immediate feedback to providers about conditions and medications
Partners and roles	Determine how data from EHR systems will be transferred to payers and ensure it is transferred in a useful format Integrate data into a single platform that can be queried efficiently Manufacturers can provide tools and resources, including patient programs with care managers and related services Consider integration of the manufacturers’ care management program with IDN services
Restrictions	Privacy/HIPAA limitations for data sharing Including more than 2 parties in an arrangement complicates data sharing Need to build trust

CMS = Centers for Medicare & Medicaid Services; EHR = electronic health record; HIPAA = Health Insurance Portability and Accountability Act; IDN = integrated delivery network; VBA = value-based agreement.