What is the VITAL program?
VITAL is an innovative test-and-learn platform that leverages claims-level and clinical data in an accelerated real-world test environment to produce evidence for commercial products. Using integrated clinical, medical cost, and patient experience data, the VITAL team designs targeted studies to evaluate the clinical and cost-effectiveness of commercially available devices, tests, and processes that have not been widely adopted.
Why was the VITAL program created?
In an effort to promote innovation in a highly competitive Western Pennsylvania market, Highmark Health designed the VITAL program to support clinician efforts to creatively solve for care delivery challenges.
Since its launch in 2015 the VITAL program has become a central mechanism for fostering collaboration — and driving value — across Highmark Health: Providers are rewarded for innovative thinking and funding to propose and champion solutions to key issues; eligible members of a Pennsylvania health plan gain earlier access to promising new treatment options with proven outcomes; and the Pennsylvania health plan derives medical policy efficiencies and cost savings as clinically- and cost-effective solutions are adopted.
How is the VITAL program structured?
Highmark Health has developed VITAL’s platform to leverage the unique capabilities, data, and expertise of each constituency within the system.
Highmark Health Role
Highmark Health funds the VITAL program and provides the enterprise analytics to support the VITAL’s research studies. In addition, the parent company is responsible for the identification of the eligible members for studies. The VITAL team, which sits within Highmark Health’s parent organization, aggregates, analyzes, and packages study results for Plan and provider consumption.
Allegheny Health Network Role
Aligned Allegheny Health Network clinicians source, champion, and develop proposals for candidate solutions based on needs identified in the clinical setting. All VITAL projects require a physician sponsor. AHN clinicians also support execution of specific study activities, such as patient enrollment, patient treatment and monitoring, and survey collection and patient outreach following clinical interventions.
Large Pennsylvania Health Plan Role
The participating Pennsylvania health plan provides oversight to VITAL’s solution selection process, and claims data required to measure cost-efficiency. The health plan also reimburses providers for standard ancillary services surrounding VITAL studies. Importantly, the health plan is seen as a “customer” of the VITAL program, and has helped inform VITAL’s health plan-focused evidence outputs, as well as its prioritization of solutions within VITAL’s pipeline.
What is the duration of VITAL tests?
Typical end-to-end evaluation processes span 6 – 18 months, depending on the quality of evidence available for review prior to test launch. The VITAL team evaluates new solutions and conducts tests in parallel as capacity allows.
Who is the VITAL team?
VITAL’s core team is comprised of ~10 data scientists, clinical researchers, business development leads with robust analytical and program management expertise. The team, which sits within Highmark Health’s innovation and transformation division, is responsible for managing concurrent research projects and interfacing with vendors, Plans, providers, and IDN enterprise leaders. Also, unlike many traditional clinical trial researchers, the VITAL team is also equipped to tailor evidence deliverables to meet health plan needs.
Who are VITAL's clinical research partners?
VITAL’s clinical partners currently include aligned clinicians. The Allegheny Health Network is made up of ~2,800 clinicians across 8 hospitals in Western PA plus independent physicians and other strategic partners. The VITAL team also leverages expertise from the Allegheny Health Network Research Institute, which specializes in more than 120 areas of medicine, and hosts a wide range of clinical trial and primary research programs.
What quality controls are in place to ensure the credibility of study results?
Prior to a study’s launch, the VITAL team thoroughly vets candidates for the program through Landscape Assessment and Solution Impact Assessment processes, selecting only those solutions most likely to produce positive outcomes. KPIs are monitored to ensure that projects are scaled, adjusted, or curtailed as appropriate.
In addition, a multi-disciplinary governing body comprised of Highmark Health enterprise, provider, and health plan leaders reviews scientific, clinical and business analyses for candidate solutions prior to study initiation.
Scientific analyses includes review of study design and analysis methodologies, enrollment feasibility, sample size analysis, and suitability of outcome measures
Clinical analyses includes review of unmet clinical need, solution feasibility and workflow fit, other competing technologies, potential risks, short and long term clinical impact
Business analyses includes review of potential ROI and long term savings projections, scaling and adoption path, market differentiation, reimbursement and coverage guidance
What types of solutions are tested?
The VITAL team evaluates health care technologies, labs, and/or processes that are commercially available and have received FDA approval — or other certification equivalents (e.g., CLIA certification for labs) — but have not yet received coverage under most health plan medical policies. Furthermore, candidates are prioritized based on alignment between a solution’s evidence deficits and Highmark Health/VITAL capabilities. Pharmaceutical therapies are not being tested at this time, though the program may expand to evaluate pharmacological products in the future.
What are the VITAL program's clinical focus areas?
Program clinical focus areas currently include oncology, women’s services, cardiac care, diabetes, chronic obstructive pulmonary disease (COPD), precision medicine, and digital therapeutics; however, additional opportunities outside these clinical areas may be considered on a case-by-case basis.
What is the size of the member population available for VITAL studies?
VITAL tests currently draw on data from more than 5 million health plan members.
What has VITAL tested so far and what is currently in the VITAL program's pipeline?
Since the program’s inception, the VITAL team has developed a full and focused pipeline. As of January 2018, more than 40 new ideas were under evaluation or under development. Additional growth is expected as the program continues to scale; by 2020, the team projects capacity for 10+ innovation projects annually.
Can vendor partners influence the VITAL program's evidence outputs?
The VITAL team is committed to preserving objective and transparent processes. As such, the VITAL team will disseminate all relevant study results to health plan constituents, regardless of indication — whether positive, negative, or inconclusive. Vendor partners will not be allowed to reserve the right to prevent or influence study outcome distribution.
Can my local AMC partner participate in VITAL studies?
At this time, VITAL studies are executed by only certain providers. However, additional opportunities to coordinate and scale studies across Plan geographies are currently being explored.
Could VITAL's evidence outputs be leveraged to support a negative medical policy determination?
The primary aim of the VITAL program is to support health care delivery improvement. To this end, the VITAL team and its governance committee select solutions based on the expectation that they will deliver positive health and patient experience outcomes at competitive costs. Predictions notwithstanding, the VITAL team is also committed to its role as an objective, transparent source for evidence, and will disseminate positive, negative, and inconclusive outcomes for all evaluated solutions. Plans retain full discretion over whether and how to apply findings internally, and, in some cases, study outcomes may be used to support a Plan’s rationale for excluding a solution from coverage.