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.