OBJECTIVES : Medical devices and tests have the potential to save resources and they need to be approved by the health plan. Devices may facilitate medication delivery and/or regulate patient care. Some tests allow clinicians to identify diseases and others identify markers to enhance the likelihood of therapy effectiveness. To understand how U.S. health plans review+approve medical devices,lab+diagnostic tests.

METHODS : Online interactive survey of U.S. health plan officers. Survey topics included: respondent+plan information, involvement and components in the review of medical devices+tests, and types of tests covered. Results compared with prior surveys (changes>2% reported).

RESULTS : Survey completed by 85 respondents,42.9% were the senior officer,13.1% regional,8.3% payor specific,1.2% therapeutic area specific. 36.9% worked for health plans,13.1% PBMs,9.5% IDNs,2.4% PPOs/IPAs,1.2% Government. Plans were National=29.9%, Regional=24.7% or Local=22.1% and cover multiple member types: commercial (58.6%=FFS,77.8%=HMO/PPO),Medicaid (Traditional=27.8%,HMO/PPO=72.3%), Medicare (71%,PDP-only=51%), Employer/Self-funded=79% and IDN (43.6%,340B Qualified=43.8%). Genomic tests for Oncology were covered by 88.3% of plans, OB/GYN tests 65%↑7.1%, Cardiovascular tests 63.3%↓12.4% and other tests 16.7%↑2.6%. Genetic conditions tests were largely covered, either in all cases 60.7%↑2.9% or if under a threshold 23%. Disease-marker tests were covered in all cases by 78.3%↓6.9% or if under a threshold by 15%↑4.6%. Therapy responses tests were covered in all cases by 69.5%↑3.7%, and if under a threshold by 20.3%. Involvement in decisions for medical devices (All=63.3%,some=50.7%), genetic tests (All=31.4%,some=45.7%) and diagnostic tests (All=31.4%,some=45.7%). Dossiers were not required in 66.7% of device reviews and 67% of tests. Reviewers used budget impact models for: medical devices (All=18.5%,some=61.1%), genetic-tests (All=17%,some=58.5%) and diagnostic-tests (All=17.6%,some=54.9%). Devices were considered non-experimental if: listed in a compendia=37.9%,more than 2 RCTs=29.3%, listed in a guideline=17.2% or listed in 2 compendia=15.5%.

CONCLUSIONS : The managed care decision-making process goes beyond pharmaceuticals and is undergoing a series of changes. Medical+pharmacy directors, who commonly regulate utilization, have distinct opinions as to how to manage their plans expenditures+outcomes.