OBJECTIVES : To understand how United States health plans review and approve medical devices, lab and diagnostic tests

METHODS : Online interactive survey of US health plan officers on: respondant+plan information; reviews of medical devices and tests. Topics included: officer+plan information, involvement and components in reviews, and types of tests covered.

RESULTS : The survey was completed by 77 respondents, 57% were MDs and 43% were the senior officer,19% were payor specific, 9.9% regional,1.3% therapeutic area specific. 40.5% of respondents worked for health plans, 11.4% for PBMs,8.9% for IDNs,3.8% for PPOs/IPAs,1.3% for Government. Plans were National=39.2%, regional=27.5% or local=33.3%. Plans cover multiple types of members: commercial (68.8%=FFS, 76.5%=HMO/PPO), Medicaid (Traditional=36.4%, HMO/PPO=67.9%), Medicare (71.2%, PDP-only=50%), Employer/Self-funded=77.1%,and IDN (47.7%,3 40B=43.5%). Only 37.5% of plans required test ordering through an EMR. Genomic tests for Oncology were covered by 87.7% of plans, OB/GYN tests 57.9%, Cardiovascular tests 50.9% and "other" tests 19.3%. Genetic conditions tests are largely covered, either in all cases 63.6% or if under a price threshold 23.6%. Disease markers tests were covered in all cases 71.4% or is under a threshold 19.6%. Therapy responses tests were covered 73.2% all cases, and 19.6% if under a threshold. Respondents involvement in decisions for medical devices (All=34.5%, some=58.2%), Genetic tests (All=26.3%,some=57.9%) and diagnostic tests (All=22.8%, some=64.9%). Dossiers were not required in 67.5% of device reviews and >70% of tests, however the reviews used budget impact models for: medical devices (All=10.2%, some=71.4%), genetic tests (All=4.1%, some=73.5%) and diagnostic tests (All=4.1%, some=69.4%).

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