2health coverage to provide coverage to women without cost sharing that includes“preventive care and screenings . . . as provided for in the comprehensive guidelinessupported by the Health Resources and Services Administration [‘HRSA’].” 42 U.S.C.§ 300gg-13(a)(4). “Without cost sharing” in this context means free of cost to thepatient.The Government issued interim final regulations implementing this preventiveservices coverage provision on July 19, 2010, requiring a group health plan or healthinsurance issuer offering non-grandfathered health coverage to provide, without costsharing, the recommended preventive services for plan years beginning on or after oneyear from the date the recommendation is issued (“HRSA Mandate”). 75. Fed. Reg.41,728–41,729.The HRSA enlisted the Institute of Medicine (“IOM”), an independent, non-profitorganization established under the National Academy of Sciences, to developrecommendations for the HRSA guidelines.
Institute of Medicine, Clinical Servicesfor Women: Closing the Gaps 2 (2011) (“IOM Rep.”). The IOM issued a report thatrecommended the HRSA guidelines include, among other things, “the full range of Foodand Drug Administration [‘FDA’]-approved contraceptive methods, sterilizationprocedures, and patient and education counseling for women with reproductivecapacity.”
at 10. FDA-approved contraceptive methods, in turn, are found to includeoral contraceptives, “emergency contraceptive” abortifacients (such as “Plan B” and“Ella”), and intrauterine devices. FDA, Birth Control Guide 10–12, 16–20 (2012),
http:// www.fda.gov/ ForConsumers/ ByAudience/ ForWomen/ ucm118465.On August 1, 2011, the HRSA adopted the IOM’s recommendations in full.
2:12-cv-12061-RHC-MJH Doc # 39 Filed 10/31/12 Pg 2 of 29 Pg ID 541