(2) The impact copayment coupons and other patient assistance programs have in the Medicare Part D program established under part D of title XVIII of the Social Security Act ( 42 U.S.C. 1395w–101 et seq.) on utilization of higher-cost brand drugs and lower utilization of generic drugs in that program. (3) The extent to which manufacturers report or obtain tax benefits, including deductions of business expenses and charitable contributions, for any of the following: (A) Offering copayment coupons or other patient assistance programs. (B) Sponsoring manufacturer patient assistance programs. (C) Paying for sponsorships at outreach and advocacy events organized by patient assistance programs. (4) The efficacy of oversight conducted to ensure that independent charity patient assistance programs adhere to guidance from the Office of the Inspector General of the Department of Health and Human Services on avoiding waste, fraud, and abuse. (b) Definitions In this section: (1) Independent charity patient assistance program The term independent charity patient assistance program means any organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under section 501(a) of such Code and which is not a private foundation (as defined in section 509(a) of such Code) that offers patient assistance. (2) Manufacturer The term manufacturer has the meaning given that term in section 1927(k)(5) of the Social Security Act ( 42 U.S.C. 1396r–8(k)(5) ). (3) Manufacturer patient assistance program The term manufacturer patient assistance program means an organization, including a private foundation (as so defined), that is sponsored by, or receives funding from, a manufacturer and that offers patient assistance. Such term does not include an independent charity patient assistance program. (4) Patient assistance The term patient assistance means assistance provided to offset the cost of drugs for individuals. Such term includes free products, coupons, rebates, copay or discount cards, and other