; and (D) identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and State plans under title XIX of such Act ( 42 U.S.C. 1396 et seq.) into the Medicare program. (c) Novel medical products described For purposes of this section, a novel medical product described in this subsection is a medical product, including a drug, biological (including gene and cell therapy), or medical device, that has been designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a) ), a breakthrough device under section 515B of such Act ( 21 U.S.C. 360e–3 ), or a regenerative advanced therapy under section 506(g) of such Act ( 21 U.S.C. 356(g) ). 145. Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives Section 1862(l) of the Social Security Act ( 42 U.S.C. 1395y(l) ) is amended by adding at the end the following new paragraph: (7) Patient consultation in national and local coverage determinations The Secretary may consult with patients and organizations representing patients in making national and local coverage determinations. . 146. GAO study on increases to Medicare and Medicaid spending due to copayment coupons and other patient assistance programs (a) Study The Comptroller General of the United States shall conduct a study on the impact of copayment coupons and other patient assistance programs on prescription drug pricing and expenditures within the Medicare and Medicaid programs. The study shall assess the following: (1) The extent to which copayment coupons and other patient assistance programs contribute to inflated prescription drug prices under such programs. (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