; and ; and (D) by adding at the end the following new subclause: (IX) any prices used under an insulin assistance program supported under section 320C of the Public Health Service Act. . (c) Deductibles for underinsured individuals participating in insulin assistance programs Subpart I of part A of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg et seq. ) is amended by adding at the end the following: 2710. Deductibles and other out-of-pocket expenses for underinsured individuals participating in insulin assistance programs (a) In general A group health plan that is a high-deductible health plan and a health insurance issuer offering a high-deductible health plan shall, with respect to any individual who is enrolled in such plan and obtains insulin during a plan year through an insulin card issued to the individual by a State, Indian tribe, or tribal organization carrying out an insulin assistance program under section 320C, count the amount the State, Indian tribe, or tribal organization pays a pharmacy for insulin for such individual for such plan year towards any deductible or other out-of-pocket expenses required to be paid under the plan. (b) High-Deductible health plan For purposes of this section, the term high-deductible health plan has the meaning given such term in section 320C(j). . 3. Annual fees applicable to insulin manufacturers (a) Definitions For purposes of this section: (1) Annual payment date The term annual payment date means, with respect to a calendar year, the date determined by the Secretary, but in no event later than September 30 of such calendar year. (2) Covered entity The term covered entity , with respect to a calendar year, means an entity that— (A) is the holder of an application approved under subsection (c) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), or of a license issued under subsection (a) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), for an insulin product