insulin
(2) High deductible health plan (A) In general The term “high deductible health plan” means a health plan— (i) which has an annual deductible which is not less than— (I) $1,000 for self-only coverage, and (II) twice the dollar amount in subclause (I) for family coverage, and (ii) the sum of the annual deductible and the other annual out-of-pocket expenses required to be paid under the plan (other than for premiums) for covered benefits does not exceed— (I) $5,000 for self-only coverage, and (II) twice the dollar amount in subclause (I) for family coverage. (B) Exclusion of certain plans Such term does not include a health plan if substantially all of its coverage is coverage described in paragraph (1)(B). (C) Safe harbor for absence of preventive care deductible A plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for preventive care (within the meaning of section 1861 of the Social Security Act, except as otherwise provided by the Secretary). (D) Special rules for network plans In the case of a plan using a network of providers— (i) Annual out-of-pocket limitation Such plan shall not fail to be treated as a high deductible health plan by reason of having an out-of-pocket limitation for services provided outside of such network which exceeds the applicable limitation under subparagraph (A)(ii). (ii) Annual deductible Such plan’s annual deductible for services provided outside of such network shall not be taken into account for purposes of subsection (b)(2). (E) Safe harbor for absence of deductible for telehealth In the case of— (i) months beginning after March 31, 2022 , and before January 1, 2023 , and (ii) plan years beginning on or before December 31, 2021 , or after December 31, 2022 , and before January 1, 2025 , a plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for telehealth and other remote care services. (F) Special rule for surprise billing A plan shall not fail to be treated as a high deductible health plan by reason of providing benefits for medical care in accordance with section 9816 or 9817, section 2799A–1 or 2799A–2 of the Public Health Service Act, or section 716 or 717 of the Employee Retirement Income Security Act of 1974, or any State law providing similar protections to individuals, prior to the satisfaction of the deductible under paragraph (2)(A)(i). (G) Safe harbor for absence of deductible for certain insulin products (i) In general A plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for selected insulin products. (ii) Selected insulin products For purposes of this subparagraph— (I) In general The term “selected insulin products” means any dosage form (such as vial, pump, or inhaler dosage forms) of any different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin. (II) Insulin The term “insulin” means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 ( Public Law 111–148 ) and continues to be marketed pursuant to such licensure.