I 113th CONGRESS 1st Session H. R. 1801 IN THE HOUSE OF REPRESENTATIVES April 26, 2013 Mr. Higgins (for himself, Ms. Moore , Ms. Pingree of Maine , Mr. Cicilline , Mrs. Capps , Mr. Grijalva , Ms. Wilson of Florida , Mr. Hastings of Florida , Mr. King of New York , Mr. Rangel , Mr. Larsen of Washington , Mr. McGovern , Mr. Peters of California , Mr. Wolf , Mr. Moran , and Mr. Farr ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Ways and Means and Education and the Workforce , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide for coverage of oral anticancer drugs on terms no less favorable than the coverage provided for anticancer medications administered by a health care provider.

1. Short title This Act may be cited as the Cancer Drug Coverage Parity Act of 2013 . 2. Parity in coverage for oral anticancer drugs (a) Employee Retirement Income Security Act of 1974 amendments (1) Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 is amended by adding at the end the following new section: 716. Parity in coverage for oral anticancer drugs (a) In general Subject to subsection (b), a group health plan, and a health insurance issuer providing health insurance coverage in connection with a group health plan, that provides benefits with respect to anticancer medications administered by a health care provider shall provide for no less favorable coverage for prescribed, patient-administered anticancer medications that are used to kill, slow, or prevent the growth of cancerous cells and that have been approved by the Food and Drug Administration. (b) Limitation Subsection (a) shall only apply to an anticancer medication that is prescribed based on a finding by the treating physician that the medication— (1) is medically necessary for the purpose of killing, slowing, or preventing the growth of cancerous cells; or (2) is clinically appropriate in terms of type, frequency, extent site, and duration. (c) Application of cost-Sharing and restrictions (1) In general The coverage of anticancer medication under subsection (a) may be subject to annual deductibles and coinsurance or copayments so long as such deductibles, coinsurance, and copayments do not exceed the deductibles, coinsurance, and copayments that are applicable to anticancer medications administered by a health care provider under the plan or coverage for the same purpose. (2) Restriction A group health plan or health insurance issuer may not, in order to comply with the requirement of subsection (a)— (A) impose an increase in out-of-pocket costs with respect to anticancer medications; (B) reclassify benefits with respect to anticancer medications; or (C) apply more restrictive limitations on prescribed orally-administered anticancer medications or intravenously administered or injected anticancer medications. (d) Application of notice, prohibitions, etc The provisions of subsections (b), (c), (d), and (e)(2) of section 713 shall apply with respect to the coverage required by subsection (a) in the same manner as they apply with respect to the coverage required under such section, except that January 1, 2014, shall be substituted for the date referred to in subsection (b)(3) of such section. (e) Construction Nothing in this section shall be construed— (1) to require the use of orally-administered anticancer medications as a replacement for other anticancer medications; or (2) to prohibit a group health plan or health insurance issuer from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any chemotherapy. . (2) Section 731(c) of such Act (29 U.S.C. 1191(c)) is amended by striking section 711 and inserting sections 711 and 716 . (3) Section 732(a) of such Act (29 U.S.C. 1191a(a)) is amended by striking section 711 and inserting sections 711 and 716 . (4) The table of contents in section 1 of such Act is amended by inserting after the item relating to section 714 the following new items: Sec. 715. Additional market reforms. Sec. 716. Parity in coverage for oral anticancer drugs. . (b) Public health service act amendments (1) Title XXVII of the Public Health Service Act is amended by inserting after section 2728 ( 42 U.S.C. 300gg–28 ), as redesignated by section 1001(2) of the Patient Protection and Affordable Care Act ( Public Law 111–148 ), the following new section: 2729. Parity in coverage for oral anticancer drugs (a) In general Subject to subsection (b), a group health plan, and a health insurance issuer offering health insurance coverage, that provides benefits with respect to anticancer medications administered by a health care provider shall provide for no less favorable coverage for prescribed, patient-administered anticancer medications that are used to kill, slow, or prevent the growth of cancerous cells and that have been approved by the Food and Drug Administration. (b) Limitation Subsection (a) shall only apply to an anticancer medication that is prescribed based on a finding by the treating physician that the medication— (1) is medically necessary for the purpose of killing, slowing, or preventing the growth of cancerous cells; or (2) is clinically appropriate in terms of type, frequency, extent site, and duration. (c) Application of cost-Sharing and restrictions (1) In general The coverage of anticancer medication under subsection (a) may be subject to annual deductibles and coinsurance or copayments so long as such deductibles, coinsurance, and copayments do not exceed the deductibles, coinsurance, and copayments that are applicable to anticancer medications administered by a health care provider under the plan or coverage for the same purpose. (2) Restriction A group health plan or health insurance issuer may not, in order to comply with the requirement of subsection (a)— (A) impose an increase in out-of-pocket costs with respect to anticancer medications; (B) reclassify benefits with respect to anticancer medications; or (C) apply more restrictive limitations on prescribed orally-administered anticancer medications or intravenously administered or injected anticancer medications. (d) Application of notice, prohibitions, etc The provisions of subsections (b), (c), (d), and (e)(2) of section 713 of the Employee Retirement and Income Security Act of 1974 shall apply with respect to the coverage required by subsection (a) in the same manner as they apply with respect to the coverage required under such section, except that January 1, 2014, shall be substituted for the date referred to in subsection (b)(3) of such section. (e) Construction Nothing in this section shall be construed— (1) to require the use of orally-administered anticancer medications as a replacement for other anticancer medications; or (2) to prohibit a group health plan or health insurance issuer from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any chemotherapy. . (2) Section 2724(c) of such Act (42 U.S.C. 300gg–23(c)), as redesignated by section 1001(4) and subsection (c)(14) of the section 1563 (relating to conforming amendments) of Public Law 111–148 , is amended by striking section 2704 and inserting sections 2725 and 2729 . (3) Section 2762(b)(2) of such Act (42 U.S.C. 300gg–62(b)(2)) is amended by striking section 2751 and inserting sections 2751 and 2729 . (4) For purposes of applying section 2729 of the Public Health Service Act, as inserted by paragraph (1), to individual health insurance coverage before 2014, the provisions of such section shall be treated as also included under part B of title XXVII of the Public Health Service Act. (c) Internal revenue code amendments (1) In general Subchapter B of chapter 100 of the Internal Revenue Code of 1986, as amended by subsection (f) of the section 1563 (relating to conforming amendments) of Public Law 111–148 , is amended by adding at the end the following new section: 9816. Parity in coverage for oral anticancer drugs (a) In general Subject to subsection (b), a group health plan that provides benefits with respect to anticancer medications administered by a health care provider shall provide for no less favorable coverage for prescribed, patient-administered anticancer medications that are used to kill, slow, or prevent the growth of cancerous cells and that have been approved by the Food and Drug Administration. (b) Limitation Subsection (a) shall only apply to an anticancer medication that is prescribed based on a finding by the treating physician that the medication— (1) is medically necessary for the purpose of killing, slowing, or preventing the growth of cancerous cells; or (2) is clinically appropriate in terms of type, frequency, extent site, and duration. (c) Application of cost-Sharing and restrictions (1) In general The coverage of anticancer medication under subsection (a) may be subject to annual deductibles and coinsurance or copayments so long as such deductibles, coinsurance, and copayments do not exceed the deductibles, coinsurance, and copayments that are applicable to anticancer medications administered by a health care provider under the plan for the same purpose. (2) Restriction A group health plan may not, in order to comply with the requirement of subsection (a)— (A) impose an increase in out-of-pocket costs with respect to anticancer medications; (B) reclassify benefits with respect to anticancer medications; or (C) apply more restrictive limitations on prescribed orally-administered anticancer medications or intravenously administered or injected anticancer medications. (d) Application of notice, prohibitions, etc The provisions of subsections (b), (c), (d), and (e)(2) of section 713 of the Employee Retirement and Income Security Act of 1974 shall apply with respect to the coverage required by subsection (a) in the same manner as they apply with respect to the coverage required under such section, except that January 1, 2014, shall be substituted for the date referred to in subsection (b)(3) of such section. (e) Construction Nothing in this section shall be construed— (1) to require the use of orally-administered anticancer medications as a replacement for other anticancer medications; or (2) to prohibit a group health plan or health insurance issuer from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any chemotherapy. . (2) Clerical amendment The table of sections for such subchapter is amended by adding at the end the following new items: Sec. 9815. Additional market reforms. Sec. 9816. Parity in coverage for oral anticancer drugs. . (d) Clarifying amendment regarding application to grandfathered plans Section 1251(a)(4)(A) of the Patient Protection and Affordable Care Act ( Public Law 111–148 ; 42 U.S.C. 18011(a)(4)(A)), as added by section 2301(a) of Public Law 111–152 , is amended by adding at the end the following new clause: (v) Section 2729, as added by section 2(b) of the Cancer Drug Coverage Parity Act of 2013 . . (e) Effective date The amendments made by this section shall apply with respect to group health plans for plan years beginning on or after January 1, 2014, and with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after such date. (f) Study Not later than 2 years after the date of the enactment of this Act— (1) the Medicare Payment Advisory Commission shall complete a study that assesses how closing the Medicare part D donut hole under the amendments made by section 3301 of the Patient Protection and Affordable Care Act ( Public Law 111–148 ), as amended by section 1101 of the Health Care and Education Reconciliation Act of 2010 ( Public Law 111–152 ), affects Medicare coverage for orally administered anticancer medications, with a particular focus on cost and accessibility; and (2) submit a report to Congress on the results of such study.