<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="H1B9D7B5C8CA042E3991D041CBF49F63F" public-private="public">
	<form>
		<distribution-code display="yes">I</distribution-code>
		<congress>112th CONGRESS</congress>
		<session>1st Session</session>
		<legis-num>H. R. 2746</legis-num>
		<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
		<action>
			<action-date date="20110801">August 1, 2011</action-date>
			<action-desc><sponsor name-id="H001038">Mr. Higgins</sponsor>
			 introduced the following bill; which was referred to the
			 <committee-name committee-id="HIF00">Committee on Energy and
			 Commerce</committee-name>, and in addition to the Committees on
			 <committee-name committee-id="HWM00">Ways and Means</committee-name> and
			 <committee-name committee-id="HED00">Education and the
			 Workforce</committee-name>, 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</action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>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 intravenously administered anticancer
		  medications.</official-title>
	</form>
	<legis-body id="HCACD71DDAFB4475BB0A3F48D1839D882" style="OLC">
		<section id="HFAB2472129F54D1EBFB89FE06074D964" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the
			 <quote><short-title>Cancer Drug Coverage Parity Act of
			 2011</short-title></quote>.</text>
		</section><section id="HAF71BBB4D0B349C3986462899A2EC443"><enum>2.</enum><header>Parity in
			 coverage for oral anticancer drugs</header>
			<subsection id="H558B5C1A6D744D2DB95465D9CB2E18D5"><enum>(a)</enum><header>Employee
			 Retirement Income Security Act of 1974 amendments</header><paragraph commented="no" display-inline="yes-display-inline" id="HD94E8C99CE0E4BAE98FEB3774C36853D"><enum>(1)</enum><text>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:</text>
					<quoted-block display-inline="no-display-inline" id="H29D72FC494AE42E98F68D2A0D35087BD" style="OLC">
						<section id="HCD95E42C55DF487D8E8702CC11A772E9"><enum>716.</enum><header>Parity in
				coverage for oral anticancer drugs</header>
							<subsection id="H2BFF86243BE048E1B395C851A0CD385C"><enum>(a)</enum><header>In
				general</header><text display-inline="yes-display-inline">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 intravenously administered or injected anticancer
				medications shall provide for no less favorable coverage for prescribed, orally
				administered anticancer medication that is used to kill or slow the growth of
				cancerous cells and that has been approved by the Food and Drug
				Administration.</text>
							</subsection><subsection commented="no" id="H28DE6F140E2D49DDB5F35E0EF85E0933"><enum>(b)</enum><header>Limitation</header><text>Subsection
				(a) shall only apply to anticancer medication that is prescribed based on a
				finding by the treating physician that the medication—</text>
								<paragraph commented="no" id="H4CD4506007E64587B89485B66D9287DE"><enum>(1)</enum><text>is medically
				necessary for the purpose of killing or slowing the growth of cancerous cells
				in a manner that is in accordance with nationally accepted standards of medical
				practice;</text>
								</paragraph><paragraph commented="no" id="H7CE7C8146DE1452D9A78BD31F85D33DD"><enum>(2)</enum><text>is clinically
				appropriate in terms of type, frequency, extent site, and duration; and</text>
								</paragraph><paragraph commented="no" id="HCFE957407CC743B18F0A0A01981F82CE"><enum>(3)</enum><text>is not primarily
				for the convenience of the patient, physician, or other health care
				provider.</text>
								</paragraph></subsection><subsection id="HDE24767A8C284851950DBD46F426CFF8"><enum>(c)</enum><header>Application of
				cost-Sharing and restrictions</header>
								<paragraph id="HB86268DA74624BC8A8A3C5DFDDF84037"><enum>(1)</enum><header>In
				general</header><text>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 intravenously administered
				or injected anticancer medications under the plan or coverage for the same
				purpose.</text>
								</paragraph><paragraph commented="no" id="H7195BEE818EF4B0588292D5A752B5388"><enum>(2)</enum><header>Restriction</header><text display-inline="yes-display-inline">A group health plan or health insurance
				issuer may not, in order to comply with the requirement of subsection
				(a)—</text>
									<subparagraph commented="no" id="H032DDDE013A94616890E96FBFA3A622B"><enum>(A)</enum><text>impose an increase
				in out-of-pocket costs with respect to anticancer medications; or</text>
									</subparagraph><subparagraph commented="no" id="HF6AB6CCC8BB04BAEA4693EF9C4F4A139"><enum>(B)</enum><text display-inline="yes-display-inline">reclassify benefits with respect to
				anticancer medications.</text>
									</subparagraph></paragraph></subsection><subsection id="H24DE7ED361D94B9C9728F053AA6E169F"><enum>(d)</enum><header>Application of
				notice, prohibitions, Etc</header><text>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, 2012, shall be
				substituted for the date referred to in subsection (b)(3) of such
				section.</text>
							</subsection><subsection id="H3E5DCA8EBE644EBB9FC28A01AF469B8C"><enum>(e)</enum><header>Construction</header><text>Nothing
				in this section shall be construed—</text>
								<paragraph id="H60F9CB40D14D415C93E7AD35843FEC05"><enum>(1)</enum><text display-inline="yes-display-inline">to require the use of orally administered
				anticancer medications as a replacement for other anticancer medications;
				or</text>
								</paragraph><paragraph id="HFA858890AF9C4A8F90B720497FC05749"><enum>(2)</enum><text>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.</text>
								</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
				</paragraph><paragraph id="HE94AC090B7EF41E5A1EA3D5FCAFA2BA5" indent="up1"><enum>(2)</enum><text>Section 731(c) of such Act (29 U.S.C.
			 1191(c)) is amended by striking <quote>section 711</quote> and inserting
			 <quote>sections 711 and 716</quote>.</text>
				</paragraph><paragraph id="H9611429F0D72459F982C5730305F32F3" indent="up1"><enum>(3)</enum><text>Section 732(a) of such Act (29 U.S.C.
			 1191a(a)) is amended by striking <quote>section 711</quote> and inserting
			 <quote>sections 711 and 716</quote>.</text>
				</paragraph><paragraph id="H8E59C822278841C79267F79342E9F100" indent="up1"><enum>(4)</enum><text>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:</text>
					<quoted-block id="H583D55DA0BFA4B6CBC6E15CAC551FD42" style="OLC">
						<toc regeneration="no-regeneration">
							<toc-entry level="section">Sec. 715. Additional market
				reforms.</toc-entry>
							<toc-entry level="section">Sec. 716. Parity in coverage for oral
				anticancer
				drugs.</toc-entry>
						</toc>
						<after-quoted-block>.</after-quoted-block></quoted-block>
				</paragraph></subsection><subsection display-inline="no-display-inline" id="HDD8FC50A0DE948538642AA7F4299D431"><enum>(b)</enum><header>Public health
			 service act amendments</header><paragraph commented="no" display-inline="yes-display-inline" id="H2ECD4F2EBBA848AB8E805C01FF1953AB"><enum>(1)</enum><text display-inline="yes-display-inline">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:</text>
					<quoted-block id="HFB561E326802483DAB18A50A93368EE9" style="OLC">
						<section id="HE625E46FC9494C85B25AEAA65A29ADE6"><enum>2729.</enum><header>Parity in
				coverage for oral anticancer drugs</header>
							<subsection display-inline="no-display-inline" id="H45CC60C25E8C4949B2B043CA68691CA2"><enum>(a)</enum><header>In
				general</header><text display-inline="yes-display-inline">Subject to subsection
				(b), a group health plan, and a health insurance issuer offering group or
				individual health insurance coverage, that provides benefits with respect to
				intravenously administered or injected anticancer medications shall provide for
				no less favorable coverage for prescribed, orally administered anticancer
				medication that is used to kill or slow the growth of cancerous cells and that
				has been approved by the Food and Drug Administration.</text>
							</subsection><subsection commented="no" id="H29F0F4ED5C2D44C7B750D81AF8DE3C3A"><enum>(b)</enum><header>Limitation</header><text>Subsection
				(a) shall only apply to anticancer medication that is prescribed based on a
				finding by the treating physician that the medication—</text>
								<paragraph commented="no" id="HDE67FCE0096546ABBECF645CCAE47B3D"><enum>(1)</enum><text>is medically
				necessary for the purpose of killing or slowing the growth of cancerous cells
				in a manner that is in accordance with nationally accepted standards of medical
				practice;</text>
								</paragraph><paragraph commented="no" id="HB6A6C75BAA5348249E12427B4CDA4DA5"><enum>(2)</enum><text>is clinically
				appropriate in terms of type, frequency, extent site, and duration; and</text>
								</paragraph><paragraph commented="no" id="H81C39F0096934282AB4445B0E02BF238"><enum>(3)</enum><text>is not primarily
				for the convenience of the patient, physician, or other health care
				provider.</text>
								</paragraph></subsection><subsection id="H3E77BCD1399144ABA177319F037C5F03"><enum>(c)</enum><header>Application of
				cost-Sharing and restrictions</header>
								<paragraph id="H082001347C754DBEACCF2E10ECA04278"><enum>(1)</enum><header>In
				general</header><text display-inline="yes-display-inline">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 intravenously administered or injected anticancer medications
				under the plan or coverage for the same purpose.</text>
								</paragraph><paragraph commented="no" id="H7D0193BE79414A3BAE40B8D8DD2604FE"><enum>(2)</enum><header>Restriction</header><text display-inline="yes-display-inline">A group health plan or health insurance
				issuer may not, in order to comply with the requirement of subsection
				(a)—</text>
									<subparagraph commented="no" id="H2313FFB5911648D98730891144AD4AC3"><enum>(A)</enum><text>impose an increase
				in out-of-pocket costs with respect to anticancer medications; or</text>
									</subparagraph><subparagraph commented="no" id="H30871C28D26B4F4ABB9A9D54E45E1048"><enum>(B)</enum><text display-inline="yes-display-inline">reclassify benefits with respect to
				anticancer medications.</text>
									</subparagraph></paragraph></subsection><subsection id="HB7907D52AEB64BC0A9DB38F173A551B0"><enum>(d)</enum><header>Application of
				notice, prohibitions, Etc</header><text display-inline="yes-display-inline">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,
				2012, shall be substituted for the date referred to in subsection (b)(3) of
				such section.</text>
							</subsection><subsection id="H3E3AE8990068414585F81DB2BC4B556C"><enum>(e)</enum><header>Construction</header><text>Nothing
				in this section shall be construed—</text>
								<paragraph id="H923D8965670647B2A03E8BB2AD56D803"><enum>(1)</enum><text display-inline="yes-display-inline">to require the use of orally administered
				anticancer medications as a replacement for other anticancer medications;
				or</text>
								</paragraph><paragraph id="H1AE8CBAC64BE4B3B899401E2F44C55AA"><enum>(2)</enum><text>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.</text>
								</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
				</paragraph><paragraph id="HA08D91DF46994AD2BDB3FD345F758B2B" indent="up1"><enum>(2)</enum><text>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 <quote>section 2704</quote> and inserting
			 <quote>sections 2725 and 2729</quote>.</text>
				</paragraph><paragraph id="HF00E99E8E26543FEADF1469D63DDDCD6" indent="up1"><enum>(3)</enum><text>Section 2762(b)(2) of such Act (42
			 U.S.C. 300gg–62(b)(2)) is amended by striking <quote>section 2751</quote> and
			 inserting <quote>sections 2751 and 2729</quote>.</text>
				</paragraph><paragraph id="HD7BD39BF43A54939894E353C2337644A" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">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.</text>
				</paragraph></subsection><subsection id="H7BB14B0EFB2245E893ECF637B014F0D7"><enum>(c)</enum><header>Internal revenue
			 code amendments</header>
				<paragraph id="H62EF9F285E3A49C6AEE1F4E6BFE37E1C"><enum>(1)</enum><header>In
			 general</header><text>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:</text>
					<quoted-block display-inline="no-display-inline" id="HB20CF68C675B48DFAB533ED9DF4B0735" style="OLC">
						<section id="H63DCC89042F34099BC9FFA3E540A6637"><enum>9816.</enum><header>Parity in
				coverage for oral anticancer drugs</header>
							<subsection id="H22541E9424CA4F0AAD04D13E96F51AF3"><enum>(a)</enum><header>In
				general</header><text display-inline="yes-display-inline">Subject to subsection
				(b), a group health plan that provides benefits with respect to intravenously
				administered or injected anticancer medications shall provide for no less
				favorable coverage for prescribed, orally administered anticancer medication
				that is used to kill or slow the growth of cancerous cells and that has been
				approved by the Food and Drug Administration.</text>
							</subsection><subsection commented="no" id="H22E51523F867451D94C4D9737A52BA02"><enum>(b)</enum><header>Limitation</header><text>Subsection
				(a) shall only apply to anticancer medication that is prescribed based on a
				finding by the treating physician that the medication—</text>
								<paragraph commented="no" id="H127EA13668CA45D987C5FF34FAE04DCA"><enum>(1)</enum><text>is medically
				necessary for the purpose of killing or slowing the growth of cancerous cells
				in a manner that is in accordance with nationally accepted standards of medical
				practice;</text>
								</paragraph><paragraph commented="no" id="H04DE222348C342B5828939E86DA09B7B"><enum>(2)</enum><text>is clinically
				appropriate in terms of type, frequency, extent site, and duration; and</text>
								</paragraph><paragraph commented="no" id="HDCB4596EAA9A48CFBAC404B9C13F38F1"><enum>(3)</enum><text>is not primarily
				for the convenience of the patient, physician, or other health care
				provider.</text>
								</paragraph></subsection><subsection id="H54D78019FD644E9985E27EEF8811E106"><enum>(c)</enum><header>Application of
				cost-Sharing and restrictions</header>
								<paragraph id="H5603A591BA024A9CA62F4E34C06697D8"><enum>(1)</enum><header>In
				general</header><text display-inline="yes-display-inline">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 intravenously administered or injected anticancer medications
				under the plan for the same purpose.</text>
								</paragraph><paragraph commented="no" id="H598668D6F4294E50B09745FD850FD6A9"><enum>(2)</enum><header>Restriction</header><text display-inline="yes-display-inline">A group health plan may not, in order to
				comply with the requirement of subsection (a)—</text>
									<subparagraph commented="no" id="HB89E02E7C71E43B6BA305D0155548ACC"><enum>(A)</enum><text>impose an increase
				in out-of-pocket costs with respect to anticancer medications; or</text>
									</subparagraph><subparagraph commented="no" id="HD72D05A99C444A0099A50A829A0CA01F"><enum>(B)</enum><text display-inline="yes-display-inline">reclassify benefits with respect to
				anticancer medications.</text>
									</subparagraph></paragraph></subsection><subsection id="HAA539CECDD3F4DBEB98928B5AF63CD1C"><enum>(d)</enum><header>Application of
				notice, prohibitions, Etc</header><text>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, 2012, shall be substituted for the date
				referred to in subsection (b)(3) of such section.</text>
							</subsection><subsection id="H63F25A33D100420893CDFBADF031D86C"><enum>(e)</enum><header>Construction</header><text>Nothing
				in this section shall be construed—</text>
								<paragraph id="H46ED8B4AF3A64E55AA3BD62821813379"><enum>(1)</enum><text display-inline="yes-display-inline">to require the use of orally administered
				anticancer medications as a replacement for other anticancer medications;
				or</text>
								</paragraph><paragraph id="HD85A00B85F3C4191800B17A93694326E"><enum>(2)</enum><text>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.</text>
								</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
				</paragraph><paragraph id="H72E781C8AF9443A1B82F4ACD7BD5F85D"><enum>(2)</enum><header>Clerical
			 amendment</header><text>The table of sections for such subchapter is amended by
			 adding at the end the following new items:</text>
					<quoted-block id="HCF1544D59EA84C61B0E329076823E3DA" style="OLC">
						<toc regeneration="no-regeneration">
							<toc-entry level="section">Sec. 9815. Additional market
				reforms.</toc-entry>
							<toc-entry level="section">Sec. 9816. Parity in coverage for oral
				anticancer
				drugs.</toc-entry>
						</toc>
						<after-quoted-block>.</after-quoted-block></quoted-block>
				</paragraph></subsection><subsection display-inline="no-display-inline" id="HBAE4B3FD7C834C269D92D329D1088ACE"><enum>(d)</enum><header>Clarifying
			 amendment regarding application to grandfathered plans</header><text display-inline="yes-display-inline">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:</text>
				<quoted-block display-inline="no-display-inline" id="H727573EEACE249BF871F1E404561CBD0" style="OLC">
					<clause id="H28933816E4584AC39D6D948A6C9E5322"><enum>(v)</enum><text display-inline="yes-display-inline">Section 2729 (relating to standards
				relating to benefits for minor child’s congenital or developmental deformity or
				disorder), as added by section 2(b) of the <short-title>Cancer Drug Coverage Parity Act of
				2011</short-title>.</text>
					</clause><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection><subsection id="H035DA7E96AB64C9FA59FEBB2F8E092CF"><enum>(e)</enum><header>Effective
			 date</header><text display-inline="yes-display-inline">The amendments made by
			 this section shall apply with respect to group health plans for plan years
			 beginning on or after January 1, 2012, and with respect to health insurance
			 coverage offered, sold, issued, renewed, in effect, or operated in the
			 individual market on or after such date.</text>
			</subsection><subsection id="H44C25A4627984A019DDFA918CCFEAABA"><enum>(f)</enum><header>Study</header><text display-inline="yes-display-inline">Not later than 2 years after the date of
			 the enactment of this Act—</text>
				<paragraph id="HFB5B7E2F1BAB4FC9B684CE8D60CE7D96"><enum>(1)</enum><text>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</text>
				</paragraph><paragraph id="H79168E68FB4C44F18BA048F591D81031"><enum>(2)</enum><text>submit a report to
			 Congress on the results of such study.</text>
				</paragraph></subsection></section></legis-body>
</bill>
