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<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="H9A7F789CDC4D4C05A6C4E9323F395E41" public-private="public">
	<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>113 HR 5815 IH: Generic Drug Pricing Fairness Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2014-12-09</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
</dublinCore>
</metadata>
<form>
		<distribution-code display="yes">I</distribution-code>
		<congress>113th CONGRESS</congress>
		<session>2d Session</session>
		<legis-num>H. R. 5815</legis-num>
		<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
		<action>
			<action-date date="20141209">December 9, 2014</action-date>
			<action-desc><sponsor name-id="C001093">Mr. Collins of Georgia</sponsor> (for himself and <cosponsor name-id="L000565">Mr. Loebsack</cosponsor>) 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>, <committee-name committee-id="HAS00">Armed Services</committee-name>, and <committee-name committee-id="HGO00">Oversight and Government Reform</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 title XVIII of the Social Security Act to provide for pharmacy benefits manager standards
			 under the Medicare prescription drug program to further transparency of
			 payment methodologies to pharmacies, and for other purposes.</official-title>
	</form>
	<legis-body id="H1A735E6D193C4321A81F50026F5BD812" style="OLC">
		<section id="H79CF5C742A0444FFBEF5A5DAB871C949" 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>Generic Drug Pricing Fairness Act</short-title></quote>.</text>
		</section><section id="HA83762EC648F4FB2B456E3B060FFA921"><enum>2.</enum><header>Pharmacy benefits manager standards under the Medicare program</header>
			<subsection id="H29B0D3EA6FAA497AA4508356D4A729FC"><enum>(a)</enum><header>In general</header><text>Section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended by adding at the
			 end the following new paragraph:</text>
				<quoted-block display-inline="no-display-inline" id="H93A0628EE023435CB7071A614EB13B2C" style="OLC">
					<paragraph id="HF042DE4711AA430188BF271D04B67DE8"><enum>(7)</enum><header>Pharmacy benefits manager transparency requirements</header><text>Each contract entered into with a PDP sponsor under this part with respect to a prescription drug
			 plan offered by such sponsor shall provide that the PDP may not enter into
			 a contract with any pharmacy benefits manager (referred to in this
			 paragraph as a <quote>PBM</quote>) to manage the prescription drug coverage provided under such plan, or to control the costs of the
			 prescription drug coverage under such plan, unless the PBM adheres to the
			 following criteria when handling personally identifiable utilization and
			 claims data or other sensitive patient data:</text>
						<subparagraph id="HBCA69A128B2C44A6B33B96EC57D74554"><enum>(A)</enum><text>The PBM may not transmit any personally identifiable utilization or claims data, with respect to a
			 plan enrollee, to a pharmacy owned by a PBM if the plan enrollee has not
			 voluntarily elected in writing or via secure electronic means to fill that
			 particular prescription at the PBM-owned pharmacy.</text>
						</subparagraph><subparagraph id="HB178A6761D8248DDBD1CF9EDF7DFC098"><enum>(B)</enum><text>The PBM may not require that a plan enrollee use a retail pharmacy, mail order pharmacy, specialty
			 pharmacy, or other pharmacy entity providing pharmacy services in which
			 the PBM has an ownership interest or that has an ownership interest in the
			 PBM or provide an incentive to a plan enrollee to encourage the enrollee
			 to use a retail pharmacy, mail order pharmacy, specialty pharmacy, or
			 other pharmacy entity providing pharmacy services in which the PBM has an
			 ownership interest or that has an ownership interest in the PBM, if the
			 incentive is applicable only to such pharmacies.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection><subsection id="H1171BB34E3654B62AC87D4DEC666F2DD"><enum>(b)</enum><header>Regular update of prescription drug pricing standard</header><text>Paragraph (6) of section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended
			 to read as follows:</text>
				<quoted-block display-inline="no-display-inline" id="H47696EE176D34FF1B71097B74EFF51D2" style="OLC">
					<paragraph id="H4759A413C0674DB2B7812280AB6F06E5"><enum>(6)</enum><header>Regular update of prescription drug pricing standard</header>
						<subparagraph id="H56668C60FFFB4580BD0121B7B085CDD0"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">If the PDP sponsor of a prescription drug plan uses a standard for reimbursement (as described in
			 subparagraph (B)) of pharmacies based on the cost of a drug, each contract
			 entered into with such sponsor under this part with respect to the plan
			 shall provide that the sponsor shall—</text>
							<clause id="HFACB2A06305245B8AA3F716F23F869DC"><enum>(i)</enum><text>update such standard not less frequently than once every 7 days, beginning with an initial update
			 on January 1 of each year, to accurately reflect the market price of
			 acquiring the drug;</text>
							</clause><clause id="HD472BDDB56E74DEAAB119F3D47B6136B"><enum>(ii)</enum><text>disclose to applicable pharmacies the sources used for making any such update;</text>
							</clause><clause id="HD81174171B7241D7BA3BD214825545BF"><enum>(iii)</enum><text display-inline="yes-display-inline">if the source for such a standard for reimbursement is not publicly available, disclose to the
			 applicable pharmacies all individual drug prices to be so updated in
			 advance of the use of such prices for the reimbursement of claims; and</text>
							</clause><clause id="H19349341C333496B96AA4F42397ABC44"><enum>(iv)</enum><text display-inline="yes-display-inline">establish a process to appeal, investigate, and resolve disputes regarding individual drug prices
			 that are less than the pharmacy acquisition price for such drug.</text>
							</clause></subparagraph><subparagraph id="H9B1E5BAF2E3F412BBC16C59759D29576"><enum>(B)</enum><header>Prescription drug pricing standard defined</header><text display-inline="yes-display-inline">For purposes of subparagraph (A), a standard for reimbursement of a pharmacy is any methodology or
			 formula for varying the pricing of a drug or drugs during the term of the
			 pharmacy reimbursement contract that is based on the cost of the drug
			 involved, including drug pricing references and amounts that are based
			 upon average wholesale price, wholesale average cost, average manufacturer
			 price, average sales price, maximum allowable cost (MAC), or other costs,
			 whether publicly available or not.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection><subsection id="HE50116336A5840D382CDB616A1B63447"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to plan years beginning on or after January 1,
			 2015.</text>
			</subsection></section><section id="H66B5C028AE2F4C0B89838E937554B90E"><enum>3.</enum><header>Regular update of prescription drug pricing standard under TRICARE retail pharmacy program</header><text display-inline="no-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/10/1074g">Section 1074g(d)</external-xref> of title 10, United States Code, is amended by adding at the end the following new
			 paragraph:</text>
			<quoted-block display-inline="no-display-inline" id="HA5AEA8BD77194B5F93EDE4E6CA5FC8A5" style="USC">
				<paragraph id="HB9B33785E8754ED1BBCC1F39FE8388EA" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">To the extent practicable, with respect to the TRICARE retail pharmacy program described in
			 subsection (a)(2)(E)(ii), the Secretary shall ensure that a contract
			 entered into with a TRICARE managed care support contractor includes
			 requirements described in section 1860D–12(b)(6) of the Social Security
			 Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)(6)</external-xref>) to ensure the provision of information
			 regarding the pricing standard for prescription drugs.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
		</section><section id="H301A775B2A9F4471AD17307489442EBD"><enum>4.</enum><header>Prescription drug transparency in the Federal Employee Health Benefits program</header>
			<subsection id="H3C0DA2A97E5641B1AEEA7F3186C97FB5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/5/8902">Section 8902</external-xref> of title 5, United States Code, is amended by adding at the end the following new
			 subsections:</text>
				<quoted-block display-inline="no-display-inline" id="H21701A0477414A0084832B9EF78BDC7E" style="USC">
					<subsection id="H6780D93564DE4001BA4A2CB43ED7D4B9"><enum>(p)</enum><text display-inline="yes-display-inline">A contract may not be made or a plan approved under this chapter under which a carrier has an
			 agreement with a pharmacy benefits manager (in this subsection referred to
			 as a <quote>PBM</quote>) to manage prescription drug coverage or to control the costs of the prescription drug coverage
			 unless the carrier and PBM adhere to the following criteria:</text>
						<paragraph id="HED41315DB83743C6ABC94B96F4BF3FEC"><enum>(1)</enum><text>The PBM may not transmit any personally identifiable utilization or claims data with respect to an
			 individual enrolled under such contract or plan to a pharmacy owned by the
			 PBM if the individual has not voluntarily elected in writing or via secure
			 electronic means to fill that particular prescription at such a pharmacy.</text>
						</paragraph><paragraph id="H3EA95B8875FD4FF594B1431C05D26CAE"><enum>(2)</enum><text>The PBM may not require that an individual enrolled under such contract or plan use a retail
			 pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy
			 entity providing pharmacy services in which the PBM has an ownership
			 interest or that has an ownership interest in the PBM or provide an
			 incentive to a plan enrollee to encourage the enrollee to use a retail
			 pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy
			 entity providing pharmacy services in which the PBM has an ownership
			 interest or that has an ownership interest in the PBM, if the incentive is
			 applicable only to such pharmacies.</text>
						</paragraph></subsection><subsection id="HA89248F3B9C24207B424C7FD3FF8551E"><enum>(q)</enum>
						<paragraph commented="no" display-inline="yes-display-inline" id="H995BB05E48574A6080E83D6592240070"><enum>(1)</enum><text>If a contract made or plan approved under this chapter provides for a standard for reimbursement
			 (as described in paragraph (2)) with respect to a prescription drug plan,
			 such contract or plan shall provide that the applicable carrier—</text>
							<subparagraph id="HDE6E2B9DC0A74E6D9B2EFAAEBB714B3D" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">update such standard not less frequently than once every 7 days, beginning with an initial update
			 on January 1 of each year, to accurately reflect the market price of
			 acquiring the drug;</text>
							</subparagraph><subparagraph id="H437CF4AB01864112874E9BC21CA2FC6C" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">disclose to applicable pharmacies the sources used for making any such update;</text>
							</subparagraph><subparagraph id="H3AD25542FF1341A7A17D2572ABED9533" indent="up1"><enum>(C)</enum><text>if the source for such a standard for reimbursement is not publicly available, disclose to the
			 applicable pharmacies all individual drug prices to be so updated in
			 advance of the use of such prices for the reimbursement of claims; and</text>
							</subparagraph><subparagraph id="H8F2B2FDB8C6B4E939EE026EBA46D0210" indent="up1"><enum>(D)</enum><text>establish a process to appeal, investigate, and resolve disputes regarding individual drug prices
			 that are less than the pharmacy acquisition price for such drug.</text>
							</subparagraph></paragraph><paragraph id="H59C765C59834476EB7CC94B7D35A069C" indent="up1"><enum>(2)</enum><text>For purposes of paragraph (1), a standard for reimbursement of a pharmacy is any methodology or
			 formula for varying the pricing of a drug or drugs during the term of the
			 pharmacy reimbursement contract that is based on the cost of the drug
			 involved, including drug pricing references and amounts that are based
			 upon average wholesale price, wholesale average cost, average manufacturer
			 price, average sales price, maximum allowable cost, or other costs,
			 whether publicly available or not.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection><subsection id="H69A3C5D037474EA7B018A21A9F5041D9"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">The amendment made by subsection (a) shall apply to any contract entered into under section 8902 of
			 title 5, United States Code, on or after the date of enactment of this
			 section.</text>
			</subsection></section></legis-body>
</bill>


