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<bill bill-stage="Introduced-in-Senate" bill-type="olc" dms-id="A1" public-print="no" public-private="public" stage-count="1" star-print="no-star-print">
	<form display="yes">
		<distribution-code display="yes">II</distribution-code>
		<congress display="yes">111th CONGRESS</congress>
		<session display="yes">1st Session</session>
		<legis-num display="yes">S. 1040</legis-num>
		<current-chamber display="yes">IN THE SENATE OF THE UNITED
		  STATES</current-chamber>
		<action display="yes">
			<action-date date="20090514">May 14, 2009</action-date>
			<action-desc><sponsor name-id="S235">Mrs. Hutchison</sponsor> (for
			 herself and <cosponsor name-id="S284">Ms. Stabenow</cosponsor>) introduced the
			 following bill; which was read twice and referred to the
			 <committee-name committee-id="SSFI00">Committee on
			 Finance</committee-name></action-desc>
		</action>
		<legis-type display="yes">A BILL</legis-type>
		<official-title display="yes">To establish a demonstration program
		  requiring the utilization of Value-Based Insurance Design in order to
		  demonstrate that reducing the copayments or coinsurance charged Medicare
		  beneficiaries for selected medications can increase adherence to prescribed
		  medication, and for other purposes.</official-title>
	</form>
	<legis-body display-enacting-clause="yes-display-enacting-clause" style="OLC">
		<section commented="no" display-inline="no-display-inline" id="S1" section-type="section-one"><enum>1.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This Act may be cited as the
			 <quote><short-title>Seniors' Medication Copayment
			 Reduction Act of 2009</short-title></quote>.</text>
		</section><section commented="no" display-inline="no-display-inline" id="IDb34e5895f260437b9240cff8704ed6d9" section-type="subsequent-section"><enum>2.</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="no-display-inline">Congress makes the following
			 findings:</text>
			<paragraph commented="no" display-inline="no-display-inline" id="ID6e073e8e795e4d7eba263ff99d41b028"><enum>(1)</enum><text display-inline="yes-display-inline">A growing body of evidence demonstrates
			 that patient-level financial barriers, including copayments and coinsurance for
			 medications, systematically reduce the use of high value medical
			 services.</text>
			</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4e26e0951a444cf0a921111ec2c41016"><enum>(2)</enum><text display-inline="yes-display-inline">Empirical studies demonstrate that
			 reductions in cost-sharing can mitigate the adverse health consequences
			 attributable to cost related decreases in the utilization of prescription
			 medications and reduce aggregate medical expenditures as a result.</text>
			</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID8c11670f7c8d4a6c91d2a9591d2708d7"><enum>(3)</enum><text display-inline="yes-display-inline">Financial barriers to prescription
			 medications that are of high value should be reduced or eliminated to increase
			 adherence to prescribed medication.</text>
			</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID06aa3ba4c5ef4b6db118f96651d6de6d"><enum>(4)</enum><text display-inline="yes-display-inline">Value-Based Insurance Design recognizes
			 that medical services and prescription medications differ in the clinical
			 benefit achieved and that patient out-of-pocket costs should be adjusted
			 according to the value of the services provided.</text>
			</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2177787f39264fa9a119aa6bb2fe83bc"><enum>(5)</enum><text display-inline="yes-display-inline">The current <quote>one size fits
			 all</quote> copayment or coinsurance design for medications provided under the
			 Medicare program does not recognize the well-established value differences in
			 health outcomes produced by various medical interventions.</text>
			</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDdd2d30ccddee499a89771ef67b401895"><enum>(6)</enum><text display-inline="yes-display-inline">The establishment by Medicare of copayment
			 and coinsurance requirements for medications using Value-Based Insurance Design
			 will optimize clinical gains for each dollar spent, which would be a benefit to
			 seniors and a fiscally responsible use of taxpayer dollars.</text>
			</paragraph></section><section commented="no" display-inline="no-display-inline" id="IDc2995c743db94c02b10cfb3f4e302336" section-type="subsequent-section"><enum>3.</enum><header display-inline="yes-display-inline">Demonstration program</header>
			<subsection commented="no" display-inline="no-display-inline" id="ID819e1fa005e14a5c8e4c1d3ba06dca29"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
			 enactment of this Act, the Secretary of Health and Human Services (in this
			 section referred to as the <quote>Secretary</quote>) shall establish a
			 demonstration program to test Value-Based Insurance Design methodologies for
			 Medicare beneficiaries with chronic conditions.</text>
			</subsection><subsection commented="no" display-inline="no-display-inline" id="ID969dd98c553b4e4aabfe502da01f3e39"><enum>(b)</enum><header display-inline="yes-display-inline">Demonstration program design</header>
				<paragraph commented="no" display-inline="no-display-inline" id="id470D9B7C166147518D6383C8970D4D9B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall select not less than 2
			 Medicare Advantage plans to participate in this demonstration program under
			 this section initially.</text>
				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA834D893EFC544D18A1FDDE3109CEB6E"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">A plan selected to participate in the
			 demonstration program under paragraph (1) shall meet the following
			 requirements:</text>
					<subparagraph commented="no" display-inline="no-display-inline" id="ID1b1d796ef44a400db67d14ef6bc1685c"><enum>(A)</enum><text display-inline="yes-display-inline">The plan offers a coordinated Part D drug
			 benefit.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID82aa43a3e02c4d11b40ddf20f44b584d"><enum>(B)</enum><text display-inline="yes-display-inline">The plan and organization offering such
			 plan meet such other criteria as the Secretary determines appropriate.</text>
					</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID2b8f61d7502947e1aeb0188b30b096cb"><enum>(c)</enum><header display-inline="yes-display-inline">Duration</header>
				<paragraph commented="no" display-inline="no-display-inline" id="ID7ce5eda9be2542b58eb5c54dbe4a30dc"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to subsection (b), the
			 demonstration program under this section shall be conducted for a 5-year
			 period.</text>
				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7972a4fd3d3b4d16b5d849188cdc81fc"><enum>(2)</enum><header display-inline="yes-display-inline">Expansion of demonstration program;
			 implementation of demonstration program results</header>
					<subparagraph commented="no" display-inline="no-display-inline" id="ID1062d1cdcc764a38ace6fedf7668339a"><enum>(A)</enum><header display-inline="yes-display-inline">Expansion of demonstration
			 program</header><text display-inline="yes-display-inline">If the report under
			 paragraph subsection (e) or (f)(3) contains an evaluation that the
			 demonstration program under this section—</text>
						<clause commented="no" display-inline="no-display-inline" id="ID1e87cb1b570c4ec99e8015c5cfb91784"><enum>(i)</enum><text display-inline="yes-display-inline">reduces expenditures under the Medicare
			 program; or</text>
						</clause><clause commented="no" display-inline="no-display-inline" id="IDe371d5731bfc44cabfb693872a04e762"><enum>(ii)</enum><text display-inline="yes-display-inline">does not increase expenditures under the
			 Medicare program and increases the quality of health care services provided to
			 Medicare beneficiaries,</text>
						</clause><continuation-text commented="no" continuation-text-level="subparagraph">then the Secretary shall continue
			 the existing demonstration program and may expand the demonstration
			 program.</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb1e4d8fc98eb46e7a9db8ff942ec4e04"><enum>(B)</enum><header display-inline="yes-display-inline">Implementation of demonstration program
			 results</header><text display-inline="yes-display-inline">If the report under
			 subsection (e) or (f)(3) contains an evaluation contained in clause (i) or (ii)
			 of subparagraph (A), the Secretary may issue regulations to implement, on a
			 permanent basis, the components of the demonstration program that are
			 beneficial to the Medicare program.</text>
					</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID9297f9727a72443d98ee78ca33156908"><enum>(d)</enum><header display-inline="yes-display-inline">Value-Based Insurance Design
			 methodology</header>
				<paragraph commented="no" display-inline="no-display-inline" id="ID5a05010ddf0c466a9c09c55186387097"><enum>(1)</enum><header display-inline="yes-display-inline">Reduction of copayments and
			 coinsurance</header><text display-inline="yes-display-inline">Utilizing
			 Value-Based Insurance Design methodologies, the Secretary shall identify each
			 medication for which the amount of the copayment or coinsurance payable should
			 be reduced or eliminated.</text>
				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID86b33786c8b04aac8a89aed03dcd6ec6"><enum>(2)</enum><header display-inline="yes-display-inline">Value-Based Insurance Design</header><text display-inline="yes-display-inline">For purposes of this section,
			 <quote>Value-Based Insurance Design</quote> is a methodology for identifying
			 specific medications or classes of medications for which copayments or
			 coinsurance should be reduced or eliminated due to the high value and
			 effectiveness of such medications when prescribed for particular clinical
			 conditions.</text>
				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDf38ca8841b984b9fb3de4b64e6dd95af"><enum>(3)</enum><header display-inline="yes-display-inline">Particular medications</header><text display-inline="yes-display-inline">In identifying medications for purposes of
			 paragraph (1), the Secretary shall, at a minimum, consider the medications
			 utilized in the treatment of the following conditions:</text>
					<subparagraph commented="no" display-inline="no-display-inline" id="ID8886425ba2d04296b748e944a7c43a4b"><enum>(A)</enum><text display-inline="yes-display-inline">Asthma.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDacc7bb67140a421d8c7bd93b9e109ed2"><enum>(B)</enum><text display-inline="yes-display-inline">Atrial fibrillation.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa617051286e44c0cb9f80de9ce8f9eaa"><enum>(C)</enum><text display-inline="yes-display-inline">Deep venous thrombosis.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9d44d36681b74649a686874e04cb5d2a"><enum>(D)</enum><text display-inline="yes-display-inline">Chronic obstructive pulmonary
			 disease.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID850b175f3f6b40c9adabda39608f29a6"><enum>(E)</enum><text display-inline="yes-display-inline">Chronic renal failure.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDcc861ba4c96c440289123d13dfd5c15b"><enum>(F)</enum><text display-inline="yes-display-inline">Congestive heart failure.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID03bfaf7f889f45b880d1d4a3549b65ff"><enum>(G)</enum><text display-inline="yes-display-inline">Coronary artery disease.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDbb0ba245a4c14c50a18b95b4186ee5c1"><enum>(H)</enum><text display-inline="yes-display-inline">Myocardial infarction.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1e9fdea4cac64356bb6157c7555d9c65"><enum>(I)</enum><text display-inline="yes-display-inline">Depression.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1bf6be1ac84c4e0097087c2bbe77912c"><enum>(J)</enum><text display-inline="yes-display-inline">Epilepsy.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID900737b875e24a248b636592b90e389d"><enum>(K)</enum><text display-inline="yes-display-inline">Diabetes mellitus.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2416cb7ff3f44a2d9c6f2add7fec10cb"><enum>(L)</enum><text display-inline="yes-display-inline">Hypertension.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID66b4474d26084eaaaf323c9b8d6acec5"><enum>(M)</enum><text display-inline="yes-display-inline">Hypothyroidism.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc97c8f3c461a4c2dbd5ae9fda90b02ea"><enum>(N)</enum><text display-inline="yes-display-inline">Schizophrenia.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDef3507c2f36a435f8a8d29a4b4c395c1"><enum>(O)</enum><text display-inline="yes-display-inline">Tobacco abuse disorder.</text>
					</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDa98517c89e8d4264b01150bf1015e44f"><enum>(e)</enum><header display-inline="yes-display-inline">Report on implementation</header>
				<paragraph commented="no" display-inline="no-display-inline" id="idEB74DBB8DCE84E5AA8411DE63300ADC9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
			 enactment of this Act, the Secretary shall submit to Congress a report on the
			 implementation by the Secretary of the demonstration program under this
			 section.</text>
				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDddf896e2a44a4950906b2c8a05f96858"><enum>(2)</enum><header display-inline="yes-display-inline">Elements</header><text display-inline="yes-display-inline">The report required by paragraph (1) shall
			 include the following:</text>
					<subparagraph commented="no" display-inline="no-display-inline" id="IDe9870e128c1f4646b196d159efa82acb"><enum>(A)</enum><text display-inline="yes-display-inline">A statement setting forth each medication
			 identified pursuant to subsection (d)(1).</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID88dd95335c7146368c19da776012efa1"><enum>(B)</enum><text display-inline="yes-display-inline">For each such medication, a statement of
			 the amount of the copayment or coinsurance required to be paid for such
			 medication and the amount of the reduction from previous levels.</text>
					</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDb44b6087c96b4b9f9af066cf0714394c"><enum>(f)</enum><header display-inline="yes-display-inline">Review and assessment of utilization of
			 methodologies</header>
				<paragraph commented="no" display-inline="no-display-inline" id="IDfd166f97239a487eb4be7d6fe8d9549e"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall enter into a contract
			 or agreement with an independent entity having expertise in Value-Based
			 Insurance Design to review and assess the implementation by the Secretary of
			 the demonstration program under this section. The review and assessment shall
			 include the following:</text>
					<subparagraph commented="no" display-inline="no-display-inline" id="IDee3dd493a27a4de78cf098a26f6292c1"><enum>(A)</enum><text display-inline="yes-display-inline">An assessment of the utilization by the
			 Secretary of the methodologies referred to in subsection (d).</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2996ad047a664c58bb5018b5d40e1d3d"><enum>(B)</enum><text display-inline="yes-display-inline">An analysis of whether reducing or
			 eliminating the copayment or coinsurance for each medication identified by the
			 Secretary pursuant to subsection (d)(1) resulted in increased adherence to
			 medication regimens and better health outcomes.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID31e0fcbf6a85482090d0a7cd4480cfaf"><enum>(C)</enum><text display-inline="yes-display-inline">An analysis of the cost savings resulting
			 from reducing or eliminating the copayment or coinsurance for each medication
			 so identified.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID47d16f7ce1064074885f329f67fad4ba"><enum>(D)</enum><text display-inline="yes-display-inline">Such other matters as the Secretary
			 considers appropriate.</text>
					</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDdb4cc087bc2e46b5af891ef4e1b59354"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">The contract or agreement entered into
			 under paragraph (1) shall require the entity concerned to submit to the
			 Secretary a report on the review and assessment conducted by the entity under
			 that paragraph in time for the inclusion of the results of such report in the
			 report required by paragraph (3).</text>
				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID00604a4258aa45fb908038062e42aa8a"><enum>(3)</enum><header display-inline="yes-display-inline">Report to Congress</header><text display-inline="yes-display-inline">Not later than 3 years after the date of
			 the enactment of this Act, the Secretary shall submit to Congress a report on
			 the review and assessment conducted under this subsection. The report shall
			 include the following:</text>
					<subparagraph commented="no" display-inline="no-display-inline" id="IDbabb8652fdaa420d93d140ea1681c8ef"><enum>(A)</enum><text display-inline="yes-display-inline">A description of the results of the review
			 and assessment.</text>
					</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID68742111ecd04c07bd5e5d3a7d4a72e0"><enum>(B)</enum><text display-inline="yes-display-inline">Such recommendations as the Secretary
			 considers appropriate for enhancing the utilization of the methodologies
			 referred to in subsection (a)(1) so as to reduce copayments and coinsurance
			 paid by Medicare beneficiaries for medications furnished under the Medicare
			 program and to otherwise improve the quality of health care provided under such
			 Medicare program.</text>
					</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idCB057A7B977A4E418F9A01810F20B4D9"><enum>(g)</enum><header display-inline="yes-display-inline">Waiver</header><text display-inline="yes-display-inline">The Secretary may waive such provisions of
			 titles XI and XVIII of the Social Security Act as may be necessary to carry out
			 the demonstration program under this section.</text>
			</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4b9e9f686839425d9a61fa54de7072a5"><enum>(h)</enum><header display-inline="yes-display-inline">Implementation funding</header><text display-inline="yes-display-inline">For purposes of carrying out the
			 demonstration program under this section, the Secretary shall provide for the
			 transfer from the Federal Hospital Insurance Trust Fund under section 1817 of
			 the Social Security Act (42 U.S.C. 1395i) and the Federal Supplementary
			 Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C.
			 1395t), including the Medicare Prescription Drug Account in such Trust Fund, in
			 such proportion as determined appropriate by the Secretary, of such sums as may
			 be necessary.</text>
			</subsection></section></legis-body>
</bill>
