109 HR 6281 IH: Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2006 U.S. House of Representatives 2006-09-29 text/xml EN 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.
I 109th CONGRESS 2d Session H. R. 6281 IN THE HOUSE OF REPRESENTATIVES September 29, 2006 Mr. Doggett (for himself, Mr. Rangel, Mr. Stark, Mr. McDermott, Mr. Lewis of Georgia, Mr. Neal of Massachusetts, Mr. McNulty, Mr. Becerra, Mrs. Jones of Ohio, Mr. Larson of Connecticut, Mr. Emanuel, Mr. Allen, Mrs. Capps, Mrs. Davis of California, Ms. DeLauro, Mr. Frank of Massachusetts, Mr. Al Green of Texas, Mr. Gene Green of Texas, Mr. Grijalva, Mr. Hinchey, Ms. Jackson-Lee of Texas, Ms. Eddie Bernice Johnson of Texas, Ms. Kaptur, Mr. Kennedy of Rhode Island, Ms. Kilpatrick of Michigan, Mr. Langevin, Mrs. Lowey, Mrs. Maloney, Ms. McCollum of Minnesota, Mr. McGovern, Mr. Meehan, Ms. Moore of Wisconsin, Mr. Moran of Virginia, Mr. Nadler, Mr. Oberstar, Mr. Ortiz, Mr. Reyes, Ms. Schakowsky, Mr. Waxman, Mr. Weiner, and Ms. Woolsey) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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 title XVIII of the Social Security Act to provide comprehensive improvements to the Medicare prescription drug program, and for other purposes.
1.
Short title; table of contents
(a)
Short title
This Act may be cited as the Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2006. (b)
Table of contents
The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Title I—Medicare Operated Prescription Drug Plan Option Sec. 101. Establishment of medicare operated prescription drug plan option. Title II—Medicaid and Low-Income Improvements Sec. 201. Change in base used in computing State clawback provision. Sec. 202. Elimination of cost-sharing for certain full-benefit dual eligibles. Sec. 203. Elimination of the indexing on the price-sharing for dual-eligibles and qualifying low income beneficiaries. Sec. 204. Expediting low-income subsidies under the Medicare prescription drug program. Sec. 205. Increase in permitted resources to obtain low-income subsidies. Sec. 206. Waiver of late enrollment penalty for subsidy eligible individuals for first 24 months of non-enrollment. Title III—Fraud and Abuse Provisions Sec. 301. Criminal penalty for fraud in connection with enrollment under an MA plan or prescription drug plan. Sec. 302. Recourse for slamming practices. Sec. 303. Protection from loss of employment-based retiree health coverage upon enrollment for medicare prescription drug benefit during 2006. Sec. 304. Required application of intermediate sanctions to protect against fraud and abuse. Sec. 305. Repeal of special waiver authority for State licensure. Title IV—Relation to Social Security Benefits Sec. 401. Protection of Social Security benefits against decrease due to part D medicare premium increases. Title V—Beneficiary Protection Provisions Sec. 501. Extension of open enrollment period; suspension of late enrollment penalties; allowing one-time change in plan during first year of enrollment. Sec. 502. Counting expenditures under State drug assistance programs against true out-of-pocket costs. Sec. 503. Price disclosure. Sec. 504. Removal of covered part D drugs from the prescription drug plan formulary. Sec. 505. Codification of requirement for coverage of all or substantially all of drugs within six categories of drugs. Sec. 506. Removal of exclusion of benzodiazepines from required coverage under the medicare prescription drug program. Sec. 507. Standardized forms and procedures for reconsiderations and appeals. Sec. 508. Elimination of MA Regional Stabilization Fund (Slush Fund); elimination of certain MA overpayments. Title VI—Fair and Speedy Treatment of Medicare Prescription Drug Claims Sec. 601. Prompt payment by Medicare prescription drug plans and MA–PD plans under part D. Sec. 602. Restriction on co-branding. Sec. 603. Minimum dispensing fees for generic covered part D drugs. Sec. 604. Provision of medication therapy management services under part D.
<enum>I</enum><header>Medicare Operated Prescription Drug Plan Option</header> <section id="H95719204E5CC4118835281BBA6DA7317"><enum>101.</enum><header>Establishment of medicare operated prescription drug plan option</header> <subsection id="H3F9820D1B174452AA147493C000413E8"><enum>(a)</enum><header>In general</header><text>Subpart 2 of part D of the <act-name parsable-cite="SSA">Social Security Act</act-name> is amended by inserting after section 1860D–11 the following new section:</text> <quoted-block act-name="Social" id="H699715E26C614D859DCC1DC5FA5E4BB4" style="traditional"> <section id="H4E86F9FE45DC44B7BE2512EA70EC57DC"><enum>1860D–11A.</enum><header>Medicare operated prescription drug plan option</header> <subsection commented="no" display-inline="yes-display-inline" id="H941CE8A4604D4DE0A5B21092A1B384E4"><enum>(a)</enum><header>In general</header><text>Notwithstanding any other provision of this part, for each year (beginning with 2007), in addition to any plans offered under section 1860D–11, the Secretary shall offer one or more medicare operated prescription drug plans (as defined in subsection (c)) with a service area that consists of the entire United States and shall enter into negotiations with pharmaceutical manufacturers to reduce the purchase cost of covered part D drugs for eligible part D individuals in accordance with subsection (b).</text> </subsection> <subsection id="H46EFBFA27169400EA130E37CC901BF4F"><enum>(b)</enum><header>Negotiations</header> <paragraph id="HD95C00A5B58E4DDDB02C9E4E5DA8DAC3"><enum>(1)</enum><header>In general</header><text>Notwithstanding section 1860D–11(i), for purposes of offering a medicare operated prescription drug plan under this section, the Secretary shall negotiate with pharmaceutical manufacturers with respect to the purchase price of covered part D drugs and shall encourage the use of more affordable therapeutic equivalents to the extent such practices do not override medical necessity as determined by the prescribing physician. To the extent practicable and consistent with the previous sentence, the Secretary shall implement strategies similar to those used by other Federal purchasers of prescription drugs, and other strategies, to reduce the purchase cost of covered part D drugs.</text> </paragraph> <paragraph id="HF38E30C2BFA949C99FBD67AC03673883"><enum>(2)</enum><header>Permitting application of some or all of savings to reduction in coverage gap</header><text display-inline="yes-display-inline">Notwithstanding any other provision of this part, the Secretary may increase the initial coverage limit under section 1860D–2(b)(3) for a year, but only with respect to the medicare operated prescription drug plan, by an amount not to exceed the actuarial value of the reductions in expenditures during such year resulting from the application of paragraph (1).</text> </paragraph></subsection> <subsection id="H74AB2CBB693B48B293368F4D58972085"><enum>(c)</enum><header>Medicare operated prescription drug plan defined</header><text>For purposes of this part, the term <term>medicare operated prescription drug plan</term> means a prescription drug plan that offers qualified prescription drug coverage and access to negotiated prices described in section 1860D–2(a)(1)(A). Such a plan may offer supplemental prescription drug coverage in the same manner as other qualified prescription drug coverage offered by other prescription drug plans.</text> </subsection> <subsection id="H347F17D9B0DF49C89C28D92842AC5584"><enum>(d)</enum><header>Monthly beneficiary premium</header> <paragraph id="H6401C96A295C4B8585FFDD7257D5E72"><enum>(1)</enum><header>Qualified prescription drug coverage</header><text>The monthly beneficiary premium for qualified prescription drug coverage and access to negotiated prices described in section 1860D–2(a)(1)(A) to be charged under a medicare operated prescription drug plan shall be uniform nationally. Such premium for months in a year shall be based on the average monthly per capita actuarial cost of offering the medicare operated prescription drug plan for the year involved, including administrative expenses, as determined by the Secretary and as certified by the chief actuary of the Centers for Medicare & Medicaid Services.</text> </paragraph> <paragraph id="H1E437DCDB24A408EAFE2E832B38CF13"><enum>(2)</enum><header>Supplemental prescription drug coverage</header><text>Insofar as a medicare operated prescription drug plan offers supplemental prescription drug coverage, the Secretary may adjust the amount of the premium charged under paragraph (1).</text> </paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="H6E8E6F86C73E423C88FD3BDB0978D468"><enum>(b)</enum><header>Auto-enrollment of subsidy eligible individuals in medicare operated prescription drug plan</header><text display-inline="yes-display-inline">Section 1860D–1(b)(1)(C) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101(b)(1)(C)</external-xref>) is amended—</text> <paragraph id="H1152872061744C84BD71ECE3D91DB5AC"><enum>(1)</enum><text>by designating the matter beginning with <quote>The process established </quote> as a clause (i) with the heading <quote><header-in-text level="clause" style="OLC">Auto-enrollment for dual eligibles and certain other subsidy eligible individuals</header-in-text></quote>;</text> </paragraph> <paragraph id="HBDDE21ECF21B4FFD922134B76CB702F1"><enum>(2)</enum><text>by inserting <quote>or who is a subsidy eligible individual described in section 1860D–14(a)(1)</quote> after <quote>section 1935(c)(6))</quote>;</text> </paragraph> <paragraph id="HBCACEB0BC132493995D45FD28980DD28"><enum>(3)</enum><text>by striking <quote>for the enrollment in</quote> and all that follows through <quote>in the PDP region.</quote> and inserting <quote>for the enrollment in the medicare operated prescription drug plan (as defined in section 1860D–11A(c)). </quote>; and</text> </paragraph> <paragraph id="H44F54D310F56497BAC203C29C4E8599F"><enum>(4)</enum><text>by adding at the end the following new clauses:</text> <quoted-block display-inline="no-display-inline" id="H0749E2D6AD424379A0000046D7C2C56C" style="OLC"> <clause id="H75F861525FCD4E919D326EC3A65B19B1"><enum>(ii)</enum><header>Application in case of premium increases or plan discontinuation</header><text display-inline="yes-display-inline">The process under subparagraph (A) shall also provide for enrollment described in clause (i) in the case of such an individual who is enrolled in a prescription drug plan that has a monthly beneficiary premium that does not exceed the premium assistance available under section 1860D–14(a)(1)(A)) if such plan is discontinued or the premium under such plan is increased so it exceeds such available premium assistance.</text> </clause> <clause id="H6CE2C12213EC4C5B8B8E0883F2E9620"><enum>(iii)</enum><header>Notice</header> <subclause id="HB443C370F7FF4E4C981E3B2B639FA3BA"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall provide for notice to each individual auto-enrolled under clause (i) or (ii) that the individual has the right and the opportunity to select another prescription drug plan (or MA–PD plan) through which to obtain prescription drug coverage.</text> </subclause> <subclause id="H4FAEB92F39694D5C97F9F800A16E113E"><enum>(II)</enum><header>Additional notice</header><text>In the case of an individual described in clause (ii), both the sponsor of the plan in which the individual is enrolled and the Secretary shall provide notice to the individual that enrollment in the plan will be discontinued or have a premium above the benchmark and, as a result, the individual will be enrolled in the medicare operated prescription drug plan for the following year unless the individual affirmatively acts otherwise.</text> </subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="HE5CAB2ED8EE34E79ABB48CC770E699B9"><enum>(c)</enum><header>Application of monthly premium for premium subsidy purposes</header><text display-inline="yes-display-inline">Section 1860D–14(b)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww-114">42 U.S.C. 1395ww–114(b)(1)</external-xref>) is amended by striking <quote>the amount specified in paragraph (3)</quote> and inserting <quote>the greater of the amount specified in paragraph (3) or the monthly premium amount specified in section 1860D–11A(d)(1)</quote>.</text> </subsection> <subsection id="H3E48EFA073C9474F00EBAA13237882E7"><enum>(d)</enum><header>Conforming amendments, including elimination of unnecessary plan requirement and fallback plan provisions</header><text></text> <paragraph id="H889BFCE6E53B4D8988397CD700F667AA"><enum>(1)</enum><text>Section 1860D–3 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-103">42 U.S.C. 1395w–103</external-xref>) is repealed.</text> </paragraph> <paragraph id="HD3329CCE25AD498491A4BBC97C7CF1"><enum>(2)</enum><text>Section 1860D–11 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-111">42 U.S.C. 1395w–111</external-xref>) is amended—</text> <subparagraph id="HE0DD26BF22E84338ABAF00832518A63"><enum>(A)</enum><text>by striking subsection (f), (g), and (h); and</text> </subparagraph> <subparagraph id="HF2B3CC27279E4E3791ABCDA216DC04FD"><enum>(B)</enum><text>in subsection (i), by inserting <quote>except as provided in section 1860D–11A(b),</quote> after <quote>in carrying out this part,</quote>.</text> </subparagraph></paragraph> <paragraph id="H19445E47C8FA482A90162605F31350B2"><enum>(3)</enum><text>Section 1860D–12(b) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended by striking paragraph (2).</text> </paragraph> <paragraph id="H13A5250AD7544AA2A493B6B54EB76566"><enum>(4)</enum><text>Section 1860D–13(c) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-113">42 U.S.C. 1395w–113(c)</external-xref>) is amended by striking paragraph (3).</text> </paragraph> <paragraph id="HAFBADC211972458F87A0F55182A48FCE"><enum>(5)</enum><text>Section 1860D–15 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115</external-xref>) is amended by striking subsection (g).</text> </paragraph> <paragraph id="H51B66C27B2F14F5D95533607CA64DC00"><enum>(6)</enum><text>Section 1860D–16(b)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-116">42 U.S.C. 1395w–116(b)(1)</external-xref>) is amended by striking subparagraph (B) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H5CAE7190FF0540A29390369098FDD6BE" style="OLC"> <subparagraph id="H320D6492AFF943BC91AF1541D7A14D81"><enum>(B)</enum><text>payments for expenses incurred with respect to the operation of medicare operated prescription drug plans under section 1860D–11A.</text> </subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph> <paragraph id="H875241688D4A4A809C19C0E27785004B"><enum>(7)</enum><text>Section 1860D–41(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww-141">42 U.S.C. 1395ww–141(a)</external-xref>) is amended by striking paragraph (5) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="HD1B2BD47E29E47D88070E7B8645209DA" style="OLC"> <paragraph display-inline="no-display-inline" id="HA6BCFF1A34B14F189C48CAE930ADB315"><enum>(5)</enum><header>Medicare operated prescription drug plan</header><text>The term <term>medicare operated prescription drug plan</term> has the meaning given such term in section 1860D–11A(c).</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph> <paragraph id="H788816D1419F48348B9BDF821E49AFCF"><enum>(8)</enum><text>Section 1860D–42(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-142">42 U.S.C. 1395w–142(a)</external-xref>) is amended by striking <quote>, including section 1860D–3(a)(1),</quote>.</text> </paragraph></subsection> <subsection id="H6B74399D776243F0BA46953DE17BF8BC"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall take effect as if included in the enactment of section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2071).</text> </subsection></section> <enum>II</enum><header>Medicaid and Low-Income Improvements</header> <section id="H3C9FBE0A04BD4B1E9B5CC05ED2F200DB"><enum>201.</enum><header>Change in base used in computing State clawback provision</header> <subsection id="H340C29089A6A479BA891C05BEC192430"><enum>(a)</enum><header>In general</header><text>Section 1935(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1936u-5">42 U.S.C. 1936u–5(c)</external-xref>) is amended—</text> <paragraph id="H4EE09C1B09754CCA9D95E073BC36B48"><enum>(1)</enum><text>in paragraph (2)(A)(ii), by inserting <quote>, subject to paragraph (7),</quote> after <quote>increased for each year (</quote>;</text> </paragraph> <paragraph id="H33FFFA654EB0441F9EB15690DEE36259"><enum>(2)</enum><text>in paragraph (3), by inserting <quote>Subject to paragraph (7)—</quote> after <quote><header-in-text level="paragraph" style="OLC">dual eligible individuals.—</header-in-text></quote> in the matter before subparagraph (A); and</text> </paragraph> <paragraph id="HCBE99C506AF7475F995C1E6700C3B872"><enum>(3)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H6DC50004A7A54CAF8D71C552ACDB3CC" style="OLC"> <paragraph id="H0F0E4611BBB947468B0000FC5294A98E"><enum>(7)</enum><header>Use of 2005 as base</header><text>This subsection shall be applied by substituting <quote>2005</quote> for <quote>2003</quote> each place it appears in paragraph (3) if such substitution results in a reduced amount under paragraph (1)(A) of this subsection and, in the case of such substitution, the reference in paragraph (2)(A)(ii) to <quote>2004</quote> is deemed a reference to <quote>2006.</quote></text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="H409BE2EA36804F3AB25386A6EE79EECC"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply to payments for calendar quarters beginning on or after January 1, 2007.</text> </subsection></section> <section id="HAC7FF65178884A5393285D12E5F55FDF"><enum>202.</enum><header>Elimination of cost-sharing for certain full-benefit dual eligibles</header> <subsection id="HCBEEE5E90CBA4A8DB9701247C8F01163"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–14(a)(1)(D)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)(1)(D)(i)</external-xref>) is amended—</text> <paragraph id="H1FF9C3999299467388A283E42645D3DB"><enum>(1)</enum><text>in the heading, by striking <quote><header-in-text level="clause" style="OLC">Institutionalized individuals.—</header-in-text>In</quote> and inserting <quote><header-in-text level="clause" style="OLC">Elimination of cost-sharing for certain full-benefit dual eligible individuals</header-in-text>.—</quote> and the following:</text> <quoted-block display-inline="no-display-inline" id="HB40DB750439243338052BA78771592F1" style="OLC"> <subclause id="H08819B1A5FF84DE6B09C09D4EDABEA56"><enum>(I)</enum><header>Institutionalized individuals</header><text>In</text> </subclause><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph> <paragraph id="HCBC62156C8DD4F79BAEB2574940067E0"><enum>(2)</enum><text>by adding at the end the following new subclauses:</text> <quoted-block display-inline="no-display-inline" id="H74E5464C6FB845DCA9C25FEEC237FA6" style="OLC"> <subclause id="HCD9487EFF944456E861B6B59541992FE"><enum>(II)</enum><header>Certain other individuals</header><text display-inline="yes-display-inline">In the case of an individual who is a full-benefit dual eligible individual and who receives services from a facility or program described in subclause (III), the elimination of any beneficiary coinsurance described in section 1860D–2(b)(2) (for all amounts through the total amount of expenditures at which benefits are available under section 1860D–2(b)(4)).</text> </subclause> <subclause id="H68BBE678B8744B05A190EF4EFA5EBCF9"><enum>(III)</enum><header>Facility described</header><text display-inline="yes-display-inline">For purposes of subclause (II), a facility or program described in this subclause is a custodial care facility or group home (as such terms are defined by the Secretary) or any other facility or program that the Secretary determines provides services without which the individual would require long-term care in a medical or mental health institution or nursing facility.</text> </subclause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="H850EB67A78724A40BAC1C8D1B1F8DEF4"><enum>(b)</enum><header>Effective date</header> <paragraph id="H047C708284F14DAC96CF1C00D66E8159"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The amendments made by subsection (a) shall take effect as if included in the enactment of section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>).</text> </paragraph> <paragraph id="H966CD1EE0888424B9BD7631B5CF6F7CF"><enum>(2)</enum><header>Reimbursement of cost-sharing payments</header><text display-inline="yes-display-inline">The Secretary shall provide for reimbursement of any beneficiary coinsurance described in section 1860D–2(b)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)(2)</external-xref>) paid by or on behalf of an individual described in section 1860D–14(a)(1)(D)(i)(II) of such Act, as added by subsection (a), during the period beginning on January 1, 2006, and ending on the date of enactment of this Act.</text> </paragraph></subsection></section> <section id="H76C0D481E73440E7833432231360B5B1"><enum>203.</enum><header>Elimination of the indexing on the price-sharing for dual-eligibles and qualifying low income beneficiaries</header> <subsection id="HDAD33C86E617495A994BCB72B58DA723"><enum>(a)</enum><header>In general</header><text>Section 1860D–14(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)</external-xref>) is amended by striking paragraph (4).</text> </subsection> <subsection id="H6119502B226D41C0AE47F77CBC17BE4D"><enum>(b)</enum><header>Effective date</header><text><?xm-replace_text "?>The amendment made by subsection (a) shall take effect on enactment and apply to cost-sharing incurred on or after January 1, 2007.</text> </subsection></section> <section display-inline="no-display-inline" id="H290E21A25ED04A66BDE261A3008645D3" section-type="subsequent-section"><enum>204.</enum><header>Expediting low-income subsidies under the Medicare prescription drug program</header> <subsection id="H69F4D851F3B44CA489298E0025BD52B2"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–14 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="HBDB5F654C5494D36B588D1B8C3BFD644" style="OLC"> <subsection id="H52C5336195564242B600D18C432BAC5F"><enum>(e)</enum><header>Expedited application and eligibility process</header> <paragraph id="HF86A2117B6D5488F8BA2DAB90155A328"><enum>(1)</enum><header>Expedited process</header> <subparagraph id="H460EF6E98CC740048C449DF7489BC5C"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall provide for an expedited process under this subsection for the qualification for low-income assistance under this section through a request by the Secretary to the Secretary of the Treasury as provided in subparagraphs (B) and (C) for information sufficient to identify whether the individual involved is likely eligible for subsidies under this section based on such information and the amount of premium and cost-sharing subsidies for which they would qualify based on such information. Such process shall be conducted in cooperation with the Commissioner of Social Security.</text> </subparagraph> <subparagraph id="H49182C2144AB4986B01558EAEC186161"><enum>(B)</enum><header>Opt in for newly eligible individuals</header><text>Not later than 60 days after the date of the enactment of this subsection, the Secretary shall ensure that, as part of the Medicare enrollment process, enrolling individuals—</text> <clause id="H96CA257698AC415698E157F8A3F09736"><enum>(i)</enum><text>receive information describing the low-income subsidy provided under this section; and</text> </clause> <clause id="HA9A588CE0DBF47888BC86CEC6ED7A28C"><enum>(ii)</enum><text>are provided the opportunity to opt-in to the expedited process described in this subsection by giving consent for the Secretary to screen the beneficiary for eligibility for such subsidy through a request to the Secretary of the Treasury under <external-xref legal-doc="usc" parsable-cite="usc/26/6103">section 6103(l)(7)</external-xref> of the Internal Revenue Code of 1986.</text> </clause></subparagraph> <subparagraph id="H0C01FDA7447E4FF0AB8CAF554BD3B9AE"><enum>(C)</enum><header>Transition for currently eligible individuals</header><text>In the case of any part D eligible individual to which subparagraph (B) did not apply at the time of such individual’s enrollment, the Secretary shall, as soon as practicable after implementation of subparagraph (B), request in writing that the Secretary of the Treasury disclose, pursuant to <external-xref legal-doc="usc" parsable-cite="usc/26/6103">section 6103(l)(21)</external-xref> of the Internal Revenue Code of 1986, whether such individual has either filed no income tax return or whether such individual’s income tax return indicates likely eligibility for the low-income subsidy provided under this section.</text> </subparagraph></paragraph> <paragraph id="H07AED0D85DE242A197268EBAFFBBC289"><enum>(2)</enum><header>Notification of potentially eligible individuals</header><text display-inline="yes-display-inline">Under such process, in the case of each individual identified under paragraph (1) who has not otherwise applied for, or been determined eligible for, benefits under this section (or who has applied for and been determined ineligible for such benefits based only on excess resources), the Secretary shall send them a letter (using basic, uncomplicated language) containing the following:</text> <subparagraph id="H1D36D05E8EAB4216A8D3F70747AD6FE"><enum>(A)</enum><header>Eligibility</header><text>A statement that, based on the information obtained under paragraph (1), the individual is likely eligible for low-income subsidies under this section.</text> </subparagraph> <subparagraph id="HD9642F0005C940F2A69B039C044274A9"><enum>(B)</enum><header>Amount of subsidies</header><text>A description of the amount of premium and cost-sharing subsidies under this section for which the individual would likely be eligible based on such information.</text> </subparagraph> <subparagraph id="H10732958EEE3436A8BCAF74B0099452C"><enum>(C)</enum><header>Enrollment opportunity</header><text>In case the individual is not enrolled in a prescription drug plan or MA–PD plan—</text> <clause id="H45046AA08CF14F679D758B7ECB8EBA04"><enum>(i)</enum><text>a statement that—</text> <subclause id="H8CBBB94312CE4973989B3024DB0091C4"><enum>(I)</enum><text>the individual has the opportunity to enroll in a prescription drug plan or MA–PD plan for benefits under this part, but is not required to be so enrolled; and</text> </subclause> <subclause id="H6FDD7A4189E741B4851473297B950243"><enum>(II)</enum><text>if the individual has creditable prescription drug coverage, the individual need not so enroll;</text> </subclause></clause> <clause id="H9EE6962FE731450EBEF305F596733346"><enum>(ii)</enum><text>a list of the prescription drug plans and MA–PD plans in which the individual is eligible to enroll;</text> </clause> <clause id="HA2E5D1073A3944C18C5BFBB55F78E790"><enum>(iii)</enum><text display-inline="yes-display-inline">an enrollment form that may be used to enroll in such a plan by mail and that provides that if the individual wishes to enroll but does not designate a plan, the Secretary is authorized to enroll the individual in the medicare operated prescription drug plan in accordance with section 1860D–1(b)(1)(C); and</text> </clause> <clause id="H9F91E1C9C6B743848B5800C176884FA"><enum>(iv)</enum><text>a statement that the individual may also enroll online or by telephone, but, in order to qualify for low-income subsidies, the individual must complete the attestation described in subparagraph (D) or otherwise apply for such subsidies.</text> </clause></subparagraph> <subparagraph id="HB4E235EAE34643F199C2DF8C83D4239B"><enum>(D)</enum><header>Attestation</header><text>A one-page application form that provides for a signed attestation, under penalty of law, as to the amount of income and assets of the individual and constitutes an application for the low-income subsidies described in subparagraph (B). Such form—</text> <clause id="H7D9661B60A0E458A96D723E2136BEBB3"><enum>(i)</enum><text>shall not require the submittal of additional documentation regarding income or assets;</text> </clause> <clause id="H2A384BD852384F7FAC494DE14CA7B8BF"><enum>(ii)</enum><text>shall permit the appointment of a personal representative described in paragraph (6); and</text> </clause> <clause id="HEE1CE0E7BA64431E9CD6D0736D042720"><enum>(iii)</enum><text>may provide for the specification of a language (other than English) that is preferred for subsequent communications with respect to the individual under this part.</text> </clause></subparagraph> <subparagraph id="H9979002B30F34A6DB9A75B5EFAD7AFD5"><enum>(E)</enum><header>Information on SHIP</header><text>Information on how the individual may contact the State Health Insurance Assistance Program (SHIP) for the State in which the individual is located in order to obtain assistance regarding enrollment and benefits under this part.</text> </subparagraph><continuation-text continuation-text-level="paragraph">If a State is doing its own outreach to low-income seniors regarding enrollment and low-income subsidies under this part, such process shall be coordinated with the State’s outreach effort.</continuation-text></paragraph> <paragraph id="HC25BAB8BA0844ABFB65D8EBD8458ECB1"><enum>(3)</enum><header>Follow-up communications</header><text display-inline="yes-display-inline">If the individual does not respond to the letter described in paragraph (2) either by making an enrollment described in paragraph (2)(C), completing an attestation described in paragraph (2)(D), or declining either or both, the Secretary shall make additional attempts to contact the individual to obtain such an affirmative response.</text> </paragraph> <paragraph id="H556EEE509E0E45B8A4587BF6624BDF79"><enum>(4)</enum><header>Hold-harmless</header><text>Under such process, if an individual in good faith and the absence of fraud executes an attestation described in paragraph (2)(D) and is provided low-income subsidies under this section on the basis of such attestation, if the individual is subsequently found not eligible for such subsidies, there shall be no recovery made against the individual because of such subsidies improperly paid.</text> </paragraph> <paragraph id="H51A6EA86ED334771BEB5FED6E49087B5"><enum>(5)</enum><header>Use of authorized representative</header><text>Under such process, with proper authorization (which may be part of the attestation form described in paragraph (2)(D)), an individual may authorize another individual to act as the individual’s personal representative with respect to communications under this part and the enrollment of the individual under a prescription drug plan (or MA–PD plan) and for low-income subsidies under this section.</text> </paragraph> <paragraph id="HD9DB9404711041A0A1B0CF3F000000F8"><enum>(6)</enum><header>Use of preferred language in subsequent communications</header><text>In the case an attestation described in paragraph (2)(D) is completed and in which a language other than English is specified under clause (iii) of such paragraph, the Secretary shall provide that subsequent communications to the individual under this part shall be in such language.</text> </paragraph> <paragraph id="H524FBCC39414456A87E39B4E5B9C1BCF"><enum>(7)</enum><header>Construction</header><text>Nothing in this subsection shall be construed as precluding the Secretary from taking additional outreach efforts to enroll eligible individuals under this part and to provide low-income subsidies to eligible individuals.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="H92170618771B4687955D8D32115689DB"><enum>(b)</enum><header>Transitional disclosure of return information for purposes of providing low-income subsidies under Medicare</header> <paragraph id="H64AA663CE3E848099FFA8D9F5815BDDF"><enum>(1)</enum><header>In general</header><text>Subsection (l) of <external-xref legal-doc="usc" parsable-cite="usc/26/6103">section 6103</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H3682F3BD6F8346BA9317153CE79DBDBA" style="OLC"> <paragraph id="HC1E14E8F87504829AEB0B8B00DE0617"><enum>(21)</enum><header>Transitional disclosure of return information for purposes of providing low-income subsidies under Medicare</header> <subparagraph id="H7851B0FC533A44418B64288DC87F46B8"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, upon written request from the Secretary of Health and Human Services under section 1860D–14(e)(1) of the Social Security Act for an individual described in subparagraph (C) of such section, shall disclose to officers and employees of the Department of Health and Human Services and the Social Security Administration with respect to a taxpayer for the applicable year—</text> <clause id="HE831C3A5725146C5B4B171884479DA69"><enum>(i)</enum> <subclause commented="no" display-inline="yes-display-inline" id="H0E589E037EAE457DA4943944C4F696AA"><enum>(I)</enum><text display-inline="yes-display-inline">whether the adjusted gross income, as modified in accordance with specifications of the Secretary of Health and Human Services for purposes of carrying out such section, of such taxpayer and, if applicable, such taxpayer’s spouse, for the applicable year, exceeds the amounts specified by the Secretary of Health and Human Services as indicating likely eligibility for the low-income subsidy provided under section 1860D–14 of such Act,</text> </subclause> <subclause id="H98458733C3804AE5942959D9E91EA841" indent="up1"><enum>(II)</enum><text>whether the return was a joint return, and</text> </subclause> <subclause id="H76386B3A149F41A1B850BE4F2409F2A0" indent="up1"><enum>(III)</enum><text>the applicable year, or</text> </subclause></clause> <clause id="H871C1F3F67DF402BA8698E3C376BA9C7"><enum>(ii)</enum><text>if applicable, the fact that there is no return filed for such taxpayer for the applicable year.</text> </clause></subparagraph> <subparagraph id="H4ECBC35F98904987B3D48D31ACFB895"><enum>(B)</enum><header>Definition of applicable year</header><text>For the purposes of this paragraph, the term <term>applicable year</term> means the most recent taxable year for which information is available in the Internal Revenue Service’s taxpayer data information systems, or, if there is no return filed for such taxpayer for such year, the prior taxable year.</text> </subparagraph> <subparagraph id="H420FF2BEE58443858C28672FDC392104"><enum>(C)</enum><header>Restriction on use of disclosed information</header><text>Return information disclosed under this paragraph may be used only for the purposes of identifying eligible individuals for, and administering—</text> <clause id="HAB0817E71CDE4DB39FC2D718E13CD85"><enum>(i)</enum><text>low-income subsidies under section 1860D–14 of the Social Security Act, and</text> </clause> <clause id="HA96EB923ABFA4F2599737D01731FFAB6"><enum>(ii)</enum><text>the Medicare Savings Program implemented under clauses (i), (iii), and (iv) of section 1902(a)(10)(E) of such Act.</text> </clause></subparagraph> <subparagraph id="H81B7FF45ABD84452B1A32642F31FE77B"><enum>(D)</enum><header>Termination</header><text>Return information may not be disclosed under this paragraph after the date that is one year after the date of the enactment of this paragraph.</text> </subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph> <paragraph id="HC8FCC7997A9C4B6FAC19D3BF3000B9C1"><enum>(2)</enum><header>Confidentiality</header><text>Paragraph (3) of section 6103(a) of such Code is amended by striking <quote>or (20)</quote> and inserting <quote>(20), or (21)</quote>.</text> </paragraph> <paragraph id="H53BAA4F924514B14B46D147C8D15CA2E"><enum>(3)</enum><header>Procedures and recordkeeping related to disclosures</header><text>Paragraph (4) of section 6103(p) of such Code is amended by striking <quote>or (20)</quote> each place it appears and inserting <quote>(20), or (21)</quote>.</text> </paragraph> <paragraph id="H3719DEC22CAA401DA3E463E08B275571"><enum>(4)</enum><header>Unauthorized disclosure or inspection</header><text>Paragraph (2) of section 7213(a) of such Code is amended by striking <quote>or (20)</quote> and inserting <quote>(20), or (21)</quote>.</text> </paragraph></subsection></section> <section id="HC69870AD44E741A1B484D7DFA2E99390"><enum>205.</enum><header>Increase in permitted resources to obtain low-income subsidies</header> <subsection id="H0E0A43B3532042D98C93AC32A1C6601D"><enum>(a)</enum><header>Increase in resource limits</header><text display-inline="yes-display-inline">Subparagraph (E)(i) of section 1860D–14(a)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww-114">42 U.S.C. 1395ww–114(a)(3)</external-xref>) is amended—</text> <paragraph id="H1D6F8EF3AB8240A6995339E0E7EAFD1"><enum>(1)</enum><text>in subclause (I), by striking <quote>for 2006</quote> and inserting <quote>for months in 2006 before the first day of the first month beginning after the date of the enactment of the Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2006</quote> and by striking <quote>and</quote> at the end;</text> </paragraph> <paragraph id="HB6CFB0E3F7534FB285234FC7C80603E"><enum>(2)</enum><text>by redesignating subclause (II) as subclause (III);</text> </paragraph> <paragraph id="HDD0CD0E8BD3F48988FDF348EC483B15"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after subclause (I) the following new subclause:</text> <quoted-block display-inline="no-display-inline" id="H7C201091079747D9AE2D95D5858D1F3E" style="OLC"> <subclause id="H665AD7ABC2DE430CB15D33A00D56294"><enum>(II)</enum><text display-inline="yes-display-inline">for months in 2006 beginning with the first month that begins after the date of the enactment of the <short-title>Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2006</short-title>, $50,000 (or $100,000 in the case of the combined value of the individual's assets or resources and the assets or resources of the individual's spouse); and</text> </subclause><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph> <paragraph id="H8D6E309DD998439C9DBB15A06D549801"><enum>(4)</enum><text>in the last sentence, by striking <quote>subclause (II)</quote> and inserting <quote>subclause (III)</quote>.</text> </paragraph></subsection> <subsection id="HD13F749B83E9430EBB6EC27DCA1511A5"><enum>(b)</enum><header>Not counting value of life insurance as resource</header><text>Such section is further amended—</text> <paragraph id="H5A8831AD85964405974C761126E08F37"><enum>(1)</enum><text>in subparagraphs (D) and (E), by inserting <quote>, except as provided in subparagraph (G)</quote> after <quote>supplemental security income program</quote>; and</text> </paragraph> <paragraph id="H55DC9BB25BF644A6B6EC1224E421E2F"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="HF67D656CA0CA4832B141556B08AE2E26" style="OLC"> <subparagraph id="H98F6BF051A3D48679501B4F94721774"><enum>(G)</enum><header>Exclusion of life insurance in resources</header><text>For purposes of subparagraphs (D) and (E), the value of a life insurance policy shall not be counted as a resource for months beginning after the date of the enactment of this subparagraph.</text> </subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection></section> <section id="H954ED0C2253C405182266FD1CDE62800"><enum>206.</enum><header>Waiver of late enrollment penalty for subsidy eligible individuals for first 24 months of non-enrollment</header><text display-inline="no-display-inline">Section 1860D–13(b)(3)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-113">42 U.S.C. 1395w–113(b)(3)(B)</external-xref>) is amended by inserting before the period at the end the following: <quote>, except that in the case of a subsidy eligible individual (as defined in section 1860D–14(a)(3)(A)) the first 24 uncovered months shall not be counted</quote>.</text> </section> <enum>III</enum><header>Fraud and Abuse Provisions</header> <section id="H7F90F0B3A5854185BC92A89F00A225FE"><enum>301.</enum><header>Criminal penalty for fraud in connection with enrollment under an MA plan or prescription drug plan</header> <subsection id="H8F04E7B78A8D4AEAB8879E0441718C99"><enum>(a)</enum><header>In general</header><text>Section 1857 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="H0897617570DE4677934DC5C79F834338" style="OLC"> <subsection id="H10A7533E7F59400DAD902F641128B06F"><enum>(j)</enum><header>Criminal penalty for fraud in connection with enrollment under an MA plan or prescription drug plan</header><text display-inline="yes-display-inline">Whoever knowingly and willfully—</text> <paragraph id="HD37BA69B622041D2AA951926E27C72E6"><enum>(1)</enum><text>defrauds an individual in connection with the enrollment (or nonenrollment) of the individual with a Medicare Advantage plan under this part or a prescription drug plan under part D; or</text> </paragraph> <paragraph id="H626B2DCFCBE547B0B6C8817B29C55C28"><enum>(2)</enum><text>fraudulently or falsely represents an entity to be such a plan for purposes of inducing enrollment in such entity;</text> </paragraph><continuation-text continuation-text-level="subsection">shall be fined under title 18, United States Code, or imprisoned not less than 3 years and not more than 10 years, or both.</continuation-text></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="H630A2D3E60804E898C7CB78E1E7C17B1"><enum>(b)</enum><header>Conforming reference in part D</header><text>Section 1860D–12(b) of such 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="H807D8712EBE54DCBB499745DE55E9088" style="OLC"> <paragraph id="H3ABA80EA16574925BD49D76677F3BE29"><enum>(4)</enum><header>Reference to penalty for fraud in connection with enrollment under a prescription drug plan</header><text display-inline="yes-display-inline">For provision imposing a criminal penalty for defrauding an individual in connection with the enrollment of such individual under a prescription drug plan, see section 1857(j).</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HB67B2C6276EA48388D1E6B786B15BA57"><enum>(c)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply to fraudulent acts and to fraudulent or false representations made on or after the date of the enactment of this Act.</text> </subsection></section> <section id="H391D4813D90D4F6088BDDFBAE089BF2F"><enum>302.</enum><header>Recourse for slamming practices</header><text display-inline="no-display-inline">Section 1851 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="H5D767C35D1C048F084999B50814BBE65" style="OLC"> <subsection id="HDBE8B71C0FE749F3B4F0D6915B62884F"><enum>(j)</enum><header>Sanctions against slamming practices</header> <paragraph id="HFD0703CD0CEE49C897DE79E9BE049332"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall establish procedures, consistent with this subsection and the complaint processes otherwise available, under which Medicare Advantage eligible individuals who have been enrolled into an MA–PD plan without their informed consent may file a complaint with the Secretary regarding such enrollment. Such a complaint shall be signed and shall attest, under penalty of perjury, as to the accuracy of the statements therein.</text> </paragraph> <paragraph id="HB0E481EA456B4EDABE029797C51000D4"><enum>(2)</enum><header>Response to the complaint</header><text>If the Secretary finds that the complaint is justified by the facts in the case, the Secretary shall permit the individual to be enrolled under the original medicare fee-for-service program and the medicare operated prescription drug plan or under another MA plan in which the individual was previously enrolled. An individual who is dissatisfied with the Secretary’s decision on the complaint may have a hearing on the complaint before an administrative law judge in a manner similar to the manner in which such a hearing is permitted under this title with respect to other determinations under this title.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section> <section id="H37C9C7643D1F467BB0F2E6FF7C2BB385"><enum>303.</enum><header>Protection from loss of employment-based retiree health coverage upon enrollment for medicare prescription drug benefit during 2006</header><text display-inline="no-display-inline">Section 1860D–22(a)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-132">42 U.S.C. 1395w–132(a)(2)</external-xref>) is amended by adding at the end the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="H1DC4797AAA4544D296FF2DCFD2D2900" style="OLC"> <subparagraph id="H14440E81BE8949869BA0B8218F71015"><enum>(D)</enum><header>Protection from loss of employment-based coverage</header><text>The sponsor of the plan may not involuntarily discontinue coverage of an individual under a group health plan before January 1, 2008, based upon the individual’s decision to enroll in a prescription drug plan or an MA–PD plan under this part.</text> </subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </section> <section id="H116755A5F68643019BBEFB854651AE54"><enum>304.</enum><header>Required application of intermediate sanctions to protect against fraud and abuse</header> <subsection id="H71B03A8D47AE400AAC60B9F9E0D4F44D"><enum>(a)</enum><header>In general</header><text>Section 1860D–12(b)(3)(E) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)(3)(E)</external-xref>) is amended by inserting <quote>and the reference to <quote>may provide</quote> in section 1857(g)(1) is deemed a reference to <quote>shall provide</quote></quote> after <quote>this part</quote>.</text> </subsection> <subsection id="HF03210F2440141E5009D494CCBFF95ED"><enum>(b)</enum><header>Application to MA–PD plans</header><text>Section 1857(g)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27(g)(1)</external-xref>) is amended by inserting <quote>(or in the case of an MA–PD plan or a prescription drug plan under part D, the Secretary shall provide)</quote> after <quote>may provide</quote>.</text> </subsection></section> <section id="HA2F3A13392C4431C883F66A4F9C747AB"><enum>305.</enum><header>Repeal of special waiver authority for State licensure</header><text display-inline="no-display-inline">Subsection (d) of <external-xref legal-doc="regulation" parsable-cite="cfr/42/423.410">section 423.410</external-xref> of title 42, Code of Federal Regulations, is repealed, and the Secretary of Health and Human Services has no authority to provide for a waiver of a State licensure requirement described in such subsection except pursuant to section 1855(a)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-25">42 U.S.C. 1395w–25(a)(2)(B)</external-xref>).</text> </section> <enum>IV</enum><header>Relation to Social Security Benefits</header> <section id="H8BAE0DF791A84139B8719F2157576979"><enum>401.</enum><header>Protection of Social Security benefits against decrease due to part D medicare premium increases</header> <subsection id="H9F24A482D45D45D690F07BE570517E71"><enum>(a)</enum><header>Protection against decrease in Social Security benefits</header> <paragraph id="H9B82A0D445F2404D8EA0FD97D9402800"><enum>(1)</enum><header>Application to enrollees in prescription drug plans</header><text>Section 1860D–13(a)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww-113">42 U.S.C. 1395ww–113(a)(1)</external-xref>) is amended—</text> <subparagraph id="H4957B1F81BC3412A928B5FBA5740E53D"><enum>(A)</enum><text>in subparagraph (F), by striking <quote>(D) and (E),</quote> and inserting <quote>(D), (E), and (F),</quote>;</text> </subparagraph> <subparagraph id="HE0399634FEC04104A6E0F12D008D76ED"><enum>(B)</enum><text>by redesignating subparagraph (F) as subparagraph (G); and</text> </subparagraph> <subparagraph id="H6A6DA82CEA054C10963ED26380B1BCD6"><enum>(C)</enum><text>by inserting after subparagraph (E) the following new subparagraph:</text> <quoted-block id="HAA7A9AE5E0A44FCD90DC000008C4D4DF"> <subparagraph id="H47A676F78D5C4B0798138E5F2B6317BA"><enum>(F)</enum><header>Protection of Social Security benefits</header><text>For any calendar year, if an individual is entitled to monthly benefits under section 202 or 223 or to a monthly annuity under section 3(a), 4(a), or 4(f) of the Railroad Retirement Act of 1974 for November and December of the preceding year and was enrolled under a prescription drug plan or MA–PD plan for such months, the base beneficiary premium otherwise applied under this paragraph for the individual for months in that year shall be decreased by the amount (if any) by which the sum of the amounts described in the following clauses (i) and (ii) exceeds the amount of the increase in such monthly benefits for that individual attributable to section 215(i):</text> <clause id="H452BCEE7E2DF4C82B4ACB2066C48DF83"><enum>(i)</enum><header>Part D premium increase factor</header> <subclause id="HF4ADDA7BF5E141A890F466EDBA5B34E1"><enum>(I)</enum><header>In general</header><text>Except as provided in this clause, the amount of the increase (if any) in the adjusted national average monthly bid amount (as determined under subparagraph (B)(iii)) for a month in the year over such amount for a month in the preceding year.</text> </subclause> <subclause id="H0F686B85C8944131B44B406E8F202C77"><enum>(II)</enum><header>No application to full premium subsidy individuals</header><text>In the case of an individual enrolled for a premium subsidy under section 1860D–14(a)(1), zero.</text> </subclause> <subclause id="H056CF419F21E4492B42BEA58993E12B9"><enum>(III)</enum><header>Special rule for partial premium subsidy individuals</header><text>In the case of an individual enrolled for a premium subsidy under section 1860D–14(a)(2), a percent of the increase described in subclause (I) equal to 100 percent minus the percent applied based on the linear scale under such section.</text> </subclause></clause> <clause id="H7AA225C7B031441889BE8B784B379E80"><enum>(ii)</enum><header>Part B premium increase factor</header><text>If the individual is enrolled for such months under part B—</text> <subclause id="H77E73D6575C74DCB903F499DCE00BB21"><enum>(I)</enum><header>In general</header><text>Except as provided in subclause (II), the amount of the annual increase in premium effective for such year resulting from the application of section 1839(a)(3), as reduced (if any) under section 1839(f).</text> </subclause> <subclause id="H77548B7596C44EC4A88172BA9CF0DD3B"><enum>(II)</enum><header>No application to individuals participating in medicare savings program</header><text>In the case of an individual who is enrolled for medical assistance under title XIX for medicare cost-sharing described in section 1905(p)(3)(A)(ii), zero.</text> </subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph> <paragraph id="H07A6D851652B4BFCB87698F969A8ABB"><enum>(2)</enum><header>Application under Medicare Advantage program</header><text>Section 1854(b)(2)(B) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-24">42 U.S.C. 1395w–24(b)(2)(B)</external-xref>), as in effect as of January 1, 2006, relating to MA monthly prescription drug beneficiary premium, is amended by inserting after <quote>as adjusted under section 1860D–13(a)(1)(B)</quote> the following: <quote>and section 1860D–13(a)(1)(F)</quote>.</text> </paragraph> <paragraph id="HBC4348804D344BA89EADC21FFE615DE"><enum>(3)</enum><header>Payment from medicare prescription drug account</header><text>Section 1860D–16(b) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-116">42 U.S.C. 1395w–116(b)</external-xref>) is amended—</text> <subparagraph id="HBE67CD121A7C473FAC009F566774FAD0"><enum>(A)</enum><text>in paragraph (1), as amended by section 101(c)(5)—</text> <clause id="H3105CCCB96DB4ECAB31983CBC7A23369"><enum>(i)</enum><text>by striking <quote>and</quote> at the end of subparagraph (D);</text> </clause> <clause id="H59DA6E51250641A096A1082260BE4E49"><enum>(ii)</enum><text>by striking the period at the end of subparagraph (E) and inserting <quote>; and</quote>; and</text> </clause> <clause id="H05FCA5449FCD47AA8CA25904E0DC4688"><enum>(iii)</enum><text>by adding at the end the following new subparagraph:</text> <quoted-block id="H62F48D336E4A45BC84ACB076FF9CE34C"> <subparagraph id="H366581F139604EB8BA003FD17C49EBC"><enum>(F)</enum><text>payment under paragraph (5) of premium reductions effected under section 1860D–13(a)(1)(F).</text> </subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph> <subparagraph id="HE2F4A5540FF24184A8134DFD81DB39FA"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block id="H6F7EE1CDF9AF48308D23823981F8AB1B"> <paragraph id="H8767D4C4BB774C6DAD739947DD8017E6"><enum>(5)</enum><header>Payment for Social Security benefit protection premium reductions</header> <subparagraph id="H41550D67BA0C415691398000917C75FB"><enum>(A)</enum><header>In general</header><text>In addition to payments provided under section 1860D–15 to a PDP sponsor or an MA organization, in the case of each part D eligible individual who is enrolled in a prescription drug plan offered by such sponsor or an MA–PD plan offered by such organization and who has a premium reduced under section 1860D–13(a)(1)(F), the Secretary shall provide for payment to such sponsor or organization of an amount equivalent to the amount of such premium reduction.</text> </subparagraph> <subparagraph id="H005E17DC07C94FAD86997441E2BC468E"><enum>(B)</enum><header>Application of provisions</header><text>The provisions of subsections (d) and (f) of section 1860D–15 (relating to payment methods and disclosure of information) shall apply to payment under subparagraph (A) in the same manner as they apply to payments under such section.</text> </subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph></subsection> <subsection id="H03188D870B524959A018561300020455"><enum>(b)</enum><header>Disregard of premium reductions in determining dedicated revenues under MMA cost containment</header><text>Section 801(c)(3)(D) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>) is amended by adding at the end the following: <quote>Such premiums shall also be determined without regard to any reductions effected under section 1839(f) or 1860D–13(a)(1)(F) of such title.</quote>.</text> </subsection> <subsection id="HDBF28A4D0AD34ED4B35CC405187EB700"><enum>(c)</enum><header>Effective dates</header> <paragraph id="H4AD473DFF6F341BE98823DA92D15F9CD"><enum>(1)</enum><header>Part D premium</header><text>The amendments made by subsection (a) apply to premiums for months beginning with January 2007.</text> </paragraph> <paragraph id="H13051F050C904F76A2A61ED8BABFACC6"><enum>(2)</enum><header>MMA provision</header><text>The amendment made by subsection (b) shall take effect on the date of the enactment of this Act.</text> </paragraph></subsection></section> <enum>V</enum><header>Beneficiary Protection Provisions</header> <section display-inline="no-display-inline" id="H0745E51F073A42538CE05694B0CB2C34" section-type="subsequent-section"><enum>501.</enum><header>Extension of open enrollment period; suspension of late enrollment penalties; allowing one-time change in plan during first year of enrollment</header> <subsection id="H3D13212DBF58451EB1E6384450D010F6"><enum>(a)</enum><header>Extension of open enrollment period for 2006</header><text display-inline="yes-display-inline">Section 1851(e)(3)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21(e)(3)(B)</external-xref>) is amended in clause (iii) by striking <quote>May 15, 2006</quote> and inserting <quote>November 14, 2006</quote>.</text> </subsection> <subsection id="HB6E158560D2A4145B888E4ACA12C00F9"><enum>(b)</enum><header>No late enrollment penalties for months before January 2008</header><text>Section 1860D–13(b)(3)(B) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-113">42 U.S.C. 1395w–113(b)(3)(B)</external-xref>) is amended by inserting <quote>(after December 2007)</quote> after <quote>any month</quote>.</text> </subsection> <subsection id="H15E0868C23EA47BBA16C304BF9FF00EE"><enum>(c)</enum><header>Change in plan during first year of enrollment</header><text>Section 1860D–1(b)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101(b)(1)</external-xref>) is amended by adding at the end the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="HE95FD065D7F1418F007BFA7EEEC85EDE" style="OLC"> <subparagraph id="H0FC19A57ED8D48C5832B36E89051C617"><enum>(D)</enum><header>Change in prescription drug plan allowed during first year of enrollment</header> <clause id="HE3799C61ABB34271A7B6BC9117279392"><enum>(i)</enum><header>In general</header><text>Subject to clause (ii), at any time during the 12-month period beginning with the first month in which a part D eligible individual is enrolled in a prescription drug plan under this part, the individual may change the prescription drug plan in which the individual is enrolled.</text> </clause> <clause id="H8FD40796B24C47F7B2CDCB86C7DAFEE"><enum>(ii)</enum><header>Limitation of one change during period</header><text>An individual may exercise the right under clause (i) only once during such 12-month period and the exercise of such right shall be in addition to the exercise of any other rights to change such an enrollment during such period.</text> </clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section> <section id="H25A58FE2329441F885D672315D8DDD79"><enum>502.</enum><header>Counting expenditures under State drug assistance programs against true out-of-pocket costs</header><text display-inline="no-display-inline">Section 1860D–2(b)(4)(C)(ii) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)(4)(C)(ii)</external-xref>) is amended by inserting <quote>, AIDS Drug Assistance Program, or other State drug assistance program</quote> after <quote>State Pharmaceutical Assistance Program</quote>.</text> </section> <section id="HCD03E92B0A8B4506A7351433D96BB6C7"><enum>503.</enum><header>Price disclosure</header> <subsection id="H3B8F2B4BEA8E4E7D836ED87E0053DD7"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–2(d)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(d)(2)</external-xref>) is amended—</text> <paragraph id="H16176C1C5C2D422FB19354E5AD472FE4"><enum>(1)</enum><text>in the first sentence, by striking <quote>which are passed through</quote> and all that follows through <quote>other dispensers</quote>;</text> </paragraph> <paragraph id="H143651AA4625426BB83C843E0969004E"><enum>(2)</enum><text>in the second sentence, by inserting <quote>do not</quote> before <quote>apply</quote>; and</text> </paragraph> <paragraph id="H805962E0CB234BDA8993B8DBAF2BE534"><enum>(3)</enum><text>in the second sentence, by inserting before the period at the end the following: <quote>and the Secretary shall make the information described in the previous sentence available to the public</quote>.</text> </paragraph></subsection> <subsection id="H3137B640A3234FBE8D50B4BA109CF238"><enum>(b)</enum><header>Conforming amendment</header><text>Section 1927(b)(3)(D) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(b)(3)(D)</external-xref>) is amended by striking the last sentence.</text> </subsection></section> <section commented="no" display-inline="no-display-inline" id="HC326F05BB9E3487B8359007FC61254E0"><enum>504.</enum><header>Removal of covered part D drugs from the prescription drug plan formulary</header><text display-inline="no-display-inline">Section 1860D–4(b)(3)(E) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(b)(3)(E)</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H124979DB48E741E5B9C9E762FCA0DFE" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="H06C6CF0B1D87445EBF00BBA5514B1BA5"><enum>(E)</enum><header>Removing drug from formulary or changing preferred or tier status of drug</header> <clause commented="no" display-inline="no-display-inline" id="H7C34D8F45B994C2680BD043FC1DCD0FF"><enum>(i)</enum><header>Limitation on removal or change</header><text>Beginning with 2006, except as provided in clause (iii), the PDP sponsor of a prescription drug plan may not—</text> <subclause id="H2CA8874E00AB4CE4B6FBE1F4231F62F2"><enum>(I)</enum><text>remove a covered part D drug from the plan formulary;</text> </subclause> <subclause id="H2F163FA610464B06B5A0D1F5B2BB229C"><enum>(II)</enum><text>change the preferred or tiered cost-sharing status of such a drug to a status less favorable to an enrollee; or</text> </subclause> <subclause id="HD6DA0C9E352A415388F8BD7C76C585F1"><enum>(III)</enum><text>introduce a barrier, such as step therapy, prior authorization, or quantity limitation, to access to covered part D drugs,</text> </subclause><continuation-text continuation-text-level="clause">unless advance notice under clause (ii) of such removal, change, or introduction has been provided and unless such removal, change, or introduction is only effective beginning on January 1 of the year following the year in which such notice is provided.</continuation-text></clause> <clause commented="no" display-inline="no-display-inline" id="H15A1706FFCE54F9C99BCD695B3F69FCD"><enum>(ii)</enum><header>Notice</header><text>The notice under this clause is an appropriate notice (such as under subsection (a)(3)) to the Secretary, affected enrollees, physicians, pharmacies, and pharmacists during the period beginning on September 1 and ending on October 31 of a year. Such notice shall ensure that such information is made available prior to the annual, coordinated open election period described in section 1851(e)(3)(B)(iii), as applied under section 1860D–1(b)(1)(B)(iii).</text> </clause> <clause id="H2EA176622EAD40FDAA8E6C00E8D500C4"><enum>(iii)</enum><header>Exception</header><text>Clause (i) shall not apply to a covered part D drug—</text> <subclause id="HC08F3702FEA843BBA7CFC79B7DEDF98D"><enum>(I)</enum><text>if it has been determined to be unsafe by the Food and Drug Administration; and</text> </subclause> <subclause id="HC32931DF1A344008A4F36447793255E2"><enum>(II)</enum><text>if, during a plan year, the drug changes from being a single source drug to a multiple source drug (as defined in section 1927(k)), and the prescription drug plan covers another bioequivalent multiple source drug at the same or lower cost-sharing to enrolled individuals.</text> </subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </section> <section display-inline="no-display-inline" id="H81D24A43F6E84ED09CEAB3196200A4A1"><enum>505.</enum><header>Codification of requirement for coverage of all or substantially all of drugs within six categories of drugs</header> <subsection id="H91956B1868BD43699873C894707E10A4"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–4(b)(3) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(b)(3)</external-xref>) is amended—</text> <paragraph id="HD9DC0A716BC046FE833C3DD88CDC983D"><enum>(1)</enum><text>in subparagraph (C)(i), by striking <quote>The formulary</quote> and inserting <quote>Subject to subparagraph (G), the formulary</quote>; and</text> </paragraph> <paragraph id="HB90C9C105B684F69B6F55E7CD1DFF9A9"><enum>(2)</enum><text>by inserting after subparagraph (F) the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="H584812FC8CDB4F89AEC573E25B9F5142" style="OLC"> <subparagraph id="H5145574FD8774B13B74B2F8622F1E63B"><enum>(G)</enum><header>Required inclusion of drugs in certain categories and classes</header> <clause id="H90DA491E593F4C38BD42A2770077D878"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The formulary must include all or substantially all drugs in the following categories that are available as of April 17 of the prior year and shall include at least some drugs from each category without restrictions or limitations on coverage (such as through the application of a less-preferred cost-sharing tier or status, usage restriction, step therapy, prior authorization, or a quantity limitation):</text> <subclause id="HE87F26C487774AA79084B2C560D59945"><enum>(I)</enum><text>Immunosuppressant.</text> </subclause> <subclause id="HBA96DBE51C824AC08BC000B2604F81D"><enum>(II)</enum><text>Antidepressant.</text> </subclause> <subclause id="HFAC08E05C4C246F8B715E8ABEEE90000"><enum>(III)</enum><text>Antipsychotic.</text> </subclause> <subclause id="HC2F98105A6D54F8F9784A8B89700433"><enum>(IV)</enum><text>Anticonvulsant.</text> </subclause> <subclause id="H26B473078D5E485ABA1446E1661E3939"><enum>(V)</enum><text>Antiretroviral.</text> </subclause> <subclause id="HA5F83A6A5DAB414991802C199DFE0876"><enum>(VI)</enum><text>Antineoplastic.</text> </subclause></clause> <clause id="HE763F786FCA1479A80A55873597C278F"><enum>(ii)</enum><header>Substantially all defined</header><text>For purposes of clause (i), the term <term>substantially all</term> means all drugs and unique dosage forms in the categories described in such clause, except for—</text> <subclause id="HCD0FC07FCCE9465AA89600D952126E15"><enum>(I)</enum><text>multi-source brands of the identical molecular structure;</text> </subclause> <subclause id="HB07D2693CD804426B6C7B000B5C3984E"><enum>(II)</enum><text>extended release products when the immediate-release product is included on the formulary;</text> </subclause> <subclause id="HEBAC1FEE144F4D7A8F2E434253CCB951"><enum>(III)</enum><text>products that have the same active ingredient; and</text> </subclause> <subclause id="H27677266301645A29DD1CF804EB23FD3"><enum>(IV)</enum><text>dosage forms that do not provide a unique route of administration, such as tablets and capsules.</text> </subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="HEED64999C39D4080000748D723AA8623"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by subsection (a) shall apply to contract years beginning on or after January 1, 2007.</text> </subsection></section> <section id="H0E8160D2E8C54688B6AB72931C00BD80" section-type="subsequent-section"><enum>506.</enum><header>Removal of exclusion of benzodiazepines from required coverage under the medicare prescription drug program</header> <subsection id="H985CDB7AD7454BE18002FF673686A19F"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–2(e)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(e)(2)</external-xref>) is amended—</text> <paragraph id="HC80C02DF71574656B3D2FB7FB6A86257"><enum>(1)</enum><text>by striking <quote>subparagraph (E)</quote> and inserting <quote>subparagraphs (E) and (J)</quote>; and</text> </paragraph> <paragraph id="HF74D35F0E0F94F39BDD78E3BC1D9C11F"><enum>(2)</enum><text>by inserting <quote>and benzodiazepines</quote> after <quote>smoking cessation agents</quote>.</text> </paragraph></subsection> <subsection id="H4D9E8874AEFC4102A881FDC2D46E902D"><enum>(b)</enum><header>Review of benzodiazepine prescription policies to assure appropriateness and to avoid abuse</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall review the policies of medicare prescription drug plans (and MA–PD plans) under parts C and D of title XVIII of the Social Security Act regarding the filling of prescriptions for benzodiazepine to ensure that these policies are consistent with accepted clinical guidelines, are appropriate to individual health histories, and are designed to minimize long term use, guard against over-prescribing, and prevent patient abuse.</text> </subsection> <subsection id="H9795114D80A64532AC6C7606E73678A7"><enum>(c)</enum><header>Development by medicare quality improvement organizations of educational guidelines for physicians regarding prescribing of benzodiazepines</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall provide, in contracts entered into with medicare quality improvement organizations under part B of title XI of the Social Security Act, for the development by such organizations of appropriate educational guidelines for physicians regarding the prescribing of benzodiazepines.</text> </subsection> <subsection id="H126DC98D678C411B841320BC51AB7FC8"><enum>(d)</enum><header>Effective date</header><text>The amendments made by this section shall be effective as if included in the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>).</text> </subsection></section> <section id="H94F5E57B6D564779AA005F36594BC48C"><enum>507.</enum><header>Standardized forms and procedures for reconsiderations and appeals</header> <subsection id="H747C4E8BA5E54C24BC7FA466141DFEEB"><enum>(a)</enum><header>In general</header><text>Section 1860D–4 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="H6624D3FC067A4D93B7E3FA7247D464EF" style="OLC"> <subsection id="HFC31D8A17F0B4160806D00F3B5F95394"><enum>(l)</enum><header>Standardized forms and procedures for reconsiderations and appeals</header> <paragraph id="H2117DC32D3F7458B9DF625F2F0195CC6"><enum>(1)</enum><header>Standard enrollee notice</header><text>The Secretary shall develop a standard notice to be distributed by a prescription drug plan (or an MA–PD plan) to an enrollee when a covered part D drug prescribed for the enrollee is not covered, or the coverage of such drug is otherwise restricted, by the plan.</text> </paragraph> <paragraph id="H51BE8E45533E452D8310D07C1D1321AE"><enum>(2)</enum><header>Standardized process for reconsiderations and appeals</header><text>The Secretary shall require prescription drug plans and MA–PD plans to follow the same standardized process for reconsiderations and redeterminations under subsections (g) and (h). Such process shall require that determinations regarding medical necessity are based on professional medical judgement, the medical condition of the enrollee, the treating physician's recommendation, and other medical evidence.</text> </paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HD0EB1E2DEA604C0B91C1B988E2BC6BE3"><enum>(b)</enum><header>Effective date</header><text>The Secretary of Health and Human Services shall provide for the standard notice and the standardized process, and the application of such notice and process, under the amendment made by subsection (a) by not later than January 1, 2007.</text> </subsection></section> <section id="HDDF8B33BD07C40E790F78370A68FA9A6"><enum>508.</enum><header>Elimination of MA Regional Stabilization Fund (Slush Fund); elimination of certain MA overpayments</header> <subsection id="H17C92AF961744B00868E5EC86445008B"><enum>(a)</enum><header>Elimination of slush fund</header> <paragraph id="H8444C71533D44C88ACDB1B003B348F00"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subsection (e) of section 1858 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27a">42 U.S.C. 1395w–27a</external-xref>) is repealed.</text> </paragraph> <paragraph id="HE52F8298C6FB409D926DD90068DD7FB5"><enum>(2)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">Section 1858(f)(1) of the Social Security Act (42 U.S.C. 1395w–27a(f)(1)) is amended by striking <quote>subject to subsection (e),</quote>.</text> </paragraph> <paragraph id="H744033AC13CE4B90882D4FA3C1909D8D"><enum>(3)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this subsection shall take effect as if included in the enactment of section 221(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2181).</text> </paragraph></subsection> <subsection display-inline="no-display-inline" id="H1163ECFFA05B46079402F9AFA005BFA"><enum>(b)</enum><header>Elimination of certain Medicare Advantage overpayments</header> <paragraph id="HCE73F2E4AF8B4A29B8AF168600AC44A"><enum>(1)</enum><header>In general</header><text>Section 1853(a)(1)(C)(ii) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-23">42 U.S.C. 1395w–23(a)(1)(C)(ii)</external-xref>), as added by section 5301 of the Deficit Reduction Act of 2005, is amended—</text> <subparagraph id="H34C34ACFB4134724A089B325642251EF"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text level="clause" style="OLC">during phase-out of budget neutrality factor</header-in-text></quote>;</text> </subparagraph> <subparagraph id="HE7D3D8ABD11847B984A315F180EBAD56"><enum>(B)</enum><text>in the matter preceding subclause (I), by striking <quote>through 2010</quote> and inserting <quote>and subsequent years</quote>; and</text> </subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H919ABB3D4F2B4E22B22817F24F4295BB"><enum>(C)</enum><text>in subclause (II), by striking <quote>only for 2008, 2009, and 2010</quote> and inserting <quote>for 2008 and subsequent years</quote>.</text> </subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H4919F6C6D4F2451C9800F989EE8E66B9"><enum>(2)</enum><header>Effective date</header><text>The amendments made by this subsection shall take effect as if included in the enactment of section 5301 of the Deficit Reduction Act of 2005.</text> </paragraph></subsection></section> <enum>VI</enum><header>Fair and Speedy Treatment of Medicare Prescription Drug Claims</header> <section id="HA4AD537453554D00A42D562FD09F2FB6"><enum>601.</enum><header>Prompt payment by Medicare prescription drug plans and MA–PD plans under part D</header> <subsection id="H159DE892045C43B098216EF1A65FFD46"><enum>(a)</enum><header>Application to prescription drug plans</header><text>Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112 (b)), as amended by section 301(b), is amended by adding at the end the following new paragraph:</text> <quoted-block id="H48EA6D049EFF434EB7601D82AFC42EB" style="OLC"> <paragraph id="H5DC9A00DFCA146B694BB55C4BD6740FF"><enum>(5)</enum><header>Prompt payment of clean claims</header> <subparagraph id="HA9C3BBA523A24E1D867D987BFAF52344"><enum>(A)</enum><header>Prompt payment</header><text>Each contract entered into with a PDP sponsor under this subsection with respect to a prescription drug plan offered by such sponsor shall provide that payment shall be issued, mailed, or otherwise transmitted with respect to all clean claims submitted under this part within the applicable number of calendar days after the date on which the claim is received.</text> </subparagraph> <subparagraph id="H9FF11B081B724A2799FE95807B61CAC9"><enum>(B)</enum><header>Definitions</header><text>In this paragraph:</text> <clause id="H40C945FD448F4523BF62D239F3742335"><enum>(i)</enum><header>Clean claim</header><text>The term <term>clean claim</term> means a claim, with respect to a covered part D drug, that has no apparent defect or impropriety (including any lack of any required substantiating documentation) or particular circumstance requiring special treatment that prevents timely payment from being made on the claim under this part.</text> </clause> <clause id="HC0AB81E85637449E9733D01E9D0325E7"><enum>(ii)</enum><header>Applicable number of calendar days</header><text>The term <term>applicable number of calendar days</term> means—</text> <subclause id="HD0776EF416984408A95ED120B9BF5EF7"><enum>(I)</enum><text>with respect to claims submitted electronically, 14 calendar days; and</text> </subclause> <subclause id="HE9EFD88EC559447EB312495DB968232C"><enum>(II)</enum><text>with respect to claims submitted otherwise, 30 calendar days.</text> </subclause></clause></subparagraph> <subparagraph id="H4021EA579963441A001C88E755F1FB49"><enum>(C)</enum><header>Interest payment</header><text>If payment is not issued, mailed, or otherwise transmitted within the applicable number of calendar days (as defined in subparagraph (B)) after a clean claim is received, interest shall be paid at a rate used for purposes of <external-xref legal-doc="usc" parsable-cite="usc/31/3902">section 3902(a)</external-xref> of title 31, United States Code (relating to interest penalties for failure to make prompt payments), for the period beginning on the day after the required payment date and ending on the date on which payment is made.</text> </subparagraph> <subparagraph id="H4487296A340245A88B70227BF4437049"><enum>(D)</enum><header>Procedures involving claims</header> <clause id="H6161685805B9491C8C7EAA15DA4DA214"><enum>(i)</enum><header>Claims deemed to be clean claims</header> <subclause id="H0D9AF979E71248B4A7EA6E4CF4940032"><enum>(I)</enum><header>In general</header><text>A claim for a covered part D drug shall be deemed to be a clean claim for purposes of this paragraph if the PDP sponsor involved does not provide a notification of deficiency to the claimant by the 10th day that begins after the date on which the claim is submitted.</text> </subclause> <subclause commented="no" id="H7E94538AA6F440D3AB09015689C1E83"><enum>(II)</enum><header>Notification of deficiency</header><text>For purposes of subclause (II), the term <term>notification of deficiency</term> means a notification that specifies all defects or improprieties in the claim involved and that lists all additional information or documents necessary for the proper processing and payment of the claim.</text> </subclause></clause> <clause id="HF7D27E87B92A45D485A95555E6C4AC84"><enum>(ii)</enum><header>Payment of clean portions of claims</header><text>A PDP sponsor shall, as appropriate, pay any portion of a claim for a covered part D drug that would be a clean claim but for a defect or impropriety in a separate portion of the claim in accordance with subparagraph (A).</text> </clause> <clause id="HF3287857E6EC4CECBB58AE5261E4E85D"><enum>(iii)</enum><header>Obligation to pay</header><text>A claim for a covered part D drug submitted to a PDP sponsor that is not paid or contested by the provider within the applicable number of calendar days (as defined in subparagraph (B)) shall be deemed to be a clean claim and shall be paid by the PDP sponsor in accordance with subparagraph (A).</text> </clause> <clause id="HCD91FA49BDBD485DB70700729E3165EE"><enum>(iv)</enum><header>Date of payment of claim</header><text>Payment of a clean claim under subparagraph (A) is considered to have been made on the date on which full payment is received by the provider.</text> </clause></subparagraph> <subparagraph id="H0C29640F7CF44F37A0ABEB03A6099166"><enum>(E)</enum><header>Electronic transfer of funds</header><text>A PDP sponsor shall pay all clean claims submitted electronically by an electronic funds transfer mechanism.</text> </subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="H2B13E61270BF413F8B85006F7804A7AC"><enum>(b)</enum><header>Application to MA–PD plans</header><text>Section 1857(f) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block id="H234991D340FC4A5A96219375F71B8835" style="OLC"> <paragraph id="H43744178AD7B49B29FE7DB24A8798CC2"><enum>(3)</enum><header>Incorporation of certain prescription drug plan contract requirements</header><text>The provisions of section 1860D–12(b)(5) shall apply to contracts with a Medicare Advantage organization in the same manner as they apply to contracts with a PDP sponsor offering a prescription drug plan under part D.</text> </paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="H0371FE6CEBD843E7A8CC621DB0149EC7"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to contracts entered into or renewed on or after the date of the enactment of this Act.</text> </subsection></section> <section id="H42729A6F59C34A0DB868953C33858C35"><enum>602.</enum><header>Restriction on co-branding</header> <subsection id="H5C5DC1E1E65D4E89853582C5C4F28BBB"><enum>(a)</enum><header>In general</header><text>Section 1860D–4(b)(2)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(b)(2)(A)</external-xref>) is amended by adding at the end the following new sentences: <quote>It is unlawful for a PDP sponsor of a prescription drug plan to display on such a card the name, brand, or trademark of any pharmacy.</quote></text> </subsection> <subsection id="H4C4BBA3C964346BC9DCA13429C3DDB7D"><enum>(b)</enum><header>Effective date</header><text>With respect to cards dispensed before, on, or after the date of the enactment of this Act, the amendment made by this section shall apply to such cards on and after the date that is 90 days after such date of enactment. Any card dispensed before such date that is 90 days after the date of enactment that violates the second sentence of section 1860D–4(b)(2)(A) of the Social Security Act, as added by subsection (a), shall be reissued by such 90-day date.</text> </subsection></section> <section id="H5E3AC8B411044E0F817050D7822EA3A5"><enum>603.</enum><header>Minimum dispensing fees for generic covered part D drugs</header> <subsection id="H1583F9A9B8594717945C4CCDE471F967"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–4(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(b)(1)</external-xref>) is amended by adding at the end the following new subparagraph:</text> <quoted-block id="H33D06CE08D614CA9AEA9D23862FDA8D" style="OLC"> <subparagraph id="HD09C5BFE639A42E2ADC748CFEDBC5AB"><enum>(F)</enum><header>Payment of minimum dispensing fees to encourage use of generic drugs</header> <clause id="H7879FA54CBFF42B8BBE7A4B5C297D7F6"><enum>(i)</enum><header>In general</header><text>Subject to clauses (ii) and (iii), with respect to a generic covered part D drug that is therapeutically equivalent and bioequivalent to a brand name drug that is a covered part D drug dispensed through a participating pharmacy, the amount of the dispensing fee paid to the pharmacy for the generic covered part D drug shall be an amount that is at least the greater of—</text> <subclause id="H76A6A7E780414490AA1E2813718B2948"><enum>(I)</enum><text>50 percent greater than the amount of the dispensing fee for the brand name drug; or</text> </subclause> <subclause id="H95950910FCFF4A6B9E16D9964DA575E4"><enum>(II)</enum><text>$10.</text> </subclause></clause> <clause id="H139671EB47D94553B052A65B4546C615"><enum>(ii)</enum><header>Safe harbor for brand name drug dispensing fee amounts</header> <subclause id="H4A4239A6504F4918A0E1381157B7C56C"><enum>(I)</enum><header>In general</header><text>For purposes of clause (i) and subject to subclause (II), a prescription drug plan under this section shall not decrease the amount of the dispensing fee paid by the plan to a participating pharmacy for a brand name drug described in such clause to an amount that is less than the amount of the dispensing fee paid by such plan to such pharmacy for such drug on the date of the enactment of this subparagraph.</text> </subclause> <subclause id="H1829BF4D88154A409F83AF772662B298"><enum>(II)</enum><header>Exception</header><text>The Secretary may waive the prohibition under subclause (I) with respect to a dispensing fee paid by a prescription drug plan for a brand name drug, as the Secretary determines appropriate.</text> </subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HEC861A16EBA545E78F6D941C17C722DB"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply to prescriptions filled on or after the date that is the first day of the first contract year after the date of the enactment of this Act.</text> </subsection></section> <section commented="no" display-inline="no-display-inline" id="H59DD0A550E744EE696B64F8D97D5B28F"><enum>604.</enum><header>Provision of medication therapy management services under part D</header> <subsection commented="no" display-inline="no-display-inline" id="HF0B2D5279C8F4978B9ACCB7172707B4"><enum>(a)</enum><header>Provision of Medication Therapy Management Services under part D</header> <paragraph commented="no" display-inline="no-display-inline" id="HBB15869A756B41E1AEDA54BA6C9A3FB"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–4(c)(2) of the Social Security Act (42 U.S.C.1395w–104(c)(2)) is amended—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HD375C8CFA1AE463992F241DE7EBC685B"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text> <clause commented="no" display-inline="no-display-inline" id="HAC02F2B04FB34803B081428525AF3695"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i)—</text> <subclause commented="no" display-inline="no-display-inline" id="HC1B8419811D74637A365A3A017830478"><enum>(I)</enum><text display-inline="yes-display-inline">by inserting <quote>or other health care provider with advanced training in medication management</quote> after <quote>furnished by a pharmacist</quote>; and</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H0F9F13FBA36D4524B69834856B2E32A1"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>targeted beneficiaries described in clause (ii)</quote> and inserting <quote>targeted beneficiaries specified under clause (ii)</quote></text> </subclause></clause> <clause commented="no" display-inline="no-display-inline" id="HCD0490C53D324FAEA3BBCAAA403F6363"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking clause (ii) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H9D5EF6A4087D4E8BB9CD00283C1364D1" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="H60D09AE3ED294839847442538BBE9CC4"><enum>(ii)</enum><header>Targeted beneficiaries</header><text display-inline="yes-display-inline">The Secretary shall specify the population of part D eligible individuals appropriate for services under a medication therapy management program based on the following characteristics:</text> <subclause commented="no" display-inline="no-display-inline" id="H3B2BFC03D2D54994A0A90465BB541F9B"><enum>(I)</enum><text display-inline="yes-display-inline">Having a disease state in which evidence-based medicine has demonstrated the benefit of medication therapy management intervention based on objective outcome measures.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H9548D08E8C3C4A5A99B000EDF42C0912"><enum>(II)</enum><text display-inline="yes-display-inline">Taking multiple covered part D drugs or having a disease state in which a complex combination medication regimen is utilized.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H43BDBB688E9D42CC8964C9A8F0EBB807"><enum>(III)</enum><text display-inline="yes-display-inline">Being identified as likely to incur annual costs for covered part D drugs that exceed a level specified by the Secretary or where acute or chronic decompensation of disease would likely increase expenditures under the Federal Hospital Insurance Trust Fund or the Federal Supplementary Medical Insurance Trust Fund under sections 1817 and 1841, respectively, such as through the requirement of emergency care or acute hospitalization.</text> </subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block> </clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H5EB86FFA56DB4847B59FA59276FF20B"><enum>(B)</enum><text display-inline="yes-display-inline">by striking subparagraph (B) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H01B56AD84AF643DD9DD5BDE9F9F6D79" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="HB82F566AD5AF4FCF0065A6F5A4B56591"><enum>(B)</enum><header>Elements</header> <clause commented="no" display-inline="no-display-inline" id="H8FE4B85FAD234C6CA68BEC1D515124C0"><enum>(i)</enum><header>Minimum defined package of services</header><text display-inline="yes-display-inline">The Secretary shall specify a minimum defined package of medication therapy management services that shall be provided to each enrollee. Such package shall be based on the following considerations:</text> <subclause commented="no" display-inline="no-display-inline" id="H5F9B7CB3F76F46E8AC47835324C2C2E5"><enum>(I)</enum><text display-inline="yes-display-inline">Performing necessary assessments of the health status of each enrollee.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="HB78CB2AAE52341618246C15943FD9F00"><enum>(II)</enum><text display-inline="yes-display-inline">Providing medication therapy review to identify, resolve, and prevent medication-related problems, including adverse events.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H440C4C47684E419DB2B400A0F678F062"><enum>(III)</enum><text display-inline="yes-display-inline">Increasing enrollee understanding to promote the appropriate use of medications by enrollees and to reduce the risk of potential adverse events associated with medications, through beneficiary and family education, counseling, and other appropriate means.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H29FD7ABE72C2418C97F4C7CD362F75FF"><enum>(IV)</enum><text display-inline="yes-display-inline">Increasing enrollee adherence with prescription medication regimens through medication refill reminders, special packaging, and other compliance programs and other appropriate means.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H6A8B630938374470AA6125C678D872FF"><enum>(V)</enum><text display-inline="yes-display-inline">Promoting detection of adverse drug events and patterns of overuse and underuse of prescription drugs.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="HCA868798B1FD4B9EBFC6004814A73037"><enum>(VI)</enum><text display-inline="yes-display-inline">Developing a medication action plan which may alter the medication regimen, when permitted by the State licensing authority. This information should be provided to, or accessible by, the primary health care provider of the enrollee.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H132BDFA233604C9489006806BECA3564"><enum>(VII)</enum><text display-inline="yes-display-inline">Monitoring and evaluating the response to therapy and evaluating the safety and effectiveness of the therapy, which may include laboratory assessment.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H3860EF57DF494CE2A0DFA7DB04135774"><enum>(VIII)</enum><text display-inline="yes-display-inline">Providing disease-specific medication therapy management services when appropriate.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="HBF881863D0DD4AE689EAF2A0AADAD46F"><enum>(IX)</enum><text display-inline="yes-display-inline">Coordinating and integrating medication therapy management services within the broader scope of health care management services being provided to each enrollee.</text> </subclause></clause> <clause commented="no" display-inline="no-display-inline" id="H5A561E1E1A3040C3A85635E942440069"><enum>(ii)</enum><header>Delivery of services</header> <subclause commented="no" display-inline="no-display-inline" id="H5447B1053619494A80D962F8C9B702DE"><enum>(I)</enum><header>Personal delivery</header><text display-inline="yes-display-inline">To the extent feasible, face-to-face interaction shall be the preferred method of delivery of medication therapy management services.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H30671B27745B475400D437937FD10843"><enum>(II)</enum><header>Individualized</header><text display-inline="yes-display-inline">Such services shall be patient-specific and individualized and shall be provided directly to the patient by a pharmacist or other health care provider with advanced training in medication management.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H7E7E72D1B1774F65B76B375BC90044F4"><enum>(III)</enum><header>Distinct from other activities</header><text display-inline="yes-display-inline">Such services shall be distinct from any activities related to formulary development and use, generalized patient education and information activities, and any population-focused quality assurance measures for medication use.</text> </subclause></clause> <clause commented="no" display-inline="no-display-inline" id="H0CE0B28A297049C8B85D376344DA04F1"><enum>(iii)</enum><header>Opportunity to identify patients in need of medication therapy management services</header><text display-inline="yes-display-inline">The program shall provide opportunities for health care providers to identify patients who should receive medication therapy management services.</text> </clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H29DE01F6D95B453BA19D28BF1FB178C"><enum>(C)</enum><text display-inline="yes-display-inline">by striking subparagraph (E) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="HAA40FD2379B7449FBB80D9856359EBCB" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="H008DB37276D8403CA43FC439EFD0A2E9"><enum>(E)</enum><header>Pharmacy fees</header> <clause commented="no" display-inline="no-display-inline" id="H182CFDB5D9D94E3DA77300F57D0588D8"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The PDP sponsor of a prescription drug plan shall pay pharmacists and others providing services under the medication therapy management program under this paragraph based on the time and intensity of services provided to enrollees.</text> </clause> <clause commented="no" display-inline="no-display-inline" id="HE4CA355E5B6644ED8CF309DF71E7A2"><enum>(ii)</enum><header>Submission along with plan information</header><text display-inline="yes-display-inline">Each such sponsor shall disclose to the Secretary upon request the amount of any such payments and shall submit a description of how such payments are calculated along with the information submitted under section 1860D–11(b). Such description shall be submitted at the same time and in a similar manner to the manner in which the information described in paragraph (2) of such section is submitted.</text> </clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HC439BA1FD3F246F59B3FC953C6DBD66"><enum>(D)</enum><text display-inline="yes-display-inline">by adding at the end the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="HA36927CDB146447092250236B698E8D" style="OLC"> <subparagraph commented="no" display-inline="no-display-inline" id="HA50B282ADB0148228DB9FBC3002BC2C6"><enum>(F)</enum><header>Pharmacy access requirements</header><text display-inline="yes-display-inline">The PDP sponsor of a prescription drug plan shall secure the participation in its network of a sufficient number of retail pharmacies to assure that enrollees have the option of obtaining services under the medication therapy management program under this paragraph directly from community-based retail pharmacies.</text> </subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HA6339306C8B24E87B18777EA261B6E65"><enum>(2)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this subsection shall apply to medication therapy management services provided on or after January 1, 2008.</text> </paragraph></subsection> <subsection commented="no" display-inline="no-display-inline" id="H363AC2C18091461C8953033DE83499B0"><enum>(b)</enum><header>Medication therapy management demonstration program</header><text display-inline="yes-display-inline">Section 1860D–4(c) of the Social Security Act (42 U.S.C.1395w–104(c)) is amended by adding at the end the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H75B5ABAE613B43979D61CAC4D1CAAA21" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="H261C12A8DC524BF8BB2330F0A898C900"><enum>(3)</enum><header>Community-based medication therapy management demonstration program</header> <subparagraph commented="no" display-inline="no-display-inline" id="HF4E9271872274B51A2213EBB00538050"><enum>(A)</enum><header>Establishment</header> <clause commented="no" display-inline="no-display-inline" id="H60F9571F27B84B30A7492385A5412C1E"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">By not later than January 1, 2008, the Secretary shall establish a 2-year demonstration program, based on the recommendations of the Best Practices Commission established under subparagraph (B), with both PDP sponsors of prescription drug plans and Medicare Advantage Organizations offering MA–PD plans, to examine the impact of medication therapy management furnished by a pharmacist in a community-based or ambulatory-based setting on quality of care, spending under this part, and patient health.</text> </clause> <clause commented="no" display-inline="no-display-inline" id="H557510A2190148C3AEF5A84FF477D92"><enum>(ii)</enum><header>Sites</header> <subclause commented="no" display-inline="no-display-inline" id="HDD1FC9F5DDCF4068A6A66869DC00BD7E"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to subclause (II), the Secretary shall designate not less than 10 PDP sponsors of prescription drug plans or Medicare Advantage organizations offering MA–PD plans, none of which provide prescription drug coverage under such plans in the same PDP or MA region, respectively, to conduct the demonstration program under this paragraph.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H449A1F3ED7294F609940B5DB0046F1B2"><enum>(II)</enum><header>Designation consistent with recommendations of best practices commission</header><text display-inline="yes-display-inline">The Secretary shall ensure that the designation of sites under subclause (I) is consistent with the recommendations of the Best Practices Commission under subparagraph (B)(ii).</text> </subclause></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HE55A49E761CB42D1B69EEA86ABAE5453"><enum>(B)</enum><header>Best practices commission</header> <clause commented="no" display-inline="no-display-inline" id="H30ED114273A8488CB7F95F2EE6FBDC00"><enum>(i)</enum><header>Establishment</header><text display-inline="yes-display-inline">The Secretary shall establish a Best Practices Commission composed of representatives from pharmacy organizations, health care organizations, beneficiary advocates, chronic disease groups, and other stakeholders (as determined appropriate by the Secretary) for the purpose of developing a best practices model for medication therapy management.</text> </clause> <clause commented="no" display-inline="no-display-inline" id="HA18678245BB8460C002135006B48B0A4"><enum>(ii)</enum><header>Recommendations</header><text display-inline="yes-display-inline">The Commission shall submit to the Secretary recommendations on the following:</text> <subclause commented="no" display-inline="no-display-inline" id="H61976AA872814860BFB9013702851024"><enum>(I)</enum><text display-inline="yes-display-inline">The minimum number of enrollees that should be included in the demonstration program, and at each demonstration program site, to determine the impact of medication therapy management furnished by a pharmacist in a community-based setting on quality of care, spending under this part, and patient health.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="H8B275012E19347ACB544869C88F17948"><enum>(II)</enum><text display-inline="yes-display-inline">The number of urban and rural sites that should be included in the demonstration program to ensure that prescription drug plans and MA–PD plans offered in urban and rural areas are adequately represented.</text> </subclause> <subclause commented="no" display-inline="no-display-inline" id="HF1124444467046CCA3511138A0DC24C"><enum>(III)</enum><text display-inline="yes-display-inline">A best practices model for medication therapy management to be implemented under the demonstration program under this paragraph.</text> </subclause></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H2F2D025DA76B4913B9A0314D128B5B70"><enum>(C)</enum><header>Reports</header> <clause commented="no" display-inline="no-display-inline" id="H4E8876B15D7144D486582D23D45670D2"><enum>(i)</enum><header>Interim report</header><text display-inline="yes-display-inline">Not later than 1 year after the commencement of the demonstration program, the Secretary shall submit to Congress an interim report on such program.</text> </clause> <clause commented="no" display-inline="no-display-inline" id="HF17608B9E30C4CC39E60328F34B28E48"><enum>(ii)</enum><header>Final report</header><text display-inline="yes-display-inline">Not later than 6 months after the completion of the demonstration program, the Secretary shall submit to Congress a final report on such program, together with recommendations for such legislation and administrative action as the Secretary determines appropriate.</text> </clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H0BFC361FCF304AF6B326E048AAF70290"><enum>(D)</enum><header>Waiver authority</header><text display-inline="yes-display-inline">The Secretary may waive such requirements of titles XI and XVIII as may be necessary for the purpose of carrying out the demonstration program under this paragraph.</text> </subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section>