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<bill bill-stage="Introduced-in-Senate" bill-type="olc" dms-id="A1" public-private="public" star-print="no-star-print">

	<form display="yes">

		<distribution-code display="yes">II</distribution-code>

		<congress display="yes">109th CONGRESS</congress>

		<session display="yes">2d Session</session>

		<legis-num display="yes">S. 2563</legis-num>

		<current-chamber display="yes">IN THE SENATE OF THE UNITED

		  STATES</current-chamber>

		<action display="yes">

			<action-date date="20060406">April 6, 2006</action-date>

			<action-desc><sponsor name-id="S136">Mr. Cochran</sponsor> (for

			 himself, <cosponsor name-id="S254">Mr. Enzi</cosponsor>, and

			 <cosponsor name-id="S286">Mr. Talent</cosponsor>) introduced the following

			 bill; which was read twice and referred to the

			 <committee-name committee-id="SSFI00">Committee on

			 Finance</committee-name></action-desc>

		</action>

		<legis-type display="yes">A BILL</legis-type>

		<official-title display="yes">To amend title XVIII of the Social Security

		  Act to require prompt payment to pharmacies under part D, to restrict pharmacy

		  co-branding on prescription drug cards issued under such part, and to provide

		  guidelines for Medication Therapy Management Services programs offered by

		  prescription drug plans and MA–PD plans under such part.</official-title>

	</form>

	<legis-body display-enacting-clause="yes-display-enacting-clause" style="OLC">

		<section commented="no" display-inline="no-display-inline" id="S1" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the

			 <quote><short-title>Pharmacist Access and Recognition in

			 Medicare (PhARM) Act of 2006</short-title></quote>.</text>

		</section><section commented="no" display-inline="no-display-inline" id="IDd2dd490e14e540cd8708a01f3720a4d3" section-type="subsequent-section"><enum>2.</enum><header>Prompt payment by

			 prescription drug plans and MA–PD plans under part D</header>

			<subsection commented="no" display-inline="no-display-inline" id="ID459b87d037e144b5a884dd57519f7c25"><enum>(a)</enum><header>Prompt payment

			 by prescription drug plans</header><text display-inline="yes-display-inline">Section 1860D–12(b) of the Social Security

			 Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following new

			 paragraph:</text>

				<quoted-block display-inline="no-display-inline" id="idE7C3B4737A1142D39369D1D3FF8D2733" style="OLC">

					<paragraph commented="no" display-inline="no-display-inline" id="ID4b34b72624d94f82956de77df2a617b3"><enum>(4)</enum><header>Prompt payment

				of clean claims</header>

						<subparagraph commented="no" display-inline="no-display-inline" id="ID5de4166193e44396a94523ad0e6c949e"><enum>(A)</enum><header>Prompt

				payment</header>

							<clause commented="no" display-inline="no-display-inline" id="ID8bba8f006f7f4e3484d5271f4fa6e0d4"><enum>(i)</enum><header>In

				general</header><text display-inline="yes-display-inline">Each contract entered

				into with a PDP sponsor under this section 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>

							</clause><clause commented="no" display-inline="no-display-inline" id="IDfd7b2fb6743a43f4a0eea1e36f678d3d"><enum>(ii)</enum><header>Clean claim

				defined</header><text display-inline="yes-display-inline">In this paragraph,

				the term <term>clean claim</term> means a claim 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></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf2e49c52e4244a3bb0c80be000042d39"><enum>(B)</enum><header>Applicable

				number of calendar days defined</header><text display-inline="yes-display-inline">In this paragraph, the term

				<term>applicable number of calendar days</term> means—</text>

							<clause commented="no" display-inline="no-display-inline" id="ID894b363c806a4eeab8f0aad9db72aa8a"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to claims submitted

				electronically, 14 days; and</text>

							</clause><clause commented="no" display-inline="no-display-inline" id="ID0091a51fab9c482d87d50a86cca4ee8d"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to claims submitted otherwise,

				30 days.</text>

							</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe33946998b45490887b7ffa3dafc32ba"><enum>(C)</enum><header>Interest

				payment</header><text display-inline="yes-display-inline">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 section 3902(a) 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 commented="no" display-inline="no-display-inline" id="ID482e5cacc76548858db801aba66241fb"><enum>(D)</enum><header>Procedures

				involving claims</header>

							<clause commented="no" display-inline="no-display-inline" id="ID9146811fbf3b43d9854f3c2277373d0a"><enum>(i)</enum><header>In

				general</header><text display-inline="yes-display-inline">A contract entered

				into with a PDP sponsor under this section with respect to a prescription drug

				plan offered by such sponsor shall provide that, not later than 10 days after

				the date on which a clean claim is submitted, the PDP sponsor shall provide the

				claimant with a notice that acknowledges receipt of the claim by such sponsor.

				Such notice shall be considered to have been provided on the date on which the

				notice is mailed or electronically transferred.</text>

							</clause><clause commented="no" display-inline="no-display-inline" id="ID7e064ea015434b669651a9ba3bb85d13"><enum>(ii)</enum><header>Claim deemed

				to be clean</header><text display-inline="yes-display-inline">A claim is deemed

				to be a clean claim if the PDP sponsor involved does not provide notice to the

				claimant of any deficiency in the claim within 10 days of the date on which the

				claim is submitted.</text>

							</clause><clause commented="no" display-inline="no-display-inline" id="IDa065dde9556b4690adbe7dd81753d7f3"><enum>(iii)</enum><header>Claim

				determined to not be a clean claim</header>

								<subclause commented="no" display-inline="no-display-inline" id="ID0d64c3ef7bc8457e8423793c4bb0400b"><enum>(I)</enum><header>In

				general</header><text display-inline="yes-display-inline">If a PDP sponsor

				determines that a submitted claim is not a clean claim, the PDP sponsor shall,

				not later than the end of the period described in clause (ii), notify the

				claimant of such determination. Such notification shall specify all defects or

				improprieties in the claim and shall list all additional information or

				documents necessary for the proper processing and payment of the claim.</text>

								</subclause><subclause commented="no" display-inline="no-display-inline" id="ID9d786fbc697044819d99383dd79d9260"><enum>(II)</enum><header>Determination

				after submission of additional information</header><text display-inline="yes-display-inline">A claim is deemed to be a clean claim under

				this paragraph if the PDP sponsor involved does not provide notice to the

				claimant of any defect or impropriety in the claim within 10 days of the date

				on which additional information is received under subclause (I).</text>

								</subclause><subclause commented="no" display-inline="no-display-inline" id="ID45031a34faf848cd80e93292029016ac"><enum>(III)</enum><header>Payment of

				clean portion of a claim</header><text display-inline="yes-display-inline">A

				PDP sponsor shall pay any portion of a claim 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>

								</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDeb1c4d0527dc4a53a8585ee0e4874c35"><enum>(iv)</enum><header>Obligation to

				pay</header><text display-inline="yes-display-inline">A claim submitted to a

				PDP sponsor that is not paid or contested by the provider within the applicable

				number of 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 commented="no" display-inline="no-display-inline" id="ID7386482fe8b74c8c9b0aa21dbd03c582"><enum>(v)</enum><header>Date of payment

				of claim</header><text display-inline="yes-display-inline">Payment of a clean

				claim under such subparagraph is considered to have been made on the date on

				which full payment is received by the provider.</text>

							</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe6cc5b970a334475bcadac2a60bfb432"><enum>(E)</enum><header>Electronic

				transfer of funds</header><text display-inline="yes-display-inline">A PDP

				sponsor shall pay all clean claims submitted electronically by electronic

				transfer of

				funds.</text>

						</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>

			</subsection><subsection commented="no" display-inline="no-display-inline" id="ID59cc1f8d098e4d81afae746fd39e1dfe"><enum>(b)</enum><header>Prompt payment

			 by MA–PD Plans</header><text display-inline="yes-display-inline">Section

			 1857(f) of the Social Security Act (42 U.S.C. 1395w–27(f)) is amended by adding

			 at the end the following new paragraph:</text>

				<quoted-block display-inline="no-display-inline" id="idD13A012205274E73B29757BF6191908C" style="OLC">

					<paragraph commented="no" display-inline="no-display-inline" id="ID0f7de7a85a864473a0881c417f7ce39f"><enum>(3)</enum><header>Incorporation

				of certain prescription drug plan contract requirements</header><text display-inline="yes-display-inline">The provisions of section 1860D–12(b)(4)

				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 commented="no" display-inline="no-display-inline" id="ID4578f1920031447c9ccf3d30adcd5f78"><enum>(c)</enum><header>Effective

			 date</header><text display-inline="yes-display-inline">The amendments made by

			 this section shall apply to contracts entered into or renewed on or after the

			 date that is 90 days after the date of the enactment of this Act.</text>

			</subsection></section><section commented="no" display-inline="no-display-inline" id="ID708dc677ad32405d94cf54eb24859438" section-type="subsequent-section"><enum>3.</enum><header>Restriction on

			 pharmacy co-branding on medicare prescription drug cards issued by prescription

			 drug plans and MA–PD Plans</header>

			<subsection commented="no" display-inline="no-display-inline" id="id2AB86E7A86614C9797E5481CAE316937"><enum>(a)</enum><header>In

			 general</header><text display-inline="yes-display-inline">Section 1860D–4 of

			 the Social Security Act (42 U.S.C. 1395w–104) is amended—</text>

				<paragraph commented="no" display-inline="no-display-inline" id="idDA3A9192C6604A42B59C766E0891D4F8"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)(2)(A), by striking

			 <quote>The PDP sponsor</quote> and inserting <quote>Subject to subsection (l),

			 the PDP sponsor</quote>; and</text>

				</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE5BC28F13E8F4E6786D3CACD1FF6D505"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following new

			 subsection:</text>

					<quoted-block display-inline="no-display-inline" id="id534A16AA79BA4255BD4F5E3CA96D333A" style="OLC">

						<subsection commented="no" display-inline="no-display-inline" id="id8BA9F44C7DB84D18BC057F3DE564971A"><enum>(l)</enum><header>Co-branding

				prohibited</header><text display-inline="yes-display-inline">A card that is

				issued under subsection (b)(2)(A) for use under a prescription drug plan

				offered by a PDP sponsor shall not display the name, brand, or trademark of any

				pharmacy.</text>

						</subsection><after-quoted-block>.</after-quoted-block></quoted-block>

				</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id69642AFFBCEE46AC9EF1DB61AF202DA3"><enum>(b)</enum><header>Effective

			 date</header><text display-inline="yes-display-inline">The amendments made by

			 this section shall apply to cards distributed on or after the date that is 90

			 days after the date of enactment of this Act.</text>

			</subsection></section><section commented="no" display-inline="no-display-inline" id="ID0b09ea21685840f1bd7a707c430f3359" section-type="subsequent-section"><enum>4.</enum><header>Provision of

			 Medication Therapy Management Services under part D</header>

			<subsection commented="no" display-inline="no-display-inline" id="ID197070f81ff34adaaaffa7316714bfce"><enum>(a)</enum><header>Provision of

			 Medication Therapy Management Services under part D</header>

				<paragraph commented="no" display-inline="no-display-inline" id="id93A3957B351441AF987BA80B80566A10"><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="id985CCD27985843B2B5FEC34238FFB5E0"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>

						<clause commented="no" display-inline="no-display-inline" id="idFBA9CD1F83184B24AE990D1028ACA1F0"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i)—</text>

							<subclause commented="no" display-inline="no-display-inline" id="id1395044E4F9F40F3A2F4A7DBE159A94B"><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="idF517122A9B704473BB8686D2C6E8CF21"><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="id475A4E92ABD8490790015EE788C56973"><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="id67EB98BF36FA4FB9A7F64D143068D5E6" style="OLC">

								<clause commented="no" display-inline="no-display-inline" id="id51801072AA174183BD8582D666CBE5F6"><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="IDfa3f5dfb8014417493fc710750a5469a"><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="ID64f74d723a234bcb995835ed6dccbf35"><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="ID15be9e0326644a5ca994e2442555542c"><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="idEB3C9569298C4A22A4962BE2D62E1AFF"><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="idF370F01B58DF46149064B3F0ABA1D73C" style="OLC">

							<subparagraph commented="no" display-inline="no-display-inline" id="id50834C418D5148B18B2C7EB4CCC58FDB"><enum>(B)</enum><header>Elements</header>

								<clause commented="no" display-inline="no-display-inline" id="id17F9BB65053A437A99BBAD3416076F7F"><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="ID18ec2104d4a949fe88b19abff4e0368f"><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="ID03a20ce27283471497c2ae6a7f0669b3"><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="id616C992DF86E4D36B513496D1B89BBD5"><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="id4F53E55881C54DE2B484D6750824D5D5"><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="id65A919BDA4DC457BAC12BE1142081058"><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="IDc42565915b39468eaebd06a52f4d2fea"><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="ID1cb8b56e50954143bc3a314b4e460fd4"><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="IDb11416ed3d1644b38a77d92409a2dbd1"><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="IDe96d59a4c3b0419d863e52bbaf9ed1fa"><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="id6862AB7AF4EE47D4B1898A6721F8CC3E"><enum>(ii)</enum><header>Delivery of

				services</header>

									<subclause commented="no" display-inline="no-display-inline" id="id2ACD056345754A70952EDDE558634D85"><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="id651E2A23E08743D3B71998745D112773"><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="idDDB19560721D4869A753CF2BBA7A0D60"><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="idDC75C584EEBC42639C1703A9B43E465C"><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="id6E1E76972E2649E9BEF761538827BEC2"><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="idFC40A579A38F4E44B23015F5A4C3EEE4" style="OLC">

							<subparagraph commented="no" display-inline="no-display-inline" id="idD7D46011849B44808C6F8ED9263BF9D4"><enum>(E)</enum><header>Pharmacy

				fees</header>

								<clause commented="no" display-inline="no-display-inline" id="id4A3E69224ADB46D5AEB0CA2E30821242"><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="id1D6E00104CFE464BBCCAB65DBD0D910B"><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="id14EAADE8AD624B2D900F6A5DBE029968"><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="id6FA0364ECAFF41629BA317F364A4002C" style="OLC">

							<subparagraph commented="no" display-inline="no-display-inline" id="id8DE108E1D7DC4118A05C106C6CC7BEBB"><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="id4250127859D943A09262871FC46E7550"><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="id58F7B30923EC42B08D14B50890672F67"><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="id03CA5C8DE64440A2A7BF38C25678BE0E" style="OLC">

					<paragraph commented="no" display-inline="no-display-inline" id="idE7325660116D4ACEBFA62540751AA416"><enum>(3)</enum><header>Community-based

				medication therapy management demonstration program</header>

						<subparagraph commented="no" display-inline="no-display-inline" id="id9CB654AF741D430888017862F025C37E"><enum>(A)</enum><header>Establishment</header>

							<clause commented="no" display-inline="no-display-inline" id="id52E99BF200A5448999449F868D9D4A30"><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="id46CB19D67A9649979C025F10028CE0CB"><enum>(ii)</enum><header>Sites</header>

								<subclause commented="no" display-inline="no-display-inline" id="id506FA10FEEC841A1B07EAB589F501F5D"><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="id43BB857FDE614FF4888D085C980097ED"><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="idD746D5723EA7433A891315FD476DA922"><enum>(B)</enum><header>Best practices

				commission</header>

							<clause commented="no" display-inline="no-display-inline" id="idC089A9E85D094C029595C7D89661B7F5"><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="idB48CD7977DE24A318FB0FA9108AED051"><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="idFC1ABF25395B47A3BF407D904868DCAB"><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="id0CE65B965BEE4393B0660C16D2111061"><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="idDB544251E35D483E8D5B7C4D2BBF058E"><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="id18C6AB81061649368516555E61EF6D38"><enum>(C)</enum><header>Reports</header>

							<clause commented="no" display-inline="no-display-inline" id="id1E655CD8558D454DB2FC883A7619216D"><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="id80461D4A797340A3A1E0FE826A3084DD"><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="idFF9F10DEA4464581BCA5D31C27FA376B"><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></legis-body>

</bill>

