,i #aacth ,,congress #ast ,session ,h4 ,r4 #ibh ,,in ,,the ,,house ,,of ,,representatives ,february #bh1 #bjac ,ms4 ,schakowsky 7for herself1 ,mr4 ,farr1 ,ms4 ,lee of ,california1 ,mr4 ,george ,miller of ,california1 and ,ms4 ,pingree of ,maine7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 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 deliver a meaningful benefit and lower prescription drug prices under the ,medicare ,program4 #a4 ,short title ,this ,act may be cited as the ,medicare ,prescription ,drug ,savings and ,choice ,act of #bjac4 #b4 ,establishment of ,medicare operated prescription drug plan option 7a7 ,in general ,subpart #b of part ,d of title ,,xviii of the ,social ,security ,act is amended by inserting after section #ahfj;,d-#aa 7#db ,u4,s4,c4 #aciew-#aaa7 the following new section3 #ahfj;,d-#aa;,a4 ,medicare operated prescription drug plan option 7a7 ,in general ,notwithstanding any other provision of this part1 for each year 7beginning with #bjab71 in addition to any plans offered under section #ahfj;,d-#aa1 the ,secretary shall offer one or more ,medicare operated prescription drug plans 7as defined in subsection 7c77 with a service area that consists of the entire ,united ,states and shall enter into negotiations in accordance with subsection 7b7 with pharmaceutical manufacturers to reduce the purchase cost of covered part ,d drugs for eligible part ,d individuals who enroll in such a plan4 7b7 ,negotiations ,notwithstanding section #ahfj;,d-#aa7;i71 for purposes of offering a ,medicare operated prescription drug plan under this section1 the ,secretary shall negotiate with pharmaceutical manufacturers with respect to the purchase price of covered part ,d drugs in a ,medicare operated prescription drug plan 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 physician4 ,to the extent practicable and consistent with the previous sentence1 the ,secretary shall implement strategies similar to those used by other ,federal purchasers of prescription drugs1 and other strategies1 including the use of a formulary and formulary incentives in subsection 7e71 to reduce the purchase cost of covered part ,d drugs4 7c7 ,medicare operated prescription drug plan defined ,for purposes of this part1 the term ,medicare operated prescription drug plan means a prescription drug plan that offers qualified prescription drug coverage and access to negotiated prices described in section #ahfj;,d-#b7;a77#a77;,a74 ,such a plan may offer supplemental prescription drug coverage in the same manner as other qualified prescription drug coverage offered by other prescription drug plans4 7d7 ,monthly beneficiary premium 7#a7 ,qualified prescription drug coverage ,the monthly beneficiary premium for qualified prescription drug coverage and access to negotiated prices described in section #ahfj;,d-#b7;a77#a77;,a7 to be charged under a ,medicare operated prescription drug plan shall be uniform nationally4 ,such premium for months in #bjad and each succeeding year shall be based on the average monthly per capita actuarial cost of offering the ,medicare operated prescription drug plan for the year involved1 including administrative expenses4 7#b7 ,supplemental prescription drug coverage ,insofar as a ,medicare operated prescription drug plan offers supplemental prescription drug coverage1 the ,secretary may adjust the amount of the premium charged under paragraph 7#a74 7e7 ,use of a formulary and formulary incentives 7#a7 ,in general ,with respect to the operation of a ,medicare operated prescription drug plan1 the ,secretary shall establish and apply a formulary 7and may include formulary incentives described in paragraph 7#b77;,c77ii77 in accordance with this subsection in order to-- 7,a7 increase patient safety2 7,b7 increase appropriate use and reduce inappropriate use of drugs2 and 7,c7 reward value4 7#b7 ,development of initial formulary 7,a7 ,in general ,in selecting covered part ,d drugs for inclusion in a formulary1 the ,secretary shall consider clinical benefit and price4 7,b7 ,role of ,,ahrq ,the ,director of the ,agency for ,healthcare ,research and ,quality shall be responsible for assessing the clinical benefit of covered part ,d drugs and making recommendations to the ,secretary regarding which drugs should be included in the formulary4 ,in conducting such assessments and making such recommendations1 the ,director shall-- 7i7 consider safety concerns including those identified by the ,federal ,food and ,drug ,administration2 7ii7 use available data and evaluations1 with priority given to randomized controlled trials1 to examine clinical effectiveness1 comparative effectiveness1 safety1 and enhanced compliance with a drug regimen2 7iii7 use the same classes of drugs developed by ,united ,states ,pharmacopeia for this part2 7iv7 consider evaluations made by-- 7,i7 the ,director under section #ajac of ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc2 7,,ii7 other ,federal entities1 such as the ,secretary of ,veterans ,affairs2 and 7,,iii7 other private and public entities1 such as the ,drug ,effectiveness ,review ,project and ,medicaid programs2 and 7v7 recommend to the ,secretary-- 7,i7 those drugs in a class that provide a greater clinical benefit1 including fewer safety concerns or less risk of side-effects1 than another drug in the same class that should be included in the formulary2 7,,ii7 those drugs in a class that provide less clinical benefit1 including greater safety concerns or a greater risk of side-effects1 than another drug in the same class that should be excluded from the formulary2 and 7,,iii7 drugs in a class with same or similar clinical benefit for which it would be appropriate for the ,secretary to competitively bid 7or negotiate7 for placement on the formulary4 7,c7 ,consideration of ,,ahrq recommendations 7i7 ,in general ,the ,secretary1 after taking into consideration the recommendations under subparagraph 7,b77v71 shall establish a formulary1 and formulary incentives1 to encourage use of covered part ,d drugs that-- 7,i7 have a lower cost and provide a greater clinical benefit than other drugs2 7,,ii7 have a lower cost than other drugs with same or similar clinical benefit2 and 7,,iii7 drugs that have the same cost but provide greater clinical benefit than other drugs4 7ii7 ,formulary incentives ,the formulary incentives under clause 7i7 may be in the form of one or more of the following3 7,i7 ,tiered copayments4 7,,ii7 ,reference pricing4 7,,iii7 ,prior authorization4 7,,iv7 ,step therapy4 7,v7 ,medication therapy management4 7,,vi7 ,generic drug substitution4 7iii7 ,flexibility ,in applying such formulary incentives the ,secretary may decide not to impose any cost-sharing for a covered part ,d drug for which-- 7,i7 the elimination of cost sharing would be expected to increase compliance with a drug regimen2 and 7,,ii7 compliance would be expected to produce savings under part ,a or ,b or both4 7#c7 ,limitations on formulary ,in any formulary established under this subsection1 the formulary may not be changed during a year1 except-- 7,a7 to add a generic version of a covered part ,d drug that entered the market2 7,b7 to remove such a drug for which a safety problem is found2 and 7,c7 to add a drug that the ,secretary identifies as a drug which treats a condition for which there has not previously been a treatment option or for which a clear and significant benefit has been demonstrated over other covered part ,d drugs4 7#d7 ,adding drugs to the initial formulary 7,a7 ,use of advisory committee ,the ,secretary shall establish and appoint an advisory committee 7in this paragraph referred to as the advisory committee7-- 7i7 to review petitions from drug manufacturers1 health care provider organizations1 patient groups1 and other entities for inclusion of a drug in1 or other changes to1 such formulary2 and 7ii7 to recommend any changes to the formulary established under this subsection4 7,b7 ,composition ,the advisory committee shall be composed of #i members and shall include representatives of physicians1 pharmacists1 and consumers and others with expertise in evaluating prescription drugs4 ,the ,secretary shall select members based on their knowledge of pharmaceuticals and the ,medicare population4 ,members shall be deemed to be special ,government employees for purposes of applying the conflict of interest provisions under section #bjh of title #ah1 ,united ,states ,code1 and no waiver of such provisions for such a member shall be permitted4 7,c7 ,consultation ,the advisory committee shall consult1 as necessary1 with physicians who are specialists in treating the disease for which a drug is being considered4 7,d7 ,request for studies ,the advisory committee may request the ,agency for ,healthcare ,research and ,quality or an academic or research institution to study and make a report on a petition described in subparagraph 7,a77ii7 in order to assess-- 7i7 clinical effectiveness2 7ii7 comparative effectiveness2 7iii7 safety2 and 7iv7 enhanced compliance with a drug regimen4 7,e7 ,recommendations ,the advisory committee shall make recommendations to the ,secretary regarding-- 7i7 whether a covered part ,d drug is found to provide a greater clinical benefit1 including fewer safety concerns or less risk of side-effects1 than another drug in the same class that is currently included in the formulary and should be included in the formulary2 7ii7 whether a covered part ,d drug is found to provide less clinical benefit1 including greater safety concerns or a greater risk of side-effects1 than another drug in the same class that is currently included in the formulary and should not be included in the formulary2 and 7iii7 whether a covered part ,d drug has the same or similar clinical benefit to a drug in the same class that is currently included in the formulary and whether the drug should be included in the formulary4 7,f7 ,limitations on review of manufacturer petitions ,the advisory committee shall not review a petition of a drug manufacturer under subparagraph 7,a77ii7 with respect to a covered part ,d drug unless the petition is accompanied by the following3 7i7 ,raw data from clinical trials on the safety and effectiveness of the drug4 7ii7 ,any data from clinical trials conducted using active controls on the drug or drugs that are the current standard of care4 7iii7 ,any available data on comparative effectiveness of the drug4 7iv7 ,any other information the ,secretary requires for the advisory committee to complete its review4 7,g7 ,response to recommendations ,the ,secretary shall review the recommendations of the advisory committee and if the ,secretary accepts such recommendations the ,secretary shall modify the formulary established under this subsection accordingly4 ,nothing in this section shall preclude the ,secretary from adding to the formulary a drug for which the ,director of the ,agency for ,healthcare ,research and ,quality or the advisory committee has not made a recommendation4 7,h7 ,notice of changes ,the ,secretary shall provide timely notice to beneficiaries and health professionals about changes to the formulary or formulary incentives4 7f7 ,informing beneficiaries ,the ,secretary shall take steps to inform beneficiaries about the availability of a ,medicare operated drug plan or plans including providing information in the annual handbook distributed to all beneficiaries and adding information to the official public ,medicare ,web site related to prescription drug coverage available through this part4 7g7 ,application of all other requirements for prescription drug plans ,except as specifically provided in this section1 any ,medicare operated drug plan shall meet the same requirements as apply to any other prescription drug plan1 including the requirements of section #ahfj;,d-#d7;b77#a7 relating to assuring pharmacy access74 4 7b7 ,conforming amendments 7#a7 ,section #ahfj;,d-#c7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajc7;a77 is amended by adding at the end the following new paragraph3 7#d7 ,availability of the medicare operated prescription drug plan ,a ,medicare operated prescription drug plan 7as defined in section #ahfj;,d-#aa;,a7c77 shall be offered nationally in accordance with section #ahfj;,d-#aa;,a4 4 7#b7 7,a7 ,section #ahfj;,d-#c of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajc7 is amended by adding at the end the following new subsection3 7c7 ,provisions only applicable in #bjjf through #bjac ,the provisions of this section shall only apply with respect to #bjjf through #bjac4 4 7,b7 ,section #ahfj;,d-#aa7;g7 of such ,act 7#db ,u4,s4,c4 #aciew-#aaa7;g77 is amended by adding at the end the following new paragraph3 7#h7 ,no authority for fallback plans after #bjac ,a fallback prescription drug plan shall not be available after ,december #ca1 #bjac4 4 7#c7 ,section #ahfj;,d-#ac7;c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aac7;c77#c77 is amended-- 7,a7 in the heading1 by inserting and ,medicare operated prescription drug plans after ,fallback plans2 and 7,b7 by inserting or a ,medicare operated prescription drug plan after a fallback prescription drug plan4 7#d7 ,section #ahfj;,d-#af7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4#aciew-#aaf7;b77#a77 is amended-- 7,a7 in subparagraph 7,c71 by striking and after the semicolon at the end2 7,b7 in subparagraph 7,d71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new subparagraph3 7,e7 payments for expenses incurred with respect to the operation of ,medicare operated prescription drug plans under section #ahfj;,d-#aa;,a4 4 7#e7 ,section #ahfj;,d-#da7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77 is amended by adding at the end the following new paragraph3 7#ai7 ,medicare operated prescription drug plan ,the term ,medicare operated prescription drug plan has the meaning given such term in section #ahfj;,d-#aa;,a7c74 4 #c4 ,improved appeals process under the ,medicare operated prescription drug plan ,section #ahfj;,d-#d7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acjew-#ajd7;h77 is amended by adding at the end the following new paragraph3 7#d7 ,appeals process for ,medicare operated prescription drug plan 7,a7 ,in general ,the ,secretary shall develop a well-defined process for appeals for denials of benefits under this part under the ,medicare operated prescription drug plan4 ,such process shall be efficient1 impose minimal administrative burdens1 and ensure the timely procurement of non-formulary drugs or exemption from formulary incentives when medically necessary4 ,medical necessity shall be based on professional medical judgment1 the medical condition of the beneficiary1 and other medical evidence4 ,such appeals process shall include-- 7i7 an initial review and determination made by the ,secretary2 and 7ii7 for appeals denied during the initial review and determination1 the option of an external review and determination by an independent entity selected by the ,secretary4 7,b7 ,consultation in development of process ,in developing the appeals process under subparagraph 7,a71 the ,secretary shall consult with consumer and patient groups1 as well as other key stakeholders to ensure the goals described in subparagraph 7,a7 are achieved4 4