,i #aacth ,,congress #ast ,session ,h4 ,r4 #ccib ,,in ,,the ,,house ,,of ,,representatives ,october #cj1 #bjac,mr4 ,bilirakis 7for himself and ,mr4 ,ben ,ray ,lujn of ,new ,mexico7 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 provide for a ,,pdp safety program to prevent fraud and abuse in the dispensing of controlled substances under part ,d of the ,medicare program1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,medicare ,part ,d ,patient ,safety and ,drug ,abuse ,prevention ,act of #bjac4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,establishing ,,pdp safety program to prevent fraud and abuse in ,medicare prescription drug plans4,sec4 #c4 ,part ,d suspension of claims payment4,sec4 #d4 ,improving activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs74,sec4 #e4 ,requiring e-prescribing for coverage of covered part ,d controlled substances4 #b4 ,establishing ,,pdp safety program to prevent fraud and abuse in ,medicare prescription drug plans 7a7 ,,pdp safety program ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is amended-- 7#a7 in paragraph 7#a77;,d7-- 7,a7 by inserting 1 designed to after program2 and 7,b7 by inserting 1 that includes the procedures described in paragraph 7#d7 after waste2 and 7#b7 by adding at the end the following3 7#d7 ,safe pharmacy access program 7,a7 ,,pdp sponsor procedures ,a ,,pdp sponsor 7or an ,,ma organization offering an ,,ma-,,pd plan7 shall have in place procedures designed-- 7i7 to identify an individual who has obtained coverage for a covered part ,d drug that is a frequently abused schedule ,,ii1 ,,iii1 ,,iv1 or ,v controlled substance1 as determined in accordance with utilization guidelines established by the ,secretary and the sponsor 7or ,,ma organization71 and to notify such individuals that they have been so identified2 7ii7 to contract with pharmacies authorized to dispense such controlled substances to create a safe pharmacy network that meets the criteria specified in subparagraph 7,c72 7iii7 taking into account the location of the individual's residence 7or residences71 work site1 mobility1 and other relevant factors1 to limit coverage to schedule ,,ii1 ,,iii1 ,,iv1 or ,v controlled substances for some or all classes of covered part ,d drugs for an individual identified under clause 7i7 7or under subparagraph 7,b77 to drugs dispensed by one or more pharmacies contracted with under clause 7ii72 7iv7 to provide to the ,secretary the name1 and other information that the ,secretary may require1 of individuals so identified and of the fact of such individual's disenrollment 7if any7 from the plan of the sponsor 7or the ,,ma-,,pd plan offered by the ,,ma organization72 7v7 to provide for an appeals process whereby an individual so identified may appeal such identification on the basis that the identification was not appropriate2 7vi7 to provide for a process whereby an individual so identified may petition for the termination of such identification on the basis that the limitation on coverage is no longer necessary to prevent fraud and abuse by the individual2 and 7vii7 to provide that coverage shall be provided for a schedule ,,ii1 ,,iii1 ,,iv1 or ,v controlled substance only if it prescribed in accordance with an electronic prescribing program under subsection 7e71 except in such exceptional circumstances as the ,secretary may permit4 7,b7 ,sharing information for subsequent plan enrollments ,the ,secretary shall share information1 with respect to the identity of an individual identified under subparagraph 7,a77i7 who disenrolls from a plan under subparagraph 7,a77iv71 with a ,,pdp sponsor 7or ,,ma organization7 that subsequently enrolls such individual under another plan in order that the provisions of subparagraph 7,a77iii7 would apply under such subsequent enrollment4 7,c7 ,safe pharmacy network criteria ,the criteria specified in this subparagraph for a safe pharmacy network are the following3 7i7 ,the pharmacies in the network are able to properly monitor the usage of schedule ,,ii1 ,,iii1 ,,iv1 and ,v controlled substances4 7ii7 ,such pharmacies and network meet such other drug safety criteria as the ,secretary or the ,,pdp sponsor 7or ,,ma organization7 determines to be appropriate1 such as use of a ,state prescription drug monitoring program1 if such a program is available in the ,state4 4 7b7 ,dual eligibles ,section #ahfj;,d-#a7;b77#c77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;b77#c77;,d77 is amended by inserting 1 subject to such limits as the ,secretary may establish for individuals identified pursuant to section #ahfj;,d-#d7;c77#d77;,a77i7 after the ,secretary4 7c7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning after the date that is #h months after the date of the enactment of this ,act4 #c4 ,part ,d suspension of claims payment ,amend #ahfj;,d-#ab7;b77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#d77 is amended by adding at the end the following new subparagraph3 7,h7 ,suspension of payments pending investigation of credible allegations of fraud by pharmacies 7i7 ,in general ,a ,,pdp sponsor may suspend payments and clean claim notifications to a pharmacy pending an investigation of a credible allegation of fraud 7as defined in clause 7ii77 against the pharmacy1 unless the ,secretary determines there is a good cause not to suspend payments4 7ii7 ,credible allegation of fraud defined ,in this subparagraph1 the term credible allegation of fraud includes-- 7,i7 a complaint made on the ,medicare fraud hotline2 7,,ii7 detection of potential fraud through the analysis of claims data2 7,,iii7 detection of potential fraud through identification of inappropriate dispensing through audits1 civil false claims cases1 and law enforcement investigations2 and 7,,iv7 claims referred to ,medicare drug integrity contractors 7,m,e,d,i,cs74 7iii7 ,rule of construction ,nothing in this subparagraph shall be construed as limited the authority of a ,,pdp sponsor to conduct post-claim payment review4 4 #d4 ,improving activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7a7 ,in general ,section #ahic of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ddd7 is amended by adding at the end the following new subsection3 7j7 ,improving activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,access to ,in general ,under contracts entered into under this section 7each in this subsection referred to as a ,,medic contract7 with ,medicare drug integrity contractors 7each in this subsection referred to as a ,,medic71 the ,secretary shall authorize ,m,e,d,i,cs to directly obtain prescription and medical records from entities such as pharmacies1 ,,pdp and physicians4 7#b7 ,requirement for acknowledgment of referrals ,if a ,,pdp sponsor refers information to a ,,medic for investigation1 under the ,,medic contract the ,,medic must acknowledge receipt of the referral and must report back to the sponsor the result of the ,,medic's investigation within #de days of the date of the referral and share such results with appropriate agencies1 such as law enforcement officials and ,state licensing authority4 7#c7 ,uniform annual report criteria ,in order to assess the performance of ,m,e,d,i,cs1 the ,secretary shall develop a uniform reporting criteria for the annual reporting of the results of investigations by ,m,e,d,i,cs to the ,secretary and to ,congress4 ,each such annual report shall include information on the number of referrals for investigation made to a ,,medic1 the average time required for investigation1 the results of the investigation1 and the number of results that were referred to the ,inspector ,general of the ,department of ,health and ,human ,services and to ,state licensing officials for further investigations4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect on the date of the enactment of this ,act and shall apply as quickly as possible to ,,medic contracts1 including ,,medic contracts entered into before such date of enactment4 #e4 ,requiring e-prescribing for coverage of covered part ,d controlled substances 7a7 ,in general ,section #ahfj;,d-#d7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77 is amended by adding at the end the following3 7#g7 ,requirement of e-prescribing for controlled substances ,except in such emergent circumstances as the ,secretary may specify1 coverage shall not be provided for a covered part ,d drug under a prescription drug plan 7or under an ,,ma-,,pd plan7 for a schedule ,,ii1 ,,iii1 ,,iv1 or ,v controlled substance unless the prescription for the drug has been transmitted electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph 7#b74 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to coverage of drugs prescribed on or after ,january #a1 #bjae4