,i #aadth ,,congress #ast ,session ,h4 ,r4 #bbih ,,in ,,the ,,house ,,of ,,representatives ,may #ac1 #bjae ,mr4 ,bilirakis 7for himself1 ,mr4 ,ben ,ray ,lujn of ,new ,mexico1 and ,mr4 ,long7 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 programs to prevent prescription drug abuse under parts ,c and ,d of the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,medicare ,patient ,safety and ,drug ,abuse ,prevention ,act4 #b4 ,programs to prevent prescription drug abuse under ,medicare parts ,c and ,d 7a7 ,drug management program for at-,risk beneficiaries 7#a7 ,in general ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77 is amended by adding at the end the following3 7#e7 ,drug management program for at-risk beneficiaries 7,a7 ,authority to establish ,a ,,pdp sponsor may establish a drug management program for at-risk beneficiaries under which1 subject to subparagraph 7,b71 the ,,pdp sponsor may1 in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such ,,pdp sponsor1 limit such beneficiary's access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by a prescriber selected under subparagraph 7,d71 and dispensed for such beneficiary by a pharmacy selected under such subparagraph4 7,b7 ,requirement for notices 7i7 ,in general ,a ,,pdp sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor-- 7,i7 provides to the beneficiary an initial notice described in clause 7ii7 and a second notice described in clause 7iii72 and 7,,ii7 verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse4 7ii7 ,initial notice ,an initial notice described in this clause is a notice that provides to the beneficiary-- 7,i7 notice that the ,,pdp sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse2 7,,ii7 information describing all ,state and ,federal public health resources that are designed to address prescription drug abuse to which the beneficiary has access1 including mental health services and other counseling services2 7,,iii7 notice of1 and information about1 the right of the beneficiary to appeal such identification under subsection 7h7 and the option of an automatic escalation to external review2 7,,iv7 a request for the beneficiary to submit to the ,,pdp sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor to select under subparagraph 7,d7 in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause 7iii77,i72 7,v7 an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse1 including an explanation of the drug management program established by the ,,pdp sponsor pursuant to subparagraph 7,a72 7,,vi7 clear instructions that explain how the beneficiary can contact the ,,pdp sponsor in order to submit to the ,,pdp sponsor the preferences described in subclause 7,,iv7 and any other communications relating to the drug management program for at-risk beneficiaries established by the ,,pdp sponsor2 and 7,,vii7 contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program 7similar to the information provided by the ,secretary in other standardized notices provided to part ,d eligible individuals enrolled in prescription drug plans under this part74 7iii7 ,second notice ,a second notice described in this clause is a notice that provides to the beneficiary notice-- 7,i7 that the ,,pdp sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse2 7,,ii7 that such beneficiary is subject to the requirements of the drug management program for at-risk beneficiaries established by such ,,pdp sponsor for such plan2 7,,iii7 of the prescriber and pharmacy selected for such individual under subparagraph 7,d72 7,,iv7 of1 and information about1 the beneficiary's right to appeal such identification under subsection 7h7 and the option of an automatic escalation to external review2 7,v7 that the beneficiary can1 in the case that the beneficiary has not previously submitted to the ,,pdp sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor select under subparagraph 7,d71 submit such preferences to the ,,pdp sponsor2 and 7,,vi7 that includes clear instructions that explain how the beneficiary can contact the ,,pdp sponsor4 7iv7 ,timing of notices 7,i7 ,in general ,subject to subclause 7,,ii71 a second notice described in clause 7iii7 shall be provided to the beneficiary on a date that is not less than #fj days after an initial notice described in clause 7ii7 is provided to the beneficiary4 7,,ii7 ,exception ,in the case that the ,,pdp sponsor1 in conjunction with the ,secretary1 determines that concerns identified through rulemaking by the ,secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the ,,pdp sponsor to provide a second notice described in clause 7iii7 to the beneficiary on a date that is earlier than the date described in subclause 7,,ii71 the ,,pdp sponsor may provide such second notice on such earlier date4 7,c7 ,at-risk beneficiary for prescription drug abuse 7i7 ,in general ,for purposes of this paragraph1 the term at-risk beneficiary for prescription drug abuse means a part ,d eligible individual who is not an exempted individual described in clause 7ii7 and-- 7,i7 who is identified through the use of clinical guidelines developed by the ,secretary in consultation with ,,pdp sponsors and other stakeholders described in subsection 7f77#b77;,a72 or 7,,ii7 with respect to whom the ,,pdp sponsor of a prescription drug plan1 upon enrolling such individual in such plan1 received notice from the ,secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug abuse under the prescription drug plan in which such individual was most recently previously enrolled and such identification has not been terminated under subparagraph 7,f74 7ii7 ,exempted individual described ,an exempted individual described in this clause is an individual who-- 7,i7 an individual who receives hospice care under this title2 or 7,,ii7 an individual1 such as an individual who is a resident of a long-term care facility1 who the ,secretary elects to treat as an exempted individual for purposes of clause 7i74 7,d7 ,selection of prescribers 7i7 ,in general ,with respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor1 a ,,pdp sponsor shall1 based on the preferences submitted to the ,,pdp sponsor by the beneficiary pursuant to clauses 7ii77,,iv7 and 7iii77,v7 of subparagraph 7,b71 select-- 7,i7 one or more individuals who are authorized to prescribe frequently abused drugs 7referred to in this paragraph as prescribers7 who may write prescriptions for such drugs for such beneficiary2 and 7,,ii7 one or more pharmacies that may dispense such drugs to such beneficiary4 7ii7 ,reasonable access ,in making the selection under this subparagraph1 a ,,pdp sponsor shall ensure that the beneficiary continues to have reasonable access to drugs described in subparagraph 7,g71 taking into account geographic location1 beneficiary preference1 impact on cost-sharing1 and reasonable travel time4 7iii7 ,beneficiary preferences 7,i7 ,in general ,if an at-risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor select in response to a notice under subparagraph 7,b71 the ,,pdp sponsor shall-- 7aa7 review such preferences2 7bb7 select or change the selection of a prescriber or pharmacy for the beneficiary based on such preferences2 and 7cc7 inform the beneficiary of such selection or change of selection4 7,,ii7 ,exception ,in the case that the ,,pdp sponsor determines that a change to the selection of a prescriber or pharmacy under item 7bb7 by the ,,pdp sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary1 the ,,pdp sponsor may change the selection of a prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in subclause 7,i74 7iv7 ,confirmation ,before selecting a prescriber or pharmacy under this subparagraph1 a ,,pdp sponsor must request and receive confirmation from the prescriber or pharmacy acknowledging and accepting that the beneficiary involved is in the drug management program for at-risk beneficiaries4 7,e7 ,terminations and appeals ,the identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph1 a coverage determination made under a drug management program for at-risk beneficiaries1 and the selection of a prescriber or pharmacy under subparagraph 7,d7 with respect to such individual shall be subject to reconsideration and appeal under subsection 7h7 and the option of an automatic escalation to external review to the extent provided by the ,secretary4 7,f7 ,termination of identification 7i7 ,in general ,the ,secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph4 ,under such standards such identification shall terminate as of the earlier of-- 7,i7 the date the individual demonstrates that the individual is no longer likely1 in the absence of the restrictions under this paragraph1 to be an at-risk beneficiary for prescription drug abuse described in subparagraph 7,c77i72 or 7,,ii7 the end of such maximum period of identification as the ,secretary may specify4 7ii7 ,rule of construction ,nothing in clause 7i7 shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph 7,c77i7 after such termination on the basis of additional information on drug use occurring after the date of notice of such termination4 7,g7 ,frequently abused drug ,for purposes of this subsection1 the term frequently abused drug means a drug that is a controlled substance that the ,secretary determines to be frequently abused or diverted4 7,h7 ,data disclosure ,in the case of an at-risk beneficiary for prescription drug abuse whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a ,,pdp sponsor under this paragraph1 such ,,pdp sponsor shall disclose data1 including any necessary individually identifiable health information1 in a form and manner specified by the ,secretary1 about the decision to impose such limitations and the limitations imposed by the sponsor under this part4 7,i7 ,education ,the ,secretary shall provide education to enrollees in prescription drug plans of ,,pdp sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph1 including education-- 7i7 provided by medicare administrative contractors through the improper payment outreach and education program described in section #ahgd;,a7h72 and 7ii7 through current education efforts 7such as ,state health insurance assistance programs described in subsection 7a77#a77;,a7 of section #aai of the ,medicare ,improvements for ,patients and ,providers ,act of #bjjh 7#db ,u4,s4,c4 #acie;b-#c note77 and materials directed toward such enrollees4 7,j7 ,application under ,,ma-,,pd plans ,pursuant to section #ahfj;,d-#ba7;c77#a71 the provisions of this paragraph apply under part ,d to ,,ma organizations offering ,,ma-,,pd plans to ,,ma eligible individuals in the same manner as such provisions apply under this part to a ,,pdp sponsor offering a prescription drug plan to a part ,d eligible individual4 4 7#b7 ,information for consumers ,section #ahfj;,d-#d7;a77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#a77;,b77 is amended by adding at the end the following3 7v7 ,the drug management program for at-risk beneficiaries under subsection 7c77#e74 4 7b7 ,utilization management programs ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 as amended by subsection 7a77#a71 is further amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,a utilization management tool to prevent drug abuse 7as described in paragraph 7#f77;,a774 2 and 7#b7 by adding at the end the following new paragraph3 7#f7 ,utilization management tool to prevent drug abuse 7,a7 ,in general ,a tool described in this paragraph is any of the following3 7i7 ,a utilization tool designed to prevent the abuse of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies4 7ii7 ,retrospective utilization review to identify-- 7,i7 individuals that receive frequently abused drugs at a frequency or in amounts that are not clinically appropriate2 and 7,,ii7 providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries4 7iii7 ,consultation with the ,contractor described in subparagraph 7,b7 to verify if an individual enrolling in a prescription drug plan offered by a ,,pdp sponsor has been previously identified by another ,,pdp sponsor as an individual described in clause 7ii77,i74 7,b7 ,reporting ,a ,,pdp sponsor offering a prescription drug plan 7and an ,,ma organization offering an ,,ma-,,pd plan7 in a ,state shall submit to the ,secretary and the ,medicare drug integrity contractor with which the ,secretary has entered into a contract under section #ahic with respect to such ,state a report1 on a monthly basis1 containing information on-- 7i7 any provider of services or supplier described in subparagraph 7,a77ii77,,ii7 that is identified by such plan sponsor 7or organization7 during the #cj-;day period before such report is submitted2 and 7ii7 the name and prescription records of individuals described in paragraph 7#e77;,c74 4 7c7 ,expanding ,activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,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 ,expanding ,activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,access to information ,under contracts entered into under this section with ,medicare drug integrity contractors1 the ,secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies1 prescription drug plans1 ,,ma-,,pd plans1 and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse1 as defined in section #ahfj;,d-#d7;c77#e77;,c74 7#b7 ,requirement for acknowledgment of referrals ,if a ,,pdp sponsor or ,,ma organization refers information to a contractor described in paragraph 7#a7 in order for such contractor to assist in the determination described in such paragraph1 the contractor shall-- 7,a7 acknowledge to the sponsor or organization receipt of the referral2 and 7,b7 in the case that any ,,pdp sponsor or ,,ma organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described such paragraph1 shall inform such sponsor or organization of such determination on a date that is not later than #ae days after the date on which the sponsor or organization contacts the contractor4 7#c7 ,making data available to other entities 7,a7 ,in general ,for purposes of carrying out this subsection1 subject to subparagraph 7,b71 the ,secretary shall authorize ,m,e,d,i,cs to respond to requests for information from ,,pdp sponsors and ,,ma organizations1 ,state prescription drug monitoring programs1 and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud1 waste1 and abuse4 7,b7 ,,hipaa compliant information only ,information may only be disclosed by a ,,medic under subparagraph 7,a7 if the disclosure of such information is permitted under the ,federal regulations 7concerning the privacy of individually identifiable health information7 promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 4 7#b7 ,,oig study and report on effectiveness of ,m,e,d,i,cs 7,a7 ,study ,the ,inspector ,general of the ,department of ,health and ,human ,services shall conduct a study on the effectiveness of ,medicare drug integrity contractors in identifying combating1 and preventing fraud under the ,medicare program1 including under the authority provided under section #ahic7;j7 of the ,social ,security ,act1 as added by paragraph 7#a74 7,b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,inspector ,general shall submit to ,congress a report on the study conducted under subparagraph 7,a74 ,such report shall include such recommendations for improvements in the effectiveness of such contractors as the ,inspector ,general determines appropriate4 7d7 ,treatment of certain complaints for purposes of quality or performance assessment ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is amended by adding at the end the following new subsection3 7d7 ,treatment of certain complaints for purposes of quality or performance assessment ,in conducting a quality or performance assessment of a ,,pdp sponsor1 the ,secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such ,,pdp sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries4 4 7e7 ,sense of congress regarding use of technology tools ,to combat fraud ,it is the sense of ,congress that ,,ma organizations and ,,pdp sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under ,,ma-,,pd plans and prescription drug plans under parts ,c and ,d of the ,medicare program4 7f7 ,effective date 7#a7 ,in general ,the amendments made by this section shall apply to prescription drug plans 7and ,,ma-,,pd plans7 for plan years beginning more than #a year after the date of the enactment of this ,act4 7#b7 ,stakeholder meetings prior to effective date 7,a7 ,in general ,not later than ,january #a1 #bjaf1 the ,secretary of ,health and ,human ,services shall convene stakeholders1 including individuals entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled under part ,b of such title of such ,act1 advocacy groups representing such individuals1 clinicians1 plan sponsors1 entities delegated by plan sponsors1 and biopharmaceutical manufacturers for input regarding the topics described in subparagraph 7,b74 7,b7 ,topics described ,the topics described in this subparagraph are the topics of-- 7i7 the impact on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans of ,,pdp sponsors1 and enrollees in ,,ma-,,pd plans1 who are at-risk beneficiaries for prescription drug abuse 7as defined in subparagraph 7,c7 of paragraph 7#e7 of section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c7772 7ii7 the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug abuse under such paragraph 7similar to the processes established under the ,medicare ,advantage program under part ,c of title ,,xviii of the ,social ,security ,act that allow an automatic escalation to external review of claims submitted under such part72 7iii7 the types of enrollees that should be treated as exempted individuals1 as described in subparagraph 7,c77ii7 of such paragraph2 7iv7 the manner in which terms and definitions in such paragraph should be applied1 such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in subparagraph 7,c7 of such paragraph2 7v7 the information to be included in the notices described in subparagraph 7,b7 of such paragraph and the standardization of such notices2 and 7vi7 with respect to a ,,pdp sponsor 7or ,medicare ,advantage organization7 that establishes a drug management program for at-risk beneficiaries under such paragraph1 the responsibilities of such ,,pdp sponsor 7or organization7 with respect to the implementation of such program4 7g7 ,rulemaking ,the ,secretary of ,health and ,human ,services shall promulgate regulations based on the input gathered pursuant to subsection 7f77#b77;,a74